60536 Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices 

educational measures in the Head Start 

Program. This includes the Head Start 

National Reporting System (NRS). The 

Committee is to provide 

recommendations for integrating NRS 

with other ongoing assessments of the 

effectiveness of the program. The 

Committee will make recommendations 

as to how NRS and other assessment 

data can be included in the broader 

Head Start measurement efforts found in 

the Family and Child Experiences 

Survey (FACES), the national Head Start 

Impact Study, Head Start’s Performance 

Based Outcome System and the ongoing 

evaluation of the Early Head Start 

program. 

Date: November 1, 2005, 8:30 a.m.–

5:30 p.m. (Dinner Recess). November 2, 

2005, 8:30 a.m.–4:30 p.m. 

Place: The Beacon Hotel, 1615 Rhode 

Island Ave, NW., Washington, DC 

20036. 

Agenda: The Committee will hear 

presentations related to existing Head 

Start evaluations and NRS 

implementation and will continue the 

discussions begun at the first meeting in 

June 2005. 

SUPPLEMENTARY INFORMATION: This, the 

second meeting of the Committee, is 

open to the public. Persons wishing to 

bring written statements or papers 

focused on relevant, existing research 

with Head Start populations or on 

measures appropriate for low-income 

four- and five-year-old children are 

welcome to do so. Individuals may email such documents to 

Secretaryadvisory-hs@esi-dc.com or 

mail to: ESI, ATTN: Xzavier Wright, 

Head Start Bureau—Secretary’s 

Advisory Committee, 7735 Old 

Georgetown Road, Suite 600, Bethesda, 

Maryland 20814. 

Documents received shall be 

presented to the Committee. 

The Committee meeting records shall 

be kept at the Aerospace Center located 

at 901 D Street, SW., Washington, DC 

20447. The Head Start Bureau will also 

make material related to this meeting 

available on the Head Start Web site 

http://www2.acf.dhhs.gov/programs/ 

hsb/. 

An interpreter for the deaf and hard 

of hearing will be available upon 

advance request by contacting 

xzavier@esi-dc.com. 

Naomi Goldstein, 

Director, Office of Planning, Research and 

Evaluation. 

[FR Doc. 05–20758 Filed 10–17–05; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0410] 

Prescription Drug User Fee Act; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting on the Prescription Drug 

User Fee Act (PDUFA). The legislative 

authority for PDUFA expires in 

September 2007. Without further 

legislation, we will no longer be able to 

collect user fees for the prescription 

drug program and resources critical to 

running the program would become 

unavailable to us. We invite public 

comment on the PDUFA program and 

suggestions regarding what features we 

should propose for the next PDUFA 

program. 

DATES: The public meeting will be held 

on November 14, 2005, from 9 a.m. to 

5 p.m. Registration to attend the meeting 

must be received by October 31, 2005. 

You may register electronically at 

CBERTraningSuggestions@cber.fda.gov. 

Walk-in registration at the meeting site 

will also be accepted. Submit written 

comments by December 14, 2005. 

ADDRESSES: The meeting will be held at 

the Natcher Conference Center, National 

Institutes of Health, Bldg. 45, Center Dr., 

9000 Rockville Pike, Bethesda, MD 

20815. Parking is limited, and there may 

be delays entering the NIH campus due 

to increased security. All visitors’

vehicles will be inspected, and visitors 

must show one form of identification 

(ID) (such as a government-issued photo 

ID, driver’s license, passport, etc.) We 

recommend arriving by subway 

(Metrorail) if possible. NIH is accessible 

from the Metrorail’s ‘‘Red Line’’ at the 

Medical Center/NIH station. 

Submit written comments 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. 

FOR FURTHER INFORMATION CONTACT: 

For information regarding this notice: 

Patricia A. Stewart, Office of Policy 

and Planning (HFP–1), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–

827–2647, FAX: 301–594–6777, email: Patricia.Stewart@oc.fda.gov. 

For information regarding 

registration: Melanie Whelan or 

Kathy Eberhart, Office of 

Communication, Training and 

Manufacturers Assistance (HFM–

49), Center for Biologics Evaluation 

and Research, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852, 

301–827–2000, FAX: 301–827–

3079. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

FDA is announcing its intention to 

hold a public meeting on PDUFA. The 

authority for PDUFA expires in 

September 2007. Without further 

legislation, FDA would no longer be 

able to collect user fees for the 

prescription drug program. Resources 

critical to running the program would 

become unavailable to FDA. We are now 

considering what features we should 

propose for the next PDUFA program. 

We are convening a public meeting to 

hear stakeholder views on this subject. 

We are offering the following two 

general questions for consideration, and 

we are interested in responses to these 

questions and any other pertinent 

information stakeholders would like to 

share: 

1. What is your assessment of the 

overall performance of the PDUFA 

program thus far? 

2. What aspects of PDUFA should be 

retained, or what should be changed to 

further strengthen and improve the 

program? 

We provide the following background 

on the PDUFA program so potential 

participants can better understand the 

history and evolution of the PDFUA 

program and its current status. 

II. What is PDUFA? What Does It Do? 

PDUFA, in broad terms, is a series of 

laws that have authorized us to collect 

fees from companies that produce 

certain human drug and biological 

products. The original PDUFA (PDUFA 

I) was enacted in 1992 (as the 

Prescription Drug User Fee Act, Public 

Law 102–571) and had a 5-year life. In 

1997, as PDUFA I expired, Congress 

passed the FDA Modernization Act 

(FDAMA, Public Law 105–115). 

FDAMA included, among other things, 

an extension of PDUFA (PDUFA II) for 

an additional 5 years. In 2002, Congress 

extended PDUFA again for 5 years 

(PDUFA III) through the Public Health 

Security and Bioterrorism Preparedness 

and Response Act (Public Law 107–

188). 

PDUFA’s original intent was to 

provide additional revenues to us so 

that we could hire more staff to improve 

the process for the review of human 

Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices 60537 

drugs to make important drug therapies 

available to patients sooner without 

compromising review quality. 

Under PDUFA, the industry provided 

additional funds through user fees that 

would be available to FDA, in addition 

to appropriated funds, to spend on the 

process for the review of human drugs. 

Our authority to collect user fees is 

‘‘triggered’’ only when a base amount of 

appropriated funds, adjusted for 

inflation, is spent. 

In conjunction with PDUFA, we set 

review performance goals that became 

more stringent each year. These goals 

applied to the review of original new 

human drug and biological product 

applications, resubmissions of original 

applications, and supplements to 

approved applications. During the first 

few years of PDUFA I, we eliminated 

backlogs of original applications and 

supplements that had formed in earlier 

years when the program had fewer 

resources. Phased in over the 5 years of 

PDUFA I, the goals were to review and 

act on 90 percent of priority new drug 

applications (NDAs), biologics license 

applications (BLAs), and efficacy 

supplements (i.e., submissions for 

products providing significant 

therapeutic gains) within 6 months of 

submission of a complete application; to 

review and act on 90 percent of 

nonpriority original NDAs, BLAs, and 

efficacy supplements within 12 months, 

and on resubmissions and 

manufacturing supplements within 6 

months. Over the course of PDUFA I, we 

exceeded all of these performance goals. 

Under PDUFA II, some review 

performance goals continued to shorten. 

For example, by 2002, the PDUFA II 

goals called on us to review and act on 

90 percent of the following: 

• Standard new drug and biological 

product applications and efficacy 

supplements within 10 months; 

• Chemistry and Manufacturing 

Control supplements requiring prior 

FDA approval within 4 months; and 

• Class 1 resubmissions (that respond 

to relatively minor deficiencies such as 

labeling changes) within 2 months. 

In addition, PDUFA II added a new 

set of procedural goals intended to 

improve our interactions with industry 

sponsors during the early years of drug 

development. For example, these goals 

called for us to meet with sponsors and 

provide followup meeting minutes 

within a certain number of days, and 

provide responses to questions on 

industry submitted special study 

protocols within a certain number of 

days. 

We met or exceeded nearly all of our 

goals for application review and for 

these other procedures under PDUFA II. 

Under PDUFA III, additional money 

from user fees was authorized, and a 

mechanism placed in the act to annually 

account for increases in workload 

associated with the process for the 

review of human drugs. For the first 

time, PDUFA III also authorized us to 

spend user fee funds on certain aspects 

of postmarket risk management. The 

review performance and procedural 

goals associated with PDUFA III were 

similar to those under PDUFA II for 

fiscal year (FY) 2002 performance 

levels, but the PDUFA III program 

addressed drug safety issues and 

established several new initiatives to 

improve application submissions and 

agency-sponsor interactions during drug 

development and application review. 

The goals under PDUFA III also 

included new provisions, for example, 

to develop guidance for industry on 

good risk assessment, risk management, 

and pharmacovigilance practices, to 

fund outside expert consultants to help 

evaluate and improve review 

management processes, and to 

centralize accountability and funding 

for all PDUFA information technology 

initiatives and activities. 

Furthermore, in conjunction with 

PDUFA’s reauthorization in 2002, we 

committed to the creation of a guidance 

for our review staff and industry on 

good review management principles and 

practices as they apply to the first cycle 

review of NDAs, BLAs, and efficacy 

supplements, and we announced the 

guidance’s availability in the Federal 

Register of March 31, 2005 (70 FR 

16507). We also set a goal of testing 

whether providing early review of 

selected applications and additional 

feedback and advice to sponsors during 

drug development for selected products 

can shorten drug development and 

review times. There were two 

continuous marketing application 

(CMA) pilot programs; CMA Pilot 1 

provides for the review of a limited 

number of presubmitted portions of 

NDAs and BLAs. Under CMA Pilot 2, 

FDA and applicants can enter into 

agreements to engage in frequent 

scientific feedback and interactions 

during the investigational new drug 

phase of product development. The 

first-cycle and CMA initiatives are 

currently being evaluated to determine 

their impact on the effectiveness and 

efficiency of FDA-sponsor 

communications, product development, 

and regulatory review. 

We have published a number of 

reports that may help inform the public 

about PDUFA and its implementation. 

Key Federal Register documents, such 

as, PDUFA-related guidances, 

legislation, performance reports, and 

financial reports, can be found at http:// 

www.fda.gov/oc/pdufa/ and 

www.fda.gov/cder/pdufa. We may make 

additional information about PDUFA 

available on our Web site at http:// 

www.fda.gov/oc/pdufa. Additional 

information about the activities of the 

involved FDA product centers can be 

found in the Center for Drug Evaluation 

and Research 2004 Report to the Nation 

(http://www.fda.gov/cder/reports/rtn/ 

2004/rtn2004.htm), and the Center for 

Biologics Evaluation and Research FY 

2004 Annual Report (http:// 

www.fda.gov/cber/inside/annrpt.htm). 

III. What Information Should You 

Know About the Meeting? 

A. When and Where Will the Meeting 

Occur? What Format Will We Use? 

Through this notice, we are 

announcing that we will convene a 

public meeting to hear stakeholder 

views on what features we should 

advance in proposing the PDUFA IV 

program. 

We will conduct the meeting on 

November 14, 2005, at the Natcher 

Conference Center, National Institutes of 

Health (NIH) (see ADDRESSES). In 

general, the meeting format will include 

presentations by FDA and a series of 

panels representing different 

stakeholder interest groups (such as 

patient advocates, consumer protection, 

industry, health professionals, and 

academic researchers). We will also 

provide an opportunity for individuals 

to make presentations at the meeting, 

and for organizations and individuals to 

submit written comments to the docket 

after the meeting 

B. What Questions Would We Like the 

Public to Consider? 

Please consider the following 

questions for this meeting: 

1. What is your assessment of the 

overall performance of the PDUFA 

program thus far? 

2. What aspects of PDUFA should be 

retained, or what should be changed to 

further strengthen and improve the 

program? 

C. How Do You Register for the Meeting 

or Submit Comments? 

If you wish to attend and/or make a 

presentation at the meeting, please send 

an e-mail message to: 

CBERTrainingSuggestions@cber.fda.gov 

by October 31, 2005. Your e-mail should 

include the following information: 

Name, company, company address, 

company phone number, and e-mail 

address. You will receive a confirmation 

within 2 business days. 

We also will accept walk-in 

registration at the meeting site, but 

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