54942 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 

[FR Doc. 05–18514 Filed 9–16–05; 8:45 am] 

BILLING CODE 4160–01–C 

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. 

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54944 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 54945 

[FR Doc. 05–18513 Filed 9–16–05; 8:45 am] 

BILLING CODE 4160–01–C 

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Draft Guidance for Industry on Acne 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availability of a draft guidance for 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comments on the draft guidance by 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 

on agency guidance documents are 

welcome at any time. 

ADDRESSES: 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 http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

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: 

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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