66636 Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 808 and 820

[Docket No. 00N–1561]

Exemption From Federal Preemption

of State and Local Cigarette and

Smokeless Tobacco Requirements;

Revocation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revoking its

regulation governing the exemption

from Federal preemption of State and

local medical device requirements for

the sale and distribution of cigarettes

and smokeless tobacco to children and

adolescents. This action is being taken

in response to the Supreme Court

Decision of March 21, 2000, in which

the court held that Congress has not

given FDA the authority to regulate

tobacco products as customarily

marketed. On March 31, 2000, FDA

removed its regulations restricting the

sale and distribution of cigarettes and

smokeless tobacco to children and

adolescents. Because these regulations

are not in effect, the State requirements

are not preempted. Therefore, FDA is

revoking its regulations exempting the

State and local requirements from

preemption. This rule is also adding a

regulation that was inadvertently

removed in a previous document.

DATES: This rule is effective November

7, 2000.

FOR FURTHER INFORMATION CONTACT: Rosa

M. Gilmore, Center for Devices and

Radiological Health (HFZ–215), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301–827–

2970.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 28, 1996 (61

FR 44398), FDA issued a final regulation

restricting the sale and distribution of

cigarettes and smokeless tobacco to

children and adolescents. In the Federal

Register of November 28, 1997 (62 FR

63271), FDA issued a final rule granting

exemption from preemption under

section 521 of the Federal Food, Drug,

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

360k) for certain cigarette and smokeless

tobacco requirements in Alabama,

Alaska, and Utah. These requirements

were preempted under section 521 of

the act because they were different from

FDA’s requirements but they could be

exempted because they were more

stringent than FDA’s requirements.

On March 21, 2000, in Food and Drug

Administration vs. Brown & Williamson

Tobacco Corp., et al., the Supreme Court

ruled that Congress has not granted FDA

jurisdiction to regulate tobacco products

as customarily marketed. In accordance

with this ruling, the agency issued a

final rule in the Federal Register of

March 31, 2000 (65 FR 17135), removing

its regulations restricting the sale and

distribution of cigarettes and smokeless

tobacco to children and adolescents.

The agency inadvertently failed to

remove the regulations granting

exemptions from Federal preemption for

these three States. Because the FDA

regulations are not in effect, the State

requirements are not preempted and

may remain in effect. The agency also

inadvertently removed § 820.1(e) (21

CFR 820.1(e)) (65 FR 17135). Section

820.1(e) did not relate to tobacco.

Therefore, it is being added in this rule.

List of Subjects

21 CFR Part 808

Intergovernmental relations, Medical

devices.

21 CFR Part 820

Medical devices, 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 parts 808

and 820 are amended as follows:

PART 808—EXEMPTIONS FROM

FEDERAL PREEMPTION OF STATE

AND LOCAL MEDICAL DEVICE

REQUIREMENTS

1. The authority citation for 21 CFR

part 808 continues to read as follows:

Authority: 21 U.S.C. 360j, 360k, 371.

§ 808.51 [Removed]

2. Remove § 808.51.

§ 808.52 [Removed]

3. Remove § 808.52.

§ 808.94 [Removed]

4. Remove § 808.94.

PART 820—QUALITY SYSTEM

REGULATION

5. The authority citation for 21 CFR

part 820 continues to read as follows:

Authority: 21 U.S.C. 351, 352, 360, 360c,

360d, 360e, 360h, 360i, 360j, 360l, 371, 374,

381, 383.

6. Section 820.1 is amended by

adding paragraph (e) to read as follows:

§ 820.1 Scope.

* * * * *

(e) Exemptions or variances. (1) Any

person who wishes to petition for an

exemption or variance from any device

quality system requirement is subject to

the requirements of section 520(f)(2) of

the act. Petitions for an exemption or

variance shall be submitted according to

the procedures set forth in § 10.30 of

this chapter, the FDA’s administrative

procedures. Guidance is available from

the Center for Devices and Radiological

Health, Division of Small Manufacturers

Assistance (HFZ–220), 1350 Piccard Dr.,

Rockville, MD 20850, U.S.A., telephone

1–800–638–2041 or 1–301–443–6597,

FAX 301–443–8818.

(2) FDA may initiate and grant a

variance from any device quality system

requirement when the agency

determines that such variance is in the

best interest of the public health. Such

variance will remain in effect only so

long as there remains a public health

need for the device and the device

would not likely be made sufficiently

available without the variance.

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28522 Filed 11–6–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 17

RIN 2900–AK57

VA Payment for Non-VA Public or

Private Hospital Care and Non-VA

Physician Services That Are

Associated With Either Outpatient or

Inpatient Care

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

SUMMARY: This document amends our

medical regulations concerning VA

payment for non-VA public or private

hospital care provided to eligible VA

beneficiaries. This document also

amends our medical regulations

concerning VA payment for non-VA

physician services that are associated

with either outpatient or inpatient care

provided to eligible VA beneficiaries at

non-VA facilities. With certain

exceptions, these payments have been

based on Medicare methodology.

Sometimes VA can negotiate contracts

with hospitals or physicians or with

their agents to reduce the payment

amounts. This document amends these

Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Rules and Regulations 66637

regulations to allow VA to make lower

payments based on such negotiations.

DATES: Effective Date: November 7,

2000.

FOR FURTHER INFORMATION CONTACT:

Tony Guagliardo, Health Administration

Service, (10C3), Veterans Health

Administration, Department of Veterans

Affairs, 810 Vermont Avenue, NW.,

Washington, DC 20420, (202) 273–8307.

(This is not a toll-free number.)

SUPPLEMENTARY INFORMATION:

Administrative Procedure Act

This document allows VA to pay

hospitals and physicians the amount

that they on their own or through agents

have negotiated to receive from VA.

Accordingly, this document reflects

contract actions that are exempt from

the prior notice-and-comment and

delayed effective date provisions of 5

U.S.C. 553.

Unfunded Mandates

The Unfunded Mandates Reform Act

requires (in section 202) that agencies

prepare an assessment of anticipated

costs and benefits before developing any

rule that may result in an expenditure

by State, local, or tribal governments, in

the aggregate, or by the private sector of

$100 million or more in any given year.

This rule would have no consequential

effect on State, local, or tribal

governments.

Regulatory Flexibility Act

The Secretary hereby certifies that

this rule will not have a significant

economic impact on a substantial

number of small entities as they are

defined in the Regulatory Flexibility

Act, 5 U.S.C. 601–612. This rule would

affect only a small portion of the

business of the affected entities.

Accordingly, pursuant to 5 U.S.C.

605(b), this rule is exempt from the

initial and final regulatory flexibility

analysis requirements of §§ 603 and 604.

Catalog of Federal Domestic Assistance

Numbers

The Catalog of Federal domestic assistance

numbers for the programs affected by this

rule are 64.005, 64.007, 64.008, 64.009,

64.010, 64.011, 64.012, 64.013, 64.014,

64.015, 64.016, 64.018, 64.019, 64.022, and

64.025.

List of Subjects in 38 CFR Part 17

Administrative practice and

procedure, Alcohol abuse, Alcoholism,

Claims, Day care, Dental health, Drug

abuse, Foreign relations, Government

contracts, Grant programs health, Grant

programs-veterans, Health care, Health

facilities, Health professions, Health

records, Homeless, Medical and dental

schools, Medical devices, Medical

research, Mental health programs,

Nursing homes, Philippines, Reporting

and record-keeping requirements,

Scholarships and fellowships, Travel

and transportation expenses, Veterans.

Approved: October 31, 2000.

Hershel W. Gober,

Acting Secretary of Veterans Affairs.

For the reasons set out in the

preamble, 38 CFR part 17 is amended as

set forth below:

PART 17—MEDICAL

1. The authority citation for part 17

continues to read as follows:

Authority: 38 U.S.C. 501, 1721, unless

otherwise noted.

2. In § 17.55, a new paragraph (k) is

added; and the authority citation at the

end of the section is revised, to read as

follows:

§ 17.55 Payment for authorized public or

private hospital care.

* * * * *

(k) Notwithstanding other provisions

of this section, VA, for public or private

hospital care covered by this section,

will pay the lesser of the amount

determined under paragraphs (a)

through (j) of this section or the amount

negotiated with the hospital or its agent.

(Authority: 38 USC 513, 1703, 1728; § 233 of

P. L. 99–576)

3. Remove the undesignated center

heading immediately before § 17.56.

4. In § 17.56, a new paragraph (e) is

added to read as follows:

§ 17.56 Payment for non-VA physician

services associated with outpatient and

inpatient care provided at non-VA facilities.

* * * * *

(e) Notwithstanding other provisions

of this section, VA, for physician

services covered by this section, will

pay the lesser of the amount determined

under paragraphs (a) through (d) of this

section or the amount negotiated with

the physician or the physician’s agent.

(Authority: 38 U.S.C. 513, 38 U.S.C. 1703,

38 U.S.C. 1728)

5. Add an undesignated center

heading immediately before § 17.57 to

read as follows:

Use of Community Nursing Home

Care Facilities.

[FR Doc. 00–28472 Filed 11–06–00; 8:45 am]

BILLING CODE 8320–01–P

LEGAL SERVICES CORPORATION

45 CFR Part 1628

Recipient Fund Balances

AGENCY: Legal Services Corporation.

ACTION: Final rule.

SUMMARY: This final rule revises the

Corporation’s rule on recipient fund

balances to provide the Corporation

with more discretion to determine

whether to permit a recipient to

maintain a fund balance of up to 25%

of its LSC support for a particular

reporting period and to specify a limited

number of extraordinary and compelling

circumstances for which LSC has

discretion to permit a recipient to

maintain a fund balance in excess of

25% of its LSC support. The final rule

also adds additional requirements and

limitations applicable to waiver requests

and the use of excess fund balances.

Finally, the rule is restructured for

clarity and for consistency with other

Corporation regulations.

EFFECTIVE DATE: This final rule is

effective on December 7, 2000.

FOR FURTHER INFORMATION CONTACT:

Victor M. Fortuno, Vice President for

Legal Affairs, Legal Services

Corporation, 750 First Street, NE.—Suite

1000, Washington, DC 20002–4250;

202–336–8800.

SUPPLEMENTARY INFORMATION: On

September 11, 1998, the Operations and

Regulations Committee (‘‘Committee’’)

of the Legal Services Corporation

(‘‘LSC’’ or ‘‘the Corporation’’) Board of

Directors (‘‘Board’’) met to consider

proposed revisions to the Corporation’s

rule governing recipient fund balances,

45 CFR part 1628. The Committee

adopted a proposed rule that was

published in the Federal Register for

public comment at 63 FR 56591

(October 22, 1998). Nineteen comments

were received and considered by the

Corporation.

Following the close of the comment

period, the Committee met on February

21, 1999, to review the public comment

on the proposed rule. No action was

taken on the proposed rule at that time

as the Committee was advised by the

Corporation’s staff that additional time

was needed to consider fully a number

of issues raised by the public comment

and to formulate informed

recommendations for the Committee’s

consideration in adopting a final rule.

The Committee was briefed by staff on

two issues raised by one commenter

which challenged the legal sufficiency

of the proposed rulemaking and the

legal authority for the Corporation to

permit any carryover of fund balances