33520 Federal Register / Vol. 61, No. 125 / Thursday, June 27, 1996 / Notices

ATSDR MINIMAL RISK LEVELS (MRLS) FOR HAZARDOUS SUBSTANCES—Continued

[March 1996]

Substance name CAS No. Route Duration Value Factors End point

ORAL ......................... CHRONIC .................. 0.002 mg/kg/day ........ 100 Hematological.

2,6-DINITROTOLUENE 000606–20–2 ORAL ......................... INTERMEDIATE ........ 0.04 mg/kg/day .......... 100 Neurological.

4,4′-METHYLENE-BIS

(2-CHLOROANILINE).

000101–14–4 ORAL ......................... CHRONIC .................. 0.003 mg/kg/day ........ 3000 Hepatic.

4,6-DINITRO-O-CRESOL.000534–52–1 ORAL ......................... ACUTE ...................... 0.004 mg/kg/day ........ 100 Neurological.

ORAL ......................... INTERMEDIATE ........ 0.004 mg/kg/day ........ 100 Neurological.

[FR Doc. 96–12991 Filed 5–22–96; 8:45 am]

BILLING CODE 1505–01–D

Centers for Disease Control and

Prevention

[Announcement Number 662]

Applied Research in Emerging

Infections—Controlling the Spread of

Antimicrobial Resistance in

Community-Acquired Bacterial

Pathogens

Introduction

The Centers for Disease Control and

Prevention (CDC) is implementing a

program for competitive cooperative

agreement and/or research project grant

applications to support applied research

on emerging infections. CDC announces

the availability of fiscal year (FY) 1996

funds to provide assistance for a

program to conduct research on

controlling the spread of antimicrobial

resistance among community-acquired

bacterial pathogens.

The 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

Immunization and Infectious Diseases.

(For ordering a copy of Healthy People

2000, see the section Where To Obtain

Additional Information.)

Authority

This program is authorized under

sections 301(a) and 317(k)(2) [42 U.S.C.

241(a) and 247b(k)(2)] of the Public

Health Service Act, as amended.

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the nonuse of

all tobacco products, and Public Law

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,

including 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 women-owned businesses are eligible

to apply.

Availability of Funds

Approximately $250,000 is available

in FY 1996 to fund one or two awards.

It is expected that the awards will begin

on or about September 30, 1996, and

will be made for a 12-month budget

period within a project period of up to

two years. Funding estimates may vary

and are subject to change. Continuation

awards within an approved project

period will be made on the basis of

satisfactory progress and availability of

funds.

Purpose

The purpose of the emerging

infections extramural research program

is to provide financial and technical

assistance for applied research projects

on emerging infections in the United

States. As a component of this emerging

infections extramural research program,

this announcement focuses on

controlling the spread of antimicrobial

resistance among community-acquired

bacterial respiratory pathogens.

Specifically, the purpose of this

announcement is to provide assistance

for the development and

implementation of a program to promote

judicious antimicrobial use in an

outpatient population, and the

evaluation of its impact on carriage or

infection with community-acquired

drug-resistant bacterial respiratory

pathogens. If successful, such a project

could serve as the scientific foundation

for national efforts to change antibiotic

use practices of physicians in order to

decrease the spread of resistance.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for the activities

under A., below and CDC shall be

responsible for conducting activities

under B., below. In Recipient Activities

below, the study of drug resistant S.

pneumoniae, H. influenzae, or M.

catarrhalis in a pediatric population are

examples of an appropriate approach

and are provided for illustration

purposes. Applicants may propose

studies which focus on other

populations and/or pathogens which are

appropriate under the Purpose section

of this announcement.

A. Recipient Activities

1. Select study population. This may

include selection of non-overlapping

control and intervention groups of

patients for participation. One example

of an appropriate approach would be to

enroll children from two groups of day

care centers, from two small towns, or

from two communities within a large

metropolitan area. These groups of

children would constitute discrete

populations and be served by different

medical care providers. They would be

similar demographically, have similar

utilization of medical care, and

comparable baseline rates of carriage or

infection with resistant pathogens.

2. Collect and analyze baseline data.

For example, nasopharyngeal (NP)

carriage rates for drug-resistant

Streptococcus pneumoniae (DRSP) and/

or β-lactamase producing Haemophilus

influenzae or Moraxella catarrhalis

could be measured in the two groups of

children by separate NP swab surveys

conducted several months before and

immediately prior to the start of the

intervention phase. NP surveys for the

intervention and control groups would

be done concurrently. Laboratory

methods would include evaluating the

potential for carriage of multiple

populations of pneumococci, which
Federal Register / Vol. 61, No. 125 / Thursday, June 27, 1996 / Notices 33521

may have different resistance patterns,

by analysis of multiple pneumococcal

colonies per culture plate.

3. Design and implement an

intervention promoting judicious

antimicrobial use. Again, using a

pediatric age population as an example,

develop and implement an intensive

program to reduce the rate of antibiotic

use focusing on pediatric providers and

the children’s parents from one of the

study groups. The control group would

allow comparison of outcomes.

Techniques with proven effectiveness,

such as face-to-face discussions with

‘‘peer-counselors,’’ would be an

important component of such an

intervention. Educational materials for

physicians, including written guidelines

for diagnosis and management of

common respiratory conditions

established in collaboration with

professional organizations, and

materials to educate parents on the

potential adverse effects of unnecessary

antibiotic use would be made available

from CDC. Materials may also be

developed by the recipient for use in the

intervention. Other techniques that may

be applicable in some settings include

providing feedback to physicians

comparing their practices with those of

their colleagues and providing

incentives which promote judicious

antimicrobial use.

4. Measure effect of the intervention.

Measure the differences in the rate of

antimicrobial resistance among isolates

obtained from carriers or persons with

infection in the intervention and control

groups. Other appropriate measures or

analyses could include: (a) differences

between control and intervention

groups in rates and types of

antimicrobial use; (b) differences in

carriage or infection with resistant

bacterial pathogens among family

members or the community in general;

(c) differences in the rate of recurrent or

refractory infections; and (d) changes in

parent or provider knowledge and

attitudes regarding antimicrobial use.

5. Disseminate research findings.

Disseminate research results by

appropriate methods such as

publication in journals, presentation at

meetings, conferences, etc.

B. CDC Activities

1. Research Project Grants. A research

project grant is one in which substantial

programmatic involvement by CDC is

not anticipated by the recipient during

the project period. Applicants for grants

must demonstrate an ability to conduct

the proposed research with minimal

assistance, other than financial support,

from CDC. This would include

documenting that applicant has

sufficient resources for clinical,

laboratory, and data management

services, and for demonstrating a level

of scientific expertise to achieve the

objectives described in the research

proposal without substantial technical

assistance from CDC.

2. Cooperative Agreements. In a

cooperative agreement, CDC will assist

recipients in conducting the proposed

research. The application should be

presented in a manner that

demonstrates the applicant’s ability to

address the research problem in a

collaborative manner with CDC. In

addition to the financial support

provided, CDC will collaborate by: (1)

Providing technical assistance in the

design and conduct of the research

including intervention methods and

analytic approach; (2) performing

selected laboratory tests as appropriate;

and (3) participating in data

management, the analysis of research

data, and the interpretation and

presentation of research findings.

C. Determination of Which Instrument

To Use

Applicants must specify the type of

award for which they are applying,

either grant or cooperative agreement.

CDC will review the applications in

accordance with the Evaluation Criteria

section of this announcement. Before

issuing awards, CDC will determine

whether a grant or cooperative

agreement is the appropriate instrument

based upon the need for substantial CDC

involvement in the project.

Notice of Intent To Apply

In order to assist CDC in planning for

and executing the evaluation of

applications submitted under this

announcement, all parties intending to

submit an application are requested to

inform CDC of their intention to do so

at their earliest convenience prior to the

application due date. Notification

should include: (1) Name and address of

institution, and (2) name, address, and

phone number of contact person.

Notification should be provided by

facsimile, postal mail, or E-mail to Greg

Jones, M.P.A., National Center for

Infectious Diseases, 1600 Clifton Road,

NE., Mailstop C–19, Atlanta, Georgia

30333, E-mail gjj1@cidod1.em.cdc.gov,

facsimile (404) 639–4195.

Evaluation Criteria

The applications will be reviewed and

evaluated according to the following

criteria:

1. Background and Need (15 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/cooperative

agreement program. Extent to which

applicant illustrates and justifies the

need for the proposed project that is

consistent with the purpose and

objectives of this program.

2. Capacity (35 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 from non-applicant

organizations, individuals, etc. Extent to

which the letters clearly indicate the

author’s commitment to participate as

described in the operational plan. (5

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 program and

which are measurable and time-phased.

(10 points)

b. Extent to which applicant presents

a detailed operational plan for initiating

and conducting the project, which

clearly and appropriately addresses all

Recipient Activities. 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 proposed studies and

extent to which the plan is adequate to

accomplish the study objectives. Extent

to which applicant describes specific

study protocols or plans for the

development of study protocols that are

appropriate for achieving project

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 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; and (4) a statement as to

whether the plans for recruitment and

outreach for study participants include

the process of establishing partnerships
33522 Federal Register / Vol. 61, No. 125 / Thursday, June 27, 1996 / Notices

with community(ies) and recognition of

mutual benefits. (20 points)

c. Extent to which applicant describes

adequate and appropriate collaboration

with CDC and/or others during various

phases of the project. (10 points)

d. Extent to which applicant provides

a detailed and adequate plan for

evaluating study results and for

evaluating progress toward achieving

project objectives. If the proposed

project involves notifiable conditions,

the degree to which applicant describes

an adequate process for providing

necessary information to appropriate

State and/or local health departments.

(10 points)

4. Budget (not scored): Extent to

which the proposed budget is

reasonable, clearly justifiable, and

consistent with the intended use of

grant/cooperative agreement funds.

5. Human Subjects (not scored): If the

proposed project involves human

subjects, whether or not exempt from

the DHHS regulations, the extent to

which adequate procedures are

described for the protection of human

subjects. Note: Objective Review Group

(ORG) recommendations on the

adequacy of protections include: (1)

Protections appear adequate and there

are no comments to make or concerns to

raise, or (2) protections appear adequate,

but there are comments regarding the

protocol, or (3) protections appear

inadequate and the ORG has concerns

related to human subjects, or (4)

disapproval of the application is

recommended because the research

risks are sufficiently serious and

protection against the risks are

inadequate as to make the entire

application unacceptable.

Executive Order 12372 Review

This program is not subject to

Executive Order 12372 Review,

Intergovernmental Review of Federal

Programs.

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 is 93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from ten or more

individuals and funded by the grant/

cooperative agreement will be subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act.

Human Subjects

If the proposed project involves

research on 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. Assurance 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 evidence of

this assurance in accordance with the

appropriate guidelines and form

provided in the application kit.

Women, Racial and Ethnic Minorities

It is the policy of the Centers for

Disease Control and Prevention (CDC)

and the Agency for Toxic Substances

and Disease Registry (ATSDR) to ensure

that individuals of both sexes and the

various racial and ethnic groups will be

included in CDC/ATSDR- 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,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic. 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 exist that

inclusion is inappropriate or not

feasible, 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, pages 47947–47951,

dated Friday, September 15, 1995.

Application Submission and Deadline

The original and two copies of each

application PHS Form 5161–1 (Revised

7/92, OMB Control Number 0937–0189)

must be submitted to Sharron P. Orum,

Grants Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 314,

Mailstop E–18, Atlanta, GA 30305, on or

before August 6, 1996.

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

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.)

2. Late Applications: Applications

which 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

applicant.

Where To Obtain Additional

Information

A complete program description and

information on application procedures

are contained in the application

package. An application package and

business management and technical

assistance may be obtained from Marsha

Driggans, 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–18, Room 300, Atlanta, GA

30305, telephone (404) 842–6523, Email address

mdd2@opspgo1.em.cdc.gov, facsimile

(404) 842–6513.

Programmatic technical assistance

may be obtained from Dr. Benjamin

Schwartz, Division of Bacterial and

Mycotic Diseases, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Mailstop C–09,

Atlanta, GA 30333, telephone (404)

639–4747, E-mail address

bxs1@ciddbd1.em.cdc.gov.

Important Notice: Atlanta, GA, will be

the host of the 1996 Summer Olympics

Games, July 19 through August 4, 1996.

As a result of this event, it is likely that

the Procurement and Grants Office

(PGO), CDC, may experience delays in

the receipt of both regular and overnight

mail deliveries. Contacting PGO

employees during this time frame may

also be hindered due to the possible

telephone disruptions. To the extent

authorized, please consider the use of

voice mail, E-mail, and facsimile

transmission to the maximum extent

practicable. However, do not fax lengthy

documents or grant applications.

You may obtain this announcement

from one of two Internet sites on the

actual publication date: CDC’s

homepage at http://www.cdc.gov or at

the Government Printing Office

homepage (including free on-line access

to the Federal Register at http://

www.access.gpo.gov).
Federal Register / Vol. 61, No. 125 / Thursday, June 27, 1996 / Notices 33523

Please refer to Announcement

Number 662 when requesting

information regarding this program.

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 through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512- 1800.

Dated: June 21, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16388 Filed 6–26–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement Number 644]

Ecology of the Deer Mouse

(Peromyscus maniculatus) in

Peridomestic Settings

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for a cooperative agreement

program to provide assistance for

studies on the behavior, movement,

reproductive biology, population

structure, and relative infection status of

deer mice (Peromyscus maniculatus)

and deer-mouse populations inhabiting

peridomestic environments.

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

Immunization and Infectious Diseases.

(For ordering a copy of Healthy People

2000, see the section —Where To Obtain

Additional Information.—)

Authority

This program is authorized under

sections 301(a) and 317(k)(2) [42 U.S.C.

241(a) and 247b(k)(2)] of the Public

Health Service Act, as amended.

Applicable program regulations are

found in 42 CFR Part 52, Grants for

Research Projects.

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’s 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 women-owned

businesses are eligible to apply.

Availability of Funds

Approximately $150,000 is available

in FY 1996 to fund one award. It is

expected that the award will begin on or

about September 30, 1996, and will be

made for a 12-month budget period

within a project period of up to 3 years.

Funding estimates may vary and are

subject to change. Continuation awards

within an approved project period will

be made on the basis of satisfactory

progress and availability of funds.

Purpose

The purpose of this cooperative

agreement is to assist the recipient in

gaining knowledge about the behavior,

movement, reproductive biology,

population structure, and relative

infection status of deer mice and deermouse populations inhabiting

peridomestic environments. This

knowledge will lead to improved

assessment of the risk of hantaviral

infection in peridomestic environments

and more effective reservoir control and

risk reduction. Because the major

reservoir of Sin Nombre virus (SNV) in

the western United States has been the

deer mouse, the initial studies should

concentrate on the ecology of this

species. However, as more information

about North American hantaviruses and

their rodent hosts becomes available,

additional studies of other virus/rodent

pairings may be appropriate.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under A. below, and CDC will be

responsible for conducting activities

under B. below:

A. Recipient Activities

1. Locate an area containing a variety

of structures (occupied, unoccupied, or

seasonally occupied; houses, trailers,

and outbuildings; heated and nonheated) where SNV infected deer mice

are known to occur.

2. Use standard ecological and

virological methods to monitor the

dynamics of deer mouse populations

and the dynamics of viral infection

within host populations. Ecological

techniques should include markrecapture and/or radio telemetry

studies. Virological techniques should

be CDC approved and should include

serology (on periodic blood samples

taken from marked animals); methods

may also include antigen-capture

enzyme immunoassay and polymerase

chain reaction for virus detection.

3. Studies similar to those outlined in

#2 above with other virus/rodent

relationships may be appropriate and

should be considered as more

information about North American

hantaviruses and their rodent hosts

becomes available.

4. Analyze and publish study results.

B. CDC Activities

1. Provide consultation and scientific

and technical assistance to the recipient.

2. In collaboration with recipient,

analyze study results.

Evaluation Criteria

Applications will be reviewed and

evaluated according to the following

criteria:

A. Background and Need

Extent to which applicant

demonstrates a clear understanding of

the purpose and objectives of this

proposed cooperative agreement. Extent

to which applicant demonstrates a clear

understanding of the requirements,

responsibilities, interactions, problems,

constraints, complexities, etc., that may

be encountered in conducting the

project and performing the studies. (30

points)

B. Capacity

Extent to which applicant describes

adequate resources and facilities (both

technical and administrative) for

conducting the project including

appropriate laboratory facilities. 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 in this

cooperative agreement as evidenced by

curriculum vitae, publications, etc. (35

points)

C. Objectives and Technical Approach

Extent to which applicant describes

objectives of the proposed project which

are consistent with the purpose and

program requirements of this