49246 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN

Form No. 21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

FDA Form 2657

Transmittal of Labels

and Circulars 601.2(a) and 601.12(a) 387 7.2 2,800 .16 448

There are no capital costs or operating and maintenance costs associated with this information collection of information.

Dated: September 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–24954 Filed 9–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0378]

Food Code; 1997 Revision; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the 1997 revision of the

Food Code. This 1997 revision was

initiated in cooperation with the

Conference for Food Protection (CFP) to

help ensure that safe, unadulterated,

and honestly presented food is sold or

offered for human consumption by retail

food establishments.

ADDRESSES: The 1997 revision of the

Food Code is available for public

examination in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Regarding questions about this

document: Betty Harden, Office of

Field Programs, Center for Food

Safety and Applied Nutrition (HFS–

627), 200 C St. SW., Washington,

DC 20204, 202–205–8140.

Regarding additional information

about the CFP: Leon Townsend,

Conference for Food Protection, 110

Tecumseh Trail, Frankfort, KY

40601, 502–695–0253.

SUPPLEMENTARY INFORMATION: FDA

provides assistance to local, State, and

Federal governmental bodies to ensure

that the food that is provided to

consumers by retail food establishments

is not a vector of communicable

diseases. One mechanism for providing

that assistance is the publication of a

model code that sets out FDA’s best

advice for a uniform system of

regulation to ensure that the food sold

or offered for human consumption at

retail is safe, properly protected, and

accurately presented.

The CFP was originally established in

1971 by State and Federal officials and

by representatives of industry. In 1988,

the CFP adopted a constitution and bylaws to provide a formal structure under

which State regulatory authorities could

meet and consider guidelines for

improving food safety in the retail

segment of the food industry.

At the 1986 CFP meeting, FDA

presented a White Paper that

recommended combining the three

distinct model codes that existed at that

time (retail food stores, food service

facilities, and vending) into a Food

Protection Unicode. The CFP endorsed

the approach that FDA would develop

a model Food Protection Unicode as a

priority project. FDA formed a Unicode

Task Group and published a notice of

the Unicode’s availability for comment

in the Federal Register of May 9, 1988

(53 FR 16472), when the Task Group

completed a draft. Based on comments

submitted in response to that notice,

and in consideration of subsequent

comments provided by regulatory

officials, industry representatives,

academia, and consumer representatives

at the CFP meetings in 1988, 1990, and

1992, FDA modified the document and

finalized it as the 1993 Food Code.

Based on field application trials, further

comment, and input from the 1994 CFP

meeting, FDA issued a revised version

of the 1993 Food Code as the 1995 Food

Code.

The CFP wrote a letter to FDA on May

28, 1996, and suggested changes in the

1995 Food Code. The CFP developed

these suggestions in cooperation with

the Association of Food and Drug

Officials (AFDO).

The 1997 Food Code responds to

those suggestions. Noteworthy changes

from the 1995 Food Code include the

following:

(1) Modification of the definition of

potentially hazardous food to

specifically state that a food might

contain pathogens even though it does

not qualify as a potentially hazardous

food;

(2) Identification of three methods of

complying with the knowledge

requirements for the person in charge;

(3) Addition of Shigella spp. and E.

coli O157:H7 to the list of organisms

that warrant restriction or exclusion if a

food worker is found to be an

asymptomatic shedder;

(4) Removal of the special

handwashing procedures and

reservation of that section;

(5) Allowance for the storage of

potentially hazardous food at 45 °F (7

°C) under certain conditions;

(6) Adjustment of the number of days

that prepared foods may be stored at 41

°F (5 °C) and 45 °F from 10 to 7 and

from 3 to 4, respectively;

(7) Revision of certain cooking

temperatures and times, e.g., for

preparing ratites and formed roast beef

and for microwave cooking;

(8) Modifications throughout the

document to coincide with the seafood

hazard analysis critical control point

rule at 21 CFR parts 123 and 1240;

(9) Provision for the regulatory

authority to approve alternatives to the

rule of no bare hand contact with readyto-eat food;

(10) Insertion of an explanation of the

current status of the consumer advisory

language recommended by the CFP;

(11) Use of the term ‘‘raw shell eggs’’

to distinguish provisions that apply to

in-shell eggs versus in-shell eggs that

were subjected to in-shell pasteurization

at a food processing plant;

(12) Addition of a statement that shell

eggs placed, upon receipt, in a

refrigerated unit that maintains food at

the required temperature constitutes

satisfactory compliance;

(13) Addition of a section that collates

and expands the Food Code’s special

precautions for highly susceptible

populations;

(14) Removal of the requirement for a

specified carbonator backflow

prevention device and reservation of the

section; and

(15) Update of information and

addition of user aides in the annexes.

The 1997 revision of the Food Code

is available for public examination in
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Notices 49247

the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Copies of the 1997 Food Code are

available on the World Wide Web at

http://vm.cfsan.fda.gov/list.html or at

http://www.fedworld.com. The 1997

Food Code also may be purchased from

the National Technical Information

Service, U.S. Department of Commerce,

Springfield, VA 22161, in several

formats: Spiral bound, WordPerfect 6.1

files on diskette, or enhanced electronic

version on diskette or CD–Rom. The

enhanced versions include electronic

features such as hypertext links that

enable the reader to quickly locate a

specific code provision and to

simultaneously read the text of crossreferenced documents.

Dated: September 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–24956 Filed 9–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0362]

A New 510(k) Paradigm; Draft of

Alternate Approaches to

Demonstrating Substantial

Equivalence in Premarket

Notifications; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft document entitled

‘‘A New 510(k) Paradigm—Alternate

Approaches to Demonstrating

Substantial Equivalence in Premarket

Notifications.’’ The draft 510(k)

paradigm, which is neither final nor in

effect at this time, presents two

alternative methods of demonstrating

substantial equivalence in premarket

notifications, and it is intended to

conserve FDA’s review resources while

facilitating the introduction of safe and

effective devices into interstate

commerce. The paradigm addresses the

type of data needed by the Center for

Devices and Radiological Health (CDRH)

to implement alternative procedures in

establishing substantial equivalence.

The agency requests comments on this

draft paradigm.

DATES: Submit written comments by

November 18, 1997.

ADDRESSES: Submit written requests for

single copies of the draft paradigm

entitled ‘‘A New 510(k) Paradigm—

Alternate Approaches to Demonstrating

Substantial Equivalence in Premarket

Notifications’’ to the Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send two self-addressed adhesive labels

to assist that office in processing your

request, or fax your request to 301–443–

8818. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the paradigm. Submit written

comments on the document to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20850.

FOR FURTHER INFORMATION CONTACT:

Robert I. Chissler, Program Operations

Staff (HFZ–404), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Background

The draft paradigm announced in this

document presents device

manufacturers with several optional

approaches for obtaining marketing

clearance for their Class II devices.

While the draft paradigm maintains the

traditional method of demonstrating

substantial equivalence under section

510(k) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

360(k)), it also represents two

alternatives. The first alternative, the

‘‘Special 510(k): Device

Modification,’’utilizes certain aspects of

the quality system regulation, while the

second alternative, the ‘‘abbreviated

510(k),’’ relies on the use of special

controls and consensus standards to

facilitate 510(k) review.

Under section 510(k) of the act, a

person who intends to introduce a

device into commercial distribution is

required to submit a premarket

notification, or 510(k), to FDA at least

90 days before commercial distribution

is to begin. Section 513(i) of the act (21

U.S.C. 360c(i)) stipulates that FDA may

issue an order of substantial

equivalence, only upon making a

determination that the device to be

introduced into commercial distribution

is as safe and effective as a legally

marketed device. Under 21 CFR 807.87,

FDA has codified the content

requirements for premarket notifications

to be submitted by device manufacturers

in support of the substantial

equivalence decision. However, FDA

has discretion in the type of information

it deems necessary to meet those

content requirements.

A. Special 510(k): Device Modification

The Safe Medical Devices Act of 1990

(the SMDA) (Pub. L. 101–629) amended

section 520(f) of the act (21 U.S.C.

360j(f)), providing FDA with the

authority to issue regulations requiring

pre-production design controls. Under

the authority provided by the SMDA,

FDA revised its current good

manufacturing practice requirements to

include pre-production design controls

that device manufacturers must follow

when initially designing devices or

when making subsequent modifications

to those designs.

Effective June 1, 1997, manufacturers

of Class II and certain Class I devices

must follow design control procedures

for their devices including device

modifications. Product modifications

that could significantly affect safety and

effectiveness are subject to 510(k)

submission requirements under 21 CFR

807 as well as design control

requirements under 21 CFR 820.30.

Because design controls are now in

effect and require the conduct of

verification and validation studies of a

type that have traditionally been

included in 510(k) submissions, FDA

believes that test results generated

under the new design control

requirements will be sufficient to serve

as a basis for certain substantial

equivalence decisions. In light of the

design control requirements, FDA

believes that it may be appropriate, in

certain circumstances, to forgo a

detailed review of the underlying data

normally required in 510(k)’s. While

FDA would not rely on the design

controls procedure requirements to

issue a determination of substantive

equivalence, it would rely on the

existence of data generated in

accordance with those procedures to

issue a substantial equivalence

determination.

Under the draft 510(k) paradigm, a

manufacturer would use the FDA

guidance document entitled, ‘‘Deciding

When to Submit A 510(k) for a Change

to an Existing Device’’ to decide if a

device modification could be

implemented without submission of a

new 510(k). If a new 510(k) is needed

for the modification and if the

modification does not affect the

intended use of the device or the basic

fundamental scientific technology of the

device, conformance with design

controls could form the basis for

clearing the application.

Special 510(k)’s will be processed by

the Office of Device Evaluation (ODE)

within 30 days of receipt by the