Notice2023-25969
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Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Extension of Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 24, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 In that notice, FDA requested comments on the revised draft guidance for industry entitled, "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical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.
Full Text
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<title>Federal Register, Volume 88 Issue 225 (Friday, November 24, 2023)</title>
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[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Notices]
[Pages 82385-82386]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25969]
[[Page 82385]]
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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Products: Questions and Answers; Revised Draft Guidance for Industry;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.
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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:
<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-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 <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.
<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 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.
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,
<a href="/cdn-cgi/l/email-protection#f0a0a2b1a384919696b0969491de989883de979f86"><span class="__cf_email__" data-cfemail="bdedeffceec9dcdbdbfddbd9dc93d5d5ce93dad2cb">[email protected]</span></a>.
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
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