
[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71875-71876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22966]


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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.

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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, 
[email protected].

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

[[Page 71876]]

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[supreg]) 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\
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                                                   Number of
 Type of respondent/interview      Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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Content Validity--Digital                  175               1             175  0.25 (15                      44
 Survey Arm.                                                                     minutes).
Content Validity--Digital                   25               1              25  1.5 (90 minutes)              38
 Survey and Cognitive
 Interview Arm.
Reliability Survey Arm--                   250               1             250  0.33 (20                      83
 Digital Survey.                                                                 minutes).
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    Total.....................             450  ..............             450  ................             165
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\1\ There 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


