Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 30053 

meeting all programmatic goals under 

the current SMP grant. 

Dated: May 26, 2021. 

Alison Barkoff, 

Acting Administrator and Assistant Secretary 

for Aging. 

[FR Doc. 2021–11779 Filed 6–3–21; 8:45 am] 

BILLING CODE 4154–01–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; Draft 

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 draft 

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) 

outlines critical enhanced drug 

distribution security requirements for 

building an electronic, interoperable 

system by November 27, 2023, that will 

identify and trace certain prescription 

drugs at the package level as they are 

distributed within the United States. 

This draft guidance clarifies these 

requirements and provides 

recommendations on the system 

attributes necessary to enable the secure 

tracing of product at the package level, 

including allowing for the use of 

verification, inference, and aggregation, 

as necessary. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 3, 2021 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 draft 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 draft 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 Stephen Ripley, 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 draft guidance for industry entitled 

‘‘Enhanced Drug Distribution Security at 

the Package Level Under the Drug 

Supply Chain Security Act.’’ 

30054 Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 

The DSCSA (Title II of Pub. L. 113– 

54) was signed into law on November 

27, 2013. The DSCSA outlines critical 

steps for building an electronic, 

interoperable system by November 27, 

2023, that will identify and trace 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. 360eee– 

1), 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 a 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 the oversight of trading 

partners in the supply chain that are 

involved in the manufacturing, 

repackaging, wholesale distribution, 

warehousing or logistical activities, or 

dispensing of prescription drugs. The 

gradual implementation of the DSCSA 

requirements for product tracing, 

product identification, authorized 

trading partners, and verification 

facilitates the development of an 

electronic, interoperable system to 

enhance the security of the 

pharmaceutical distribution supply 

chain. 

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

forth the general requirements for 

enhanced drug distribution security, 

including: 

• 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; and 

• systems and processes needed to 

promptly respond in the event of a 

recall or to investigate suspect and 

illegitimate products. 

This draft guidance clarifies the 

enhanced drug distribution 

requirements and 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 draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This draft guidance, when finalized, 

will represent the current thinking of 

FDA on enhanced drug distribution 

security at the package level under the 

DSCSA. 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 draft guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR 211.132 for 

tamper-evident packaging of a drug 

product have been approved under 

OMB control number 0910–0139. The 

collections of information in 21 CFR 

201.57 for establishing 

anticounterfeiting technologies, such as 

physical-chemical identifiers, have been 

approved under 0910–0572. The 

collections of information for 

identifying suspect drug product have 

been approved under OMB control 

number 0910–0806. The collections of 

information for establishing: (1) An 

electronic, interoperable system and (2) 

system attributes necessary for enabling 

the secure tracing of drug product have 

been approved under OMB control 

number 0910–0859. 

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/ 

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

www.regulations.gov. 

Dated: May 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11734 Filed 6–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0609] 

Drug Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification; 

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 ‘‘Drug 

Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification.’’ The 

guidance addresses provisions in the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), as amended by the Drug 

Supply Chain Security Act (DSCSA). 

The guidance is intended to aid certain 

trading partners (manufacturers, 

repackagers, wholesale distributors, and 

dispensers) in identifying a suspect 

product and specific scenarios that 

could significantly increase the risk of a 

suspect product entering the 

pharmaceutical distribution supply 

chain. The guidance also describes how 

trading partners should notify FDA of 

illegitimate product and sets forth a 

process for terminating notifications of 

illegitimate product in consultation 

with FDA. In addition, this guidance 

describes when manufacturers should 

notify FDA of a high risk that a product 

is illegitimate. This guidance responds 

to comments from stakeholders in order 

to clarify certain points and finalizes the 

remaining draft portion of the final 

guidance for industry entitled ‘‘Drug 

Supply Chain Security Act 

Implementation: Identification of 

Suspect Product and Notification,’’ 

issued in December 2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 4, 2021. 

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