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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Public Meeting on Animal Models—Essential Elements to Address Efficacy Under the Animal Rule; and Reopening of Comment Period

Docket No. FDA–2009–D–0007

November 5, 2010

8:00AM - 5:30PM

A public meeting will be held at the FDA White Oak Complex, 10903 New Hampshire Ave., Bldg. 31, Rm 1503, Silver Spring, MD, 20993–0002 on November 5, 2010, from 8:00 am-5:30 PM

SUMMARY

The Food and Drug Administration’s (FDA or agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing a public meeting to solicit comments and concerns of industry, other government agencies, and interested parties on the regulatory and scientific challenges as addressed in the draft document entitled ‘‘Guidance for Industry: Animal Models—Essential Elements to Address Efficacy Under the Animal Rule’’ dated January 2009 (Draft Guidance), and as related to the development of medical countermeasures under the ‘‘Animal Rule’’ with respect to chemical, biological, radiological, or nuclear (CBRN) threats. Comments on these issues will be considered in connection with the development of a final version of the Draft Guidance.

PURPOSE AND SCOPE

The purpose of this meeting is to receive comments from a broad group of stakeholders on the regulatory and scientific challenges related to the development of medical countermeasures under the Animal Rule (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products) for CBRN threats as addressed in the Draft Guidance. Each session will have a panel composed of FDA representatives from CBER and CDER to interact with the presenter as necessary to clarify comments and provide limited scientific discussion as appropriate. FDA is particularly interested in obtaining information and public comment on the following areas:

Topic Area A: (1) Natural course of the CBRN agent-induced disease or condition; and (2) Pathophysiologic comparability of the CBRN agent-induced disease or condition between animals and humans.

Topic Area B: (1) Characteristics of the CBRN agent; and (2) Host susceptibility in response to the agent.

Topic Area C: Characterization of medical intervention.

Topic Area D: Design considerations for the animal efficacy studies

Topic Area E: General comments.

PUBLIC MEETING ORAL PRESENTATIONS & WRITTEN COMMENTS

Attendees who wish to request to make an oral presentation at the public meeting must register and submit their comments electronically by October 1, 2010. All non-presenting attendees must register electronically by October 27, 2010. The comment period for the Draft Guidance has been reopened until January 5, 2011. Submit electronic comments on the Draft Guidance to http://www.regulations.gov. Refer to Background, for information on submission of comments.

COMMENTS ON DRAFT GUIDANCE

Regardless of attendance at the public meeting, interested persons may submit either electronic or written comments regarding the Draft Guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management, (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number FDA– 2009–D–0007. 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 either electronic or written comments on Draft Guidance by January 5, 2011. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

BACKGROUND

In the Federal Register of January 21, 2009 (74 FR 3610), FDA announced the availability of a draft document entitled ‘‘Guidance for Industry, ‘‘Animal Models Essential Elements to Address Efficacy Under the Animal Rule’’ dated January 2009 (Draft Guidance). The purpose of the Draft Guidance, when finalized, is to assist sponsors in identifying the critical characteristics of an animal model that should be addressed when efficacy of an investigational product will be established under the ‘‘Animal Rule’’ (May 31, 2002, 67 FR 37988). FDA requested comments on the Draft Guidance by March 23, 2009. In 2010, reviews to assess our nation’s preparedness against CBRN threats, as well as the major issues and challenges to achieving the desired state of emergency preparedness, were conducted under the auspices of the Public Health Emergency Medical Countermeasure Enterprise. Among the many issues noted was the difficulty of the regulatory path when developing drug or biological products for approval or licensure, respectively, under the ‘‘Animal Rule.’’ Therefore, to address this and related issues, FDA is holding a public meeting to solicit comments and concerns on the challenges related to the development of medical countermeasures under the Animal Rule for CBRN threats. FDA will consider the oral comments presented at the public meeting and comments submitted to docket on the Draft Guidance in developing the final version of the Guidance. Please see Guidance for Industry: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule.

REGISTRATION AND REQUEST FOR ORAL PRESENTATIONS

November 5, 2010

8:00AM - 5:30PM

A. Registration

The FDA Conference Center at the White Oak Complex is a Federal facility with security procedures and limited seating. There is no registration fee for the public meeting; however, advance registration is required for all attendees including members of the press and FDA employees. Registrations will be confirmed in the order in which they are received. Attendees who wish to make an oral presentation at the public meeting must register and submit their comments electronically by October 1, 2010 (see section III.B for additional information on requests for oral presentations). All non-presenting attendees must register electronically by October 27, 2010. To register, attendees must e-mail contact information (including name, title, and affiliation, address, e-mail, and telephone number), and any requests to make oral presentations to: AnimalModelGuidance@fda.hhs.gov.

Special Accommodations: If you need special accommodations because of a disability, please contact FDA (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

B . Requests for Oral Presentations

Attendees who wish to make an oral presentation at the public meeting must register for the meeting, request to present, and submit their comments electronically to AnimalModelGuidance@fda.hhs.gov by October 1, 2010.

The FDA has specified five topic areas for comment (see Purpose and Scope above). Presenters will also need to identify by letter (A through E) the topic area or areas on which they will comment. Submitted comments to be presented at the public meeting that exceed 10 pages should include a one-page executive summary. Oral presentations are limited to statements; slide presentations will not be permitted.

The FDA will do its best to accommodate requests to make oral presentations, and will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. Prior to the meeting, presenters will be notified of their allotted time and the approximate scheduled time of their remarks. An agenda of the public meeting, including the oral presentation schedule, will be available approximately 3 days before the public meeting at the Division of Dockets Management (Docket No. FDA–2009–D–0007) and on the Internet at http://www.regulations.gov.

Pre-registered participants will receive additional information on parking and public transportation with their e-mail registration confirmation.

TRANSCRIPTS

Transcripts of the meeting will be available for review at the Division of Dockets Management and on the Internet at http://www.regulations.gov approximately 45 days after the meeting. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI–35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Eris Mackey, Career Development and Directed Training Branch, Center for Biologics Evaluation and Research (HFM–49), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301–827–2000, e-mail: AnimalModelGuidance@fda.hhs.gov; or Susie Dill, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6183, Silver Spring, MD 20993–0002, 301–796–3437, e-mail: AnimalModelGuidance@fda.hhs.gov.