[Federal Register Volume 62, Number 126 (Tuesday, July 1, 1997)]
[Notices]
[Pages 35501-35506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17124]


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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

[[Page 35502]]

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