Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31469

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

revise the regulation that sets forth the

requirements for the carcinogenicity

testing of compounds used in foodproducing animals to allow the agency

and sponsors greater flexibility when

choosing the types of studies used for

testing the carcinogenicity of

compounds used in food-producing

animals. FDA is proposing to revise the

study requirements because FDA

recognizes that advances in models used

to assess the carcinogenicity of

compounds have been made. The

specific requirement that a sponsor

must conduct oral, chronic, doseresponse studies would be deleted

under the proposed regulation.

Sponsors would have more options for

testing the carcinogenicity of

compounds used in food-producing

animals. This proposal implements the

goals stated by the National

Performance Review.

DATES: Written comments by September

3, 1996.

ADDRESSES: Written comments to the

Dockets Managements Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Comments should

be identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen at the Dockets Management Branch

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

through Friday.

FOR FURTHER INFORMATION CONTACT:

Margaret A. Miller, Center for

Veterinary Medicine (HFV–100), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0205.

SUPPLEMENTARY INFORMATION: Section

500.80(b) (21 CFR 500.80(b)) sets forth

the requirements for the carcinogenicity

testing of compounds used in foodproducing animals. Specifically, the

regulation states, ‘‘The bioassays that a

sponsor conducts must be oral, chronic,

dose-response studies and must be

designed to assess carcinogenicity and

to determine the quantitative aspects of

any carcinogenic response.’’

At the time that this regulation was

written, a chronic study was considered

to be the standard test for

carcinogenicity. However, FDA

recognizes that advances in models used

to assess carcinogenicity have been

made in recent years. For example,

scientists now agree that, depending on

the compound, a chronic study (as

required under current regulations) may

not measure the appropriate time point

necessary to assess carcinogenicity.

Study designs other than chronic may

result in a better evaluation of the

compound. Thus, FDA is proposing to

remove the requirement for oral,

chronic, dose-response studies to allow

sponsors the option of using other study

designs when assessing carcinogenicity

of compounds used for food-producing

animals.

This proposal is aligned with the

goals stated by the National

Performance Review. This proposed

rule is a result of the President’s

directive to conduct a comprehensive

review of all rules to identify those that

are obsolete and burdensome and to

delete or revise them. The agency has

determined that this rule is in need of

revision as described herein.

I. Environmental Impact

The agency has carefully considered

the potential environmental effects of

this action. FDA has determined that

this action is categorically excluded

under 21 CFR 25.24(a)(8). The

procedure for testing the carcinogenicity

of compounds used for food-producing

animals is being revised. This revision

will not cause an increase in the

existing level of use or cause a change

in the intended uses of the product or

its substitutes. Therefore, neither an

environmental assessment nor an

environmental impact statement is

required.

II. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(Pub. L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so is not subject to

review under the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because the proposed rule

would clarify FDA policy and simplify

the process for submitting certain

applications, the agency certifies that

the proposed rule will not have a

significant economic impact on a

substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

III. Paperwork Reduction Act of 1995

The agency has determined that this

proposed rule contains no collection of

information requirements under the

Paperwork Reduction Act of 1995 (44

U.S.C. chapter 35).

IV. Federalism

FDA has analyzed this proposal in

accordance with the principles and

criteria set forth in Executive Order

12612 and has determined that this

proposal does not warrant the

preparation of a Federalism Assessment.

V. Request for Comments

Interested persons may, on or before

September 3, 1996 submit to the

Dockets Management Branch (address

above) written comments regarding this

proposal. 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. Received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 500

Animal drugs, Animal feeds, Cancer,

Labeling, Polychlorinated biphenyls

(PCB’s).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 500 is

amended as follows:

Part 500—General

1. The authority citation for 21 CFR

part 500 continues to read as follows:

Authority: Secs. 201, 301, 402, 403, 409,

501, 502, 503, 512, 701 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 321, 331,

342, 343, 348, 351, 352, 353, 360b, 371).

§ 500.80 [Amended]

2. Section 500.80 Scope of this

subpart is amended in paragraph (b) by

removing the phrase ‘‘must be oral,

chronic, dose-response studies and.’’

Dated: June 13, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–15725 Filed 6–19–96; 8:45 am]

BILLING CODE 4160–01–F
31470 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

INTERNATIONAL BOUNDARY AND

WATER COMMISSION

22 CFR Part 1102

United States and Mexico, United

States Section, Freedom of Information

Act: Uniform Fee Schedule and

Administrative Guidelines

AGENCY: United States Section,

International Boundary and Water

Commission.

ACTION: Proposed rule.

SUMMARY: This proposed rule will revise

the United States Section, International

Boundary and Water Commission

(IBWC) regulations that implement the

Freedom of Information Act (FOIA) fee

schedule. This revision pertains to the

charge for recovery of the full, allowable

direct costs of searching for and

reviewing records requested under the

FOIA and section 1102.4 of the IBWC

rules, unless such fees are restricted or

waived in accordance with section

1102.6. These fees are being revised to

correspond to modifications of rates of

pay approved by the U.S. Congress.

DATES: All comments received on or

before July 22, 1996, will be considered

before final action is taken on this

proposed rule.

ADDRESSES: Please submit any written

comments to the Freedom of

Information Act Officer, International

Boundary and Water Commission,

United States Section, The Commons,

Bldg. C, Suite 310, 4171 N. Mesa, El

Paso, TX 79902–1441, telephone: (915)

534–6697.

FOR FURTHER INFORMATION CONTACT:

Dell Driver, telephone (915) 534–6697.

SUPPLEMENTARY INFORMATION: The IBWC

is modifying section 1102.4(a) of the

rules which pertains to the charges for

searching and reviewing records

requested under the Freedom of

Information Act (FOIA).

The FOIA requires Federal agencies to

establish a schedule of fees for the

processing of requests for agency

records in accordance with fee guidance

issued by the Office of Management and

Budget (OMB). In 1987, OMB issued its

Uniform Freedom of Information Act

Fee Schedule and Guidelines. However,

since the FOIA requires that each

agency’s fees be based upon its direct

costs of providing FOIA services, OMB

did not provide a unitary, government

wide selection of fees.

List of Subjects in 22 CFR Part 1102

Freedom of information.

For the reasons set out in the

preamble, part 1102.4(a)(1) of title 22 of

the Code of Federal Regulations is

proposed to be amended as follows:

PART 1102—FREEDOM OF

INFORMATION ACT

1. The authority for this part

continues to read as follows:

Authority: 5 U.S.C. 552 (Pub. L. 90–23, as

amended by Pub. L. 93–502 and Pub. L. 99–

570).

2. Section 1102.4 (a)(1) and (a)(2) are

revised to read as follows:

§ 1102.4 Fees.

(a) The following shall be applicable

with respect to services rendered to the

public under this subpart:

(1) Fee Schedule.

(i) Searching for records, per hour or

fraction thereof, per individual:

Professional............................................$23.71

Technical................................................$16.57

Clerical ...................................................$13.38

Includes the salary of the category of

employee who actually performs the search

computed at Step 5 of each grade level plus

an additional 24% of that rate for personnel

benefits. These fees will be periodically

modified to correspond to changes in pay

approved by Congress.

(ii) The cost for computer searches

will be calculated based on the salary of

the category of employee who actually

performs the computer search, plus 24%

of that rate to include personnel

benefits, plus the direct costs of the

central processing unit, input-output

devices, and memory capacity of the

actual computer configuration.

(iii) Reproduction fees:

Pages no larger than 81⁄2 × 14 inches when

reproduced by routine electrostatic copying:

$0.10 per page.

Pages requiring reduction, enlargement, or

other special services will be billed at direct

cost to the Section. Reproduction by other

than routine electrostatic copying will be

billed at direct cost to the Section.

(iv) Certification of each record as a

true copy—$1.00.

(v) Duplication of architectural

photographs and drawings:

Blueprinting.............................$1.00 per sq. ft.

Vellum Reproducible from blueprints

........................................... $5.00 per sq. ft.

(vi) Postage and handling. Full costs

will be recovered from the requestor if

special mailing such as express mail is

indicated. Otherwise, records will be

sent by first-class certified mail,

domestic addresses only, direct cost

paid by the U.S. Section.

(2) Only requesters who are seeking

documents for commercial use will be

charged for time spent reviewing

records to determine whether they are

exempt from mandatory disclosure. The

cost for review will be calculated based

on the salary of the category of the

employee who actually performed the

review plus 24% of the rate to cover

personal benefits. Charges will be

assessed only for the initial review (i.e.,

review undertaken the first time in

order to analyze the applicability of

specific exemption(s) to a particular

record or portion of record) and not

review at the administrative appeal

level of the exemption(s) already

applied.

Dell Driver,

Freedom of Information Act Officer.

[FR Doc. 96–15344 Filed 6–19–96; 8:45 am]

BILLING CODE 7010–01–M

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

25 CFR Part 142

RIN 1076 AD66

Operation of U.S.M.S.‘‘North Star’’

Between Seattle, Washington, and

Stations of the Bureau of Indian Affairs

and Other Government Agencies,

Alaska

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Proposed rule.

SUMMARY: The Bureau of Indian Affairs

(BIA) is proposing to revise its

regulations in Alaska Resupply

Operation as mandated by Executive

Order 12866 to streamline the regulatory

process and enhance the planning and

coordination of existing regulations.

DATES: Comments must be received on

or before August 19, 1996.

ADDRESSES: Mail comments to Warren

Heisler, Assistant Area Director, Juneau

Area Office, Bureau of Indian Affairs,

Department of the Interior, 709 West 9th

Street, Juneau, Alaska 99802; OR, hand

deliver them to the above address.

Comments will be available for

inspection at this address from 9:00 a.m.

to 4:00 p.m., Monday through Friday

beginning approximately two weeks

after publication of this document in the

Federal Register.

FOR FURTHER INFORMATION CONTACT:

Warren Heisler, Assistant Area Director,

Juneau Area Office, Bureau of Indian

Affairs at telephone (907) 586–7177.

SUPPLEMENTARY INFORMATION:

Background

The U.S.M.S. North Star has been

decommissioned. However, the need for

a resupply operation in Alaska

continues. The Juneau Area Office