2632 Federal Register / Vol. 5, No. 11 / Tuesday, January 18, 2000 / Notices

Application for Exemption From

Federal Preemption of State and Local

Medical Device Requirements—21 CFR

Part 808 (OMB Control No. 0910–

0129)—Extension

Section 521(a) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360k(a)) provides that no State or

local government may establish, or

continue in effect, any requirement with

respect to a medical device that is

different from, or in addition to, any

Federal requirement applicable to the

device under the act. Under section

521(b) of the act, following receipt of a

written application from the State or

local government involved, FDA may

exempt from preemption a requirement

that is more stringent than the Federal

requirement, or that is necessitated by

compelling local conditions and

compliance with the requirement would

not cause the device to be in violation

of any portion of any requirement under

the act. Exemptions are granted by

regulation issued after notice and

opportunity for an oral hearing.

The regulations in 21 CFR 808.20

require a State or local government that

is seeking an exemption from

preemption to submit an application to

FDA. The application must include a

copy of the State or local requirement,

as well as information about its

interpretation and application, and a

statement as to why the applicant

believes that the requirement qualifies

for exemption from preemption under

the act. FDA will use the information in

the application to determine whether

the requirement meets the criteria for

exemption in the act and whether

granting an exemption would be in the

interest of the public health.

In addition, 21 CFR 808.25 provides

that an interested person may request a

hearing on an application by submitting

a letter to FDA following the publication

by FDA of a proposed response to the

application.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

808.20 3 1 3 100 300

808.25 3 1 3 10 30

Total 330

1There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA based its estimates of the number

of submissions expected in the future

contained in Table 1 of this document

on the number of submissions

submitted in the last 3 years and on the

number of inquiries received indicating

that applications would be submitted in

the next year. FDA based its estimates

of the time required to prepare

submissions on discussions with those

who have prepared submissions in the

last 3 years.

Dated: January 10, 1999.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–992 Filed 1–14–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–1502]

Agency Information Collection

Activities; Announcement of OMB

Approval; Quality Mammography

Standards; Lay Summaries for Patients

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Quality Mammography Standards; Lay

Summaries for Patients’’ has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 18, 1999 (64

FR 56210), 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 0910–0426. The

approval expires on December 31, 2002.

A copy of the supporting statement for

this information collection is available

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: January 10, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–987 Filed 1–14–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98P–0683]

Agency Information Collection

Activities; Announcement of OMB

Approval; Record Retention

Requirements for the Soy Protein/

Coronary Heart Disease Health Claim

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Record Retention Requirements for the

Soy Protein/CHD Health Claim’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 26, 1999 (64

FR 57700 at 57726), 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