Agency Forms Undergoing Paperwork Reduction Act Review, 33294-33296 [2021-13434]
Download as PDF
<![CDATA[
khammond on DSKJM1Z7X2PROD with NOTICES
33294
Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices
an offeror to nominate a port/terminal of
loading they recommend for the
purposes of evaluation of their offer and
indicate whether the prices proposed
are based on f.o.b. origin or f.o.b.
destination. The contracting officer uses
the information to ensure that offers are
evaluated and awards are made on the
basis of the lowest laid down cost to the
Government at the overseas port of
discharge.
• FAR 52.247–52, Clearance and
Documentation Requirements—
Shipments to DOD Air or Water
Terminal Transshipment Points. This
clause directs the contractor to provide
the Government certain information
regarding shipments to DoD air or water
terminal transshipment points. The
Government transportation office uses
this information to support applications
for export release and to prepare the
Transportation Control and Movement
Document (TCMD).
• FAR 52.247–53, Freight
Classification Description. When the
Government purchases supplies that are
new to the supply system, nonstandard,
or modifications of previously shipped
items, and different freight
classifications may apply, this provision
requests an offeror provide the full
Uniform Freight Classification (rail)
description, or the National Motor
Freight Classification description
applicable to the supplies. The
contracting officer uses this information
to determine the proper freight for
supplies.
• FAR 52.247–57, Transportation
Transit Privilege Credits. This clause
allows the offeror to identify any
transportation charges, including any
transit charges, that the offeror will
agree to pay, subject to reimbursement
by the Government. The contracting
officer uses this information to ensure
consideration of an offeror’s transit
credits when evaluating an f.o.b. origin
price for shipping supplies to the
designated Government destinations.
• FAR 52.247–60, Guaranteed
Shipping Characteristics. This clause
requires the offeror to provide details on
the shipping container(s) to be used for
each part or component that is packed
or packaged separately. The contracting
officer uses this information to
determine transportation costs for
evaluation purposes.
• FAR 52.247–63, Preference for U.S.Flag Air Carriers. In the event that a
contractor selects a carrier other than a
U.S.-flag air carrier for international air
transportation during performance of
the contract, this clause requires the
contractor to include a statement
regarding the unavailability of U.S.-Flag
Air Carriers on vouchers involving such
VerDate Sep<11>2014
19:19 Jun 23, 2021
Jkt 253001
transportation. The Government uses
the information provided on the
voucher to ensure compliance with
section 5 of the International Air
Transportation Fair Competitive
Practices Act of 1974 (49 U.S.C. 40118),
which requires the Government and its
contractors and subcontractors to use
U.S.-flag air carriers for U.S.
Government-financed international air
transportation of personnel (and their
personal effects) or property, to the
extent that service by those carriers is
available.
• FAR 52.247–64, Preference for
Privately Owned U.S.-Flag Commercial
Vessels. This clause requires a
contractor to provide the contracting
officer and the Maritime
Administration’s one legible copy of
rated on-board ocean bill of lading for
each shipment made by the contractor
or its subcontractors. The Government
uses this information to ensure
compliance with the Cargo Preference
Act of 1954.
• FAR 52.247–67, Submission of
Transportation Documents for Audit.
This clause requires the contractor to
submit for prepayment audit
transportation documents on which the
United States will assume freight
charges that were paid by the contractor
under a cost-reimbursement contract or
by the contractor’s first-tier
subcontractor (for a cost-reimbursement
subcontract). For freight shipment bills
under $100 are to be retained on-site by
the contractor and made available for
on-site audits. The Government uses
this information to conduct a
prepayment audit of transportation
charges on a cost-reimbursement
contract when reimbursement of
transportation as a direct charge to the
contract or subcontract is authorized.
The prepayment audit is required to
comply with agency prepayment audit
programs established pursuant to 31
U.S.C. 3726.
• FAR 52.247–68, Report of Shipment
(REPSHIP). This clause requires
contractors to send an advance notice of
shipment to the consignee
transportation officer to be received at
least 24 hours before the arrival of the
shipment, unless otherwise directed by
a contracting officer. The Government
uses this information to alert the
receiving activity of certain shipments.
The advance notice facilitates
arrangements for transportation control,
labor, space, and use of materials
handling equipment at destination. The
timely receipt of notices by the
consignee transportation office
precludes the Government from
incurring demurrage and vehicle
detention charges.
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
• FAR 47.303, Clauses for Standard
Delivery Terms. The following FAR
clauses require the contractor to (as
appropriate to the delivery terms
specified in the contract): Prepare or
provide special annotation on a
Government or commercial bill of
lading; provide an ocean bill of lading
or airway bill; annotate commercial
shipping documents; distribute copies
of the bill of lading; provide applicable
transportation receipts; assist in
obtaining documents for exportation or
importation destinations; and/or obtain
insurance documents. The contracting
officer and the Government
transportation office use this
information in awarding and
administering contracts to ensure: (1)
Acquisitions are made on the basis most
advantageous to the Government; and
(2) supplies arrive in good order and
condition and on time at the required
place.
C. Annual Burden
Respondents: 17,565.
Recordkeepers: 940.
Total Annual Responses: 256,208.
Total Burden Hours: 23,097. (22,079
reporting hours + 1,018 recordkeeping
hours).
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. 9000–0061, Federal
Acquisition Regulation Part 47:
Transportation Requirements.
William F. Clark,
Director, Federal Acquisition Policy Division,
Office of Governmentwide Acquisition Policy,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2021–13393 Filed 6–23–21; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–21AC]
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 The GAIN
(Greater Access and Impact with NAT)
Study: Improving HIV Diagnosis,
Linkage to Care, and Prevention
E:\FR\FM\24JNN1.SGM
24JNN1
33295
Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices
Services with HIV Point-of-Care Nucleic
Acid Tests (NATs) 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 December
21, 2020 to obtain comments from the
public and affected agencies. CDC
received two comments related to the
previous 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
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
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,
Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Pre-exposure prophylaxis (PrEP) can
prevent HIV acquisition among persons
at risk. To prevent the emergence of
drug-resistant HIV strains, prior to
initiating PrEP, persons must be tested
for HIV to ensure that they are not
infected. Current rapid point-of-care
(POC) 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 are still at high-risk to
become HIV infected. 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.
CDC requests OMB approval to
conduct the GAIN (Greater Access and
Impact with NAT) study at two clinics
in Seattle, Washington. 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. 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.
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 HIVpositive 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.
OMB approval is requested for three
years. Participation is voluntary and
there are no costs to respondents other
than their time. The total estimated
annualized burden is 1,067 hours.
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Type of respondent
Form name
Participating clinic ..........................................................
Baseline data collection variables
list.
Monthly study report form ................
Release of information form ............
2
1
2
2
1530
12
1
15/60
10/60
Study visit survey .............................
Release of information form ............
1530
165
1
1
15/60
10/60
Study visit survey .............................
Release of information form ............
165
333
1
1
15/60
10/60
Study visit survey .............................
333
1
15/60
Participants in prospective study of HIV-negative patients seeking HIV testing and/or PrEP services.
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.
VerDate Sep<11>2014
19:19 Jun 23, 2021
Jkt 253001
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
E:\FR\FM\24JNN1.SGM
24JNN1
33296
Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Average
burden per
response
(in hours)
Form name
Participants in survey group examining POC NAT acceptability.
Participants in cross-sectional comparison of several
point-of-care NATs.
POC NAT acceptability survey ........
117
1
20/60
Release of information form ............
333
1
10/60
Study visit survey .............................
POC NAT acceptability survey,
focus group, or interview.
333
33
1
1
15/60
1
Acceptability/feasibility assessment among clinical and
community providers.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–13434 Filed 6–23–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Needs and Challenges in Personal
Protective Equipment (PPE) Use for
Underserved User Populations
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Request for information.
AGENCY:
NIOSH requests information
on the Needs and Challenges in
Personal Protective Equipment (PPE)
Use for Underserved User Populations.
DATES: Submit a letter of information by
August 23, 2021.
ADDRESSES: Interested parties should
submit information to: NIOSH, Attn:
Sherri Diana, National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998,
Email address: ppeconcerns@cdc.gov.
FOR FURTHER INFORMATION CONTACT: N.
Katherine Yoon, Ph.D., National
Institute for Occupational Safety and
Health, Centers for Disease Control and
Prevention, Email Address: NYoon@
cdc.gov, Phone number: 412–386–6752
[non-toll-free number]
SUPPLEMENTARY INFORMATION:
Background: The NIOSH National
Personal Protective Technology
Laboratory (NPPTL) is expanding its
portfolio to include activities that
consider the needs of U.S. worker
populations who are underserved
related to personal protective equipment
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondent
VerDate Sep<11>2014
19:19 Jun 23, 2021
Jkt 253001
(PPE) use, availability, accessibility,
acceptability, or knowledge.
Underserved PPE user populations may
include, but are not limited to, workers
who are of an atypical size; who are
members of a gender, racial, ethnic, or
linguistic minority group; who conduct
non-traditional worker activities; or who
are members of sub-disciplines that are
not the primary focus of the current PPE
activities within their larger field. To
inform the possible design and
execution of these activities, NPPTL
seeks information from the public,
including individuals/organizations
who/that (1) advocate for these worker
populations, (2) actively conduct PPE
research, services, or policymaking for
these worker populations, (3) are
planning to conduct PPE research,
services, or policymaking for these
worker populations, (4) have direct
knowledge about research, service, or
policy gaps affecting these worker
populations, or (5) are current or former
PPE users that experienced PPE use,
availability, accessibility, acceptability,
or knowledge issues.
Information Needs: CDC is
particularly interested in receiving
information being sought in Request (1).
As such, responders are requested to
provide information responsive to
Request (1), and may address any or all
of the topics identified in Requests (2)
and (3):
Request (1) Describe respondent(s)
i. Individual or company/institution
name, location, and website (if any)
ii. Individual or company/institution
contact information (include the
respondent’s role in the organization,
address, phone number, and email
address)
iii. The primary motivation(s) for why
you (or your organization) are
responding to this Notice
iv. Any additional relevant
background information about yourself
or your organization as well as names of
any other organizations currently
working in applicable issues
Request (2) Describe your experiences
related to PPE use, availability,
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
accessibility, acceptability, and
knowledge issues for underserved PPE
user populations within the U.S. (e.g.,
individuals of small or large size;
members of gender, racial, ethnic or
other minority group of a specific
occupation, non-traditional workers,
etc.)
i. What experiences have you had in
recent years related to PPE use,
availability, accessibility, acceptability,
and knowledge issues for underserved
PPE user populations? Also, specify and
describe the underserved PPE user
group(s) with which you have had
experience.
ii. What data/information/resources
did you find to be the most relevant/
valuable to the experiences described in
Request 2(i)?
iii. How long have you or your
organization been working in the areas
of work identified in Request 2(i)? Did
your or your organization’s involvement
change over time, and if so, how and
why?
iv. What achievements were a result
of your work in PPE use, availability,
accessibility, acceptability, and
knowledge for underserved PPE user
populations? (e.g., publications,
guidance, new/revised policies or
procedures, establishment of a key
committee)
v. What is your future work plan on
PPE use, availability, accessibility, and
knowledge for underserved PPE user
populations?
Request (3) Describe PPE gaps/barriers
that remain to be addressed for
underserved PPE user populations
within the U.S. related to PPE use,
availability, accessibility, acceptability,
and knowledge issues (if any)
i. What research gaps/barriers remain
to be addressed?
ii. What service gaps/barriers remain
to be addressed?
iii. What policy gaps/barriers remain
to be addressed?
Informational submissions in
response to this Notice are due no later
than August 23, 2021. Please limit
informational submission to three pages
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33294-33296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13434]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-21AC]
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 The GAIN (Greater Access and Impact with NAT)
Study: Improving HIV Diagnosis, Linkage to Care, and Prevention
[[Page 33295]]
Services with HIV Point-of-Care Nucleic Acid Tests (NATs) 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 December 21, 2020 to obtain comments from
the public and affected agencies. CDC received two comments related to
the previous 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 the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
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,
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Pre-exposure prophylaxis (PrEP) can prevent HIV acquisition among
persons at risk. To prevent the emergence of drug-resistant HIV
strains, prior to initiating PrEP, persons must be tested for HIV to
ensure that they are not infected. Current rapid point-of-care (POC)
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 are still
at high-risk to become HIV infected. 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.
CDC requests OMB approval to conduct the GAIN (Greater Access and
Impact with NAT) study at two clinics in Seattle, Washington. 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. 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.
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.
OMB approval is requested for three years. Participation is
voluntary and there are no costs to respondents other than their time.
The total estimated annualized burden is 1,067 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Participating clinic.................. Baseline data collection 2 1 2
variables list.
Monthly study report 2 12 15/60
form.
Participants in prospective study of Release of information 1530 1 10/60
HIV-negative patients seeking HIV form.
testing and/or PrEP services.
Study visit survey...... 1530 1 15/60
Participants in prospective study of Release of information 165 1 10/60
HIV-positive patients seeking STI form.
testing.
Study visit survey...... 165 1 15/60
Participants in RCT of POC NAT or Release of information 333 1 10/60
Standard of Care for HIV-positive form.
patients.
Study visit survey...... 333 1 15/60
[[Page 33296]]
Participants in survey group examining POC NAT acceptability 117 1 20/60
POC NAT acceptability. survey.
Participants in cross-sectional Release of information 333 1 10/60
comparison of several point-of-care form.
NATs.
Study visit survey...... 333 1 15/60
Acceptability/feasibility assessment POC NAT acceptability 33 1 1
among clinical and community survey, focus group, or
providers. interview.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-13434 Filed 6-23-21; 8:45 am]
BILLING CODE 4163-18-P
