Source: https://www.federalregister.gov/documents/2017/03/17/2017-05350/presiding-officer-for-an-appeal-and-informal-hearing-technical-amendments
Timestamp: 2018-11-19 09:25:46
Document Index: 654577866

Matched Legal Cases: ['arts 1', '§\u20091', '§\u200916', 'art;\n3', '§\u20091', '§\u20091', '§\u20091', '§\u200916', '§\u200916', '§\u2009101', 'art 112', '§\u2009112', '§\u2009112', 'art 115', '§\u2009115', 'art 117', '§\u2009117', '§\u2009117', 'art 118', '§\u2009118', '§\u2009118', 'art 507', '§\u2009507', '§\u2009507', 'art 800', '§\u2009800', '§\u200916']

Federal Register :: Presiding Officer for an Appeal and Informal Hearing; Technical Amendments
A Rule by the Food and Drug Administration on 03/17/2017
82 FR 14143
14143-14147 (5 pages)
2017-05350
https://www.federalregister.gov/d/2017-05350 https://www.federalregister.gov/d/2017-05350
The 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'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's regulations.
Peter Fox, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20852, 240-402-1857.
The FDA Office of Regulatory Affairs has dissolved the Regional Food and Drug Director position. Certain duties related to administrative appeals and informal hearings formerly held by Regional Food and Drug Directors will transfer to Office of Regulatory Affairs Program Directors. The revisions made by this rule pertain solely to the designation of FDA officials and do not alter any substantive standards.
The regulations specified in this rule have been revised to replace all references to the “Regional Food and Drug Director” with “Office of Regulatory Affairs Program Director,” to reflect the change in designation. In addition, the regulations have been revised to authorize other FDA officials senior to an FDA District Director to perform duties related to administrative appeals and informal hearings. Finally, we have made minor conforming amendments and grammatical changes as necessary to accommodate the new language.
We are making these technical amendments to revise descriptions of the FDA officials designated to preside over administrative appeals and at informal hearings on appeal. The rule does not impose any new regulatory requirements on affected parties. The amendments are editorial in nature and should not be construed as modifying any substantive standards or requirements.
FDA has determined that this rulemaking meets the notice and comment exemption requirements in 5 U.S.C. 553(b)(3)(A) and (b)(3)(B). FDA's revisions make technical or non-substantive changes that pertain solely to the designation of FDA officials, and do not alter any substantive standard. FDA does not believe public comment is necessary for these minor revisions.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 1, 101, 112, 115, 117, 118, 507, and 800 are amended as follows:
2. Amend § 1.403 by revising paragraph (f) to read as follows:
What requirements apply to an informal hearing?
(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;
3. Revise § 1.404 to read as follows:
§ 1.404
Who serves as the presiding officer for an appeal and for an informal hearing?
4. Amend § 1.980 by revising paragraphs (g)(3)(iv) and (g)(4) to read as follows:
Administrative detention of drugs.
(iv) Paragraph (g)(4) of this section, rather than § 16.42(a) of this chapter, describes the FDA employees, i.e., Office of Regulatory Affairs Program Directors or other FDA officials senior to an FDA District Director, who preside at hearings under this section.
(4) The presiding officer of a regulatory hearing on an appeal of a detention order, who also must decide the appeal, must be an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director who is permitted by § 16.42(a) of this chapter to preside over the hearing.
6. Amend § 101.17 by revising paragraphs (h)(7)(ii) introductory text, (h)(7)(ii)(B), (h)(7)(ii)(C) introductory text, (h)(7)(ii)(C)( 1), (h)(7)(ii)(C)(4), (h)(7)(ii)(C)(5), (h)(7)(ii)(C)(6), (h)(7)(ii)(D), (h)(7)(ii)(E), and (h)(7)(ii)(F) to read as follows:
(ii) The person on whom the order for relabeling, diversion, or destruction is served may either comply with the order or appeal the order to an Office of Regulatory Affairs Program Director.
(B) Summary decision. A request for a hearing may be denied, in whole or in part and at any time after a request for a hearing has been submitted, if the Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director determines that no genuine and substantial issue of fact has been raised by the material submitted in connection with the hearing or from matters officially noticed. If the presiding FDA official determines that a hearing is not justified, written notice of the determination will be given to the parties explaining the reason for denial.
(C) Informal hearing. Appearance by any appellant at the hearing may be by mail or in person, with or without counsel. The informal hearing shall be conducted by an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director, and a written summary of the proceedings shall be prepared by the presiding FDA official.
(1) The presiding FDA official may direct that the hearing be conducted in any suitable manner permitted by law and this section. The presiding FDA official has the power to take such actions and make such rulings as are necessary or appropriate to maintain order and to conduct an informal, fair, expeditious, and impartial hearing, and to enforce the requirements concerning the conduct of hearings.
(4) The party requesting the hearing may have the hearing transcribed, at the party's expense, in which case a copy of the transcript is to be furnished to FDA. Any transcript of the hearing will be included with the presiding FDA official's report of the hearing.
(5) The presiding FDA official shall prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. Whenever time permits, the presiding FDA official may give the parties the opportunity to review and comment on the report of the hearing.
(6) The presiding FDA official shall 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 shall include a recommended decision, with a statement of reasons.
(D) Written appeal. If the appellant appeals the detention order but does not request a hearing, the presiding FDA official shall render a decision on the appeal affirming or revoking the detention within 5-working days after the receipt of the appeal.
(E) Presiding FDA official's decision. If, based on the evidence presented at the hearing or by the appellant in a written appeal, the presiding FDA official finds that the shell eggs were held in violation of this section, he shall affirm the order that they be relabeled, diverted under the supervision of an officer or employee of FDA for processing under the EPIA, or destroyed by or under the supervision of an officer or employee of FDA; otherwise, the presiding FDA official shall issue a written notice that the prior order is withdrawn. If the presiding FDA official affirms the order, he shall order that the relabeling, diversion, or destruction be accomplished within 10-working days from the date of the issuance of his decision. The presiding FDA official's decision shall be accompanied by a statement of the reasons for the decision. The decision of the presiding FDA official shall constitute final agency action, reviewable in the courts.
(F) No appeal. If there is no appeal of the order and the person in possession of the shell eggs that are subject to the order fails to relabel, divert, or destroy them within 10-working days, or if the demand is affirmed by the presiding FDA official after an appeal and the person in possession of such eggs fails to relabel, divert, or destroy them within 10-working days, the FDA district office, or, if applicable, the State or local agency may designate an officer or employee to divert or destroy such eggs. It shall be unlawful to prevent or to attempt to prevent such diversion or destruction of the shell eggs by the designated officer or employee.
7. The authority citation for part 112 continues to read as follows:
8. Revise § 112.209 to read as follows:
§ 112.209
Who is the presiding officer for an appeal and for an informal hearing?
9. The authority citation for part 115 continues to read as follows:
10. Amend § 115.50 by revising paragraphs (e)(2) introductory text, (e)(2)(ii), (e)(2)(iii) introductory text, (e)(2)(iii)(A), (e)(2)(iii)(D), (e)(2)(iii)(E), (e)(2)(iii)(F), (e)(2)(iv), (e)(2)(v), and (e)(2)(vi) to read as follows:
(iii) Informal hearing. Appearance by any appellant at the hearing may be by mail or in person, with or without counsel. The informal hearing shall be conducted by the Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director, and a written summary of the proceedings shall be prepared by the presiding FDA official.
(A) The presiding FDA official may direct that the hearing be conducted in any suitable manner permitted by law and this section. The presiding FDA official has the power to take such actions and make such rulings as are necessary or appropriate to maintain order and to conduct an informal, fair, expeditious, and impartial hearing, and to enforce the requirements concerning the conduct of hearings.
(D) The party requesting the hearing may have the hearing transcribed, at the party's expense, in which case a copy of Start Printed Page 14146the transcript is to be furnished to FDA. Any transcript of the hearing will be included with the presiding FDA official's report of the hearing.
(E) The presiding FDA official shall prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. Whenever time permits, the presiding FDA official may give the parties the opportunity to review and comment on the report of the hearing.
(F) The presiding FDA official shall 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 shall include a recommended decision, with a statement of reasons.
(iv) Written appeal. If the appellant appeals the detention order but does not request a hearing, the presiding FDA official shall render a decision on the appeal affirming or revoking the detention within 5-working days after the receipt of the appeal.
(v) Presiding FDA official's decision. If, based on the evidence presented at the hearing or by the appellant in a written appeal, the presiding FDA official finds that the shell eggs were held in violation of this section, he shall affirm the order that they be diverted, under the supervision of an officer or employee of FDA for processing under the EPIA or destroyed by or under the supervision of an officer or employee of FDA; otherwise, the presiding FDA official shall issue a written notice that the prior order is withdrawn. If the presiding FDA official affirms the order, he shall order that the diversion or destruction be accomplished within 10-working days from the date of the issuance of his decision. The presiding FDA official's decision shall be accompanied by a statement of the reasons for the decision. The decision of the presiding FDA official shall constitute final agency action, reviewable in the courts.
(vi) No appeal. If there is no appeal of the order and the person in possession of the shell eggs that are subject to the order fails to divert or destroy them within 10-working days, or if the demand is affirmed by the presiding FDA official after an appeal and the person in possession of such eggs fails to divert or destroy them within 10-working days, FDA's district office or appropriate State or local agency may designate an officer or employee to divert or destroy such eggs. It shall be unlawful to prevent or to attempt to prevent such diversion or destruction of the shell eggs by the designated officer or employee.
11. The authority citation for part 117 continues to read as follows:
12. Revise § 117.274 to read as follows:
§ 117.274
Presiding officer for an appeal and for an informal hearing.
13. The authority citation for part 118 continues to read as follows:
Authority: 21 U.S.C. 321, 331- 334, 342, 371, 381, 393, 42 U.S.C. 243, 264, 271.
14. Amend § 118.12 by revising paragraphs (a)(1)(i) introductory text, (a)(2) introductory text, (a)(2)(ii), (a)(2)(iii) introductory text, (a)(2)(iii)(A), (a)(2)(iii)(D), (a)(2)(iii)(E), (a)(2)(iii)(F), (a)(2)(v), and (a)(2)(vi) to read as follows:
§ 118.12
(F) The presiding FDA official 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, Start Printed Page 14147and must include a recommended decision, with a statement of reasons.
15. The authority citation for part 507 continues to read as follows:
16. Revise § 507.75 to read as follows:
§ 507.75
Residing officer for an appeal and for an informal hearing.
17. The authority citation for part 800 continues to read as follows:
18. Amend § 800.55 by revising paragraphs (g)(3)(iv) and (g)(4) to read as follows:
(4) The presiding officer of a regulatory hearing on an appeal of a detention order, who also shall decide the appeal, shall be an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director who is permitted by § 16.42(a) of this chapter to preside over the hearing.
[FR Doc. 2017-05350 Filed 3-16-17; 8:45 am]