Agency Information Collection Activities: Proposed Collection; Comment Request, 7607-7608 [2015-02852]
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices
Prevention, 1600 Clifton Road NE.,
Mailstop E–46, Atlanta, GA 30329,
telephone: (404) 639–6007, email: lig7@
cdc.gov.
Scientific questions should be
addressed to Michele Owen, National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., Mailstop A–25,
Atlanta, GA 30329; Phone 404–639–
1046, email smo2@cdc.gov.
SUPPLEMENTARY INFORMATION: HHS/CDC
seeks to collaborate with one or more
companies that have developed a
simplified nucleic acid test that can
detect acute or established HIV–1
infection. Acute HIV infection is the
early infection period associated with
high viral load that occurs before the
development of HIV antibodies, and
established infection is that which
occurs once antibodies are detectable.
The objective of the collaboration is
timely collection of data to evaluate the
performance characteristics of
simplified nucleic acid tests when used
in their intended applications. The
evaluation will be conducted in phases.
The first round of evaluation will be
done on well characterized stored or
mock laboratory specimens. Following
the initial round of evaluation, a subset
of tests with high performance will be
evaluated with prospectively collected
specimens. Only tests that are near
production (i.e., not first generation
prototypes) will be eligible for the
collaboration. Companies that are
interested in collaborating must be
planning to produce a simplified
nucleic acid test for distribution in the
United States and to seek FDA approval
for diagnostic or prognostic use (priority
given to tests with both applications).
Confidential proposals, preferably six
pages or less (excluding appendices),
are solicited from companies which
have a product that is suitable for
commercial distribution. This
collaboration will have an expected
duration of 1 to 6 years.
Currently, nucleic acid testing
conducted as part of HHS/CDC’s
laboratory algorithm is associated with
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.
Rapid identification of acute and
established HIV–1 infection using a
simplified nucleic acid test may have a
significant impact on patients with
positive test results obtaining care and
services more quickly. Therapeutic
monitoring could also be conducted
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more efficiently using a simplified
nucleic acid test.
For this project, preference may be
given to manufacturers that have
produced rapid nucleic acid tests that
can aid in HIV–1 diagnosis, and be used
for monitoring responses to therapy.
Tests should be simple to use on
unprocessed specimens (e.g., whole
blood) or include specimen processing
in the design of the test. Preference will
also be given for tests that can be
performed in 60 minutes or less, that
have the potential to be designated
moderately complex or waived under
the Clinical Laboratory Improvement
Amendments (CLIA), and that are
capable of both qualitative and
quantitative applications.
HHS/CDC and Collaborator
Responsibilities
HHS/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 appropriate panels of
specimens, and conducting the tests;
(3) Planning and conducting research
studies of the diagnostic tests and
interpreting results; and
(4) Publishing research results.
HHS/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/AIDS Prevention access to
necessary data about the diagnostic tests
in support of the research 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 and/
or DNA.
(3) Information on:
a. the time required to perform the
test;
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;
(4) Information on the storage
requirements and stability of the test.
(5) Plans and capability of the
company to seek HHS/FDA approval
and whether the company intends to
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7607
seek a diagnostic claim, a prognostic
claim (for patient monitoring) or both.
(6) Plans the company has for seeking
CLIA waiver status, if FDA approved.
Dated: February 6, 2015.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2015–02793 Filed 2–10–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10433]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid 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 (the
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments must be received by
April 13, 2015.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number (OCN). To be
assured consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
SUMMARY:
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7608
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
tkelley on DSK3SPTVN1PROD with NOTICES
CMS–10433 Initial Plan Data Collection
To Support Qualified Health Plan
(QHP) Certification and Other Financial
Management and Exchange Operations
Under the 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
requires federal agencies to publish a
60-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.
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Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Initial Plan Data
Collection to Support Qualified Health
Plan (QHP) Certification and Other
Financial Management and Exchange
Operations; Use: As required by the
CMS–9989–F, Patient Protection and
Affordable Care Act; Establishment of
Exchanges and Qualified Health Plans;
Exchange Standards for Employers (77
FR 18310) (Exchange Establishment
Rule), each Exchange must assume
responsibilities related to the
certification and offering of Qualified
Health Plans (QHPs). In addition to data
collection for the certification of QHPs,
the reinsurance and risk adjustment
programs outlined by the Affordable
Care Act, detailed in 45 CFR part 153,
as established by CMS–9975–F, Patient
Protection and Affordable Care Act;
Standards for Reinsurance, Risk
Corridors, and Risk Adjustment (77 FR
17220), have general information
reporting requirements that apply to
issuers, group health plans, third party
administrators, and plan offerings
outside of the Exchanges. Subsequent
regulations for these programs including
the final HHS Notice of Benefit and
Payment Parameters for 2014 and the
Program Integrity: Exchange, Premium
Stabilization Programs, and Market
Standards; Amendments to the HHS
Notice of Benefit and Payment
Parameters for 2014, and the final HHS
Notice of Benefit and Payment
Parameters for 2015 provide further
reporting requirements. Form Number:
CMS–10433 (OMB control number
0938–1187); Frequency: Once; Affected
Public: Individuals and households,
private sector—business or other forprofits and not-for-profit institutions,
State, Local or Tribal Governments;
Number of Respondents: 900; Total
Annual Responses: 900; Total Annual
Hours: 150. (For policy questions
regarding this collection contact Jaya
Ghildiyal at 301–492–5149.)
Dated: February 6, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–02852 Filed 2–10–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Tribal Consultation Meeting
Office of Head Start (OHS),
Administration for Children and
Families, HHS.
ACTION: Notice of meeting.
AGENCY:
Pursuant to the Improving
Head Start for School Readiness Act of
2007, Public Law 110–134, notice is
hereby given of one 1-day Tribal
Consultation Session to be held between
the Department of Health and Human
Services, Administration for Children
and Families, Office of Head Start
leadership and the leadership of Tribal
Governments operating Head Start
(including Early Head Start) programs.
The purpose of this Consultation
Session is to discuss ways to better meet
the needs of American Indian and
Alaska Native children and their
families, taking into consideration
funding allocations, distribution
formulas, and other issues affecting the
delivery of Head Start services in their
geographic locations [42 U.S.C. 9835,
Section 640(l)(4)].
DATES: March 16, 2015, from 1:00 p.m.
to 5:00 p.m.
Location: Southwest Consortium of
Indian Head Start, Native American
Child and Family Conference, Hotel
Albuquerque at Old Town, 800 Rio
Grande Boulevard Northwest,
Albuquerque, New Mexico 87104.
FOR FURTHER INFORMATION CONTACT:
Robert Bialas, Regional Program
Manager, Region XI, Office of Head
Start, email Robert.Bialas@acf.hhs.gov
or phone (202) 205–9497. Additional
information and online meeting
registration is available at https://
eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/
tc2015.
SUPPLEMENTARY INFORMATION: The
Department of Health and Human
Services (HHS) announces an Office of
Head Start (OHS) Tribal Consultation
for leaders of Tribal Governments
operating Head Start and Early Head
Start programs.
The agenda for the scheduled OHS
Tribal Consultation in Albuquerque,
New Mexico, will be organized around
the statutory purposes of Head Start
Tribal Consultations related to meeting
the needs of American Indian/Alaska
Native children and families, taking into
consideration funding allocations,
distribution formulas, and other issues
affecting the delivery of Head Start
services in their geographic locations. In
SUMMARY:
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Agencies
[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7607-7608]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02852]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10433]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 (the 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 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
DATES: Comments must be received by April 13, 2015.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number (OCN). To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
[[Page 7608]]
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number ___, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10433 Initial Plan Data Collection To Support Qualified Health Plan
(QHP) Certification and Other Financial Management and Exchange
Operations
Under the 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 requires federal agencies
to publish a 60-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.
Information Collection
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Initial Plan Data
Collection to Support Qualified Health Plan (QHP) Certification and
Other Financial Management and Exchange Operations; Use: As required by
the CMS-9989-F, Patient Protection and Affordable Care Act;
Establishment of Exchanges and Qualified Health Plans; Exchange
Standards for Employers (77 FR 18310) (Exchange Establishment Rule),
each Exchange must assume responsibilities related to the certification
and offering of Qualified Health Plans (QHPs). In addition to data
collection for the certification of QHPs, the reinsurance and risk
adjustment programs outlined by the Affordable Care Act, detailed in 45
CFR part 153, as established by CMS-9975-F, Patient Protection and
Affordable Care Act; Standards for Reinsurance, Risk Corridors, and
Risk Adjustment (77 FR 17220), have general information reporting
requirements that apply to issuers, group health plans, third party
administrators, and plan offerings outside of the Exchanges. Subsequent
regulations for these programs including the final HHS Notice of
Benefit and Payment Parameters for 2014 and the Program Integrity:
Exchange, Premium Stabilization Programs, and Market Standards;
Amendments to the HHS Notice of Benefit and Payment Parameters for
2014, and the final HHS Notice of Benefit and Payment Parameters for
2015 provide further reporting requirements. Form Number: CMS-10433
(OMB control number 0938-1187); Frequency: Once; Affected Public:
Individuals and households, private sector--business or other for-
profits and not-for-profit institutions, State, Local or Tribal
Governments; Number of Respondents: 900; Total Annual Responses: 900;
Total Annual Hours: 150. (For policy questions regarding this
collection contact Jaya Ghildiyal at 301-492-5149.)
Dated: February 6, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2015-02852 Filed 2-10-15; 8:45 am]
BILLING CODE 4120-01-P