78 FR 93 pg. 28224 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Product Labeling; Medication Guide Requirements
Type: NOTICEVolume: 78Number: 93Page: 28224
Docket number: [Docket No. FDA-2011-N-0902]
FR document: [FR Doc. 2013-11364 Filed 5-13-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0902]
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, ila.mizrachi@fda.hhs.gov.
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.
[FR Doc. 2013-11364 Filed 5-13-13; 8:45 am]
BILLING CODE 4160-01-P