24934 Federal Register / Vol. 63, No. 87 /Wednesday, May 6, 1998 /Rules and Regulations

of a United States Court of Appeals on

an issue, we may decide under certain

conditions to relitigate that issue within

the same circuit. We may relitigate only

when the conditions specified in

paragraphs (c)(2) and (3) of this section

are met, and, in general, one of the

events specified in paragraph (c)(1) of

this section occurs.

(1) Activating events:

(i) An action by both Houses of

Congress indicates that a circuit court

decision on which an Acquiescence

Ruling was based was decided

inconsistently with congressional

intent, such as may be expressed in a

joint resolution, an appropriations

restriction, or enactment of legislation

which affects a closely analogous body

of law;

(ii) A statement in a majority opinion

of the same circuit indicates that the

court might no longer follow its

previous decision if a particular issue

were presented again;

(iii) Subsequent circuit court

precedent in other circuits supports our

interpretation of the Social Security Act

or regulations on the issue(s) in

question; or

(iv) A subsequent Supreme Court

decision presents a reasonable legal

basis for questioning a circuit court

holding upon which we base an

Acquiescence Ruling.

(2) The General Counsel of the Social

Security Administration, after

consulting with the Department of

Justice, concurs that relitigation of an

issue and application of our

interpretation of the Social Security Act

or regulations to selected claims in the

administrative review process within

the circuit would be appropriate.

(3) We publish a notice in the Federal

Register that we intend to relitigate an

Acquiescence Ruling issue and that we

will apply our interpretation of the

Social Security Act or regulations

within the circuit to claims in the

administrative review process selected

for relitigation. The notice will explain

why we made this decision.

(d) Notice of relitigation. When we

decide to relitigate an issue, we will

provide a notice explaining our action

to all affected claimants. In adjudicating

claims subject to relitigation,

decisionmakers throughout the SSA

administrative review process will

apply our interpretation of the Social

Security Act and regulations, but will

also state in written determinations or

decisions how the claims would have

been decided under the circuit standard.

Claims not subject to relitigation will

continue to be decided under the

Acquiescence Ruling in accordance

with the circuit standard. So that

affected claimants can be readily

identified and any subsequent decision

of the circuit court or the Supreme

Court can be implemented quickly and

efficiently, we will maintain a listing of

all claimants who receive this notice

and will provide them with the relief

ordered by the court.

(e) Rescission of an Acquiescence

Ruling. We will rescind as obsolete an

Acquiescence Ruling and apply our

interpretation of the Social Security Act

or regulations by publishing a notice in

the Federal Register when any of the

following events occurs:

(1) The Supreme Court overrules or

limits a circuit court holding that was

the basis of an Acquiescence Ruling;

(2) A circuit court overrules or limits

itself on an issue that was the basis of

an Acquiescence Ruling;

(3) A Federal law is enacted that

removes the basis for the holding in a

decision of a circuit court that was the

subject of an Acquiescence Ruling; or

(4) We subsequently clarify, modify or

revoke the regulation or ruling that was

the subject of a circuit court holding

that we determined conflicts with our

interpretation of the Social Security Act

or regulations, or we subsequently

publish a new regulation(s) addressing

an issue(s) not previously included in

our regulations when that issue(s) was

the subject of a circuit court holding

that conflicted with our interpretation of

the Social Security Act or regulations

and that holding was not compelled by

the statute or Constitution.

[FR Doc. 98–11945 Filed 5–5–98; 8:45 am]

BILLING CODE 4190–11–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0119]

21 CFR Part 801

Natural Rubber-Containing Medical

Devices; User Labeling

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; interpretation.

SUMMARY: The Food and Drug

Administration (FDA) is providing

notice that it does not intend to apply

to combination products currently

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

that contains natural rubber that

contacts humans. FDA is taking this

action, in part, in response to a citizen

petition and other communications from

industry that the agency has received

since the publication of the final rule.

FDA intends to initiate a proceeding to

propose natural rubber labeling

requirements for drugs and biologics,

including combination products that are

currently regulated under drug and

biologic labeling provisions. Such a

proceeding may include a combination

of rulemaking and guidance and will

offer opportunity for public comment.

EFFECTIVE DATE: September 30, 1998.

FOR FURTHER INFORMATION CONTACT:

Brian L. Pendleton, Center for Drug

Evaluation and Research (HFD–7),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–594–5649; or

Robert A. Yetter, Center for Biologics

Evaluation and Research (HFM–10),

Food and Drug Administration,

8800 Rockville Pike, Bethesda, MD

20892, 301–827–0737.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 30, 1997

(62 FR 51021), FDA published a final

rule to be codified at 21 CFR 801.437

requiring certain labeling statements on

medical devices that contain or have

packaging that contains natural rubber

that contacts humans. The labeling

statements alert users that a product

contains either dry natural rubber or

natural rubber latex, and for products

containing natural rubber latex that the

presence of this material may cause

allergic reactions. The final rule, which

becomes effective September 30, 1998,

was adopted because natural rubber

may cause a significant health risk to

persons who are sensitized to natural

latex proteins.

In response to a comment on the

proposed latex labeling regulation (61

FR 32618, June 24, 1996) about the

applicability of the requirements to

combination products, FDA stated in

the preamble to the final rule that it

intended to require combination

products (i.e., drug/device and biologic/

device combinations) that contain

natural rubber device components to be

labeled in accordance with § 801.437

(62 FR 51021 at 51026). Because the

entities that comprise a combination

product meet more than one

jurisdictional definition, the agency may

apply one or more sets of regulatory

provisions to such products, as

specified in the Intercenter Agreement

Between the Center for Drug Evaluation

and Research and the Center for Devices

and Radiological Health and the

Intercenter Agreement Between the

Center for Biologics Evaluation and

Research and the Center for Devices and
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