22236 Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Notices

Sponsor NADA Number Product (Drug) 21 CFR Cite Affected

(Sponsor Drug Labeler Code)

............................................................................. NADA 30–330 Tylocine Sulfa Tablets (sul

fadiazine, sulfamerazine,

sulfamethazine, tylosin).

not applicable

............................................................................. NADA 31–962 Tylan plus Neomycin Eye

Powder (neomycin sulfate, tylosin).

524.2640 (000986)

............................................................................. NADA 40–123 Toptic Ointment

(cephalonium, flumethasone,

iodochlorhydroxyquin, piperocaine hydrochloride, polymyxin B sulfate).

524.321 (000986)

............................................................................. NADA 47–092 Tribodine (ticarbodine) ........ 520.2460a (000986)

............................................................................. NADA 47–353 Ferti-Cept (chorionic

gonadotropin).

522.1081(b) (000986)

............................................................................. NADA 92–602 Cephalothin Discs

(cephaloridine).

529.360 (000986)

............................................................................. NADA 96–678 Tribodine Capsules

(ticarbodine).

520.2460b (000986)

Bioproducts, Inc., 320 Springside Dr., suite 300,

Fairlawn, OH 44333–2435.

NADA 93–518 Tylan 10 Plus (tylosin

phosphate).

558.625(b)(2) (051359)

Young’s Inc., Roaring Spring, PA 16673 ............. NADA 96–162 Hog Grow-R-Mix-4000, Hog

Grow-R-Mix–800 (tylosin phosphate).

558.625(b)(13) (035393)

Veterinary Laboratories, Inc., 12340 Santa Fe

Dr., Lenexa, KS 66215.

NADA 42–889 Oxytocin Injection (oxytocin) 522.1680(b) (000857)

Webel Feeds, Inc., R.R. 3, Pittsfield, IL 62363 ... NADA 116–196 Webel Tylan Premix

(tylosin phosphate).

558.625(b)(73) (035098)

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10), redelegated to the Center

for Veterinary Medicine (21 CFR 5.84),

and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approval of NADAs 12–585, 15–207,

30–330, 31–962, 40–123, 42–889, 47–

092, 47–353, 92–602, 93–518, 96–162,

96–678, and 116–196, and all

supplements and amendments thereto,

is hereby withdrawn, effective May 14,

2001.

In a final rule published elsewhere in

this issue of the Federal Register, FDA

is amending the animal drug regulations

by removing those portions that reflect

approval of the NADAs.

Dated: April 23, 2001.

Linda Tollefson,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 01–11071 Filed 5–2–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Single Source Cooperative Agreement

to Support the National Center for

Natural Products Research (NCNPR),

University of Mississippi

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

intention to accept and consider a single

source application for the award of a

cooperative agreement to the University

of Mississippi (UM) to support the

National Center for Natural Products

Research (NCNPR), which is located on

UM’s Campus at Oxford, MS. FDA

anticipates providing up to $1 million

in fiscal year 2001 (direct and indirect

costs) for this project, with an additional

4 years of funding up to $1 million per

year predicated upon acceptable

performance and the availability of

future fiscal year funding. These

collaborations will support and benefit

the public health by promoting more

efficient development and

dissemination of natural products

research and science and will

complement the diverse activities of

both the public and private sector that

may become collaborators.

DATES: Submit applications by June 18,

2001.

ADDRESSES: An application is available

from, and should be submitted to

Rosemary Springer, Grants Management

Specialist, Division of Contracts and

Procurement Management (HFA–520),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–7182, e-mail:

rspringe@oc.fda.gov. Applications handcarried or commercially delivered

should be addressed to rm. 2129, 5630

Fishers Lane, Rockville, MD 20857.

Application forms can also be found at

http://www.nih.gov/grants/funding/

phs398/formsltoc.html.

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and

financial management aspects of this

notice: Rosemary Springer (address

above).

Regarding the programmatic aspects:

Jeanne I. Rader, Center for Food Safety

and Applied Nutrition (HFS–840), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–5375,

e-mail: JRader@CFSAN.fda.gov.

SUPPLEMENTARY INFORMATION: FDA is

announcing its intention to accept and

consider a single source application

from UM for a cooperative agreement to

support NCNPR. FDA’s authority to

enter into grants and cooperative

agreements is detailed under section

301 of the Public Health Service Act (42

U.S.C. 241). FDA’s research program is

described in the Catalog of Federal

Domestic Assistance at 93.103. Before

entering into cooperative agreements,

FDA carefully considers the benefits

such agreements will provide to the

public.

The Public Health Service (PHS)

strongly encourages all award recipients

to provide a smoke-free work place and

to discourage the use of all tobacco

products. This is consistent with the

PHS mission to protect and advance the

physical and mental health of the

American people.

FDA is committed to achieving the

health promotion and disease

prevention objectives of Healthy People

2010, a national activity to reduce

morbidity and mortality and to improve

the quality of life. Applicants may

obtain a hard copy of Healthy People

2010 objectives, volumes I and II,

Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Notices 22237

conference edition (B0074) for $22 per

set, by writing to the Office of Disease

Prevention and Health Promotion

(ODPHP) Communication Support

Center, P.O. Box 37366, Washington, DC

20013–7366. Each of the 28 chapters of

Healthy People 2010 is priced at $2 per

copy. Telephone orders can be placed to

the ODPHP Center on 301–468–5690.

The ODPHP Center also sells the

complete conference edition in CD–

ROM format (B0071) for $5. This

publication is available as well on the

Internet at www.health.gov/

healthypeople/. Web site viewers

should proceed to ‘‘Publications.’’

I. Background

Congress amended the Federal Food,

Drug, and Cosmetic Act (the act) with

the passage of the Dietary Supplement

Health and Education Act of 1994, to

create a regulatory framework for

dietary supplements under food

provisions of the act. FDA has primary

responsibility for ensuring that

appropriate regulatory actions are taken

against marketed products that: (a)

Present an unreasonable or significant

risk of illness or injury when used

according to label directions or under

ordinary conditions of use, or (b) bear

labeling that is false or misleading.

The ability to identify and analyze

specific components in ingredients,

including botanical ingredients, and in

finished products is an essential

component of research and regulatory

programs directed at ensuring that

dietary supplements are safe and that

their labeling is truthful and not

misleading. The availability of

authenticated reference materials is an

essential prerequisite to the accurate

identification and quantitative analysis

of ingredients or finished products. For

many botanical ingredients currently

used in marketed dietary supplement

products, however, appropriate

reference materials are not readily

available, their authenticity is not well

documented, and their compositional

characteristics are not adequately

defined and evaluated for biological

effects.

The use of botanical products in

dietary supplements in the U.S. has

increased significantly in recent years.

The newness of the regulatory

approaches and marketed uses of these

products has created a critical need for

bringing sound science to a number of

issues that are necessary to ensure that

marketed products are safe and their

labeling is truthful and not misleading.

Therefore, it is essential that general

principles and criteria for ensuring

scientific validity in manufacturing of

botanical products and the use of

botanical ingredients in dietary

supplements be developed through

scientific discussion and consensusbuilding. Such general principles and

criteria will be applicable not only to

FDA regulatory and research activities,

but will also promote consistency and

scientific rigor with respect to research

and standard-setting activities

performed by other organizations and

agencies, and will assist in the

development of quality control practices

by industry.

II. Goals and Objectives

A. Concept

FDA believes that cooperative

research with the UM–NCNPR will

provide opportunities to address

important national and international

problems in natural products research

in a timely manner. However, only FDA

employees will perform any official

regulatory activities. Further, FDA

believes that cooperative research

through UM will promote the efficient

use of the complementary resources of

both parties.

The applicant would propose to

design, implement, and evaluate a

comprehensive, multidisciplinary array

of scientific activities in the broad area

of natural products’ ingredients. The

applicant’s proposal must be designed

to meet the objectives of the request for

applications (RFA). The applicant’s

proposal should identify and assess

innovative approaches to address the

RFA objectives relative to the broad area

of natural product identification and

safety.

The purpose of this cooperative

agreement would be to:

• Coordinate scientific workshops and

conferences on relevant topics of public

interest to address high priority science

and research needs;

• Obtain and characterize

authenticated reference materials for

botanicals;

• Develop literature reviews on

relevant topics; and

• Share technical information and

scientific concepts.

B. Project Emphasis

The purpose is to augment and

enhance research and scientific

expertise in natural products research.

There is a critical need to address the

increasingly complex problems in such

areas as acquisition, validation, and

characterization of botanical reference

materials, related research and literature

reviews to ensure the safety or

effectiveness of marketed products, and

the development of sound scientific

principles and consensus-building for

dealing with these ingredients and

products. Since there is increased

concern regarding the safety of dietary

supplements, the need to find other

ways of expanding the current science

base is essential.

The sharing of complementary

resources will create opportunities for

important national and international

issues in natural products research to be

addressed in a timely and scientifically

sound manner. Many of these issues

(e.g., development and characterization

of authenticated botanical reference

standards, and scientific review and

consensus-building) can only be

addressed with close cooperation of the

public and private sectors. UM’s

expertise and facilities for obtaining and

characterizing authenticated botanical

reference materials are needed to

conduct investigations at the forefront of

natural products research. Additionally,

UM’s experimental field plots, vast

repository containing thousands of

natural products extracts for testing in a

variety of biological assays, and their

expertise and long history of active

scientific investigations are well known

in these areas. University personnel will

provide enhanced scientific expertise in

advanced techniques for the

characterization of natural products as

well as expand the current capabilities

in research to support regulatory actions

and respond to emergency situations.

C. Summary

FDA believes that research conducted

at the UM is a sound investment in the

future public health of American

consumers. It provides an opportunity

for extensive cooperation with

university scientists; and it will

stimulate collaborative efforts to ensure

a safe food supply contributing

significantly to the implementation of

the goals for government, academia,

industry, and consumers to work

together to improve the safety of natural

products. The UM scientists would

bring a special perspective to advancing

the knowledge of natural products

germane to the public interest.

Interaction among those scientists will

stimulate creativity and innovation.

FDA’s participation in this venture will

promote a greater awareness and

understanding of regulatory science and

practice among academic scientists,

thereby providing economic and

program benefits to both. In summary,

collaboration between the public and

the private sector provides an efficient

means of remaining current with

scientific and technical

accomplishments in the areas of natural

products research.

22238 Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Notices

III. Mechanism of Support

A. Award Instrument

Support for this program, if awarded,

will be in the form of a cooperative

agreement. The award will be subject to

all policies and requirements that

govern the research grant programs of

the PHS, including the provisions of 42

CFR part 52, 45 CFR parts 74 and 92,

and PHS’s grants policy statement. The

regulations issued under Executive

Order 12372 do not apply.

B. Length of Support

The length of support will be for 1

year with the possibility of an

additional 4 years of noncompetitive

support. Continuation, beyond the first

year, will be based upon performance

during the preceding year and the

availability of Federal fiscal year

appropriations. The National Institutes

of Health (NIH) modular grant program

does not apply to this FDA program.

IV. Reasons for Single Source Selection

Competition is limited to UM

because: (1) FDA’s appropriations

language has included funds for

collaborative research on dietary

supplements between UM–NCNPR and

FDA; and (2) UM has been determined

to be the only institution with the

unique capability of providing a broad

range of highly relevant scientific

expertise and facilities that are

physically co-located and singularly

dedicated to natural products research.

FDA believes that there is compelling

evidence that UM is uniquely qualified

to fulfill the objectives of the proposed

cooperative agreement. UM is a

comprehensive research institution with

numerous academic programs relevant

to natural products which can help to

ensure that market products are safe for

the American public. The UM School of

Pharmacy has been in existence for 90

years and has an outstanding 30-year

track record for isolating and developing

prospective new pharmaceuticals from

plants and microorganisms.

NCNPR, which opened in July 1999,

is a division of the Research Institute of

Pharmaceutical Sciences of the UM’s

School of Pharmacy. NCNPR was

created to bring together an alliance of

academia, government, and the

pharmaceutical and agrochemical

industries to integrate research,

development, and commercialization of

potentially useful natural products. The

facility is the nation’s only universityaffiliated research center devoted to

improving human health and

agricultural productivity through the

discovery, development, and

commercialization of pharmaceuticals

and agrochemicals derived from natural

products. The goal of NCNPR in

botanical dietary supplements is to

enable safe, effective, and proper use of

high quality botanical products by

informed professionals and consumers.

NCNPR conducts basic and applied

multidisciplinary research to discover

and develop natural products for use as

pharmaceuticals, dietary supplements

and agrochemicals. NCNPR also

maintains a repository of several

thousand natural product extracts that

are available for screening by

collaborators working in other areas.

NCNPR has substantial expertise to

carry forward specific discoveries,

products, and technologies. Most of the

projects to develop promising high

priority products or technology are

conducted in collaboration with

industrial partners or through externally

funded grants and contract. NCNPR is

staffed with a highly synergistic mix of

full-time research faculty and support

staff and employs a number of

undergraduate and graduate students

and postdoctoral scientists.

Additionally, the USDA’s National

Products Utilization Research Unit is

co-housed and programmatically

integrated with the NCNPR thus

expanding the available expertise and

facilities. Together, the faculty,

scientists, staff, students, USDA

scientists, and external collaborators,

provide the human resources required

to accomplish the research and

development goals of the RFA.

Additionally, FDA’s appropriations

language includes funds for

collaborative research on dietary

supplements between NCNPR and FDA.

NCNPR has the unique capability to

bring together diverse scientific

expertise on bioactive natural products

research from: (a) The UM faculty in the

School of Pharmacy involving

researchers in the Departments of

Pharmacognosy, Medicinal Chemistry,

Pharmaceutics, Pharmacology, and the

Research Institute of Pharmaceutical

Sciences; (b) research scientists in the

U.S. Department of Agriculture/

Agricultural Research Service’s (USDA/

ARS) National Products Utilization

Research Unit who are physically cohoused and programmatically integrated

in the NCNPR; and (c) its close

academic links and historical

collaborations with agricultural and

botanical programs and facilities at the

UM system. UM–NCNPR’s ability to

successfully and uniquely collaborate

with FDA is also enhanced by its a

repository of several thousand natural

product extracts; and its long history of

successful basic and applied

multidisciplinary research to discover

and develop natural products for use as

bioactive ingredients in dietary

supplements and pharmaceuticals, and

for improving the quality and safety of

dietary supplements. Finally, the large

number of established collaborations

among NCNPR scientists and other

government agencies, academic

organizations, and research institutions

will also be useful in enhancing the

collaborative efforts with FDA. These

collaborations will support and benefit

the public health by promoting more

efficient development and

dissemination of natural products

research and science and will

complement the diverse activities of

both the public and private sector that

may become collaborators.

Research in NCNPR is focused on

using state-of-the-art knowledge and

technology to discover bioactive natural

products, develop novel technologies or

processes that facilitate the discovery of

bioactive natural products, and provide

research-based information on plant

derived products with health

applications. These programs, facilities,

and expertise are essential for

supporting the needs to ensure that

sound science is available for ensuring

the safety and truthfulness of labeling of

marketed dietary supplement products.

Collaboration between the public and

private sector is an efficient means for

both FDA and UM to remain current

with scientific and technical

accomplishments from a natural

products research perspective.

Harmonizing regulatory activities is but

one example of the need for and use of

this natural products research

knowledge and expertise. The

partnership between FDA and UM will

provide both the technical and

educational expertise necessary for

effective mechanisms that will facilitate

the movement of new technology and

provide direct usefulness to the public

health.

V. Reporting Requirements

An annual financial status report

(FSR) (SF–269) is required. The original

and two copies of this report must be

submitted to FDA’s Grants Management

Officer within 90 days of the budget

expiration date of the grant. Failure to

file the FSR in a timely fashion will be

grounds for suspension or termination

of the grant.

An annual program progress report is

also required. The noncompeting

continuation application (PHS 2590)

will be considered the annual program

progress report. The progress report

must include a description of the

progress and accomplishments for each

objective stated in the RFA.

Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Notices 22239

A final program progress report, FSR

(SF–269), and invention statement must

be submitted within 90 days after the

expiration of the project period as noted

on the notice of grant award.

VI. Delineation of Substantive

Involvement

Substantive involvement by the

awarding agency is inherent in the

cooperative agreement award.

Accordingly, FDA will have substantial

involvement in the program activities of

the project funded by the cooperative

agreement. Substantive involvement

includes, but is not limited to, the

following:

1. FDA will work closely with the

grantee and have final approval on all

project activities. This could include

management structure for the program,

development of plans and strategies for

key scientific approaches and projects,

and for identifying and carrying out the

research.

2. FDA will participate in all

functions directly related to the

guidance and development of the

program.

3. FDA will provide technical

monitoring and/or direction of the work,

including monitoring of data analysis,

interpretation of analytical findings and

their significance.

4. FDA will assist and approve (as

deemed appropriate) the substance of

publications, co-authorship of

publications and data release.

5. FDA will have final approval on

any re-directions proposed during the

course of the project.

VII. Review Procedures

A. Review Method

The application submitted in

response to this RFA will first be

reviewed by grants management and

program staff for responsiveness. The

application will be considered

nonresponsive if it is not in compliance

with this document. If an application is

found to be nonresponsive it will be

returned to the applicant without

further consideration. An application is

considered nonresponsive for the

following reasons: (1) The applicant

organization is ineligible; (2) it is

received after the specified receipt date;

(3) it is incomplete; (4) it is illegible; (5)

it is not responsive to the RFA; (6) the

material presented is insufficient to

permit an adequate review; and/or (7) it

exceeds the recommended threshold

amount reflected in the RFA.

A responsive application will be

reviewed and evaluated for scientific

and technical merit by an ad hoc panel

of experts in the subject field. A

responsive application will also be

subject to a second level of review by a

National Advisory Council for

concurrence with the recommendations

made by the first level reviewers. The

Commissioner of FDA or his/her

designee will make final funding

decisions.

B. Review Criteria

1. Responsiveness to RFA

The application must demonstrate

that the objectives and goals of the RFA

are understood and the applicant shall

offer a logical program to meet the

objectives of the RFA.

2. Adequacy of Plan

The applicant must provide a detailed

plan to establish a collaborative natural

products research program as a

multidisciplinary effort (i.e., FDA and

academia). The application will be

evaluated on the thoroughness of the

plan, the reasonableness of the

approach, and adherence to the concept

and its objectives, as stated in the RFA.

The detailed plan must form the basis

of a balanced natural products research

program directed toward development

of skills and expertise in aspects of

natural products research, as stated in

the RFA. Included will be development

of: Scientific expertise in natural

products research involving researchers

in pharmacognosy, medicinal

chemistry, pharmacology, and

pharmaceutical sciences; state of the art

knowledge and technology to discover

bioactive natural products; novel

technologies or processes that facilitate

the discovery of bioactive natural

products; and research-based

information on potential health

applications of plant derived products.

The plan must also include a schedule

for accomplishing the objectives

outlined above.

3. Timeliness of Program

Implementation

The application will be evaluated for

the applicant’s ability to establish

natural products research in an

expeditious manner.

4. Adequacy and availability of research

facilities

The application must demonstrate

that the applicant has adequate research

facilities in the areas of:

Pharmacognosy, medicinal chemistry,

pharmacology, and pharmaceutical

sciences, as stated in the RFA.

5. Ability to Conduct Proprietary

Research

The application shall demonstrate the

applicant’s ability to conduct

proprietary research and to protect

confidentiality of data, procedures, etc.

6. Staff Experience and Capabilities

The application must demonstrate the

availability of core staff with the

experience and capability to conduct

research as described in the detailed

plan presented in item 2 above. The

staff must have the capability to deal

with natural products research as well

as plan long-range research to assess

future needs. The availability of

sufficient administrative and support

personnel to meet the RFA objectives

must also be demonstrated.

7. Reasonableness of proposed budget

The application is evaluated on the

bases of the reasonableness of costs.

VIII. Submission Requirements

The original and two copies of the

completed grant application form PHS

398 (Rev. 4/98), with appendices for

each of the copies, should be delivered

to Rosemary Springer (address above).

The application receipt date is June 18,

2001. No supplemental or addendum

material will be accepted after the

receipt date. The outside of the mailing

package and item 2 of the application

face page should be labeled: ‘‘Response

to RFA–FDA–CFSAN–2001–2.’’

IX. Method of Application

A. Submission Instructions

Applications will be accepted during

normal business hours, 8 a.m. to 4:30

pm., Monday through Friday, on or

before the established receipt date.

Applications will be considered

received on time if sent or mailed on or

before the receipt date as evidenced by

a legible U.S. Postal Service dated

postmark or a legible date receipt from

a commercial carrier, unless they arrive

too late for orderly processing. Private

metered postmarks shall not be

acceptable as proof of timely mailing.

Applications not received on time will

not be considered for review and will be

returned to the applicant. (Applicants

should note that the U.S. Postal Service

does not uniformly provide dated

postmarks. Before relying on this

method, applicants should check with

their local post office.) Do not send

applications to the Center for Scientific

Research (CSR), NIH. Any application

that is sent to NIH, that is then

forwarded to FDA and not received in

time for orderly processing, will be

deemed nonresponsive and returned to

the applicant. Applications must be

submitted via mail delivery as stated

above. FDA is unable to receive

applications electronically. Instructions

for completing the application form can

22240 Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Notices

be found on the following Web site:

http://www.nih.gov/grants/funding/

phs398/phs398.html. The forms can be

found at http://www.nih.gov/grants/

funding/phs398/formsltoc.html.

Applicants are advised that FDA does

not adhere to the page limitations or the

type size and line spacing requirements

imposed by NIH on its applications.

B. Format for Application

Submission of the application must be

on Grant Application Form PHS 398

(Rev. 4/98). All ‘‘General Instructions’’

and ‘‘Specific Instructions’’ in the

application kit should be followed with

the exception of the receipt dates and

mailing label address. The face page of

the application should reflect the

request for applications number RFA–

FDA–CFSAN–2001–2.

Data included in the application, if

restricted with the legend specified

below, may be entitled to confidential

treatment as trade secret or confidential

commercial information within the

meaning of the Freedom of Information

Act (5 U.S.C. 552(b)(4)) and FDA’s

implementing regulations (21 CFR

20.61).

Information collection requirements

requested on Form PHS 398 and the

instructions have been submitted by

PHS to the Office of Management and

Budget (OMB) and were approved and

assigned OMB control number 0925–

0001.

C. Legend

Unless disclosure is required by the

Freedom of Information Act as amended

(5 U.S.C. 552) as determined by the

freedom of information officials of

DHHS or by a court, data contained in

the portions of this application that

have been specifically identified by

page number, paragraph, etc., by the

applicant as containing restricted

information shall not be used or

disclosed except for evaluation

purposes.

Dated: April 30, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11159 Filed 5–2–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Anesthetic and Life Support Drugs

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). The

meeting will be open to the public.

Name of Committee: Anesthetic and Life

Support Drugs Advisory Committee.

General Function of the Committee: To

provide advice and recommendations to the

agency on FDA’s regulatory issues.

Date and Time: The meeting will be held

on June 14 and 15, 2001, 8 a.m. to 5 p.m.

Location: Holiday Inn, The Ballroom, Two

Montgomery Village Ave., Gaithersburg, MD.

Contact: Kimberly Topper, Center for Drug

Evaluation and Research (HFD–21), Food and

Drug Administration, 5600 Fishers Lane,

Rockville MD 20857, 301–827–7001, e-mail:

topperk@cder.fda.gov, FAX 301–827–6801,

or FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12529. Please

call the Information Line for up-to-date

information on this meeting.

Agenda: On both days the committee will

discuss the medical use of opiate analgesics

in various patient populations, including

pediatric patients and patients with chronic

pain of nonmalignant etiology, as well as the

risk to benefit ratio of extending opiate

treatment into these populations. It will also

address concerns regarding the abuse

potential, diversion and increasing incidence

of addiction to opiate analgesics, especially

to the modified release opiate analgesics.

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 June 7, 2001.

Oral presentation from the public will be

scheduled between approximately 1 p.m. and

2 p.m each day. Time allotted for each

presentation may be limited. Those desiring

to make formal oral presentations should

notify the contact person before June 7, 2001,

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.

Background material from FDA will be

posted 24 hours before the meeting at the

Anesthetic and Life Support Drugs Advisory

Committee docket site at http://

www.fda.gov/ohrms/dockets/ac/

acmenu.htm. (Click on the year 2001 and

scroll down to Anesthetic and Life Support

Drugs meetings.) This is the same Web site

where you can find the minutes, transcript,

and slides from the meeting. This material is

generally posted about 3 weeks after the

meeting.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: April 27, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–11157 Filed 4–30–01; 4:16 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0184]

Compliance Policy Guide: ‘‘Statement

of Policy for Labeling and Preventing

Cross-Contact of Common Food

Allergens;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a compliance policy

guide (CPG) entitled ‘‘Statement of

Policy for Labeling and Preventing

Cross-Contact of Common Food

Allergens.’’ This CPG is intended to set

forth FDA’s internal enforcement

priorities concerning undeclared food

allergens.

DATES: Submit written comments on

this CPG at any time.

ADDRESSES: Submit written requests for

single copies of the CPG entitled

‘‘Statement of Policy for Labeling and

Preventing Cross-Contact of Common

Food Allergens’’ to the Director,

Division of Compliance Policy (HFC–

230), Office of Enforcement, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send two

self-addressed 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 CPG

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Technical questions concerning

allergens in foods: Kathy Gombas,

Office of Field Programs (HFS–615),

Center for Food Safety and Applied

Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–

4231, FAX 202–260–0136.

Questions concerning regulatory

actions: MaryLynn Datoc, Office of

Enforcement (HFC–230), 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 CPG on FDA’s

internal enforcement process

concerning undeclared allergens in