30058 Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 

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draft guidance contains no collection of 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 guidance at https://

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

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

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

www.regulations.gov. 

Dated: May 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11735 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–2018–D–3175] 

Product Identifiers Under the Drug 

Supply Chain Security Act: Questions 

and Answers; 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 entitled ‘‘Product Identifiers 

Under the Drug Supply Chain Security 

Act: Questions and Answers.’’ The 

guidance is intended to address 

questions regarding product identifiers 

that, under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) as amended 

by the Drug Supply Chain Security Act 

(DSCSA), are required to be affixed to, 

or imprinted on, packages and 

homogenous cases of certain drug 

products intended to be introduced in a 

transaction into commerce. This 

guidance is intended to clarify FDA’s 

interpretation of these requirements, 

including as they relate to the linear 

barcode requirements under the Code of 

Federal Regulations. This guidance 

finalizes the draft guidance issued on 

September 20, 2018. 

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 

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– 

2018–D–3175 for ‘‘Product Identifiers 

Under the Drug Supply Chain Security 

Act: Questions and Answers.’’ 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 the 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. Send one self-addressed adhesive 

label to assist the office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: Tia 

Harper-Velazquez, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4262, 

Silver Spring, MD 20993–0002, 301– 

796–3130. 

SUPPLEMENTARY INFORMATION: 

Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 30059 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Product Identifiers Under the Drug 

Supply Chain Security Act: Questions 

and Answers.’’ The DSCSA (Title II of 

Pub. L. 113–54) was signed into law on 

November 27, 2013. Section 202 of the 

DSCSA, which added sections 581 and 

582 to the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

360eee and 360eee–1), set forth new 

definitions and requirements for 

manufacturers, repackagers, wholesale 

distributors, and dispensers to facilitate 

the tracing of product through the 

pharmaceutical distribution supply 

chain. 

A product identifier is defined under 

section 581(14) of the FD&C Act as a 

standardized graphic that includes the 

product’s standardized numerical 

identifier (composed of the National 

Drug Code and a unique alphanumeric 

serial number), lot number, and 

expiration date, in both human- and 

machine-readable formats. Under 

sections 582(b)(2)(A) and 582(e)(2) of 

the FD&C Act, respectively, 

manufacturers and repackagers are 

required to ‘‘affix or imprint a product 

identifier to each package and 

homogenous case of a product intended 

to be introduced in a transaction into 

commerce.’’ 

In the Federal Register of September 

20, 2018 (83 FR 47626), FDA announced 

the availability of the draft guidance of 

the same title dated September 20, 2018. 

FDA received several comments on the 

draft guidance and considered those 

comments as we finalized the guidance. 

Among the key substantive changes, we 

revised the recommendations regarding 

the expiration date format—specifically, 

we no longer recommend using a space 

between the day, month, and year; we 

now recommend using a hyphen or 

forward slash between the expiration 

date elements. In addition, we also 

modified our statements regarding use 

of the human-readable GS1 Global 

Trade Identification Number to explain 

the importance of the three segment 

NDC format for patient safety. We also 

clarified how to affix or imprint 

multiple barcodes on the label with 

sufficient space to avoid confusion in 

reading or scanning. We made 

additional, editorial changes to improve 

clarity. The guidance announced in this 

notice finalizes the draft guidance dated 

September 20, 2018. 

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 ‘‘Product Identifiers 

Under the Supply Chain Security Act: 

Questions and Answers.’’ 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 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 guidance at either 

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

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

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

www.regulations.gov. 

Dated: May 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–11733 Filed 6–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0476] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before July 6, 2021. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0476, and 

project title for reference, to Sherrette 

Funn, the Reports Clearance Officer, 

Sherrette.funn@hhs.gov, or call 202– 

795–7714. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (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. 

Title of the Collection: ASPA COVID– 

19 Public Education Campaign Market 

Research. 

Type of Collection: OMB #0990–0476. 

Abstract: U. S. Department of Health 

and Human Services (HHS), the Office 

of the Secretary, the Office of the 

Assistant Secretary for Public Affairs 

(ASPA), is requesting an extension on a 

currently approved collection that 

includes three components: 1. COVID– 

19 Current Events Tracker; 2. 

Foundational Focus Groups; and 3. 

Copy Testing Surveys. Together, these 

efforts support the development and 

execution of the COVID–19 Public 

Education Campaign. The broad 

purpose of each effort is as follows: 

Current Events Tracker 

The primary purpose of the COVID– 

19 Current Events Tracker (CET) survey 

is to continuously track key metrics of 

importance to the Campaign, including 

vaccine confidence, familiarity with and 

trust in HHS, and the impact of external 

events on key attitudes and behaviors. 

Tracking Americans’ attitudes about, 

perceptions of, and behavior toward the 

COVID–19 pandemic will inform the 

Campaign of key metrics around vaccine 

confidence and uptake, as well as 

towards vaccine messengers such as 

HHS and key public health officials. It 

will also inform changes in messaging 

strategies necessary to effectively reach 

the entire U.S. population or specific 

subgroups. 

The weekly tracking of this 

information will be critical for the 

Campaign’s ability to respond to shifting 

events and attitudes in real-time, 

helping guide the American public with 

accurate information about the vaccine 

rollout as well as on how to take 

protective actions. 

Foundational Focus Groups 

ASPA is collecting information 

through the COVID–19 Public Education 

Campaign Foundational Focus Groups 

to inform the Campaign about audience 

risk knowledge, perceptions, current 

behaviors, and barriers and motivators 

to healthy behaviors (including COVID– 

19 vaccination). Ultimately these focus 

groups will provide in-depth insights