[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Notices]
[Pages 82385-82386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25969]



[[Page 82385]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0053]


Communications From Firms to Health Care Providers Regarding 
Scientific Information on Unapproved Uses of Approved/Cleared Medical 
Products: Questions and Answers; Revised Draft Guidance for Industry; 
Availability; Agency Information Collection Activities; Proposed 
Collection; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice of availability that 
published in the Federal Register of October 24, 2023. In that notice, 
FDA requested comments on the revised draft guidance for industry 
entitled, ``Communications From Firms to Health Care Providers 
Regarding Scientific Information on Unapproved Uses of Approved/Cleared 
Medical Products: Questions and Answers.'' The Agency is taking this 
action in response to requests for an extension to allow interested 
persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice published on 
October 24, 2023 (88 FR 73031). Submit either electronic or written 
comments by January 5, 2024, to ensure that the Agency considers your 
comments on this revised draft guidance before it begins work on the 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-2008-D-0053 for ``Communications From Firms to Health Care 
Providers Regarding Scientific Information on Unapproved Uses of 
Approved/Cleared Medical Products: 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.
     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 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.

FOR FURTHER INFORMATION CONTACT: 
    With regard to the draft guidance: Kathleen David, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-0002, 301-
796-1200; Anne Taylor, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911; Ana Loloei, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 5504, Silver Spring, MD 20993-
0002, 301-796-8774; Office of Surveillance and Compliance, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl. 
(HFV-6), Rockville, MD 20855, 240-402-7082; Julie Finegan, Office of 
Policy, Office of the Commissioner, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 32, Rm. 4252, Silver Spring, MD 20993-0002, 
301-827-4830.
    With regard to the proposed collection of information: Domini Bean, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of October 24, 2023, 
FDA published a notice announcing the availability of a revised draft 
guidance for industry entitled, ``Communications From Firms to Health 
Care Providers Regarding Scientific Information on Unapproved Uses of 
Approved/Cleared Medical Products: Questions and Answers.'' Interested 
persons were originally given until December 26, 2023, to comment on 
the revised draft guidance.

[[Page 82386]]

    The Agency received requests for extension of the comment period 
for the revised draft guidance. After considering the requests, and in 
light of the fact that the original comment period is scheduled to 
close on December 26, 2023, FDA has decided to extend the comment 
period for the revised draft guidance until January 5, 2024. The Agency 
believes that this extension allows adequate time for interested 
persons to submit comments to ensure that FDA can consider the comments 
before it begins work on the final version of the guidance.

    Dated: November 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25969 Filed 11-22-23; 8:45 am]
BILLING CODE 4164-01-P