Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices 7465

Other Requirements

Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations, 45 CFR Part 46,

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and forms provided in the

application kit.

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by this grant program will

be subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act.

Women and Minority Inclusion Policy

It is the policy of the CDC to ensure

that women and racial and ethnic

groups will be included in CDC

supported research projects involving

human subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic. Applicants shall

ensure that women, racial and ethnic

minority populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exist that

inclusion is inappropriate or not

feasible, this situation must be

explained as part of the application.

In conducting the review of

applications for scientific merit, review

groups will evaluate proposed plans for

inclusion of minorities and both sexes

as part of the scientific assessment and

assigned score. This policy does not

apply to research studies when the

investigator cannot control the race,

ethnicity and/or sex of subjects. Further

guidance to this policy is contained in

the Federal Register, Vol. 60, No. 179,

Friday, September 15, 1995, pages

47947–47951.

Application Submission and Deadlines

A. Preapplication Letter of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter should

be submitted to the Grants Management

Specialist (whose address is reflected in

section B, ‘‘Applications’’). It should be

postmarked no later than March 20,

1997. The letter should identify the

announcement number, name the

principal investigator, and specify the

priority area of study the proposal

addresses as outlined under the section

Programmatic Priorities. The letter of

intent does not influence review or

funding decisions, but it will enable

CDC to plan the review more efficiently,

and will ensure that each applicant

receives timely and relevant information

prior to application submission.

B. Applications

Applicants should use Form PHS–398

(OMB No. 0925–0001 Revised 5/95) and

adhere to the ERRATA Instruction Sheet

for Form PHS–398 contained in the

Grant Application Kit. Please submit an

original and five copies, on or before

April 22, 1997, to: Lisa G. Tamaroff,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 321,

Atlanta, Georgia 30305, telephone (404)

842–6796.

C. Deadlines

1. Applications shall be considered as

meeting a deadline if they are either:

A. Received at the above address on

or before the deadline date, or

B. Sent on or before the deadline date

to the above address, and received in

time for the review process. Applicants

should request a legibly dated U.S.

Postal Service postmark or obtain a

legibly dated receipt from a commercial

carrier or the U.S. Postal Service. Private

metered postmarks shall not be

acceptable as proof of timely mailings.

2. Applications which do not meet the

criteria above are considered late

applications and will be returned to the

applicant.

Where to Obtain Additional Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and telephone number and will

need to refer to Announcement 723.

You will receive a complete program

description, information on application

procedures, and application forms.

Business management technical

information may be obtained from Lisa

Tamaroff, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Mailstop E–13, Atlanta, GA 30305,

telephone (404) 842–6796 or internet:

<lgt1.cdc.gov≤.

Programmatic technical assistance

may be obtained from Ted Jones, Project

Officer, Extramural Research Grants

Branch, National Center for Injury

Prevention and Control, Centers for

Disease Control and Prevention (CDC),

Mailstop K–58, 4770 Buford Highway,

NE., Atlanta, Georgia 30341–3724,

telephone (770) 488–4824, internet:

<tmj1.cdc.gov≤.

This and other CDC announcements

are also available through the CDC

homepage on the Internet. The address

for the CDC homepage is <http://

www.cdc.gov≤.

CDC will not send application kits by

facsimile or express mail.

Please refer to Announcement

Number 723 when requesting

information and submitting an

application.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) through

the Superintendent of Documents,

Government Printing Office,

Washington, D.C. 20402–9325,

telephone (202) 512–1800.

Copies of Injury Control in the 1990s:

A National Plan for Action. Atlanta:

Centers for Disease Control and

Prevention, 1993 and A Framework for

Assessing the Effectiveness of Disease

and Injury Prevention, (CDC, Morbidity

and Mortality Weekly Report, March 27,

1992, Volume 41, Number RR–3, pages

5–11) may be obtained by calling (770)

488–4265.

Information for obtaining the

suggested readings, Understanding

Violence Against Women, Violence and

the Public’s Health, Understanding and

Preventing Violence, and Violence in

America: A Public Health Approach, is

included on a separate sheet with the

application kit.

Dated: February 11, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–4010 Filed 2–18–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 93F–0195]

Fish and Fishery Products Hazards

and Controls Guide; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the
7466 Federal Register / Vol. 62, No. 33 / Wednesday, February 19, 1997 / Notices

availability of the first edition of the

‘‘Fish and Fishery Products Hazards and

Controls Guide’’ (the guide). FDA has

prepared the guide as, among other

things, an adjunct to the regulations it

issued on the safe and sanitary

processing and importing of fish and

fishery products using Hazard Analysis

and Critical Control Point (HACCP)

methodology.

DATES: Submit written comments on the

guide by May 20, 1997. Comments

received after that date will be

considered for subsequent editions.

ADDRESSES: Submit written requests for

single copies of the guide to the Office

of Seafood (HFS–400), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3133.

The guide may also be obtained from

FDA district offices (contact Donald

Kraemer (address below) for FDA

district office addresses). Send two selfaddressed adhesive labels to assist those

offices in processing your requests.

Copies of the guide on diskette (in

WordPerfect 6.0) may be ordered for

$30.00 each, plus handling, from the

National Technical Information Service

(NTIS), U.S. Department of Commerce,

by calling 703–487–4650 and requesting

PB96–503180. Paper copies may be

ordered for $30.00 each, plus handling,

by requesting PB 96–207337. The

diskette and paper copies may be

ordered as a set for $50.00, plus

handling, by requesting PB96–207329.

Payment may be made by charge card

(American Express, VISA, or

Mastercard), check, money order, or

other billing arrangements made with

NTIS. Rush orders may be placed by

calling 800–553–NTIS. Persons with

access to the Internet may obtain the

guide via the World Wide Web at FDA’s

web site (http://www.fda.gov) by

selecting ‘‘Foods’’ and then selecting

‘‘HACCP.’’ Alternately, it may be

accessed directly at http://

www.cfsan.fda.gov/∼lrd/haccpsub.html.

The guide is also being issued as a

companion document to the ‘‘HACCP:

Hazard Analysis Critical Control Point

Training Curriculum’’ (the training

document), which was developed by the

Seafood HACCP Alliance for Training

and Education (the Alliance). The

Alliance is an organization of Federal

and State regulators, including FDA,

academia, and food industry trade

associations. FDA encourages

processors of fish and fishery products

to use the two documents together in

the development of their HACCP

systems. Copies of the training

document and the guide may be

obtained from North Carolina Sea Grant,

North Carolina State University, P.O.

Box 8605, Raleigh, NC 27695, 919–515–

2454. The cost for both of these

documents is $35.00, payable by check

or money order to ‘‘N.C. Sea Grant.’’

Submit written comments on the guide

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. The guide and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Donald W. Kraemer, Center for Food

Safety and Applied Nutrition (HFS–

400), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3160.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 18, 1995

(60 FR 65096), FDA published a final

rule entitled ‘‘Procedures for the Safe

and Sanitary Processing and Importing

of Fish and Fishery Products,’’ which

requires that HACCP principles be

applied in the commercial processing of

fish and fishery products for

distribution in interstate commerce.

HACCP involves: (1) The identification

of food safety hazards that are

reasonably likely to occur in a particular

product; (2) the selection of the

appropriate control measures to reduce

the risk of occurrence of these hazards;

and (3) the preparation of a HACCP plan

that sets out how these measures will be

applied.

To aid processors in responding to the

new requirements and in developing

their HACCP plans, FDA has developed

the guide. The controls and practices

provided in the guide are, for the most

part, recommendations and guidance to

the fish and fishery products industry.

The guide provides information that

will likely result in a HACCP plan that

is acceptable to FDA under ordinary

circumstances. However, the guide is in

no way a binding set of requirements.

Processors may choose to use other

control measures, provided that they

provide an equivalent degree of

assurance that the product will be safe.

Nor is the guide a substitute for the

performance of a hazard analysis by a

processor of fish or fishery products, as

required by FDA’s regulations. A hazard

analysis is an assessment of what, if

any, food safety hazards are reasonably

likely to occur in a product being

produced by a specific processor, and

whether those hazards can be controlled

by that processor. While the guide

contains FDA’s best advice for most

ordinary circumstances, it does not

cover every situation. For example,

hazards not covered by the guide may

be relevant to certain products in certain

circumstances. In particular, processors

should be alert to new or emerging

problems (e.g., the occurrence of natural

toxins in fish not previously associated

with that toxin).

In the Federal Register of March 18,

1994 (59 FR 12949), FDA published a

notice of availability of a draft version

of the guide (the draft guide) and

requested comments on it. The agency

has carefully reviewed the comments it

received. Based on these comments,

FDA has made significant changes in

the format and content of the guide.

Given the magnitude of the changes,

FDA believes that additional comment

by the public would be useful.

A number of comments stated that,

while the draft guide provided useful

information on fish and fishery products

hazards and controls, it did not

adequately explain how to develop a

HACCP plan on the basis of this

information.

In response to these comments, the

agency has revised the guide to provide

a step-by-step procedure for the

preparation of a HACCP plan. The

agency has tried to provide information

that will help the processor answer

questions that are likely to arise during

this process.

To further facilitate HACCP plan

development, the guide provides

samples of key portions of HACCP plans

for each of the categories of hazards that

are discussed. The guide also contains

a fill-in-the-blank HACCP plan and a

blank hazard analysis worksheet that

may be used by processors.

Many comments stressed that the

draft guide unnecessarily restricted their

flexibility in developing hazard control

strategies that were uniquely tailored to

their operations. It did so, they

contended, by limiting its advice to only

one or a few control strategies per

hazard even though other strategies may

also exist, depending upon the

circumstances.

It was never the intent of the guide to

limit a processor’s flexibility to only the

control strategies provided in the guide.

The agency could not realistically

provide advice on every valid control

strategy that might be available under

every circumstance. Nonetheless, the

guide is intended to be as inclusive as

is reasonably possible about known

control strategies. Therefore, FDA has

revised the guide to provide more

control strategy examples than were

provided in the draft guide. For

example, the guide includes
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