21 CFR 514.12 - Confidentiality of data and information in an investigational new animal drug notice.

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There is 1 rule appearing in the Federal Register for 21 CFR 514. View below or at eCFR (GPOAccess)
§ 514.12 Confidentiality of data and information in an investigational new animal drug notice.
(a) The existence of an INAD notice will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged.
(b) The availability for public disclosure of all data and information in an INAD file shall be handled in accordance with provisions established in § 514.11.

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-01; vol. 79 # 126 - Tuesday, July 1, 2014
    1. 79 FR 37175 - New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Direct final rule; confirmation of effective date.
      Effective date of final rule published in the Federal Register of March 17, 2014 (79 FR 14609) confirmed: July 30, 2014.
      21 CFR Part 514

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 514 after this date.

  • 2014-07-01; vol. 79 # 126 - Tuesday, July 1, 2014
    1. 79 FR 37175 - New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Direct final rule; confirmation of effective date.
      Effective date of final rule published in the Federal Register of March 17, 2014 (79 FR 14609) confirmed: July 30, 2014.
      21 CFR Part 514