Family-to-Family Health Information Center Program, 55588-55589 [2010-22663]
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mstockstill on DSKB9S0YB1PROD with NOTICES
55588
Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices
CFDA Number: 93.504.
Justification for the Exception to
Competition: The former grantee, P2P of
Vermont, has relinquished all grants
held under the P2P legal name due to
an organizational merger with VFN. The
former grantee has requested that HRSA
transfer the F2F HIC funds to VFN in
order to implement and carry out grant
activities originally proposed under P2P
of Vermont grant applications.
A single-source award was made to
VFN because of the organizational
merger of P2P into VFN and the
following program determinations: (1)
Continuing need for the project; (2) that
the time required to obtain competition
would seriously jeopardize the success
of the project and put at risk the health
of the people being served by the
project; (3) that there will be no
significant change in the scope or
objectives (including any reduction) of
the previously approved project or
activity; (4) that the replacement
recipient is eligible to receive the award
and its facilities and resources allow for
the successful performance of the
project.
CYSHCN are defined as ‘‘those
children and youth who have or are at
increased risk for a chronic physical,
developmental, behavioral, or emotional
condition and who also require health
and related services of a type or amount
beyond that required by children
generally’’ (American Academy of
Pediatrics, 1998). This is particularly
relevant since 2006 National survey data
showed more than 17% of CYSHCN in
Vermont had problems getting referrals
to care. Also, because of changes
occurring in State services and funding
for CYSHCN, many families and
providers alike need to be kept up to
date on these changes so that they can
access appropriate services. This center
is urgently needed to address these gaps
and disparities in information and
services.
It is critical that VFN continue
helping families of CYSHCN gain access
to information they need to make
informed health care decisions, be full
partners in decisionmaking, and access
needed resources/referrals and
financing for those services in the state
of Vermont. It is also imperative that the
center continues to train and support
health care providers and other
professionals in public and private
agencies who serve Vermont’s CYSHCN,
helping them better understand the
needs of children, youth and their
families.
VFN will receive funding through
May 31, 2011 to continue the same
state-wide services as previously
outlined in the originally competed and
VerDate Mar<15>2010
17:21 Sep 10, 2010
Jkt 220001
approved grant application submitted
by the P2P of Vermont. This
replacement award will maintain
Congress’ mandate under the 2005
Budget Deficit Reduction Act/Family
Opportunity Act and the Patient
Protection and Affordable Care Act
(Pub. L. 111–148) that there shall be an
F2F HIC in all 50 States and the District
of Columbia by June 2009. It will also
ensure that an F2F HIC will be
accessible to families and professionals
to continue providing essential
information, referral and support
services to families with CYSHCN
throughout Vermont and in a manner
which avoids any disruption of services.
Dated: September 3, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010–22664 Filed 9–10–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Family-to-Family Health Information
Center Program
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) will be
transferring the Florida Family-toFamily Health Information Center (F2F
HIC) grant (H84MC00006) from the
Florida Institute of Family Involvement
´
(FIFI) to the Family Cafe in Tallahassee
due to financial difficulties resulting in
closure of FIFI facilities and programs.
This action ensures the continued
provision of health resources, financing,
related services and parent-to-parent
support for families with children and
youth with special health care needs
(CYSHCN) in the state of Florida.
FOR FURTHER INFORMATION CONTACT:
LaQuanta Person, Project Officer,
Integrated Services Branch, Division of
Services for Children with Special
Health Needs, Maternal and Child
Health Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 18A–18, Rockville, MD
20857; 301.443.2370; lperson@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Former Grantee of Record: Florida
Institute of Family Involvement.
Original Grant Period: June 1, 2006 to
May 31, 2011.
Replacement Awardee: The Family
´
Cafe.
SUMMARY:
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Frm 00050
Fmt 4703
Sfmt 4703
Amount of Replacement Award: Up to
$95,700 for the remaining of the project
period.
Period of Replacement Award: The
period of support for the replacement
award is June 1, 2010 to May 31, 2011.
Authority: Section 501(c)(1)(A) of the
Social Security Act, as amended.
CFDA Number: 93.504.
Justification for the Exception to
Competition: The former grantee, FIFI,
has relinquished all grants due to
financial difficulties resulting in closure
of FIFI facilities and programs. The
former grantee has requested that HRSA
transfer the F2F HIC funds to the Family
´
Cafe in order to implement and carry
out grant activities originally proposed
under FIFI grant applications.
A single-source award was made to
´
the Family Cafe because of the financial
difficulties of FIFI and the following
program determinations: (1) Continuing
need for the project; (2) that the time
required to obtain competition would
seriously jeopardize the success of the
project and put at risk the health of the
people being served by the project; (3)
that there will be no significant change
in the scope or objectives (including any
reduction) of the previously approved
project or activity; (4) that the
replacement recipient is eligible to
receive the award and its facilities and
resources allow for the successful
performance of the project.
CYSHCN are defined as ‘‘those
children and youth who have or are at
increased risk for a chronic physical,
developmental, behavioral, or emotional
condition and who also require health
and related services of a type or amount
beyond that required by children
generally’’ (American Academy of
Pediatrics, 1998). This is particularly
relevant since 2006 National survey data
showed more than 26% of CYSHCN in
Florida had problems getting referrals to
care. Florida was ranked fourth
nationally for the highest estimated
number of CYSHCN in the state
(551,263). In addition, because of
changes occurring in state services and
funding for CYSHCN, many families
and providers alike need to be kept up
to date on these changes so that they can
access appropriate services. This center
is urgently needed to address these gaps
and disparities in information and
services. It is critical that the Family
´
Cafe continue helping families of
CYSHCN gain access to information
they need to make informed health care
decisions, be full partners in decisionmaking and access needed resources/
referrals and financing for those services
in the state of Florida. It is also
imperative that the center continues to
E:\FR\FM\13SEN1.SGM
13SEN1
Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices
train and support health care providers
and other professionals in public and
private agencies who serve Florida’s
CYSHCN, helping them better
understand the needs of children, youth
and their families.
´
The Family Cafe will receive funding
through May 31, 2011 to continue the
same state-wide services as previously
outlined in the originally competed and
approved grant application submitted
by FIFI. This replacement award will
maintain Congress’ mandate under the
2005 Budget Deficit Reduction Act/
Family Opportunity Act and the Patient
Protection and Affordable Care Act
(Pub. L. 111–148) that there shall be an
F2F HIC in all 50 states and the District
of Columbia by June 2009. It will also
ensure that an F2F HIC will be
accessible to families and professionals
to continue providing essential
information, referral and support
services to families with CYSHCN
throughout Florida and in a manner
which avoids any disruption of services.
Dated: September 3, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010–22663 Filed 9–10–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0463]
Fee for Using a Priority Review
Voucher in Fiscal Year 2011
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates for using a tropical disease
priority review voucher for fiscal year
(FY) 2011. The Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by title XI of the Food and
Drug Administration Amendments Act
of 2007 (FDAAA), authorizes FDA to
determine and collect priority review
user fees for certain applications for
approval of drug or biological products
when those applications use a priority
review voucher awarded by the
Secretary of Health and Human
Services. These vouchers are awarded to
the sponsor of certain tropical disease
product applications, submitted after
September 27, 2007, upon FDA
approval of such applications. The
amount of the fee to be submitted to
FDA with applications using a priority
mstockstill on DSKB9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:21 Sep 10, 2010
Jkt 220001
review voucher is determined each
fiscal year (FY) based on the average
cost incurred by FDA in the review of
a human drug application subject to
priority review in the previous FY.
This notice establishes the priority
review fee rate for FY 2011.
FOR FURTHER INFORMATION CONTACT:
David Miller, Office of Financial
Management (HFA–100), Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 301–796–7103.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1102 of FDAAA added new
section 524 to the FD&C Act (21 U.S.C.
360n). In section 524, Congress
encouraged development of new drug
and biological products for prevention
and treatment of certain tropical
diseases by offering additional
incentives for obtaining FDA approval
of such products. Under section 524, the
sponsor of an eligible human drug
application submitted after September
27, 2007, for a qualified tropical disease
(as defined in section 524(a)(3)), shall
receive a priority review voucher upon
approval of the tropical disease product
application. The recipient of a priority
review voucher may either use the
voucher with a future submission to
FDA under section 505(b)(1) of the
FD&C Act (21 U.S.C. 355(b)(1)) or
section 351 of the Public Health Service
Act (21 U.S.C. 262), or transfer
(including by sale) the voucher to
another party that may then use it. A
priority review is a review conducted
with a Prescription Drug User Fee Act
(PDUFA) goal date of 6 months.
The applicant that uses a priority
review voucher is entitled to a priority
review but must pay FDA a priority
review user fee in addition to any other
fee required by PDUFA. FDA has
published a draft guidance on its Web
site about how this priority review
voucher program will operate (available
at: https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatory
Information/Guidances/
ucm080599.pdf).
This notice establishes the priority
review fee rate for 2011 of $4,582,000,
and outlines FDA’s process for
implementing the collection of the
priority review user fees. This rate is
effective on October 1, 2010, and will
remain in effect through September 30,
2011, for applications submitted with a
priority review voucher, and the
payment of this priority review user fee
is required in addition to the payment
of any other fee that would normally
apply to such an application under
PDUFA before FDA considers the
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
55589
application complete and acceptable for
filing.
II. Priority Review User Fee for FY
2011
Under section 524(c)(2) of the FD&C
Act, the amount of the priority review
user fee is to be determined each FY
based on the average cost incurred by
FDA in the review of a human drug
application subject to priority review in
the previous FY.
A priority review is a review
conducted with a PDUFA goal date of 6
months. Normally, an application for a
Center for Drug Evaluation and Research
(CDER) product will qualify for a
priority review if FDA determines that
the product, if approved, would provide
safe and effective therapy where no
satisfactory alternative therapy exists or
would be a significant improvement
compared to marketed products,
including non-drug products and/or
therapies, in the treatment, diagnosis, or
prevention of a disease. A Center for
Biologics Evaluation and Research
(CBER) product will qualify for a
priority review if FDA determines that
the product, if approved, would be a
significant improvement in the safety or
effectiveness of the treatment, diagnosis,
or prevention of a serious or lifethreatening disease. FDA has committed
to a goal to review and act on 90 percent
of the applications that have been
granted priority review status no later
than 6 months after receipt. An
application that does not receive a
priority designation will receive a
‘‘standard’’ review. Under the goals
identified in the letters referenced in
section 101(c) of FDAAA, FDA commits
to a goal to review and act on 90 percent
of ‘‘standard’’ applications within 10
months of the date of receipt. A priority
review involves a more intensive level
of effort and a higher level of resources
than a standard review.
Section 524 of the FD&C Act specifies
that the fee amount should be based on
the average cost incurred by the Agency
for a priority review in the previous FY.
Because FDA has never tracked the cost
of reviewing applications that get
priority review as a separate cost subset,
FDA estimated this cost based on other
data that the Agency has tracked and
kept. FDA started by using data that the
Agency estimates and publishes on its
Web site each year—standard costs for
review. FDA does not publish a
standard cost for ‘‘the review of a human
drug application subject to priority
review in the previous fiscal year.’’
However, we expect all such
applications would contain clinical
data. The standard cost application
E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 75, Number 176 (Monday, September 13, 2010)]
[Notices]
[Pages 55588-55589]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22663]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Family-to-Family Health Information Center Program
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration (HRSA) will
be transferring the Florida Family-to-Family Health Information Center
(F2F HIC) grant (H84MC00006) from the Florida Institute of Family
Involvement (FIFI) to the Family Caf[eacute] in Tallahassee due to
financial difficulties resulting in closure of FIFI facilities and
programs. This action ensures the continued provision of health
resources, financing, related services and parent-to-parent support for
families with children and youth with special health care needs
(CYSHCN) in the state of Florida.
FOR FURTHER INFORMATION CONTACT: LaQuanta Person, Project Officer,
Integrated Services Branch, Division of Services for Children with
Special Health Needs, Maternal and Child Health Bureau, Health
Resources and Services Administration, 5600 Fishers Lane, Room 18A-18,
Rockville, MD 20857; 301.443.2370; lperson@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Former Grantee of Record: Florida Institute of Family Involvement.
Original Grant Period: June 1, 2006 to May 31, 2011.
Replacement Awardee: The Family Caf[eacute].
Amount of Replacement Award: Up to $95,700 for the remaining of the
project period.
Period of Replacement Award: The period of support for the
replacement award is June 1, 2010 to May 31, 2011.
Authority: Section 501(c)(1)(A) of the Social Security Act, as
amended.
CFDA Number: 93.504.
Justification for the Exception to Competition: The former grantee,
FIFI, has relinquished all grants due to financial difficulties
resulting in closure of FIFI facilities and programs. The former
grantee has requested that HRSA transfer the F2F HIC funds to the
Family Caf[eacute] in order to implement and carry out grant activities
originally proposed under FIFI grant applications.
A single-source award was made to the Family Caf[eacute] because of
the financial difficulties of FIFI and the following program
determinations: (1) Continuing need for the project; (2) that the time
required to obtain competition would seriously jeopardize the success
of the project and put at risk the health of the people being served by
the project; (3) that there will be no significant change in the scope
or objectives (including any reduction) of the previously approved
project or activity; (4) that the replacement recipient is eligible to
receive the award and its facilities and resources allow for the
successful performance of the project.
CYSHCN are defined as ``those children and youth who have or are at
increased risk for a chronic physical, developmental, behavioral, or
emotional condition and who also require health and related services of
a type or amount beyond that required by children generally'' (American
Academy of Pediatrics, 1998). This is particularly relevant since 2006
National survey data showed more than 26% of CYSHCN in Florida had
problems getting referrals to care. Florida was ranked fourth
nationally for the highest estimated number of CYSHCN in the state
(551,263). In addition, because of changes occurring in state services
and funding for CYSHCN, many families and providers alike need to be
kept up to date on these changes so that they can access appropriate
services. This center is urgently needed to address these gaps and
disparities in information and services. It is critical that the Family
Caf[eacute] continue helping families of CYSHCN gain access to
information they need to make informed health care decisions, be full
partners in decision-making and access needed resources/referrals and
financing for those services in the state of Florida. It is also
imperative that the center continues to
[[Page 55589]]
train and support health care providers and other professionals in
public and private agencies who serve Florida's CYSHCN, helping them
better understand the needs of children, youth and their families.
The Family Caf[eacute] will receive funding through May 31, 2011 to
continue the same state-wide services as previously outlined in the
originally competed and approved grant application submitted by FIFI.
This replacement award will maintain Congress' mandate under the 2005
Budget Deficit Reduction Act/Family Opportunity Act and the Patient
Protection and Affordable Care Act (Pub. L. 111-148) that there shall
be an F2F HIC in all 50 states and the District of Columbia by June
2009. It will also ensure that an F2F HIC will be accessible to
families and professionals to continue providing essential information,
referral and support services to families with CYSHCN throughout
Florida and in a manner which avoids any disruption of services.
Dated: September 3, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010-22663 Filed 9-10-10; 8:45 am]
BILLING CODE 4165-15-P
