2023-14714. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products and Related Authorities

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments (including recommendations) on the collection of information by August 11, 2023.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910–0595. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–3794, [e-mail].

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Emergency Use Authorization of Medical Products and Related Authorities

OMB Control Number 0910–0595—Revision

This information collection helps support FDA's implementation of sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3, 360bbb–3a, and 360bbb–3b), which govern the authorization of medical products for use in emergencies. The statutes authorize FDA to permit the introduction into interstate commerce a drug, device, or biological product intended for use in an actual or potential emergency. The purpose of these provisions is to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear agents, including emerging infectious disease threats.

We are revising the information collection to discuss the guidance document entitled, “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID–19),” announced in the Federal Register of March 27, 2023 (88 FR 18144). The guidance document describes a phased-in approach intended to help avoid disruption in device supply and help facilitate compliance with applicable legal requirements. The recommendations discussed in the guidance document result in the one-time collection of information intended to ensure an orderly and transparent transition from temporary policies established during the COVID–19 public health emergency to normal operations.

In the Federal Register of December 23, 2021 (86 FR 72978), FDA published a 60-day notice requesting public comment on the proposed collection of information. However, upon further review, we find the recommendations discussed in the guidance document apply to specific medical devices already issued EUAs and characterize the activity as non-standardized followup designed to clarify responses to approved collections of information, i.e., plans for continued compliance unique to that medical device issued an EUA. We therefore believe the activity constitutes the collection of non-identical and/or followup information, as defined under 5 CFR 1320.3. At the same time, we expect some degree of fluctuation in submissions under 21 CFR 814.20, as a result of implementation of the medical device transition plan. Information collection associated with 21 CFR part 814 is currently approved in OMB control number 0910–0231.

Dated: July 6, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.