27086 Federal Register / Vol. 61, No. 105 / Thursday, May 30, 1996 / Notices

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 PRECOSETM

(acarbose). PRECOSETM is indicated as

an adjunct to diet to lower blood

glucose in patients with noninsulindependent diabetes mellitus who

hyperglycemia cannot be managed by

diet alone. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for PRECOSETM (U.S. Patent

No. 4,904,769) from Bayer AG, and the

Patent and Trademark Office requested

FDA’s assistance in determining this

patent’s eligibility for patent term

restoration. In a letter dated December

27, 1995, FDA advised the Patent and

Trademark Office that this human drug

product had undergone a regulatory

review period that the approval of

PRECOSETM 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

PRECOSETM is 5,647 days. Of this time,

3,789 days occurred during the testing

phase of the regulatory review period,

while 1,858 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: March 23, 1980. FDA

has verified the applicant’s claim that

the date that the investigational new

drug application became effective was

on March 23, 1980.

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: August 6, 1990. The

applicant claims August 9, 1990, as the

date the new drug application (NDA) for

PRECOSETM (NDA 20–086) was initially

submitted. However, FDA records

indicate that NDA 20–086 for the active

ingredient in PRECOSETM (acarbose)

was received by the agency on August

6, 1990. This NDA was withdrawn on

August 28, 1991. A subsequent NDA for

PRECOSETM (NDA 20–482) was

received on September 6, 1994.

Therefore, NDA 20–086 signifies the

end of the testing phase and the

beginning of the approval phase for

PRECOSETM, while NDA 20–482

signifies the end of the approval phase.

The NDA initially submitted date is

August 6, 1990.

3. The date the application was

approved: September 6, 1995. FDA

verified the applicant’s claim that NDA

20–482 was approved on September 6,

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 922 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 29, 1996, 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 November 26, 1996, 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: May 16, 1996.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 96–13535 Filed 5–29–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[HCFA–2552–96]

Agency Information Collection

Activities: Submission for OMB

Review; 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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. 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: Revision of a currently

approved collection; Title of

Information Collection: Hospital and

Hospital Health Care Complex Cost

Report; Form No.: HCFA–2552–96; Use:

This form is required by statute and

regulation for participation in the

Medicare program. The information is

used to determine final payment for

Medicare. Hospitals and related

complexes are the main users.

Frequency: Annually; Affected Public:

Business or other for-profit, Not-for

profit institutions, and State, Local or

Tribal Government; Number of

Respondents: 7,000; Total Annual

Responses: 7,000; Total Annual Hours

Requested: 4,599,000.

To request copies of the proposed

paperwork collections referenced above,

E-mail your request, including your

address, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections should be sent

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,
Federal Register / Vol. 61, No. 105 / Thursday, May 30, 1996 / Notices 27087

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: May 22, 1996.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 96–13520 Filed 5–29–96; 8:45 am]

BILLING CODE 4120–03–P

Health Resources and Services

Administration

Maternal and Child Health Services;

Federal Set-Aside Program;

Continuing Education and

Development Cooperative Agreements

AGENCY: Health Resources and Services

Administration (HRSA), HHS.

ACTION: Extension of application

deadline date.

The Maternal and Child Health

Services; Federal Set-Aside Program;

Continuing Education and Development

Cooperative Agreements notice deadline

date published on April 26, 1996,

beginning on page 18613, is hereby

extended to July 8, 1996.

The rest of the notice remains as

published.

Dated: May 24, 1996.

Ciro V. Sumaya,

Administrator.

[FR Doc. 96–13578 Filed 5–29–96; 8:45 am]

BILLING CODE 4160–15–P

Public Health Service

Health Resources and Services

Administration;

Statement of Organization, Functions

and Delegations of Authority

Part H, Chapter HB (Health Resources

and Services Administration) of the

Statement of Organization, Functions

and Delegations of Authority of the

Department of Health and Human

Services (47 FR 38409–24, August 31,

1982, as amended most recently at 61

FR 24939–40, May 17, 1996). The

changes are as follows:

1. Under Part HB, Health Resources

and Services Administration Section

HB–20–Functions, ‘‘Bureau of Health

Resources Development (HBB)’’ delete

the statement in its entirety and replace

by the following

Bureau of Health Resources

Development (HBB).

Administers Federal policy and

programs pertaining to health care

facilities, activities associated with

organ donations, procurements,

transplantation, and a variety of

program activities related to HIV

infection and acquired immune

deficiency syndrome (AIDS). This

includes financial, capital,

organizational, and physical matters.

Specifically: (1) Provides national

leadership in supporting, identifying,

and interpreting national trends and

issues of significance relative to the

health status of persons with AIDS, and

with HIV infections, including the

provision of facilities and services for

AIDS and AIDS-related patients,

persons in need and provision of

services to persons and families of low

income; and administers block and

discretionary grants, contracts, and

funding arrangements designed to

address those issues; (2) administers

and coordinates AIDS-related grants

programs of national significance; (3)

administers grant, loan, loan guarantees

and interest subsidy programs relating

to the construction, modernization,

conversion, and closure of health and

health care organizations; (4) develops

long and short range program goals and

objectives for health facilities, and for

specific health promotional, organ

transplantation, and AIDS activities; (5)

manages contracts to provide Federal

oversight for the Organ Procurement

and Transplantation Network, the

Scientific Registry of Transplant

Recipients and the National Marrow

Donor Programs and works to increase

the availability of donor organs and

unrelated bone narrow donors by

working with the Organ Procurement

Organizations (OPOS) and Donor

Centers; (6) serves as advisor to and

coordinates activities with other Agency

organizational elements, other Federal

organizations within and outside the

Department, State, and local bodies,

professional and scientific

organizations; (7) develops, promotes,

and directs efforts to improve the

management, operational effectiveness,

and efficiency of health care systems,

organizations, and facilities; (8)

provides technical assistance to OPOs

and health care delivery systems and

facilities in a wide variety of specific

technical and technological systems; (9)

administers HRSA’s regional facility

engineering and construction activities;

(10) designs and implements special

epidemiological and evaluation studies

of the impact of the Bureau health care

programs and of the characteristics of

the population serviced; (11) evaluates

models of health care delivery systems

through grants, contracts, direct

activities designs, and tests; (12) plans

and develops collaborative efforts in the

scientific aspects of Bureau programs

with other PHS agencies, Federal

departments, universities, and other

scientific organizations; and (13)

maintains liaison and coordinates with

non-Federal public and private entities

as necessary for the accomplishment of

Bureau missions and objectives; and

2. Delete the Division of Trauma and

Emergency Medical System (HBB8) in

its entirety.

Delegations of Authority

All delegations and redelegations of

authorities to officers and employees of

the Bureau of Health Resources

Development which were in effect

immediately prior to the effective date

of this reorganization will be continued

in effect in them or their successors,

pending further redelegations, provided

they are consistent with this

reorganization.

These changes are effective upon date

of signature.

Dated: May 15, 1996.

Ciro V. Sumaya,

Administrator, Health Resources and Services

Administration.

[Fr. Doc. 96–13539 Filed 5–29–96; 8:45 am]

BILLING CODE 4160–15–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–3917–N–84]

Office of the Assistant Secretary for

Public and Indian Housing; Notice of

Proposed Information Collection for

Public Comment

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: July 29, 1996.

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. Hamman, Reports Liaison

Officer, Public and Indian Housing,

Department of Housing and Urban

Development, 451—7th Street, SW,

Room 4255, Washington, D.C. 20410–

5000.