Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Biosimilar User Fee Cover Sheet; Form FDA 3792

---
identifier: "/us/fr/2016-01883"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Biosimilar User Fee Cover Sheet; Form FDA 3792"
title_number: 0
title_name: "Federal Register"
section_number: "2016-01883"
section_name: "Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Biosimilar User Fee Cover Sheet; Form FDA 3792"
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currency: "2016-02-03"
last_updated: "2016-02-03"
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generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2016-01883"
document_type: "notice"
publication_date: "2016-02-03"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "81 FR 5763"
fr_volume: 81
docket_ids:
  - "Docket No. FDA-2012-N-0194"
fr_action: "Notice."
---


#  Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Biosimilar User Fee Cover Sheet; Form FDA 3792

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Biosimilar User Fee Cover Sheet; Form FDA 3792” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

**FOR FURTHER INFORMATION CONTACT:**

FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, *[email protected]* .

**SUPPLEMENTARY INFORMATION:**

On June 23, 2015, the Agency submitted a proposed collection of information entitled “Biosimilar User Fee Cover Sheet; Form FDA 3792” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0718. The approval expires on December 31, 2018. A copy of the supporting statement for this  information collection is available on the Internet at *http://www.reginfo.gov/public/do/PRAMain* .

Dated: January 28, 2016.

Leslie Kux,

Associate Commissioner for Policy.