Document ID: FDA-2012-N-0438-0028
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals
Posted Date: 2019-02-11T05:00Z

[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3191-3192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01812]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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: 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 to respond to, a collection of

[[Page 3192]]

information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
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                                            OMB Control    Date approval
           Title of collection                  No.           expires
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Recommendations for Early Food Safety          0910-0583      10/31/2021
 Evaluation of New Non-Pesticidal
 Proteins Produced by New Plant
 Varieties Intended for Food Use........
Guidance for Industry on Controlled            0910-0797      10/31/2021
 Correspondence Related to Generic Drug
 Development............................
Guidance for Industry on Adverse Event         0910-0800      10/31/2021
 Reporting for Outsourcing Facilities
 Under Section 503B of the Federal Food,
 Drug, and Cosmetic Act.................
Generic Clearance for the Collection of        0910-0810      10/31/2021
 Quantitative Data on Tobacco Products
 and Communications.....................
MedWatch: Adverse Event and Product            0910-0291      11/30/2021
 Experience Reporting System (Paper-
 Based).................................
Electronic User Fee Payment Form               0910-0805      11/30/2021
 Requests...............................
Labeling of Red Blood Cell Units with          0910-0862      11/30/2021
 Historical Antigen Typing Results......
Postmarketing Adverse Drug Experience          0910-0230      12/31/2021
 Reporting..............................
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    Dated: February 5, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01812 Filed 2-8-19; 8:45 am]
 BILLING CODE 4164-01-P