Biosimilar User Fee Cover Sheet - Form FDA 3792

Forms and Documents

Document Name	Status
Form Form FDA 3792 Form FDA 3792 Form and Instruction	Modified
0718 83C for Email Follow up expanded.FINAL.12-21-2017.pdf Justification for No Material/Nonsubstantive Change	2018-01-03
SUPPORTING STATEMENT FINAL 0718 6-22-2015.doc Supporting Statement A	2015-06-22

IC Document Collections

IC ID	Document Title	Status
202806	Form FDA 3792 Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0718	ICR Reference No: 201801-0910-002
Status: Historical Active	Previous ICR Reference No: 201708-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Biosimilar User Fee Cover Sheet - Form FDA 3792
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/31/2018
	Date Received in OIRA: 01/04/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	12/31/2018	12/31/2018
Responses	35	0	20
Time Burden (Hours)	60	0	10
Cost Burden (Dollars)	0	0	0

---

Abstract: 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 provides a cross-reference of the fees submitted for a submission with the actual submission by using a unique number tracking system. The information collected is 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, biosimilar biological product INDs, applications, and supplements.

---

Authorizing Statute(s): US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 21 USC 301 et. seq. Name of Law: Federal Food Drug and Cosmetic Act
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 4272	01/27/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 31603	06/03/2015
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Form FDA 3792	Form FDA 3792	Biosimilar User Fee Cover Sheet

---

ICR Summary of Burden

	Total Approved	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	35	20	0	15	0	0
Annual Time Burden (Hours)	60	10	0	50	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: Program office wants to ask additional questions of respondents.

---

Annual Cost to Federal Government: $920

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? Uncollected

---

Common Form ICR:  No

---

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: 01/04/2018

---