Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices 76471 

substantial impact on prevention 

program development and monitoring at 

the local, State, and national levels. 

CDC estimates that NHBS will 

involve, per year in each of the 25 

MSAs, eligibility screening of 50 to 200 

persons and eligibility screening plus 

the behavioral assessment with 500 

eligible respondents, resulting in a total 

of 37,500 eligible survey respondents 

and 7,500 ineligible screened persons 

during a 3-year period. Data collection 

will rotate such that interviews will be 

conducted among one group per year: 

MSM in year 1, IDU in year 2, and HET 

in year 3. The type of data collected for 

each group will vary slightly due to 

different sampling methods and risk 

characteristics of the group. 

Participation of respondents is 

voluntary and there is no cost to the 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondent Form Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(hours) 

Total burden 

(in hours) 

Year 1: 

Men Approached at Eligible 

Venue.

Screener ........................................... 17,500 1 5/60 1,458 

Eligible Men ............................... Behavioral Assessment .................... 12,500 1 60/60 12,500 

Year 2: 

Injecting Drug Users Referred 

by Peer Recruiters.

Screener ........................................... 13,750 1 5/60 1,146 

Eligible Injecting Drug Users ..... Behavioral Assessment .................... 12,500 1 85/60 17,708 

Year 3: 

Heterosexual Men and Women 

Referred by Peer Recruiters.

Screener ........................................... 13,750 1 5/60 1,146 

Eligible Heterosexual Men and 

Women.

Behavioral Assessment .................... 12,500 1 70/60 14,583 

Total .................................... ........................................................... 45,000 1 ........................ 48,541 

Dated: December 2, 2010. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–30763 Filed 12–7–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3234–N] 

Medicare Program; Renewal of the 

Medicare Evidence Development & 

Coverage Advisory Committee 

(MEDCAC) 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

renewal of the Medicare Evidence 

Development & Coverage Advisory 

Committee (MEDCAC). 

ADDRESSES: Copies of the Charter: To 

obtain a copy of the Secretary’s Charter 

for the MEDCAC submit a request to: 

See FOR FURTHER INFORMATION CONTACT. 

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, C1–09–06, 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 

On December 14, 1998, we published 

a notice in the Federal Register (63 FR 

68780) announcing the establishment of 

the Medicare Coverage Advisory 

Committee (MCAC). The Secretary 

signed the initial charter for the MCAC 

on November 24, 1998. The MCAC was 

originally established to provide 

independent guidance and expert 

advice to CMS on specific clinical 

topics. In 2007 the Charter was renewed 

and the name MCAC was modified to 

Medicare Evidence Development and 

Coverage Advisory Committee 

(MEDCAC) to more accurately reflect 

the Committee’s role. The MEDCAC is 

advisory, with the final decision on all 

issues resting with CMS. Under the 

current charter, the MEDCAC advises 

the Secretary of the Department of 

Health and Human Services (DHHS) and 

the Administrator of the CMS, on the 

quality of evidence on clinical topics 

under review by CMS. 

The MEDCAC consists of a pool of 

100 appointed members. Members are 

selected from authorities in clinical 

medicine of all specialties, 

administrative medicine, public health, 

biologic and physical sciences, health 

care data and information management 

and analysis, patient advocacy, the 

economics of health care, medical ethics 

and other related professions such as 

epidemiology and biostatistics, and 

methodology of trial design. There are 

94 at-large standing voting members. Six 

of the members are patient advocates 

and six are nonvoting members 

representing the industry interest. 

II. Provisions of this Notice 

This notice announces the signing of 

the MEDCAC charter renewal by the 

Secretary on November 23, 2010. The 

new charter makes the following 

changes: 

• There are 4–8 meetings per year. 

• A period of service for the Chair 

and Vice-Chair of no more than 4 years. 

The MEDCAC functions on a 

committee basis. The MEDCAC—(1) 

Hears public testimony; (2) reviews 

medical literature, technology 

assessments and other relevant evidence 

and advises CMS on the strength and 

weaknesses of that evidence; (3) advises 

CMS of any evidence gaps that may 

exist and recommends the types of 

evidence that should be developed to 

fill those evidentiary gaps. The 

Committee may be asked to develop 

recommendations about specific clinical 

issues under review and to review and 

comment upon proposed or existing 

Medicare coverage policies. The 

Committee may also be asked to 

comment on pertinent aspects of 


jlentini on DSKJ8SOYB1PROD with NOTICES
76472 Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices 

proposals being considered and other 

policies. The Committee works from an 

agenda provided by the designated 

Federal official that lists specific issues. 

Authority: 5 U.S.C. App. 2, section 10(a)(1) 

and (a)(2). 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare— 

Supplementary Medical Insurance Program). 

Dated: November 16, 2010. 

Barry M. Straube, 

CMS Chief Medical Officer, Director, Office 

of Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services. 

[FR Doc. 2010–30761 Filed 12–7–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0602] 

Biologics Price Competition and 

Innovation Act of 2009; Meetings on 

User Fee Program for Biosimilar and 

Interchangeable Biological Product 

Applications; Request for Notification 

of Stakeholder Intention To Participate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for notification 

of participation. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

notice to request that public 

stakeholders, including patient and 

consumer advocacy groups, health care 

professionals, and scientific and 

academic experts, notify FDA of their 

intent to participate in consultation 

meetings relating to the development of 

a user fee program for biosimilar and 

interchangeable biological product 

applications submitted under the Public 

Health Service Act (PHS Act). FDA is 

holding these consultation meetings to 

satisfy the requirement in the Patient 

Protection and Affordable Care Act that 

FDA consult with such public 

stakeholders regarding the development 

of recommendations to present to 

Congress with respect to the goals, and 

plans for meeting the goals, for the 

process for the review of biosimilar and 

interchangeable biological product 

applications for fiscal years (FYs) 2013 

through 2017. To ensure continuity and 

to support the development of 

recommendations for establishing a user 

fee program for biosimilars and 

interchangeable products, the Agency 

requests stakeholder representation 

throughout this consultation process. 

DATES: Submit notification of intention 

to participate by January 10, 2011. 

Stakeholder discussions with FDA will 

occur during negotiations with the 

regulated industry. 

ADDRESSES: Submit notification of 

intention to participate in stakeholder 

meetings by e-mail to Biosimilars

UserFeeProgram@fda.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Sunanda Bahl, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 51, rm. 1168, 

Silver Spring, MD 20993–0002, 301– 

796–3584, FAX: 301–847–8443, e-mail: 

sunanda.bahl@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 23, 2010, President Obama 

signed into law the Patient Protection 

and Affordable Care Act (Affordable 

Care Act) (Pub. L. 111–148). The 

Affordable Care Act contains a subtitle 

called the Biologics Price Competition 

and Innovation Act of 2009 (BPCI Act) 

that amends the PHS Act and other 

statutes to create an abbreviated 

approval pathway for biological 

products shown to be highly similar 

(biosimilar) to, or interchangeable with, 

an FDA-licensed reference biological 

product. (See sections 7001 through 

7003 of the BPCI Act.) Section 351(k) of 

the PHS Act (42 U.S.C. 262(k)), added 

by the BPCI Act, allows a company to 

submit an application for licensure of a 

biosimilar or interchangeable biological 

product. 

The BPCI Act amends section 735 of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 379g) to 

include 351(k) applications for 

biosimilar or interchangeable biological 

products in the definition of ‘‘human 

drug application’’ for the purposes of the 

prescription drug user fee provisions. 

(See section 7002(f)(3)(A) of the BPCI 

Act.) The authority conferred by the 

FD&C Act’s prescription drug user fee 

provisions expires in September 2012. 

The BPCI Act directs FDA to develop 

recommendations for a user fee program 

for biosimilar and biological product 

applications for FYs 2013 through 2017. 

(See section 7002(f)(1) of the BPCI Act.) 

II. FDA Consultation With Stakeholders 

FDA is required to develop 

recommendations to present to Congress 

by January 15, 2012, that address the 

goals, and plans for meeting the goals, 

for the process for the review of 

biosimilar and interchangeable 

biological product applications for FYs 

2013 through 2017. (See section 

7002(f)(1) of the BPCI Act.) In 

developing such recommendations, 

FDA must consult with a range of 

groups, including scientific and 

academic experts; health care 

professionals; representatives of patient 

and consumer advocacy groups; and 

regulated industry. (See section 

7002(f)(1) of the BPCI Act.) FDA 

initiated this consultation process on 

November 2 and 3, 2010, by holding a 

public hearing at which stakeholders 

and other members of the public were 

given an opportunity to present their 

views on issues associated with the 

implementation of the BPCI Act. To 

facilitate identification of regulated 

industry, in the Federal Register notice 

that announced the November 2010 

public hearing, FDA requested that 

comments identify companies that 

would be affected by a user fee program 

for biosimilar or interchangeable 

biological products, as well as industry 

associations representing such 

companies. (See 75 FR 61497, October 

5, 2010.) 

FDA is issuing this Federal Register 

notice to request that other stakeholders, 

including patient and consumer 

advocacy groups, health care 

professionals, and scientific and 

academic experts, notify FDA of their 

intent to participate in consultation 

meetings related to the development of 

recommendations for a user fee program 

for biosimilar and interchangeable 

biological product applications. FDA 

believes that consistent stakeholder 

representation at these consultation 

meetings will be important to ensure 

progress in the discussions. If you wish 

to participate in this process, please 

designate one or more representatives 

from your organization who will 

commit to attending these meetings and 

preparing for the discussions as needed. 

Stakeholders who identify themselves 

through this notice will be included in 

future stakeholder discussions as FDA 

negotiates with regulated industry. 

These discussions will satisfy the 

requirement for consultation with 

public stakeholders in section 7002(f)(1) 

of the BPCI Act. 

III. Additional Information on the BPCI 

Act 

There are several sources of 

information on FDA’s Web site that may 

serve as useful resources for 

stakeholders intending to participate in 

consultation meetings: 

• The Federal Register notice that 

announced the November 2 and 3, 2010, 

public hearing and requested public 

comments is available at http:// 

edocket.access.gpo.gov/2010/pdf/2010–

24853.pdf. 


jlentini on DSKJ8SOYB1PROD with NOTICES