42730 Federal Register / Vol. 87, No. 136 / Monday, July 18, 2022 / Notices 

• 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– 

2022–N–1366 for ‘‘Data Standards; 

Requirement Begins for the Clinical 

Data Interchange Standards Consortium 

Versions 1.2 and 1.3 of the Analysis 

Data Model Implementation Guide.’’ 

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, 

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FOR FURTHER INFORMATION CONTACT: 

CDER: Helena Sviglin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1117, 

Silver Spring, MD 20993–0002, 240– 

402–6511, cderdatastandards@

fda.hhs.gov. 

CBER: 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: FDA’s 

CBER and CDER are issuing this Federal 

Register notice to announce the date 

that support begins for versions 1.2 and 

1.3 of the CDISC ADaMIG and the date 

that this version update is required in 

certain submissions. The FDA guidance 

for industry ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data’’ (June 2021) 

(eStudy Data guidance), posted on 

FDA’s Study Data Standards Resources 

web page at https://www.fda.gov/ 

forindustry/datastandards/studydata

standards/default.htm, implements the 

electronic submission requirements of 

section 745A(a) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

379k–1(a)) for study data contained in 

NDAs, ANDAs, certain BLAs, and 

certain INDs submitted to CDER or 

CBER by specifying the format for 

electronic submissions. The eStudy Data 

guidance states that a Federal Register 

notice will specify any new standards 

and version updates to FDA-supported 

study data standards that will be added 

to the Catalog, when the support for 

such standards and version updates 

begins or ends, and when the 

requirement to use such standards and 

version updates in submissions begins 

or ends. 

Support for versions 1.2 and 1.3 of the 

CDISC ADaMIG begins July 18, 2022. 

The transition date for this version 

update is March 15, 2023. The 

requirement for electronic submissions 

to be submitted using versions 1.2 and 

1.3 of the CDISC ADaMIG is March 15, 

2024, for NDAs, ANDAs, certain BLAs, 

and certain INDs. 

Dated: July 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–15248 Filed 7–15–22; 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. This 

Federal Register notice seeks public 

comment on the revision recently 

submitted to OMB for review and 

approval. These comments will be 

reviewed and taken into consideration if 

the Department intends to make any 

revisions to the information collection 

request approved under [0990–0476]. 

Interested persons are invited to submit 

comments regarding the aforementioned 

non-substantive changes or any other 

aspect of this collection of information, 

including: the necessity and utility of 

the proposed information collection for 

the proper performance of the agency’s 

functions, the accuracy of the estimated 

burden, ways to enhance the quality, 

utility and clarity of the information to 

be collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments on the ICR must be 

received on or before August 17, 2022. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice. To be assured consideration, 

comments and recommendations must 

be submitted www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 264–0041. When submitting 

comments or requesting information, 

please include the document identifier 

0990–0476–30D and project title for 

reference. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 136 / Monday, July 18, 2022 / Notices 42731 

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: Revision. 

OMB No. 0990–0476—Office of the 

Assistant Secretary for Public Affairs 

(ASPA) within Office of the Secretary. 

Abstract 

The Office of the Assistant Secretary 

for Public Affairs (ASPA), U.S. 

Department of Health and Human 

Services (HHS) is requesting a revision 

on a currently approved collection 

including three components: 1. Current 

Events Tracker (CET), 2. Qualitative 

data collection in the form of focus 

groups, interviews, and dyads, and 3. 

Copy testing surveys. This revision 

supports continuation of the approved 

data collection by adding burden and 

iterations to support the program during 

the ongoing COVID–19 public health 

emergency and through the expiration 

of the package 0990–0476 in early 2024. 

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 and uptake, 

familiarity with and trust in HHS and 

other trusted messengers, and the 

impact of external events on key 

attitudes and behaviors. This 

information will inform Campaign 

development and execution including 

changes in messaging strategies 

necessary to effectively reach the entire 

U.S. population or specific subgroups. 

Focus Groups/Interviews/Dyads 

ASPA is collecting information 

qualitatively 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, interviews, and/or dyads will 

provide in-depth insights 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. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Form name Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

CET ................................................... CET Questionnaire ........................... a 138,000 1 7.2/60 16,560 

Foundational Focus Groups, Interviews, and/or Dyads b.Screener and Interview .................... c 50,000 1 9.3/60 7,750 

Copy Testing Survey ........................ Screener and Survey ....................... d 540,000 1 3.78/60 34,020 

Sum of All Studies ..................... ........................................................... 728,000 ........................ ........................ 58,330 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2022–15235 Filed 7–15–22; 8:45 am] 

BILLING CODE 4150–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review 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: Center for Scientific 

Review Special Emphasis Panel; 

Neurobiology of Pain and Itch. 

Date: July 29, 2022. 

Time: 1:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: M. Catherine Bennett, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5182, 

MSC 7846, Bethesda, MD 20892, (301) 435– 

1766, bennettc3@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: July 13, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–15283 Filed 7–15–22; 8:45 am] 

BILLING CODE 4140–01–P 


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