Federal Register / Vol. 66, No. 26 / Wednesday, February 7, 2001 / Notices 9347

and accomplishments characteristics, (c)

better develop CBO technical assistance

(TA) materials, and (d) provide TA to

CBOs that have already been selected by

CDC for funding. This study will also

yield more hypotheses for statistical

testing, instruments with reliability and

validity data for use in other studies,

and a model that can be used and

revised to meet the context of a

particular CBO. The questionnaire will

be administered to 766 CBOs that have

applied for CDC funding under program

announcements 00023, 00100, 99047,

99091, 99092, 99096. The total annual

cost to respondents is estimated at

$26,044 based on an average salary of

$35,000 ($17.00 per hour) for program

managers.

Respondents No. of

respondents

No. of

responses

per

respondent

Average

burden per

response

(in hrs.)

Total

burden

(in hrs.)

Model Survey ................................................................................................................... 766 1 2 1532

Total .......................................................................................................................... .................... .................... .................... 1532

Dated: February 1, 2001.

Nancy Cheal,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 01–3178 Filed 2–6–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Delegations of Authority

Notice is hereby given that on January

19, 2001 the Director of Child Support

Enforcement redelegated to the Deputy

Commissioner of Child Support

Enforcement, all the authorities

delegated to the Deputy Director/

Commissioner of Child Support

Enforcement by the Director of Child

Support Enforcement. This delegation is

subject to any limitations or conditions

contained in the delegations to the

Deputy Director/Commissioner.

Dated: January 19, 2001.

Olivia A. Golden,

Director, Child Support Enforcement.

[FR Doc. 01–3114 Filed 2–6–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1651]

Devices—Inspections of Medical

Device Manufacturers Compliance

Program Guidance Manual, CP

7382.845; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a compliance program

(CP) entitled ‘‘Inspection of Medical

Device Manufacturers.’’ This CP is

intended to help FDA components and

industry comply with FDA’s internal

inspection and compliance processes

concerning quality system/good

manufacturing practice (QS/GMP)

inspections of manufacturers of medical

devices.

DATES: Submit written comments on

this CP at any time.

ADDRESSES: Submit written requests for

single copies of CP 7382.845

‘‘Inspections of Medical Device

Manufacturers’’ to the Freedom of

Information Office (HFI–35), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Copies of

the CP may also be downloaded to a

personal computer with access to the

Internet. The Office of Regulatory

Affairs (ORA) home page includes the

CP and may be accessed at http://

www.fda.gov/ora. The CP will be

available on the compliance references

page for ORA. Submit written comments

on the CP to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Technical questions concerning

inspections of medical device

manufacturers: Denise D. Dion, Division

of Emergency and Investigational

Operations (HFC–130), Office of

Regional Operations, Office of

Regulatory Affairs, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–5645,

FAX 301–443–6919.

Questions concerning regulatory

actions and all comments: Wes W.

Morgenstern, Division of Program

Operations (HFZ–305), Office of

Compliance, Center for Devices and

Radiological Health, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–4699,

FAX 301–594–4715.

SUPPLEMENTARY INFORMATION: FDA has

renumbered CP 7382.830 as CP

7382.845 and revised it to reflect a

change in the guidance on how a QS/

GMP inspection of a medical device

manufacturer should be conducted. The

new inspectional method is known as

the quality systems inspection

technique. The revision to the CP also

reflects changes in when FDA may

consider a firm out of compliance with

the medical device quality system

regulation (21 CFR part 820).

The CP is intended to provide policy

and regulatory guidance to FDA’s field

and headquarters staff with regard to

medical device manufacturer

inspections. It also contains information

that may be useful to the regulated

industry and to the public.

The CP is being issued as a guidance

document and represents the agency’s

current thinking on the subject. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. FDA published a

notice making a draft of the CP available

for public comment in the Federal

Register (64 FR 44024, August 12,

1999).

The agency has adopted good

guidance practice (GGP) regulations (65

FR 56468, September 19, 2000) that set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents. This CP is issued as a level

1 guidance consistent with GGP’s.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding the

CP entitled ‘‘Inspections of Medical

Device Manufacturers’’ at any time. Two

copies of any comments are to be

submitted, except individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. A copy of the CP and