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Bacteria and clinicians have how to get ventolin in the us one thing in common. Resistance. As widespread antibiotic use has increased, antimicrobial resistance has risen.1 Despite this, many clinicians remain resistant to changing their antibiotic-prescribing habits.1 Antimicrobial stewardship—which focuses on interventions to help optimise antibiotic selection, dose and duration—has gained substantial public health interest while continuing to face frequent frontline clinician opposition.2 3 In this issue of BMJ Quality and Safety, Saini and colleagues’ findings support a seemingly simple antimicrobial stewardship tool. Documentation of antibiotic indications so that explicit reasons for the prescription are recorded.4 In a scoping review of 123 publications, Saini and colleagues found beneficial effects of antibiotic indication documentation on the quality of patient care, including preventing errors, improving antibiotic prescribing and supporting communication at care transitions.4 Yet, critical barriers—often in the form of clinician resistance—diminish the ability of many antibiotic stewards to implement the documentation of antibiotic indication. Critical questions remain unanswered related to best practices for implementation of antibiotic indications to maximise the benefits and minimise these challenges.

Here, we seek to address these questions and offer key insights for implementation.The competing purposes of antibiotic documentationTo understand how best to implement antibiotic indication documentation and engage stakeholders, it is important to understand the myriad and often competing purposes of documentation. Generally, documentation—both related and unrelated to antibiotics—serves many purposes. These vary from the immediately patient relevant (eg, improving interclinician or patient/clinician communication, enabling prospective audit and feedback by pharmacists) to those with delayed clinical relevance (eg, enhancing retrospective research), and those largely for administrative purposes (eg, billing, resource distribution). In some countries, such as the USA where 35 of the studies included in the scoping review occurred, documentation also serves for legal protection (ie, defensive medicine).5 For antimicrobial stewardship in particular, there is another useful purpose of documentation to consider. Improved mindfulness.

Specifically, the act of documentation itself may trigger a mindful moment that forces clinicians to pause and move from system 1 (fast) to system 2 (slow) thinking.6 Slower, deliberative thinking has been shown to serve as an antibiotic self-timeout which reminds clinicians to reconsider antibiotic necessity and appropriateness.7 Similarly, accountable justification, which requires clinicians to explicitly justify an antibiotic treatment plan, has been shown to reduce inappropriate antibiotic prescribing.8Because documentation purposes and thus priorities vary, changes in antibiotic indication documentation can be difficult to implement. For example, Saini and colleagues found that notable barriers to documenting antibiotic indications included competing priorities and time burden.9–11 In our practice, we find that documentation that is not directly and immediately clinically useful is often perceived by clinicians as an irrelevant administrative burden. Likewise, documentation interventions that hinder billing or quality compliance (eg, public reporting) may encounter leadership resistance. Thus, to engage clinicians and improve rates of antibiotic indication documentation, antimicrobial stewardship programmes must reframe the need for documentation in terms of clinical relevance, while not running counter to administrative needs.9One way to improve clinician buy-in is by focusing on the salient, patient-relevant reasons for improving antibiotic documentation. Take, as one example, care transitions.

Nowhere is the need for documentation more acute than during transitions of care, where adverse events are common, often harmful, and where accurate documentation can serve as a critical tool for improving communication.12 Because other forms of communication (eg, notes, verbal) are less common and reliable during care transitions (eg, to retail pharmacies), accurate documentation of antibiotic indications can prevent medication errors.13 When antibiotic prescriptions sent to pharmacies do not include the indication within the patient instructions, the pharmacist is left inferring the indication, reducing their ability to confirm prescription accuracy and prevent errors.13 Antibiotic stewards who wish to improve antibiotic indication documentation at discharge for one purpose (ie, optimising discharge antibiotic prescribing) could therefore have more successful clinical buy-in if they instead framed documentation in terms of improving communication and reducing harmful errors (eg, ‘bug-drug’ mismatch).What do we mean by good documentation?. As we pause to consider best practices for implementation, it is important to first define what we mean by antibiotic indication documentation. Critically, this includes where documentation should occur. As clinicians ourselves, we recognise that clinicians often document antibiotic indications not once—but many times—including in clinician notes, interclinician handoff tools, inpatient antibiotic orders, outpatient antibiotic prescriptions and patient instructions. This complexity is not accounted for in most studies of antibiotic indications.

In Saini and colleagues’ paper only 19 of the studies refer to documentation of the antibiotic indication as part of the prescription itself. For better or worse, many documentation interventions are operationalised in orders, including adjustments to the electronic health record (EHR) through order sets, drop-down menus and prompted indications.4 This type of EHR-driven documentation can serve as a nudge to improve prescribing, but come with unintended costs.14Notably, all documentation interventions require additional clinician work. While demonstrably important, EHR-focused documentation interventions fail to account for documentation that may—or may not—already be occurring elsewhere. For example, the rise of EHR note templates can both hinder and benefit documentation. While note templates may remind clinicians to include antibiotic indications, they can lead to ‘note bloat’ and additions that are clinically irrelevant.

The disjointed approach to documentation can lead to alert fatigue and annoy end-users who fail to see the value in including an indication in the order when it is already documented elsewhere.10 Similarly, too many documentation requirements can lead clinicians to over-ride or bypass mandatory fields.10 11 Finding the ‘sweet spot’ of antibiotic documentation to improve compliance and help stewardship without impeding clinician workflow is critical.Best practices for implementation of antibiotic indicationsWe have summarised some high-level best practices for increasing antibiotic indication documentation in table 1. Critically, improving antibiotic indications requires an easy, user-centred, well-designed process. When not designed and implemented with end-user engagement, clinicians may manipulate or game clinical decision support tools to bypass restrictions and take short cuts. For example, in a study by Baysari and colleagues, the investigators created a drop-down system for restricted antibiotics that was meant to improve antibiotic-prescribing habits.10 The drop-down included only appropriate indications and clinicians were required to obtain stewardship approval if the planned use was for an indication other than in the drop-down. Rather than waste time by calling for approval, clinicians instead bypassed the approval process and gamed the system by selecting ‘appropriate’ indications, even when that indication was untrue.10 Because of this gaming, the intervention had no effect on antibiotic prescribing or documentation habits.10 When interviewed about these workarounds, clinicians reported they wanted to save time and minimise disruptions to their workflow.10View this table:Table 1 Documentation best practices, barriers and additional questionsIn their scoping review, Saini and colleagues mapped barriers and facilitators using the Capability, Opportunity, Motivation (COM-B) model for behaviour change.

They acknowledge opportunity in the form of incentives, rewards and EHR improvements may overcome barriers to documentation such as lack of time and logistical challenges.4 Long term, we need better systems to allow open interactions between all members of the patient’s care team and improve interclinician communication around antibiotic indications. For example, in Taiwan, cloud-based technology allows clinicians, nurses and pharmacists to access patients’ prescription history and has resulted in enhanced medication safety.15 A similar system exists in the USA for opioids and controlled substances. However, this is a state-dependent rather than a nationwide database. As technology improves, having interoperable systems to allow communication of medication information—including antibiotic indication, dose and duration—may become more feasible.Additionally, Saini and colleagues noted strategies to reduce alert fatigue and increase ease of documentation could help with clinicians’ capability and motivation to provide an indication on the antibiotic prescription.4 For example, automating or prepopulating indications based on documentation elsewhere (eg, in notes) could reduce the burden on clinicians and prevent gaming. Or the reverse—prepopulating notes based on antibiotic orders or prescriptions may better fit into workflow where orders are often written before notes.

This latter solution would also provide an opportunity to incorporate ‘nudges’ to prod clinicians towards better prescribing.In summary, we operate in an imperfect system where antibiotic indication documentation serves many purposes and occurs in many forms which can impede implementation. Myriad strategies to improve documentation have been attempted with mixed results. Until we have a system that can facilitate communication across all pertinent individuals, we must work to optimise what we have. This includes leveraging technology and behaviour change strategies to help documentation serve multiple purposes simultaneously. Doing all that, without increasing burden on clinicians, is the key to any successful antimicrobial stewardship—or documentation—intervention.Ethics statementsPatient consent for publicationNot applicable..

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Interested individuals and organizations should submit comments electronically to connectedhealth@ostp.eop.gov and include “Connected Health RFI” in the subject line of the email. While email is ventolin the same as flovent is preferred, brief voicemail messages may be left at 202-456-3030. Due to time constraints, mailed paper submissions will not be accepted, and electronic submissions received after the deadline cannot be ensured to be incorporated or taken into consideration. Instructions Response to this RFI is voluntary. Each responding is ventolin the same as flovent entity (individual or organization) is requested to submit only one response.

OSTP welcomes responses to inform and guide policies and actions related to strengthening community health through digital health technologies. Please feel free to respond to one or as many prompts as you choose. Please be concise with your submissions, which must not exceed 3 pages in 12-point or larger is ventolin the same as flovent font, with a page number provided on each page. Responses should include the name of the person(s) or organization(s) filing the comment. OSTP invites input from all stakeholders including members of the public, representing all backgrounds and perspectives.

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If a comment is is ventolin the same as flovent submitted on behalf of an organization, the individual respondent's role in the organization may also be provided on a voluntary basis. Comments containing references, studies, research, and other empirical data that are not widely published should include copies or electronic links of the referenced materials. No business proprietary information, copyrighted information, or personally identifiable information should be submitted in response to this RFI. Please be aware that comments submitted in response to this RFI may be posted on OSTP's is ventolin the same as flovent website or otherwise released publicly. In accordance with Federal Acquisition Regulation (FAR) 15.202(3), responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract.

Additionally, those submitting responses are solely responsible for all expenses associated with response preparation. Start Further Info For additional information, please direct is ventolin the same as flovent questions to Jacqueline Ward at connectedhealth@ostp.eop.gov or leave by voicemail at 202-456-3030. End Further Info End Preamble Start Supplemental Information Background. Despite decades of investment in the digital health ecosystem, the asthma treatment ventolin illuminated continuing, substantial limitations in the U.S. Healthcare systems, including is ventolin the same as flovent profound disparities in healthcare and associated poorer health outcomes within certain communities.

Yet the ventolin has also provided an opportunity for innovation in healthcare delivery across the U.S. And internationally, particularly in community-based settings. As part of OSTP's mission to maximize the benefits of science and technology to advance health and our charge is ventolin the same as flovent to drive innovation in healthcare and improve health for all Americans, we are seeking Start Printed Page 493 information and comments about how digital health technologies are used, or could be used in the future, to improve community health, individual wellness, and health equity. Community health, defined as the collective influence of socioeconomic factors, physical environment, health behaviors, and availability of quality clinical care services, serves as one of the most important drivers of health and wellness for all Americans. This request is part of an initiative dedicated to Community Connected Health—an effort that will explore and act upon how innovation in science and technology can lower the barriers to access quality healthcare and lead healthier lives by meeting people where they are in their communities.

Scope and terminology. OSTP invites input from all interested parties as outlined in the is ventolin the same as flovent instructions. The term `digital health technologies' should be interpreted broadly as any tool or set of tools that improve health or enable better healthcare delivery by connecting people with other people, with data, or with health information. Examples of this include but are not limited to. Telehealth, remote patient monitoring devices, health trackers, mobile devices ( e.g., smart phones, tablets), mobile health apps, and technologies for managing health information including electronic is ventolin the same as flovent health records.

Information Requested. Respondents may provide information for one or as many topics below as they choose. 1 is ventolin the same as flovent. Successful models within the U.S.. Descriptions of innovative examples or models of how community health providers within the United States successfully use digital health technology to deliver healthcare, enable healthier lifestyles, or reduce health disparities.

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It would be very helpful for respondents to indicate how these barriers may align to the following broad categories. Technical (including broadband access), training, costs, reimbursement/policies, buy-in across organization or community, user education/comfort, or other. In the case of barriers that include user comfort/willingness to use the technology, it would be useful for respondents to detail any concerns users might have such as privacy, security, discrimination, the effectiveness of the technology, or other such concerns. 3. Trends from the ventolin.

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Descriptions about what is needed to train and/or certify community health organizations and workers on the use of digital health technologies for their work are also welcome. 6. Proposed government actions. Opportunities for the Federal Government to support the transformation of community health settings through the uptake of innovative digital health technologies and telemedicine at the community level. Please specify whether these opportunities could take place in the immediate future ( i.e., 0-2 years), in the next 5 years, in the next 10 years or beyond.

7. Health Equity. Information about how digital health technologies have been used, or could be used, in community-based settings to drive towards a reduction in health disparities or achieving health equity. This could include any concerns about the health equity impacts of digital health technologies 8. International models.

Examples from outside of the United States, particularly from low or middle-income countries, that exemplify innovation at the intersection of healthcare delivery and technology. This can include. The key features of the organizations and/or the digital health technologies that have been most successful, what is needed to support the scale up beyond individual organizations, examples of best practices, examples of important user protections to institute ( e.g., privacy best practices), examples of positive user experiences, metrics of how community health providers measure outcomes or success, and creative ideas or models that may be in nascent stages. We encourage responses that extrapolate to how these international models could be applied within the United States healthcare system.

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Interested persons and organizations are invited to submit how to get ventolin in the us comments on or before 5:00 p.m. ET on February 28, 2022. Interested individuals and organizations should submit comments electronically to connectedhealth@ostp.eop.gov and include “Connected Health RFI” in the subject line of the email.

While email how to get ventolin in the us is preferred, brief voicemail messages may be left at 202-456-3030. Due to time constraints, mailed paper submissions will not be accepted, and electronic submissions received after the deadline cannot be ensured to be incorporated or taken into consideration. Instructions Response to this RFI is voluntary.

Each responding entity (individual or how to get ventolin in the us organization) is requested to submit only one response. OSTP welcomes responses to inform and guide policies and actions related to strengthening community health through digital health technologies. Please feel free to respond to one or as many prompts as you choose.

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Please be aware that comments how to get ventolin in the us submitted in response to this RFI may be posted on OSTP's website or otherwise released publicly. In accordance with Federal Acquisition Regulation (FAR) 15.202(3), responses to this notice are not offers and cannot be accepted by the Federal Government to form a binding contract. Additionally, those submitting responses are solely responsible for all expenses associated with response preparation.

Start Further Info For additional information, please direct questions to Jacqueline Ward at connectedhealth@ostp.eop.gov or leave how to get ventolin in the us by voicemail at 202-456-3030. End Further Info End Preamble Start Supplemental Information Background. Despite decades of investment in the digital health ecosystem, the asthma treatment ventolin illuminated continuing, substantial limitations in the U.S.

Healthcare systems, including profound disparities in how to get ventolin in the us healthcare and associated poorer health outcomes within certain communities. Yet the ventolin has also provided an opportunity for innovation in healthcare delivery across the U.S. And internationally, particularly in community-based settings.

As part of OSTP's mission to maximize the benefits of science and technology to advance health and our charge to drive innovation in healthcare and improve health for all Americans, we are seeking Start Printed Page 493 information and comments about how digital health technologies are used, or could be used in how to get ventolin in the us the future, to improve community health, individual wellness, and health equity. Community health, defined as the collective influence of socioeconomic factors, physical environment, health behaviors, and availability of quality clinical care services, serves as one of the most important drivers of health and wellness for all Americans. This request is part of an initiative dedicated to Community Connected Health—an effort that will explore and act upon how innovation in science and technology can lower the barriers to access quality healthcare and lead healthier lives by meeting people where they are in their communities.

Scope and terminology. OSTP invites input from all interested parties as outlined in how to get ventolin in the us the instructions. The term `digital health technologies' should be interpreted broadly as any tool or set of tools that improve health or enable better healthcare delivery by connecting people with other people, with data, or with health information.

Examples of this include but are not limited to. Telehealth, remote patient monitoring devices, health trackers, mobile devices ( e.g., smart phones, tablets), mobile health apps, and technologies for managing health information how to get ventolin in the us including electronic health records. Information Requested.

Respondents may provide information for one or as many topics below as they choose. 1 how to get ventolin in the us. Successful models within the U.S..

Descriptions of innovative examples or models of how community health providers within the United States successfully use digital health technology to deliver healthcare, enable healthier lifestyles, or reduce health disparities. This can include how to get ventolin in the us. The key features of the organizations and/or the digital health technologies that have been most successful, what is needed to support the scale up beyond individual organizations, examples of best practices, examples of important user protections to institute ( e.g., privacy best practices), examples of positive user experiences, metrics or measurement strategies of how community health providers measure outcomes or success, and creative ideas or models that may be in nascent stages.

2. Barriers. Specific descriptions of the current barriers faced by individuals or organizations to the use of digital health technologies in community-based settings.

It would be very helpful for respondents to indicate how these barriers may align to the following broad categories. Technical (including broadband access), training, costs, reimbursement/policies, buy-in across organization or community, user education/comfort, or other. In the case of barriers that include user comfort/willingness to use the technology, it would be useful for respondents to detail any concerns users might have such as privacy, security, discrimination, the effectiveness of the technology, or other such concerns.

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This includes impressions of what is likely to continue, or not, after the end of the public health emergency or asthma treatment ventolin. 4. User experience.

Descriptions of how technology developers, community-based healthcare providers, or other community-based stakeholders consider and/or assess the patient and client experience in the use of health technologies. This includes direct experiences from individuals and patients who have used digital health technologies. We welcome descriptions of how digital health technologies could be better designed with the user experience ( e.g., community health workers, healthcare providers, or patients) in mind, as well as aspects of the user experience that could be changed to help remove barriers due to willingness to use ( e.g., privacy protections).

5. Tool and training needs. Information about the current technological tools, equipment, and infrastructure needs of community health workers and other community-based health providers.

Descriptions about what is needed to train and/or certify community health organizations and workers on the use of digital health technologies for their work are also welcome. 6. Proposed government actions.

Opportunities for the Federal Government to support the transformation of community health settings through the uptake of innovative digital health technologies and telemedicine at the community level. Please specify whether these opportunities could take place in the immediate future ( i.e., 0-2 years), in the next 5 years, in the next 10 years or beyond. 7.

Health Equity. Information about how digital health technologies have been used, or could be used, in community-based settings to drive towards a reduction in health disparities or achieving health equity. This could include any concerns about the health equity impacts of digital health technologies 8.

International models. Examples from outside of the United States, particularly from low or middle-income countries, that exemplify innovation at the intersection of healthcare delivery and technology. This can include.

The key features of the organizations and/or the digital health technologies that have been most successful, what is needed to support the scale up beyond individual organizations, examples of best practices, examples of important user protections to institute ( e.g., privacy best practices), examples of positive user experiences, metrics of how community health providers measure outcomes or success, and creative ideas or models that may be in nascent stages. We encourage responses that extrapolate to how these international models could be applied within the United States healthcare system.

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They need to know if you have any of the following conditions:

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• pregnant or trying to get pregnant
• breast-feeding

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KHN Midwest correspondent Lauren Weber discussed how the asthma treatment ventolin Where can i buy viagra over the counter usa has affected home health care and those expired ventolin with disabilities on WBEZ’s “Reset With Sasha-Ann Simons” on March 21. KHN Montana correspondent Katheryn Houghton discussed the high levels of lead in drinking water across Montana schools on WBUR’s “Here and Now” on March 18. Dr expired ventolin. Céline Gounder, KHN senior fellow and editor-at-large for public health, discussed the difficulty of fighting asthma treatment amid political divisions in the U.S.

On WBUR’s expired ventolin “On Point’s asthma Hours” on March 17. Related Topics Contact Us Submit a Story TipNASHVILLE, Tenn. €” RaDonda Vaught, a former nurse criminally prosecuted for a fatal drug error in 2017, was convicted of gross neglect of an impaired adult and negligent homicide Friday after a three-day trial that gripped nurses across the country. Vaught faces three to six years in prison for neglect and one to expired ventolin two years for negligent homicide as a defendant with no prior convictions, according to sentencing guidelines provided by the Nashville district attorney’s office.

Vaught is scheduled to be sentenced May 13, and her sentences are likely to run concurrently, said DA spokesperson Steve Hayslip. Vaught was expired ventolin acquitted of reckless homicide. Criminally negligent homicide was a lesser charge included under reckless homicide. Vaught’s trial has been closely watched by nurses and medical professionals across the country, many of whom worry it could set a precedent of criminalizing medical mistakes.

Medical errors are generally handled by professional licensing boards or civil courts, expired ventolin and criminal prosecutions like Vaught’s case are exceedingly rare. Janie Harvey Garner, the founder of Show Me Your Stethoscope, a Facebook nursing group with more than 600,000 members, worried the conviction would have a chilling effect on nurses disclosing their own errors or near-errors, which would have a detrimental effect on the quality of patient care. €œHealth care just expired ventolin changed forever,” she said after the verdict. €œYou can no longer trust people to tell the truth because they will be incriminating themselves.” EMAIL SIGN-Up Subscribe to California Healthline's free Daily Edition. In the wake of the verdict, the American Nurses Association issued a statement expressing similar concerns about Vaught’s conviction, saying it sets a “dangerous precedent” of “criminalizing the honest reporting of mistakes.” Some medical errors are “inevitable,” the statement said, and there are more “effective and just mechanisms” to address them than criminal prosecution.

€œThe nursing profession is already extremely short-staffed, strained and facing immense pressure — an unfortunate multi-year trend that was further exacerbated by the effects of the ventolin,” the statement said. €œThis ruling will have a long-lasting negative impact on the profession.” Vaught, 38, of Bethpage, Tennessee, was arrested in 2019 and charged with reckless homicide and gross neglect of an impaired adult in connection with the killing of Charlene Murphey, who died at Vanderbilt University Medical expired ventolin Center in late December 2017. The neglect charge stemmed from allegations that Vaught did not properly monitor Murphey after she was injected with the wrong drug. Murphey, 75, expired ventolin of Gallatin, Tennessee, was admitted to Vanderbilt for a brain injury.

At the time of the error, her condition was improving, and she was being prepared for discharge from the hospital, according to courtroom testimony and a federal investigation report. Murphey was prescribed a sedative, Versed, to calm her before being scanned in a large, MRI-like machine. Vaught was tasked to retrieve Versed from a computerized medication cabinet but instead grabbed a powerful paralyzer, expired ventolin vecuronium. According to an investigation report filed in her court case, the nurse overlooked several warning signs as she withdrew the wrong drug — including that Versed is a liquid but vecuronium is a powder — and then injected Murphey and left her to be scanned.

By the time the error was discovered, Murphey was brain-dead. During the trial, prosecutors painted Vaught as an irresponsible and uncaring nurse who ignored her training and abandoned her patient. Assistant District Attorney Chad Jackson likened Vaught to a drunken driver who killed a bystander, but said the nurse was “worse” because it was as if she was “driving with [her] eyes closed.” “The immutable fact of this case is that Charlene Murphey is dead because RaDonda Vaught could not bother to pay attention to what she was doing,” Jackson said. Vaught’s attorney, Peter Strianse, argued that his client made an honest mistake that did not constitute a crime and became a “scapegoat” for systemic problems related to medication cabinets at Vanderbilt University Medical Center in 2017.

[embedded content] But Vanderbilt officials countered on the stand. Terry Bosen, Vanderbilt’s pharmacy medication safety officer, testified that the hospital had some technical problems with medication cabinets in 2017 but that they were resolved weeks before Vaught pulled the wrong drug for Murphey. In his closing statement, Strianse targeted the reckless homicide charge, arguing that his client could not have “recklessly” disregarded warning signs if she earnestly believed she had the right drug and saying that there was “considerable debate” over whether vecuronium actually killed Murphey. During the trial, Dr.

Eli Zimmerman, a Vanderbilt neurologist, testified it was “in the realm of possibility” Murphey’s death was caused entirely by her brain injury. Additionally, Davidson County Chief Medical Examiner Feng Li testified that although he determined Murphey died from vecuronium, he couldn’t verify how much of the drug she actually received. Li said a small dose may not have been lethal. €œI don’t mean to be facetious,” Strianse said of the medical examiner’s testimony, “but it sort of sounded like some amateur ‘CSI’ episode — only without the science.” Vaught did not testify.

On the second day of the trial, prosecutors played an audio recording of Vaught’s interview with law enforcement officials in which she admitted to the drug error and said she “probably just killed a patient.” During a separate proceeding before the Tennessee Board of Nursing last year, Vaught testified that she allowed herself to become “complacent” and “distracted” while using the medication cabinet and did not double-check which drug she had withdrawn despite multiple opportunities. €œI know the reason this patient is no longer here is because of me,” Vaught told the nursing board, starting to cry. €œThere won’t ever be a day that goes by that I don’t think about what I did.” This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation).

KFF is an endowed nonprofit organization providing information on health issues to the nation. Related Topics Contact Us Submit a Story Tip.

KHN Midwest correspondent Lauren Weber discussed how to get ventolin in the us how the asthma treatment ventolin has affected home health care and those with disabilities on WBEZ’s “Reset With Sasha-Ann Simons” on March 21. KHN Montana correspondent Katheryn Houghton discussed the high levels of lead in drinking water across Montana schools on WBUR’s “Here and Now” on March 18. Dr how to get ventolin in the us. Céline Gounder, KHN senior fellow and editor-at-large for public health, discussed the difficulty of fighting asthma treatment amid political divisions in the U.S.

On WBUR’s “On Point’s asthma Hours” on March how to get ventolin in the us 17. Related Topics Contact Us Submit a Story TipNASHVILLE, Tenn. €” RaDonda Vaught, a former nurse criminally prosecuted for a fatal drug error in 2017, was convicted of gross neglect of an impaired adult and negligent homicide Friday after a three-day trial that gripped nurses across the country. Vaught faces three to six years in prison for neglect and one to how to get ventolin in the us two years for negligent homicide as a defendant with no prior convictions, according to sentencing guidelines provided by the Nashville district attorney’s office.

Vaught is scheduled to be sentenced May 13, and her sentences are likely to run concurrently, said DA spokesperson Steve Hayslip. Vaught was acquitted of reckless homicide how to get ventolin in the us. Criminally negligent homicide was a lesser charge included under reckless homicide. Vaught’s trial has been closely watched by nurses and medical professionals across the country, many of whom worry it could set a precedent of criminalizing medical mistakes.

Medical errors are generally handled by professional licensing boards or civil courts, and criminal prosecutions like Vaught’s case are how to get ventolin in the us exceedingly rare. Janie Harvey Garner, the founder of Show Me Your Stethoscope, a Facebook nursing group with more than 600,000 members, worried the conviction would have a chilling effect on nurses disclosing their own errors or near-errors, which would have a detrimental effect on the quality of patient care. €œHealth care just changed forever,” how to get ventolin in the us she said after the verdict. €œYou can no longer trust people to tell the truth because they will be incriminating themselves.” EMAIL SIGN-Up Subscribe to California Healthline's free Daily Edition. In the wake of the verdict, the American Nurses Association issued a statement expressing similar concerns about Vaught’s conviction, saying it sets a “dangerous precedent” of “criminalizing the honest reporting of mistakes.” Some medical errors are “inevitable,” the statement said, and there are more “effective and just mechanisms” to address them than criminal prosecution.

€œThe nursing profession is already extremely short-staffed, strained and facing immense pressure — an unfortunate multi-year trend that was further exacerbated by the effects of the ventolin,” the statement said. €œThis ruling will have a long-lasting negative impact on the profession.” Vaught, 38, of Bethpage, Tennessee, was arrested in 2019 and how to get ventolin in the us charged with reckless homicide and gross neglect of an impaired adult in connection with the killing of Charlene Murphey, who died at Vanderbilt University Medical Center in late December 2017. The neglect charge stemmed from allegations that Vaught did not properly monitor Murphey after she was injected with the wrong drug. Murphey, 75, of Gallatin, Tennessee, was admitted how to get ventolin in the us to Vanderbilt for a brain injury.

At the time of the error, her condition was improving, and she was being prepared for discharge from the hospital, according to courtroom testimony and a federal investigation report. Murphey was prescribed a sedative, Versed, to calm her before being scanned in a large, MRI-like machine. Vaught was tasked to retrieve Versed from a computerized medication how to get ventolin in the us cabinet but instead grabbed a powerful paralyzer, vecuronium. According to an investigation report filed in her court case, the nurse overlooked several warning signs as she withdrew the wrong drug — including that Versed is a liquid but vecuronium is a powder — and then injected Murphey and left her to be scanned.

By the time the how to get ventolin in the us error was discovered, Murphey was brain-dead. During the trial, prosecutors painted Vaught as an irresponsible and uncaring nurse who ignored her training and abandoned her patient. Assistant District Attorney Chad Jackson likened Vaught to a drunken driver who killed a bystander, but said the nurse was “worse” because it was as if she was “driving with [her] eyes closed.” “The immutable fact of this case is that Charlene Murphey is dead because RaDonda Vaught could not bother to pay attention to what she was doing,” Jackson said. Vaught’s attorney, Peter Strianse, argued that his client made an honest mistake that did not constitute a crime and became a “scapegoat” for systemic problems related to medication cabinets at Vanderbilt how to get ventolin in the us University Medical Center in 2017.

[embedded content] But Vanderbilt officials countered on the stand. Terry Bosen, Vanderbilt’s pharmacy medication safety officer, testified that the hospital had some technical problems with medication cabinets in 2017 but that they were resolved weeks before Vaught pulled the wrong drug for Murphey how to get ventolin in the us. In his closing statement, Strianse targeted the reckless homicide charge, arguing that his client could not have “recklessly” disregarded warning signs if she earnestly believed she had the right drug and saying that there was “considerable debate” over whether vecuronium actually killed Murphey. During the trial, Dr.

Eli Zimmerman, a how to get ventolin in the us Vanderbilt neurologist, testified it was “in the realm of possibility” Murphey’s death was caused entirely by her brain injury. Additionally, Davidson County Chief Medical Examiner Feng Li testified that although he determined Murphey died from vecuronium, he couldn’t verify how much of the drug she actually received. Li said a small dose how to get ventolin in the us may not have been lethal. €œI don’t mean to be facetious,” Strianse said of the medical examiner’s testimony, “but it sort of sounded like some amateur ‘CSI’ episode — only without the science.” Vaught did not testify.

On the second day of the trial, prosecutors played an audio recording of Vaught’s interview with law enforcement officials in which she admitted to the drug error and said she “probably just killed a patient.” During a separate proceeding before the Tennessee Board of Nursing last year, Vaught testified that she allowed herself to become “complacent” and “distracted” while using the medication cabinet and did not double-check which drug she had withdrawn despite multiple opportunities. €œI know the reason this patient is how to get ventolin in the us no longer here is because of me,” Vaught told the nursing board, starting to cry. €œThere won’t ever be a day that goes by that I don’t think about what I did.” This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis how to get ventolin in the us and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation).

KFF is an endowed nonprofit organization providing information on health issues to the nation. Related Topics Contact Us Submit a Story Tip.

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Start Preamble Federal buy ventolin tablets online Emergency Management Agency, Department http://michaelowengolf.com/%e7%90%83%e5%9c%ba%e9%a3%8e%e5%85%89/ of Homeland Security. Notice. The Federal Emergency Management Agency (FEMA) is publishing the text of one additional Plan of Action under the Voluntary Agreement for the Manufacture and Distribution of buy ventolin tablets online Critical Healthcare Resources Necessary to Respond to a ventolin. Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment. Start Further Info Robert Glenn, Office of Business, Start Printed Page 6881 Industry, Infrastructure Integration, OB3I@fema.dhs.gov, or (202) 212-1666.

End Further Info End Preamble Start Supplemental Information Background and Legal Authority The Defense Production Act buy ventolin tablets online (DPA), 50 U.S.C. 4501 et seq., authorizes the making of “voluntary agreements and plans of action” with, among others, representatives of industry and business to help provide for the national defense.[] The President's authority to facilitate voluntary agreements was delegated to the Secretary of Homeland Security with respect to responding to the spread of asthma treatment within the United States in Executive Order 13911.[] The Secretary of Homeland Security has further delegated this authority to the FEMA Administrator.[] On August 17, 2020, after the appropriate consultations with the Attorney General and the Chairman of the Federal Trade Commission, FEMA completed and published in the Federal Register a “Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a ventolin” (Voluntary Agreement).[] Unless terminated prior to that date, the Voluntary Agreement is effective until August 17, 2025, and may be extended subject to additional approval by the Attorney General after consultation with the Chairman of the Federal Trade Commission. The Voluntary Agreement may be used to prepare for or respond to any ventolin, including asthma treatment, during that time. Previously, FEMA has announced the activation of five Plans of Action under the Voluntary Agreement buy ventolin tablets online. (1) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Personal Protective Equipment (PPE) to Respond to asthma treatment.

(2) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Diagnostic Test Kits and other Testing Components to Respond to asthma treatment. (3) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of buy ventolin tablets online Drug Products, Drug Substances, and Associated Medical Devices to Respond to asthma treatment. (4) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices to Respond to asthma treatment. (5) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to asthma treatment. FEMA has now buy ventolin tablets online activated a sixth Plan of Action under the Voluntary Agreement.

(6) Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment. This Plan is necessitated by continued transportation-related concerns and shortfalls that interfere with the movement of critical resources for our nation's asthma treatment response. Appropriate members of the private sector have been invited to join the Plan of buy ventolin tablets online Action as Sub-Committee Participants. Provided that a Sub-Committee Participant acts in accordance with the terms of the Plan, the DPA affords the Participant an affirmative defense to certain civil and criminal actions brought under the antitrust laws (or any similar law of any state) for appropriate actions taken to carry out the Plan. The Plan is designed to foster a close working relationship among FEMA, Department of Health and Human Services, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA.

The Attorney General, in consultation with the Chairman of the Federal Trade Commission, has made the buy ventolin tablets online required finding for the Plan of Action that the purposes of section 708(c)(1) of the DPA cannot reasonably be achieved without the Plan of Action, or by a Plan of Action having less anticompetitive effects than the proposed Plan of Action. Pursuant to section 708(f)(1)(B) of the DPA, the Department of Justice separately published the finding for this Plan of Action in the Federal Register .[] The FEMA Administrator has certified in writing that the Plan of Action is necessary to help provide for the national defense. Text of the Plan of Action To Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains To Respond to asthma treatment Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a ventolin Plan of Action To Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains To Respond to asthma treatment Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a ventolin Preface Pursuant to section 708 of the Defense Production Act of 1950 (DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management Agency (FEMA) Administrator (Administrator), after consultation with the Secretary of the Department of Health and Human Services (HHS), the Attorney General of the United States (Attorney General), and the Chair of the Federal Trade Commission (FTC), developed a Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a ventolin (Voluntary Agreement), 85 buy ventolin tablets online FR 50035 (August 17, 2020). The Voluntary Agreement, which operates through a series of Plans of Action, maximizes the manufacture and efficient distribution of Critical Healthcare Resources nationwide to respond to a ventolin by establishing unity of effort between Participants and the Federal Government for integrated coordination, planning, information sharing with FEMA, as authorized by FEMA, and distribution of Critical Healthcare Resources.

This document establishes a Plan of Action (Plan) to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment. This Plan will be implemented under the Voluntary Agreement buy ventolin tablets online by one or more Sub-Committees, beginning with a Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains and may also include. (1) Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains, (2) Sub-Committee for Aviation, (3) Sub-Committee for Surface Transportation (including Highway, Motor Carriers, and Freight Rail), and (4) Sub-Committee for Maritime Transportation. Start Printed Page 6882 FEMA may combine these Sub-Committees or establish additional Sub-Committees under this Plan, so long as. (1) The Sub-Committee addresses one specific and well-defined buy ventolin tablets online component of the National Multimodal Healthcare Supply Chains System.

And (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains. The purpose of the Plan and Sub-Committees is to evaluate and optimize coordination of National Multimodal Healthcare Supply Chains System resources related to the asthma treatment response. The primary goal of the Plan is to create a mechanism to immediately address exigent needs within the National Multimodal Healthcare Supply Chains System and to ensure actions to address such needs do buy ventolin tablets online not come with unacceptable risks or interfere with other efforts to meet critical End-User requirements. When the requirements of the Plan are met, it affords Sub-Committee Participants defenses to civil and criminal actions brought under the antitrust laws (or any similar law of any state) for actions taken within the scope of the Plan. The Plan is designed to foster a close working relationship among FEMA, HHS, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA.

Table of buy ventolin tablets online Contents I. Purpose II. Authorities III. General Provisions A buy ventolin tablets online. Definitions B.

Plan of Action Participation C. Effective Date and Duration of Participation buy ventolin tablets online D. Withdrawal E. Plan of Action Activation and Deactivation F. Rules and buy ventolin tablets online Regulations G.

Modification and Amendment H. Expenses I. Record Keeping IV buy ventolin tablets online. Antitrust Defense V. Terms and Conditions A.

Plan of Action Execution buy ventolin tablets online B. Information Management and Responsibilities C. Oversight VI. Establishment of buy ventolin tablets online the Sub-Committees VII. Application and Agreement VIII.

Assignment I. Purpose A ventolin may present conditions that pose a direct threat to the national defense of the United States or its preparedness programs such that, pursuant to DPA section 708(c)(1), it becomes necessary to establish an agreement and plan to collaboratively evaluate and coordinate resources within the National Multimodal Healthcare Supply Chains buy ventolin tablets online System. This Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment is established under the Voluntary Agreement and initially establishes up to four Sub-Committees responsible for the Plan's oversight and implementation. The Plan and Sub-Committees will optimize the coordination of National Multimodal Healthcare Supply Chains and create a prioritization protocol based upon End-Users' demonstrated or projected requirements. II.

Authorities Section 708, Defense Production Act (50 U.S.C. 4558). Sections 402(2) &. 501(b), Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C.

5121-5207). Sections 503(b)(2)(B) &. 504(a)(10) &. (16) of the Homeland Security Act of 2002 (6 U.S.C. 313(b)(2)(B), 314(a)(10) &.

(16)). Sections 201, 301, National Emergencies Act (50 U.S.C. 1601 et seq. ). Section 319, Public Health Service Act (42 U.S.C.

247d). Executive Order (E.O.) 13911, 85 FR 18403 (March 27, 2020). Pursuant to DPA section 708(f)(1)(A), the Administrator certifies that this Plan is necessary for the national defense. III. General Provisions A.

Definitions Administrator The FEMA Administrator is the Sponsor of the Voluntary Agreement. Pursuant to a delegation or redelegation of the functions given to the President by DPA section 708, the Administrator proposes and provides for the development and carrying out of the Voluntary Agreement, including through the development and implementation of Plans of Action. The Administrator is responsible for carrying out all duties and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and for appointing one or more Chairpersons to manage and administer the Committee and all Sub-Committees formed to carry out the Voluntary Agreement. Agreement The Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a ventolin (Voluntary Agreement).

Allotment The process of analyzing and determining the relative distribution among one or more competing requests from End-Users utilizing the same National Multimodal Healthcare Supply Chains. Through the allotment process, FEMA—with participation from Sub-Committee Participants—will assess the actual needs of End-Users and determine how to divide the available and projected capabilities of National Multimodal Healthcare Supply Chains to minimize impacts to life, safety, and economic disruption associated with shortages. Allotment will take place only under Exigent Circumstances. With the exception of all forms of civil transportation resources under the jurisdiction of the Department of Transportation, which are excluded from this Plan, FEMA retains decision-making authority for allotment under this Plan. Attendees Subject matter experts, invited by the Chairperson or a Sub-Committee Chairperson to attend meetings authorized under the Voluntary Agreement or this Plan, to provide technical advice or to represent other government agencies or interested parties.

Invitations to attendees will be extended as required for Committee or Sub-Committee meetings and deliberations. Chairperson FEMA senior executive(s), appointed by the Administrator, to chair the Committee for the Distribution of Healthcare Resources Necessary to Respond to a ventolin (Committee). The Chairperson shall be responsible for the overall management and administration of the Committee, the Voluntary Agreement, and Plans of Action developed under the Voluntary Agreement while remaining under the supervision of the Administrator. Shall initiate, or approve in advance, each meeting held to discuss problems, determine policies, recommend actions, and make decisions necessary to carry out the Voluntary Agreement. Appoint one or more co-Chairpersons to chair the Committee, and otherwise shall carry out all duties and responsibilities assigned to him.

With the approval of the Administrator, the Chairperson may create one or more Sub-Committees, and Start Printed Page 6883 may appoint one or more Sub-Committee Chairpersons to chair the Sub-Committees, as appropriate. Committee Committee for the Distribution of Healthcare Resources Necessary to Respond to a ventolin established under the Voluntary Agreement. Competitively Sensitive Information Competitively Sensitive Information that is shared pursuant to this Plan may include any Document or other tangible thing or oral transmission that contains financial, business, commercial, scientific, technical, economic, or engineering information or data, including, but not limited to financial statements and data, customer and supplier lists, price and other terms of sale to customers, sales records, projections and forecasts, inventory levels, capacity and capacity utilization, cost information, sourcing and procurement information, manufacturing and production information, delivery and shipping information, systems and data designs, and methods, techniques, processes, procedures, programs, codes, or similar information, whether tangible or intangible, and regardless of the method of storage, compilation, or recordation, if the owner thereof has taken reasonable measures to protect the information from disclosure to the public or competitors. These measures may be evidenced by marking or labeling the items as “competitively sensitive information” during submission to FEMA or in the Participant's customary and existing treatment of such information (regardless of labeling). All Competitively Sensitive Information provided by a Sub-Committee Participant as described herein is deemed Competitively Sensitive Information, except for Information that.

A. Is published or has been made publicly available at the time of disclosure by the Sub-Committee Participant. B. Was in the possession of, or was lawfully and readily available to, FEMA from another source at the time of disclosure without breaching any obligation of confidentiality applicable to the other source. Or c.

Was independently developed or acquired without reference to or reliance upon the Sub-Committee Participant's Competitively Sensitive Information. Where information deemed Competitively Sensitive Information is required to be disclosed by law, regulation, or court order, the “Competitively Sensitive” (or substantially similar) label will continue to attach to all information and portion(s) of documents that are not made public through the required disclosure. Document Any information, on paper or in electronic/audio/visual format, including written, recorded, and graphic materials of every kind, in the possession, custody, or control of the Participant and used or shared in the course of participation in the Voluntary Agreement or a subsequent Plan of Action. End-User This includes all direct and ancillary medical support including, but not limited to, hospitals, independent healthcare providers, nursing homes, medical laboratories, dental care providers, independent physician offices, first responders, alternate care facilities, distributors, wholesalers, and the general public that reasonably represents the totality of the nation's response to asthma treatment. Exigent Circumstances As determined by the Chairperson, the actual or forecasted shortage of resources and their impact on the National Multimodal Healthcare Supply Chains which likely cannot be fulfilled via usual market mechanisms for an acute, critical time period, and where immediate and substantial harm is projected to occur from lack of intervention.

National Multimodal Healthcare Supply Chains System Any or all of the necessary resources and processes contributing to the supply, production, and distribution of critical healthcare resources necessary to respond to asthma treatment. This Plan focuses on resources, entities, and processes within the Transportation Systems Sector, identified under Presidential Policy Directive (PPD)-21, Critical Infrastructure Security and Resilience, that support National Multimodal Healthcare Supply Chains. ventolin A ventolin is defined as an epidemic that has spread to human populations across a large geographic area that is subject to one or more declarations under the National Emergencies Act, the Public Health Service Act, or the Robert T. Stafford Disaster Relief and Emergency Assistance Act, or if the Administrator determines that one or more declarations is likely to occur and the epidemic poses a direct threat to the national defense or its preparedness programs. For example, asthma Disease 2019 (asthma treatment) meets the definition of a ventolin.

Participant An individual, partnership, corporation, association, or private organization, other than a federal agency, that has substantive capabilities, resources or expertise to carry out the purpose of the Voluntary Agreement, that has been specifically invited to participate in the Voluntary Agreement by the Chairperson, and that has applied and agreed to the terms of the Voluntary Agreement. €œParticipant” includes a corporate or non-corporate entity entering into the Voluntary Agreement and all subsidiaries and affiliates of that entity in which that entity has 50 percent or more control either by stock ownership, board majority, or otherwise. The Administrator may invite Participants to join the Voluntary Agreement at any time during its effective period. Plan of Action (Plan) This document. A documented method, pursuant to 50 U.S.C.

4558(b)(2), proposed by FEMA to implement a particular set of activities under the Voluntary Agreement, through a Sub-Committee focused on a particular Critical Healthcare Resource, or ventolin response workstream or functional area necessary for the national defense. Plan of Action Agreement A separate commitment made by Participants upon invitation and agreement to participate in a Plan of Action as part of one or more Sub-Committees. Completing the Plan of Action Agreement confers responsibilities on the Participant consistent with those articulated in the Plan of Action and affords Participants a defense against antitrust claims under section 708 for actions taken to develop or carry out the Plan and the appropriate Sub-Committee(s), as described in Section IV below. Representatives The representatives the Administrator identifies and invites to the Committee from FEMA, HHS, and other federal Start Printed Page 6884 agencies with equities in this Plan, and empowered to speak on behalf of their agencies' interests. The Attorney General and the Chair of the FTC, or their delegates, may also attend any meeting as a Representative.

Sub-Committee A body formed by the Administrator from select Participants to implement a Plan of Action. Sub-Committee Chairperson FEMA executive, appointed by the Chairperson, to chair a Sub-Committee to implement a Plan of Action. The Sub-Committee Chairperson shall be responsible for the overall management and administration of the Sub-Committee in furtherance of this Plan while remaining under the supervision of the Administrator and the Chairperson. Sub-Committee Members Collectively the Sub-Committee Chairperson(s), Representatives, and Sub-Committee Participants. Jointly responsible for developing and executing this Plan.

Sub-Committee Participant A subset of Participants of the Committee, that have been specifically invited to participate in a Sub-Committee by the Sub-Committee Chairperson, and that have applied and agreed to the terms of this Plan and signed the Plan of Action Agreement. The Sub-Committee Chairperson may invite Participants in the Committee to join a Sub-Committee as a Sub-Committee Participant at any time during the Plan's effective period. B. Plan of Action Participation This Plan will be carried out by a subset of the Participants in the Voluntary Agreement through several Sub-Committees, which may include. (1) Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains, (2) Sub-Committee for Aviation, (3) Sub-Committee for Surface Transportation (including Highway, Motor Carriers, and Freight Rail), and (4) Sub-Committee for Maritime Transportation.

FEMA may combine these Sub-Committees or establish additional Sub-Committees under this Plan, so long as. (1) The Sub-Committee addresses one specific and well-defined component of the National Multimodal Healthcare Supply Chains System. And (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains. Each Sub-Committee will consist of the (1) Sub-Committee Chairperson(s), (2) Representatives from FEMA, HHS, the Department of Justice (DOJ), and other federal agencies with equities in this Plan, and (3) Sub-Committee Participants that have substantive capabilities, resources or expertise to carry out the purpose of this Plan and have signed the Plan of Action Agreement. The Chairperson shall invite Sub-Committee Participants who, in his or her determination, are reasonably representative of the appropriate industry or segment of such industry.

Other Attendees—invited by the Sub-Committee Chairperson as subject matter experts to provide technical advice or to represent the interests of other government agencies or interested parties—may also participate in Sub-Committee meetings. The naming of these Sub-Committees does not commit the Administrator to creating them unless and until circumstances dictate. C. Effective Date and Duration of Participation This Plan is effective immediately upon satisfaction of the requirements of DPA section 708(f)(1). This Plan shall remain in effect until terminated in accordance with 44 CFR 332.4.

It shall be effective for no more than five (5) years from August 17, 2020, when the requirements of DPA section 708(f)(1) were satisfied for the Voluntary Agreement, unless otherwise terminated pursuant to DPA section 708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 708(f)(2). No action may take place under this Plan until it is activated, as described in Section III(E), below. D. Withdrawal Participation in the Plan is voluntary, as is the acceptance of most obligations under the Plan. Sub-Committee Participants may withdraw from this Plan or from an individual Sub-Committee at any point, subject to the fulfillment of obligations previously agreed upon by the Participant prior to the date of withdrawal.

Note that the obligations outlined in V.B regarding information management and associated responsibilities apply once a party has shared or received information through a Sub-Committee and remain in place after the party's withdrawal from the Sub-Committee or Plan. If a Sub-Committee Participant indicates an intent to withdraw from the Plan due to a modification or amendment of the Plan (described below), the Sub-Committee Participant will not be required to perform actions directed by that modification or amendment. Withdrawal from the Plan will automatically trigger withdrawal from all Sub-Committees. However, a Participant may withdraw from a Sub-Committee without also withdrawing from the Plan or other Sub-Committees. To withdraw from the Plan or from an individual Sub-Committee, a Participant must provide written notice to the Administrator at least fifteen (15) calendar days prior to the effective date of that Sub-Committee Participant's withdrawal specifying the scope of withdrawal.

Following receipt of such notice, the Administrator will inform the other Sub-Committee Participants of the date and the scope of the withdrawal. Upon the effective date of the withdrawal from the Plan, the Sub-Committee Participant must cease all activities under the Plan. Upon the effective date of the withdrawal from one or more Sub-Committee(s), the Sub-Committee Participant must cease all activities under the Plan that pertain to the withdrawn Sub-Committee(s). E Website. Plan of Action Activation and Deactivation The Administrator, in consultation with the Chairperson and Sub-Committee Chairperson, will invite a select group of Participants in the Voluntary Agreement to form at least one of the following Sub-Committees, beginning with the Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains, which will be responsible for implementing this Plan.

(1) Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains, (2) Sub-Committee for Aviation, (3) Sub-Committee for Surface Transportation (including Highway, Motor Carriers, and Freight Rail), and (4) Sub-Committee for Maritime Transportation. FEMA may combine these Sub-Committees or establish additional Sub-Committees under this Plan, so long as. (1) The Sub-Committee addresses one specific and well-defined component of the National Multimodal Healthcare Supply Chains System. And (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains. This Plan will be activated for each invited Participant when the Participant executes a Plan of Action Agreement, and a Participant may not participate in a Sub-Committee until the Plan of Start Printed Page 6885 Action Agreement is executed.

Participants will be invited to join this Plan at the discretion of the Chairperson or the Sponsor to the Voluntary Agreement. Participants will be further invited to attend specific meetings of one or more Sub-Committees at the discretion of the Chairperson. F. Rules and Regulations Sub-Committee Participants acknowledge and agree to comply with all provisions of DPA section 708, as amended, and regulations related thereto which are promulgated by FEMA, the Department of Homeland Security, HHS, the Attorney General, and the FTC. FEMA has promulgated standards and procedures pertaining to voluntary agreements in 44 CFR part 332.

The Administrator shall inform Participants of new rules and regulations as they are issued. G. Modification and Amendment The Administrator, after consultation with the Attorney General and the Chair of the FTC, may terminate or modify, in writing, this Plan at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may terminate or modify, in writing, this Plan at any time. Sub-Committee Participants may propose modifications or amendments to the Plan or to the Sub-Committees at any time.

Where possible, material modifications to the Plan or a Sub-Committee will be subject to a 30-calendar day delayed implementation and opportunity for notice and comment by Sub-Committee Participants to the Chairperson. This delayed implementation period may be shortened or eliminated if the Administrator deems it necessary. The Administrator shall inform Sub-Committee Participants of modifications or amendments to the Plan or to the Sub-Committees as they are proposed and issued. The Administrator, after consultation with the Attorney General and the Chair of the FTC, may remove Sub-Committee Participants from the Plan or from a Sub-Committee at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may remove Sub-Committee Participants from this Plan or from a Sub-Committee at any time.

If a Participant is removed from the Plan or from a Sub-Committee, the Participant may request written notice of the reasons for removal from the Chairperson, who shall provide such notice in a reasonable time period. H. Expenses Participation in this Plan or in a Sub-Committee does not confer funds to Sub-Committee Participants, nor does it limit or prohibit any pre-existing source of funds. Unless otherwise specified, all expenses, administrative or otherwise, incurred by Sub-Committee Participants associated with participation in this Plan or a Sub-Committee shall be borne exclusively by the Sub-Committee Participants. I.

Record Keeping Each Sub-Committee Chairperson shall have primary responsibility for maintaining records in accordance with 44 CFR part 332 and shall be the official custodian of records related to carrying out this Plan. Each Sub-Committee Participant shall maintain for five years all minutes of meetings, transcripts, records, documents, and other data, including any communications with other Sub-Committee Participants or with any other member of the Sub-Committee, including drafts, related to the carrying out of this Plan or incorporating data or information received in the course of carrying out this Plan. Each Sub-Committee Participant agrees to produce to the Administrator, the Attorney General, and the Chair of the FTC upon request any item that this section requires the Participant to maintain. Any record maintained in accordance with 44 CFR part 332 shall be available for public inspection and copying, unless exempted on the grounds specified in 5 U.S.C. 552(b)(1), (3) or (4) or identified as privileged and confidential information in accordance with DPA section 705(d), and 44 CFR 332.5.

IV. Antitrust Defense Under the provisions of DPA subsection 708(j), each Sub-Committee Participant in this Plan shall have available as a defense to any civil or criminal action brought for violation of the antitrust laws (or any similar law of any State) with respect to any action to develop or carry out this Plan, that such action was taken by the Sub-Committee Participant in the course of developing or carrying out this Plan, that the Sub-Committee Participant complied with the provisions of DPA section 708 and the rules promulgated thereunder, and that the Sub-Committee Participant acted in accordance with the terms of the Voluntary Agreement and this Plan. Except in the case of actions taken to develop this Plan, this defense shall be available only to the extent the Sub-Committee Participant asserting the defense demonstrates that the action was specified in, or was within the scope of, this Plan and within the scope of the appropriate Sub-Committee(s), including being taken at the direction and under the active supervision of FEMA. This defense shall not apply to any actions taken after the termination of this Plan. Immediately upon modification of this Plan, no defense to antitrust claims under Section 708 shall be available to any subsequent action that is beyond the scope of the modified Plan.

The Sub-Committee Participant asserting the defense bears the burden of proof to establish the elements of the defense. The defense shall not be available if the person against whom the defense is asserted shows that the action was taken for the purpose of violating the antitrust laws. V. Terms and Conditions As the sponsoring agency, FEMA will maintain oversight over Sub-Committee activities and direct and supervise actions taken to carry out this Plan, including by retaining decision-making authority over actions taken pursuant to the Plan to ensure such actions are necessary to address a direct threat to the national defense. The Attorney General and the Chair of the FTC will monitor activities of the Sub-Committees to ensure they execute their responsibilities in a manner consistent with this Plan and their actions have the least anticompetitive effects possible.

A. Plan of Action Execution This Plan will be used to support ventolin response by maximizing the coordination for selected National Multimodal Healthcare Supply Chains and creating a prioritization protocol for End-Users. Each Sub-Committee will support the following objectives to mitigate the loss of life and public health threats associated with asthma treatment. 1. Objectives (1) Identify capabilities to effectively support National Multimodal Healthcare Supply Chains.

(2) Ensure effective coordination of National Multimodal Healthcare Supply Chains System resources that may be required for the Response to asthma treatment. (3) Ensure ongoing competition continues within the National Multimodal Healthcare Supply Chains System to the greatest extent possible under the DPA. 2. Actions Sub-Committee Participants may be asked to support these objectives by taking the following specific actions. Start Printed Page 6886 (1) Assist the Chairperson in identifying priorities and challenges within the National Multimodal Healthcare Supply Chains System that should be addressed within the Plan's Sub-Committees because of their importance to the national response to asthma treatment.

Using the best evidence available, Participants should consider whether current and projected National Multimodal Healthcare Supply Chains System resources are sufficient to meet essential needs of End-Users and geographic areas, and if there are any critical shortfalls of such resources that may be of concern for the response to asthma treatment. (2) Create a collaborative process for evaluating and addressing competing National Multimodal Healthcare Supply Chains System claims, as directed and decided by the Chairperson. (3) Develop a mechanism to inform prioritization of the distribution of healthcare products through National Multimodal Healthcare Supply Chains, as directed and decided by the Chairperson. (4) Prepare a general strategy to accomplish the activities listed in V(A)(2) and V(A)(5) regarding activities in Exigent Circumstances consistent with the decisions made by the Chairperson. (5) In Exigent Circumstances, with review and concurrence in all possible instances by DOJ in consultation with FTC.

Facilitate maximum use of the National Multimodal Healthcare Supply Chains System to meet requirements of the nation or particular geographic areas by deconflicting overlapping demands from the collective Participants' End-Users, as directed and decided by the Chairperson. Facilitate maximum availability of resources provided within the National Multimodal Healthcare Supply Chains System to meet requirements of the nation or particular geographic areas, as directed and decided by the Chairperson. Facilitate the efficient distribution of resources through the National Multimodal Healthcare Supply Chains System by deconflicting overlapping distribution chain activities of Sub-Committee Members, as directed and decided by the Chairperson. Establish a process and means of collaboration to address exigent End-User requirements in a manner aligned with the objectives of this Plan, as directed and decided by the Chairperson. (6) Provide data and information necessary to validate the efforts of the Sub-Committee including the actual and planned asthma treatment response activities that may foreseeably impact National Multimodal Healthcare Supply Chains throughout the nation, as determined by the Chairperson.

(7) Provide feedback to the Chairperson and Sub-Committee Members on outcomes, accomplishments, and impediments of collective efforts to accomplish objectives and actions outlined in this Plan. (8) Advise the Chairperson whether additional Participants or Attendees should be invited to join this Plan and its Sub-Committees. (9) Carry out other activities that the Sub-Committees under this Plan determine to be necessary for the coordination of National Multimodal Healthcare Supply Chains System resources to address the asthma treatment ventolin's direct threat to the national defense, as determined and directed by the Chairperson, where such activities have been reviewed and approved by DOJ and FTC and received concurrence from Sub-Committee members. B. Information Management and Responsibilities FEMA will request only the data and information from Sub-Committee Participants that is necessary to meet the objectives of the Plan and consistent with the scope of the relevant Sub-Committees.

Upon signing a Plan of Action Agreement for this Plan, FEMA requests that Participants endeavor to cooperate with diligence and speed, and to the extent permissible under this Plan, and to share with FEMA any data and information necessary to meet the objectives of this Plan. Sub-Committee Participants agree to share with FEMA the following data with diligence and speed to the extent permissible under this Plan, and to abide by the following guidelines where feasible and consistent with the data that is owned by each Sub-Committee Participant. (1) In general, Participants will not be asked to share Competitively Sensitive Information directly with other Participants. (2) FEMA will only request direct sharing of Competitively Sensitive Information among Participants during Exigent Circumstances where there is a mission critical need or timeline such that sharing only through FEMA is impractical or threatens the outcome of the Plan or Sub-Committee action. Such requests, if made, will be only among Participants whose participation is necessary to meet the objectives of the Plan, will be limited in scope to the greatest extent possible, and will be shared only pursuant to safeguards subject to prior review and audit by DOJ and FTC.

Direct sharing of Competitively Sensitive Information with other Participants will be limited in scope and circumstances to the greatest extent possible. Participants may not share Competitively Sensitive Information directly with other Participants unless specifically requested by FEMA, in consultation with DOJ and FTC. All Competitively Sensitive Information delivered to FEMA or to another Sub-Committee Participant shall be delivered by secure means, for example, password-protected or encrypted electronic files or drives with the password/key delivered by separate communication or method or via upload to an appropriately secure web portal as directed by FEMA. All data delivered to the web portal designated by FEMA is deemed to be Competitively Sensitive Information. (3) To allow FEMA to identify and appropriately protect documents containing Competitively Sensitive Information by the Sub-Committee Participant providing the documents, the Sub-Committee Participant will make good faith efforts to designate any Competitively Sensitive Information by placing restrictive markings on documents and things considered to be competitively sensitive, the restrictive markings being sufficiently clear in wording and visibility to indicate the restricted nature of the data.

The Sub-Committee Participant will identify Competitively Sensitive Information that is disclosed verbally by oral warning. Information designated as competitively sensitive will, to the extent allowed by law, be presumed to constitute trade secrets, or commercial or financial information, and be provided by the Sub-Committee Participant to FEMA with the expectation that it will be kept confidential by both parties, as such terms are understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of Information Act and federal judicial interpretations of this statute. FEMA agrees that to the extent any information designated as competitively sensitive by a Sub-Committee Participant is responsive to a request for disclosure under the Freedom of Information Act, FEMA will consult with the Sub-Committee Participant and afford the Participant ten (10) working days to object to any disclosure by FEMA. (4) FEMA will make good faith efforts to appropriately recognize unmarked Documents containing Competitively Sensitive Information as Competitively Sensitive Information.

However, FEMA cannot guarantee that all unmarked Start Printed Page 6887 Documents will be recognized as being Competitively Sensitive Information and protected from disclosure to third parties. If the unmarked Documents have not been disclosed without restriction outside of FEMA, the Sub-Committee Participant may retroactively request to have appropriate designations placed on the Documents. If the unmarked Documents have been disclosed without restriction outside of FEMA, FEMA will, to the extent practicable, remove any requested information from public forums controlled by FEMA and will work promptly to request that a receiving party return or destroy disclosed unmarked Documents if requested by the Sub-Committee Participant. (5) Competitively Sensitive Information may be used by FEMA, alone or in combination with additional information, including Documents and Competitively Sensitive Information received from third parties, to support FEMA's implementation of this Plan as determined by the Chairperson. In all situations, FEMA will aggregate and anonymize Competitively Sensitive Information to the greatest extent possible to protect the interests retained by the owners of the data while still allowing the objectives of the Plan and Sub-Committee to be achieved.

To the greatest extent possible, such aggregation will render the competitively sensitive nature of the Competitively Sensitive Information of the Sub-Committee Participant no longer recognizable in a commercially sensitive manner, and without sufficient information to enable, by inference or otherwise, attribution to Sub-Committee Participant or its affiliates (as clearly identified and disclosed to FEMA). Any disclosure of Competitively Sensitive Information by FEMA, within or outside a Sub-Committee, will be subject to review and approval by DOJ and FTC. (6) Except as otherwise expressly permitted by applicable federal law, FEMA shall not disclose any Competitively Sensitive Information or use any Competitively Sensitive Information for any purpose other than in connection with the purposes of this Plan, and FEMA will not sell any Competitively Sensitive Information of any Sub-Committee Participant. (7) Except as described below, FEMA may disclose Competitively Sensitive Information only to its employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors). Any individual with access to Competitively Sensitive Information will be expected to comply with the terms of this Plan.

a. Information Sharing within the Sub-Committee. FEMA may share Competitively Sensitive Information with Sub-Committee Participants and Federal Representatives of the Plan, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) where there is a need to know and where disclosure is reasonably necessary in furtherance of implementing the Plan. FEMA will aggregate and anonymize data prior to sharing with the Sub-Committee Participants to the greatest extent possible while still allowing the objectives of the Plan to be achieved, and will not share data—particularly to competitors of the submitter—prior to consultation with and approval by the DOJ and FTC. i.

Sub-Committee Participants, when providing Competitively Sensitive Information to FEMA, may request that this Information not be shared with other Sub-Committee Participants. Where these requests are made in good faith and are reasonable in nature, FEMA will respect these requests to the greatest extent possible and will consult the owner of the data prior to any release made to Sub-Committee Participants. b. Restricted Reports. FEMA may communicate Competitively Sensitive Information to appropriate government officials through Restricted Reports.

The information contained in Restricted Reports shall be aggregated and anonymized to the greatest extent possible, while recognizing that these officials may need a certain amount of granularity and specificity of information to appropriately respond to asthma treatment. FEMA will aim to aggregate data to the County level, and will not share Restricted Reports prior to consultation and approval from the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White House and Administration officials and State Governors, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) who have a need to know and to whom such disclosure is reasonably necessary solely in furtherance of the implementation of this Plan. FEMA shall take appropriate action (by instructions, agreement, or otherwise) to ensure that receiving parties comply with all data-sharing confidentiality and obligations under this Plan as if such persons or entities had been parties to this Plan. c.

Public Reports. FEMA may share information with the public through Public Reports. Data contained in Public Reports shall be fully aggregated and anonymized. Public Reports shall be aggregated to at least a state level and may be publicly disclosed after consultation and approval from the DOJ and FTC. (8) Where possible and not obviated by Exigent Circumstances, FEMA will notify Sub-Committee Participants prior to the release of any Competitively Sensitive Information that has not been fully aggregated and anonymized.

In consultation with DOJ and FTC, FEMA will consider any good-faith requests made by Sub-Committee members to hold the release of data or requests for further aggregation or anonymization. In general, FEMA will not provide notification prior to the release of Public Reports, under the presumption that the data in these reports has already been fully anonymized and de-identified. (9) Any party receiving Competitively Sensitive Information through this Plan shall use such information solely for the purposes outlined in the Plan and take steps, such as imposing previously approved firewalls or tracking usage, to prevent misuse of the information. Disclosure and use of Competitively Sensitive Information will be limited to the greatest extent possible, and any party receiving Competitively Sensitive Information shall follow the procedures outlined in paragraph 7 above. (10) At the conclusion of a Participant's involvement in a Plan—due to the deactivation of the Plan or due to the Participant's withdrawal or removal—each Participant will be requested to sequester any and all Competitively Sensitive Information received through participation in the Plan.

This sequestration shall include the deletion of all Competitively Sensitive Information unless required to be kept pursuant to the Record Keeping requirements as described supra, Section I, 44 CFR part 332, or any other provision of law. C. Oversight Each Sub-Committee Chairperson is responsible for ensuring that the Attorney General, or suitable delegate(s) from the DOJ, and the FTC Chair, or suitable delegate(s) from the FTC, have awareness of activities under this Plan, including activation, deactivation, and scheduling of meetings. The Attorney General, the FTC Chair, or their delegates may attend Sub-Committee meetings and request to be apprised of any activities taken in accordance with activities under this Plan. DOJ or FTC Representatives may request and review Start Printed Page 6888 any proposed action by the Sub-Committee or Sub-Committee Participants undertaken pursuant to this Plan, including the provision of data.

If any DOJ or FTC Representative believes any actions proposed or taken are not consistent with relevant antitrust protections provided by the DPA, he or she shall provide warning and guidance to the Sub-Committee as soon as the potential issue is identified. If questions arise about the antitrust protections applicable to any particular action, FEMA may request DOJ, in consultation with the FTC, provide an opinion on the legality of the action under relevant DPA antitrust protections. VI. Establishment of the Sub-Committees This Plan establishes Sub-Committees to implement the Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment to provide the Federal Government and the Participants a forum to maximize the coordination of selected National Multimodal Healthcare Supply Chain resources and to create a prioritization protocol based upon existing or projected needs of End-Users and geographic areas within the National Multimodal Healthcare Supply Chains System. The outcome should include a framework to expeditiously meet critical needs within the National Multimodal Healthcare Supply Chains System that may arise in Exigent Circumstances, and to ensure actions to address such needs do not come with unacceptable risks to End-Users or interfere with other efforts to meet critical End-User requirements.

A Sub-Committee Chairperson designated by the Chairperson will convene and preside over each Sub-Committee. Sub-Committees will not be used for contract negotiations or contract discussions between the Participants and the Federal Government. Such negotiations or discussions will be in accordance with applicable federal contracting policies and procedures. However, this shall not limit any discussion within a Sub-Committee about the operational utilization of existing and potential contracts between the Participants and Representatives when seeking to align their use with overall manufacturing and distribution efforts consistent with this Plan. Each Sub-Committee will consist of designated Representatives from FEMA, HHS, other federal agencies with equities in this Plan, and each Sub-Committee Participant.

The Attorney General and Chair of the FTC, or their delegates, may also join each Sub-Committee and attend meetings at their discretion. Attendees may also be invited at the discretion of a Sub-Committee Chairperson as subject matter experts, to provide technical advice, or to represent other government agencies, but will not be considered part of the Sub-Committee. Only to the extent necessary to respond to asthma treatment as explicitly directed by the Sub-Committee Chairperson, and subject to the provisions of Section V(B), Sub-Committee Members may be asked to provide technical advice, share information, help identify and validate places and resources of the greatest need, help project future manufacturing and distribution demands, assist in identifying and resolving the allotment of scarce resources under Exigent Circumstances, and take other actions necessary to maximize the timely coordination of National Multimodal Healthcare Supply Chains System resources for the asthma treatment. A Sub-Committee Chairperson or his or her designee, at the Sub-Committee Chairperson's sole discretion, will make decisions on these issues in order to ensure the maximum efficiency and effectiveness in the use of Sub-Committee Member's resources. All Sub-Committee Participants will be invited to open Sub-Committee meetings.

For selected Sub-Committee meetings, attendance may be limited to designated Sub-Committee Participants to meet specific operational requirements, as determined by FEMA. Each Sub-Committee Chairperson shall notify the Attorney General, the Chair of the FTC, Representatives, and Participants of the time, place, and nature of each meeting and of the proposed agenda of each meeting to be held to carry out this Plan. Additionally, each Sub-Committee Chairperson shall provide for publication in the Federal Register of a notice of the time, place, and nature of each meeting. If a meeting is open, a Federal Register notice will be published reasonably in advance of the meeting. A Sub-Committee Chair may restrict attendance at meetings only on the grounds outlined by 44 CFR 332.5(c)(1)-(3).

If a meeting is closed, a Federal Register notice will be published within ten (10) days of the meeting and will include the reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2). The Sub-Committee Chairperson shall establish the agenda for each meeting, be responsible for adherence to the agenda, and provide for a written summary or other record of each meeting and provide copies of transcripts or other records to FEMA, the Attorney General, the Chair of the FTC, and all Sub-Committee Participants. The Chairperson shall take necessary actions to protect from public disclosure any data discussed with or obtained from Sub-Committee Participants which a Sub-Committee Participant has identified as a trade secret or as privileged and confidential in accordance with DPA sections 708(h)(3) and 705(d), or which qualifies for withholding under 44 CFR 332.5. VII. Application and Agreement The Sub-Committee Participant identified below hereby agrees to join in the Federal Emergency Management Agency sponsored Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment under the Voluntary Agreement for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a ventolin and to become a Participant in one or more Sub-Committees established by this Plan.

This Plan will be published in the Federal Register. This Plan is authorized under section 708 of the Defense Production Act of 1950, as amended. Regulations governing the Voluntary Agreement for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a ventolin and all subsequent Plans of Action at 44 CFR part 332. The applicant, as a Sub-Committee Participant, agrees to comply with the provisions of section 708 of the Defense Production Act of 1950, as amended, the regulations at 44 CFR part 332, and the terms of this Plan. VIII.

Assignment No Sub-Committee Participant may assign or transfer this Plan, in whole or in part, or any protections, rights or obligations hereunder without the prior written consent of the Sub-Committee Chairperson. When requested, the Sub-Committee Chairperson will respond to written requests for consent within 10 (ten) business days of receipt. Start Printed Page 6889 (Company name) (Name of authorized representative) (Signature of authorized representative) (Date) Administrator (Sponsor) (Date) Start Signature Deanne Criswell, Administrator, Federal Emergency Management Agency. End Signature End Supplemental Information [FR Doc. 2022-02549 Filed 2-3-22.

Start Preamble Federal can you buy ventolin over the counter in canada Emergency Management Agency, how to get ventolin in the us Department of Homeland Security. Notice. The Federal Emergency Management Agency (FEMA) is publishing the text of one additional Plan of Action under the how to get ventolin in the us Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a ventolin. Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment. Start Further Info Robert Glenn, Office of Business, Start Printed Page 6881 Industry, Infrastructure Integration, OB3I@fema.dhs.gov, or (202) 212-1666.

End Further Info End Preamble Start Supplemental Information Background and Legal Authority The Defense Production Act (DPA), 50 U.S.C how to get ventolin in the us. 4501 et seq., authorizes the making of “voluntary agreements and plans of action” with, among others, representatives of industry and business to help provide for the national defense.[] The President's authority to facilitate voluntary agreements was delegated to the Secretary of Homeland Security with respect to responding to the spread of asthma treatment within the United States in Executive Order 13911.[] The Secretary of Homeland Security has further delegated this authority to the FEMA Administrator.[] On August 17, 2020, after the appropriate consultations with the Attorney General and the Chairman of the Federal Trade Commission, FEMA completed and published in the Federal Register a “Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a ventolin” (Voluntary Agreement).[] Unless terminated prior to that date, the Voluntary Agreement is effective until August 17, 2025, and may be extended subject to additional approval by the Attorney General after consultation with the Chairman of the Federal Trade Commission. The Voluntary Agreement may be used to prepare for or respond to any ventolin, including asthma treatment, during that time. Previously, FEMA has announced the activation of five Plans of Action how to get ventolin in the us under the Voluntary Agreement. (1) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Personal Protective Equipment (PPE) to Respond to asthma treatment.

(2) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Diagnostic Test Kits and other Testing Components to Respond to asthma treatment. (3) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Drug Products, how to get ventolin in the us Drug Substances, and Associated Medical Devices to Respond to asthma treatment. (4) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices to Respond to asthma treatment. (5) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to asthma treatment. FEMA has now activated a sixth Plan of Action how to get ventolin in the us under the Voluntary Agreement.

(6) Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment. This Plan is necessitated by continued transportation-related concerns and shortfalls that interfere with the movement of critical resources for our nation's asthma treatment response. Appropriate members of the private sector have been invited to join the Plan of Action as Sub-Committee how to get ventolin in the us Participants. Provided that a Sub-Committee Participant acts in accordance with the terms of the Plan, the DPA affords the Participant an affirmative defense to certain civil and criminal actions brought under the antitrust laws (or any similar law of any state) for appropriate actions taken to carry out the Plan. The Plan is designed to foster a close working relationship among FEMA, Department of Health and Human Services, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA.

The Attorney General, in consultation with the Chairman of the Federal Trade how to get ventolin in the us Commission, has made the required finding for the Plan of Action that the purposes of section 708(c)(1) of the DPA cannot reasonably be achieved without the Plan of Action, or by a Plan of Action having less anticompetitive effects than the proposed Plan of Action. Pursuant to section 708(f)(1)(B) of the DPA, the Department of Justice separately published the finding for this Plan of Action in the Federal Register .[] The FEMA Administrator has certified in writing that the Plan of Action is necessary to help provide for the national defense. Text of the Plan of Action To Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains To Respond to asthma treatment Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a ventolin Plan of Action To Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains To Respond to asthma treatment Implemented Under the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a ventolin Preface Pursuant to section 708 of the Defense Production Act of 1950 (DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management Agency (FEMA) Administrator (Administrator), after consultation with the Secretary of the Department of Health and Human Services (HHS), the Attorney General of the United States (Attorney General), and the Chair of the Federal Trade Commission (FTC), how to get ventolin in the us developed a Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a ventolin (Voluntary Agreement), 85 FR 50035 (August 17, 2020). The Voluntary Agreement, which operates through a series of Plans of Action, maximizes the manufacture and efficient distribution of Critical Healthcare Resources nationwide to respond to a ventolin by establishing unity of effort between Participants and the Federal Government for integrated coordination, planning, information sharing with FEMA, as authorized by FEMA, and distribution of Critical Healthcare Resources.

This document establishes a Plan of Action (Plan) to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment. This Plan how to get ventolin in the us will be implemented under the Voluntary Agreement by one or more Sub-Committees, beginning with a Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains and may also include. (1) Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains, (2) Sub-Committee for Aviation, (3) Sub-Committee for Surface Transportation (including Highway, Motor Carriers, and Freight Rail), and (4) Sub-Committee for Maritime Transportation. Start Printed Page 6882 FEMA may combine these Sub-Committees or establish additional Sub-Committees under this Plan, so long as. (1) The Sub-Committee addresses one specific and how to get ventolin in the us well-defined component of the National Multimodal Healthcare Supply Chains System.

And (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains. The purpose of the Plan and Sub-Committees is to evaluate and optimize coordination of National Multimodal Healthcare Supply Chains System resources related to the asthma treatment response. The primary goal of the how to get ventolin in the us Plan is to create a mechanism to immediately address exigent needs within the National Multimodal Healthcare Supply Chains System and to ensure actions to address such needs do not come with unacceptable risks or interfere with other efforts to meet critical End-User requirements. When the requirements of the Plan are met, it affords Sub-Committee Participants defenses to civil and criminal actions brought under the antitrust laws (or any similar law of any state) for actions taken within the scope of the Plan. The Plan is designed to foster a close working relationship among FEMA, HHS, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA.

Table of how to get ventolin in the us Contents I. Purpose II. Authorities III. General Provisions how to get ventolin in the us A. Definitions B.

Plan of Action Participation C. Effective Date and Duration of how to get ventolin in the us Participation D. Withdrawal E. Plan of Action Activation and Deactivation F. Rules and Regulations how to get ventolin in the us G.

Modification and Amendment H. Expenses I. Record Keeping IV how to get ventolin in the us. Antitrust Defense V. Terms and Conditions A.

Plan of Action how to get ventolin in the us Execution B. Information Management and Responsibilities C. Oversight VI. Establishment of the Sub-Committees VII how to get ventolin in the us. Application and Agreement VIII.

Assignment I. Purpose A ventolin may present conditions that pose a direct threat to the national defense of the United States or its preparedness programs such that, pursuant to DPA section 708(c)(1), it becomes necessary to establish an agreement and plan to collaboratively evaluate and coordinate resources within the National how to get ventolin in the us Multimodal Healthcare Supply Chains System. This Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment is established under the Voluntary Agreement and initially establishes up to four Sub-Committees responsible for the Plan's oversight and implementation. The Plan and Sub-Committees will optimize the coordination of National Multimodal Healthcare Supply Chains and create a prioritization protocol based upon End-Users' demonstrated or projected requirements. II.

Authorities Section 708, Defense Production Act (50 U.S.C. 4558). Sections 402(2) &. 501(b), Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C.

5121-5207). Sections 503(b)(2)(B) &. 504(a)(10) &. (16) of the Homeland Security Act of 2002 (6 U.S.C. 313(b)(2)(B), 314(a)(10) &.

(16)). Sections 201, 301, National Emergencies Act (50 U.S.C. 1601 et seq. ). Section 319, Public Health Service Act (42 U.S.C.

247d). Executive Order (E.O.) 13911, 85 FR 18403 (March 27, 2020). Pursuant to DPA section 708(f)(1)(A), the Administrator certifies that this Plan is necessary for the national defense. III. General Provisions A.

Definitions Administrator The FEMA Administrator is the Sponsor of the Voluntary Agreement. Pursuant to a delegation or redelegation of the functions given to the President by DPA section 708, the Administrator proposes and provides for the development and carrying out of the Voluntary Agreement, including through the development and implementation of Plans of Action. The Administrator is responsible for carrying out all duties and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and for appointing one or more Chairpersons to manage and administer the Committee and all Sub-Committees formed to carry out the Voluntary Agreement. Agreement The Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a ventolin (Voluntary Agreement).

Allotment The process of analyzing and determining the relative distribution among one or more competing requests from End-Users utilizing the same National Multimodal Healthcare Supply Chains. Through the allotment process, FEMA—with participation from Sub-Committee Participants—will assess the actual needs of End-Users and determine how to divide the available and projected capabilities of National Multimodal Healthcare Supply Chains to minimize impacts to life, safety, and economic disruption associated with shortages. Allotment will take place only under Exigent Circumstances. With the exception of all forms of civil transportation resources under the jurisdiction of the Department of Transportation, which are excluded from this Plan, FEMA retains decision-making authority for allotment under this Plan. Attendees Subject matter experts, invited by the Chairperson or a Sub-Committee Chairperson to attend meetings authorized under the Voluntary Agreement or this Plan, to provide technical advice or to represent other government agencies or interested parties.

Invitations to attendees will be extended as required for Committee or Sub-Committee meetings and deliberations. Chairperson FEMA senior executive(s), appointed by the Administrator, to chair the Committee for the Distribution of Healthcare Resources Necessary to Respond to a ventolin (Committee). The Chairperson shall be responsible for the overall management and administration of the Committee, the Voluntary Agreement, and Plans of Action developed under the Voluntary Agreement while remaining under the supervision of the Administrator. Shall initiate, or approve in advance, each meeting held to discuss problems, determine policies, recommend actions, and make decisions necessary to carry out the Voluntary Agreement. Appoint one or more co-Chairpersons to chair the Committee, and otherwise shall carry out all duties and responsibilities assigned to him.

With the approval of the Administrator, the Chairperson may create one or more Sub-Committees, and Start Printed Page 6883 may appoint one or more Sub-Committee Chairpersons to chair the Sub-Committees, as appropriate. Committee Committee for the Distribution of Healthcare Resources Necessary to Respond to a ventolin established under the Voluntary Agreement. Competitively Sensitive Information Competitively Sensitive Information that is shared pursuant to this Plan may include any Document or other tangible thing or oral transmission that contains financial, business, commercial, scientific, technical, economic, or engineering information or data, including, but not limited to financial statements and data, customer and supplier lists, price and other terms of sale to customers, sales records, projections and forecasts, inventory levels, capacity and capacity utilization, cost information, sourcing and procurement information, manufacturing and production information, delivery and shipping information, systems and data designs, and methods, techniques, processes, procedures, programs, codes, or similar information, whether tangible or intangible, and regardless of the method of storage, compilation, or recordation, if the owner thereof has taken reasonable measures to protect the information from disclosure to the public or competitors. These measures may be evidenced by marking or labeling the items as “competitively sensitive information” during submission to FEMA or in the Participant's customary and existing treatment of such information (regardless of labeling). All Competitively Sensitive Information provided by a Sub-Committee Participant as described herein is deemed Competitively Sensitive Information, except for Information that.

A. Is published or has been made publicly available at the time of disclosure by the Sub-Committee Participant. B. Was in the possession of, or was lawfully and readily available to, FEMA from another source at the time of disclosure without breaching any obligation of confidentiality applicable to the other source. Or c.

Was independently developed or acquired without reference to or reliance upon the Sub-Committee Participant's Competitively Sensitive Information. Where information deemed Competitively Sensitive Information is required to be disclosed by law, regulation, or court order, the “Competitively Sensitive” (or substantially similar) label will continue to attach to all information and portion(s) of documents that are not made public through the required disclosure. Document Any information, on paper or in electronic/audio/visual format, including written, recorded, and graphic materials of every kind, in the possession, custody, or control of the Participant and used or shared in the course of participation in the Voluntary Agreement or a subsequent Plan of Action. End-User This includes all direct and ancillary medical support including, but not limited to, hospitals, independent healthcare providers, nursing homes, medical laboratories, dental care providers, independent physician offices, first responders, alternate care facilities, distributors, wholesalers, and the general public that reasonably represents the totality of the nation's response to asthma treatment. Exigent Circumstances As determined by the Chairperson, the actual or forecasted shortage of resources and their impact on the National Multimodal Healthcare Supply Chains which likely cannot be fulfilled via usual market mechanisms for an acute, critical time period, and where immediate and substantial harm is projected to occur from lack of intervention.

National Multimodal Healthcare Supply Chains System Any or all of the necessary resources and processes contributing to the supply, production, and distribution of critical healthcare resources necessary to respond to asthma treatment. This Plan focuses on resources, entities, and processes within the Transportation Systems Sector, identified under Presidential Policy Directive (PPD)-21, Critical Infrastructure Security and Resilience, that support National Multimodal Healthcare Supply Chains. ventolin A ventolin is defined as an epidemic that has spread to human populations across a large geographic area that is subject to one or more declarations under the National Emergencies Act, the Public Health Service Act, or the Robert T. Stafford Disaster Relief and Emergency Assistance Act, or if the Administrator determines that one or more declarations is likely to occur and the epidemic poses a direct threat to the national defense or its preparedness programs. For example, asthma Disease 2019 (asthma treatment) meets the definition of a ventolin.

Participant An individual, partnership, corporation, association, or private organization, other than a federal agency, that has substantive capabilities, resources or expertise to carry out the purpose of the Voluntary Agreement, that has been specifically invited to participate in the Voluntary Agreement by the Chairperson, and that has applied and agreed to the terms of the Voluntary Agreement. €œParticipant” includes a corporate or non-corporate entity entering into the Voluntary Agreement and all subsidiaries and affiliates of that entity in which that entity has 50 percent or more control either by stock ownership, board majority, or otherwise. The Administrator may invite Participants to join the Voluntary Agreement at any time during its effective period. Plan of Action (Plan) This document. A documented method, pursuant to 50 U.S.C.

4558(b)(2), proposed by FEMA to implement a particular set of activities under the Voluntary Agreement, through a Sub-Committee focused on a particular Critical Healthcare Resource, or ventolin response workstream or functional area necessary for the national defense. Plan of Action Agreement A separate commitment made by Participants upon invitation and agreement to participate in a Plan of Action as part of one or more Sub-Committees. Completing the Plan of Action Agreement confers responsibilities on the Participant consistent with those articulated in the Plan of Action and affords Participants a defense against antitrust claims under section 708 for actions taken to develop or carry out the Plan and the appropriate Sub-Committee(s), as described in Section IV below. Representatives The representatives the Administrator identifies and invites to the Committee from FEMA, HHS, and other federal Start Printed Page 6884 agencies with equities in this Plan, and empowered to speak on behalf of their agencies' interests. The Attorney General and the Chair of the FTC, or their delegates, may also attend any meeting as a Representative.

Sub-Committee A body formed by the Administrator from select Participants to implement a Plan of Action. Sub-Committee Chairperson FEMA executive, appointed by the Chairperson, to chair a Sub-Committee to implement a Plan of Action. The Sub-Committee Chairperson shall be responsible for the overall management and administration of the Sub-Committee in furtherance of this Plan while remaining under the supervision of the Administrator and the Chairperson. Sub-Committee Members Collectively the Sub-Committee Chairperson(s), Representatives, and Sub-Committee Participants. Jointly responsible for developing and executing this Plan.

Sub-Committee Participant A subset of Participants of the Committee, that have been specifically invited to participate in a Sub-Committee by the Sub-Committee Chairperson, and that have applied and agreed to the terms of this Plan and signed the Plan of Action Agreement. The Sub-Committee Chairperson may invite Participants in the Committee to join a Sub-Committee as a Sub-Committee Participant at any time during the Plan's effective period. B. Plan of Action Participation This Plan will be carried out by a subset of the Participants in the Voluntary Agreement through several Sub-Committees, which may include. (1) Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains, (2) Sub-Committee for Aviation, (3) Sub-Committee for Surface Transportation (including Highway, Motor Carriers, and Freight Rail), and (4) Sub-Committee for Maritime Transportation.

FEMA may combine these Sub-Committees or establish additional Sub-Committees under this Plan, so long as. (1) The Sub-Committee addresses one specific and well-defined component of the National Multimodal Healthcare Supply Chains System. And (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains. Each Sub-Committee will consist of the (1) Sub-Committee Chairperson(s), (2) Representatives from FEMA, HHS, the Department of Justice (DOJ), and other federal agencies with equities in this Plan, and (3) Sub-Committee Participants that have substantive capabilities, resources or expertise to carry out the purpose of this Plan and have signed the Plan of Action Agreement. The Chairperson shall invite Sub-Committee Participants who, in his or her determination, are reasonably representative of the appropriate industry or segment of such industry.

Other Attendees—invited by the Sub-Committee Chairperson as subject matter experts to provide technical advice or to represent the interests of other government agencies or interested parties—may also participate in Sub-Committee meetings. The naming of these Sub-Committees does not commit the Administrator to creating them unless and until circumstances dictate. C. Effective Date and Duration of Participation This Plan is effective immediately upon satisfaction of the requirements of DPA section 708(f)(1). This Plan shall remain in effect until terminated in accordance with 44 CFR 332.4.

It shall be effective for no more than five (5) years from August 17, 2020, when the requirements of DPA section 708(f)(1) were satisfied for the Voluntary Agreement, unless otherwise terminated pursuant to DPA section 708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 708(f)(2). No action may take place under this Plan until it is activated, as described in Section III(E), below. D. Withdrawal Participation in the Plan is voluntary, as is the acceptance of most obligations under the Plan. Sub-Committee Participants may withdraw from this Plan or from an individual Sub-Committee at any point, subject to the fulfillment of obligations previously agreed upon by the Participant prior to the date of withdrawal.

Note that the obligations outlined in V.B regarding information management and associated responsibilities apply once a party has shared or received information through a Sub-Committee and remain in place after the party's withdrawal from the Sub-Committee or Plan. If a Sub-Committee Participant indicates an intent to withdraw from the Plan due to a modification or amendment of the Plan (described below), the Sub-Committee Participant will not be required to perform actions directed by that modification or amendment. Withdrawal from the Plan will automatically trigger withdrawal from all Sub-Committees. However, a Participant may withdraw from a Sub-Committee without also withdrawing from the Plan or other Sub-Committees. To withdraw from the Plan or from an individual Sub-Committee, a Participant must provide written notice to the Administrator at least fifteen (15) calendar days prior to the effective date of that Sub-Committee Participant's withdrawal specifying the scope of withdrawal.

Following receipt of such notice, the Administrator will inform the other Sub-Committee Participants of the date and the scope of the withdrawal. Upon the effective date of the withdrawal from the Plan, the Sub-Committee Participant must cease all activities under the Plan. Upon the effective date of the withdrawal from one or more Sub-Committee(s), the Sub-Committee Participant must cease all activities under the Plan that pertain to the withdrawn Sub-Committee(s). E. Plan of Action Activation and Deactivation The Administrator, in consultation with the Chairperson and Sub-Committee Chairperson, will invite a select group of Participants in the Voluntary Agreement to form at least one of the following Sub-Committees, beginning with the Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains, which will be responsible for implementing this Plan.

(1) Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains, (2) Sub-Committee for Aviation, (3) Sub-Committee for Surface Transportation (including Highway, Motor Carriers, and Freight Rail), and (4) Sub-Committee for Maritime Transportation. FEMA may combine these Sub-Committees or establish additional Sub-Committees under this Plan, so long as. (1) The Sub-Committee addresses one specific and well-defined component of the National Multimodal Healthcare Supply Chains System. And (2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for asthma treatment National Multimodal Healthcare Supply Chains. This Plan will be activated for each invited Participant when the Participant executes a Plan of Action Agreement, and a Participant may not participate in a Sub-Committee until the Plan of Start Printed Page 6885 Action Agreement is executed.

Participants will be invited to join this Plan at the discretion of the Chairperson or the Sponsor to the Voluntary Agreement. Participants will be further invited to attend specific meetings of one or more Sub-Committees at the discretion of the Chairperson. F. Rules and Regulations Sub-Committee Participants acknowledge and agree to comply with all provisions of DPA section 708, as amended, and regulations related thereto which are promulgated by FEMA, the Department of Homeland Security, HHS, the Attorney General, and the FTC. FEMA has promulgated standards and procedures pertaining to voluntary agreements in 44 CFR part 332.

The Administrator shall inform Participants of new rules and regulations as they are issued. G. Modification and Amendment The Administrator, after consultation with the Attorney General and the Chair of the FTC, may terminate or modify, in writing, this Plan at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may terminate or modify, in writing, this Plan at any time. Sub-Committee Participants may propose modifications or amendments to the Plan or to the Sub-Committees at any time.

Where possible, material modifications to the Plan or a Sub-Committee will be subject to a 30-calendar day delayed implementation and opportunity for notice and comment by Sub-Committee Participants to the Chairperson. This delayed implementation period may be shortened or eliminated if the Administrator deems it necessary. The Administrator shall inform Sub-Committee Participants of modifications or amendments to the Plan or to the Sub-Committees as they are proposed and issued. The Administrator, after consultation with the Attorney General and the Chair of the FTC, may remove Sub-Committee Participants from the Plan or from a Sub-Committee at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may remove Sub-Committee Participants from this Plan or from a Sub-Committee at any time.

If a Participant is removed from the Plan or from a Sub-Committee, the Participant may request written notice of the reasons for removal from the Chairperson, who shall provide such notice in a reasonable time period. H. Expenses Participation in this Plan or in a Sub-Committee does not confer funds to Sub-Committee Participants, nor does it limit or prohibit any pre-existing source of funds. Unless otherwise specified, all expenses, administrative or otherwise, incurred by Sub-Committee Participants associated with participation in this Plan or a Sub-Committee shall be borne exclusively by the Sub-Committee Participants. I.

Record Keeping Each Sub-Committee Chairperson shall have primary responsibility for maintaining records in accordance with 44 CFR part 332 and shall be the official custodian of records related to carrying out this Plan. Each Sub-Committee Participant shall maintain for five years all minutes of meetings, transcripts, records, documents, and other data, including any communications with other Sub-Committee Participants or with any other member of the Sub-Committee, including drafts, related to the carrying out of this Plan or incorporating data or information received in the course of carrying out this Plan. Each Sub-Committee Participant agrees to produce to the Administrator, the Attorney General, and the Chair of the FTC upon request any item that this section requires the Participant to maintain. Any record maintained in accordance with 44 CFR part 332 shall be available for public inspection and copying, unless exempted on the grounds specified in 5 U.S.C. 552(b)(1), (3) or (4) or identified as privileged and confidential information in accordance with DPA section 705(d), and 44 CFR 332.5.

IV. Antitrust Defense Under the provisions of DPA subsection 708(j), each Sub-Committee Participant in this Plan shall have available as a defense to any civil or criminal action brought for violation of the antitrust laws (or any similar law of any State) with respect to any action to develop or carry out this Plan, that such action was taken by the Sub-Committee Participant in the course of developing or carrying out this Plan, that the Sub-Committee Participant complied with the provisions of DPA section 708 and the rules promulgated thereunder, and that the Sub-Committee Participant acted in accordance with the terms of the Voluntary Agreement and this Plan. Except in the case of actions taken to develop this Plan, this defense shall be available only to the extent the Sub-Committee Participant asserting the defense demonstrates that the action was specified in, or was within the scope of, this Plan and within the scope of the appropriate Sub-Committee(s), including being taken at the direction and under the active supervision of FEMA. This defense shall not apply to any actions taken after the termination of this Plan. Immediately upon modification of this Plan, no defense to antitrust claims under Section 708 shall be available to any subsequent action that is beyond the scope of the modified Plan.

The Sub-Committee Participant asserting the defense bears the burden of proof to establish the elements of the defense. The defense shall not be available if the person against whom the defense is asserted shows that the action was taken for the purpose of violating the antitrust laws. V. Terms and Conditions As the sponsoring agency, FEMA will maintain oversight over Sub-Committee activities and direct and supervise actions taken to carry out this Plan, including by retaining decision-making authority over actions taken pursuant to the Plan to ensure such actions are necessary to address a direct threat to the national defense. The Attorney General and the Chair of the FTC will monitor activities of the Sub-Committees to ensure they execute their responsibilities in a manner consistent with this Plan and their actions have the least anticompetitive effects possible.

A. Plan of Action Execution This Plan will be used to support ventolin response by maximizing the coordination for selected National Multimodal Healthcare Supply Chains and creating a prioritization protocol for End-Users. Each Sub-Committee will support the following objectives to mitigate the loss of life and public health threats associated with asthma treatment. 1. Objectives (1) Identify capabilities to effectively support National Multimodal Healthcare Supply Chains.

(2) Ensure effective coordination of National Multimodal Healthcare Supply Chains System resources that may be required for the Response to asthma treatment. (3) Ensure ongoing competition continues within the National Multimodal Healthcare Supply Chains System to the greatest extent possible under the DPA. 2. Actions Sub-Committee Participants may be asked to support these objectives by taking the following specific actions. Start Printed Page 6886 (1) Assist the Chairperson in identifying priorities and challenges within the National Multimodal Healthcare Supply Chains System that should be addressed within the Plan's Sub-Committees because of their importance to the national response to asthma treatment.

Using the best evidence available, Participants should consider whether current and projected National Multimodal Healthcare Supply Chains System resources are sufficient to meet essential needs of End-Users and geographic areas, and if there are any critical shortfalls of such resources that may be of concern for the response to asthma treatment. (2) Create a collaborative process for evaluating and addressing competing National Multimodal Healthcare Supply Chains System claims, as directed and decided by the Chairperson. (3) Develop a mechanism to inform prioritization of the distribution of healthcare products through National Multimodal Healthcare Supply Chains, as directed and decided by the Chairperson. (4) Prepare a general strategy to accomplish the activities listed in V(A)(2) and V(A)(5) regarding activities in Exigent Circumstances consistent with the decisions made by the Chairperson. (5) In Exigent Circumstances, with review and concurrence in all possible instances by DOJ in consultation with FTC.

Facilitate maximum use of the National Multimodal Healthcare Supply Chains System to meet requirements of the nation or particular geographic areas by deconflicting overlapping demands from the collective Participants' End-Users, as directed and decided by the Chairperson. Facilitate maximum availability of resources provided within the National Multimodal Healthcare Supply Chains System to meet requirements of the nation or particular geographic areas, as directed and decided by the Chairperson. Facilitate the efficient distribution of resources through the National Multimodal Healthcare Supply Chains System by deconflicting overlapping distribution chain activities of Sub-Committee Members, as directed and decided by the Chairperson. Establish a process and means of collaboration to address exigent End-User requirements in a manner aligned with the objectives of this Plan, as directed and decided by the Chairperson. (6) Provide data and information necessary to validate the efforts of the Sub-Committee including the actual and planned asthma treatment response activities that may foreseeably impact National Multimodal Healthcare Supply Chains throughout the nation, as determined by the Chairperson.

(7) Provide feedback to the Chairperson and Sub-Committee Members on outcomes, accomplishments, and impediments of collective efforts to accomplish objectives and actions outlined in this Plan. (8) Advise the Chairperson whether additional Participants or Attendees should be invited to join this Plan and its Sub-Committees. (9) Carry out other activities that the Sub-Committees under this Plan determine to be necessary for the coordination of National Multimodal Healthcare Supply Chains System resources to address the asthma treatment ventolin's direct threat to the national defense, as determined and directed by the Chairperson, where such activities have been reviewed and approved by DOJ and FTC and received concurrence from Sub-Committee members. B. Information Management and Responsibilities FEMA will request only the data and information from Sub-Committee Participants that is necessary to meet the objectives of the Plan and consistent with the scope of the relevant Sub-Committees.

Upon signing a Plan of Action Agreement for this Plan, FEMA requests that Participants endeavor to cooperate with diligence and speed, and to the extent permissible under this Plan, and to share with FEMA any data and information necessary to meet the objectives of this Plan. Sub-Committee Participants agree to share with FEMA the following data with diligence and speed to the extent permissible under this Plan, and to abide by the following guidelines where feasible and consistent with the data that is owned by each Sub-Committee Participant. (1) In general, Participants will not be asked to share Competitively Sensitive Information directly with other Participants. (2) FEMA will only request direct sharing of Competitively Sensitive Information among Participants during Exigent Circumstances where there is a mission critical need or timeline such that sharing only through FEMA is impractical or threatens the outcome of the Plan or Sub-Committee action. Such requests, if made, will be only among Participants whose participation is necessary to meet the objectives of the Plan, will be limited in scope to the greatest extent possible, and will be shared only pursuant to safeguards subject to prior review and audit by DOJ and FTC.

Direct sharing of Competitively Sensitive Information with other Participants will be limited in scope and circumstances to the greatest extent possible. Participants may not share Competitively Sensitive Information directly with other Participants unless specifically requested by FEMA, in consultation with DOJ and FTC. All Competitively Sensitive Information delivered to FEMA or to another Sub-Committee Participant shall be delivered by secure means, for example, password-protected or encrypted electronic files or drives with the password/key delivered by separate communication or method or via upload to an appropriately secure web portal as directed by FEMA. All data delivered to the web portal designated by FEMA is deemed to be Competitively Sensitive Information. (3) To allow FEMA to identify and appropriately protect documents containing Competitively Sensitive Information by the Sub-Committee Participant providing the documents, the Sub-Committee Participant will make good faith efforts to designate any Competitively Sensitive Information by placing restrictive markings on documents and things considered to be competitively sensitive, the restrictive markings being sufficiently clear in wording and visibility to indicate the restricted nature of the data.

The Sub-Committee Participant will identify Competitively Sensitive Information that is disclosed verbally by oral warning. Information designated as competitively sensitive will, to the extent allowed by law, be presumed to constitute trade secrets, or commercial or financial information, and be provided by the Sub-Committee Participant to FEMA with the expectation that it will be kept confidential by both parties, as such terms are understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of Information Act and federal judicial interpretations of this statute. FEMA agrees that to the extent any information designated as competitively sensitive by a Sub-Committee Participant is responsive to a request for disclosure under the Freedom of Information Act, FEMA will consult with the Sub-Committee Participant and afford the Participant ten (10) working days to object to any disclosure by FEMA. (4) FEMA will make good faith efforts to appropriately recognize unmarked Documents containing Competitively Sensitive Information as Competitively Sensitive Information.

However, FEMA cannot guarantee that all unmarked Start Printed Page 6887 Documents will be recognized as being Competitively Sensitive Information and protected from disclosure to third parties. If the unmarked Documents have not been disclosed without restriction outside of FEMA, the Sub-Committee Participant may retroactively request to have appropriate designations placed on the Documents. If the unmarked Documents have been disclosed without restriction outside of FEMA, FEMA will, to the extent practicable, remove any requested information from public forums controlled by FEMA and will work promptly to request that a receiving party return or destroy disclosed unmarked Documents if requested by the Sub-Committee Participant. (5) Competitively Sensitive Information may be used by FEMA, alone or in combination with additional information, including Documents and Competitively Sensitive Information received from third parties, to support FEMA's implementation of this Plan as determined by the Chairperson. In all situations, FEMA will aggregate and anonymize Competitively Sensitive Information to the greatest extent possible to protect the interests retained by the owners of the data while still allowing the objectives of the Plan and Sub-Committee to be achieved.

To the greatest extent possible, such aggregation will render the competitively sensitive nature of the Competitively Sensitive Information of the Sub-Committee Participant no longer recognizable in a commercially sensitive manner, and without sufficient information to enable, by inference or otherwise, attribution to Sub-Committee Participant or its affiliates (as clearly identified and disclosed to FEMA). Any disclosure of Competitively Sensitive Information by FEMA, within or outside a Sub-Committee, will be subject to review and approval by DOJ and FTC. (6) Except as otherwise expressly permitted by applicable federal law, FEMA shall not disclose any Competitively Sensitive Information or use any Competitively Sensitive Information for any purpose other than in connection with the purposes of this Plan, and FEMA will not sell any Competitively Sensitive Information of any Sub-Committee Participant. (7) Except as described below, FEMA may disclose Competitively Sensitive Information only to its employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors). Any individual with access to Competitively Sensitive Information will be expected to comply with the terms of this Plan.

a. Information Sharing within the Sub-Committee. FEMA may share Competitively Sensitive Information with Sub-Committee Participants and Federal Representatives of the Plan, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) where there is a need to know and where disclosure is reasonably necessary in furtherance of implementing the Plan. FEMA will aggregate and anonymize data prior to sharing with the Sub-Committee Participants to the greatest extent possible while still allowing the objectives of the Plan to be achieved, and will not share data—particularly to competitors of the submitter—prior to consultation with and approval by the DOJ and FTC. i.

Sub-Committee Participants, when providing Competitively Sensitive Information to FEMA, may request that this Information not be shared with other Sub-Committee Participants. Where these requests are made in good faith and are reasonable in nature, FEMA will respect these requests to the greatest extent possible and will consult the owner of the data prior to any release made to Sub-Committee Participants. b. Restricted Reports. FEMA may communicate Competitively Sensitive Information to appropriate government officials through Restricted Reports.

The information contained in Restricted Reports shall be aggregated and anonymized to the greatest extent possible, while recognizing that these officials may need a certain amount of granularity and specificity of information to appropriately respond to asthma treatment. FEMA will aim to aggregate data to the County level, and will not share Restricted Reports prior to consultation and approval from the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White House and Administration officials and State Governors, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) who have a need to know and to whom such disclosure is reasonably necessary solely in furtherance of the implementation of this Plan. FEMA shall take appropriate action (by instructions, agreement, or otherwise) to ensure that receiving parties comply with all data-sharing confidentiality and obligations under this Plan as if such persons or entities had been parties to this Plan. c.

Public Reports. FEMA may share information with the public through Public Reports. Data contained in Public Reports shall be fully aggregated and anonymized. Public Reports shall be aggregated to at least a state level and may be publicly disclosed after consultation and approval from the DOJ and FTC. (8) Where possible and not obviated by Exigent Circumstances, FEMA will notify Sub-Committee Participants prior to the release of any Competitively Sensitive Information that has not been fully aggregated and anonymized.

In consultation with DOJ and FTC, FEMA will consider any good-faith requests made by Sub-Committee members to hold the release of data or requests for further aggregation or anonymization. In general, FEMA will not provide notification prior to the release of Public Reports, under the presumption that the data in these reports has already been fully anonymized and de-identified. (9) Any party receiving Competitively Sensitive Information through this Plan shall use such information solely for the purposes outlined in the Plan and take steps, such as imposing previously approved firewalls or tracking usage, to prevent misuse of the information. Disclosure and use of Competitively Sensitive Information will be limited to the greatest extent possible, and any party receiving Competitively Sensitive Information shall follow the procedures outlined in paragraph 7 above. (10) At the conclusion of a Participant's involvement in a Plan—due to the deactivation of the Plan or due to the Participant's withdrawal or removal—each Participant will be requested to sequester any and all Competitively Sensitive Information received through participation in the Plan.

This sequestration shall include the deletion of all Competitively Sensitive Information unless required to be kept pursuant to the Record Keeping requirements as described supra, Section I, 44 CFR part 332, or any other provision of law. C. Oversight Each Sub-Committee Chairperson is responsible for ensuring that the Attorney General, or suitable delegate(s) from the DOJ, and the FTC Chair, or suitable delegate(s) from the FTC, have awareness of activities under this Plan, including activation, deactivation, and scheduling of meetings. The Attorney General, the FTC Chair, or their delegates may attend Sub-Committee meetings and request to be apprised of any activities taken in accordance with activities under this Plan. DOJ or FTC Representatives may request and review Start Printed Page 6888 any proposed action by the Sub-Committee or Sub-Committee Participants undertaken pursuant to this Plan, including the provision of data.

If any DOJ or FTC Representative believes any actions proposed or taken are not consistent with relevant antitrust protections provided by the DPA, he or she shall provide warning and guidance to the Sub-Committee as soon as the potential issue is identified. If questions arise about the antitrust protections applicable to any particular action, FEMA may request DOJ, in consultation with the FTC, provide an opinion on the legality of the action under relevant DPA antitrust protections. VI. Establishment of the Sub-Committees This Plan establishes Sub-Committees to implement the Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment to provide the Federal Government and the Participants a forum to maximize the coordination of selected National Multimodal Healthcare Supply Chain resources and to create a prioritization protocol based upon existing or projected needs of End-Users and geographic areas within the National Multimodal Healthcare Supply Chains System. The outcome should include a framework to expeditiously meet critical needs within the National Multimodal Healthcare Supply Chains System that may arise in Exigent Circumstances, and to ensure actions to address such needs do not come with unacceptable risks to End-Users or interfere with other efforts to meet critical End-User requirements.

A Sub-Committee Chairperson designated by the Chairperson will convene and preside over each Sub-Committee. Sub-Committees will not be used for contract negotiations or contract discussions between the Participants and the Federal Government. Such negotiations or discussions will be in accordance with applicable federal contracting policies and procedures. However, this shall not limit any discussion within a Sub-Committee about the operational utilization of existing and potential contracts between the Participants and Representatives when seeking to align their use with overall manufacturing and distribution efforts consistent with this Plan. Each Sub-Committee will consist of designated Representatives from FEMA, HHS, other federal agencies with equities in this Plan, and each Sub-Committee Participant.

The Attorney General and Chair of the FTC, or their delegates, may also join each Sub-Committee and attend meetings at their discretion. Attendees may also be invited at the discretion of a Sub-Committee Chairperson as subject matter experts, to provide technical advice, or to represent other government agencies, but will not be considered part of the Sub-Committee. Only to the extent necessary to respond to asthma treatment as explicitly directed by the Sub-Committee Chairperson, and subject to the provisions of Section V(B), Sub-Committee Members may be asked to provide technical advice, share information, help identify and validate places and resources of the greatest need, help project future manufacturing and distribution demands, assist in identifying and resolving the allotment of scarce resources under Exigent Circumstances, and take other actions necessary to maximize the timely coordination of National Multimodal Healthcare Supply Chains System resources for the asthma treatment. A Sub-Committee Chairperson or his or her designee, at the Sub-Committee Chairperson's sole discretion, will make decisions on these issues in order to ensure the maximum efficiency and effectiveness in the use of Sub-Committee Member's resources. All Sub-Committee Participants will be invited to open Sub-Committee meetings.

For selected Sub-Committee meetings, attendance may be limited to designated Sub-Committee Participants to meet specific operational requirements, as determined by FEMA. Each Sub-Committee Chairperson shall notify the Attorney General, the Chair of the FTC, Representatives, and Participants of the time, place, and nature of each meeting and of the proposed agenda of each meeting to be held to carry out this Plan. Additionally, each Sub-Committee Chairperson shall provide for publication in the Federal Register of a notice of the time, place, and nature of each meeting. If a meeting is open, a Federal Register notice will be published reasonably in advance of the meeting. A Sub-Committee Chair may restrict attendance at meetings only on the grounds outlined by 44 CFR 332.5(c)(1)-(3).

If a meeting is closed, a Federal Register notice will be published within ten (10) days of the meeting and will include the reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2). The Sub-Committee Chairperson shall establish the agenda for each meeting, be responsible for adherence to the agenda, and provide for a written summary or other record of each meeting and provide copies of transcripts or other records to FEMA, the Attorney General, the Chair of the FTC, and all Sub-Committee Participants. The Chairperson shall take necessary actions to protect from public disclosure any data discussed with or obtained from Sub-Committee Participants which a Sub-Committee Participant has identified as a trade secret or as privileged and confidential in accordance with DPA sections 708(h)(3) and 705(d), or which qualifies for withholding under 44 CFR 332.5. VII. Application and Agreement The Sub-Committee Participant identified below hereby agrees to join in the Federal Emergency Management Agency sponsored Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to asthma treatment under the Voluntary Agreement for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a ventolin and to become a Participant in one or more Sub-Committees established by this Plan.

This Plan will be published in the Federal Register. This Plan is authorized under section 708 of the Defense Production Act of 1950, as amended. Regulations governing the Voluntary Agreement for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a ventolin and all subsequent Plans of Action at 44 CFR part 332. The applicant, as a Sub-Committee Participant, agrees to comply with the provisions of section 708 of the Defense Production Act of 1950, as amended, the regulations at 44 CFR part 332, and the terms of this Plan. VIII.

Assignment No Sub-Committee Participant may assign or transfer this Plan, in whole or in part, or any protections, rights or obligations hereunder without the prior written consent of the Sub-Committee Chairperson. When requested, the Sub-Committee Chairperson will respond to written requests for consent within 10 (ten) business days of receipt. Start Printed Page 6889 (Company name) (Name of authorized representative) (Signature of authorized representative) (Date) Administrator (Sponsor) (Date) Start Signature Deanne Criswell, Administrator, Federal Emergency Management Agency. End Signature End Supplemental Information [FR Doc. 2022-02549 Filed 2-3-22.