Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Notices 31121

Ann Malester, FTC/S–2308,

Washington, D.C. 20580. (202) 326–

2682.

SUPPLEMENTARY INFORMATION: On

Tuesday, November 7, 1995, there was

published in the Federal Register, 60 FR

56153, a proposed consent agreement

with analysis In the Matter of The

Upjohn Company, et al., for the purpose

of soliciting public comment.

Interested parties were given sixty

(60) days in which to submit comments,

suggestions or objections regarding the

proposed form of the order.

No comments having been received,

the Commission has ordered the

issuance of the complaint in the form

contemplated by the agreement, made

its jurisdictional findings and entered

an order to divest, as set forth in the

proposed consent agreement, in

disposition of this proceeding.

(Sec. 6, 38 Stat. 721; 15 U.S.C. 46. Interpret

or apply sec. 5, 38 Stat. 719, as amended; sec.

7, 38 Stat. 731, as amended; 15 U.S.C. 45, 18)

Donald S. Clark,

Secretary.

[FR Doc. 96–15495 Filed 6–18–96; 8:45 am]

BILLING CODE 6750–01–M

GENERAL ACCOUNTING OFFICE

Federal Accounting Standards

Advisory Board

AGENCY: General Accounting Office.

ACTION: Cancellation of meeting.

SUMMARY: Pursuant to section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), as amended, notice is

hereby given that the Federal

Accounting Standards Advisory Board

meeting previously scheduled for

Thursday, June 20, 1996, is hereby

cancelled. The next meeting will be

held on Thursday, July 25, 1996, for

which due notice will be given.

FOR FURTHER INFORMATION CONTACT:

Ronald S. Young, Executive Staff

Director, 750 First St., N.E., Room 1001,

Washington, D.C. 20002, or call (202)

512–7350.

Authority: Federal Advisory Committee

Act. Pub. L. No. 92–463, Section 10(a)(2), 86

Stat. 770, 774 (1972) (current version at 5

U.S.C. app. section 10(a)(2) (1988); 41 CFR

101–6.1015 (1990).

Dated: June 14, 1996.

Ronald S. Young,

Executive Director.

[FR Doc. 96–15586 Filed 6–18–96; 8:45 am]

BILLING CODE 1610–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement Number 663]

Applied Research in Emerging

Infections—Genetics of Antimicrobial

Resistance and Novel Methods for

Detection of Antiviral Resistance

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 grant/

cooperative agreement program to

conduct research on the genetic analysis

of antimicrobial resistance

determinants.

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 and 317 of the Public

Health Service Act, as amended (42

U.S.C. 241 and 247b).

Smoke-Free Workplace

The 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 up to three awards.

It is expected that the average award

will be $125,000, ranging from $80,000

to $250,000.

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 the emerging

infections extramural research program,

the purpose of this grant/cooperative

agreement announcement is to provide

assistance for projects addressing the

following two focus areas:

1. Mechanisms of Dissemination of

Antimicrobial Resistance Genes

The focus of the investigations should

be the examination of the role of

plasmids, transposons, and integrons in

antimicrobial resistance gene

dissemination, the natural variation of

the nucleotide sequences of resistance

genes, and the impact of those changes

on the resistance phenotype mediated

by the genes. This should include

examination of the role of antimicrobial

use in institutions and its effect on gene

dissemination. Assistance under this

focus area will be provided for projects

specifically addressing either of the

following:

a. Improving understanding of the

mechanisms by which vancomycin

resistance genes in enterococci or genes

encoding extended-spectrum βlactamases in Klebsiella pneumoniae are

spread in hospitals or other healthcare

institutions (including nursing homes

and clinics) and become part of the

endemic flora of the institution.

b. Improving understanding of the

mechanisms by which macrolide

resistance genes (such as those encoding

erythromycin resistance) are acquired

and disseminated in Streptococcus

pneumoniae in communities.

2. Antiviral Susceptibility

Determination Methods: Development

of improved methods for measuring the

susceptibility of herpes simplex virus

(HSV) isolates to acyclovir. Current

methods for measuring drug
31122 Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Notices

susceptibility of HSV isolates are laborintensive, expensive, and have not been

standardized. These shortcomings stand

as impediments to surveillance for

acyclovir-resistant HSV or resistance in

other viral pathogens. Specifically,

assistance will be provided for projects

focusing on development of assays

based on novel methods or approaches

for measuring the susceptibility of HSV

to acyclovir. Such assays should be

capable of providing results comparable

to current plaque reduction and dyeuptake assays.

Applicants may submit separate

applications for projects under one or

both focus areas.

Program Requirements

Recipients may separately apply and

receive support for projects under one

or both of the two focus areas. In

conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for the activities

under A.1. or A.2. (depending upon

which focus areas the recipient applies

and receives support for) and CDC shall

be responsible for conducting activities

under B., below:

A. Recipient Activities

1. Mechanisms of Dissemination of

Antimicrobial Resistance Genes

a. Select study sites: Study sites may

include (a) one or more hospitals or

related health care institutions known to

have endemic or emerging problems

with antimicrobial-resistant organisms

in which extensive monitoring of

antimicrobial-resistant strains has been

conducted or (b) communities with

extensive active surveillance.

b. Collect isolates with corresponding

epidemiologic and clinical data: Assure

that the isolates are well characterized

with respect to phenotype, genotype,

and mode of transmission from patient

to patient. Collect bacterial strain typing

information such as that derived by

pulsed-field gel electrophoresis (PFGE),

arbitrary primed polymerase chain

reaction (PCR), restriction fragment

length polymorphism (RFLP), plasmid

fingerprinting, serotyping, or other

highly discriminatory strain typing

methods. Obtain antibiograms expressed

as minimal inhibitory concentrations

(MICs) of common antibiotics. One

example of an appropriate approach to

collection of isolates and data would be

to assemble a series of isolates of

vancomycin-resistant enterococci (VRE)

from a single hospital with the

corresponding PFGE data documenting

the routes of transmission of the isolates

among patients in the institution. The

overall rates of infections over several

years and the diversity of strains present

in the institutions or communities

would be determined. This would

presumably involve microbiology

laboratories, infection control

practitioners (for health care

institutions), public health officials, and

epidemiologists. Additionally,

collection of data regarding

antimicrobial use (expressed as Defined

Daily Doses per 1000 patient-days) by

area of the institution (e.g., intensive

care unit or other inpatient ward) or in

communities would be useful.

c. Characterize the resistance

determinants present by phenotypic and

molecular methods: Obtain MICs to an

extended array of antimicrobial agents

to classify the phenotype (e.g.,

teicoplanin to distinguish VanA from

VanB). Determine strain types (when

appropriate), the presence of plasmids

or other genetic elements, and the

presence of resistance genes in the

strains as identified by using DNA

probes or specific PCR, LCR, or other

genetic assays.

d. Monitor transmission and evaluate

data: Characterize the resistance genes

present in the isolates, the modes of

genetic exchange of the resistance

determinants among isolates in the

institutions or communities, and

determine whether changes in the DNA

or amino acid sequences of the genes are

associated with broadening of the

phenotype of the isolates carrying the

genes. Consider the influence of

antimicrobial use on frequency and

mode of gene transmission and on

changes in the phenotype of the isolates.

Depending on the studies conducted,

questions that could be addressed

include: (1) Is an initial period of

plasmid transfer among organisms

followed by dissemination of a

transposable element to multiple

plasmids in strains of enterococci

resulting in the vancomycin resistance

phenotype being present in multiple

strains of enterococci (as evidenced by

widely divergent pulsed-field gel

electrophoresis types)? (2) Do changes

in the sequence of vanB correlate with

increased resistance to teicoplanin? (3)

Do the mode of transfer and the

phenotype vary by antimicrobial use

patterns in the institution or in certain

wards of the institution?

e. Disseminate research findings:

Disseminate research results by

appropriate methods such as

publication in journals, presentation at

meetings and conferences, etc.

2. Antiviral Susceptibility

Determination Methods

a. Study isolates: Identify a source of

HSV isolates for study. Ideally, this

should include isolates from fresh

clinical specimens that can be tested in

parallel with the plaque reduction or

dye uptake methods and for which

acyclovir resistance has previously been

documented.

b. Devise a novel assay for

determining the level of acyclovir

susceptibility of clinical HSV isolates:

Establish a quality control system to

insure the reproducibility of the assay.

A quality control strain of HSV should

be designated as part of the testing

method and data showing its

effectiveness should be established. A

useful novel assay should be at least

equivalent in performance and (ideally)

substantially less expensive than

current assays. The new method should

be adaptable to a high-throughput, semiautomated format. Establish criteria for

designating HSV isolates as

‘‘susceptible’’ or ‘‘resistant’’ to

acyclovir.

c. Evaluate the performance of the

new assay in comparison with the

plaque reduction assay. To be useful for

surveillance of resistance, any new

assay should be substantially equivalent

to those in current use (Am. J. Med.

73:380–382,1982).

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

possessing sufficient resources for

clinical, laboratory, and data

management services and a level of

scientific expertise to achieve the

objectives described in their 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; (2)

performing selected laboratory tests as

appropriate; (3) participate in data

management, the analysis of research

data, and the interpretation and

presentation of research findings; and
Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Notices 31123

(4) providing biological materials (e.g.,

strains) as necessary for studies, etc.

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.

Before issuing awards, CDC will inform

the proposed grantee 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

Program 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, 2)

name, address, and phone number of

contact person, and 3) under which

focus area(s) application(s) will be

submitted. Notification should be

provided to Greg Jones, M.P.A., by

facsimile (404) 639–4195, E-mail

gjj1@cidod1.em.cdc.gov or postal mail

at National Center for Infectious

Diseases, Centers for Disease Control

and Prevention, 1600 Clifton Road, NE.,

Mailstop C–19, Atlanta, Georgia 30333.

Application Process

Applicants may apply for assistance

for projects in one or both of the specific

programmatic focus areas identified

under Purpose and Program

Requirements above. If applying for

assistance for more than one of the two

focus areas, a separate and complete

application must be submitted for each

project/focus area.

Evaluation Criteria

The applications will be reviewed and

evaluated according to the following

criteria:

1. Background and Need (20 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 grant/cooperative

agreement 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 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. (10

points)

3. Objectives and Technical Approach

(40 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/

cooperative agreement 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 and

describes appropriate study sites (per

Recipient Activities 1.a.) or HSV isolates

(per Recipient Activities 2.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 proposed studies and

extent to which the plan is adequate to

accomplish the objectives. Extent to

which applicant describes specific

study protocols or plans for the

development of study protocols that are

appropriate for achieving project

objectives.

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). (15 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. (5 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.

Executive Order 12372 Review

This program is not subject to

Executive Order 12372,

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
31124 Federal Register / Vol. 61, No. 119 / Wednesday, June 19, 1996 / Notices

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. In addition to other

applicable committees, Indian Health

Service (IHS) institutional review

committees also must review the project

if any component of IHS will be

involved or will support the research. If

any American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it. 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 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 exists 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

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 Form PHS–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 300,

Mailstop E–18, Atlanta, Georgia 30305,

Attention: Marsha Driggans, on or before

August 5, 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,

Georgia 30305, telephone (404) 842–

6523, E-mail

mdd2@opspgo1.em.cdc.gov, facsimile

(404) 842–6513.

Programmatic technical assistance

may be obtained from Dr. Fred C.

Tenover, Hospital Infections Program,

National Center for Infectious Diseases,

Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road,

NE., Mailstop G–08, Atlanta, Georgia

30333, E-mail fnt1@cidhip1.em.cdc.gov,

telephone (404) 639–3246.

Please refer to Announcement

Number 663 when requesting

information regarding this program.

Important Notice: Atlanta, Georgia,

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).

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 11, 1996.

Joseph R. Carter,

Acting Associate Director for Management

And Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–15558 Filed 6–18–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement Number 532A]

Cooperative Agreements for a National

System of Integrated Activities To

Prevent HIV Infection and Other

Serious Health Problems Among

Students, Especially Postsecondary

Students and Those in High-Risk

Situations

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for cooperative agreements to

establish a national system of integrated

activities for preventing HIV infection

and other serious health problems

among the nation’s students, especially

postsecondary students and those in

high-risk situations. This program

announcement is an amendment to

Announcement Number 532 published

in the Federal Register on June 16,

1995, pages 31721 through 31724 [60 FR

31721]. (A cooperative agreement is a

legal agreement in which CDC provides

financial assistance and substantial

programmatic assistance to the recipient

during the project.)

The CDC is committed to

implementing the recommendations

outlined in the External Review of HIV

Prevention Strategies and 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 program announcement is

related to the priority areas of Health

Promotion and Preventive Services with

a particular focus on HIV Infection

Objective 18.11, to ‘‘Provide HIV

education for students and staff in at

least 90% of colleges and universities’’;