Federal Register / Vol. 5, No. 11 / Tuesday, January 18, 2000 / Notices 2631

of the functions of the agency, including

whether the information shall have

practical utility; (b) The accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

Ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) Ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

for other forms of information

technology. Send comments to Seleda

Perryman, CDC Assistant Reports

Clearance Officer, 1600 Clifton Road,

MS–D24, Atlanta, GA 30333. Written

comments should be received within 60

days of this notice.

Proposed Projects

1. Preventive Health and Health

Services Block Grant, Annual

Application and Reports (0920–0106)—

Renewal—The National Center for

Chronic Disease Prevention and Health

Promotion—In 1994, the Office of

Management and Budget approved the

collection of information provided in

the grant applications and annual

reports for the Preventive Health and

Health Services Block Grant (0920–

0106). This approval expires on

November 30, 2000. CDC is requesting

an extension of OMB clearance for this

legislatively mandated information

collection until November 30, 2001. The

extension is limited to one year to allow

for the development and adherence to

Healthy People 2010 to be released the

Spring of 2000. The Preventive Health

and Health Services Block Grant is

mandated according to section 1904 to

adhere to the Healthy People

framework, therefore, the current

application and report format will be

restructured to coincide with 2010 and

resubmitted for OMB clearance at that

time.

This information collected through

the applications from the official State

health agencies is required from section

1905 of the Public Health Service Act.

There is no change in the proposed

information collection from previous

years. The information collected from

the annual reports is required by section

1906, specifically the requirement for

uniform data sets matching the uses of

funds. The total cost to all respondents

is $137,250, estimated at $25/burden

hour.

Respondents No. of respondents

No. of responses/respondentAverage

burden per

response

Total burden

Application ....................................................................................................................... 61 1 30 1830

Report .............................................................................................................................. 61 1 60 3660

Total .......................................................................................................................... .................... .................... .................... 5490

Dated: January 11, 2000.

Nancy Cheal,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 00–1027 Filed 1–14–00; 8:45 am]

BILLING CODE 4163–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0002]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Application for

Exemption From Federal Preemption

of State and Local Medical Device

Requirements

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 requirements for State and local

government applications for exemption

from preemption for medical device

requirements.

DATES: Submit written comments on the

collection of information by March 20,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (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 Schlosburg, Office of Information

Resources Management (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: (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.

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