[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