[Federal Register Volume 63, Number 105 (Tuesday, June 2, 1998)]
[Notices]
[Pages 29998-30001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14464]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 98049]
National Institute for Occupational Safety and Health; Evaluation
Of Toxicologic Risk Assessment Models Using Epidemiology Data Notice of
Availability of Funds for Fiscal Year 1998
Introduction
The Centers for Disease Control and Prevention (CDC), the nation's
prevention agency, announces the availability of fiscal year (FY) 1998
funds for a cooperative agreement program to evaluate the toxicologic
risk assessment models using epidemiology data.
CDC is committed to achieving the health promotion and disease
prevention objectives of Healthy People 2000, a national activity to
reduce morbidity and mortality and improve the quality of life. This
announcement is related to the priority area of Occupational Safety and
Health. (For ordering a copy of Healthy People 2000, see the section
WHERE TO OBTAIN ADDITIONAL INFORMATION.)
CDC, NIOSH is committed to the program priorities developed by the
National Occupational Research Agenda (NORA). For ordering a copy of
the NORA, see the section WHERE TO OBTAIN ADDITIONAL INFORMATION.)
Authority
This program is authorized under Sections 20(a) and 22(e)(7) of the
Occupational Safety and Health Act of 1970 [29 U.S.C. 669(a) and
671(e)(7)].
Smoke-Free Workplace
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products, and
Pub. L. 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities that receive Federal funds in which education,
library, day care, health care, and early childhood development
services are provided to children.
Eligible Applicants
Applications may be submitted by public and private, nonprofit and
for-profit organizations and governments and their agencies. Thus,
universities, colleges, research institutions, hospitals, other public
and private organizations, State and local governments or their bona
fide agents, federally recognized Indian tribal governments, Indian
tribes or Indian tribal organizations, and small, minority- and/or
woman-owned businesses are eligible to apply.
Note: An organization described in section 501(c)(4) of the
Internal Revenue Code of 1986 which engages in lobbying activities
shall not be eligible to receive Federal funds constituting an
award, grant, contract, loan, or any other form of funding.
Availability of Funds
Approximately $106,000 is available in FY 1998 to fund one award.
The award will be made for a 12-month budget period within a project
period of up to three years. The amount of funding available may vary
and is subject to change. The award is expected to begin on or about
September 30, 1998. Continuation awards within the project period will
be made on the basis of satisfactory progress and availability of
funds.
Use of Funds
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of HHS funds
for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. Section 1352 (which has been in effect since
December 23, 1989), recipients (and their subtier contractors) are
prohibited from using appropriated Federal funds (other than profits
from a Federal contract) for lobbying Congress or any Federal agency in
connection with the award of a particular contract, grant, cooperative
agreement, or loan. This includes grants/cooperative agreements that,
in whole or in part, involve conferences for which Federal funds cannot
be used directly or indirectly to encourage participants to lobby or to
instruct participants on how to lobby.
In addition, the FY 1998 Department of Labor, Health and Human
Services, and Education, and Related Agencies Appropriations Act (Pub.
L. 105-78) states in Section 503(a) and (b) that no part of any
appropriation contained in this Act shall be used, other than for
normal and recognized executive-legislative relationships, for
publicity or propaganda purposes, for the preparation, distribution, or
use of any kit, pamphlet, booklet, publication, radio, television, or
video presentation designed to support or defeat legislation pending
before the Congress or any State legislature, except in presentation to
the Congress or any State legislature itself. No part of any
appropriation contained in this Act shall be used to pay the salary or
expenses of any grant or contract recipient, or agent acting for such
recipient, related to any activity designed to influence legislation or
appropriations pending before the Congress or any State legislature.
Background
Research on risk assessment methodology is one of the NORA priority
areas. Quantitative risk assessment has become a requirement for the
development of NIOSH recommended exposure limits and ultimately
Occupational Safety and Health Administration and Mining Safety and
Health Administration regulations. Animal bioassays have provided the
scientific basis for most risk assessment models. The validity of
[[Page 29999]]
using animal bioassay data for predicting human risks has been
increasingly under attack. Despite these concerns, toxicologic data is
expected to remain a vitally important resource for risk assessment and
risk management decisions. There is a clear need to gain a better
understanding of when toxicologic data provide valid estimates of human
risk and when they do not.
Epidemiologic studies that have information on exposures have been
used by a few authors in an attempt to make comparisons with risk
predictions from animal based models for cancer. However, these
validation exercises have not been performed in a thorough and
systematic fashion and questions have been raised about the
appropriateness of the methods that have been used for these analyses.
Furthermore, the evaluations that have been performed to date have been
solely concerned with cancer and there has been virtually no research
on the concordance between animal bioassay data and epidemiologic data
for non-carcinogenic hazards. See the section WHERE TO OBTAIN
ADDITIONAL INFORMATION for reference materials.
Purpose
The purpose of this program is to provide information on the
validity and precision of risk estimates derived from risk assessment
models based on toxicologic data for predicting human risk from
occupational exposures in the workplace. This information will be
useful to regulators and policy makers who frequently need to base
decisions on setting safe levels of exposures in the workplace on
animal bioassay data, since adequate human data is not available.
The major objective of this program is to develop and apply methods
for evaluating the predictions from toxicologic risk assessment models
for human risk using epidemiologic data. Some of the fundamental
questions that may be addressed by this research would be:
How good is the concordance between the risk predictions
from exposure-response relationships observed in toxicologic and
epidemiologic studies for cancer and non-cancer health effects?
How does the degree of concordance vary for different
cancer sites and non-carcinogenic health hazards?
What factors influence the discordance between toxicologic
and epidemiologic model predictions?
Are the risk estimates developed from toxicologic models
generally over or underestimates of the risk observed in epidemiologic
studies?
How may the pattern of exposures used in the toxicologic
studies (lifetime) versus those experienced by workers in the
epidemiologic studies (intermittent) influence the risk comparisons?
Are there ways of adjusting the predictions from
toxicologic models to more accurately predict human risks?
Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for activities under A. (Recipient
Activities), and CDC/NIOSH will be responsible for the activities
listed under B. (CDC/NIOSH Activities).
A. Recipient Activities
The recipient will have primary responsibility for:
1. The identification of appropriate data resources,
2. Design of the study,
3. Management of the data,
4. Statistical analysis of the data, and
5. Prepare a report summarizing the study methodology, results
obtained, and conclusions reached. Develop recommendations. Report
study results to the scientific community.
B. CDC/NIOSH Activities
1. Provide scientific and technical collaboration for the
successful completion of this project.
2. Identify linkages with researchers and public and private sector
agencies and organizations to provide data.
3. Collaborate with the recipient in safety and health
communication and dissemination efforts of prevention information.
4. Cooperate in preparation and publication of the written reports.
Technical Reporting Requirements
An original and two copies of annual progress reports are required.
Timelines for the annual reports will be established at the time of
award. Final financial status and performance reports are required no
later than 90 days after the end of the project period. All reports are
submitted to the Grants Management Branch, Procurement and Grants
Office, CDC.
Annual progress report should include:
A. A brief program description.
B. A listing of program goals and objectives accompanied by a
comparison of the actual accomplishments related to the goals and
objectives established 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
completeness, timeliness and quality of data.
Application Content
The entire application, including appendices, should not exceed 40
pages and the Proposal Narrative section contained therein should not
exceed 25 pages. Pages should be clearly numbered and a complete index
to the application and any appendices included. The original and each
copy of the application must be submitted unstapled and unbound. All
materials must be typewritten, double-spaced, with unreduced type (font
size 12 point) on 8\1/2\'' by 11'' paper, with at least 1'' margins,
headers, and footers, and printed on one side only. Do not include any
spiral or bound materials or pamphlets.
A. Title Page
The heading should include the title of grant program, project
title, organization, name and address, project director's name, address
and telephone number.
B. Abstract
A one page, singled-spaced, typed abstract must be submitted with
the application. The heading should include the title of grant program,
project title, organization, name and address, project director and
telephone number. This abstract should include a work plan identifying
activities to be developed, activities to be completed, and a time-line
for completion of these activities.
C. Proposal Narrative
The narrative of each application must:
1. Briefly state the applicant's understanding of the need or
problem to be addressed, the purpose, and goals over the 3 year period
of this project.
2. Describe in detail the objectives and the methods to be used to
achieve the objectives of the project. The objectives should be
specific, time-phased, measurable, and achievable during each budget
period. The objectives should directly relate to the program goals.
Identify the steps to be taken in planning and implementing the
objectives and the responsibilities of the applicant for carrying out
the steps.
3. Provide the name, qualifications, and proposed time allocation
of the Project Director who will be responsible for administering the
project. Describe
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staff, experience, facilities, equipment available for performance of
this project, and other resources that define the applicant's capacity
or potential to accomplish the requirements stated above. List the
names (if known), qualifications, and time allocations of the existing
professional staff to be assigned to (or recruited for) this project,
the support staff available for performance of this project, and the
available facilities including space.
4. Document the applicant's expertise, and extent of involvement in
the areas of risk assessment, epidemiology and toxicology.
5. Provide letters of support or other documentation demonstrating
collaboration of the applicant's ability to work with diverse groups,
establish linkages, and facilitate awareness information.
D. Budget
Provide a detailed budget which indicates anticipated costs for
personnel, equipment, travel, communications, supplies, postage, and
the sources of funds to meet these needs. The applicant should be
precise about the program purpose of each budget item. For contracts
described within the application budget, applicants should name the
contractor, if known; describe the services to be performed; and
provide an itemized breakdown and justification for the estimated costs
of the contract; the kinds of organizations or parties to be selected;
the period of performance; and the method of selection. Do not put
these pages in the body of the application. CDC may not approve or fund
all proposed activities.
Evaluation Criteria
The application will be reviewed and evaluated according to the
following criteria:
A. Understanding of the Problem (20%)
Responsiveness including: (a) applicant's understanding of the
objectives; and (b) evidence of ability to design an effective
evaluation study.
B. Experience (20%)
The extent to which the applicant's prior work and experience in
risk assessment, epidemiology and toxicology issues is documented.
Actual experience in evaluating toxicologic risk assessment models
using epidemiologic data would be extremely helpful.
C. Goals, Objectives and Methods (25%)
The extent to which the proposed goals and objectives are clearly
stated, time-phased, and measurable. The extent to which the methods
are sufficiently detailed to allow assessment of whether the objectives
can be achieved for the budget period. Clearly state the evaluation
method for evaluating the accomplishments. The extent to which a
qualified plan is proposed that will help achieve the goals stated in
the proposal.
D. Facilities and Resources (10%)
The adequacy of the applicant's facilities, equipment, and other
resources available for performance of this project.
E. Project Management and Staffing Plan (15%)
The extent to which the management staff and their working partners
are clearly described, appropriately assigned, and have pertinent
skills and experiences. The extent to which the applicant proposes to
involve appropriate personnel who have the needed qualifications to
implement the proposed plan. The extent to which the applicant has the
capacity to design, implement, and evaluate the proposed intervention
program.
F. Collaboration (10%)
The extent to which all partners are clearly described and their
qualifications and the extent to which their intentions to participate
are explicitly stated. The extent to which the applicant provides proof
of support (e.g., letters of support and/or memoranda of understanding)
for proposed activities. Evidence or a statement should be provided
that these funds do not duplicate already funded components of ongoing
projects.
G. Budget Justification (Not Scored)
The budget will be evaluated to the extent that it is reasonable,
clearly justified, and consistent with the intended use of funds.
Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets
up a system for State and local government review of proposed Federal
assistance applications. Applicants should contact their State Single
Point of Contact (SPOC) as early as possible to alert them to the
prospective applications and receive any necessary instructions on the
State process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each affected State. A
current list of SPOCs is included in the application kit. If SPOCs have
any State process recommendations on applications submitted to CDC,
they should be sent to Victoria Sepe, Grants Management Specialist,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,
Mailstop E-13, Room 321, Atlanta, GA 30305, no later than 60 days after
the application deadline date. The Program Announcement Number 98049
and Program Title, Evaluation of Toxicologic Risk Assessment Models
Using Epidemiology Data, should be referenced on the document. The
granting agency does not guarantee to ``accommodate or explain'' State
process recommendations it receives after that date.
Public Health System Reporting Requirements
The applicant is not subject to review under the Public Health
System Reporting Requirements.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.262.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from ten or
more individuals and funded by this cooperative agreement will be
subject to review and approval by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act.
Application Submission and Deadlines
A. Preapplication Letter of Intent
Although not a prerequisite of application, a non-binding letter of
intent-to-apply is requested from potential applicants. The letter
should be submitted to Victoria F. Sepe, Grants Management Specialist,
Grants Management Branch, Procurement and Grants Office, CDC at the
address listed in this section. It should be postmarked no later than
June 17, 1998. The letter should identify program announcement number
98049, and name of the principal investigator. The letter of intent
does not influence review or funding decisions, but it will enable CDC
to plan the review more efficiently and will ensure that each applicant
receives timely and relevant information prior to application
submission.
B. Application
The original and five copies of the application PHS Form 398
(Revised 5/95, OMB Number 0925-0001) must be submitted to Victoria
Sepe, Grants
[[Page 30001]]
Management Specialist, Grants Management Branch, Procurement and Grants
Office, Centers for Disease Control and Prevention (CDC), 255 East
Paces Ferry Road, NE, Room 321, Atlanta, GA 30305, on or before July
15, 1998.
1. Deadline: Applications will be considered as meeting the
deadline if they are either:
(a) Received on or before the deadline date, or
(b) Sent on or before the deadline date and received in time for
submission to the objective review group. (The applicants must request
a legibly dated U.S. Postal Service postmark or obtain a receipt from a
commercial carrier or the U.S. Postal Service. Private metered
postmarks will not be acceptable as proof of timely mailing.)
2. Late Applicants: Applications that do not meet the criteria in
1.(a) or 1.(b) above are considered late applications. Late
applications will not be considered in the current competition and will
be returned to the applicants.
Where to Obtain Additional Information
To receive additional written information call 1-888-GRANTS4. You
will be asked to leave your name, address, and phone number and will
need to refer to NIOSH Announcement 98049. You will receive a complete
program description, information on application procedures, and
application forms. CDC will not send application kits by facsimile or
express mail. Please refer to NIOSH announcement 98049 when requesting
information and submitting an application.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Victoria Sepe, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), Mailstop E-13, Room 321, 255 East Paces Ferry Road,
NE., Atlanta, GA 30305, telephone (404) 842-6804, Internet:
vxw1@cdc.gov.
Programmatic technical assistance may be obtained from Leslie
Stayner, Education and Information Division, National Institute for
Occupational Safety and Health, Center for Disease Control and
Prevention (CDC), 4676 Columbia Parkway, Cincinnati, OH 45226,
telephone (513) 533-8365, or Internet address: lts2@cdc.gov.
This and other CDC announcements are available through the CDC
homepage on the Internet. The address for the CDC homepage is: http://
www.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.
NORA
The National Occupational Research Agenda: copies of this
publication may be obtained from The National Institute of Occupational
Safety and Health, Publications Office, 4676 Columbia Parkway,
Cincinnati, OH 45226-1998 or phone 1-800-356-4674, and is available
through the NIOSH homepage, ``http:/www.cdc.gov/niosh/nora.html''.
Reference Materials
Allen BC, Crump KS and Shipp AM (1988). Correlation between
carcinogenic potency of chemicals in animals and humans. Risk Analysis
8(4): 531-557.
Ames B.N. and Gold L.S. (1990). Chemical carcinogenesis: Too many
rodent carcinogens. Proc. Natl. Acad. Sci. 87;7772-7776.
Goodman G, and Wilson R. (1991). Quantitative predictions of human
cancer risk from rodent carcinogenic potencies: A closer look at the
epidemiological evidence for some chemicals not definitively
carcinogenic in humans. Reg Tox and Pharm, 14;118-146.
Stayner LT and Bailer AJ (1993). Comparing toxicologic and
epidemiologic studies: Methylene chloride--A case study. Risk Analysis,
13(6); 667-673.
Zeiss L. In Chemical Risk Assessment and Occupational Health
(1994). Current Applications, Limitations and Future Prospects. CM
Smith, DC Christiani and KT Kelsey eds. Auburn House, Westport, Conn.
Dated: May 26, 1998.
Diane D. Porter,
Acting Director, National Institute For Occupational Safety and Health,
Centers for Disease Control and Prevention (CDC).
[FR Doc. 98-14464 Filed 6-1-98; 8:45 am]
BILLING CODE 4163-19-P
