[Federal Register Volume 83, Number 118 (Tuesday, June 19, 2018)]
[Notices]
[Pages 28430-28431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13098]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2013-N-0545; FDA-2013-N-0878; FDA-2014-N-0998; FDA-
2014-N-1076; FDA-2017-N-6162; FDA-2011-N-0510; FDA-2014-N-1414; FDA-
2008-D-0610; FDA-2010-D-0073; FDA-2013-N-0080; FDA-2017-N-6397; FDA-
2014-D-0313; FDA-2014-N-1030; and FDA-2014-D-1837]
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 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.
[[Page 28431]]
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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Infant Formula Requirements............. 0910-0256 5/31/2021
Premarket Notification for a New Dietary 0910-0330 5/31/2021
Ingredient.............................
Regulations for In Vivo 0910-0409 5/31/2021
Radiopharmaceuticals Used for Diagnosis
and Monitoring.........................
Guidance for Industry: Formal Dispute 0910-0563 5/31/2021
Resolution; Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice....
Requests for Inspection by an Accredited 0910-0569 5/31/2021
Person Under the Inspection for
Accredited Persons Program.............
Substances Prohibited from Use in Animal 0910-0627 5/31/2021
Food or Feed...........................
Class II Special Controls Guidance 0910-0633 5/31/2021
Document: Labeling for Natural Rubber
Latex Condoms Classified Under 21 CFR
884.5300...............................
Guidance for Industry: Postmarketing 0910-0701 5/31/2021
Adverse Event Reporting for Medical
Products and Dietary Supplements During
an Influenza Pandemic..................
Guidance on Consultation Procedures: 0910-0704 5/31/2021
Foods Derived From New Plant Varieties.
Human Subject Protection; Acceptance of 0910-0741 5/31/2021
Data From Clinical Investigations for
Medical Devices........................
Food Labeling; Calorie Labeling of 0910-0782 5/31/2021
Articles of Food in Vending Machines
and Nutrition Labeling of Standard Menu
Items in Restaurants and Similar Retail
Food Establishments....................
Guidance for Industry, Researchers, 0910-0787 5/31/2021
Patient Groups, and Food and Drug
Administration Staff on Meetings with
the Office of Orphan Products
Development............................
Food Allergen Labeling and Reporting.... 0910-0792 5/31/2021
Transfer of a Premarket Notification 0910-0852 5/31/2021
Clearance..............................
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Dated: June 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13098 Filed 6-18-18; 8:45 am]
BILLING CODE 4164-01-P