Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 45455 

information to support applications for 

parametric release of human and 

veterinary drug products terminally 

sterilized by moist heat processes. 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. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collection of 

information requested in the draft 

guidance is covered under FDA 

regulations at 21 CFR 314.50, 314.70, 

and 314.81(b)(2) for human drugs, 21 

CFR 514.1, 514.8, 514.8(b)(4) and (c) for 

animal drugs, and 21 CFR 601.2 and 

601.12 for biologics. The collection of 

information is approved under the 

following OMB control numbers: 0910–

0001 for human drugs, 0910–0600 for 

animal drugs, and 0910–0338 for 

biologics. 

III. 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 and submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/cder/guidance/index.htm, 

http://www.fda.gov/cber/ 

guidelines.htm, or http:// 

www.regulations.gov. 

Dated: July 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17855 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–0417] 

Draft Guidance for the Public and the 

Food and Drug Administration Staff on 

Convening 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 draft guidance 

document entitled ‘‘Guidance for the 

Public and FDA Staff on Convening 

Advisory Committee Meetings.’’ This 

draft guidance is intended to provide 

guidance on when FDA should consider 

referring a matter to an advisory 

committee. Elsewhere in this issue of 

the Federal Register, FDA is 

announcing the availability of four 

guidances intended to improve FDA’s 

advisory committee procedures. 

DATES: Although you can comment on 

any guidance at any time (see 

§ 10.115(g)(5) (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 

October 6, 2008. 

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. 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 . See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: Jill 

Hartzler Warner, Office of Policy and 

Planning (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 draft guidance entitled ‘‘Guidance for 

the Public and FDA Staff on Convening 

Advisory Committee Meetings,’’ dated 

July 2008. Advisory committees provide 

FDA with independent, expert advice 

on a range of complex scientific and 

technical issues related to the products 

it regulates. These issues typically focus 

on a specific food or medical product, 

a class of foods or medical products, the 

development and implementation of a 

specific regulatory program, or the 

development and implementation of a 

regulatory policy. Advisory committee 

meetings also facilitate public 

discussion of important topics and 

provide a means for the public to 

provide comments to the agency. 

To enhance the transparency of FDA’s 

advisory committee program, the agency 

is publishing this draft guidance to 

provide its current thinking on when to 

bring a matter to an advisory committee. 

In some instances, FDA refers a matter 

to an advisory committee because it is 

required to do so by law. In others, FDA 

convenes an advisory committee 

meeting at its own discretion. 

Regardless, FDA recognizes that 

advisory committee meetings demand 

significant resource commitments by 

advisory committee members, sponsors, 

and other public participants, as well as 

for FDA itself, and should be used for 

important matters. The draft guidance is 

intended to clarify how the agency 

identifies which matters should be 

referred. 

In developing this draft guidance, 

FDA has been mindful of the legal 

requirements of the Federal Advisory 

Committee Act (FACA), other relevant 

statutes, regulations, guidance, and 

policies, and the goals of FDA’s of 

advisory committee program. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The draft 

guidance represents the agency’s current 

thinking on when FDA convenes an 

advisory committee meeting. 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. 


dwashington3 on PRODPC61 with NOTICES
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