13648 Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices

Dated: March 17, 1997.

Bob Williams,

Commissioner Administration on

Developmental Disabilities.

[FR Doc. 97–7212 Filed 3–20–97; 8:45 am]

BILLING CODE 4184–01–P

Food and Drug Administration

[Docket No. 97N–0098]

Agency Information Collection

Activities: Proposed Collection;

Comment Request; Extension

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

Form FDA 3038, ‘‘Interstate Shellfish

Dealer’s Certificate.’’

DATES: Submit written comments on the

collection of information by May 20,

1997.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

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: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Interstate Shellfish Dealers

Certificate—(OMB Control Number

0910–0021)—Extension

Under 42 U.S.C. 243, FDA is required

to cooperate with and aid State and

local authorities in the enforcement of

their health regulations and is

authorized to assist States in the

prevention and suppression of

communicable diseases. Under this

authority, FDA participates with State

regulatory agencies, some foreign

nations, and the molluscan shellfish

industry in the National Shellfish

Sanitation Program (NSSP). The NSSP is

a voluntary, cooperative program to

promote the safety of molluscan

shellfish by providing for the

classification and patrol of shellfish

growing waters and for the inspection

and certification of shellfish processors.

Each participating State and foreign

nation monitors its molluscan shellfish

processors and issues certificates for

those that meet the State or foreign

shellfish control authority’s criteria.

Each participating State and nation

provides a certificate of its certified

shellfish processors to FDA on Form

FDA 3038, ‘‘Interstate Shellfish Dealer’s

Certificate.’’ FDA uses this information

to publish the ‘‘Interstate Certified

Shellfish Shippers List,’’ a monthly

comprehensive listing of all molluscan

shellfish processors certified under the

cooperative program. If FDA did not

collect the information necessary to

compile this list, participating States

would not be able to identify and keep

out shellfish processed by uncertified

processors in other States and foreign

nations. Consequently, the NSSP would

not be able to control the distribution of

uncertified and possibly unsafe shellfish

in interstate commerce, and its

effectiveness would be nullified.

FDA estimates the burden of this

collection of information as follows:

ESTIMATED ANNUAL REPORTING BURDEN

Form No. No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

FDA 3038 33 70 2,310 .10 231

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

This estimate is based on the numbers

of certificates received in 1996.

Dated: March 13, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–7137 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97N–0092]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Reinstatement

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and
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.