Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices 55331 

that they will establish a Medicaid RAC 

program. States have broad discretion 

regarding the Medicaid RAC program 

design and the number of entities with 

which they elect to contract. Many 

States already have experience utilizing 

contingency-fee-based Third Party 

Liability recovery contractors. Form 

Number: CMS–10343 (OMB#: 0938– 

NEW); Frequency: Once; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 56. (For policy questions 

regarding this collection contact Mary Jo 

Cook at 410–786–3231 or Eva Tetteyfio 

at 410–786–3653. For all other issues 

call 410–786–1326.) 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Advance 

Beneficiary Notice of Noncoverage 

(ABN); Use: Under section 1879 of the 

Social Security Act, a physician, 

provider, practitioner, or supplier of 

items or services participating in the 

Medicare program, or taking a claim on 

assignment, may bill a Medicare 

beneficiary for items or services usually 

covered under Medicare, but denied in 

an individual case under one of the 

several statutory exclusions, if they 

inform the beneficiary, prior to 

furnishing the service, that Medicare is 

likely to deny payment. Sections 42 CFR 

411.404(b) and (c), and 411.408(d)(2) 

and (f), require written notice be 

provided to inform beneficiaries in 

advance of potential liability for 

payment. Form Number: CMS–R–131 

(OMB#: 0938–0566); Frequency: 

Reporting: Weekly, Monthly, Yearly, 

Biennially and Occasionally; Affected 

Public: Private Sector: Business or other 

for-profits and Not-for-profit 

institutions; Number of Respondents: 

1,326,282 ; Total Annual Responses: 

43,725,850; Total Annual Hours: 

5,099,309. (For policy questions 

regarding this collection contact Evelyn 

Blaemire at 410–786–1803. For all other 

issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by November 9, 2010: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: September 3, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–22593 Filed 9–9–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0041] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; SAPHRIS 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

SAPHRIS 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 SAPHRIS 

(asenapine). SAPHRIS is an atypical 

antipsychotic indicated for acute 

treatment of schizophrenia in adults and 

acute treatment of manic or mixed 

episodes associated with bipolar I 

disorder in adults. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for SAPHRIS (U.S. Patent 

No. 5,763,476) from NV Organon, 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 SAPHRIS 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. 


srobinson on DSKHWCL6B1PROD with NOTICES
55332 Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices 

FDA has determined that the 

applicable regulatory review period for 

SAPHRIS is 4,547 days. Of this time, 

3,833 days occurred during the testing 

phase of the regulatory review period, 

while 714 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: March 4, 1997. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on March 4, 1997. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: August 31, 2007. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

SAPHRIS (NDA 22–117) was submitted 

on August 31, 2007. 

3. The date the application was 

approved: August 13, 2009. FDA has 

verified the applicant’s claim that NDA 

22–117 was approved on August 13, 

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 1,827 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 9, 

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 March 9, 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: August 13, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–22519 Filed 9–9–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0527] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ULORIC 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ULORIC 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 ULORIC 

(febuxostat). ULORIC is indicated for 

chronic management of hyperuricemia 

in patients with gout. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for ULORIC (U.S. Patent No. 

5,614,520) from Teijin Pharma 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 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 ULORIC 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 

ULORIC is 3,395 days. Of this time, 

1,873 days occurred during the testing 

phase of the regulatory review period, 

while 1,522 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 31, 

1999. The applicant claims April 28, 

1999, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was October 31, 1999, 

which was 30 days after FDA receipt of 

the active IND. 


srobinson on DSKHWCL6B1PROD with NOTICES