Draft Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment; Availability, 54945-54946 [05-18512]

Download as PDF 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 Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0340] Draft Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS.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 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Acne Vulgaris: Developing Drugs for Treatment.’’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 DATES: Submit written or electronic comments on the draft guidance by December 19, 2005.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 VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 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SUPPLEMENTARY INFORMATION: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Acne Vulgaris: Developing Drugs for Treatment.’’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 E:\FR\FM\19SEN1.SGM 19SEN1 En19se05.002</GPH> [FR Doc. 05–18513 Filed 9–16–05; 8:45 am] 54945 54946 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices clinical trial design and analysis plan meet defined objectives. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on this topic. 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 contains information collection provisions 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 collection of information in this guidance has been approved under OMB control number 0910–0001 (expires May 31, 2008). 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. The draft guidance and 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 either https://www.fda.gov/cder/guidance/ index.htm or https://www.fda.gov/ ohrms/dockets/default.htm. Dated: September 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–18512 Filed 9–16–05; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2002D–0018] (formerly 02D– 0018) Guidance for Industry on the Collection of Race and Ethnicity Data in Clinical Trials; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Collection of Race and Ethnicity Data in Clinical Trials.’’ This guidance provides recommendations on a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products. This document provides guidance on meeting the requirements in the 1998 final rule on Investigational New Drug Applications and New Drug Applications (Demographic Rule) (63 FR 6854, February 11, 1998). DATES: Submit written or electronic comments on agency guidances at any time. Submit written requests for single copies of this 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, or the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. Submit written comments on the 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 guidance document. FOR FURTHER INFORMATION CONTACT: Katherine Hollinger, Office of Women’s Health, Office of Science and Health Communication (HF–8), 5600 Fishers Lane, Rockville, MD 20857, 301–827–0935, or ADDRESSES: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), 1401 Rockville Pike, Rockville, MD 20852, 301–827–6210, or Investigational Device Exemption Staff (HFV–403), Center for Devices and Radiological Health, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–1190. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Collection of Race and Ethnicity Data in Clinical Trials.’’ A draft of this guidance was issued on January 30, 2003 (68 FR 4788). Based on comments received on the draft and the refinement of agency thinking on this topic, FDA has revised the draft guidance and is now issuing a guidance. This guidance is intended to assist sponsors in the collection of race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products using a standardized approach. The standardized approach was developed by the Office of Management and Budget (OMB). FDA believes that the use of the OMB approach will facilitate comparisons across clinical studies analyzed by FDA and data collected by other Federal agencies. Although FDA has long requested the racial and ethnic ancestral origins of subjects in certain clinical trials, the agency is now making recommendations on the methods and categories to use when collecting and reporting data. The Department of Health and Human Services (HHS) issued a 1999 report entitled ‘‘Improving the Collection and Use of Racial and Ethnic Data in HHS,’’ in which HHS announced the adoption of OMB Directive 15 as part of its policy on collecting and reporting data on racial and ethnic ancestral origins. FDA received several comments in response to the January 2003 draft guidance and has made some clarifying changes in the final version of the guidance. Specifically, we have: 1. Added reference to 21 CFR 314.50(d)(5)(v) to include studies for efficacy. 2. Clarified the traceability/mapping between more granular characterizations for racial and ethnic ancestral origins: ‘‘When more detailed characterizations are desired, the use of Race and Ethnicity vocabulary tables located within Health Level Seven’s Reference Information Model Structural Vocabulary Tables is recommended. These tables provide the five and two OMB characterizations traceable to more detailed characterizations and concept E:\FR\FM\19SEN1.SGM 19SEN1

Agencies

[Federal Register Volume 70, Number 180 (Monday, September 19, 2005)]
[Notices]
[Pages 54945-54946]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18512]


-----------------------------------------------------------------------

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 self-addressed 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.

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

[[Page 54946]]

clinical trial design and analysis plan meet defined objectives.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on this topic. 
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 contains information collection provisions 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 
collection of information in this guidance has been approved under OMB 
control number 0910-0001 (expires May 31, 2008).

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. The draft guidance and 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 
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.

    Dated: September 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18512 Filed 9-16-05; 8:45 am]
BILLING CODE 4160-01-S

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