31224 Federal Register / Vol. 63, No. 109 / Monday, June 8, 1998 / Notices

human subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian or

Alaskan Native, Asian, Black or African

American, Native Hawaiian or Other

Pacific Islander, and Hispanic or Latino.

Applicants shall ensure that women and

racial and ethnic minority populations

are appropriately represented in

applications for research involving

human subjects. Where clear and

compelling rationale exist that inclusion

is not feasible, this situation must be

explained as part of the application. In

conducting the review of applications

for scientific merit, review groups will

evaluate proposed plans for inclusion of

minorities and both sexes as part of the

scientific assessment and assigned

score. This policy does not apply to

research studies when the investigator

cannot control the race, ethnicity and/

or sex of subjects. Further guidance to

this policy is contained in the Federal

Register, Vol. 60, No. 179, Friday,

September 15, 1995, pages 47947–

47951.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (Revised

5/96, OMB Number 0937–0189) must be

submitted to Sharron P. Orum, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers For Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 314,

Mailstop E–18, Atlanta, GA 30305, on or

before July 1, 1998.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date; or

(b) Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be accepted as proof

of timely mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.(a) or

1.(b) above are considered late

applications. Late applications will not

be considered and will be returned to

the applicant.

Where To Obtain Additional

Information

To receive additional written

information, call (888) 472–6874. You

will be asked to leave your name,

address, and telephone number. Please

refer to Announcement 98079. You will

receive a complete program description,

information on application procedures,

and application forms. If you have

questions after reviewing the contents of

all the documents, business

management technical assistance may

be obtained from Sheryl L. Heard,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 314, Mail

Stop E–18, Atlanta, GA 30305,

telephone (404) 842–6802; electronic

mail at slh3@cdc.gov.

Programmatic technical assistance

may be obtained from Sarah Kuester,

MS, RD, Division of Nutrition and

Physical Activity, National Center for

Chronic Disease Prevention and Health

Promotion, Centers for Disease Control

and Prevention (CDC), 4770 Buford

Highway, NE., Mail Stop K–26, Atlanta,

GA 30341–3724, telephone (770) 488–

6019, fax (770) 488–6000, or Internet or

CDC WONDER electronic mail at

sak2@cdc.gov.

You may obtain this announcement

from CDC’s homepage at http://

www.cdc.gov.

Please refer to Program

Announcement 98079 when requesting

information and submitting an

application.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report; Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report;

Stock No. 017–001–00473–1) referenced

in the ‘‘Introduction’’ through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: June 1, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–15122 Filed 6–5–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0362]

Draft Guidance for Industry on Stability

Testing of Drug Substances and Drug

Products; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Stability Testing of

Drug Substances and Drug Products.’’

The draft guidance provides

recommendations regarding the stability

studies that should be performed to

support new drug applications,

abbreviated new drug applications,

investigational new drug applications,

biologics license applications, product

license applications, and supplements

to these applications.

DATES: Written comments on the draft

guidance may be submitted by

September 9, 1998. General comments

on agency guidance documents are

welcome at any time.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm or http://www.fda.gov/cber/

guidelines.htm. Submit written requests

for single copies of the draft guidance

entitled ‘‘Stability Testing of Drug

Substances and Drug Products’’ to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, or to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville MD 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your request.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Kenneth J. Furnkranz, Center for Drug

Evaluation and Research (HFD–

625), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855–2737, 301–

827–5848, or

Rebecca A. Devine, Center for

Biologics Evaluation and Research

(HFM–10), 1401 Rockville Pike,

Rockville, MD 20852, 301–827–

0373.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘Stability

Testing of Drug Substances and Drug

Products.’’ The draft guidance provides

recommendations regarding the stability

studies that should be performed by

pharmaceutical applicants to support

applications submitted to the Center for
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