Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices 60217 

Dated: August 28, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18841 Filed 8–30–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2024] 

Enhanced Drug Distribution Security at 

the Package Level Under the Drug 

Supply Chain Security Act; Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Enhanced Drug Distribution Security at 

the Package Level Under the Drug 

Supply Chain Security Act.’’ This 

guidance clarifies the enhanced drug 

distribution security requirements listed 

in the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). In addition, this 

guidance outlines and makes 

recommendations on the system 

attributes necessary to enable secure 

tracing of product at the package level, 

including allowing for the use of 

verification, inference, and aggregation, 

as necessary. This guidance finalizes the 

draft guidance of the same title issued 

on June 4, 2021. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 31, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2020–D–2024 for ‘‘Enhanced Drug 

Distribution Security at the Package 

Level Under the Drug Supply Chain 

Security Act.’’ 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, 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. 

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 to 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: 

Abha Kundi, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3130, drugtrackandtrace@

fda.hhs.gov; 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 

‘‘Enhanced Drug Distribution Security at 

the Package Level Under the Drug 

Supply Chain Security Act.’’ The Drug 

Supply Chain Security Act (DSCSA) 

(Title II of Pub. L. 113–54) was signed 

into law on November 27, 2013. 

The DSCSA outlines critical steps to 

achieve electronic pharmaceutical 

supply chain interoperability by 

November 27, 2023, that will enhance 


ddrumheller on DSK120RN23PROD with NOTICES1
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