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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24016 Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Aviva Walker-Sicard, (410) 786–8648. 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a hospice provided certain 

requirements are met. Sections 

1861(dd)(2) of the Social Security Act 

(the Act) establish distinct criteria for 

facilities seeking designation as a 

hospice program. Regulations 

concerning provider agreements are at 

42 CFR part 489 and those pertaining to 

activities relating to the survey and 

certification of facilities are at 42 CFR 

part 488. The regulations at 42 CFR part 

418, specify the conditions that a 

hospice must meet in order to 

participate in the Medicare program, the 

scope of covered services, and the 

conditions for Medicare payment for 

Hospice care. 

Generally, in order to enter into a 

provider agreement with the Medicare 

program, a hospice must first be 

certified by a State survey agency as 

complying with the conditions or 

requirements set forth in part 418 of our 

regulations. Thereafter, the hospice is 

subject to regular surveys by a State 

survey agency to determine whether it 

continues to meet these requirements. 

There is an alternative, however, to 

surveys by State agencies. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

If an accrediting organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national 

accrediting organization applying for 

deeming authority under part 488, 

subpart A, must provide us with 

reasonable assurance that the 

accrediting organization requires the 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the 

reapproval of accrediting organizations 

are set forth at § 488.4 and § 488.8(d)(3). 

The regulations at § 488.8(d)(3) require 

accrediting organizations to reapply for 

continued deeming authority every 6 

years or as we determine. 

CHAP’s term of approval as a 

recognized accreditation program for 

hospices expires November 21, 2009. 

II. Approval of Deeming Organizations 

Section 1865(a)(2) of the Act and our 

regulations at § 488.8(a) require that our 

findings concerning review and 

reapproval of a national accrediting 

organization’s requirements consider, 

among other factors, the applying 

accrediting organization’s: 

Requirements for accreditation; survey 

procedures; resources for conducting 

required surveys; capacity to furnish 

information for use in enforcement 

activities; monitoring procedures for 

provider entities found not in 

compliance with the conditions or 

requirements; and ability to provide us 

with the necessary data for validation. 

Section 1865(a)(3)(A) of the Act 

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accrediting 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We have 210 days from the receipt of a 

complete application to publish notice 

of approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of CHAP’s 

request for continued deeming authority 

for hospices. This notice also solicits 

public comment on whether CHAP’s 

requirements meet or exceed the 

Medicare conditions for participation 

for hospices. 

III. Evaluation of Deeming Authority 

Request 

CHAP submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

reapproval as a deeming organization 

for hospices. This application was 

determined to be complete on March 27, 

2009. Under section 1865(a)(2) of the 

Act and our regulations at § 488.8 

(Federal review of accrediting 

organizations), our review and 

evaluation of CHAP will be conducted 

in accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of CHAP’s 

standards for a hospice as compared 

with CMS’ hospice conditions of 

participation. 

• CHAP’s survey process to 

determine the following: 

—The composition of the survey team, 

surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

—The comparability of CHAP’s 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

—CHAP’s processes and procedures for 

monitoring hospices found out of 

compliance with CHAP’s program 

requirements. These monitoring 

procedures are used only when CHAP 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews, the State survey 

agency monitors corrections as 

specified at § 488.7(d). 

—CHAP’s capacity to report deficiencies 

to the surveyed facilities and respond 


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Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices 24017 

to the facility’s plan of correction in 

a timely manner. 

—CHAP’s capacity to provide us with 

electronic data and reports necessary 

for effective validation and 

assessment of the organization’s 

survey process. 

—The adequacy of CHAP’s staff and 

other resources, and its financial 

viability. 

—CHAP’s capacity to adequately fund 

required surveys. 

—CHAP’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys 

are unannounced. 

—CHAP’s agreement to provide us with 

a copy of the most current 

accreditation survey together with any 

other information related to the 

survey as we may require (including 

corrective action plans). 

IV. Response to Public Comments and 

Notice Upon Completion of Evaluation 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a final notice in the Federal 

Register announcing the result of our 

evaluation. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: May 14, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–12031 Filed 5–21–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1407–N] 

Medicare Program; Public Meeting in 

Calendar Year 2009 for New Clinical 

Laboratory Tests Payment 

Determinations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 

public meeting to receive comments and 

recommendations (and data on which 

recommendations are based) from the 

public on the appropriate basis for 

establishing payment amounts for a 

specified list of new Clinical Procedural 

Terminology (CPT) codes for clinical 

laboratory tests in calendar year (CY) 

2010. The meeting provides a forum for 

interested parties to make oral 

presentations and submit written 

comments on the new codes that will be 

included in Medicare’s Clinical 

Laboratory Fee Schedule for CY 2010, 

which will be effective on January 1, 

2010. The development of the codes for 

clinical laboratory tests is largely 

performed by the CPT Editorial Panel 

and will not be further discussed at the 

Centers for Medicare & Medicaid 

Services (CMS) meeting. 

DATES: Meeting Date: The public 

meeting is scheduled for Tuesday, July 

14, 2009 from 9 a.m. to 2 p.m., Eastern 

Standard Time (E.S.T.). 

Deadline for Registration of 

Presenters: All presenters for the public 

meeting must register by July 9, 2009. 

Deadline for Submitting Requests for 

Special Accommodations: Requests for 

special accommodations must be 

received no later than 5 p.m., E.S.T. on 

July 9, 2009, the final day of 

registration. 

Deadline for Submission of Written 

Comments: Interested parties may 

submit written comments on the 

proposed payment determinations by 

September 18, 2009, to the address 

specified in the ADDRESSES section of 

this notice. 

ADDRESSES: The public meeting will be 

held in the main auditorium of the 

central building of the Centers for 

Medicare & Medicaid Services (CMS), 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

FOR FURTHER INFORMATION CONTACT: 

Glenn McGuirk, (410) 786–5723. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 531(b) of the Medicare, 

Medicaid, and SCHIP Benefits 

Improvement and Protection Act of 

2000 (BIPA) (Pub. L. 106–554) required 

the Secretary to establish procedures for 

coding and payment determinations for 

new clinical diagnostic laboratory tests 

under Part B of title XVIII of the Social 

Security Act (the Act) that permit public 

consultation in a manner consistent 

with the procedures established for 

implementing coding modifications for 

International Classification of Diseases 

(ICD–9–CM). The procedures and public 

meeting announced in this notice for 

new clinical laboratory tests are in 

accordance with the procedures 

published on November 23, 2001 in the 

Federal Register (66 FR 58743) to 

implement section 531(b) of BIPA. 

Section 942(b) of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) (Pub. 

L. 108–173) added section 1833(h)(8)(B) 

of the Act, which sets forth the methods 

for determining payment bases for new 

tests. Section 1833(h)(8)(A) of the Act 

states that new tests are any clinical 

diagnostic laboratory tests with respect 

to which a new or substantially revised 

health care common procedures code 

(HCPCS) is assigned on or after January 

1, 2005 (hereinafter referred to as, ‘‘new 

test’’ or ‘‘new clinical laboratory test’’). 

Pertinent to this notice, section 

1833(h)(8)(B)(i) and (ii) of the Act 

requires the Secretary to make available 

to the public a list that includes new 

tests for which establishment of a 

payment amount is being considered for 

a year and, on the same day that the list 

is made available, to publish in the 

Federal Register a notice of a meeting 

to receive comments and 

recommendations (and data on which 

recommendations are based) from the 

public on the appropriate basis for 

establishing payment amounts for new 

tests. Section 1833(h)(8)(B)(iii) of the 

Act requires that we convene a public 

meeting not less than 30 days after 

publication of the notice in the Federal 

Register. These requirements are 

codified at 42 CFR part 414, subpart G. 

A newly created Current Procedural 

Terminology (CPT) code can either 

represent a refinement or modification 

of existing test methods, or a 

substantially new test method. The 

preliminary list of newly created CPT 

codes for calendar year (CY) 2010 will 

be published on our Web site at 

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

ClinicalLabFeeSched when this notice is 

published in the Federal Register. 

Two methods are used to establish 

payment amounts for new tests 


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