42558 Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Findings of Scientific Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

SUMMARY: Notice is hereby given that

the Office of Research Integrity (ORI)

has made a final finding of scientific

misconduct in the following case:

David N. Shapiro, M.D., St. Jude

Children’s Research Hospital: Based

upon a report from St. Jude Children’s

Research Hospital as well as

information obtained by the Office of

Research Integrity (ORI) during its

oversight review, ORI found that Dr.

Shapiro, former faculty member, St.

Jude Children’s Research Hospital,

engaged in scientific misconduct by

falsifying the authorship of five

publications listed in his biographical

sketches in several National Institutes of

Health (NIH) grant applications,

including applications submitted to the

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

(NIAMS), the National Institute of

General Medical Sciences (NIGMS), the

National Institute of Diabetes and

Digestive and Kidney Diseases (NIDDK),

and the National Cancer Institute (NCI).

Specifically, Dr. Shapiro listed

himself as an author when he was not.

Dr. Shapiro also fabricated data for

Figures 5 and 7 in the following

publication: Sublett, J.E., Jeon, I.S., &

Shapiro, D.N. ‘‘The aveolar

rhabdomyosarcoma PAX3/FKHR fusion

protein is a transcriptional activator.’’

Oncogene 11:545–552, 1995. Dr.

Shapiro has submitted a letter to

Oncogene requesting retraction of these

figures.

Dr. Shapiro has accepted the ORI

finding and has entered into a Voluntary

Exclusion Agreement with ORI in which

he has voluntarily agreed:

(1) To exclude himself from serving in

any advisory capacity to the Public

Health Service (PHS), including but not

limited to service on any PHS advisory

committee, board, and/or peer review

committee, or as a consultant for a

period of three (3) years, beginning on

July 29, 1997;

(2) To exclude himself 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 as

defined in 45 CFR part 76 (Debarment

Regulations) for a period of two (2)

years, beginning on July 29, 1997;

(3) That any institution that submits

an application for PHS support for a

research project on which Dr. Shapiro’s

participation is proposed or that uses

him in any capacity on PHS supported

research must concurrently submit a

plan for supervision of his duties to the

funding agency for approval for a period

of one (1) year following the two (2) year

exclusion. The supervisory plan must be

designed to ensure the scientific

integrity of Dr. Shapiro’s research

contribution. The institution also must

submit a copy of the supervisory plan to

ORI.

FOR FURTHER INFORMATION CONTACT:

Acting Director, Division of Research

Investigations, Office of Research

Integrity, 5515 Security Lane, Suite 700,

Rockville, MD 20852, (301) 443–5330.

Chris B. Pascal,

Acting Director, Office of Research Integrity.

[FR Doc. 97–20816 Filed 8–6–97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Toxic Substances and

Disease Registry

Notice of Meeting

The Agency for Toxic Substances and

Disease Registry announces the

following meeting.

Name: Expert Workshop Regarding

Medical Monitoring in Bunker Hill, Idaho.

Times and Dates: 8:30 a.m.–5 p.m., August

19, 1997. 8:30 a.m.–5 p.m., August 20, 1997.

Place: Kellogg Middle School Library, 800

Bunker Avenue, Kellogg, Idaho 83837,

telephone 208/784–1348.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 100 people.

Purpose: Target population(s) of residents

and workers in and surrounding the former

Bunker Hill lead and zinc smelting facility in

Idaho have received past exposures to lead

(and possibly other heavy metals).

The exposures have decreased markedly,

but studies show adverse health outcomes in

these populations, most probably as a result

of the past exposures. The literature supports

an association between known adverse health

outcomes and lead exposure.

ATSDR wants to determine if there is a

definable population at significantly

increased risk of disease who may benefit

from a medical monitoring program. ATSDR

will judge the appropriateness of such a

program by applying its medical monitoring

criteria. If a program is deemed appropriate,

the agency will develop a medical

monitoring plan for the target population(s).

ATSDR is planning three workshops

consisting of external experts to provide

individual input and guidance about

applying the medical monitoring criteria to

Bunker Hill. This announcement is for the

first workshop; all three workshops will be

open to the public.

Matters To Be Considered: The objective of

the first workshop is to use all available

information from ATSDR and other relevant

data to make individual recommendations

and answer questions related to the

application of the first four ATSDR medical

monitoring criteria at Bunker Hill, definition

of the target populations, and specific

outcomes as candidates for monitoring.

Community and local health representatives

and nationally recognized lead experts will

convene to consider the first four ATSDR

Medical Monitoring Criteria as they apply to

Bunker Hill.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Vivian Rush, M.D., Medical Officer, ATSDRDivision of Health Education and Promotion,

1600 Clifton Road, NE, M/S E–33, Atlanta,

Georgia 30333; telephone 404/639–5080.

Dated: August 1, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–20785 Filed 8–6–97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Toxic Substances and

Disease Registry

[ATSDR–123]

ATSDR’s Interim Policy Guideline and

Technical Support Document on

Dioxin and Dioxin-Like Compounds in

Soil

AGENCY: Agency for Toxic Substances

and Disease Registry (ATSDR),

Department of Health and Human

Services (HHS).

ACTION: Notice of availability.

SUMMARY: This notice announces the

availability of ATSDR’s ‘‘Interim Policy

Guideline: Dioxin and Dioxin-Like

Compounds in Soil,’’ and the

‘‘Technical Support Document for

ATSDR Interim Policy Guideline:

Dioxin and Dioxin-Like Compounds in

Soil.’’ ATSDR has adopted this interim

policy guideline to assess the public

health implications of dioxin and

dioxin-like compounds in residential

soils near or on hazardous waste sites.

These compounds include 2,3,7,8-

tetrachlorodibenzo-p-dioxin (TCDD),

related chlorinated dibenzo-p-dioxins

(CDDs), chlorinated dibenzofurans

(CDFs), and other structurally related

groups of chemicals from the family of

halogenated aromatic hydrocarbons.
Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42559

DATES: Comments concerning this

notice and the interim guidelines must

be received by October 6, 1997.

ADDRESSES: Requests for a copy of these

documents should be sent to the

attention of Ms. Kim E. Jenkins,

Division of Toxicology, Agency for

Toxic Substances and Disease Registry,

Mailstop E–29, 1600 Clifton Road, NE

Atlanta, Georgia 30333. Requests for the

documents must be in writing.

Comments on this notice should bear

the docket control number ATSDR–123

and should be sent to the attention of

Dr. Jim Holler, Agency for Toxic

Substances and Disease Registry,

Division of Toxicology, Emergency

Response and Scientific Assessment

Branch, 1600 Clifton Road, NE Mailstop

E–29, Atlanta, Georgia 30333.

Comments on this notice will be

available for public inspection at the

Agency for Toxic Substances and

Disease Registry, Building 4, Executive

Park Drive, Atlanta, Georgia (not a

mailing address), from 8 a.m. until 4:30

p.m., Monday through Friday, except for

legal holidays. Because all public

comments are available for public

inspection, no confidential business

information should be submitted in

response to this notice.

FOR FURTHER INFORMATION CONTACT: Dr.

Christopher T. De Rosa, Director,

Division of Toxicology, Agency for

Toxic Substances and Disease Registry,

1600 Clifton Road, NE Mailstop E–29,

Atlanta, Georgia 30333, telephone (404)

639–6300.

SUPPLEMENTARY INFORMATION: This

interim policy guideline provides a

description of ATSDR’s current

approaches and judgments regarding

hazards posed by the presence of TCDD

and its less toxic dioxin-like congeners,

the CDDs and CDFs, in residential soils.

Likely users of this interim policy

guideline include health assessors at

ATSDR and in the States, and ATSDR

partners including relevant Federal,

State, and local health and

environmental entities, and concerned

community groups who may be

involved in a range of health assessment

and risk management decisions.

The technical support document is

intended to serve as technical

background and support for the agency

interim policy guideline and, to the

extent practicable, harmonize such

efforts with those of other Federal

agencies and relevant organizations.

This document reflects an assessment of

current practice within the agency and

defines the appropriate roles of

professional judgment and emerging

scientific principles in ATSDR’s public

health assessments of exposures to

dioxin and dioxin-like compounds.

These guidelines and procedures

apply to human exposure by direct

ingestion of soils contaminated with

dioxin and dioxin-like compounds in

residential areas and may not be

appropriate for exposure by other routes

or media. This guidance will be

evaluated in the future in view of new

data that may become available.

Dated: July 31, 1997.

Georgi Jones,

Director, Office of Policy and External Affairs,

Agency for Toxic Substances and Disease

Registry.

[FR Doc. 97–20740 Filed 8–6–97; 8:45 am]

BILLING CODE 4163–70–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0040]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by September

8, 1997.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Survey of Food Safety Practices of Food

Processing Firms—New Collection

FDA is evaluating the marginal costs

of requiring food processors to use

Hazard Analysis and Critical Control

Point (HACCP) systems. HACCP is

already required for seafood processors,

and FDA is considering whether to issue

regulations requiring HACCP for

processors of other foods under the

agency’s jurisdiction. The analysis of

marginal costs requires information

about the prevalence of specific HACCP

systems and practices among food

manufacturers and repackers. FDA will

collect this information through an

anonymous voluntary survey of a

random sample of food processors.

Additionally, through a series of onsite

visits to selected processors, a

contractor will collect information on

the marginal cost of various procedures

required to operate a HACCP system.

The information will help the Center for

Food Safety and Applied Nutrition

determine the baseline level of HACCP

use from which to estimate the

economic costs to the industry of

mandatory HACCP regulations for foods

other than seafood. FDA will use this

information in tailoring any HACCP

regulations that may issue so that costs

and benefits of such regulations are

appropriately considered.

In the Federal Register of February

28, 1997 (62 FR 9194), the agency

requested comments on the proposed

collection of information. FDA received

one comment that supported the

implementation of HACCP but

questioned several aspects associated

with the proposed survey. First, the

comment questioned whether the

survey would yield ‘‘reliable’’ or

‘‘practical’’ data because it was difficult

to interpret what ‘‘critical control point’’

means and what the term ‘‘hazards’’

includes. The comment stated ‘‘it is

difficult to identify costs attributable

only to HACCP in facilities where the

system has been implemented.’’ This

comment is not relevant to the survey

because the survey does not ask

processors about critical control points,

hazards, or costs of HACCP but, instead,

seeks information on the processes and

controls currently in place.

The comment also stated that FDA

should use other sources of data. In fact,

FDA is already planning to used

multiple sources of information to

estimate the marginal costs of requiring

HACCP. These sources include

interviews with food processing firms

and information taken from pilot plants

that are already using HACCP, and

comments received during other HACCP

rulemakings.