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

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Food and Drug Administration, HHS.




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.

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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,

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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​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 collectionOMB control No.Date approval expires
Mammography Quality Standards Act Requirements0910-030910/31/2022
Prescription Drug Product Labeling; Medication Guide Requirements0910-039310/31/2022
Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed0910-051310/31/2022
Current Good Manufacturing Practice for Positron Emission0910-066710/31/2022
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Abbreviated New Animal Drug Applications0910-066910/31/2022
Medical Devices: Use of Certain Symbols in Labeling—Glossary to Support the Use of Symbols in Labeling0910-074010/31/2022
Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act0910-076810/31/2022
Investigational Device Exemptions Reports and Records0910-007811/30/2022
510(k) Third-Party Review Program0910-037511/30/2022
Guidance for Industry With the Center for Veterinary Medicine's Electronic Submission System0910-045411/30/2022
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Dated: December 16, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-28249 Filed 12-30-19; 8:45 am]