[Federal Register Volume 66, Number 124 (Wednesday, June 27, 2001)]
[Notices]
[Pages 34203-34204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16043]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[Program Announcement 01165]
Thimerosal Pharmacokinetics: Assessment of the Distribution,
Metabolism and Excretion; Notice of Availability of Funds
A. Purpose
The Agency for Toxic Substances and Disease Registry (ATSDR)
announces the availability of fiscal year (FY) 2001 funds for a grant
program for Thimerosal Studies as part of the applied research program.
This program addresses the ``Healthy People 2010'' focus area(s) of
Environmental Health.
The purpose of this program is to define and characterize the
appropriate pharmacokinetics of both methyl mercury and thimerosal
distribution, metabolism, and elimination that are needed to accurately
characterize the comparative neurotoxicity of these substances and
develop recommendations for future extrapolation of these results to
possible human exposure scenarios.
B. Eligible Applicants
Applications may be submitted by official public health agencies of
the States, or their bonafide agents. This includes the District of
Columbia, American Samoa, Guam, the Commonwealth of Puerto Rico, the
Commonwealth of the Northern Mariana Islands, the Federated States of
Micronesia, the Virgin Islands, the Federated States of Marshall
Island, the Republic of Palau, federally-recognized Indian tribal
governments, public and private non-profit universities and colleges.
C. Availability of Funds
Approximately $130,000 is available in FY 2001 to fund one award.
It is expected that the award will begin on or about September 30,
2001, and will be made for a 12-month budget period within a project
period of one year. Funding estimates may change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required reports
and the 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. Property may be acquired only when authorized in the
grant. The grantee, as part of the application process, should provide
a justification of need to acquire property, the description, and the
cost of purchase versus lease. At the completion of the project, the
equipment must be returned to ATSDR.
D. Program Requirements
The objectives of this program are to conduct research studies to
achieve the following: (1) Animal Model and Dose Selection studies
including literature search, determine appropriate in vitro tests,
animal model and doses; (2) Thimerosal cleavage kinetics including
investigating in vitro (serum or blood) reaction, determine the role of
liver in metabolism of thimerosal; (3) Model dependent kinetic
parameters including tissue partition coefficients of thimerosal and
ethyl mercury, time course studies for levels of thimerosal and ethyl
mercury in blood, brain, fat, liver and muscle; (4) Model development
and analysis including development of a pharmacokinetic model for
thimerosal; and (5) Develop recommendations for extrapolating these
results to human exposure scenarios.
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the following activities:
1. Identification and description of specific parameters that are
necessary to accurately characterize the distribution, metabolism, and
elimination associated with methyl mercury toxicity;
2. Identification and characterization of the metabolic pathways
and sequences associated with conversion of thimerosal to the toxic
inorganic mercury species (Hg++);
3. Characterization of tissue levels and time-course for
thimerosal, ethyl mercury, and Hg++ following parenteral
exposure to thimerosal; and
4. Publish the findings and results as journal article(s).
E. 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.
F. Submission and Deadline
Submit the original and five copies of PHS 398 (OMB Number 0937-
0189) on or before August 15, 2001. Submit the application to the
Grants Management Specialist identified in the ``Where to Obtain
Additional Information'' section of this announcement.
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 independent 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.)
Late Applications: Applications which do not meet the criteria in
1. or 2. above are considered late applications, will not be
considered, and will be returned to the applicant.
[[Page 34204]]
G. Evaluation Criteria
Each application will be evaluated individually against the
following criteria by an independent review group appointed by ATSDR:
1. Proposed Research--50 percent
The extent to which the applicant's project addresses:
a. The scientific merit of the hypothesis of the proposed project,
including the originality of the approach and the feasibility,
adequacy, and rationale of the design (the design of the study should
ensure statistical validity for comparison with other research
projects)(25 percent);
b. The technical merit of the methods and procedures (analytic
procedures should be state of the art), 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 (15
percent);
c. The proposed project schedule, including clearly established
obtainable project objectives for which progress toward attainment can
and will be measured including plans for publishing research results in
peer reviewed journals (10 percent); and
2. Program Personnel--45 percent
Because of the importance and potential impact of the outcome of
this project on a number of public health programs:
a. The Principal Investigator must be a recognized expert on organic
and inorganic mercury (20 percent); and
b. The Principal Investigator must have experience, validated by
publication, in working with Thimerosal (10 percent); and
c. Commitment and ability of the Principal Investigator and his/her
Associates to devote adequate time and effort to provide effective
leadership (15 percent).
3. Institutional Resources and Commitment--5 percent
Description of the adequacy and commitment of the institutional
resources to administer the program and the adequacy of the facilities
as they impact on performance of the proposed study.
4. Program Budget--(NOT SCORED)
The extent to which the budget is reasonable, clearly justified,
and consistent with intended use of grant funds.
5. Human Subjects--(NOT SCORED)
Does the application adequately address the requirements of Title
45 CFR Part 46 for the protection of human subjects?
H. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of
1. annual progress reports;
2. financial status report, no more than 90 days after the end of the
budget period; and
3. final financial 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. For a complete description of each, see Attachment I in the
application kit.
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
AR-22 Research Integrity
I. 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.
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.''
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 the
documents, business management technical assistance may be obtained
from: Ms. Nelda Godfrey, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention, Room 3000, 2920 Brandywine Road, Atlanta, GA
30341-4146, Telephone number: 770-488-2722, Email address:
[email protected].
For program technical assistance, contact(s): Dr. Dennis Jones,
Division of Toxicology, ATSDR, 1600 Clifton Road, N.E., Mail Stop E-29,
Atlanta, Georgia 30333, Telephone number: 404-498-0160, Email address:
[email protected] or Dr. Moiz Mumtaz, Division of Toxicology, 1600 Clifton
Road, N.E., Mail Stop E-29, Atlanta, Georgia 30333, Telephone number:
404-498-0727, Email address: [email protected].
Dated: June 20, 2001.
Georgi Jones,
Director, Office of Policy and External Affairs, Agency for Toxic
Substances and Disease Registry.
[FR Doc. 01-16043 Filed 6-26-01; 8:45 am]
BILLING CODE 4163-70-P