Proposed Data Collection Submitted for Public Comment and Recommendations, 83087-83089 [2020-28113]
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Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice.
Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve a new information
collection requirement regarding
documents, records, reports, and
processes associated with determining
compliance with FAR part 25,
Protecting Life in Global Health
Assistance.
SUMMARY:
Submit comments on or before
January 20, 2021.
ADDRESSES: Written comments and
recommendations for this information
collection should be sent within 30 days
of publication of this notice to
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.
Additionally submit a copy to GSA
through https://www.regulations.gov and
follow the instructions on the site. This
website provides the ability to type
short comments directly into the
comment field or attach a file for
lengthier comments.
Instructions: All items submitted
must cite OMB Control No. 9000–0200,
Protecting Life in Global Health
Assistance. Comments received
generally will be posted without change
to https://www.regulations.gov, including
any personal and/or business
confidential information provided. To
confirm receipt of your comment(s),
please check www.regulations.gov,
approximately two to three days after
submission to verify posting. If there are
difficulties submitting comments,
contact the GSA Regulatory Secretariat
Division at 202–501–4755 or
GSARegSec@gsa.gov.
FOR FURTHER INFORMATION CONTACT:
Email FARPolicy@gsa.gov or call 202–
969–4075.
SUPPLEMENTARY INFORMATION:
DATES:
A. OMB Control Number, Title, and
Any Associated Form(s): 9000–0200,
Protecting Life in Global Health.
B. Needs and Uses
The Secretary of State approved on
May 9, 2017, a plan to implement the
manner in which U.S. Government
Departments and Agencies will apply
the provisions of the ‘‘Mexico City
Policy,’’ which was reinstated in the
January 23, 2017 Presidential
Memorandum, to foreign
VerDate Sep<11>2014
00:23 Dec 19, 2020
Jkt 253001
nongovernmental organizations (NGOs)
that receive U.S. funding for global
health assistance; this included the
extension of the policy to Federal
contracts. This clearance covers the
information contractors must keep and
make available to the Government to
comply with the requirements of FAR
clause 52.225–XX.
a. 52.225–XX(c)(2)(i) requires foreign
prime contractors to allow authorized
Government representatives to inspect
documents and materials maintained or
prepared by the Contractor in the usual
course of its operations that describe the
health activities implemented by the
Contractor.
b. 52.225–XX(j)(1)(ii)(A) requires
foreign subcontractors to allow
authorized Government representatives
to inspect documents and materials
maintained or prepared by the
subcontractor in the usual course of its
operations that describe the health
activities of the subcontractor.
c. 52.225–XX(e) requires the
Contractor to provide the Contracting
Officer a request for consent to
subcontract if the contract includes the
clause at FAR 52.244–2, Subcontracts.
d. 52.225–XX(g)(2) requires the
Contractor to provide the Contracting
Officer the results of a subcontractor
review when the Government has
reason to believe that a foreign
subcontractor may have violated the
requirements of this clause.
e. 52.225–XX(j)(2) and (j)(3) requires
the Contractor to review the foreign
subcontractor’s health program to
determine if a violation has occurred,
and to consult with the Contracting
Officer prior to terminating the
subcontract or determining other
corrective action is warranted.
C. Annual Burden
Respondents: 253.
Total Annual Responses: 1,089.
Total Burden Hours: 38,992.
D. Public Comment
A 60-day proposed rule was
published within the proposed FAR rule
(2018–002, Protecting Life in Global
Health) in the Federal Register at 85 FR
56549, on September 14, 2020. Some
comments regarding the Paperwork
Reduction Burden were received;
however, it did not change the estimate
of the burden.
Comment: The proposed rule
provided an estimate of the public
reporting burden for required
information collection of nearly 39,000
total response burden hours. Please
provide the assumptions and
methodology used in calculating this
estimate.
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83087
Response: Requesters may obtain a
copy of the supporting statement from
GSA.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the GSA
Regulatory Secretariat Division, by
calling 202–501–4755 or emailing
GSARegSec@gsa.gov. Please cite OMB
Control No. 9000–0200, Protecting Life
in Global Health.
William F. Clark,
Director,Office of Governmentwide
Acquisition Policy,Office of Acquisition
Policy,Office of Governmentwide Policy.
[FR Doc. 2020–28152 Filed 12–18–20; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-21–21AC; Docket No. CDC–2020–
0110]
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 proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled The GAIN (Greater Access and
Impact with NAT) Study: Improving
HIV Diagnosis, Linkage to Care, and
Prevention Services with HIV Point-ofCare Nucleic Acid Tests (NATs). GAIN
is an implementation study to compare
a point-of-care nucleic acid HIV test
(HIV RNA POC NAT) to standard labbased HIV testing.
DATES: CDC must receive written
comments on or before February 19,
2021.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0110 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
SUMMARY:
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Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices
Disease Control and Prevention, 1600
Clifton Road, NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(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–
D74, Atlanta, Georgia 30329; phone:
404–639–7118; 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.
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;
disproportionately affected populations,
and provide opportunities to approach
the goal of no new HIV infections. The
purpose of this research is to develop
feasible and effective models for using
HIV POC NATs to: (1) Improve PrEP
initiation, and duration of PrEP use,
among persons at high-risk for acquiring
HIV infection; and (2) reduce the time
between testing in community-based
and clinical-based settings and linkage
to HIV care, ART initiation, and viral
suppression.
GAIN is an implementation study to
compare a point-of-care nucleic acid
HIV test (HIV RNA POC NAT) to
standard lab-based HIV testing. Study
activities include: 1. Retrospective
baseline data collection from clinical
site electronic medical records. This
will establish baseline PrEP and HIV
care metrics for comparison after study
implementation; 2. A longitudinal,
prospective study of HIV-negative
patients seeking HIV testing and/or PrEP
services; 3. A longitudinal, prospective
study of HIV-positive patients seeking
STI testing; 4. An RCT of POC NAT or
Standard of Care for HIV-positive
patients; 5. A survey, interviews, and
focus groups examining POC NAT
acceptability among HIV-negative and
HIV-positive patients; 6. A crosssectional comparison of several pointof-care NATs among HIV-positive
patients; 7. Acceptability/feasibility
assessment among clinical and
community providers and costing
analyses. These data will be analyzed
and disseminated to describe the realworld performance and clinical effects
of HIV RNA POC NAT testing
technology. This study will develop
functional models to integrate HIV RNA
POC NAT testing technology into HIV
prevention and treatment services.
There are no costs to respondents other
than their time.
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; and
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.
5. Assess information collection costs.
Proposed Project
The GAIN (Greater Access and Impact
with NAT) Study: Improving HIV
Diagnosis, Linkage to Care, and
Prevention Services with HIV Point-ofCare Nucleic Acid Tests (NATs)—
NEW—National Center for HIV/AIDS,
STD, and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Current rapid point-of-care (POC) HIV
testing technologies do not reliably
detect the earliest HIV infections and
lab-based testing can introduce delays
while patients wait for test results.
During this time, patients can drop out
of care and remain at high-risk to
acquire HIV. Direct molecular detection
of HIV through nucleic acid tests
(NATs) can identify early HIV
infections, which have high potential
for transmission. NATs that are used at
the point-of-care (POC NAT) can
provide results in 60 to 90 minutes.
Obtaining timely molecular test results
from a POC NAT in clinics or
community settings can expand
prevention as well as HIV treatment
services, improve our reach into
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondent
Form name
Participants in prospective study of HIV-negative
patients seeking HIV testing and/or PrEP services.
Consent form ................
HIPPA form ..................
1150
1150
1
1
30/60
10/60
575
192
Release of information
form.
Study visit survey .........
Consent form ................
HIPPA form ..................
Release of information
form.
Study visit survey .........
Consent form ................
HIPPA form ..................
1150
1
10/60
192
1150
125
125
125
1
1
1
1
15/60
30/60
10/60
10/60
288
63
21
21
125
250
250
1
1
1
15/60
30/60
10/60
31
125
42
Participants in prospective study of HIV-positive
patients seeking STI testing.
Participants in RCT of POC NAT or Standard of
Care for HIV-positive patients.
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83089
Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
Participants in survey group examining POC
NAT acceptability.
Participants in cross-sectional comparison of
several point-of-care NATs.
Acceptability/feasibility assessment among clinical and community providers.
Total ...............................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–28113 Filed 12–18–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2020–0122]
Advisory Committee on Immunization
Practices (ACIP); Correction
Notice is hereby given of a change in
the meeting of the Advisory Committee
on Immunization Practices (ACIP);
December 11, 2020, 12:00 p.m.–5:00
p.m., EST; and December 13, 2020,
12:00 p.m.–4:00 p.m., EST (times
subject to change, see the ACIP website
for any updates: https://www.cdc.gov/
vaccines/acip/) which was
published in the Federal Register on
December 9, 2020, Volume 85, Number
237, pages 79814–79815.
The meeting dates and times should
read as follows:
DATES:
The meeting will be held on
December 11, 2020 from 12:00 p.m. to
5:00 p.m., EST and December 12, 2020
from 11:00 a.m. to 3:00 p.m., EST (times
subject to change, see the ACIP website
for any updates: https://www.cdc.gov/
vaccines/acip/).
Written comments must be received
on or before December 14, 2020.
The meeting is open to the public.
FOR FURTHER INFORMATION CONTACT:
Stephanie Thomas, ACIP Committee
Management Specialist, Centers for
Disease Control and Prevention,
National Center for Immunization and
VerDate Sep<11>2014
22:33 Dec 18, 2020
Jkt 253001
Number of
responses per
respondent
Number of
respondents
Form name
Release of information
form.
Study visit survey .........
POC NAT acceptability
survey.
Consent ........................
Release of information
form.
Study visit survey .........
POC NAT acceptability
survey, focus group,
or interview.
.......................................
1
10/60
42
250
87
1
1
15/60
20/60
63
29
250
250
1
1
30/60
10/60
125
42
250
25
1
1
15/60
1
63
25
........................
........................
........................
1,667
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–28091 Filed 12–18–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–20OJ]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘National YRBS
Test-Retest Reliability Study’’ to the
Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on June 2, 2020 to obtain
comments from the public and affected
agencies. CDC received no comments to
Frm 00063
Fmt 4703
Total burden
(in hours)
250
Respiratory Diseases, 1600 Clifton Road,
NE, MS–H24–8, Atlanta, GA 30329–
4027; Telephone: 404–639–8367; Email:
ACIP@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
PO 00000
Average
burden per
response
(in hours)
Sfmt 4703
the 60 day Federal Register Notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) 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;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
E:\FR\FM\21DEN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83087-83089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28113]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-21-21AC; Docket No. CDC-2020-0110]
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 proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled The GAIN (Greater Access and
Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and
Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs).
GAIN is an implementation study to compare a point-of-care nucleic acid
HIV test (HIV RNA POC NAT) to standard lab-based HIV testing.
DATES: CDC must receive written comments on or before February 19,
2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0110 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for
[[Page 83088]]
Disease Control and Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta,
Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (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-D74, Atlanta, Georgia 30329; phone: 404-639-7118; 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; and
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.
5. Assess information collection costs.
Proposed Project
The GAIN (Greater Access and Impact with NAT) Study: Improving HIV
Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-
Care Nucleic Acid Tests (NATs)--NEW--National Center for HIV/AIDS, STD,
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
Current rapid point-of-care (POC) HIV testing technologies do not
reliably detect the earliest HIV infections and lab-based testing can
introduce delays while patients wait for test results. During this
time, patients can drop out of care and remain at high-risk to acquire
HIV. Direct molecular detection of HIV through nucleic acid tests
(NATs) can identify early HIV infections, which have high potential for
transmission. NATs that are used at the point-of-care (POC NAT) can
provide results in 60 to 90 minutes. Obtaining timely molecular test
results from a POC NAT in clinics or community settings can expand
prevention as well as HIV treatment services, improve our reach into
disproportionately affected populations, and provide opportunities to
approach the goal of no new HIV infections. The purpose of this
research is to develop feasible and effective models for using HIV POC
NATs to: (1) Improve PrEP initiation, and duration of PrEP use, among
persons at high-risk for acquiring HIV infection; and (2) reduce the
time between testing in community-based and clinical-based settings and
linkage to HIV care, ART initiation, and viral suppression.
GAIN is an implementation study to compare a point-of-care nucleic
acid HIV test (HIV RNA POC NAT) to standard lab-based HIV testing.
Study activities include: 1. Retrospective baseline data collection
from clinical site electronic medical records. This will establish
baseline PrEP and HIV care metrics for comparison after study
implementation; 2. A longitudinal, prospective study of HIV-negative
patients seeking HIV testing and/or PrEP services; 3. A longitudinal,
prospective study of HIV-positive patients seeking STI testing; 4. An
RCT of POC NAT or Standard of Care for HIV-positive patients; 5. A
survey, interviews, and focus groups examining POC NAT acceptability
among HIV-negative and HIV-positive patients; 6. A cross-sectional
comparison of several point-of-care NATs among HIV-positive patients;
7. Acceptability/feasibility assessment among clinical and community
providers and costing analyses. These data will be analyzed and
disseminated to describe the real-world performance and clinical
effects of HIV RNA POC NAT testing technology. This study will develop
functional models to integrate HIV RNA POC NAT testing technology into
HIV prevention and treatment services. There are no costs to
respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Participants in prospective Consent form.... 1150 1 30/60 575
study of HIV-negative HIPPA form...... 1150 1 10/60 192
patients seeking HIV testing
and/or PrEP services.
Release of 1150 1 10/60 192
information
form.
Study visit 1150 1 15/60 288
survey.
Participants in prospective Consent form.... 125 1 30/60 63
study of HIV-positive HIPPA form...... 125 1 10/60 21
patients seeking STI testing.
Release of 125 1 10/60 21
information
form.
Study visit 125 1 15/60 31
survey.
Participants in RCT of POC NAT Consent form.... 250 1 30/60 125
or Standard of Care for HIV- HIPPA form...... 250 1 10/60 42
positive patients.
[[Page 83089]]
Release of 250 1 10/60 42
information
form.
Study visit 250 1 15/60 63
survey.
Participants in survey group POC NAT 87 1 20/60 29
examining POC NAT acceptability
acceptability. survey.
Participants in cross- Consent......... 250 1 30/60 125
sectional comparison of Release of 250 1 10/60 42
several point-of-care NATs. information
form.
Study visit 250 1 15/60 63
survey.
Acceptability/feasibility POC NAT 25 1 1 25
assessment among clinical and acceptability
community providers. survey, focus
group, or
interview.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 1,667
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-28113 Filed 12-18-20; 8:45 am]
BILLING CODE 4163-18-P
