Federal Register / Vol. 63, No. 109 / Monday, June 8, 1998 / Notices 31225

Drug Evaluation and Research (CDER)

and the Center for Biologics Evaluation

and Research (CBER).

The draft guidance for industry

entitled ‘‘Stability Testing of Drug

Substances and Drug Products’’ revises,

updates, and is intended to supersede

the guidance entitled ‘‘Submitting

Documentation for the Stability of

Human Drugs and Biologics’’ (February

1987). This draft guidance relies on and

incorporates the ICH Q1A guidance

‘‘Stability Testing of New Drug

Substances and Products’’ (59 FR 48754,

September 22, 1994) and its annexes.

This draft guidance represents the

agency’s current thinking on stability

testing of human drugs and biologics

regulated by CDER and CBER. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirement of the

applicable statute, regulations, or both.

Interested persons may, on or before

September 9, 1998, submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number

found in brackets in the heading of this

document. The draft guidance and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: June 2, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15148 Filed 6–5–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Receipt of Application for the

Proposed Issuance of a Permit To

Allow Incidental Take of an

Endangered Species at the Los Osos

Center, LLC, Proposed Commercial

Development Project, in Los Osos,

California

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of document availability;

request for comments.

SUMMARY: This notice advises the public

that Los Osos Center, LLC (Applicant),

has applied for an incidental take

permit from the Fish and Wildlife

Service pursuant to Section 10(a)(1)(B)

of the Endangered Species Act of 1973

(Act), as amended. The Applicant is

requesting the Service issue a 5-year

permit to allow the incidental take of

the federally listed as endangered Morro

shoulderband snail (Helminthoglypta

walkeriana) associated with a proposed

5.5-acre commercial development

project in the community of Los Osos,

San Luis Obispo County, California. The

permit application includes a Habitat

Conservation Plan and an

Implementation Agreement, both of

which are available for pubic review

and comment. The Service also

announces the availability of an

Environmental Assessment for the

proposed issuance of the incidental take

permit. All comments received will

become part of the administrative record

and may be released to the public.

DATES: Written comments on the permit

application and Environmental

Assessment should be received on or

before July 8, 1998.

ADDRESSES: Comments regarding the

application or the Environmental

Assessment, or requests for these

documents, should be addressed to

Diane Noda, Field Supervisor, Fish and

Wildlife Service, 2493 Portola Road,

Suite B, Ventura, California 93003;

facsimile (805) 644–3958.

FOR FURTHER INFORMATION CONTACT: Kate

Symonds, Fish and Wildlife Biologist, at

the above address or telephone (805)

644–1766.

SUPPLEMENTARY INFORMATION:

Document Availability

Individuals wishing copies of the

documents for review should

immediately contact the office listed

above. Documents also will be available

for inspection, by appointment, during

normal business hours at the above

address.

Background

Under Section 9 of the Act and its

implementing regulations, ‘‘taking’’ of

threatened and endangered species is

prohibited. However, the Service, under

limited circumstances, may issue

permits to take threatened or

endangered wildlife species if such

taking is incidental to, and not the

purpose of, otherwise lawful activities.

Regulations governing permits for

threatened and endangered species are

found at 50 CFR part 13 and 50 CFR

17.22 and 17.32.

The incidental taking would occur as

the result of the Applicant’s proposed

commercial development project, which

would result in the permanent loss of

0.5 acres of Morro shoulderband snail

habitat within the 5.5-acre project site.

The permit application includes a

Habitat Conservation Plan (Plan) and

the Implementation Agreement which

defines the responsibilities of all of the

parties under the Plan. The Plan

addresses impacts to the Morro

shoulderband snail that are associated

with the proposed commercial

development project and provides for

implementation of measures to

minimize and mitigate adverse impacts

to the Morro shoulderband snail.

The Applicant will pay a mitigation

compensation fee to the Service’s land

acquisition and management designee to

be used for the acquisition and

management in perpetuity of 0.5 acres

of high-quality offsite Morro

shoulderband snail habitat, as part of a

larger habitat acquisition program in Los

Osos. The 0.5-acre land acquisition will

compensate for the permanent loss of

0.5 acres of snail habitat that will result

from project implementation and will

benefit the long-term conservation of the

snail.

The Plan and the Environmental

Assessment consider three alternatives

to the proposed commercial

development project: the NoDevelopment Project Alternative, the

Reduced Intensity Alternative, and the

Alternate Site Alternative.

Under the No-Development Project

Alternative, no commercial

development project would be

conducted. The Service would not issue

a Section 10(a)(1)(B) permit because

there would be no take of Morro

shoulderband snails. This alternative

would not adversely affect biological

resources occurring on this site;

therefore, impacts would be less than

those of the proposed project. This

alternative assumes the continuation of

the existing conditions (i.e.,

undeveloped area). However, the NoDevelopment Project Alternative would

not substantially benefit the Morro

shoulderband snail. Non-native plants

would continue to occupy the project

site and human disturbances would

likely continue. Under this alternative,

no contribution to the acquisition,

preservation, and management of highquality offsite Morro shoulderband snail

habitat would occur.

The Reduced Intensity Alternative

involves proceeding with a commercial

development on the proposed 5.5-acre

project site, but with a smaller

construction configuration so as to

avoid physical disturbance to the areas

of Morro shoulderband snail habitat

within the project site. This alternative

would involve not developing

approximately 1.5 acres within the 5.5-

acre parcel. A Reduced Intensity

Alternative would not benefit the Morro

shoulderband snail because it would
31226 Federal Register / Vol. 63, No. 109 / Monday, June 8, 1998 / Notices

further isolate the habitat. Under this

alternative, no contribution to the

acquisition, preservation, and

management of high-quality offsite

Morro shoulderband snail habitat would

occur.

The Alternate Site Alternative

involves the use of a site for a

commercial development project that

does not support any listed species;

therefore, the project would not result in

the incidental take of a listed species.

This alternative is considered to be

unfeasible from a business and

commercial standpoint given market,

development, and private contractual

constraints. Although this alternative

would result in no impact at the

proposed project site, it would not

substantially benefit the Morro

shoulderband snail. The project site

contains marginal snail habitat,

including non-native plants. Human

disturbances to the project site would

likely continue. Under this alternative,

no contribution to the acquisition,

preservation, and management of highquality offsite Morro shoulderband snail

habitat would occur.

This notice is provided pursuant to

Section 10(c) of the Act and Service

regulations for implementing the

National Environmental Policy Act of

1969 (40 CFR 1506.6). The Service will

evaluate the application, its associated

documents, and submitted comments to

determine whether the application

meets the requirements of law. If the

Service determines that the

requirements are met, a permit will be

issued for the incidental take of the

Morro shoulderband snail. A final

decision on permit issuance will be

made no sooner than 30 days from the

date of this notice.

Dated: June 1, 1998.

Thomas Dwyer,

Acting Regional Director, Region 1, Portland,

Oregon.

[FR Doc. 98–15069 Filed 6–5–98; 8:45 am]

BILLING CODE 4310–55–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Availability of a Revised Application

for an Incidental Take Permit and

Revised Environmental Assessment

for Obyan Beach Resort Associates,

Saipan, Commonwealth of the

Northern Mariana Islands and the

Commonwealth of the Northern

Mariana Islands Department of Lands

and Natural Resources

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Notice of availability.

SUMMARY: This notice advises the public

that the Obyan Beach Resort Associates

and the Commonwealth of the Northern

Mariana Islands (Commonwealth)

Department of Lands and Natural

Resources (Applicants) have applied to

the Fish and Wildlife Service for an

incidental take permit (PRT–824821)

pursuant to section 10(a)(1)(B) of the

Endangered Species Act of 1973, as

amended (Act). The application package

includes a Habitat Conservation Plan

(Plan), Implementation Agreement, and

the Saipan Upland Mitigation Bank

Agreement (Agreement). The Service

also announces the availability of an

Environmental Assessment for the

proposed issuance of the incidental take

permit. The proposed permit would

authorize the incidental take of the

federally listed endangered nightingale

reed-warbler (Acrocephalus luscinia)

and Micronesian megapode

(Megapodius laperouse), and/or their

habitat during the construction of a

proposed 36-hole golf course and resort.

Green sea turtles (Chelonia mydas) may

nest at the beach near the project site,

but outside of the project boundaries,

and are not expected to be impacted by

the project. The permit would be in

effect for 50 years.

The Plan, Implementation Agreement

and Environmental Assessment were

circulated for public review in February,

1997, in accordance with the Act and

the National Environmental Policy Act

(62 FR 7794). The original permit

application proposed establishment of a

mitigation bank on Saipan to

compensate for impacts to nightingale

reed-warblers. Since that time, the

proposed Saipan Upland Mitigation

Bank (Mitigation Bank) has been

developed, and a Mitigation Bank

Agreement has been prepared. This

Agreement is now included in the

permit application. Other than

development of the Mitigation Bank and

associated Agreement, no major

revisions have been made to the permit

application and Environmental

Assessment. This notice advises the

public that the revised Plan,

Implementation Agreement and

Environmental Assessment, and the

Agreement are available for review and

comment. All comments received,

including names and addresses, will

become part of the administrative record

and may be made available to the

public. This notice is provided pursuant

to section 10(c) of the Act and National

Environmental Policy Act regulations

(40 CFR 1506.6).

DATES: Written comments on the permit

application and Environmental

Assessment should be received on or

before June 23, 1998.

ADDRESSES: Comments regarding the

permit application, Plan, Agreement, or

Environmental Assessment, or requests

for these documents, should be

addressed to Brooks Harper, Field

Supervisor, Fish and Wildlife Service,

P.O. Box 50088, Honolulu, Hawaii

96850; Fax (808) 541–3470. Please refer

to permit number PRT–824821 when

submitting comments.

FOR FURTHER INFORMATION CONTACT:

Brooks Harper or Gina Shultz, Pacific

Islands Fish and Wildlife Office,

telephone (808) 541–3441.

SUPPLEMENTARY INFORMATION: Section 9

of the Act prohibits the ‘‘taking’’ of a

species listed as threatened or

endangered. However, the Service,

under limited circumstances, may issue

permits to take listed species incidental

to, and not the purpose of, otherwise

lawful activities. Regulations governing

permits for threatened species are

promulgated in 50 CFR 17.32;

regulations governing permits for

endangered species are promulgated in

50 CFR 17.22.

Background

The Applicants propose to construct a

36-hole golf course and resort on the

southeastern part of Saipan,

Commonwealth of the Northern Mariana

Islands. The Applicants seek coverage

for impacts to 814 acres that contain

nightingale reed-warbler and

Micronesian megapode habitat. To

compensate for project impacts, the

Applicants will: (1) Minimize on-site

impacts and maintain habitat on-site for

10 pairs of nightingale reed-warblers,

and (2) develop a Mitigation Bank and

purchase 24 nightingale reed-warbler

credits from the Mitigation Bank.

Purchase of 24 credits from the

Mitigation Bank will result in the

permanent protection of 24 existing

nightingale reed-warbler territories and

permanent protection and enhancement

of habitat to establish an additional 24

territories. Other measures are specified

in the Plan to minimize potential for

take during construction activities.

The Environmental Assessment

considers the environmental

consequences of three alternatives.

Alternative 3, the proposed action,

consists of the issuance of an incidental

take permit, development of the

Mitigation Bank, and implementation of

the Plan and its implementation

Agreement. This alternative is preferred

because: (1) It satisfies the purpose and

needs of the Service and Applicants; (2)

impacts are minimized during

construction; and (3) incidental take is