60538 Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices 

space is limited, and we will close 

registration when maximum seating 

capacity (approximately 500) is reached. 

We will try to accommodate all 

persons who wish to make a 

presentation. The time allotted for 

presentations may depend on the 

number of persons who wish to speak. 

If you require special 

accommodations due to a disability, 

please contact Patricia A. Stewart at 

least 7 days in advance. 

If you would like to submit comments 

regarding PDUFA IV, please send your 

comments to the Division of Dockets 

Management (see ADDRESSES). Submit a 

single copy of electronic comments or 

two paper copies of any written 

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. 

D. Will Meeting Transcripts Be 

Available? 

We will prepare a meeting transcript, 

and we will make the transcript 

available on our Web site (http:// 

www.fda.gov) after the meeting. We 

anticipate that transcripts will be 

available approximately 30 working 

days after the meeting. The transcript 

will also be available for public 

examination at the Division of Dockets 

Management (see ADDRESSES), between 

9 a.m. and 4 p.m. Monday through 

Friday. 

Dated: October 12, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20875 Filed 10–14–05; 8:57 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review, 

Comment Request; 5 A Day 

Customized Survey 

SUMMARY: In compliance with the 

requirement of Section 3507(a)(1)(D) of 

the Paperwork Reduction Act of 1995 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI), 

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. The proposed 

information collection below was 

previously published in the Federal 

Register on May 18, 2005, page 28544–

28545 and allowed 60-days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised or 

implemented after October 1, 1995, 

unless it displays a currently valid OMB 

control number. 

Proposed Collection: Title: 5 A Day 

Customized Survey. Type of 

Information Collection Request: New. 

Need and Use of Information Collection: 

The purpose of the 5 A Day Customized 

Survey is to further the development of 

standardized measures of consumer 

knowledge, attitudes, and behaviors 

regarding the consumption of fruits and 

vegetables. Specifically, the Customized 

Survey will allow for validation of the 

new ‘‘cup’’ portion sizes (consistent 

with the 2005 Dietary Guidelines) and 

identify the most efficacious short 

screener methods of fruit and vegetable 

intake. In addition, the Customized 

Survey will measure established 

predictors of fruit and vegetable 

consumption at the national level and 

explore new predictors and constructs 

not previously examined for fruit and 

vegetable consumption. The sample will 

be drawn from a consumer opinion 

panel methodology using balancing 

techniques to mirror the U.S. general 

population on a set of key demographic 

variables. A separate sample of African 

Americans will be drawn from the 

panel. 

Prior to fielding the Customized 

Survey, two pilot studies will be 

completed as the first phase of this 

research. Pilot respondents will be 

drawn from the same consumer panel 

and have similar demographics as 

respondents in the main study. A brief 

description of the two pilot studies 

follows. In pilot study 1, respondents 

will initially complete a brief screener 

questionnaire, three 24-hour dietary 

recalls over the phone, followed by the 

Customized Survey by mail. To account 

for diversity in eating habits, dietary 

recalls will be obtained for 2 weekdays 

and 1 weekend per respondent. The 

recalls will be conducted via phone by 

trained interviewers using the 

University of Minnesota’s Nutrition 

Data System (NDS). After completing 

the dietary recalls pilot respondents will 

be mailed the Customized Survey 

within 2 weeks. Fruit and vegetable 

consumption as assessed by the average 

of the three 24-hour recalls will be 

compared with the fruit and vegetable 

consumption measures from the 

Customized Survey. In pilot study 2, 

respondents will complete the 

Customized Survey by mail at two 

points in time, six to eight weeks apart. 

The analysis in pilot study 2 will focus 

on a rigorous evaluation of the 

psychometric properties of the 

Customized Survey instrument to 

ensure that item-level and instrumentlevel reliability and validity has been 

achieved before proceeding to the main 

data collection phase of the study. 

Based on the findings of the pilot 

studies, minor modifications may be 

made to the Customized Survey prior to 

the implementation of the main study. 

Frequency of response: Main study, one 

time response (5 A Day Customized 

Survey). Pilot study 1, five times 

(screener, three 24-hour dietary recalls, 

5 A Day Customized Survey). Pilot 

study 2, two times (5 A Day Customized 

Survey at two points in time). Affected 

Public: Individuals. Type of 

Respondents: U.S. adults. The annual 

reporting burden is as follows: 

Estimated Number of Respondents: 

5,875; Estimated Number of Responses 

per Respondent: 1, 2 or 5; Average 

Burden Hours per Response: .416; and 

Estimated Total Annual Burden Hours 

Requested: 2,467.90. The annualized 

cost to respondents is estimated at: 

$46,384.28. The annual reporting 

burden is summarized in exhibit 1 

below. There are no Operating or 

Maintenance Costs to report. 

EXHIBIT 1 

Type of respondents * Number of 

respondents 

Frequency of 

response 

Average 

burden hours 

Annual hour 

burden 

Pilot Study 1: 

Screener ................................................................................................... 480 1 .08 38.4 

Dietary Recall 1 ........................................................................................ 380 1 .50 190 

Dietary Recall 2 ........................................................................................ 325 1 .50 162.5 

Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices 60539 

EXHIBIT 1—Continued 

Type of respondents * Number of 

respondents 

Frequency of 

response 

Average 

burden hours 

Annual hour 

burden 

Dietary Recall 3 ........................................................................................ 290 1 .50 145 

Mail Survey ............................................................................................... 200 1 .42 84 

Pilot Study 2: 

Mail Survey ............................................................................................... 200 2 .42 168 

Main Implementation 

5 A Day Customized Survey .................................................................... 4,000 1 .42 1,680 

Total ................................................................................................... 5,875 ........................ ........................ 2,467.90 

*All respondents are consumer panel members. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the 

proposed performance of the functions 

of the agency, including whether the 

information shall have practical utility; 

(2) the accuracy of the estimate of the 

burden of the proposed collection of 

information including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, New Executive 

Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Amy 

Lazarus Yaroch, Ph.D., Project Officer, 

National Cancer Institute, NIH, EPN 

4074, 6130 Executive Boulevard MSC 

7335, Bethesda, Maryland 20892–7335, 

or call non-toll-free number 301–402–

8425, or FAX your request to 301–480–

2087, or E-mail your request, including 

your address, to yarocha@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of this notice. 

Dated: October 5, 2005. 

Rachelle Ragland-Greene, 

NCI OMB Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 05–20756 Filed 10–17–05; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of Biotechnology Activities, 

Office of the Director; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a special meeting of 

the National Science Advisory Board for 

Biosecurity (NSABB) that was held by 

teleconference on September 29, 2005. 

The Secretary determined that advance 

notice was not possible, and that the 

meeting had to be closed to the public 

in accordance with the provisions set 

forth in section 552b(c)(4) and 

552b(c)(6), Title 5 U.S.C., as amended. 

Under authority 42 U.S.C. 217a, 

Section 222 of the Public Health Service 

Act, as amended, the Department of 

Health and Human Services established 

NSABB to provide advice, guidance and 

leadership regarding Federal oversight 

of dual-use research, defined as 

biological research with legitimate 

scientific purposes that could be 

misused to pose a biological threat to 

public health and/or national security. 

Name of Committee: National Science 

Advisory Board for Biosecurity. 

Date: September 29, 2005. 

Closed: 10 a.m. to 12 p.m. 

Agenda: To review confidential 

information. 

Place: 6705 Rockledge Drive, Bethesda, 

Maryland, (Telephone Conference Call). 

Contact Person: Allison Chamberlain, 

NSABB Program Assistant, 6705 Rockledge 

Drive, Bethesda, Maryland 20892, (301) 496–

9838. 

Dated: October 4, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–20748 Filed 10–17–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the President’s Cancer 

Panel, October 24, 2005, 8 a.m. to 

October 24, 2005, 5 p.m., Hotel 

Washington, Pennsylvania Ave at 15th 

Street, NW., Washington, DC, 20004 

which was published in the Federal 

Register on September 27, 2005, 70 FR 

56477. 

This meeting is amended to change 

the end time of the open session from 

5 p.m. to 4 p.m. on October 24, 2005 

and the date and time of the closed 

session from 1 p.m.–4 p.m. on October 

25, 2005 to 4:15 p.m.–6:15 p.m. on 

October 24, 2005. The meeting is 

partially Closed to the public. 

Dated: October 5, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–20742 Filed 10–17–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closing Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting.