Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792, 36279-36281 [2012-14740]
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Federal Register / Vol. 77, No. 117 / Monday, June 18, 2012 / Notices
approval. In some cases, similar
research is being conducted in different
laboratories for the same medical
countermeasure need. Participants will
be encouraged to share experiences and
join in collaborations to prevent
duplication of research and avoid
repetition of failed efforts and otherwise
join in support of each other to attain
shared goals and facilitate
countermeasure development and
approval.
mstockstill on DSK4VPTVN1PROD with NOTICES
3. Continuing Education—Areas of
Focus
a. GLP in high and maximum
containment.—This portion of the
training will be a joint UTMB/FDA
effort, with UTMB providing the course
foundation and FDA offering the field
inspector perspective. Lecture examples
would include a GLP Refresher, Good
Documentation practices, Internal GLP
Audits, Equipment Validation and
Calibration, and Effective SOPs.
Lectures could be followed with
practical exercises pointing out specific
challenges in meeting GLP requirements
that have been encountered in BSL–3
and BSL–4 studies conducted at UTMB.
b. The ‘‘Animal Rule.’’—FDA will
provide an overview of the regulations
for approval of new drugs and biologics
based on evidence of effectiveness from
studies in animals, including the status
of FDA’s draft document entitled,
‘‘Guidance for Industry: Animal
Models—Essential Elements to Address
Efficacy Under the Animal Rule’’ dated
January 2009 (Draft Guidance) and the
animal model qualification process.
c. Animal welfare.—This portion of
the training will review animal welfare
laws, policies guidelines and
requirements, including lectures and
discussions on the role of the
veterinarian, determination of humane
endpoints, and use of supportive care
measures in BSL–4 studies.
d. Telemetry.—Use of telemetry for
remote monitoring of routine clinical
parameters, such as body temperature,
heart rate, respiration rate, and blood
pressure is a helpful and sometimes an
essential tool for conducting studies in
BSL–4 laboratories. An entire half-day
will be devoted to teaching what is
available and how to implement
telemetry techniques into BSL–4
studies.
4. Dissemination of Successful
Enhancements to the Regulatory Science
and Regulation of Animal Rule Studies
for Medical Countermeasure
Development
UTMB and OCET will collaborate to
incorporate any new FDA guidances
and educational tools into the training
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17:02 Jun 15, 2012
Jkt 226001
program as new measures are developed
(e.g., drug development tool guidance,
updates to GLPs).
C. Eligibility Information
As work in regulatory science for
medical countermeasure development
progresses, OCET and UTMB anticipate
additional collaboration through
seminars and training programs,
particularly in the areas of GLP in
maximum and high biocontainment
laboratories, training FDA field
inspectors how to effectively conduct
GLP inspections in a high or maximum
biocontainment laboratories, and
training laboratorians and regulators in
how to work in high or maximum
biocontainment laboratories. With the
financial and scientific support from
FDA, UTMB is uniquely qualified to
undertake these activities, given its
mandate as an educational and
scientific institution, its high visibility
as a pioneer in implementing GLP in
maximum and high biocontainment
laboratories, and its access to worldwide
scientific and regulatory expertise.
UTMB has demonstrated a GLP
reporting structure and large animal in
vivo GLP BSL–4 expertise. In addition,
the FDA/UTMB training program will
be accessible to researchers at all other
university, government, and private
organizations.
36279
https://grants2.nih.gov/grants/funding/
phs398/phs398.html. For all paper
application submissions, the following
steps are required:
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number.
• Step 2: Register With Central
Contractor Registration.
• Step 3: Register With Electronic
Research Administration (eRA)
Commons.
Steps 1 and 2, in detail, can be found
at https://www07.grants.gov/applicants/
organization_registration.jsp. Step 3, in
detail, can be found at https://
commons.era.nih.gov/commons/
registration/registrationInstructions.jsp.
After you have followed these steps,
submit paper applications to: Gladys
Melendez Bohler, Office of Acquisitions
and Grants Services (HFA–500), 5630
Fishers Lane, Rm. 1078, Rockville, MD
20857.
Dated: June 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14741 Filed 6–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
II. Award Information/Funds Available
[Docket No. FDA–2012–N–0194]
A. Award Amount
Only one award will be made.
OCET anticipates providing in
FY2012 up to $150,000 (total costs
include direct and indirect costs) for
one award subject to availability of
funds in support of this project. The
possibility of four additional years of
support up to $600,000 of funding is
contingent upon successful performance
and the availability of funds.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Biosimilars User
Fee Cover Sheet; Form FDA 3792
B. Length of Support
The timeframe for this project is 5
years from the award date of the initial
application.
III. Paper Application, Registration,
and Submission Information
To submit a paper application in
response to this FOA, applicants should
first review the full announcement
located at (https://www.fda.gov/
EmergencyPreparedness/Medical
Countermeasures/default.htm). (FDA
has verified the Web site addresses
throughout this document, but FDA is
not responsible for any subsequent
changes to the Web sites after this
document publishes in the Federal
Register). Persons interested in applying
for a grant may obtain an application at
PO 00000
Frm 00030
Fmt 4703
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 18,
2012.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Biosimilars User Fee Cover Sheet;
Form FDA 3792’’. Also include the FDA
ADDRESSES:
E:\FR\FM\18JNN1.SGM
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36280
Federal Register / Vol. 77, No. 117 / Monday, June 18, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
301–796–7651,
juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Biosimilars User Fee Cover Sheet; Form
FDA 3792—(OMB Control Number
0910-New)
The March 23, 2010 Affordable Care
Act contains a subtitle called the
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) that
amends the Public Health Service Act
(PHS Act) and other statutes to create an
abbreviated approval pathway for
biological products shown to be
biosimilar to or interchangeable with an
FDA-licensed reference biological
product. Section 351(k) of the PHS Act,
added by the BPCI Act, allows a
company to submit an application for
licensure of a biosimilar or
interchangeable biological product. The
BPCI Act also amends section 735 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379g) to include
351(k) applications in the definition of
‘‘human drug application’’ for the
purposes of the prescription drug user
fee provisions. 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
biosimilar biological product user fee
program for FYs 2013 through 2017.
FDA’s recommendations for a biosimilar
biological product user fee program
were submitted to Congress on January
13, 2012. If enacted into law, FDA’s
proposed biosimilar biological product
user fee program would require FDA to
assess and collect user fees for certain
meetings concerning biosimilar
biological product development (BPD
meetings), investigational new drug
applications (INDs) intended to support
a biosimilar biological product
application, and biosimilar biological
product applications and supplements.
Proposed Form FDA 3792, the
Biosimilars User Fee Cover Sheet,
requests the minimum necessary
information to determine the amount of
the fee required, and to account for and
track user fees. The form would provide
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17:02 Jun 15, 2012
Jkt 226001
a cross-reference of the fees submitted
for a submission with the actual
submission by using a unique number
tracking system. The information
collected would be used by FDA’s
Center for Drug Evaluation and Research
(CDER) and Center for Biologics
Evaluation and Research (CBER) to
initiate the administrative screening of
biosimilar biological product INDs,
applications, and supplements, and to
account for and track user fees
associated with BPD meetings.
In the Federal Register of March 13,
2012 (77 FR 14809), FDA published a
60-day notice requesting public
comment on the proposed collection of
information, Form FDA 3792, the
Biosimilar User Fee Cover Sheet. FDA
received the following comments:
(Comment 1) Suggests FDA use the
term ‘‘Biosimilar Biological Product
Licensing Application (BBLA)’’ or
‘‘Interchangeable Biosimilar Biological
Product Application (IBLA)’’ for a
biosimilar application instead of
Biologics License Application (BLA) to
avoid confusion and provide greater
clarity.
(Response) FDA notes the Biosimilar
User Fee Cover Sheet serves a billing
and collections purpose, and does not
indicate FDA’s position on reference
terms. However, to maintain
consistency throughout the document
and avoid any confusion, FDA refers to
a biologics license application
submitted under section 351(k) of the
Public Health Service Act as a ‘‘351(k)
application’’. Under FDA’s proposed
biosimilar biological product user fee
program, user fees would be assessed
only for those 351(k) applications that
fall within the scope of the defined term
‘‘biosimilar biological product
application.’’ Accordingly, FDA has
made changes to the Biosimilar User Fee
Cover Sheet to clarify that Form 3792
need not be submitted for certain
specified types of 351(k) applications.
Additionally, to address the need for
greater clarity, FDA has added
definitions of several other key terms to
the Biosimilar User Fee Cover Sheet.
(Comment 2) Requests FDA to ask for
all available product names, including
the product’s code name in addition to
trade and proper names, because the
Biosimilar User Fee Cover Sheet should
be consistent with Form FDA 1571.
Further, requests FDA to amend the
‘‘Product Name’’ information field to
‘‘Product Name(s).’’
(Response) We agree that the
Biosimilar User Fee Cover sheet should
be consistent with Form 1571, where
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Frm 00031
Fmt 4703
Sfmt 4703
applicable. Accordingly, FDA amended
the instructions to request proper name,
trade or proprietary name, and code
name, as applicable, and amended the
‘‘Product Name’’ information field to
‘‘Product Name(s)’’.
(Comment 3) Requests FDA to remove
the question about whether the
application requires clinical data, other
than comparative bioavailability
studies, for approval because this
information does not affect the fee
amount.
(Response) FDA notes this question
applies only to fees for biosimilar
biological product applications, and not
to fees for biosimilar biological products
in development. Under FDA’s proposed
biosimilar biological product user fee
program, the fee amount for a biosimilar
biological product application depends
on whether clinical data with respect to
safety or effectiveness are required.
Specifically:
• A full fee is assessed for a
biosimilar biological product
application for which clinical data
(other than comparative bioavailability
studies) with respect to safety or
effectiveness are required for approval;
• A half fee is assessed for a
biosimilar biological product
application for which clinical data
(other than comparative bioavailability
studies) with respect to safety or
effectiveness are not required for
approval;
• A half fee is assessed for a
supplement for which clinical data
(other than comparative bioavailability
studies) with respect to safety or
effectiveness are required for approval;
and
• No fee is assessed for a supplement
for which clinical data (other than
comparative bioavailability studies)
with respect to safety or effectiveness
are not required for approval.
Therefore, FDA has retained the
question on the Biosimilar User Fee
Cover Sheet concerning whether clinical
data are required because it requests
information necessary to determine the
fee amount for a biosimilar biological
product application or supplement.
(Comment 4) Requests FDA to decline
to require a patent certification as part
of a 351(k) application.
(Response) FDA notes this comment
is outside the scope of the proposed
collection of information, Form FDA
3792, the Biosimilar User Fee Cover
Sheet.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\18JNN1.SGM
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Federal Register / Vol. 77, No. 117 / Monday, June 18, 2012 / Notices
36281
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA 3792 .............................................................................
1 There
9
Average
burden per
response
Total annual
responses
1
9
0.5
(30 minutes)
Total hours
4.5
are no capital costs or operating maintenance costs associated with this collection of information.
Respondents to this proposed
collection of information would be
manufacturers of biosimilar biological
product candidates. Based on FDA’s
database system, there are an estimated
18 manufacturers that fall into this
category. However, not all
manufacturers will have submissions in
a given year and some may have
multiple submissions. FDA estimates 9
annual responses that include the
following: 6 INDs or BPD meetings, 2
applications, and 1 supplement. The
estimated hours per response are based
on FDA’s past experience with other
submissions, which average 30 minutes.
Dated: June 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14740 Filed 6–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
[Docket Number OIG–1301–N]
Solicitation of Information and
Recommendations for Revising OIG’s
Provider Self-Disclosure Protocol
Office of Inspector General
(OIG), HHS.
ACTION: Notice and Opportunity for
Comment.
AGENCY:
This Federal Register notice
informs the public that OIG: (1) Intends
to update the Provider Self-Disclosure
Protocol (63 FR 58399, October 30,
1998) and (2) solicits input from the
public for OIG to consider in updating
the Protocol.
DATES: To ensure consideration, public
comments must be delivered to the
address provided below by no later than
5 p.m. on August 17, 2012.
ADDRESSES: In commenting, please refer
to file code OIG–1301–N. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
three ways (no duplicates, please):
1. Electronically. You may submit
electronic comments on specific
SUMMARY:
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Number of
responses per
respondent
Number of
respondents
Form
VerDate Mar<15>2010
17:02 Jun 15, 2012
Jkt 226001
recommendations and proposals
through the Federal eRulemaking Portal
at https://www.regulations.gov.
2. By regular, express, or overnight
mail. You may send written comments
to the following address: Kenneth D.
Kraft, Office of Inspector General,
Department of Health and Human
Services, Attention: OIG–1301–N, Room
5541B, Cohen Building, 330
Independence Avenue SW.,
Washington, DC 20201. Please allow
sufficient time for mailed comments to
be received before the close of the
comment period.
3. By hand or courier. If you prefer,
you may deliver, by hand or courier,
your written comments before the close
of the comment period to Kenneth D.
Kraft, Office of Inspector General,
Department of Health and Human
Services, Cohen Building, 330
Independence Avenue SW.,
Washington, DC 20201. Because access
to the interior of the Cohen Building is
not readily available to persons without
Federal Government identification,
commenters are encouraged to schedule
their delivery with one of our staff at
(202) 708–9848.
All submissions must include the
agency name and docket number for this
Federal Register document. All
comments, including attachments and
other supporting material received, are
subject to public disclosure.
FOR FURTHER INFORMATION CONTACT:
Kenneth D. Kraft, Department of Health
and Human Services, Office of Inspector
General, Office of External Affairs, at
(202) 708–9848.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the end of the comment
period are available for viewing by the
public. All comments will be posted on
https://www.regulations.gov after they
have been received. Comments received
timely will also be available for public
inspection as they are received at Office
of Inspector General, Department of
Health and Human Services, Cohen
Building, 330 Independence Avenue
SW., Washington, DC 20201, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone (202) 708–9848.
PO 00000
Frm 00032
Fmt 4703
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Background: In 1998, OIG published
the Provider Self-Disclosure Protocol
(the Protocol) to establish a process for
health care providers to disclose
potential fraud involving the Federal
health care programs. The Protocol
provides guidance on how to investigate
this conduct, quantify damages, and
report the conduct to OIG to resolve the
provider’s liability exposure under
OIG’s civil money penalty (CMP)
authorities. Over the past 14 years, we
have resolved over 800 disclosures,
resulting in recovering over $280
million to the Federal health care
programs. Through our experience in
resolving Protocol matters, we identified
areas where additional guidance would
be beneficial to the provider community
and would improve the efficient
resolution of Protocol matters.
Specifically, we issued three Open
Letters to Health Care Providers to
address some of these issues. First, in
2006 we announced an initiative to
encourage disclosure of conduct
creating liability under OIG’s antikickback and physician self-referral law
CMP authorities. In 2008, we issued
additional guidance and requirements
for Protocol submissions to increase the
efficiency of the Protocol, including
new requirements for the initial
submission and specific time
commitments from the provider. This
Open Letter also announced the
presumption of not requiring a
compliance agreement as part of settling
a cooperative and complete disclosure.
Finally, in 2009, we stated we would no
longer accept disclosure of a matter into
the Protocol that involved only liability
under the physician self-referral law in
the absence of a colorable anti-kickback
violation. We also announced a
minimum $50,000 settlement amount
for kickback-related submissions.
After over a decade of experience in
resolving Protocol disclosures, we are
considering revising the Protocol to
provide additional guidance. We are
soliciting comments, recommendations,
and other suggestions from concerned
parties and organizations on how best to
revise the Protocol to address relevant
issues and to provide useful guidance to
the health care industry.
E:\FR\FM\18JNN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 117 (Monday, June 18, 2012)]
[Notices]
[Pages 36279-36281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14740]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0194]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Biosimilars User Fee
Cover Sheet; Form FDA 3792
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July
18, 2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title ``Biosimilars User Fee Cover Sheet; Form FDA 3792''. Also include
the FDA
[[Page 36280]]
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Biosimilars User Fee Cover Sheet; Form FDA 3792--(OMB Control Number
0910-New)
The March 23, 2010 Affordable Care Act contains a subtitle called
the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)
that amends the Public Health Service Act (PHS Act) and other statutes
to create an abbreviated approval pathway for biological products shown
to be biosimilar to or interchangeable with an FDA-licensed reference
biological product. Section 351(k) of the PHS Act, added by the BPCI
Act, allows a company to submit an application for licensure of a
biosimilar or interchangeable biological product. The BPCI Act also
amends section 735 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 379g) to include 351(k) applications in the definition
of ``human drug application'' for the purposes of the prescription drug
user fee provisions. 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 biosimilar
biological product user fee program for FYs 2013 through 2017. FDA's
recommendations for a biosimilar biological product user fee program
were submitted to Congress on January 13, 2012. If enacted into law,
FDA's proposed biosimilar biological product user fee program would
require FDA to assess and collect user fees for certain meetings
concerning biosimilar biological product development (BPD meetings),
investigational new drug applications (INDs) intended to support a
biosimilar biological product application, and biosimilar biological
product applications and supplements. Proposed Form FDA 3792, the
Biosimilars User Fee Cover Sheet, requests the minimum necessary
information to determine the amount of the fee required, and to account
for and track user fees. The form would provide a cross-reference of
the fees submitted for a submission with the actual submission by using
a unique number tracking system. The information collected would be
used by FDA's Center for Drug Evaluation and Research (CDER) and Center
for Biologics Evaluation and Research (CBER) to initiate the
administrative screening of biosimilar biological product INDs,
applications, and supplements, and to account for and track user fees
associated with BPD meetings.
In the Federal Register of March 13, 2012 (77 FR 14809), FDA
published a 60-day notice requesting public comment on the proposed
collection of information, Form FDA 3792, the Biosimilar User Fee Cover
Sheet. FDA received the following comments:
(Comment 1) Suggests FDA use the term ``Biosimilar Biological
Product Licensing Application (BBLA)'' or ``Interchangeable Biosimilar
Biological Product Application (IBLA)'' for a biosimilar application
instead of Biologics License Application (BLA) to avoid confusion and
provide greater clarity.
(Response) FDA notes the Biosimilar User Fee Cover Sheet serves a
billing and collections purpose, and does not indicate FDA's position
on reference terms. However, to maintain consistency throughout the
document and avoid any confusion, FDA refers to a biologics license
application submitted under section 351(k) of the Public Health Service
Act as a ``351(k) application''. Under FDA's proposed biosimilar
biological product user fee program, user fees would be assessed only
for those 351(k) applications that fall within the scope of the defined
term ``biosimilar biological product application.'' Accordingly, FDA
has made changes to the Biosimilar User Fee Cover Sheet to clarify that
Form 3792 need not be submitted for certain specified types of 351(k)
applications. Additionally, to address the need for greater clarity,
FDA has added definitions of several other key terms to the Biosimilar
User Fee Cover Sheet.
(Comment 2) Requests FDA to ask for all available product names,
including the product's code name in addition to trade and proper
names, because the Biosimilar User Fee Cover Sheet should be consistent
with Form FDA 1571. Further, requests FDA to amend the ``Product Name''
information field to ``Product Name(s).''
(Response) We agree that the Biosimilar User Fee Cover sheet should
be consistent with Form 1571, where applicable. Accordingly, FDA
amended the instructions to request proper name, trade or proprietary
name, and code name, as applicable, and amended the ``Product Name''
information field to ``Product Name(s)''.
(Comment 3) Requests FDA to remove the question about whether the
application requires clinical data, other than comparative
bioavailability studies, for approval because this information does not
affect the fee amount.
(Response) FDA notes this question applies only to fees for
biosimilar biological product applications, and not to fees for
biosimilar biological products in development. Under FDA's proposed
biosimilar biological product user fee program, the fee amount for a
biosimilar biological product application depends on whether clinical
data with respect to safety or effectiveness are required.
Specifically:
A full fee is assessed for a biosimilar biological product
application for which clinical data (other than comparative
bioavailability studies) with respect to safety or effectiveness are
required for approval;
A half fee is assessed for a biosimilar biological product
application for which clinical data (other than comparative
bioavailability studies) with respect to safety or effectiveness are
not required for approval;
A half fee is assessed for a supplement for which clinical
data (other than comparative bioavailability studies) with respect to
safety or effectiveness are required for approval; and
No fee is assessed for a supplement for which clinical
data (other than comparative bioavailability studies) with respect to
safety or effectiveness are not required for approval.
Therefore, FDA has retained the question on the Biosimilar User Fee
Cover Sheet concerning whether clinical data are required because it
requests information necessary to determine the fee amount for a
biosimilar biological product application or supplement.
(Comment 4) Requests FDA to decline to require a patent
certification as part of a 351(k) application.
(Response) FDA notes this comment is outside the scope of the
proposed collection of information, Form FDA 3792, the Biosimilar User
Fee Cover Sheet.
FDA estimates the burden of this collection of information as
follows:
[[Page 36281]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Form Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
FDA 3792........................ 9 1 9 0.5 4.5
(30 minutes)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating maintenance costs associated with this collection of information.
Respondents to this proposed collection of information would be
manufacturers of biosimilar biological product candidates. Based on
FDA's database system, there are an estimated 18 manufacturers that
fall into this category. However, not all manufacturers will have
submissions in a given year and some may have multiple submissions. FDA
estimates 9 annual responses that include the following: 6 INDs or BPD
meetings, 2 applications, and 1 supplement. The estimated hours per
response are based on FDA's past experience with other submissions,
which average 30 minutes.
Dated: June 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14740 Filed 6-15-12; 8:45 am]
BILLING CODE 4160-01-P
