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

22242 Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Notices

the system. At the second voice prompt

press 1 to order a document. Enter the

document number (1332) followed by

the pound sign (#). Follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

using the Internet. CDRH maintains an

entry on the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with Internet access.

Updated on a regular basis, the CDRH

home page includes the civil money

penalty guidance documents package,

device safety alerts, Federal Register

reprints, information on premarket

submissions (including lists of approved

applications and manufacturers’

addresses), small manufacturers’

assistance, information on video

conferencing and electronic

submissions, Mammography Matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. Guidance

documents are also available on the

Dockets Management Branch Web site at

http://www.fda.gov/ohrms/ dockets/

default.htm.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

draft guidance by August 1, 2001.

Submit two copies of any comments,

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 guidance document and

received comments may be seen in the

Dockets Management Branch between 9

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

Friday.

Dated: April 30, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11231 Filed 5–1–01; 12:40 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–116]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Clinical

Laboratory Improvement Amendments

(CLIA) Application Form and

Supporting Regulations in 42 CFR

493.1—.2001; Form No.: HCFA–116

(OMB# 0938–0581); Use: Certification

requirements have been established for

any entity that performs testing on

human beings for diagnostic or

treatment purposes. Laboratories must

apply for and obtain a certificate in

order to perform this testing; Frequency:

Biennially; Affected Public: Business or

other for profit, Not for profit

institutions, Federal Government, and

State, local or tribal government;

Number of Respondents: 16,000; Total

Annual Responses: 16,000; Total

Annual Hours: 20,000.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, Room N2–14–

26, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: April 23, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Standards and

Support Group, Division of HCFA Enterprise

Standards.

[FR Doc. 01–11044 Filed 5–2–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–18]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Extension of a curently

approved collection; Title of

Information Collection Application for

Hospital Insurance in 42 CFR 406.7;

Form No.: HCFA–18 (OMB# 0938–

0251); Use: The HCFA–18F5 is used to

establish entitlement to hospital

insurance and supplementary medical

insurance for beneficiaries entitled

under title XVIII of the Social Security

Act; Frequency: On occasion; Affected

Public: Individuals or households;

Number of Respondents: 50,000; Total

Annual Responses: 50,000; Total

Annual Hours: 12,500.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone