45456 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 

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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/ohrms/dockets/ 

default.htm or http:// 

www.regulations.gov. 

Dated: August 1, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–18002 Filed 8–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0196] (formerly 

Docket No. 2007D–0449) 

Guidance for Food and Drug 

Administration Advisory Committee 

Members and Food and Drug 

Administration Staff: Voting 

Procedures for Advisory Committee 

Meetings; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document for 

FDA advisory committee members and 

FDA staff entitled ‘‘Voting Procedures 

for Advisory Committee Meetings.’’ This 

document is intended to provide 

guidance on advisory committee voting 

procedures that should be used when 

votes are taken during advisory 

committee meetings. It does not define 

when votes should be taken. Elsewhere 

in this issue of the Federal Register, 

FDA is announcing the availability of 

three additional guidances and one draft 

guidance, intended to improve FDA’s 

advisory committee procedures. 

DATES: The guidance is effective August 

5, 2008. Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Policy (HF–11), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit telephone requests to 800–835–

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

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 http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Jill 

Hartzler Warner, Office of Policy, 

Planning, and Preparedness (HF–11), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–3370. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for FDA advisory committee 

members and FDA staff entitled ‘‘Voting 

Procedures for Advisory Committee 

Meetings,’’ dated August 2008. FDA’s 

advisory committees provide 

independent and expert advice on 

scientific, technical, and policy matters 

related to the development and 

evaluation of products regulated by 

FDA. Advisory committees are a 

valuable resource to FDA, and they 

make an important contribution to the 

agency’s decisionmaking processes. 

Although advisory committees provide 

recommendations to FDA, the agency 

makes the final decisions. 

Advisory committees typically 

communicate advice or 

recommendations to the agency in two 

ways. First, FDA learns from the 

discussion and exchange that occurs 

among advisory committee members, 

and from individual recommendations 

and suggestions made during the 

discussion of any advisory committee 

meeting. Second, advisory committees 

often vote on a question or series of 

questions posed to the committee 

during a committee meeting. 

Votes can be an effective means of 

communicating with FDA because they 

provide feedback on discrete questions. 

These questions are generally scientific 

in nature and can involve a range of 

subjects, including evaluation of 

postmarket safety data or premarket 

assessment of a product’s risk/benefit 

profile. Because all members vote on the 

same question, the results help FDA 

gauge a committee’s collective view on 

complex, multi-faceted issues. This 

view helps inform the agency’s own 

deliberations on scientific and 

regulatory matters. 

This guidance recommends adopting 

uniform voting procedures to help 

maximize the integrity and meaning of 

voting results. In developing these 

recommendations, FDA was mindful of 

the legal requirements of the Federal 

Advisory Committee Act, other relevant 

statutes (e.g., the Federal Food, Drug, 

and Cosmetic Act), regulations (e.g., 21 

CFR part 14), guidance, policies, and the 

goals of FDA’s of advisory committee 

program. 

FDA issued a draft of this guidance on 

November 19, 2007 (72 FR 65046), and 

gave interested persons an opportunity 

to comment on the agency’s proposal. 

FDA carefully evaluated the comments 

submitted to that docket and considered 

them in preparation of the guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance document represents the 

agency’s current thinking on uniform 

procedures that should be used for the 

voting process when votes are taken 

during advisory committee meetings. 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. 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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 


dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 45457 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Electronic Access: 

Persons with access to the Internet 

may obtain the document at: http:// 

www.regulations.gov. 

Dated: August 1, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–18001 Filed 8–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0425] (formerly 

Docket No. 2007D–0021) 

Guidance for Industry: Advisory 

Committee Meetings—Preparation and 

Public Availability of Information Given 

to Advisory Committee Members; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: Advisory 

Committee Meetings—Preparation and 

Public Availability of Information Given 

to Advisory Committee Members,’’

dated August 2008. This document 

provides guidance to industry sponsors, 

applicants, and petitioners who 

develop, prepare, or submit briefing 

materials that will be given to advisory 

committee members as background 

information before an open FDA 

advisory committee meeting. The 

guidance announced in this notice 

finalizes the draft guidance of the same 

title dated February 2007. Elsewhere in 

this issue of the Federal Register, FDA 

is announcing the availability of three 

additional guidances and one draft 

guidance, intended to improve FDA’s 

advisory committee procedures. 

DATES: The guidance is effective August 

5, 2008. Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Policy (HF–11), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit telephone requests to 800–835–

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

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 http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Jill 

Hartzler Warner, Office of Policy, 

Planning, and Preparedness (HF–11), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–3370. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Advisory Committee 

Meetings—Preparation and Public 

Availability of Information Given to 

Advisory Committee Members,’’ dated 

August 2008. This guidance is intended 

to provide information to industry 

sponsors, applicants, and petitioners on 

the development, preparation, and 

submission of briefing materials that 

will be provided to advisory committee 

members as background information 

prior to open FDA advisory committee 

meetings. The guidance is intended to 

help minimize the time and resources 

spent in preparing such materials for 

public availability. The guidance also 

describes the process FDA intends to 

follow when we make briefing materials 

available to the public. 

An important goal of the guidance is 

to help ensure that briefing materials are 

made available to the public in 

accordance with section 10(b) of the 

Federal Advisory Committee Act 

(FACA) (5 U.S.C. app. 2). We interpret 

FACA to require that, with respect to 

any open advisory committee meeting 

convened under FACA, whenever 

practicable and subject to any 

applicable exemptions under the 

Freedom of Information Act (FOIA) (5 

U.S.C. 552), those materials that we 

provide to advisory committee members 

in connection with that meeting must be 

made available for public inspection 

and copying either before or at the time 

of the advisory committee meeting. 

In the guidance, the term ‘‘briefing 

materials’’ is used to describe the 

package of information that FDA 

provides to advisory committee 

members before a meeting. The briefing 

materials for a particular meeting 

generally include information prepared 

by FDA and/or the sponsor (if the 

meeting involves a product application 

or otherwise involves a particular 

product). This guidance includes (in the 

Appendices) timelines for preparing and 

submitting briefing materials to FDA. 

For open advisory committee 

meetings for which the briefing 

materials may contain information that, 

under certain circumstances, could be 

considered to be exempt from public 

disclosure under FOIA, we intend to: 

• Post a publicly available version of 

the briefing materials on FDA’s Web site 

at least 2 full business days before the 

meeting is scheduled to occur. 

For meetings for which the briefing 

materials do not contain information 

that, under certain circumstances, could 

be considered to be exempt from public 

disclosure under FOIA, such as many 

meetings concerning guidance 

documents and policy issues, we will 

try to: 

• Make the briefing materials 

available on FDA’s Web site more than 

2 full business days before the meeting. 

In the Federal Register of February 

28, 2007 (72 FR 9008), FDA announced 

the availability of the draft guidance of 

the same title dated February 2007. FDA 

received a number of comments on the 

draft guidance and those comments 

were considered as the guidance was 

finalized. In addition, editorial changes 

were made to improve clarity. This 

guidance finalizes the draft guidance 

and replaces three previously issued 

draft guidance documents entitled: (1) 

‘‘Guidance for Industry: Disclosing 

Information Provided to Advisory 

Committees in Connection With Open 

Advisory Committee Meetings Related 

to the Testing or Approval of New Drugs 

and Convened by the Center for Drug 

Evaluation and Research, Beginning on 

January 1, 2000,’’ dated December 1999; 

(2) ‘‘Guidance for Industry: Disclosing 

Information Provided to Advisory 

Committees in Connection With Open 

Advisory Committee Meetings Related 

to the Testing or Approval of Biologic 

Products and Convened by the Center 

for Biologics Evaluation and Research,’’

dated February 2001; and (3) 

‘‘Availability of Information Given to 

Advisory Committee Members in 

Connection With CDRH Open Public 

Panel Meetings; Draft Guidance for 

Industry and FDA Staff,’’ dated July 18, 

2001. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’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. 


dwashington3 on PRODPC61 with NOTICES