Federal Register / Vol. 62, No. 162 / Thursday, August 21, 1997 / Notices 44477

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: July 31, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–22265 Filed 8–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E–0272]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; INTEGRA Artificial Skin

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

INTEGRA Artificial Skin 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 which

claims that medical device.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 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 medical devices,

the testing phase begins with a clinical

investigation of the device and runs

until the approval phase begins. The

approval phase starts with the initial

submission of an application to market

the device and continues until

permission to market the device is

granted. 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 (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 medical device will include

all of the testing phase and approval

phase as specified in 35 U.S.C.

156(g)(3)(B).

FDA recently approved for marketing

the medical device INTEGRA

Artificial Skin. INTEGRA Artificial

Skin is indicated for the post-excisional

treatment of life-threatening fullthickness or deep partial-thickness

thermal injury where sufficient autograft

is not available at the time of excision

or not desirable due to the physiological

condition of the patient. Subsequent to

this approval, the Patent and Trademark

Office received a patent term restoration

application for INTEGRA Artificial

Skin (U.S. Patent No. 4,947,840) from

the Massachusetts Institute of

Technology, and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated March 12, 1997, FDA

advised the Patent and Trademark

Office that this medical device had

undergone a regulatory review period

and that the approval of INTEGRA

Artificial Skin represented the first

commercial marketing of the product.

Shortly thereafter, the Patent and

Trademark Office represented that FDA

determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

INTEGRA Artificial Skin is 4,477 days.

Of this time, 3,173 days occurred during

the testing phase of the regulatory

review period, while 1,304 days

occurred during the approval phase.

These periods of time were derived from

the following dates:

1. The date a clinical investigation

involving this device was begun:

November 30, 1983. FDA has verified

the applicant’s claim that the date the

investigational device exemption (IDE),

required under section 520(g)of the

Federal Food, Drug, and Cosmetic Act,

for human tests to begin became

effective on November 30, 1983.

2. The date an application was

initially submitted with respect to the

device under section 515 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360e): August 6, 1992. The applicant

claims May 4, 1990, as the date the

premarket approval application (PMA)

for INTEGRA Artificial Skin (PMA

P900033) was initially submitted.

However, FDA records indicate that the

PMA P900033, which was mailed May

4, 1990, was received by FDA on May

7, 1990. However, FDA notified the

applicant that the PMA contained

insufficient information for filing on

June 22, 1990. After a number of

additional documents were submitted to

the PMA, the PMA was ultimately filed

based on a document received August 6,

1992, which is considered the initially

submitted date for the PMA.

3. The date the application was

approved: March 1, 1996. FDA has

verified the applicant’s claim that PMA

P900033 was approved on March 1,

1996.

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 923 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before October 20, 1997, submit to

the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,

any interested person may petition FDA,

on or before February 17, 1998, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. 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
44478 Federal Register / Vol. 62, No. 162 / Thursday, August 21, 1997 / Notices

and petitions should be submitted to the

Dockets Management Branch (address

above) in three copies (except that

individuals may submit single copies)

and 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: August 14, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–22266 Filed 8–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Grass Roots Biotechnology Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration

(FDA) is announcing the following

meeting: Grass Roots Biotechnology

Meeting. The topics to be discussed are

product classification (Biologic/Device/

Drug/Food), the preapproval inspection

process, the inspectional environment

after product approval, and overall

communications with the field offices.

This meeting, which is cosponsored by

FDA’s Office of External Affairs and the

New England District, Northeast Region;

the Massachusetts Biotechnology

Council; and the Biotechnology

Association of Maine, is being held to

promote the President’s initiative for a

partnership approach between frontline

regulators and the people affected by the

work of the agency.

Date and Time: The meeting will be

held on Tuesday, September 23, 1997 (8

a.m. to 8:30 a.m. registration), 8:30 a.m.

to 4 p.m.

Location: The meeting will be held at

Ramada Hotel, 15 Middlesex Canal

Park, Woburn, MA, 617–279–1675.

Contact: Donald J. Johnson, Special

Assistant to the District Director, New

England District Office, Northeast

Region, Food and Drug Administration

(HFR–NE 252), Food and Drug

Administration, One Montvale Ave.,

Stoneham, MA 02180, 617–279–1675,

ext. 129, FAX 617–279–1733.

Registration: Send registration

information (including name, title, firm

name, address, telephone, and fax

number) to Janice T. Bourque, Executive

Director, Massachusetts Biotechnology

Council, 245 First St., 14th Fl.,

Cambridge, MA 02142, 617–577–8198.

Because attendance is limited to 100,

preregistration is recommended.

However, there is no cutoff date for

registration.

If you need special accommodations

due to a disability, please contact

Donald J. Johnson at least 7 days in

advance.

Supplementary Information: This

meeting will feature a general session at

which Federal regulations and

procedures will be discussed, followed

by four morning breakout sessions to

identify problems or concerns in the

topical areas, and four afternoon

breakout sessions to recommend

solutions to the problems or concerns

identified previously.

A summary of the meeting will be

provided to all registered participants.

However, the public may request a

summary of the meeting in writing from

the Freedom of Information Office (HFI–

35), Food and Drug Administration, rm.

12A–16, 5600 Fishers Lane, Rockville,

MD 20857.

Dated: August 15, 1997.

William K. Hubbard,

Acting Deputy Commissioner for Policy.

[FR Doc. 97–22267 Filed 8–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–94]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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 the 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: Medicaid

Sterilization Regulations 45 CFR 96.73,

42 CFR 441 subpart F and Consent

Form; Form No.: HCFA–R–94; Use: All

Medicaid-eligible individuals seeking

sterilization are required to sign the

federally mandated consent form,

acknowledging that they understand the

benefits and risks of sterilization, and

have received oral information

concerning the sterilization operation

from the provider. Frequency: Other

(each time sterilization is sought);

Affected Public: Individuals or

Households; Number of Respondents:

112,526; Total Annual Responses:

112,526; Total Annual Hours: 140,658.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, E-mail your request,

including your address and phone

number, 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,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: August 11, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 97–22124 Filed 8–20–97; 8:45 am]

BILLING CODE 4120–03–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–216]

Agency Information Collection

Activities: Submission for OMB

Review; 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