2018-12338. Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
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Start Preamble
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.
Start Further InfoFOR 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, PRAStaff@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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 Start Printed Page 26699to respond to, a collection of information unless it displays a currently valid OMB control number.
Start SignatureTable 1—List of Information Collections Approved by OMB
Title of collection OMB control No. Date approval expires Biological Products—General Records and Postmarket Adverse Experience Reporting 0910-0308 4/30/2021 Guidance for Industry: Fast Track, Drug Development Programs—Designation, Development, and Application Review 0910-0389 4/30/2021 Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 0910-0498 4/30/2021 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling 0910-0624 4/30/2021 Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics 0910-0629 4/30/2021 Guidance of Industry: Expedited Programs for Serious Conditions—Drugs and Biologics 0910-0765 4/30/2021 Evaluation of the Food and Drug Administration's Point-of-Sale Campaign 0910-0851 4/30/2021 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
Document Information
- Published:
- 06/08/2018
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice.
- Document Number:
- 2018-12338
- Pages:
- 26698-26699 (2 pages)
- Docket Numbers:
- 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
- PDF File:
- 2018-12338.pdf
- Supporting Documents:
- » Statement of Organization, Functions, and Delegations of Authority
- » Statement of Organization, Functions, and Delegations of Authority