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Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Extension of Comment Period, 82385-82386 [2023-25969]

Download as PDF Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 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Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Extension of Comment Period AGENCY: Food and Drug Administration,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. Notice of availability; extension of comment period. ACTION: 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 In that notice, FDA requested comments on the revised draft guidance for industry entitled, ‘‘Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical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electronic or written comments by January 5, 2024, to ensure that the Agency considers your comments on this revised draft guidance before it begins work on the final version of the guidance.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: ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: 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 VerDate Sep<11>2014 21:46 Nov 22, 2023 Jkt 262001 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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 82385 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-201509-18/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, PRAStaff@fda.hhs.gov. 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. E:\FR\FM\24NON1.SGM 24NON1 82386 Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Presidential Advisory Council on HIV/AIDS Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice of a virtual meeting. AGENCY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/ AIDS (PACHA or the Council) will convene the 79th full council meeting utilizing virtual technologies on Wednesday, December 6, 2023. The meeting will be open to the public and there will be a public comment session during the meeting; pre-registration is required to provide public comment. To pre-register to provide public comment, please send an email to PACHA@ hhs.gov and include your name, organization, and title by close of business Monday, November 27, 2023. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing PACHA@hhs.gov by close of business Wednesday, December 13, 2023. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/federalresponse/pacha/about-pacha prior to the meeting. DATES: The meeting will be held on Wednesday, December 6 from approximately 11:00 a.m.–06:00 p.m. (ET). ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: To attend the meeting virtually, please visit www.hhs.gov/live. ADDRESSES: VerDate Sep<11>2014 21:46 Nov 22, 2023 Jkt 262001 Ms. Caroline Talev, MPA, Senior Management Analyst, at PACHA@ hhs.gov or Caroline.Talev@hhs.gov or (202) 795–7622. Additional information can be obtained by accessing the Council’s page on the HIV.gov site at www.hiv.gov/pacha. SUPPLEMENTARY INFORMATION: PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996 and is currently operating under the authority given in Executive Order 14048, dated September 30, 2021. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective HIV diagnosis, treatment, prevention, and quality care services. The functions of the Council are solely advisory in nature. The Council consists of not more than 35 members. Council members are selected from prominent community leaders with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, population health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. PACHA selections also include persons with lived HIV experience and racial/ethnic and sexual and gender minority persons disproportionately affected by HIV. Council members are appointed by the Secretary. FOR FURTHER INFORMATION CONTACT: Dated: October 31, 2023. B. Kaye Hayes, Deputy Assistant Secretary for Infectious Disease, Director, Office of Infectious Disease and HIV/AIDS Policy, Executive Director, Presidential Advisory Council on HIV/AIDS, Office of the Assistant Secretary for Health, Department of Health and Human Services. [FR Doc. 2023–25877 Filed 11–22–23; 8:45 am] BILLING CODE 4150–43–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Center for Advancing Translational Sciences Special Emphasis Panel, Preclinical Proof of Concept Studies for Rare Diseases (R21) January 24, 2024, 9:00 a.m. to January 25, 2024, 5:00 p.m., National Institutes of Health, National Center for Advancing Translational PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 Sciences, 6701 Democracy Boulevard, Bethesda, MD, 20892 which was published in the Federal Register on November 14, 2023, FR DOC 2023– 25070, 88 FR 78052. The meeting is being rescheduled due to panel member availability. The meeting will be held on February 1, 2024, 9:00 a.m. to February 2, 2024, 5:00 p.m. This meeting will be held virtually. The meeting is closed to the public. Dated: November 17, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–25885 Filed 11–22–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed). Date: December 20, 2023. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 903 South 4th Street, RML 31/3118, Hamilton, MT 59840 (Virtual Meeting). Contact Person: Kristin L. McNally, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 903 South 4th Street, RML 31/3118, Hamilton, MT 59840 mcnallyk@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) E:\FR\FM\24NON1.SGM 24NON1

Agencies

[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]]

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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.

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

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

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