58918 Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations

(Pearson v. Shalala, 14 F. Supp. 2d 10

(D.D.C. 1998)); however, the U.S. Court

of Appeals for the D.C. Circuit reversed

the district court’s decision. The court

of appeals held the regulations

codifying FDA’s decision not to

authorize the four health claims invalid

and instructed FDA to reconsider the

four health claims (Pearson v. Shalala,

164 F.3d 650 (D.C. Cir. 1999)).

In the Nutrition Labeling and

Education Act of 1990, Congress made

health claims for dietary supplements

subject to a procedure and standard to

be established by FDA (see section

403(r)(5)(D) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

343(r)(5)(D)). FDA adopted the same

procedure for health claims in dietary

supplement labeling that Congress had

prescribed for health claims in the

labeling of conventional foods (see

section 403(r)(3) and (r)(4) of the act).

This procedure requires the evidence

supporting a health claim to be

presented to FDA for review before the

claim may appear in labeling. Unless

and until FDA adopts a regulation

authorizing the claim, a dietary

supplement bearing the claim is subject

to regulatory action as a misbranded

food (see section 403(r)(1)(B) of the act,

a misbranded drug (see section 502(f)(1)

of the act (21 U.S.C. 352(f)(1)), and as an

unapproved new drug (see section

505(a) of the act (21 U.S.C. 355(a)).

Recently, the U.S. District Court for

the District of Columbia denied the

Pearson plaintiffs’ motion for a

preliminary injunction granting them

immediate permission to make the four

health claims that FDA is reconsidering.

In their motion, the plaintiffs argued

that because the court of appeals had

invalidated the regulations codifying

FDA’s decision not to authorize the four

claims, the claims should be permitted

in dietary supplement labeling if

accompanied by disclaimers suggested

by the court of appeals. The district

court rejected this argument. The court’s

decision said in part that a preliminary

injunction was not in order because the

plaintiffs may not bypass FDA’s preclearance process for health claims.

‘‘Plaintiffs’ fatal assumption is that the

Court of Appeals’ invalidation of the

regulations allows them to now make

their health claims with disclaimers,

without any further pre-clearance by

FDA. It does not. Invalidation of the

regulations merely puts plaintiffs back

at square one, which means they must

again go through the pre-clearance

process * * *.’’ (Pearson v. Shalala, No.

Civ. A. 95–1865, 2000 WL 767584, at *2

(D.D.C. May 24, 2000)).

Thus, while FDA is revoking the

regulations codifying its original

decision not to authorize the four health

claims that were challenged in Pearson,

such claims still may not be used in

labeling pending reconsideration of

these claims by FDA. FDA expects to

complete its reconsideration of the four

claims and issue a decision on each

claim by October 10, 2000.

II. Effective Date

The Administrative Procedure Act

and FDA regulations provide that an

agency may dispense with notice-andcomment rulemaking procedures when

the agency for good cause finds that

such procedures are impracticable,

unnecessary, or contrary to the public

interest (5 U.S.C. 553(b)(3)(B);

§ 10.40(e)(1) (21 CFR 10.40(e)(1))).

Because this final rule is being issued in

response to a court order, FDA finds

that notice and comment are

unnecessary. In addition, the

Commissioner of Food and Drugs finds

good cause under 5 U.S.C. 553(d)(3) and

§ 10.40(c)(4)(ii) to make this final rule

effective upon publication.

List of Subjects in 21 CFR Part 101

Food labeling, Nutrition, 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 101 is

amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21

U.S.C. 321, 331, 342, 343, 348, 371.

§ 101.71 [Amended]

2. Section 101.71 Health claims:

claims not authorized is amended by

removing paragraphs (a), (c), and (e);

and by redesignating paragraph (b) as

paragraph (a), and paragraph (d) as

paragraph (b).

§ 101.79 [Amended]

3. Section 101.79 Health claims:

Folate and neural tube defects is

amended by removing paragraph

(c)(2)(i)(G), and by redesignating

paragraph (c)(2)(i)(H) as (c)(2)(i)(G).

Dated: September 25, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–25352 Filed 10–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

42 CFR Part 36

Contracts Under the Indian SelfDetermination Act; Removal of

Regulations

AGENCY: Indian Health Service, HHS.

ACTION: Final rule.

SUMMARY: The Indian Health Service

(IHS) is eliminating regulations on

contracts under the Indian SelfDetermination Act as mandated by

Executive Order 12866 to streamline the

regulatory process and enhance the

planning and coordination of new and

existing regulations.

EFFECTIVE DATE: October 3, 2000.

FOR FURTHER INFORMATION CONTACT:

Leslie M. Morris, Director, Division of

Regulatory and Legal Affairs, Indian

Health Service, Suite 450, 12300

Twinbrook Parkway, Rockville, MD

20852; telephone (301) 443–1116. (This

is not a toll-free number.)

SUPPLEMENTARY INFORMATION: On June

24, 1996, The Department of Health and

Human Services (HHS) and the

Department of the Interior (DOI) issued

joint regulations authorized by section

107 of the Indian Self-Determination

and Education Assistance Act (ISDA),

Public Law 93–638, as amended, 25

U.S.C. 450k. These joint regulations,

published in the Federal Register on

June 24, 1996, and codified at 25 CFR

part 900, replaced Department

regulations codified at 42 CFR part 36,

subpart I, ‘‘Contracts under the ISDA’’;

48 CFR section 352.280–4, ‘‘Contracts

awarded under the ISDA’’; 48 CFR

section 352.380–4, ‘‘Contracts awarded

under the ISDA’’; and 48 CFR subpart

380.4, ‘‘Contracts awarded under the

ISDA’’; because they are no longer

necessary for the Administration of the

IHS Program.

Section 107(b) of the ISDA provides

in pertinent part that ‘‘the secretary is

authorized to repeal any regulation

inconsistent with the provisions of this

act.’’ The HHS has proposed at 64 FR

1344 to revise 48 CFR, Chapter 3, to

streamline and simplify its acquisition

regulations (HHSRA) in accordance

with the directions of the National

Performance Review. In so doing, the

sections of 48 CFR liminated by the

joint rule (25 CFR part 900) issued by

the HHS and the DOI would be

removed. Therefore, the IHS proposed at

65 FR 4797 the elimination of only

Subpart I of 42 CFR part 36. No

comments were received in response to

the proposed rule. The proposed rule is

converted to a final rule without change.

Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Rules and Regulations 58919

Executive Order 12866

This rule is not a significant

regulatory action under Executive Order

12866 and has not been reviewed by the

Office of Management and Budget. It

removes obsolete regulations.

Regulatory Flexibility Act

The HHS certifies that this document

will not have a significant economic

effect on a substantial number of small

entities under the Regulatory Flexibility

Act since it only removes obsolete

regulations.

Executive Order 12612

The Department has determined that

this rule does not have significant

Federalism effects because it pertains

solely to Federal-Tribal relations and

will not interfere with the roles, rights,

and responsibilities of States.

Paperwork Reduction Act of 1995

This regulation contains no

information collection requirement that

would require notification of the Office

of Management and Budget.

The authority to eliminate these

regulations is 42 U.S.C. 2003 and 25

U.S.C. 13.

List of Subjects in 42 CFR Part 36

American Indians, Alaska Natives,

Government health care, Indians—

business and finance, property.

Dated: September 12, 2000.

Michel E. Lincoln,

Deputy Director, Indian Health Service.

Approved: September 26, 2000.

Donna E. Shalala,

Secretary of Health and Human Services.

For the reasons set out in the

preamble, and under the authority of 42

U.S.C. 2003 and 25 U.S.C. 13, subpart I

of 42 CFR part 36 is removed and

reserved.

[FR Doc. 00–25292 Filed 10–2–00; 8:45 am]

BILLING CODE 4160–16–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 413, 489, and 498

[HCFA–1005–CN4]

RIN 0938–AI56

Medicare Program; Prospective

Payment System for Hospital

Outpatient Services: Provider-Based

Criteria; Delay of Effective Date and

Correction

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of delay of effective date

and correction.

SUMMARY: In the April 7, 2000 Federal

Register (65 FR 18434), we published a

final rule with comment period entitled,

‘‘Prospective Payment System for

Hospital Outpatient Services.’’ New

§§ 413.24(d)(6) and 413.65 and revisions

to §§ 489.24, 498.2, and 498.3

established requirements for facilities or

organizations seeking provider-based

status. This document delays the

effective date of these provider-based

regulations from October 10, 2000 to

January 10, 2001, applicable for

provider cost reporting periods

beginning on or after January 10, 2001.

In this document, we are also making a

conforming change in the regulations

text at § 413.65(i) concerning

enforcement.

DATES: Effective date: The effective date

of new §§ 413.24(d)(6) and 413.65 and

revised §§ 489.24, 498.2, and 498.3 is

delayed until January 10, 2001.

Applicability date: New

§§ 413.24(d)(6) and 413.65 and revised

§§ 489.24, 498.2, and 498.3 are

applicable for provider cost reporting

periods beginning on or after January

10, 2001.

FOR FURTHER INFORMATION CONTACT:

George Morey, (410) 786–4653.

SUPPLEMENTARY INFORMATION:

I. Background

On April 7, 2000, we published in the

Federal Register (65 FR 18434), a final

rule with comment period entitled

‘‘Prospective Payment System for

Hospital Outpatient Services.’’ Among

the regulatory provisions included were

new §§ 413.24(d)(6) and 413.65 and

revisions to §§ 489.24, 498.2, and 498.3.

These regulations established

requirements for facilities or

organizations that seek provider-based

status (departments, provider-based

entities, satellite facilities, and remote

locations of hospitals). The effective

date of the provider-based regulations,

as stated in the April 2000 rule, is

October 10, 2000.

New § 413.65(i) states that we will

recover any overpayments resulting

from inappropriate treatment of a

facility or organization as providedbased. However, this provision states

that no recovery will be made for any

period prior to October 10, 2000, if the

management of the facility or

organization made a ‘‘good faith’’ effort

to operate it as provided-based (as

described in § 413.65(i)(3)). The

reference to October 10, 2000 was

included to limit the ‘‘good faith’’

exception to periods before the effective

date of the new requirements.

II. Provisions of This Notice

Based on the following concerns, we

have decided to delay the effective date

of the provider-based portions of the

April 2000 final rule until January 10,

2001, applicable for provider cost

reporting periods beginning on or after

January 10, 2001. For example, a

provider whose cost reporting periods

begins on April 1 will not be affected by

these provider-based regulations until

its cost reporting period beginning on

April 1, 2001.

To provide for smooth

implementation of the provider-based

regulations, we must clarify a number of

administrative, procedural, and

technical issues and provide our

regional offices, which are charged with

responsibility for making providerbased determinations, and hospitals

with further training and guidance. We

have completed a variety of training and

informational activities, developed

responses to ‘‘Frequently Asked

Questions,’’ and held numerous

meetings with individual providers and

provider associations in order to

communicate our policies and plans for

implementing the new regulations. In

the course of these activities, the need

for additional guidance interpreting the

regulations and addressing procedural

and administrative concerns has become

apparent. Given the time needed to

complete and disseminate this material,

we have concluded that implementation

of the new provider-based regulations

on October 10, 2000 would be

imprudent.

A delay in the effective date of the

provider-based regulations will allow

for dissemination of the additional

material described above, and will give

hospitals and other providers additional

time to fully assess the potential impact

of both the new hospital outpatient

prospective payment system and the

new provider-based regulations on their

facilities and organizations. A delay in