65214 Federal Register / Vol. 66, No. 243 / Tuesday, December 18, 2001 / Notices

Rockville, MD 20857, 301–827–7001, email: SomersK@cder.fda.gov, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12542.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss

supplemental new drug application

(NDA) 21–386, ZOMETA (zoledronic

acid for injection), Novartis

Pharmaceuticals Corp., indicated for the

treatment of bone metastases in patients

with multiple myeloma, breast cancer,

prostate cancer and other solid tumors.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by January 24, 2002. Oral

presentations from the public will be

scheduled between approximately 8:45

a.m. and 9:45 a.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before January 24, 2002, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

After the scientific presentations, a 30-

minute open public session may be

conducted for interested persons who

have submitted their request to speak by

January 24, 2002, to address issues

specific to the topic before the

committee.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: December 10, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–31025 Filed 12–17–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0503]

Draft Compliance Policy Guide: ‘‘Filth

from Insects, Rodents, and Other

Pests in Food;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft compliance policy

guide (CPG) currently entitled ‘‘Filth

from Insects, Rodents, and Other Pests

in Food.’’ The purpose of this draft CPG

is to revise, clarify, and redefine existing

guidance on the interpretation of filth in

foods within the context of current

science. The draft CPG will provide

written guidance to FDA components as

well as to the industry.

DATES: Submit written or electronic

comments on this draft CPG by February

19, 2002.

ADDRESSES: Submit written requests for

single copies of the draft CPG ‘‘Filth

from Insects, Rodents, and Other Pests

in Food’’ to the Director, Division of

Compliance Policy (HFC–230), Office of

Enforcement, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that

office in processing your request, or

FAX your request to 301–827–0482. See

the SUPPLEMENTARY INFORMATION section

for electronic access to the document.

Submit written comments on the draft

CPG to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Submit

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Technical Questions Concerning Filth

in Foods: Alan R. Olsen,

Microanalytical Branch (HFS–315),

Office of Plant, Dairy Foods, and

Beverages, Center for Food Safety

and Applied Nutrition, Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–

4438, FAX 202–205–4091.

Questions Concerning Regulatory

Actions: MaryLynn Datoc, Division

of Compliance Policy (HFC–230),

Office of Enforcement, Office of

Regulatory Affairs, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

0413, FAX 301–827–0482.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has developed a draft CPG to

revise, clarify, and redefine existing

guidance on foods that contain filth

from insects, rodents, and other pests to

reflect recent advances in science. The

purpose of this draft CPG is to provide

clear policy to FDA’s field and

headquarters staff with regard to filth

from insects, rodents, and other pests in

foods. It also contains information that

may be useful to the regulated industry

and to the public.

The draft CPG, when finalized, will

supersede the current CPG and

represents the agency’s current thinking

on the subject. 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 an approach satisfies the

requirements of applicable statutes or

regulations.

This level 1 guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115).

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written or electronic comments

on the draft CPG entitled ‘‘Filth from

Insects, Rodents, and Other Pests in

Food.’’ Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments

should be identified with the docket

number found in brackets in the

heading of this document. A copy of the

draft CPG and received comments may

be seen in the Dockets Management

Branch (address above) between 9 a.m.

and 4 p.m., Monday through Friday.

III. Electronic Access

Copies of the draft CPG may also be

downloaded to a personal computer

with access to the Internet. The Office

of Regulatory Affairs home page

includes the draft CPG and may be

accessed at http://www.fda.gov/ora

under ‘‘Compliance References.’’

Dated: December 11, 2001.

Dennis E. Baker,

Associate Commissioner for Regulatory

Affairs.

[FR Doc. 01–31024 Filed 12–17–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by agencies of the U.S.

Government and are available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of

federally-funded research and

development. Foreign patent

applications are filed on selected

inventions to extend market coverage

for companies and may also be available

for licensing.