Memorandum of Understanding Between the Food and Drug Administration and the Veterans Health Administration, 54942-54945 [05-18513]
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54942
Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices
ACTION:
BILLING CODE 4160–01–C
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA and
the Veterans Health Administration
(VHA). The purpose of this MOU is to
extend an existing formal collaboration
between FDA and VHA for the purpose
of developing and implementing
terminology standards for medication
information.
DATES: The agreement became effective
June 28, 2005.
FOR FURTHER INFORMATION CONTACT:
Randy Levin, Health and Regulatory
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA 225–05–3000]
Memorandum of Understanding
Between the Food and Drug
Administration and the Veterans
Health Administration
AGENCY:
Food and Drug Administration,
HHS.
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Data Standards (HFD–001), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
5411.
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
Dated: September 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
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Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices
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Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices
BILLING CODE 4160–01–C
on agency guidance documents are
welcome at any time.
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
guidance to the Division of Dockets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.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0340]
Draft Guidance for Industry on Acne
Vulgaris: Developing Drugs for
Treatment; 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 entitled ‘‘Acne Vulgaris:
Developing Drugs for Treatment.’’ This
document has been developed to
provide guidance on the development of
drug products for the treatment of acne
vulgaris other than nodulocystic acne.
DATES: Submit written or electronic
comments on the draft guidance by
December 19, 2005. General comments
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FOR FURTHER INFORMATION CONTACT:
Frank Cross, Center for Drug Evaluation
and Research (HFD–540), Food and
Drug Administration, 9201 Corporate
Blvd., Rockville, MD 20850, 301–827–
2020.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Acne Vulgaris: Developing Drugs for
Treatment.’’ This document has been
developed to provide guidance on the
development of drug products for the
treatment of acne vulgaris other than
nodulocystic acne. The information
presented may help applicants plan
clinical studies, design clinical
protocols, implement and appropriately
monitor the conduct of clinical trials,
collect relevant data for analysis, and
perform appropriate types of analyses of
study data.
The recommendations in the draft
guidance are based on careful
assessment of important issues raised in
the review of clinical trials for acne
vulgaris. These recommendations
represent the agency’s current thinking
regarding design of clinical trials
intended to support the approval of
drug products for the treatment of acne
vulgaris. Applicants are encouraged to
discuss development plans with the
agency review division before
embarking on a study, to ensure that the
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[FR Doc. 05–18513 Filed 9–16–05; 8:45 am]
54945
]]>Agencies
[Federal Register Volume 70, Number 180 (Monday, September 19, 2005)]
[Notices]
[Pages 54942-54945]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18513]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA 225-05-3000]
Memorandum of Understanding Between the Food and Drug
Administration and the Veterans Health Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between FDA and the Veterans Health
Administration (VHA). The purpose of this MOU is to extend an existing
formal collaboration between FDA and VHA for the purpose of developing
and implementing terminology standards for medication information.
DATES: The agreement became effective June 28, 2005.
FOR FURTHER INFORMATION CONTACT: Randy Levin, Health and Regulatory
Data Standards (HFD-001), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-594-5411.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and MOUs between FDA and others
shall be published in the Federal Register, the agency is publishing
notice of this MOU.
Dated: September 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160-01-S
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[FR Doc. 05-18513 Filed 9-16-05; 8:45 am]
BILLING CODE 4160-01-C
