[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