[Federal Register Volume 59, Number 157 (Tuesday, August 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20011]
[[Page Unknown]]
[Federal Register: August 16, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[Announcement 505]
Health Activities Recommendation Panel Site-Specific Health
Activities; Availability of Funds for Fiscal Year 1995
Introduction
The Agency for Toxic Substances and Disease Registry (ATSDR)
announces the anticipated availability of fiscal year (FY) 1995 funds
for a cooperative agreement/grant program for Health Activities
Recommendation Panel Site-Specific Health Activities. This program will
conduct site-specific health activities related to human exposure to
hazardous substances at waste sites or releases. The activities will be
conducted in communities near hazardous waste sites for which ATSDR (or
a State under cooperative agreement) has prepared a preliminary public
health assessment, public health assessment, public health advisory,
health consultation, or other site-related report and the Health
Activities Recommendation Panel (HARP) has determined that specific
public health actions are warranted. Emphasis will be given to the
sites rated as ``Urgent Public Health Hazard'' and ``Public Health
Hazard.''
Note: This announcement is a continuation of a previously
announced initiative, Program Announcement No. 407--Health
Activities Recommendation Panel Site-Specific Health Activities,
which was published in the Federal Register on August 9, 1993 [58 FR
42327].
The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of ``Healthy People
2000,'' a PHS-led national activity to reduce morbidity and mortality
and improve the quality of life. This announcement is related to the
priority area of Environmental Health. (For ordering a copy of
``Healthy People 2000,'' see the Section ``Where to Obtain Additional
Information.'')
Authority
This program is authorized under Sections 104(i)(1)(E),(7),(9), and
(15) of the Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA) of 1980 as amended by the Superfund Amendments
and Reauthorization Act (SARA) of 1986 [42 U.S.C. 9604 (i)(1)(E) (7),
(9), and (15)].
Smoke-Free Workplace
The Public Health Service strongly encourages all grant recipients
to provide a smoke-free workplace and promote the non-use of all
tobacco products. This is consistent with the PHS mission to protect
and advance the physical and mental health of the American people.
Eligible Applicants
Eligible applicants are the official public health agencies of
States or their bona fide agents or instrumentalities. This includes
the District of Columbia, American Samoa, the Commonwealth of Puerto
Rico, the Virgin Islands, the Federated States of Micronesia, Guam, the
Northern Mariana Islands, the Republic of Marshall Islands, the
Republic of Palau, and federally recognized Indian tribal governments.
State organizations, including State universities, must establish that
they meet their respective State's legislature definition of a State
entity or political subdivision to be considered an eligible applicant.
Availability of Funds
Approximately $2,000,000 is expected to be available in FY 1995 to
fund an estimated 10 competing new awards and 10 noncompeting
continuation awards. It is expected that the awards will range from
$75,000 to $125,000. Awards are funded for a 12-month budget period
within a project period of up to 2 years. Continuation awards within
the project period will be made on the basis of satisfactory progress
and the availability of funds.
Purpose
The purpose of the program is to assist public health agencies in
conducting site-specific health activities recommended by HARP to
assess the public health impact of human exposure to hazardous
substances in communities located near hazardous waste sites or
releases. A current list of sites in the applicant's State rated as
Urgent Public Health Hazard, Public Health Hazard, and Indeterminate
Public Health Hazard may be obtained from Wendell Webb, Agency for
Toxic Substances and Disease Registry, Public Health Practice
Coordination Group, telephone (404) 639-0566.
Program Requirements
Applicants must specify the type of award for which they are
applying, either grant or cooperative agreement. These two types of
Federal assistance are explained below.
A. Grants
In a grant, the applicant will be required to conduct the proposed
study without substantial programmatic involvement from the funding
agency. Therefore, the grantee's application should be presented in a
manner that demonstrates the applicant's ability to conduct the study.
Applications should include a protocol which will undergo scientific
peer review as required by ATSDR. The applicant's protocol should
contain consent forms and questionnaires, baseline morbidity and
mortality information, procedures for collecting biologic and
environmental specimens and for conducting laboratory analysis of the
test specimens, statistical and epidemiologic analysis of the study
information, and a description of the safeguards for protecting the
confidentiality of individuals on whom data are collected. The
applicant must include in the application a methodology for ongoing
community interaction/involvement. By comparison, the activities of the
recipient and the ATSDR relating to a cooperative agreement are
different and are described in paragraph B.
B. Cooperative Agreements
In a cooperative agreement, the funding agency will assist the
collaborator in conducting the study. The application should be
presented in a manner that demonstrates the applicant's ability to
address the health study in a collaborative manner with the funding
agency. The cooperative activities of the recipient agency and the
funding agency are:
1. Recipient Activities
a. The recipient will develop a protocol and conduct the
recommended study. This protocol will undergo scientific peer review as
required by ATSDR.
b. The recipient is required to provide proof by citing a State
code or regulation or other State pronouncement under authority of law,
that medical information obtained pursuant to the agreement will be
protected from disclosure when the consent of the individual to release
identifying information is not obtained.
c. The recipient will develop a mechanism for ongoing interaction
with the affected community.
2. ATSDR Activities
a. ATSDR will provide assistance in both the planning and
implementation phases of the field work called for under the study
protocol.
b. ATSDR will provide consultation and assist in monitoring the
data and specimen collection.
c. ATSDR will participate in the study analysis.
d. ATSDR will collaborate in interpreting the study findings.
e. ATSDR will conduct technical and peer review.
Evaluation Criteria
Applications will be reviewed and evaluated according to the
following criteria:
A. Scientific and Technical Review Criteria of New Applications
1. Proposed Program--50%
The extent to which the applicant's proposal and protocol addresses
(a) the study as recommended by HARP; (b) the approach, feasibility,
adequacy, and rationale of the proposed project design; (c) the
technical merit of the proposed project, including the degree to which
the project can be expected to yield results that meet the program
objective as described in the ``Purpose'' section of this announcement
and the technical merit of the methods and procedures (including
quality assurance and quality control procedures) for the proposed
project; (d) the proposed project timeline, including clearly
established project objectives for which progress toward attainment can
and will be measured; (e) the proposed community involvement strategy;
and (f) the proposed method to disseminate the results to State and
local public health officials, community residents, and other concerned
individuals and organizations.
2. Program Personnel--30%
The extent to which the proposal has described (a) the
qualifications, experience, and commitment of the principal
investigator (or project director) and his/her ability to devote
adequate time and effort to provide effective leadership; and (b) the
competence of associates to accomplish the proposed activity, their
commitment, and the time they will devote.
3. Applicant Capability and Coordination Efforts--20%
The extent to which the proposal has described (a) the capability
of the applicant's administrative structure to foster successful
scientific and administrative management of a study; (b) the capability
of the applicant to demonstrate an appropriate plan for interaction
with the community; and (c) the suitability of facilities and equipment
available or to be purchased for the project.
4. Program Budget--(Not Scored)
The extent to which the budget is reasonable, clearly justified,
and consistent with intended use of cooperative agreement/grant funds.
B. Review of Continuation Applications
Continuation awards within the project period will be made on the
basis of the following criteria:
1. Satisfactory progress has been made in meeting project
objectives;
2. Objectives for the new budget period are realistic, specific,
and measurable;
3. Proposed changes in described objectives, methods of operation,
need for grant support, and/or evaluation procedures will lead to
achievement of project objectives; and
4. The budget request is clearly justified and consistent with the
intended use of grant/cooperative agreement funds.
Executive Order 12372 Review
Applications are subject to the Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 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. If SPOCs have
any State process recommendations on applications submitted to CDC,
they should send them to Henry S. Cassell, III, Grants Management
Officer, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, Room 300, Mailstop E13, NE., Atlanta, Georgia 30305, no later
than 60 days after the application deadline date. The Program
Announcement Number and Program Title should be referenced on the
document. The granting agency does not guarantee to ``accommodate or
explain'' State process recommendations it receives after that date.
Indian tribes are strongly encouraged to request tribal government
review of the proposed application. If tribal governments have any
tribal process recommendations on applications submitted to CDC, they
should forward them to Henry S. Cassell, III, Grants Management
Officer, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, Room 300, Mailstop E13, NE., Atlanta, Georgia 30305, no later
than 60 days after the application deadline date. The Program
Announcement Number and Program Title should be referenced on the
document. The granting agency does not guarantee to ``accommodate or
explain'' 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 93.203, Health
Programs for Toxic Substances and Disease Registry.
Other Requirements
A. 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 Native American community is
involved, its tribal government must also approve that portion of the
project applicable to it. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
form provided in the application kit.
B. Cost Recovery:
CERCLA as amended by the SARA provides for the recovery of costs
incurred for health assessments and health effects studies at each
Superfund site from potentially responsible parties. The recipient will
agree to maintain an accounting system that will keep an accurate,
complete, and current accounting of all financial transactions on a
site-specific basis, i.e., individual time, travel, and associated cost
including indirect cost, as appropriate for the site. The recipient
will retain the documents and records to support these financial
transactions, for possible use in a cost recovery case, for a minimum
of ten years after submission of a final Financial Status Report,
unless there is a litigation, claim, negotiation, audit or other action
involving the specific site, then the records will be maintained until
resolution of all issues on the specific site.
C. Paperwork Reduction Act:
Projects that involve the collection of information from 10 or more
individuals and funded by the cooperative agreement will be subject to
review by the Office of Management and Budget under the Paperwork
Reduction Act.
D. Third Party Agreements:
Project activities which are approved for contracting pursuant to
the prior approval provisions shall be formalized in a written
agreement that clearly establishes the relationship between the grantee
and the third party. The written agreement shall at a minimum:
1. State or incorporate by reference all applicable requirements
imposed on the contractors under the grant by the terms of the grant,
including requirements concerning peer review and technical review as
required by ATSDR, release of data, ownership of data and the
arrangement for copyright when publications, data or other
copyrightable works are developed under or in the course of work under
a PHS grant supported project or activity.
2. State that any copyrighted or copyrightable works shall be
subject to a royalty-free, nonexclusive, and irrevocable license to the
government to reproduce, publish, or otherwise use them, and to
authorize others to do so for Federal government purposes.
3. State that whenever any work subject to this copyright policy
may be developed in the course of a grant by a contractor under a
grant, the written agreement (contract) must require the contractor to
comply with these requirements and can in no way diminish the
government's right in that work.
4. State the activities to be performed, the time schedule for
those activities, the policies and procedures to be followed in
carrying out the agreement, and the maximum amount of money for which
the grantee may become liable to the third party under the agreement.
5. State that the contractor must comply with all peer review and
technical review requirements. The written agreement required shall not
relieve the grantee of any part of its responsibility or accountability
to PHS under the grant. The agreement shall, therefore, retain
sufficient rights and control to the grantee to enable it to fulfill
this responsibility.
Application and Submission Deadlines
The original and two copies of the application Form PHS 5161-1 must
be submitted to Henry S. Cassell, III, Grants Management Officer,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,
Room 300, Mailstop E13, Atlanta, Georgia 30305, in accordance with the
submission schedule below.
This is a continuous announcement and the proposed timetable for
receiving new applications and making awards is shown below:
------------------------------------------------------------------------
Submission deadlines
new applications Review dates Award dates
------------------------------------------------------------------------
October 14, 1994....... November 15, 1994...... January 16, 1995
January 17, 1995....... February 15, 1995...... March 30, 1995
April 14, 1995......... May 15, 1995........... July 1, 1995
July 14, 1995.......... August 14, 1995........ September 30, 1995
------------------------------------------------------------------------
A. Deadline
Applications shall be considered as meeting the deadline if they
are either:
1. Received on or before the deadline date, or
2. Sent on or before the deadline date and received in time for
submission to the 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.)
B. Late Applications
Applications which do not meet the criteria in A. above are
considered late applications. Late applications will not be considered
in the current competition and may either be returned to the applicant
or held for the next review cycle.
Where to Obtain Additional Information
A complete program description, information on application
procedures, an application package, and business management technical
assistance may be obtained from Maggie Slay, Grants Management
Specialist, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Room 300, Mailstop E13, Atlanta, Georgia 30305, telephone
(404) 842-6797. Programmatic technical assistance may be obtained from
Dr. Jeffrey A. Lybarger, Director, Division of Health Studies, Agency
for Toxic Substances and Disease Registry, 1600 Clifton Road, NE.,
Mailstop E31, Atlanta, Georgia 30333, telephone (404) 639-6200.
Please refer to Announcement Number 505 when requesting information
and submitting an application.
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 Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238.
Dated: August 10, 1994.
Claire V. Broome, M.D.,
Deputy Administrator, Agency for Toxic Substances and Disease Registry.
[FR Doc. 94-20011 Filed 8-15-94; 8:45 am]
BILLING CODE 4163-70-P
