Cooperative Agreement for American Indian/Alaska Native Infectious Disease Programs

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 792]

Cooperative Agreement for American Indian/Alaska Native

Infectious Disease Programs

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1997 funds for a cooperative agreement

to establish Infectious Disease Programs (IDPs) to assist Native

American Federally Recognized Tribes (NAFRTs), tribal groups, and

Alaska Native Corporations (ANCs) in enhancing their capacity to

address emerging and reemerging infectious diseases within their

communities. Specifically, this program will assist them in the areas

of disease prevention, health promotion, research, and education and

training.

CDC is committed to achieving the health promotion and disease

prevention objectives of ``Healthy People 2000,'' a national activity

to reduce morbidity and mortality and improve the quality of life. This

announcement is related to the priority area of Immunization and

Infectious Diseases. (For ordering a copy of ``Healthy People 2000,''

see the section Where to Obtain Additional Information.)

Authority

This program is authorized under Sections 301, 317(k)(1) and

317(k)(2) of the Public Health Service Act, as amended (42 U.S.C. 241,

247b(k)(1) and 247b(k)(2).

Smoke-Free Workplace

CDC strongly encourages all grant recipients to provide a smoke-

free workplace and to promote the non-use of all tobacco products, and

Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in

certain facilities that receive Federal funds in which education,

library, day care, health care, and early childhood development

services are provided to children.

Eligible Applicants

The only organizations eligible to apply are all recognized NAFRTs,

tribal groups, and ANCs, in accordance with the 1976 Indian Health Care

Improvement Act, Pub. L. 94-43. No other applications will be accepted.

Note: Effective January 1, 1996, Public Law 104-65 states that

an organization described in section 501(c)(4) of the Internal

Revenue Code of 1986 which engages in lobbying activities will not

be eligible for the receipt of Federal funds constituting an award,

grant, cooperative agreement, contract, loan, or any other form.

Availability of Funds

Approximately $150,000 is available in FY 1997 to fund up to two

awards. Approximately 50 percent of the funds is allocated for one

award to an eligible applicant representing American Indians in the

contiguous 48 United States and approximately 50 percent of the funds

is allocated for one award to an eligible applicant representing Alaska

Natives. It is expected that the average annual award (direct plus

indirect) will be approximately $75,000, ranging from $50,000 to

100,000. It is expected that the awards will begin on or about

September 29, 1997, and will be made for a 12-month budget period

within a project period of up to five years. Funding estimates may vary

and are subject to change. Continuation awards within the project

period will be made on the basis of satisfactory progress and the

availability of funds.

Use of Funds

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of Department

of Health and Human Services (HHS) funds for lobbying of Federal or

State legislative bodies. Under the provisions of 31 U.S.C. Section

1352 (which has been in effect since December 23, 1989), recipients

(and their subtier contractors) are prohibited from using appropriated

Federal funds (other than profits from a Federal contract) for lobbying

Congress or any Federal agency in connection with the award of a

particular contract, grant, cooperative agreement or loan. This

includes grants/cooperative agreements that, in whole or in part,

involve conferences for which Federal funds cannot be used directly or

indirectly to encourage participants to lobby or to instruct

participants on how to lobby.

In addition, the FY 1997 Departments of Labor, HHS, and Education,

and Related Agencies Appropriations Act, which became effective October

1, 1996, expressly prohibits the use of 1997 appropriated funds for

indirect or ``grass roots'' lobbying efforts that are designed to

support or defeat legislation pending before State legislatures.

Section 503 of this new law, as enacted by the Omnibus Consolidated

Appropriations Act, 1997, Division A, Title I, Section 101(e), Pub. L.

No. 104-208 (September 30, 1996), provides as follows:

Sec. 503(a) No part of any appropriation contained in this Act

shall be used, other than for normal and recognized executive-

legislative relationships, for publicity or propaganda purposes, for

the preparation, distribution, or use of any kit, pamphlet, booklet,

publication, radio, television, or video presentation designed to

support or defeat legislation pending before the Congress, * * * except

in presentation to the Congress or any State legislative body itself.

Sec. 503(b) No part of any appropriation contained in this Act

shall be used to pay the salary or expenses of any grant or contract

recipient, or agent acting for such recipient, related to any activity

designed to influence legislation or appropriations pending before the

Congress or any State legislature.

Background

Infectious diseases remain the leading cause of illness and death

worldwide. In the United States, infectious diseases increasingly

threaten public health and contribute significantly to morbidity,

mortality and the cost of health care. Because of multiple

sociocultural characteristics, access to adequate health care, and

other factors, infectious diseases are particularly important causes of

morbidity and mortality among minority group members in the United

States. Incidence of tuberculosis, HIV infection, hepatitis A and B,

and Hemophilus influenzae type b and pneumococcal invasive diseases are

much higher among members of minority groups than in the White

population. American Indians and Alaska Natives (AI/AN), the smallest

and most linguistically and culturally diverse U.S. ethnic groups, have

some of the highest rates of certain infectious diseases, notably

respiratory syncytial virus infection, tuberculosis, pneumococcal and

Hemophilus influenzae type b invasive disease.

Emerging infectious diseases, including those which are new or

previously unrecognized, whose incidence in humans has increased within

the past two decades or threatens to increase in the near future, and

those which are reemerging pose a particular threat to native

populations. In 1993, an outbreak of severe respiratory illness

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was first described in the southwestern United States leading to the

discovery of Hantavirus pulmonary syndrome, which was caused by a

previously unrecognized hantavirus. Conditions in many sparsely

populated areas, including relative isolation, overcrowded dwellings,

and resource-poor environments, tend to promote infectious disease

emergence and transmission.

The Department of Health and Human Services (DHHS), primarily

through the Indian Health Service (IHS), was responsible for providing

Federal health services to American Indians and Alaska Natives. The

Indian Health Program became a primary responsibility of DHHS under

Pub. L. 83-568, the Transfer Act, in 1954. The 1975 Indian Self-

Determination Act, Pub. L. 94-638, built upon IHS policy by giving

tribes the option of staffing and managing IHS programs in their

communities and provided for funding for improvement of tribal

capability to contract under the Act. The 1976 Indian Health Care

Improvement Act, Pub. L. 94-43, was intended to elevate the health

status of AIs/ANs to a level equal to that of the general population

through a program of authorizing higher resource levels in the IHS

budget. It appropriated resources which were used to expand health

services, build and renovate medical facilities, and construct

facilities for water treatment and sanitary disposal. It also

established programs designed to increase the number of AI/AN health

professionals and to improve health care access for AIs/ANs living in

urban areas. In recent years, the operation of health care systems has

been assumed by AIs/ANs themselves. Significant progress in the areas

of advancing tribal sovereignty, self-governance and self-

determination, and improved health status have been documented.

However, much remains to be done before the goal of improving the

health status among AIs/ANs to a level comparable to that of the White

population is achieved. Based on the results published in the Report of

the Secretary's Task Force on Black and Minority Health, CDC

established a goal to reduce the excess burden of disability and death

experienced by minority populations in the United States. In response

to the problem of emerging infections, CDC, in partnership with other

Federal agencies, State and local health departments, academic

institutions and others, developed a plan for revitalizing the nation's

ability to identify, control and prevent illness from emerging

infectious diseases. The plan, Addressing Emerging Infectious Disease

Threats: A Prevention Strategy for the United States proposes three

major surveillance activities, as well as objectives in areas of

applied research, prevention and control and infrastructure. It

particularly recognizes the special vulnerability of minority and

underserved populations to emerging and reemerging infections, and

prioritizes these activities in minority populations.

In 1995, CDC began to address the objective of establishing

population-based programs to ensure adequate capacity to conduct

epidemiologic and laboratory surveillance and response through

cooperative agreements with State health departments. This program

announcement describes cooperative agreements which would establish

infectious disease infrastructure-enhancing programs (IDPs) with NAFRTs

and ANCs. These programs (AI/AN IDPs) will help ensure that as AI/AN

communities assume responsibility for health care services to Native

peoples, they will also have the opportunity to assume responsibility

for infectious disease prevention, research, and training activities.

IDPs will also assist NAFRTs and ANCs to identify emerging infectious

disease prevention research priorities in their communities. Priority

setting accomplished through a participatory process, the main goal of

this program announcement, will result in prevention research programs

that are responsive to high priority, community-validated needs within

defined populations. Additionally, it will facilitate tribal

consultation and tribal input in CDC activities that impact these

communities, as recommended in the Annual Report of the Administration

Working Group on American Indians and Alaska Natives: Two Years After

the President's Meeting with Tribal Leaders.

Purpose

The purpose of this cooperative agreement is to assist NAFRTs and

ANCs to establish AI/AN IDPs. This program will be designed to enhance

the capabilities of these entities to: (1) Identify infectious disease

prevention research priorities in AI/AN communities; (2) develop,

propose, and evaluate a prevention or intervention project, and; (3)

within this process, provide infectious disease prevention training,

education, and professional work experience opportunities designed to

increase the numbers of AI/AN public health professionals. Activities

of the AI/AN IDPs will be focused in the areas of vaccine preventable

or potentially vaccine-preventable diseases, drug-resistant infections,

foodborne and waterborne diseases, or other emerging or reemerging

infectious disease problems that are identified as important in the

population. The AI/AN IDPs will be located to serve a variety of

geographical areas, diverse groups, and difficult to reach populations.

They will enlist the participation of community-based organizations,

individuals who have recognition in the communities, academic

institutions, local health departments and other public (including

Federal and State government) and private organizations, and will seek

support from other sources in addition to CDC to operate the program.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for addressing activities in A.,

below, and CDC will be responsible for conducting activities under B.,

below:

A. Recipient Activities

1. Develop a AI/AN IDP which will:

a. Identify infectious disease prevention priorities in one or more

AI/AN communities. Specific activities should include survey(s),

interviews, focus groups, and other activities to identify the

community's concerns and priorities related to infectious disease(s),

such as otitis media, meningitis, or diarrhea, or chronic diseases with

an infectious etiology, such as hepatic or cervical cancer or peptic

ulcer disease, and emerging or reemerging infectious diseases.

b. Conduct either (1) or (2) below:

Plan, implement and evaluate:

1. A prevention or intervention program to address an infectious

disease prevention priority identified in section ``a.'' above, or

focused in another area of vaccine preventable or potentially

preventable disease, drug resistant infections, or food or waterborne

diseases of importance in the AI/AN community.

or

2. A collaborative project in applied epidemiology or applied

laboratory research on an emerging infectious disease priority

identified in section ``a.'' above, or another area of importance in

AI/AN communities.

2. Collaborate with other appropriate organizations.

a. Develop collaborative relationships with appropriate community-

based organizations and/or other entities to accomplish activities

under this program.

b. Work to obtain technical and/or financial assistance from other

parties to supplement support from CDC.

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3. Monitor and evaluate scientific and/or operational

accomplishments and progress in achieving the purpose of this program.

4. Provide infectious disease prevention training, education, and

professional work experience opportunities designed to increase the

number of AIs/ANs in public health, epidemiology, and laboratory

professions. Identification and recruitment of AI/AN candidates for

training, education and professional work experiences.

5. Disseminate findings, etc.

B. CDC Activities

1 Provide consultation and scientific and technical assistance in

general operation of the AI/AN IDP and in designing and conducting

individual AI/AN IDP projects.

2. Participate in analysis and interpretation of data from AI/AN

IDP projects, facilitate timely dissemination of findings and

information stemming from AI/AN IDP projects.

3. Assist in monitoring and evaluating scientific and operational

accomplishments of the AI/AN IDP and progress in achieving the purpose

and overall goals of this program.

4. As needed, perform laboratory evaluation of specimens and

isolates (e.g., molecular epidemiologic studies, evaluation of

diagnostic tools) and integrate results with other data from AI/AN

IDP(s) projects.

5. Assist in recruitment and support of AI/AN candidates for

training, education, and professional work experiences.

CDC collaboration for recipients in Alaska will be provided by the

Arctic Investigations Program, National Center for Infectious Diseases

(NCID) based in Anchorage, Alaska. CDC collaboration for recipients in

other states will be provided by the appropriate NCID division or

program that is responsible for the area on which the recipient has

focused.

Technical Reporting Requirements

Semiannual progress reports are required and must be submitted no

later than 30 days after each semiannual reporting period. The

semiannual progress reports must include the following for each

program, function, or activity involved: (1) status of the core

activity (community-based identification of research priorities); (2)

progress toward development and implementation of a prevention or

intervention or an applied research project; and, (3) progress toward

overall objectives as represented in the Purpose and Recipient

Activities sections of this announcement. The final progress report is

required no later than 90 days after the end of the project period. All

abstracts, presentations, or publications as a result of the work

supported in part or whole by the cooperative agreement will be

submitted with the progress reports.

An annual financial status report (FSR) must be submitted no later

than 90 days after the end of the budget period. The final financial

status report is due no later than 90 days after the end of the project

period.

An original and two copies of all reports should be submitted to

the Grants Management Officer, Procurement and Grants Office, Grants

Management Branch, CDC.

Required Format for Applications

All applicants must develop their application in accordance with

the PHS Form 5161-1 (revised 7/92), information contained in this

cooperative agreement announcement, and the instructions outlined

below. In order to ensure an objective, impartial, and prompt review,

applications which do not conform to these instructions may be

disqualified.

1. All pages must be clearly numbered.

2. A complete index to the application and its appendices must be

included.

3. To facilitate photocopying, the original and both copies of the

application must be submitted unstapled and unbound. Bound materials

will NOT be accepted in the narrative or appendices. Do not include

page separators between sections.

4. All materials must be typewritten, single spaced, and in font

size of 12 or greater, on 8\1/2\'' by 11'' white paper, with at least

1'' margins.

5. All pages must be printed on one side only.

Application Content

The application narrative must not exceed 12 pages (excluding

budget, appendices, and the protocols for the core and potential

additional projects in the Operational Plan below.) Applications in

which the narrative exceeds 12 pages will NOT be accepted. All

information requested below, aside from what is requested as

appendices, must appear in the narrative. Material or information that

should be part of the narrative will not be accepted if placed in the

appendices.

The application narrative must contain the following sections in

the order presented below:

1. Background:

In this section, demonstrate a clear understanding of the

objectives of the IDP. Use this section to explain the background and

objectives of this cooperative agreement program, the problem of

emerging infectious diseases, and the requirements, responsibilities,

problems, constraints and complexities that may be encountered in

establishing and operating the IDP, such as widely dispersed

populations, language difficulties, difficulties related to travel,

etc.

2. Description of Population in Which IDP Will Operate

In this section, clearly define the geographic area and population

base in which the IDP will operate, including as much detail as is

available and relevant, such as number of persons by age-group,

language(s) spoken in the area, major occupations, major tribal

affiliation(s). Describe various special populations in the IDP area as

they relate to the proposed activities of the IDP, such as elders,

women, underserved infants and children.

3. Description of Existing Public Health Infectious Disease

Epidemiologic and/or Laboratory Research Capacity:

a. In this section, describe past experience in conducting or

collaborating in surveys or behavioral research, applied epidemiologic

and applied laboratory research, or prevention research in general.

Describe any past experience in conducting or assisting in research,

including studies of infections caused by antimicrobial-resistant

organisms; foodborne, waterborne, potentially or currently vaccine-

preventable diseases; cervical cancer; hepatitis, etc. Include

participation in other CDC-sponsored or other surveillance and research

programs and participation in investigations of outbreaks of emerging

infectious diseases. To demonstrate applicant's ability to develop and

maintain strong cooperative relationships with both public and private

local and regional medical, public health, laboratory, academic and

community-based organizations, describe previous or current

collaborative relationships with such parties. Demonstrate applicant's

ability to solicit and secure financial and technical support and

programmatic collaboration from other public and private organizations

for conducting public health research projects.

b. Provide in an appendix (Appendix 1) letters of support from non-

applicant participating agencies, institutions, organizations,

laboratories, individuals, consultants, community-based organizations,

etc. which are indicated in the applicant's operational plan.

[[Page 35504]]

Letters of support should clearly indicate their willingness to be

participants in, or collaborators with, the IDP, or its activities. Do

not include letters of support from CDC personnel. Award of a

cooperative agreement implies participation by CDC staff members as

indicated in ``CDC activities.''

4. Operational Plan:

a. Present a plan for establishing and operating the population-

based IDP which simply and clearly describes the proposed

organizational and operating structure/procedures and clearly

identifies the roles and responsibilities of all participating

agencies, organization, institutions and individuals. Whether or not

exempt from DHHS regulations, in any proposed project(s) involving

human subjects, describe for each such project in an appendix (Appendix

2) adequate procedures for the protection of human subjects. Also,

ensure that women, racial and ethnic minority populations are

appropriately represented in applications for research involving human

subjects by including a description of the composition of the proposed

study population (for example, addressing the inclusion of women and

members of minority groups and their sub-populations in the section

that will describe the research design). Where clear and compelling

rationale exist that inclusion is inappropriate or not feasible, this

situation must be explained as part of the application. See the Other

Requirements section for additional information.

b. Describe applicant's partnerships with necessary and appropriate

organizations establishing and operating the proposed IDP and for

conducting individual IDP projects. Describe plans or willingness to

accommodate training opportunities for researchers-and providers-in-

training (e.g., AI/AN college, graduate and medical students,

infectious disease fellows).

c. Describe collaboration plans:

1. To collaborate with community-based organizations.

2. Describe plans to solicit and secure financial and technical

assistance from other public and private organizations (e.g., schools

of public health, centers of excellence, university medical schools,

public health laboratories, community-based organizations, other

Federal and State government agencies, including the Indian Health

Service, research organizations, foundations, etc.) to supplement the

core funding from CDC.

d. For the planned prevention activities beyond the initial

planning of the IDP, intervention or applied research program, submit

in an appendix (Appendix 3), a brief proposal (no more than three

pages) and an estimated budget describing how they will be

accomplished. The protocols should demonstrate that the applicant

understands the concept of active surveillance, epidemiologic studies

or pilot prevention or applied research program, and can propose

collaborative efforts to conduct these.

5. Personnel Qualification and Management Plan

a. Identify and provide in an appendix (Appendix 4) curriculum

vitae for applicant's key professional personnel to be assigned to the

IDP and IDP projects. Clearly identify their respective roles in the

management and operation of the IDP. Describe their experience in

conducting work similar to that proposed in this announcement.

b. Identify and provide in an appendix (Appendix 5) curriculum

vitae for key professional personnel from other participating or

collaborating institutions, agencies, organizations outside of the

applicant's agency that will be working on IDP activities if more than

10 percent effort is anticipated in the first year of the grant.

Clearly identify their respective roles.

c. Fully describe all support staff and services to be assigned to

the IDP.

d. Describe approach to maintaining sufficiently flexible IDP

staffing to accommodate the likelihood that the requirements of IDP

projects will change from time to time due to changes in the need for

information or the emergence of new diseases.

6. Evaluation Plan

Provide an evaluation plan (which can be less than one page) for

monitoring process and outcome-based criteria which evaluates:

a. The timeliness and completeness of the accomplishments of the

IDP and its recipient activity. This would specifically include

criteria by which the Research Priorities Identification activity and

the subsequent activity will be evaluated.

b. Progress in achieving the research, prevention and training

goals of the IDP.

7. Appendix

Provide in an appendix (Appendix 6) a detailed line-item budget and

accompanying justification consistent with the purposes and objectives

of this program. For each line item or object class category, show both

Federal and non-Federal (e.g., recipient, State, private) shares of

total cost for the IDP. If requesting funds for any contracts, provide

the following information for each proposed contract: (1) Name of

proposed contractor, (2) breakdown and justification for estimated

costs, (3) description and scope of activities to be performed by

contractor, (4) period of performance, and (5) method of contractor

selection (e.g., sole-source or competitive solicitation).

Evaluation Criteria

The applications will be reviewed and evaluated according to the

following Criteria: (Total 100 points).

1. The extent to which the applicant demonstrates in the Background

section a clear understanding of this cooperative agreement program, in

which the main goal is priority setting, accomplished through a

participatory process to identify high priority research and prevention

issues and needs within defined AI/AN populations. The extent to which

applicant demonstrates a clear understanding of the requirements,

responsibilities, problems, constraints and complexities that may be

encountered in establishing and operating the IDP by citing these

requirements in the Background section and anticipating some of the

problems and complexities. (13 points)

2. a. The extent to which the applicant clearly defines the

geographic area and population base in which the IDP will operate. The

extent to which the applicant defines a population base for the IDP

that is large enough and appropriate for the accomplishment of proposed

IDP activities. The extent to which the applicant clearly describes

various special populations in the IDP area, such as the rural or urban

poor, underserved women, infants and children, elders, or subsistence

hunters, that could be the focus of one or more IDP projects. (15

points)

b. The degree to which the applicant has met the CDC Policy

requirements regarding the inclusion of women, ethnic, and racial

groups in the proposed research. This includes: (1) The proposed plan

for the inclusion of both sexes and racial and ethnic minority

populations for appropriate representation. (2) The proposed

justification when representation is limited or absent. (3) A statement

as to whether the design of the study is adequate to measure

differences when warranted. (4) A statement as to whether the plans for

recruitment and outreach for study participants include the process of

establishing partnerships with community(ies) and recognition of mutual

benefits. (2 points)

3. The extent to which the applicant demonstrates its capacity and

ability to collaborate in surveys, behavioral

[[Page 35505]]

studies, applied epidemiologic and applied laboratory research, and/or

prevention research in emerging infectious diseases. The extent to

which applicant demonstrates its ability to solicit and secure

financial and technical support and programmatic collaboration from

other public and private organizations for conducting public health

research projects. The extent to which applicant provides letters of

support from non-applicant participating agencies, institutions,

organizations, individuals, consultants, etc., indicating their

willingness to participate, as represented in applicant's operational

plan, in establishing and operating the center. (25 points)

4. a. The extent to which the applicant's proposed plan for

collaborating in the establishment and operation of the IDP is detailed

and clearly describes the proposed organizational and operating

structure/procedures and clearly identifies the roles and

responsibilities of all participating agencies, organizations,

institutions, and individuals. The extent to which the applicant

describes plans for collaboration with CDC in the establishment and

ongoing operation of the IDP and its projects. The extent to which the

applicant's plan addresses all Recipient Activities listed in this

announcement and appears feasible and capable of accomplishing the

purpose of the program. If any proposed project involves human

subjects, whether or not exempt from the DHHS regulations, the extent

to which adequate procedures are described for the protection of human

subjects. Note: Objective Review Group (ORG) recommendations on the

adequacy of protections include (1) protections appear adequate and

there are no comments to make or concerns to raise, (2) protections

appear adequate, but there are comments regarding the protocol, (3)

protections appear inadequate and/or has concerns related to human

subjects, or (4) disapproval of the application is recommended because

the research risks are sufficiently serious and protection against the

risk are inadequate as to make the entire application unacceptable. (10

points)

b. The extent to which the applicant's plan clearly describes

partnerships with appropriate organizations for establishing and

operating the proposed IDP and for conducting individual projects.

Partner organizations must include community-based organizations (7

points) and may also be academic institutions and other public and

private organizations with an interest in addressing public health

issues relating to emerging infectious diseases (e.g., other Federal

and State government agencies, research organizations, medical

institutions, etc.). (3 points--for 10 points total)

c. The extent to which the applicant describes activities beyond

the initial planning of the IDP project(s) that are consistent with the

Purpose and Recipient Activities stated in this announcement.

The extent to which proposed projects/activities are consistent

with expressed community needs and appear feasible. The extent to which

proposed projects/activities include appropriate methodology and

documentation of plans for recruitment and outreach for study

participants. (10 points)

5. The extent to which the applicant identifies its own

professional and support staff, and professional and support staff from

other agencies, institutions, and organizations, that have the

experience, authority and willingness to carry out recipient activities

as evidenced by job descriptions, curriculum vitae, organizational

charts, etc. The extent to which the applicant describes an approach to

maintain a sufficiently flexible staffing pattern. (10 points)

6. The extent to which applicant provides an adequate evaluation

plan, which includes time-based and outcome-based criteria. The quality

of the proposed plan for monitoring accomplishments of the IDP and of

individual IDP project(s). The quality of the proposed evaluation plan

for monitoring progress in achieving the purpose and overall goals of

this program. (5 points)

7. The extent to which the proposed budget is reasonable, clearly

justifiable, and consistent with the intended use of cooperative

agreement funds. The extent to which both Federal and non-Federal

(e.g., State funding) contributions are presented. (not scored)

Executive Order 12372

Applications are subject to Intergovernmental Review of Federal

Programs as governed by Executive Order 12372. E.O. 12372 sets up a

system for State and local government review of proposed Federal

assistance applications. Applicants (other than federally recognized

Indian tribal governments) should contact their State Single Point of

Contact (SPOC) as early as possible to alert them to the prospective

applications and receive any necessary instructions on the State

process. For proposed projects serving more than one State, the

applicant is advised to contact the SPOC for each affected State. A

current list of SPOCs is included in the application kit. Indian tribes

are strongly encouraged to request tribal government review of the

proposed application. If SPOCs or tribal governments have any process

recommendations on applications submitted to CDC, they should forward

them to Sharron P. Orum, Grants Management Officer, Grants Management

Branch, Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-18, Room

305, Atlanta, Georgia 30305. The due date for State process

recommendations is no later than 30 days after the application deadline

date. The granting agency does not guarantee to ``accommodate or

explain'' for State process recommendations it receives after that

date.

Public Health System Reporting Requirements

This program is not subject to the Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance Number is 93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from ten or

more individuals and are funded by the cooperative agreement will be

subject to review by the Office of Management and the Budget (OMB)

under the Paperwork Reduction Act.

Human Subjects

If the proposed project involves research on human subjects, the

applicant must comply with the Department of Health and Human Services

Regulations (45 CFR part 46) regarding the protection of human

subjects. Assurance must be provided to demonstrate that the project

will be subject to initial and continuing review by an appropriate

institutional review committee. In addition to other applicable

committees, Indian Health Service (IHS) institutional review committees

also must review the project if any component of IHS will be involved

or will support the research. If any American Indian community is

involved, its tribal government must also approve that portion of the

project applicable to it. The applicant will be responsible for

providing evidence of this assurance in accordance with the appropriate

guidelines and form provided in the application kit.

[[Page 35506]]

Women, Racial and Ethnic Minorities

It is the policy of the Centers for Disease Control and Prevention

(CDC) and Agency for Toxic Substances and Disease Registry (ATSDR) to

ensure that individuals of both sexes and the various racial and ethnic

groups will be included in CDC/ATSDR-supported research projects

involving human subjects, whenever feasible and appropriate. Racial and

ethnic groups are those defined in OMB Directive No. 15 and include

American Indian, Alaskan Native, Asian, Pacific Islander, Black, and

Hispanic. Applicants shall ensure that women, racial and ethnic

minority populations are appropriately represented in applications for

research involving human subjects. Where clear and compelling rationale

exists that inclusion is inappropriate or not feasible, this situation

must be explained as part of the application. This policy does not

apply to research studies when the investigator cannot control the

race, ethnicity and/or sex subjects. Further guidance to this policy is

contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951,

dated Friday, September 15, 1995.

Application Submission and Deadline

The original and two copies of the application Form PHS-5161-1

(Revised 7/92) must be submitted to Sharron P. Orum, Grants Management

Officer, Grants Management Branch, Procurement and Grants Office,

Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry

Road, NE., Room 314, Mailstop E-18, Atlanta, Georgia 30305, on or

before August 15, 1997. No applications or additional materials will be

accepted after the deadline.

1. 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 and received in time

for submission to the objective 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.)

2. Late Applications: Applications which do not meet the criteria

in 1.a. or 1.b. above are considered late applications. Late

applications will not be considered in the current competition and will

be returned to the applicant.

Where to Obtain Additional Information

To receive additional written information, call (404) 332-4561. You

will be asked to leave your name, address, and telephone number. Please

refer to Announcement Number 792. You will receive a complete program

description, information on application procedures and application

forms. If you have questions after reviewing the contents of all the

documents, the business management technical assistance may be obtained

from Gladys T. Gissentanna, Grants Management Specialist, Grants

Management Branch, Procurement and Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 314,

Mailstop E-18, Atlanta, GA 30305, telephone (404) 842-6801, facsimile

(404) 842-6513.

Programmatic technical assistance may be obtained from Earl Long,

Ph.D., National Center for Infectious Diseases, Centers for Disease

Control and Prevention (CDC), Mailstop C-12, 1600 Clifton Road, NE.,

Atlanta, GA, 30333, telephone 404-639-2456. You may obtain this

announcement from one of two Internet sites on the actual publication

date: CDC's homepage at http://www.cdc.gov or at the Government

Printing Office homepage (including free on-line access to the Federal

Register at http://www.access.gpo.gov). Other CDC Announcements are

also listed on the Internet on the CDC homepage.

Please refer to Announcement Number 792 when requesting information

regarding this program.

Potential applicants may obtain a copy of ``Healthy People 2000''

(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000''

(Summary Report, Stock No. 017-001-00473-1) referenced in the

Introduction through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.

Potential applicants may obtain a copy of ``Addressing Emerging

Infectious Disease Threats: A Prevention Strategy for the United

States'' via the CDC homepage (http://www.cdc.gov/ncidod/publications/

eid_plan/home.htm) or through the Centers for Disease Control and

Prevention (CDC), National Center for Infectious Diseases, Office of

Planning and Health Communication--EP, Mailstop C-14, 1600 Clifton

Road, Atlanta, GA 30333. Requests may also be sent by facsimile to

(404) 639-3039.

Dated: June 25, 1997.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97-17124 Filed 6-30-97; 8:45 am]

BILLING CODE 4163-18-P