53314 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices 

TABLE 1.—PROPOSED DESIGN (4 X 5 + 2) 

Information Type 

Efficacy Level 

Smallest Effect Smaller Effect Mid-Size Effect Larger Effect Largest Effect 

Absolute Frequency 81% vs. 82% 61% vs. 82% 41% vs. 82% 21% vs. 82% 1% vs. 82% 

Absolute Frequency + 

Qualitative Label 

Fewer 

81% vs. 82% 

Fewer 

61% vs. 82% 

Fewer 

41% vs. 82% 

Fewer 

21% vs. 82% 

Fewer 

1% vs. 82% 

Absolute Difference + 

Qualitative Label 

Fewer (1%) Fewer (21%) Fewer (41%) Fewer (61%) Fewer (81%) 

Absolute Frequency + 

Absolute Difference + 

Qualitative Label 

Fewer (1%) 

81% vs. 82% 

Fewer (21%) 

61% vs. 82% 

Fewer (41%) 

41% vs. 82% 

Fewer (61%) 

21% vs. 82% 

Fewer (81%) 

1% vs. 82% 

Note. Two other cells will be tested: (1) No information and (2) Qualitative label only (fewer). This design (22 cells) will also be used to test risk 

information (for a total of 44 cells). The specific numbers in the table are placeholders only. Qualitative label example: ‘‘fewer people taking drug 

X had disease/symptom Y.’’ 

The test product will be for the 

treatment of high prevalence medical 

condition and modeled on an actual 

drug used to treat that condition. 

Participants will be consumers who 

have been diagnosed with the medical 

condition of interest. They will be 

randomly assigned to read one ad 

version. After reading the ad, 

participants will answer a series of 

questions about the drug. We will test 

how the information type affects 

perceived efficacy, perceived risk, 

behavioral intention, and accurate 

understanding of the benefit and risk 

information. 

Interviews are expected to last no 

more than 20 minutes. A total of 11,750 

participants will be involved in the 

study. This will be a one-time (rather 

than annual) collection of information. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Pretest 750 1 750 20 minutes 250 

Main Study 11,000 1 11,000 20 minutes 3,667 

Total 3,917 

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

Dated: August 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21629 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–2009–E–0084] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; PRISTIQ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

PRISTIQ and is publishing this notice of 

that determination as required by law. 

FDA has made the determination 

because of the submission of 

applications to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of patents 

which claim 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 


srobinson on DSKHWCL6B1PROD with NOTICES
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