Conducting Remote Regulatory Assessments-Questions and Answers; Revised Draft Guidance for Industry; Availability

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2022-D-0810]</DEPDOC> <SUBJECT>Conducting Remote Regulatory Assessments—Questions and Answers; Revised Draft Guidance for Industry; Availability</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice of availability. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or Agency) is announcing the availability for comment of a revised draft guidance for industry entitled “Conducting Remote Regulatory Assessments—Question and Answers.” FDA has revised and is reissuing the draft guidance in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will describe FDA's current thinking regarding its use of remote regulatory assessments (RRAs). FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help maximize compliance of FDA-regulated products. This revised draft guidance provides answers to frequently asked questions regarding RRAs. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit either electronic or written comments on the draft guidance by March 26, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments on any guidance at any time as follows: <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2022-D-0810 for “Conducting Remote Regulatory Assessments; Questions and Answers; Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, Element Building, 12420 Parklawn Dr., Rockville, MD 20852. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by emailing ORA at <E T="03">orapolicystaffs@fda.hhs.gov.</E> See the <E T="02">SUPPLEMENTARY INFORMATION</E> section for electronic access to the draft guidance document. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Ben Firschein, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Silver Spring, MD 20993-0002, <E T="03">Ben.Firschein@fda.hhs.gov,</E> 240-402-0613; or Patrick Clouser, Office of Regulatory Affairs, Food and Drug Administration, Element Building, 12420 Parklawn Dr., Rockville, MD 20857, <E T="03">Patrick.Clouser@fda.hhs.gov,</E> 240-402-5276. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> FDA is announcing the availability of a revised draft guidance for industry entitled “Conducting Remote Regulatory Assessments—Questions and Answers.” This draft revises the draft guidance entitled “Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry,” which was announced in the <E T="04">Federal Register</E> on July 25, 2022 (87 FR 44129) (hereafter, the “original draft guidance”). FDA issued the original draft guidance to describe the Agency's thinking regarding its use of RRAs, to help increase the industry's understanding of voluntary and mandatory RRAs, and to facilitate FDA's process for conducting remote assessments for all types of FDA-regulated products outside of the COVID-19 public health emergency. The comment period for the original draft guidance ended on September 23, 2022. One of the mandatory RRAs FDA discussed in the original draft guidance was the requirement that establishments engaged in manufacturing, preparing, propagating, compounding, or processing drugs produce, upon request from FDA, records or other information by in advance of or in lieu of an inspection, under section 704(a)(4) of the FD&C Act. In the revised draft guidance we have clarified our answers to questions regarding: (1) the benefits of an RRA, and any consequences for not participating; (2) how a facility will know an RRA is being requested, and whether it is mandatory or voluntary; (3) when and how FDA may initiate an RRA; (4) how FDA may conduct RRAs in relation to FDA inspections or to activities by state and foreign regulatory partners; (5) what an establishment should expect during an RRA, including overall process and technological expectations, and how consent may be established for a voluntary RRA; (6) how FDA will seek to provide for ongoing communication between FDA and an establishment; and (7) what may occur upon the completion of an RRA. The revised draft guidance also contains revisions to align with recent changes to section 704(a)(4) of the FD&C Act made by the Food and Drug Omnibus Reform Act of 2022 (FDORA). <SU>1</SU> <FTREF/> Specifically, FDORA amended section 704(a)(4) of the FD&C Act in several ways: <FTNT> <SU>1</SU>  On December 29, 2022, the President signed into law FDORA, which was enacted as part of the Consolidated Appropriations Act, 2023, Public Law 117-328 (2022). </FTNT> 1. FDORA sections 3611(b)(1)(A) and 3612(a) expanded those subject to mandatory requests for records or other information under section 704(a)(4) of the FD&C Act to include: (a) establishments that engage in the manufacture, preparation, propagation, compounding, or processing of a device, and (b) sites or facilities that are subject to inspection under section 704(a)(5)(C) ( <E T="03">i.e.,</E> bioresearch monitoring inspections) (21 U.S.C. 374(a)(5)). 2. FDORA section 3611(b)(1)(B) added a requirement that FDA provide a rationale for requesting records or other information under section 704(a)(4) of the FD&C Act. 3. FDORA section 3613(b) inserted new section 704(a)(4)(C) of the FD&C Act providing that FDA may rely on any records or other information obtained under section 704(a)(4) to satisfy requirements that may pertain ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 12k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━