32978 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 /Rules and Regulations

materials filed in connection with these

reports, except for reports of

compliance, and supplemental materials

filed in connection with Commission

orders requiring divestitures or

establishment of business enterprises of

facilities, which are confidential until

the last divestiture or establishment of

a business enterprise or facility, as

required by a particular order, has been

finally approved by the Commission,

and staff letters to respondents advising

them that their compliance reports do

not warrant any further action. At the

time each such report is submitted the

filing party may request confidential

treatment in accordance with paragraph

(c) of this section and the General

Counsel or the General Counsel’s

designee will pass upon such request in

accordance with that paragraph;

* * * * *

(c) Confidentiality and in camera

material. (1) Persons submitting material

to the Commission described in this

section may designate that material or

portions of it confidential and request

that it be withheld from the public

record. All requests for confidential

treatment shall be supported by a

showing of justification in light of

applicable statutes, rules, orders of the

Commission or its administrative law

judges, orders of the courts, or other

relevant authority. The General Counsel

or the General Counsel’s designee will

act upon such request with due regard

for legal constraints and the public

interest. No such material or portions of

material (including documents

generated by the Commission or its staff

containing or reflecting such material or

portions of material) will be placed on

the public record until the General

Counsel or the General Counsel’s

designee has ruled on the request for

confidential treatment and provided any

prior notice to the submitter required by

law.

* * * * *

(3) To the extent that any material or

portions of material otherwise falling

within paragraph (b) of this section

contain information that is not required

to be made public under § 4.10 of this

part, the General Counsel or the General

Counsel’s designee may determine, with

due regard for legal constraints and the

public interest, to withhold such

materials from the public record.

6. Section 4.11 is amended by revising

paragraphs (c), (d), (f) and (g) to read as

follows:

§ 4.11 Disclosure requests.

* * * * *

(c) Requests from Federal and State

law enforcement agencies. Requests

from law enforcement agencies of the

Federal government for nonpublic

records shall be addressed to the liaison

officer for the requesting agency, or if

there is none, to the General Counsel.

Requests from State agencies for

nonpublic records shall be addressed to

the General Counsel. With respect to

requests under this paragraph, the

General Counsel, the General Counsel’s

designee, or the appropriate liaison

officer is delegated the authority to

dispose of them. Alternatively, the

General Counsel may refer such requests

to the Commission for determination,

except that requests must be referred to

the Commission for determination

where the Bureau having the material

sought and the General Counsel do not

agree on the disposition. Prior to

granting access under this section to any

material submitted to the Commission,

the General Counsel, the General

Counsel’s designee, or the liaison officer

will obtain from the requester a

certification that such information will

be maintained in confidence and will be

used only for official law enforcement

purposes. The certificate will also

describe the nature of the law

enforcement activity and the anticipated

relevance of the information to that

activity. A copy of the certificate will be

forwarded to the submitter of the

information at the time the request is

granted unless the agency requests that

the submitter not be notified.

(d) Requests from Federal and State

agencies for purposes other than law

enforcement. Requests from Federal and

State agencies for access to nonpublic

records for purposes not related to law

enforcement should be addressed to the

General Counsel. The General Counsel

or the General Counsel’s designee is

delegated the authority to dispose of

requests under this paragraph.

Disclosure of nonpublic information

will be made consistent with sections

6(f) and 21 of the FTC Act. Requests

under this section shall be subject to the

fee and fee waiver provisions of § 4.8.

* * * * *

(f) Requests by current or former

employees to use nonpublic memoranda

as writing samples shall be addressed to

the General Counsel. The General

Counsel or the General Counsel’s

designee is delegated the authority to

dispose of such requests consistent with

applicable nondisclosure provisions,

including sections 6(f) and 21 of the

FTC Act.

(g) Employees are encouraged to

engage in teaching, lecturing, and

writing that is not prohibited by law,

Executive order, or regulation. However,

an employee shall not use information

obtained as a result of his Government

employment, except to the extent that

such information has been made

available to the general public or will be

made available on request, or when the

General Counsel or the General

Counsel’s designee gives written

authorization for the use of nonpublic

information on the basis that the use is

in the public interest.

7. Section 4.15 is amended by revising

paragraph (c)(3) to read as follows:

§ 4.15 Commission meetings.

* * * * *

(c) * * *

(3) Closed meeting transcripts or

minutes required by 5 U.S.C. 552b(f)(1)

will be released to the public insofar as

they contain information that either is

not exempt from disclosure under 5

U.S.C. 552b(c), or, although exempt,

should be disclosed in the public

interest. The Commission will

determine whether to release, in whole

or in part, the minutes of its executive

sessions to consider oral arguments.

With regard to all other closed meetings,

the General Counsel or the General

Counsel’s designee shall determine, in

accordance with § 4.9(c), which portions

of the transcripts or minutes may be

released.

* * * * *

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 98–16030 Filed 6–16–98; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. 96N–0007]

Labeling of Drugs for Use in MilkProducing Animals

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

new animal drug regulations to remove

the existing 96-hour withdrawal time

limitation, eliminate the requirement to

calculate and label on the basis of the

number of 12-hour milking periods that

have elapsed since treatment, and

permit a milk-discard or withdrawal

time to be calculated by elapsed hours

since treatment. The agency is taking

these actions to allow greater flexibility
Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 /Rules and Regulations 32979

in the labeling of new animal drugs for

use in milk-producing animals. The

increased flexibility will make it easier

and more economical for sponsors to

comply with the regulations. These

actions are part of FDA’s continuing

effort to achieve the objectives set forth

in the President’s ‘‘National

Performance Review’’ initiative, which

is intended to provide a comprehensive

review of all rules to identify those that

are obsolete and burdensome and to

delete or revise them.

DATES: July 17, 1998.

FOR FURTHER INFORMATION CONTACT:

Steven D. Vaughn, Center for Veterinary

Medicine (HFV–130), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1642.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of April 4,

1996 (61 FR 15003), FDA published a

proposed rule to amend the new animal

drug regulations to: (1) Remove the

existing regulatory limitation regarding

a milk-discard or withdrawal time of not

more than 96 hours, (2) eliminate the

requirement to calculate and label on

the basis of the number of 12-hour

milking periods that have elapsed since

the last treatment, and (3) permit a milkdiscard or withdrawal time to be

calculated on the basis of hours that

have elapsed from the most recent

treatment.

The requirements for labeling of new

animal drugs intended for use in milkproducing animals at §§ 510.105 and

510.106 (21 CFR 510.105 and 510.106)

of the new animal drug regulations

provide for specific labeling for

antibiotics, antibiotic-containing drugs,

and other drugs intended for use in

milk-producing animals.

The maximum 96-hour limitation in

§ 510.105 was based on FDA’s

perception that 96 hours constituted a

maximum practical withdrawal time for

the dairy industry. However, FDA now

recognizes that a withdrawal time

longer than 96 hours may be desirable

and practical in certain circumstances.

Accordingly, in the proposed rule, FDA

proposed to remove the 96-hour

limitation to allow the possibility of

longer withdrawal times to be

considered for milk-producing animals

on a case-by-case basis depending on

the use and safety of the drug.

Similarly, the 12-hour milking

schedule in § 510.106 was established

to calculate the number of milkings that

occur during the withdrawal period.

The 12-hour milking interval was

considered to be generally reflective of

dairy practice when this regulation was

published; however, alternative milking

schedules are in common use in the

dairy industry today. Accordingly, in

the proposed rule, FDA proposed to

revise the regulation so that the length

of the milking cycle is not specified,

eliminating the reference to the milking

interval as long as milk is discarded for

the assigned number of hours after the

latest drug treatment.

No comments were received on the

proposed rule.

Because the agency has determined

that the underlying rationale in support

of the proposed amendment remains

sound and because no comments were

received, the revisions set forth in the

proposed rule are reflected in the final

rule. In addition, in the final rule, the

agency has deleted the phrase ‘‘(in

llll milkings)’’ in § 510.105 to

make it consistent with § 510.106 as

amended. Also, in the final rule, the

agency has added the word ‘‘violative’’

before the word ‘‘residues’’ in the first

sentence of § 510.105(c)(2) and the

second sentence of § 510.106 to clarify

that labeling statements do not refer to

any residues at or below permitted

tolerance levels that might be present.

Accordingly, the final rule: (1)

Removes the existing regulatory

limitation regarding a milk-discard or

withdrawal time of not more than 96

hours, (2) eliminates the requirement to

calculate and label on the basis of the

number of 12-hour milking periods that

have elapsed since the last treatment, (3)

permits a milk-discard or withdrawal

time to be calculated on the basis of

hours that have elapsed from the most

recent treatment, and makes minor

corrections for purposes of consistency

and clarification.

These amendments will apply only to

future approvals and will not affect

currently approved new animal drugs

unless a sponsor submits a supplement

providing for revised labeling.

As stated in the proposal, these

revisions are consistent with the goals of

the President’s National Performance

Review. The agency’s actions are part of

its continuing effort to achieve the

objectives set forth in that initiative,

which is intended to provide a

comprehensive review of all rules to

identify those that are obsolete and

burdensome and to delete or revise

them.

II. Environmental Impact

FDA has carefully considered the

potential environmental effects of this

action and has determined under 21

CFR 25.30(k) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. This action

revises the labeling requirements for

drugs, antibiotics, and antibioticcontaining drugs intended for use in

milk-producing animals, but 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.

III. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866,

under the Regulatory Flexibility Act (5

U.S.C. 601–612), and under the

Unfunded Mandates Reform Act (Pub.

L. 104–4). 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, and distributive

impacts and equity). The Regulatory

Flexibility Act requires agencies to

examine the economic impact of a rule

on small entities. The Unfunded

Mandates Reform Act requires agencies

to prepare an assessment of anticipated

costs and benefits before enacting any

rule that may result in an expenditure

in any one year by State, local and tribal

governments, in the aggregate, or by the

private sector, of $100,000,000 (adjusted

annually for inflation).

This amendment to the new animal

drug regulations will remove the

existing regulatory requirement that

mandates a withdrawal time not exceed

96 hours, and will permit withdrawal

times to be calculated from the most

recent treatment rather than requiring a

12-hour milking schedule. These actions

will permit greater flexibility in the

labeling of new animal drugs for use in

milk-producing animals. These

amendments will apply only to future

approvals and will not affect currently

approved new animal drugs unless a

sponsor submits a supplement

providing for revised labeling. The only

compliance cost estimated for this rule

would be for those drugs that are

currently being reviewed for approval

and are still unapproved on the date the

final rule becomes effective. To the

extent that any of these drugs exist, their

sponsoring companies would incur a

very small administrative expense of

preparing a supplement to the

application to change the warning

language.

FDA concludes that this final rule is

consistent with the principles set forth

in the Executive Order and in the two

statutes. In addition, the agency has
32980 Federal Register / Vol. 63, No. 116 /Wednesday, June 17, 1998 /Rules and Regulations

determined that this rule is not a

significant regulatory action as defined

by the Executive Order, 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 rule would clarify

FDA policy, the agency certifies that the

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.

Section 202 of the Unfunded

Mandates Reform Act requires that

agencies prepare an assessment of

anticipated costs and benefits before

proposing any expenditure by State,

local, and tribal governments, in the

aggregate, or by the private sector of

$100 million (adjusted annually for

inflation) in any one year. The final rule

allowing greater flexibility in the

labeling of new animal drugs for use in

milk-producing animals is estimated to

result in insignificant expenditures of

funds by the private sector, and none by

State, local, and tribal governments.

Because the expenditures are estimated

to be insignificant, FDA is not required

to perform a cost/benefit analysis

according to the Unfunded Mandates

Reform Act.

IV. Paperwork Reduction Act of 1995

FDA has determined that this rule

contains no collections of information

under the Paperwork Reduction Act of

1995 (44 U.S.C. 3501–3520). FDA

concludes that the labeling

requirements described in this

document are not subject to review by

the Office of Management and Budget

(OMB) because they do not constitute a

‘‘collection of information’’ but rather

constitute warning statements that are a

‘‘public disclosure of information

originally supplied by the Federal

Government to the recipient for the

purpose of disclosure to the public’’ (5

CFR 1320.3(c)(2)). For that portion of

the labeling statement required by

§ 510.105(c)(2) that is not supplied to

the manufacturer (the number of hours

necessary to avoid residue in milk used

for food), the necessary information is

already required under a separate

regulation (§ 514.1(b)(7)(i)). This

information has already been cleared by

OMB (OMB Control number 0910–

0032).

V. Federalism

FDA has analyzed the final rule in

accordance with the principles set forth

in Executive Order 12612 and has

determined that this final rule does not

warrant the preparation of a Federalism

Assessment.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 510 is

amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

2. Section 510.105 is amended by

revising paragraph (c)(2) to read as

follows:

§ 510.105 Labeling of drugs for use in

milk-producing animals.

* * * * *

(c) * * *

(2) The label should bear the

following statement: ‘‘Warning: Milk

that has been taken from animals during

treatment and for llll hours after

the latest treatment must not be used for

food’’, the blank being filled in with the

figure that the manufacturer has

determined by appropriate investigation

is needed to insure that the milk will

not carry violative residues resulting

from use of the preparation. If the use

of the preparation as recommended does

not result in contamination of the milk,

neither of the above warning statements

is required.

3. Section 510.106 is revised to read

as follows:

§ 510.106 Labeling of antibiotic and

antibiotic-containing drugs intended for use

in milk-producing animals.

Whenever the labeling of an antibiotic

drug included in the regulations in this

chapter suggests or recommends its use

in milk-producing animals, the label of

such drugs shall bear either the

statement ‘‘Warning: Not for use in

animals producing milk, since this use

will result in contamination of the

milk’’ or the statement ‘‘Warning: Milk

that has been taken from animals during

treatment and for llll hours after

the latest treatment must not be used for

food’’, the blank being filled in with the

figure that the Commissioner has

authorized the manufacturer of the drug

to use. The Commissioner shall

determine what such figures shall be

from information submitted by the

manufacturer and which the

Commissioner considers is adequate to

prove that period of time after the latest

treatment that the milk from treated

animals will contain no violative

residues from use of the preparation. If

the Commissioner determines from the

information submitted that the use of

the antibiotic drug as recommended

does not result in its appearance in the

milk, the Commissioner may exempt the

drug from bearing either of the above

warning statements.

Dated: June 9, 1998.

William K. Hubbard

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–16063 Filed 6–16–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[AR–2–1–7393; FRL–6111–3]

Approval and Promulgation of State

Implementation Plans; Arkansas;

Recodification of Air Quality Control

Regulations and Correction of Sulfur

Dioxide Enforceability Deficiencies

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Removal of direct final rule

amendments.

SUMMARY: On April 10, 1998 (63 FR

17680), EPA published a direct final

approval and a proposed approval (63

FR 17793), of a revision to the Arkansas

State Implementation Plan (SIP) which

added Arkansas Department of

Pollution Control and Ecology

Regulation #19, ‘‘Compilation of

Regulations of the Arkansas State

Implementation Plan for Air Pollution

Control,’’ as adopted by the Arkansas

Commission on Pollution Control and

Ecology on July 24, 1992, and submitted

to EPA on September 14, 1992. The

direct final action was published

without prior proposal because the

Agency anticipated no adverse

comments. The EPA received adverse

comments on the two April 10, 1998,

actions. The commenters asked EPA not

to consider the regulation as a revision

to the Arkansas SIP. In addition, EPA

also received a letter from the Governor

of Arkansas dated May 8, 1998,

requesting that the Federal Register

approval of the 1992 Regulation #19 be

withdrawn and that the 1992 submittal

be returned to the State. Therefore,

Region 6 is withdrawing its direct final

approval action by removing the

amendments made by the direct final

rule and restoring the regulatory text