Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 1097 

Responses: 30; Total Annual Hours: 

1,790. (For policy questions regarding 

this collection contact: Beverly Boston 

at 410–786–4186.) 

3. Title of Information Collection: 

Behavioral Health Clinic Quality Data 

Reporting; Type of Information 

Collection Request: Revision of an active 

collection of information request; Use: 

This Information Collection concerns 

the Behavioral Health Clinic Quality 

Data Reporting Template (hereinafter 

‘‘Reporting Template’’ or ‘‘Template’’), 

developed in partnership with the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) and 

the Assistant Secretary for Planning and 

Evaluation (ASPE) (collectively, ‘‘the 

Agencies’’). The Reporting Template is 

designed to collect quality measure data 

and to report at the clinic level. The 

Agencies developed the Template to 

provide states and clinics with a 

streamlined and structured tool to 

report quality measures data. The 

Reporting Template aims to eliminate 

the time required for states or clinics to 

develop their own reporting templates 

for quality measure data reporting and 

minimizes inconsistencies in reporting. 

Furthermore, the Reporting Template, 

with its accompanying instructions, 

support an innovative approach to 

improve behavioral health, a key focus 

of health care reform. Form Number: 

CMS–10398 (#48) (OMB control 

number: 0938–1148); Frequency: 

Annual; Affected Public: Private Sector 

(Businesses or other for profits and Not 

for profit institutions) and State, Local, 

or Tribal Governments; Number of 

Respondents: 429; Total Annual 

Responses: 1,009; Total Annual Hours: 

6,814. (For policy questions regarding 

this collection contact: Beverly Boston 

at 410–786–4186.) 

Dated: January 4, 2024. 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–00205 Filed 1–8–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the award 

of the priority review voucher. FDA has 

determined that CASGEVY 

(exagamglogene autotemcel), 

manufactured by Vertex 

Pharmaceuticals, Inc., meets the criteria 

for a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, 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 is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that CASGEVY (exagamglogene 

autotemcel), manufactured by Vertex 

Pharmaceuticals, Inc., meets the criteria 

for a priority review voucher. 

CASGEVY (exagamglogene 

autotemcel) is indicated for treatment of 

sickle cell disease in patients 12 years 

of age and older with recurrent vasoocclusive crises. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/industry/ 

developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For 

further information about CASGEVY 

(exagamglogene autotemcel), go to the 

Center for Biologics Evaluation and 

Research’s Approved Cellular and Gene 

Therapy Products website at https://

www.fda.gov/vaccines-blood-biologics/ 

cellular-gene-therapy-products/ 

approved-cellular-and-gene-therapyproducts. 

Dated: January 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00263 Filed 1–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0987] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Clearance 

for the Collection of Qualitative Data 

on Tobacco Products and 

Communications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the collection of 

qualitative data on tobacco products and 

communications. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

March 11, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 11, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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 


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1098 Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 

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– 

2014–N–0987 for ‘‘Generic Clearance for 

the Collection of Qualitative Data on 

Tobacco Products and 

Communications.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Generic Clearance for the Collection of 

Qualitative Data on Tobacco Products 

and Communications 

OMB Control Number 0910–0796— 

Extension 

This information collection supports 

Food and Drug Administration (FDA, 

us, or we) programs. Under section 

1003(d)(2)(D) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(D)), FDA is authorized to 

conduct educational and public 

information programs. 

In conducting studies relating to the 

regulation and communications related 

to tobacco products, FDA will need to 

employ formative qualitative research 

including but not limited to focus 

groups, usability and/or psychometric 

testing, indepth interviews (IDIs), 

cognitive interviews and asynchronous 

qualitative discussions (e.g., online 

journaling or web-based discussion 

boards), naturalistic observation and 

ethnographic studies to assess 

knowledge and perceptions about 

tobacco-related topics with specific 

target audiences. The information 

collected will serve four major 

purposes. First, foundational research 

will provide critical knowledge and 

insights about intended audiences. FDA 

must first understand people’s 

knowledge of, perceptions of, and 

reactions to tobacco related topics prior 

to developing survey/research questions 

as well as stimuli for experimental 

studies. Second, formative research will 

provide information about people’s 

responses, thoughts, and feelings 

regarding potential creative messaging, 

or stimuli. Third, by collecting 

communications usability information, 

FDA will be able to serve and respond 

to the ever-changing demands of 

consumers of tobacco products. 

Additionally, we will be able to 

determine the best way to communicate 

with intended audiences around 

tobacco prevention and cessation. 

Fourth, cognitive testing will allow FDA 

to assess consumer understanding of 

survey/research questions and study 

stimuli. Focus groups and/or IDIs with 

a sample of the intended audience will 

allow FDA to refine the survey/research 

questions and study stimuli while they 

are still in the developmental stage. 

FDA will collect, and interpret 

information gathered through this 

generic clearance to: (1) better 

understand characteristics of the 

intended audience—its perceptions, 


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Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 1099 

knowledge, attitudes, beliefs, and 

behaviors—and use these in the 

development of appropriate survey/ 

research questions, study stimuli, or 

communications; (2) more efficiently 

and effectively design survey/research 

questions and study stimuli; and (3) 

more efficiently and effectively design 

experimental studies. 

FDA is requesting approval of an 

extension of this generic clearance for 

collecting information using qualitative 

methods (e.g., interviews, focus groups, 

asynchronous discussion boards, etc.) 

for studies involving all tobacco 

products regulated by FDA. This 

information will be used to explore 

concepts of interest and assist in the 

development of quantitative study 

proposals, complementing other 

important research efforts in the 

Agency. This information may also be 

used to help identify and develop 

communication messages, which may 

be used in education campaigns. 

Qualitative research plays an important 

role in gathering information because it 

allows for an indepth understanding of 

individuals’ attitudes, beliefs, 

motivations, and feelings. Qualitative 

research serves the narrowly defined 

need for direct and informal public 

opinion on a specific topic. 

The number of respondents to be 

included in each new study may vary, 

depending on the nature of the study 

(e.g., foundational, formative, etc.), 

approach (synchronous vs. 

asynchronous, or virtual vs. in person) 

and the intended audience. Table 1 

provides examples of the types of 

studies that may be administered and 

estimated burden levels during the 3- 

year period. Time to read, view, or 

listen to the message being tested is 

built into the ‘‘Average Burden per 

Response’’ figures. FDA estimates the 

burden of this collection of information 

as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of Interview Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

In-Person Individual Indepth Interviews ................... 4,500 1 4,500 1 ................................ 4,500 

Indepth Interview Screener ...................................... 22,500 1 22,500 0.083 (5 minutes) ...... 1,875 

Focus Group Screener ............................................ 56,000 1 56,000 0.25 (15 minutes) ...... 14,000 

Focus Group Discussion .......................................... 252,000 1 252,000 1.5 ............................. 378,000 

Discussion Board Screener ..................................... 8,000 1 8,000 0.083 (5 minutes) ...... 667 

Discussion Board Participation ................................ 100 1 100 1.5 ............................. 150 

Total .................................................................. ........................ ........................ ........................ .................................... 399,192 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated burden for the 

information collection reflects an 

overall increase of 384,258 hours and a 

corresponding increase of 314,926 

responses. We attribute this adjustment 

to the number of study responses used 

during the current approval and now 

estimated for the next 3 years. A greater 

number of qualitative studies will be 

conducted over the next 3 years due to 

the need to develop new creative 

messages and content. Recent years 

have seen a dramatic change in media. 

With the shift to digital media, FDA 

must adapt to communicate effectively 

in a digital environment. As digital 

tobacco use prevention/interventions 

are still in their infancy, we must better 

understand the types of digital channels 

available. To impact public health 

outcomes, we need to understand how 

to reach our intended audience. New 

foundational studies are needed 

(including those on digital metrics, 

measurement, and implementation). As 

a result, we have adjusted our burden 

estimate and revised the number of 

respondents to the information 

collection. 

Dated: January 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00221 Filed 1–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3168] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Extralabel Drug 

Use in Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 8, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0325. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Extralabel Drug Use in Animals—21 

CFR Part 530 

OMB Control Number 0910–0325— 

Extension 

This information collection supports 

FDA implementation of section 512 of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 360b), which 

governs new animal drugs. Agency 

regulations in 21 CFR part 530 permit 

FDA, if we find that there is a 

reasonable probability that the 

extralabel use of an animal drug may 

present a risk to public health, to 

establish a safe level for a residue from 


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