Document ID: FDA-2012-N-0115-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2018-10-11T04:00Z

[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Notices]
[Pages 51464-51465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22101]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-N-0341; FDA-2012-N-0115; FDA-2018-N-1011; FDA-
2010-N-0110; FDA-2012-N-0547; FDA-2014-N-2347; FDA-2016-D-2285; FDA-
2016-D-1307; FDA-2016-D-4318; FDA-2016-N-0407; and FDA-2018-N-0270]

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 51465]]

        Table 1--List of Information Collections Approved by OMB
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                                            OMB control    Date approval
           Title of collection                number          expires
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New Animal Drugs for Investigational Use       0910-0117       8/31/2021
Guidance for Industry and FDA Staff,           0910-0594       8/31/2021
 Class II Special Controls: Automated
 Blood Cell Separator Device Operating
 by Centrifugal or Filtration Separation
 Principle..............................
Petition to Request an Exemption from          0910-0608       8/31/2021
 100 Percent Identity Testing of Dietary
 Ingredients: Current Good Manufacturing
 Practice in Manufacturing, Packaging,
 Labeling, or Holding Operations for
 Dietary Supplements....................
Prescription Drug Advertisements........       0910-0686       8/31/2021
Survey of the Occurrence of Foodborne          0910-0744       8/31/2021
 Illness Risk Factors in Selected Retail
 and Foodservice Facility Types.........
Permanent Discontinuation or                   0910-0759       8/31/2021
 Interruption in Manufacturing of
 Certain Drug and Biological Products...
Food and Cosmetic Export Certificate           0910-0793       8/31/2021
 Applications Process...................
Guidance for Industry: Medical Product         0910-0856       8/31/2021
 Communications That are Consistent With
 the Food and Drug Administration
 Required Labeling--Questions and
 Answers................................
Guidance for Industry: Drug and Device         0910-0857       8/31/2021
 Manufacturer Communications with
 Payors, Formulary Committees, and
 Similar Entities Questions and Answers.
Guidance for Industry: Compounding and         0910-0858       8/31/2021
 Repackaging of Radiopharmaceuticals by
 State-Licensed Nuclear Pharmacies,
 Federal Facilities, and Certain Other
 Entities...............................
Drug Supply Chain Security Act Pilot           0910-0859       8/31/2021
 Program................................
Survey on the Occurrence of Foodborne          0910-0799       9/30/2021
 Illness Risk Factors in Selected
 Institutional and Retail Food Stores
 and Facility Types (2015-2025).........
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    Dated: October 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22101 Filed 10-10-18; 8:45 am]
 BILLING CODE 4164-01-P