[Federal Register Volume 62, Number 131 (Wednesday, July 9, 1997)]
[Notices]
[Pages 36824-36827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17847]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement Number 793]


Cooperative Agreement for the Development of New Diagnostic 
Methods and a Research Program To Determine the Incidence of Emerging 
Human Spongiform Encephalopathies

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1997 funds to provide assistance 
through a cooperative agreement for developing new diagnostic methods 
and a research program to determine the incidence of emerging human 
spongiform encephalopathies.
    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 and 317 (42 U.S.C. 
241 and 247b), of the Public Health Service Act, as amended.

Smoke-Free Workplace

    CDC encourages all grant recipients to provide a smoke-free 
workplace and to promote the nonuse of all tobacco products, and Pub. 
L. 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

    Applications may be submitted by public and private non-profit 
organizations and governments and their agencies. Thus, universities, 
colleges, research institutions, hospitals, other public and private 
non-profit organizations are eligible to apply.
    Applicant staff must have certification to practice neuropathology 
(a medical field focusing on examination and study of brain tissues) in 
the United States or certification to practice pathology (or neurology) 
in the United States and show, in their curriculum vitae, the extent of 
their experience in neuropathology.

    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 $65,000 is available in FY 1997 to fund one award. It 
is expected that the award will begin on or about September 20, 1997, 
and will be made for a 12-month budget period within a project period 
of up to 5 years. Funding estimates may vary and are subject to change. 
Continuation awards within an approved project period will be made on 
the basis of satisfactory progress and 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

    In 1986, a newly recognized cattle disease, bovine spongiform

[[Page 36825]]

encephalopathy (BSE, commonly known as ``mad cow'' disease), was 
reported in Britain. As of mid-1997, more than 166,000 British cattle 
have been confirmed with BSE in more than 33,900 herds. The practice of 
feeding cattle rendered animal protein was shown to be responsible in 
greatly amplifying the BSE outbreak. Transmission of the BSE agent to 
domestic cats and other zoo animals, possibly through contaminated 
feeds, raised concerns that the human population might also be 
susceptible to this new disease. These concerns were heightened in 
March 1996 when the Spongiform Encephalopathy Advisory Committee (SAEC) 
to the government of Britain announced 10 young Creutzfeldt-Jakob 
disease (CJD) patients with unusual clinical and neuropathological 
features. In the absence of known recognizable risk factors for CJD or 
any other plausible explanation for the clustering of these 
extraordinarily young CJD patients, the British researchers concluded 
that the patients may represent spread of the BSE agent to the human 
population.
    In addition to the young age at onset, this new variant of CJD has 
been characterized by atypical clinical features with prominent 
behavioral changes at the time of clinical presentation and subsequent 
onset of neurologic abnormalities including ataxia within weeks or 
months, dementia and myoclonus late in the illness, a duration of 
illness of at least six months, and nondiagnostic 
electroencephalographic changes. The specific, uniform neuropathology 
includes, in both the cerebellum and cerebrum, numerous kuru-type 
amyloid plaques surrounded by vacuoles and prion protein accumulation 
at high concentration, indicated by immunocytochemical analysis.
    As of May 6, 1997, five additional confirmed and one probable cases 
of new variant CJD were identified in the United Kingdom and one 
confirmed case was identified in France. Although a definitive 
scientific causal association of new variant CJD with BSE has not yet 
been established, the evidence for a causal link has been accumulating.

Purpose

    The purpose of this cooperative agreement is to provide assistance 
for the development of new diagnostic techniques and a research program 
to determine the incidence of potentially emerging human spongiform 
encephalopathies in the United States.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient shall be responsible for the activities under A., below, 
and CDC shall be responsible for conducting activities under B., below:

A. Recipient Activities

    1. Test the application of novel diagnostic methods to research the 
incidence of emerging human spongiform encephalopathies.
    2. Develop research programs that can be used to monitor the 
emergence of human spongiform encephalopathies.
    3. Identify new cases of human spongiform encephalopathies.
    4. Disseminate result of research findings.

B. CDC Activities

    Provide assistance in the dissemination of results and other 
technical assistance as required.

Technical Reporting Requirements

    Narrative 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) A comparison of actual 
accomplishments to the goal established for the period; (2) the reasons 
for failure, if established goals were not met; and (3) other pertinent 
information including, when appropriate, analysis and explanation of 
performance costs significantly higher than expected. All manuscripts 
published 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) is required no later than 
90 days after the end of each budget period. A final performance report 
and financial status report are 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, Grants Management Branch, Procurement 
and Grants Office, CDC.

Required Format for Application

    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 appendixes must be 
included.
    3. The original and two copies of the application must be submitted 
unstapled and unbound.
    4. Any reprints, brochures, or other enclosures must be copied onto 
8\1/2\'' by 11'' white paper by the applicant. No bound materials will 
be accepted.
    5. All materials must be typewritten, single spaced, and in 
unreduced type (no smaller than font size 12) on 8\1/2\'' by 11'' white 
paper, with at least 1'' margins, headers, and footers.
    6. All pages must be printed on one side only.

Application Content

    The application narrative must not exceed 10 pages (excluding 
budget and appendixes). Unless indicated otherwise, all information 
requested below must appear in the narrative.
    Materials 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

    Discuss the background and need for the proposed project. 
Demonstrate a clear understanding of the purpose and objectives of this 
cooperative agreement program.

2. Capacity and Personnel

    Describe applicant's past experience in conducting projects/studies 
similar to that being proposed. Describe applicant's resources, 
facilities, and professional personnel that will be involved in 
conducting the project. Include in an appendix curriculum vitae for key 
professional personnel involved with the project. Describe plans for 
administration of the project and identify administrative resources/
personnel that will be assigned to the project.

3. Objectives and Technical Approach

    Describe specific objectives for the proposed project which are 
measurable and time-phased and are consistent with the purpose and 
goals of this cooperative agreement. Present a detailed operational 
plan for initiating and conducting the project which clearly and 
appropriately addresses all Recipient Activities (provide a detailed 
description of first-year activities and a brief overview of activities 
in subsequent years. Clearly state the proposed length of the project 
period). Clearly identify specific assigned

[[Page 36826]]

responsibilities for all key professional personnel. Include a clear 
description of applicant's technical approach/methods which are 
directly relevant to the study objectives to include obtaining study 
samples. Describe the nature and extent of collaboration with CDC and/
or others during various phases of the project. Describe in detail a 
plan for evaluating study results and for evaluating progress toward 
achieving project objectives.

4. Budget

    Provide in an appendix a budget and accompanying detailed 
justification for the first-year of the project that is consistent with 
the purpose and objectives of this program. Also, provide estimated 
total budget for each subsequent year. If requesting funds for 
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).

5. Human Subjects

    Whether or not exempt from DHHS regulations, if the proposed 
project involves human subjects, describe in an appendix 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.

Evaluation Criteria

    The applications will be reviewed and evaluated according to the 
following criteria:

1. Background and Need (5 points)

    Extent to which applicant's discussion of the background for the 
proposed project demonstrates a clear understanding of the purpose and 
objectives of this cooperative agreement program. Extent to which 
applicant illustrates and justifies the need for the proposed project 
that is consistent with the purpose and objectives of this cooperative 
agreement program.

2. Capacity (70 points total)

    a. Extent to which applicant describes adequate resources and 
facilities (both technical and administrative) for conducting the 
project. (10 points)
    b. Extent to which applicant documents that professional personnel 
involved in the project are qualified and have past experience and 
achievements in research related to transmissible spongiform 
encephalopathies, particularly in the application of CJD diagnostic 
methods such as neuropathology, immunocytochemistry, Western blot 
testing, and genetic analysis in determining the incidence of emerging 
human spongiform encephalopathies; these qualifications have to be 
evidenced by curriculum vitae, publications, etc. Applicants must 
provide curriculum vitae of their program staff and relevant scientific 
articles published in peer-reviewed journals within the last five 
years. (40 points)
    c. Extent to which applicant demonstrates the ability to 
collaborate with as many neuropathologists and/or pathologists working 
in human spongiform encephalopathy research to include how study 
samples will be collected. (20 points)

3. Objectives and Technical Approach (25 points total)

    a. Extent to which applicant describes specific objectives of the 
proposed project which are consistent with the purpose and goals of 
this cooperative agreement program and which are measurable and time-
phased. (5 points)
    b. Extent to which applicant presents a detailed operational plan 
for initiating and conducting the project, which clearly and 
appropriately addresses all Recipient Activities. Extent to which 
applicant clearly identifies specific assigned responsibilities for all 
key professional personnel. Extent to which the plan clearly describes 
applicant's technical approach/methods for conducting the proposed 
studies and extent to which the plan is adequate to accomplish the 
objectives. Extent to which applicant describes specific study 
protocols or plans for the development of study protocols that are 
appropriate for achieving project objectives. If the 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 the ORG 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 risks are inadequate as to make the entire 
application unacceptable. The degree to which the applicant has met the 
CDC policy requirements regarding the inclusion of women, ethnic, and 
racial groups in 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; and (4) documentation of plans for 
recruitment and outreach for study participants that includes the 
process of establishing partnerships with community(ies) and 
recognition of mutual benefits. (15 points)
    c. Extent to which applicant provides a detailed and adequate plan 
for evaluating study results and for evaluating progress toward 
achieving project objectives. (5 points)

4. Budget (not scored)

    Extent to which the proposed budget is reasonable, clearly 
justifiable, and consistent with the intended use of cooperative 
agreement funds.

Executive Order 12372 Review

    This program is not subject to Executive Order 12372 Review.

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

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

[[Page 36827]]

subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing evidence of this assurance in accordance with the appropriate 
guidelines and form provided in the application kit.

Women, Racial and Ethnic Minorities

    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the 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 
exist 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 of 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 PHS Form 5161-1 
(revised 7/92, OMB Number 0937-0189) must be submitted to Sharron 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 305, Mailstop E-18, Atlanta, Georgia 
30305, on or before August 8, 1997.
    1. Deadline: Applications shall be considered as meeting the 
deadline if they are either:
     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 793. 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, business management technical assistance may be obtained 
from Gladys T. Gissentanna, Grant 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. 
Programmatic technical assistance may be obtained from Lawrence B. 
Schonberger, MD, National Center for Infectious Diseases, Centers for 
Disease Control and Prevention (CDC), Atlanta, GA 30333, telephone: 
(404) 639-3091, Email address: [email protected]. You may also obtain this 
announcement from one of two Internet sites on the actual publication 
date: CDC's homepage at http://www.cdc.gov or 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 793 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.

    Dated: July 1, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-17847 Filed 7-8-97; 8:45 am]
BILLING CODE 4163-18-P