[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