Advisory Committee on Immunization Practices: Notice of Charter Renewal, 18504 [2010-8254]
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Federal Register / Vol. 75, No. 69 / Monday, April 12, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
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Dated: April 6, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–8259 Filed 4–9–10; 8:45 am]
[Docket No. FDA–2010–D–0166]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee on Immunization
Practices: Notice of Charter Renewal
sroberts on DSKD5P82C1PROD with NOTICES
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the
Advisory Committee on Immunization
Practices, Centers for Disease Control
and Prevention, Department of Health
and Human Services, has been renewed
for a 2-year period through April 1,
2012.
For information, contact Larry
Pickering, M.D., Executive Secretary,
Advisory Committee on Immunization
Practices, Centers for Disease Control
and Prevention, Department of Health
and Human Services, 1600 Clifton Road,
NE., Mailstop E05, Atlanta, Georgia
30333, telephone 404/639–8767 or fax
404/639–8626.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: April 6, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–8254 Filed 4–9–10; 8:45 am]
BILLING CODE 4163–18–P
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17:58 Apr 09, 2010
Jkt 220001
Food and Drug Administration
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Draft
Guidance for Industry on Studies to
Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in FoodProducing Animals: Marker Residue
Depletion Studies to Establish Product
Withdrawal Periods (VICH GL48);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry (#207) entitled ‘‘Draft Guidance
for Industry on Studies to Evaluate the
Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Animals: Marker Residue Depletion
Studies to Establish Product Withdrawal
Periods,’’ (VICH GL48). This draft
guidance has been developed for
veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). This draft VICH guidance
document is intended to provide study
design recommendations which will
facilitate the universal acceptance of the
generated residue depletion data to
fulfill this recommendation.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by May 12, 2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
PO 00000
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Number of responses per
respondent
1
Average
burden per
response
(in hours)
1
Submit written comments on the draft
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 draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Julia
Oriani, Center for Veterinary Medicine
(HFV–151), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8204, email: julia.oriani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry (#207)
entitled ‘‘Draft Guidance for Industry on
Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in
Food-Producing Animals: Marker
Residue Depletion Studies to Establish
Product Withdrawal Periods,’’ (VICH
GL48). In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote the
international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and has expressed its
commitment to seek scientifically based
harmonized technical procedures for the
development of pharmaceutical
products. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Conference on
Harmonisation of Technical
Requirements for Approval of
Pharmaceuticals for Human Use for
several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union
(EU), Japan, and the United States. The
VICH is a parallel initiative for
veterinary medicinal products. The
VICH is concerned with developing
harmonized technical requirements for
the approval of veterinary medicinal
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[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Page 18504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8254]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Advisory Committee on Immunization Practices: Notice of Charter
Renewal
This gives notice under the Federal Advisory Committee Act (Pub. L.
92-463) of October 6, 1972, that the Advisory Committee on Immunization
Practices, Centers for Disease Control and Prevention, Department of
Health and Human Services, has been renewed for a 2-year period through
April 1, 2012.
For information, contact Larry Pickering, M.D., Executive
Secretary, Advisory Committee on Immunization Practices, Centers for
Disease Control and Prevention, Department of Health and Human
Services, 1600 Clifton Road, NE., Mailstop E05, Atlanta, Georgia 30333,
telephone 404/639-8767 or fax 404/639-8626.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Dated: April 6, 2010.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2010-8254 Filed 4-9-10; 8:45 am]
BILLING CODE 4163-18-P
