5858 Federal Register / Vol. 69, No. 25 / Friday, February 6, 2004 / Notices 

available for inspection at the offices of 

the Board of Governors. Interested 

persons may express their views in 

writing on the standards enumerated in 

the BHC Act (12 U.S.C. 1842(c)). If the 

proposal also involves the acquisition of 

a nonbanking company, the review also 

includes whether the acquisition of the 

nonbanking company complies with the 

standards in section 4 of the BHC Act 

(12 U.S.C. 1843). Unless otherwise 

noted, nonbanking activities will be 

conducted throughout the United States. 

Additional information on all bank 

holding companies may be obtained 

from the National Information Center 

website at www.ffiec.gov/nic/.

Unless otherwise noted, comments 

regarding each of these applications 

must be received at the Reserve Bank 

indicated or the offices of the Board of 

Governors not later than March 1, 2004.

A. Federal Reserve Bank of St. Louis

(Randall C. Sumner, Vice President) 411 

Locust Street, St. Louis, Missouri 63166-

2034:

1. LBT Bancshares, Inc., Litchfield, 

Illinois; to acquire 53.98 percent of 

Security Bancshares, Inc., and thereby 

indirectly acquire Security National 

Bank, both of Witt, Illinois.

Board of Governors of the Federal Reserve 

System, February 2, 2004.

Robert deV. Frierson,

Deputy Secretary of the Board.

[FR Doc. 04–2656 Filed 2–5–04; 8:45 am]

BILLING CODE 6210–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Interest Rate on Overdue 

Debts 

Section 30.13 of the Department of 

Health and Human Services’ claims 

collection regulations (45 CFR part 30) 

provides that the Secretary shall charge 

an annual rate of interest as fixed by the 

Secretary of the Treasury after taking 

into consideration private consumer 

rates of interest prevailing on the date 

that HHS becomes entitled to recovery. 

The rate generally cannot be lower than 

the Department of Treasury’s current 

value of funds rate or the applicable rate 

determined from the ‘‘Schedule of 

Certified Interest Rates with Range of 

Maturities.’’ This rate may be revised 

quarterly by the Secretary of the 

Treasury and shall be published 

quarterly by the Department of Health 

and Human Services in the Federal 

Register. 

The Secretary of the Treasury has 

certified a rate of 12% for the quarter 

ended December 31, 2003. This interest 

rate will remain in effect until such time 

as the Secretary of the Treasury notifies 

HHS of any change.

Dated: January 29, 2004. 

George Strader, 

Deputy Assistant Secretary, Finance.

[FR Doc. 04–2548 Filed 2–5–04; 8:45 am] 

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003E–0248]

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EXTRANAEAL

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

EXTRANAEAL 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 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 EXTRANAEAL 

(icodextrin). EXTRANAEAL is indicated 

for a single daily exchange for the long 

(8–to 16–hour) dwell during continuous 

ambulatory peritoneal dialysis (CAPD) 

or automated peritoneal dialysis (APD) 

for the management of chronic renal 

failure. Subsequent to this approval, the 

Patent and Trademark Office received a 

patent term restoration application for 

EXTRANAEAL (U.S. Patent No. 

4,761,237) from Baxter International, 

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 

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 EXTRANAEAL 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 

EXTRANAEAL is 2,207 days. Of this 

time, 1,478 days occurred during the 

testing phase of the regulatory review 

period, while 729 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: December 6, 

1996. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on December 6, 1996.

2. The date the application was 

initially submitted with respect to the 

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