29998 Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 / Notices

Frequency: Annually.

Respondents: State Agencies on

Aging.

Estimated Number of Responses: 52.

Total Estimated Burden Hours: 9,000.

Additional Information or Comments:

The Administration on Aging is

submitting to the Office of Management

and Budget, for approval, an extension,

with no revisions, of a reporting form

and instructions for the State Annual

Long-Term Care Ombudsman Report,

pursuant to requirements in Section

712(b) and (h) of the Older Americans

Act.

The form for which extension is

requested was approved by the Office of

Management and Budget, on an

emergency basis, for use by the states in

reporting on activities in FY 1997. It is

the same form used by the states for

their FY 1996 reports, except for minor

changes made for the FY 1997

emergency request. These changes:

(1) modified the wording of some of

the complaint categories to assist

respondent in categorizing some

complaints which had previously been

placed under the ‘‘other’’ categories and

(2) Stipulated that several narrative

responses which had not changed since

the previous report do not need to be

repeated.

The reporting form is for federal fiscal

years 1998–2000. Written comments

and recommendations for the proposed

information collection should be sent

within 30 days of the publication of this

notice directly to the following address:

Ms. Allison Herron Eydt, AoA Desk

Officer, Office of Management and

Budget, 1725 17th Street, N.W., Room

10235, Washington, D.C. 20503.

Dated: May 27, 1998.

Harry Posman,

Director, Executive Secretariat and Policy

Coordination.

[FR Doc. 98–14477 Filed 6–1–98; 8:45 am]

BILLING CODE 4150–04–M

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 forprofit 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 executivelegislative 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
Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 / Notices 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 noncarcinogenic 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 81⁄2′′ 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, timephased, 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
30000 Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 / Notices

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
Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 / Notices 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Good Clinical Practices In

Investigational Product Research

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration

(FDA) (Office of Regulatory Affairs, New

Orleans District Office) is announcing

the following meeting: ‘‘Good Clinical

Practices In Investigational Product

Research.’’ The topics to be discussed

are FDA regulatory requirements for the

conduct of investigational product

research and practical issues, such as,

how to prepare for a data audit, what to

expect during an investigation, and how

to get current information from FDA.

The purpose of this meeting is to

promote and encourage open dialogue

between FDA and professionals

involved in investigational product

research: Physicians, researchers,

research coordinators, nurses, allied

health professionals, and any other

interested parties.

Date and Time: The meeting will be

held on Friday, July 17, 1998;

registration from 7:45 a.m. to 8:30 a.m.;

meeting from 8:30 a.m. to 5 p.m.

Location: The meeting will be held at

the Louisiana State University Medical

Center, Medical Education Bldg.,

Lecture Room A, 1901 Perdido, New

Orleans, LA 70112.

Contact: Rebecca A. Asente, Food and

Drug Administration, New Orleans

District Office (HFR–SE440), 4298

Elysian Fields Ave., New Orleans, LA

70122, 504–589–6344, ext. 158, FAX

504–589–6360.

Registration: Send registration

information (including name, title, firm

name, address, telephone, and fax

number) to the contact person by

Friday, July 10, 1998. There is no

registration fee for this meeting.

Attendance will be limited to the first

200 applicants, therefore, interested

parties are encouraged to register early.

Priority will be given to those

individuals located in Louisiana and

Mississippi. Individuals located outside

these States may register to attend the

meeting and will be accepted if space is

available.

If you need special accommodations

due to a disability, please contact

Rebecca A. Asente at least 7 days in

advance.

Dated: May 21, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14463 Filed 6–1–98; 8:45 am]

BILLING CODE 4160–01–F