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, 76472-76473 [2010-30713]
Download as PDF
<![CDATA[
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
I. Background
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.
Notice; request for notification
of participation.
ACTION:
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.
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:23 Dec 07, 2010
Jkt 223001
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:
DATES:
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
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
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 https://
edocket.access.gpo.gov/2010/pdf/2010–
24853.pdf.
E:\FR\FM\08DEN1.SGM
08DEN1
76473
Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices
• Comments submitted in response to
the November 2010 public hearing
notice can be found at https://
www.regulations.gov using Docket No.
FDA–2010–N–0477.
• Additional information regarding
implementation of the BPCI Act is
available at: https://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.
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]
[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
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
Number of
respondents
Instrument
Responses
per
respondent
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:
Total
responses
Hours per
response
jlentini on DSKJ8SOYB1PROD with NOTICES
Rural Health Care Services Outreach Grant Program ....
Rural Health Network Development ................................
Delta States Rural Development Network Grant Program .............................................................................
Small Health Care Provider Quality Improvement Grant
Program ........................................................................
Network Development Planning Grant Program .............
Rural Health Workforce Development Program ..............
111
49
1
1
111
49
12
1
12
3
59
30
20
1
1
1
59
30
20
6
1
1.75
Total ..........................................................................
281
........................
281
..........................
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
VerDate Mar<15>2010
18:23 Dec 07, 2010
Jkt 223001
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
2.75
2
Total burden
hours
305.25
98
36
354
30
35
858.25
should be received within 60 days of
this notice.
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Notices]
[Pages 76472-76473]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30713]
-----------------------------------------------------------------------
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
BiosimilarsUserFeeProgram@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 https://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf.
[[Page 76473]]
Comments submitted in response to the November 2010 public
hearing notice can be found at https://www.regulations.gov using Docket
No. FDA-2010-N-0477.
Additional information regarding implementation of the
BPCI Act is available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/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
BiosimilarsUserFeeProgram@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
