Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 71875 

Labeling/RulesRegulationsGuidance/ 

default.htm, or https:// 

www.regulations.gov. 

Dated: October 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22976 Filed 10–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3595] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Improving the 

Quality and Representativeness of the 

Treatment Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification 

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 and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on a proposed 

information collection entitled 

‘‘Improving the Quality and 

Representativeness of the Treatment 

Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification.’’ 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

December 18, 2023. 

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 

December 18, 2023. 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 

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– 

2023–N–3595 for ‘‘Improving the 

Quality and Representativeness of the 

Treatment Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification.’’ 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 

before submitting the collection to OMB 

for approval. To comply with this 


ddrumheller on DSK120RN23PROD with NOTICES1
71876 Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 

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. 

Improving the Quality and 

Representativeness of the Treatment 

Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format To Minimize 

Misclassification 

OMB Control Number 0910–NEW 

FDA has a need for valid, high-quality 

surveillance data on misuse of 

pharmaceutical products and use of 

other substances in the United States. 

FDA is funding the evaluation and 

improvement of the data validity and 

reliability of the Researched Abuse, 

Diversion and Addiction-Related 

Surveillance (RADARS®) Substance 

Abuse Treatment Center Programs 

Combined (TCPC) survey. The RADARS 

TCPC is comprised of two unique 

programs, the Opioid Treatment 

Program and the Survey of Key 

Informants’ Patients Program. These two 

programs use the same core paper data 

collection form and complement each 

other by providing information from 

patients entering both private and 

public opioid addiction treatment 

programs. Patients enrolling in the 

study complete a self-administered 

anonymous questionnaire, within the 

first week of admission. The objective of 

these programs is to provide timely 

prevalence estimates of abuse of legal 

and illegal opioids and other 

substances, within the past month, 

among patients enrolling in treatment 

primarily for opioid use disorders. 

Surveillance data collected by these 

programs are used by FDA as well as 

researchers, industry, and other public 

health stakeholders to inform policy and 

regulatory decisions. FDA will be 

providing public health expertise on the 

survey validity and reliability questions 

before implementation to ensure that 

they generate quality data. FDA will 

also be providing its expert input on the 

results, analysis, and interpretation, as 

well as how the survey may be 

improved in light of the results. 

This FDA-funded information 

collection will include three survey 

arms, two arms focused on survey 

validity (is the survey measuring what 

it is intended to measure) and the third 

arm focused on survey reliability (do the 

questions consistently produce the same 

results when asked at different time 

points and in a different format). For 

both survey validity arms—a digital 

survey only and digital survey plus 

interview arm—volunteer participants 

will be asked to pause after answering 

each survey question to answer a series 

of content validation questions 

concerning comprehension and quality 

of survey items. Items assessed will 

include survey instructions, active 

pharmaceutical ingredient and product 

content, reason for use, and route of 

administration. For the survey 

reliability arm, TCPC paper survey 

participants at selected sites will be 

invited to voluntarily participate in a 

second, digital survey, and the results of 

the two survey formats will be 

compared. The data collected through 

the three arms of this information 

collection will be analyzed to validate 

the content of a modified TCPC survey 

and to then determine the reliability 

among a proxy population for the target 

population. Results from the three arms 

will inform the format, structure, and 

wording of the modified digital TCPC 

survey, prior to its launch. 

The annual participant burden hours 

requested are based on the number of 

collections FDA expects the contractor 

to conduct over the requested time 

frame for this clearance. FDA estimates 

the burden of this collection of 

information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of respondent/interview Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Content Validity—Digital Survey Arm .................. 175 1 175 0.25 (15 minutes) .......... 44 

Content Validity—Digital Survey and Cognitive 

Interview Arm.

25 1 25 1.5 (90 minutes) ............ 38 

Reliability Survey Arm—Digital Survey ................ 250 1 250 0.33 (20 minutes) .......... 83 

Total .............................................................. 450 ........................ 450 ....................................... 165 

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

Dated: October 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22966 Filed 10–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0465; FDA–2023– 

N–1529; FDA–2010–N–0583; FDA–2020–N– 

0145; FDA–2023–N–0918; FDA–2014–N– 

1721] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 


ddrumheller on DSK120RN23PROD with NOTICES1