Family-To-Family Health Information Center Program, 38034-38035 [E9-18125]
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Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Federico
Goodsaid, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2148,
Silver Spring, MD 20903–0002,
301–796–1535; or Jennifer Catalano,
Center for Biologics Evaluation and
Research (HFM–735), Food and
Drug Administration, 1401
Rockville Pike, Rockville, MD
20852–1448, 301–827–0706.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
erowe on DSK5CLS3C1PROD with NOTICES
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
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15:34 Jul 29, 2009
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Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In June 2009, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘E16 Genomic Biomarkers
Related to Drug Response: Context,
Structure, and Format of Qualification
Submissions’’ should be made available
for public comment. The draft guidance
is the product of the E16 Expert
Working Group of the ICH. Comments
about this draft will be considered by
FDA and the E16 Expert Working
Group.
The use of biomarkers in drug
discovery, development, and
postapproval has the potential to
facilitate development of safer and more
effective medicines, to guide dose
selection, and to enhance the benefitrisk profile of approved medicines. This
draft guidance describes
recommendations regarding context,
structure, and format of regulatory
submissions for qualification of genomic
biomarkers. To support the evaluation
of genomic biomarkers, the draft
guidance describes and defines a
submission standard applicable across
regions. The recommendations are
based on previous experiences in the
various regions with submissions
containing genomic biomarker data.
Such submissions have been either
stand-alone biomarker qualification
applications or a component of
medicinal product-related regulatory
process. Where appropriate, the
proposed document format is expected
to facilitate incorporation of genomic
biomarker data into specific productrelated applications.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. Submit
a single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
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submit one paper copy. Comments are
to be identified 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: July 23, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18227 Filed 7–29–09; 8:45 am]
BILLING CODE 4160–01–S
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 of noncompetitive
replacement award to Colorado NonProfit Development Center.
SUMMARY: The Health Resources and
Services Administration (HRSA) will be
transferring Family Voices Colorado
Family-To-Family Health Information
Center (F2F HIC) grant (H84 MC 09577)
from Cerebral Palsy of Colorado to the
Colorado Non-Profit Development
Center in Denver in order to ensure the
continued provision of health resources,
financing, related services and parentto-parent support for families with
children and youth with special health
care needs in the State of Colorado.
SUPPLEMENTARY INFORMATION:
Former Grantee of Record: Cerebral
Palsy of Colorado.
Original Period of Grant Support:
June 1, 2008, to May 31, 2011.
Replacement awardee: Colorado NonProfit Development Center.
Amount of Replacement Award:
$153,572 for year 2 and $95,700 for year
3 of the remaining project period.
Period of Replacement Award: The
period of support for the replacement
award is July 1, 2009, to May 31, 2011.
Authority: Section 501(c)(1)(A) of the
Social Security Act.
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erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices
CFDA Number: 93.110.
Justification for the Exception to
Competition:
The F2F HICs were legislated by
Congress under the Family Opportunity
Act/Budget Deficit Reduction Act.
Congress specified that there be a family
staffed center in each State and the
District of Columbia by June 2009. The
former grantee, Family Voices of
Colorado, received a competitive grant
in 2008 operating under the non-profit,
Cerebral Palsy of Colorado. Family
Voices of Colorado notified HRSA that
it would be unable to continue
providing services to families and
providers as had been proposed in their
Family-To-Family Health Information
Center grant application under Cerebral
Palsy of Colorado and will now be
providing services under the Colorado
Nonprofit Development Center.
It is critical that Family Voices of
Colorado continue helping families of
children and youth with special health
care needs (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 Colorado.
It is also critical that they continue to
train and support healthcare providers
and other professionals in public and
private agencies who serve Colorado’s
CYSHCN, helping them better
understand the needs of children, youth
and their families.
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 more than 28% of
CYSHCN in Colorado had problems
getting referrals to care. Only 22% of
Colorado families of a CYSHCN
identified that community-based service
systems are organized for easy use. In
addition, because of changes occurring
in State services and their funding for
CYSHNC, 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.
The Colorado Non-Profit
Development Center was identified as
an umbrella agency with a demonstrated
history of providing a full array of
technical assistance and fiscal
management services to entities such as
Family Voices of Colorado. This
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15:34 Jul 29, 2009
Jkt 217001
replacement award will ensure that
Family Voices of Colorado can continue
to provide critical information, referral
and support services to families with
children having special health care
needs throughout Colorado and in a
manner which avoids any disruption of
services.
FOR FURTHER INFORMATION CONTACT:
Diana Denboba, Integrated Services
Branch Chief, Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Rockville, MD 20857, via e-mail at
DDenboba@hrsa.gov or via telephone at
301 443–9332.
Dated: July 22, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9–18125 Filed 7–29–09; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0128] (formerly
Docket No. 2007D–0396)
Guidance for Industry on Drug-Induced
Liver Injury: Premarketing Clinical
Evaluation; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Drug-Induced Liver Injury:
Premarketing Clinical Evaluation.’’ This
guidance is intended to assist the
pharmaceutical industry and others
engaged in new drug development in
the assessment of the potential of a drug
to cause severe drug-induced liver
injury (DILI) during the conduct of
premarketing trials. This guidance
defines severe DILI as injury that is fatal
or requires liver transplantation.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. The guidance may also
be obtained from the Center for
Biologics Evaluation and Research by
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38035
mail by calling 1–800–835–4709 or 301–
827–1800. Send one self-addressed
adhesive label to assist that office in
processing your requests. Submit
written comments on the guidance to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Hee Shelia Lianos, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5329,
Silver Spring, MD 20993–0002,
301–796–4147; or
Steve Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852, 310–827–
6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘DrugInduced Liver Injury: Premarketing
Clinical Evaluation.’’ Severe DILI has
been an important cause of drug
marketing withdrawal. This has led
FDA to pay particular attention to how
the risk of severe DILI can be predicted
before a drug is approved. The science
of detecting and evaluating DILI during
drug development is evolving, and FDA
is working with industry, academia, and
other government groups toward better
understanding of how best to do this.
Even for drugs that prove to be
significant hepatotoxins in some
patients (e.g., bromfenac, troglitazone,
and ximelagatran), it is unlikely that
cases of severe DILI will be identified
during a drug development program
with only a few thousand exposed
subjects. Therefore, it is critical to
discover signals of a drug’s potential to
cause such injury during drug
development by detection of lesser
degrees of liver injury that may be more
frequently seen. There are a number of
such signals that have varying levels of
sensitivity and specificity in predicting
the potential for severe DILI. However,
the most specific finding to date is a
finding of cases of serum
aminotransferase elevation together
with elevated bilirubin concentration
(and no evidence of biliary obstruction
or impaired ability to conjugate
bilirubin) in some trial subjects (i.e.,
Hy’s Law cases).
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]]>Agencies
[Federal Register Volume 74, Number 145 (Thursday, July 30, 2009)]
[Notices]
[Pages 38034-38035]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18125]
-----------------------------------------------------------------------
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 of noncompetitive replacement award to Colorado Non-
Profit Development Center.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration (HRSA) will
be transferring Family Voices Colorado Family-To-Family Health
Information Center (F2F HIC) grant (H84 MC 09577) from Cerebral Palsy
of Colorado to the Colorado Non-Profit Development Center in Denver in
order to ensure 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 in the State of
Colorado.
SUPPLEMENTARY INFORMATION:
Former Grantee of Record: Cerebral Palsy of Colorado.
Original Period of Grant Support: June 1, 2008, to May 31, 2011.
Replacement awardee: Colorado Non-Profit Development Center.
Amount of Replacement Award: $153,572 for year 2 and $95,700 for
year 3 of the remaining project period.
Period of Replacement Award: The period of support for the
replacement award is July 1, 2009, to May 31, 2011.
Authority: Section 501(c)(1)(A) of the Social Security Act.
[[Page 38035]]
CFDA Number: 93.110.
Justification for the Exception to Competition:
The F2F HICs were legislated by Congress under the Family
Opportunity Act/Budget Deficit Reduction Act. Congress specified that
there be a family staffed center in each State and the District of
Columbia by June 2009. The former grantee, Family Voices of Colorado,
received a competitive grant in 2008 operating under the non-profit,
Cerebral Palsy of Colorado. Family Voices of Colorado notified HRSA
that it would be unable to continue providing services to families and
providers as had been proposed in their Family-To-Family Health
Information Center grant application under Cerebral Palsy of Colorado
and will now be providing services under the Colorado Nonprofit
Development Center.
It is critical that Family Voices of Colorado continue helping
families of children and youth with special health care needs (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
Colorado. It is also critical that they continue to train and support
healthcare providers and other professionals in public and private
agencies who serve Colorado's CYSHCN, helping them better understand
the needs of children, youth and their families.
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 more
than 28% of CYSHCN in Colorado had problems getting referrals to care.
Only 22% of Colorado families of a CYSHCN identified that community-
based service systems are organized for easy use. In addition, because
of changes occurring in State services and their funding for CYSHNC,
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.
The Colorado Non-Profit Development Center was identified as an
umbrella agency with a demonstrated history of providing a full array
of technical assistance and fiscal management services to entities such
as Family Voices of Colorado. This replacement award will ensure that
Family Voices of Colorado can continue to provide critical information,
referral and support services to families with children having special
health care needs throughout Colorado and in a manner which avoids any
disruption of services.
FOR FURTHER INFORMATION CONTACT: Diana Denboba, Integrated Services
Branch Chief, Maternal and Child Health Bureau, HRSA, 5600 Fishers
Lane, Rockville, MD 20857, via e-mail at DDenboba@hrsa.gov or via
telephone at 301 443-9332.
Dated: July 22, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9-18125 Filed 7-29-09; 8:45 am]
BILLING CODE 4165-15-P
