60218 Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices 

the identification and tracing of certain 

prescription drugs as they are 

distributed within the United States. 

Section 202 of the DSCSA added section 

582 to the FD&C Act (21 U.S.C. 360eee1), which established product tracing, 

product identifier, authorized trading 

partner, and verification requirements 

for manufacturers, repackagers, 

wholesale distributors, and dispensers 

to facilitate the tracing of products 

through the pharmaceutical distribution 

supply chain. Section 582 of the FD&C 

Act also imposed requirements for 

enhanced drug distribution security that 

go into effect on November 27, 2023. 

Trading partners, along with Federal 

and State authorities, have an important 

role in ensuring the quality of 

prescription drugs and protecting the 

integrity of the pharmaceutical 

distribution supply chain. The DSCSA 

requirements, which have been phased 

in since 2013, improve supply chain 

security activities by trading partners 

involved in prescription drug 

manufacturing, repackaging, wholesale 

distribution, warehousing or related 

logistical activities, and dispensing. The 

gradual implementation of the DSCSA 

requirements for product tracing, 

product identification, authorized 

trading partners, and verification 

facilitates the development of electronic 

interoperability to enhance the security 

of the pharmaceutical distribution 

supply chain. 

Section 582(g)(1) of the FD&C Act sets 

forth the requirements for enhanced 

drug distribution security as of 

November 27, 2023, including (as 

described in that provision and 

generally summarized here): 

• The exchange of transaction 

information and transaction statements 

in a secure, interoperable, electronic 

manner. 

• Transaction information that 

includes the product identifier at the 

package level for each package included 

in the transaction. 

• Systems and processes for 

verification of product at the package 

level. 

• Systems and processes needed to 

promptly respond to requests from FDA 

(or other appropriate Federal or State 

officials) for product transaction 

information in the event of a recall or 

to investigate suspect and illegitimate 

products. 

This guidance clarifies the enhanced 

drug distribution security requirements 

and pursuant to section 582(h)(3) of the 

FD&C Act describes recommendations 

for system attributes necessary for 

enhanced product tracing and enhanced 

verification, including when the use of 

aggregation and inference may be 

appropriate. 

This guidance finalizes the draft 

guidance entitled ‘‘Enhanced Drug 

Distribution Security at the Package 

Level Under the Drug Supply Chain 

Security Act’’ issued on June 4, 2021 (86 

FR 30053). FDA considered comments 

received on the draft guidance as the 

guidance was finalized. Changes from 

the draft to the final guidance include 

removal of the term ‘‘enhanced system’’ 

when referring to the requirements in 

section 582(g) of the FD&C Act to avoid 

confusion and clarification of 

recommendations addressing (1) 

reconciliation of transaction 

information, (2) aggregation and 

inference, and (3) verification of 

saleable returns, including a brief 

discussion of the sunset provisions of 

section 582(k) of the FD&C Act. Changes 

also include clarification of 

requirements for provision of certain 

information in response to requests 

stemming from investigation of suspect 

or illegitimate product. In addition, 

editorial changes were made 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 ‘‘Enhanced Drug 

Distribution Security at the Package 

Level Under the Drug Supply Chain 

Security 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 

This guidance includes information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). FDA intends to solicit public 

comment and obtain OMB approval for 

any information collections 

recommended in this guidance that are 

new or that would represent substantive 

or material modifications to those 

previously approved collections of 

information found in FDA regulations or 

guidance. 

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: August 28, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18831 Filed 8–30–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Supporting Healthy Start Performance 

Project 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Announcing period of 

performance supplement for the 

Supporting Healthy Start Performance 

Project (SHSPP) recipient. 

SUMMARY: HRSA will provide 

supplemental award funds to the 

current SHSPP recipient, in fiscal year 

2023 to provide new and continued 

support to Healthy Start grant 

recipients. 

FOR FURTHER INFORMATION CONTACT: 

Rochelle Logan, Healthy Start Team 

lead, Division of Healthy Start and 

Perinatal Services, Maternal and Child 

Health Bureau, Health Resources and 

Services Administration, at rlogan@

hrsa.gov or (301) 443–0543. 

SUPPLEMENTARY INFORMATION: 

Amount of Non-Competitive 

Award(s): One award for $1,900,000. 

Project Period: June 1, 2023, to May 

31, 2024. 

Assistance Listing (CFDA) Number: 

93.926. 

Award Instrument: Supplement. 

Authority: 42 U.S.C. 254c–8 (title III, 

section 330H of the Public Health 

Service Act). 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices 60219 

TABLE 1—RECIPIENTS AND AWARD AMOUNTS

Grant No. Award recipient name City, state Award 

amount 

UF5MC32750 .......................... National Institute for Children’s Health Quality ........................ Boston, MA ............................. $1,900,000 

Justification: HRSA will provide 

supplemental award funds to the 

current SHSPP recipient in fiscal year 

2023 to provide new and continued 

support to Healthy Start grant 

recipients. The current recipient of the 

SHSPP is best positioned to address the 

objectives that to be supported by the 

supplemental funds, including 

supporting data collection and 

evaluation and implementing applicable 

Executive Orders. 

Carole Johnson, 

Administrator. 

[FR Doc. 2023–18798 Filed 8–30–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

HRSA-Initiated Supplemental Funding 

to the Supporting Maternal Health 

Innovation Program 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of supplemental award. 

SUMMARY: HRSA is providing 

supplemental funds not to exceed 

$1,500,000 to the Supporting Maternal 

Health Innovation Program, also 

referred to as the Maternal Health 

Learning and Innovation Center 

(MHLIC), in fiscal year (FY) 2023 to 

provide support and capacity building 

to HRSA’s new maternal health award 

recipients under the State Maternal 

Health Innovation (MHI) Program 

(HRSA–23–108). 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Sherman, Chief, Maternal and 

Women’s Health Branch, Division of 

Healthy Start and Perinatal Services, 

Maternal and Child Health Bureau, 

HRSA, at ksherman@hrsa.gov or (301) 

443–1702. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of the Award: One 

award to the University of North 

Carolina at Chapel Hill, the current 

recipient under the Supporting Maternal 

Health Innovation Program, now known 

as MHLIC, as listed in Table 1. 

Amount of Non-Competitive Award: 

Up to $1,500,000. 

Project Period: September 30, 2019, to 

September 29, 2024. 

CFDA Number: 93.110. 

Award Instrument: Supplement. 

Authority: 42 U.S.C. 701(a)(2) (title V, 

section 501(a)(2) of the Social Security 

Act). 

TABLE 1—SUPPORTING MHI PROGRAM AWARD RECIPIENT (2019–2024) 

Grant No. Grantee organization City, state Award 

amount 

U7CMC33636 University of North Carolina at Chapel Hill ..................................................................................... Raleigh, NC ... $1,500,000 

Justification: The Consolidated 

Appropriations Act, 2023 (Pub. L. 117– 

328) included additional Special 

Projects of Regional and National 

Significance funding. The Explanatory 

Statement accompanying the 

Consolidated Appropriations Act 

specified a $26 million increase for the 

State MHI Program to establish new 

cooperative agreements in FY 2023 with 

up to 23 new states. MHLIC provides 

support and capacity building to 

HRSA’s maternal health award 

recipients. Supplemental funds to 

MHLIC will be used to provide support 

and capacity building to the new cohort 

of FY 2023 State MHI award recipients. 

The requested activities are within 

scope of the Supporting Maternal Health 

Innovation Program. 

Carole Johnson, 

Administrator. 

[FR Doc. 2023–18799 Filed 8–30–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney 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 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; NIDDK SEP High 

Risk Multi-Center Clinical Study Cooperative 

Agreement U01. 

Date: September 28, 2023. 

Time: 12:00 p.m. to 1:00 p.m. 

Agenda: To review and evaluate 

cooperative agreement applications. 

Place: National Institutes of Health, 

NIDDK, Democracy II, Suite 7000A, 6707 

Democracy Boulevard, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Cheryl Nordstrom, Ph.D., 

MPH, Scientific Review Officer, NIDDK/ 

Scientific Review Branch, National Institutes 

of Health, 6707 Democracy Blvd., Room 

7013, Bethesda, MD 20892, 301–402–6711, 

cheryl.nordstrom@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 


ddrumheller on DSK120RN23PROD with NOTICES1