Current Traumatic Brain Injury State Implementation Partnership Grantees; Non-Competitive One-Year Extension Funds, 9929-9930 [2013-03153]
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Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Notices
Secretary initiates a regulatory action
that could precipitate a drug shortage or
exacerbate an existing drug shortage;
• Plans for effective communication
with outside stakeholders, including
who the Secretary should alert about
potential or actual drug shortages, how
the communication should occur, and
what types of information should be
shared;
• Plans for considering the impact of
drug shortages on research and clinical
trials; and
• An examination of whether to
establish a ‘‘qualified manufacturing
partner program’’ as described in
section 506D(a)(1)(C) of the FD&C Act.
tkelley on DSK3SPTVN1PROD with NOTICES
II. Scope of Public Input Requested
Per the directive in section 506D, FDA
has formed an internal Drug Shortages
Task Force (Task Force) to develop and
implement the drug shortages strategic
plan. The Task Force is seeking
comments from the public on issues
related to the development of this
strategic plan. Importantly, although
FDASIA refers only to a drug shortages
strategic plan, we anticipate that the
strategic plan will consider prevention
and mitigation of both drug and
biological product shortages.
Accordingly, we are interested in
receiving comments on these questions
from all parties, including those with an
interest in biological products. The Task
Force is specifically interested in
seeking public input on the following
questions:
1. In an effort to address the major
underlying causes of drug and biological
product shortages, FDA is seeking new
ideas to encourage high-quality
manufacturing and to facilitate
expansion of manufacturing capacity.
a. To assist in the evaluation of
product manufacturing quality, FDA is
exploring the broader use of
manufacturing quality metrics. With
that in mind, FDA would like input on
the following issues: What metrics do
manufacturers currently use to monitor
production quality? To what extent do
purchasers and prescribers use
information about manufacturing
quality when deciding how to purchase
or utilize products? What kinds of
manufacturing quality metrics might be
valuable for purchasers and prescribers
when determining which manufacturers
to purchase from or which
manufacturers’ products to prescribe?
What kinds of manufacturing quality
metrics might be valuable for
manufacturers when choosing a contract
manufacturer? How frequently would
such metrics need to be updated to be
meaningful?
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b. The use of a qualified
manufacturing partner program similar
to one used under the Biomedical
Advanced Research and Development
Authority (BARDA) has been suggested
as a potentially useful approach to
expanding manufacturing capacity and
preventing shortages. FDA recognizes
that there are important potential
differences between the BARDA
program and the use of a parallel
program to address shortages. For
example, the BARDA program covers a
relatively stable and limited number of
products, but drugs at risk of shortage
are many, may change rapidly over
time, and are difficult to predict in
advance. In addition, FDA does not
have funding to pay manufacturers to
participate in a drug shortages qualified
manufacturing partner program or to
guarantee purchase of the end product.
With these differences in mind, is it
possible to design a qualified
manufacturing partner program that
would have a positive impact on
shortages?
c. Are there incentives that FDA can
provide to encourage manufacturers to
establish and maintain high-quality
manufacturing practices, to develop
redundancy in manufacturing
operations, to expand capacity, and/or
to create other conditions to prevent or
mitigate shortages?
2. In our work to prevent shortages of
drugs and biological products, FDA
regularly engages with other U.S.
Government Agencies. Are there
incentives these Agencies can provide,
separately or in partnership with FDA,
to prevent shortages?
3. When notified of a potential or
actual drug or biological product
shortage, FDA may take certain actions
to mitigate the impact of the shortage,
including expediting review of
regulatory submissions, expediting
inspections, exercising enforcement
discretion, identifying alternative
manufacturing sources, extending
expiration dates based on stability data,
and working with the manufacturer to
resolve the underlying cause of the
shortage. Are there changes to these
existing tools that FDA can make to
improve their utility in managing
shortages? Are there other actions that
FDA can take under its existing
authority to address impending
shortages?
4. To manage communications to help
alleviate potential or actual shortages,
FDA uses a variety of tools, including
posting information on our public
shortages Web sites and sending
targeted notifications to specialty
groups. Are there other communication
tools that FDA should use or additional
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9929
information the Agency should share to
help health care professionals,
manufacturers, distributors, patients,
and others manage shortages more
effectively? Are there changes to our
public shortage Web sites that would
help enhance their utility for patients,
prescribers, and others in managing
shortages?
5. What impact do drug and biological
product shortages have on research and
clinical trials? What actions can FDA
take to mitigate any negative impact of
shortages on research and clinical trials?
6. What other actions or activities
should FDA consider including in the
strategic plan to help prevent or mitigate
shortages?
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: February 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–03198 Filed 2–11–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Current Traumatic Brain Injury State
Implementation Partnership Grantees;
Non-Competitive One-Year Extension
Funds
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of Non-Competitive OneYear Extension Funds for Current
Traumatic Brain Injury (TBI) State
Implementation Partnership (H21)
Grantees.
AGENCY:
The Health Resources and
Services Administration (HRSA) will
issue funding for a non-competitive oneyear extension for the State
Implementation Partnerships (H21)
awards to current grantees whose
awards are scheduled to end in fiscal
year (FY) 2013. Up to $250,000 per
SUMMARY:
E:\FR\FM\12FEN1.SGM
12FEN1
9930
Federal Register / Vol. 78, No. 29 / Tuesday, February 12, 2013 / Notices
grantee will be awarded over a one-year
extended project period.
The HRSA TBI Program was initially
authorized by the Traumatic Brain
Injury Act of 1996 (Pub. L. 104–166) and
was most recently reauthorized by the
Traumatic Brain Injury Act of 2008
(Pub. L. 110–206). Under this authority,
the HRSA TBI Program is charged with
improving access to rehabilitation and
other services for individuals with
traumatic brain injury and their
families. The TBI State Implementation
Partnership Grants support activities
that complement existing state
infrastructure to provide needed
services following TBI. Through
comprehensive and periodic needs and
resources assessments, activities
supported by grant funds are aligned
with the highest priority areas as
determined by providers, individuals
with TBI and their families, advocates,
and other stakeholders. Recipients of
grant funds are expected to modify
infrastructure in such a way that
improvements in service delivery will
be sustained beyond the grant period.
As part of this charge, grantees must
specifically have or develop the
following four core components:
(1) A Statewide Advisory Board
consisting of members of the
community, and representatives of other
state agencies with an interest in TBI,
such as State Departments of Health,
Rehabilitation, Human Services,
Education, Transportation, or Labor.
Grantee/organization name
Grant number
Alabama Department of Rehabilitation Services .....................................................
Arizona Department of Economic Security ..............................................................
Idaho State University .............................................................................................
Indiana Vocational Rehabilitation Services .............................................................
Iowa Department of Public Health ...........................................................................
Massachusetts Rehabilitation Commission .............................................................
Michigan Department of Community Health ............................................................
Missouri Department of Health and Senior Services ..............................................
Nebraska Department of Education ........................................................................
Health Research, Inc./New York State Department of Health ................................
North Carolina Department of Health and Human Services ...................................
State of Ohio Rehabilitation Services Commission .................................................
Tennessee Department of Health ...........................................................................
Virginia Department of Rehabilitative Services .......................................................
West Virginia University ...........................................................................................
Oregon State Department of Education ..................................................................
Texas Health & Human Services Commission .......................................................
Grantees
of record and intended award amounts
are:
SUPPLEMENTARY INFORMATION:
H21MC06738
H21MC06754
H21MC07735
H21MC06756
H21MC06748
H21MC06737
H21MC06747
H21MC06740
H21MC06758
H21MC06742
H21MC06746
H21MC06771
H21MC06739
H21MC06763
H21MC11468
H21MC06769
H21MC16375
Amount of the Award(s): Up to
$250,000 per grantee over a one-year
project period. CFDA Number: 93.234
Current Project Period:
• All grants in this cohort except
Texas: 4/1/2006–3/31/2013 (competing
continuations awarded 4/1/2009)
• Texas: 4/1/2006–8/31/2013
(competing award 9/1/2009)
Period of Additional Funding:
• All grants in this cohort except
Texas: 4/1/2013—3/31/2014
• Texas: 9/1/2013—8/31/2014
Authority: Public Health Service Act, Title
XII, Section 1252 (42 USC 300d–52) as
amended by the Children’s Health Act of
2000, sec.1304, Pub. L. 106–310, as further
amended by the Traumatic Brain Injury Act
of 2008, sec. 6(a), Pub. L. 110–206.
tkelley on DSK3SPTVN1PROD with NOTICES
This board should also have strong
representation from individuals with
TBI and/or family members; and also
organizations that serve individuals
with TBI; and other service providers,
medical and non-medical;
(2) A designated state agency that
takes responsibility for carrying out
activities of the grant;
(3) A statewide needs and resources
assessment; and
(4) A comprehensive Statewide
Action Plan for assisting individuals
with TBI and their families to increase
access to needed services and supports.
Justification: The Maternal Child
Health Bureau (MCHB) within HRSA
has determined, through assessment of
its State Implementation Partnership
(H21) grants, that a series of services are
commonly identified as ‘‘needs’’ via
state-conducted assessments and as
such are common programmatic
activities pursued under the auspices of
VerDate Mar<15>2010
16:40 Feb 11, 2013
Jkt 229001
H21 grants. MCHB proposes a one-year
extension of the current grant cohort to
allow time to refine the focus of the H21
program, defining these common
activities, crafting appropriate
performance measures, and securing
clearance to collect uniform data on
these activities that demonstrate the
impact of this program on the target
population.
In the interest of continuing to align
the structure of the program with the
needs of this population, and therefore
fulfilling our legislative charge, the TBI
Program proposes this course of action:
To align the next grant competition with
demonstrated areas of need, to capture
uniform data on the impact of this
program, to provide for sufficient fiscal
resources to continue programmatic
activities, and to maintain MCHB
programmatic support with the least
disruption to the state, community,
affected constituencies who are
currently receiving assistance and
services from these grantees, and the
grantees themselves.
PO 00000
Frm 00048
Fmt 4703
Sfmt 9990
State
AL
AZ
ID
IN
IA
MA
MI
MO
NE
NY
NC
OH
TN
VA
WV
OR
TX
FY2012
authorized
funding level
$245,100
249,915
250,000
249,739
250,000
250,000
250,000
250,000
250,000
249,909
250,000
248,500
250,000
250,000
250,000
249,999
250,000
FY2013
estimated
funding level
$245,100
249,915
250,000
249,739
250,000
250,000
250,000
250,000
250,000
249,909
250,000
248,500
250,000
250,000
250,000
249,999
250,000
In general, the project period for 17
TBI State Implementation Partnership
grantees would end March 31, 2013, and
a robust competitive process would
have taken place in December 2012.
MCHB does not believe the idea of
conducting a competition at this time is
appropriate or cost effective. Therefore,
MCHB proposes to extend the project
period of these grants into FY 2014.
Awards will be subject to the
availability of funds.
FOR FURTHER INFORMATION CONTACT:
LCDR Donelle McKenna, Maternal and
Child Health Bureau, Health Resources
and Services Administration, 5600
Fishers Lane, Room 13–61, Rockville,
Maryland 20857 or email
dmckenna@hrsa.gov.
Dated: February 5, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013–03153 Filed 2–11–13; 8:45 am]
BILLING CODE 4165–15–P
E:\FR\FM\12FEN1.SGM
12FEN1
]]>Agencies
[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Notices]
[Pages 9929-9930]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03153]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Current Traumatic Brain Injury State Implementation Partnership
Grantees; Non-Competitive One-Year Extension Funds
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of Non-Competitive One-Year Extension Funds for Current
Traumatic Brain Injury (TBI) State Implementation Partnership (H21)
Grantees.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration (HRSA) will
issue funding for a non-competitive one-year extension for the State
Implementation Partnerships (H21) awards to current grantees whose
awards are scheduled to end in fiscal year (FY) 2013. Up to $250,000
per
[[Page 9930]]
grantee will be awarded over a one-year extended project period.
The HRSA TBI Program was initially authorized by the Traumatic
Brain Injury Act of 1996 (Pub. L. 104-166) and was most recently
reauthorized by the Traumatic Brain Injury Act of 2008 (Pub. L. 110-
206). Under this authority, the HRSA TBI Program is charged with
improving access to rehabilitation and other services for individuals
with traumatic brain injury and their families. The TBI State
Implementation Partnership Grants support activities that complement
existing state infrastructure to provide needed services following TBI.
Through comprehensive and periodic needs and resources assessments,
activities supported by grant funds are aligned with the highest
priority areas as determined by providers, individuals with TBI and
their families, advocates, and other stakeholders. Recipients of grant
funds are expected to modify infrastructure in such a way that
improvements in service delivery will be sustained beyond the grant
period. As part of this charge, grantees must specifically have or
develop the following four core components:
(1) A Statewide Advisory Board consisting of members of the
community, and representatives of other state agencies with an interest
in TBI, such as State Departments of Health, Rehabilitation, Human
Services, Education, Transportation, or Labor. This board should also
have strong representation from individuals with TBI and/or family
members; and also organizations that serve individuals with TBI; and
other service providers, medical and non-medical;
(2) A designated state agency that takes responsibility for
carrying out activities of the grant;
(3) A statewide needs and resources assessment; and
(4) A comprehensive Statewide Action Plan for assisting individuals
with TBI and their families to increase access to needed services and
supports.
SUPPLEMENTARY INFORMATION: Grantees of record and intended award
amounts are:
----------------------------------------------------------------------------------------------------------------
FY2012 FY2013
Grantee/organization name Grant number State authorized estimated
funding level funding level
----------------------------------------------------------------------------------------------------------------
Alabama Department of Rehabilitation Services........ H21MC06738 AL $245,100 $245,100
Arizona Department of Economic Security.............. H21MC06754 AZ 249,915 249,915
Idaho State University............................... H21MC07735 ID 250,000 250,000
Indiana Vocational Rehabilitation Services........... H21MC06756 IN 249,739 249,739
Iowa Department of Public Health..................... H21MC06748 IA 250,000 250,000
Massachusetts Rehabilitation Commission.............. H21MC06737 MA 250,000 250,000
Michigan Department of Community Health.............. H21MC06747 MI 250,000 250,000
Missouri Department of Health and Senior Services.... H21MC06740 MO 250,000 250,000
Nebraska Department of Education..................... H21MC06758 NE 250,000 250,000
Health Research, Inc./New York State Department of H21MC06742 NY 249,909 249,909
Health..............................................
North Carolina Department of Health and Human H21MC06746 NC 250,000 250,000
Services............................................
State of Ohio Rehabilitation Services Commission..... H21MC06771 OH 248,500 248,500
Tennessee Department of Health....................... H21MC06739 TN 250,000 250,000
Virginia Department of Rehabilitative Services....... H21MC06763 VA 250,000 250,000
West Virginia University............................. H21MC11468 WV 250,000 250,000
Oregon State Department of Education................. H21MC06769 OR 249,999 249,999
Texas Health & Human Services Commission............. H21MC16375 TX 250,000 250,000
----------------------------------------------------------------------------------------------------------------
Amount of the Award(s): Up to $250,000 per grantee over a one-year
project period. CFDA Number: 93.234
Current Project Period:
All grants in this cohort except Texas: 4/1/2006-3/31/2013
(competing continuations awarded 4/1/2009)
Texas: 4/1/2006-8/31/2013 (competing award 9/1/2009)
Period of Additional Funding:
All grants in this cohort except Texas: 4/1/2013--3/31/
2014
Texas: 9/1/2013--8/31/2014
Authority: Public Health Service Act, Title XII, Section 1252
(42 USC 300d-52) as amended by the Children's Health Act of 2000,
sec.1304, Pub. L. 106-310, as further amended by the Traumatic Brain
Injury Act of 2008, sec. 6(a), Pub. L. 110-206.
Justification: The Maternal Child Health Bureau (MCHB) within HRSA
has determined, through assessment of its State Implementation
Partnership (H21) grants, that a series of services are commonly
identified as ``needs'' via state-conducted assessments and as such are
common programmatic activities pursued under the auspices of H21
grants. MCHB proposes a one-year extension of the current grant cohort
to allow time to refine the focus of the H21 program, defining these
common activities, crafting appropriate performance measures, and
securing clearance to collect uniform data on these activities that
demonstrate the impact of this program on the target population.
In the interest of continuing to align the structure of the program
with the needs of this population, and therefore fulfilling our
legislative charge, the TBI Program proposes this course of action: To
align the next grant competition with demonstrated areas of need, to
capture uniform data on the impact of this program, to provide for
sufficient fiscal resources to continue programmatic activities, and to
maintain MCHB programmatic support with the least disruption to the
state, community, affected constituencies who are currently receiving
assistance and services from these grantees, and the grantees
themselves.
In general, the project period for 17 TBI State Implementation
Partnership grantees would end March 31, 2013, and a robust competitive
process would have taken place in December 2012. MCHB does not believe
the idea of conducting a competition at this time is appropriate or
cost effective. Therefore, MCHB proposes to extend the project period
of these grants into FY 2014. Awards will be subject to the
availability of funds.
FOR FURTHER INFORMATION CONTACT: LCDR Donelle McKenna, Maternal and
Child Health Bureau, Health Resources and Services Administration, 5600
Fishers Lane, Room 13-61, Rockville, Maryland 20857 or email
dmckenna@hrsa.gov.
Dated: February 5, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-03153 Filed 2-11-13; 8:45 am]
BILLING CODE 4165-15-P
