Federal Register / Vol. 61, No. 126 / Friday, June 28, 1996 / Notices 33745

in Figures 2a and 2b, which are labeled

to indicate they represent the results of

research from different DNA samples

when in fact a number of lanes are

duplicates. Although Dr. Kumar denies

that he intended to deceive anyone,

C.I.T. concluded in its Report that the

‘‘deliberate presentation of duplications

of one experiment which are labeled to

indicate they came from separate DNA

samples deceives the reader as to the

real source of the DNA in the

experiment, where the central point of

the experiment is the similarity of

results among different sources.’’ ORI

also accepted the C.I.T. conclusion that

Dr. Kumar presented Figure 2c of the

JEM paper ‘‘in a very misleading

fashion.’’ The central observation of the

JEM paper is that both alleles of the

alpha chain of the T-cell receptor gene

are frequently rearranged. This

conclusion was based, in part, on Figure

2c, which C.I.T. found had been labeled

in a misleading fashion that led the

reader to believe that the heavy band at

the top of the blot was an 8kb restriction

fragment (i.e., representing an internal

control) rather than undigested material

that failed to enter the gel. Examination

of the original film indicates that there

was no evidence that the second alphachain rearranges in mature T-cells.

Thus, ORI further accepted the C.I.T.

conclusion that Figure 2 was

intentionally falsified and/or fabricated

and that, as a result, ‘‘one of the main

scientific results of this paper was not

substantiated by the original data.’’

In addition, ORI found that Dr. Kumar

committed scientific misconduct by

falsifying and/or fabricating Figure 5b of

a manuscript that was submitted for

publication to the journal Cell (Cell

manuscript), but was later withdrawn.

ORI accepted the C.I.T. conclusion that

lanes 6, 7 and 8 of Figure 5b are the

same as lanes 11, 12 and 13,

respectively, even though they are

labeled as being from different samples.

ORI also accepted the C.I.T. conclusion

that Dr. Kumar made a number of other

materially misleading statements in the

Cell manuscript that were not supported

by the primary data. For example, C.I.T.

concluded that Dr. Kumar made a

number of materially misleading

statements about the age of mice and the

timing of the injection of peptides into

these mice in a paper published in the

Proceedings of the National Academy of

Sciences, 87:1337–1341 (1990) (PNAS

paper). This information is material

because induction of the disease studied

(i.e., allergic encephalomyelitis) is

dependent upon the age of the mice.

Based upon the findings of scientific

misconduct in the C.I.T. Report, the JEM

and PNAS papers were retracted prior to

ORI’s findings in this case.

ORI and Dr. Kumar agreed to resolve

the case through a negotiated settlement

and limited voluntary exclusion

agreement (Agreement), which the

parties agreed shall not be construed as

an admission of liability or wrongdoing

on the part of the Dr. Kumar. Dr. Kumar

plans to submit a letter to ORI in which

he summarizes his response to ORI’s

findings. Dr. Kumar has agreed to

exclude himself voluntarily from

serving in any advisory capacity to the

PHS, including service on any PHS

advisory committee, board, and/or peer

review committee, or as a consultant for

a period of three years. Dr. Kumar has

also agreed to exclude himself

voluntarily, for a period of eighteen (18)

months from any contracting or

subcontracting with any agency of the

United States Government and from

eligibility for, or involvement in,

nonprocurement transactions (e.g.

grants and cooperative agreements) of

the United States Government.

However, this provision will not apply

to a currently pending PHS grant

application involving Dr. Kumar.

In addition, any institution that uses

Dr. Kumar in any capacity on PHS

supported research must concurrently

submit a plan for supervision of Dr.

Kumar’s duties, designed to ensure the

scientific integrity of Dr. Kumar’s

research, for a period of three (3) years.

Similarly, any institution employing Dr.

Kumar must submit, in conjunction

with each application for PHS funds or

report of PHS funded research in which

Dr. Kumar is involved, a certification

that the data provided by Dr. Kumar are

based on actual experiments or are

otherwise legitimately derived and that

the data, procedures and methodology

are accurately reported in the

application or research report, for a

period of three (3) years.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Research

Investigations, Office of Research

Integrity, 5515 Security Lane, Suite 700,

Rockville, MD 20852.

Dorothy K. Macfarlane,

Acting Director, Office of Research Integrity.

[FR Doc. 96–16561 Filed 6–27–96; 8:45 am]

BILLING CODE 4160–17–P

Agency for Health Care Policy and

Research

Notice of Health Care Policy and

Research Special Emphasis Panel

Meeting

In accordance with section 10(a) of

the Federal Advisory Committee Act (5

U.S.C., Appendix 2) announcement is

made of the following special emphasis

panel scheduled to meet during the

month of August 1996:

Name: Health Care Policy and Research

Special Emphasis Panel.

Date and Time: August 1–2, 1996, 8:00

a.m.

Place: Ramada Inn, 1775 Rockville Pike,

Conference Room TBA, Rockville, Maryland

20852.

Open August 1, 8:00 a.m. to 8:15 a.m.

Closed for remainder of meeting.

Purpose: This Panel is charged with

conducting the initial review of grant

applications proposing to conduct research

related to patient referrals from primary care

to specialty care. Applications were sought

for studies that (1) describe how changes in

health care organization affect referral

practices, and/or (2) measure quality of care,

economic and other outcomes resulting from

decisions by primary care providers (PCPs)

who refer, or do not refer, patients to

specialty providers.

Agenda: The open session of the meeting

on August 1, from 8:00 a.m. to 8:15 a.m., will

be devoted to a business meeting covering

administrative matters. During the closed

session, the committee will be reviewing and

discussing grant applications dealing with

health services research issues. In accordance

with the Federal Advisory Committee Act,

section 10(d) of 5 U.S.C., Appendix 2 and 5

U.S.C., 552b(c)(6), the Administrator,

AHCPR, has made a formal determination

that this latter session will be closed because

the discussions are likely to reveal personal

information concerning individuals

associated with the grant applications. This

information is exempt from mandatory

disclosure.

Anyone wishing to obtain a roster of

members or other relevant information

should contact Karen Rudzinski, Ph.D.,

Agency for Health Care Policy and Research,

Suite 400, 2101 East Jefferson Street,

Rockville, Maryland 20852, Telephone (301)

594–1452 x1610.

Agenda items for this meeting are subject

to change as priorities dictate.

Dated: June 24, 1996.

Clifton R. Gaus,

Administrator.

[FR Doc. 96–16560 Filed 6–27–96; 8:45 am]

BILLING CODE 4160–90–M

Centers for Disease Control and

Prevention

[Announcement 652]

1996 State Pediatric Nutrition

Surveillance Systems

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds to support a cooperative

agreement program in development of

the State Pediatric Nutrition
33746 Federal Register / Vol. 61, No. 126 / Friday, June 28, 1996 / Notices

Surveillance System (PedNSS) to

collect, analyze, and disseminate data

for children aged 5–17 years who are

routinely seen for well-child care in

public health clinics.

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

areas of Nutrition and Maternal and

Child Health. (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) of the

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

241(a) and 42 U.S.C. 247b(k)(2)], as

amended.

Smoke-Free Workplace

PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and 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

Eligible applicants are the official

public health agencies of States or their

bona fide agents. This includes the

District of Columbia, American Samoa,

the Commonwealth of Puerto Rico, the

Virgin Islands, the Federated States of

Micronesia, Guam, the Northern

Mariana Islands, the Republic of the

Marshall Islands, the Republic of Palau,

and federally recognized Indian tribal

governments.

Eligible applicants must have the

ability to collect Statewide data on

height, weight, anemia status, and

sociodemographic information for at

least 5,000 children, aged 5–17 years

who receive well-child care in public

health clinics. Written documentation

must be provided as evidence of this

ability (a computerized record layout of

these specified data items may be used

as evidence).

Availability of Funds

Approximately $150,000 is available

to fund approximately 3 awards. It is

expected that the average award will be

$50,000, ranging from $40,000 to

$60,000. 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 3 years. Funding estimates may

vary and are subject to change.

Continuation awards within the

project period will be made on the basis

of satisfactory performance and

availability of funds.

Purpose

These awards are to assist States to

develop and use the PedNSS to collect,

analyze, and disseminate data for

children aged 5–17 years who are

routinely seen for well-child care in

public health clinics.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for conducting

activities under A., and CDC shall be

responsible for conducting activities

under B.

A. Recipient Activities

1. Develop and use the PedNSS to

collect, analyze, and disseminate data

for children aged 5–17 years who are

routinely seen for well-child care by

public health clinics.

2. In accordance with guidelines to be

provided by CDC, establish and

maintain a data system to collect

PedNSS data items including

sociodemographic variables (geographic

location, ethnicity, race, age),

anthropometry (height, weight) and

hematology (hematocrit and/or

hemoglobin) for children aged 5–17

years who receive well-child care in

public health clinics. If available,

additional data items related to obesity

such as dietary information and

physical activity should be included in

the database.

3. Develop and carry out procedures

to ensure the completeness and quality

of the data, including training and data

editing.

4. With technical assistance and/or

provision of software from CDC,

produce data for analysis and generation

of reports.

5. Develop and carry out a plan for the

analysis, interpretation, and use of

surveillance data in appropriate

prevention and intervention programs

as needed to reduce the prevalence of

thinness, overweight, and anemia

among older children.

6. Prepare and disseminate

surveillance information, through

presentation and publication in

appropriate forums.

B. CDC Activities

1. Provide standardized data items,

code definitions, and methods to collect

the desired surveillance information.

2. Provide training in the appropriate

skills to collect anthropometric and

hematologic data.

3. Provide technical support for

mainframe and personal computer

software programs available from CDC

for data processing and analysis.

4. Assist States with the analyses,

interpretation, and use of the

surveillance data for program planning

and evaluation at the State and local

level.

Evaluation Criteria (100 Points)

Applications will be reviewed and

evaluated according to the following

criteria:

A. Statement of Need (5 Points)

Evidence of the need for data on

thinness, overweight, and anemia

among older children.

B. Goals and Objectives (5 Points)

The appropriateness of goals,

objectives, and whether objectives are

specific, measurable, time-phased, and

feasible.

C. Operational Plan (45 points)

The adequacy of the plan to develop

the PedNSS system:

1. To collect data on children aged 5–

17 years, provide additional data items.

2. To design, test, and provide data in

a timely manner.

3. To assure completeness and quality

of data.

4. To analyze, interpret, and use

surveillance data in decision making.

5. To disseminate surveillance

findings.

D. Capability (35 Points)

1. The availability of current and

historic Statewide data for children aged

5–17 years (such as 100 percent of

clinics or service providers of the

program).

2. Existing case management system

to improve compliance with routine

well-child clinic visits.

3. The extent to which key staff have

experience with surveillance systems

and data analysis and evaluation; and

evidence of a strong working

relationship with relevant

organizational entities is provided.

E. Project Evaluation (10 Points)

The appropriateness of the project

evaluation to assess:

1. The completeness and quality of

data shared with CDC for analysis.

2. The use of surveillance data for

program planning and evaluation.
Federal Register / Vol. 61, No. 126 / Friday, June 28, 1996 / Notices 33747

3. The dissemination of data through

presentations and publications.

F. Budget (Not Weighted)

The extent to which the applicant

describes the total amount of funds

requested in each of the object class

categories and clearly links the budget

items to objectives and activities

proposed for the budget period.

G. Human Subjects: (Not Weighted)

Whether or not exempt from the

Department of Health and Human

Services (DHHS) regulations, are

procedures adequate for the protection

of human subjects? 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

Objective Review Group 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

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372. E.O. 12372 sets up

a system for State and local government

review of proposed Federal assistance

applications. Applicants (other than

federally recognized Indian tribal

Governments) should contact their State

Single Point of Contact (SPOC) as early

as possible to alert them to the

prospective applications and receive

any necessary instructions on the State

process. For proposed projects serving

more than one State, the applicant is

advised to contact the SPOC of each

affected State. A current list of SPOCs

is included in the application kit. If

SPOCs have any State process

recommendations on applications

submitted to CDC, they should send

them 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, mail

Stop E–18, Atlanta, Georgia 30305, no

later than 30 days after the application

deadline. The appropriation for this

financial assistance program was

received late in the fiscal year and

would not allow for an application date

which would accommodate the 60-day

State recommendation process period.

The Program Announcement Number

and Program Title should be referenced

on the document. The granting agency

does not guarantee to ‘‘accommodate or

explain’’ State process

recommendations it receives after that

date.

Indian tribes are strongly encouraged

to request tribal government review of

the proposed application. If tribal

governments have any tribal process

recommendations on applications

submitted to CDC, they should forward

them to Sharron P. Orum, Grants

Management Office, Grants Management

Branch, Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry

Road, NE., Room 314, Mailstop E–18,

Atlanta, Georgia 30305. This should be

done no later than 30 days after the

application deadline. The granting

agency does not guarantee to

‘‘accommodate or explain’’ for tribal

process recommendations it receives

after that date.

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 10 or more individuals

and funded by the 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. 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 assurance in

accordance with the appropriate

guidelines and form provided in the

application kit. Should human subjects

review be required, the proposed

workplan should incorporate timelines

for such development and review

activities.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (Revised

7/92, OMB 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, Mail

Stop E–18, Atlanta, Georgia 30305, on or

before July 29, 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 the U.S. Postal Service. Private

metered postmarks shall not be

acceptable as proof of timely mailing.)

2. Late Application: Applications that

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,

information on application procedures,

application package, and business

management technical assistance may

be obtained from Albertha Carey, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 314, Mail

Stop E–18, Atlanta, Georgia 30305, or by

telephone on (404) 842–6508; by fax on

(404) 842–6513; or by Internet or CDC

WONDER electronic mail at

<ayc1@opspgo1.em.cdc.gov>.

Technical assistance may be obtained

from Diane Clark, Public Health

Nutritionist, Division of Nutrition,

National Center for Chronic Disease

Prevention and Health Promotion,

Centers for Disease Control and

Prevention (CDC), Mail Stop K–25, 4770

Buford Highway, NE., Atlanta, Georgia

30341–3724, or by telephone on (770)

488–4913; by fax on (770) 488–4728; or
33748 Federal Register / Vol. 61, No. 126 / Friday, June 28, 1996 / Notices

by Internet or CDC WONDER electronic

mail at <ldc2@ccddn1.em.cdc.gov.

Please refer to Announcement 652

when requesting information and

submitting an application.

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.

There may be delays in mail delivery

and difficulty in reaching the cdc

atlanta offices during the 1996 summer

olympics. therefore, CDC suggests using

internet, following all instructions in

this announcement and leaving

messages on the contact person’s voice

mail for more timely responses to any

questions.

Dated: June 24, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16546 Filed 6–27–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement Number 645]

Applied Research in Emerging

Infections—Tickborne Diseases

Introduction

The Centers for Disease Control and

Prevention (CDC) is implementing a

program for competitive cooperative

agreements and/or research project

grants to support applied research on

emerging infections. CDC announces the

availability of fiscal year (FY) 1996

funds for cooperative agreements and/or

research project grants to conduct

applied research on domestic tickborne

diseases (e.g., ehrlichiosis, babesiosis,

Rocky Mountain spotted fever,

tularemia, Colorado tick fever, etc.). 1.

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.

1. Note: An existing CDC cooperative

agreement program supports research

focusing on Lyme disease caused by Borrelia

burgdorferi, specifically. Therefore, this new

program will not support research projects

which focus substantially on classical Lyme

disease caused by B. burgdorferi.

(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

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,

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 $300,000 is available

in FY 1996 to fund approximately two

to four awards. It is expected that

approximately two-thirds of the funds

will be made available for the first

programmatic focus (epidemiologic

studies focusing on ehrlichiosis) and

one-third for the second (development

of improved diagnostic tests for

babesiosis). 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 three

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

announcement is to provide assistance

for tickborne disease projects addressing

the following two programmatic focus

areas:

1. Epidemiologic studies focusing on

ehrlichiosis

2. Development and evaluation of

improved diagnostic tests for babesiosis.

Applicants may submit separate

applications for projects in one or both

programmatic areas. See Application

Content of the program announcement

included in the application kit for

detailed application instructions.

Program Requirements

Applicants may apply and receive

support for projects under one or both

of the two programmatic focus areas. In

conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under either A.1. or A.2., or both, below;

and CDC will be responsible for

conducting activities under B., below:

A. Recipient Activities

1. Epidemiologic Studies

Implement an active prospective

ehrlichiosis surveillance system in a

geographic area where the disease(s)

(monocytic or granulocytic) is/are

believed to be present, utilizing case

finding based on a standardized clinical

case definition. Cases should be

laboratory confirmed, using

standardized methods such as isolation

or direct detection of the etiologic agent

from clinical specimens by antigen

detection or PCR; and/or serology.

Laboratory diagnosis should be

validated by retesting clinical

specimens in a reference laboratory. A

population based study in which

incidence can be calculated and that

simultaneously captures incident cases

of babesiosis in the same location is

most desirable.

2. Development and Evaluation of

Improved Diagnostic Tests for

Babesiosis:

a. Develop and evaluate improved

laboratory methods for the diagnosis of

babesiosis, which may include methods

for antibody or antigen detection,

molecular techniques, and isolation of

the parasite from clinical specimens.

Consider such characteristics of the test

as sensitivity (e.g., ability to detect

subpotent infection), specificity (e.g.,

ability to distinguish Babesia infection

from other infections and conditions,

ability to distinguish persistent from

remote Babesia infection, genus- vs.

species-level specificity), and ease of

automation.

b. As part of certain projects and as

appropriate, obtain and provide such