[Federal Register Volume 84, Number 73 (Tuesday, April 16, 2019)]
[Notices]
[Page 15623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07467]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-N-0742; FDA-2018-N-1967; FDA-2018-N-2970; FDA-
2017-N-1779; FDA-2008-N-0500; FDA-2012-N-0129; FDA-2009-D-0268; FDA-
2014-D-0609; and FDA-2011-N-0776]


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.

        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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Registration of Producers of Drugs and         0910-0045      12/31/2021
 Listing of Drugs in Commercial
 Distribution...........................
Biosimilar User Fee Program.............       0910-0718      12/31/2021
Surveys and Interviews with                    0910-0863      12/31/2021
 Investigational New Drug Sponsors to
 Assess Current Communication Practices
 with FDA Review Staff Under the Sixth
 Authorization of the Prescription Drug
 User Fee Act...........................
Disclosures of Descriptive Presentations       0910-0864      12/31/2021
 in Professional Oncology Prescription
 Drug Promotion.........................
Requirements on Content and Format of          0910-0572       1/31/2022
 Labeling for Human Prescription Drug
 and Biological Products................
General Licensing Provisions; Section          0910-0719       1/31/2022
 351(k) Biosimilar Applications.........
Labeling of Certain Beers Subject to the       0910-0728       1/31/2022
 Labeling Jurisdiction of the FDA.......
Implementation of the Drug Supply Chain        0910-0806       1/31/2022
 Security Act--Identification of Suspect
 Product and Notification...............
Reclassification Petitions for Medical         0910-0138       2/28/2022
 Devices................................
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    Dated: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-07467 Filed 4-15-19; 8:45 am]
 BILLING CODE 4164-01-P