60400 Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–04–0493] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 498–1210 or send an 

email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Human 

Resources and Housing Branch, New 

Executive Office Building, Room 10235, 

Washington, DC 20503 or by fax to (202) 

395–6974. Written comments should be 

received within 30 days of this notice. 

Proposed Project 

The National School-based Youth 

Risk Behavior Survey, OMB No. 0920–

0493—Reinstatement with change—

National Center for Chronic Disease 

Prevention and Health Promotion 

(NCCDPHP), Centers for Disease Control 

and Prevention (CDC). 

The purpose of this request is to 

renew OMB clearance to continue an 

ongoing biennial survey among high 

school students attending regular 

public, private, and Catholic schools in 

grades 9–12. Data will be collected in 

the Spring of 2005 and the Spring of 

2007 to assess priority health risk 

behaviors related to the major 

preventable causes of mortality, 

morbidity, and social problems among 

both youth and adults in the U.S. OMB 

clearance for the 2003 Youth Risk 

Behavior Survey (OMB No. 0920–0493) 

expired November 2003. 

Data on the health risk behaviors of 

adolescents is the focus of 

approximately 40 national health 

objectives in Healthy People 2010. The 

Youth Risk Behavior Survey provides 

data to measure at least 10 of these 

health objectives and 3 of the 10 

Leading Health Indicators. In addition, 

the Youth Risk Behavior Survey can 

identify racial and ethnic disparities in 

health risk behaviors. No other national 

source of data measures as many of the 

2010 objectives that address behaviors 

of adolescents. The data will also have 

significant implications for policy and 

program development for school health 

programs nationwide. There are no costs 

to respondents. The estimated 

annualized burden over the three-year 

period is 6,115 hours.

Respondents 

Number of 

respondents

(05–07) 

Number of 

responses 

per respondent 

Average burden per response

(in hrs) 

High School Students ........................................................................................................................ 8,000 1 45/60 

School Administrators ........................................................................................................................ 230 1 30/60 

Dated: October 4, 2004. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–22713 Filed 10–7–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Competitive 

Funds for National Programs To 

Improve the Health, Education, and 

Well-Being of Young People, Program 

Announcement Number 04010 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting:

Name: Disease, Disability, and Injury 

Prevention and Control Special Emphasis 

Panel (SEP): Competitive Funds for National 

Programs to Improve the Health, Education, 

and Well-Being of Young People, Program 

Announcement Number 04010. 

Times and Dates: 10 a.m.–10:30 a.m., 

October 26, 2004 (Open). 10:30 a.m.–12:30 

p.m., October 26, 2004 (Closed). 

Place: Teleconference Number: 

1.888.576.9873 pass code 13503 for the open 

portion of the meeting. 

Status: Portions of the meeting will be 

closed to the public in accordance with 

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

(6), title 5 U.S.C., and the Determination of 

the Director, Management Analysis and 

Services Office, CDC, pursuant to Public Law 

92–463. 

Matters to be Discussed: The meeting will 

include the review, discussion, and 

evaluation of applications received in 

response to Program Announcement Number 

04010. 

Contact Person for More Information:

Nosrat Irannejad, MPH, Lead Education 

Program Specialist, National Center for 

Chronic Disease Prevention and Health 

Promotion, 4770 Buford Highway, MS–K31, 

Atlanta, GA 30341, Telephone 770.488.6124. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry.

Dated: October 1, 2004. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–22712 Filed 10–7–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–67776, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 69 FR 48247–48249, 

dated August 9, 2004, is amended to 

reflect the consolidation of the Centers 

for Disease Control and Prevention 

budget execution functions within the 

Financial Management Office, Office of 

the Chief Operating Officer. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: 

Revise the functional statement for 

the Financial Management Office 

(CAJ2), Office of the Chief Operating 

Officer (CAJ) as follows: 

Delete in their entirety the title and 

functional statement for the Financial 

Policy and Internal Quality Assurance 

Activity (CAJ212).

Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Notices 60401

Delete the functional statement for the 

Budget Branch (CAJ23) and insert the 

following: 

Budget Execution Branch (CAJ23). (1) 

Promotes structured, ongoing 

partnerships between the CIOs, FMO 

leadership, Lead Budget Analysis, and 

Budget Execution staff; (2) provides 

leadership, consultation, guidance, and 

advice on budgetary matters for the CDC 

through senior advisory leadership roles 

in partnership with FMO and CIO 

Directors; (3) provides submission and 

execution of the CDC budget within the 

framework of HHS, OMB, Congressional 

regulations, and policies of the CDC 

Office of the Director; (4) supports the 

functions provided by the Budget 

Oversight and Analysis Activity and 

Budget Execution Services Activity; (5) 

provides leadership, consultation, 

guidance and advice on financial policy 

and internal quality assurance matters 

for CDC; (6) develops, analyzes, and 

evaluates financial management 

policies, guidelines, and services which 

have CDC-wide impact; (7) works with 

personnel from all disciplines within 

CEC to identify the areas in which 

financial policy needs to be 

strengthened; (8) reviews, assesses, and 

recommends financial policy that is 

consistent with internal controls and the 

hierarchy of Federal and Department of 

Health and Human Services policies 

and procedures; (9) ensures that 

resources are safeguarded against fraud, 

waste, and abuse; managed 

economically and efficiently; and 

desired results are achieved; (10) 

reviews and independently assesses the 

soundness, adequacy, and application of 

budgetary and accounting controls; (11) 

reviews the reliability and integrity of 

financial and budget information and 

the means used to identify, measure, 

classify, and report such information; 

(12) reviews the adequacy and 

effectiveness of systems and procedures 

having an impact on expenditures of 

funds and use of resources; and (13) 

assesses the reliability and accuracy of 

accounting and budgetary data and 

reports. 

Budget Oversight and Analysis 

Activity (CAJ232). (1) Supports the 

formulation of CDC’s annual budget and 

provides agency-level and departmental 

budget execution functions and 

reporting; (2) oversees budget execution 

services provided to terrorism and 

stockpile, global health, and OC/OCOO 

functions; (3) develops standard 

operating procedures for budget 

processes, collaborates with the Chief 

Learning Officer and Corporate 

University to develop appropriate 

training, and provides technical 

assistance in the interpretation of rules 

and regulations. 

Budget Execution Services Activity 

(CAJ233). (1) Provides budget execution 

services to CIOs; (2) coordinates budget 

services through formalized and 

integrated communication with CIO 

programs throughout its service offering 

to ensure effective and efficiently 

delivery of services to its customers; (3) 

supports the formulation of CIO annual 

budgets, develops spending plans, and 

manages budget execution activities 

ensuring funds are expended in 

accordance with Congressional intent. 

Delete item (4) of the functional 

statement for the Administrative 

Services Branch (Spokane) (CC114), 

Office of Administrative and 

Management Services (CC11), Office of 

the Director (CC1), National Institute for 

Occupational Safety and Health (CC),

and renumber the remaining items 

accordingly. 

Delete item (3) of the functional 

statement for the Office of Program 

Management and Operations (CE13), 

Office of the Director (CE1), National 

Center for Injury Prevention and Control 

(CE), and insert the following: (3) 

prepares annual budget formulation and 

budget justifications. 

Delete item (4) of the functional 

statement for the Office of the Director 

(CJ1), National Immunization Program 

(CJ), and insert the following: (4) 

prepares, reviews, and coordinates 

informational and programmatic 

documents.

Delete item (4) of the functional 

statement for the Planning and 

Evaluation Office (CK15), Office of the 

Director (CKI), National Center for HIV, 

STD, and TB Prevention (CK), and 

renumber the remaining items 

accordingly. 

Delete item (3) of the functional 

statement for the Office of the Director 

(CK61), Global AIDS Program (CK6), and 

insert the following: (3) provides GAPwide administrative and management 

services including personnel, contracts, 

grants and cooperative agreements, and 

interagency/reimbursable agreements, 

travel, facility management, and 

equipment inventory and coordinates or 

ensures coordination with the 

appropriate NCHSTP or CDC staff 

offices. 

Delete item (6) of the functional 

statement for the Office of the Director 

(CK61), Global AIDS Program (CK6), and 

renumber the remaining items 

accordingly. 

Delete item (4) of the functional 

statement for the Country Program 

Support (CK63), and insert the 

following: (4) coordinates with BEB/

FMO in the development, disbursement, 

and oversight of country budgets. 

Delete item (6) of the functional 

statement for the Country Program 

Support (CK63) in its entirety. 

Delete items (2) and (11) of the 

functional statement for the Program 

Services Branch (CL17), Office of the 

Director (CL1), National Center for 

Chronic Disease Prevention and Health 

Promotion (CL), and insert the 

following: (2) provides leadership, 

planning, coordination, advice, and 

guidance in the execution and 

maintenance of the Center’s 

administrative functions;* * *(11) 

provides overall programmatic direction 

for planning and management oversight 

of allocated resources. 

Delete item (5) of the functional 

statement for the Office of the Director 

(CN1), National Center for 

Environmental Health (CN), and insert 

the following: (5) provides overall 

programmatic direction for planning 

and management oversight of allocated 

resources, human resource management 

and administrative support. 

Delete item (5) of the functional 

statement for the Office of Financial and 

Administrative Services (CN14), and 

insert the following: (5) formulates and 

provides overall programmatic direction 

for planning and management oversight 

of allocated resources, human resource 

management and administrative 

support. 

Delete item (7) of the functional 

statement for the Office of the Director 

(CR21), Division of Global Migration 

and Quarantine (CR2), National Center 

for Infectious Diseases (CR), and 

renumber the remaining items 

accordingly. 

Delete item (6) of the functional 

statement for the Office of the Director 

(CRJ1), Artic Investigations Program 

(CRJ), and insert the following: (6) 

responsible for budget formulation. 

Delete items (1), (6) and (8) of the 

functional statement for the Office of 

Planning, Budget and Legislation 

(CS17), Office of the Director (CS1), 

National Center for Health Statistical 

(CS), and insert the following: (1) 

Provides a focus for short and long 

range statistic programs, policy 

development, and program analysis; 

. . . (6) serves as principal advisor in 

areas of resource development and 

budget formulation; * * * (provides 

overall programmatic oversight of 

allocated resources.

60402 Federal Register / Vol. 69, No. 195 / Friday, October 8, 2004 / Notices 

Dated: September 29, 2004. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention (CDC).

[FR Doc. 04–22603 Filed 10–7–04; 8:45 am] 

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0441]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Application for 

FDA Approval to Market a New Drug

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements governing applications for 

FDA approval to market a new drug.

DATES: Submit written or electronic 

comments on the collection of 

information by December 7, 2004.

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA 305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Management 

Programs (HFA 250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301 827 1482.

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information listed below.

With respect to the following 

collection of information, FDA invites 

comments on: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of FDA’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s 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 respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology.

Applications for FDA Approval to 

Market a New Drug— 21 CFR Part 

314—(OMB Control Number 0910 

0001)—Extension

Under Section 505(a) of the Federal 

Food, Drug, and Cosmetic Act (the Act) 

(21 U.S.C. 355(a)), a new drug may not 

be commercially marketed in the United 

States, imported, or exported from the 

United States, unless an approval of an 

application filed with FDA under 

section 505(b) or 505(j) of the act is 

effective with respect to such drug. 

Section 505(b) and 505(j) of the act 

requires a sponsor to submit to FDA a 

new drug application (NDA) containing, 

among other things, full reports of 

investigations that show whether or not 

the drug is safe and effective for use, a 

full list of articles used as components 

in the drug, a full description of 

manufacturing methods, samples of the 

drugs required, specimens of the 

labeling proposed to be used, and 

certain patent information as applicable. 

Under the act, it is the sponsor’s 

responsibility to provide the 

information needed by FDA to make a 

scientific and technical determination 

that the product is safe and effective.

This information collection approval 

request is for all information 

requirements imposed on sponsors by 

the regulations under part 314 (21 CFR 

314), who apply for approval of a new 

drug application in order to market or 

to continue to market a drug.

Section 314.50(a) requires that an 

application form (Form FDA 356h) be 

submitted that includes introductory 

information about the drug as well as a 

checklist of enclosures.

Section 314.50(b) requires that an 

index be submitted with the archival 

copy of the application and that it 

reference certain sections of the 

application.

Section 314.50(c) requires that a 

summary of the application be 

submitted that presents a good general 

synopsis of all the technical sections 

and other information in the 

application.

Section 314.50(d) requires that the 

NDA contain the following technical 

sections about the new drug: Chemistry, 

manufacturing, and controls; 

nonclinical pharmacology and 

toxicology; human pharmacokinetics 

and bioavailability; microbiology; 

clinical data; and statistical section.

Section 314.50(e) requires the 

applicant to submit samples of the drug 

if requested by FDA. In addition, the 

archival copy of the application must 

include copies of the label and all 

labeling for the drug.

Section 314.50(f) requires that case 

report forms and tabulations be 

submitted with the archival copy.

Section 314.50(h) requires that patent 

information, as described under 

§ 314.53, be submitted with the 

application.

Section 314.50(i) requires that patent 

certification information be submitted 

in 505(b)(2) applications for patents 

claiming the drug, drug product, 

method of use, or method of 

manufacturing.

Section 314.50(j) requires that 

applicants that request a period of 

marketing exclusivity submit certain 

information with the application.

Section 314.50(k) requires that an 

archival, review, and field copy of the 

application be submitted.

Section 314.52 requires that notice of 

certification of invalidity or 

noninfringement of a patent to patent 

holders and NDA holders be sent by 

505(b)(2) applicants.

Section 314.54 sets forth the content 

requirements for applications filed 

under section 505(b)(2) of the act.

Section 314.60 sets forth reporting 

requirements for sponsors who amend 

an unapproved application.

Section 314.65 states that the sponsor 

must notify FDA when withdrawing an 

unapproved application.

Sections 314.70 and 314.71 require 

that supplements be submitted to FDA