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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, 10A63, 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
Request for Information From U.S. Processors That Export to the European Community0910-03205/31/2020
Guidance for Industry: Special Protocol Assessment0910-04705/31/2020
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use0910-05535/31/2020
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements0910-06065/31/2020
Guidance for Industry: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products0910-06755/31/2020
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Focus Groups About Drug Products as Used by the Food and Drug Administration0910-06775/31/2020
Testing Communication on Medical Devices and Radiation-Emitting Products0910-06785/31/2020
Tracking Network for PETNet, LivestockNet, and SampleNet0910-06805/31/2020
Medical Devices: Pediatric Uses of Devices; Requirements for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device is Intended to Treat, Diagnose, or Cure0910-07485/31/2020
Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics0910-07655/31/2020
Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs0910-08315/31/2020
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Dated: June 27, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

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[FR Doc. 2017-13890 Filed 6-30-17; 8:45 am]