3878 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

fields, and governmental jurisdictions

with populations of less than 50,000.

This action will not have a significant

economic impact on a substantial

number of small entities because the

original requirements did not have a

significant effect on a substantial

number of small entities. The extension

on the suspension does not change

those original requirements. Any future

regulatory action on this issue will

address any economic impacts,

including impacts on small entities.

Therefore, the Coast Guard certifies

under section 605(b) of the Regulatory

Flexibility Act (5 U.S.C. 601 et seq.) that

this extension to a suspension of a final

rule will not have a significant

economic impact on a substantial

number of small entities.

Assistance for Small Entities

The Small Business and Agriculture

Regulatory Enforcement Ombudsman

and 10 Regional Fairness Boards were

established to receive comments from

small businesses about Federal agency

enforcement actions. The Ombudsman

will annually evaluate the enforcement

activities and rate each agency’s

responsiveness to small business. If you

wish to comment on the enforcement

actions of the Coast Guard, call 1–888–

REG–FAIR (1–888–734–3247).

Collection of Information

This action does not provide for a

collection of information under the

Paperwork Reduction Act of 1995 (44

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

Federalism

We have analyzed this action under

E.O. 13132 and have determined that it

does not have implications for

federalism under that Order. Because

this action extends a suspension of a

final rule, it does not preempt any state

action.

Unfunded Mandates Reform Act

This action will not result in an

unfunded mandate under the Unfunded

Mandates Reform Act of 1995 (2 U.S.C.

1531–1538).

Taking of Private Property

This action will not effect a taking of

private property or otherwise have

taking implications under E.O. 12630,

Governmental Actions and Interference

with Constitutionally Protected Property

Rights.

Civil Justice Reform

This action meets applicable

standards in sections 3(a) and 3(b)(2) of

E.O. 12988, Civil Justice Reform, to

minimize litigation, eliminate

ambiguity, and reduce burden.

Protection of Children

We have analyzed this action under

E.O. 13045, Protection of Children from

Environmental Health Risks and Safety

Risks. This rule is not an economically

significant rule and does not concern an

environmental risk to health or risk to

safety that may disproportionately affect

children.

Environment

We considered the environmental

impact of this proposed rule and

concluded that preparation of an

Environmental Impact Statement is not

necessary. An Environmental

Assessment and a Finding of No

Significant Impact are available in the

docket where indicated under

ADDRESSES.

List of Subjects in 33 CFR Part 155

Hazardous substances, Incorporation

by reference, Oil pollution, Reporting

and recordkeeping requirements.

For the reasons discussed in the

preamble, the Coast Guard amends 33

CFR part 155 as follows:

PART 155—OIL OR HAZARDOUS

MATERIAL POLLUTION PREVENTION

REGULATIONS FOR VESSELS

1. The authority citation for part 155

continues to read as follows:

Authority: 33 U.S.C. 1231, 1321(j); 46

U.S.C. 3715, 3719; sec. 2, E.O. 12777, 56 FR

54757, 3 CFR, 1991 Comp., p. 351; 49 CFR

1.46, 1.46 (iii).

Sections 155.110–155.130, 155.350–

155.400, 155.430, 155.440, 155.470,

155.1030(j) and (k), and 155.1065(g) also

issued under 33 U.S.C. 1903(b); and

§§ 155.1110–155.1150 also issued 33 U.S.C.

2735.

Note: Additional requirements for vessels

carrying oil or hazardous materials appear in

46 CFR parts 30 through 36, 150, 151, and

153.

§ 155.1050 [Amended]

2. In § 155.1050, paragraph (k)(3) is

suspended until February 12, 2004.

§ 155.1052 [Amended]

3. In § 155.1052, the last sentence in

paragraph (f) is suspended until

February 12, 2004.

Dated: January 10, 2001.

R.C. North,

Rear Admiral, U.S. Coast Guard, Assistant

Commandant for Marine Safety and

Environmental Protection.

[FR Doc. 01–1205 Filed 1–11–01; 2:28 pm]

BILLING CODE 4910–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICE

45 CFR Part 46

RIN 0925–AA14

Protection of Human Research

Subjects

AGENCY: Department of Health and

Human Services (DHHS).

ACTION: Final rule.

SUMMARY: The Department of Health and

Human Services (DHHS) is amending its

human subjects protection regulations.

These regulations provide additional

protections for pregnant women and

human fetuses involved in research and

pertains to human in vitro fertilization.

The rule continues the special

protections for pregnant women and

human fetuses that have existed since

1975. The rule enhances the

opportunity for participation of

pregnant women in research by

promoting a policy of presumed

inclusion, by permitting the pregnant

woman to be the sole decision maker

with regard to her participation in

research, and by exempting from the

regulations six categories of research.

The rule also provides a mechanism for

the Secretary of HHS to conduct or fund

research not otherwise approvable after

consultation with an expert panel and

public review and comment.

DATES: Effective date: March 19, 2001.

FOR FURTHER INFORMATION CONTACT:

Susan Sherman, JD, Office for Human

Research Protections (OHRP), 6100

Executive Blvd, Suite 3B01, Rockville,

MD 20892–7507. Telephone 301–496–

7005. Email: ShermanS@od.nih.gov.

SUPPLEMENTARY INFORMATION:

Background

The Department of Health and Human

Services (DHHS) regulates research

involving human subjects conducted or

supported by the agency through

regulations codified at Title 45, part 46,

of the Code of Federal Regulations.

Subpart B of 45 CFR part 46,

promulgated on August 8, 1975,

pertains to research involving fetuses,

pregnant women, and human in vitro

fertilization. The 1975 regulations were

jointly published in the Federal

Register with the report and

recommendations of the National

Commission for the Protection of

Human Subjects of Biomedical and

Behavioral Research, Research on the

Fetus (40 FR 33526). Subsequent

changes were incorporated January 11,

1978 (43 FR 1758), November 3, 1978

(43 FR 51559), and June 1, 1994 (59 FR

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 3879

28276). This preamble refers to these

rules as the ‘‘1975 regulations.’’

Recent guidelines issued by

components of DHHS have addressed

the participation of women in research

as follows:

• Food and Drug Administration 1993

Guideline for the Study and Evaluation

of Gender Differences in the Clinical

Evaluation of Drugs (58 FR 39406);

• National Institutes of Health 1994

Guidelines on the Inclusion of Women

and Minorities as Subjects in Clinical

Research (59 FR 14508); and

• Centers for Disease Control and

Prevention 1995 Policy on the Inclusion

of Women and Racial and Ethnic

Minorities in Externally Awarded

Research (60 FR 47947), and February

16, 1996 policy Inclusion of Women and

Racial and Ethnic Minorities in

Research.

These policies are all designed, in

part, to improve the opportunity for

women to be included as subjects in

research.

A Committee on the Ethical and Legal

Issues Relating to the Inclusion of

Women in Clinical Studies of the

Institute of Medicine issued a report in

1994 on Women and Health Research

that included the recommendation that

DHHS revise subpart B in accordance

with the Committee’s other

recommendations. The Committee

believed that women and men should

have the opportunity to participate

equally in the benefits and burdens of

research, and many of the Committee’s

recommendations were aimed at

enhancing the participation of women,

including pregnant women, in clinical

research.

The National Task Force on AIDS

Drug Development and the Presidential

Advisory Council on HIV/AIDS

subsequently recommended that the

lack of paternal consent should not

disqualify a pregnant woman from

participation in a federally funded

clinical trial.

These guidelines and

recommendations, and the lack of a

formal review of subpart B for over two

decades, led DHHS to determine that a

substantive examination of subpart B

was appropriate.

Based on this review the Department

proposed to amend subpart B in a

Notice of Proposed Rulemaking (NPRM)

published on May 20, 1998 (63 FR

27794). The Department proposed that a

policy of presumed opportunity for

inclusion of pregnant women in

research replace one of presumed

exclusion. The Department also

concurred with the recommendations of

the National Task Force on AIDS Drug

Development, the Presidential Advisory

Council on HIV/AIDS, and the IOM

Committee regarding paternal consent

and proposed to modify the consent

requirement to remove potential barriers

to research that might provide a medical

benefit to a fetus.

The exemptions in 45 CFR part 46,

Subpart A, Basic DHHS Policy for

Protection of Human Research Subjects,

were proposed to apply to subpart B.

These exemptions of certain categories

of research (e.g., survey research

without subject identifiers) have applied

since 1981 to research involving

nonpregnant women.

In light of the 1993 legislative

nullification of the regulatory

requirement for ethical advisory board

review of research involving in vitro

fertilization of human ova (Public Law

103–43), the Department proposed a

mechanism for the Secretary to modify

or waive certain requirements of

Subpart B, following consultation with

experts and public input, in place of the

provision that the Department have a

standing ethical advisory board.

Nonsubstantive technical, formatting,

and clarifying changes were also

proposed.

Discussion of Comments

During the public comment period

that ended August 18, 1998, the

Department received 13 public

comments on the proposed rule from

interested parties. The comments are

summarized as follows:

General Comments

One commenter endorsed the NPRM

in its entirety. One commenter

suggested that there be three classes of

research that mirror the categories in

subpart D of part 46, Additional DHHS

Protections for Children Involved as

Subjects in Research. Those categories

are: no greater than minimal risk, greater

than minimal risk but presenting the

prospect of direct benefit, and greater

than minimal risk and no prospect of

direct benefit. The Department finds

that modification of the format of

subpart B to parallel the categories of

research in subpart D would not

enhance the protection of women or

fetuses and would likely cause

confusion. Subpart B, since its inception

in 1975 and in this final rule, requires

that the risk to the fetus be the least

possible risk for achieving the research

objectives and any risk which is greater

than minimal must hold out the

prospect of direct benefit for the fetus or

the woman.

One commenter objected to

distinctions between ‘‘therapeutic’’ and

‘‘nontherapeutic’’ research as illogical,

because, by definition, the purpose of

research is always to contribute to

generalizable knowledge. The

commenter noted that this distinction

confuses therapy with research. The

Department concurs with this comment

and has modified the final rule to

eliminate language implying that the

purpose of research is ever therapeutic.

The final rule uses the phrases ‘‘***

interventions or procedures that hold

out the prospect of direct benefit * * *’’

and ‘‘* * * research [that] holds out the

prospect of enhancing the probability of

survival * * *’’ to describe research

from which a subject may benefit

(§ 46.204(b) and § 46.205(b)(1)(i)).

Applicability (Section 46.201)

The Department proposed that the

exemptions at 45 CFR 46.101(b)(1)–(6)

of subpart A apply to subpart B. These

exemptions of six categories of research

were promulgated in 1981, subsequent

to the last substantive revision of

subpart B, and have applied to research

with nonpregnant subjects since that

time. Two commenters endorsed the

incorporation of the exemptions into

subpart B. One commenter noted that

pregnancy should not preclude women

from participating in these types of

research; one stated that pregnant

women are autonomous decision

makers and should not be treated as

vulnerable or impaired because of their

condition. Consistent with these

comments, the exemptions are retained

in the final rule (§ 46.201(b)).

The Department has retained in the

final rule language specifying that the

requirements of subpart B are in

addition to those imposed under the

other subparts of 45 CFR part 46, for

purposes of clarity (§ 46.201(d)).

Definitions (Section 46.202)

The proposed definitions were

substantively the same as those in the

1975 regulations.

The Department proposed the

following simplified definition of

‘‘fetus:’’ ‘‘fetus means the product of

conception during pregnancy until a

determination is made after delivery

that it is viable.’’ One commenter noted

that ‘‘product of conception’’ is

generally understood to mean the

associated placenta as well. The

Department intends that research with

the placenta prior to delivery be

governed by 45 CFR 46.204, Research

involving pregnant women or fetuses

prior to delivery. For purposes of

clarity, the definition of ‘‘fetus’’ in the

final rule utilizes the phrase ‘‘from

implantation,’’ which is the same phrase

used in the definition of ‘‘pregnancy.’’

Since 1975, subpart B has included

the fetus ex utero until such time as

3880 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

viability of the fetus is determined. The

Department proposed to replace the

phrase ‘‘ex utero’’ with ‘‘after delivery.’’

No comments were received on that

proposal and the final rule retains the

proposed language.

The Department also proposed the

term ‘‘newborn,’’ equating newborn

with ‘‘fetus after delivery,’’ because

some persons may prefer one term to the

other depending on the length of the

gestation period. Two commenters

found the introduction of this term

confusing and inconsistent because after

delivery there exists an entity that could

be called either fetus or newborn. The

Department concurs with these

comments and has deleted the term

‘‘newborn’’ from the final rule.

One commenter noted that newborns

can be of any species and believed that

the term ‘‘child’’ should be used in

place of ‘‘newborn.’’ Another

commenter stated that a viable fetus is

generally understood to mean a fetus

after the point of viability, generally at

5–6 months gestation. In response to

these comments the Department has

defined ‘‘viable’’ in the final rule and

emphasized that, as it pertains to the

fetus, ‘‘viable’’ means a fetus after

delivery and the regulations at 45 CFR

part 46, subpart D, are applicable

(§ 46.202(h)).

Research Involving Pregnant Women or

Fetuses Prior to Delivery (Section

46.204)

For purposes of clarity, the scope of

§ 46.204 has been narrowed in the final

rule to research involving pregnant

women or fetuses prior to delivery, and

those provisions of proposed § 46.204

that are applicable to research involving

fetuses after delivery have been repeated

in section § 46.205 (see § 46.205(a)(1)–

(6) and (b)(1)(i)).

The Department proposed to require,

as a prerequisite to research on pregnant

women or fetuses, preclinical and

clinical studies, including studies on

nonpregnant women, that provide data

for assessing potential risks to pregnant

women and fetuses. One commenter

endorsed the increased specificity and

noted that it would ensure that

reproductive toxicity data are available.

Another commenter found that to

require pregnant women to wait until

studies have been conducted on

nonpregnant women is to neglect them

as a population. The Department notes

that preclinical and clinical studies are

required only when scientifically

appropriate. The final rule retains the

proposed provision for preclinical and

clinical studies (§ 46.204(a) and

§ 46.205(a)(1)).

To strengthen protections for the

pregnant woman and fetus, the

Department proposed a new informed

consent provision: that the woman be

fully informed regarding the reasonably

foreseeable impact of the research on

the fetus. No commenters objected to

this provision. The final rule, at

§ 46.204(e), retains this requirement

with the clarification that it also applies

to the legally authorized representative.

This provision is repeated in

§ 46.205(a)(2), so that the person whose

informed consent is a prerequisite to

participation in the research must be

fully informed of the reasonably

foreseeable impact of the research on

the fetus.

One commenter stated that informed

consent should highlight known or

suspected risks and should incorporate

unknown harms. The Department notes

that provisions of subpart A at 45 CFR

part 46.116(a)(2) and § 46.116(b)(1),

respectively, also applicable to subpart

B, address these concerns. The

commenter further noted that

researchers should work to ensure that

the woman or her legally authorized

representative understands the

information that has been disclosed,

that checks for understanding should be

tailored according to the situation of

particular women or representatives,

and women should be encouraged to

discuss research participation with their

obstetrician before making a final

decision about enrollment. The

Department notes that ensuring that

information is understood and checks

for understanding tailored to particular

situations are not precluded by the

regulations, nor are they unique to

research with pregnant women. Subpart

A affords IRBs the opportunity and the

authority to ensure the adequacy of

informed consent and protections by

imposing additional requirements or

monitoring the research or the consent

process. Similarly, with regard to the

suggestion concerning encouragement of

discussion with an obstetrician, the

Department notes that the rules do not

preclude encouragement to discuss

participation with obstetricians or any

other individuals and that subpart A

requires that consent be sought only

under circumstances that provide

sufficient opportunity to consider

participation (45 CFR 46.116).

The Department proposed to modify

the consent requirements in the 1975

regulations by permitting research with

pregnant women or fetuses prior to

delivery based on the consent of the

woman or her legally authorized

representative. The Department

recognizes and encourages paternal

involvement in decisions affecting the

pregnant woman and fetus prior to

delivery. Nonetheless, in some cases the

father’s consent has been a barrier to

participation in research of the woman

or fetus prior to delivery. The

recommendations of the National Task

Force on AIDS Drug Development, the

Presidential Advisory Council on HIV/

AIDS, and the IOM Committee were

unanimous that the consent of the father

should not be a condition of the

participation of a pregnant woman in

research.

Ten commenters endorsed or

applauded the proposal to modify the

parental consent requirement, many

describing specific research trials in

which pregnant women were unable to

participate in potentially beneficial

research because of the requirement that

the father’s consent be secured. One

commenter believed the consent of the

father should continue to be required

and that waivers from the Secretary

should be sought if the father’s consent

is difficult to obtain. The Department

concludes that the decision making

authority for research participation of

the pregnant woman or fetus prior to

delivery should rest with the pregnant

woman and has retained this provision

in the final rule (§ 46.204(d)).

One commenter indicated that the

rules are unclear whether a researcher

may inform a pregnant woman of

nonresearch alternatives. The

Department notes that subpart B does

not address alternatives to research, but

that subpart A, at 45 CFR part

46.116(a)(4), also applicable to subpart

B, requires disclosure of appropriate

alternative procedures or courses of

treatment that might be advantageous to

the subject.

The Department has also decided to

continue the use of the word

‘‘terminate’’ in sections 204 and 205

instead of utilizing the proposed change

to the word ‘‘abort.’’ The Department

believes that the original language is

clearer.

Research Involving Fetuses After

Delivery (Section 46.205)

As indicated above, those provisions

proposed in § 46.204 that are applicable

to research involving fetuses after

delivery are reiterated in the final rule

under § 46.205(a) and (b)(1)(i).

One commenter requested that the

Department explain why this section is

separate from subpart D. As noted

above, the 1975 regulations extended

the definition of fetus to include the

fetus ex utero until such time as a fetus

is determined to be viable. The final

rule continues this extension because

nonviable fetuses, and fetuses whose

viability has not yet been determined

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 3881

after delivery, require protection and are

not covered by subpart D. Accordingly,

subpart B permits research with fetuses

of uncertain viability only if the

research holds out the prospect of

enhancing the probability of survival or

there will be no risk resulting from the

research and the purpose is the

development of important biomedical

knowledge that cannot be obtained by

other means (§ 46.205(b)). Research with

nonviable fetuses after delivery, which

must be considered dying subjects, must

meet the five criteria at § 46.205(c)(1)–

(5), also intended to provide protection

for such subjects.

Section 498(a), ‘‘Fetal Research,’’ of

the Public Health Service Act, 42 U.S.C.

289g(a), places statutory restrictions on

research involving nonviable living

fetuses ex utero or living fetuses ex

utero for whom viability has not been

ascertained. The statute permits

research under either of the following

two conditions: ‘‘the research * * * (1)

may enhance the well-being or meet the

health needs of the fetus or enhance the

probability of its survival to viability; or

(2) will pose no added risk of suffering,

injury, or death to the fetus and the

purpose * * * is the development of

important biomedical knowledge that

cannot be obtained by other means.’’

This rule exceeds those requirements for

fetuses of uncertain viability by

permitting research only if it either (1)

holds out the prospect of enhancing the

probability of survival of the particular

fetus to the point of viability, or (2)

poses no risk to the fetus and the

purpose is the development of

important biological knowledge that

cannot be obtained by other means. This

rule also exceeds the statutory

requirements for nonviable living

fetuses ex utero by specifying that vital

functions of the nonviable fetus may not

be artificially maintained and the

research may not terminate the

heartbeat or respiration of the fetus.

The consent requirements for research

involving fetuses of uncertain viability

and nonviable fetuses at § 46.205(b)(2)

and § 46.205(c)(5), respectively, also

ensure protection of the fetus. Research

involving fetuses of uncertain viability

may proceed with the consent of either

parent (or under certain circumstances

the consent of a legally authorized

representative), but the research must

hold the prospect of enhancing the

probability of survival of the fetus to the

point of viability or pose no risk to the

fetus. The Department recognizes that,

in cases of uncertain viability, a

decision regarding research

participation must often be made very

quickly, especially where the research

presents the prospect of enhancing the

probability of survival of the fetus.

Thus, the consent of only one parent (or

legally authorized representative) is

required. However, if both parents are

readily available at the time when a

decision is needed, reasonable efforts

should be made to provide all relevant

information to both parents. The

Department believes that research

involving the nonviable fetus should

only proceed with the consent of both

parents (unless one is unavailable,

incompetent, or temporarily

incapacitated), and the consent of a

representative is expressly prohibited.

The individual(s) providing consent

under § 46.205(b)(2) or (c)(5) must be

fully informed regarding the reasonably

foreseeable impact of the research on

the fetus (§ 46.205(a)(2)).

Research after delivery, involving

fetuses determined to be viable, is

governed by Subpart D (§ 46.205(d)).

Research Not Otherwise Approvable

That Presents Certain Opportunities

section 46.207)

The Department proposed to replace

the 1975 regulatory authority of the

Secretary to modify or waive specific

requirements with the approval of an

ethical advisory board, with the

authority to modify or waive

requirements after consultation with

appropriate experts and opportunity for

public review and comment. The

proposal would have required the

Secretary to consider whether the risks

to the subjects were so outweighed by

the sum of the benefits to the subjects

and the importance of the knowledge to

be gained as to warrant modification or

waiver. One commenter noted that the

proposed waiver provision did not

require IRB review, as does the similar

section in subpart D (45 CFR 46.407).

The commenter further noted that the

proposed wording appeared to require

that the overarching consideration be

‘‘beneficence’’ based, and that adopting

the language in 45 CFR 46.407 would

encompass all of the ethical principles

in the Belmont Report and ensure

consistency between subparts B and D.

The Department concurs with these

comments and the final rule, at § 46.207,

is consistent with 45 CFR 46.407, with

conforming and clarifying changes.

Under this provision the waiver

authority is limited to the requirements

of § 46.204 applicable to pregnant

women and fetuses prior to delivery.

The other requirements of subpart B,

including those in § 46.205, cannot be

waived. Even though the Secretary has

the authority to waive the requirements

of § 46.205 that exceed the statutory

requirements of section 498(a), ‘‘Fetal

Research,’’ of the Public Health Service

Act, 42 U.S.C. 289g(a) (see discussion of

§ 46.205 above), it was determined that

the additional protections afforded by

§ 46.205 are essential and should not be

waived under any circumstances.

Conclusion

After considering the comments, the

Department is adopting the rule as

proposed except for the changes noted

above and editorial changes to clarify

the intent of the regulation. Distinctions

between therapeutic and nontherapeutic

research are eliminated. The term

‘‘newborn’’ is deleted in the final rule

for purposes of clarity, and the

definition of ‘‘viable’’ as it pertains to

the fetus is clarified. Section 46.207,

regarding approval by the Secretary of

research that would not otherwise be

approvable under § 46.204, is modified

consistent with the similar provision in

subpart D. The Department has also

incorporated additional nonsubstantive

editorial and clarifying revisions in the

final rule.

The rule is effective 60 days after

publication to give Institutional Review

Boards (IRBs) time to incorporate the

regulations into their review of research

protocols. All initial and ongoing

projects reviewed after the effective date

by IRBs under Multiple Project

Assurances or other Assurances with

the DHHS, Office for Human Research

Protections, OHRP (formerly OPRR),

must be reviewed in accordance with

these rules.

Executive Order 12866

Executive Order 12866 requires that

all regulatory actions reflect

consideration of the costs and benefits

they generate and that they meet certain

standards, such as avoiding the

imposition of unnecessary burdens on

the affected public. If an action is

deemed to fall within the scope of the

definition of the term ‘‘significant

regulatory action’’ contained in § 3(f) of

the Order, a pre-publication review by

the Office of Management and Budget’s

(OMB’s) Office of Information and

Regulatory Affairs (OIRA) is necessary.

OMB deemed this rule a ‘‘significant

regulatory action,’’ as defined by

Executive Order 12866. Therefore, the

rule was submitted to OIRA for review

prior to its publication in the Federal

Register.

Regulatory Flexibility Act

The Regulatory Flexibility Act (5

U.S.C. Chapter 6) requires that

regulatory actions be analyzed to

determine whether they create a

significant impact on a substantial

number of small entities. This rule

primarily affects individual research

3882 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

subjects and institutions that receive

funding from the Department of Health

and Human Services for research

involving human subjects. It will not

have the effect of imposing significant

additional costs on small research

institutions that are within the

definition of small entities. Therefore,

the Secretary certifies that this rule will

not have significant impact on a

substantial number of small entities and

that preparation of an initial regulatory

flexibility analysis is not required.

Paperwork Reduction Act

This rule does not contain any new

information collection requirements that

are subject to Office of Management and

Budget (OMB) approval under the

Paperwork Reduction Act of 1995 (44

U.S.C. Chapter 35).

List of Subjects in 45 CFR Part 46

Health—clinical research, medical

research.

Dated: September 21, 2000.

David Satcher,

Assistant Secretary for Health and Surgeon

General.

Approved: October 30, 2000.

Donna E. Shalala,

Secretary of Health and Human Services.

Accordingly, the Department of

Health and Human Services amends

part 46 of the Regulations for the

Protection of Human Subjects (45 CFR

part 46), as follows:

1. authority citation for 45 CFR part

46 is revised to read as follows:

Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).

2. Supbart B of 45 CFR part 46 is

revised to read as follows:

Subpart B—Additional Protections for

Pregnant Women and Human Fetuses

Involved in Research, and Pertaining

to Human In Vitro Fertilization

Sec.

46.201 To what do these regulations apply?

46.202 Definitions.

46.203 Duties of IRBs in connection with

research involving pregnant women,

fetuses, and human in vitro fertilization.

46.204 Research involving pregnant women

or fetuses prior to delivery.

46.205 Research involving fetuses after

delivery.

46.206 Research involving, after delivery,

the placenta, the dead fetus, or fetal

material.

46.207 Research not otherwise approvable

which presents an opportunity to

understand, prevent, or alleviate a

serious problem affecting the health or

welfare of pregnant women or fetuses.

§ 46.201 To what do these regulations

apply?

(a) Except as provided in paragraph

(b) of this section, this subpart applies

to all research involving pregnant

women or human fetuses, and to all

research involving the in vitro

fertilization of human ova, conducted or

supported by the Department of Health

and Human Services (DHHS). This

includes all research conducted in

DHHS facilities by any person and all

research conducted in any facility by

DHHS employees.

(b) The exemptions at § 46.101(b)(1)

through (6) are applicable to this

subpart.

(c) The provisions of § 46.101(c)

through (i) are applicable to this

subpart. Reference to State or local laws

in this subpart and in § 46.101(f) is

intended to include the laws of federally

recognized American Indian and Alaska

Native Tribal Governments.

(d) The requirements of this subpart

are in addition to those imposed under

the other subparts of this part.

§ 46.202 Definitions.

The definitions in § 46.102 shall be

applicable to this subpart as well. In

addition, as used in this subpart:

(a) Dead fetus means a fetus after

delivery that exhibits neither heartbeat,

spontaneous respiratory activity,

spontaneous movement of voluntary

muscles, nor pulsation of the umbilical

cord. Delivery means complete

separation of the fetus from the woman

by expulsion or extraction or any other

means.

(b) Fetus means the product of

conception from implantation until a

determination is made after delivery

that it is viable.

(c) In vitro fertilization means any

fertilization of human ova which occurs

outside the body of a female, either

through admixture of donor human

sperm and ova or by any other means.

(d) Nonviable fetus means a fetus after

delivery that, although living, is not

viable.

(e) Pregnancy encompasses the period

of time from implantation until

delivery. A woman shall be assumed to

be pregnant if she exhibits any of the

pertinent presumptive signs of

pregnancy, such as missed menses, until

the results of a pregnancy test are

negative or until delivery.

(f) Secretary means the Secretary of

Health and Human Services and any

other officer or employee of the

Department of Health and Human

Services to whom authority has been

delegated.

(g) Viable as it pertains to the fetus

means being able, after delivery, to

survive (given the benefit of available

medical therapy) to the point of

independently maintaining heartbeat

and respiration. The Secretary may from

time to time, taking into account

medical advances, publish in the

Federal Register guidelines to assist in

determining whether a fetus is viable for

purposes of this subpart. If a fetus after

delivery is viable then it is a child as

defined by § 46.402(a), and subpart D of

this part is applicable.

§ 46.203 Duties of IRBs in connection with

research involving pregnant women,

fetuses, and human in vitro fertilization.

In addition to other responsibilities

assigned to IRBs under this part, each

IRB shall review research covered by

this subpart and approve only research

which satisfies the conditions of all

applicable sections of this subpart and

the other subparts of this part.

§ 46.204 Research involving pregnant

women or fetuses prior to delivery.

Pregnant women or fetuses prior to

delivery may be involved in research if

all of the following conditions are met:

(a) Where scientifically appropriate,

preclinical studies, including studies on

pregnant animals, and clinical studies,

including studies on nonpregnant

women, have been conducted and

provide data for assessing potential risks

to pregnant women and fetuses;

(b) The risk to the fetus is not greater

than minimal, or any risk to the fetus

which is greater than minimal is caused

solely by interventions or procedures

that hold out the prospect of direct

benefit for the woman or the fetus;

(c) Any risk is the least possible for

achieving the objectives of the research;

(d) The woman’s consent or the

consent of her legally authorized

representative is obtained in accord

with the informed consent provisions of

subpart A of this part, unless altered or

waived in accord with § 46.101(i) or

§ 46.116(c) or (d);

(e) The woman or her legally

authorized representative, as

appropriate, is fully informed regarding

the reasonably foreseeable impact of the

research on the fetus or resultant child;

(f) For children as defined in 45 CFR

46.402(a) who are pregnant, assent and

permission are obtained in accord with

the provisions of subpart D of this part;

(g) No inducements, monetary or

otherwise, will be offered to terminate a

pregnancy;

(h) Individuals engaged in the

research will have no part in any

decisions as to the timing, method, or

procedures used to terminate a

pregnancy; and

Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations 3883

(i) Individuals engaged in the research

will have no part in determining the

viability of a fetus.

§ 46.205 Research involving fetuses after

delivery.

(a) After delivery, fetuses may be

involved in research if all of the

following conditions are met:

(1) Where scientifically appropriate,

preclinical and clinical studies have

been conducted and provide data for

assessing potential risks to fetuses.

(2) The individual(s) providing

consent under paragraph (b)(2) or (c)(5)

of this section is fully informed

regarding the reasonably foreseeable

impact of the research on the fetus or

resultant child.

(3) No inducements, monetary or

otherwise, will be offered to terminate a

pregnancy.

(4) Individuals engaged in the

research will have no part in any

decisions as to the timing, method, or

procedures used to terminate a

pregnancy.

(5) Individuals engaged in the

research will have no part in

determining the viability of a fetus.

(6) The requirements of paragraph (b)

or (c) of this section have been met as

applicable.

(b) Fetuses of uncertain viability.

After delivery, and until it has been

ascertained whether or not a fetus is

viable, a fetus may not be involved in

research covered by this subpart unless

the following additional conditions are

met:

(1) The IRB determines that:

(i) The research holds out the

prospect of enhancing the probability of

survival of the particular fetus to the

point of viability, and any risk is the

least possible for achieving the

objectives of the research, or

(ii) The purpose of the research is the

development of important biomedical

knowledge which cannot be obtained by

other means and there will be no risk to

the fetus resulting from the research;

and

(2) The legally effective informed

consent of either parent of the fetus or,

if neither parent is able to consent

because of unavailability,

incompetence, or temporary incapacity,

the legally effective informed consent of

either parent’s legally authorized

representative is obtained in accord

with subpart A of this part, unless

altered or waived in accord with

§ 46.101(i) or § 46.116(c) or (d).

(c) Nonviable fetuses. After delivery,

a nonviable fetus may not be involved

in research covered by this subpart

unless all of the following additional

conditions are met:

(1) Vital functions of the fetus will not

be artificially maintained;

(2) The research will not terminate the

heartbeat or respiration of the fetus;

(3) There will be no risk to the fetus

resulting from the research;

(4) The purpose of the research is the

development of important biomedical

knowledge that cannot be obtained by

other means; and

(5) The legally effective informed

consent of both parents of the fetus is

obtained in accord with subpart A of

this part, except that the waiver and

alteration provisions of § 46.116(c) and

(d) do not apply. However, if either

parent is unable to consent because of

unavailability, incompetence, or

temporary incapacity, the informed

consent of one parent of a nonviable

fetus will suffice to meet the

requirements of this paragraph. The

consent of a legally authorized

representative of either or both of the

parents of a nonviable fetus will not

suffice to meet the requirements of this

paragraph.

(d) Viable fetuses. A fetus, after

delivery, that has been determined to be

viable is a child as defined by

§ 46.402(a) and may be included in

research only to the extent permitted by

and in accord with the requirements of

subparts A and D of this part.

§ 46.206 Research involving, after delivery,

the placenta, the dead fetus, or fetal

material.

(a) Research involving, after delivery,

the placenta; the dead fetus; macerated

fetal material; or cells, tissue, or organs

excised from a dead fetus, shall be

conducted only in accord with any

applicable Federal, State, or local laws

and regulations regarding such

activities.

(b) If information associated with

material described in paragraph (a) of

this section is recorded for research

purposes in a manner that living

individuals can be identified, directly or

through identifiers linked to those

individuals, those individuals are

research subjects and all pertinent

subparts of this part are applicable.

§ 46.207 Research not otherwise

approvable which presents an opportunity

to understand, prevent, or alleviate a

serious problem affecting the health or

welfare of pregnant women or fetuses.

The Secretary will conduct or fund

research that the IRB does not believe

meets the requirements of § 46.204 only

if:

(a) The IRB finds that the research

presents a reasonable opportunity to

further the understanding, prevention,

or alleviation of a serious problem

affecting the health or welfare of

pregnant women or fetuses; and

(b) The Secretary, after consultation

with a panel of experts in pertinent

disciplines (for example: science,

medicine, ethics, law) and following

opportunity for public review and

comment, including a public meeting

announced in the Federal Register, has

determined either:

(1) That the research in fact satisfies

the conditions of § 46.204, as applicable,

or

(2) The following:

(i) The research presents a reasonable

opportunity to further the

understanding, prevention, or

alleviation of a serious problem

affecting the health or welfare of

pregnant women or fetuses;

(ii) The research will be conducted in

accord with sound ethical principles;

and

(iii) Informed consent will be

obtained in accord with the informed

consent provisions of subpart A and

other applicable subparts of this part,

unless altered or waived in accord with

§ 46.101(i) or § 46.116(c) or (d).

[FR Doc. 01–1122 Filed 1–16–01; 8:45 am]

BILLING CODE 4140–01–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[DA 01–43, MM Docket No. 00–179, RM–

9947]

Digital Television Broadcast Service;

Arkadelphia, AR

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: The Commission, at the

request of Arkansas Educational

Television Commission, licensee of

noncommercial educational station

KETG(TV), substitutes DTV *13 for DTV

channel *46 at Arkadelphia. See 65 FR

59389, October 5, 2000. DTV channel

*13 can be allotted to Arkadelphia in

compliance with the principle

community coverage requirements of

Section 73.625(a) at reference

coordinates (33–54–26 N. and 93–06–46

W.) with a power of 7.3, HAAT of 320.9

meters and with a DTV service

population of 277 thousand. With is

action, this proceeding is terminated.

DATES: Effective February 26, 2001.

FOR FURTHER INFORMATION CONTACT: Pam

Blumenthal, Mass Media Bureau, (202)

418–1600.

SUPPLEMENTARY INFORMATION: This is a

synopsis of the Commission’s Report