Source: https://www.law.cornell.edu/cfr/text/21/1.403
Timestamp: 2017-06-23 22:47:34
Document Index: 112743089

Matched Legal Cases: ['art 1', '§ 1', 'art 16', '§ 1', '§ 16', '§ 16', '§ 16', '§ 16', '§ 16', '§ 16', '§ 1', '§ 16', 'art 16', '§ 16', '§ 16', '§ 10', 'art 1', 'art 1', 'art 1', 'arts 1', 'art 1']

21 CFR 1.403 - What requirements apply to an informal hearing? | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 1 › Subpart K › Section 1.403 21 CFR 1.403 - What requirements apply to an informal hearing?
§ 1.403 What requirements apply to an informal hearing?
If FDA grants a request for an informal hearing on an appeal of a detention order, FDA must conduct the hearing in accordance with part 16 of this chapter, except that:
(a) The detention order under § 1.393, rather than the notice under § 16.22(a) of this chapter, provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter;
(b) A request for a hearing under this section must be addressed to the FDA District Director in whose district the article of food involved is located;
(c) The provision in § 16.22(b) of this chapter, providing that a person not be given less than 3 working days after receipt of notice to request a hearing, does not apply to a hearing under this subpart;
(d) The provision in § 16.24(e) of this chapter, stating that a hearing may not be required to be held at a time less than 2 working days after receipt of the request for a hearing, does not apply to a hearing under this subpart;
(e) Section 1.406, rather than § 16.24(f) of this chapter, describes the statement that will be provided to an appellant where a detention order is based on classified information;
(f) Section 1.404, rather than § 16.42(a) of this chapter, describes the FDA employees, i.e., Office of Regulatory Affairs Program Directors or other officials senior to a District Director, who preside at hearings under this subpart;
(g) The presiding officer may require that a hearing conducted under this section be completed within 1 calendar day, as appropriate;
(h) Section 16.60(e) and (f) of this chapter does not apply to a hearing under this subpart. The presiding officer must prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. The presiding officer must include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and must include a proposed decision, with a statement of reasons. The hearing participant may review and comment on the presiding officer's report within 4 hours of issuance of the report. The presiding officer will then issue the final agency decision.
(i) Section 16.80(a)(4) of this chapter does not apply to a regulatory hearing under this subpart. The presiding officer's report of the hearing and any comments on the report by the hearing participant under § 1.403(h) are part of the administrative record.
(j) No party shall have the right, under § 16.119 of this chapter to petition the Commissioner of Food and Drugs for reconsideration or a stay of the presiding officer's final agency decision.
(k) If FDA grants a request for an informal hearing on an appeal of a detention order, the hearing must be conducted as a regulatory hearing pursuant to regulation in accordance with part 16 of this chapter, except that § 16.95(b) does not apply to a hearing under this subpart. With respect to a regulatory hearing under this subpart, the administrative record of the hearing specified in §§ 16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 1.403(i) constitutes the exclusive record for the presiding officer's final decision on an administrative detention. For purposes of judicial review under § 10.45 of this chapter, the record of the administrative proceeding consists of the record of the hearing and the presiding officer's final decision.
[ 69 FR 31701, June 4, 2004, as amended at 82 FR 14144, Mar. 17, 2017]
Title 21 published on 10-May-2017 03:43The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1 after this date.2017-04-06; vol. 82 # 65 - Thursday, April 6, 201782 FR 16733 - Waivers From Requirements of the Sanitary Transportation of Human and Animal Food Rule
typeregulations.gov FR Doc.2017-06854 RIN Docket No.FDA-2013-N-0013 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification. The waivers are effective as of April 6, 2017. 21 CFR Part 1 SummaryThe Food and Drug Administration (FDA, Agency, or we) is publishing three waivers from the requirements of the Sanitary Transportation of Human and Animal Food (the Sanitary Transportation rule). The Agency is taking this action in accord with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2017-03-30; vol. 82 # 60 - Thursday, March 30, 201782 FR 15627 - Requirements To Submit Prior Notice of Imported Food; Technical Amendments
typeregulations.gov FR Doc.2017-06201 RIN Docket No.FDA-2017-N-0011 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective March 30, 2017. 21 CFR Part 1 SummaryThe Food and Drug Administration (FDA or we) is amending the prior notice of imported food regulations to reflect a change in the electronic data interchange system and its expanded capabilities, to correct inaccurate number designations in section headings, and to reflect a change in an office&apos;s name. This action is ministerial or editorial in nature.
2017-03-17; vol. 82 # 51 - Friday, March 17, 201782 FR 14143 - Presiding Officer for an Appeal and Informal Hearing; Technical Amendments
typeregulations.gov FR Doc.2017-05350 RIN Docket No.FDA-2017-N-0011 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective March 17, 2017. 21 CFR Parts 1, 101, 112, 115, 117, 118, 507, and 800 SummaryThe Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency&apos;s organizational structure, including the dissolution of the Regional Food and Drug Director position. The revisions replace references to the Regional Food and Drug Director, who is designated to preside over administrative appeals and at informal hearings on appeal, with references to Office of Regulatory Affairs Program Directors. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency&apos;s regulations.
2016-12-27; vol. 81 # 248 - Tuesday, December 27, 201681 FR 95068 - Questions and Answers Regarding Food Facility Registration (Seventh Edition); Revised Draft Guidance for Industry; Availability
2014-10-23; vol. 79 # 205 - Thursday, October 23, 201479 FR 63346 - Food and Drug Administration Food Safety Modernization Act; Public Meeting
2014-03-31; vol. 79 # 61 - Monday, March 31, 201479 FR 17947 - Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3); Availability
typeregulations.gov FR Doc.2014-07046 RIN Docket No.FDA-2011-N-0179 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of availability. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 30, 2014. 21 CFR Part 1 SummaryThe Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled “Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3).” The draft guidance addresses questions received since the publication of the second edition of the guidance in May 2004 and includes information related to the Food Safety Modernization Act (FSMA), which amended the Federal Food, Drug, and Cosmetic Act, to require the name of any country to which an article has been refused entry be reported in a prior notice. The draft guidance is intended to help the food industry and others comply with prior notice requirements.
2014-02-14; vol. 79 # 31 - Friday, February 14, 201479 FR 8907 - Sanitary Transportation of Human and Animal Food; Public Meetings on Proposed Rule
21 CFR 1.405 — When Does FDA Have to Issue a Decision on an Appeal?