60630 Federal Register / Vol. 69, No. 196 / Tuesday, October 12, 2004 / Notices 

Respondents Number of respondents 

Number of responses/respondent Average burden/response

(in hrs.) 

Principal Investigators funded through the first round of the EPRP who self-report that they 

did not use a participatory research approach ........................................................................ 26 1 30/60 

Dated: October 4, 2004. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–22819 Filed 10–8–04; 8:45 am] 

BILLING CODE 4163–18–U

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0034] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Medical Devices; Current Good 

Manufacturing Practices Quality 

System Regulation

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Medical Devices; Current Good 

Manufacturing Practices Quality System 

Regulation’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995.

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: In the 

Federal Register of June 14, 2004 (69 FR 

33035), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0073. The 

approval expires on September 30, 

2007. A copy of the supporting 

statement for this information collection 

is available on the Internet at http://

www.fda.gov/ohrms/dockets.

Dated: October 4, 2004. 

Jeffrey Shuren, 

Assistant Commissioner for Policy.

[FR Doc. 04–22761 Filed 10–8–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0103] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry on Special 

Protocol Assessment

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry on Special 

Protocol Assessment’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 9, 2004 (69 FR 

41502), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0470. The 

approval expires on September 30, 

2007. A copy of the supporting 

statement for this information collection 

is available on the Internet at http://

www.fda.gov/ohrms/dockets.

Dated: October 4, 2004. 

Jeffrey Shuren, 

Assistant Commissioner for Policy.

[FR Doc. 04–22762 Filed 10–8–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0442] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Recall Regulations 

(Guidelines)

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 collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

FDA’s recall regulations (guidelines) 

and provides guidance to manufacturers 

on recall responsibilities.

DATES: Submit written or electronic 

comments on the collection of 

information by December 13, 2004.

ADDRESSES: Submit electronic 

comments on the collection of to 

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:

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1472.

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