2013-11364. 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, [e-mail].

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.