85298 Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 

1FDA recognizes that some compounders and 

other stakeholders may currently be in the process 

of compiling a nomination for the 503A bulks list 

for submission to the Agency. FDA intends to 

categorize nominations of bulk drug substances 

received prior to the date in which FDA announces 

the availability of the final guidance. FDA believes 

that this will provide a sufficient amount of time 

in which to submit nominations that are currently 

in progress. 

section 503A because they are not the 

subject of an applicable USP or NF 

monograph, components of FDAapproved drug products, or on the 503A 

bulks list. One of those conditions is 

that the bulk drug substance appears in 

Category 1. If the 2023 503A Interim 

Policy Draft Guidance is finalized in its 

current form, a substance nominated on 

or after the date of publication of that 

final guidance would not be categorized 

and would not be within the scope of 

the policy for substances that appear in 

Category 1.1 However, FDA would 

consider the substance for inclusion on 

the 503A bulks list in accordance with 

the process and criteria established in 

the FD&C Act and FDA regulations (see 

section 503A(b)(1)(A) of the FD&C Act 

and 21 CFR 216.23(c)). Substances that 

already appear in Category 1 (including 

substances nominated with adequate 

supporting information prior to the date 

of publication of the final guidance) 

may continue to be eligible for the 

policy that applies to Category 1 

substances, as described in the final 

guidance, until FDA promulgates a final 

rule determining whether they will be 

placed on the 503A bulks list in 

accordance with section 

503A(b)(1)(A)(i)(III) of the FD&C Act or 

unless the Agency removes the 

substances from Category 1 based on, for 

example, information about safety risks. 

FDA encourages interested parties to 

focus their comments on the limited 

revisions to the interim policy included, 

for public comment, in the 2023 503A 

Interim Policy Draft Guidance. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Interim Policy on Compounding 

Using Bulk Drug Substances Under 

Section 503A of the Federal Food, Drug, 

and Cosmetic Act.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26886 Filed 12–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: The Alliance 

for Innovation on Maternal Health 

Biannual Survey, OMB No. 0915– 

xxxx—New 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 5, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

The Alliance for Innovation on Maternal 

Health Biannual Survey, OMB No. 

0915–xxxx—New. 

Abstract: The Alliance for Innovation 

on Maternal Health (AIM) program is 

administered by HRSA and authorized 

by 42 U.S.C. 254c–21 (Public Health 

Service Act, title III section 330O), as 

added by the Consolidated 

Appropriations Act, 2022 (Pub. L. 117– 

103). 

The AIM program supports the 

identification, development, 

implementation, and dissemination of 

maternal (patient) safety bundles to 

promote safe care for every U.S. birth 

and assist with addressing the complex 

problem of high maternal mortality and 

severe maternal morbidity rates within 

the U.S. The mission of AIM is to 

support best practices that make birth 

safer, improve the quality of maternal 

health care and outcomes, and save 

lives. Maternal patient safety bundles 

address topics commonly associated 

with health complications or risks 

related to prenatal, labor and delivery, 

and postpartum care. 

The AIM program consists of two 

components: The AIM Capacity program 

and the AIM Technical Assistance (TA) 

Center. The AIM Capacity awards began 

in fiscal year 2023 and directly fund 28 

States and jurisdictions (including U.S. 

Territories and the District of Columbia) 

to implement AIM maternal patient 

safety bundles. The second component, 

the AIM TA Center, is funded through 

a cooperative agreement to provide TA 

to all 50 States, the District of Columbia, 

jurisdictions, U.S. Territories, Tribal 

communities, and birthing facilities 

who participate in the AIM program. 

The TA Center builds data capacity for 

participating entities to track progress 

on bundle implementation and support 

improvement of data collection. 

The funding amount for the AIM 

program was increased in fiscal year 

2023, which allowed HRSA to directly 

fund States and Territories to support 

AIM bundle implementation. 

Previously, HRSA supported AIM 

through one cooperative agreement to 

develop maternal patient safety bundles, 

provide TA on bundle implementation, 

and enroll States and Territories in the 

program. The shift to directly fund 

States and jurisdictions for the work 

makes the collection of information 

about the reach of the program, 

participation by birthing facilities, and 

TA needs necessary. The AIM Biannual 

Survey will be administered to AIM 

State Teams (the State-or jurisdictionlevel entity leading AIM 

implementation) twice a year in all 

States and jurisdictions enrolled in 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 85299 

AIM. Respondents will include AIM 

State Teams that receive HRSA funding 

through the AIM Capacity program, as 

well as AIM State Teams that do not 

receive HRSA funding to implement 

AIM, to gauge the full reach of the 

program. 

Need and Proposed Use of the 

Information: The information will be 

used by the HRSA program team to 

understand and report on AIM program 

reach and potential growth regarding 

participating birthing facilities and 

patient safety bundles implemented, 

inform development of resources and 

types of TA offered, and develop 

program targets. In addition, 

information on the number of 

participating birthing facilities and 

patient safety bundles being 

implemented is shared on the HRSA 

and ACOG AIM websites. The biannual 

survey is the only place this information 

is collected. 

Likely Respondents: Respondents are 

AIM State Teams in all States and 

jurisdictions enrolled in AIM, including 

AIM Capacity award recipients and AIM 

State Teams that do not receive direct 

funding from HRSA. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

Total Estimated Annualized Burden 

Hours: 

Form name Number of 

respondents 

Number of responses 

per respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

AIM Biannual Survey ........................ 52 1 per survey; 2 surveys per year ..... 104 1 104 

Total ........................................... 52 1 per survey; 2 surveys per year ..... 104 1 104 

HRSA specifically requests comments 

on (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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–26902 Filed 12–6–23; 8:45 am] 

BILLING CODE 4165–15–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 

Advisory Council, January 18, 2024, 

11:00 a.m. to January 19, 2024, 6:00 

p.m., National Institutes of Health, One 

Democracy Plaza, 6701 Democracy 

Boulevard, Bethesda, MD 20892 which 

was published in the Federal Register 

on November 03, 2023, FR Doc. 2023– 

24224, 88 FR 75295. 

This notice is being amended to 

change the meeting date from January 

18, 2024, to January 19, 2024. The 

meeting times and location remain the 

same as stated above. This meeting is 

partially closed to the public. 

Dated: December 4, 2023. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–26903 Filed 12–6–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[OMB Control Number 1615–0013] 

Agency Information Collection 

Activities; Revision of a Currently 

Approved Collection: Application for 

Travel Document 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 

ACTION: 60-Day notice. 

SUMMARY: The Department of Homeland 

Security (DHS), U.S. Citizenship and 

Immigration (USCIS) invites the general 

public and other Federal agencies to 

comment upon this proposed extension 

of a currently approved collection of 

information. In accordance with the 

Paperwork Reduction Act (PRA) of 

1995, the information collection notice 

is published in the Federal Register to 

obtain comments regarding the nature of 

the information collection, the 

categories of respondents, the estimated 

burden (i.e., the time, effort, and 

resources used by the respondents to 

respond), the estimated cost to the 

respondent, and the actual information 

collection instruments. 

DATES: Comments are encouraged and 

will be accepted for 60 days until 

February 5, 2024. 

ADDRESSES: All submissions received 

must include the OMB Control Number 

1615–0013 in the body of the letter, the 

agency name and Docket ID USCIS– 

2007–0045. Comments must be 

submitted in English, or an English 

translation must be provided. Submit 

comments via the Federal eRulemaking 

Portal website at http://

www.regulations.gov under e-Docket ID 

number USCIS–2007–0045. 

FOR FURTHER INFORMATION CONTACT: 

USCIS, Office of Policy and Strategy, 

Regulatory Coordination Division, 

Samantha Deshommes, Chief, telephone 

number (240) 721–3000 (This is not a 

toll-free number. Comments are not 

accepted via telephone message). Please 

note contact information provided here 

is solely for questions regarding this 

notice. It is not for individual case 

status inquiries. Applicants seeking 

information about the status of their 

individual cases can check Case Status 

Online, available at the USCIS website 

at https://www.uscis.gov, or call the 

USCIS Contact Center at 800–375–5283 

(TTY 800–767–1833). 

SUPPLEMENTARY INFORMATION: 

Comments 

You may access the information 

collection instrument with instructions, 

or additional information by visiting the 


ddrumheller on DSK120RN23PROD with NOTICES1