[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.

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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