83 FR 111 pgs. 26698-26699 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Type: NOTICEVolume: 83Number: 111Pages: 26698 - 26699
Pages: 26698, 26699Docket number: [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]
FR document: [FR Doc. 2018-12338 Filed 6-7-18; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[top] 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
| 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]
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