[Federal Register Volume 61, Number 82 (Friday, April 26, 1996)]
[Notices]
[Pages 18603-18609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10362]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry
[Announcement 607]


Program to Build Capacity to Conduct Site-Specific Activities

Introduction

    The Agency for Toxic Substances and Disease Registry (ATSDR) 
announces the availability of fiscal year (FY) 1996 funds for a 
cooperative agreement program for State health agencies to conduct 
site-specific health activities to determine the public health impact 
of human exposure to hazardous substances at hazardous waste sites or 
releases. Specifically, funds will be used to build capacity to conduct 
``Core'' site-specific activities including public health assessments, 
health consultations, exposure investigations, community involvement, 
and preventive health education; and ``Optional'' follow-up health 
investigations/studies. ATSDR considers a site as consisting of the 
actual boundaries of a release or facility along with the resident 
community and area impacted by the subject release or facility.
    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 under Sections 104(i) (1)(E), (4), (6), 
(7), (9), (14) 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), (4), (6), (7), (9), (14) and (15)], and Section 3019 
(b) and (c) of the Resource Conservation and Recovery Act (RCRA), as 
amended (Hazardous and Solid Waste Amendments of 1984) [42 U.S.C. 6939a 
(b) and (c)].

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

    Participation is limited to 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. 
This program is comprised of Core activities and Optional activities. 
All applicants must compete for Core Activities (Public Health 
Assessments/Consultations, Exposure Investigations, and Community 
Involvement and Preventive Health Education). Site-Specific Health 
Investigations/Studies are considered Optional Activities to the Core 
Activities award.

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 cooperative agreement.
    It is expected that approximately $11,500,000 will be available in 
FY 1996 to fund an estimated 22 awards. The average new award is 
expected to be $300,000, ranging from $100,000 to $500,000. It is 
expected that the awards will begin on or about September 29, 1996, and 
will be made for a 12-month budget period within a 5-year project 
period. Funding estimates may vary and are subject to change.
    Approximately $10,000,000 of the $11,500,000 will be available to 
fund an estimated 22 Core Activities awards (range $100,000 to 
$500,000). Personnel funded under Core Activities should include, at a 
minimum, 1-2 full time employee (FTE) health assessors and 1-2 FTE 
health educators/community involvement specialists. Funds in the amount 
of $1,000,000 will be available for Optional Activities via the initial

[[Page 18604]]

award for epidemiologist or health scientist personnel. It is 
anticipated that $500,000 of supplemental funds may be made available 
for conducting site- specific human health studies after review of 
site-specific data, submission of study protocol with supplemental 
budget for proposed study, technical, objective, and peer review and 
approval of study protocols. In years subsequent to FY 1996, it is 
anticipated that funds in the amount of $2,000,000 will be available 
for site-specific studies.
    The Core Activities Award establishes the funding for this 
cooperative agreement. Only applicants funded for a Core Activities 
Award are eligible to receive awards for Optional Activities. 
Applicants who apply and are awarded for Core Activities only will not 
be eligible to add Optional Activities during the project period.
    This program is open to all eligible applicants, whether or not 
current participants in ATSDR grant or cooperative agreement programs. 
Grantees currently funded under ATSDR's Program Announcements 227, 415, 
325 and 443, can apply and, if successful, the current award would 
replace the previous award (competitive renewal) for a total project 
period of up to 5 years. If a current grantee applies under this 
competitive renewal announcement and is unsuccessful or chooses not to 
apply under this announcement, it will not jeopardize the current 
award; ATSDR will honor the current awards through the expiration of 
the project period, subject to satisfactory progress and the 
availability of funds.
    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 funded under this cooperative agreement 
is to work toward the ultimate goal of reducing exposures to hazardous 
substances and mitigating potential adverse health effects from such 
exposures. The specific purpose of the Core Activities is to assist 
public health agencies to build capacity, in coordination and 
cooperation with ATSDR, to conduct health related activities under 
CERCLA and RCRA. This includes conducting health consultations, public 
health assessments, and exposure investigations. Core Activities will 
also assist recipients to conduct community involvement activities, and 
to develop, disseminate, and evaluate site- specific preventive health 
education materials and other programs related to exposure to hazardous 
substances in the environment.
    Optional activities will assist public health agencies in 
conducting site-specific health activities recommended by the Technical 
Project Team to assess the public health impact of human exposure to 
hazardous substances in communities located near hazardous waste sites 
or releases.

Program Requirements

    ATSDR will assist or work jointly with the recipient in conducting 
the activities of this cooperative agreement program. The application 
should be presented in a manner that demonstrates the applicant's 
ability to address the health issues in a collaborative manner with 
ATSDR.

    Note: Recipient activities may not be conducted with funds from 
this cooperative agreement program at any Federal site where the 
State is a party to litigation at the site.

    Recipient and ATSDR activities are listed below:

A. Recipient Core Activities

    All activities will be conducted via an annually negotiated work 
plan, mutually agreed upon at the time of the annual budget discussions 
between ATSDR and recipient, that complies with requirements of 
applicable sections of CERCLA, as amended.

1. Public Health Assessments

    Conduct Public Health Assessments, including petitions, on National 
Priority Lists (NPL), Comprehensive Environmental Response, 
Compensation, and Liability Information System (CERCLIS), or other 
sites or facilities within the recipient's territorial boundary in 
accordance with the methodology provided in the ATSDR Public Health 
Assessment Guidance Manual, ATSDR's Review and Handling Procedures for 
Public Health Assessments, and other applicable guidance. The following 
activities are also considered integral in the public health assessment 
process:
    a. Prepare addenda to update public health assessments.
    b. Prepare Site Review and Updates (SRU) to evaluate current 
conditions and determine the need for further actions.

2. Health Consultations

    Prepare a written or verbal response to a specific question or 
specific request for information about health risks posed by a specific 
site (including Site Accelerated Cleanup Model (SACM)), chemical 
release, or hazardous material. Health consultations may also be 
written as a follow-up to Public Health Assessments or SRUs. 
Consultations may include the evaluation of environmental data, 
community concerns, health outcome data, and demographic 
characterizations, and the conduct of community outreach and 
interaction activities and site workplans.

3. Exposure Investigations

    Exposure Investigations may be conducted as part of a health 
assessment or health consultation response. Exposure Investigation 
involves a collection of data on less than 10 households.

4. Community Involvement

    Site-specific community involvement is designed to develop 
partnerships with communities living near hazardous waste sites in the 
development, implementation, and evaluation of site-specific 
activities, which may include needs assessment, site evaluation 
activities, participation in community meetings, and availability to 
the community to gather and address health concerns. The recipient 
will:
    a. Develop a site-specific community involvement plan which, at a 
minimum, should include: (1) A needs assessment strategy, (2) an 
implementation strategy, and (3) an evaluation strategy.
    b. Implement the community involvement plan and, where warranted 
based on the needs assessment, establish Community Assistance Panels.

5. Health Education

    Site-specific health education encompasses a program of education 
activities implemented in communities to enable them to prevent or 
mitigate the health impact of exposure to hazardous substances present 
at waste sites and releases. Prevention of exposure is the focus of 
community health education. Prevention of health effects from exposure 
is the focus of health professions education. Based on the community 
needs assessment, a coordinated health education program to address the 
needs identified for each target audience should be developed. The 
recipient will:
    a. Develop materials that are appropriate for the target audience 
considering such issues as literacy level, cultural values, and 
languages spoken.
    b. Recipient should give priority to those sites where specific 
actions can be taken to reduce or prevent exposures or where a 
significant public health concern exists.
    c. Materials and programs targeted to a community's health care 
providers should be designed to improve the knowledge and skill of 
health care professionals concerning the potential

[[Page 18605]]

exposure to hazardous substances at the selected sites. Examples 
include programs and materials designed to enhance the ability of 
health care providers to communicate risk, counsel and advise community 
members including their patients, recognize and evaluate potential 
exposures, obtain appropriate consultation from environmental health 
experts when needed or diagnose and treat conditions that may arise 
from exposure to hazardous substances.
    d. Implement the planned actions such as distributing materials, 
and conducting projects such as Grand Rounds, short courses, seminars, 
poster display sessions, and public availability sessions.

6. Site-Specific Evaluation

    As part of the workplan for Core Activities (Public Health 
Assessments/Health Consultations, Site-specific Involvement and Health 
Education), develop a site- specific evaluation plan prior to 
conducting activities. The plan should contain a component for each 
activity undertaken at the site. Conduct evaluation of activities and 
projects and site-specific programs to determine if community's needs 
have been met as well as intended purpose of the activities. Both 
process and impact/outcome measures should be included in the 
evaluation plan.

7. Program Evaluation

    An evaluation of effectiveness of overall capacity building effort 
in addressing public health issues in communities living near hazardous 
waste sites will be conducted jointly by all participants. This 
evaluation will focus on outcome and impact measurements using a 
standard evaluation instrument. Both process and impact/outcome 
measures will be included in the evaluation.

B. Recipient Optional Activities

    1. For all health assessments and/or health consultations prior to 
October 1, 1995, for which a health follow-up activity was recommended, 
the recipient will reassess community, environmental, and human data 
and provide in writing a disposition of their assessment.
    2. For those studies recommended previously, the recipient will 
develop a protocol and conduct the recommended study. This protocol 
will undergo scientific peer review as required by ATSDR and may 
require clearance by the Office of Management and Budget (OMB) before 
data collection can begin.
    3. 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.

4. Evaluation

    As part of the workplan for Optional Activities (Public Health 
Studies/Investigations), develop a site-specific evaluation plan, 
including a standard evaluation instrument prior to the conduct of 
site-specific activities. The plan should contain a component for each 
activity undertaken at the site. Conduct evaluation of activities, 
projects, and site-specific programs to determine if community's needs 
as well as intended purpose of the activities have been met. Both 
process and impact/outcome measures should be included in the 
evaluation plan.

C. Other Activities

    1. Participate in Technical Project team (TPT) review and comply 
with established review and handling procedures for incorporating the 
results of recommendations into site evaluation activities.
    2. Provide abstraction overview to ATSDR on each site for which 
site evaluation activities have been conducted for inclusion in the 
HAZDAT.
    3. Review and prepare written comments on EPA's draft Remedial 
Investigation/Feasibility Study (RI/FS), RI/FS workplans, and Records 
of Decision, and site-specific documents of the State's environmental 
department.

4. Workshops

    a. Participate in local, State, and Federal health and 
environmental workshops and community meetings to discuss and respond 
to questions concerning a particular site's impact on public health.
    b. Participate in ATSDR-scheduled training classes or workshops to 
increase knowledge and skills in environmental public health.
    5. Respond to ATSDR's requests concerning congressional inquiries/
testimonies, program evaluation, or other information in carrying out 
the purpose of the project.

D. ATSDR Core Activities

    All activities will be conducted via an annually negotiated work 
plan, mutually agreed upon at the time of the annual budget discussions 
between ATSDR and recipient, that complies with requirements of 
applicable sections of CERCLA, as amended.
    As requested by the recipient, ATSDR is available to provide the 
following:

1. Public Health Assessments

    Collaborate with and assist recipient in conducting Public Health 
Assessment activities on CERCLIS or other sites or facilities within 
the recipient's territorial boundary, which includes:
    a. Collaborate and assist in preparing addenda to update public 
health assessments.
    b. Collaborate and assist in preparing Site Review and Updates 
(SRU) to evaluate current conditions and determine the need for further 
actions.

2. Health Consultations

    Collaborate and assist recipient in preparing a written or verbal 
response to a specific question or specific request for information 
about health risks posed by a specific site (including SACM), chemical 
release, or hazardous material.

3. Exposure Investigations

    Collaborate and assist in conducting Exposure Investigations.

4. Community Involvement

    a. Assist in developing effective methods to conduct needs 
assessments in communities living near hazardous waste sites and in 
defining goals and objectives.
    b. Assist in development, implementation, and evaluation of the 
community involvement plan.

5. Site-specific Health Education

    a. Collaborate in developing and reviewing all educational 
materials to ensure scientific accuracy. Provide existing materials as 
requested. Collaborate in developing projects for specific target 
audiences.
    c. Collaborate with the State in the implementation of programs and 
the distribution of materials.

6. Evaluation

    ATSDR will lead the evaluation of each recipient's total program. 
This evaluation will focus on outcome and impact measurements using a 
standard evaluation instrument. In addition, ATSDR will conduct an 
evaluation of effectiveness of overall capacity building effort in 
addressing public health issues in communities living near hazardous 
waste sites. Both process and impact/outcome measures will be included 
in the evaluation.

E. ATSDR Optional Activities

    As requested by the recipient, ATSDR is available to provide the 
following:
    1. Provide assistance in both the planning and implementation 
phases of

[[Page 18606]]

the field work called for under the study protocol.
    2. Provide consultation and assist in monitoring the data and 
specimen collection.
    3. Participate in the study analysis.
    4. Collaborate in interpreting the study findings.
    5. ATSDR will conduct technical and peer review.
    6. Evaluation--ATSDR will evaluate each recipient's total program. 
This evaluation will focus on outcome and impact measurements using a 
standard evaluation instrument. In addition, ATSDR will conduct an 
evaluation of effectiveness of overall capacity building effort in 
addressing public health issues in communities living near hazardous 
waste sites. Both process and impact/outcome measures will be included 
in the evaluation.

F. Other ATSDR Activities

    1. Initiate and conduct review by Technical Project Team.
    2. Assist with abstraction overview for the database on each site 
for which site evaluation activities have been conducted.
    3. Assist with recipient's review and preparation of written 
comments on EPA's draft Remedial Investigation/Feasibility Study (RI/
FS), RI/FS workplans, and Records of Decision, and site-specific 
documents of the State's environmental department.

4. Workshops

    a. Assist recipient with participation in local, State, and Federal 
health and environmental workshops and community meetings to discuss 
and respond to questions concerning a particular site's impact on 
public health.
    b. Initiate and conduct ATSDR-scheduled training classes or 
workshops to increase recipients knowledge and skills in environmental 
public health.
    5. Assist recipient with ATSDR's requests concerning congressional 
inquiries/testimonies, program evaluation, or other information in 
carrying out the purpose of the project.

Evaluation Criteria

    The proposed program, whether made up of Core Activities or Core 
Activities and Optional Activities, will account for a total of 70% of 
the score from the evaluation criteria. Applications will be reviewed 
and evaluated according to the following criteria:

A. Applications for Core Activities Only

1. Proposed Program--70%
    Applicant's ability to address the following:
    a. Ability to respond to specific public health issues that occur 
as a result of actual or potential human exposure to a hazardous 
substance including methods to evaluate and analyze toxicological, 
community, and environmental health data; and to conduct and analyze 
data from exposure investigations.
    b. Description of involvement with communities in response to 
concern about a particular site's impact on public health. Ability to 
develop and provide preventive health education in a timely fashion in 
response to public health issues including appropriateness and 
thoroughness of the methods used to evaluate preventive health 
education; and the extent to which evaluation plan includes measures of 
program outcome (i.e., effect of participant's knowledge, attitudes, 
skills, behaviors, exposure to hazardous substances).
2. Program Personnel--15%
    The extent to which the proposal has described or provided 
biographical data on the:
    a. Manner in which an integrated ``core'' team will be developed to 
address components of this program. A consistent core team is vital to 
this effort. ATSDR recommends that the team consist of, at minimum, 1-2 
FTE health assessors and 1-2 FTE health educators/community involvement 
specialists for core activities, and 1 FTE epidemiologist or health 
scientist for Optional Activities.
    b. Appropriate qualifications, experience, leadership ability, and 
percentage of time project director (or principle investigator) will 
commit to the project.
    c. Appropriate qualifications, experience, and description of how 
staff will be utilized in relation to the activities to be performed to 
accomplish the work and their percentage of time to be spent on the 
project; CVs should be provided.
    d. Ability of recipient to adhere to ``Third Party Agreements'' 
under ``Other Requirements'' of this announcement if contractors are 
proposed.
3. Capability--15%
    Description of the applicant's capability to carry out the proposed 
project and suitability of facilities and equipment available or to be 
purchased for the project.
4. Program Budget--(not scored)
    The extent to which the budget relates directly to project 
activities, is clearly justified, and is consistent with intended use 
of funds. The budget should include funds for one health assessor, one 
health educator, and one epidemiologist or health scientist to attend 
the annual training meeting in Atlanta (five days).
5. Human subjects--(not scored)
    Whether or not exempt from the DHHS regulations, are procedures 
adequate for the protection of human subjects?
    Recommendations on the adequacy of protections include: (1) 
Protections appear adequate and there are no comments to make or 
concerns to raise, or (2) protections appear adequate, but there are 
comments regarding the protocol, or (3) protections appear inadequate 
and the Objective Review Group (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.
6. Continuation Awards
    Continuation awards within the project period will be made on the 
basis of the following criteria:
    a. Satisfactory progress has been made in meeting project 
objectives;
    b. Objectives for the new budget period are realistic, specific, 
and measurable;
    c. Proposed changes in described methods of operation, need for 
financial support, and/or evaluation procedures will lead to 
achievement of project objectives; and
    d. The budget request is clearly justified and consistent with the 
intended use of cooperative agreement funds.

B. Applications for Core Plus Optional Activities

1. Proposed Program--70%
    Applicant's ability to address the following:
    a. Ability to respond to specific public health issues that occur 
as a result of actual or potential human exposure to a hazardous 
substance including methods to evaluate and analyze toxicological, 
community, and environmental health data; and to conduct and analyze 
data from exposure investigations.
    b. Description of involvement with communities in response to 
concern about a particular site's impact on public health. Ability to 
develop and provide preventive health education in a timely fashion in 
response to public health issues including appropriateness and 
thoroughness of the methods used to evaluate preventive health 
education; and the extent to which evaluation plan

[[Page 18607]]

includes measures of program outcome (i.e., effect of participant's 
knowledge, attitudes, skills, behaviors, exposure to hazardous 
substances).
    c. An understanding of and capability to conduct human health 
studies. The application for Core and Optional activities should 
include a protocol for a human health study from those previously 
recommended by ATSDR for sites in the recipient's State for which a 
study has not commenced. Site-specific protocol will be reviewed based 
on the following: (a) the approach, feasibility, adequacy, and 
rationale of the proposed study design; (b) the technical merit of the 
proposed study, including the methods and procedures (including quality 
assurance and quality control procedures) for the proposed study; (c) 
the proposed timeline, including clearly established objectives for 
which progress toward attainment can and will be measured; and (d) the 
proposed method to disseminate the results of the study to State and 
local public health officials, community residents, and other concerned 
individuals and organizations.
2. Program Personnel--15%
    The extent to which the proposal has described or provided 
biographical data on the:
    a. Manner in which an integrated ``core'' team will be developed to 
address components of this program. A consistent core team is vital to 
this effort. ATSDR recommends that the team consist of, at minimum, 1-2 
FTE health assessors and 1-2 FTE health educators/community involvement 
specialists for core activities, and 1 FTE epidemiologist or health 
scientist for Optional Activities.
    b. Appropriate qualifications, experience, leadership ability, and 
percentage of time project director (or principle investigator) will 
commit to the project.
    c. Appropriate qualifications, experience, and description of how 
staff will be utilized in relation to the activities to be performed to 
accomplish the work and their percentage of time to be spent on the 
project; CVs should be provided.
    d. Ability of recipient to adhere to ``Third Party Agreements'' 
under ``Other Requirements'' of this announcement if contractors are 
proposed.
3. Capability--15%
    Description of the applicant's capability to carry out the proposed 
project and suitability of facilities and equipment available or to be 
purchased for the project.
4. Program Budget--(not scored)
    The extent to which the budget relates directly to project 
activities, is clearly justified, and is consistent with intended use 
of funds. The budget should include funds for one health assessor, one 
health educator, and one epidemiologist or health scientist to attend 
the annual training meeting in Atlanta (five days).
5. Human subjects--(not scored)
    Whether or not exempt from the DHHS regulations, are procedures 
adequate for the protection of human subjects?
    Recommendations on the adequacy of protections include: (1) 
Protections appear adequate and there are no comments to make or 
concerns to raise, or (2) protections appear adequate, but there are 
comments regarding the protocol, or (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.
6. Continuation Awards
    Continuation awards within the project period will be made on the 
basis of the following criteria:
    a. Satisfactory progress has been made in meeting project 
objectives;
    b. Objectives for the new budget period are realistic, specific, 
and measurable;
    c. Proposed changes in described methods of operation, need for 
financial support, and/or evaluation procedures will lead to 
achievement of project objectives; and
    d. The budget request is clearly justified and consistent with the 
intended use of cooperative agreement funds.

Funding Priorities

    Applicants must demonstrate the ability to address the activities 
described in the Program Requirements section of this announcement. 
Priority will be given for the following:
    1. Number of proposed and/or listed National Priorities List (NPL) 
sites (Federal and non-Federal) based on most current listing by EPA.
    2. Number of Comprehensive Environmental Response, Compensation, 
and Liability Information System (CERCLIS) sites (Federal and non- 
Federal) based on most current listing by EPA.
    3. Those applicants who apply for both Core Activities and Optional 
Activities in order to develop an integrated program.
    4. Geographic distribution across the entire United States.
    Interested persons are invited to comment on the proposed funding 
priority. All comments received on or before May 28, 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 receipt of applications.
    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 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 should contact their State Single 
Point of Contact (SPOC) as early as possible to alert them to the 
prospective applications and to 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., Atlanta, GA 30305, no later than 60 days after the 
application deadline date. 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 ATSDR, 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. This

[[Page 18608]]

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 numbers are 93.200, 
93.202, 93.203.

Other Requirements

A. Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act. ATSDR has developed standard multi-use interview forms 
that may be made available for use by States conducting investigations 
and/or studies under this cooperative agreement.

B. Protection of Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with Department of Health and Human Services 
Regulations (45 CFR Part 46) regarding the protection of human 
subjects. Assurances must be provided to demonstrate that the project 
will be subject to initial and continuing review by appropriate 
institutional review committees. In addition to other applicable 
committees, Indian Health Service (IHS) institutional review committees 
must also review the project if any component of IHS will be involved 
or will support the research. If any American Indian 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.

C. Cost Recovery

    CERCLA, as amended by SARA, provides for the recovery of costs 
incurred for response actions 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 would also maintain 
documentation that describes the site-specific response actions taken 
with respect to the site, e.g., contracts, work assignments, progress 
reports, and other documents that describe the work performed at a 
site. The recipient will retain the documents and records to support 
these financial transactions and documentation of work performed, 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 
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.

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 
recipient 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 terms of the grant and/or 
cooperative agreement, including requirements concerning technical 
review (ATSDR selected reviewers), 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 non-conflict of interest concerning activities conducted 
for ATSDR and site-remediation activities for other parties.
    The written agreement required shall not relieve the recipient of 
any part of its responsibility or accountability to PHS under the 
cooperative agreement. The agreement shall, therefore, retain 
sufficient rights and control to the recipient to enable it to fulfill 
this responsibility and accountability.

E. 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.

Application Submission and Deadline

    The original and two copies of application PHS Form 5161-1 (OMB 
Number 0937-0189) should 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, Mailstop E13, Atlanta, GA 30305, on or 
before June 14, 1996. (By formal agreement, the CDC Procurement and 
Grants Office will act for and on behalf of ATSDR on this matter.)
    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. 1. or 2. 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 607. You will receive a complete program 
description, information on application procedures

[[Page 18609]]

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- 6630, or INTERNET address, 
<a href="/cdn-cgi/l/email-protection#741917074d341b04075a04131b455a11195a1710175a131b02"><span class="__cf_email__" data-cfemail="b0ddd3c389f0dfc0c39ec0d7df819ed5dd9ed3d4d39ed7dfc6">[email protected]</span></a>.
    Programmatic technical assistance may be obtained from Sharon 
Campolucci, Deputy Director, Division of Health Studies, Agency for 
Toxic Substances and Disease Registry, 1600 Clifton Road, NE., Mailstop 
E-31, Atlanta, GA 30333, telephone (404) 639-6200, or INTERNET address, 
<a href="/cdn-cgi/l/email-protection#473434247607263334232f347569222a6924232469202831"><span class="__cf_email__" data-cfemail="562525356716372225323e256478333b7835323578313920">[email protected]</span></a>.

Please Refer to Announcement Number 607 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 the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800.

    Dated: April 22, 1996.
Claire V. Broome,
Deputy Administrator, Agency for Toxic Substances and Disease Registry.
[FR Doc. 96-10362 Filed 4-25-96; 8:45 am]
BILLING CODE 4163-70-P

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