[Federal Register Volume 63, Number 163 (Monday, August 24, 1998)]
[Notices]
[Pages 45067-45069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry
[Program Announcement 98104]


Notice of Availability of Funds; Cooperative Agreement for a 
Research Program to Study the Dermal Toxicokinetics of Methyl Parathion

A. Purpose

    The Agency for Toxic Substances and Disease Registry (ATSDR) 
announces the availability of fiscal year (FY) 1998 funds for a 
cooperative agreement, for a research program to study the dermal 
toxicokinetics of methyl parathion. This program addresses the Healthy 
People 2000 priority areas of: Environmental Health and Surveillance 
and Data Systems. Dermal exposure is the primary route of exposure in 
residential scenarios. Since November 1996,

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approximately 18,000 people (including 10,000 children) have been 
affected by the illegal spraying of methyl parathion in private 
residences in several states. In addition, methyl parathion has been 
identified at 16 National Priorities List (NPL) sites throughout the 
United States. The purpose of this program is to assess dermal 
absorption, distribution, metabolism, and excretion of methyl parathion 
in laboratory studies. The data will be important for planning, 
designing, and determining the need for future toxicology and 
epidemiology studies.

B. Eligible Applicants

    Assistance will be provided only to the health departments of 
States and their bona fide agents, including the District of Columbia, 
the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth 
of the Northern Mariana Islands, American Samoa, Guam, federally 
recognized Indian tribal governments, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau. State organizations, including State universities, State 
colleges, and State research institutions, must affirmatively establish 
that they meet their respective State's legislative definition of a 
State entity or political subdivision to be considered an eligible 
applicant.

C. Availability of Funds

    Approximately $250,000 is available in FY 1998 to fund one award. 
The award is expected to begin on or about September 30, 1998, for a 
12-month budget and project period.

D. 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 awardee, as the direct and 
primary recipient of ATSDR cooperative agreement 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. Applicant must justify the need to use a contractor. 
If contractors are proposed, the following must be provided: (1) Name 
of contractor, (2) method of selection, (3) period of performance, (4) 
detailed budget, (5) justification for use of contractor, and (6) 
assurance of non-conflict of interest.
    Equipment may be purchased with cooperative agreement funds. 
However, the equipment proposed should be appropriate and reasonable 
for the activity to be conducted. The applicant, as part of the 
application process, should provide: (1) A justification for the need 
to acquire the equipment, (2) the description of the equipment, (3) the 
intended use of the equipment, and (4) the advantages/disadvantages of 
purchase versus lease of the equipment (if applicable). Requests for 
equipment purchases will be reviewed and approved only under the 
following conditions: (1) ATSDR retains the right to request return of 
all equipment purchased (in operable condition) with cooperative 
agreement funds at the conclusion of the project period, and (2) 
equipment purchased must be compatible with ATSDR hardware. Computers 
purchased with ATSDR funds should be IBM compatible and adhere to the 
Centers for Disease Control and Prevention (CENTERS FOR DISEASE 
CONTROL) and ATSDR hardware standards.

E. Program Requirements

    ATSDR may assist and 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:
1. Recipient Activities
    The recipient will have primary responsibilities as follows:
    a. Perform a range finding study with methyl parathion to determine 
appropriate chronic doses that should be used to compare the kinetic 
parameters through various routes.
    b. Perform studies to determine the rate of absorption and specific 
concentrations reached in tissues of appropriate laboratory animals 
following dermal methyl parathion treatment.
    c. Through experimental studies in laboratory animals, measure the 
absorption, distribution, metabolism of methyl parathion over a 90-day 
period. Establish correlations between the amount of methyl parathion 
absorbed and the blood levels of p-nitrophenol, its principal 
metabolite.
    d. Through experimental studies and measurements, determine the 
transfer of methyl parathion and its metabolites across the placenta 
and determine the distribution of these compounds in the fetus.
    e. Publish results of studies in accordance with AR98-17 (attached)
2. ATSDR Activities
    ATSDR will:
    a. If needed, assist recipient or collaborate in the preparation of 
reports and briefing materials on a timely basis in effort to present 
and write publications, including abstracts and journal articles.

F. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. The application will be evaluated on the criteria 
listed, so it is important to follow them in laying out the program 
plan. The application must include a 200 word or less abstract of the 
proposal. 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 Application

    Submit the original and five copies of PHS 398 (OMB Number 0925-
0001)(adhere to the instructions on the Erata Instruction Sheet for PHS 
398). Forms are in the application kit. On or before September 23, 
1998, submit the application to: Patrick A. Smith, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Announcement 98104, Centers for Disease Control and Prevention (CENTERS 
FOR DISEASE CONTROL), Room 300, 255 East Paces Ferry Road, NE., MS E-
13, Atlanta, Georgia 30305-2209.
    If your application does not arrive in time for submission to the 
independent review group, it will not be considered in the current 
competition unless you can provide proof that you mailed it on or 
before the deadline (i.e., receipt from U.S. Postal Service or a 
commercial carrier; private metered postmarks are not acceptable).

H. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by ATSDR:
    Scientific and Technical Review Criteria of Applications
1. Appropriateness and Knowledge of Study Design--25 Percent
    The extent to which the applicant's proposal addresses:
    (a) rationale for the proposed study design; (b) measurement of 
actual dose

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absorbed and the documentation of accompanying toxicity; and (c) a 
detailed plan for analysis of the data.
2. Proposed Study--25 Percent
    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 Percent
    The extent to which the application addresses the areas of 
investigation.
4. Technical Merit of the Methods and Procedures--15 Percent
    The technical merit of the methods and procedures (analytic 
procedures should be state of the art, including participation in a 
quality assurance and quality control program for comparison with other 
research projects) for the proposed project, including the degree to 
which the project can be expected to yield results that meet the 
program objective as described in the PURPOSE section of this 
announcement.
5. Applicant Capability and Coordination Efforts--10 Percent
    The extent to which the proposal has described: the capability of 
the applicant's administrative structure to foster successful 
scientific and administrative management of a study and the suitability 
of facilities and equipment available.
6. Program Personnel--10 Percent
    The extent to which the proposed program staff is qualified and 
appropriate, and the time allocated for them to accomplish program 
activities is adequate.
7. Program Budget--(Not Scored)
    The extent to which the budget is reasonable, clearly justified, 
and consistent with intended use of cooperative agreement funds.

I. Other Requirements

Technical Reporting Requirements

    Provide ATSDR with original plus two copies of:
    1. Quarterly progress reports; the progress reports must report on 
progress toward addressing activities mutually agreed to by ATSDR and 
the recipient at the time of award and should include the following for 
each program, function or activity involved: (1) a comparison of actual 
accomplishments to the goals established for the period; (2) the 
reasons for slippage if established goals were not met; and (3) other 
pertinent information.
    2. Financial status report, no more than 90 days after the end of 
the budget/project period.
    Send all reports to: Patrick A. Smith, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CENTERS FOR DISEASE 
CONTROL), Room 300, 255 East Paces Ferry Road, NE., MS E-13, Atlanta, 
GA 30305-2209.
    The following additional requirements are applicable to this 
program. For a complete description of each requirement, see Attachment 
1 in the application kit.

AR98-3  Animal Subjects Requirements
AR98-9  Paperwork Reduction Act Requirements
AR98-10  Smoke-Free Workplace Requirements
AR98-11  Healthy People 2000
AR98-17  Peer and Technical Reviews of Final Reports of Health 
Studies--ATSDR
AR98-18  Cost Recovery--ATSDR
AR98-19 Third Party Agreements--ATSDR

J. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under Sections 104(i), 5(A)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)5(A) and (15)].
    The Catalog of Federal Domestic Assistance numbers are 93.200, 
93.201, 93.203.

K. Where To Obtain Additional Information

    Please refer to Announcement Number 98104 when requesting 
information and submitting an application.
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all of the 
documents, business management technical assistance may be obtained 
from: Patrick A. Smith, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CENTERS FOR DISEASE CONTROL), 255 East Paces Ferry Road, 
NE., Room 300, Mailstop E-13, Atlanta, Georgia 30305-2209, telephone 
(404) 842-6803.
    INTERNET address [email protected].
    For programmatic technical assistance contact: Mike Youson, Deputy 
Director, Division of Toxicology, Agency for Toxic Substances and 
Disease Registry (ATSDR), 1600 Clifton Road, NE., Mailstop E-29, 
Atlanta, Georgia 30333, telephone (404) 639-6300.
    INTERNET address [email protected].
    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) through the Superintendent 
of Documents, Government Printing Office, Washington, DC 20402-9325, 
telephone (202) 512-1800.
    This and other CENTERS FOR DISEASE CONTROL/ATSDR announcements are 
available through the CDC homepage on the Internet: http://www.cdc.gov.

    Dated: August 18, 1998.
Georgi Jones,
Director, Office of Policy and External Affairs, Agency for Toxic 
Substances and Disease Registry.
[FR Doc. 98-22605 Filed 8-21-98; 8:45 am]
BILLING CODE 4163-70-P