Pilot Program for Parallel Review of Medical Products; Correction, 66309 [2011-27694]
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Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Notices
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 76 FR 50223—50224,
dated August 12, 2011) is amended to
reflect the reorganization of the Office of
Public Health Preparedness and
Response, Centers for Disease Control
and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows:
After item (7) in the functional
statement for the Office of Public Health
Preparedness and Response (CG),
Division of Strategic National Stockpile
(CGE), Office of the Director (CGE1),
insert the following: And (8) provides
leadership, guidance, and technical
assistance to state, tribal and local
territories for healthcare preparedness
and emergency response and for the
integration of preparedness planning
across the public health, healthcare, and
emergency management sectors.
Dated: October 14, 2011.
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–27497 Filed 10–25–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4434, Silver Spring,
MD 20993–0002, 301–796–6579.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–25907, appearing on page 62808
in the Federal Register of Tuesday,
October 11, 2011, the following
corrections are made:
1. On page 62808, in the third
column, under the heading ‘‘A. Parallel
Review Proposal,’’ the Web site address
‘‘https://www.parallel-review.fda.gov’’ is
corrected to read ‘‘https://www.fda.gov/
parallel-review’’.
2. On page 62809, in the second
column, under the heading ‘‘B.
Appropriate Candidates,’’ the e-mail
address ‘‘parallel-review@fda.gov’’ is
corrected to read ‘‘parallelreview@fda.hhs.gov’’.
3. On page 62809, in the third
column, under the heading ‘‘1.
Nomination,’’ the Web site address
‘‘https://www.parallel-review.fda.gov’’ is
corrected to read ‘‘https://www.fda.gov/
parallel-review’’.
Dated: October 17, 2011.
Jacquelyn Y. White,
Director, Office of Strategic Operations and
Regulatory Affairs. Centers for Medicare &
Medicaid Services.
Dated: October 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy,
Food and Drug Administration.
[FR Doc. 2011–27694 Filed 10–25–11; 8:45 am]
BILLING CODE 4160–01–P
[CMS–3180–N2]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0308]
Administration for Children and
Families
Pilot Program for Parallel Review of
Medical Products; Correction
Food and Drug Administration,
Centers for Medicare and Medicaid
Services, HHS.
ACTION: Notice; correction.
AGENCY:
The Food and Drug
Administration (FDA) and the Centers
for Medicare and Medicaid Services
(CMS) are correcting a notice that
appeared in the Federal Register of
October 11, 2011 (76 FR 62808). The
document announced a pilot program
for sponsors of innovative device
technologies to participate in a program
of parallel FDA–CMS review. The
document was published with an
incorrect Web page address and an
incorrect email address. This document
corrects those errors.
FOR FURTHER INFORMATION CONTACT: Jean
Olson, Center for Devices and
jlentini on DSK4TPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:53 Oct 25, 2011
Jkt 226001
Proposed Information Collection
Activity; Comment Request
Title: Affordable Care Act Tribal
Maternal, Infant and Early Childhood
Home Visiting Program Annual Report.
OMB No.: New.
Description
Section 511(h)(2)(A) of Title V of the
Social Security Act, as added by Section
2951 of the Patient Protection and
Affordable Care Act of 2010 (Pub. L.
111–148, Affordable Care Act or ACA),
authorizes the Secretary of HHS to
award grants to Indian Tribes (or a
consortium of Indian Tribes), Tribal
Organizations, or Urban Indian
Organizations to conduct an early
childhood home visiting program.
The legislation sets aside 3 percent of
the total ACA Maternal, Infant, and
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
66309
Early Childhood Home Visiting Program
appropriation (authorized in Section
511(j)) for grants to Tribal entities and
requires that the Tribal grants, to the
greatest extent practicable, be consistent
with the requirements of the Maternal,
Infant, and Early Childhood Home
Visiting Program grants to States and
territories (authorized in Section
511(c)), and include (1) Conducting a
needs assessment similar to the
assessment required for all States under
the legislation and (2) establishing
quantifiable, measurable 3- and 5-year
benchmarks consistent with the
legislation.
The Administration for Children and
Families, Office of Child Care, in
collaboration with the Health Resources
and Services Administration, Maternal
and Child Health Bureau, has awarded
grants for the Tribal Maternal, Infant,
and Early Childhood Home Visiting
Program (Tribal Home Visiting). The
Tribal Home Visiting grant awards
support 5-year cooperative agreements
to conduct community needs
assessments, plan for and implement (in
accordance with an Implementation
Plan submitted at the end of Year 1)
high-quality, culturally-relevant,
evidence-based and promising home
visiting programs in at-risk Tribal
communities, and participate in
research and evaluation activities to
build the knowledge base on home
visiting among Native populations.
In the Affordable Care Act Tribal
Maternal, Infant, and Early Childhood
Home Visiting Program Needs
Assessment and Plan for Responding to
Identified Needs (‘‘Implementation Plan
Guidance’’) (OMB Control No. 0970–
0389, Expiration Date 6/30/14), grantees
were notified that in Years 2–5 of their
grant they must comply with the
requirement for submission of an
Annual Report to the Secretary
regarding the program and activities
carried out under the program.
This Report Shall Address the Following
Home Visiting Program Goals and
Objectives.
Implementation of Home Visiting
Program in Targeted Community(ies).
Progress toward Meeting Legislatively
Mandated Benchmark Requirements.
Research and Evaluation Update.
Home Visiting Program Continuous
Quality Improvement (CQI) Efforts.
Administration of Home Visiting
Program.
Technical Assistance Needs.
Respondents
E:\FR\FM\26OCN1.SGM
26OCN1
]]>Agencies
[Federal Register Volume 76, Number 207 (Wednesday, October 26, 2011)]
[Notices]
[Page 66309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27694]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[CMS-3180-N2]
Food and Drug Administration
[Docket No. FDA-2010-N-0308]
Pilot Program for Parallel Review of Medical Products; Correction
AGENCY: Food and Drug Administration, Centers for Medicare and Medicaid
Services, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) and the Centers for
Medicare and Medicaid Services (CMS) are correcting a notice that
appeared in the Federal Register of October 11, 2011 (76 FR 62808). The
document announced a pilot program for sponsors of innovative device
technologies to participate in a program of parallel FDA-CMS review.
The document was published with an incorrect Web page address and an
incorrect email address. This document corrects those errors.
FOR FURTHER INFORMATION CONTACT: Jean Olson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4434, Silver Spring, MD 20993-0002, 301-796-6579.
SUPPLEMENTARY INFORMATION: In FR Doc. 2011-25907, appearing on page
62808 in the Federal Register of Tuesday, October 11, 2011, the
following corrections are made:
1. On page 62808, in the third column, under the heading ``A.
Parallel Review Proposal,'' the Web site address ``https://www.parallel-review.fda.gov'' is corrected to read ``https://www.fda.gov/parallel-review''.
2. On page 62809, in the second column, under the heading ``B.
Appropriate Candidates,'' the e-mail address ``parallel-review@fda.gov'' is corrected to read ``parallel-review@fda.hhs.gov''.
3. On page 62809, in the third column, under the heading ``1.
Nomination,'' the Web site address ``https://www.parallel-review.fda.gov'' is corrected to read ``https://www.fda.gov/parallel-review''.
Dated: October 17, 2011.
Jacquelyn Y. White,
Director, Office of Strategic Operations and Regulatory Affairs.
Centers for Medicare & Medicaid Services.
Dated: October 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy, Food and Drug Administration.
[FR Doc. 2011-27694 Filed 10-25-11; 8:45 am]
BILLING CODE 4160-01-P
