[Federal Register Volume 67, Number 116 (Monday, June 17, 2002)]
[Notices]
[Pages 41236-41239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15152]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[Program Announcement 02133]
Program for Research and Development of Methods for the Joint
Toxicity Assessment of Environmental Mixtures; Notice of Availability
of Funds
A. Purpose
The Agency for Toxic Substances and Disease Registry (ATSDR)
announces the availability of fiscal year (FY) 2002 funds for a
cooperative agreement program for Research and Development of Methods
for the Joint Toxicity Assessment of Mixtures. This program addresses
the ``Healthy People 2010'' Environmental Health focus area.
The purpose of the program is to conduct research and develop
methods for the assessment of health effects of environmental chemical
mixtures that can impact human health.
Measurable outcomes of the program will be in alignment with the
following performance goal for ATSDR: Evaluate relationships between
hazardous substances in the environment and adverse human health
outcomes.
[[Page 41237]]
B. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized in Sections 104(i)(5)(A) and (15) of the
Comprehensive Environmental Response, Compensation, and Liability Act
of 1980 (CERCLA), as amended by the Superfund Amendments and
Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)(5)(A) and (15)];
and section 106, subsection 118(e) of the Great Lakes Critical Programs
Act of 1990 [33 U.S.C. 1268(e)]. The Catalog of Federal Domestic
Assistance number is 93.161.
C. Eligible Applicants
Assistance will be provided only to the health departments of
states or their bona fide agents, and additionally the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the
Commonwealth of Northern Mariana Islands, American Samoa, Guam, the
Federal States of Micronesia, 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 affirmatively establish that they
meet their respective State's legislative definitions of State entity
or political subdivision to be considered as an eligible applicant.
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant or loan.
D. Availability of Funds
Approximately $350,000 is available in FY 2002 to fund three to
four awards. It is expected that the average award will be $100,000,
ranging from $75,000 to $200,000. It is expected that the awards will
begin on September 1, 2002, and will be made for a 12-month budget
period within a project period of five years. Funding estimates may
change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by the required
reports and availability of funds.
Use of Funds
Funds may be expended for reasonable program purposes, such as
personnel, travel, supplies and services. Funds for contractual
services may be requested; however, the grantee, as the direct and
primary recipient of ATSDR grant funds, must perform a substantive role
in carrying out project activities and not merely serve as a conduit
for an award to another party or provide funds to an ineligible party.
Equipment may be purchased with grant funds. However, the equipment
proposed should be appropriate and reasonable for the research activity
to be conducted. Equipment may be acquired only when authorized, and
the application should provide a justification of need to acquire
equipment, the description, and the cost of purchase versus lease. To
the greatest extent practicable, all equipment and products purchased
with CDC/ATSDR funds should be American made. ATSDR retains the right
to request return of all equipment purchased (in operable condition)
with grant funds at the conclusion of the project period.
E. Program Requirements
In conducting activities to achieve the objectives of this program,
the recipient will be responsible for the activities listed under 1.
Recipient Activities, and ATSDR will be responsible for conducting
activities listed under 2. CDC Activities.
1. Recipient Activities
a. To conduct research to investigate the toxicity of chemical
mixtures found in the environment through one or more of the following
activities: evaluate the potential toxicity of chemical mixtures to
human populations; identify relevant endpoints of toxicity common to
chemical mixtures; evaluate pharmacokinetic interactions of chemical
mixtures in biological systems; explore the role of toxicogenomics in
deciphering interaction mechanisms; combine the knowledge gained
through experimental work into the development of biologically based
models; apply biologically based models to estimate and predict low-
level interaction threshold effects; and develop methods for
assessments of multiple health effects.
b. Establish and maintain a research plan and system for collecting
information.
c. Share current information, and communicate opinions and research
findings through reports and other means.
d. Participate in planning workshops or symposia to exchange
current information, opinions, and research finding on mixtures.
2. ATSDR Activities
a. Provide consultative, administrative and technical assistance,
as needed, in the development of the program of research activities for
the enhancement of identified disciplinary areas.
b. Collaborate with the recipient in the establishment of a
research plan and system for collecting data and developing periodic
reports on activity.
c. Collaborate in analysis of data, assistance in interpretation of
results, and further synthesis of conclusions so as to effectively
communicate with partners and other interested parties.
d. Assist the recipient in writing and presenting publications
including abstracts and journal articles.
e. Develop briefing materials for agency officials involved in
public hearings.
f. Participate and collaborate with the applicant in planning
workshops or symposia to exchange current information, opinions, and
research findings on mixtures.
F. Application Content
Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. Your application will be evaluated on the criteria
listed, so it is important to follow them in laying out your program
plan. The narrative should be no more than 25 double-spaced pages,
printed on one side, with one inch margins, and unreduced font.
Although this program does not require in-kind support or matching
funds, the applicant should describe any in-kind support in the
application. For example, if the in-kind support includes personnel,
the applicant should provide the qualifying experience of the personnel
and clearly state the type of activity to be performed.
The application pages must be clearly numbered, and a complete
index to the application and its appendices must be included. The
original and each copy of the application must be submitted unstapled
and unbound.
G. Submission and Deadline
Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are available at the following Internet address:
www.cdc.gov/od/pgo/forminfo.htm.
The application must be received on or before 5:00 P.M. Eastern
Time on July 22, 2002. Submit the application to: Technical Information
Management--PA 02133, Acquisition and Assistance Branch B, Procurement
and Grants Office, Centers for Disease Control and Prevention, 2920
Brandywine Road, Room 3000, Atlanta, GA 30341-4146.
Deadline: Applications shall be considered as meeting the deadline
if
[[Page 41238]]
they are received before 5:00 P.M. Eastern Time on the deadline date.
Applicants sending applications by the United States Postal Service or
commercial delivery services must ensure that the carrier will be able
to guarantee delivery of application by the closing date and time. If
an application is received after the closing date due to (1) carrier
error, when the carrier accepted the package with a guarantee of
delivery by the closing date and time, or (2) significant weather
delays or natural disasters, CDC will--upon receipt of proper
documentation--consider the application as having been received by the
deadline. Applications which do not meet the above criteria will not be
eligible for competition and will be discarded. Applicants will be
notified of their failure to meet submission requirements.
H. Evaluation Criteria
Applicants are required to provide measures of effectiveness that
will demonstrate the accomplishment of various identified objectives of
the cooperative agreement. Measures of effectiveness must relate to the
performance goal stated in section ``A. Purpose'' of this announcement.
Measures must be objective and quantitative and must measure intended
outcome. These measures of effectiveness shall be submitted with the
application and shall be an element of evaluation.
Each applicant will be evaluated individually against the following
criteria by an independent review group appointed by ATSDR:
1. Appropriateness and Knowledge of Study Design (25 points)
The extent to which the applicant's proposal addresses: (a)
rationale for the proposed study design; (b) a plan for exposure
assessment and/or a plan for evaluating adverse health outcomes; and
(c) a detailed plan for analysis of the data.
2. Proposed Study (25 points)
The adequacy of the proposal relevant to: (a) The study purpose,
objectives, and rationale; (b) the quality of program objectives in
terms of specificity, measurability, and feasibility; (c) the
specificity and feasibility of the applicant's timetable for
implementing program activities and timely completion of the study; and
(d) the likelihood of the applicant completing proposed program
activities and attaining proposed objectives based on the thoroughness
and clarity of the overall program.
3. Relationship to Initiative (15 points)
The extent to which the application addresses the areas of
investigation outlined by ATSDR.
4. Quality of Data Collection (15 points)
The extent to which: (a) the laboratory tests (if applicable) are
sensitive and specific for the chemical or disease outcome of interest
and (b) the quality control, quality assurance, precision and accuracy
of information for the proposed tests are provided and acceptable.
5. Applicant Capability and Coordination Efforts (10 points)
The extent to which the proposal has described: (a) the capability
of the applicant's administrative structure to foster successful
scientific and administrative management of a study and (b) the
suitability of facilities and equipment available.
6. Program Personnel (10 points)
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 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, health scientist or principal
investigator to attend annual training meetings in Atlanta (five days).
8. Human Subjects (Not Scored)
Whether or not exempt from the DHHS regulations, are procedures
adequate for the protection of human subjects? Does the application
adequately address the requirements of Title 45 CFR part 46 for the
protection of human subjects?
I. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of:
1. Semi-annual progress report which should include:
a. A brief program description.
b. A listing of program goals and objectives accompanied by a
comparison of actual accomplishments related to the goals and
objectives for the period.
c. If established goals and objectives to be accomplished were
delayed, describe both the reason for the deviation and anticipated
corrective action or deletion of the activity from the project.
d. Other pertinent information, including the status of the
program.
e. Measures of effectiveness data requirement to be submitted with,
or incorporated into the semi-annual progress reports.
f. Financial recap of obligated dollars to date as a percentage of
total available funds.
2. Financial Status Report (FSR), no more than 90 days after the
end of the budget period.
3. Final FSR and performance reports, no more than 90 days after
the end of the project period.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
The following additional requirements are applicable to this
program:
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-3 Animal Subjects Requirements
AR-7 Executive Order 12372 Review
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobby Restrictions
AR-17 Peer and Technical Reviews of Final Reports of Health Studies--
ATSDR
AR-18 Cost Recovery--ATSDR
AR-19 Third Party Agreements--ATSDR
J. Where To Obtain Additional Information
This and other ATSDR announcements can be found on the CDC home
page Internet address--http://www.cdc.gov. Click on ``Funding'' then
``Grants and Cooperative Agreements.''
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from: Edna Green, Grants Management Specialist, Acquisition and
Assistance Branch B, Procurement and Grants Office, Centers for Disease
Control and Prevention, Announcement 02133, Room 3000, 2920 Brandywine
Road, Atlanta, GA 30341-4146, Telephone (770) 488-2743, E-mail address:
[email protected].
For program technical assistance, contact(s): Dr. Moiz Mumtaz,
Division of Toxicology, 1600 Clifton Road, N.E., Mail Stop E-29,
Atlanta, Georgia 30333, Telephone (404) 498-0727, E-mail address:
[email protected].
[[Page 41239]]
Dated: June 11, 2002.
Sandra Manning,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 02-15152 Filed 6-14-02; 8:45 am]
BILLING CODE 4163-70-P