Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505(b)(2) Applications

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2011-N-0830] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Abbreviated New Drug Applications and 505(b)(2) Applications” 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, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov . SUPPLEMENTARY INFORMATION: On October 6, 2016, the Agency submitted a proposed collection of information entitled “Abbreviated New Drug Applications and 505(b)(2) Applications” 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 0910-0786. The approval expires on November 30, 2019. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/​public/​do/​PRAMain . Dated: November 22, 2016. Leslie Kux, Associate Commissioner for Policy. [ FR Doc. 2016-28655 Filed 11-28-16; 8:45 am] BILLING CODE 4164-01-P