65046 Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices 

[FR Doc. 07–5748 Filed 11–16–07; 8:45 am] 

BILLING CODE 4160–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0449] 

Draft Guidance for Food and Drug 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availability of a draft guidance 

document for FDA advisory committee 

members and FDA staff entitled, 

‘‘Voting Procedures for Advisory 

Committee Meetings.’’ This draft 

document is intended to provide 

guidance on advisory committee voting 

procedures that can be used for the 

voting process when votes are taken 

during advisory committee meetings. It 

does not to define when votes should be 

taken. 

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 comment on the 

draft guidance by January 18, 2007. 

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.fda.gov/dockets/ 

ecomments or 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, 

Planning, and Preparedness (HF–11), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–3370. 


rwilkins on PROD1PC63 with NOTICESEN19NO07.019</GPH>
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices 65047 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for FDA advisory 

committee members and FDA staff 

entitled, ‘‘Voting Procedures for 

Advisory Committee Meetings,’’ dated 

November 2007. 

FDA’s advisory committees provide 

independent, expert advice to the 

agency on a range of complex scientific, 

technical, and policy issues, including 

questions 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 decision-making processes. 

Although advisory committees provide 

recommendations to FDA, FDA makes 

the final decisions. 

Advisory committees typically 

communicate advice or 

recommendations to the agency in two 

ways. First, committee members 

routinely share their individual 

thoughts and recommendations during 

the discussion of a particular matter at 

an 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 pre-market 

assessment of a product’s risk/benefit 

profile. Since 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 draft guidance recommends 

adopting uniform voting procedures to 

help maximize the integrity and 

meaning of voting results. In developing 

these recommendations, FDA is 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, 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 (21 CFR 10.115). 

The draft guidance represents the 

agency’s current thinking on 

recommended uniform procedures that 

can 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 in January 2008, the 

FDA Web site is expected to transition 

to the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. After the transition 

date, electronic submissions will be 

accepted by FDA through the FDMS 

only. When the exact date of the 

transition to FDMS is known, FDA will 

publish a Federal Register notice 

announcing that date. 

Dated: November 14, 2007. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. 07–5751 Filed 11–15–07; 9:06 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Proposed 

Collection; Comment Request; 

Formative Research and Pilot Studies 

for the National Children’s Study 

SUMMARY: In compliance with the 

requirement of section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute of Child Health and 

Human Development (NICHD), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Formative 

Research and Pilot Studies for the 

National Children’s Study. Type of 

Information Collection Request: NEW. 

Need and use of information collection: 

The NICHD seeks to obtain OMB’s 

generic approval to conduct pilot and 

formative research to be used in the 

development of instruments, materials, 

and procedures for the National 

Children’s Study (NCS). The NCS is a 

long-term cohort study of environmental 

influences on child health and 

development authorized under the 

Children’s Health Act of 2000. The Act 

specifies a broad definition of 

environment, including biologic, 

chemical, physical, and psycho-social 

factors and authorizes the NICHD to 

plan, develop, and implement a 

prospective cohort study, from birth to 

adulthood, to evaluate the effects of 

those exposures on child health and 

human development. Further details 

pertaining to the NCS background and 

planning, including the NCS Research 

Plan, can be found at: http:// 

nationalchildrensstudy.gov. The 

proposed data collection program will 

include community outreach materials, 

medical provider and participant 

materials, questionnaires and measures, 

use of technology such as Interactive 

Voice Recognition (IVR), and other 

aspects related to data collection. 

Activities will include small focused 

studies to test data collection items and 

methods on a specific or targeted 

population, validation of questionnaires 

for targeted populations, focus groups 

within the NCS communities to test 

forms and procedures, cognitive 

interviews to test data items, and the 

use of materials on targeted populations 

such as medical providers and 

hospitals, and materials translated into 

other languages. These activities will be 

conducted over the life of the study to 

develop procedures and materials for 

each stage of data collection. The results 

of these pilot tests will be used to 

maximize the efficiency of study 

procedures, materials, and methods for 

community outreach, engagement of the 

medical community, for recruiting and 

retaining study subjects prospectively 

across study visits and to ensure that 

data collection methodologies are 

efficient and valid for all potential 

participants. Without this information, 

NCS will be hampered in its efforts to 

effectively publicize the NCS, gain 

public and professional support, and 

effectively recruit and retain 

respondents and collect data over the 

life of the Study. Affected entities: 

Individuals. Types of respondents: 

People potentially affected by this 

action are pregnant women or women of 

childbearing age, their husbands or 

partners, health care professionals, and 

community leaders. The annual 


rwilkins on PROD1PC63 with NOTICES