41582 Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices

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 1,273 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before October 5, 1998, 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 1, 1999, 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 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–20739 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0462]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Posicor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

Posicor 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 human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6620.

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 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 Posicor

(mibefradil dihydrochloride). Posicor

is indicated for the treatment of

hypertension and chronic stable angina

pectoris. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for Posicor (U.S. Patent

No. 4,808,605) from Hoffman-La Roche,

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

December 29, 1997, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of Posicor 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

Posicor is 1,793 days. Of this time,

1,326 days occurred during the testing

phase of the regulatory review period,

467 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: July 25, 1992.

The applicant claims July 24, 1992, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was July 25, 1992,

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: March 11, 1996. The

applicant claims March 8, 1996, as the

date the new drug application (NDA) for

Posicor (NDA 20–689) was initially

submitted. However, FDA records

indicate that NDA 20–689 was

submitted on March 11, 1996.

3. The date the application was

approved: June 20, 1997. FDA has

verified the applicant’s claim that NDA

20–689 was approved on June 20, 1997.

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 1,130 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before October 5, 1998, 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 1, 1999, 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.
Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices 41583

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 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–20743 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0453]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Medical Devices: Third-Party Review

Program Under the U.S./EC MRA’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 2, 1998 (63 FR

36241), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0378. The

approval expires on January 31, 1999.

Dated: July 24, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20703 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0331]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Medical Devices; FDAMA Third-Party

Review’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 22, 1998 (63 FR

28388), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0375. The

approval expires on November 30, 1998.

Dated: July 24, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20706 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4349–N–29]

Submission for OMB Review:

Comment Request

AGENCY: Office of the Assistant

Secretary for Administration, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been 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 date: September

3, 1998.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be

received within thirty (30) days from the

date of this Notice. Comments should

refer to the proposal by name and/or

OMB approval number and should be

sent to: Joseph F. Lackey, Jr., OMB Desk

Officer, Office of Management and

Budget, Room 10235, New Executive

Office Building, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management

Officer, Department of Housing and

Urban Development, 451 7th Street,

Southwest, Washington, DC 20410,

telephone (202) 708–1305. This is not a

toll-free number. Copies of the proposed

forms and other available documents

submitted to OMB may be obtained

from Mr. Eddins.

SUPPLEMENTARY INFORMATION: The

Department has submitted the proposal

for the collection of information, as

described below, to OMB for review, as

required by the Paperwork Reduction

Act (44 U.S.C. Chapter 35).

The Notice lists the following

information: (1) The title of the

information collection proposal; (2) the

office of the agency to collect the

information; (3) the OMB approval

number, if applicable; (4) the

description of the need for the

information and its proposed use; (5)

the agency form number, if applicable;

(6) what members of the public will be

affected by the proposal; (7) how

frequently information submissions will

be required; (8) an estimate of the total

number of hours needed to prepare the

information submission including

number of respondents, frequency of

response, and hours of response; (9)

whether the proposal is new, an

extension, reinstatement, or revision of

an information collection requirement;

and (10) the names and telephone

numbers of an agency official familiar

with the proposal and of the OMB Desk

Officer for the Department.

Authority: Section 3507 of the Paperwork

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

amended.