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
Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices 76473 

• Comments submitted in response to 

the November 2010 public hearing 

notice can be found at http:// 

www.regulations.gov using Docket No. 

FDA–2010–N–0477. 

• Additional information regarding 

implementation of the BPCI Act is 

available at: http://www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/UCM215031. 

IV. Notification of Intent To Participate 

in Consultation Meetings 

If you intend to participate in 

stakeholder consultation meetings 

regarding the development of 

recommendations for a user fee program 

for biosimilar and interchangeable 

biological product applications for FYs 

2013 through 2017, please provide 

notification by e-mail to BiosimilarsUser

FeeProgram@fda.hhs.gov by January 10, 

2011. Your e-mail should contain 

complete contact information, including 

name, title, affiliation, address, e-mail 

address, telephone number, and notice 

of any special accommodations required 

because of disability. Stakeholders will 

receive confirmation and additional 

information about the first meeting once 

FDA receives their notification. 

Dated: December 2, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30713 Filed 12–7–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the Agency; (b) the 

accuracy of the Agency’s estimate of the 

burden of the proposed collection of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and 

(d) ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Data Collection Tool 

for Rural Health Community-Based 

Grant Programs (OMB No. 0915– 

0319)—[Revision] 

On May 20, 2008, OMB approved the 

Agency’s request for the collection of 

data related to program and clinical 

measures (OMB No. 0915–0319) and set 

an expiration date of May 31, 2011. The 

Agency is now proceeding to submit a 

revised package which will include 

program specific measures that are 

further aligned with the agency’s 

updated clinical measures. These 

measures were modified based on the 

feedback received from grantees and to 

reflect ORHP and HRSA’s current 

priorities and clarify certain measures 

across all 330A programs. In addition, 

these revisions will enhance data 

collection and analysis in an effort to 

strengthen the value of the data 

collection tool. 

There are currently six rural health 

grant programs that operate under the 

authority of Section 301 of the Public 

Health Service (PHS) Act. These 

programs include: (1) Rural Health Care 

Services Outreach Grant Program 

(Outreach); (2) Rural Health Network 

Development Grant Program (Network 

Development); (3) Small Healthcare 

Provider Quality Grant Program 

(Quality); (4) Delta States Rural 

Development Network Grant Program 

(Delta); (5) Network Planning Grant 

Program and (6) Rural Health Workforce 

Development Grant Program. These 

grants are to provide for the expanded 

delivery of health care services, the 

planning and implementation of 

integrated health care networks, and the 

planning and implementation of quality 

improvement and workforce activities— 

all in rural areas. 

For these programs, performance 

measures were drafted to provide data 

useful to the programs and to enable 

HRSA to provide aggregate program data 

required by Congress under the 

Government Performance and Results 

Act (GPRA) of 1993. These measures 

cover the principal topic areas of 

interest to ORHP, including: (a) Access 

to care; (b) the underinsured and 

uninsured; (c) workforce recruitment 

and retention; (d) sustainability; (e) 

health information technology; (f) 

network development, and (g) health 

related clinical measures. Several 

measures will be used for all six 

programs. All measures will speak to 

the Office’s progress toward meeting the 

goals set. 

The annual estimate of burden is as 

follows: 

Instrument Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Rural Health Care Services Outreach Grant Program .... 111 1 111 2 .75 305 .25 

Rural Health Network Development ................................ 49 1 49 2 98 

Delta States Rural Development Network Grant Program ............................................................................. 12 1 12 3 36 

Small Health Care Provider Quality Improvement Grant 

Program ........................................................................ 59 1 59 6 354 

Network Development Planning Grant Program ............. 30 1 30 1 30 

Rural Health Workforce Development Program .............. 20 1 20 1 .75 35 

Total .......................................................................... 281 ........................ 281 .......................... 858 .25 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 


jlentini on DSKJ8SOYB1PROD with NOTICES