Department of Health and Human Services

Regulatory Relief To Support Economic Recovery; Request for Information (RFI)

AGENCY: Office of the Secretary, Department of Health and Human Services.

ACTION: Request for information.

75720 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020 / Notices

The United States Department of Health and Human Services (HHS) is considering making permanent and/or keeping as temporary the regulatory standards and amendments promulgated in response to the COVID–19 crisis, issued in order to improve early access to care and reduce costs.

The HHS, via executive presidential order, has an obligation to continue to remove regulatory barriers that could be challenging to the American economic recovery. In compliance with this obligation, the Department is reviewing certain regulatory practices.

HHS intends that some of these regulatory changes and flexibilities will remain temporary, some permanent, or permanent with modification. Through the mechanism of this RFI, HHS is seeking to gather feedback and relevant evidence from the key stakeholders to support their decision making process—healthcare providers, advocacy groups; industry trade groups; health insurance issuers, research and policy experts; industry and professional associations; patients and patient advocacy groups; Medicare and Medicaid beneficiaries, and any other interested members of the public.

Here is your opportunity to help shape, amend and/or request discontinuation of the regulatory changes implemented by the FDA via the Emergency Use Authorisation (EUA).

Based upon commenters evidence, the HHS will consider phasing out or discontinuing regulatory changes that show the negative impacts outweighing any benefit of the regulatory change on a temporary basis or would have negative impacts outweighing the benefits if continued beyond the current crisis.

Attachment A of the federal register notice provides a list (note it is declared not exhaustive) of the regulatory changes for which the HHS is requesting feedback. Items 22 through 74, relate to the FDA and includes issues relating to animal medicines, decontamination procedures, ventilators, hand sanitisers and PPE equipment.

The key questions presented for comments:

Of the regulatory changes that have been made in response to the crisis, please identify which changes;

a. Have been beneficial to healthcare providers, human services systems, or to the patients and clients, and under what circumstances;

b. Have been detrimental to healthcare providers, human services systems, or to the patients and clients, and under what circumstances;

c. Have been beneficial to healthcare providers, human services systems, or to the patients and clients on a temporary basis, but would be detrimental if continued following the current crisis

Of the regulatory changes that have been implemented in response to the pandemic, please identify which changes:

a. Should be maintained only for the duration of the pandemic

b. Should be maintained permanently

c. Should be extended for a period of time, however not made permanent

d. Should be modified but maintained after the end of the pandemic, and thus made permanent with modifications

e. Should be discontinued immediately

If you are an interested party and/or a key stakeholder, to be assured that your comments are considered, you must submit your evidence electronically to http://www.regulations.gov no later 11:59 p.m. on 28 December 2020.

It must be further noted that all comments received before the close of the comment period will be available for viewing by the public.

Please see the link below to view the RFI document and the relevant Attachment A.

75720 Federal Register / Vol. 85, No. 228 / Wednesday, November 25, 2020

Kimyoung@instem.com

K Young

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