Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices 38659

Dated: July 9, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–19030 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0393]

National Shellfish Sanitation Program

Guide for the Control of Molluscan

Shellfish; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guide entitled ‘‘National

Shellfish Sanitation Program (NSSP)

Guide for the Control of Molluscan

Shellfish.’’ The guide was developed

cooperatively by FDA and the Interstate

Shellfish Sanitation Conference (ISSC)

with the intent of replacing the existing

NSSP Manuals of Operation, Parts I and

II. The guide contains a Model

Ordinance for ensuring that only safe

and sanitary shellfish are offered for sale

in interstate commerce. Language

contained in the Model Ordinance has

been codified for easy adoption into law

or regulation by State regulatory

agencies. The guide also includes

documentation supportive of the

codified language of the Model

Ordinance, including: The NSSP’s

history, public health reasons and

explanations specific to the guidelines

contained in the Model Ordinance,

NSSP guidance documents, suggested

NSSP forms, shellfish policy setting

documents, pertinent Federal

regulations, and references to the public

health reasons and explanations. These

supportive materials aid in ensuring

consistent and uniform implementation

of a national shellfish safety program.

DATES: Comments on the guide may be

submitted at any time.

ADDRESSES: Submit written comments

on the guide to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Submit

written requests for single copies of the

guide entitled ‘‘National Shellfish

Sanitation Program Guide for the

Control of Molluscan Shellfish’’ to the

contact person in the nearest regional

office listed in the SUPPLEMENTARY

INFORMATION section of this

document. Send two self-addressed

adhesive labels to assist in processing

your requests. An electronic version of

the guide is available on the World

Wide Web at (http/www.issc.org).

FOR FURTHER INFORMATION CONTACT: Paul

W. DiStefano, Office of Seafood, Center

for Food Safety and Applied Nutrition

(HFS–417), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3150,

FAX: 202–418–3198, e-mail:

‘‘pdistefa@bangate.fda.gov’’, or the

contact person in the nearest regional

office as listed in the

SUPPLEMENTARY INFORMATION

section of this document.

SUPPLEMENTARY INFORMATION: Copies of

the guide entitled ‘‘National Shellfish

Sanitation Program Guide for the

Control of Molluscan Shellfish’’ can be

obtained from the nearest regional office

as follows:

FDA Addresses Contact Person

Stoneham District Office, State Programs Branch, One Montvale Ave.,

Stoneham, MA 02180

David G. Field

New York Regional Office, 850 Third Ave., Brooklyn, NY 11232–1593 Jerry H. Mulnick

Baltimore District Office, Investigations Branch, 900 Madison Ave., Baltimore, MD 21201Al A. Ondis

Atlanta Regional Office, State Cooperative Programs, 60 Eighth St.

NE., Atlanta, GA 30309

James A. Casey

Charleston Resident Post, 334 Meeting St., rm. 505, P.O. Box 21077,

Charleston, SC 29413

Donald Hesselman

Tallahassee Resident Post, Hobbs Federal Bldg., 227 North Bronough

St., suite 4150, Tallahassee, FL 32301

Marc B. Glatzer

Baton Rouge Resident Post, 5353 Essen Lane, suite 220, Baton

Rouge, LA 70809

John E. Veazey

Detroit District Resident Post, 1560 East Jefferson Ave., Detroit, MI

48207

Nicholas L. Majerus

Dallas Regional Office, 7920 Elmbrook Dr., suite 102, Dallas, TX 75247 David A. Blevins

Seattle District Office, 100 Second Ave., suite 2400, Seattle, WA 98104 Tim E. Sample

Shellfish Safety Team (HFS–628), 200 C St. SW., Washington, DC

20204

Stanley D. Ratcliffe

FDA is the Federal agency responsible

for administration of the NSSP. The

NSSP is a voluntary program in which

State shellfish control agencies, the

shellfish industry, FDA, and other

Federal agencies participate. The NSSP,

which has been in existence since 1925,

addresses the sanitary control of fresh

and frozen molluscan shellfish (oysters,

clams, mussels, and scallops) offered for

sale in interstate commerce. To promote

uniform administrative and technical

controls, the NSSP has developed and

maintained recommended shellfish

control practices for adoption by

member States. These control practices,

which were initially published as the

NSSP Manuals of Operation, Parts I and

II, are contained in the guide ‘‘NSSP

Guide for the Control of Molluscan

Shellfish.’’

In 1982, interested State officials and

members of the shellfish industry

formed the ISSC to provide a structure

wherein State regulatory authorities

could meet on a regular basis to discuss

ways to improve shellfish sanitation and

safety. FDA and the ISSC entered into

a memorandum of understanding

(MOU) that was published in the

Federal Register of March 30, 1984 (49

FR 12751), agreeing, among other

things, that FDA would provide

technical assistance to the ISSC. The

ISSC in turn would help FDA develop

or revise program criteria and guidelines

in the NSSP Manuals of Operation.

Based on the MOU, and in cooperation

with the ISSC, FDA periodically

publishes revisions of the NSSP
38660 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices

Manuals of Operation based on

resolutions adopted by voting delegates

of the ISSC and with which FDA

concurs.

The success of the NSSP is largely

dependent on the States adopting and

implementing the recommended

shellfish control practices for the

operation of effective programs. These

recommended practices, which

traditionally have been incorporated

into the NSSP Manuals of Operation

have been reconstituted in the form of

a ‘‘NSSP Guide for the Control of

Molluscan Shellfish.’’ The purpose of

the ‘‘NSSP Guide for the Control of

Molluscan Shellfish’’ handbook is

twofold. First, it serves to redraft

existing guidelines contained in the

NSSP Manuals of Operation into a NSSP

Model Ordinance, which contains

language that can be readily codified

into law or regulation by a State.

Second, it sets forth supportive

documentation pertinent to the codified

language of the Model Ordinance,

including: The NSSP’s history, public

health reasons and explanations specific

to the guidelines contained in the Model

Ordinance, NSSP guidance documents,

suggested NSSP forms, shellfish policysetting documents, pertinent Federal

regulations, and references to the public

health reasons and explanations.

Redrafting of the NSSP Manuals of

Operation was accomplished through

the efforts of the ISSC working in

cooperation with FDA. This effort began

in 1989 and continued through

December 1997. Wherever possible, the

concepts and language contained in the

NSSP Manuals of Operation were used

in the NSSP Model Ordinance. Where

language did not exist to explain a

requirement (e.g., flow charts), an

explanation was developed. In cases

where the intent of the NSSP Manuals

of Operation was not clear, new

definitions were developed. Apparently

conflicting requirements in the Manuals

of Operation were resolved by selecting

the requirement that most clearly

reflected the intent of the NSSP or by

selecting the more restrictive

requirement.

In 1997, FDA was asked by the ISSC

to adopt the Model Ordinance. FDA

recognized that if it were to do so, the

NSSP Model Ordinance would be a FDA

guideline, and as such, it would be

subject to the policy of FDA relating to

the development, issuance, and use of

guidance documents, as expressed in

the Federal Register of February 27,

1997 (62 FR 8961 at 8969 through 8971).

This policy states that the public will be

afforded an opportunity to comment on

guidance documents in accordance with

Level 1 Good Guidance Practices

documents as set out in the Federal

Register of February 27, 1997 (62 FR

8961).

The annual meeting of the ISSC, in

the past and again at the July 1997

meeting, provided an essential forum for

the development of revisions to the

NSSP. The participatory process that

occurs at this meeting serves the

purposes and principles set forth in the

agency’s guidance documents policy.

Therefore, in a notice published in the

Federal Register of June 26, 1997 (62 FR

34480), FDA announced that the Model

Ordinance was to be discussed at the

July 1997 ISSC meeting, and that this

meeting would act as the forum for

public comment on the Model

Ordinance as an FDA guidance

document. FDA requested comment on

the procedure, but received none.

With concurrence from FDA, the

NSSP Model Ordinance was adopted by

the ISSC at its July 1997 meeting in

Sturbridge, MA. With this notice, FDA

is announcing the availability of the

Model Ordinance as contained within

the guide ‘‘NSSP Guide for the Control

of Molluscan Shellfish.’’ At the Federal

level, the Model Ordinance has the

status of guidance and, as such, does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. However, through

their participation in the NSSP and the

ISSC, participating States have

voluntarily agreed to follow the Model

Ordinance as the requirements which

are minimally necessary for

membership.

The public may comment on this

document at anytime. The public may

comment in one of two ways: (1) By

attending the ISSC conference held

annually for the purpose of, among

other things, considering changes to the

Model Ordinance; or (2) by commenting

to FDA. Those comments that the

agency finds meritorious will be offered

by FDA for consideration and vote at a

subsequent ISSC.

The NSSP Model Ordinance will

facilitate uniform adoption of the

recommended shellfish control

practices by States for regulation of their

shellfish industry. Adoption of the

NSSP Model Ordinance by each State

will strengthen the credibility of the

National Shellfish Sanitation Program

and the ‘‘Interstate Certified Shellfish

Shippers List’’ (ICSSL), which identifies

shellfish dealers certified by their State

of residence as being in compliance

with NSSP guidelines. Assurance that

all shellfish dealers are meeting the

minimum criteria will foster confidence

in product safety.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on the guide. Two copies of

any comments should be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday. At

the discretion of FDA, received

comments will be used to develop

issues for submission to the ISSC for

consideration at its July 1999, annual

meeting.

Dated: July 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19029 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Dental Research;

Notice of Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Commission: National Institute of

Dental Research Special Emphasis Panel,

Emphasis Panel 44 & 45.

Date: July 26–28, 1998.

Time: 8:00 am to 5:00 pm.

Agenda: To review and evaluate grant

applications.

Place: Ritz-Carlton Hotel at Pentagon City,

1250 South Hayes Street, Arlington, VA

22202.

Contact Person: Yong A. Shin, PhD,

Scientific Review Administrator, 4500 Center

Drive, Natcher Building, Rm. 4AN44F,

National Institutes of Health, Bethesda, MD

20892, (301) 594–2372.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalog of Federal Domestic Assistance

Program Nos. 93.121, Oral Diseases and