Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices 32667

information and submitting an

application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the ‘‘INTRODUCTION’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

A copy of American Society for

Testing and Materials (ASTM) Number

1292 may be obtained from ASTM,

Customer Services, 1916 Race Street,

Philadelphia, PA 19103–1187,

telephone (215) 299–5585.

Dated: June 9, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–15805 Filed 6–12–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0378]

Agency Information Collection

Activities: Proposed Collection;

Comment Request; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of May 19, 1998 (63 FR 27581).

The document announced an

opportunity for public comment on the

proposed collection of certain

information by the agency. The

document published with the incorrect

docket number. This document corrects

that error.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

In FR Doc. No. 98–13228, appearing

on page 27581 in the Federal Register

of Tuesday, May 19, 1998, the following

correction is made:

1. On page 27581, in the first column,

‘‘[Docket No. 98N–0194]’’ is corrected to

read ‘‘[Docket No. 98N–0378]’’.

Dated: June 5, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15770 Filed 6–12–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0357]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by July 15,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Medical Devices; Current Good

Manufacturing Practice (CGMP)

Quality System (QS) (21 CFR Part

820)—(OMB Control Number 0910–

0073—Reinstatement)

Under section 520(f) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360j(f)), the Secretary of the

Department of Health and Human

Services (the Secretary) has the

authority to prescribe regulations

requiring that the methods used in, and

the facilities and controls used for, the

manufacture, pre-production design

validation (including a process to assess

the performance of a device but not

including an evaluation of the safety

and effectiveness of a device), packing,

storage, and installation of a device

conform to CGMP, as described in such

regulations, to assure that the device

will be safe and effective and otherwise

in compliance with the act.

The CGMP/QS regulation

implementing the authority provided by

this statutory provision is found in part

820 of the Code of Federal Regulations

(21 CFR part 820) and sets forth basic

CGMP requirements governing the

design, manufacture, packing, labeling,

storage, installation, and servicing of all

finished medical devices intended for

human use. Section 820.20(a) through

(e) requires management with executive

responsibility to establish, maintain,

and/or review: The quality policy; the

organizational structure; the quality

plan; and the quality system procedures

of the organization. Section 820.22

requires the conduct and documentation

of quality system audits and reaudits.

Section 820.25(b) requires the

establishment of procedures to identify

training needs and documentation of

such training.

Section 820.30(a)(1) and (b) through

(j) requires, in the following respective

order, the establishment, maintenance,

and/or documentation of: Procedures to

control design of class III and class II

devices, and certain class I devices as

listed therein; plans for design and

development activities and updates;

procedures identifying, documenting,

and approving design input

requirements; procedures defining

design output, including acceptance

criteria, and documentation of approved

records; procedures for formal review of

design results and documentation of

results in the design history file (DHF);

procedures for verifying device design

and documentation of results and

approvals in the DHF; procedures for

validating device design, including

documentation of results in the DHF;

procedures for translating device design

into production specifications;

procedures for documenting, verifying

validating approved design changes

before implementation of changes; and

the records and references constituting

the DHF for each type of device.

Section 820.40 requires the

establishment and maintenance of

procedures for the review, approval,

issuance and documentation of required

records (documents) and changes to

those records.

Section 820.50 requires the

establishment and maintenance of

procedures and requirements to ensure

service and product quality, records of

acceptable suppliers and purchasing