Agency Information Collection Activities; Proposals, Submissions, and Approvals: Format and Content Requirements for Over-the-Counter Drug Product Labeling

This Notice document was issued by the Food and Drug Administration (FDA)

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Food and Drug Administration
[Docket No. FDA-2010-N-0248]

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Format and Content Requirements for Over-the-Counter Drug Product Labeling


Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Format and Content Requirements for Over-the-Counter Drug Product Labeling” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

For Further Information Contact

Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3792,

Supplementary Information

In theFederal Registerof August 13, 2010 (75 FR 49495), the Agency announced that the proposed information collection had been submitted 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 0910-0340. The approval expires on January 31, 2014. A copy of the supporting statement for this information collection is available onthe Internet at

Dated: February 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
FR Doc. 2011-3475 Filed 2-15-11; 8:45 am]
Comment Period Closed
ID: FDA-2010-N-0248-0003
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Document Information

Date Posted: Feb 16, 2011
Federal Register Number: 2011-03475
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