Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations 24935

Radiological Health (the Intercenter

Agreements).

Concerning the implementation of the

final rule for these combination

products, the FDA stated that natural

rubber combination products that are

listed in the Intercenter Agreements as

being regulated under device labeling

provisions will be required to comply

with the final rule on the effective date.

FDA stated that natural rubber

combination products that are listed in

the Intercenter Agreements as being

regulated under drug or biologic

labeling provisions will be subject to the

labeling requirements on September 30,

1998, or when FDA amends the

Intercenter Agreements to provide that

these types of combination products are

subject to the requirements, whichever

is later. FDA stated that it would

provide notice in the Federal Register of

the amendments to the Intercenter

Agreements to apply the labeling

requirements to all natural rubber

combination products regulated under

drug and biologic provisions. FDA also

stated then that: ‘‘the agency anticipates

that the Drug/Device Intercenter

Agreement will be amended to reflect

that prefilled drug vial containers,

transdermal patches, infusion pumps,

and prefilled syringes that presently are

regulated under drug authorities are also

subject to this regulation’’ (62 FR 51021

at 51026).

The agency has received numerous

inquiries about, and objections to, the

application of the natural rubber

labeling requirements to combination

drug/device products and to

combination biologic/device products

that currently are regulated under drug

and biologic labeling provisions. These

include a citizen petition submitted by

the Health Industry Manufacturers

Association (Docket No. 98P–0012/CP1).

One concern was that some combination

products may raise different labeling

issues than single-entity device

products. In addition, a concern was

raised that adequate notice and

opportunity for comment was not

provided with regard to the

applicability of the rule to combination

products that currently are regulated

under drug and biologic labeling

provisions.

FDA believes that the notice provided

was legally sufficient. However, upon

consideration of these comments and

the need to provide a uniform labeling

approach for all drug and biological

products, including combination

products currently regulated under drug

and biologic labeling provisions, FDA

has decided that further opportunity for

public comment should be provided on

how natural rubber labeling

requirements should be applied to all

products regulated as drugs and

biologics. FDA believes that it would

benefit from additional public comment

on whether there are labeling issues that

are unique to products regulated as

drugs and biologics as well as on

whether the agency should adopt rules

and guidance that would apply to all

natural rubber-containing products

regulated under the drug and biologic

labeling provisions rather than only to

combination products.

Therefore, FDA is announcing that it

does not intend to amend the

Intercenter Agreements as stated in the

preamble to the final rule. Instead, FDA

intends to initiate a proceeding to

propose requirements for labeling

statements on products regulated as

drugs and biologics, including

combination products currently

regulated under drug and biologic

labeling provisions, that contain natural

rubber that contacts humans. Such a

proceeding may include a combination

of proposed rulemaking and guidance

and will offer opportunity for public

comment. In the interim, FDA is

providing notice that it does not intend

to apply to combination products

regulated under human drug or biologic

labeling provisions its September 30,

1997, final rule requiring certain

labeling statements for all medical

devices that contain or have packaging

containing natural rubber that contacts

humans.

Dated: April 30, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–11982 Filed 5–5–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[OR–67–7282, OR–70–7285; FRL–5976–5]

Approval and Promulgation of State

Implementation Plans: Oregon

AGENCY: Environmental Protection

Agency.

ACTION: Final rule.

SUMMARY: Pursuant to procedures

described in the January 19, 1989

Federal Register, EPA recently

approved two minor State

Implementation Plan (SIP) revisions

submitted by the Oregon Department of

Environmental Quality (ODEQ). These

revisions include: changes to the

definition of Volatile Organic

Compounds (VOC) in the Oregon

Administrative Rules (OAR) consistent

with changes made in the federal

definition and delisting certain

compounds no longer considered VOCs;

and, changes in the OAR that increase

Air Contaminant Discharge Permit Fees

for stationary sources to recover costs of

operating the state permit program. This

document lists the revisions EPA has

approved and incorporates the relevant

material into the Code of Federal

Regulations.

EFFECTIVE DATE: June 5, 1998.

ADDRESSES: Copies of Oregon’s State SIP

revision requests and EPA’s letter

notices of approval are available for

public inspection during normal

business hours at the following

locations: EPA, Region 10, Office of Air

Quality (OAQ–107), 1200 Sixth Avenue,

Seattle, Washington 98101; State of

Oregon Department of Environmental

Quality, 811 SW Sixth Ave., Portland,

OR 97204–1390.

FOR FURTHER INFORMATION CONTACT:

Tracy Oliver, Office of Air Quality

(OAQ–107), EPA, Seattle, Washington,

(206) 553–1388.

SUPPLEMENTARY INFORMATION: EPA

Region 10 has approved the following

minor SIP revision requests under

section 100(a) of the Clean Air Act (Act):

State Subject matter Date of submission

Date of approval

OR ..................... Changes to the definition of VOC in the OAR consistent with changes in the federal definition. Delisting perchloroethylene, acetone, HFC 43–10mee and HCFC 225ca and cb

which are no longer considered VOCs.

5–22–97 6–16–97

OR ..................... Changes in the OAR that increase the Air Contaminate Permit Fees for stationary sources

and allow the state to recover the costs of operating the permit program.

11–13–97 2–13–98
24936 Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations

EPA has determined that each of these

SIP revisions complies with all

applicable requirements of the Act and

EPA policy and regulations concerning

such revisions. Due to the minor nature

of these revisions, EPA concluded that

conducting notice-and-comment

rulemaking prior to approving the

revisions would have been

‘‘unnecessary and contrary to the public

interest’’ and hence not required by the

Administrative Procedure Act, 5 U.S.C.

553(b). Each of these SIP approvals

became final and effective on the date

of EPA approval as listed in the chart

above.

I. Administrative Requirements

A. Executive Order 12866

The Office of Management and Budget

(OMB) has exempted this regulatory

action from E.O. 12866 review.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act,

5 U.S.C. 600 et seq., EPA must prepare

a regulatory flexibility analysis

assessing the impact of any proposed or

final rule on small entities. 5 U.S.C. 603

and 604. Alternatively, EPA may certify

that the rule will not have a significant

impact on a substantial number of small

entities. Small entities include small

businesses, small not-for-profit

enterprises, and government entities

with jurisdiction over populations of

less than 50,000.

SIP approvals under section 110 and

subchapter I, part D, of the Clean Air

Act do not create any new requirements

but simply approve requirements that

the State is already imposing. Therefore,

because the Federal SIP approval does

not impose any new requirements, the

Administrator certifies that it does not

have a significant impact on any small

entities affected. Moreover, due to the

nature of the Federal-State relationship

under the CAA, preparation of a

flexibility analysis would constitute

Federal inquiry into the economic

reasonableness of State action. The

Clean Air Act forbids EPA to base its

actions concerning SIPs on such

grounds. Union Electric Co. v. U.S. EPA,

427 U.S. 246, 255–66 (1976); 42 U.S.C.

7410(a)(2).

C. Unfunded Mandates

Under Section 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a Federal mandate that

may result in estimated costs to State,

local, or tribal governments in the

aggregate, or to the private sector, of

$100 million or more. Under Section

205, EPA must select the most costeffective and least burdensome

alternative that achieves the objectives

of the rule and is consistent with

statutory requirements. Section 203

requires EPA to establish a plan for

informing and advising any small

governments that may be significantly

or uniquely impacted by the rule.

EPA has determined that the approval

action promulgated does not include a

Federal mandate that may result in

estimated costs of $100 million or more

to either State, local, or tribal

governments in the aggregate, or to the

private sector. This Federal action

approves pre-existing requirements

under State or local law, and imposes

no new requirements. Accordingly, no

additional costs to State, local, or tribal

governments, or to the private sector,

result from this action.

D. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 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. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. This rule is not a

major rule as defined by 5 U.S.C. 804(2).

E. Petitions for Judicial Review

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by July 6, 1998.

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 in 40 CFR Part 52

Environmental protection, Air

pollution control, Incorporation by

reference, Intergovernmental relations,

Reporting and recordkeeping

requirements, Volatile organic

compounds.

Note: Incorporation by reference of the

Implementation Plan for the State of Oregon

was approved by the Director of the Office of

Federal Register on July 1, 1982.

Dated: February 20, 1998.

Chuck Findley,

Acting Regional Administrator, Region X.

Part 52, chapter I, title 40 of the Code

of Federal Regulations is amended as

follows:

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

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

Subpart MM—Oregon

2. Section 52.1970 is amended by

adding paragraph (c)(123) to read as

follows:

§ 52.1970 Identification of plan.

* * * * *

(c) * * *

(123) On May 22, 1997, ODEQ

submitted changes to the definition of

Volatile Organic Compounds (VOC) in

the Oregon Administrative Rules (OAR)

consistent with changes made in the

federal definition and delisted certain

compounds no longer considered VOCs

under the new definition. On November

13, 1997, ODEQ submitted changes in

the OAR that increased Air Contaminant

Discharge Permit Fees for stationary

sources to recover costs of operating the

state permit program.

(i) Incorporation by reference.

(A) Oregon Administrative Rules 340–

022–0102(73) and 340–028–0110(129),

effective May 9, 1997; Oregon

Administrative Rule 340–028–1750,

effective August 27, 1997.

[FR Doc. 98–11882 Filed 5–5–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300649; FRL–5787–9]

RIN 2070–AB78

Various Inert Ingredients; Tolerance

Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

exemptions from the requirement of a

tolerance exemptions for residues of 2-