2014-09914. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

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 Expedited Programs for Serious Conditions—Drugs and Biologics” 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 December 31, 2013, the Agency submitted a proposed collection of information entitled “Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and Biologics” 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 0910-0765. The approval expires on March 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/​public/​do/​PRAMain.

Dated: April 25, 2014.

Leslie Kux,

Assistant Commissioner for Policy.