78 FR 244 pg. 76841 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Type: NOTICEVolume: 78Number: 244Page: 76841
Page: 76841Docket number: [Docket No. FDA-2008-D-0150]
FR document: [FR Doc. 2013-30146 Filed 12-18-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0150]
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims" 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, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
On September 10, 2013, the Agency submitted a proposed collection of information entitled "Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims" 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 0910-0670. The approval expires on December 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: December 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30146 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P