49954 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Proposed Rules

and Cosmetic Act (21 U.S.C. 321, 331, 351,

352, 353, 355, 356, 357, 371); sec. 351 of the

Public Health Service Act (42 U.S.C. 262).

2. Section 312.42 is amended by

adding new paragraph (b)(1)(v) and by

revising paragraph (b)(2)(i) to read as

follows:

§ 312.42 Clinical holds and requests for

modification.

* * * * *

(b) * * *

(1) * * *

(v) The IND is for the study of an

investigational drug intended to treat a

life-threatening illness or disease that

affects both genders, and men or women

with reproductive potential who have

the disease being studied are excluded

from eligibility in any phase of clinical

investigation because of a risk or

potential risk of reproductive (i.e.,

toxicities to reproductive organs) or

developmental (i.e., toxicities to

potential offspring) toxicity from use of

the investigational drug. The phrase

‘‘women with reproductive potential’’

does not include pregnant women. For

purposes of this paragraph, ‘‘lifethreatening illnesses or diseases’’ are

defined as ‘‘diseases or conditions

where the likelihood of death is high

unless the course of the disease is

interrupted.’’ The clinical hold would

not apply under this paragraph to

clinical studies conducted:

(A) Under special circumstances, such

as studies of a single-gender population

(e.g., studies evaluating the excretion of

a drug in semen or the effects on

menstrual function); or

(B) In men, as long as a study that

does not exclude subjects with

reproductive potential has been planned

or is being conducted in women.

(2) * * *

(i) Any of the conditions in

paragraphs (b)(1)(i) through (b)(1)(v) of

this section apply; or

* * * * *

Dated: September 16, 1997.

Michael A. Friedman,

Lead Deputy Commissioner for the Food and

Drug Administration.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 97–25268 Filed 9-23-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 17

RIN 1018–AE30

Endangered and Threatened Wildlife

and Plants; Public Hearing and

Extension of Comment Period on

Proposed Endangered Status for

Keck’s Checker-Mallow

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Proposed rule; notice of public

hearing and extension of comment

period.

SUMMARY: The Fish and Wildlife Service

(Service), pursuant to the Endangered

Species Act of 1973, as amended (Act),

provides notice of a public hearing and

extension of the comment period on the

proposed endangered status for Sidalcea

keckii (Keck’s checker-mallow). The

comment period is extended to

accommodate a public hearing that was

requested by California Assemblyman

Roy Ashburn, Thirty-Second District.

DATES: The public hearing will be held

on Tuesday, October 21, from 6:00 p.m.

to 8:00 p.m. in Visalia, California. The

comment period closes November 10,

1997.

ADDRESSES: The public hearing will be

held at the Visalia Convention Center,

303 East Acequia Street, Visalia,

California. Comments and materials

concerning this proposal should be sent

to the Field Supervisor, U.S. Fish and

Wildlife Service, Sacramento Fish and

Wildlife Office, 3310 El Camino

Avenue, Suite 130, Sacramento,

California 95821–6340. Comments and

materials received will be available for

public inspection, by appointment,

during normal business hours at the

above address.

FOR FURTHER INFORMATION CONTACT: Ken

Fuller of the Sacramento Fish and

Wildlife Office (see ADDRESSES section)

at (916) 979–2120.

SUPPLEMENTARY INFORMATION:

Background

On July 28, 1997, the Service

published a rule proposing endangered

status for Sidalcea keckii in the Federal

Register (62 FR 40325). The original

comment period was to close on

September 26, 1997. Section 4(b)(5)(E)

of the Act (16 U.S.C. 1531 et seq.)

requires that a public hearing be held if

it is requested within 45 days of the

publication of the proposed rule. In

response to a request for a public

hearing from California Assemblyman

Roy Ashburn, a public hearing will be

held in Visalia, California on October

21, 1997, at the Visalia Convention

Center. Parties wishing to make

statements for the record should bring a

copy of their statements to the hearing.

Oral statements may be limited in

length, if the number of parties present

at the hearing necessitates such a

limitation. There are no limits to the

length of written comments or materials

presented at the hearing or mailed to the

Service. Written comments carry the

same weight as oral comments. The

comments period now closes on

November 10, 1997. Written comments

should be submitted to the Service in

the ADDRESSES section.

Sidalcea keckii is an annual plant that

is known from one population in the

hilly annual grasslands of south-central

Tulare County. The plant is threatened

by agricultural land conversion, urban

development, and naturally occurring

events. Comments from the public

regarding the accuracy of this proposed

rule are sought, especially regarding:

(1) Biological, commercial trade, or

other relevant data concerning any

threat (or lack thereof) to the species

listed above;

(2) The location of any additional

populations of the species and the

reasons why any habitat should or

should not be determined to be critical

habitat as provided by section 4 of the

Act;

(3) Additional information concerning

the range, distribution, and population

sizes of the species; and

(4) Current or planned activities in the

subject area and their possible impacts

on the species.

Author

The primary author of this notice is

Ken Fuller (see ADDRESSES section).

Authority

The authority for this action is the

Endangered Species Act of 1973 (16

U.S.C. 1531 et seq.).

Dated: September 16, 1997.

Cynthia Barry,

Acting Regional Director, Region 1, Portland,

Oregon.

[FR Doc. 97–25061 Filed 9–23–97; 8:45 am]

BILLING CODE 4310–55–P