Document ID: FDA-2021-D-0593-0001
Agency: fda
Document Type: Notice
Title: Collecting and Providing 702(b) Portions of Food and Drug Administration Official Samples—Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2022-01-21T05:00Z

[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3302-3303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01143]

-----------------------------------------------------------------------

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Administration Official Samples--Questions and Answers; Draft Guidance 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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry and FDA staff entitled 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 This draft guidance is intended to assist 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DATES: Submit either electronic or written comments on the draft 
guidance by February 22, 2022 to ensure that we consider your comment 
on this draft guidance before we begin work on the final version of the 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:
     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-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 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.'' 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 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.

[[Page 3303]]

    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 
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, 
[email protected].

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 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, or https://www.regulations.gov.

    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