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the availability of the draft guidance of 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draft guidance and considered those 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notice finalizes the draft guidance dated 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 

30060 Federal Register / Vol. 86, No. 106 / Friday, June 4, 2021 / Notices 

regarding information needed by 

Campaign audiences as well as their 

attitudes and behaviors related to 

COVID–19 and the COVID–19 vaccines. 

These will be used to inform the 

development of Campaign messages and 

strategy. 

Copy Testing Surveys 

Prior to placing Campaign 

advertisements in market, ASPA will 

conduct copy testing surveys to ensure 

the final Campaign messages have the 

intended effect on target attitudes and 

behaviors. Copy testing surveys will be 

conducted with sample members who 

comprise the target audiences; these 

surveys will assess perceived 

effectiveness of the advertisements as 

well as the effect of exposure to an ad 

on key attitudes and behavioral 

intentions. The results from these 

surveys will be used internally by ASPA 

to inform decisions on Campaign 

messages and materials; for example, to 

identify revisions to the materials or 

determine which advertisement to move 

to market. 

Need and Proposed Use: In light of 

the current COVID–19 crisis, this 

information is needed given the impact 

of the pandemic on the nation. The 

Secretary of the Department of Health 

and Human Services (HHS) has declared 

a public health emergency effective 

January 27, 2020, under section 319 of 

the Public Health Service Act (42 U.S.C. 

247d [1]) and renewed it continually 

since its issuance (see links to the 

determination here and here). 

Additionally, in accordance with 5 CFR 

1320.13, HHS previously requested 

emergency submissions (sections 1320 

(a)(2)(ii) and (2)(iii) of the federal 

regulations. 

ESTIMATED ANNUALIZED BURDEN HOUR TABLE

CET Foundational 

focus groups 

Copy testing 

survey 

Hours to screen ........................................................................................................................... N/A .09 0.03 

Screening completes (per wave) ................................................................................................. N/A 2,500 6,700 

Screening participants (total/screened out) ................................................................................. N/A 20,000/19,136 53,600/45,600 

Hours to complete survey/group ................................................................................................. 0.12 1.5 0.33 

Participants (per wave/round) ...................................................................................................... 1,000 108 1,000 

Number of waves/rounds ............................................................................................................. 92 8 8 

Burden per wave/round ............................................................................................................... 120 387 330 

Total participants .................................................................................................................. 92,000 864 8,000 

Total respondents * ............................................................................................................... 92,000 20,000 53,600 

Total burden hours ............................................................................................................... 11,040 3,096 4,248 

* Total respondents = total participants for each effort + total people screened out. 

Sum of All Studies 

Total Respondents: 165,600. 

Total Burden Hours: 18,384. 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2021–11723 Filed 6–3–21; 8:45 am] 

BILLING CODE 4150–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) 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 

Allergy and Infectious Diseases Special 

Emphasis Panel; Integrated Preclinical/ 

Clinical AIDS Vaccine Development Program 

(IPCAVD) (U19 Clinical Trial Not Allowed). 

Date: June 30, 2021. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G36, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Poonam Pegu, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, 5601 

Fishers Lane, MSC–9823, Rockville, MD 

20892, 240–292–0719, poonam.pegu@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: May 28, 2021. 

Tyeshia M. Roberson, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–11711 Filed 6–3–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 10(d) 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 on 

Alcohol Abuse and Alcoholism Special 

Emphasis Panel; SARS-CoV–2, COVID–19 

and Consequences of Alcohol Use (RFA AA 

21–002, AA 21–003 and AA21–004). 

Date: July 15–16, 2021. 

Time: 9:00 a.m. to 6:00 p.m.