61020 Federal Register / Vol. 69, No. 198 / Thursday, October 14, 2004 / Notices 

greater than what has been reported to 

the Texas Department of Health. We 

propose to conduct surveillance 

activities to identify the prevalence of 

ciguatera fish poisoning around Texas 

Gulf Coast oil rigs. This study will 

provide critical data in guiding efforts to 

characterize the scope of ciguatera 

poisonings, to identify risk factors, and 

to prevent an emerging illness 

associated with reef ecosystems. 

A questionnaire will be administered 

over a one-year period to recreational 

spear-fishers and to hook-and-line 

anglers who have consumed fish caught 

on the reef ecosystems off the Texas 

Gulf Coast. There are no costs to 

respondents. The annualized burden is 

estimated to be 230 hours.

Respondent No. of

respondents 

No. of

responses/

respondent 

Average burden per

response

(in hours) 

Screening study participants ....................................................................................................... 750 1 5/60 

Texas Saltwater Fishers .............................................................................................................. 500 1 20/60 

Dated: October 7, 2004. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–23023 Filed 10–13–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30 Day–04–0215] 

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 

Application Form and Related Forms 

for the Operation of the National Death 

Index, (0920–0215)—Extension—

National Center for Health Statistics 

(NCHS), Centers for Disease Control and 

Prevention (CDC). 

Background 

The National Death Index (NDI) is a 

national data base containing 

identifying death record information 

submitted annually to NCHS by all the 

state vital statistics offices, beginning 

with deaths in 1979. Searches against 

the NDI file provide the states with 

dates of death, and the death certificate 

numbers of deceased study subjects. 

Since the implementation of the NDI 

Plus service, researchers have the option 

of also receiving cause of death 

information for deceased subjects, thus 

reducing the need to request copies of 

death certificates from the states. The 

NDI Plus option currently provides the 

ICD codes for the underlying and 

multiple causes of death for the years 

1979–2002. Health researchers must 

complete five administrative forms in 

order to apply for NDI services, and 

submit records of study subjects for 

computer matching against the NDI file. 

While there are five forms, it is rare for 

an NDI user to complete more than one 

of each per year; therefore, the burden 

table addresses respondents and not 

forms. There are no costs to respondents 

except for their time. The estimated 

annualized burden is 228 hours.

Respondents No. of

respondents 

No. of

responses per 

respondents 

Average

burden per

response

(in hrs.) 

Government researchers ............................................................................................................. 48 1 1.9 

University researchers ................................................................................................................. 60 1 1.9 

Private industry researchers ........................................................................................................ 12 1 1.9 

Dated: October 6, 2004. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–23024 Filed 10–13–04; 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: Centers for 

Construction Safety and Health, 

Request for Applications (RFA) OH–

04–002 

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): Centers for Construction Safety 

and Health, Request for Applications (RFA) 

OH–04–002. 

Times and Dates: 6 p.m.–6:30 p.m., 

November 15, 2004 (open). 6:30 p.m.–8 p.m., 

November 15, 2004 (closed). 8 a.m.–5 p.m., 

November 16 2004 (closed). 

Place: Embassy Suites Hotels, 1900 

Diagonal Road, Alexandria, VA 23114, phone 

703–684–5900. 

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 

Federal Register / Vol. 69, No. 198 / Thursday, October 14, 2004 / Notices 61021

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 Request for Applications OH–04–

002. 

Contact Person for More Information: S. 

Price Connor, Ph.D., Research Grants 

Program Officer, Office of Extramural 

Programs, National Institute for Occupational 

Safety and Health, CDC, 1600 Clifton Road, 

NE., MS–E74, Atlanta, GA. 30333, Telephone 

404–498–2530. 

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 6, 2004. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention (CDC).

[FR Doc. 04–23022 Filed 10–13–04; 8:45 am] 

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel: Occupational Health 

and Safety Research, Program 

Announcement (PA) 04038 

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): Occupational Health and Safety 

Research, Program Announcement (PA) 

04038. 

Times and Dates: 2:30 p.m.–2:45 p.m., 

November 1, 2004 (open). 

2:45 p.m.–5:30 p.m., November 1, 2004 

(closed). 

Place: Office of Extramural Programs, 

Room 1419, Building 24, Executive Park 

Drive, Atlanta, GA 30333, Telephone: 888–

414–5419 Pass Code 18205 (this meeting will 

be held via teleconference). 

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 

04038. 

Contact Person for More Information:

Pamela J. Wilkerson, Designated Federal 

Official, Office of Extramural Programs, 

National Institute for Occupational Safety 

and Health, CDC, 1600 Clifton Road, NE., 

MS–E74, Atlanta, GA. 30333, Telephone 

404–498–2530. 

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 6, 2004. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–23025 Filed 10–13–04; 8:45 am] 

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0437]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request;Medical Devices; 

Third-Party Review Under the Food 

and Drug Administration 

Modernization Act, Third-Party 

Premarket Submission Review, and 

Quality System Inspections Under the 

United States/European Community 

Mutual Recognition Agreement

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 (the 

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 information 

collection, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

information collection requirements for 

medical devices; third-party review 

under the Food and Drug 

Administration Modernization Act 

(FDAMA), third-party premarket 

submission review, and quality system 

inspections under the United States/

European Community (U.S./E.C.) 

Mutual Recognition Agreement (MRA).

DATES: Submit written and electronic 

comments on the collection of 

information by December 13, 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:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

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 set forth in this document.

With respect to the following 

collection of information, FDA invites 

comments on these topics: (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.

Medical Devices; Third-Party Review 

Under FDAMA, Third-Party Premarket 

Submission Review, and Quality 

System Inspections Under U.S./E.C. 

Mutual Recognition Agreement (OMB 

Control Number 0910–0378)—Extension