24014 Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare Part D 

Reporting Requirements and Supporting 

Regulations under 42 CFR 423.505; 

Form Number: CMS–10185 (OMB#: 

0938–0992); Use: Title I, Part 423, 

§ 423.514 describes CMS’ regulatory 

authority to establish requirements for 

Part D sponsors. It is noted that each 

Part D plan sponsor must have an 

effective procedure to develop, compile, 

evaluate, and report to CMS, its 

enrollees, and the general public, at the 

times and in the manner that CMS 

requires, statistics in the following 

areas: (1) The cost of its operations; (2) 

The availability of utilization of its 

services; (3) The availability, 

accessibility; and acceptability of its 

services; (4) Information demonstrating 

that the Part D plan sponsor has a 

fiscally sound operation; and (5) other 

matters that CMS may require. 

Subsection 423.505 of the Medicare 

Prescription Drug Modernization and 

Modernization Act establishes as a 

contract provision that Part D Sponsors 

must comply with the reporting 

requirements for submitting drug claims 

and related information to CMS. Data 

collected via Medicare Part D Reporting 

Requirements will be an integral 

resource for oversight, monitoring, 

compliance and auditing activities 

necessary to ensure quality provision of 

the Medicare Prescription Drug Benefit 

to beneficiaries. Please see the 

supporting documentation, ‘‘Revisions 

to 2nd Draft of CY 2010 Part D 

Reporting Requirements’’ document to 

view a list of current changes. 

Frequency: Reporting—yearly, quarterly 

and semi-annually; Affected Public: 

Business or other for-profit; Number of 

Respondents: 4,526; Total Annual 

Responses: 380,184; Total Annual 

Hours: 157,450. (For policy questions 

regarding this collection contact Alice 

Lee-Martin at 410–786–4578. For all 

other issues call 410–786–1103.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Prescription Drug Benefit Plan Program: 

Use: Part D plans use the information 

discussed to comply with the eligibility 

and associated Part D participating 

requirements. CMS will use this 

information to approve contract 

applications, monitor compliance with 

contract requirements, make proper 

payment to plans, and to ensure that 

correct information is disclosed to 

enrollees, both potential and current 

enrollees. Form Number: CMS–10141 

(OMB#: 0938–0964); Frequency: 

Reporting—quarterly, semi-annually 

and yearly; Affected Public: Business or 

other for-profits and Individuals or 

households; Number of Respondents: 

19,937,772; Total Annual Responses: 

38,152,764; Total Annual Hours: 

34,730,676. (For policy questions 

regarding this collection contact 

Eugenia Mattison-Gibson at 410–786– 

2564. 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 

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

PaperworkReductionActof1995, or 

E-mail 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on June 22, 2009: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: May 15, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–11939 Filed 5–21–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–E–0307] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; INTELENCE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

INTELENCE 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 written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

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 human drug 

product 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 


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Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices 24015 

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 INTELENCE 

(etravirine). INTELENCE, in 

combination with other antiretroviral 

agents, is indicated for the treatment of 

HIV–1 infection in treatmentexperienced adult patients who have 

evidence of viral replication and HIV– 

1 strains resistant to an NNRTYI and 

other retroviral agents. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for INTELENCE (U.S. Patent 

No. 7,037,917) from Janssen 

Pharmaceutica, N.V., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated June 10, 2008, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of INTELENCE 

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 

INTELENCE is 2,235 days. Of this time, 

2,050 days occurred during the testing 

phase of the regulatory review period, 

while 185 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 7, 

2001. The applicant claims December 

27, 2001, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

December 7, 2001. The applicant was 

notified by telephone on December 7, 

2001, that they were allowed to proceed 

with clinical trials. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: July 18, 2007. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) for 

INTELENCE (NDA 22–187) was initially 

submitted on July 18, 2007. 

3. The date the application was 

approved: January 18, 2008. FDA has 

verified the applicant’s claim that NDA 

22–187 was approved on January 18, 

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 404 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) written or 

electronic comments and ask for a 

redetermination by July 21, 2009. 

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 

November 18, 2009. 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. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

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

Monday through Friday. 

Dated: May 13, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–12050 Filed 5–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[CMS–2900–PN] 

Medicare and Medicaid Programs; 

Application by the Community Health 

Accreditation Program for Continued 

Deeming Authority for Hospices 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of a deeming 

application from the Community Health 

Accreditation Program (CHAP) for 

continued recognition as a national 

accrediting organization for hospices 

that wish to participate in the Medicare 

or Medicaid programs. The statute 

requires that within 60 days of receipt 

of an organization’s complete 

application, we publish a notice that 

identifies the national accrediting body 

making the request, describes the nature 

of the request, and provides at least a 

30-day public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on June 22, 2009. 

ADDRESSES: In commenting, please refer 

to file code CMS–2900–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–2900–PN, P.O. Box 8010, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address only: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–2900–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 


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