Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices 38285

for HIV, STD, and TB Prevention,

Centers for Disease Control and

Prevention, 1600 Clifton Road N.W.,

Mailstop E–35, Atlanta, Georgia 30333,

Telephone: (404) 639–5200, Email:

DFB2@CDC.gov

Dated: June 14, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–15463 Filed 6–19–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00109]

Cooperative Agreements for National

Programs That Build the Capacity of

Schools To Prevent Foodborne Illness

Through Coordinated School Food

Safety Programs; Notice of Availability

of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for cooperative agreements that

establish a national program to assist the

nation’s schools and health departments

to prevent foodborne illness through

coordinated school food safety

programs.

The purpose of this announcement is

to develop a national program that

builds the capacity of national nongovernmental, non-profit organizations’

constituents to help schools prevent

foodborne illness. CDC recognizes that

many state education agencies (SEAs)

and local education agencies (LEAs)

have implemented components of a

coordinated school health program that

addresses important health risk

behaviors and health problems. This

announcement provides support to

national non-governmental, non-profit

organizations to collaborate with state

education agencies, state health

agencies and others engaged in activities

related to Coordinated School Health

Programs to focus on foodborne illness

prevention and school food safety.

CDC is committed to working

collaboratively with the nation’s state

education and health agencies and to

helping them implement comprehensive

school health education as part of a

coordinated school health program that

can prevent the leading causes of death

and disability. CDC is also committed to

achieving the health promotion and

disease prevention objectives of

‘‘Healthy People 2010,’’ a national

activity to reduce morbidity and

mortality and improve the quality of

life. This announcement is related to the

focus area(s) of Educational and

Community-Based Programs. For the

conference copy of ‘‘Healthy People

2010’’ , visit the internet site: http://

www.health.gov/healthypeople.

B. Eligible Applicants

Assistance will be provided only to

national organizations that are private

health, education, or social service

agencies (professional, or voluntary);

and must qualify as a non-profit 501

(c)(3) entity. Priority will be given to

organizations whose constituencies

have a direct impact on the school food

safety program including school food

service professionals, school nurses, and

administrators. Eligible applicants must

have the capacity and experience to

assist their local affiliates. Applicants

and their local affiliates must have

experience working with personnel

from state and local education agencies,

state or local health agencies, or other

relevant agencies within the previous

ten years that could contribute toward

foodborne illness prevention efforts

through coordinated school food safety

programs. Eligible organizations must

have affiliate offices or local/state/or

regional membership constituencies in a

minimum of 10 states and territories.

Affiliate offices and local/state/or

regional membership constituencies

may not apply in lieu of, or on behalf

of, their parent national office.

National organizations that are funded

currently by CDC/Division of

Adolescent and School Health (DASH)

under program announcements 99023,

and 97065, 00026,or 00037 are not

eligible for this program announcement.

A listing of CDC/DASH funded national

organizations that are not eligible to

apply is provided on the DASH website,

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

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $420,000 is available

in FY 2000 to fund approximately three

awards. It is expected that the average

award will be $140,000, ranging from

$125,000 to $155,000 and that the

project period will be for 3 years. It is

expected that the awards will begin on

or about September 30, 2000. Funding

estimates may change. Continuation

awards within an approved project

period will be made on the basis of

satisfactory progress as evidenced by

required reports and the availability of

funds.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for conducting

activities under section 1 (Recipient

Activities), and CDC will be responsible

for conducting activities under section 2

(CDC Activities) as listed below:

1. Recipient Activities

a. Collaborate with constituents; state

and local education, health, agriculture,

and social service agencies; nongovernmental partners; and federal

government agencies to develop a

national strategy to prevent foodborne

illness within school-based food safety

programs.

b. Establish specific, measurable, and

realistic goals and objectives that reduce

and or manage school foodborne illness

outbreaks.

c. Establish an operational plan that

includes collaborating with federal and

state agencies and others engaged in

coordinated school food safety programrelated activities, in developing targetaudience and discipline-specific

training materials needed to effectively

build the capacity of school personnel

to implement a model coordinated

school food safety program.

d. Specific activities can also include:

1. Build the capacity of constituents

to better prevent school foodborne

illness and implement a model

coordinated school food safety program

through participation in 3–4 training

workshops facilitated by a State

Education Agency;

2. Develop discipline-specific training

materials for accompanying a model

coordinated school food safety program

for constituents;

3. Evaluate the effectiveness of the

program in achieving goals and

objectives;

4. Disseminate programmatic

information through appropriate

methods, such as:

a. Sharing materials that would

reduce school foodborne illness through

a variety of mechanisms (e.g.

clearinghouses, conferences and/or

workshops, newsletters, annual progress

reports, etc.).

b. Sharing project-related news and

information with State and Local

Education Agencies, State Health

Agencies, national organizations, and

others through the Internet, other

computer networks, the mail and at

workshops and conferences;

38286 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices

5. Help schools, or other agencies that

serve young people, conduct

coordinated programs that prevent

behaviors that place elementary through

college-aged young people at risk for

foodborne illness;

6. Collaborate with other national

organizations to establish and maintain

initiatives to prevent behaviors that

place elementary through college-aged

young people at risk for foodborne

illness;

7. Educate and enable managers,

leaders, teachers, school food service

managers, school nurses, and decision

makers who are members of the national

organizations to act individually and

collectively to support locally

determined programs to reduce/manage

school foodborne illness outbreaks;

8. Educate and enable families, media,

businesses, and others in the

community to act individually and

collectively to support coordinated

school health programs to reduce/

manage school foodborne illness

outbreaks;

9. Build the capacity of community

agencies and parents to establish and/or

maintain programs that reduce/manage

school foodborne illness outbreaks;

10. Provide technical assistance and

training to professionals and parents to

use proven, effective strategies and

programs to prevent behaviors that

place elementary through college-aged

young people at risk for foodborne

illness.

11. Participate in national conferences

to promote model coordinated school

food safety programs.

12. Participate in CDC-planned

meetings of national, state, and local

education agencies and other

appropriate agencies to address issues

and program activities related to

improving coordinated school health

programs; and strengthen the capacity of

post-secondary institutions and youthserving agencies to prevent foodborne

illness through coordinated school food

safety programs.

2. CDC Activities

a. Provide and periodically update

information related to the purposes or

activities of this program

announcement.

b. Coordinate with national, state, and

local education, health and social

service agencies as well as other

relevant organizations in planning and

conducting national strategies designed

to prevent foodborne illness through

coordinated school food safety

programs.

c. Provide programmatic consultation

and guidance related to program

planning, implementation, and

evaluation; assessment of program

objectives; and dissemination of

successful strategies, experiences, and

evaluation reports.

d. Plan meetings of national, state,

and local education agencies and other

appropriate agencies to address issues

and program activities related to

improving coordinated school health

programs; and strengthen the capacity of

postsecondary institutions and youthserving agencies to prevent foodborne

illness through coordinated school food

safety programs.

e. Assist in the evaluation of program

activities.

E. Application Content

Use the information in the Purpose,

Program Requirements, Other

Requirements, and Evaluation Criteria

sections to develop the application

content. Your application will be

evaluated on the criteria listed, so it is

important to follow the criteria as you

construct your program plan. The

narrative should be no more than

twenty (20) double-spaced pages,

printed on one side, with one inch

margins, and unreduced font.

1. Background (No More Than 4 Pages)

a. Describe your organization’s

current structure (mission, goals and its

primary constituency). Describe how

that structure can support school-based

food safety programs that are part of a

coordinated school health program,

including the potential role of your

organization’s primary constituency in a

school food safety initiative. Identify

current gaps in the existing structure

and implementation of school-based

food safety programs and discuss how

your constituency can enhance the state

and local education agencies’ ability to

deliver an optimal food safety program.

b. Describe your organization’s

constituency experience in assisting the

state education, state health and state

agriculture departments’ current school

food safety program. Include in your

description constituency experience

assisting these agencies’ use of existing

protocols, training, and educational

materials available from the USDA and

FDA related to food safety and

foodborne illness outbreaks. Describe

barriers within state and local education

agencies to effectively reporting

foodborne illnesses and outbreaks and

indicate how your organization and

constituency can build that capacity.

c. Describe your organization’s

experience in developing and

implementing policy related to food

safety programs and reporting schoolbased foodborne outbreaks. Discuss

potential limitations to existing policies

and describe, if any, the need for new

policies that address school food safety

and the prevention of foodborne illness.

d. Describe your organization’s

experience in developing and

implementing model policy, curricula,

training programs, surveillance

activities, and evaluation protocols.

Describe your organization’s experience

providing technical assistance and

training.

2. Operational Plan (No More Than 8

Pages)

a. Provide short-term (1-year) and

long-term (3-year) objectives for the

proposed project that build the capacity

of coordinated school food safety

programs nationwide. The objectives

must be specific, time-phased,

measurable, and realistic. The proposed

objectives should compliment ongoing

activities related to ‘‘From Farm to

Table: A National Food Safety

Initiative’’ (see the U.S. government

food safety information gateway website

http://www.foodsafety.gov for more

information on activities related to the

National Food Safety Initiative).

b. Submit a plan that proposes first

year activities to build the capacity of

your organization and others to

implement a model food safety program

designed to prevent foodborne illness in

schools. Include a time-line for the

completion of each component or major

activity that describes who will do what

by when. Examples of acceptable

activities can include, but are not

limited to the Recipient Activities

Described in Section D Program

Requirements.

3. Administration and Management (No

More Than 2 Pages)

a. Describe how the proposed

professional staff will contribute to the

overall school food safety program.

Describe how the current or proposed

placement of each staff will assure that

program implementation among state

education, health, and agriculture

agencies, their affiliates, and partners is

coordinated with your organization’s

constituents.

b. Demonstrate that existing or

proposed professional staff have or will

have the necessary background and

qualifications for the proposed

responsibilities. Indicate how your

organization can ensure that for each

professional working on the project,

their position description requires the

appropriate level of education and

experience related to the level of

responsibility and expected duties. A

curriculum vitae (no more than two

pages for each professional staff) should

be included in an appendix to the

Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices 38287

application for existing staff who are

assigned to this project.

c. In an appendix to the application,

provide an organizational chart that

identifies lines of communication,

accountability, reporting, authority, and

describes management and control

systems within your organization.

4. Collaboration (No More Than 2

Pages)

a. Describe the organization’s current

collaboration with states’ health,

education, and agricultural

departments. Describe your

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, whether their

efforts are school-based or not. Discuss

how your collaborative relationship can

strengthen this project. Indicate who

you propose to collaborate with to

implement the proposed Operational

Plan. Include letters of participation and

support documenting these anticipated

collaborations. In particular, describe

how the proposed activities compliment

or build on existing food safety

programs.

b. Describe collaborative activities or

anticipated relationships with other

national organizations who support

school-based health education

programs. Include letters of

participation and support documenting

these anticipated collaborations. In

particular, describe how your

organization can compliment the

activities of existing national

organizations and how their expertise

can support this proposed project.

5. Evaluation Plan (No More Than 2

Pages)

Describe plans to evaluate progress in

meeting objectives and conducting

activities during the budget period.

Specify what data will be obtained and

present a plan that includes how the

data will be obtained, disseminated, and

used to improve the program. Indicate

in the plan who will do what and when.

6. Budget and Justification (No More

Than 2 Pages)

Provide a detailed budget and lineitem justification for all operating

expenses that are consistent with

proposed objectives and planned

activities. The budget should include

funds for travel to two CDC meetings

during the budget year.

F. Submission and Deadline

Application Content

Submit the original and two copies of

PHS 5161–1 (OMB Number 0937–0189).

Forms are in the application kit. Submit

the application kit on or before August

1, 2000, to the Grants Management

Specialist (GMS) identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Deadline: Applications will be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date; or

(b) Sent on or before the deadline

date. (Applicants must request a legibly

dated U.S. Postal Service postmark or

obtain a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks are

not acceptable as proof of timely

mailing).

Late Applications: Applications

which do not meet the criteria in (a) or

(b) above are considered late

applications, will not be considered,

and will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the following

evaluation criteria by an independent

review group appointed by CDC.

1. Background and Need (30 Points)

a. (10 points) The extent to which the

applicant describes the current

organizational structure, how that

structure can support school-based food

safety programs, and identifies current

gaps in the existing structure of state

agencies that decreases the states’ ability

to deliver an optimal food safety

program.

b. (10 points) The extent to which the

applicant discusses barriers within

states to using existing resources that

contribute to the prevention of

foodborne illnesses, describes

experience in assisting state education,

state health and state agriculture

departments’ current school food safety

programs and describes experience

assisting state agencies’ use of existing

protocols, training, and educational

materials.

c. (5 points) The extent to which the

applicant describes experience in

developing policy related to food safety

programs and reporting school-based

foodborne outbreaks, discusses gaps in

the existing policy at the state level and

discusses a proposal for new policy.

d. (5 points) The extent to which the

applicant describes experience in

developing and implementing model

policy, curricula, training programs,

surveillance activities, and evaluation

protocol and describes your

organization’s experience providing

technical assistance and training.

2. Operational Plan (30 Points)

a. (15 Points) The extent to which the

applicant provides short-term (1-year)

and long-term (3-year) objectives for the

proposed project that build the capacity

of coordinated school food safety

programs nationwide. The objectives

must be specific, time-phased,

measurable, and realistic. The proposed

objectives should compliment ongoing

activities related to ‘‘From Farm to

Table: A National Food Safety

Initiative’’ (see the U.S. government

food safety information gateway

website, http://www.foodsafety.gov, for

more information on activities related to

the National Food Safety Initiative).

b. (15 points) The extent to which the

applicant submits a plan that builds the

capacity of its constituents and others to

assist state and local education agencies

in establishing a model school food

safety program designed to prevent

foodborne illness and includes a timeline for the completion of each

component or major activity that

describes who will do what by when.

The extent to which the proposed

activities are comparable to the

identified Recipient Activities

Described in Section D Program

Requirements.

3. Administration and Management (15

Points)

a. (5 points) The extent to which the

applicant provides job descriptions for

existing and proposed professional

positions and describes how the

proposed professional staff will

contribute to the overall school food

safety program. To the extent to which

the applicant describes how the current

or proposed placement of each staff will

assure that program implementation

among state education, health, and

agriculture agencies, their affiliates, and

partners is coordinated with the

organization’s constituents.

b. (5 points) The extent to which the

applicant demonstrates that existing or

proposed staff have or will have the

necessary background and qualifications

for the proposed responsibilities and

indicates how the organization can

ensure that for each professional

working on the project, their position

description requires the appropriate

level of education and experience

related to the level of responsibility and

expected duties. The extent to which

the applicant provides a curriculum

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