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Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

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Food and Drug Administration, HHS.




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.

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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,

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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​public/​do/​PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of Start Printed Page 3192information unless it displays a currently valid OMB control number.

Table 1—List of Information Collections Approved by OMB

Title of collectionOMB Control No.Date approval expires
Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use0910-058310/31/2021
Guidance for Industry on Controlled Correspondence Related to Generic Drug Development0910-079710/31/2021
Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act0910-080010/31/2021
Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications0910-081010/31/2021
MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)0910-029111/30/2021
Electronic User Fee Payment Form Requests0910-080511/30/2021
Labeling of Red Blood Cell Units with Historical Antigen Typing Results0910-086211/30/2021
Postmarketing Adverse Drug Experience Reporting0910-023012/31/2021
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Dated: February 5, 2019.

Lowell J. Schiller,

Acting Associate Commissioner for Policy.

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[FR Doc. 2019-01812 Filed 2-8-19; 8:45 am]