Proposed Data Collection Submitted for Public Comment and Recommendations, 1501-1502 [2025-00166]
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1501
Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices
case, cluster, and outbreak prevention
and control strategies. CRF data
elements and the CRF were designed for
administration via telephone interviews
with individuals ill with
cryptosporidiosis, or their designated
proxy.
CDC requests OMB approval for an
estimated 125 annual burden hours.
Providing information is voluntary, and
there are no costs to respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Form name
Individuals ill with cryptosporidiosis, or their
designated proxy.
CryptoNet Case Report Form ........................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2025–00162 Filed 1–7–25; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–25–1357; Docket No. CDC–2024–
0104]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other federal
agencies the opportunity to comment on
a continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled The Greater
Access and Impact with NAT (GAIN)
Study: Improving HIV Diagnosis,
Linkage to Care, and Prevention
Services with HIV Point-of-Care Nucleic
Acid Tests (NATs). This study will
identify facilitators and barriers with
implementation of HIV point-of-care
(POC) nucleic acid tests (NATs) in
clinical settings, estimate the sensitivity
and specificity of the HIV POC NAT,
and assess the impact of the test in
decreased time to receipt of HIV
prevention and care.
DATES: CDC must receive written
comments on or before March 10, 2025.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:50 Jan 07, 2025
Jkt 265001
Number of
respondents
You may submit comments,
identified by Docket No. CDC–2024–
0104 by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to
the address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road, NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7570; Email: omb@
cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
ADDRESSES:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
500
Number of
responses per
respondent
1
Average
burden per
response
(in hours)
15/60
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
The Greater Access and Impact with
NAT (GAIN) Study: Improving HIV
Diagnosis, Linkage to Care, and
Prevention Services with HIV Point-ofCare Nucleic Acid Tests (NATs) (OMB
Control No. 0920–1357, Exp. 12/31/
2024)—Reinstatement—National Center
for HIV, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC)
Background and Brief Description
HIV prevention and care services can
be improved by the availability of Pointof-care (POC) HIV viral RNA testing in
clinical settings. Viral RNA tests are the
most sensitive HIV tests for the
detection of early infection. The
purpose of this data collection is to
develop feasible and effective models to
integrate HIV POC nucleic acid tests
(NATs) in HIV prevention and treatment
services. The HIV POC NAT can be used
to test persons at high-risk of acquiring
HIV infection to reduce the time
E:\FR\FM\08JAN1.SGM
08JAN1
1502
Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices
between testing in community-based
and clinical-based settings and linkage
to HIV care, ART initiation, and viral
suppression.
Data will be used to compare an HIV
RNA POC NAT to standard lab-based
HIV testing. The data will be analyzed
and disseminated to describe the realworld performance and clinical
usefulness of HIV RNA POC NAT
technology. Data will be gathered
through: clinical site extraction of
electronic medical records for use as a
retrospective baseline comparator after
study implementation; a longitudinal,
prospective study of persons without
HIV seeking HIV testing or PrEP
services; a longitudinal, prospective
study of persons with HIV seeking STI
testing; a randomized clinical trial of
HIV POC NAT or standard of care for
persons with HIV; a survey, interviews,
and focus groups to understand HIV
POC NAT acceptability among persons
without HIV and persons with HIV; an
assessment of the performance of an
HIV POC NAT among persons with HIV;
and an acceptability/feasibility
assessment among clinical and
community providers and costing
analyses.
CDC is requesting OMB approval for
estimated 880 annual burden hours.
There are no costs to respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Participating Clinic ............................
Baseline data collection variables
list.
Monthly study report form ................
Release of information form .............
2
1
2
4
2
850
12
1
15/60
10/60
6
142
Study visit survey .............................
Release of information form .............
850
50
1
1
15/60
10/60
213
8
Study visit survey .............................
Release of information form .............
50
212
1
1
15/60
10/60
13
35
Study visit survey .............................
POC NAT acceptability survey ........
212
500
1
1
15/60
20/60
53
167
Release of information form .............
333
1
10/60
56
Participants in the acceptability/feasibility assessment.
Study visit survey .............................
POC NAT acceptability survey,
focus group, or interview.
333
100
1
1
15/60
1
83
100
Total ...........................................
...........................................................
........................
........................
........................
880
Participants in prospective study of
persons without HIV seeking HIV
testing and/or PrEP services.
Participants in prospective study of
persons with HIV seeking STI testing.
Participants in RCT of POC NAT or
Standard of Care for persons with
HIV.
Participants in survey group examining POC NAT acceptability.
Participants in cross-sectional comparison of several point-of-care
NATs.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2025–00166 Filed 1–7–25; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0435]
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses
per respondent
Number of respondents
Type of respondent
Obesity and Overweight: Developing
Drugs and Biological Products for
Weight Reduction; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
VerDate Sep<11>2014
17:50 Jan 07, 2025
Jkt 265001
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Obesity
and Overweight: Developing Drugs and
Biological Products for Weight
Reduction.’’ This draft guidance
provides recommendations to industry
regarding the development of drugs and
biological products regulated within the
Center for Drug Evaluation and Research
intended for reduction and long-term
maintenance of body weight in patients
with obesity or overweight. This draft
guidance revises and replaces the draft
guidance for industry ‘‘Developing
Products for Weight Management’’
issued in February 2007.
You may submit comments
on any guidance at any time as follows:
SUMMARY:
ADDRESSES:
Submit either electronic or
written comments on the draft guidance
by April 8, 2025 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
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
DATES:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[Federal Register Volume 90, Number 5 (Wednesday, January 8, 2025)]
[Notices]
[Pages 1501-1502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00166]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-1357; Docket No. CDC-2024-0104]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled The Greater Access and Impact with NAT (GAIN) Study: Improving
HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-
of-Care Nucleic Acid Tests (NATs). This study will identify
facilitators and barriers with implementation of HIV point-of-care
(POC) nucleic acid tests (NATs) in clinical settings, estimate the
sensitivity and specificity of the HIV POC NAT, and assess the impact
of the test in decreased time to receipt of HIV prevention and care.
DATES: CDC must receive written comments on or before March 10, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0104 by either of the following methods:
Federal eRulemaking Portal: www.regulations.gov. Follow
the instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.regulations.gov) or by U.S. mail to the address listed
above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road, NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses; and
5. Assess information collection costs.
Proposed Project
The Greater Access and Impact with NAT (GAIN) Study: Improving HIV
Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-
Care Nucleic Acid Tests (NATs) (OMB Control No. 0920-1357, Exp. 12/31/
2024)--Reinstatement--National Center for HIV, Viral Hepatitis, STD,
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention
(CDC)
Background and Brief Description
HIV prevention and care services can be improved by the
availability of Point-of-care (POC) HIV viral RNA testing in clinical
settings. Viral RNA tests are the most sensitive HIV tests for the
detection of early infection. The purpose of this data collection is to
develop feasible and effective models to integrate HIV POC nucleic acid
tests (NATs) in HIV prevention and treatment services. The HIV POC NAT
can be used to test persons at high-risk of acquiring HIV infection to
reduce the time
[[Page 1502]]
between testing in community-based and clinical-based settings and
linkage to HIV care, ART initiation, and viral suppression.
Data will be used to compare an HIV RNA POC NAT to standard lab-
based HIV testing. The data will be analyzed and disseminated to
describe the real-world performance and clinical usefulness of HIV RNA
POC NAT technology. Data will be gathered through: clinical site
extraction of electronic medical records for use as a retrospective
baseline comparator after study implementation; a longitudinal,
prospective study of persons without HIV seeking HIV testing or PrEP
services; a longitudinal, prospective study of persons with HIV seeking
STI testing; a randomized clinical trial of HIV POC NAT or standard of
care for persons with HIV; a survey, interviews, and focus groups to
understand HIV POC NAT acceptability among persons without HIV and
persons with HIV; an assessment of the performance of an HIV POC NAT
among persons with HIV; and an acceptability/feasibility assessment
among clinical and community providers and costing analyses.
CDC is requesting OMB approval for estimated 880 annual burden
hours. There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Participating Clinic.......... Baseline data 2 1 2 4
collection
variables list.
Monthly study 2 12 15/60 6
report form.
Participants in prospective Release of 850 1 10/60 142
study of persons without HIV information
seeking HIV testing and/or form.
PrEP services.
Study visit 850 1 15/60 213
survey.
Participants in prospective Release of 50 1 10/60 8
study of persons with HIV information
seeking STI testing. form.
Study visit 50 1 15/60 13
survey.
Participants in RCT of POC NAT Release of 212 1 10/60 35
or Standard of Care for information
persons with HIV. form.
Study visit 212 1 15/60 53
survey.
Participants in survey group POC NAT 500 1 20/60 167
examining POC NAT acceptability
acceptability. survey.
Participants in cross- Release of 333 1 10/60 56
sectional comparison of information
several point-of-care NATs. form.
Study visit 333 1 15/60 83
survey.
Participants in the POC NAT 100 1 1 100
acceptability/feasibility acceptability
assessment. survey, focus
group, or
interview.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 880
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2025-00166 Filed 1-7-25; 8:45 am]
BILLING CODE 4163-18-P
