Presiding Officer for an Appeal and Informal Hearing; Technical Amendments, 14143-14147 [2017-05350]

Download as PDF Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Rules and Regulations 8. Amend Form F–10 (referenced in § 239.40) by revising paragraph D of General Instruction II to read as follows: ■ Note: The text of Form F–10 does not, and this amendment will not, appear in the Code of Federal Regulations. United States Securities and Exchange Commission Washington, DC 20549 Form F–10 Registration Statement Under the Securities Act of 1933 * * * * * General Instructions * * * * mstockstill on DSK3G9T082PROD with RULES * By the Commission. Dated: March 1, 2017. Brent J. Fields, Secretary. [FR Doc. 2017–04365 Filed 3–16–17; 8:45 am] PART 249—FORMS, SECURITIES EXCHANGE ACT OF 1934 * * * * D. A registrant must file the registration statement in electronic format via the Commission’s Electronic Data Gathering, Analysis, and Retrieval (EDGAR) system in accordance with the EDGAR rules set forth in Regulation S– T (17 CFR part 232). For assistance with technical questions about EDGAR or to request an access code, call the EDGAR Filer Support Office at (202) 551–8900. For assistance with the EDGAR rules, call the Office of Information Technology in the Division of Corporation Finance at (202) 551–3600. Include an exhibit index in the registration statement, which must appear before the required signatures in the document. The exhibit index must list each exhibit according to the letter or number assigned to it. If an exhibit is incorporated by reference, this must be noted in the exhibit index. Each exhibit identified in the exhibit index (other than an exhibit filed in eXtensible Business Reporting Language) must include an active link to an exhibit that is filed with the registration statement or, if the exhibit is incorporated by reference an active hyperlink to the exhibit separately filed on EDGAR. If the registration statement is amended, each amendment must include active hyperlinks to the exhibits required with the amendment. For paper filings, the pages of the manually signed original registration statement should be numbered in sequence, and the exhibit index should give the page number in the sequential numbering system where each exhibit can be found. If filing the registration statement in paper under a hardship exemption in Rule 201 or 202 of Regulation S–T (17 CFR 232.201 or 232.202), or as otherwise permitted, a registrant must file with the Commission at its principal 19:31 Mar 16, 2017 report is amended, each amendment must include active hyperlinks to the exhibits required with the amendment. For paper filings, the pages of the manually signed original registration statement should be numbered in sequence, and the exhibit index should give the page number in the sequential numbering system where each exhibit can be found. * * * * * BILLING CODE 8011–01–P * II. Application of General Rules and Regulations VerDate Sep<11>2014 office five copies of the complete registration statement and any amendments, including exhibits and all other documents filed as a part of the registration statement or amendment. The registrant must bind, staple or otherwise compile each copy in one or more parts without stiff covers. The registrant must further bind the registration statement or amendment on the side or stitching margin in a manner that leaves the reading matter legible. The registrant must provide three additional copies of the registration statement or amendment without exhibits to the Commission. * * * * * 14143 Jkt 241001 9. The authority citation for part 249 continues to read in part as follows: ■ Authority: 15 U.S.C. 78a et seq. and 7201 et seq.; 12 U.S.C. 5461 et seq.; 18 U.S.C. 1350; Sec. 953(b) Pub. L. 111–203, 124 Stat. 1904; Sec. 102(a)(3) Pub. L. 112–106, 126 Stat. 309 (2012), Sec. 107 Pub. L. 112–106, 126 Stat. 313 (2012), and Sec. 72001 Pub. L. 114–94, 129 Stat. 1312 (2015), unless otherwise noted. * * * * * ■ 10. Amend Form 20–F (referenced in § 249.220f) by revising the fourth paragraph of the introductory text under ‘‘Instructions as to Exhibits’’ to read as follows: Note: The text of Form 20–F does not, and this amendment will not, appear in the Code of Federal Regulations. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 101, 112, 115, 117, 118, 507, and 800 [Docket No. FDA–2017–N–0011] Presiding Officer for an Appeal and Informal Hearing; Technical Amendments AGENCY: Food and Drug Administration, HHS. Final rule; technical amendments. ACTION: 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. DATES: This rule is effective March 17, 2017. FOR FURTHER INFORMATION CONTACT: Peter Fox, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20852, 240–402–1857. SUPPLEMENTARY INFORMATION: SUMMARY: Form 20–F * * * * * * * * Part III * * Item 19. Exhibits * * * * * Instructions as to Exhibits * * * * * Include an exhibit index in each registration statement or report you file, which must appear before the required signatures in the document. The exhibit index must list each exhibit according to the number assigned to it below. If an exhibit is incorporated by reference, this must be noted in the exhibit index. Each exhibit identified in the exhibit index (other than an exhibit filed in eXtensible Business Reporting Language) must include an active link to an exhibit that is filed with the registration statement or report or, if the exhibit is incorporated by reference an active hyperlink to the exhibit separately filed on EDGAR. If a registration statement or PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\17MRR1.SGM 17MRR1 14144 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Rules and Regulations I. Background 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. II. Description of the Technical Amendments 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. mstockstill on DSK3G9T082PROD with RULES Publication of this document constitutes final action of these changes under the Administrative Procedure Act (5 U.S.C. 553). Section 553 of the Administrative Procedure Act (APA) exempts ‘‘rules of agency organization, procedure, or practice’’ from proposed rulemaking (i.e., notice and comment rulemaking). 5 U.S.C. 553(b)(3)(A). Rules are also exempt when an agency finds ‘‘good cause’’ that notice and comment rulemaking procedures would be ‘‘impracticable, unnecessary, or contrary to the public interest.’’ 5 U.S.C. 553(b)(3)(B). 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 nonsubstantive 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. 19:31 Mar 16, 2017 Jkt 241001 List of Subjects 21 CFR Part 1 Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 101 Food labeling, Nutrition, Reporting and recordkeeping requirements. 21 CFR Part 112 Dietary foods, Food grades and standards, Foods, Fruits, Packaging and containers, Reporting and recordkeeping requirements, Safety, Vegetables. 21 CFR Part 115 Eggs and egg products, Foods. 21 CFR Part 117 360ccc, 360ccc–1, 360ccc–2, 362, 371, 373, 374, 379j–31, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107–188, 116 Stat. 594, 668–69; Pub. L. 111–353, 124 Stat. 3885, 3889. 2. Amend § 1.403 by revising paragraph (f) to read as follows: ■ § 1.403 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? The presiding officer for an appeal, and for an informal hearing, must be an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director. ■ 4. Amend § 1.980 by revising paragraphs (g)(3)(iv) and (g)(4) to read as follows: § 1.980 Administrative detention of drugs. * Food packaging, Foods. 21 CFR Part 118 Eggs and egg products, Food grades and standards, Reporting and recordkeeping requirements. 21 CFR Part 507 III. Notice and Public Comment VerDate Sep<11>2014 The APA allows an effective date less than 30 days after publication as ‘‘provided by the agency for good cause found and published with the rule’’ (5 U.S.C. 553(d)(3)). A delayed effective date is unnecessary in this case because the amendments do not impose any new regulatory requirements on affected parties. As a result, affected parties do not need time to prepare before the rule takes effect. Therefore, FDA finds good cause for the amendments to become effective on the date of publication of this action. Animal foods, Labeling, Packaging and containers, Reporting and recordkeeping requirements. 21 CFR Part 800 Administrative practice and procedure, Medical devices, Ophthalmic goods and services, Packaging and containers, Reporting and recordkeeping requirements. 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: PART 1—GENERAL ENFORCEMENT REGULATIONS * * * * (g) * * * (3) * * * (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. * * * * * PART 101—FOOD LABELING 5. The authority citation for part 101 continues to read as follows: ■ Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271. 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: ■ 1. The authority citation for part 1 continues to read as follows: ■ Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350e, 350j, 350k, 352, 355, 360b, PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\17MRR1.SGM 17MRR1 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Rules and Regulations § 101.17 Food labeling warning, notice, and safe handling statements. mstockstill on DSK3G9T082PROD with RULES * * * * * (h) * * * (7) * * * (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) VerDate Sep<11>2014 19:31 Mar 16, 2017 Jkt 241001 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. * * * * * PART 112—STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION 7. The authority citation for part 112 continues to read as follows: ■ Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271. ■ 8. Revise § 112.209 to read as follows: § 112.209 Who is the presiding officer for an appeal and for an informal hearing? The presiding officer for an appeal, and for an informal hearing, must be an PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 14145 Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director. PART 115—SHELL EGGS 9. The authority citation for part 115 continues to read as follows: ■ Authority: 21 U.S.C. 342, 371; 42 U.S.C. 243, 264, 271. 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: ■ § 115.50 Refrigeration of shell eggs held for retail distribution. * * * * * (e) * * * (2) The person on whom the order for diversion or destruction is served may either comply with the order or appeal the order to an Office of Regulatory Affairs Program Director in accordance with the following procedures: * * * * * (ii) 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. (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 E:\FR\FM\17MRR1.SGM 17MRR1 mstockstill on DSK3G9T082PROD with RULES 14146 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Rules and Regulations 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. (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 10working 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. * * * * * VerDate Sep<11>2014 19:31 Mar 16, 2017 Jkt 241001 PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISKBASED PREVENTIVE CONTROLS FOR HUMAN FOOD 11. The authority citation for part 117 continues to read as follows: ■ Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271. 12. Revise § 117.274 to read as follows: ■ § 117.274 Presiding officer for an appeal and for an informal hearing. The presiding officer for an appeal, and for an informal hearing, must be an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director. PART 118—PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS 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 Enforcement and compliance. * * * * * (a) * * * (1) * * * (i) Order for diversion or destruction under the PHS Act. Any district office of FDA or any State or locality acting under paragraph (c) of this section, upon finding shell eggs that have been produced or held in violation of this regulation, may serve a written order upon the person in whose possession the eggs are found requiring that the eggs be diverted, under the supervision of an officer or employee of the issuing entity, for processing in accordance with the EPIA (21 U.S.C. 1031 et seq.) or by a treatment that achieves at least a 5-long destruction of SE or destroyed by or under the supervision of the issuing entity, within 10-working days from the date of receipt of the order, unless under paragraph (a)(2)(iii) of this section, a hearing is held, in which case the eggs must be diverted or destroyed consistent with the decision of the Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director under paragraph (a)(2)(v) of this section. The PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 order must include the following information: * * * * * (2) The person on whom the order for diversion or destruction is served may either comply with the order or appeal the order to an Office of Regulatory Affairs Program Director in accordance with the following procedures: * * * * * (ii) 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. (iii) Informal hearing. Appearance by any appellant at the hearing may be by mail or in person, with or without counsel. The informal hearing must 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 must 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 by 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 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. (E) The presiding FDA official must 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 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, E:\FR\FM\17MRR1.SGM 17MRR1 Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Rules and Regulations § 507.75 Residing officer for an appeal and for an informal hearing. ACTION: The presiding officer for an appeal, and for an informal hearing, must be an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA District Director. SUMMARY: PART 507—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK– BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS mstockstill on DSK3G9T082PROD with RULES and must 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 must render a decision on the appeal affirming or revoking the detention order 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 produced or held in violation of this section, he must affirm the order that they be diverted, under the supervision of an officer or employee of FDA for processing under the EPIA or by a treatment that achieves at least a 5-log destruction of SE or destroyed by or under the supervision of an officer or employee of FDA; otherwise, the presiding FDA official must issue a written notice that the prior order is withdrawn. If the presiding FDA official affirms the order, he must 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 must be accompanied by a statement of the reasons for the decision. The decision of the presiding FDA official constitutes final agency action, subject to judicial review. (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, if applicable, the State or local representative 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. * * * * * 29 CFR Part 503 14147 15. The authority citation for part 507 continues to read as follows: ■ Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271. ■ 19:31 Mar 16, 2017 Jkt 241001 17. The authority citation for part 800 continues to read as follows: ■ Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 361, 362, 371. 18. Amend § 800.55 by revising paragraphs (g)(3)(iv) and (g)(4) to read as follows: ■ § 800.55 Administrative detention. * * * * * (g) * * * (3) * * * (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 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. * * * * * Dated: March 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–05350 Filed 3–16–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY The U.S. Department of Homeland Security (DHS) and the U.S. Department of Labor (DOL) (collectively, ‘‘the Departments’’) are jointly issuing this final rule to adjust for inflation the civil monetary penalties assessed or enforced in connection with the employment of temporary nonimmigrant workers under the H–2B program, pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990 as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Inflation Adjustment Act). The Inflation Adjustment Act provides that agencies shall adjust civil monetary penalties notwithstanding Section 553 of the Administrative Procedure Act (APA). Additionally, the Inflation Adjustment Act provides a cost-of-living formula for adjustment of the civil penalties. Accordingly, this final rule sets forth the Departments’ 2017 annual adjustments for inflation to the H–2B civil monetary penalties, effective March 17, 2017. This final rule is effective March 17, 2017. As provided by the Inflation Adjustment Act, the increased penalty levels apply to any penalties assessed after March 17, 2017. DATES: FOR FURTHER INFORMATION CONTACT: Pamela Peters, Program Analyst, U.S. Department of Labor, Room S–2312, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693–5959 (this is not a toll-free number). Copies of this final rule may be obtained in alternative formats (large print, Braille, audio tape or disc), upon request, by calling (202) 693–5959 (this is not a tollfree number). TTY/TDD callers may dial toll-free 1–877–889–5627 to obtain information or request materials in alternative formats. [CIS No. 2585–16] SUPPLEMENTARY INFORMATION: RIN 1615–AC10 I. Regulatory Information DEPARTMENT OF LABOR The Inflation Adjustment Act required agencies to: (1) Adjust the level of civil monetary penalties with an initial ‘‘catch-up’’ adjustment through an interim final rule (IFR); and (2) make subsequent annual adjustments for inflation. Agencies are required to publish an annual inflation adjustment no later than January 15, 2017, and by January 15 of each subsequent year. On July 1, 2016, the Departments established the initial catch-up adjustment for civil monetary penalties assessed or enforced in connection with the employment of temporary nonimmigrant workers under the H–2B Wage and Hour Division RIN 1235–AA16 Department of Homeland Security and Department of Labor Federal Civil Penalties Inflation Adjustment Act Annual Adjustments for the H–2B Temporary Non-agricultural Worker Program Department of Homeland Security; Wage and Hour Division, Department of Labor. AGENCY: 16. Revise § 507.75 to read as follows: VerDate Sep<11>2014 PART 800—GENERAL Final rule. PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\FR\FM\17MRR1.SGM 17MRR1

Agencies

[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Rules and Regulations]
[Pages 14143-14147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05350]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 101, 112, 115, 117, 118, 507, and 800

[Docket No. FDA-2017-N-0011]


Presiding Officer for an Appeal and Informal Hearing; Technical 
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: 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.

DATES: This rule is effective March 17, 2017.

FOR FURTHER INFORMATION CONTACT: Peter Fox, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, 
MD 20852, 240-402-1857.

SUPPLEMENTARY INFORMATION: 

[[Page 14144]]

I. Background

    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.

II. Description of the Technical Amendments

    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.

III. Notice and Public Comment

    Publication of this document constitutes final action of these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Section 
553 of the Administrative Procedure Act (APA) exempts ``rules of agency 
organization, procedure, or practice'' from proposed rulemaking (i.e., 
notice and comment rulemaking). 5 U.S.C. 553(b)(3)(A). Rules are also 
exempt when an agency finds ``good cause'' that notice and comment 
rulemaking procedures would be ``impracticable, unnecessary, or 
contrary to the public interest.'' 5 U.S.C. 553(b)(3)(B).
    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.
    The APA allows an effective date less than 30 days after 
publication as ``provided by the agency for good cause found and 
published with the rule'' (5 U.S.C. 553(d)(3)). A delayed effective 
date is unnecessary in this case because the amendments do not impose 
any new regulatory requirements on affected parties. As a result, 
affected parties do not need time to prepare before the rule takes 
effect. Therefore, FDA finds good cause for the amendments to become 
effective on the date of publication of this action.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 112

    Dietary foods, Food grades and standards, Foods, Fruits, Packaging 
and containers, Reporting and recordkeeping requirements, Safety, 
Vegetables.

21 CFR Part 115

    Eggs and egg products, Foods.

21 CFR Part 117

    Food packaging, Foods.

21 CFR Part 118

    Eggs and egg products, Food grades and standards, Reporting and 
recordkeeping requirements.

21 CFR Part 507

    Animal foods, Labeling, Packaging and containers, Reporting and 
recordkeeping requirements.

21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic 
goods and services, Packaging and containers, Reporting and 
recordkeeping requirements.

    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:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 
362, 371, 373, 374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a, 
387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188, 
116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.

0
2. Amend Sec.  1.403 by revising paragraph (f) to read as follows:


Sec.  1.403  What requirements apply to an informal hearing?

* * * * *
    (f) Section 1.404, rather than Sec.  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;
* * * * *

0
3. Revise Sec.  1.404 to read as follows:


Sec.  1.404  Who serves as the presiding officer for an appeal and for 
an informal hearing?

    The presiding officer for an appeal, and for an informal hearing, 
must be an Office of Regulatory Affairs Program Director or another FDA 
official senior to an FDA District Director.

0
4. Amend Sec.  1.980 by revising paragraphs (g)(3)(iv) and (g)(4) to 
read as follows:


Sec.  1.980  Administrative detention of drugs.

* * * * *
    (g) * * *
    (3) * * *
    (iv) Paragraph (g)(4) of this section, rather than Sec.  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 Sec.  16.42(a) of this 
chapter to preside over the hearing.
* * * * *

PART 101--FOOD LABELING

0
5. The authority citation for part 101 continues to read as follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.


0
6. Amend Sec.  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:

[[Page 14145]]

Sec.  101.17  Food labeling warning, notice, and safe handling 
statements.

* * * * *
    (h) * * *
    (7) * * *
    (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.
* * * * *

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND 
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

0
7. The authority citation for part 112 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 
264, 271.


0
8. Revise Sec.  112.209 to read as follows:


Sec.  112.209   Who is the presiding officer for an appeal and for an 
informal hearing?

    The presiding officer for an appeal, and for an informal hearing, 
must be an Office of Regulatory Affairs Program Director or another FDA 
official senior to an FDA District Director.

PART 115--SHELL EGGS

0
9. The authority citation for part 115 continues to read as follows:

    Authority: 21 U.S.C. 342, 371; 42 U.S.C. 243, 264, 271.

0
10. Amend Sec.  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:


Sec.  115.50   Refrigeration of shell eggs held for retail 
distribution.

* * * * *
    (e) * * *
    (2) The person on whom the order for diversion or destruction is 
served may either comply with the order or appeal the order to an 
Office of Regulatory Affairs Program Director in accordance with the 
following procedures:
* * * * *
    (ii) 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.
    (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

[[Page 14146]]

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.
    (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.
* * * * *

PART 117--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND 
RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

0
11. The authority citation for part 117 continues to read as follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 
371, 374; 42 U.S.C. 243, 264, 271.

0
12. Revise Sec.  117.274 to read as follows:


Sec.  117.274  Presiding officer for an appeal and for an informal 
hearing.

    The presiding officer for an appeal, and for an informal hearing, 
must be an Office of Regulatory Affairs Program Director or another FDA 
official senior to an FDA District Director.

PART 118--PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS

    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.

0
14. Amend Sec.  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:


Sec.  118.12  Enforcement and compliance.

* * * * *
    (a) * * *
    (1) * * *
    (i) Order for diversion or destruction under the PHS Act. Any 
district office of FDA or any State or locality acting under paragraph 
(c) of this section, upon finding shell eggs that have been produced or 
held in violation of this regulation, may serve a written order upon 
the person in whose possession the eggs are found requiring that the 
eggs be diverted, under the supervision of an officer or employee of 
the issuing entity, for processing in accordance with the EPIA (21 
U.S.C. 1031 et seq.) or by a treatment that achieves at least a 5-long 
destruction of SE or destroyed by or under the supervision of the 
issuing entity, within 10-working days from the date of receipt of the 
order, unless under paragraph (a)(2)(iii) of this section, a hearing is 
held, in which case the eggs must be diverted or destroyed consistent 
with the decision of the Office of Regulatory Affairs Program Director 
or another FDA official senior to an FDA District Director under 
paragraph (a)(2)(v) of this section. The order must include the 
following information:
* * * * *
    (2) The person on whom the order for diversion or destruction is 
served may either comply with the order or appeal the order to an 
Office of Regulatory Affairs Program Director in accordance with the 
following procedures:
* * * * *
    (ii) 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.
    (iii) Informal hearing. Appearance by any appellant at the hearing 
may be by mail or in person, with or without counsel. The informal 
hearing must 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 must 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 by 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 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.
    (E) The presiding FDA official must 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 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,

[[Page 14147]]

and must 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 must render 
a decision on the appeal affirming or revoking the detention order 
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 produced or held 
in violation of this section, he must affirm the order that they be 
diverted, under the supervision of an officer or employee of FDA for 
processing under the EPIA or by a treatment that achieves at least a 5-
log destruction of SE or destroyed by or under the supervision of an 
officer or employee of FDA; otherwise, the presiding FDA official must 
issue a written notice that the prior order is withdrawn. If the 
presiding FDA official affirms the order, he must 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 must be accompanied by a statement of the reasons for the 
decision. The decision of the presiding FDA official constitutes final 
agency action, subject to judicial review.
    (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, if applicable, the State or 
local representative 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.
* * * * *

PART 507--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND 
RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS

0
15. The authority citation for part 507 continues to read as follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 
371, 374; 42 U.S.C. 243, 264, 271.

0
16. Revise Sec.  507.75 to read as follows:


Sec.  507.75  Residing officer for an appeal and for an informal 
hearing.

    The presiding officer for an appeal, and for an informal hearing, 
must be an Office of Regulatory Affairs Program Director or another FDA 
official senior to an FDA District Director.

PART 800--GENERAL

0
17. The authority citation for part 800 continues to read as follows:

    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 
361, 362, 371.

0
18. Amend Sec.  800.55 by revising paragraphs (g)(3)(iv) and (g)(4) to 
read as follows:


Sec.  800.55  Administrative detention.

* * * * *
    (g) * * *
    (3) * * *
    (iv) Paragraph (g)(4) of this section, rather than Sec.  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 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 Sec.  16.42(a) of this 
chapter to preside over the hearing.
* * * * *

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05350 Filed 3-16-17; 8:45 am]
 BILLING CODE 4164-01-P