Notice2022-15812
Conducting Remote Regulatory Assessments-Questions and Answers; Draft Guidance for Industry; Availability
Primary source
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Published
July 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Conducting Remote Regulatory Assessments--Question and Answers." FDA is issuing the draft guidance to describe the Agency's current thinking regarding its use of remote regulatory assessments (RRAs) in order to increase industry's understanding of RRAs and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 This draft guidance provides answers to frequently asked questions regarding what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others.
Full Text
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<title>Federal Register, Volume 87 Issue 141 (Monday, July 25, 2022)</title>
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[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Pages 44129-44130]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Conducting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the draft guidance to describe the Agency's current thinking regarding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 This draft guidance provides answers to frequently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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="/cdn-cgi/l/email-protection#1f706d7e6f7073767c666c6b7e79796c5f797b7e3177776c31787069"><span class="__cf_email__" data-cfemail="e8879a89988784818b919b9c898e8e9ba88e8c89c680809bc68f879e">[email protected]</span></a>. 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,
<a href="/cdn-cgi/l/email-protection#9eddf6ecf7edeaf1eef6fbecb0d6fbf0fafbecedf1f0def8faffb0f6f6edb0f9f1e8"><span class="__cf_email__" data-cfemail="9cdff4eef5efe8f3ecf4f9eeb2d4f9f2f8f9eeeff3f2dcfaf8fdb2f4f4efb2fbf3ea">[email protected]</span></a>, 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,
<a href="/cdn-cgi/l/email-protection#bcfed9d292fad5cecfdfd4d9d5d2fcdad8dd92d4d4cf92dbd3ca"><span class="__cf_email__" data-cfemail="baf8dfd494fcd3c8c9d9d2dfd3d4fadcdedb94d2d2c994ddd5cc">[email protected]</span></a>, 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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