Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices 13649

1The isotopes identified by the regulation are

americium-241, cesium-137, cobalt-60, iodine-125,

krypton-85, radium-226, and strontium-90.

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by April 21,

1997.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3507), FDA has submitted the

following proposed collection of

information to OMB for review and

clearance.

Irradiation in the Production,

Processing, and Handling of Food (21

CFR Part 179)—(OMB Control Number

0910–0186—Reinstatement)

Under sections 201(s) and 409 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 321(s) and 348), food

irradiation is subject to regulation as a

food additive. The regulations providing

for uses of irradiation in the production,

processing, and handling of food are

found in part 179 (21 CFR part 179).

Section 179.25(e) requires that food

processors who treat food with radiation

make and retain, for 1 year past the

expected shelf life of the products up to

a maximum of 3 years, specified records

relating to the irradiation process (e.g.,

the food treated, lot identification,

scheduled process, etc.).

Section 179.26(c) requires that food

processors label retail packages of

irradiated foods with an FDA prescribed

logo and statement, ‘‘Treated with

radiation’’ or ‘‘Treated by irradiation.’’

To ensure safe use of radiation sources,

§ 179.21(b)(1) requires that the label of

sources bear appropriate and accurate

information identifying the source of

radiation (§ 179.21(b)(1)(i)) and the

maximum energy of radiation emitted

by x-ray tube sources (§ 179.21(b)(1)(ii)).

Section 179.21(b)(2) requires that the

label or accompanying labeling bear

adequate directions for installation and

use (§ 179.21(b)(2)(i)), a statement that

no food shall be exposed to radiation

sources so as to receive an absorbed

dose of x-radiation in excess of 10 grays

(§ 179.21(b)(2)(ii)) or an absorbed dose

of certain radioisotopes1 in excess of 2

milligrays (§ 179.21(b)(2)(iii)).

The records required by § 179.25(e)

are used by FDA inspectors to assess

compliance with the regulation that

establishes limits within which

radiation may be safely used to treat

food. The agency cannot ensure safe use

without a method to assess compliance

with the dose limits, and there are no

practicable methods for analyzing most

foods to determine whether they have

been treated with ionizing radiation and

are within the limitations set forth in

part 179. Records inspection is the only

way to determine whether firms are

complying with the regulations for

treatment of foods with ionizing

radiation.

FDA estimates the burden of this

collection of information as follows:

ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

179.25(e) 3 120 360 1 360

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

The number of firms who process

food using irradiation is extremely

limited. FDA estimates that there is a

single irradiation plant whose business

is devoted primarily (i.e., approximately

100 percent) to irradiation of food and

other agricultural products. Two other

facilities also irradiate small quantities

of food (mainly spices). FDA estimates

that this irradiation accounts for no

more than 10 percent of the business for

each of these firms. Therefore, the

average estimated burden is based on:

(1) Facility devoting 100 percent of its

business (or 300 hours for

recordkeeping annually) to food

irradiation; (2) facilities devoting 10

percent of their business or 60 hours (2

x 30 hours) for recordkeeping annually,

to food irradiation or (300 + 60)/3 = 120

x 3 firms x 1 hour = 360 hours annually.

No burden has been estimated for the

labeling requirements in § 179.21(b)(1)

and (b)(2)(i) because it is a usual and

customary business practice for

manufacturers of food processing

equipment to label (identify) their

products for use by their customers.

Under 5 CFR 1320.3(b)(2), the time,

effort, and financial resources necessary

to comply with a collection of

information are excluded from the

burden estimate if the reporting,

recordkeeping, or disclosure activities

needed to comply are usual and

customary because they would occur in

the normal course of activities. In

addition, no burden has been estimated

for §§ 179.21(b)(2)(ii) and (b)(2)(iii) and

179.26(c) because FDA provides the

exact wording and logo that is to be

used on the label. Under 5 CFR

1320.3(c)(2), the public disclosure of

information originally supplied by the

Federal Government to the recipient for

the purpose of disclosure to the public

is not a collection of information.

Dated: March 13, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–7131 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97D–0099]

Draft Guidance for Industry: FDA

Approval of New Cancer Treatment

Uses for Marketed Drug and Biological

Products; Availability

AGENCY: Food and Drug Administration,

HHS.
13650 Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled,

‘‘Guidance for Industry: FDA Approval

of New Cancer Treatment Uses for

Marketed Drug and Biological

Products.’’ The draft guidance considers

the quality and quantity of data that

may be adequate to add a new use to the

prescribing information for a product

used in the treatment of cancer. The

draft guidance is part of the agency’s

‘‘New Use Initiative—Evidence for

Primary and Supplemental Approvals,’’

which is exploring ways to expedite the

development of new and supplemental

uses for drug and biological products.

Elsewhere in this issue of the Federal

Register, FDA is publishing a notice of

availability of a draft guidance that

discusses what clinical evidence of

efficacy should be provided in new drug

and biological product license

applications as well as in supplemental

applications. The agency is seeking

public comment on the draft guidance.

DATES: Written comments on the draft

guidance by May 20, 1997. General

comments on agency guidance

documents may be submitted at any

time.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Guidance for Industry: FDA

Approval of New Cancer Treatment

Uses for Marketed Drug and Biological

Products’’ to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857; or the Office

of Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send two

self-addressed adhesive labels to assist

the offices in processing your requests.

The draft guidance also may be obtained

by mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by facsimile by

calling the FAX Information System at

1–800–835–4709 or 301–827–1800. See

the SUPPLEMENTARY INFORMATION

section for electronic access to the draft

guidance. Submit written comments on

the draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Robert J. Delap, Center for Drug

Evaluation and Research (HFD–150),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–2473.

SUPPLEMENTARY INFORMATION:

I. Background

When drugs approved for one use

prove safe and effective for treating

other conditions, information on the

new use should be added to the product

labeling as soon as possible. FDA has

launched the ‘‘New Use Initiative—

Evidence for Primary and Supplemental

Approvals’’ to explore ways the agency

can improve the supplemental

application process. FDA believes it can

expedite the development of new and

supplemental uses of drug and

biological products by doing the

following: (1) Clarifying what evidence

should be provided in primary as well

as supplemental applications and (2)

working with industry to reduce barriers

to submitting applications for new uses

for their products.

Some of the information submitted in

a supplemental application may be

available from the primary application.

As a result, the agency decided that its

first step would be to clarify what

information sponsors should provide in

applications in general. Elsewhere in

this issue of the Federal Register, FDA

is announcing the availability of a draft

guidance entitled ‘‘Guidance for

Industry: Providing Clinical Evidence of

Effectiveness for Human Drug and

Biological Products,’’ The draft

guidance addresses the information that

should be provided in new drug and

biological product license applications

as well as supplemental applications.

The draft guidance entitled

‘‘Guidance for Industry: FDA Approval

of New Cancer Treatment Uses for

Marketed Drug and Biological Products’’

focuses on the particular information to

be provided when submitting an

application for the approval of a

supplemental new use for a drug

product to treat cancer. Cancer

treatments often yield potential new

uses for already marketed drugs.

Although this draft guidance does not

create or confer any rights on any

person, and does not operate to bind

FDA in any way, it does represent the

agency’s current thinking on new cancer

treatment uses for marketed drug and

biological products.

II. Request for Comments

Interested parties may submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). 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 draft guidance and

received comments may be seen in the

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

Monday through Friday.

III. Electronic Access

An electronic version of the draft

guidance also is available via Internet

using the World Wide Web (WWW)

(connect to the CDER home page at

attp://www.fda.gov/cder and go to the

‘‘Regulatory Guidance’’ section, or to the

CBER home page at http://www.fda.gov/

cber/cberfp.html).

Dated: March 14, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–7132 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97D–0100]

Draft Guidance for Industry: Providing

Clinical Evidence of Effectiveness for

Human Drug and Biological Products;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled,

‘‘Guidance for Industry: Providing

Clinical Evidence of Effectiveness for

Human Drug and Biological Products.’’

The purpose of the draft guidance is to

clarify what clinical evidence of

effectiveness should be provided in new

drug applications, biological product

license applications, and supplemental

applications. The draft guidance is part

of the agency’s ‘‘New Use Initiative—

Evidence for Primary and Supplemental

Approvals,’’ which is exploring ways to

expedite the development of new and

supplemental uses for drug and

biological products. Elsewhere in this

issue of the Federal Register, FDA is

announcing the availability of a draft

guidance that discusses the quality and

quantity of data that may be adequate to

add a new use to the prescribing

information for a product used in the

treatment of cancer. The agency is

seeking public comment on the draft

guidance.

DATES: Written comments on the draft

guidance by May 20, 1997. General

comments on agency guidance

documents may be submitted at any

time.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Guidance for Industry: