Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices 7467

recommended maximum exposure

times for temperature-sensitive fishery

products for a variety of exposure

temperatures and target pathogens,

rather than one ‘‘rule-of-thumb’’

maximum exposure time, as was the

case in the draft guide.

The agency recognizes, however, that

the inclusion of more control strategies

greatly lengthens the guide and could

make it more difficult for the smaller,

less sophisticated processor to use. FDA

specifically invites comment on

whether this will in fact be the case and

on whether the agency should attempt

to develop an abbreviated version of the

guide for those who might benefit from

it.

The guide includes tables of potential

food safety hazards that may be

associated with the hundreds of species

of fish (vertebrate and invertebrate), as

well as the numerous product forms

(e.g., breaded, cooked, raw), that are

commercially marketed in the United

States. These tables are designed to aid

the processor in the performance of the

hazard analysis.

A separate chapter is devoted to each

category of hazard (e.g., parasites,

natural toxins, pathogen growth, metal

fragments). Each chapter includes the

steps necessary to complete the hazard

analysis and, ultimately, the HACCP

plan for that hazard. These steps

include: (1) Understanding the potential

hazard; (2) determining whether the

potential hazard is significant and must

therefore be controlled; (3) identifying

the critical control points, where the

hazard can best be controlled; (4) setting

the critical limits, to which the

operation must be held at the critical

control points; (5) establishing the

monitoring procedures, to ensure that

the critical limits are consistently being

met; (6) establishing corrective action

procedures for when the critical limit is

not met; (7) establishing a recordkeeping

system to document the performance of

the monitoring, corrective action, and

verification procedures; and (8)

establishing verification procedures.

There are two areas that were

addressed in the draft guide but are not

included in the first edition because

they are the subject of policy

reevaluation by FDA. The agency will

update the guide in these areas when

the policy reevaluation is complete.

The first of these areas involves the

chemical methyl mercury. A number of

comments objected to the testing

regimen that the draft guide

recommended for the control of the

methyl mercury hazard in certain

species of fish. The agency’s

recommendation was based on the 1.0

part per million action level for methyl

mercury. While FDA has not changed

this action level, the agency is

reevaluating its policy in light of

significant new data on the health

effects of methyl mercury from

consumption of fish that have become

available since the action level was

developed.

One other area in which the guidance

contained in the guide is incomplete is

the hazard of pathogens in raw fish and

fishery products that are intended to be

cooked by the consumer or end user.

FDA policy identifies pathogens in such

products as adulterants under the

Federal Food, Drug, and Cosmetic Act.

FDA is still evaluating what would

constitute an appropriate hazard

analysis, and what would constitute the

appropriate HACCP controls for these

products. The agency welcomes

comment on this subject.

FDA expects that its reevaluation of

the methyl mercury action level and its

pathogen policy will be completed

before the effective date of the

regulations. When the reevaluation is

completed, FDA will, among other

things, update the guide by including

advice on how to assess the significance

of these potential hazards, and what

controls, if any, are necessary to ensure

the safety of fish.

The guide, which provides advice on

how to prepare a HACCP plan when a

plan is required by 21 CFR part 123,

should be used until superseded by a

subsequent edition. Although this

guidance does not create or confer any

rights, for or on any person, and does

not operate to bind FDA, it does

represent the agency’s best thinking on

how to prepare a HACCP plan for the

processing of fish and fishery products.

Interested persons may, on or before

May 20, 1997, submit to the Dockets

Management Branch (address above)

written comments on the guide for

consideration in the preparation of the

second edition of the guide. Comments

received after that date will be

considered for subsequent editions. Two

copies of any comments are to 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. The guide and received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: February 11, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4022 Filed 2–18–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[Document Identifier: HCFA–1514]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Extension of currently

approved collection; Title of

Information Collection: Hospital

Request for Certification in the

Medicare/Medicaid Program; Form No.:

HCFA–1514; Use: Section 1861 of the

Social Security Act and 42 CFR part 482

requires hospitals to be certified to

participate in the Medicare/Medicaid

program. As part of the certification

process, providers must complete form

HCFA–1514. This certification form is a

facility identification and screening

form used to initiate the certification

process and to determine if the provider

has sufficient personnel to participate in

the Medicare/Medicaid program.

Frequency: Annually; Affected Public:

State, Local or Tribal Gov’t.; Number of

Respondents: 2,500; Total Annual

Responses: 2,500; Total Annual Hours:

625.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer
7468 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices

designated at the following address:

HCFA, Office of Financial and Human

Resources, Management Analysis and

Planning Staff, Attention: John Rudolph,

Room C2–25–05, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: February 10, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources.

[FR Doc. 97–3985 Filed 2–18–97; 8:45 am]

BILLING CODE 4120–03–M

Public Health Service

Title: FNB Workshop on Folate,

Vitamin B–12, and Choline

AGENCY: Office of Disease Prevention

and Health Promotion, HHS.

ACTION: Food and Nutrition Board

Workshop on Folate, B–12, and Choline;

notice of meeting and request for

information.

SUMMARY: The Food and Nutrition Board

(FNB), Institute of Medicine, National

Academy of Sciences, under the

auspices of the Standing Committee on

the Scientific Evaluation of Dietary

Reference Intakes, will hold an open

workshop to address the nutrients

folate, vitamin B–12, and choline.

DATES: The open meeting will be held

from 12:30 until 5:30 p.m. E.S.T. on

March 3, 1997, and from 8 a.m. until

12:30 p.m. E.S.T. on March 4, 1997, at

the Jefferson Auditorium, U.S.

Department of Agriculture South

Building, 14th and Independence

Avenue, S.W., Washington, D.C. The

meeting is open to the public.

FOR FURTHER INFORMATION, CONTACT:

Diane Johnson, Program Assistant, Food

and Nutrition Board, 2101 Constitution

Avenue, NW., Washington, D.C. 20418,

(202) 334–1312, or send an e-mail to

FNB@NAS.EDU.

SUPPLEMENTARY INFORMATION: Speakers

have been invited to present evidence

bearing on requirements and adverse

effects, if any, of high levels of intake of

folate, vitamin B–12, and choline.

Information presented will be

considered by the committee in its

development of Dietary Reference

Intakes for these nutrients. Interested

individuals and organizations are

encouraged to provide written scientific

information for the committee’s use.

Those wishing to be considered for a

brief oral presentation should submit an

abstract with references to FNB, 2101

Constitution Ave., NW, Washington, DC

20418, by February 24, 1997. The study

for which this meeting is being held is

supported by the Department of Health

and Human Services (Office of Disease

Prevention and Health Promotion,

Office of Public Health and Science; the

Division of Nutrition and Physical

Activity, National Center for Chronic

Disease Prevention and Health

Promotion, Centers for Disease Control

and Prevention; and the Office of

Dietary Supplements, National

Institutes of Health).

The meeting is open to the public;

however seating is limited. If you will

require a sign language interpreter,

please call Diane Johnson (202) 334–

1312 by 4:30 p.m. E.S.T. on February 21,

1997.

Dated: February 6, 1997.

Claude Earl Fox,

Deputy Assistant Secretary for Health

(Disease Prevention and Health Promotion),

Department of Health and Human Services.

[FR Doc. 97–4040 Filed 2–18–97; 8:45 am]

BILLING CODE 4160–17–M

Office of Public Health and Science;

Notice of Partnership Initiative

Pursuant to Title XVII of the Public

Health Service Act, notice is hereby

given that the Office of Disease

Prevention and Health Promotion,

Office of Public Health and Science, is

seeking partnerships with non-Federal

organizations to promote, distribute and

encourage the implementation of ‘‘Put

Prevention into Practice.’’ ‘‘Put

Prevention into Practice’’ is a systembased approach to implementing the

recommendations of the United States

Preventive Services Task Force,

targeting patients, clinicians, and

medical offices. The goal is to increase

the impact of ‘‘Put Prevention into

Practice’’ by forming partnerships with

private sector organizations. These

cooperative efforts are intended to bring

the resources of several partners to bear

on the implementation of clinical

preventive services guidelines and on

the efforts to increase the delivery of

appropriate clinical preventive services,

efforts that are too complex for any one

organization to handle alone.

Organizations with particular

experience, expertise or interest in the

development, marketing and

distribution of prevention-related

materials to the general public,

professional organizations and managed

care organizations will be well-aligned

with current and planned initiatives of

‘‘Put Prevention into Practice’’

activities.

Note: Partnerships between ODPHP and

outside organizations will be formalized

through Memorandum of Agreements and

will not involve grants or contracts.

Date of Effectiveness: February 19,

1997.

For more information, please contact

Rika Maeshiro, M.D., M.P.H., Senior

Clinical Affairs Advisor, Office of

Disease Prevention and Health

Promotion, Office of Public Health and

Science, at 202–690–7943.

Dated: February 10, 1997.

Claude Earl Fox,

Deputy Assistant Secretary for Health

(Disease Prevention and Health Promotion).

[FR Doc. 97–4039 Filed 2–18–97; 8:45 am]

BILLING CODE 4160–17–M

Substance Abuse and Mental Health

Services Administration

Center for Substance Abuse

Prevention; Notice of Meeting

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the Drug Testing Advisory Board of the

Center for Substance Abuse Prevention

in April 1997.

The Drug Testing Advisory Board

(DTAB) is having a 3-day scientific

meeting to discuss drug testing

alternative specimens and technologies

as they apply to workplace drug testing

programs. The entire meeting is open to

the public; however, attendance by the

public will be limited to space available.

The first two days will consist of

presentations on the principles and

criteria of workplace drug testing

program requirements and industry

representatives discussing alternative

specimens/technologies (urine, hair,

saliva, sweat, and non-instrument based

on-site tests). The presentations will be

focused on the following areas for each

alternative specimen/technology:

specimen collection and chain of

custody, initial test reagents and

procedures, confirmatory test

procedures, internal quality control

program, reporting test results,

interpreting test results, and an external

quality assurance program. On the third

day, the DTAB will review the

presentations, identify areas of concern,

and make recommendations concerning

those specimens/technologies for

workplace drug testing.

Interested persons may present

information or views, orally or in

writing, on these issues pending before

the Board. Those desiring to make

formal presentations should notify the

contact person before March 7. A

coordinator for each alternative

specimen/technology will select the

presenters. The presenters who will

discuss the underlying principles and