Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices 53315 

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 PRISTIQ 

(desvenlafaxine sucinate). PRISTIQ is 

indicated for treatment of major 

depressive disorder. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for PRISTIQ (U.S. Patent 

Nos. 6,673,838 and 7,291,347) from 

Wyeth, 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 17, 2010, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of PRISTIQ 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 

PRISTIQ is 2,124 days. Of this time, 

1,324 days occurred during the testing 

phase of the regulatory review period, 

while 800 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 9, 2002. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on May 9, 2002. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 22, 2005. 

The applicant claims December 22, 

2005, as the date the new drug 

application (NDA) for PRISTIQ (NDA 

21–966) was initially submitted. 

However, FDA records indicate that the 

application initially submitted for 

PRISTIQ was NDA 21–992 and FDA has 

confirmed that NDA 21–992 was 

initially submitted on December 22, 

2005. 

3. The date the application was 

approved: February 29, 2008. FDA has 

verified the applicant’s claim that 

PRISTIQ was approved on February 29, 

2008. However FDA records indicate 

that it was NDA 21–992 that was 

approved. 

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 applications for patent extension, 

this applicant seeks 17 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) either 

electronic or written comments and ask 

for a redetermination by November 1, 

2010. 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 [insert date 180 days after 

date of publication in the Federal 

Register]. 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. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

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

through Friday. 

Dated: August 13, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–21586 Filed 8–30–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0061] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ONGLYZA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ONGLYZA 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 electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

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 ONGLYZA 

(saxagliptin). ONGLYZA is indicated as 

an adjunct to diet and exercise to 


srobinson on DSKHWCL6B1PROD with NOTICES
53316 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices 

improve glycemic control in adults with 

type 2 diabetes mellitus. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for ONGLYZA (U.S. Patent 

No. 6,395,767) from Bristol-Myers 

Squibb Co., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated March 3, 2010, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of ONGLYZA 

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 

ONGLYZA is 2,794 days. Of this time, 

2,397 days occurred during the testing 

phase of the regulatory review period, 

while 397 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 8, 

2001. The applicant claims November 8, 

2001, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was December 8, 

2001, 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: June 30, 2008. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

ONGLYZA (NDA 22–350) was 

submitted on June 30, 2008. 

3. The date the application was 

approved: July 31, 2009. FDA has 

verified the applicant’s claim that NDA 

22–350 was approved on July 31, 2009. 

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 896 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) either 

electronic or written comments and ask 

for a redetermination by November 1, 

2010. 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 [insert date 180 days after 

date of publication in the Federal 

Register]. 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. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

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

through Friday. 

Dated: August 13, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–21583 Filed 8–30–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0431] 

Draft Guidance for Food and Drug 

Administration Staff and Tobacco 

Retailers on Civil Money Penalties and 

No-Tobacco-Sale Orders for Tobacco 

Retailers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Civil Money Penalties and No-TobaccoSale Orders for Tobacco Retailers.’’ This 

guidance document is intended to 

describe FDA’s current policies with 

respect to civil money penalties and notobacco-sale orders for retailers who 

violate requirements of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) relating to tobacco products, 

including the FD&C Act requirement 

that tobacco products may not be sold 

or distributed in violation of FDA’s 

‘‘Regulations Restricting the Sale and 

Distribution of Cigarettes and Smokeless 

Tobacco to Protect Children and 

Adolescents.’’ When this guidance 

document is final, several provisions in 

the Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act) that relate to civil money penalties 

and no-tobacco-sale orders will become 

effective. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by November 1, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the guidance entitled 

‘‘Civil Money Penalties and No-TobaccoSale Orders for Tobacco Retailers’’ to the 

Center for Tobacco Products, Food and 

Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850–3229. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request or include a fax number to 

which the guidance document may be 

sent. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Gerie A. Voss, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–287–1373, 

gerie.voss@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for FDA Staff and 

tobacco retailers entitled ‘‘Civil Money 

Penalties and No-Tobacco-Sale Orders 

for Tobacco Retailers.’’ On June 22, 

2009, President Obama signed the 

Tobacco Control Act (Public Law 111– 

31) into law . The Tobacco Control Act 

grants FDA important new authority to 

regulate the manufacture, marketing and 

distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Among its many provisions, the 

Tobacco Control Act authorizes FDA to 

impose civil money penalties for 

violations of FD&C Act requirements 

that relate to tobacco products (section 

303(f)(9) of the FD&C Act (21 U.S.C. 333 


srobinson on DSKHWCL6B1PROD with NOTICES