Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices 77879 

FDA recently approved for marketing 

the medical device, FREESTYLE 

NAVIGATOR. FREESTYLE 

NAVIGATOR is indicated for 

continually recording interstitial fluid 

glucose levels in people (ages 18 and 

older) with diabetes mellitus for the 

purpose of improving diabetes 

management. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for FREESTYLE 

NAVIGATOR (U.S. Patent No. 

5,262,035) from Abbott Diabetes Care 

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 

February 17, 2010, FDA advised the 

Patent and Trademark Office that this 

medical device had undergone a 

regulatory review period and that the 

approval of FREESTYLE NAVIGATOR 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the Patent and 

Trademark Office requested that the 

FDA determine the product’s regulatory 

review period. FDA has determined that 

the applicable regulatory review period 

for FREESTYLE NAVIGATOR is 2,320 

days. Of this time, 750 days occurred 

during the testing phase of the 

regulatory review period, while 1,570 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date clinical investigation on 

humans is begun as approved by an 

institutional review board (IRB) under 

section 520(g)(3) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) and 

when no investigational device 

exemption (IDE) is required: November 

6, 2001. The applicant claims that 

investigation of the device qualified for 

a non-significant risk study for the 

purpose of establishing clinical data 

necessary to support a subsequent 

premarket approval under section 515 of 

the FD&C Act. FDA has verified the 

applicant’s claim that the device did not 

require an IDE under section 520(g) of 

the FD&C act, but did require IRB 

approval, granted November 6, 2001, for 

human tests to begin. This date 

represents the beginning of the testing 

phase of the regulatory review period. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the FD&C 

Act (21 U.S.C. 360e): November 25, 

2003. The applicant claims November 

24, 2003, as the date the first premarket 

approval application (PMA) for 

FREESTYLE NAVIGATOR (PMA 

P030048) was initially submitted. 

However, FDA records indicate that 

PMA P030048 was submitted on 

November 25, 2003. 

3. The date the application was 

approved: March 12, 2008. FDA has 

verified the applicant’s claim that PMA 

P050020 was approved on March 12, 

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) either 

electronic or written comments and ask 

for a redetermination by February 14, 

2011. 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 June 13, 2011. 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: October 22, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–31240 Filed 12–13–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–E–0037 and FDA– 

2010–E–0038] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; SAMSCA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

SAMSCA 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 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 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. 


srobinson on DSKHWCL6B1PROD with NOTICES
77880 Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices 

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 SAMSCA 

(tolvaptan). SAMSCA is indicated for 

the treatment of clinically significant 

hypervolemic and euvolemic 

hyponatremia, including patients with 

heart failure, cirrhosis, and Syndrome of 

Inappropriate Antidiuretic Hormone. 

Subsequent to this approval, the Patent 

and Trademark Office received patent 

term restoration applications for 

SAMSCA (U.S. Patent Nos. 5,258,510 

and 5,753,677) from Otsuka 

Pharmaceutical Co., Ltd., and the Patent 

and Trademark Office requested FDA’s 

assistance in determining these patents’ 

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 SAMSCA 

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 

SAMSCA is 4,722 days. Of this time, 

4,147 days occurred during the testing 

phase of the regulatory review period, 

while 575 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 FD&C Act) (21 

U.S.C. 355(i)) became effective: June 16, 

1996. The applicant claims October 23, 

1997, as the date the investigational new 

drug application (IND) became effective. 

However, according to FDA records, this 

IND was not the first IND received for 

this active ingredient. In general, FDA 

has used the first IND of the active 

ingredient of the drug product as the 

beginning of the testing phase, if 

information derived from this first IND 

was or could have been relied on or was 

relevant for approval to market the drug 

product. FDA records indicate that the 

effective date of the first IND for 

tolvaptan was June 16, 1996, which was 

30 days after FDA receipt of this first 

IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: October 23, 

2007. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for SAMSCA (NDA 22–275) was 

submitted on October 23, 2007. 

3. The date the application was 

approved: May 19, 2009. FDA has 

verified the applicant’s claim that NDA 

22–275 was approved on May 19, 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 applications for patent extension, 

this applicant seeks 1,826 days or 1,827 

days respectively 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 February 14, 

2011. 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 June 13, 2011. 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: October 22, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–31298 Filed 12–13–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; GuLF Worker Study: Gulf 

Long-Term Follow-Up Study for Oil 

Spill Clean-Up Workers and Volunteers 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute of Environmental Health 

Sciences (NIEHS), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on 7 October 2010 

on pages 62132–3 and allowed 60-days 

for public comment. One public 

comment was received and addressed 

regarding the appropriateness and 

sources for funding the survey. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

5 CFR 1320.5: Reporting and 

Recordkeeping Requirements: Final 

Rule: Respondents to this collection of 

information are not required to respond 

unless the data collection instruments 

display a currently valid OMB control 

number. 

Proposed Collection 

Title: GuLF Worker Study: Gulf LongTerm Follow-Up Study for Oil Spill 

Clean-Up Workers and Volunteers. Type 

of Information Collection Request: New. 

Need and Use of Information Collection: 

The purpose of the GuLF Study is to 

investigate potential short- and longterm health effects associated with oil 

spill clean-up activities and exposures 

surrounding the Deepwater Horizon 

disaster; and to create a resource for 

additional collaborative research on 

focused hypotheses or subgroups. Over 

55,000 persons participating in oil-spill 

clean-up activities have been exposed to 

a range of known and suspected toxins 

in crude oil, burning oil, and 

dispersants, to excessive heat, and 

possibly to stress due to widespread 

economic and lifestyle disruption. 

Exposures range from negligible to 

potentially significant, however, 

potential long-term human health 


srobinson on DSKHWCL6B1PROD with NOTICES