Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Notices 40829

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

President’s Committee on Mental

Retardation; Notice of Meeting

Agency Holding the Meeting: President’s

Committee on Mental Retardation.

Time and Date: 8:30 a.m.–12 Noon, August

24, 1997.

Place: The Washington Court Hotel, 525

New Jersey Avenue, NW., Washington, DC

20001.

Status: Full Committee Meetings are open

to the public. An interpreter for the deaf will

be available upon advance request. All

meeting sites are barrier free.

To be Considered: The Committee plans to

discuss critical issues concerning Federal

Policy, Federal Research and Demonstration,

State Policy Collaboration, Minority and

Cultural Diversity and Mission and Public

Awareness.

The PCMR acts in an advisory capacity to

the President and the Secretary of the U.S.

Department of Health and Human Services

on a broad range of topics relating to

programs, services, and supports for persons

with mental retardation. The Committee, by

Executive Order, is responsible for evaluating

the adequacy of current practices in programs

and supports for persons with mental

retardation, and for reviewing legislative

proposals that impact the quality of life that

is experienced by citizens with mental

retardation and their families.

Contact Person for More Information: Gary

H. Blumenthal, 352–G Hubert H. Humphrey

Building, 200 Independence Avenue, SW.,

Washington, DC 20201–0001 (202) 619–0634.

Dated: July 17, 1997.

Gary H. Blumenthal,

Executive Director, PCMR.

[FR Doc. 97–19983 Filed 7–29–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0502]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; BAKTM Interbody Fusion

System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for BAKTM

Interbody Fusion System 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 BAKTM Interbody

Fusion System. BAKTM Interbody

Fusion System is indicated for use with

autogenous bone graft in patients with

degenerative disc disease (DDD) at one

or two contiguous levels from L2–S1.

These DDD patients may also have up

to Grade I spondylolisthesis or

retrolisthesis at the involved level(s).

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for BAKTM

Interbody Fusion System (U.S. Patent

No. 5,015,247) from Karlin Technology,

Inc., 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

BAKTM Interbody Fusion System

represented the first commercial

marketing 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

BAKTM Interbody Fusion System is

1,731 days. Of this time, 1,341 days

occurred during the testing phase of the

regulatory review period, while 390

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:

December 27, 1991. The applicant

claims that the investigational device

exemption (IDE) required under section

520(g) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360j(g)) for

human tests to begin became effective

April 30, 1992. However, FDA records

indicate that the IDE for clinical studies

of the BAKTM Interbody Fusion System

was approved on December 27, 1991,

which represents the IDE effective date.

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 28, 1995. The applicant

claims January 17, 1995, as the date the

premarket approval application (PMA)

for BAKTM Interbody Fusion System

(PMA P950002) was initially submitted.

FDA records confirm that an incomplete

PMA P950002 was received on January

17, 1995. PMA P950002 was amended a

number of times and was determined to

be adequate for filing based on a

submission received on August 28,

1995, which is considered the initially

submitted date for the PMA.

3. The date the application was

approved: September 20, 1996. FDA has

verified the applicant’s claim that PMA

P950002 was approved on September

20, 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,
40830 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Notices

this applicant seeks 829 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 29, 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 January 27, 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 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: July 15, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–19984 Filed 7–29–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4200–N–90]

Notice of Proposed Information

Collection for Public Comment

AGENCY: Office of the Assistant

Secretary for Housing—Federal Housing

Commissioner, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due: September 29,

1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Oliver Walker, Housing, Department of

Housing and Urban Development, 451—

7th Street, SW, Room 9116, Washington,

DC 20410.

FOR FURTHER INFORMATION CONTACT: John

Coonts, Telephone number (202) 708–

3046 (this is not a toll-free number) for

copies of the proposed form and other

available documents.

SUPPLEMENTARY INFORMATION: The

Department will submit the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).

The Notice is soliciting comments

from members of the public and

affecting agencies concerning the

proposed collection of information to:

(1) Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information will have

practical utility; (2) Evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information; (3) Enhance the quality,

utility, and clarity of the information to

be collected; and (4) Minimize the

burden of the collection of information

on those who are to respond; including

through the use of appropriate

automated collection techniques or

other forms of information technology,

e.g., permitting electronic submission of

responses.

This Notice also lists the following

information:

Title of Proposal: Insurance for Home

Equity Conversion Mortgages/

Residential Loan Application for

Reverse Mortgages.

OMB Control Number: New

Collection.

Description of the need for the

information and the proposed use:

Streamlined application for reverse

mortgage customers, used to determine

if borrowers qualify for HECM loans.

Agency form numbers: N/A.

Members of affected public:

Individuals/households, business/nonprofits, Federal Government.

An estimation of the total number of

hours needed to prepare the information

collection is 5,000, the number of

respondents is 5,000, frequency of

response is on occasion and the hours

of response is 1 hour.

Status of the proposed information

collection: New collection.

Authority: Sec. 3506 of the Paperwork

Reduction Act of 1995, 44 U.S.C. Chapter 35,

as amended.

Dated: July 23, 1997.

Nicolas P. Retsinas,

Assistant Secretary for Housing—Federal

Housing Commissioner.

[FR Doc. 97–19991 Filed 7–29–97; 8:45 am]

BILLING CODE 4210–27–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4200–N–95]

Notice of Proposed Information

Collection for Public Comments

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due: September 28,

1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Mildred M. Humman, Reports Liaison

Officer, Public and Indian Housing,

Department of Housing and Urban

Development, 451 7th Street, SW.,

Room 4238, Washington, DC 20410–

5000.

FOR FURTHER INFORMATION CONTACT:

Mildred M. Hamman, (202) 708–3642,

extension 4128, for copies of the

proposed forms and other available

documents. (This is not a toll-free

number).

SUPPLEMENTARY INFORMATION: The

Department sill submit the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).

This Notice is soliciting comments

from members of the public and affected

agencies concerning the proposed

collection of information to: (1) Evaluate

whether the proposed collection of

information is necessary for the proper

performance of functions of the agency,

including whether the information will

have practical utility; (2) evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information; (3) enchance the quality,

utility, and clarity of the information to

be collected; and (4) minimize the

burden of the collection of information