[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]
=======================================================================
-----------------------------------------------------------------------
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,
[email protected].
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,
[email protected].
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