21 CFR 1.94 - Hearing on refusal of admission.

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There are 2 Updates appearing in the Federal Register for 21 CFR 1. View below or at eCFR (GPOAccess)
§ 1.94 Hearing on refusal of admission.
(a) If it appears that the article may be subject to refusal of admission, the district director shall give the owner or consignee a written notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony. Upon timely request giving reasonable grounds therefor, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility of the article, and may be introduced orally or in writing.
(b) If such owner or consignee submits or indicates his intention to submit an application for authorization to relabel or perform other action to bring the article into compliance with the act or to render it other than a food, drug, device, or cosmetic, such testimony shall include evidence in support of such application. If such application is not submitted at or prior to the hearing, the district director shall specify a time limit, reasonable in the light of the circumstances, for filing such application.

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.

  • 2014-05-29; vol. 79 # 103 - Thursday, May 29, 2014
    1. 79 FR 30716 - Administrative Detention of Drugs Intended for Human or Animal Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective June 30, 2014.
      21 CFR Parts 1 and 16

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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 1 after this date.

  • 2014-09-29; vol. 79 # 188 - Monday, September 29, 2014
    1. 79 FR 58524 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; supplemental notice of proposed rulemaking.
      Submit either electronic or written comments on the proposed rule by December 15, 2014 Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 15, 2014 (see the “Paperwork Reduction Act of 1995” section of this document).
      21 CFR Parts 1, 16, and 117