3138 Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices

B. Applications

Applicants should use Form PHS–398

(OMB Number 0925–0001) and adhere

to the ERRATA Instruction Sheet for

Form PHS–398 contained in the Grant

Application Kit. Please submit an

original and five copies on or before

April 16, 1998 to: Ron Van Duyne,

Grants Management Officer, ATTN:

Joanne Wojcik, Grants Management

Branch, Procurement and Grants Office,

Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry

Road, NE., Room 300, MS E–13, Atlanta,

GA 30305.

C. Deadlines

1. Applications shall be considered as

meeting a deadline if they are either:

a. Received at the above address on or

before the deadline date, or

b. Sent on or before the deadline date

to the above address, and received in

time for the review process.

Applicants should request a legibly

dated U.S. Postal Service postmark or

obtain a legibly dated receipt from a

commercial carrier or the U.S. Postal

Service. Private metered postmarks shall

not be accepted as proof of timely

mailings.

2. Applications which do not meet the

criteria above are considered late

applications and will be returned to the

applicant.

Where to Obtain Additional

Information

To receive additional written

information call 1–888–GRANTS4. You

will be asked your name, address, and

telephone number and will need to refer

to Announcement 817. You will receive

a complete program description,

information on application procedures,

and application forms. In addition, this

announcement is also available through

the CDC Home Page on the Internet. The

address for the CDC Home Page is

(http://www.cdc.gov).

If you have questions after reviewing

the contents of all the documents,

business management information may

be obtained from Joanne Wojcik, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., MS E–13,

Atlanta, GA 30305, telephone (404)

842–6535; fax: (404) 842–6513; Internet:

jcw6@cdc.gov.

Programmatic technical assistance

may be obtained from Roy M. Fleming,

Sc.D., Director Research Grants

Program, National Institute for

Occupational Safety and Health, Centers

for Disease Control and Prevention

(CDC), 1600 Clifton Road, NE., Building

1, Room 3053, MS–D30, Atlanta, GA

30333, telephone 404–639–3343; fax

404–639–4616; internet: rmf2@cdc.gov.

Please refer to announcement number

817 when requesting information and

submitting an application.

This and other CDC Announcements

can be found on the CDC homepage

(http://www.cdc.gov) under the

‘‘Funding’’ section, as well as on the

NIOSH homepage (http://www.cdc.gov/

niosh/homepage.html) under ‘‘Funding

Opportunities/Extramural Programs.’’

For your convenience, you may be able

to retrieve a copy of the PHS Form 398

from (http://www.nih.gov/grants/

funding/phs398/phs398.html). CDC will

not send application kits by facsimile or

express mail.

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.

Useful References

The following documents may also

provide useful information: National

Committee for Childhood Agricultural

Injury Prevention. Children and

Agriculture: Opportunities for Safety

and Health. Marshfield, WI: Marshfield

Clinic, 1996.

National Institute for Occupational

Safety and Health. National

Occupational Research Agenda.

Cincinnati, OH: U.S. Department of

Health and Human Services, Public

Health Service, Centers for Disease

Control and Prevention, National

Institute for Occupational Safety and

Health, DHHS (NIOSH) Publication No.

96–115 (http://www.cdc.gov/niosh/

nora.html).

Dated: January 14, 1998.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health Centers for

Disease Control and Prevention (CDC).

[FR Doc. 98–1331 Filed 1–20–98; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 98019]

Fiscal Year 1998 Pfiesteria-Related

Illness Surveillance and Prevention

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1998

funds for cooperative agreements for

Pfiesteria-Related Illness Surveillance

and Prevention. These cooperative

agreements are intended to strengthen

and provide interstate uniformity for

surveillance programs, epidemiologic

and laboratory investigations,

prevention and control activities, and

identification of exposed cohorts at the

State and local levels.

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

Environmental Health. (For ordering a

copy of Healthy People 2000, see the

section Where to Obtain Additional

Information.)

Authority

This program is authorized under

section 301(a) and 317 of the Public

Health Service Act, (42 U.S.C. 241(a)

and 247b), as amended.

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

of all tobacco products, and Public Law

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds and in which

education, library, day care, health care,

and early childhood development

services are provided to children.

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
Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices 3139

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 current HHS

Appropriations Act expressly prohibits

the use of appropriated funds for

indirect or grass roots lobbying efforts

that are designed to support or defeat

legislation pending before State

legislatures.

Section 503 of the law provides as

follows:

(a) 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.

(b) 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.

Eligible Applicant

Applicants will be limited to the

official State public health departments

of States having confirmed (i.e., cases

meeting the CDC set of exposure criteria

and clinical signs and symptoms for

Pfiesteria) or suspected cases of

Pfiesteria-related illness that are being

investigated by State health

departments, or those States with

coastal waters that have been infected

by Pfiesteria or Pfiesteria-like

organisms.

The CDC set of exposure criteria and

clinical signs and symptoms for

Pfiesteria are defined as: Exposure to

estuarine water characterized by one of

the following: (1) Fish with lesions

consistent with Pfiesteria piscicida or

morphologically related organisms

(MRO) toxicity (20 percent of at least 50

fish of one species having lesions); (2)

a fish kill with fish having lesions

consistent with Pfiesteria or MRO

toxicity; or (3) a fish kill involving fish

without lesions, in the presence of

Pfiesteria or MRO, without an

alternative reason for the fish kill. The

clinical features include the following

signs and symptoms: (1) Memory loss,

(2) confusion, (3) acute skin burning

(upon direct contact with water), or (4)

three or more of the following: a.

headaches; b. skin rash; c. eye irritation;

d. upper respiratory irritation; e. muscle

cramps; f. nausea/vomiting/diarrhea/

abdominal cramps.

Availability of Funds

Up to $3.5 million will be available in

FY 1998 to fund up to 8 awards. Awards

for the initial budget period will be

based upon the extent of the problem

and are expected to range from

approximately $150,000 to $450,000.

The awards will be made on or about

March 15, 1998, for a 12-month budget

period and a project period of up to 5

years. Funding estimates may vary and

are subject to change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Purpose

The purpose of the Pfiesteria-related

Surveillance and Prevention Program is

to assist State/local public health

departments with: (1) Surveillance

activities for adverse human health

outcomes and exposure to infected

waters; (2) epidemiologic studies

including objective review of human

health outcomes; (3) laboratory

investigations; and (4) prevention and

control activities.

Program Requirements

Cooperative Activities

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for conducting

activities under A. (Recipient

Activities), and CDC will be responsible

for conducting activities under B. (CDC

Activities).

A. Recipient Activities

The following activities should be

planned and conducted in collaboration

and coordination with CDC by State/

local health departments, and, where

appropriate, in consultation with:

—Appropriate State and local

professional associations;

—Health care providers and institutions

serving, diagnosing, or providing

treatment and care for persons having

Pfiesteria-related symptoms,

including laboratories conducting

testing;

—Community groups and organizations.

—Universities and health research

agencies.

Specific surveillance and prevention

activities should:

1. Identify individuals with high risk

of exposure to Pfiesteria-infected waters.

2. Conduct investigation of all cases of

Pfiesteria-related illnesses meeting the

CDC set of exposure conditions and

clinical signs and symptoms to

determine risk factors for illness and to

provide clinical materials for laboratory

confirmation.

3. Develop and conduct surveillance

activities to identify potential sources of

exposure to Pfiesteria or Pfiesteria-like

organisms, and provide samples to CDC

for additional laboratory analysis.

4. Assess clinical data on persons

with Pfiesteria-related illnesses to assist

in guiding the development of treatment

strategies.

5. Develop and implement

appropriate prevention strategies and

develop information materials for use by

health professionals and the public to

aid in prevention and control of

Pfiesteria-related illness.

B. CDC Activities

1. Provide consultation and scientific

and technical assistance and training, in

planning, implementing, and evaluating

Pfiesteria exposure cohort studies,

surveillance, epidemiologic research,

laboratory and prevention activities.

2. Assist in developing a format for

reporting surveillance data including

case report forms, database, and

assistance in establishing and

maintaining the reporting system.

3. Bank and conduct laboratory

analysis of biological specimens.

4. Participate with States to finalize

mutually agreed upon standardized

study protocols and, where appropriate,

data collection instruments for the

projects/studies.

5. Coordinate clinical evaluations and

studies to assure comparability of data

and therapeutic protocols.

6. Provide or assist in preparing

standard data collection forms,

questionnaires, etc., as needed in

surveillance activities and special

epidemiologic investigations.

7. Assist in the evaluation of the

overall effectiveness of program

operations, including the impact of

surveillance data on the development of

public policy, and on targeting and

evaluating prevention activities.

8. Participate in the analysis of

information and data gathered from

program activities and facilitate the

transfer of information and technology

among all States and communities.

Technical Reporting Requirements

An original and two copies of a

semiannual progress report must be

submitted 30 days after the end of each

semiannual period. Final financial and

performance reports are due no later

than 90 days after the end of the project

period. All reports will be submitted to

the Grants Management Branch,

Procurement and Grants Office, CDC.
3140 Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices

Application Content

Applications must be developed in

accordance with PHS Form 5161–1

(OMB Number 0937–0189), information

contained in the program

announcement and the instructions and

format provided below.

1. Abstract

A one-page, single spaced, typed

abstract must be submitted with the

application. The heading should

include the title of the grant program,

project title, organization name and

address, project director and telephone

number. The abstract should briefly

summarize the program for which funds

are requested, the activities to be

undertaken, and the applicants’s

organization and composition. The

abstract should follow application forms

and precede the Program Narrative.

2. Program Narrative

The Program Narrative should

specifically address all items in the

Program Requirements section of this

announcement. The applicant should

provide a description of the planned

first year activities, and briefly describe

future year objectives and activities. The

criteria listed in the Evaluation Criteria

section will serve as the basis for

evaluating the application; therefore, the

narrative of the application should

address the following.

a. Applicant’s understanding of the

problem.

b. Applicant’s ability to carry out the

project.

c. Technical and program personnel

capability.

d. Women, Racial and Ethnic

Minorities. A description of the

proposed plan for the inclusion of both

sexes and racial and ethnic minority

populations for appropriate

representation.

e. Budget justification.

f. Human Subjects review: The project

involves research on human subjects,

and therefore, the applicant must

describe and demonstrate that the

project has been subject to initial review

by an appropriate institutional review

committee, and that continuing review

will occur. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and Human Subjects

Assurance form provided in the

application kit.

The Program Narrative section should

not exceed 40 double-spaced pages

excluding attachments (e.g., resumes,

appendices, etc.). Do not include a

detailed budget or detailed budget

justification as part of the Program

Narrative.

An original application and two

copies should be submitted. The

original and each copy of the

application must be submitted

unstapled and unbound. All material

must be typewritten, double-spaced,

with un-reduced type on 81⁄2′′ by 11′′

paper, with at least 1′′ margins, headers

and footers, and printed on one side

only.

All graphics, maps, overlays, etc.,

should be in black and white and meet

the above criteria.

Omissions or incomplete information

may affect the rating of the application.

Evaluation Criteria

Each application will be reviewed and

evaluated individually according to the

following criteria:

A. Understanding of the Problem—25

Points

Extent to which the applicant

understands the purpose and

requirements of the program. This

includes the extent of the applicant’s

identification and description of the

problem, the realistic presentation of

objectives to establish effective

surveillance system and prevention

programs, and evaluation criteria

established to assess surveillance,

epidemiologic research, and prevention

activities.

B. Ability to Carry Out the Project—25

Points

Degree to which the applicant

provides evidence of ability to carry out

the proposed project and the extent to

which the applicant documents

demonstrated capability to achieve the

objectives of the proposed program.

This may include plans, approaches,

and methods to be used in conducting

and evaluating surveillance,

epidemiologic research, and prevention

programs, and may include

collaborating with universities or other

health research agencies.

C. Technical Approach—20 Points

Degree to which proposed objectives

are clearly stated, realistic, measurable,

time-phased, and related to the stated

purpose of this project. Also, the

adequacy of the proposed surveillance,

epidemiologic research, and prevention

plans to achieve the objectives. The

degree to which the applicant has met

the CDC Policy requirements regarding

the inclusion of women, ethnic, and

racial groups in the proposed project.

This includes: (a) The proposed plan for

the inclusion of both sexes and racial

and ethnic minority populations for

appropriate representation; (b) The

proposed justification when

representation is limited or absent; (c) A

statement as to whether the design of

the study is adequate to measure

differences when warranted; and (d) A

statement as to whether the plans for

recruitment and outreach for study

participants include the process of

establishing partnerships with

communities and recognition of mutual

benefits will be documented.

D. Personnel—20 Points

Extent to which professional

personnel involved in this project are

qualified, including evidence of

experience similar to this project.

E. Plans for Administration—10 Points

Adequacy of plans for administering

the project.

F. Funding Requirements—(Not

Weighted)

Itemized budget for conducting the

project, along with justification, is

provided and is reasonable.

G. Human Subjects—(Not Weighted)

The extent to which the applicant

complies with the Department of Health

and Human Services Regulations (45

CFR part 46) regarding the protection of

human subjects.

Executive Order 12372

Applications are subject to the

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 application and receive any

necessary instructions on the State

process. Since the proposed project will

serve more than one State, the applicant

is advised to contact the SPOC of each

affected State. A current list of SPOCs

is included in the application kit. If

SPOCs have any State process

recommendations on the application

submitted to CDC, they should forward

them to Ron Van Duyne, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 321,

Mailstop E–13, Atlanta, Georgia 30305,

no later than 60 days after the receipt

date of the application.

The granting agency does not

guarantee to ‘‘accommodate or explain’’

State process recommendations it

receives after that date.
Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices 3141

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number for this program is

93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by the cooperative

agreement will be subject to review and

approval by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act.

Human Subjects

The applicant must comply with the

Department of Health and Human

Services Regulations, 45 CFR part 46,

regarding the protection of human

subjects. Assurances must be provided

to demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and forms provided in the

application kit.

Women, Racial and Ethnic Minorities

It is the policy of the CDC to ensure

that individuals of both sexes and the

various racial and ethnic groups will be

included in CDC-supported research

projects involving human subjects,

whenever feasible and appropriate.

Racial and ethnic groups are those

defined in OMB Directive No. 15 and

include American Indian or Alaska

Native, Asian, Black or African

American, Hispanic or Latino, and

Native Hawaiian or other Pacific

Islander. Applicants shall ensure that

women, racial and ethnic minority

populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exists that

inclusion is inappropriate or not

reasonable, this situation must be

explained as part of the application.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, Friday, September 15,

1995, pages 47947–47951 (a copy is

included in the application kit).

Application Submission and Deadline

The original and two copies of the

application, PHS Form 5161–1 (OMB

Number 0937–0189), must be submitted

to Ron Van Duyne, Grants Management

Officer, Attention: Patrick A. Smith,

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, Georgia 30305, on or

before February 23, 1998. 1. Deadline: Applications shall 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. (Applicants

should 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 proof of timely mailing.) 2. Late Applications: Applications

which do not meet the criteria in 1.a. or

1.b. above are considered late

applications. Late applications shall not

be considered in the current

competition for funding and will be

returned to the applicant.

Where To Obtain Additional

Information

To receive additional written

information call 1–888–GRANTS4. You

will be asked to leave your name,

address, and telephone number and will

need to refer to NCEH Announcement

98019. 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 announcement number

98019 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 Patrick

Smith, 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, Atlanta, Georgia 30305,

telephone (404) 842–6803, Internet:

phs3@cdc.gov. Programmatic technical assistance

may be obtained from Lawrence E.

Posey, Health Studies Branch, Division

of Environmental Health, National

Center for Environmental Health,

Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road,

NE., Mailstop F–46, Atlanta, Georgia

30333, telephone (770) 488–7350,

Internet: lep1@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)

referenced in the INTRODUCTION may be

obtained through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

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.

Dated: January 14, 1998.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–1327 Filed 1–20–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0531]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by February

20, 1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed