Federal Register / Vol. 65, No. 215 / Monday, November 6, 2000 / Rules and Regulations 66511

System. Those provisions have already

been subject to a notice of proposed

rulemaking, and publication of a new

proposed rule is therefore unnecessary.

See 58 FR 20802 (April 16, 1993). In

addition, while EPA’s approval/

disapproval decisions described in this

document do not constitute rulemaking,

EPA has nonetheless received

substantial public comment on these

decisions. See 63 FR 10221 (March 2,

1998) (notice of receipt of State

Guidance submission and request for

comment); 65 FR 38830 (June 22, 2000)

(notice of letter identifying

inconsistencies and request for

comment). EPA also believes the public

interest is best served by fulfilling the

CWA’s requirements without further

delay and publication of a notice of

proposed rulemaking therefore would

be contrary to the public interest. Thus,

notice and public procedure are

unnecessary. EPA finds that this

constitutes good cause under 5 U.S.C.

553(b)(B).

III. Administrative Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’ and

is therefore not subject to review by the

Office of Management and Budget.

Because the agency has made a ‘‘good

cause’’ finding that this action is not

subject to notice-and-comment

requirements under the Administrative

Procedure Act or any other statute, as

described in Section II, above, it is not

subject to the regulatory flexibility

provisions of the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.), or to sections

202 and 205 of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). In addition, because this

action does not promulgate any new

requirements, but only makes certain

existing provisions of 40 CFR part 132

effective in Wisconsin, it does not

impose any new costs. The costs of 40

CFR part 132 were considered by EPA

when it promulgated that regulation.

Therefore, today’s rule does not

significantly or uniquely affect small

governments or impose a significant

intergovernmental mandate, as

described in sections 203 and 204 of

UMRA, or significantly or uniquely

affect the communities of Tribal

governments, as specified by Executive

Order 13084 (63 FR 27655, May 10,

1998). This rule will not have

substantial direct effects on the State, on

the relationship between the national

government and the State, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132 (64 FR 43255,

August 10, 1999). This rule also is not

subject to Executive Order 13045 (62 FR

19885, April 23, 1997), because it is not

economically significant.

This action does not involve technical

standards; thus, the requirements of

section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (15 U.S.C. 272 note) do not

apply. The rule also does not involve

special consideration of environmental

justice related issues as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994). In issuing this rule,

EPA has taken the necessary steps to

eliminate drafting errors and ambiguity,

minimize potential litigation, and

provide a clear legal standard for

affected conduct, as required by section

3 of Executive Order 12988 (61 FR 4729,

February 7, 1996). This rule does not

impose an information collection

burden under the provisions of the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.).

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. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

This rule is not a major rule as defined

by 5 U.S.C. 804(2). 40 CFR 132.6(f), (h)–

(j) is effective on December 6, 2000. 40

CFR 132.6(g) is effective on February 5,

2001.

List of Subjects in 40 CFR Part 132

Environmental protection,

Administrative practice and procedure,

Great Lakes, Indian-lands,

Intergovernmental relations, Reporting

and recordkeeping requirements, Water

pollution control.

Dated: October 31, 2000.

Carol M. Browner,

Administrator.

For the reasons set forth above, EPA

amends 40 CFR part 132 as follows:

PART 132—WATER QUALITY

GUIDANCE FOR THE GREAT LAKES

SYSTEM

1. The authority citation for part 132

continues to read as follows:

Authority: 33 U.S.C. 1251 et seq.

2. Section 132.6 is amended by

adding paragraphs (f) through (i) to read

as follows:

§ 132.6 Application of part 132

requirements in Great Lakes States and

Tribes.

* * * * *

(f) Effective December 6, 2000, the

acute and chronic aquatic life criteria

for copper and nickel in Tables 1 and

2 of this part and the chronic aquatic

life criterion for endrin in Table 2 of this

part shall apply to the waters of the

Great Lakes System in the State of

Wisconsin.

(g) Effective February 5, 2001, the

chronic aquatic life criterion for

selenium in Table 2 of this part shall

apply to the waters of the Great Lakes

System in the State of Wisconsin.

(h) Effective December 6, 2000, the

requirements of procedure 3 in

appendix F of this part shall apply for

purposes of developing total maximum

daily loads in the Great Lakes System in

the State of Wisconsin.

(i) Effective December 6, 2000, the

requirements of paragraphs D and E of

procedure 5 in appendix F of this part

shall apply to discharges within the

Great Lakes System in the State of

Wisconsin.

(j) Effective December 6, 2000, the

requirements of paragraph D of

procedure 6 in appendix F of this part

shall apply to discharges within the

Great Lakes System in the State of

Wisconsin.

Dated: October 31, 2000.

Carol M. Browner,

Administrator.

[FR Doc. 00–28419 Filed 11–3–00; 8:45 am]

BILLING CODE 6560–50–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

42 CFR Part 63

RIN 0925–AA11

Traineeships

AGENCY: National Institutes of Health,

HHS.

ACTION: Final rule.

SUMMARY: The National Institutes of

Health (NIH) is amending the

regulations governing traineeships to

add conditions under which NIH may

terminate traineeship awards and revise

the authorities for the awards.

EFFECTIVE DATE: This final rule is

effective on December 6, 2000.

FOR FURTHER INFORMATION CONTACT: Jerry

Moore, NIH Regulations Officer,

66512 Federal Register / Vol. 65, No. 215 / Monday, November 6, 2000 / Rules and Regulations

National Institutes of Health, 6011

Executive Boulevard, Room 601, MSC

7669, Rockville, MD 20852; telephone

301–496–4607 (not a toll-free number;

Fax 301–402–0169; or E-mail

(jm40z@nih.gov)). For information about

traineeship awards contact James

Alexander, Acting Director, Office of

Education, Office of Intramural

Research, National Institutes of Health,

Building 10, Room 1C–129, 10 Center

Drive, MSC 1158, Bethesda, MD 20892–

1158; telephone 301–496–2427 (not a

toll-free number).

SUPPLEMENTARY INFORMATION: Section

405(b)(1)(C) of the Public Health Service

(PHS) Act, as amended, authorizes the

Secretary, acting through the directors

of the national research institutes of

NIH, to conduct and support research

training for which fellowship support is

not provided under section 487 of the

PHS Act, and which is not residency

training of physicians or other health

professionals. The Director, NIH, has

similar authority under section

402(b)(13) of the PHS Act. Additionally,

section 485D(a) of the PHS Act

authorizes the Director of the National

Center for Complementary and

Alternative Medicine to support

research training; section 472 of the PHS

Act authorizes the award of traineeships

in medical library science and related

fields; and section 413(b)(3) of the PHS

Act authorizes the Director of the

National Cancer Institute (NCI), in

carrying out the National Cancer

Program, to support appropriate

programs of education and training

(including continuing education and

laboratory and clinical research

training). Unlike the NIH authority set

forth in section 405(b)(1)(C) of the PHS

Act, the NCI authority does not exclude

residency training. Under these

authorities, NIH awards research

traineeships to qualified individuals.

The regulations codified at 42 CFR part

63 govern these traineeships. NIH

revised the regulations in their entirety,

February 27, 1995 (60 FR 10718).

NIH proposed amendments to Part 63

in a notice of proposed rulemaking

(NPRM) published in the Federal

Register, October 30, 1998 (63 FR

58336). The NPRM provided for a 60-

day comment period. The comment

period expired December 29, 1998. NIH

received no comments. Consequently,

except for minor clarifying and editorial

changes, the final regulations described

below are the same as those proposed in

October 1998.

In these final regulations, NIH is

revising § 63.9 by amending paragraph

(b) to add scientific misconduct as a

ground for termination and by adding

new paragraphs (c) and (d), which add

conviction of a felony and certain other

criminal offenses and programmatic

changes or lack of funds, respectively,

as grounds for termination.

Additionally, NIH is amending the

authority citation by adding a reference

to section 413(b)(3) of the PHS Act

pertaining to the National Cancer

Program that was inadvertently

excluded from the proposed rule and

removing the reference to section

485B(b) of the PHS Act and the parallel

U.S. Code citation to reflect the

renaming of the National Center for

Human Genome Research as the

National Human Genome Research

Institute (NHGRI), effective January 27,

1997 (62 FR 3900). As a result of the

establishment of this new research

institute, the current reference to section

485B is redundant and unnecessary.

The current references to the National

Center for Human Genome Research and

section 485B of the PHS Act in § 63.1

and § 63.2 are also redundant and

unnecessary as a result of the renaming.

Consequently, NIH is removing the

references to the National Center for

Human Genome Research and section

485B of the PHS Act in paragraph (a) of

§ 63.1 and in the definitions set forth in

§ 63.2 of the terms ‘‘award,’’ ‘‘awardee,’’

‘‘director,’’ and ‘‘traineeship.’’ Also NIH

is adding to § 63.2 the definition of

‘‘misconduct in science,’’ as set forth in

the PHS regulations governing the

responsibility of awardees and

applicants for dealing with misconduct

in science, 42 CFR part 50, subpart A.

Finally, NIH is revising the references

set forth in unnumbered paragraphs 8,

9, and 10 of § 63.10 to comply with

Federal Register format requirements.

NIH provides the following

statements as public information.

Executive Order 12866

The Office of Management and

Budget’s (OMB) Office of Information

and Regulatory Affairs (OIRA) reviewed

this rule as required under Executive

Order 12866, Regulatory Planning and

Review. The OMB deemed it to be not

significant, as defined under the Order.

Regulatory Flexibility Act

The Regulatory Flexibility Act (5

U.S.C. chapter 6) requires that

regulatory actions be analyzed to

determine whether they will have a

significant impact on a substantial

number of small entities. The Director,

NIH, certifies that the changes in the

traineeship regulations will not have a

significant economic impact on a

substantial number of small entities

and, therefore, a regulatory flexibility

analysis, as defined under the

Regulatory Flexibility Act, is not

required.

Executive Order 13132

Executive Order 13132, Federalism,

requires that Federal agencies consult

with State and local government

officials in the development of

regulatory policies with federalism

implications. We reviewed the rule as

required under the Order and

determined that it does not have any

federalism implications. The Director,

NIH, certifies that the changes in the

traineeships regulations will not have

an effect on the States or on the

distribution of power and

responsibilities among the various

levels of government.

Paperwork Reduction Act

This rule does not contain any

information collection requirements that

are subject to OMB approval under the

Paperwork Reduction Act of 1995 (44

U.S.C. chapter 35).

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic

Assistance (CFDA) numbered program

affected by this rule is: 93.140—

Intramural Research Training Award.

List of Subjects in 42 CFR Part 63

Grant programs—health, Health

professions, Libraries, Manpower

training programs, Medical research,

Students.

Dated: August 3, 2000.

Ruth L. Kirschstein,

Principal Deputy Director, National Institutes

of Health.

Accordingly, part 63 of title 42 of the

Code of Federal Regulations is amended

as set forth below.

PART 63—TRAINEESHIPS

1. The authority citation for part 63 is

revised to read as follows:

Authority: 42 U.S.C. 216, 282(b)(13),

284(b)(1)(C), 285a–2(b)(3), 286b–3, 287c–

21(a).

2. Section 63.1 is revised to read as

follows:

§ 63.1 To what programs do these

regulations apply?

(a) The regulations in this part apply

to research traineeships awarded by the

Director, NIH, each director of a

national research institute of NIH, the

Director of the National Library of

Medicine, and the Director of the

National Center for Complementary and

Alternative Medicine, or their

designees, pursuant to sections

402(b)(13), 405(b)(1)(C), 413(b)(3), 472,

and 485(D)(a) of the Act, respectively.

Federal Register / Vol. 65, No. 215 / Monday, November 6, 2000 / Rules and Regulations 66513

(b) The regulations of this part do not

apply to research training under the

National Research Service Award

Program governed by 42 CFR part 66 or

to the Mental Health Traineeship

Program governed by 42 CFR part 64a.

(c) Except as otherwise permitted

under section 413(b)(3) of the Act, the

regulations of this part do not apply to

residency training of physicians or other

health professionals.

3. Section 63.2 is amended by revising

the definitions of ‘‘Award,’’ ‘‘Awardee,’’

‘‘Director,’’ and ‘‘Traineeship,’’ and

adding in alphabetical order a new

definition of ‘‘Misconduct in science,’’

to read as follows:

§ 63.2 Definitions.

* * * * *

Award means an award of funds

under sections 402(b)(13), 405(b)(1)(C),

413(b)(3), 472, 485D(a), or other sections

of the Act which authorize research

training or traineeships.

Awardee means an individual

awarded a traineeship under sections

402(b)(13), 405(b)(1)(C), 413(b)(3), 472,

485D(a), or other sections of the Act

which authorize research training or

traineeships.

Director means the Director, NIH, the

director of a national research institute

of NIH, the Director of the National

Library of Medicine, and the Director of

the National Center for Complementary

and Alternative Medicine, or any

official of NIH to whom the authority

involved has been delegated.

* * * * *

Misconduct in science shall have the

same meaning as prescribed in § 50.102

of this chapter.

* * * * *

Traineeship means an award under

the regulations of this part to a qualified

individual for that person’s subsistence

and other expenses during the period

that person is participating in the

research training approved under the

award.

4. Section 63.9 is revised to read as

follows:

§ 63.9 How may NIH terminate awards?

The Director may terminate a

traineeship at any time:

(a) Upon written request of the

awardee; or

(b) If it is determined that the awardee

has committed misconduct in science, is

ineligible, or has materially failed to

comply with the terms and conditions

of the award or to carry out the purpose

for which the award was made; or

(c) If the awardee is convicted of a

felony, or an offense involving any

illegal drug or substance, or any offense

involving a lack of financial integrity or

business honesty; or

(d) Because of programmatic changes

or lack of funds.

5. Section 63.10 is amended by

removing the last three entries in the list

of policies and regulations and adding

three new entries in their place to read

as follows:

§ 63.10 Other HHS regulations and policies

that apply.

* * * * *

59 FR 14508 (March 28, 1994)—NIH

Guidelines on the Inclusion of Women and

Minorities as Subjects in Clinical Research.

(Note: Interested persons should contact the

Office of Research on Women’s Health, NIH,

Room 201, Building 1, MSC 0161, Bethesda,

MD 20892–0161; telephone 301–402–1770

(not a toll-free number) to obtain copies of

this policy.)

59 FR 34496 (July 5, 1994)—NIH

Guidelines for Research Involving

Recombinant DNA Molecules. (Note:

Interested persons should contact the Office

of Biotechnology Activities, NIH, Suite 323,

6000 Executive Boulevard, MSC 7010,

Bethesda, MD 20892–7010; telephone 301–

496–9838 (not a toll-free number) to obtain

copies of the policy.)

‘‘Public Health Service Policy on Humane

Care and Use of Laboratory Animals’’

(Revised September 1986), Office of

Laboratory Animal Welfare, NIH. (Note:

Interested persons should contact the Office

of Laboratory Animal Welfare, NIH,

Rockledge Building I, 6705 Rockledge Drive,

Suite 1050, MSC 7982, Bethesda, MD 20892–

7982; telephone 301–496–7163 (not a tollfree number) to obtain copies of the policy.)

[FR Doc. 00–28341 Filed 11–3–00; 8:45 am]

BILLING CODE 4140–01–P