Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Product Labeling; Medication Guide Requirements

---
identifier: "/us/fr/2013-11364"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Product Labeling; Medication Guide Requirements"
title_number: 0
title_name: "Federal Register"
section_number: "2013-11364"
section_name: "Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Product Labeling; Medication Guide Requirements"
positive_law: false
currency: "2013-05-14"
last_updated: "2013-05-14"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2013-11364"
document_type: "notice"
publication_date: "2013-05-14"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "78 FR 28224"
fr_volume: 78
docket_ids:
  - "Docket No. FDA-2011-N-0902"
fr_action: "Notice."
---


#  Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Product Labeling; Medication Guide Requirements

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Prescription Drug Product Labeling; Medication Guide Requirements” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

**FOR FURTHER INFORMATION CONTACT:**

Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7726, *[email protected].*

**SUPPLEMENTARY INFORMATION:**

On April 30, 2012, the Agency submitted a proposed collection of information entitled “Prescription Drug Product Labeling; Medication Guide Requirements” 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 0910-0393. The approval expires on January 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at *http://www.reginfo.gov/public/do/PRAMain.*

Dated: May 8, 2013.

Leslie Kux,

Assistant Commissioner for Policy.