AD 2026-21-02

64606 Federal Register / Vol. 91, No. 195 / Friday, October 9, 2026 / Rules and Regulations similarly unaffiliated with any handler); and (2) The remaining producer member(s) selected from and representing all other independent and small cooperative producers. (b) Pursuant to section § 989.26(b)(2), and commencing with the term of office beginning May 1, 2026, apportionment of the independent and small cooperative marketing association handlers shall be: (1) Two members selected from and representing the four handler(s) other than major cooperative marketing association handler(s) who acquired the largest percentage of the total raisin acquisitions during the preceding crop year; and (2) The remaining member(s) selected from and representing all other handlers, including small cooperative marketing association handler(s) and all processors. ■ 14. Revise and republish § 989.129 to read as follows: § 989.129 Voting at nomination meetings. Any person (defined in § 989.3 as an individual, partnership, corporation, association, or any other business unit) who is engaged, in a proprietary capacity, in the production of grapes which are sun-dried or dehydrated by artificial means to produce raisins and who qualifies under the provisions of § 989.29(b)(2) shall be eligible to cast one vote for a nominee for each producer member position and one vote for a nominee for each producer alternate member position on the Committee which is to be filled. Such person must be the one who or which: Owns and farms land resulting in his or its ownership of such grapes produced thereon; rents and farms land, resulting in his or its ownership of all or a portion of such grapes produced thereon; or owns land which he or it does not farm and, as rental for such land, obtains the ownership of a portion of such grapes or the raisins. In this connection, a partnership shall be deemed to include two or more persons (including a husband and wife) with respect to land the title to which, or leasehold interest in which, is vested in them as tenants in common, joint tenants, or under community property laws, as community property. In a landlord- tenant relationship, wherein each of the parties is a producer, each such producer shall be entitled to one vote for a nominee for each producer member position and one vote for each producer alternate member position. Hence, where two persons operate land as landlord and tenant on a share-crop basis, each person is entitled to one vote for each such position to be filled. Where land is leased on a cash rental basis, only the person who is the tenant or cash renter (producer) is entitled to vote. A partnership or corporation, when eligible, is entitled to cast only one vote for a nominee for each producer position to be filled. Erin Morris, Administrator, Agricultural Marketing Service. [FR Doc. 2026–20792 Filed 10–8–26; 8:45 am] BILLING CODE P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA–2026–11805; Project Identifier MCAI–2026–00811–R; Amendment 39–23491; AD 2026–21–02] RIN 2120–AA64 Airworthiness Directives; Airbus Helicopters Deutschland GmbH (AHD) Helicopters AGENCY : Federal Aviation Administration (FAA), DOT. ACTION : Final rule; request for comments. SUMMARY : The FAA is adopting a new airworthiness directive (AD) for all Airbus Helicopters Deutschland GmbH (AHD) Model MBB–BK 117 C–1 helicopters. This AD was prompted by a report of a louver box assembly detaching in flight due to incorrect installation. This AD requires repetitively accomplishing a play check of the affected louver box assembly and, depending on the results of the check, accomplishing corrective actions. The FAA is issuing this AD to address the unsafe condition on these products. DATES : This AD is effective October 26, 2026. The FAA must receive comments on this AD by November 23, 2026. ADDRESSES : You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods: • Federal eRulemaking Portal: Go to regulations.gov. Follow the instructions for submitting comments. • Fax: (202) 493–2251. • Mail: U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE, Washington, DC 20590. • Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. AD Docket: You may examine the AD docket at regulations.gov under Docket No. FAA–2026–11805; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the mandatory continuing airworthiness information (MCAI), any comments received, and other information. The street address for Docket Operations is listed above. FOR FURTHER INFORMATION CONTACT : Aryanna Sanchez, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (817) 222–4058; email: aryanna.t.sanchez@faa.gov. SUPPLEMENTARY INFORMATION : Comments Invited The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments using a method listed under ADDRESSES . Include ‘‘Docket No. FAA–2026–11805; Project Identifier MCAI–2026–00811–R’’ at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments. Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule. Confidential Business Information CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as ‘‘PROPIN.’’ The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket VerDate Sep<11>2014 16:14 Oct 08, 2026 Jkt 271001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\09OCR1.SGM 09OCR1 lotter on DSK8BHNXB4PROD with RULES1

64607 Federal Register / Vol. 91, No. 195 / Friday, October 9, 2026 / Rules and Regulations of this AD. Submissions containing CBI should be sent to Aryanna Sanchez, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking. Background The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2026–0152, dated July 30, 2026 (EASA AD 2026–0152) (also referred to as ‘‘the MCAI’’), to correct an unsafe condition on all AHD Model MBB–BK 117 C–1 helicopters. The MCAI states an occurrence was reported of an affected louver box assembly of the vapor cycle air cooling system part number (P/N) 117–820014 detaching in-flight due to incorrect installation. This condition, if not addressed, could lead to in-flight loss of parts, which could impact the main or tail rotor, lead to reduced control of the helicopter, necessitate an emergency landing, or cause injury to persons on the ground. You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA–2026–11805. FAA’s Determination These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA’s bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design. AD Requirements This AD requires repetitively accomplishing a play check of the louver box assembly of vapor cycle air cooling system part number (P/N) 117– 820014, and if there is any play accomplishing corrective actions in accordance with a method approved by the Manager, International Validation Branch, FAA; or EASA; or AHD’s EASA Design Organization Approval (DOA). The owner/operator (pilot) holding at least a private pilot certificate may accomplish a play check of the louver box assembly of vapor cycle air cooling system installed on the helicopter, by pulling it upward by hand on all four corners, and must enter compliance into the helicopter maintenance records in accordance with 14 CFR 43.9(a) and 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439. The pilot may perform this action because it only involves checking to see if the louver box assembly is installed firmly, which could be performed equally well by a pilot or mechanic. This is an exception to the FAA’s standard maintenance regulations. Justification for Immediate Adoption and Determination of the Effective Date Section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for ‘‘good cause,’’ finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause. An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies forgoing notice and comment prior to adoption of this rule because if a louver box assembly is incorrectly installed, it could lead to parts separating from the helicopter in flight and impacting the main rotor blade or the tail rotor blade. This condition could also lead to an emergency landing, or impact of parts to persons on ground. The root cause of this separation has been identified as incorrect installation; however, the specific installation deficiency has not yet been fully determined. To ensure this unsafe condition is immediately detected and does not reoccur, a play check for looseness must be done before the first flight of each day. This compliance time is shorter than the time necessary for the public to comment and for publication of the final rule. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b). In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forgo notice and comment. Regulatory Flexibility Act The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without prior notice and comment, RFA analysis is not required. Interim Action The FAA considers that this AD is an interim action. If final actions are later identified, the FAA might consider further rulemaking. Costs of Compliance The FAA estimates that this AD affects 9 helicopters of U.S. registry. The FAA estimates the following costs to comply with this AD: E STIMATED C OSTS Action Labor cost Parts cost Cost per product Cost on U.S. operators Play check of the louver box assembly (per check). 1 work-hour × $85 per hour = $85 (per check). $0 $85 (per check) $765 (per check). The actions needed as a result of any play in the assembly could vary significantly from helicopter to helicopter. The FAA was unable to obtain costs of any corrective actions from the design approval holders within the time necessary to address the unsafe condition. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA’s authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs describes in more detail the scope of the Agency’s authority. The FAA is issuing this rulemaking under the authority described in VerDate Sep<11>2014 16:14 Oct 08, 2026 Jkt 271001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\09OCR1.SGM 09OCR1 lotter on DSK8BHNXB4PROD with RULES1

64608 Federal Register / Vol. 91, No. 195 / Friday, October 9, 2026 / Rules and Regulations Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866, and (2) Will not affect intrastate aviation in Alaska. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. The Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES ■ 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] ■ 2. The FAA amends § 39.13 by adding the following new airworthiness directive: 2026–21–02 Airbus Helicopters Deutschland GmbH (AHD): Amendment 39–23491; Docket No. FAA–2026–11805; Project Identifier MCAI–2026–00811–R. (a) Effective Date This airworthiness directive (AD) is effective October 26, 2026. (b) Affected ADs None. (c) Applicability This AD applies to all Airbus Helicopters Deutschland GmbH (AHD) Model MBB–BK 117 C–1 helicopters, certificated in any category. (d) Subject Joint Aircraft System Component (JASC) Code 2100, Air conditioning system. (e) Unsafe Condition This AD was prompted by a report of a louver box assembly detaching in flight due to incorrect installation. The FAA is issuing this AD to address and prevent incorrectly installed parts. The unsafe condition, if not addressed, could lead to in-flight loss of parts, which could impact the main or tail rotor, lead to reduced control of the helicopter, necessitate an emergency landing, or cause injury to persons on the ground. (f) Compliance Comply with this AD within the compliance times specified, unless already done. (g) Required Actions (1) Before the first flight of each day, accomplish a play check of the louver box assembly of the vapor cycle air cooling system part number (P/N) 117–820014, as depicted in Figure 1 to paragraph (g)(1) of this AD, by pulling it upward by hand on all four corners. The owner/operator (pilot) holding at least a private pilot certificate may accomplish this play check, and must enter compliance into the helicopter maintenance records in accordance with 14 CFR 43.9(a) and 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439. VerDate Sep<11>2014 16:14 Oct 08, 2026 Jkt 271001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4725 E:\FR\FM\09OCR1.SGM 09OCR1 ER09OC26.000</GPH> lotter on DSK8BHNXB4PROD with RULES1

64609 Federal Register / Vol. 91, No. 195 / Friday, October 9, 2026 / Rules and Regulations (2) If there is any play found during any check required by paragraph (g)(1) of this AD, before further flight, accomplish corrective actions in accordance with a method approved by the Manager, International Validation Branch, FAA; or EASA; or AHD’s EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature. (h) No Reporting Requirement Although the material referenced in EASA AD 2026–0152 specifies to submit certain information to the manufacturer, this AD does not include that requirement. (i) Alternative Methods of Compliance (AMOCs) (1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (j) of this AD and email to: AMOC@faa.gov. (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/ certificate holding district office. (j) Additional Information For more information about this AD, contact Aryanna Sanchez, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (817) 222– 4058; email: aryanna.t.sanchez@faa.gov. (k) Material Incorporated by Reference None. Issued on October 6, 2026. Steven W. Thompson, Acting Deputy Director, Compliance & Airworthiness Division, Aircraft Certification Service. [FR Doc. 2026–20722 Filed 10–7–26; 11:15 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA–2026–N–10994] Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit AGENCY : Food and Drug Administration, HHS. ACTION : Final amendment; final order. SUMMARY : The Food and Drug Administration (FDA) is classifying the hematopoietic cell enrichment kit into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hematopoietic cell enrichment kit. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens. DATES : This order is effective October 9, 2026. The classification was applicable on November 6, 2023. FOR FURTHER INFORMATION CONTACT : Allen Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3248, Silver Spring, MD 20993–0002, 301–796–4806, Allen.Williams@fda.hhs.gov. SUPPLEMENTARY INFORMATION : I. Background Upon request, FDA (the Agency or we) has classified the hematopoietic cell enrichment kit into class II (special controls), which we have determined will provide a reasonable assurance of the safety and effectiveness of the device. In addition, we believe this action will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified into, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as ‘‘postamendments devices’’ because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807). FDA may also classify a device through ‘‘De Novo’’ classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112–144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification. Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act. Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. We believe this De Novo classification will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining ‘‘substantial equivalence’’). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device. VerDate Sep<11>2014 16:14 Oct 08, 2026 Jkt 271001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 E:\FR\FM\09OCR1.SGM 09OCR1 lotter on DSK8BHNXB4PROD with RULES1