[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

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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: 
[email protected].
    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: [email protected].
    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