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

Federal Register, Volume 83 Issue 118 (Tuesday, June 19, 2018)

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

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