Document ID: FDA-2013-N-0375-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Announcement of Office of
Management and Budget Approvals
Posted Date: 2019-11-07T05:00Z

[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Notices]
[Pages 60093-60094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24263]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-N-0375, FDA-2013-N-0520, FDA-2008-D-0031, FDA-
2012-N-0386, FDA-2013-N-0377, FDA-2011-D-0147, FDA-2013-N-1588, FDA-
2013-N-0093, and FDA-2016-N-1593]

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

[[Page 60094]]

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 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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Agreement for Shipment of Devices for          0910-0131       9/30/2022
 Sterilization..........................
Substances Prohibited from Use in Animal       0910-0339       9/30/2022
 Food or Feed; Animal Proteins
 Prohibited in Ruminant Feed............
Clinical Laboratory Improvement                0910-0598       9/30/2022
 Amendments Waiver Applications.........
Registration and Product Listing for           0910-0650       9/30/2022
 Owners and Operators of Domestic
 Tobacco Product Establishments and
 Listing of Ingredients in Tobacco
 Products...............................
Tobacco Health Document Submission......       0910-0654       9/30/2022
Guidance for Industry and Food and Drug        0910-0673       9/30/2022
 Administration Staff; Section 905(j)
 Reports: Demonstrating Substantial
 Equivalence Requirements for Tobacco
 Products...............................
Exemptions From Substantial Equivalence        0910-0684       9/30/2022
 Requirements for Tobacco Products......
Evaluation of the Program for Enhanced         0910-0746       9/30/2022
 Review Transparency and Communication
 for New Molecular Entity New Drug
 Applications and Original Biologics
 License Applications in Prescription
 Drug User Fee Acts and 351(k) Biologics
 License Applications in Biosimilars
 User Fee Act...........................
Medical Device Accessories..............       0910-0823       9/30/2022
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    Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24263 Filed 11-6-19; 8:45 am]
 BILLING CODE 4164-01-P