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2018-12-07
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Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information
Notices
D09002ee1bdb7dec6
D09002ee1bdb7df09
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to obtain data, information, and comments that will assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the- counter (OTC) human use. We are asking manufacturers of food handler antiseptics and other interested parties to submit safety and effectiveness data on OTC food handler antiseptics marketed for use by food handlers in commercial or regulated environments where growth, harvest, production, manufacturing, processing, packaging, transportation, storage, preparation, service, or consumption of food occurs. We also are inviting comments and requesting data on definitions, eligibility, current conditions of use of food handler antiseptics; safety and effectiveness criteria; as well as test methods to demonstrate the effectiveness of food handler antiseptics. In general, we are seeking input on current use conditions of antiseptics used in the food handler setting and recommended testing to establish the effectiveness of OTC food handler antiseptics. This information and data will inform FDA's ongoing review of OTC antiseptic drug products and will specifically inform our review of food handler antiseptic products.
83 FR 63168
https://www.govinfo.gov/app/details/FR-2018-12-07/2018-26561
2018-26561
fr07de18-42
4164-01-P
Docket No. FDA-2018-N-3458
https://www.govinfo.gov/app/details/FR-2018-12-07/2018-26561
https://www.govinfo.gov/content/pkg/FR-2018-12-07/html/2018-26561.htm
https://www.govinfo.gov/content/pkg/FR-2018-12-07/pdf/2018-26561.pdf
9 p.
63168
63176
83 FR 63168
Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information; Federal Register Vol. 83, Issue
NOTICE
2018-26561
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-02-05
Docket No. FDA-2018-N-3458
4164-01-P
2018-26561
Notice; request for data and information.
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to obtain data, information, and comments that will assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the- counter (OTC) human use. We are asking manufacturers of food handler antiseptics and other interested parties to submit safety and effectiveness data on OTC food handler antiseptics marketed for use by food handlers in commercial or regulated environments where growth, harvest, production, manufacturing, processing, packaging, transportation, storage, preparation, service, or consumption of food occurs. We also are inviting comments and requesting data on definitions, eligibility, current conditions of use of food handler antiseptics; safety and effectiveness criteria; as well as test methods to demonstrate the effectiveness of food handler antiseptics. In general, we are seeking input on current use conditions of antiseptics used in the food handler setting and recommended testing to establish the effectiveness of OTC food handler antiseptics. This information and data will inform FDA's ongoing review of OTC antiseptic drug products and will specifically inform our review of food handler antiseptic products.
Submit either electronic or written comments, data, or information by February 5, 2019.
Pranvera Ikonomi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5418, Silver Spring, MD 20993-0002, 240- 402-0272.
Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information
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Federal Register
Vol. 83, no. 235
Office of the Federal Register, National Archives and Records Administration
2018-12-07
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349 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-12-07
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https://www.govinfo.gov/content/pkg/FR-2018-12-07/pdf/FR-2018-12-07.pdf
https://www.govinfo.gov/content/pkg/FR-2018-12-07/xml/FR-2018-12-07.xml
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