Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices 66461 

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– 

2023–N–0487 for ‘‘Discussion Paper: 

Artificial Intelligence in Drug 

Manufacturing, Notice; Request for 

Information and Comments.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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.’’ 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: 

Elizabeth Giaquinto Friedman, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4162, 

Silver Spring, MD 20993, 240–402– 

7930, Elizabeth.Giaquinto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of March 1, 2023 (88 

FR 12943), FDA established a public 

docket to solicit comments on the 

‘‘Discussion Paper: Artificial 

Intelligence in Drug Manufacturing.’’ 

The discussion paper presents areas for 

consideration and policy development 

identified by the Center for Drug 

Evaluation and Research (CDER) 

scientific and policy experts associated 

with application of artificial intelligence 

to pharmaceutical manufacturing. The 

discussion paper includes a series of 

questions to stimulate feedback from the 

public, including CDER and the Center 

for Biologics Evaluation and Research 

stakeholders. 

Interested persons were originally 

given until May 1, 2023, to comment on 

the content of the discussion paper. 

Following publication of the March 1, 

2023, notice, FDA has decided to reopen 

the public docket to allow interested 

persons additional time to comment on 

the discussion paper. We note that there 

is also a public workshop organized by 

FDA and the Product Quality Research 

Institute entitled ‘‘Regulatory 

Framework for the Utilization of 

Artificial Intelligence in Pharmaceutical 

Manufacturing: An Opportunity for 

Stakeholder Engagement,’’ which is 

scheduled for September 26 and 27, 

2023 (https://pqri.org/fda-pqriaiworkshop/). 

Dated: September 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20902 Filed 9–26–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0324] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before November 27, 

2023. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 264–0041 and PRA@HHS.GOV. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0324–60D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, PRA@

HHS.GOV or call (202) 264–0041 the 

Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Report of 

Dental Examination of Applicants to the 

Public Health Service Commissioned 

Corps. 


ddrumheller on DSK120RN23PROD with NOTICES1
66462 Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices 

Type of Collection: Reinstatement 

without change. 

OMB No.: 0990–0324. 

Abstract: Pursuant to the Paperwork 

Reduction Act of 1995, the 

Commissioned Corps Headquarters 

(CCHQ), Office of the Secretary, 

Department of Health and Human 

Services (HHS), requests that the Office 

of Management and Budget (OMB) 

renew the form PHS–6355 Report of 

Dental Examination of Applicants to the 

Commissioned Corps of the Public 

Health Service for use in determining 

the medical qualifications of applicants 

to the Commissioned Corps of the U.S. 

Public Health Service (Corps). 

Applicants to the Corps must meet the 

Corps’ medical standards for 

appointment. 

This is a 3-year request for OMB 

approval. 

Likely Respondents: U.S. citizens 

applying to the United States Public 

Health Service. 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(if necessary) 

Respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total 

burden 

hours 

PHS–6355 ......................................... Applicants ......................................... 1,000 1 1 1,000 

Total ........................................... ........................................................... ........................ ........................ ........................ 1,000 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2023–21098 Filed 9–26–23; 8:45 am] 

BILLING CODE 4150–49–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: Allergy, Immunology, 

and Transplantation Research Committee. 

Date: October 17–18, 2023. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G51A, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Thomas F. Conway, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3G51A, Bethesda, MD 

20892, 240–507–9685, thomas.conway@

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) 

Dated: September 21, 2023. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–20978 Filed 9–26–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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: Population Sciences 

and Epidemiology Integrated Review Group; 

Social Sciences and Population Studies, A 

Study Section. 

Date: October 17–18, 2023. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza Hotel, 10 Thomas 

Circle NW, Washington, DC 20005. 

Contact Person: Suzanne Ryan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3139, 

MSC 7770, Bethesda, MD 20892, (301) 435– 

1712, ryansj@csr.nih.gov. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Imaging Guided 

Interventions and Surgery Study Section. 

Date: October 19–20, 2023. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Gaithersburg Marriott 

Washingtonian Center, 9751 Washingtonian 

Blvd., Gaithersburg, MD 20878. 

Contact Person: Ella Fung Jones, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 496–0777, ella.jones@nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group; Cellular and Molecular 

Biology of Glia Study Section. 

Date: October 19–20, 2023. 

Time: 8:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Sung-Wook Jang, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 812P, 

Bethesda, MD 20892, (301) 435–1042, 

jangs2@csr.nih.gov. 

Name of Committee: Cardiovascular and 

Respiratory Sciences Integrated Review 

Group; Lung Injury, Repair, and Remodeling 

Study Section. 

Date: October 19–20, 2023. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Ghenima Dirami, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4122, 

MSC 7814, Bethesda, MD 20892, 240–498– 

7546, diramig@csr.nih.gov. 


ddrumheller on DSK120RN23PROD with NOTICES1