[Federal Register Volume 61, Number 90 (Wednesday, May 8, 1996)]
[Notices]
[Pages 20821-20824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11444]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry
[Announcement 608]


Human Health Studies; Applied Research and Development

Introduction

    The Agency for Toxic Substances and Disease Registry (ATSDR) 
announces the availability of fiscal year (FY) 1996 funds for a grant 
program designed to answer public health questions arising from 
situations commonly encountered at hazardous waste sites. The objective 
of this program is to fill gaps in knowledge, including data needs and 
health conditions, by conducting applied research and development 
studies related to human exposure to hazardous substances and to the 
ATSDR's health assessments, consultations, and health studies on 
hazardous substances prioritized by ATSDR. These Priority Health 
Conditions are identified under the Purpose section of this notice. 
Priority data needs are identified by ATSDR in its toxicological 
profiles.
    ATSDR 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 Environmental Health. 
(For ordering a copy of ``Healthy People 2000,'' see the Section Where 
to Obtain Additional Information.)

Authority

    This program is authorized in sections 104(i)(1)(E), (6), (7), (9), 
and (15) of the Comprehensive Environmental Response, Compensation, and 
Liability Act (CERCLA), as amended by the Superfund Amendments and 
Reauthorization Act (SARA) [42 U.S.C. 9604(i)(1)(E), (6), (7), (9), and 
(15)].

Smoke-Free Workplace

    ATSDR strongly encourages all grant and cooperative agreement 
recipients to provide a smoke-free workplace and 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

    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 the Marshall Islands, the 
Republic of Palau, and federally recognized Indian tribal governments. 
State organizations, including State universities, State colleges, and 
State research institutions, 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

    The Government's obligation under this grant project is contingent 
upon the availability of appropriated funds from which payment for 
grant purposes can be made. No legal liability on the part of the 
government for any obligation may arise until funds are made available 
to the grantee through the formal award of a grant/cooperative 
agreement.
    It is expected that $500,000 will be available in FY 1996 to fund 
approximately 2 awards. Awards are funded for a 12-month budget period 
within a project period of up to 3 years. Continuation awards within 
the project period will be made on the basis of

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satisfactory progress and the availability of funds.

Purpose

    The purpose of this announcement is to solicit scientific proposals 
designed to answer public health questions arising from situations 
commonly encountered at hazardous waste sites. The objective of this 
research program is to fill gaps in knowledge regarding human health 
effects of hazardous substances identified during the conduct of 
ATSDR's health assessments, consultations, toxicological profiles, and 
health studies, including but not limited to those health conditions 
prioritized by ATSDR. The ATSDR Priority Health Conditions are (in 
alphabetical order):
    1. birth defects and reproductive disorders,
    2. cancers (selected anatomic sites),
    3. immune function disorders,
    4. kidney dysfunction,
    5. liver dysfunction,
    6. lung and respiratory diseases and
    7. neurotoxic disorders.
    Substance-specific research needs are identified in ATSDR 
toxicological profiles.

Program Requirements

    Grants funded under this program will focus on one or more of the 
following:
    1. Human Populations,
    2. Use of innovative methodologies to fill data gaps identified 
through ATSDR's public health assessments and consultations at 
hazardous waste sites,
    3. Ecologic studies using data from multiple sites to assess the 
health status of several communities, or
    4. Analytical studies, including meta-analysis of existing sets of 
human data.
    Research activities may include, but not be limited to the 
following:
    1. Epidemiological studies,
    2. Health outcomes studies,
    3. Further analysis of existing human data sets,
    4. Identification, validation, and development of biomarkers of 
exposure, susceptibility, and effect,
    5. Further evaluating the link or lack of linkage between specific 
chemicals and specific health effects,
    6. Developing innovative methodologies to fill data gaps on the 
health effects associated with exposure to chemicals frequently found 
at hazardous waste sites,
    7. Relationship of environmental fate and transport of chemicals to 
human health effects,
    8. Developing innovative health education methodologies to prevent 
exposure and/or adverse human health effects,
    9. Psychological effects associated with exposure to hazardous 
substances,
    10. Health effects associated with incineration, and
    11. Improving human risk assessment.
    This program is designed for grant applications only. In a grant, 
the recipient is required to conduct the proposed study without 
substantial programmatic involvement from the funding agency.

Evaluation Criteria

    The review for scientific and technical merit by an objective 
review group will be based on the following criteria:

A. Scientific and Technical Review Criteria of New Applications

1. Appropriateness and Knowledge of Study Design--25%
    The extent to which the applicant's proposal addresses the:
    a. Scientific merit of the proposed project, including the novelty, 
originality and feasibility of the approach and the adequacy of the 
design,
    b. Technical merit of the proposed project, including the degree to 
which the project can be expected to yield or demonstrate results that 
will be useful and desirable in furthering the program objective as 
described in the Purpose section of this announcement, and
    c. Proposed project schedule, including clearly established and 
obtainable project objectives for which progress toward attainment can 
and will be measured.
2. Proposed Study--25%
    The adequacy of the proposal relevant to the:
    a. Study purpose, objectives, and rationale,
    b. Quality of program objectives in terms of specificity, 
measurability, and feasibility,
    c. Specificity and feasibility of the applicant's timetable for 
implementing program activities and timely completion of the study, and
    d. Likelihood of the applicant agency completing proposed program 
activities and attaining proposed objectives based on the thoroughness 
and clarity of the overall program.
    In addition, the degree to which the applicant has met the CDC/
ATSDR policy requirements regarding the inclusion of women, ethnic, and 
racial groups in the proposed research. This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The appropriateness of the proposed justification when 
representation is limited or absent.
    c. Whether the design of the study is adequate to measure 
differences when warranted.
    d. Whether the plans for recruitment and outreach for study 
participants include the process of establishing partnerships with 
community(ies) and recognition of mutual benefits.
3. Relationship to Initiative--15%
    The extent to which the application addresses the areas of 
investigation outlined by ATSDR.
4. Quality of Data Collection--15%
    The extent to which the:
    a. Study ascertains the information necessary to meet the 
objectives, including (but not limited to) information on pathways of 
exposure, confounding factors, and biomedical testing,
    b. Quality control and quality assurance of questionnaire data are 
provided, including (but not limited to) interviewer training and 
consistency checks of data,
    c. Laboratory tests (if applicable) are sensitive and specific for 
the analyte or disease outcome of interest, and
    d. Quality control, quality assurance, precision and accuracy of 
information for the proposed tests are provided and acceptable.
5. Applicant Capability and Coordination Efforts--10%
    The extent to which the proposal has described the:
    a. Capability of the applicant's administrative structure to foster 
successful scientific and administrative management of a study,
    b. Capability of the applicant to demonstrate an appropriate plan 
for interaction with the community, and
    c. Suitability of facilities and equipment available or to be 
purchased for the project.
6. Program Personnel--10%
    The extent to which the proposed program staff is qualified and 
appropriate, and the time allocated for them to accomplish program 
activities is adequate.
7. 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:

[[Page 20823]]

    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 long-term objectives, methods of 
operation, need for grant support, and/or evaluation procedures will 
lead to achievement of project objectives.
    4. The budget request is clearly justified and consistent with the 
intended use of grant/cooperative agreement funds.

Funding Priorities

    Priority will be given for studies which address one or more of the 
following areas of investigation:
    A. Evaluate the occurrence of adverse health effects in a 
population. This will include the evaluation of the incidence or 
prevalence of a disease, disease symptoms, self-reported health 
concerns, or biological markers of disease, susceptibility, or 
exposure.
    B. Identify risk factors for adverse health effects in populations. 
This will include hypothesis generating cohort or case-control studies 
on potentially impacted populations to identify linkages between 
exposure and adverse health effects and those risk factors which may be 
impacted by prevention actions.
    C. Develop methods to diagnose adverse health effects in 
populations. This includes medical research to evaluate currently 
available biological tests (biomarkers) and disease occurrence in 
potentially impacted populations.
    D. Develop health education methods applicable to the hazardous 
substances and their exposure pathways most commonly found at hazardous 
waste sites. These may include demonstration projects to investigate 
the effectiveness of these methods.
    Interested persons are invited to comment on the proposed funding 
priority. All comments received on or before June 7, 1996, will be 
considered before the final funding priority is established. If the 
funding priority should change as a result of any comments received, a 
revised announcement will be published in the Federal Register prior to 
the final selection of awards.
    Written comments should be addressed to Ron S. Van Duyne, 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 E-13, Atlanta, GA 30305.

Executive Order 12372

    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 forward them to Ron S. Van Duyne, 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 E-13, Atlanta, GA 30305, no later than 60 
days after the application deadline date. (By formal agreement, the CDC 
Procurement and Grants Office will act on behalf of and for ATSDR on 
this matter.)
    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 Ron S. Van 
Duyne, Grants Management Officer, Grants Management Branch, Procurement 
and Grants Office, Centers for Disease Control and Prevention (CDC), 
255 East Paces Ferry Road, NE., Mailstop E13, Atlanta, GA 30305. This 
should be done no later than 60 days after the application deadline 
date. The granting agency does not guarantee to ``accommodate or 
explain'' for tribal 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 93.161, Health 
Programs for Toxic Substances and Disease Registry.

Other Requirements

A. Protection of Human Subjects

    This program requires research on human subjects, therefore, all 
applicants must comply with 45 CFR Part 46 regarding the protection of 
human subjects. Assurances must be provided that the project or 
activity will be 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 forms provided in the application kit.

B. Women, Racial, and Ethnic Minorities

    It is the policy of CDC and 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. In conducting review for scientific merit, review 
groups will evaluate proposed plans for inclusion of minorities and 
both sexes as part of the scientific assessment and scoring.
    This policy does not apply to research studies when the 
investigator cannot control the race, ethnicity and/or sex of subject. 
Further guidance to this policy is contained in the Federal Register, 
Vol. 60, No. 179, pages 47947-47951, Friday, September 15, 1995.
    A copy of the CDC/ATSDR policy is included in the application kit.

C. Disclosure

    Recipient is required to provide proof by way of citation to State 
code or regulation or other State pronouncement given the authority of 
law, that medical information obtained pursuant to the agreement, 
pertaining to an individual, and therefore considered confidential, 
will be protected from disclosure when the consent of the individual to 
release identifying information is not obtained.

D. Cost Recovery

    CERCLA, as amended by SARA, provides for the recovery of costs 
incurred for health assessments and

[[Page 20824]]

health effects studies at each Superfund site from potentially 
responsible parties. The recipient would 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 10 years after 
submission of a final Financial Status Report (FSR), 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.

E. 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, release of data, ownership of data, and the arrangement for 
copyright when publications, data or other copyrightable works are 
developed in the course of work under an ATSDR 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 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 for carrying out the 
agreement, and the maximum amount of money for which the grantee may 
become liable to the third party.

    The written agreement required shall not relieve the grantee of any 
part of its responsibility or accountability to ATSDR under the grant. 
The agreement shall, therefore, retain sufficient rights and control to 
the grantee to enable it to fulfill this responsibility and 
accountability.

Application and Submission Deadline

A. Preapplication Letter of Intent

    Although not a prerequisite of application, a non-binding letter of 
intent-to-apply is requested from potential applicants. The letter 
should be submitted to the Grants Management Branch, CDC (see address 
below) and should be postmarked no later than June 8, 1996. The letter 
should include the following:
    1. Announcement Number,
    2. Title of the proposed area or areas of research,
    3. Name  of  the  principal  investigator/s  and
    4. Identification of any other participating institutions.
    The letter of intent does not influence review or funding 
decisions, but it will enable ATSDR to more efficiently plan the 
objective review.
    The original and two copies of the application PHS Form 5161-1 (OMB 
Number 0937-0189) must be submitted to Ron S. Van Duyne, 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, Mail Stop E-13, Atlanta, GA 30305, on 
or before July 8, 1996 (By formal agreement, the CDC Procurement and 
Grants Office will act on behalf of and for ATSDR on this matter.)
1. Deadline
    Applications shall 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 information call (404) 332-4561. You will be 
asked to leave your name, address and phone number and will need to 
refer to Announcement 608. You will receive a complete program 
description, information on application procedures and application 
forms. The announcement is also available through the CDC home page on 
the Internet. The address for the CDC home page is http://www.cdc.gov.
    If you have questions after reviewing the contents of all the 
documents, business management 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 E-
13, Atlanta, GA 30305, telephone (404) 842-6797, or INTERNET address, 
[email protected].
    Programmatic assistance may be obtained from Dr. Jeffrey A. 
Lybarger, Director, Division of Health Studies, telephone, (404) 639-
6200, or INTERNET address, [email protected]., or Dr. John 
Andrews, Associate Administer for Science, telephone (404) 639-0708, or 
INTERNET address, [email protected]., Agency for Toxic Substances 
and Disease Registry, 1600 Clifton Road, NE., Mailstop E-31, Atlanta, 
GA 30333.
    Please refer to announcement number 608 when requesting information 
and submitting an application.
    There may be delays in mail delivery as well as difficulty in 
reaching the CDC Atlanta offices during the 1996 Summer Olympics (July 
19 - August 4). Therefore, in order to receive more timely response to 
questions please use INTERNET/E- Mail, follow all instructions in this 
announcement, and leave messages on the contact person's voice mail.
    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: May 1, 1996.
Claire V. Broome,
 Deputy Administrator, Agency for Toxic Substances and Disease 
Registry.
[FR Doc. 96-11444 Filed 5-7-96; 8:45 am]
BILLING CODE 4163-70-P