Fiscal Year (FY) 2009 Funding Opportunity, 38036-38037 [E9-18187]
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38036
Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices
erowe on DSK5CLS3C1PROD with NOTICES
The guidance describes the sensitivity
and specificity of various indicators of
hepatotoxic potential, as well as the
observations needed to evaluate those
indicators, including detection,
confirmation and monitoring of liver
test abnormalities, close evaluation and
exclusion of other causes, and careful
supportive care and follow-up to
normality or return to baseline status.
The guidance makes specific
recommendations about the use of Hy’s
Law and interpretation of Hy’s Law
cases that are identified during clinical
development and suggests research
opportunities to learn more about what
makes certain people more susceptible
to DILI than are most persons exposed
to the drug.
The guidance was issued in draft form
in October 2007 for public comments.
We received a total of 12 comments
submitted to Docket No. 2007D–0396.
FDA organized a public meeting in
March 2008 for discussion of issues
raised by the draft guidance and
reopened the public comment period
from March 6, 2008, to June 30, 2008,
with Docket No. FDA–2008–D–0128
(formerly Docket No. 2007D–0396). One
comment was submitted to Docket No.
FDA–2008–D–0128. The comments are
available at https://www.fda.gov/Drugs/
ScienceResearch/ResearchAreas/
ucm071471.htm. Presentations,
discussion, and materials from the
March 2008 public meeting also are
available at the above Web site.
FDA considered written and verbal
comments submitted to the dockets and
at the public meeting before finalizing
the guidance. The guidance reflects
clarifying and editorial changes made in
response to comments and at our own
initiative.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on the premarketing
evaluation of a drug’s potential for
causing severe DILI. 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. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312, 314,
and 601 have been approved under
VerDate Nov<24>2008
15:34 Jul 29, 2009
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OMB Control Numbers 0910–0014,
0910–0001, and 0910–0338,
respectively.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/cber/guidelines.htm, or
https://www.regulations.gov.
Dated: July 22, 2009.
Jeffrey Shuren,
Associate Comissioner for Policy and
Planning.
[FR Doc. E9–18135 Filed 7–29–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Fiscal Year (FY) 2009 Funding
Opportunity
AGENCY: Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice of intent to award a
Single Source Supplement Grant to the
Community Anti-Drug Coalitions of
America (CADCA).
SUMMARY: This notice is to inform the
public that the Substance Abuse and
Mental Health Services Administration
(SAMHSA) intends to award
approximately $30,000 (total costs) for
one year to the Community Anti-Drug
Coalitions of America (CADCA). This is
not a formal request for applications.
Assistance will be provided only to the
Community Anti-Drug Coalitions of
America (CADCA) based on the receipt
of a satisfactory application that is
approved by an independent review
group.
Funding Opportunity Title: SP–09–
007.
Catalog of Federal Domestic
Assistance (CFDA) Number: 93.243.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Authority: Sections 509, 516 and 520A of
the Public Health Service Act, as amended.
Justification: Only the Community
Anti-Drug Coalitions of America
(CADCA) is eligible to apply. The
Substance Abuse and Mental Health
Services Administration (SAMHSA) is
seeking to supplement a single source
grant to the Community Anti-Drug
Coalitions of America (CADCA) to
support a Prevention Town Hall
Meeting and a Partners Meeting at
CADCA’s Mid-Year Training Institute.
The Training Institute will disseminate
knowledge and transfer state-of-the-art
information, assisting community
leaders in developing effective local
programs, practices, and policies that
support national substance abuse goals,
outcomes and efforts, such as National
Alcohol and Drug Addiction Recovery
Month, and prevention of underage
drinking. The Prevention Town Hall
Meeting will provide an in-depth
overview of substance abuse prevention
principles, and make the link to
community-level change strategies
promoted by the Drug-Free
Communities grant program. The
Partners Meeting is intended to bring all
Federal and other key constituents
together to update and discuss new
initiatives and ongoing projects. Grant
funds will also support evaluation of the
Prevention Town Hall Meeting to obtain
findings and identify directions for
future trainings.
The Community Anti-Drug Coalitions
of America (CADCA) is uniquely
qualified to carry out the activities of
this program because the purpose of the
program is to partner with a national
organization that has special expertise
and unique broad, national-level
experience in working with community
anti-drug coalitions. CADCA is the only
national organization that annually
provides training and technical
assistance through a mid-year
leadership conference for thousands of
members of community coalitions
dedicated to preventing substance
abuse. CADCA currently is the sole
organization that plays a major role in
helping to strengthen and develop the
nation’s prevention infrastructure of
anti-drug coalitions in support of ongoing activities funded by SAMHSA’s
priority grant programs including: the
Substance Abuse Prevention and
Treatment Block Grant, the Strategic
Prevention Framework State Incentive
Grant, and the Drug Free Communities
Support Program. CADCA is the only
identified organization that currently
meets this experience level and national
reach to over 5,000 identified anti-drug
coalitions across the country.
E:\FR\FM\30JYN1.SGM
30JYN1
Federal Register / Vol. 74, No. 145 / Thursday, July 30, 2009 / Notices
Contact: Shelly Hara, Substance
Abuse and Mental Health Services
Administration, 1 Choke Cherry Road,
Room 8–1081, Rockville, MD 20857;
telephone: (240) 276–2321; E-mail:
shelly.hara@samhsa.hhs.gov.
Dated: July 24, 2009.
Toian Vaughn,
Committee Management Officer, Substance
Abuse and Mental Health, Services
Administration.
[FR Doc. E9–18187 Filed 7–29–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
erowe on DSK5CLS3C1PROD with NOTICES
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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Immunobiology of
Xenotransplantation.
Date: September 18, 2009.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, 3264, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Maryam Feili-Hariri, PhD,
Scientific Review Officer, Immunology
Review Branch, Scientific Review Program,
National Institutes of Health/NIAID, 6700B
Rockledge Drive, MSC 7616, Bethesda, MD
20892–7616, 301–402–5658,
haririmf@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: July 24, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–18225 Filed 7–29–09; 8:45 am]
BILLING CODE 4140–01–P
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15:34 Jul 29, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
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 meetings.
The meetings 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: National Institute on
Drug Abuse Special Emphasis Panel; NIDA–
F Special Emphasis Panel.
Date: August 3, 2009.
Time: 1 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6101
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Nadine Rogers, PhD,
Scientific Review Administrator, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC
8401, 6101 Executive Boulevard, Bethesda,
MD 20892–8401, 301–402–2105,
rogersn2@nida.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Diversity-promoting Institutions’ Drug Abuse
Research Development Program.
Date: August 3, 2009.
Time: 1 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6101
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Nadine Rogers, PhD,
Scientific Review Administrator, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC
8401, 6101 Executive Boulevard, Bethesda,
MD 20892–8401, 301–402–2105,
rogersn2@nida.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
PO 00000
Frm 00059
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38037
Dated: July 23, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–18017 Filed 7–29–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Diabetes and Digestive and Kidney
Diseases Advisory Council.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meetings 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: National Diabetes and
Digestive and Kidney Diseases Advisory
Council.
Date: September 9, 2009.
Open: 8:30 a.m. to 11:45 a.m.
Agenda: To present the Director’s Report
and other scientific presentations.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Closed: 4:15 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, PhD,
Director, Division of Extramural Activities,
National Institute of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.,
Room 715, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council Diabetes, Endocrinology, and
Metabolic Diseases Subcommittee.
E:\FR\FM\30JYN1.SGM
30JYN1
]]>Agencies
[Federal Register Volume 74, Number 145 (Thursday, July 30, 2009)]
[Notices]
[Pages 38036-38037]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18187]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Fiscal Year (FY) 2009 Funding Opportunity
AGENCY: Substance Abuse and Mental Health Services Administration, HHS.
ACTION: Notice of intent to award a Single Source Supplement Grant to
the Community Anti-Drug Coalitions of America (CADCA).
-----------------------------------------------------------------------
SUMMARY: This notice is to inform the public that the Substance Abuse
and Mental Health Services Administration (SAMHSA) intends to award
approximately $30,000 (total costs) for one year to the Community Anti-
Drug Coalitions of America (CADCA). This is not a formal request for
applications. Assistance will be provided only to the Community Anti-
Drug Coalitions of America (CADCA) based on the receipt of a
satisfactory application that is approved by an independent review
group.
Funding Opportunity Title: SP-09-007.
Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.
Authority: Sections 509, 516 and 520A of the Public Health
Service Act, as amended.
Justification: Only the Community Anti-Drug Coalitions of America
(CADCA) is eligible to apply. The Substance Abuse and Mental Health
Services Administration (SAMHSA) is seeking to supplement a single
source grant to the Community Anti-Drug Coalitions of America (CADCA)
to support a Prevention Town Hall Meeting and a Partners Meeting at
CADCA's Mid-Year Training Institute. The Training Institute will
disseminate knowledge and transfer state-of-the-art information,
assisting community leaders in developing effective local programs,
practices, and policies that support national substance abuse goals,
outcomes and efforts, such as National Alcohol and Drug Addiction
Recovery Month, and prevention of underage drinking. The Prevention
Town Hall Meeting will provide an in-depth overview of substance abuse
prevention principles, and make the link to community-level change
strategies promoted by the Drug-Free Communities grant program. The
Partners Meeting is intended to bring all Federal and other key
constituents together to update and discuss new initiatives and ongoing
projects. Grant funds will also support evaluation of the Prevention
Town Hall Meeting to obtain findings and identify directions for future
trainings.
The Community Anti-Drug Coalitions of America (CADCA) is uniquely
qualified to carry out the activities of this program because the
purpose of the program is to partner with a national organization that
has special expertise and unique broad, national-level experience in
working with community anti-drug coalitions. CADCA is the only national
organization that annually provides training and technical assistance
through a mid-year leadership conference for thousands of members of
community coalitions dedicated to preventing substance abuse. CADCA
currently is the sole organization that plays a major role in helping
to strengthen and develop the nation's prevention infrastructure of
anti-drug coalitions in support of on-going activities funded by
SAMHSA's priority grant programs including: the Substance Abuse
Prevention and Treatment Block Grant, the Strategic Prevention
Framework State Incentive Grant, and the Drug Free Communities Support
Program. CADCA is the only identified organization that currently meets
this experience level and national reach to over 5,000 identified anti-
drug coalitions across the country.
[[Page 38037]]
Contact: Shelly Hara, Substance Abuse and Mental Health Services
Administration, 1 Choke Cherry Road, Room 8-1081, Rockville, MD 20857;
telephone: (240) 276-2321; E-mail: shelly.hara@samhsa.hhs.gov.
Dated: July 24, 2009.
Toian Vaughn,
Committee Management Officer, Substance Abuse and Mental Health,
Services Administration.
[FR Doc. E9-18187 Filed 7-29-09; 8:45 am]
BILLING CODE 4162-20-P
