Federal Register / Vol. 66, No. 97 / Friday, May 18, 2001 / Rules and Regulations 27599

SUPPLEMENTARY INFORMATION: On

January 18, 2001, the Department of

Health and Human Services (DHHS)

published in the Federal Register a

Final Rule, with an effective date of

March 19, 2001 (66 F.R. 4674), intended

to amend Subpart D of 42 CFR part 482,

Subpart C of 42 CFR part 416, and

Subpart F of 42 CFR part 485 of the

Code of Federal Regulations.

The Department has determined that

there is a need to delay this rule’s

effective date in order to consider (1)

whether a Governor may certify to the

Department, after consultation with the

State’s Boards of Medicine and Nursing,

or their equivalents, and consistent with

State law, that it is in the best interests

of the citizens of the State that licenced

Certified Registered Nurse Anesthetists

(CRNAs) within the State administer

anesthesia services without physician

supervision, and (2) whether a

prospective study should be undertaken

to assess the impact of different state

CRNA practices. The Department will,

therefore, very shortly issue a proposed

rule to afford the public the opportunity

to comment on these changes.

The notice and comment

requirements of 5 U.S.C. 553 do not

apply to this delay of the rule’s effective

date, which is a rule of procedure. See

5 U.S.C. 553(b)(3)(A). To the extent that

section 553 applies in these

circumstances, however, the

Department finds that the action comes

within that provision’s good cause

exceptions in that obtaining public

comment is impracticable, unnecessary,

and contrary to the public interest. See

5 U.S.C. 553(b)(3)(B). Given the

imminence of the effective date, and the

imminence of a new notice of proposed

rulemaking, seeking prior public

comment on this delay is impracticable,

as well as contrary to the public interest

in the orderly promulgation and

implementation of regulations. Further,

comment is unnecessary because no

harm is caused by delay of the effective

date of the regulations, as the current

rules will remain in effect pending any

further action by the Department, and

any action taken will be subject to

notice and comment before final

publication.

Dated: May 16, 2001.

Tommy G. Thompson,

Secretary.

[FR Doc. 01–12765 Filed 5–17–01; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

45 CFR Part 46

RIN: 0925–AA14

Protection of Human Research

Subjects: Delay of Effective Date

AGENCY: Department of Health and

Human Services (DHHS).

ACTION: Final Rule; Delay of Effective

Date.

SUMMARY: To give the Department an

opportunity to obtain comment on three

modifications to the rule entitled

Protection of Human Subjects,

Additional Protections for Pregnant

Women and Human Fetuses Involved in

Research, and Pertaining to Human In

Vitro Fertilization, the Department is

delaying until November 14, 2001 the

effective date of the rule, which was

published in the Federal Register on

January 17, 2001, 66 F.R. 3878, pending

the Department’s action on forthcoming

notice of proposed rulemaking. The

rule’s effective date was previously

delayed by 60 days on March 19, 2001,

in accordance with the memorandum of

January 20, 2001, from the Assistant to

the President and Chief of Staff, entitled

A Regulatory Review Plan, published in

the Federal Register on January 24,

2001. See 66 F.R. 15352.

DATES: The final rule, Protection of

Human Subjects, published in the

Federal Register on January 17, 2001, at

66 F.R. 3878 and delayed on March 19,

2001 at 66 FR 15352 is further delayed

until November 14, 2001.

FOR FURTHER INFORMATION CONTACT:

Irene Stith-Coleman, Ph.D., Office of

Human Research Protections (OHRP)

200 Independence Avenue, S.W., Room

733–E, Washington, D.C., 20201.

Telephone 202–260–1587. Email

istithco@osophs.dhhs.gov.

SUPPLEMENTARY INFORMATION: On

January 17, 2001, the Department of

Health and Human Services (DHHS)

published in the Federal Register a

Final Rule, with an effective date of

March 19, 2001 (66 Fed. Reg. 3878),

intended to amend Subpart B of 45 CFR

Part 46 of the Code of Federal

Regulations. These regulations provide

additional protections for pregnant

women and human fetuses involved in

research.

The Department has determined that

there is a need to delay this rule’s

effective date in order to consider three

limited aspects: (1) Whether paternal

consent (when the father is readily

available) should be obtained for

participation in federally funded

research that is directed solely at a fetus;

(2) whether the definition of ‘‘fetus’’

should be modified so that it describes

only the stage prior to delivery; and (3)

whether the rule should be modified to

make clear that fetuses of uncertain

viability may be subjected to added risk

only if the research is intended to

enhance the probability of survival of

the particular fetus to the point of

viability. The Department will,

therefore, very shortly issue a proposed

rule to afford the public the opportunity

to comment on these changes. In the

meantime, current Subpart B remains in

effect for the special protection of

pregnant women and human fetuses

involved in research.

The notice and comment

requirements of 5 U.S.C. section 553 do

not apply to this delay of the rule’s

effective date, which is a rule of

procedure. See 5 U.S.C. 553(b)(3)(A). To

the extent that section 553 applies in

these circumstances, however, the

Department finds that the action comes

within that provision’s good cause

exceptions in that obtaining public

comment is impracticable, unnecessary,

and contrary to the public interest. See

5 U.S.C. 553(b)(3)(B). Given the

imminence of the effective date, and the

imminence of a new notice of proposed

rulemaking, seeking prior public

comment on this delay is impracticable,

as well as contrary to the public interest

in the orderly promulgation and

implementation of regulations. Further,

comment is unnecessary because no

harm is caused by delay of the effective

date of the regulations, as the current

rule, 45 CFR part 46, Subpart B,

Protection of Human Subjects,

Additional Protections for Pregnant

Women and Human Fetuses Involved in

Research, and Pertaining to Human In

Vitro Fertilization, published in the

Federal Register on August 8, 1975 and

amended January 11, 1978 and June 1,

1994, will remain in effect pending any

further action by the Department, and

any action taken will be subject to

notice and comment before final

publication.

Dated: May 16, 2001.

Tommy G. Thompson,

Secretary.

[FR Doc. 01–12755 Filed 5–17–01; 8:45 am]

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