18776 Federal Register / Vol. 62, No. 74 / Thursday, April 17, 1997 / Notices

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 OXILANTM

(loxilan). OXILANTM is indicated for

cerebral arteriography, coronary

arteriography and left ventriculography,

visceral angiography, aortography, and

peripheral arteriography. Subsequent to

this approval, the Patent and Trademark

Office received a patent term restoration

application for OXILANTM (U.S. Patent

No. 4,954,348) from Cook Imaging

Corp., and the Patent and Trademark

Office requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

May 28, 1996, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the

approval of OXILANTM 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

OXILANTM is 2,757 days. Of this time,

1,644 days occurred during the testing

phase of the regulatory review period,

while 1,113 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: June 5, 1988. The

applicant claims April 29, 1988, as the

date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was June 5, 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(b) of the Federal Food, Drug, and

Cosmetic Act: December 4, 1992. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

OXILANTM (NDA 20–316) was initially

submitted on December 4, 1992.

3. The date the application was

approved: December 21, 1995. FDA has

verified the applicant’s claim that NDA

20–316 was approved on December 21,

1995.

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 737 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before June 16, 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 October 14, 1997, 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: April 4, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–9917 Filed 4–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[ORD–098–N]

New and Pending Demonstration

Project Proposals Submitted Pursuant

to Section 1115(a) of the Social

Security Act: February 1997

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: No new proposals for

Medicaid demonstration projects were

submitted to the Department of Health

and Human Services during the month

of February 1997 under the authority of

section 1115 of the Social Security Act.

There were no proposals approved,

disapproved, or withdrawn during that

time period. (This notice can be

accessed on the Internet at HTTP://

WWW.HCFA.GOV/ORD/

ORDHP1.HTML.)

COMMENTS: We will accept written

comments on these proposals. We will,

if feasible, acknowledge receipt of all

comments, but we will not provide

written responses to comments. We

will, however, neither approve nor

disapprove any new proposal for at least

30 days after the date of this notice to

allow time to receive and consider

comments. Direct comments as

indicated below.

ADDRESSES: Mail correspondence to:

Susan Anderson, office of Research and

Demonstrations, ealth Care Financing

Administration, Mail Stop C3–11–07,

7500 Security Boulevard, Baltimore, MD

21244–1850.

FOR FURTHER INFORMATION CONTACT:

Susan Anderson (410) 786–3996.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 1115 of the Social

Security Act (the Act), the Department

of Health and Human Services (HHS)

may consider and approve research and

demonstration proposals with a broad

range of policy objectives. These

demonstrations can lead to

improvements in achieving the

purposes of the Act.

In exercising her discretionary

authority, the Secretary has developed a

number of policies and procedures for

reviewing proposals. On September 27,

1994, we published a notice in the

Federal Register (59 FR 49249) that

specified (1) the principles that we

ordinarily will consider when

approving or disapproving

demonstration projects under the
Federal Register / Vol. 62, No. 74 / Thursday, April 17, 1997 / Notices 18777

authority in section 1115(a) of the Act;

(2) the procedures we expect States to

use in involving the public in the

development of proposed demonstration

projects under section 1115; and (3) the

procedures we ordinarily will follow in

reviewing demonstration proposals. We

are committed to a thorough and

expeditious review of State requests to

conduct such demonstrations.

As part of our procedures, we publish

a notice in the Federal Register with a

monthly listing of all new submissions,

pending proposals, approvals,

disapprovals, and withdrawn proposals.

Proposals submitted in response to a

grant solicitation or other competitive

process are reported as received during

the month that grant or bid is awarded,

so as to prevent interference with the

awards process.

II. Listing of New, Pending, Approved,

Disapproved, and Withdrawn

Proposals for the Month of February

1997

A. Comprehensive Health Reform

Programs

1. New, Pending, Approved,

Disapproved, and Withdrawn Proposals

We did not receive any new proposals

or approve or disapprove any proposals

during the month of February nor were

any proposals withdrawn during that

month. Therefore, pending proposals for

the month of January 1997 published in

the Federal Register of March 31, 1997,

62 FR 15187, remain unchanged.

B. Other Section 1115 Demonstration

Proposals

1. New, Pending, Approved,

Disapproved, and Withdrawn Proposals

We did not receive any new proposals

or approve or disapprove any Other

Section 1115 Demonstration Proposals

during the month of February nor were

any proposals withdrawn during that

month.

Pending proposals for the month of

January 1997 found in the Federal

Register of March 31, 1997, 62 FR 15187

remain unchanged, except for the

addition of the Minnesota Long Term

Care Facility Waiver (a new proposal

that was received in January).

III. Requests for Copies of a Proposal

Requests for copies of a specific

Medicaid proposal should be made to

the State contact listed for the specific

proposal. If further help or information

is needed, inquiries should be directed

to HCFA at the address above.

(Catalog of Federal Domestic Assistance

Program, No. 93.779; Health Financing

Research, Demonstrations, and Experiments.)

Dated: March 21, 1997.

Barbara Cooper,

Acting Director, Office of Research and

Demonstrations.

[FR Doc. 97–9918 Filed 4–16–97; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of June 1997:

Name: Maternal and Child Health Research

Grants Review Committee

Date and Time: June 18–20, 1997, 9:00 a.m.

Place: Conference Room ‘‘J’’, Parklawn

Building, 5600 Fishers Lane, 3rd Floor,

Rockville, Maryland 20857. Open on

Wednesday, June 18, 1997, 9:00 a.m.–10:00

a.m. Closed for remainder of meeting.

Agenda: The open portion of the meeting

will cover opening remarks by the Director,

Division of Science, Education and Analysis,

Maternal and Child Health Bureau, who will

report on program issues, congressional

activities and other topics of interest to the

field of maternal and child health. The

meeting will be closed to the public on June

18 at 10:00 a.m. for the remainder of the

meeting for the review of grant applications.

The closing is in accordance with the

provisions set forth in section 552b(c)(6),

Title 5 U.S.C., and the Determination by the

Director, Office of Policy and Information

Coordination, Health Resources and Services

Administration, pursuant to Public Law 92–

463.

Anyone requiring information regarding

the subject Council should contact Gontran

Lamberty, Dr.P.H., Executive Secretary,

Maternal and Child Health Research Grants

Review Committee, Room 18A–55, Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland 20857, Telephone (301)443–2190.

Agenda Items are subject to change as

priorities dictate.

Dated: April 11, 1997.

J. Henry Montes,

Director, Office of Policy and Information

Coordination.

[FR Doc. 97–9875 Filed 4–16–97; 8:45 am]

BILLING CODE 4160–15 P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4207–C–02]

NOFA for Rental Assistance for

Persons With Disabilities in Support of

Designated Housing Allocation Plans

and Establishment of Preferences for

Certain Section 8 Developments;

Correction

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Notice of funding availability

(NOFA); correction.

SUMMARY: On April 10, 1997, at 62 FR

17672, the Department published a

Notice of Funding Availability (NOFA)

part of which concerned Rental

Assistance for Persons With Disabilities

in Support of Preferences for Certain

Section 8 Developments. The limit on

rental assistance requested, as contained

in that NOFA, inadvertently omitted the

maximum number of units for which an

HA could apply. The following

correction adds a 200 unit limitation.

In the notice document 97–9334,

beginning on page 17672 in the issue of

Thursday, April 10, 1997, make the

following correction:

On page 17674 in the second and

third columns the paragraph headed

‘‘(3) Limit on Rental Assistance

Requested’’ should be changed to read:

(3) Limit on Rental Assistance

Requested. An HA may apply only for

the number of units needed to house

those non-elderly disabled families who

are on the waiting list of an owner of a

Section 8 project-based development,

identified in paragraph B.(1) above

where the owner elected to provide

preferences to elderly families and to

house other non-elderly disabled

families residing in the community who

would qualify for one- or zero-bedroom

units, but for not more than 200 units.

Dated: April 11, 1997.

Camille E. Acevedo,

Assistant General Counsel for Regulations.

[FR Doc. 97–9873 Filed 4–16–97; 8:45 am]

BILLING CODE 4210–33–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Conference of the Parties to the

Convention on International Trade in

Endangered Species of Wild Fauna

and Flora—Tenth Regular Meeting;

Public Meeting

AGENCY: Fish and Wildlife Service,

Interior.