Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Notices 37715 

with a protocol is required to be 

submitted at 90-day intervals. In 

addition, samples, which must be 

accompanied by a protocol, may at any 

time be required to be submitted to 

CBER if continued evaluation is deemed 

necessary. 

Samples and protocols are required by 

FDA to help ensure the safety, purity, or 

potency of a product because of the 

potential lot-to-lot variability of a 

product produced from living 

organisms. In cases of certain biological 

products (e.g., Albumin, Plasma Protein 

Fraction, and therapeutic biological 

products) that are known to have lot-tolot consistency, official lot release is not 

normally required. However, 

submissions of samples and protocols of 

these products may still be required for 

surveillance, licensing, and export 

purposes, or in the event that FDA 

obtains information that the 

manufacturing process may not result in 

consistent quality of the product. 

The following burden estimate is for 

the protocols required to be submitted 

with each sample. The collection of 

samples is not a collection of 

information under 5 CFR 1320.3(h)(2). 

Respondents to the collection of 

information under § 610.2 are 

manufacturers of licensed biological 

products. Respondents to the collection 

of information under §§ 660.6(b), 

660.36(a)(2) and (b), and 660.46(b) are 

manufacturers of the specific products 

referenced previously in this document. 

The estimated number of respondents 

for each regulation is based on the 

annual number of manufacturers that 

submitted samples and protocols for 

biological products including 

submissions for lot release, surveillance, 

licensing, or export. Based on 

information obtained from FDA’s 

database system, approximately 69 

manufacturers submitted samples and 

protocols in fiscal year (FY) 2008, under 

the regulations cited previously in this 

document. FDA estimates that 

approximately 65 manufacturers 

submitted protocols under § 610.2 and 

21 CFR 610.3 manufacturers submitted 

protocols under the regulations 

(§§ 660.6 and 660.46) for the other 

specific products. FDA received no 

submissions under § 660.36; however, 

FDA is using the estimate of one 

protocol submission in the event one is 

submitted in the future. 

The estimated total annual responses 

are based on FDA’s final actions 

completed in FY 2008, which totaled 

6,314, for the various submission 

requirements of samples and protocols 

for the licensed biological products. The 

rate of final actions is not expected to 

change significantly in the next few 

years. The hours per response are based 

on information provided by industry. 

The burden estimates provided by 

industry ranged from 1 to 5.5 hours. 

Under § 610.2, the hours per response 

are based on the average of these 

estimates and rounded to 3 hours. 

Under the remaining regulations, the 

hours per response are based on the 

higher end of the estimate (rounded to 

5 or 6 hours) since more information is 

generally required to be submitted in 

the other protocols than under § 610.2. 

In the Federal Register of March 6, 

2009 (74 FR 9820), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

610.2 65 95.5 6,208 3 18,624 

660.6(b) 2 44 88 5 440 

660.36(a)(2) and (b) 1 1 1 6 6 

660.46(b) 1 17 17 5 85 

Total 69 6,314 19,155 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: July 22, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–17978 Filed 7–28–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0072] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; RAPAFLO 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

RAPAFLO 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 

which 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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

37716 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Notices 

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 RAPAFLO 

(silodosin). RAPAFLO is indicated for 

treatment of the signs and symptoms of 

benign prostatic hyperplasia. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

RAPAFLO (U.S. Patent No. 5,387,603) 

from Kissei Pharmaceutical Co., Ltd., 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

February 26, 2009, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of RAPAFLO 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 

RAPAFLO is 3,681 days. Of this time, 

3,380 days occurred during the testing 

phase of the regulatory review period, 

while 301 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: September 12, 

1998. The applicant claims September 

17, 1998, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

September 12, 1998, 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 act: December 13, 2007. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

RAPAFLO (NDA 22–206) was initially 

submitted on December 13, 2007. 

3. The date the application was 

approved: October 8, 2008. FDA has 

verified the applicant’s claim that NDA 

22–206 was approved on October 8, 

2008. 

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 1,826 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 or 

electronic comments and ask for a 

redetermination by September 28, 2009. 

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 

January 25, 2010. 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: June 23, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–18032 Filed 7–28–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0021] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; DUREZOL 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

DUREZOL 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 

which 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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman,Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

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 

mstockstill on DSKH9S0YB1PROD with NOTICES