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

3884 Federal Register / Vol. 66, No. 11 / Wednesday, January 17, 2001 / Rules and Regulations

and Order, MM Docket No. 00–179,

adopted January 10, 2001, and released

January 11, 2001. The full text of this

Commission decision is available for

inspection and copying during normal

business hours in the FCC Reference

Center 445 12th Street, SW,

Washington, DC. The complete text of

this decision may also be purchased

from the Commission’s copy contractor,

International Transcription Services,

Inc., (202) 857–3800, 1231 20th Street,

NW, Washington, DC 20036.

List of Subjects in 47 CFR Part 73

Television, Digital television

broadcasting.

Part 73 of Title 47 of the Code of

Federal Regulations is amended as

follows:

PART 73—[AMENDED]

1. The authority citation for Part 73

continues to read as follows:

Authority: 47 U.S.C. 154, 303, 334, 336.

§ 73.622 [Amended]

2. Section 73.622(b), the Table of

Digital Television Allotments under

Arkansas, is amended by removing DTV

channel *46 and adding DTV channel

*13 at Arkadelphia.

Federal Communications Commission.

Barbara A. Kreisman,

Chief, Video Services Division, Mass Media

Bureau.

[FR Doc. 01–1185 Filed 1–16–01; 8:45 am]

BILLING CODE 6712–01–U

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Parts 73 and 74

[MM Docket No. 95–31, FCC 00–120]

Reexamination of Comparative

Standards for Noncommercial

Educational Applicants

AGENCY: Federal Communications

Commission.

ACTION: Final rule; announcement of

effective date.

SUMMARY: The Commission adopted

new rules for selecting among mutually

exclusive applicants for noncommercial

educational broadcast stations. Certain

rules contained new and modified

information collection requirements and

were published in the Federal Register

on June 8, 2000. This document

announces the effective date of these

published rules.

DATES: Effective August 1, 2000 with

respect to the amendments to §§ 73.202,

73.3527, and 77.3572 published at 65

FR 36375 (June 8, 2000).

FOR FURTHER INFORMATION CONTACT:

Irene Bleiweiss, Mass Media Bureau,

Audio Services Division, (202) 418–

2700.

SUPPLEMENTARY INFORMATION: On August

1, 2000, the Office of Management and

Budget (OMB) approved the information

collection requirements contained in

Sections 73.202; 73.3527; and 73.3572

pursuant to OMB Control Nos. 3060–

0948. Accordingly, the information

collection requirements contained in

these rules became effective on August

1, 2000.

Federal Communications Commission.

William F. Caton,

Deputy Secretary.

[FR Doc. 01–1308 Filed 1–16–01; 8:45 am]

BILLING CODE 6712–01–U

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST–99–6578]

RIN 2105–AAC49

Procedures for Transportation

Workplace Drug and Alcohol Testing

Programs; Correction

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule; correction.

SUMMARY: In its final drug and alcohol

testing rule published on December 19,

2000, the Department made an editorial

error in the numbering of a section in

the complete new version regulation.

This document corrects this error by

inserting the proper numbering. In

addition, the Department inadvertently

omitted one item from its amendments

to the existing regulation. This

document adds this item, which

concerns the responsibilities of the

medical review officer in reviewing

chain of custody documentation.

EFFECTIVE DATES: The correction to the

amendments to the current 49 CFR Part

40 (i.e., the addition of § 40.227) is

effective January 18, 2001. The

correction to the revised 49 CFR Part 40

(i.e., corrected designation of § 40.33(f))

is effective August 1, 2001.

FOR FURTHER INFORMATION CONTACT:

Robert C. Ashby, Deputy Assistant

General Counsel for Regulation and

Enforcement, Department of

Transportation, 400 7th Street, SW.,

Room 10424, Washington, DC 20590, at

(202) 366–9306 (voice), (202) 366–9313

(fax), (202) 755–7687 (TDD), or

bob.ashby@ost.dot.gov (e-mail).

SUPPLEMENTARY INFORMATION: In the

December 19, 2000, Federal Register (65

FR 79462), the Department published a

comprehensive revision to its drug and

alcohol procedures testing regulation

(49 CFR Part 40). This complete revision

becomes effective August 1, 2001. In

this revision, the Department made an

error in numbering § 40.33(f). Following

the introductory text of paragraph (f),

the Department numbered three

paragraphs (i), (ii), and (iii),

respectively. They should have been

numbered (1), (2), and (3). We are

correcting this error.

In the same Federal Register

document, we also published

amendments to the existing 49 CFR Part

40, effective January 18, 2001. We

inadvertently omitted from these

amendments one provision we intended

to make effective on this date. This

provision concerns the responsibility of

the medical review officer (MRO) to

review the chain of custody

documentation for a drug test. In

§ 40.123(b)(1) and § 40.129(a)(2) of the

complete revision of Part 40, the

Department specifies that MROs are not

required to review the laboratory

internal chain of custody

documentation as part of this process,

and that no one is authorized to cancel

a test because the MRO does not review

the internal laboratory chain of custody

documentation.

These provisions of the complete

revision of Part 40 are fully consistent

with the Department’s intent in, and

interpretation of, the existing regulation.

However, we learned last year that some

parties have been confused about this

point, and one state court decision—

mistakenly, in our view—determined

that MROs were required to review

internal laboratory chain of custody

documentation. We added the cited

provisions to the complete revision of

Part 40 to emphasize that MRO review

of this documentation is not needed.

We intended to add the substance of

these provisions to the amendments to

the existing Part 40 that become

effective January 18, 2001, lest there be

any misunderstanding of this point in

the interim before August 1, 2001.

However, through editorial oversight,

we failed to do so. We are correcting

this omission by adding a new § 40.227

to Subpart E of the existing Part 40.

The Department finds that there is

good cause to issue this correction

without a prior notice and opportunity

for comment. The underlying regulatory

provisions were part of a rulemaking

that was promulgated through the