[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 phs3@cdc.gov.
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 may1@cdc.gov.
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
