Conducting Remote Regulatory Assessments-Questions and Answers; 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; 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 of a final guidance for industry entitled “Conducting Remote Regulatory Assessments—Question and Answers.” The final guidance describes FDA's current thinking regarding its use of remote regulatory assessments (RRAs) and provides answers to frequently asked questions. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help evaluate compliance of FDA-regulated products with applicable regulatory requirements. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The announcement of the guidance is published in the <E T="04">Federal Register</E> on June 26, 2025. </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: 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 guidance to the Division of Inspectorate Policy, Office of Inspections and Investigations (OII), 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 guidance may also be obtained by mail by emailing OII at <E T="03">oiipolicystaffs@fda.hhs.gov.</E> See the <E T="02">SUPPLEMENTARY INFORMATION</E> section for electronic access to the guidance document. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Ben Firschein, Office of Inspections and Investigations, Division of Inspectorate Policy, Food and Drug Administration, 12420 Parklawn Drive, Element Building, Rockville MD 20857, <E T="03">Ben.Firschein@fda.hhs.gov,</E> 240-402-0613; or Patrick Clouser, Office of Inspections and Investigations, Division of Inspectorate Policy, 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 final guidance for industry entitled “Conducting Remote Regulatory Assessments—Questions and Answers.” The final guidance makes further revisions to and replaces the revised 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 January 26, 2024 (89 FR 5244) (hereafter, the “revised draft guidance”). FDA issued the revised 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 FDA-regulated products outside of the COVID-19 public health emergency. The revised draft guidance reflected consideration of comments on a preceding draft guidance of the same title as well as revisions to align with 2022 changes in law, <SU>1</SU> <FTREF/> including to address a requirement to issue guidance  <SU>2</SU> <FTREF/> related to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act ( <E T="03">i.e.,</E> requests for records in advance of or in lieu of an inspection; such requests are a type of RRA). The comment period for the revised draft guidance ended on March 26, 2024. <FTNT> <SU>1</SU>  See sections 3611, 3612, and 3613 of the Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted as part of the Consolidated Appropriations Act, 2023, Public Law 117-328 (2022). Among changes made by FDORA were adding (in addition to drug establishments) device establishments, and sites, entities, or facilities subject to bioresearch monitoring (BIMO) inspections, to mandatory records request authority under section 704(a)(4) of the FD&C Act. </FTNT> <FTNT> <SU>2</SU>  FDORA section 3611(b)(2) required FDA to issue (or update) guidance as draft, and then, issue final guidance, describing the circumstances under which the Agency intends to use its authority to issue requests for records or other information under section 704(a)(4) of the FD&C Act (as amended by FDORA), the processes for firms to respond, and the factors for determining whether a facility has appropriately and timely responded. </FTNT> The final guidance additionally reflects consideration of comments from interested parties on the revised draft guidance. Specifically, the final guidance includes changes to: (1) distinguish more clearly between mandatory and voluntary RRA requests; (2) clarify how FDA intends to inform establishments of the terms of participation in voluntary RRAs and obtain their consent to conduct the RRA; (3) facilitate transparency and consistency in FDA's use of RRAs across regulated products, as applicable; (4) clarify mechanisms for electronic records reviews and conditions under which live data access might occur; and (5) address concerns about confidentiality and security of establishment information reviewed by FDA. The final guidance also addresses the 2022 requirement for issuance of final guidance  <SU>3</SU> <FTREF/> relating to the Agency's use of section 704(a)(4) of the FD&C Act. <FTNT> <SU>3</SU>  Id. </FTNT> The final guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The final guidance represents the current thinking of FDA on “Conducting Remote Regulatory Assessments.” It does not establish any rights for any person and is not bin ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 11k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━