2018-13098. 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, [e-mail].

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.

Table 1—List of Information Collections Approved By OMB

Title of collection	OMB control No.	Date approval expires
Infant Formula Requirements	0910-0256	5/31/2021
Premarket Notification for a New Dietary Ingredient	0910-0330	5/31/2021
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring	0910-0409	5/31/2021
Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice	0910-0563	5/31/2021
Requests for Inspection by an Accredited Person Under the Inspection for Accredited Persons Program	0910-0569	5/31/2021
Substances Prohibited from Use in Animal Food or Feed	0910-0627	5/31/2021
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300	0910-0633	5/31/2021
Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic	0910-0701	5/31/2021
Guidance on Consultation Procedures: Foods Derived From New Plant Varieties	0910-0704	5/31/2021
Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices	0910-0741	5/31/2021
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments	0910-0782	5/31/2021
Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings with the Office of Orphan Products Development	0910-0787	5/31/2021
Food Allergen Labeling and Reporting	0910-0792	5/31/2021
Transfer of a Premarket Notification Clearance	0910-0852	5/31/2021

Dated: June 13, 2018.

Leslie Kux,

Associate Commissioner for Policy.