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finalizes the draft guidance of the same 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
45458 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the guidance. 

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. A copy of the 

guidance and received comments are 

available for public examination 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 guidance at http:// 

www.regulations.gov. 

Dated: August 1, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–17997 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–0424] (formerly 

Docket No. 2007D–0101) 

Guidance for the Public, FDA Advisory 

Committee Members, and FDA Staff on 

Procedures for Determining Conflict of 

Interest and Eligibility for Participation 

in FDA Advisory Committees; 

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 

the public, FDA advisory committee 

members, and FDA staff entitled 

‘‘Guidance for the Public, FDA Advisory 

Committee Members, and FDA Staff: 

Procedures for Determining Conflict of 

Interest and Eligibility for Participation 

in FDA Advisory Committees’’ dated 

August 2008. This guidance describes 

the factors and analyses that should be 

used in considering whether an 

advisory committee member has a 

potential conflict of interest and 

whether participation in a meeting is 

appropriate. This guidance is intended 

to help the public, FDA advisory 

committee members, and FDA staff to 

understand and implement FDA policy 

in applying the applicable statutory and 

regulatory requirements. This guidance 

finalizes the draft guidance of the same 

title dated March 2007 and replaces the 

guidance document entitled ‘‘FDA 

Waiver Criteria 2000.’’ 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: This guidance is effective for 

advisory committee meetings scheduled 

on or after December 3, 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 phone 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 the 

Public, FDA Advisory Committee 

Members, and FDA Staff; Procedures for 

Determining Conflict of Interest and 

Eligibility for Participation in FDA 

Advisory Committees,’’ 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. 

FDA is committed to strictly adhering 

to the laws and regulations governing 

the process for selecting advisory 

committee members. FDA for many 

years has screened, prior to each 

meeting, all potential members who are 

special government employees or 

regular government employees, to 

determine whether the potential for a 

financial conflict of interest exists. The 

agency may grant a waiver to allow an 

individual to participate in a meeting 

when statutory criteria are met; for 

example, when the need for the 

individual’s services outweighs the 

potential for a conflict of interest 

created by the financial interest 

involved. FDA administers several laws 

and regulations that govern conflict of 

interest determinations. The applicable 

laws have recently changed with the 

enactment of the Food and Drug 

Administration Amendments Act 

(FDAAA). Title VII of FDAAA added 

section 712 of the Federal Food, Drug, 

and Cosmectic Act (the act), which 

became effective October 1, 2007, 

replaced the conflict of interest 

provisions in section 505(n)(4) of the 

act, and introduced new requirements. 

In addition, the agency must apply 18 

U.S.C. section 208, which contains 

different standards for assessing 

conflicts of interest. FDA’s Waiver 

Criteria 2000 guidance, which this 

guidance replaces, attempted to 

comprehensively address the complex 

set of variables that can be applied in 

reaching a determination about an 

individual advisory committee 

participant. However, because of its 

complexity and discretionary elements, 

FDA staff found it difficult to achieve 

consistent results that the public could 

readily understand. As part of FDA’s 

recent internal assessment of its 

advisory committee process, the agency 

has targeted its assessment of potential 

conflicts of interest and granting of 

waivers as an area that needs 

improvement. This guidance 

implements a more stringent approach 

for considering eligibility for 

participation in FDA advisory 

committee meetings. The purpose of 

this guidance is to simplify and 

streamline the process by which FDA 

considers meeting participation, 

increase the transparency, clarity, and 

consistency of the process, and enhance 

public trust in this important function. 

In the Federal Register of March 23, 

2007 (72 FR 13805), FDA announced the 

availability of the draft guidance of the 

same title dated March 2007. FDA 

received a number of comments on the 

draft guidance and those comments 

were considered as the guidance was 


dwashington3 on PRODPC61 with NOTICES