Opportunity To Collaborate in the Evaluation of Serologic and Nucleic Acid Tests for Detecting HIV and Nucleic Acid Tests for Quantifying HIV, 38055-38056 [2023-12435]
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Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Notices
Liabilities attributable to the U.S.
operations of a foreign financial
company that is not a foreign banking
organization are calculated in a similar
manner to the method described for
foreign banking organizations, and
liabilities of a U.S. subsidiary not
subject to the risk-based capital rule are
calculated based on the U.S.
subsidiary’s liabilities under applicable
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FR Y–9C, and the FR XX–1 to calculate
liabilities of these institutions.
By order of the Board of Governors of the
Federal Reserve System, acting through the
Director of Supervision and Regulation under
delegated authority.
Ann E. Misback,
Secretary of the Board.
[FR Doc. 2023–12389 Filed 6–9–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Opportunity To Collaborate in the
Evaluation of Serologic and Nucleic
Acid Tests for Detecting HIV and
Nucleic Acid Tests for Quantifying HIV
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: General notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS), announces an
opportunity for industry and the public
to collaborate on a project to evaluate
nucleic acid and serologic tests. CDC is
interested in evaluating serologic and
nucleic acid tests that can be used to aid
in the diagnosis of HIV–1 infection,
including serologic tests that can
secondarily differentiate recent
infection, and nucleic acid tests for the
quantitation or semi-quantitation of HIV
RNA. Tests of interest include those that
use whole blood, serum, plasma, or
dried blood spots. Performance will be
evaluated relative to Food and Drug
Administration (FDA)-approved
qualitative and quantitative nucleic acid
tests as well as serologic immunoassays.
More than one collaborator may be
selected.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
Letters of interest must be
received on or before Friday, September
15, 2023. Formal proposals must be
DATES:
VerDate Sep<11>2014
17:39 Jun 09, 2023
Jkt 259001
received on or before Friday, November
10, 2023.
ADDRESSES: Send Letters of Interest and
Formal Proposals to Division of HIV
Prevention, National Center for HIV,
Viral Hepatitis, STD, and TB
Prevention, Centers for Disease Control
and Prevention, 1600 Clifton Road NE,
Mailstop H18–2, Atlanta, Georgia 30329.
Attn: HIV Serologic and Nucleic Acid
Tests Evaluation Project.
FOR FURTHER INFORMATION CONTACT:
Jeffrey Johnson, National Center for HIV,
Viral Hepatitis, STD, and TB
Prevention, Centers for Disease Control
and Prevention, 1600 Clifton Road NE,
Mailstop 18–2, Atlanta, GA 30329;
Telephone 404–639–4976; Email: jlj6@
cdc.gov.
SUPPLEMENTARY INFORMATION:
Background
Priority for technical evaluations are
rapid tests or mail-in sample collection
methods that can be self-administered
outside of clinic settings. Secondarily,
tests or collection methods that have the
potential for both HIV–1 diagnostic and
prognostic use for monitoring responses
to therapy are preferred.
The objective of the collaboration is
timely collection of data to evaluate the
performance characteristics of
simplified nucleic acid and serologic
tests or protocols when used in their
intended applications. Only tests that
are under or near production (i.e., not
first-generation prototypes) will be
eligible for the collaboration. Companies
that are interested in collaborating must
be planning to market a test protocol for
distribution in the United States and to
seek FDA approval for diagnostic or
prognostic use.
Currently, nucleic acid testing
conducted as part of CDC’s laboratory
algorithm has a delay in returning
results because testing is often
conducted in referral laboratories.
Likewise, pooled nucleic acid testing
causes delays due to the time required
to create and break down pools in the
event of a positive pool. Moreover, there
are significant financial stability,
geographic isolation, and stigma barriers
to accessing testing in clinical settings
that prevent sustained continuum of
care for many populations, including
the most vulnerable. Methods to support
rapid identification of HIV–1 infection
or viral suppression using a simplified
nucleic acid or serologic test, or use of
self-collection methods, may have a
significant impact on individuals by
allowing them to obtain care and
services more quickly.
Tests should be simple to use on
unprocessed specimens (e.g., whole
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
38055
blood) or include specimen processing
in the design of the test. For nucleic
acid tests, preference may also be given
to tests that are capable of both
qualitative and quantitative
applications. Key benchmarks are the
ability to demonstrate improved
sensitivity of diagnostic tests over
current FDA-approved laboratory-based
tests and nucleic acid monitoring test
protocols that are suitable for lower
complexity settings.
CDC and Collaborator Roles and
Responsibilities
CDC’s role may include, but will not
be limited to, the following:
(1) Providing scientific and technical
expertise needed for the research
project;
(2) Providing assistance with project
management and data analysis;
(3) Providing testing support as
determined by CDC as needed; and
(4) Publishing research results.
CDC anticipates that the role of the
successful collaborator(s) will include
the following:
(1) Providing tests and finalized
protocols that can be used in the
evaluation; and
(2) Providing the CDC Division of HIV
Prevention access to necessary data
about the diagnostic tests in support of
the evaluation activities.
Selection Criteria
Proposals submitted for consideration
should address, as fully as possible and
to the extent relevant to the proposal,
each of the following:
(1) Data available on the performance
of the test in persons with acute and
established HIV–1 infection.
(2) Information on the technology
used for the test and its basic operating
principals for detecting HIV RNA, DNA,
antibody, or antigen.
(3) Information on:
a. the time required to perform the
test or sample collection method;
b. whether the test is performed on
whole blood, serum, plasma, or dried
blood spots; and
c. the steps involved in performing
the test on each specimen type or
sample collection method;
(4) Information on the storage
requirements and stability of the test.
(5) Plans, capability, and clinical trial
designs of the company to seek HHS/
FDA approval and whether the
company intends to seek a diagnostic
claim, a prognostic claim (for patient
monitoring), or both.
(6) Plans the company has for seeking
CLIA waiver status, for appropriate
tests, if FDA approved.
E:\FR\FM\12JNN1.SGM
12JNN1
38056
Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Notices
Letters of Interest
The letter of interest is not considered
a formal proposal and is not required;
however, it is highly recommended as it
will assist CDC in planning for the
review process. The formal proposal
will still need to be submitted according
to the instructions in this notice.
Formal Proposals
Confidential proposals, preferably six
pages or less (excluding appendices),
are solicited from companies which
have a product that is suitable for
regulatory approval and
commercialization. This collaboration
will have an expected duration of 1 to
4 years.
Dated: June 7, 2023.
Tiffany Brown,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2023–12435 Filed 6–9–23; 8:45 am]
BILLING CODE 4163–18–P
Comments on the collection(s) of
information must be received by the
OMB desk officer by July 12, 2023.
ADDRESSES: Written 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.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
Services
SUPPLEMENTARY INFORMATION:
[Document Identifier: CMS–4040 and CMS–
R–297]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
other forms of information technology to
minimize the information collection
burden.
VerDate Sep<11>2014
17:39 Jun 09, 2023
Jkt 259001
William Parham at (410) 786–4669.
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. The term ‘‘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 publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Request for
Enrollment in Supplementary Medical
Insurance (SMI); Use: CMS regulations
42 CFR 407.11 lists the CMS–4040 as
the application to be used by
individuals who are not eligible for
monthly Social Security/Railroad
Retirement Board benefits or free Part A.
The CMS–4040 solicits the information
that is used to determine entitlement for
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
individuals who meet the requirements
in section 1836 as well as the
entitlement of the applicant or their
spouses to an annuity paid by OPM for
premium deduction purposes. The
application follows the application
questions and requirements used by
SSA. This is done not only for
consistency purposes but to comply
with other Title II and Title XVIII
requirements because eligibility to Title
II benefits and free Part A under Title
XVIII must be ruled out in order to
qualify for enrollment in Part B only.
Form Number: CMS–4040 (OMB control
number: 0938–0245); Frequency: Once;
Affected Public: Individuals or
households; Number of Respondents:
42,011; Total Annual Responses:
42,011; Total Annual Hours: 10,503.
(For policy questions regarding this
collection contact Carla Patterson at
410–786–8911.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Request for
Employment Information; Use: The form
CMS–L564, also referred to as CMS–R–
297, is used, in conjunction with form
CMS–40–B, Application for
Supplementary Medical Insurance,
during an individual’s special
enrollment period (SEP). Completed by
an employer, the CMS–L564 provides
proof of an applicant’s employer group
health coverage. The Social Security
Administration (SSA) uses it to obtain
information from employers regarding
whether a Medicare beneficiary’s
coverage under a group health plan is
based on current employment status.
The form is available online via
Medicare.gov and CMS.gov for
individuals who are requesting the SEP
to obtain and submit to their employer
for completion. The employer must
complete and sign the form, and submit
it to the individual to accompany their
enrollment or late enrollment penalty
reduction request. The information on
the completed form is reviewed
manually by SSA. Form Number: CMS–
R–297 (OMB control number: 0938–
0787); Frequency: Once; Affected
Public: Individuals or households,
Business or other for-profits, Not-forprofit institutions; Number of
Respondents: 676,526; Total Annual
Responses: 676,526; Total Annual
Hours: 56,355. (For policy questions
regarding this collection contact Carla
Patterson at 410–786–8911.)
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38055-38056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12435]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Opportunity To Collaborate in the Evaluation of Serologic and
Nucleic Acid Tests for Detecting HIV and Nucleic Acid Tests for
Quantifying HIV
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: General notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), within
the Department of Health and Human Services (HHS), announces an
opportunity for industry and the public to collaborate on a project to
evaluate nucleic acid and serologic tests. CDC is interested in
evaluating serologic and nucleic acid tests that can be used to aid in
the diagnosis of HIV-1 infection, including serologic tests that can
secondarily differentiate recent infection, and nucleic acid tests for
the quantitation or semi-quantitation of HIV RNA. Tests of interest
include those that use whole blood, serum, plasma, or dried blood
spots. Performance will be evaluated relative to Food and Drug
Administration (FDA)-approved qualitative and quantitative nucleic acid
tests as well as serologic immunoassays. More than one collaborator may
be selected.
DATES: Letters of interest must be received on or before Friday,
September 15, 2023. Formal proposals must be received on or before
Friday, November 10, 2023.
ADDRESSES: Send Letters of Interest and Formal Proposals to Division of
HIV Prevention, National Center for HIV, Viral Hepatitis, STD, and TB
Prevention, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, Mailstop H18-2, Atlanta, Georgia 30329. Attn: HIV Serologic
and Nucleic Acid Tests Evaluation Project.
FOR FURTHER INFORMATION CONTACT: Jeffrey Johnson, National Center for
HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease
Control and Prevention, 1600 Clifton Road NE, Mailstop 18-2, Atlanta,
GA 30329; Telephone 404-639-4976; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Background
Priority for technical evaluations are rapid tests or mail-in
sample collection methods that can be self-administered outside of
clinic settings. Secondarily, tests or collection methods that have the
potential for both HIV-1 diagnostic and prognostic use for monitoring
responses to therapy are preferred.
The objective of the collaboration is timely collection of data to
evaluate the performance characteristics of simplified nucleic acid and
serologic tests or protocols when used in their intended applications.
Only tests that are under or near production (i.e., not first-
generation prototypes) will be eligible for the collaboration.
Companies that are interested in collaborating must be planning to
market a test protocol for distribution in the United States and to
seek FDA approval for diagnostic or prognostic use.
Currently, nucleic acid testing conducted as part of CDC's
laboratory algorithm has a delay in returning results because testing
is often conducted in referral laboratories. Likewise, pooled nucleic
acid testing causes delays due to the time required to create and break
down pools in the event of a positive pool. Moreover, there are
significant financial stability, geographic isolation, and stigma
barriers to accessing testing in clinical settings that prevent
sustained continuum of care for many populations, including the most
vulnerable. Methods to support rapid identification of HIV-1 infection
or viral suppression using a simplified nucleic acid or serologic test,
or use of self-collection methods, may have a significant impact on
individuals by allowing them to obtain care and services more quickly.
Tests should be simple to use on unprocessed specimens (e.g., whole
blood) or include specimen processing in the design of the test. For
nucleic acid tests, preference may also be given to tests that are
capable of both qualitative and quantitative applications. Key
benchmarks are the ability to demonstrate improved sensitivity of
diagnostic tests over current FDA-approved laboratory-based tests and
nucleic acid monitoring test protocols that are suitable for lower
complexity settings.
CDC and Collaborator Roles and Responsibilities
CDC's role may include, but will not be limited to, the following:
(1) Providing scientific and technical expertise needed for the
research project;
(2) Providing assistance with project management and data analysis;
(3) Providing testing support as determined by CDC as needed; and
(4) Publishing research results.
CDC anticipates that the role of the successful collaborator(s)
will include the following:
(1) Providing tests and finalized protocols that can be used in the
evaluation; and
(2) Providing the CDC Division of HIV Prevention access to
necessary data about the diagnostic tests in support of the evaluation
activities.
Selection Criteria
Proposals submitted for consideration should address, as fully as
possible and to the extent relevant to the proposal, each of the
following:
(1) Data available on the performance of the test in persons with
acute and established HIV-1 infection.
(2) Information on the technology used for the test and its basic
operating principals for detecting HIV RNA, DNA, antibody, or antigen.
(3) Information on:
a. the time required to perform the test or sample collection
method;
b. whether the test is performed on whole blood, serum, plasma, or
dried blood spots; and
c. the steps involved in performing the test on each specimen type
or sample collection method;
(4) Information on the storage requirements and stability of the
test.
(5) Plans, capability, and clinical trial designs of the company to
seek HHS/FDA approval and whether the company intends to seek a
diagnostic claim, a prognostic claim (for patient monitoring), or both.
(6) Plans the company has for seeking CLIA waiver status, for
appropriate tests, if FDA approved.
[[Page 38056]]
Letters of Interest
The letter of interest is not considered a formal proposal and is
not required; however, it is highly recommended as it will assist CDC
in planning for the review process. The formal proposal will still need
to be submitted according to the instructions in this notice.
Formal Proposals
Confidential proposals, preferably six pages or less (excluding
appendices), are solicited from companies which have a product that is
suitable for regulatory approval and commercialization. This
collaboration will have an expected duration of 1 to 4 years.
Dated: June 7, 2023.
Tiffany Brown,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2023-12435 Filed 6-9-23; 8:45 am]
BILLING CODE 4163-18-P
