26866 Federal Register / Vol. 66, No. 94 / Tuesday, May 15, 2001 / Notices

participants in the United States will address

the implications of the findings and

conclusions of this report in the context of

domestic research.

3. In the United States, committees that

review the ethics of human research

protocols are referred to in regulation and

practice as Institutional Review Boards

(IRBs). In other countries, different names

might be used, such as research ethics

committees or ethics review committees. In

this report, references and recommendations

that are specific to the United States will

refer to these committees as IRBs. References

and recommendations that refer to such

committees generally regardless of their

geographic location will call them ethics

review committees.

4. Although these protections are generally

meant to apply to all research involving more

than minimal risk, there are exceptions in

certain guidelines for informed consent to be

waived in research involving minimal risk.

FOR FURTHER INFORMATION ABOUT THE

REPORT CONTACT: Eric M. Meslin, Ph.D.,

Executive Director, National Bioethics

Advisory Commission, or to obtain

copies of the report contact the NBAC

office at 6705 Rockledge Drive, Suite

700, Bethesda, Maryland 20892–7979,

telephone number (301) 402–4242, fax

number (301) 480–6900. Copies may

also be obtained through the NBAC

website: www.bioethics.gov.

Dated: May 9, 2001.

Eric M. Meslin,

Executive Director, National Bioethics

Advisory Commission.

[FR Doc. 01–12142 Filed 5–14–01; 8:45 am]

BILLING CODE 4167–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E–1413]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Xenical

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for Xenical

and is publishing this notice of that

determination as required by law. FDA

has made the determination because of

the submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent that claims

that human drug product.

ADDRESSES: Submit written comments

and petitions to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Regulatory Policy

Staff (HFD–007), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–5645.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and

Patent Term Restoration Act (Public

Law 100–670) generally provide that a

patent may be extended for a period of

up to 5 years so long as the patented

item (human drug product, animal drug

product, medical device, food additive,

or color additive) was subject to

regulatory review by FDA before the

item was marketed. Under these acts, a

product’s regulatory review period

forms the basis for determining the

amount of extension an applicant may

receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted, as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product Xenical

(orlistat). Xenical is a lipase inhibitor

indicated for obesity management that

acts by inhibiting the absorption of

dietary fats. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for Xenical (U.S. Patent No.

4,598,089) from HLR Technology

Corporation, and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated August 7, 2000, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of Xenical

represented the first permitted

commercial marketing or use of the

product. Shortly thereafter, the Patent

and Trademark Office requested that

FDA determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

Xenical is 3,969 days. Of this time,

3,091 days occurred during the testing

phase of the regulatory review period,

while 878 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

355) became effective: June 12, 1988.

The applicant claims June 24, 1988, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was June 12, 1988,

which was 30 days after FDA receipt of

the IND.

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: November 27, 1996. The

applicant claims November 26, 1996, as

the date the new drug application

(NDA) for Xenical (NDA 20–766) was

initially submitted. However, FDA

records indicate that NDA 20–766 was

submitted on November 27, 1996.

3. The date the application was

approved: April 23, 1999. FDA has

verified the applicant’s claim that NDA

20–766 was approved on April 23, 1999.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,824 days of patent

term extension.

Anyone with knowledge that any of

the dates as published are incorrect may

submit to the Dockets Management

Branch (address above) written

comments and ask for a redetermination

by July 16, 2001. Furthermore, any

interested person may petition FDA for

a determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period by November 15, 2001. To meet

its burden, the petition must contain

sufficient facts to merit an FDA

investigation. (See H. Rept. 857, part 1,

98th Cong., 2d sess., pp. 41–42, 1984.)

Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch. Three copies of any information

Federal Register / Vol. 66, No. 94 / Tuesday, May 15, 2001 / Notices 26867

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. Comments

and petitions may be seen in the

Dockets Management Branch between 9

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

Friday.

Dated: March 7, 2001.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug

Evaluation and Research.

[FR Doc. 01–12093 Filed 5–14–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0192]

Draft Guidance for Industry on Forms

for Registration of Producers of Drugs

and Listing of Drugs in Commercial

Distribution; 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 ‘‘Forms for

Registration of Producers of Drugs and

Listing of Drugs in Commercial

Distribution.’’ The draft guidance is

intended to assist establishments that

are required to register (‘‘registrants’’)

and submit listing information for drugs

and biological products in obtaining and

submitting the necessary forms to meet

registration and listing requirements;

this draft guidance will also assist those

private label distributors that are not

required to register, but elect to submit

designated information directly to FDA.

FDA proposes to make available through

the Internet, rather than through

conventional mail, the following

registration and listing forms: Form FDA

2656 (Registration of Drug

Establishment), Form FDA 2656e

(Annual Update of Drug Establishment),

Form FDA 2657 (Drug Product Listing),

and Form FDA 2658 (Registered

Establishments’ Report of Private Label

Distributors).

DATES: Submit written comments on

this draft guidance document by July 16,

2001. General comments on agency

guidance documents are welcome at any

time.

ADDRESSES: Submit written requests for

single copies of this draft guidance to

the Division of Drug Information (HFD–

240), Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance

document.

FOR FURTHER INFORMATION CONTACT:

For human drugs: Kathy Smith,

Center for Drug Evaluation and

Research (HFD–90), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–

1086.

For biological drugs: Robert A. Yetter,

Center for Biologics Evaluation and

Research (HFM–10), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852, 301–

827–0373, yetter@cber.fda.gov.

For veterinary drugs: Lowell Fried,

Center for Veterinary Medicine

(HFV–212), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–

0165, lfried@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Under part 207 (21 CFR part 207), as

authorized and required by section 510

of the Federal Food, Drug, and Cosmetic

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

sections 351 and 361 of the Public

Health Service Act (PHS Act) (42 U.S.C.

262 amd 264), establishments (e.g.

manufacturers, repackers, and

relabelers) engaged in the manufacture,

preparation, propagation, compounding,

or processing of human drugs,

veterinary drugs, and biological

products, with certain exceptions, are

required to register and submit listing

information.

Under part 207, these ‘‘registrants’’

use Form FDA 2656 to submit

establishment registration information

and to submit annual re-registration

information (FDA had also used Form

FDA 2656e for annual re-registration,

but this form will no longer be

necessary); private label distributors use

Form FDA 2656 to obtain a labeler code;

registrants and, in some cases, private

label distributors use Form FDA 2657 to

submit listing information for drugs and

biological products and to update listing

information; and registrants use Form

FDA 2658 to submit listing information

for private label distributors (FDA has

also used the compliance verification

report for updating listing information).

Registrants will use new Form FDA

3356 to submit establishment and listing

information for those human cells,

tissues, and cellular and tissue-based

products regulated as drugs and/or

biological products under the act and

section 351 of the PHS Act beginning

January 21, 2003.

If a registrant or private label

distributor prefers to receive any of

these forms through conventional mail,

they may direct such requests to the

designated agency contacts. Under the

draft guidance, information previously

submitted on Form FDA 2656e would

be submitted on Form FDA 2656.

Distribution of these forms through the

Internet will reduce administrative costs

to the agency. The draft guidance also

contains registration information

applicable to human cells, tissue, and

cellular and tissue-based product

establishments.

The draft guidance explains that,

unless specifically requested otherwise,

FDA is discontinuing the conventional

mailing of these forms to registrants and

private label distributors. These forms

are available on the Internet.

Registrants, and if appropriate, private

label distributors must continue to

submit completed forms to FDA in

accordance with the registration and

listing requirements in part 207. The

draft guidance explains where to obtain

the forms on the Internet, how to make

changes to information, and where to

submit completed forms.

Internet availability of these forms

(instead of availability by conventional

mail) is part of an agency initiative to

use modern technology to facilitate the

submission of establishment registration

and listing information. FDA is

developing software to make possible

the electronic submission of the

requisite registration and listing

information for drugs and biological

products. The agency plans to propose

rulemaking that would revise the

requirements for registration and listing

and would require registrants to submit

this information electronically.

This Level 1 draft guidance is being

issued consistent with FDA’s good

guidance practices regulation (21 CFR

10.115; 65 FR 56468, September 19,

2000). This draft guidance represents

the agency’s current thinking on this

topic. 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

requirements of the applicable statutes

and regulations.