76990 Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices 

enrollments through Internet-based 

Provider Enrollment, Chain and 

Ownership System (PECOS). 

In order to allow a provider or 

supplier to delegate the Medicare 

credentialing process to another 

individual or organization, it is 

necessary to establish a Security 

Consent Form for those providers and 

suppliers who choose to have another 

individual or organization access their 

enrollment information and complete 

enrollments on their behalf. These users 

could consist of administrative staff, 

independent contractors, or 

credentialing departments and are 

represented as Employer Organizations. 

Employer Organizations and its 

members must request access to 

enrollment data through a Security 

Consent Form. The security consent 

form replicates business service 

agreements between Medicare 

applicants and organizations providing 

enrollment services. 

We are proposing two different 

versions of the Security Consent Form. 

The form, once signed, mailed and 

approved, grants an employer 

organization or its members access to all 

current and future enrollment data for 

the Medicare provider. Form Number: 

CMS–10220 (OMB#: 0938–1035); 

Frequency: Occasionally; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

197,500; Total Annual Responses: 

197,500; Total Annual Hours: 49,375. 

(For policy questions regarding this 

collection contact Alisha Banks at 410– 

786–0671. 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 February 8, 2011: 

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: December 6, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–31071 Filed 12–9–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0510] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; COARTEM 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

COARTEM 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 (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. 

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 COARTEM 

(artemether/lumefantrine). COARTEM is 

indicated for treatment of acute, 

uncomplicated malaria infections due to 

Plasmodium falciparum in patients of 5 

kilograms bodyweight and above. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

COARTEM (U.S. Patent No. 5,677,331) 

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 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 COARTEM 

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 

COARTEM is 285 days. Of this time, 

zero days occurred during the testing 

phase of the regulatory review period, 

while 285 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: not 

applicable. FDA has verified the 

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Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices 76991 

applicant’s claim that there was no 

investigational new drug application for 

COARTEM. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C act: June 27, 2008. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) 

22–268 was submitted on June 27, 2008. 

3. The date the application was 

approved: April 7, 2009. FDA has 

verified the applicant’s claim that NDA 

22–268 was approved on April 7, 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 284 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 8, 

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 8, 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. 2010–31074 Filed 12–9–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–E–0039 and FDA– 

2010–E–0040] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; MULTAQ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

MULTAQ 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. 

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 MULTAQ 

(dronedarone hydrochloride). MULTAQ 

is indicated to reduce the risk of 

cardiovascular hospitalization in 

patients with paroxysmal or persistent 

atrial fibrillation (AF) or atrial flutter 

(AFL), with a recent episode of AF/AFL 

and associated cardiovascular risk 

factors who are in sinus rhythm or who 

will be cardioverted. Subsequent to this 

approval, the Patent and Trademark 

Office received patent term restoration 

applications for MULTAQ (U.S. Patent 

Nos. 5,223,510 and 7,323,493) from 

Sanofi-Aventis, and the Patent and 

Trademark Office requested FDA’s 

assistance in determining the 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 MULTAQ 

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 

MULTAQ is 5,076 days. Of this time, 

3,593 days occurred during the testing 

phase of the regulatory review period, 

while 1,483 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 FFD&C act) (21 

U.S.C. 355(i)) became effective: August 

10, 1995. FDA has verified the 

applicant’s claim that the date the 

investigational new drug application 

became effective was on August 10, 

1995. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FFD&C act: June 10, 2005. 

FDA has verified the applicant’s claim 

that the first new drug application 

(NDA) for MULTAQ (NDA 21–913) was 

submitted on June 10, 2005. 

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