Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices 29559 

violation of the requirements of the 

Agreement or other good cause shown. 

The termination shall not be effective 

earlier than 30 days after the date of 

notice to the Manufacturer of such 

termination. 

(c) The Secretary shall provide, upon 

request, a Manufacturer a hearing with 

a hearing officer concerning such 

termination if requested in writing 

within 15 days of receiving notice of the 

termination, and such hearing shall take 

place prior to the effective date of the 

termination with sufficient time for 

such effective date to be repealed if the 

Secretary determines appropriate. If the 

Manufacturer receives an unfavorable 

decision from the hearing officer, the 

Manufacturer may request review by the 

CMS Administrator. The decision of the 

CMS Administrator is final and binding. 

(d) The Manufacturer may terminate 

this Agreement for any reason. Any 

such termination shall be effective as of 

the day after the end of the plan year if 

the termination occurs before January 30 

of a plan year or as of the day after the 

end of the succeeding plan year if the 

termination occurs on or after January 

30 of a plan year. 

(e) Any termination shall not affect 

applicable discounts for applicable 

drugs of the Manufacturer that were 

incurred under the Agreement before 

the effective date of its termination. 

(f) Manufacturer reinstatement will be 

available only upon payment of any and 

all outstanding applicable discounts 

incurred during any previous period of 

the Agreement. The timing of any such 

reinstatements will be consistent with 

the requirements for entering into an 

Agreement under section 1860D– 

14A(b)(1)(C) of the Act. 

VIII. General Provisions 

(a) Any notice required to be given 

pursuant to the terms and provisions of 

this Agreement will be sent in writing. 

1. Notice to the Secretary will be sent 

to: Center for Medicare, Division of 

Pharmaceutical Manufacturer 

Management, Mailstop C1–26–16, 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

2. The CMS address may be updated 

upon written notice to the 

Manufacturer. 

3. Notices to the Manufacturer will be 

sent to the address as provided with this 

Agreement and updated upon 

Manufacturer notification to CMS at the 

address in this Agreement. 

(b) In the event of a transfer in 

ownership of the Manufacturer or 

product, this Agreement is 

automatically assigned to the new 

owner, and all terms and conditions of 

this Agreement remain in effect. 

(c) Nothing in this Agreement will be 

construed to require or authorize the 

commission of any act contrary to law. 

If any provision of this Agreement is 

found to be invalid by a court of law 

with competent jurisdiction, this 

Agreement will be construed in all 

respects as if any invalid or 

unenforceable provision were 

eliminated, and without any effect on 

any other provision. 

(d) Nothing in this Agreement shall be 

construed as a waiver or relinquishment 

of any legal rights of the Manufacturer 

or the Secretary under the Constitution, 

the Act, other Federal laws, or State 

laws. 

(e) This Agreement shall be construed 

in accordance with Federal law and 

ambiguities shall be interpreted in the 

manner which best effectuates the 

statutory scheme. 

(f) The terms ‘‘Medicare’’ and 

‘‘Manufacturer’’ incorporate any 

contractors which fulfill responsibilities 

pursuant to the Agreement unless 

specifically provided for in this 

Agreement or specifically agreed to by 

an appropriate CMS official in 

accordance with paragraph (g) of this 

section. 

(g) Except for the conditions specified 

in section VIII.(a) of this Agreement, this 

Agreement once finalized, will not be 

altered by the parties. 

(h) Nothing in this Agreement shall be 

construed as requiring coverage under 

Part D of a Manufacturer’s product if 

that product does not otherwise meet 

the definition of a covered Part D drug 

under 42 CFR 423.100. 

IX. Signatures 

FOR THE SECRETARY OF HEALTH 

AND HUMAN SERVICES 

By: llllllllllllllll

(please print name) 

lllllllllllllllllll

(signature) 

Title: lllllllllllllll

Date: llllllllllllllll

ACCEPTED FOR THE 

MANUFACTURER 

I certify that I have made no 

alterations, amendments or other 

changes to this Coverage Gap Discount 

Program Agreement. 

By: llllllllllllllll

(please print name) 

lllllllllllllllllll

(signature) 

Title: lllllllllllllll

Name of Manufacturer: lllllll

Manufacturer’s Mailing Address: lll

Manufacturer’s E-mail Address: lll

Manufacturer labeler Code(s): llll

Date: llllllllllllllll

Authority: Section 3301 of the Patient 

Protection Affordable Care Act and section 

1101 of the Health Care and Education 

Reconciliation Act of 2010 (Sections 1860D– 

43 and 1860D–14A of the Social Security 

Act) Program No. 93.774, Medicare— 

Supplementary Medical Insurance Program). 

Dated: May 13, 2010. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: May 20, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–12559 Filed 5–21–10; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

The 13th Annual Food and Drug 

Administration-Orange County 

Regulatory Affairs Educational 

Conference in Irvine, California: 

‘‘Regulatory Affairs: The Business of 

Regulatory Affairs’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of conference. 

The Food and Drug Administration 

(FDA) is announcing the following 

conference: 13th Annual Educational 

Conference co-sponsored with the 

Orange County Regulatory Affairs 

Discussion Group (OCRA). The 

conference is intended to provide the 

drug, device, biologics and dietary 

supplement industries with an 

opportunity to interact with FDA 

reviewers and compliance officers from 

the centers and District Offices, as well 

as other industry experts. The main 

focus of this interactive conference will 

be product approval, compliance, and 

risk management in the four medical 

product areas. Industry speakers, 

interactive Q & A, and workshop 

sessions will also be included to assure 

open exchange and dialogue on the 

relevant regulatory issues. 

Date and Time: The conference will 

be held on June 16 and 17, 2010, from 

7:30 a.m. to 5 p.m. 

Location: The conference will be held 

at the Irvine Marriott, 18000 Von 

Karman Ave., Irvine, CA 92612. 

Contact: Linda Hartley, Food and 

Drug Administration, 19701 Fairchild, 

Irvine, CA 92612, Voice: 949–608–4413, 

FAX: 949–608–4417; or Orange County 

Regulatory Affairs Discussion Group 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
29560 Federal Register / Vol. 75, No. 101 / Wednesday, May 26, 2010 / Notices 

(OCRA), Attention to Detail, 5319 

University Dr., suite 641, Irvine, CA 

92612, Voice: 949–387–9046, FAX: 949– 

387–9047, Web site: www.ocra-dg.org. 

Registration and Meeting Information: 

See OCRA’s Web site at www.ocradg.org. Contact Attention to Detail at 

949–387–9046. 

Registrations fees are as follows: 

$725.00 for members, $775.00 for nonmembers, and $475.00 for FDA/ 

Government/Students. OCRA student 

rate applies to those individuals 

enrolled in a regulatory or quality 

related academic program at an 

accredited institution. Proof of 

enrollment is required. 

The registration fee will cover actual 

expenses including refreshments, lunch, 

materials, parking, and speaker 

expenses. 

If you need special accommodations 

due to a disability, please contact Linda 

Hartley (see Contact) at least 10 days in 

advance. 

Dated: May 20, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–12615 Filed 5–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0237] 

Identifying Unmet Public Health Needs 

and Facilitating Innovation in Medical 

Device Development; Notice of Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Identifying Unmet Public 

Health Needs and Facilitating 

Innovation in Medical Device 

Development.’’ The purpose of the 

workshop is to obtain public input on 

what are the most important unmet 

public health needs and what are the 

barriers to the development of medical 

devices that can cure, significantly 

improve, or prevent these illnesses and 

injuries. 

Dates and Times: This workshop will 

be held on June 24, 2010, from 8 a.m. 

to 5 p.m. Persons interested in attending 

the meeting must register by 5 p.m. on 

June 10, 2010. Submit electronic or 

written comments by July 23, 2010. 

Location: The public workshop will 

be held at Hilton Washington DC/North 

Gaithersburg, 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Contact Person: Melanie Fleming, 

Office of the Center Director, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 5407, 

Silver Spring, MD 20993, 301–796– 

5424, FAX: 301–847–8510, 

melanie.fleming@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: Interested persons may 

register at http://www.fda.gov/ 

MedicalDevices/NewsEvents/ 

WorkshopsConferences/default.htm 

(select the appropriate meeting from the 

list). Registrants must provide the 

following information: (1) name, (2) 

title, (3) company or organization (if 

applicable), (4) mailing address, (5) 

telephone number, and (6) e-mail 

address. There is no registration fee for 

the public workshop. Early registration 

is recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 7:30 

a.m. 

If you wish to make an oral 

presentation during any of the open 

comment sessions at the meeting (see 

section II of this document), you must 

indicate this at the time of registration. 

FDA requests that presentations focus 

on the areas defined in section III of this 

document. You should also identify 

which discussion topic you wish to 

address in your presentation and you 

must submit a brief statement that 

describes your experience and/or 

expertise relevant to your proposed 

presentation. In order to keep each open 

session focused on the discussion topic 

at hand, each oral presentation should 

address only one discussion topic. FDA 

will do its best to accommodate requests 

to speak. 

If you need special accommodations 

due to a disability, please contact 

Melanie Fleming (see Contact Person) at 

least 7 days in advance. 

Comments: FDA is holding this public 

workshop to obtain information on a 

number of specific questions regarding 

unmet public health needs and steps the 

Federal Government can take to reduce 

barriers to the development of medical 

devices that can cure, significantly 

improve, or prevent these illnesses and 

injuries. The deadline for submitting 

comments regarding this public 

workshop is July 23, 2010. 

Regardless of attendance at the public 

workshop, interested persons may 

submit electronic comments to http:// 

www.regulations.gov, or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. In addition, 

when responding to specific questions 

as outlined in section III of this 

document, please identify the question 

you are addressing. Received comments 

may be seen in the Division of Dockets 

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

Monday through Friday. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA’s Center for Devices and 

Radiological Health (CDRH) has 

undertaken an initiative to proactively 

facilitate medical device innovation to 

address unmet public health needs 

defined as illnesses and injuries that 

meet the following criteria: (1) Are 

serious or have moderate adverse 

impact on health, but affect many 

individuals; (2) could be cured, 

significantly improved, or prevented by 

the development or redesign of a device; 

and (3) the device(s) is not being 

developed or redesigned due to barriers 

that the Federal Government can 

directly or indirectly remove or 

minimize, where those barriers are out 

of proportion to what is warranted 

based on the public health needs. 

Medical device development and/or 

redesign is responsible for significant 

public health benefits, including the 

prevention, treatment, diagnosis, and 

monitoring of serious or life-threatening 

diseases and improved quality of life. 

However, unnecessary barriers to 

market may exist either due to market 

failures or regulatory inefficiencies. For 

example, payment practices can affect 

financial incentives for manufacturers to 

develop a new or improved technology. 

A predictable and consistent regulatory 

pathway can encourage would-be 

innovators to invest in the development 

of an innovative device. 

As part of this initiative, CDRH 

established a Council on Medical Device 

Innovation composed of participants 

from federal agencies. Agencies 

represented include the National 

Institutes of Health, the Centers for 

Disease Control and Prevention, the 

Centers for Medicare and Medicaid 

Services, the Agency for Healthcare 

Research and Quality, the Department of 

Defense, the Defense Advanced 

Research Projects Agency, and the 

Department of Veterans Affairs. The 

purpose of the Council is to identify the 

most important unmet public health 

needs, the barriers to innovative 

medical device development or redesign 

that could address those needs, and 

actions the Federal Government can 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1