Notice2023-22966
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 18, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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."
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 200 (Wednesday, October 18, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71875-71876]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22966]
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#f0a0a2b1a384919696b0969491de989883de979f86"><span class="__cf_email__" data-cfemail="d484869587a0b5b2b294b2b0b5fabcbca7fab3bba2">[email protected]</span></a>.
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\
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent/interview Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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).
---------------------------------------------------------------------------------
Total..................... 450 .............. 450 ................ 165
----------------------------------------------------------------------------------------------------------------
\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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on October 18, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.