65448 Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Rules and Regulations

1Editorial Note: This document was received at

the Office of the Federal Register on December 12,

2001.

the shipping packages or, if the exported

product does not have a shipping

package or container, on shipping

invoices or other documents

accompanying the exported product;

and

(4) Records demonstrating that the

product is not sold or offered for sale in

the United States: This may consist of

production and shipping records for the

exported product and promotional

materials.

(c) Additional recordkeeping

requirements for partially processed

biological products exported under

section 351(h) of the Public Health

Service Act. In addition to the

requirements in paragraph (b) of this

section, persons exporting a partially

processed biological product under

section 351(h) of the Public Health

Service Act shall maintain, for the same

period of time as required for records

subject to good manufacturing practice

or quality systems regulations

applicable to the product, and make

available to FDA, upon request, during

an inspection for review and copying by

FDA, the following records:

(1) Records demonstrating that the

product for export is a partially

processed biological product and not in

a form applicable to the prevention,

treatment, or cure of diseases or injuries

of man;

(2) Records demonstrating that the

partially processed biological product

was manufactured in conformity with

current good manufacturing practice

requirements;

(3) Records demonstrating the

distribution of the exported partially

processed biological products; and

(4) Copies of all labeling that

accompanies the exported partially

processed biological product and other

records demonstrating that the exported

partially processed biological product is

intended for further manufacture into a

final dosage form outside the United

States; this may include a container

label with the statement, ‘‘Caution: For

Further Manufacturing Use Only’’ and

any package insert.

(d) Notification requirements for

drugs, biological products, and devices

exported under section 802 of the act.

(1) Persons exporting a human drug,

biological product, or device under

section 802 of the act, other than a drug,

biological product, or device for

investigational use exported under

section 802(c) of the act, or a drug,

biological product, or device exported

in anticipation of marketing

authorization under section 802(d) of

the act, shall provide written

notification to FDA. The notification

shall identify:

(i) The product’s trade name;

(ii) If the product is a drug or

biological product, the product’s

abbreviated or proper name or, if the

product is a device, the type of device;

(iii) If the product is a drug or

biological product, a description of the

product’s strength and dosage form or,

if the product is a device, the product’s

model number; and

(iv) If the export is to a country not

listed in section 802(b)(1) of the act, the

country that is to receive the exported

article. The notification may, but is not

required to, identify countries listed in

section 802(b)(1) of the act or state that

the export is intended for a listed

country without identifying the listed

country.

(2) The notification shall be sent to

the following addresses:

(i) For biological products and devices

regulated by the Center for Biologics

Evaluation and Research—Division of

Case Management (HFM–610), Office of

Compliance and Biologics Quality,

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

rm. 200N, Rockville, MD 20852–1448;

(ii) For human drug products—

Division of Labeling and

Nonprescription Drug Compliance

(HFD–310), Center for Drug Evaluation

and Research, Food and Drug

Administration, 7520 Standish Pl.,

Rockville, MD 20855–2737;

(iii) For devices—Division of Program

Operations (HFZ–305), Center for

Devices and Radiological Health, Food

and Drug Administration, 2094 Gaither

Rd., Rockville, MD 20850.

(e) Recordkeeping requirements for

products subject to section 802(g) of the

act. (1) Any person exporting a product

under any provision of section 802 of

the act shall maintain records of all

drugs, biological products, and devices

exported and the countries to which the

products were exported. In addition to

the requirements in paragraph (b) of this

section, such records include, but are

not limited to, the following:

(i) The product’s trade name;

(ii) If the product is a drug or

biological product, the product’s

abbreviated or proper name or, if the

product is a device, the type of device;

(iii) If the product is a drug or

biological product, a description of its

strength and dosage form and the

product’s lot or control number or, if the

product is a device, the product’s model

number;

(iv) The consignee’s name and

address; and

(v) The date on which the product

was exported and the quantity of

product exported.

(2) These records shall be kept at the

site from which the products were

exported or manufactured, and be

maintained for the same period of time

as required for records subject to good

manufacturing practice or quality

systems regulations applicable to the

product. The records shall be made

available to FDA, upon request, during

an inspection for review and copying by

FDA.

Dated: March 1, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

Dated: April 10, 2001.1

Timothy E. Skud,

Acting Deputy Assistant Secretary of the

Treasury.

[FR Doc. 01–31026 Filed 12–18–01; 8:45 am]

BILLING CODE 4160–01–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 62

[KS 0145–1145a; FRL–7120–2]

Approval and Promulgation of State

Plans for Designated Facilities and

Pollutants; Control of Emissions From

Hospital/Medical/Infectious Waste

Incinerators; State of Kansas

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is approving a revision to

the state of Kansas’ section 111(d) plan

for controlling emissions from existing

hospital/medical/infectious waste

incinerators. The state revised its

existing plan to establish increments of

progress and a new compliance date for

two HMIWI sources. Approval of the

revised state plan will ensure that these

requirements are Federally enforceable.

DATES: This direct final rule will be

effective February 19, 2002. unless EPA

receives adverse comments by January

18, 2002. If adverse comments are

received, EPA will publish a timely

withdrawal of the direct final rule in the

Federal Register informing the public

that the rule will not take effect.

ADDRESSES: Comments may be mailed to

Wayne Kaiser, Environmental

Protection Agency, Air Planning and

Development Branch, 901 North 5th

Street, Kansas City, Kansas 66101.

Copies of documents relative to this

action are available for public

inspection during normal business

Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Rules and Regulations 65449

hours at the above-listed Region 7

location. The interested persons

wanting to examine these documents

should make an appointment with the

office at least 24 hours in advance.

FOR FURTHER INFORMATION CONTACT:

Wayne Kaiser at (913) 551–7603.

SUPPLEMENTARY INFORMATION:

Throughout this document whenever

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean

EPA.

Information regarding this action is

presented in the following order:

What is a 111(d) plan?

What are the regulatory requirements for

HMIWIs?

What changes did the state make to its 111(d)

plan?

What action are we taking in this action?

What Is a 111(d) Plan?

Section 111(d) of the Clean Air Act

(CAA) requires states to submit plans to

control certain pollutants (designated

pollutants) at existing facilities

(designated facilities) whenever

standards of performance have been

established under section 111(b) for new

sources of the same type, and EPA has

established emission guidelines (EG) for

such existing sources. A designated

pollutant is any pollutant for which no

air quality criteria have been issued, and

which is not included on a list

published under section 108(a) or

section 112(b)(1)(A) of the CAA, but

emissions of which are subject to a

standard of performance for new

stationary sources.

What Are the Regulatory Requirements

for HMIWIs?

Standards and guidelines for new and

existing HMIWIs were promulgated

under the authority of sections 111 and

129 of the CAA on September 15, 1997

(62 FR 48374). These standards are 40

CFR part 60, subpart Ec for new sources,

and 40 CFR part 60, subpart Ce for

existing sources.

The subpart Ce EG is not a direct

Federal regulation but is a ‘‘guideline’’

for states to use in regulating existing

HMIWIs. The EG requires states to

submit for EPA approval a section

111(d) state plan containing air

emission regulations and compliance

schedules for existing HMIWIs.

What Changes Did the State Make to Its

111(d) Plan?

We originally approved the state’s

HMIWI 111(d) plan on July 14, 2000 (65

FR 43702), and it became effective on

September 12, 2000. Sources were

required to be in compliance within one

year of the effective date of EPA

approval of the state plan, i.e.,

September 12, 2001, or in any case no

later than September 15, 2002. Sources

may petition the state for a compliance

date extension beyond September 12,

2001, if they are planning to install air

pollution control equipment and if they

commit to an increment of progress

schedule. The final compliance date

cannot extend beyond September 15,

2002, however.

Two HMIWIs in Kansas, one each

located in Johnson and Wyandotte

Counties, requested that they be granted

until September 15, 2002, or an

additional year, to come into

compliance. Both sources justified the

need for additional time in order to

install air pollution control equipment

and related operating and monitoring

equipment. The state has approved

these requests.

The state has included increments of

progress dates in the sources’

compliance schedules. Dates have been

established for: award of contracts,

commence on-site construction,

complete initial startup, calibration and

adjustment, conduct required

performance testing, and demonstrate

final compliance. The final compliance

date is September 15, 2002.

These compliance extensions

constitute a revision to the compliance

date that was contained in the approved

111(d) plan. Thus, the state has

submitted the new compliance

schedules for these two sources to us for

approval as an amendment to its 111(d)

plan.

This action will ensure consistency

between the state plan and the approved

Federal plan, and ensure Federal

enforceability of the approved state

plan.

What Action Are We Taking in This

Action?

We are approving these revisions to

the state’s HMIWI 111(d) plan. We are

processing this action as a final action

because the revisions make routine

changes to the existing plan which are

noncontroversial. Therefore, we do not

anticipate any adverse comments.

Please note that if EPA receives adverse

comment on part of this rule and if that

part can be severed from the remainder

of the rule, EPA may adopt as final

those parts of the rule that are not the

subject of an adverse comment.

Administrative Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’ and

therefore is not subject to review by the

Office of Management and Budget. For

this reason, this action is also not

subject to Executive Order 13211,

‘‘Actions Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use’’ (66 FR 28355, May

22, 2001). This action merely approves

a state action as meeting Federal

requirements and imposes no additional

requirements. Accordingly, the

Administrator certifies that this rule

will not have a significant economic

impact on a substantial number of small

entities under the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.). Because this

rule approves a state action and does

not impose any additional enforceable

duty, it does not contain any unfunded

mandate or significantly or uniquely

affect small governments, as described

in the Unfunded Mandates Reform Act

of 1995 (Public Law 104–4). For the

same reason, this rule also does not

significantly or uniquely affect the

communities of tribal governments, as

specified by Executive Order 13084 (63

FR 27655, May 10, 1998). This rule will

not have substantial direct effects on the

states, on the relationship between the

national government and the states, or

on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132 (64 FR 43255,

August 10, 1999), because it merely

approves a state action relating to a

Federal standard, and does not alter the

relationship or the distribution of power

and responsibilities established in the

CAA. This rule also is not subject to

Executive Order 13045 (62 FR 19885,

April 23, 1997), because it is not

economically significant.

In reviewing state plan submissions,

our role is to approve state choices,

provided that they meet the criteria of

the CAA. In this context, in the absence

of a prior existing requirement for the

state to use voluntary consensus

standards (VCS), we have no authority

to disapprove state submissions for

failure to use VCS. It would thus be

inconsistent with applicable law for

EPA, when it reviews state submissions,

to use VCS in place of state submissions

that otherwise satisfy the provisions of

the CAA. Thus, the requirements of

section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (15 U.S.C. 272 note) do not

apply. As required by section 3 of

Executive Order 12988 (61 FR 4729,

February 7, 1996), in issuing this rule,

we have taken the necessary steps to

eliminate drafting errors and ambiguity,

minimize potential litigation, and

provide a clear legal standard for

affected conduct. EPA has complied

with Executive Order 12630 (53 FR

8859, March 15, 1988) by examining the

takings implications of the rule in

65450 Federal Register / Vol. 66, No. 244 / Wednesday, December 19, 2001 / Rules and Regulations

accordance with the ‘‘Attorney

General’s Supplemental Guidelines for

the Evaluation of Risk and Avoidance of

Unanticipated Takings’’ issued under

the Executive Order. This rule does not

impose an information collection

burden under the provisions of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.).

The Congressional Review Act, 5

U.S.C. section 801 et seq., as added by

the Small Business Regulatory

Enforcement Fairness Act of 1996,

generally provides that before a rule

may take effect, the agency

promulgating the rule must submit a

rule report, which includes a copy of

the rule, to each House of the Congress

and to the Comptroller General of the

United States. We will submit a report

containing this rule and other required

information to the United States Senate,

the United States House of

Representatives, and the Comptroller

General of the United States prior to

publication of the rule in the Federal

Register. A major rule cannot take effect

until 60 days after it is published in the

Federal Register. This action is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

Under section 307(b)(1) of the CAA,

petitions for judicial review of this

action must be filed in the United States

Court of Appeals for the appropriate

circuit by February 19, 2002. Filing a

petition for reconsideration by the

Administrator of this final rule does not

affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed, and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects 40 CFR Part 62

Environmental protection, Air

pollution control, Carbon monoxide,

Hydrocarbons, Intergovernmental

relations, Lead, Nitrogen dioxide,

Particulate matter, Reporting and

recordkeeping requirements, Sulfur

oxides.

Dated: December 7, 2001.

James B. Gulliford,

Region Administrator, Region 7.

Chapter I, title 40 of the Code of

Federal Regulations is amended as

follows:

PART 62—[AMENDED]

1. The authority citation for part 62

continues to read as follows:

Authority: 42 U.S.C. 7401 et seq.

Subpart R—Kansas

2. Section 62.4179 is amended by

adding paragraph (d) to read as follows:

§ 62.4179 Identification of plan.

* * * * *

(d) Amended plan for the control of

air emissions from hospital/medical/

infectious waste incinerators submitted

by the Kansas Department of Health and

Environment on October 25, 2001. This

plan revision establishes a final

compliance date of September 15, 2002,

for two incinerators in Johnson and

Wyandotte Counties, Kansas. The

effective date of the amended plan is

February 19, 2002.

[FR Doc. 01–31238 Filed 12–18–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301179A; FRL–6814–4]

RIN 2070–AB78

Sethoxydim; Pesticide Tolerance

Technical Correction

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule; technical correction.

SUMMARY: EPA issued a final rule in the

Federal Register of October 10, 2001,

establishing time-limited tolerances for

combined residues of sethoxydim and

its metabolites containing the 2-

cyclohexen-1-one moiety (calculated as

the herbicide). Inadvertently the

regulatory text showed the maximum

permissible level for residues of

sethoxydim in or on ‘‘Sheep, mbyp’’ at

‘‘0.5 ppm’’. This document makes a

technical correction to the regulatory

text of the tolerance regulation in 40

CFR 180.412(b) to correctly show the

maximum permissible level for residues

of sethoxydim in or on ‘‘Sheep, mbyp’’

at ‘‘1.0 ppm’’.

DATES: This regulation is effective

December 19, 2001. Objections and

request for hearings, identified by

docket control number OPP–301179A,

must be received by EPA on or before

February 19, 2002.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method provided in Adverse comments

may be submitted by mail,

electronically, or in person. Please

follow the detailed instructions for each

method as provided in Unit II. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

OPP–301179A in the subject line on the

first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Libby Pemberton, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–9364; e-mail address:

pemberton.libby@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

You may be potentially affected by

this action if you are an agricultural

producer, food manufacturer, or

pesticide manufacturer. Potentially

affected categories and entities may

include, but are not limited to:

Categories NAICS

codes

Examples of Potentially Affected

Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

II. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

theFederal Register listings at http://

www.epa.gov/fedrgstr/. A frequently

updated electronic version of 40 CFR

part 180 is available at http://