Federal Register / Vol. 66, No. 101 / Thursday, May 24, 2001 / Notices 28751

with hazardous waste sites and other

environmental releases. An important

step in ATSDR’s assessment process is

examining exposures to contaminants

under site-specific conditions and

determining whether people are being

exposed to harmful levels. In most of

the agency’s evaluations, the

environmental concentration serves as a

surrogate for ‘‘exposure.’’

To refine its assessments and to fill

data gaps, ATSDR sometimes identifies

ways to more precisely quantify

exposures, such as measuring body

burdens of a particular contaminant or

its metabolites (e.g., lead in blood). On

a site-by-site basis, ATSDR evaluates

what additional exposure data might be

practical and useful to obtain to further

support public health evaluations and

ultimately to help determine the disease

potential of a particular exposure.

ATSDR seeks to determine the overall

utility of hair analysis as one such

exposure assessment tool. ATSDR’s

overall goal is to receive expert opinion

on the following four general questions

related to hair analysis. A number of

specific questions related to these issues

will also be discussed.

• When is it appropriate to consider

hair analysis in assessing human

exposures to environmental

contaminants?

• When is it inappropriate to consider

hair analysis in assessing human

exposures to environmental

contaminants?

• What data gaps exist that limit the

interpretation and use of hair analysis in

the assessment of environmental

exposures? What research is needed to

fill these data gaps?

• For what substances do reliable hair

analysis methods exist?

Contact Person for More Information:

Dr. Allan Susten, Assistant Director for

Science, Division of Health Assessment

and Consultation, ATSDR, at 404–639–

0625 or Dr. Deanna Harkins, Medical

Officer, Commissioned Corps of the U.S.

Public Health Service, Division of

Health Education and Promotion,

ATSDR, at 404–639–4669. For questions

about logistics, contact ERG at 781–674–

7374.

The Director, Management Analysis

and Services Office, has been delegated

the authority to sign Federal Register

Notices pertaining to announcements of

meetings and other committee

management activities, for both the

Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: May 18, 2001.

John Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention.

[FR Doc. 01–13128 Filed 5–23–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01066]

Applied Research on Antimicrobial

Resistance; 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 grant program for Applied

Research on Antimicrobial Resistance

(AR). This program addresses the

‘‘Healthy People 2010’’ focus area

Immunization and Infectious Diseases.

The purpose of the program is to

provide assistance for applied research

aimed at prevention and control of the

emergence and spread of antimicrobial

resistance in the U.S. This AR research

program will focus on two areas: (1) AR

in rural areas; and (2) Microbiologic

mechanisms of dissemination of AR

genes and relationship to antimicrobial

drug use, including (a) in health care

settings and (b) from food animals to

humans. This program’s design will

implement Part 1 of the Public Health

Action Plan to Combat Antimicrobial

Resistance, Domestic Issues. For more

information visit the internet site:

www.cdc.gov/drugresistance/

actionplan/index.htm.

1. AR in Rural Areas (See Attachment

II for additional information)

This research includes four

components that will provide

information needed to prevent and

control AR in rural areas in the U.S.:

Surveillance of antimicrobial infections,

promoting appropriate antimicrobial

drug prescribing, preliminary

assessment of environmental impact of

antimicrobials, and development of new

antimicrobial products.

2. Microbiologic Mechanisms of

Dissemination of AR Genes and

Relationship to Antimicrobial Drug Use

(See Attachment III for additional

information)

This research will develop

information necessary to prevent and

control the emergence and spread of

resistance in selected bacteria in health

care settings and from food animals to

humans, including mechanisms of

resistance, dissemination of resistance,

and the impact of antimicrobial use on

dissemination of resistance.

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.

Applicants may apply for either

Antimicrobial Resistance in Rural Areas

or Microbiologic Mechanisms of

Dissemination of AR Genes and

Relationship to Antimicrobial Drug Use

or both. Proposals for Antimicrobial

Resistance in Rural Areas must address

all four components: Surveillance,

Promoting Appropriate Antimicrobial

Drug Prescribing, Assessment of

Environmental Impact of Antimicrobials

(environmental sampling or sentinel

human populations), and New

Antimicrobial Products.A separate

application is required for each research

area (rural health and microbiologic

mechanisms).

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 $3,100,000 is available

in FY 2001 as follows: Approximately

$2,200,000 will be available for one

award in focus area (1) and

approximately $900,000 will be

available for five awards in focus area

(2), for an average award of $100,000 to

$500,000. 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. The funding estimates

may change.

A continuation award within an

approved project period will be made

on the basis of satisfactory progress as

28752 Federal Register / Vol. 66, No. 101 / Thursday, May 24, 2001 / Notices

evidenced by required reports and the

availability of funds.

D. Program Requirements

Projects must meet the following

requirements

1. AR in Rural Areas (See Attachment

II for additional information)

Develop and implement

comprehensive intervention projects to

prevent and control AR in rural areas in

the U.S.

a. Surveillance

Implement a practical, cost-effective

system for monitoring antimicrobial

drug resistance and use patterns that is

operationally useful for prevention and

control efforts in rural areas.

Taking into account factors relevant

in rural settings, implement an

epidemiologically representative,

clinical laboratory based surveillance

network for acute bacterial infections of

public health importance that are

commonly acquired in one or more of

three settings: The community, healthcare system, and/or the food supply.

b. Promoting Appropriate Antimicrobial

Drug Prescribing

Measure antimicrobial drug

prescribing and assess factors that

influence such prescribing in rural

areas. Use these data to conduct and

evaluate appropriate use programs.

Promote appropriate antimicrobial drug

prescribing in human medicine and

optionally in veterinary medicine.

c. Preliminary Assessment of

Environmental Impact of Antimicrobials

Through pilot studies, assess the

likelihood of environmental impact of

antimicrobial drug use in modern

agriculture and/or aquaculture.

d. New Antimicrobial Products

Identify and Investigate compounds,

particularly naturally occurring

substances, that may be useful in

combating antimicrobial resistance in

rural settings.

2. Microbiologic Mechanisms of

Dissemination of AR Genes and

Relationship to Antimicrobial Drug Use

(See Attachment III for additional

information)

Develop information necessary to

prevent and control the emergence and

spread of resistance in selected bacteria

(see below) through better

understanding the mechanisms through

which resistance develops and spreads

in field settings.

Projects should address one or more

of the following: (1) Vancomycin

resistance in staphylococci; (2)

Cephalosporin resistance in Klebsiella

pneumoniae, Salmonellae, or other

Enterobacteriaceae through extendedspectrum β-lactamases, AmpC, or other

β-lactamases; (3) Streptogramin (e.g.,

quinupristin/dalfopristin) resistance in

enterococci; or (4) Fluoroquinolone

resistance in Escherichia coli.

E. Application Content

Letter of Intent (LOI)

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter of intent

shall be submitted on or before June 15,

2001 to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement. The letter should

identify the announcement number,

name the principal investigator, and

briefly describe the scope and intent of

the proposed research work. The letter

of intent does not influence review or

funding decisions, but the number of

letters received will enable CDC to plan

the review more effectively and

efficiently.

Application

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. The application

will be evaluated on the evaluation

criteria listed below. The Research Plan

for each research area should be no

more than 25 pages, printed on one side,

with one inch margins, and letters must

not be smaller than 10 point font.

F. Submission and Deadline

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).

On or before July 16, 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 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 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: Applications

which do not meet the criteria in (a) or

(b) above are considered late

applications, will not be considered,

and 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. Background and Need (10 points)

Extent to which applicant’s

discussion of the background for the

proposed project demonstrates a clear

understanding of the purpose and

objectives of this grant program. Extent

to which applicant illustrates and

justifies the need for the proposed

project that is consistent with the

purpose and objectives of this grant

program.

2. Capacity (40 points total)

a. Extent to which applicant describes

adequate resources and facilities (both

technical and administrative) for

conducting the project. (10 points)

b. Extent to which applicant

documents that professional personnel

involved in the project are qualified and

have past experience and achievements

in research related to that proposed as

evidenced by curriculum vitae,

publications, etc. (20 points)

c. Extent to which applicant includes

letters of support appropriate nonapplicant organizations, individuals,

etc. Extent to which the letters clearly

indicate the author’s commitment to

participate and/or collaborate as

described in the operational plan. (10

points)

3. Objectives and Technical Approach

(50 points total)

a. Extent to which applicant describes

specific objectives of the proposed

project which are consistent with the

purpose and goals of this grant program

and which are measurable and timephased. (10 points)

b. Extent to which applicant presents

a detailed operational plan for initiating

and conducting the project, which

clearly and appropriately addresses all

Program Requirements. Extent to which

applicant clearly identifies and

describes appropriate study sites (per

Program Requirements 1.a and 3.a).

Extent to which applicant clearly

identifies specific assigned

responsibilities for all key professional

personnel. Extent to which the plan

clearly describes applicant’s technical

approach/methods for conducting the

Federal Register / Vol. 66, No. 101 / Thursday, May 24, 2001 / Notices 28753

proposed studies and extent to which

the plan is adequate to accomplish the

objectives. Extent to which applicant

describes specific study protocol(s), the

roles of partners or collaborators or

plans for the development of study

protocols that are appropriate for

achieving project objectives. (30 points)

c. If the proposed project involves

human subjects, the degree to which the

applicant has met the 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

minority 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. (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 will be documented.

(see Other Requirements for additional

information regarding this requirement

for research projects). (5 points)

d. Extent to which applicant provides

a detailed and adequate plan for

evaluating study results and for

evaluating progress toward achieving

project objectives. (5 points)

4. Budget (not scored)

Extent to which the proposed budget

is reasonable, clearly justifiable, and

consistent with the intended use of

grant funds.

5. Human Subjects (not scored)

Does the application adequately

address the requirements of Title 45

CFR Part 46 for the protection of human

subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with an original plus

two copies of the following:

1. Annual 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.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

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) and 317(k)(2) of the

Public Health Service Act, [42 U.S.C.

Sections 241(a) and 247b(k)(2)], 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

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,

Room 3000, 2920 Brandywine Road,

Mailstop K75, Atlanta, GA 30341–4146,

Telephone number: 770–488–2753,

Email address: gcg4@cdc.gov.

For program technical assistance,

contact: Marsha Jones, Health Scientist,

National Center for Infectious Diseases,

Centers for Disease Control and

Prevention, 1600 Clifton Road, N.E.,

Mailstop C–12, Atlanta, GA 30333,

Telephone number: 404–639–2603.

Email address: maj4@cdc.gov.

Dated: May 17, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–13127 Filed 5–23–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Office of Planning, Research and

Evaluation; Grant to the Institute for

Responsible Fatherhood and Family

Revitalization

AGENCY: Office of Planning, Research

and Evaluation, ACF, DHHS.

ACTION: Award announcement.

SUMMARY: Notice is hereby given that a

noncompetitive grant award is being

made to the Institute for Responsible

Fatherhood and Family Revitalization to

build the Institute’s capacity and

infrastructure and expand the provision

of direct services to reunite fathers and

families. As a Congressional setaside,

this one-year project is being funded

noncompetitively. The Institute has

community-based service centers in

several states and has successfully

served so far more than 7000 fathers and

their families. The cost of this one-year

project is $500,000.

FOR FURTHER INFORMATION CONTACT: K.

A. Jagannathan, Administration for

Children and Families, Office of

Planning, Research and Evaluation, 370

L’Enfant Promenade, SW., Washington,

DC 20447, Phone: 202–205–4829.

Dated: May 18, 2001.

Howard Rolston,

Director, Office of Planning, Research and

Evaluation.

[FR Doc. 01–13143 Filed 5–23–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P–1340]

Determination That ROWASA

(mesalamine) Rectal Suppositories,

500 Milligrams, Was Not Withdrawn

From Sale for Reasons of Safety or

Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

determination that ROWASA

(mesalamine) Rectal Suppositories, 500

milligrams (mg) was not withdrawn

from sale for reasons of safety or

effectiveness. This determination will

allow FDA to approve abbreviated new

drug applications (ANDAs) for