General Licensing Provisions; Section 351(k) Biosimilar Applications

Forms and Documents

Document	Type	Status	Availability
0719 Change Request to include BsUFA performance goals JAN 2021.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-01-26	Missing upstream
0719 351k Applications SSA 2018 Ext.pdf	Supporting Statement A	Uploaded 2018-12-05	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
245442	BsUFA Performance Goals and Procedures for FYs 2018 THROUGH 2022	Other-Performance Goals	New
202640	Patent Infringement Notifications - 351(l)(6)(C)		Unchanged
202639	Interchangeable Product Applications or Supplements - 351(k)(2)(B) and (k)(4)		Unchanged
202638	Biosimilar Product Applications - 351(k)(2)(A)(i) and (k)(2)(A)(iii)		Modified

ICR Details

OMB Control No: 0910-0719	ICR Reference No: 202101-0910-014
Status: Received in OIRA	Previous ICR Reference No: 201810-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: General Licensing Provisions; Section 351(k) Biosimilar Applications
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/27/2021

	Requested	Previously Approved
Expiration Date	01/31/2022	01/31/2022
Responses	179	20
Time Burden (Hours)	12,883	9,478
Cost Burden (Dollars)	0	0

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Abstract: 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. The information submitted in a 351(k) application or supplement is used by FDA to make a determination of biosimilarity or interchangeability of a proposed 351(k) product.

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Authorizing Statute(s): US Code: 42 USC 262(k) Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 31153	07/03/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 58583	11/20/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Biosimilar Product Applications - 351(k)(2)(A)(i) and (k)(2)(A)(iii)
Interchangeable Product Applications or Supplements - 351(k)(2)(B) and (k)(4)
Patent Infringement Notifications - 351(l)(6)(C)
BsUFA Performance Goals and Procedures for FYs 2018 THROUGH 2022

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	179	20	0	0	159	0
Annual Time Burden (Hours)	12,883	9,478	0	0	3,405	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: We are requesting a non-substantive change to the information collection to incorporate the the document entitled “BsUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022” (BsUFA II letter). We have adjusted the overall burden by 159 annual responses and 3,405 annual hours to account for the change.

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Annual Cost to Federal Government: $250,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/27/2021

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