Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees, 19488-19489 [05-7342]
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Federal Register / Vol. 70, No. 70 / Wednesday, April 13, 2005 / Notices
will be sent to all grantees after the
awards are made.
VII. Agency Contacts
Program Office Contact: Katherine
Gray, U.S. Department of Health and
Human Services, Administration for
Children and Families, ACYF—Head
Start Bureau, 330 C Street SW., Switzer
Room 2211, Washington, DC 20447,
Phone: 312–353–2260, E-mail:
kgray@acf.hhs.gov.
Grants Management Office Contact:
Delores Dickenson, U.S. Department of
Health and Human Services,
Administration for Children and
Families, ACYF—Head Start Bureau,
330 C Street SW., Switzer Room 2220,
Washington, DC 20447, Phone: 202–
260–7622, E-mail:
dedickenson@acf.hhs.gov.
VIII. Other Information
Applicants will not be sent
acknowledgements of received
applications.
Notice: Beginning with FY 2006, the
Administration for Children and
Families (ACF) will no longer publish
grant announcements in the Federal
Register. Beginning October 1, 2005,
applicants will be able to find a
synopsis of all ACF grant opportunities
and apply electronically for
opportunities via: https://
www.Grants.gov. Applicants will also be
able to find the complete text of all ACF
grant announcements on the ACF Web
site located at: https://www.acf.hhs.gov/
grants/.
Dated: March 31, 2005.
Joan E. Ohl,
Commissioner, Administration on Children,
Youth and Families.
[FR Doc. 05–7030 Filed 4–12–05; 8:45 am]
elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to remove portions
reflecting approval of this NADA.
DATES: Withdrawal of approval is
effective April 25, 2005.
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for
Veterinary Medicine (HFV–212), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 301–827–
7818, e-mail: pesposit@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Natchez
Animal Supply Co., 201 John R. Junkin
Dr., Natchez, MS 39120, has requested
that FDA withdraw approval of NADA
121–557 for THR Worm (dichlorophene
and toluene) Capsules used in dogs and
cats for removal of certain intestinal
parasites. This action is requested
because the product is no longer
manufactured or marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
(21 CFR 5.10), redelegated to the Center
for Veterinary Medicine (21 CFR 5.84),
and in accordance with 21 CFR 514.115
Withdrawal of approval of applications,
notice is given that approval of NADA
121–557 and all supplements and
amendments thereto, is hereby
withdrawn, effective April 25, 2005.
In a final rule published elsewhere in
this issue of the Federal Register, FDA
is amending the animal drug regulations
to reflect the withdrawal of approval of
this NADA.
Dated: March 31, 2005.
Catherine P. Beck,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. 05–7338 Filed 4–12–05; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
Request for Nominations for Voting
Consumer Representative Members on
Public Advisory Committees
[Docket No. 2005N–0059]
Withdrawal of Approval of a New
Animal Drug Application;
Dichlorophene and Toluene Capsules
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) for dichlorophene
and toluene capsules used in dogs and
cats for removal of certain intestinal
parasites. In a final rule published
VerDate jul<14>2003
18:37 Apr 12, 2005
Jkt 205001
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting consumer
representatives to serve on its advisory
committees that are under the purview
of the Center for Drug Evaluation and
Research (CDER).
FDA has a special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on its advisory
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committees and, therefore, encourages
nominations of qualified candidates
from these groups.
DATES: Nominations will be accepted for
current vacancies and for those that will
or may occur through December 31,
2005. Because vacancies occur on
various dates throughout the year, there
is no cutoff date for the receipt of
nominations.
All nominations should be
sent to the contact person listed in the
ADDRESSES:
FOR FURTHER INFORMATION CONTACT
section of this document.
Igor
Cerny, Center for Drug Evaluation and
Research (HFD–21), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, Maryland 20857, 301–827–
7001, e-mail: cerny@cder.fda.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
consumer representatives to all of its
advisory committees identified in
section I of this document.
FOR FURTHER INFORMATION CONTACT:
I. Functions
The functions of advisory committees
under the purview of CDER are listed in
the following paragraphs.
A. Arthritis Advisory Committee
The committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of arthritis,
rheumatism, and related diseases and
makes appropriate recommendations to
the Commissioner of Food and Drugs
(the Commissioner).
B. Anti-Infective Drugs Advisory
Committee
The committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of infectious
diseases and disorders and makes
appropriate recommendations to the
Commissioner.
C. Cardiovascular and Renal Drugs
Advisory Committee
The committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of cardiovascular
and renal disorders and makes
appropriate recommendations to the
Commissioner.
D. Dermatologic and Ophthalmic Drugs
Advisory Committee
The committee reviews and evaluates
available data concerning the safety and
E:\FR\FM\13APN1.SGM
13APN1
Federal Register / Vol. 70, No. 70 / Wednesday, April 13, 2005 / Notices
effectiveness of marketed and
investigational human drug products for
use in the treatment of dermatologic and
ophthalmic disorders and makes
appropriate recommendations to the
Commissioner.
E. Endocrinologic and Metabolic Drugs
Advisory Committee
The committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of endocrine and
metabolic disorders and makes
appropriate recommendations to the
Commissioner.
F. Nonprescription Drugs Advisory
Committee
The committee reviews and evaluates
available data concerning the safety and
effectiveness of over-the-counter
(nonprescription) human drug products,
or any other FDA-regulated product, for
use in the treatment of a broad spectrum
of human symptoms and diseases and
advises the Commissioner either on the
issuance of monographs establishing
conditions under which these drugs are
generally recognized as safe and
effective and not misbranded, or on the
approval of new drug applications for
such drugs. The committee serves as a
forum for the exchange of views
regarding the prescription and
nonprescription status, including
switches from one status to another, of
these various drug products and
combinations thereof. The committee
may also conduct peer review of agency
sponsored intramural and extramural
scientific biomedical programs in
support of FDA’s mission and regulatory
responsibilities.
G. Pulmonary-Allergy Drugs Advisory
Committee
The committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of pulmonary
disease and diseases with allergic and/
or immunologic mechanisms and makes
appropriate recommendations to the
Commissioner.
II. Criteria for Members
Persons who are nominated for
membership on the committees as
consumer representatives must meet the
following criteria: (1) Demonstrate ties
to consumer and community-based
organizations, (2) be able to analyze
technical data, (3) understand research
design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy
of products under review. The
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18:37 Apr 12, 2005
Jkt 205001
19489
consumer representative must be able to
represent the consumer perspective on
issues and actions before the advisory
committee; serve as a liaison between
the committee and interested
consumers, associations, coalitions, and
consumer organizations; and facilitate
dialogue with the advisory committees
on scientific issues that affect
consumers.
Compliance Policy Guide Sec.
560.400—Imported Milk and Cream—
Federal Import Milk Act (Compliance
Policy Guide 7119.05); Availability
III. Selection Procedures
AGENCY:
The selection of members
representing consumer interests is
conducted through procedures that
include the use of organizations
representing the public interest and
consumer advocacy groups. The
organizations have the responsibility of
recommending candidates of the
agency’s selection.
ACTION:
All nominations must include a cover
letter, a curriculum vitae or resume (that
includes the nominee’s office address,
telephone number, and e-mail address),
and a list of consumer or communitybased organizations for which the
candidate can demonstrate active
participation.
Any interested person or organization
may nominate one or more qualified
persons for membership on one or more
of the advisory committees to represent
consumer interests. Self-nominations
are also accepted. FDA will ask the
potential candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
a conflict of interest. The nomination
should specify the committee(s) of
interest. The term of office is up to 4
years, depending on the appointment
date.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: April 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–7342 Filed 4–12–05; 8:45 am]
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Food and Drug Administration
[Docket No. 2004D–0453]
Food and Drug Administration,
HHS.
IV. Nomination Procedures
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a compliance policy
guide (CPG) entitled ‘‘Sec. 560.400—
Imported Milk and Cream—Federal
Import Milk Act (CPG 7119.05).’’ The
CPG provides guidance on the
applicability of the Federal Import Milk
Act (FIMA) to imported milk and cream.
This document updates the existing
CPG.
Submit written or electronic
comments concerning the CPG or the
supporting document at any time.
ADDRESSES: Submit written requests for
single copies of the CPG entitled ‘‘Sec.
560.400—Imported Milk and Cream—
Federal Import Milk Act (CPG 7119.05)’’
to the Division of Compliance Policy
(HFC–230), Office of Enforcement,
Office of Regulatory Affairs, Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send two
self-addressed adhesive labels to assist
that office in processing your request, or
fax your request to 240–632–6861. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the document.
Submit written comments on the
revised CPG 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Esther Lazar, Center for Food Safety and
Applied Nutrition (HFS–306), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
301–436–1485, FAX: 301–436–2632.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
In the Federal Register of October 29,
2004 (69 FR 63158), FDA announced the
availability of a draft CPG entitled ‘‘Sec.
560.400—Imported Milk and Cream—
Federal Import Milk Act (CPG
7119.05).’’ After considering comments
received, FDA has finalized the CPG.
The CPG updates and replaces ‘‘CPG
Sec. 560.400—Imported Milk and
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[Federal Register Volume 70, Number 70 (Wednesday, April 13, 2005)]
[Notices]
[Pages 19488-19489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7342]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Voting Consumer Representative
Members on Public Advisory Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting consumer representatives to serve on its
advisory committees that are under the purview of the Center for Drug
Evaluation and Research (CDER).
FDA has a special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on its
advisory committees and, therefore, encourages nominations of qualified
candidates from these groups.
DATES: Nominations will be accepted for current vacancies and for those
that will or may occur through December 31, 2005. Because vacancies
occur on various dates throughout the year, there is no cutoff date for
the receipt of nominations.
ADDRESSES: All nominations should be sent to the contact person listed
in the FOR FURTHER INFORMATION CONTACT section of this document.
FOR FURTHER INFORMATION CONTACT: Igor Cerny, Center for Drug Evaluation
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
Rockville, Maryland 20857, 301-827-7001, e-mail: cerny@cder.fda.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
consumer representatives to all of its advisory committees identified
in section I of this document.
I. Functions
The functions of advisory committees under the purview of CDER are
listed in the following paragraphs.
A. Arthritis Advisory Committee
The committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of arthritis, rheumatism, and related diseases and
makes appropriate recommendations to the Commissioner of Food and Drugs
(the Commissioner).
B. Anti-Infective Drugs Advisory Committee
The committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of infectious diseases and disorders
and makes appropriate recommendations to the Commissioner.
C. Cardiovascular and Renal Drugs Advisory Committee
The committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of cardiovascular and renal disorders
and makes appropriate recommendations to the Commissioner.
D. Dermatologic and Ophthalmic Drugs Advisory Committee
The committee reviews and evaluates available data concerning the
safety and
[[Page 19489]]
effectiveness of marketed and investigational human drug products for
use in the treatment of dermatologic and ophthalmic disorders and makes
appropriate recommendations to the Commissioner.
E. Endocrinologic and Metabolic Drugs Advisory Committee
The committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of endocrine and metabolic disorders and makes
appropriate recommendations to the Commissioner.
F. Nonprescription Drugs Advisory Committee
The committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (nonprescription) human
drug products, or any other FDA-regulated product, for use in the
treatment of a broad spectrum of human symptoms and diseases and
advises the Commissioner either on the issuance of monographs
establishing conditions under which these drugs are generally
recognized as safe and effective and not misbranded, or on the approval
of new drug applications for such drugs. The committee serves as a
forum for the exchange of views regarding the prescription and
nonprescription status, including switches from one status to another,
of these various drug products and combinations thereof. The committee
may also conduct peer review of agency sponsored intramural and
extramural scientific biomedical programs in support of FDA's mission
and regulatory responsibilities.
G. Pulmonary-Allergy Drugs Advisory Committee
The committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of pulmonary disease and diseases
with allergic and/or immunologic mechanisms and makes appropriate
recommendations to the Commissioner.
II. Criteria for Members
Persons who are nominated for membership on the committees as
consumer representatives must meet the following criteria: (1)
Demonstrate ties to consumer and community-based organizations, (2) be
able to analyze technical data, (3) understand research design, (4)
discuss benefits and risks, and (5) evaluate the safety and efficacy of
products under review. The consumer representative must be able to
represent the consumer perspective on issues and actions before the
advisory committee; serve as a liaison between the committee and
interested consumers, associations, coalitions, and consumer
organizations; and facilitate dialogue with the advisory committees on
scientific issues that affect consumers.
III. Selection Procedures
The selection of members representing consumer interests is
conducted through procedures that include the use of organizations
representing the public interest and consumer advocacy groups. The
organizations have the responsibility of recommending candidates of the
agency's selection.
IV. Nomination Procedures
All nominations must include a cover letter, a curriculum vitae or
resume (that includes the nominee's office address, telephone number,
and e-mail address), and a list of consumer or community-based
organizations for which the candidate can demonstrate active
participation.
Any interested person or organization may nominate one or more
qualified persons for membership on one or more of the advisory
committees to represent consumer interests. Self-nominations are also
accepted. FDA will ask the potential candidates to provide detailed
information concerning such matters as financial holdings, employment,
and research grants and/or contracts to permit evaluation of possible
sources of a conflict of interest. The nomination should specify the
committee(s) of interest. The term of office is up to 4 years,
depending on the appointment date.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: April 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-7342 Filed 4-12-05; 8:45 am]
BILLING CODE 4160-01-S
