28522 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

proposed collaborators and partners,

and describes how they will coordinate

or collaborate with relevant agencies

and organizations to conduct their

proposed activities and integrate their

proposed activities with national youth

media campaign messages and activities

that promote healthy activity, especially

physical activity, among youth.

6. Evaluation Plan (5 Points)

The extent and method to which the

applicant proposes to measure progress

in meeting objectives and program

effectiveness, and presents a reasonable

plan for obtaining data, reporting the

results, and using the results for

programmatic decisions.

7. Budget and Justification (Reviewed,

But Not Scored)

The extent to which the budget is

reasonable and consistent with the

purposes and activities of the program.

H. Other Requirements

Technical Reporting Requirement

Provide CDC with the original plus

two copies of:

1. Annual progress reports.

2. Financial status report, no more

than 90 days after the end of the budget

period.

3. Final financial report and

performance report, no more than 90

days after the end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I of the

application kit.

AR–7 Executive Order 12372 Review

AR–8 Public Health System Reporting

Requirement

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–14 Accounting System

Requirements

AR–15 Proof of Non-Profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301(a), 311(b) and (c), and 317

(k)(2) [42 U.S.C. 241(a), 243 (b) and (c),

and 247b(K)(2)] of the Public Health

Service Act, as amended. The Catalog of

Federal Domestic Assistance number is

93.938.

J. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address http://www.cdc.gov.

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’

Cynthia Collins, Grants Management

Specialist, Grants Management

Branch, Centers for Disease Control

and Prevention (CDC), Program

Announcement 01031, 2920

Brandywine Rd., Room 3000, MS E–

18, Atlanta, GA 30341–4146,

Telephone number: 770–488–2757,

Fax: 770–488–2820, Email:

coc9@cdc.gov.

For program technical assistance,

contact:

Mary Vernon-Smiley, Chief, Special

Populations Program Section,

Division of Adolescent and School

Health, National Center for Chronic

Disease Prevention and Health

Promotion, Centers for Disease

Control and Prevention (CDC), 4770

Buford Highway, NE MS K–31,

Atlanta, GA 30341, Telephone

number: 770–488–6199, Email:

mev0@cdc.gov.

Dated: May 17, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–12984 Filed 5–22–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01110]

Applied Research in Emerging

Infections Investigations of West Nile

Virus; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a cooperative agreement

program for Applied Research in

Emerging Infections Investigations of

West Nile Virus. This program

addresses the ‘‘Healthy People 2010’’

focus area Immunization and Infectious

Diseases.

The purpose of the program is to

provide assistance to organizations in

developing applied research efforts

pertaining to West Nile (WN) virus and

other arboviruses that occur in the

United States (U.S.).

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and by governments and

their agencies; that is, universities,

colleges, research institutions, hospitals,

other public and private nonprofit

organizations, State and local

governments or their bona fide agents,

including the District of Columbia, the

Commonwealth of Puerto Rico, the

Virgin Islands, the Commonwealth of

the Northern Mariana Islands, American

Samoa, Guam, the Federated States of

Micronesia, the Republic of the

Marshall Islands, and the Republic of

Palau, federally recognized Indian tribal

governments, Indian tribes, or Indian

tribal organizations.

Note: Title 2 of the United States Code,

Chapter 26, Section 1611 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $2,000,000 is available

in FY 2001 to fund approximately ten to

twelve awards. It is expected that the

average award will be $150,000, ranging

from $100,000 to $300,000. It is

expected that the awards will begin on

or about September 30, 2001, and will

be made for a 12-month budget period

within a project period of up to three

years. Funding estimates may change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), and CDC

will be responsible for the activities

listed under 2. (CDC Activities).

1. Recipient Activities

Develop and implement applied

research investigations on one or more

of the following topics:

a. Determine the current and future

geographic distribution of WN virus.

Utilize longitudinal laboratory-based

surveillance systems for WN virus in

humans, birds, other selected animals,

and mosquitoes to determine the

geographic distribution of WN virus in

the Western Hemisphere.

b. Determine the contribution of bird

migration to WN virus dispersal.

Develop laboratory and field-based

systems to better understand avian

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28523

dissemination of WN virus. Studies

could include determining the

frequency and duration of chronic avian

infections that would allow the long

range transport and recrudescence of

viremias necessary to infect mosquitoes.

c. Characterize WN virus mosquito

vector and vertebrate host relationships.

Analyze the vertebrate host and

mosquito vector relationships of WN

virus in the U.S. and the Western

Hemisphere. Target selected species

involved in maintenance, epidemic/

epizootic transmission cycles, or both to

determine what effective prevention and

control strategies will be required. It is

critical that the principal species and

the range of these species be

determined.

d. Characterize mosquito biology,

behavior, and vector competence for

WN virus in the U.S. Investigate the

different vector species important in

WN virus transmission in each

geographic or ecologic region to

understand better their biology and

behavior. Investigate the principal

mosquito vectors involved in

maintenance, bridge (from enzootic to

peridomestic), and epidemic/epizootic

transmission to understand and design

more effective methods for prevention

and control.

e. Develop and evaluate prevention

strategies. These strategies can include

but are not limited to better defining

target areas for mosquito control in

response to documented WN virus

activity, derivation and implementation

of new, natural compounds to repel and

control mosquito-vectors of disease and

determining the efficacy of public

outreach materials and campaigns in

reducing risk from WN virus infection.

f. Develop laboratory diagnostic tests

that are more sensitive, specific and

reproducible than current laboratory

methods used to detect West Nile virus.

Test methods may include, but are not

limited to serology, culture, nucleic acid

amplification or antigen detection.

g. Identify the clinical spectrum of

North American WN virus disease and

its long-term prognosis in humans.

Determine the spectrum of illness

caused by WN virus infection in

humans, including the long-term

consequences of acute infection of the

central nervous system. In addition to

the severe end of the clinical spectrum

(viral encephalitis), determine the

degree to which mild viral syndromes

occur, whether these patients have any

unique clinical presentations that may

be characteristic or even

pathognomonic, whether they have

viremia and, if so, its magnitude and

duration. Determine if effective clinical

management of severe disease will

require detailed clinical studies of

confirmed human cases of WN virus

infection.

h. Identify risk factors for WN virus

exposure and disease. Data on the risk

factors associated with human and

animal infection with WN virus are

required to develop more effective

prevention strategies, particularly when

educating the public to take specific

prevention measures to reduce exposure

to infection.

i. Characterize the genetics,

pathogenesis, virulence and possible

direct transmission and persistence of

the North American strain of WN virus

as it compares to other WN viruses in

animal models and wildlife. Little is

known about the pathogenesis of WN

virus in humans or other animals.

Investigate, to better understand,

whether genetic changes in WN viruses

influence their phenotypic expression

(e.g., host and vector range); the

possibility of persistent infections

including the duration of chronic

infection and reactivation in birds or

other animals; the possibility and

importance of direct transmission

without the help of mosquitoes; and the

identification of overwintering

mechanisms in Culex and Aedes species

mosquitoes.

2. CDC Activities

a. Provide technical assistance, as

requested, in the design or evaluation of

experimentation.

b. Assist in the analysis of laboratory

test data, as appropriate, depending on

the needs of the recipient.

c. Assist in the acquisition of

appropriate samples for study, as

requested.

d. Assist in the coordination of

research activities among different

recipient sites.

e. Assist in the development of a

research protocol for Institutional

Review Board (IRB) review by all

cooperating institutions participating in

the research project. The CDC IRB will

review and approve the protocol

initially and on at least an annual basis

until the research project is completed.

E. Content

Letter of Intent (LOI)

An LOI is optional for this program.

The narrative should be no more than 3

single-spaced pages, printed on one

side, with one inch margins, and

unreduced font. Your letter of intent

will be used to enable CDC to plan for

the review, and should include the

following information (1) the program

announcement number 01110, (2) name

and address of institution, (3) name,

address, and telephone number of

contact person and (4) the applied

research investigation topic(s) selected

for submission. Notification can be

provided by facsimile, postal mail, or

electronic mail (E-mail).

Applications

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 25 double-spaced pages, printed on

one side, with one inch margins, and

unreduced font.

1. Abstract

Provide a brief (two pages maximum)

abstract of the project and specify the

applied research investigation topic(s)

selected for submission. Clearly identify

the project period proposed.

2. Background and Need

Discuss the background and need for

the proposed project. Demonstrate a

clear understanding of the purpose and

objectives of this program

announcement. Discuss and

demonstrate how the proposed project

addresses an important gap which is of

public health importance.

3. Capacity and Personnel

Describe applicant’s past experience

in conducting activities similar to that

being proposed. Describe applicant’s

resources, facilities, and professional

personnel that will be involved in

conducting the project. Include in an

appendix curriculum vitae for all

professional personnel involved with

the project. Describe plans for

administration of the project and

identify administrative resources/

personnel that will be assigned to the

project. Clearly identify specific

assigned responsibilities for all key

professional personnel. Provide in an

appendix letters of support from all key

participating non-applicant

organizations, individuals, etc. (if any),

which clearly indicate their

commitment to participate as described

in the operational plan.

4. Objectives and Technical Approach

Present specific objectives for the

proposed research which are

measurable and time-phased and are

consistent with the Purpose and

Recipient Activities of this

announcement. Present a detailed

operational plan for initiating and

conducting the research which clearly

28524 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

and appropriately addresses these

objectives (if proposing a multi-year

project, provide a detailed description

of first-year activities and a brief

overview of subsequent-year activities).

Include a clear description of

applicant’s technical approach/methods

which are directly relevant to the above

objectives. Describe specific study

protocols or plans for the development

of study protocols. Describe the nature

and extent of collaboration with CDC

and/or others during various phases of

the research. Describe in detail a plan

for evaluating progress toward achieving

process and outcome project objectives.

If the project will employ a particular

research subject population, describe

characteristics of the patient population

and how research in this subject group

will yield generalizable information.

Describe contingency plans which

acknowledge how the research will

address likely obstacles and assure that

the proposed task(s) can still be

completed. Include sample size

calculations where appropriate to assure

that measurable objectives can be

evaluated.

5. Budget

Provide a detailed budget as outlined

in the application Errata Instruction

Sheet for PHS 398.

F. Submission and Deadline

Letter of Intent (LOI)

On or before June 15, 2001, submit the

LOI to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

Application

Submit the original and five copies of

PHS–398 (OMB Number 0925–0001)

(adhere to the instructions on the Errata

Instruction Sheet for PHS 398)]. Forms

are available in the application kit and

at the following Internet address:

www.cdc.gov/od/pgo/forminfo.htm

On or before July 15, 2001, submit the

application to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

Deadline: Applications shall be

considered as meeting the deadline if

they are either:

1. Received on or before the deadline

date; or

2. Sent on or before the deadline date

and received in time for submission to

the independent review group.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

Late: Applications which do not meet

the criteria in 1. or 2. above will be

returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Plan (20 Points)

The extent the proposed research plan

shows scientific validity and whether

the plan addresses a stated purpose of

this program.

2. Capacity (40 Points)

a. The extent the applicant documents

and describes their general expertise in

the areas relevant to their submitted

application (e.g., diagnostic test

development, field studies with

zoonotic diseases, working with small

animal models of disease).

b. The extent the applicant describes

and documents their experience in

research on mosquito-borne viral

diseases and flaviviruses in particular.

c. The extent to which the applicant

has the appropriate project personnel,

organizational structure, and

administrative support to assure

meeting proposed objectives.

d. The extent to which the applicant

has access to necessary biological

materials or study populations.

3. Objectives and Prospects (15 points)

The extent the objectives along with

the prospects for successfully achieving

them and the likelihood that the

product(s) of the investigation will

result in the development of better

prevention or intervention measures.

4. Evaluation (20 points)

a. The feasibility of completing the

proposed studies and meeting

measurable objectives within the project

period.

b. The extent to which the applicant

proposes appropriate methods for

evaluating the projects and/or design

methods that are adequate to measure

differences, when warranted.

5. Inclusion of Women, Ethnic, and

Racial Groups (5 points)

Applicants should meet CDC Policy

requirements regarding the inclusion of

women, ethnic, and racial groups in the

proposed research. This includes: (1)

The proposed plan for the inclusion of

both sexes and racial and ethnic

populations for appropriate

representation, (2) the proposed

justification when representation is

limited or absent, (3) a statement as to

whether the design of the study is

adequate to measure differences when

warranted, and (4) a statement as to

whether the plans for recruitment and

outreach for study participants include

the process of establishing partnerships

with community(ies) and recognition of

mutual benefits.

6. Budget (Not scored)

The extent to which the budget is

reasonable, clearly justified, and

consistent with the intended use of

cooperative agreement funds.

7. Human Subjects (Not scored)

Does the application adequately

address the requirements of Title 45

CFR part 46 for the protection of human

subjects? (Not scored; however, an

application can be disapproved if the

research risks are sufficiently serious

and protection against risks is so

inadequate as to make the entire

application unacceptable.)

8. Animal Subjects (Not scored)

Does the application adequately

address the requirements of the PHS

Policy on Humane Care and Use of

Laboratory animals by Awardee

Institutions?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus

two copies of:

1. semiannual progress reports;

2. financial status report, no more

than 90 days after the end of the budget

period; and

3. final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit of the announcement.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–3 Animal Subjects Requirements

AR–7 Executive Order 12372 Review

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28525

AR–14 Accounting System

Requirements

AR–15 Proof of Non-Profit Status

AR–22 Research Integrity

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 301(a) [42 U.S.C. 241(a)] and

317(k)(2) [42 U.S.C. 247b(k)(2) of the

Public Health Service Act, as amended.

The Catalog of Federal Domestic

Assistance number is 93.283.

J. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’

To receive additional written

information and to request an

application kit, call 1–888–GRANTS4

(1–888–472–6874). You will be asked to

leave your name and address and will

be instructed to identify the Program

Announcement number of interest.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from: Gladys

Gissentanna, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

number: 770–488–2753, E-mail address:

gcg4@cdc.gov.

For program technical assistance,

contact: Dr. John Roehrig, Division of

Vector-Borne Infectious Diseases,

National Center for Infectious Diseases,

Centers for Disease Control and

Prevention, P. O. Box 2087 (Foothills

Campus), Fort Collins, CO 80522,

Telephone number: 970–221–6442, Email address: jtr1@cdc.gov.

Dated: May 17, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–12982 Filed 5–22–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Program Announcement No. ACF/

ACYF/CB FY 2001–01A;

Announcement of the Availability of

Financial Assistance and Request for

Applications to Support Adoption

Opportunities Demonstration Projects,

Child Abuse and Neglect Discretionary

Activities, Abandoned Infants

Assistance Awards, and Project To

Build the Analytical Capacity of State

Child Welfare Programs

AGENCY: Administration on Children,

Youth and Families (ACYF), ACF.

ACTION: Correction.

SUMMARY: This document contains a

correction to the Notice that was

published in the Federal Register on

Tuesday, May 1, 2001 (66 FR 21760). On

page 21761, Column three, the

information in the ‘‘Project Duration’’

section of priority area 2001B.1 National

Resource Center on Child Maltreatment

is in error. The correct information is as

follows: The cooperative agreement will

be awarded for a project period not to

exceed 36 months. The initial grant

award will be awarded for a 12-month

budget period. The award of

continuation funding beyond the 12-

month budget period will be subject to

the availability of funds, satisfactory

progress on the part of the grantee, and

a determination that continued funding

would be in the best interest of the

government.

FOR FURTHER INFORMATION CONTACT: The

ACYF Operations Center at 1–800–351–

2293 or send an email to cb@cgnet.com.

You may also contact Sally Flanzer,

Children’s Bureau, at 202–215–8914.

Dated: May 18, 2001.

James A. Harrell,

Acting Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 01–13044 Filed 5–22–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01F–0233]

Alcide Corp.; Filing of Food Additive

Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Alcide Corp. has filed a petition

proposing that the food additive

regulations be amended to provide for

the safe use of acidified sodium chlorite

solutions as an antimicrobial agent in

processing waters applied to processed

fruits and vegetables.

DATES: Submit written comments on the

petitioner’s environmental assessment

by June 22, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Robert L. Martin, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204–0001, 202–418–

3074.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 1A4729) has been filed by

Alcide Corp., 8561 154th Ave. NE.,

Redmond, WA 98052. The petition

proposes to amend the food additive

regulations in § 173.325 Acidified

sodium chlorite solutions (21 CFR

173.325) to provide for the safe use of

acidified sodium chlorite solutions as

an antimicrobial agent in processing

waters applied to processed fruits and

vegetables.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations issued under

the National Environmental Policy Act

(40 CFR 1501.4(b)), the agency is

placing the environmental assessment

submitted with the petition that is the

subject of this notice on public display

at the Dockets Management Branch

(address above) for public review and

comment. Interested persons may

submit to the Dockets Management

Branch written comments by June 22,

2001. Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday. FDA will also place on

public display any amendments to, or

comments on, the petitioner’s

environmental assessment without

further announcement in the Federal

Register. If, based on its review, the

agency finds that an environmental

impact statement is not required and