[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Pages 44129-44130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15812]


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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; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Conducting 
Remote Regulatory Assessments--Question and Answers.'' FDA is issuing 
the draft guidance to describe the Agency's current thinking regarding 
its use of remote regulatory assessments (RRAs) in order to increase 
industry's understanding of RRAs and facilitate FDA's process for 
conducting RRAs. FDA has used RRAs to conduct oversight, mitigate risk, 
meet critical public health needs and help maximize compliance of FDA-
regulated products. This draft guidance provides answers to frequently 
asked questions regarding what RRAs are, when and why FDA may use them, 
and how FDA may conduct them, among others.

DATES: Submit either electronic or written comments on the draft 
guidance by September 23, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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.
     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:
     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.
     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.
     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 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

[[Page 44130]]

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 email by emailing ORA at [email protected]. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Christopher Henderson, Office of 
Regulatory Affairs, Food and Drug Administration, Element Building, 
12420 Parklawn Dr., Rockville, MD 20857, 
[email protected], 240-402-8186; or Ben Firschein, 
Office of Regulatory Affairs, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Silver Spring, MD 20993-0002, 
[email protected], 240-402-8186.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Conducting Remote Regulatory Assessments--Questions and 
Answers.'' FDA is issuing the draft guidance to describe the Agency's 
current thinking regarding its use of RRAs in order to help increase 
industry's understanding of RRAs, thereby facilitating FDA's process 
for conducting remote assessments. RRAs include requests for records 
and other information for FDA review and interactive evaluations of an 
FDA-regulated establishment or product with the use of, for example, 
livestreaming video. RRAs can be either voluntary or mandated. FDA has 
used RRAs to conduct oversight, mitigate risk, meet critical public 
health needs, and help maximize compliance with applicable FDA 
requirements, for all types of FDA-regulated products.
    For example, during the Coronavirus Disease 2019 (COVID-19) 
pandemic, FDA has used RRAs to inform approval and licensing decisions, 
verify corrective actions for establishments with an acceptable 
compliance status, and gain compliance insight into establishments that 
FDA has been unable to inspect. This experience has identified 
significant benefits of using RRAs to FDA, regulated industry, and the 
public. For these and other reasons, FDA is issuing this draft guidance 
to describe its intention to, when appropriate, continue to use RRAs 
outside of the COVID-19 public health emergency and for all FDA-
regulated product types.
    This 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 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 draft guidance 
at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov.

    Dated: July 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15812 Filed 7-22-22; 8:45 am]
BILLING CODE 4164-01-P


