Notice2022-01143
Collecting and Providing 702(b) Portions of Food and Drug Administration Official Samples-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
January 21, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry and FDA staff entitled "Collecting and Providing 702(b) Portions of FDA Official Samples-- Questions and Answers." This draft guidance is intended to assist industry and FDA staff with issues and questions related to the requirements for FDA to collect and provide a part of an official sample of an article to any person named on the label of the article, or the owner thereof, or his attorney or agent.
Full Text
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<title>Federal Register, Volume 87 Issue 14 (Friday, January 21, 2022)</title>
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[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3302-3303]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01143]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0593]
Collecting and Providing 702(b) Portions of Food and Drug
Administration Official Samples--Questions and Answers; Draft Guidance
for Industry and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry and FDA staff entitled
``Collecting and Providing 702(b) Portions of FDA Official Samples--
Questions and Answers.'' This draft guidance is intended to assist
industry and FDA staff with issues and questions related to the
requirements for FDA to collect and provide a part of an official
sample of an article to any person named on the label of the article,
or the owner thereof, or his attorney or agent.
DATES: Submit either electronic or written comments on the draft
guidance by February 22, 2022 to ensure that we consider your comment
on this draft guidance before we begin work on the final version of the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-2021-D-0593 for ``Collecting and Providing 702(b) Portions and of
FDA Official Samples--Questions and Answers.'' 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.'' We will review
this copy, including the claimed confidential information, in our
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 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>.
[[Page 3303]]
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
that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Chris Henderson, Office of Regulatory
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn
Dr., Rockville, MD 20857 240-402-8186,
<a href="/cdn-cgi/l/email-protection#b8fbd0cad1cbccd7c8d0ddca96d0ddd6dcddcacbd7d6f8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="d192b9a3b8a2a5bea1b9b4a3ffb9b4bfb5b4a3a2bebf91b7b5b0ffb9b9a2ffb6bea7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Collecting and Providing 702(b) Portions of
FDA Official Samples--Questions and Answers.'' Section 702 of the FD&C
Act (21 U.S.C. 372) authorizes FDA to conduct examinations and
investigations and to collect samples. Under section 702(b) of the FD&C
Act, when FDA collects a sample of a food, drug, or cosmetic for
analysis, FDA must, upon request, provide a part of such official
sample for examination or analysis by any person named on the label of
the article, or the owner thereof, or his attorney or agent.
Additionally, FDA was authorized to establish, by regulation,
reasonable exceptions to, and impose reasonable terms and conditions
relating to, the requirement to collect and provide a 702(b) portion of
an official sample to the owner, as necessary for the proper
administration of the provisions of the FD&C Act. FDA's regulation at
21 CFR 2.10 was issued to establish those reasonable exceptions, and
terms and conditions, and to implement section 702(b) of the FD&C Act.
This draft guidance is intended to assist industry and FDA staff
with issues and questions related to the requirements for FDA to
collect and provide portions of official samples under section 702(b)
of the FD&C Act and its implementing regulation in 21 CFR 2.10.
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 ``Collecting
and Providing 702(b) Portions of FDA Official Samples--Questions and
Answers.'' 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/search-general-and-cross-cutting-topics-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents</a>, <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: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01143 Filed 1-20-22; 8:45 am]
BILLING CODE 4164-01-P
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