82 FR 14143 - Presiding Officer for an Appeal and Informal Hearing; Technical Amendments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 51 (March 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 51 (March 17, 2017)
| Page Range | 14143-14147 | |
| FR Document | 2017-05350 |
[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)] [Rules and Regulations] [Pages 14143-14147] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05350] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
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■ 8. Amend Form F–10 (referenced in office five copies of the complete report is amended, each amendment
§ 239.40) by revising paragraph D of registration statement and any must include active hyperlinks to the
General Instruction II to read as follows: amendments, including exhibits and all exhibits required with the amendment.
Note: The text of Form F–10 does not, and other documents filed as a part of the For paper filings, the pages of the
this amendment will not, appear in the Code registration statement or amendment. manually signed original registration
of Federal Regulations. The registrant must bind, staple or statement should be numbered in
otherwise compile each copy in one or sequence, and the exhibit index should
United States Securities and Exchange more parts without stiff covers. The give the page number in the sequential
Commission registrant must further bind the numbering system where each exhibit
Washington, DC 20549 registration statement or amendment on can be found.
the side or stitching margin in a manner * * * * *
Form F–10 that leaves the reading matter legible.
By the Commission.
Registration Statement Under the The registrant must provide three
additional copies of the registration Dated: March 1, 2017.
Securities Act of 1933
statement or amendment without Brent J. Fields,
* * * * * exhibits to the Commission. Secretary.
General Instructions * * * * * [FR Doc. 2017–04365 Filed 3–16–17; 8:45 am]
BILLING CODE 8011–01–P
* * * * * PART 249—FORMS, SECURITIES
II. Application of General Rules and EXCHANGE ACT OF 1934
Regulations
■ 9. The authority citation for part 249 DEPARTMENT OF HEALTH AND
* * * * * continues to read in part as follows:
D. A registrant must file the HUMAN SERVICES
registration statement in electronic Authority: 15 U.S.C. 78a et seq. and 7201
et seq.; 12 U.S.C. 5461 et seq.; 18 U.S.C. 1350; Food and Drug Administration
format via the Commission’s Electronic Sec. 953(b) Pub. L. 111–203, 124 Stat. 1904;
Data Gathering, Analysis, and Retrieval Sec. 102(a)(3) Pub. L. 112–106, 126 Stat. 309 21 CFR Parts 1, 101, 112, 115, 117, 118,
(EDGAR) system in accordance with the (2012), Sec. 107 Pub. L. 112–106, 126 Stat. 507, and 800
EDGAR rules set forth in Regulation S– 313 (2012), and Sec. 72001 Pub. L. 114–94,
T (17 CFR part 232). For assistance with 129 Stat. 1312 (2015), unless otherwise
noted. [Docket No. FDA–2017–N–0011]
technical questions about EDGAR or to
request an access code, call the EDGAR * * * * * Presiding Officer for an Appeal and
Filer Support Office at (202) 551–8900. ■ 10. Amend Form 20–F (referenced in Informal Hearing; Technical
For assistance with the EDGAR rules, § 249.220f) by revising the fourth Amendments
call the Office of Information paragraph of the introductory text under
Technology in the Division of ‘‘Instructions as to Exhibits’’ to read as AGENCY: Food and Drug Administration,
Corporation Finance at (202) 551–3600. follows: HHS.
Include an exhibit index in the Note: The text of Form 20–F does not, and Final rule; technical
ACTION:
registration statement, which must this amendment will not, appear in the Code amendments.
appear before the required signatures in of Federal Regulations.
the document. The exhibit index must SUMMARY: The Food and Drug
list each exhibit according to the letter Form 20–F Administration (FDA, the Agency, or
or number assigned to it. If an exhibit * * * * * we) is making revisions to Chapter I of
is incorporated by reference, this must its regulations. These revisions are
be noted in the exhibit index. Each Part III necessary to reflect changes to the
exhibit identified in the exhibit index * * * * * Agency’s organizational structure,
(other than an exhibit filed in eXtensible including the dissolution of the
Business Reporting Language) must Item 19. Exhibits Regional Food and Drug Director
include an active link to an exhibit that * * * * * position. The revisions replace
is filed with the registration statement references to the Regional Food and
or, if the exhibit is incorporated by Instructions as to Exhibits
Drug Director, who is designated to
reference an active hyperlink to the * * * * * preside over administrative appeals and
exhibit separately filed on EDGAR. If Include an exhibit index in each at informal hearings on appeal, with
the registration statement is amended, registration statement or report you file, references to Office of Regulatory Affairs
each amendment must include active which must appear before the required Program Directors. The rule does not
hyperlinks to the exhibits required with signatures in the document. The exhibit impose any new regulatory
the amendment. For paper filings, the index must list each exhibit according requirements on affected parties. This
pages of the manually signed original to the number assigned to it below. If an action is editorial in nature and is
registration statement should be exhibit is incorporated by reference, this intended to improve the accuracy of the
numbered in sequence, and the exhibit must be noted in the exhibit index. Each Agency’s regulations.
index should give the page number in exhibit identified in the exhibit index
DATES: This rule is effective March 17,
the sequential numbering system where (other than an exhibit filed in eXtensible
2017.
mstockstill on DSK3G9T082PROD with RULES
each exhibit can be found. Business Reporting Language) must
If filing the registration statement in include an active link to an exhibit that FOR FURTHER INFORMATION CONTACT:
paper under a hardship exemption in is filed with the registration statement Peter Fox, Office of Regulatory Affairs,
Rule 201 or 202 of Regulation S–T (17 or report or, if the exhibit is Food and Drug Administration, 12420
CFR 232.201 or 232.202), or as incorporated by reference an active Parklawn Dr., Rockville, MD 20852,
otherwise permitted, a registrant must hyperlink to the exhibit separately filed 240–402–1857.
file with the Commission at its principal on EDGAR. If a registration statement or SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014 19:31 Mar 16, 2017 Jkt 241001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\17MRR1.SGM 17MRR1](https://thefederalregister.org/doc/82_FR_14194/page/1.svg)
![Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Rules and Regulations 14147
and must include a recommended § 507.75 Residing officer for an appeal and ACTION: Final rule.
decision, with a statement of reasons. for an informal hearing.
(iv) Written appeal. If the appellant The presiding officer for an appeal, SUMMARY: The U.S. Department of
appeals the detention order but does not and for an informal hearing, must be an Homeland Security (DHS) and the U.S.
request a hearing, the presiding FDA Office of Regulatory Affairs Program Department of Labor (DOL)
official must render a decision on the Director or another FDA official senior (collectively, ‘‘the Departments’’) are
appeal affirming or revoking the to an FDA District Director. jointly issuing this final rule to adjust
detention order within 5-working days for inflation the civil monetary penalties
PART 800—GENERAL assessed or enforced in connection with
after the receipt of the appeal.
(v) Presiding FDA official’s decision. ■ 17. The authority citation for part 800 the employment of temporary
If, based on the evidence presented at continues to read as follows: nonimmigrant workers under the H–2B
the hearing or by the appellant in a program, pursuant to the Federal Civil
Authority: 21 U.S.C. 321, 334, 351, 352, Penalties Inflation Adjustment Act of
written appeal, the presiding FDA 355, 360e, 360i, 360k, 361, 362, 371.
official finds that the shell eggs were 1990 as amended by the Federal Civil
■ 18. Amend § 800.55 by revising Penalties Inflation Adjustment Act
produced or held in violation of this paragraphs (g)(3)(iv) and (g)(4) to read as
section, he must affirm the order that Improvements Act of 2015 (Inflation
follows: Adjustment Act). The Inflation
they be diverted, under the supervision
of an officer or employee of FDA for § 800.55 Administrative detention. Adjustment Act provides that agencies
processing under the EPIA or by a * * * * * shall adjust civil monetary penalties
treatment that achieves at least a 5-log (g) * * * notwithstanding Section 553 of the
destruction of SE or destroyed by or (3) * * * Administrative Procedure Act (APA).
under the supervision of an officer or (iv) Paragraph (g)(4) of this section, Additionally, the Inflation Adjustment
employee of FDA; otherwise, the rather than § 16.42(a) of this chapter, Act provides a cost-of-living formula for
presiding FDA official must issue a describes the FDA employees, i.e., adjustment of the civil penalties.
written notice that the prior order is Office of Regulatory Affairs Program Accordingly, this final rule sets forth the
withdrawn. If the presiding FDA official Directors or other FDA officials senior to Departments’ 2017 annual adjustments
affirms the order, he must order that the an FDA District Director, who preside at for inflation to the H–2B civil monetary
diversion or destruction be hearings under this section. penalties, effective March 17, 2017.
accomplished within 10-working days (4) The presiding officer of a
DATES: This final rule is effective March
from the date of the issuance of his regulatory hearing on an appeal of a
detention order, who also shall decide 17, 2017. As provided by the Inflation
decision. The presiding FDA official’s Adjustment Act, the increased penalty
the appeal, shall be an Office of
decision must be accompanied by a levels apply to any penalties assessed
Regulatory Affairs Program Director or
statement of the reasons for the after March 17, 2017.
another FDA official senior to an FDA
decision. The decision of the presiding
District Director who is permitted by FOR FURTHER INFORMATION CONTACT:
FDA official constitutes final agency
§ 16.42(a) of this chapter to preside over Pamela Peters, Program Analyst, U.S.
action, subject to judicial review.
the hearing. Department of Labor, Room S–2312, 200
(vi) No appeal. If there is no appeal Constitution Avenue NW., Washington,
* * * * *
of the order and the person in DC 20210; telephone: (202) 693–5959
possession of the shell eggs that are Dated: March 13, 2017.
(this is not a toll-free number). Copies
subject to the order fails to divert or Leslie Kux,
of this final rule may be obtained in
destroy them within 10-working days, Associate Commissioner for Policy.
alternative formats (large print, Braille,
or if the demand is affirmed by the [FR Doc. 2017–05350 Filed 3–16–17; 8:45 am] audio tape or disc), upon request, by
presiding FDA official after an appeal BILLING CODE 4164–01–P calling (202) 693–5959 (this is not a toll-
and the person in possession of such free number). TTY/TDD callers may dial
eggs fails to divert or destroy them toll-free 1–877–889–5627 to obtain
within 10-working days, FDA’s district DEPARTMENT OF HOMELAND information or request materials in
office or, if applicable, the State or local SECURITY alternative formats.
representative may designate an officer
or employee to divert or destroy such [CIS No. 2585–16] SUPPLEMENTARY INFORMATION:
eggs. It shall be unlawful to prevent or RIN 1615–AC10 I. Regulatory Information
to attempt to prevent such diversion or
destruction of the shell eggs by the DEPARTMENT OF LABOR The Inflation Adjustment Act
designated officer or employee. required agencies to: (1) Adjust the level
* * * * * Wage and Hour Division of civil monetary penalties with an
initial ‘‘catch-up’’ adjustment through
PART 507—CURRENT GOOD 29 CFR Part 503 an interim final rule (IFR); and (2) make
MANUFACTURING PRACTICE, RIN 1235–AA16 subsequent annual adjustments for
HAZARD ANALYSIS, AND RISK– inflation. Agencies are required to
BASED PREVENTIVE CONTROLS FOR Department of Homeland Security and publish an annual inflation adjustment
FOOD FOR ANIMALS Department of Labor Federal Civil no later than January 15, 2017, and by
Penalties Inflation Adjustment Act January 15 of each subsequent year.
mstockstill on DSK3G9T082PROD with RULES
■ 15. The authority citation for part 507 Annual Adjustments for the H–2B On July 1, 2016, the Departments
continues to read as follows: Temporary Non-agricultural Worker established the initial catch-up
Authority: 21 U.S.C. 331, 342, 343, 350d Program adjustment for civil monetary penalties
note, 350g, 350g note, 371, 374; 42 U.S.C. AGENCY: Department of Homeland assessed or enforced in connection with
243, 264, 271. the employment of temporary
Security; Wage and Hour Division,
■ 16. Revise § 507.75 to read as follows: Department of Labor. nonimmigrant workers under the H–2B
VerDate Sep<11>2014 19:31 Mar 16, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\FR\FM\17MRR1.SGM 17MRR1](https://thefederalregister.org/doc/82_FR_14194/page/5.svg)
Document Created: 2017-03-17 02:48:48
Document Modified: 2017-03-17 02:48:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; technical amendments. | |
| Dates | This rule is effective March 17, 2017. | |
| Contact | Peter Fox, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20852, 240-402-1857. | |
| FR Citation | 82 FR 14143 | |
| CFR Citation | 21
CFR
101 21 CFR 112 21 CFR 115 21 CFR 117 21 CFR 118 21 CFR 1 21 CFR 507 21 CFR 800 | |
| CFR Associated | Cosmetics; Drugs; Exports; Food Labeling; Imports; Labeling; Reporting and Recordkeeping Requirements; Nutrition; Dietary Foods; Food Grades and Standards; Foods; Fruits; Packaging and Containers; Safety; Vegetables; Eggs and Egg Products; Food Packaging; Animal Foods; Administrative Practice and Procedure; Medical Devices and Ophthalmic Goods and Services |
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