0719 351k Applications SSA 2018 Ext

UNITED STATES FOOD AND DRUG ADMINISTRATION
Section 351(k) Biosimilar Applications – General Licensing Provisions
Biosimilar User Fee Program
OMB Control Number 0910-0719
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports implementation of the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act). The BPCI Act amended the Public Health Service Act
(PHS Act) to establish an abbreviated licensure pathway for biological products shown to be
biosimilar to, or interchangeable with, a Food and Drug Administration (FDA)-licensed
biological reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)), 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
demonstrate interchangeability, an applicant must provide sufficient information to demonstrate
biosimilarity and that the biosimilar biological product can be expected to produce the same
clinical result as the reference product in any given patient and, if the biosimilar 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 biosimilar 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 health care
provider. (See section 351(i)(3) of the PHS Act.)
We therefore request extension of OMB approval for the information collection provisions
associated with section 351(k) biosimilar applications, as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The information collection establishes an abbreviated licensure pathway for biological products
shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference
product, and sets forth the requirements for an application for a proposed biosimilar product and
an application or a supplement for a proposed interchangeable product. We use the information

submitted in a 351(k) application or supplement to make a determination of biosimilarity or
interchangeability of a proposed 351(k) product.
3. Use of Improved Information Technology and Burden Reduction
One of our continuing objectives is to improve the timing and quality of our review and approval
programs. To make the review process more efficient for industry and FDA, we utilize
electronic information systems technology and currently accepts the submission of electronic
license applications and other similar submissions. To assist respondents, we offer guidance
documents describing the process for submitting applications to FDA in electronic format on our
website at:



http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064994.htm; and
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Gene
ral/ucm218518.htm

4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. While have established and administer
user fee programs associated with the review of other FDA-regulated products, this information
collection specifically supports information collection associated biosimilar applications filed
under section 351(k) of the PHS.
5. Impact on Small Businesses or Other Small Entities
The information collection imposes no undue burden on small entities. At the same time, we
provide assistance to small businesses through our Center for Biologics Evaluation and Research
(CBER) Office of Communications, Outreach and Development, Division of Manufacturer’s
Assistance and Training; and our Center for Drug Evaluation and Research (CDER) Office of
Communication, Division of Drug Information.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice inviting public comment in
the Federal Register of July 3, 2018 (83 FR 31152). No comments were received.

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9. Explanation of Any Payment or Gift to Respondents
No gifts or payments are provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information received is protected consistent with applicable provisions of
the Freedom of Information Act (FOIA) and FDA’s published regulations under 21 CFR Part 20,
21 CFR 601.51, and 601.70(e).
11. Justification for Sensitive Questions
There are no questions of a sensitive nature applicable to this collection of information.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Reporting Burden1
No. of
Respondents

No. of
Responses per
Respondent

351(k)(2)(A)(i) and 351(k)(2)(A)(iii)
Biosimilar Product Applications

4

2.25

9

860

7,740

351(k)(2)(B) and (k)(4)
Interchangeable Product Applications
or Supplements

2

1

2

860

1,720

351(l)(6)(C) Patent Infringement
Notifications

4

2.25

9

2

18

351(k) Applications (42 U.S.C.
262(k))

Total
Annual
Responses

Average
Burden per
Response

Total
Hours

Total
1

9,478

There are no capital costs or operating and maintenance costs associated with this collection of information.

12b. Annualized Cost Burden Estimate
Assuming a regulatory affairs specialist, at a pay rate of $50/hour, would be responsible
for preparing an submitting an application, supplement, or other similar submission, and
multiplying that figure by the total annual burden hours (9,478), we estimate an annual cost to
respondents of $ 473,900.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital costs or operating and maintenance costs associated with this collection of
information.

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14. Annualized Cost to the Federal Government
We estimate an annualized cost to FDA of $250,000. This estimate assumes 2 full-time
equivalent employees (FTEs) will be responsible for the review of license applications including
supplemental applications. The amount of time and expense incurred by the Federal government
includes the time to the review of all material submitted with an application or supplement. The
estimated average annual salary for FDA reviewers includes benefits but no overhead costs.
15. Explanation for Program Changes or Adjustments
Although we adjusted the estimated number of respondents downward, we have increased the
number of submissions per respondent, reflecting an overall increase since last OMB approval.
The increase corresponds to an increase in applications we have received over the last three
years.
16. Plans for Tabulation and Publication and Project Time Schedule
We do not intend to publish tabulated results of these information collection requirements.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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