67766 Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Chris Wheeler, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3330, 

Silver Spring, MD 20993–0002, 301– 

796–0151; or 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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Human Prescription Drug and 

Biological Products—Labeling for 

Dosing Based on Weight or Body 

Surface Area for Ready-to-Use 

Containers—‘Dose Banding.’ ’’ This 

guidance provides recommendations for 

incorporating dose banding information 

into the labeling of an injectable drug 

product that is seeking approval through 

a new drug application submitted under 

section 505(b) of the FD&C Act (21 

U.S.C. 355(b)), a biologics license 

application submitted under section 

351(a) of the PHS Act (42 U.S.C. 262(a)), 

or a supplement to one of these 

approved applications. The 

recommendations and examples in this 

guidance are relevant to situations in 

which an applicant (1) proposes to 

develop ready-to-use containers with a 

range of different strengths for an 

injectable drug product and (2) seeks to 

incorporate dose banding information 

into the prescribing information based 

on dosing information of a previously 

approved drug product that is based on 

weight or BSA. 

This guidance finalizes the draft 

guidance entitled ‘‘Human Prescription 

Drug and Biological Products—Labeling 

for Dosing Based on Weight or Body 

Surface Area for Ready-to-Use 

Containers—‘Dose Banding’ ’’ issued on 

July 21, 2022 (87 FR 43533). FDA 

considered comments received on the 

draft guidance as it developed the final 

guidance. Changes from the draft 

guidance are primarily intended to 

improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Human 

Prescription Drug and Biological 

Products—Labeling for Dosing Based on 

Weight or Body Surface Area for Readyto-Use Containers—‘Dose Banding.’ ’’ 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 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by Office of Management Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 201 have been approved 

under OMB control number 0910–0572; 

the collections of information in 21 CFR 

part 314 have been approved under 

OMB control number 0910–0001; and 

the collections of information in 21 CFR 

part 601 have been approved under 

OMB control number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

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

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: September 26, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21558 Filed 9–29–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Regional Pediatric Pandemic Network 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Announcing supplemental 

funding for Regional Pediatric Pandemic 

Network award recipients in Maryland 

and Ohio. 

SUMMARY: HRSA provided additional 

award funds to the two Regional 

Pediatric Pandemic Network (RPPN) 

Program recipients in Maryland and 

Ohio with periods of performance 

ending in fiscal year 2024. 

FOR FURTHER INFORMATION CONTACT: Sara 

Kinsman, MD, Director, Division of 

Child, Adolescent and Family Health, 

Maternal and Child Bureau, Health 

Resources and Services Administration, 

at SKinsman@hrsa.gov and 301–443– 

2250. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient(s) of the Award: 

The two award recipients of the HRSA 

Regional Pediatric Pandemic Network 

Program are Children’s National 

Medical Center in Maryland, and 

University Hospitals Cleveland Medical 

Center in Ohio, as listed in Table 1. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 67767 

TABLE 1—RECIPIENTS AND SUPPLEMENT AWARD AMOUNTS

Grant No. Award recipient name City, state Award amount 

U1IMC45814 .................................................. Children’s National Medical Center .................................................... MD $400,000 

U1IMC43532 .................................................. University Hospitals Cleveland Medical Center ................................. OH 400,000 

Amount of Non-Competitive 

Award(s): Two awards at $400,000 per 

grant recipient totaling $800,000. 

Project Period: September 1, 2023, to 

August 31, 2024. 

Assistance Listing (CFDA) Number: 

93.110. 

Award Instrument: Supplement for 

RPPN support services. 

Justification: Approximately $400,000 

in supplemental funding has been 

awarded to each RPPN cooperative 

agreement recipient to increase 

activities to coordinate among the 

nation’s pediatric hospitals and their 

communities to prepare for and respond 

to global health threats and coordinate 

research-informed responses to future 

pandemics. Projects approved by HRSA 

under this supplement are to be 

performed from the date of award 

through August 31, 2024. 

Carole Johnson, 

Administrator. 

[FR Doc. 2023–21670 Filed 9–29–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Charter Renewal for the Advisory 

Committee on Infant and Maternal 

Mortality 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, the 

Department of Health and Human 

Services is giving notice that the 

Advisory Committee on Infant and 

Maternal Mortality (ACIMM or 

Committee) is renewed. The effective 

date of the charter renewal is September 

30, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Vanessa Lee, MPH, Designated Federal 

Official, Maternal and Child Health 

Bureau, HRSA, 5600 Fishers Lane, 

Room 18N84, Rockville, Maryland 

20857; 301–443–0543; or VLee1@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACIMM is 

authorized by section 222 of the Public 

Health Service Act (42 U.S.C. 217a), as 

amended. The Committee is governed 

by provisions of Public Law 92–463, as 

amended (5 U.S.C. 10), which sets forth 

standards for the formation and use of 

Advisory Committees. ACIMM advises 

the Secretary of Health and Human 

Services on department activities, 

partnerships, policies, and programs 

directed at reducing infant mortality, 

maternal mortality and severe maternal 

morbidity, and improving the health 

status of infants and women before, 

during, and after pregnancy. The 

Committee provides advice on how best 

to coordinate Federal, State, local, 

Tribal, and Territorial governmental 

efforts designed to improve infant 

mortality, related adverse birth 

outcomes, and maternal health, as well 

as influence similar efforts in the private 

and voluntary sectors. The Committee 

provides guidance and 

recommendations on the policies, 

programs, and resources required to 

address the disparities and inequities in 

infant mortality, related adverse birth 

outcomes and maternal health 

outcomes, including maternal mortality 

and severe maternal morbidity. With its 

focus on underlying causes of the 

disparities and inequities seen in birth 

outcomes for women and infants, the 

Committee advises the Secretary of 

Health and Human Services on the 

health, social, economic, and 

environmental factors contributing to 

the inequities and proposes structural, 

policy and/or systems level changes. 

The charter renewal for ACIMM was 

approved on September 8, 2023. The 

filing date is September 30, 2023. 

Renewal of the ACIMM charter gives 

authorization for the committee to 

operate until September 30, 2025. 

A copy of the ACIMM charter is 

available on the ACIMM website at 

https://www.hrsa.gov/advisorycommittees/infant-mortality/index.html. 

A copy of the charter also can be 

obtained by accessing the FACA 

database that is maintained by the 

Committee Management Secretariat 

under the General Services 

Administration. The website address for 

the FACA database is http://

www.facadatabase.gov/. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–21716 Filed 9–29–23; 8:45 am] 

BILLING CODE 4165–15–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: Cardiovascular and 

Respiratory Sciences Integrated Review 

Group, Therapeutic Development and 

Preclinical Studies Study Section. 

Date: October 25–26, 2023. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW, 

Washington, DC 20015. 

Contact Person: Richard D Schneiderman, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4138, 

Bethesda, MD 20817, 301–402–3995, 

richard.schneiderman@nih.gov. 

Name of Committee: Interdisciplinary 

Molecular Sciences and Training Integrated 

Review Group, Cellular and Molecular 

Technologies Study Section. 

Date: October 25–26, 2023. 

Time: 9:00 a.m. to 8:00 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: Tatiana V Cohen, Ph.D., 

Scientific Review Officer, Center for 


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