Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 45863 

A.12–1—ESTIMATES OF HOUR BURDEN

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated total 

annual burden 

hours 

requested 

Telephone survey 

Individuals or households ................................................................................ 919 1 0.075 69 

Physicians ........................................................................................................ 44 1 0.075 3 

CAM/health practitioners ................................................................................. 20 1 0.075 1 

The annualized cost to respondents is 

estimated at $1,479 for the telephone 

survey. There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on the following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions; (3) Ways 

to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Christy 

Thomsen, Director, Office of 

Communications and Public Liaison, 

NCCAM, 31 Center Drive, Room 2B–11, 

Bethesda, MD 20892–2182; or fax your 

request to 301–402–4741; or e-mail 

thomsenc@mail.nih.gov. Ms. Thomsen 

can be contacted by telephone at 301– 

451–8876. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: August 27, 2009. 

Christy Thomsen, 

Director, Office of Communications and 

Public Liaison, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health. 

[FR Doc. E9–21479 Filed 9–3–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–E–0266] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; DORIBAX 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

DORIBAX 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 

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 DORIBAX 

(doripenem monohydrate). DORIBAX is 

indicated in the treatment of the 

following infections caused by 

designated susceptible bacteria: 

complicated intra-abdominal infections, 

and complicated urinary tract 

infections, including pyelonephritis. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

DORIBAX (U.S. Patent No. 5,317,016) 

from Shionogi Seiyaku Kabushiki 

Kaisha, 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 18, 2009, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 


srobinson on DSKHWCL6B1PROD with NOTICES
45864 Federal Register / Vol. 74, No. 171 / Friday, September 4, 2009 / Notices 

approval of DORIBAX 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 

DORIBAX is 1,746 days. Of this time, 

1,442 days occurred during the testing 

phase of the regulatory review period, 

while 304 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: January 2, 

2003. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on January 2, 2003. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 13, 2006. 

The applicant claims December 12, 

2006, as the date the new drug 

application (NDA) for DORIBAX (NDA 

22–106) was initially submitted. 

However, FDA records indicate that 

NDA 22–106 was submitted on 

December 13, 2006. 

3. The date the application was 

approved: October 12, 2007. FDA has 

verified the applicant’s claim that NDA 

22–106 was approved on October 12, 

2007. 

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 1,025 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 November 3, 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 

March 3, 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. E9–21365 Filed 9–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0056] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; BANZEL 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

BANZEL 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 

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 BANZEL 

(rufinamide). BANZEL is indicated for 

adjunctive treatment of seizures 

associated with Lennox-Gastaut 

syndrome in children 4 years and older 

and adults. Subsequent to this approval, 

the Patent and Trademark Office 

received a patent term restoration 

application for BANZEL (U.S. Patent 

No. 6,740,669) from Novartis 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 

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 BANZEL 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 

BANZEL is 6,595 days. Of this time, 

5,501 days occurred during the testing 

phase of the regulatory review period, 

while 1,094 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: October 27, 

1990. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on October 27, 1990. 


srobinson on DSKHWCL6B1PROD with NOTICES