Document ID: FDA-2012-N-0129-0012
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar  Applications
Posted Date: 2018-07-03T04:00Z

[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)]
[Notices]
[Pages 31152-31154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14265]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2012-N-0129]

Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection in an 
application for a proposed biosimilar product and an application for a 
supplement for a proposed interchangeable product.

DATES: Submit either electronic or written comments on the collection 
of information by September 4, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 4, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of September 4, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA 2012-N-0129 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; General Licensing Provisions; 
Section 351(k) Biosimilar Applications.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management

[[Page 31153]]

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
 351(k) Applications (42 U.S.C.      Number of     responses per   Total annual   Average burden    Total hours
             262(k))                respondents     respondent       responses     per 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....

[[Page 31154]]

 
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.

    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: June 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14265 Filed 7-2-18; 8:45 am]
 BILLING CODE 4164-01-P