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
Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices 38661

Disorders Research, National Institutes of

Health, HHS)

Dated: July 10, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–19069 Filed 7–16–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases; Notice

of Closed Meetings

Purusant 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

meetings.

The meetings will be closed to the

public in accordance with the provisons

set forth in section 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 Committee: National Institute of

Diabetes and Digestive and Kidney Diseases

Special Emphasis Panel, ZDK1 GRB–8 02.

Date: July 22–24, 1998.

Time: July 22, 1998, 7:00 pm to

Adjournment.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn Hotel, 625 El Camino

Real, Palo Alto, CA 94301–2380.

Contact Person: Robert J. Haber, Phd,

Scientific Review Administrator, Review

Branch, DEA, NIDDK, Natcher Building,

Room 6AS–37, National Institutes of Health,

Bethesda, MD 20892–6600, (301) 594–8898.

Name of Committee: National Institute of

Diabetes and Digestive and Kidney Diseases

Special Emphasis Panel, ZDK1 GRB–D (01).

Date: July 27, 1998.

Time: 10:00 am to adjournment.

Agenda: To review and evaluate grant

applications.

Place: Sheraton Crystal City Hotel, 1800

Jefferson Davis Highway, Arlington, VA

22202.

Contact Person: Ann Hagan, Chief, Review

Branch, National Institute of Diabetes and

Digestive and Kidney Diseases, National

Institutes of Health, Phs, Dhhs, Rm. 6as37,

Bldg. 45, Bethesda, MD 20892, (301) 594–

8886.

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.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.847, Diabetes,

Endocrinology and Metabolic Research;

93.848, Digestive Diseases and Nutrition

Research; 93.849, Kidney Diseases, Urology

and Hematology Research, National Institute

of Health, HHS)

Dated: July 10, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–19070 Filed 7–16–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Drug Abuse;

Notice of Closed Meetings

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

meetings.

The meetings 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/or contract proposals 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 and/or contract proposals,

the disclosure of which would

constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute on

Drug Abuse Special Emphasis Panel,

International Drug Abuse Epidemiology Data

Bank.

Date: July 17, 1998.

Time: 9:00 am to 5:00 pm.

Agenda: To review and evaluate contract

proposals.

Place: National Institute on Drug Abuse,

5600 Fishers Lane, Room 10–49, Rockville,

MD 20857 (Telephone Conference Call).

Contact Person: Eric Zatman, Contract

Review Specialist, Office of Extramural

Program Review, National Institute on Drug

Abuse, National Institutes of Health, DHHS,

5600 Fishers Lane, 10–42, Rockville, MD

20857, (301) 443–1644.

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.

Name of Committee: National Institute on

Drug Abuse Special Emphasis Panel,

Neurological Effects of Drug Addiction

Therapies.

Date: August 3, 1998.

Time: 8:30 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: Kesinee Nimit, MD, Health

Scientist Administrator, Office of Extramural

Program Review, National Institute on Drug

Abuse, National Institutes of Health, DHHS,

5600 Fishers Lane, Room 10–22, Rockville,

MD 20857, (301) 443–9042.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.277, Drug Abuse Scientist

Development Award for Clinicians, Scientist

Development Awards, and Research Scientist

Awards; 93.278, Drug Abuse National

Research Service Awards for Research

Training; 93.279, Drug Abuse Research

Programs, National Institutes of Health, HHS)

Dated: July 10, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–19071 Filed 7–16–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Children With Serious Emotional

Disturbance; Estimation Methodology

AGENCY: Center for Mental Health

Services, Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Final notice.

SUMMARY: This notice describes the final

methodology to identify and estimate

the number of children with a serious

emotional disturbance (SED) within

each State. This notice is being

published as part of the requirements of

Public Law 102–321, the ADAMHA

Reorganization Act of 1992.

EFFECTIVE DATE: October 1, 1998.

Background

Public Law 102–321, the ADAMHA

Reorganization Act of 1992, amended

the Public Health Service Act and

created the Substance Abuse and Mental

Health Services Administration

(SAMHSA). The Center for Mental

Health Services (CMHS) was established

within SAMHSA to coordinate Federal

efforts in the prevention and treatment

of mental illness, and the promotion of

mental health. Title II of Public Law

102–321 establishes a Block Grant for

Community Mental Health Services,

administered by CMHS, that permits the

allocation of funds to States for the

provision of community mental health

services for children with a SED and

adults with a serious mental illness

(SMI). Public Law 102–321 stipulates

that States estimate the incidence

(number of new cases) and prevalence

(total number of cases in a year) of

individuals with either SED or SMI in

their applications for block grant funds.