[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]


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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