Federal Register / Vol. 69, No. 25 / Friday, February 6, 2004 / Notices 5859

human drug product under section 505 

of the act: December 22, 2000. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) for 

EXTRANAEAL (NDA 21–321) was 

initially submitted on December 22, 

2000.

3. The date the application was 

approved: December 20, 2002. FDA has 

verified the applicant’s claim that NDA 

21–321 was approved on December 20, 

2002.

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 1,467 days of patent 

term extension.

Anyone with knowledge that any of 

the dates as published is incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by April 6, 2004. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

August 4, 2004. 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 Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

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

Monday through Friday.

Dated: January 13, 2004.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug 

Evaluation and Research.

[FR Doc. 04–2546 Filed 2–5–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003E–0081]

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ORTHO-EVRA

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ORTHO-EVRA 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 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent that claims that 

human drug product.

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6699.

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 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 

Director 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 ORTHO-EVRA 

(norelgestromin/ethinyl estradiol 

transdermal system). ORTHO-EVRA is 

indicated for the prevention of 

pregnancy. Subsequent to this approval, 

the Patent and Trademark Office 

received a patent term restoration 

application for ORTHO-EVRA (U.S. 

Patent No. 5,876,746) from Johnson and 

Johnson, and the Patent and Trademark 

Office requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

July 16, 2003, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of ORTHO-EVRA represented 

the first permitted commercial 

marketing or use of the product. 

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 

ORTHO-EVRA is 2,001 days. Of this 

time, 1,666 days occurred during the 

testing phase of the regulatory review 

period, while 335 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 (the act) (21 U.S.C. 

355(i)) became effective: May 31, 1996. 

The applicant claims May 30, 1996, as 

the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was May 31, 1996, 

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: December 21, 2000. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) for 

ORTHO-EVRA (NDA 21–180) was 

initially submitted on December 21, 

2000.

3. The date the application was 

approved: November 20, 2001. FDA has 

verified the applicant’s claim that NDA 

5860 Federal Register / Vol. 69, No. 25 / Friday, February 6, 2004 / Notices 

21–180 was approved on November 20, 

2001.

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 664 days of patent 

term extension.

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written 

comments or electronic comments and 

ask for a redetermination by April 6, 

2004. Furthermore, any interested 

person may petition FDA, for a 

determination regarding whether the 

applicant for extension acted with due 

diligence during the regulatory review 

period by August 4, 2004. 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 Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

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

Monday through Friday.

Dated: January 13, 2004.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug 

Evaluation and Research.

[FR Doc. 04–2547 Filed 2–5–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

Extension of General Program Test 

Regarding Post Entry Amendment 

Processing

AGENCY: Customs and Border Protection, 

Department of Homeland Security.

ACTION: General notice.

SUMMARY: This document announces 

that the general program test regarding 

post entry amendment processing is 

being extended for a one year period. 

The test will continue to operate in 

accordance with the notice published in 

the Federal Register on November 28, 

2000, as modified by the notice 

published in the Federal Register on 

February 20, 2003.

DATES: The test allowing post entry 

amendment to entry summaries is 

extended to December 31, 2004.

FOR FURTHER INFORMATION CONTACT: Don 

Yando, Chief, Entry and Drawback 

Branch, Office of Field Operations, 202–

927–1082 or Debbie Scott, Entry and 

Drawback Branch, OFO, 202–927–1962.

SUPPLEMENTARY INFORMATION: 

Background 

The Bureau of Customs and Border 

Protection (CBP) announced and 

described the post entry amendment 

processing test in a general notice 

document published in the Federal 

Register (65 FR 70872) on November 28, 

2000. That notice announced that the 

test would commence no earlier than 

December 28, 2000, and run for 

approximately one year. On January 7, 

2002, CBP published a general notice in 

the Federal Register (67 FR 768) 

extending the test for a one year period 

to December 21, 2002. CBP published 

another general notice in the Federal 

Register (68 FR 8329) on February 20, 

2003, extending the test for an 

additional year to December 31, 2003. 

This document announces that the 

test is being extended to December 31, 

2004. The test allows importers to 

amend entry summaries (not informal 

entries) prior to liquidation by filing 

with CBP either an individual 

amendment letter upon discovery of an 

error or a quarterly tracking report 

covering any errors that occurred during 

the quarter. The November 28, 2000, 

general notice described how to file post 

entry amendments for revenue related 

errors and non-revenue related errors 

and the consequences of misconduct by 

importers during the test. It also 

provided that there are no application 

procedures or eligibility requirements. 

To participate in the test, an importer 

need only follow the procedure for 

making a post entry amendment set 

forth in the November 28, 2000, general 

notice. 

Comments received in response to the 

previously published general notices 

have been reviewed and CBP continues 

to evaluate the test. Changes to the test 

based on the comments and the 

evaluation will be announced in the 

Federal Register in due course. The test 

may be further extended if warranted. 

Additional information on the post 

entry amendment procedures can be 

found under ‘‘import’’, then ‘‘cargo 

summary’’ at http://www.cbp.gov.

Dated: February 3, 2004. 

Jayson P. Ahern, 

Assistant Commissioner, Office of Field 

Operations.

[FR Doc. 04–2589 Filed 2–5–04; 8:45 am] 

BILLING CODE 4820–02–P

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–4903–N–06] 

Notice of Submission of Proposed 

Information Collection to OMB: 

Application for Healthy Homes and 

Lead Hazard Control Programs Grant 

Funding

AGENCY: Office of the Chief Information 

Officer, 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. 

This submission is a request for an 

extension of the approval to collect 

information for the applications for 

Healthy Homes and Lead Hazard 

Control Program Grant Funding to 

address and reduce the lead-based paint 

and other hazards in privately owned 

housing. Some of the information in the 

applications has be reformatted in a 

number of forms.

DATES: Comments Due Date: March 8, 

2004.

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and OMB 

approval number (2539–0015) and 

should be sent to: Melanie Kadlic, OMB 

Desk Officer, Office of Management and 

Budget, Room 10235, New Executive 

Office Building, Washington, DC 20503; 

fax number (202) 395–6974; e-mail 

Melanie_Kadlic@omb.eop.gov.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management 

Officer, AYO, Department of Housing 

and Urban Development, 451 Seventh 

Street, SW., Washington, DC 20410; email Wayne_Eddins@HUD.gov;

telephone (202) 708–2374. 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 or on HUD’s Web site 

at http://www5.hud.gov:63001/po/i/

icbts/collectionsearch.cfm.

SUPPLEMENTARY INFORMATION: The 

Department has submitted the proposal