Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Notices 44011 

merely makes technical corrections to 

the title and effective date of the Notice 

of CMS ruling, we believe it is 

unnecessary to undergo further notice 

and comment procedures. In addition, 

we believe it is in the public interest to 

have the correct information and to have 

it as soon as possible and not delay its 

dissemination. For the reasons stated 

above, we find that both notice and 

comment procedures and the 30-day 

delay in effective date for this correction 

document are unnecessary and contrary 

to the public interest. Therefore, we find 

there is good cause to waive notice and 

comment procedures and the 30-day 

delay in effective date for this correction 

document. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: July 15, 2011. 

Dawn L. Smalls, 

Executive Secretary to the Department. 

[FR Doc. 2011–18424 Filed 7–21–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3251–N] 

Medicare Program; Meeting of the 

Medicare Evidence Development and 

Coverage Advisory Committee— 

September 21, 2011 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces that a 

public meeting of the Medicare 

Evidence Development & Coverage 

Advisory Committee (MEDCAC) 

(‘‘Committee’’) will be held on 

Wednesday, September 21, 2011. The 

Committee generally provides advice 

and recommendations concerning the 

adequacy of scientific evidence needed 

to determine whether certain medical 

items and services can be covered under 

the Medicare statute. This meeting will 

focus on the currently available 

evidence regarding antivascular 

endothelial growth factor (anti-VEGF) 

treatment of diabetic macular edema 

(DME). This meeting is open to the 

public in accordance with the Federal 

Advisory Committee Act (5 U.S.C. App. 

2, section 10(a)). 

DATES: Meeting Date: The public 

meeting will be held on Wednesday, 

September 21, 2011 from 7:30 a.m. until 

4:30 p.m., Daylight Saving Time 

(D.S.T.). 

Deadline for Submission of Written 

Comments: Written comments must be 

received at the address specified in the 

ADDRESSES section of this notice by 5 

p.m. D.S.T., Monday, August 22, 2011. 

Once submitted, all comments are final. 

Deadlines for Speaker Registration 

and Presentation Materials: The 

deadline to register to be a speaker and 

to submit PowerPoint presentation 

materials and writings that will be used 

in support of an oral presentation, is 5 

p.m., D.S.T. on Monday, August 22, 

2011. Speakers may register by phone or 

via e-mail by contacting the person 

listed in the FOR FURTHER INFORMATION

CONTACT section of this notice. 

Presentation materials must be received 

at the address specified in the 

ADDRESSES section of this notice. 

Deadline for All Other Attendees 

Registration: Individuals may register 

online at http://www.cms.gov/apps/ 

events/upcomingevents.asp?str

OrderBy=1&type=3 or by phone by 

contacting the person listed in the FOR

FURTHER INFORMATION CONTACT section of 

this notice by 5 p.m. D.S.T., Friday, 

September 16, 2011. 

We will be broadcasting the meeting 

live via Webcast at http://www.cms.gov/ 

live/. 

Deadline for Submitting a Request for 

Special Accommodations: Persons 

attending the meeting who are hearing 

or visually impaired, or have a 

condition that requires special 

assistance or accommodations, are 

asked to contact the Executive Secretary 

as specified in the FOR FURTHER

INFORMATION CONTACT section of this 

notice no later than 5 p.m., D.S.T. 

Friday, September 2, 2011. 

ADDRESSES: Meeting Location: The 

meeting will be held in the main 

auditorium of the Centers for Medicare 

& Medicaid Services, 7500 Security 

Boulevard, Baltimore, MD 21244. 

Submission of Presentations and 

Comments: Presentation materials and 

written comments that will be presented 

at the meeting must be submitted via email to 

MedCACpresentations@cms.hhs.gov or 

by regular mail to the contact listed in 

the FOR FURTHER INFORMATION CONTACT

section of this notice by the date 

specified in the DATES section of this 

notice. 

FOR FURTHER INFORMATION CONTACT: 

Maria Ellis, Executive Secretary for 

MEDCAC, Centers for Medicare & 

Medicaid Services, Office of Clinical 

Standards and Quality, Coverage and 

Analysis Group, S3–02–01, 7500 

Security Boulevard, Baltimore, MD 

21244 or contact Ms. Ellis by phone 

(410–786–0309) or via e-mail at 

Maria.Ellis@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

MEDCAC, formerly known as the 

Medicare Coverage Advisory Committee 

(MCAC), provides advice and 

recommendations to CMS regarding 

clinical issues. (For more information 

on MCAC, see the December 14, 1998 

Federal Register (63 FR 68780).) This 

notice announces the September 21, 

2011, public meeting of the Committee. 

During this meeting, the Committee will 

discuss the currently available evidence 

regarding antivascular endothelial 

growth factor (anti-VEGF) treatment of 

diabetic macular edema (DME). 

Background information about this 

topic, including panel materials, is 

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

medicare-coverage-database/indexes/

medcac-meetings-index.aspx?bc=

BAAAAAAAAAAA&. CMS will no 

longer be providing paper copies of the 

handouts for the meeting. Electronic 

copies of all the meeting materials will 

be on the CMS Web site no later than 

2 business days before the meeting. We 

encourage the participation of 

appropriate organizations with expertise 

in the treatment of diabetic retinopathy 

(DR) and DME. 

II. Meeting Format 

This meeting is open to the public. 

The agenda for the day of the meeting 

offers two opportunities for the public 

to participate as either a registered 

scheduled speaker or an unscheduled 

speaker. The Committee will hear oral 

presentations from the registered 

scheduled speakers for approximately 

45 minutes. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, CMS may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by August 25, 2011. 

Your comments should focus on issues 

specific to the list of topics that we have 

proposed to the Committee. The list of 

research topics to be discussed at the 

meeting will be available on the 

following Web site prior to the meeting: 

http://www.cms.gov/medicare-coveragedatabase/indexes/medcac-meetingsindex.aspx?bc=BAAAAAAAAAAA&. 

We require that you declare at the 

meeting whether you have any financial 

involvement with manufacturers (or 

mstockstill on DSK4VPTVN1PROD with NOTICES

44012 Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Notices 

their competitors) of any items or 

services being discussed. 

The Committee will deliberate openly 

on the topics under consideration. 

Interested persons may observe the 

deliberations, but the Committee will 

not hear further comments during this 

time except at the request of the 

chairperson. The Committee will also 

allow a 15-minute open public session 

for any unscheduled speaker to address 

issues specific to the topics under 

consideration. At the conclusion of the 

day, the members will vote and the 

Committee will make its 

recommendation(s) to CMS. 

III. Registration Instructions 

CMS’ Coverage and Analysis Group is 

coordinating meeting registration. While 

there is no registration fee, individuals 

must register to attend. You may register 

online at http://www.cms.gov/apps/

events/upcoming

events.asp?strOrderBy=1&type=3 or by 

phone by contacting the person listed in 

the FOR FURTHER INFORMATION CONTACT

section of this notice by the deadline 

listed in the DATES section of this notice. 

Please provide your full name (as it 

appears on your state-issued driver’s 

license), address, organization, 

telephone, fax number(s), and e-mail 

address. You will receive a registration 

confirmation with instructions for your 

arrival at the CMS complex or you will 

be notified the seating capacity has been 

reached. 

IV. Security, Building, and Parking 

Guidelines 

This meeting will be held in a Federal 

government building; therefore, Federal 

security measures are applicable. We 

recommend that confirmed registrants 

arrive reasonably early, but no earlier 

than 45 minutes prior to the start of the 

meeting, to allow additional time to 

clear security. Security measures 

include the following: 

• Presentation of government-issued 

photographic identification to the 

Federal Protective Service or Guard 

Service personnel. 

• Inspection of vehicle’s interior and 

exterior (this includes engine and trunk 

inspection) at the entrance to the 

grounds. Parking permits and 

instructions will be issued after the 

vehicle inspection. 

• Inspection, via metal detector or 

other applicable means of all persons 

brought entering the building. We note 

that all items brought into CMS, 

whether personal or for the purpose of 

presentation or to support a 

presentation, are subject to inspection. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for 

presentation or to support a 

presentation. 

Note: Individuals who are not registered in 

advance will not be permitted to enter the 

building and will be unable to attend the 

meeting. The public may not enter the 

building earlier than 45 minutes prior to the 

convening of the meeting. All visitors must 

be escorted in areas other than the lower and 

first floor levels in the Central Building. 

Authority: 5 U.S.C. App. 2, section 10(a). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: July 18, 2011. 

Patrick Conway, 

CMS Chief Medical Officer and Director, 

Office of Clinical Standards and Quality, 

Centers for Medicare & Medicaid Services. 

[FR Doc. 2011–18562 Filed 7–21–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–P–0577 and FDA– 

2010–P–0579] 

Determination That NUVIGIL 

(Armodafinil) Tablets, 100 Milligrams 

and 200 Milligrams, Were Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that NUVIGIL (armodafinil) Tablets, 100 

milligrams (mg) and 200 mg, were not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for armodafinil 

tablets, 100 mg and 200 mg, if all other 

legal and regulatory requirements are 

met. 

FOR FURTHER INFORMATION CONTACT: 

Molly Flannery, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6237, 

Silver Spring, MD 20993–0002, 301– 

796–3543. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). The only clinical data required 

in an ANDA are data to show that the 

drug that is the subject of the ANDA is 

bioequivalent to the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

NUVIGIL (armodafinil) Tablets, 100 

mg and 200 mg, are the subject of NDA 

21–875, held by Cephalon, Inc., and 

initially approved on June 15, 2007. 

NUVIGIL is indicated to improve 

wakefulness in patients with excessive 

sleepiness associated with obstructive 

sleep apnea, narcolepsy, and shift work 

disorder. 

NUVIGIL (armodafinil) Tablets, 100 

mg and 200 mg, are currently listed in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Actavis, Inc., submitted a citizen 

petition dated November 9, 2010 

(Docket No. FDA–2010–P–0579), under 

21 CFR 10.30, requesting that the 

Agency determine that NUVIGIL 

(armodafinil) Tablets, 100 mg and 200 

mg, were not voluntarily withdrawn for 

safety or efficacy reasons. Watson 

Laboratories, Inc., also submitted a 

mstockstill on DSK4VPTVN1PROD with NOTICES