[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5244-5246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01589]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0810]


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Revised Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: 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the availability for comment of a revised draft guidance for industry 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 FDA has revised and is reissuing the draft guidance in 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 This revised draft guidance provides answers 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.

DATES: Submit either electronic or written comments on the draft 
guidance by March 26, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
    <bullet> 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'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> 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.''
    Instructions: 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> 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

[[Page 5245]]

for public viewing and posted on https://www.regulations.gov. 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: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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 <a href="/cdn-cgi/l/email-protection#3758455647585b5e544e44435651514477515356195f5f4419505841"><span class="__cf_email__" data-cfemail="d8b7aab9a8b7b4b1bba1abacb9bebeab98bebcb9f6b0b0abf6bfb7ae">[email protected]</span></a>. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ben Firschein, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Silver Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#cc8ea9a2e28aa5bebfafa4a9a5a28caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="80c2e5eeaec6e9f2f3e3e8e5e9eec0e6e4e1aee8e8f3aee7eff6">[email protected]</span></a>, 240-402-
0613; or Patrick Clouser, Office of Regulatory Affairs, Food and Drug 
Administration, Element Building, 12420 Parklawn Dr., Rockville, MD 
20857, <a href="/cdn-cgi/l/email-protection#3868594c4a515b53167b54574d4b5d4a785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="52023326203b31397c113e3d27213720123436337c3a3a217c353d24">[email protected]</span></a>, 240-402-5276.

SUPPLEMENTARY INFORMATION:

I. Background

    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 Federal 
Register 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).\1\ Specifically, FDORA 
amended section 704(a)(4) of the FD&C Act in several ways:
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    \1\ 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).
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    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) (i.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 to a preapproval or risk-based inspection, or to 
resolve deficiencies identified during such inspections, if applicable 
and appropriate.
    4. FDORA required FDA to issue or update 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 (FDORA section 3611(b)(2)).
    FDA seeks public comment on the revised draft guidance. We are 
particularly interested in receiving comments that relate to revisions 
the Agency is proposing to address the above FDORA requirements.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on 
``Conducting Remote Regulatory Assessments.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this revised draft guidance contains 
no collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

III. Electronic Access

    Persons with access to the internet may obtain the revised draft 
guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.regulations.gov.


[[Page 5246]]


    Dated: January 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01589 Filed 1-25-24; 8:45 am]
BILLING CODE 4164-01-P


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