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 The leading web portal for pharmacy resources, news, education and careers April 22, 2019
Pharmacy Choice - Pharmaceutical News - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals - April 22, 2019

Pharmacy News Article

 2/11/19 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

Agency: "Food and Drug Administration, HHS."

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,

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 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.

Table 1-List of Information Collections Approved by OMB                                                                                                                                           
Title of collection                                               OMB                                                               Date                                                          
                                                                  Control No.                                                       approval                                                      
Recommendations for Early Food Safety Evaluation of New           0910-0583                                                         10/31/2021                                                    
Non-Pesticidal Proteins Produced by New Plant Varieties Intended                                                                                                                                  
for Food Use                                                                                                                                                                                      
Guidance for Industry on Controlled Correspondence Related to     0910-0797                                                         10/31/2021                                                    
Generic Drug Development                                                                                                                                                                          
Guidance for Industry on Adverse Event Reporting for Outsourcing  0910-0800                                                         10/31/2021                                                    
Facilities Under Section 503B of the Federal Food, Drug, and                                                                                                                                      
Cosmetic Act                                                                                                                                                                                      
Generic Clearance for the Collection of Quantitative Data on      0910-0810                                                         10/31/2021                                                    
Tobacco Products and Communications                                                                                                                                                               
MedWatch: Adverse Event and Product Experience Reporting System   0910-0291                                                         11/30/2021                                                    
Electronic User Fee Payment Form Requests                         0910-0805                                                         11/30/2021                                                    
Labeling of Red Blood Cell Units with Historical Antigen Typing   0910-0862                                                         11/30/2021                                                    
Postmarketing Adverse Drug Experience Reporting                   0910-0230                                                         12/31/2021                                                    

Dated: February 5, 2019.

Lowell J. Schiller,

Acting Associate Commissioner for Policy.


Citation: "84 FR 3191"

Document Number: "Docket Nos. FDA-2012-N-0438; FDA-2018-D-1592; FDA-2014-D-2138; FDA-2018-N-0180; FDA-2014-N-1960; FDA-2015-N-1837; and FDA-2016-D-4308"

Federal Register Page Number: "3191"


Copyright (c) 2019 Federal Information & News Dispatch, Inc.

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