Submission for OMB Review; Comment Request, 73892-73893 [2014-29206]
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Federal Register / Vol. 79, No. 239 / Friday, December 12, 2014 / Notices
and hospital are submitting data in a
prospective, national, audited registry.
The data includes patient, practitioner
and facility level variables that predict
outcomes such as all-cause mortality
and quality of life.
We find that the Society of Thoracic
Surgery/American College of Cardiology
Transcatheter Valve Therapy (STS/ACC
TVT) Registry, one registry overseen by
the National Cardiovascular Data
Registry, meets the requirements
specified in the NCD on TMVR. The
TVT Registry will support a national
surveillance system to monitor the
safety and efficacy of the TMVR
technologies for the treatment of mitral
regurgitation (MR). The data will also
include the variables on the eight item
Kansas City Cardiomyopathy
Questionnaire (KCCQ–10) to assess
heath status, functioning and quality of
life. In the KCCQ, an overall summary
score can be derived from the physical
function, symptoms (frequency and
severity), social function and quality of
life domains. For each domain, the
validity, reproducibility, responsiveness
and interpretability have been
independently established. Scores are
transformed to a range of 0–100, in
which higher scores reflect better health
status.
The conduct of the STS/ACC TVT
Registry and the KCCQ–10 is pursuant
to Section 1142 of the Social Security
Act (the ACT) that describes the
authority of the Agency for Healthcare
Research and Quality (AHRQ). Under
section 1142, research may be
conducted and supported on the
outcomes, effectiveness, and
appropriateness of health care services
and procedures to identify the manner
in which disease, disorders, and other
health conditions can be prevented,
diagnosed, treated, and managed
clinically. Section 1862(a)(1)(E) of the
Act allows Medicare to cover under
coverage with evidence development
(CED) certain items or services for
which the evidence is not adequate to
support coverage under section
1862(a)(1)(A) and where additional data
gathered in the context of a clinical
setting would further clarify the impact
of these items and services on the health
of beneficiaries.
The data collected and analyzed in
the TVT Registry will be used to
determine if TMVR is reasonable and
necessary (e.g., improves health
outcomes) for Medicare beneficiaries
under Section 1862(a)(1)(A) of the ACT.
Furthermore, data from the Registry will
assist the medical device industry and
the Food and Drug Administration
(FDA) in surveillance of the quality,
safety and efficacy of new medical
devices to treat mitral regurgitation. For
purposes of the TMVR NCD, the TVT
Registry has contracted with the Data
Analytic Centers to conduct the
analyses. In addition, data will be made
available for research purposes under
the terms of a data use agreement that
only provides de-identified datasets.
Form Number: CMS–10531(OMB
Control Number: 0938–NEW);
Frequency: Annually; Affected Public:
Business or other for-profits; Number of
Respondents: 4,000; Total Annual
Responses: 16,000 Total Annual Hours:
5,600. (For policy questions regarding
this collection contact Roya Lotfi at
410–786–4072.)
Dated: December 9, 2014.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2014–29172 Filed 12–11–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Adoption and Foster Care
Analysis Reporting System for title IV–
B and title IV–E, AFCARS.
OMB No.: 0970–0422.
Description: The Adoption and Foster
Care Analysis and Reporting System
(AFCARS) is mandated by 42 U.S.C.
679. The regulation at 45 CFR part 1355
sets forth the requirements of the statute
for the collection of uniform, reliable
information on children who are under
the responsibility of the State or Tribal
title IV–B/IV–E agency for placement,
care, and adoption. Effective October 1,
2009, section 479B(b) of the Act
authorizes direct Federal funding of
Indian Tribes, Tribal organizations, and
Tribal consortia that choose to operate
a foster care, adoption assistance and, at
Tribal option, a kinship guardianship
assistance program under title IV–E of
the Act. The Federal regulations at 45
CFR 1355.40 were amended as part of
an Interim Final Rule published January
6, 2012 to apply the same regulatory
requirements for data collection and
reporting to a Tribal title IV–E agency as
are applied to a State title IV–E agency.
The data collected will inform State/
Tribal/Federal policy decisions,
program management, and responses to
Congressional and Departmental
inquiries. Specifically, the data are used
for short/long-term budget projections,
trend analysis, child and family service
reviews, and to target areas for
improved technical assistance. The data
will provide information about foster
care placements, adoptive parents,
length of time in care, delays in
termination of parental rights and
placement for adoption.
Respondents: Title IV–E State and
Tribal Child Welfare Agencies
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
AFCARS ..........................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
72
2
1786
257,184
Estimated Total Annual Burden
Hours: 257,184.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
VerDate Sep<11>2014
16:57 Dec 11, 2014
Jkt 235001
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
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collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
E:\FR\FM\12DEN1.SGM
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73893
Federal Register / Vol. 79, No. 239 / Friday, December 12, 2014 / Notices
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–29206 Filed 12–11–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Generic Clearance for Grant
Reviewer Application Form.
OMB No.: New.
Description: This notice announces
that the Administration for Children
and Families intends to submit the
proposed Information Collection
Request (Generic ICR): Generic
Clearance for Grant Reviewer
Application Form under the Paperwork
Reduction (PRA) (44 U.S.C. 3501 et.
seq.). Comments on specific aspects for
the proposed information collection are
being solicited.
This request is for approval of a plan
for conducting more than one
information collection that is very
similar, voluntary, low-burden and
uncontroversial. Information collections
under this generic clearance will be in
compliance with U.S. Department of
Health and Humans Services’ Grants
Policy Directive 2.04 ‘‘Awarding
Grants’’, and the Awarding Agency
Grants Administration Manual, Chapter
2.04C ‘‘Objective Review of Grant
Applications’’. These forms will be used
to select reviewers who will participate
in the grant review process for the
purpose of selecting successful
applications.
Respondents: Individuals.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
urden hours
er response
Total burden
hours
Grant Review Application Form .......................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
750
1
0.5
375
Estimated Total Annual Burden
Hours: 375.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
VerDate Sep<11>2014
16:57 Dec 11, 2014
Jkt 235001
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
National Institutes of Health
[FR Doc. 2014–29173 Filed 12–11–14; 8:45 am]
Center for Scientific Review; Notice of
Closed Meeting
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Special Emphasis Panel,
January 27, 2015 08:00 a.m. to January
28, 2015, 06:00 p.m., Bethesda North
Marriott & Conference Center, Bethesda,
MD 20852 which was published in the
Federal Register on November 5, 2014,
79FR65678.
The meeting notice is amended to
change the title of the meeting from
‘‘NCI Program Project Meeting II’’ to
‘‘NCI Program Project Meeting I’’. The
meeting is closed to the public.
Dated: December 9, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–29159 Filed 12–11–14; 8:45 am]
BILLING CODE 4140–01–P
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: AIDS and AIDS Related Research.
Date: December 17, 2014.
Time: 11:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Robert Freund, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216,
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]]>Agencies
[Federal Register Volume 79, Number 239 (Friday, December 12, 2014)]
[Notices]
[Pages 73892-73893]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29206]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Adoption and Foster Care Analysis Reporting System for title
IV-B and title IV-E, AFCARS.
OMB No.: 0970-0422.
Description: The Adoption and Foster Care Analysis and Reporting
System (AFCARS) is mandated by 42 U.S.C. 679. The regulation at 45 CFR
part 1355 sets forth the requirements of the statute for the collection
of uniform, reliable information on children who are under the
responsibility of the State or Tribal title IV-B/IV-E agency for
placement, care, and adoption. Effective October 1, 2009, section
479B(b) of the Act authorizes direct Federal funding of Indian Tribes,
Tribal organizations, and Tribal consortia that choose to operate a
foster care, adoption assistance and, at Tribal option, a kinship
guardianship assistance program under title IV-E of the Act. The
Federal regulations at 45 CFR 1355.40 were amended as part of an
Interim Final Rule published January 6, 2012 to apply the same
regulatory requirements for data collection and reporting to a Tribal
title IV-E agency as are applied to a State title IV-E agency.
The data collected will inform State/Tribal/Federal policy
decisions, program management, and responses to Congressional and
Departmental inquiries. Specifically, the data are used for short/long-
term budget projections, trend analysis, child and family service
reviews, and to target areas for improved technical assistance. The
data will provide information about foster care placements, adoptive
parents, length of time in care, delays in termination of parental
rights and placement for adoption.
Respondents: Title IV-E State and Tribal Child Welfare Agencies
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
AFCARS...................................... 72 2 1786 257,184
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 257,184.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All
requests should be identified by the title of the information
collection. Email address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this
[[Page 73893]]
document in the Federal Register. Therefore, a comment is best assured
of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
7285, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014-29206 Filed 12-11-14; 8:45 am]
BILLING CODE 4184-01-P
