Document ID: FDA-2012-N-0129-0013
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; General Licensing
Provisions; Section 351(k) Biosimilar Applications
Posted Date: 2018-11-20T05:00Z

[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Pages 58583-58585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25232]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2012-N-0129]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; General Licensing 
Provisions; Section 351(k) Biosimilar Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
December 20, 2018.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0719. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St.,

[[Page 58584]]

North Bethesda, MD 20852, 301-796-3794, [email protected].

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.

General Licensing Provisions; Section 351(k) Biosimilar Applications

OMB Control Number 0910-0719--Extension

    The Biologics Price Competition and Innovation Act of 2009 (BPCI 
Act) amended the Public Health Service Act (PHS Act) and other statutes 
to create an abbreviated licensure pathway for biological products 
shown to be biosimilar to, or interchangeable with, an FDA-licensed 
reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)), 
added by the BPCI Act, sets forth the requirements for an application 
for a proposed biosimilar product and an application or a supplement 
for a proposed interchangeable product. Section 351(k) defines 
biosimilarity to mean that the biological product is highly similar to 
the reference product notwithstanding minor differences in clinically 
inactive components and that ``there are no clinically meaningful 
differences between the biological product and the reference product in 
terms of the safety, purity, and potency of the product'' (see section 
351(i)(2) of the PHS Act). A 351(k) application must contain, among 
other things, information demonstrating that the biological product is 
biosimilar to a reference product based upon data derived from 
analytical studies, animal studies, and clinical studies, unless FDA 
determines, in its discretion, that certain studies are unnecessary in 
a 351(k) application (see section 351(k)(2) of the PHS Act). To meet 
the standard for interchangeability, an applicant must provide 
sufficient information to demonstrate biosimilarity and also to 
demonstrate that the biological product can be expected to produce the 
same clinical result as the reference product in any given patient and, 
if the biological product is administered more than once to an 
individual, the risk in terms of safety or diminished efficacy of 
alternating or switching between the use of the biological product and 
the reference product is not greater than the risk of using the 
reference product without such alternation or switch (see section 
351(k)(4) of the PHS Act).
    Interchangeable products may be substituted for the reference 
product without the intervention of the prescribing healthcare provider 
(see section 351(i)(3) of the PHS Act) In estimating the information 
collection burden for 351(k) biosimilar product applications and 
interchangeable product applications or supplements, we reviewed the 
number of 351(k) applications FDA has received in fiscal years 2015, 
2016, and 2017, considered responses to a survey of biosimilar sponsors 
and applicants regarding projected future 351(k) submission volumes, as 
well as the collection of information regarding the general licensing 
provisions for biologics license applications under section 351(a) of 
the PHS Act submitted to OMB (approved under OMB control number 0910-
0338).
    To submit an application seeking licensure of a proposed biosimilar 
product under sections 351(k)(2)(A)(i) and (iii) of the PHS Act, the 
estimated burden hours (FDA believes) would be approximately the same 
as noted under OMB control number 0910-0338 for a 351(a) application--
860 hours. The burden estimates for seeking licensure of a proposed 
biosimilar product that meets the standards for interchangeability 
under sections 351(k)(2)(B) and (k)(4) would also be 860 hours per 
application. FDA believes these estimates are appropriate for 351(k) 
applications because the paperwork burden for a 351(k) application is 
expected to be comparable to the paperwork burden for a 351(a) 
application.
    In addition to the collection of information regarding the 
submission of a 351(k) application for a proposed biosimilar or 
interchangeable biological product, section 351(l) of the BPCI Act 
establishes procedures for identifying and resolving patent disputes 
involving applications submitted under section 351(k) of the PHS Act. 
The burden estimate for the patent notification provisions under 
section 351(l)(6)(C) of the BPCI Act are included in table 1 and are 
based on the estimated number of 351(k) applicants. Based on similar 
reporting requirements, FDA estimates this notification will take 2 
hours.
    In the Federal Register of July 3, 2018 (83 FR 31152), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
 351(k) Applications (42 U.S.C.      Number of     responses per   Total annual     burden per      Total hours
             262(k))                respondents     respondent       responses       response
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351(k)(2)(A)(i) and                            4            2.25               9             860           7,740
 351(k)(2)(A)(iii) Biosimilar
 Product Applications...........
351(k)(2)(B) and (k)(4)                        2               1               2             860           1,720
 Interchangeable Product
 Applications or Supplements....
351(l)(6)(C) Patent Infringement               4            2.25               9               2              18
 Notifications..................
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    Total.......................  ..............  ..............  ..............  ..............           9,478
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 58585]]

    Based on a review of the information collection since our last 
request for OMB approval, the estimated burden for the information 
collection reflects an overall increase in total hours and responses. 
We attribute this adjustment to an increase in the number of 
submissions received over the last few years and additional interest in 
the biosimilars program.

    Dated: November 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25232 Filed 11-19-18; 8:45 am]
 BILLING CODE 4164-01-P