32982 Federal Register / Vol. 84, No. 133 / Thursday, July 11, 2019 / Rules and Regulations List of Subjects in 14 CFR Part 39 Section, Transport Standards Branch, FAA, Issued in Des Moines, Washington, on July has the authority to approve AMOCs for this 3, 2019. Air transportation, Aircraft, Aviation AD, if requested using the procedures found Dionne Palermo, safety, Incorporation by reference, in 14 CFR 39.19. In accordance with 14 CFR Safety. Acting Director, System Oversight Division, 39.19, send your request to your principal Aircraft Certification Service. Adoption of the Amendment inspector or local Flight Standards District Office, as appropriate. If sending information [FR Doc. 2019–14726 Filed 7–10–19; 8:45 am] Accordingly, under the authority directly to the International Section, send it BILLING CODE 4910–13–P delegated to me by the Administrator, to the attention of the person identified in the FAA amends 14 CFR part 39 as paragraph (i)(2) of this AD. Information may follows: be emailed to: 9-ANM-116-AMOC- DEPARTMENT OF HEALTH AND [email protected]. Before using any HUMAN SERVICES PART 39—AIRWORTHINESS approved AMOC, notify your appropriate DIRECTIVES principal inspector, or lacking a principal Food and Drug Administration inspector, the manager of the local flight ■ 1. The authority citation for part 39 standards district office/certificate holding 21 CFR Parts 500, 520, 522, 524, 526, continues to read as follows: district office. 529, 556, and 558 Authority: 49 U.S.C. 106(g), 40113, 44701. (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective [Docket No. FDA–2012–N–1067] actions from a manufacturer, the action must § 39.13 [Amended] RIN 0910–AG17 be accomplished using a method approved ■ 2. The FAA amends § 39.13 by adding by the Manager, International Section, New Animal Drugs; Updating the following new airworthiness Transport Standards Branch, FAA; or the directive (AD): European Aviation Safety Agency (EASA); or Tolerances for Residues of New Animal Drugs in Food 2019–10–02 Saab AB, Saab Aeronautics Saab AB, Saab Aeronautics’ EASA Design Organization Approval (DOA). If approved by (Formerly Known as Saab AB, Saab AGENCY: Food and Drug Administration, the DOA, the approval must include the Aerosystems): Amendment 39–19641; HHS. Docket No. FAA–2018–1067; Product DOA-authorized signature. Identifier 2018–NM–158–AD. ACTION: Final rule; technical (i) Related Information amendments. (a) Effective Date (1) Refer to Mandatory Continuing This AD is effective August 15, 2019. Airworthiness Information (MCAI) EASA AD SUMMARY: The Food and Drug 2018–0240, dated November 7, 2018, for Administration (FDA, the Agency, or (b) Affected ADs related information. This MCAI may be we) is issuing a final rule to revise the None. found in the AD docket on the internet at animal drug regulations for tolerances (c) Applicability http://www.regulations.gov by searching for for residues of approved new animal and locating Docket No. FAA–2018–1067. drugs. This final rule is necessary to This AD applies to Saab AB, Saab (2) For more information about this AD, standardize, simplify, and clarify the Aeronautics Model SAAB 2000 airplanes, contact Shahram Daneshmandi, Aerospace certificated in any category, all serial Engineer, International Section, Transport determination standards of tolerances numbers. Standards Branch, FAA, 2200 South 216th and provide definitions for key terms. (d) Subject St., Des Moines, WA 98198; telephone and This final rule will enhance Air Transport Association (ATA) of fax: 206–231–3220. understanding of tolerance determination and improve the overall America Code 22, Auto flight. (j) Material Incorporated by Reference readability of the relevant regulations. (e) Reason (1) The Director of the Federal Register DATES: This rule is effective September approved the incorporation by reference This AD was prompted by an event where 9, 2019. the airplane did not respond to the (IBR) of the service information listed in this flightcrew’s flight control inputs because the paragraph under 5 U.S.C. 552(a) and 1 CFR ADDRESSES: For access to the docket to pitch trim switches did not disconnect the part 51. read background documents or autopilot. We are issuing this AD to address (2) You must use this service information comments received, go to https:// events where the airplane does not respond as applicable to do the actions required by www.regulations.gov and insert the to the flightcrew’s flight control inputs this AD, unless this AD specifies otherwise. docket number found in brackets in the because the autopilot remains engaged, (i) Saab Service Bulletin 2000–22–008, heading of this final rule into the possibly resulting in loss of control of the dated June 15, 2018. ‘‘Search’’ box and follow the prompts, airplane. (ii) [Reserved] (3) For service information identified in and/or go to the Dockets Management (f) Compliance this AD, contact Saab AB, Saab Aeronautics, Staff, 5630 Fishers Lane, Rm. 1061, Comply with this AD within the SE–581 88, Linko¨ping, Sweden; telephone Rockville, MD 20852. compliance times specified, unless already +46 13 18 5591; fax +46 13 18 4874; email FOR FURTHER INFORMATION CONTACT: done. [email protected]; Dong Yan, Center for Veterinary (g) Modification internet http://www.saabgroup.com. Medicine (HFV–151), Food and Drug (4) You may view this service information Within 3,000 flight hours or 24 months Administration, 7500 Standish Pl., at the FAA, Transport Standards Branch, after the effective date of this AD, whichever Rockville, MD 20855, 240–402–0825, 2200 South 216th St., Des Moines, WA. For occurs first: Modify the wiring for the email: [email protected]. autopilot disconnect logic, in accordance information on the availability of this SUPPLEMENTARY INFORMATION: with the Accomplishment Instructions of material at the FAA, call 206–231–3195. (5) You may view this service information Saab Service Bulletin 2000–22–008, dated Table of Contents June 15, 2018. that is incorporated by reference at the National Archives and Records I. Executive Summary (h) Other FAA AD Provisions Administration (NARA). For information on A. Purpose and Coverage of the Final Rule The following provisions also apply to this the availability of this material at NARA, call B. Summary of the Major Provisions of the AD: 202–741–6030, or go to: http:// Final Rule (1) Alternative Methods of Compliance www.archives.gov/federal-register/cfr/ibr- C. Legal Authority (AMOCs): The Manager, International locations.html. D. Costs and Benefits VerDate Sep<11>2014 16:09 Jul 10, 2019 Jkt 247001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\11JYR1.SGM 11JYR1 jspears on DSK30JT082PROD with RULES Federal Register / Vol. 84, No. 133 / Thursday, July 11, 2019 / Rules and Regulations 32983 II. Table of Abbreviations/Commonly Used listings and to add cross references to (77 FR 72254) (2012 proposed rule) to Acronyms in This Document part 520, 522, 524, 526, 529, or 558 (21 revise part 556 by standardizing and III. Background CFR part 520, 522, 524, 526, 529, or 558) simplifying the codification style, A. History and Scope of This Rulemaking that contain the approved or revising the general considerations B. General Overview of the Final Rule IV. Legal Authority conditionally approved conditions of section, adding a scope section, and V. Comments on the 2012 Proposed Rule and use of the drug. adding a definition section to define key terms used in the part. The definition 2016 Supplemental Proposed Rule and C. Legal Authority FDA Response section was proposed to include the A. Introduction Our authority for issuing this final terms used by FDA in the determination B. Comments on Scope rule is provided by sections 512(b)(1)(G) of tolerances. We proposed a definition C. Comments on Definition Section and (H), (d)(1)(F), (d)(2), and (i), and section because some of the terms that D. Comments on Analytical Method 571(a)(2)(A) and (b)(1) of the Federal had been used previously in part 556, E. Comments on Subpart B, Listing of Food, Drug, and Cosmetic Act (FD&C Tolerances for Residues of Approved and subpart B were never defined, and some Conditionally Approved New Animal Act) (21 U.S.C. 360b(b)(1)(G) and (H), terminology that had been used was Drugs (d)(1)(F), (d)(2), and (i), and outdated or resulted in confusion to F. Other Comments 360ccc(a)(2)(A) and (b)(1)). These users of the part. We added a new scope VI. Effective/Compliance Date provisions relate to the information new section and proposed a revision to the VII. Economic Analysis of Impacts animal drug and conditional new general considerations section to VIII. Analysis of Environmental Impact animal drug applicants provide with provide additional information and IX. Paperwork Reduction Act of 1995 respect to proposed tolerances, clarification with respect to the X. Federalism withdrawal periods, and practicable tolerances listed in proposed subpart B. XI. Consultation and Coordination With methods, and the process by which FDA Indian Tribal Governments We issued a supplemental notice of XII. References establishes and publishes regulations proposed rulemaking in the Federal setting tolerances for residues of Register of October 28, 2016 (81 FR I. Executive Summary approved and conditionally approved 74962) (2016 supplemental proposed A. Purpose and Coverage of the Final new animal drugs. In addition, section rule) to revise the proposed changes to Rule 701(a) of the FD&C Act (21 U.S.C. part 556 to align with and clarify our 371(a)) gives FDA general rulemaking This final rule revises the animal drug current thinking. We explained our authority to issue regulations for the current thinking about analytical regulations regarding tolerances for efficient enforcement of the FD&C Act.