Federal Register / Vol. 88, No. 225 / Friday, November 24, 2023 / Notices 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comments on the revised draft guidance 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this revised draft guidance before it 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, 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1
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 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice of a virtual meeting. 

SUMMARY: 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). 

ADDRESSES: To attend the meeting 

virtually, please visit www.hhs.gov/live. 

FOR FURTHER INFORMATION CONTACT: 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. 

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 

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) 


ddrumheller on DSK120RN23PROD with NOTICES1