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
45460 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 

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: Public 

Availability of Advisory Committee 

Members’ Financial Interest Information 

and Waivers,’’ 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 implements a rigorous 

process for soliciting and vetting 

candidates for advisory committee 

meetings to minimize any potential for 

financial conflicts of interest. The 

agency is authorized by statute to grant 

waivers to allow individuals with 

potentially conflicting financial 

interests to participate in meetings 

where we conclude, after close scrutiny, 

that certain criteria are met. See 18 

U.S.C. 208(b)(1), (b)(3) and section 

712(c)(2)(B) of the Federal Food, Drug, 

and Cosmetic Act (the act) (added by the 

Food and Drug Administration 

Amendments Act of 2007, Public Law 

No. 110–85, section 701 (effective 

October 1, 2007)). 

In January 2002, FDA issued ‘‘Draft 

Guidance on Disclosure of Conflicts of 

Interest for Special Government 

Employees Participating in FDA Product 

Specific Advisory Committees,’’ and 

requested comments on the draft 

guidance (Docket No. 2002D–0049). The 

draft guidance was limited in 

application to Special Government 

Employees (SGEs) participating in 

advisory committee meetings at which 

particular matters relating to particular 

products were discussed. 

FDA has recently undertaken an 

internal assessment of its advisory 

committee process. As a result of this 

review, and based on the comments 

submitted to the docket for the January 

2002 draft guidance, FDA has revised 

the 2002 draft guidance to broaden its 

applicability, to bring as much 

transparency as possible to FDA’s 

waiver process, and to increase the 

consistency and clarity of the process. 

The guidance revises procedures, 

consistent with section 712(c)(3) of the 

act, to make publicly available relevant 

information regarding financial interests 

and waivers granted by the agency for 

SGEs and regular Government 

employees invited to participate in FDA 

advisory committee meetings. 

The guidance also includes a template 

for disclosing to the public the 

disqualifying financial interests for 

which waivers are sought and a 

template for all waivers that FDA grants. 

The guidance further describes FDA’s 

process for making these documents 

available on its Web site in advance of 

each advisory committee meeting. 

In the Federal Register of October 31, 

2007 (72 FR 61657), FDA announced the 

availability of the draft guidance of the 

same title dated October 2007. FDA 

received one comment on the draft 

guidance generally supporting the 

guidance. Editorial changes were made 

to improve clarity. 

This guidance document is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The guidance document 

represents the agency’s current thinking 

on public availability of information 

regarding advisory committee members’

financial interests and waivers granted 

by FDA to permit participation in 

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, 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 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 http:// 

www.fda.gov/opacom/morechoices/ 

industry/guidedc.htm or http:// 

www.regulations.gov. 

Dated: July 31, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–17999 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–2008–D–0434] 

Draft Guidance for Humanitarian 

Device Exemption Holders, 

Institutional Review Boards, Clinical 

Investigators, and Food and Drug 

Administration Staff; Humanitarian 

Device Exemption Regulation: 

Questions and Answers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Humanitarian Device 

Exemption (HDE) Regulation: Questions 

and Answers.’’ This draft guidance 

answers commonly asked questions 

about Humanitarian Use Devices 

(HUDs) and applications for HDE. This 

draft guidance is neither final nor is it 

in effect at this time. 

DATES: 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 

written or electronic comments on the 

draft guidance by November 3, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Humanitarian 

Device Exemption (HDE) Regulation: 

Questions and Answers’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance (HFZ–220), 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

1350 Piccard Dr., Rockville, MD 20850. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 240–276–

3151. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this draft guidance to the Division of 


dwashington3 on PRODPC61 with NOTICES