Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices 31933

(k)(2)], as amended. The Catalog of

Federal Domestic Assistance number is

93.283.

J. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov.

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’

Should you have questions after

reviewing the contents of all the

documents, business management

technical assistance may be obtained

from: Jesse Robertson, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention, Announcement

01115, Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

number: (770) 488–2747, Email address:

jrt4@cdc.gov.

For program technical assistance,

contact: Leslie Given, MPA, Public

Health Advisor, Division of Cancer

Prevention and Control, National Center

for Chronic Disease Prevention and

Health Promotion, Centers for Disease

Control and Prevention, 4770 Buford

Highway, NE, Mailstop K–57, Atlanta,

GA, Telephone: (770) 488–3099, Email

address: llg5@cdc.gov.

Dated: June 7, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–14858 Filed 6–12–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01105]

Replication and Implementation of

Scientifically-Proven Asthma

Interventions; Notice of Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a cooperative agreement

program for Replication and

Implementation of Scientifically-Proven

Asthma Interventions. This program

addresses the ‘‘Healthy People 2010’’

focus area of Respiratory Diseases.

The purpose of the program is to

implement one of the following

scientifically proven asthma

interventions: (1) ‘‘Open Airways’’ or (2)

‘‘Asthma Care Training for Kids: ACT’,

to improve quality of life, decrease acute

care visits, decrease hospitalizations,

and increase compliance with asthma

care plans and asthma medication

regimens. These existing interventions

have been selected because they have

been validated as being safe and

effective.

No research may be conducted as part

of this cooperative agreement.

B. Eligible Applicants

Applications may be submitted by

non-profit, public and private

organizations or agencies that have

affiliate/local offices in States, U.S.

territories, or Indian tribes or Indian

tribal organizations; local education

agencies; hospitals; community-based

organizations; managed care

organizations; community health

centers, and city or county public health

agencies.

To be an eligible applicant, you must

provide the following:

1. Evidence that applicant has direct

access to target populations needed to

implement these interventions.

2. Evidence of an established record

of successful service in the community,

through letters of support.

3. Evidence, through letters of

support, of working relationships with

other appropriate organizations within

the specific community of the target

populations.

4. If the applicant proposes the use of

‘‘Open Airways’’, then a specific letter

of support from the local chapter of

American Lung Association is required.

This documentation should be placed

after the face page of the application. An

applicant that does not provide the

above documentation will be

determined non-responsive and

returned without review.

Note: Title 2 of the United States Code,

Chapter 26, Section 1611 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 $1,000,000 is available

in FY 2001 to fund approximately five

to ten awards. It is expected that the

average award will be $125,000, ranging

from $100,000 to $150,000. It is

expected that the awards will begin on

or about September 30, 2001, and will

be made for a 12-month budget period

within a project period of up to three

years. 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.

Funding Preferences

Funding preferences may include: (1)

Geographic distribution, (2) racial and

ethnic populations with a

disproportionate asthma burden, (3) the

mix between the two interventions to be

implemented under this announcement,

and (4) balance of organization type (i.e.

Non-profit, managed care, communitybased organization, etc.).

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), and CDC

will be responsible for the activities

listed under 2. (CDC Activities).

1. Recipient Activities

a. Implement the selected sciencebased asthma intervention designed to

improve the quality of life of persons

with moderate to severe persistent

asthma by improving overall

management of the disease.

b. Develop a quality assurance plan

that allows confirmation that the

implementation adheres to the selected

intervention protocol.

c. Develop a plan to integrate the

intervention into the organization’s

standard practice over time assuring

institutionalization of the intervention.

If needed, institute activities to change

organizational policies and health care

provider practices to ensure

institutionalization.

2. CDC Activities

a. If requested, provide consultation

and technical assistance regarding the

implementation and evaluation of the

intervention.

b. Provide liaison among grantees and

potential sources of information and

assistance.

c. Coordinate activities among sites,

when appropriate.

d. Convene meetings among

collaborators to discuss program issues,

when appropriate.

E. Content

Letter of Intent (LOI)

A non-binding LOI is requested, and

it should include:

1. Name and address of organization;

2. Contact person; and

3. Selected intervention.

The LOI will be used to ascertain the

level of interest in this announcement

and to assist in determining the size and

composition of the independent review

panel.

31934 Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices

Applications

To develop the application content,

use the information below in addition to

the information listed in ‘‘Program

Requirements,’’ ‘‘Other Requirements,’’

and ‘‘Evaluation Criteria’’ sections. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The application, excluding

appendices, should be no more than 15

double-spaced pages, printed on one

side, with one-inch margins, and

unreduced font. The application must

be submitted unstapled and unbound.

1. Description of Applicant, Health

Problem, and Population To Be Served

Describe the applicant’s organization

type (i.e., school district, community

health center, local health department,

etc.) and structure. Describe the

population to be served and the asthma

problem that will be addressed in this

population by the intervention. Provide

data to demonstrate the number of

persons with moderate to severe

persistent asthma who will be enrolled

in the intervention over the three-year

period and describe the source of that

data.

2. Program Plan

a. Describe in detail the plans for

implementing the intervention in the

described population. Provide

information on how the applicant will

access the intervention protocol and the

materials necessary for the intervention.

Provide specific objectives for the

proposed activities that are realistic,

time-phased, and measurable, and

reflect the three-year period of this

announcement. Assure that the

intervention patients are receiving

appropriate medical care (based on the

National Asthma Education and

Prevention Program (NAEPP)

Guidelines) prior to enrollment in the

intervention activity. For school-based

projects, describe which of the

American Lung Association/Kaiser

Permanente Key Elements of Schoolbased Asthma Management are already

implemented (see attachment 2, part II,

for reference).

b. Describe in-kind contributions of

the organization to support the

intervention, the plan to integrate the

intervention into its standard practice

over time, and document the agency’s

willingness to do so. Describe policy

and practice changes necessary to make

institutionalization possible.

3. Evaluation of Intervention

Describe how progress toward

effective implementation of the

intervention will be evaluated. Describe

proposed process evaluation measures.

(Note: Because the safety and

effectiveness of the interventions to be

implemented has been demonstrated

previously, outcome evaluation will not

be funded through this announcement.)

4. Management and Staffing Plan

a. Describe the qualifications, primary

roles and responsibilities for each of the

project staff over the three-year grant

period. Include a description of

intervention staff and the management

plan for oversight of these staff.

b. Provide a plan to expedite filling of

the staff position(s) and assure that they

have been or will be approved by the

applicant’s personnel system.

c. Describe in detail needed training

for staff and how that training will be

provided.

5. Budget

This section must include a detailed

first-year budget and narrative

justification and future annual

projections. The applicant should

describe the program purpose for each

budget item. For contracts contained

within the application budget,

applicants should name the contractor,

if known; describe the services to be

performed; justify the use of a third

party; and provide a breakdown or a

justification for the estimated costs of

the contracts, the kinds of organizations

or parties to be selected, the period of

performance, and the method of

selection. [Note: The funds for this

intervention may not be used to

supplant existing funds.]

F. Submission and Deadline

Letter of Intent (LOI)

On or before July 16, 2001, submit the

LOI to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

Application

Submit the original and two copies of

PHS 5161–1 (OMB Number 0920–0428).

Forms are available in the application

kit and at the following Internet address:

www.cdc.gov/od/pgo/forminfo.htm.

On or before August 13, 2001, submit

the application to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Deadline: Applications shall be

considered as meeting the deadline if

they are either:

1. Received on or before the deadline

date; or

2. Sent on or before the deadline date

and received in time for submission to

the independent review group.

(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 shall

not be acceptable as proof of timely

mailing.)

Late: Applications which do not meet

the criteria in 1. or 2. above will be

returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Description of Applicant, Health

Problem and Population To Be Served

(15 points)

The extent to which the applicant

describes the understanding of the

population’s need. Applicant’s

description of and access to an adequate

number of the target population.

Adequate description of the source of

the data provided describing the target

population.

2. Program Plan (35 points)

a. The extent to which the applicant

describes the appropriateness of the

proposed approach to implementation

of the intervention. The ability to meet

the objectives and the adequacy of the

plan to carry out the proposed activities

within the time-line provided.

b. The extent to which objectives are

measurable against the stated purpose of

the cooperative agreement. Applicant

description of access to the information

and materials necessary for the

implementation of the intervention.

c. The extent that organizational

support and the feasibility of the plan

for institutionalization is described by

the applicant.

3. Evaluation of Intervention (30 points)

The extent to which the applicant

describes the feasibility and

appropriateness of the plan to monitor

progress toward meeting the objectives

of the project. Appropriateness of

proposed process measures.

4. Management and Staffing Plan (20

points)

The extent to which the applicant’s

overall ability to perform the proposed

activities as reflected in the staff’s

qualifications and experience are

described. The demonstration of the

timely start of the intervention plan

through the expedited hiring or

availability of staff. Description of and

access to needed training for staff.

Federal Register / Vol. 66, No. 114 / Wednesday, June 13, 2001 / Notices 31935

5. Budget (Not scored)

The extent to which the budget is

reasonable, adequately justified and

consistent with the intended use of the

cooperative agreement funds.

F. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Semi-annual progress reports;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements may be applicable to this

program. For a complete description of

each, see Attachment I of the

announcement.

AR–7 Executive Order 12372 Review

AR–8 Public Health System Reporting

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

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301 and 317 of the Public

Health Service Act, [42 U.S.C. section

241 and 247b], as amended. The Catalog

of Federal Domestic Assistance number

is 93.283.

J. Where to Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov.

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’

To obtain business management

technical assistance, contact: Sonia

Rowell, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

number: (770) 488–2724, Email address:

Srowell@cdc.gov.

For program technical assistance,

contact: Dan Burrows, Air Pollution and

Respiratory Health Branch, National

Center for Environmental Health,

Centers for Disease Control and

Prevention, 1600 Clifton Rd., NE (MSE17), Atlanta, GA 30333, Telephone

number: (404) 498–1004, Email address:

DBurrows@cdc.gov.

Dated: June 7, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–14857 Filed 6–12–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for

Nonvoting Representatives of

Consumer and Industry Interests on

Public Advisory Panels or Committees

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for nonvoting consumer

representatives and nonvoting industry

representatives to serve on certain

device panels of the Medical Devices

Advisory Committee in the Center for

Devices and Radiological Health

(CDRH). Nominations will be accepted

for current vacancies and for those that

will or may occur through July 31, 2002.

FDA has a special interest in ensuring

that women, minority groups,

individuals with disabilities, and small

businesses are adequately represented

on advisory committees and, therefore,

encourages nominations for

appropriately qualified candidates from

these groups, as well as nominations

from small businesses that manufacture

medical devices subject to the

regulations.

DATES: Nominations should be received

by July 13, 2001, for vacancies listed in

this notice.

ADDRESSES: All nominations and

curricula vitae (which includes

nominee’s office address, telephone

number, and e-mail address) for

consumer representatives should be

submitted in writing to Maureen A.

Hess (address below). All nominations

and curricula vitae (which includes

nominee’s office address, telephone

number, and e-mail address) for

industry representatives should be

submitted in writing to Kathleen L.

Walker (address below).

FOR FURTHER INFORMATION CONTACT:

Regarding consumer representatives:

Maureen A. Hess, Office of

Consumer Affairs (HFE–50), Food

and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–5006, e-mail:

MHess@OC.FDA.GOV.

Regarding industry representatives:

Kathleen L. Walker, Office of

Systems and Management (HFZ–

17), Food and Drug Administration,

2098 Gaither Rd., Rockville, MD

20850, 301–594–1283, ext. 114, email: KLW@CDRH.FDA.GOV.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations for nonvoting

members representing consumer and

industry interests for the vacancies

listed below:

Medical Devices Panels

Approximate Date Representative is Needed

Consumer Industry

Anesthesiology and Respiratory Therapy Devices Panel Dec. 1, 2001 Dec. 1, 2001

Circulatory System Devices Panel July 1, 2002 NV1

Clinical Chemistry and Clinical Toxicology Devices Panel Mar. 1, 2002 NV1

Dental Products Panel NV1 Nov. 1, 2001

General Hospital and Personal Use Devices Panel NV1 Jan. 1, 2002

Ophthalmic Devices Panel Nov. 1, 2001 Nov. 1, 2001

1NV = No vacancy

I. Function

The functions of the medical device

panels are to: (1) Review and evaluate

data on the safety and effectiveness of

marketed and investigational devices

and make recommendations for their

regulation; (2) advise the Commissioner

of Food and Drugs regarding

recommended classification or