Document ID: FDA-2008-D-0150-0019
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Posted Date: 2013-12-19T05:00Z

[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Page 76841]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30146]

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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.

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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