Page Range | 26698-26699 | |
FR Document | 2018-12338 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Notices] [Pages 26698-26699] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12338] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-N-0231; FDA-2014-N-0996; FDA-2010-N-0161; FDA- 2017-N-5624; FDA-2011-N-0085; FDA-2013-D-0575; and FDA-2016-N-3710] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or sponsor, and a person is not required [[Page 26699]] to respond to, a collection of information unless it displays a currently valid OMB control number. Table 1--List of Information Collections Approved by OMB ------------------------------------------------------------------------ OMB control Date approval Title of collection No. expires ------------------------------------------------------------------------ Biological Products--General Records and 0910-0308 4/30/2021 Postmarket Adverse Experience Reporting Guidance for Industry: Fast Track, Drug 0910-0389 4/30/2021 Development Programs--Designation, Development, and Application Review.... Export Certificates for FDA Regulated 0910-0498 4/30/2021 Products under U.S.C. Sections 801(e) and 802................................ Content and Format of Labeling for Human 0910-0624 4/30/2021 Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling..................... Guidance for Industry: Cooperative 0910-0629 4/30/2021 Manufacturing Arrangements for Licensed Biologics.............................. Guidance of Industry: Expedited Programs 0910-0765 4/30/2021 for Serious Conditions--Drugs and Biologics.............................. Evaluation of the Food and Drug 0910-0851 4/30/2021 Administration's Point-of-Sale Campaign ------------------------------------------------------------------------ Dated: June 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12338 Filed 6-7-18; 8:45 am] BILLING CODE 4164-01-P
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration | |
Section | Notices | |
Action | Notice. | |
Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
FR Citation | 83 FR 26698 |