2013-30146. 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, [e-mail].

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.