[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
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..............................
------------------------------------------------------------------------


    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


