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
Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 45459 

finalized. In addition, changes 

necessitated by the enactment of 

FDAAA were incorporated into the final 

guidance. A summary of changes 

includes the following: 

• FDA is choosing to limit the 

waivers the agency grants and 

harmonize our implementation of the 

various statutory provisions by applying 

a generally stricter test for granting 

waivers than would be required in some 

cases. FDA will ensure that all waivers 

meet the standard established by section 

712(c)(2)(B) of the act that the waiver is 

‘‘necessary to afford the advisory 

committee essential expertise.’’

• The guidance incorporates a 

progressively more stringent cap on the 

numbers of waivers issued per fiscal 

year in accordance with FDAAA. 

• Advisory committee members will 

be considered for meeting participation 

under a rigorous policy regarding the 

value of their personal financial 

interests and those of their immediate 

family that potentially could be affected 

by the meeting deliberations. If an 

individual or his spouse or minor child 

has disqualifying financial interests 

whose combined value exceeds $50,000, 

she generally would not participate in 

the meeting, regardless of the need for 

her expertise. Financial interests 

imputed to the member (e.g., the 

financial interests of a university that 

employs the member) are not subject to 

the $50,000 maximum. 

• FDA will not issue a waiver in 

certain circumstances where the agency 

has determined that the conflict of 

interest is significant. 

• Waivers may be voting or nonvoting at the discretion of the agency. 

• Past financial interests that are 

outside of the scope of 18 U.S.C. 208 

and section 712 of the act are not 

addressed in this guidance. 

• New section 712 of the act 

harmonizes with 18 U.S.C. 208 those 

exempted interests considered too 

remote or inconsequential to affect the 

integrity of the services of advisory 

committee members; therefore, the 

guidance incorporates such exemptions. 

• The guidance removes references to 

administrative steps (e.g., submission of 

internal memoranda) that staff should 

follow; internal staff instructions will be 

developed separately. 

In addition, editorial changes were 

made to improve clarity. 

This guidance is effective for advisory 

committee meetings scheduled on or 

after (see DATES). FDA staff begin 

planning and preparing for advisory 

committee meetings well in advance of 

the meeting date, in order to initiate and 

complete conflict of interest screening, 

among other things, for potential 

advisory committee participants. 

Accordingly, while staff will begin 

using the guidance directly, its impact 

on advisory committee meetings will 

not be fully apparent until 120 days 

after publication. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on procedures for 

considering conflict of interest and 

eligibility for participation in FDA 

advisory committees. 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, at any time, 

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 Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at: http:// 

www.fda.gov/ohrms/dockets/ 

default.htm 

Dated: July 31, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–17998 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–2002–D–0094] (formerly 

Docket No. 2002D–0049) 

Guidance for the Public, FDA Advisory 

Committee Members, and FDA Staff: 

Public Availability of Advisory 

Committee Members’ Financial Interest 

Information and Waivers; 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: 

Public Availability of Advisory 

Committee Members’ Financial Interest 

Information and Waivers.’’ This 

guidance is intended to help the public, 

FDA advisory committee members, and 

FDA staff to understand and implement 

FDA procedures regarding public 

availability of information regarding 

certain financial interests and waivers 

granted by FDA to permit individuals to 

participate in an advisory committee 

meeting. The guidance announced in 

this notice finalizes the draft guidance 

of the same title dated October 2007 and 

FDA’s ‘‘Draft Guidance on Disclosure of 

Conflicts of Interest for Special 

Government Employees Participating in 

FDA Product Specific Advisory 

Committees’’ dated January 2002. 

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 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 


dwashington3 on PRODPC61 with NOTICES