Federal Register / Vol. 60, No. 87 / Friday, May 5, 1995 / Notices 22401

ADDRESSES: Submit written comments

and requests for single copies of the

report to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

Comments and requests should be

identified with the docket number

found in brackets in the heading of this

document. Send two self-addressed

adhesive labels to assist that office in

processing your requests. Copies of the

document will be available at cost from

the Freedom of Information Staff (HFI–

35), Food and Drug Administration, rm.

12A-16, 5600 Fishers Lane, Rockville,

MD 20857. The report and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday thru Friday.

FOR FURTHER INFORMATION CONTACT:

Mary M. Bender, Center for Food Safety

and Applied Nutrition (HFS–165), Food

and Drug Administration, 200 C St., SW,

Washington, DC 20204, 202–205–5592.

SUPPLEMENTARY INFORMATION: The 1990

amendments amended the Federal

Food, Drug, and Cosmetic Act (the act)

to require, among other things, that

under section 403(q)(4) of the act (21

U.S.C. 343 (q)(4)), FDA: (1) Identify the

20 most frequently consumed raw fruits,

vegetables, and fish in the United States;

(2) establish guidelines for the voluntary

nutrition labeling of these raw fruits,

vegetables, and fish; and (3) issue

regulations that define ‘‘substantial

compliance’’ with respect to the

adherence by food retailers with those

guidelines. In the Federal Register of

July 2, 1991 (56 FR 30458), FDA

responded to those requirements by a

proposal, and, in the Federal Register of

November 27, 1991 (56 FR 60880), the

agency published a final rule on the

nutrition labeling of raw fruits,

vegetables, and fish (corrected on March

6, 1992 (57 FR 8174)).

FDA listed the 20 most frequently

consumed raw fruits, vegetables, and

fish in 21 CFR 101.44. In 21 CFR 101.45,

FDA set forth guidelines on nutrition

labeling for these foods. Under these

guidelines, nutrition labeling

information may be provided within the

retail departments where raw fruits,

vegetables, and fish are sold.

Information may be made available in

signs, posters, brochures, notebooks, or

leaflets and may be supplemented by

video, live demonstration, or other

media.

In § 101.43 (21 CFR 101.43), FDA

defined substantial compliance to mean

that at least 60 percent of the food

retailers sampled in a representative

survey provide nutrition labeling

information (as specified in the

guidelines) for at least 90 percent of the

foods that they sell that are included on

the listing of the most frequently

consumed raw fruits, vegetables, and

fish. FDA said that it would make

separate determinations of substantial

compliance for raw fruits and vegetables

collectively and for raw fish

(§ 101.43(a)).

Section 403(q)(4)(C)(ii) of the act

states that if substantial compliance is

achieved by food retailers, FDA is to

reassess voluntary labeling compliance

every 2 years. The act also states that if

substantial compliance is not achieved,

FDA is to propose to require that

nutrition information be provided by

any person who offers raw fruits and

vegetables or raw fish to consumers

(section 403(q)(4)(D)(i) of the act).

In the Federal Register on May 18,

1993 (58 FR 28985), FDA announced the

availability of a report that found that

there was substantial compliance under

the standard established in § 101.43 by

food retailers in the provision of

nutrition labeling information for raw

fruits, vegetables, and fish. Aggregate

percentages (i.e., percentages over all

stores sampled) for both raw fruits and

vegetables and for raw fish showed that

approximately three-fourths of the retail

food stores surveyed provided the

voluntary nutrition information.

Because substantial compliance was

achieved in 1993, section

403(q)(4)(C)(ii) of the act required that

FDA reassess voluntary labeling

compliance and issue a report in 1995.

FDA is now announcing that this

reassessment has been done. The results

of that reassessment are set forth in the

report, ‘‘Food and Drug Administration

Nutrition Labeling Information Study,

Raw Fruits/Vegetables and Raw Fish.’’

Based upon the results of this study

that was conducted under contract, FDA

once again concludes that substantial

compliance by food retailers in

providing nutrition labeling information

for raw fruits, vegetables, and fish has

been met. On a store count basis, threefourths (75.3 percent for raw produce

and 75.4 percent for raw fish) of the

sampled stores selling raw fruits,

vegetables, and fish provided nutrition

labeling information in the departments

where the raw foods are sold.

Data were also reported on an all

commodity volume (ACV) basis. ACV

data are weighted estimates that

represent annual store sales volumes

and reflect the percent of the market

serviced. ACV data approximate more

representatively than store counts, the

percent of the population exposed to the

nutrition labeling information. ACV

values were slightly higher than those

for sampled store counts.

For raw fruits/vegetables, stores in

compliance account for 81.4 percent of

the annual sales of all food stores, and

for raw fish, stores in compliance

account for 76.8 percent of the annual

sales of all food stores. These data may

be interpreted as evidencing that over

three-fourths of U.S. consumers are

exposed to nutrition labeling

information for raw fruits, vegetables,

and fish because they shop in retail food

stores that provide the labeling. Because

many consumers shop in more than one

store, the actual level of consumer

exposure is most likely to be even

higher.

FDA will again survey retail stores in

1997 to determine whether substantial

compliance in the provision of

voluntary labeling information for raw

fruits, vegetables, and fish continues to

exist. If at that time substantial

compliance is not met, the agency will

propose to modify § 101.43 to make the

program mandatory.

Dated: May 1, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–11119 Filed 5–4–95; 8:45 am]

BILLING CODE 4160–01–F

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 final findings of scientific

misconduct in the following case:

Terence S. Herman, M.D., Harvard

Medical School: The Division of

Research Investigations (DRI) of the

Office of Research Integrity (ORI)

reviewed an investigation conducted by

Harvard Medical School into possible

scientific misconduct on the part of Dr.

Herman while he was an employee of

that institution. ORI concurred with the

factual findings as set forth in the

institution’s report, and finds that Dr.

Herman committed scientific

misconduct by falsely reporting in a

published article that research had been

conducted according to a stated protocol

when, in fact, Dr. Herman knew at the

time that the protocol for tumor

measurements had not been carried out

exactly as described. The research was

supported by grant awards from the

National Cancer Institute and the

National Center for Research Resources,

National Institutes of Health.
22402 Federal Register / Vol. 60, No. 87 / Friday, May 5, 1995 / Notices

Dr. Herman accepted the misconduct

finding as part of a Voluntary

Settlement Agreement under which, for

a period of three years, an institution

which submits an application for PHS

support for a clinical research project on

which his participation is proposed or

which uses him in any capacity on PHS

supported clinical research must

concurrently submit a plan for

supervision of his duties. The

supervisory plan must be designed to

ensure the scientific integrity of Dr.

Herman’s research contribution. Dr.

Herman also is prohibited from serving

on any Public Health Service advisory

committee, board, and/or peer review

committee for a period of three years.

He has agreed to submit a letter to the

International Journal of Radiation

Oncology, Biology, Physics requesting

retraction of that portion of the article

dealing with tumor response (Herman,

et al., A Phase I–II Trial of Cisplatin,

Hyperthermia and Radiation in patients

with Locally Advanced Malignancies.

Int. J. Radiation Oncology Biol. Phys.

17:1273–1278; 1989).

FOR FURTHER INFORMATION CONTACT:

Director, Division of Research

Investigations, Office of Research

Integrity, 301–443–5330.

Lyle W. Bivens,

Director, Office of Research Integrity.

[FR Doc. 95–11118 Filed 5–4–95; 8:45 am]

BILLING CODE 4160–17–M

Public Health Service

Agency Forms Submitted to the Office

of Management and Budget for

Clearance

Each Friday the Public Health Service

(PHS) publishes a list of information

collection requests under review, in

compliance with Paperwork Reduction

Act (44 U.S.C. Chapter 35). To request

a copy of these requests, call the PHS

Report Clearance on (202) 690–7100.

The following requests have been

submitted for review since the list was

last published on April 28.

1. Application for Participation in the

National Health Service Corps

Scholarship Program—0915–0146—

Extension, no change—This request for

a two-year extension, no change, of the

approval for the application form used

by students to apply for scholarship

support. During the next year, proposed

changes to the application form will be

pilot tested. Changes to the form will be

submitted for OMB approval late in

1996. Respondents: Individuals or

households; Number of Respondents:

5,000; Number of Responses per

Respondent: 1; Average Burden per

Response: 1 hour; Estimated Annual

Burden: 5,000 hours. Send comments to

James Scanlon, Office of the Assistant

Secretary for Health, Room 737–F,

Humphrey Building, 200 Independence

Ave, S.W., Washington, D.C. 20201.

2. Surveillance of Hazardous

Substances Emergency Event—0923–

0008—Extension, no change—To

protect the public’s health, ATSDR has

established a national surveillance

system which describes the impact of

hazardous substances emergencies on

the public’s health. The information is

used to examine the distribution of

hazardous substance emergencies,

describe the type and cause of morbidity

and mortality of those affected, and

develop strategies to reduce subsequent

morbidity and mortality. Respondents:

Individuals or households; Number of

Respondents: 16; Number of Responses

per Respondent: 357; Average Burden

per Response: 1 hour: Estimated Annual

Burden: 5,593 hours. Send comments to

Shannah Koss, Human Resource and

Housing Branch, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

3. CMHC Construction Grantee

Checklist—0930–0104—Revision—To

ensure that Community Mental Health

Center (CMHC) facilities built with

Federal assistance provide mental

health services for a 20-year period as

required, the Center for Mental Health

Services will: (1) survey the universe of

CMHC construction grantees actively

fulfilling their 20-year service obligation

and (2) utilize survey results to

determine appropriate follow up, e.g.,

waivers, recovery activities.

Respondents: Not-for-profit institutions;

Number of Respondents: 295; Number

of Responses per Respondent: 1;

Average Burden per Response:. 33 hour;

Estimated Annual Burden: 97 hours.

Send comments to James Scanlon,

Office of the Assistant Secretary for

Health, Room 737–F, Humphrey

Building, 200 Independence Ave., S.W.,

Washington, D.C. 20201.

4. Assessment of Work-Related

Musculoskeletal Disorders in the Retail

Food Industry—New—Work-Related

Musculoskeletal Disorders among

grocery cashiers have risen drastically

since the introduction of the laser

scanner. NIOSH investigators and other

experts in ergonomics believe that

certain checkstand features are more

likely to impose substantial

biomechanical stresses on cashiers than

others. However, little research has been

conducted to identify those activities

and related postures of checking that

contribute to the increased prevalence

of WMD in this group of workers. The

data collected in this study will be used

to develop interventions to reduce

WMD among grocery checkers,

including redesign of checkstands and

development of better training courses.

Respondents: Individuals or

households; Number of Respondents:

1,000; Number of Responses per

Respondent: 1; Average Burden per

Response: 1.71 hours; Estimated Annual

Burden: 1,710 hours. Send comments to

Shannah Koss, Human Resources and

Housing Branch, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

5. National Sample Survey of

Registered Nurses VI—New—Current

national data on employment and

practice of registered nurses are needed

to assess the current supply and project

the future availability of nurses. This

proposed project will provide detailed

statistics on the registered nurse

population needed to prepare the

mandated Secretary’s Report to

Congress. Respondents: Individuals or

households; Number of Respondents:

41,000; Number of Responses per

Respondent: 1; Average Burden per

Response: .33 hour; Estimated Annual

Burden: 13,530 hours. Send comments

to Shannah Koss, Human Resources and

Housing Branch, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Written comments and

recommendations concerning the

proposed information collections

should be sent within 30 days of this

notice directly to the individual

designated.

Dated: April 27, 1995.

James Scanlon,

Director, Data Policy Staff, Office of the

Assistant Secretary for Health and PHS

Reports Clearance Officer.

[FR Doc. 95–10910 Filed 5–4–95; 8:45 am]

BILLING CODE 4160–01–M

Substance Abuse and Mental Health

Services Administration

Supplemental Awards to Current High

Risk Youth Demonstration Program

Grantees

AGENCY: Center for Substance Abuse

Prevention, Substance Abuse and

Mental Health Services Administration

(SAMHSA), HHS.

ACTION: Correction notice.

SUMMARY: Public notice was given in the

Federal Register on April 17, 1995,

Volume 60, No. 73, pages 19276–19277,

of the availability of supplemental funds

to demonstrate the differential

effectiveness of incorporating an HIV/

AIDS prevention curriculum into an on-