22530 Federal Register / Vol. 60, No. 88 / Monday, May 8, 1995 / Rules and Regulations

Checklist Federal requirement FR reference FR promulgation date State authority

120 ....... Wood Preserving; Amendments to Listings and

Technical Requirements.

57 FR 61492 12/24/92 TCA 68–212–104(7); 68–212–106(a)(1); 68–

212–107(d)(1),(3)&(4); 68–212–

108(a)(1),(c)&(d); TRC 1200–1–11–.02(4)(a);

.06(26)(a); .05(23)(a).

122 ....... Recycled Used Oil Management Standards;

Technical Amendments and Corrections I.

58 FR 26420

58 FR 33341

5/3/93

6/17/93

TCA 68–211–105(c); 68–211–106(a)(1)&(2); 68–

211–107(a); 68–211–111(d); 68–211–1001

et.seq.; 68–212–104(7); 68–212–106(a)(1);

68–212–107(a),(d)(1)&(d)(3); TRC 1200–1–

11–.02(1)(e); .11(1)(a);

.02(1)(d)2(x–xi); .06(1)(b)2(ii);

.05(1)(b)2(iii).

123 ....... Land Disposal Restrictions; Renewal of the Hazardous Waste Debris Case–by–Case Capacity

Variance.

58 FR 28506 5/14/93 TCA 68–212–104(7); 68–212–106(a) (1)&(2);

68–212–107(a),(d)(1),(d)(3) & (d)(9); TRC

1200–1–11–.10(2)(a).

124 ....... Land Disposal Restrictions for Ignitable and Corrosive Characteristic Wastes whose Treatment

Standards were Vacated.

58 FR 29860 5/24/93 TCA 68–212–104(7); 68–212–106 (a)(1) & (2);

68–212–107(a),(d)(1),(d)(3),&(d)(9); TRC

1200–1–11–.06(1)(b)2(v–vi);

.10(1)(a)1,(a)(5)&(a)(9); .10(2)(a);

.10(3)(a); .07(10)(a).

Approval of Tennessee’s program

revisions shall become effective July 7,

1995, unless an adverse comment

pertaining to the State’s revisions

discussed in this notice is received by

the end of the comment period.

If an adverse comment is received

EPA will publish either (1) a withdrawal

of the immediate final decision or (2) a

notice containing a response to

comments which either affirms that the

immediate final decision takes effect or

reverses the decision.

EPA shall administer any RCRA

hazardous waste permits, or portions of

permits that contain conditions based

upon the Federal program provisions for

which the State is applying for

authorization and which were issued by

EPA prior to the effective date of this

authorization. EPA will suspend

issuance of any further permits under

the provisions for which the State is

being authorized on the effective date of

this authorization.

C. Decision

I conclude that Tennessee’s

applications for these program revisions

meet all of the statutory and regulatory

requirements established by RCRA.

Accordingly, Tennessee is granted final

authorization to operate its hazardous

waste program as revised.

Tennessee now has responsibility for

permitting treatment, storage, and

disposal facilities within its borders and

carrying out other aspects of the RCRA

program, subject to the limitations of its

program revision application and

previously approved authorities.

Tennessee also has primary enforcement

responsibilities, although EPA retains

the right to conduct inspections under

Section 3007 of RCRA and to take

enforcement actions under Section

3008, 3013, and 7003 of RCRA.

Compliance With Executive Order

12866

The Office of Management and Budget

has exempted this rule from the

requirements of Section 6 of Executive

Order 12866.

Certification Under the Regulatory

Flexibility Act

Pursuant to the provisions of 5 U.S.C.

605(b), I hereby certify that this

authorization will not have a significant

economic impact on a substantial

number of small entities. This

authorization effectively suspends the

applicability of certain Federal

regulations in favor of Tennessee’s

program, thereby eliminating

duplicative requirements for handlers of

hazardous waste in the State. It does not

impose any new burdens on small

entities.

This rule, therefore, does not require

a regulatory flexibility analysis.

List of Subjects in 40 CFR Part 271

Administrative practice and

procedure, Confidential business

information, Hazardous materials

transportation, Hazardous waste, Indian

lands, Intergovernmental relations,

Penalties, Reporting and recordkeeping

requirements, Water pollution control,

Water supply.

Authority: This notice is issued under the

authority of Sections 2002(a), 3006 and

7004(b) of the Solid Waste Disposal Act as

amended (42 U.S.C. 6912(a), 6926, 6974(b)).

Dated: April 14, 1995.

Patrick M. Tobin,

Acting Regional Administrator.

[FR Doc. 95–11144 Filed 5–5–95; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

42 CFR Part 6

Federally Supported Health Centers

Assistance Act of 1992

AGENCY: Public Health Service, HHS.

ACTION: Final rule.

SUMMARY: The Secretary of Health and

Human Services (the ‘‘Secretary’’), in

consultation with the Attorney General,

issues the following rules under the

‘‘Federally Supported Health Centers

Assistance Act of 1992.’’ The Act

provides for liability protection for

certain health care professionals and

entities. This rules sets forth

information whereby an entity or a

person can determine when, and the

extent to which, it is likely to be

protected under the Act.

EFFECTIVE DATE: May 8, 1995.

FOR FURTHER INFORMATION CONTACT:

Richard C. Bohrer, Director, Division of

Community and Migrant Health, Bureau

of Primary Health Care, Health

Resources and Service Administration,

4350 East/West Highway, Bethesda,

Maryland 20814, Phone: (301) 594–

4300.

SUPPLEMENTARY INFORMATION: Section

224(a) of the Public Health Service Act

(the Act), (section 233(a) of Title 42 of

the United States Code), provides that

the remedy against the United States

provided under the Federal Tort Claims

Act (FTCA) resulting from the

performance of medical, surgical, dental

or related functions by any

commissioned officer or employee of

the Public Health Service while acting

within the scope of his office or
Federal Register / Vol. 60, No. 88 / Monday, May 8, 1995 / Rules and Regulations 22531

employment shall be exclusive of any

other civil action or proceeding. Public

Law 102–501 provides that, subject to

its provisions, certain entities and

officers, employees and contractors of

entities shall be deemed to be

employees of the Public Health Service

within the exclusive remedy provision

of section 224(a). This rule implements

certain provisions of Public Law 102–

501.

On August 19, 1994, the Secretary

published a Notice of Proposed

Rulemaking in the Federal Register (59

FR 42790) to implement Public Law

102–501. The deadline for the

submission of comments was September

19, 1994.

Changes to Proposed Regulations

Section 6.6(d) of the proposed rule

provides that acts and omissions related

to services provided to individuals who

are not patients of a covered entity will

be covered only if the Secretary

determines that provision of such

services will benefit the community

served by the entity; facilitate the

provision of services to patients of the

entity; or are otherwise required to be

provided under an employment contract

or similar arrangement between the

entity and the covered individual.

The final rule adds a new § 6.6(e)

which lists examples of services to

individuals who are not patients of a

covered entity that will be covered

under § 6.6(d).

Response to Comments

We received six comment letters: two

from groups representing interested

organizations, one from a U.S. Senator,

and three from Community Health

Centers. A discussion of these

comments and our responses follow.

Comment 1: Three commenters wrote

to express support for the proposed rule.

Comment 2: Two commenters

expressed concern regarding coverage

for services provided off-site and to

persons not registered with the Center.

One commenter requested that such

coverage be guaranteed for providers.

Another provider requested clarification

regarding when a patient becomes a

CHC enrolled patient.

Response: It is not feasible to

determine in advance of an actual claim

whether all of the activities of a

provider are covered under FTCA, since

the individual is covered only for

activities within the scope of

employment with the health center and

activities within the scope of the

approved Federal grant project. This is

consistent with the treatment of Federal

employees under the FTCA. Moreover,

this rule is not intended to constitute,

and does not constitute, a

comprehensive notice pertaining to any

provision of Pub. L. 102–501 except to

the extent that procedures pertaining to

implementation of Pub. L. 102–501 are

described explicitly therein. The

applicability of Pub. L. 102–501 and 42

U.S.C. 233(a) to a particular claim or

case will depend upon the

determination or certification (as

appropriate) by the Attorney General

that the individual or entity is covered

by Pub. L. 102–501 and was acting

within the scope of employment, in

accordance with normal Department of

Justice procedures.

However, we agree with the

commenter regarding the need for

additional clarification regarding

coverage for services provided off-site

and to persons not registered with the

Center. Thus, we have added a new

§ 6.6(e) to the regulations, including the

examples set forth in the preamble to

the Notice of Proposed Rulemaking.

This will provide in codified form

guidance on coverage of common

arrangements. In drafting this rule, we

cannot foresee every possible situation,

however, so covered entities and

covered individuals who are uncertain

whether their treatment of individuals

who are not patients of the covered

entity will be within the protection

afforded by Public Law 102–501 should

apply to the Secretary for a specific

determination under § 6.6(d).

Comment 3: One commenter

requested that the regulation provide for

consultative and risk management

functions.

Response: We did not address these

functions in the regulation because they

are not addressed in the statute being

implemented, and because we currently

provide assistance in these areas as a

part of our management of the relevant

grant programs. In addition to the ongoing technical assistance available to

address risk management and Quality

Assurance issues, we are considering

enhancing the scope and diversity of

such activities.

Comment 4: One commenter

expressed concern about its ability to

take advantage of FTCA coverage unless

Congress extends the coverage past

December 31, 1995.

Response: This is not an issue under

the scope of the regulation. However,

we anticipate that Congress will

consider an extension of the program

next year. We have accordingly removed

the reference to a specific date from

section 6.6(a), so that should Congress

extend the program, no further change

to the rule will be needed.

Waiver of Delay in Effective Date

This final rule is effective ‘‘upon

issuance’’. The Secretary has found that

good cause exists to waive the

requirement under the Administrative

Procedure Act (5 U.S.C. 553(d)) that the

effective date for a regulation be not less

than 30 days from the date of

publication. It is cost effective to permit

health centers to take advantage of the

statutory liability protection that is

clarified by these regulations at the

earliest possible date. Until these

regulations are effective, health centers

will continue to pay private insurance

premiums for liability protection that is

provided for under the FTCA.

Economic Impact

Executive Order 12866 requires that

all regulations reflect consideration of

alternatives, of costs, benefits,

incentives, equity, and availability of

information. Regulations which are

‘‘significant’’ because of cost, adverse

effects on the economy, inconsistency

with other agency actions, effects on the

budget, or novel legal or policy issues,

require special analysis. In addition, the

Regulatory Flexibility Act of 1980

requires that we include an analysis of

all rules that significantly impact small

businesses.

These regulations provide information

whereby health care entities or

individuals can determine when, and to

what extent, they are likely to be

protected against certain malpractice

claims under the FTCA. Therefore, the

Secretary certifies that these regulations

are not significant under Executive

Order 12866 and that they will not have

a significant effect on a substantial

number of small entities. For this

reason, a regulatory analysis is not

required.

Paperwork Reduction Act of 1980

This rule contains no information

collection or reporting requirements

which are subject to review by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1980.

List of Subjects in 42 CFR Part 6

Grant programs—Health.

Dated: January 18, 1995.

Philip R. Lee,

Assistant Secretary for Health.

Approved: March 24, 1995.

Donna E. Shalala,

Secretary.

Part 6 is added to chapter I of title 42

to read as follows:
22532 Federal Register / Vol. 60, No. 88 / Monday, May 8, 1995 / Rules and Regulations

PART 6—FEDERAL TORT CLAIMS

ACT COVERAGE OF CERTAIN

GRANTEES AND INDIVIDUALS

Sec.

6.1 Applicability.

6.2 Definitions.

6.3 Eligible entities.

6.4 Covered individuals.

6.5 Deeming process for eligible entities.

6.6 Covered acts and omissions.

Authority: Sections 215 and 224 of the

Public Health Service Act, 42 U.S.C. 216 and

233.

§ 6.1 Applicability.

This part applies to entities and

individuals whose acts and omissions

related to the performance of medical,

surgical, dental, or related functions are

covered by the Federal Tort Claims Act

(28 U.S.C. 1346(b) and 2671–2680) in

accordance with the provisions of

section 224(g) of the Public Health

Service Act (42 U.S.C. 233(g)).

§ 6.2 Definitions.

Act means the Public Health Service

Act, as amended.

Attorney General means the Attorney

General of the United States and any

other officer or employee of the

Department of Justice to whom the

authority involved has been delegated.

Covered entity means an entity

described in § 6.3 which has been

deemed by the Secretary, in accordance

with § 6.5, to be covered by this part.

Covered individual means an

individual described in § 6.4.

Effective date as used in § 6.5 and

§ 6.6 refers to the date of the Secretary’s

determination that an entity is a covered

entity.

Secretary means the Secretary of

Health and Human Services (HHS) and

any other officer or employee of the

Department of HHS to whom the

authority involved has been delegated.

Subrecipient means an entity which

receives a grant or a contract from a

covered entity to provide a full range of

health services on behalf of the covered

entity.

§ 6.3 Eligible entities.

(a) Grantees. Entities eligible for

coverage under this part are public and

nonprofit private entities receiving

Federal funds under any of the

following grant programs:

(1) Section 329 of the Act (relating to

grants for migrant health centers);

(2) Section 330 of the Act (relating to

grants for community health centers);

(3) Section 340 of the Act (relating to

grants for health services for the

homeless); and

(4) Section 340A of the Act (relating

to grants for health services for residents

of public housing).

(b) Subrecipients. Entities that are

subrecipients of grant funds described

in paragraph (a) of this section are

eligible for coverage only if they provide

a full range of health care services on

behalf of an eligible grantee and only for

those services carried out under the

grant funded project.

§ 6.4 Covered individuals.

(a) Officers and employees of a

covered entity are eligible for coverage

under this part.

(b) Contractors of a covered entity

who are physicians or other licensed or

certified health care practitioners are

eligible for coverage under this part if

they meet the requirements of section

224(g)(5) of the Act.

(c) An individual physician or other

licensed or certified health care

practitioner who is an officer, employee,

or contractor of a covered entity will not

be covered for acts or omissions

occurring after receipt by the entity

employing such individual of notice of

a final determination by the Attorney

General that he or she is no longer

covered by this part, in accordance with

section 224(i) of the Act.

§ 6.5 Deeming process for eligible entities.

Eligible entities will be covered by

this part only on and after the effective

date of a determination by the Secretary

that they meet the requirements of

section 224(h) of the Act. In making

such determination, the Secretary will

receive such assurances and conduct

such investigations as he or she deems

necessary.

§ 6.6 Covered acts and omissions.

(a) Only acts and omissions occurring

on and after the effective date of the

Secretary’s determination under § 6.5

and before the later date specified in

section 224(g)(3) of the Act are covered

by this part.

(b) Only claims for damage for

personal injury, including death,

resulting from the performance of

medical, surgical, dental, or related

functions are covered by this part.

(c) With respect to covered

individuals, only acts and omissions

within the scope of their employment

(or contract for services) are covered. If

a covered individual is providing

services which are not on behalf of the

covered entity, such as on a volunteer

basis or on behalf of a third-party

(except as described in paragraph (d) of

this section), whether for pay or

otherwise, acts of omissions which are

related to such services are not covered.

(d) Only acts and omissions related to

the grant-supported activity of entities

are covered. Acts and omissions related

to services provided to individuals who

are not patients of a covered entity will

be covered only if the Secretary

determines that:

(1) The provision of the services to

such individuals benefits patients of the

entity and general populations that

could be served by the entity through

community-wide intervention efforts

within the communities served by such

entity;

(2) The provision of the services to

such individuals facilitates the

provision of services to patients of the

entity; or

(3) Such services are otherwise

required to be provided to such

individuals under an employment

contract or similar arrangement between

the entity and the covered individual.

(e) Examples: The following are

examples of situations within the scope

of paragraph (d) of this section:

(1) A community health center

deemed to be a covered entity

establishes a school-based or schoollinked health program as part of its

grant supported activity. Even though

the students treated are not necessarily

registered patients of the center, the

center and its health care practitioners

will be covered for services provided, if

the Secretary makes the determination

in paragraph (d)(1) of this section.

(2) A migrant health center requires

its physicians to obtain staff privileges

at a community hospital. As a condition

of obtaining such privileges, and thus

being able to admit the center’s patients

to the hospital, the physicians must

agree to provide occasional coverage of

the hospital’s emergency room. The

Secretary would be authorized to

determine that this coverage is

necessary to facilitate the provision of

services to the grantee’s patients, and

that it would therefore be covered by

paragraph (d)(2) of this section.

(3) A homeless health services grantee

makes arrangements with local

community providers for after-hours

coverage of its patients. The grantee’s

physicians are required by their

employment contracts to provide

periodic cross-coverage for patients of

these providers, in order to make this

arrangement feasible. The Secretary may

determine that the arrangement is

within the scope of paragraph (d)(3) of

this section.

[FR Doc. 95–11217 Filed 5–5–95; 8:45 am]

BILLING CODE 4160–15–M