38288 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices

vitae for existing staff who are assigned

to this project.

c. (5 points) The extent to which the

applicant provides an organizational

chart that identifies lines of

communication, accountability,

reporting, authority, and describes

management and control systems within

the organization and discusses how the

proposed placement of the project in the

organization will increase its likelihood

of success.

4. Collaboration (20 Points)

a. (15 points) The extent to which the

applicant describes current

collaboration with states’ health,

education, and agricultural

departments, the organization’s

collaboration with other federal

agencies, national non-profit

organizations, foundations, communitybased groups, and others who have an

interest in or whose mission includes

food safety programs, and discusses

how the current collaborative

relationships can compliment the

proposed project. The extent to which

the applicant indicates proposed

collaborative relationships that will

support the proposed operational plan

and includes letters of participation and

support documenting these anticipated

collaborations especially with proposed

activities.

b. (5 points) The extent to which the

applicant describes collaborative

activities or anticipated relationships

with other national organizations who

support school-based health education

programs, and includes letters of

participation and support documenting

these anticipated collaborations. The

extent to which the applicant describes

how the organization can compliment

the activities of existing organizations

and how their expertise can support this

proposed project.

5. Evaluation Plan (5 Points)

The extent to which the applicant

describes their plan to evaluate progress

in meeting objectives and conducting

activities during the budget period

including their ability to describe: (1)

What data will be obtained; (2) how the

data will be obtained; (3) how

evaluation information will be

disseminated; (4) how the evaluation

data will be used to improve the

program; and (5) who will implement

the evaluation plan and when.

6. Budget and Justification (Not Scored)

The extent to which the budget is

reasonable and consistent with the

purposes and activities of the program.

H. Other Requirements

Technical Reporting Requirements

1. Provide CDC with original plus two

copies of the progress report, submitted

on an annual basis and due 90 days after

the end of the budget period. The

progress reports must include the

following for each program, function, or

activity involved:

• A comparison of actual

accomplishments to the objectives

established for the period;

• Documentation on why established

objectives were not met; and

• A summary of the project’s annual

progress in achieving performance

measures, which will be developed and

established in collaboration with CDC

during the first budget period.

2. Provide CDC with original plus two

copies of the financial status report, no

more than 90 days after the end of the

budget period.

3. Final financial and progress

reports, no more than 90 days after the

end of the project period, should be sent

to the business management contact

listed in Section J, ‘‘Where to Obtain

Additional Information.’’

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit.

AR–7 Executive Order 12372 Review

AR–8 Public Health System Reporting

Requirement

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–14 Accounting System

Requirements

AR–15 Proof of Non-Profit Status

AR–20 Conference Support

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301(a), 311(b) and (c), and 317

(k)(2) [42 U.S.C. 241(a), 243(b) and (c),

and 247b(K)(2)] of the Public Health

Service Act, as amended. The Catalog of

Federal Domestic Assistance number is

93.938.

J. Where To Obtain Additional

Information

If you have questions after reviewing

the contents of all documents, business

management technical assistance may

be obtained from: Jesse Robertson,

Grants Management Specialist, Grants

Management PA00109, Centers for

Disease Control and Prevention (CDC),

2920 Brandywine Rd, M/S E18, Atlanta,

Georgia 30341–4146, telephone (770)

488–2747, jtr4@cdc.gov.

This and other CDC announcements

can be found on the CDC Homepage

Internet address: http://www.cdc.gov

Also, CDC Guidelines to Promote

Healthy Eating: http://www.cdc.gov/

nccdphp/dash/nutguide.htm and CDC

Guidelines to Promote Physical

Activity: http://www.cdc.gov/nccdphp/

dash/physact.htm

For program technical assistance,

contact: Pete Hunt, Chief, School

Program Section, Program Development

and Services Branch, Division of

Adolescent and School Health, National

Center for Chronic Disease Prevention

and Health Promotion, Announcement

00109, Centers for Disease Control and

Prevention, 4770 Buford Highway, NE

MS K31, Atlanta, GA 30341, telephone:

770–488–3253, pch0@cdc.gov.

Dated: June 13, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Center for Disease Control and Prevention

(CDC).

[FR Doc. 00–15462 Filed 6–19–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1311]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Export of Medical

Devices—Foreign Letters of Approval

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

collection of information requirements

for reporting requirements for firms that

intend to export certain unapproved

medical devices.

DATES: Submit written comments on the

collection of information by August 21,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices 38289

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.

Export of Medical Devices—Foreign

Letters of Approval—Federal Food,

Drug, and Cosmetic Act—21 U.S.C.

381(e)(2) (OMB Control No. 0910–

0264)—Extension

Section 801(e)(2) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 381(e)(2)) provides for the

exportation of an unapproved device

under certain circumstances if the

exportation is not contrary to the public

health and safety and it has the approval

of the foreign country to which it is

intended for export.

Requesters communicate (either

directly or through a business associate

in the foreign country) with a

representative of the foreign government

to which they seek exportation, and

written authorization must be obtained

from the appropriate office within the

foreign government approving the

importation of the medical device.

FDA uses the written authorization

from the foreign country to determine

whether the foreign country has any

objection to the importation of the

device into their country.

The respondents to this collection of

information are companies that seek to

export medical devices.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Statute No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Section 801(e)(2) of the Federal Food, Drug, and

Cosmetic Act

20 1 20 2.5 50

Total 50

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

These estimates are based on the

experience of FDA’s medical device

program personnel, who estimate that

completion of the requirements of this

collection of information should take

approximately 2.5 hours to complete.

Prior to the enactment of the Food and

Drug Export Reform and Enhancement

Act of 1996, FDA received

approximately 800 requests from U.S.

firms to export medical devices under

section 801(e)(2) of the act. The

enactment of the Food and Drug Export

Reform and Enhancement Act of 1996

has greatly reduced the number of

export permit requests made to the

present estimated 20 per year.

Dated: June 14, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–15433 Filed 6–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–4166]

Agency Information Collection

Activities; Announcement of OMB

Approval; Electronic Records;

Electronic Signatures

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Electronic Records; Electronic

Signatures’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezutto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 1, 1999 (64

FR 53392), 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 0910–0303. The

approval expires on May 31, 2003. A

copy of the supporting statement for this

information collection is available on

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

ohrms/dockets.