[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,
[email protected].
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