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

Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Notices 22241

foods. The purpose of this CPG is to

provide clear policy and regulatory

guidance to FDA’s field and

headquarters staff. It also contains

information that may be useful to the

regulated industry and to the public.

FDA is issuing this CPG as Level 1

guidance consistent with FDA’s good

guidance practices regulation (21 CFR

10.115; 65 FR 56468, September 19,

2000). The guidance 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. The guidance

is intended to further FDA’s efforts to

prevent potential serious allergic

reactions in sensitive individuals

resulting from undeclared allergens in

foods. FDA is making this guidance

document effective immediately

because public participation prior to its

implementation is not appropriate in

these circumstances (21 CFR

10.115(g)(2); 65 FR 56478). Although the

guidance document announced in this

notice is being implemented

immediately, FDA is requesting

comments on the guidance. FDA will

review all comments received, revise

the guidance in response to the

comments as appropriate, and publish a

notice of availability if the guidance is

revised.

II. Comments

Interested persons may, at any time,

submit written comments on the CPG

entitled ‘‘Statement of Policy for

Labeling and Preventing Cross-Contact

of Common Food Allergens,’’ 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. A copy of the

CPG and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

III. Electronic Access

Copies of the CPG may also be

downloaded to a personal computer

with access to the Internet. The Office

of Regulatory Affairs (ORA) home page

includes the CPG and may be accessed

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

‘‘Compliance References.’’

Dated: April 27, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–11072 Filed 5–2–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0202]

Medical Devices: Draft ‘‘The Least

Burdensome Provisions of the FDA

Modernization Act of 1997: Concept

and Principles;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘The Least Burdensome

Provisions of the FDA Modernization

Act of 1997: Concept and Principles.’’ In

this draft guidance, FDA sets forth its

interpretation of the provisions of the

Food and Drug Administration

Modernization Act of 1997 (FDAMA)

that require FDA to take into account

the least burdensome means for

applicants to demonstrate a device’s

effectiveness or substantial equivalence.

This guidance is neither final nor is it

in effect at this time.

DATES: Submit written comments on

this draft guidance by August 1, 2001.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

draft guidance document entitled ‘‘The

Least Burdensome Provisions of the

FDA Modernization Act of 1997:

Concept and Principles’’ to the Division

of Small Manufacturers Assistance

(HFZ–220), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. Submit

written comments on this draft guidance

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

should be identified with the docket

number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT:

Joanne R. Less, Center for Devices and

Radiological Health (HFZ–403), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Background

A central purpose of FDAMA was to

ensure the timely availability of safe and

effective new products that would

benefit the American public. While

Congress wanted to reduce unnecessary

burdens associated with the premarket

clearance and approval processes,

Congress did not intend to lower the

statutory thresholds for substantial

equivalence or reasonable assurance of

safety and effectiveness. To help

achieve this goal, Congress added

section 513(a)(3)(D)(ii) and (i)(1)(D) to

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 360c).

These two paragraphs (a)(3)(D)(ii) and

(i)(1)(D) of section 513 of the law

contain what are commonly referred to

as the ‘‘least burdensome provisions’’ of

the act. During the last year, FDA has

been working with the Least

Burdensome Industry Task Force to

develop an interpretation of the least

burdensome provisions that would

accurately capture Congress’ intent and

that could be implemented consistently

by FDA and industry. This draft

guidance, in addition to the other

guidances developed by the agency, is a

part of that process. As presented in this

draft guidance, FDA has chosen to apply

the least burdensome concept beyond

the two statutory provisions in which

the language actually appears. FDA

considers the least burdensome concept

to be one that could affect almost all

premarket regulatory activities,

including presubmission meetings with

industry, premarket submissions, and

the development of guidance documents

and regulations.

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on the least burdensome provisions of

the act. 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 applicable

statutes and regulations.

The agency has adopted good

guidance practices (GGPs), and

published the final rule, which set forth

the agency’s regulations for the

development, issuance, and use of

guidance documents (21 CFR 10.115; 65

FR 56468, September 19, 2000). This

draft guidance document is issued as a

Level 1 guidance in accordance with the

GGP regulations.

III. Electronic Access

In order to receive ‘‘The Least

Burdensome Provisions of the FDA

Modernization Act of 1997: Concept and

Principles’’ via your fax machine, call

the CDRH Facts-On-Demand system at

800–899–0381 or 301–827–0111 from a

touch-tone telephone. Press 1 to enter