2015-13472. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings With the Office of Orphan Products Development

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, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development” 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, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [e-mail].

SUPPLEMENTARY INFORMATION:

On March 4, 2015, the Agency submitted a proposed collection of information entitled, “Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development” 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 0910-0787. The approval expires on May 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/​public/​do/​PRAMain.

Dated: May 29, 2015.

Leslie Kux,

Associate Commissioner for Policy.