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71794 Federal Register / Vol 71794 Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Rules and Regulations § 39.13 [Amended] 14 CFR 39.19, send your request to your DEPARTMENT OF HEALTH AND ■ 2. The FAA amends § 39.13 by adding principal inspector or local Flight Standards HUMAN SERVICES District Office, as appropriate. If sending the following new airworthiness information directly to the manager of the Food and Drug Administration directive (AD): certification office, send it to the attention of the person identified in paragraph (j) of this 2019–24–15 The Boeing Company: 21 CFR Parts 862, 864, 866, 868, 870, Amendment 39–21004; Docket No. AD. Information may be emailed to: 9-ANM- FAA–2019–0980; Product Identifier [email protected]. 872, 874, 876, 878, 880, 882, 884, 886, 2019–NM–180–AD. (2) Before using any approved AMOC, 888, 890, and 892 notify your appropriate principal inspector, [Docket Nos. FDA–2017–N–1129 and FDA– (a) Effective Date or lacking a principal inspector, the manager 2017–N–1610] This AD is effective January 14, 2020. of the local flight standards district office/ certificate holding district office. Medical Devices; Exemptions From (b) Affected ADs (3) An AMOC that provides an acceptable None. level of safety may be used for any repair, Premarket Notification for Class I and modification, or alteration required by this Class II Devices (c) Applicability AD if it is approved by The Boeing Company This AD applies to The Boeing Company Organization Designation Authorization AGENCY: Food and Drug Administration, Model 737–900ER series airplanes, (ODA) that has been authorized by the HHS. certificated in any category, as identified in Manager, Seattle ACO Branch, FAA, to make ACTION: Final amendment; final order. Boeing Special Attention Requirements those findings. To be approved, the repair Bulletin 737–25–1831 RB, dated September method, modification deviation, or alteration SUMMARY: The Food and Drug 24, 2019. deviation must meet the certification basis of Administration (FDA, Agency, or we) (d) Subject the airplane, and the approval must identified a list of class I devices and specifically refer to this AD. Air Transport Association (ATA) of class II devices that are now exempt America Code 25, Equipment/furnishings. (j) Related Information from premarket notification requirements, subject to certain (e) Unsafe Condition For more information about this AD, contact Allie Buss, Aerospace Engineer, limitations. FDA published the lists of This AD was prompted by a report of Cabin Safety and Environmental Systems final determinations in accordance with nonconforming head strike pads on the mid Section, FAA, Seattle ACO Branch, 2200 procedures established by the 21st exit doors. The FAA is issuing this AD to South 216th St., Des Moines, WA 98198; Century Cures Act (Cures Act). address nonconforming head strike pads phone and fax: 206–231–3564; email: Although each classification regulation which could result in injury to passengers in [email protected]. an otherwise survivable emergency landing for each such type of device shall be and potentially block passenger egress. (k) Material Incorporated by Reference deemed amended to incorporate such exemption, we are publishing this final (f) Compliance (1) The Director of the Federal Register approved the incorporation by reference order to amend the codified language for Comply with this AD within the (IBR) of the service information listed in this each listed class I and class II device’s compliance times specified, unless already paragraph under 5 U.S.C. 552(a) and 1 CFR classification regulation to reflect the done. part 51. final determinations. FDA’s action (g) Required Actions (2) You must use this service information decreases regulatory burden on the as applicable to do the actions required by Except as specified by paragraph (h) of this medical device industry and eliminates this AD, unless the AD specifies otherwise. AD: At the applicable times specified in the private costs and expenditures required ‘‘Compliance’’ paragraph of Boeing Special (i) Boeing Special Attention Requirements Bulletin 737–25–1831 RB, dated September to comply with certain Federal Attention Requirements Bulletin 737–25– regulations. 1831 RB, dated September 24, 2019, do all 24, 2019. applicable actions identified in, and in (ii) [Reserved] DATES: This order is effective December accordance with, the Accomplishment (3) For service information identified in 30, 2019. Instructions of Boeing Special Attention this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data FOR FURTHER INFORMATION CONTACT: Requirements Bulletin 737–25–1831 RB, Karen Fikes, Center for Devices and dated September 24, 2019. Services (C&DS), 2600 Westminster Blvd., MC 110–SK57, Seal Beach, CA 90740–5600; Radiological Health (CDRH), Food and Note 1 to paragraph (g): Guidance for phone: 562–797–1717; internet: https:// Drug Administration, 10903 New accomplishing the actions required by this www.myboeingfleet.com. AD can be found in Boeing Special Attention Hampshire Ave., Bldg. 66, Rm. 5502, (4) You may view this service information Service Bulletin 737–25–1831, dated Silver Spring, MD 20993, 301–796– at the FAA, Transport Standards Branch, September 24, 2019, which is referred to in 9603, email: [email protected]. 2200 South 216th St., Des Moines, WA. For Boeing Special Attention Requirements information on the availability of this SUPPLEMENTARY INFORMATION: Bulletin 737–25–1831 RB, dated September material at the FAA, call 206–231–3195. 24, 2019. I. Background (5) You may view this service information (h) Exceptions to Service Information that is incorporated by reference at the The Cures Act (Pub. L. 114–255) was Specifications National Archives and Records signed into law on December 13, 2016. Administration (NARA). For information on Where Boeing Special Attention Under the Cures Act, section 3054 the availability of this material at NARA, amended section 510(l) and (m) of the Requirements Bulletin 737–25–1831 RB, email [email protected], or go to: https:// dated September 24, 2019, uses the phrase Federal Food, Drug, and Cosmetic Act www.archives.gov/federal-register/cfr/ibr- ‘‘the original issue date of the Requirements (FD&C Act) (21 U.S.C. 360(l) and (m)). locations.html. Bulletin 737–25–1831 RB,’’ this AD requires As amended, section 510(l)(2) of the using ‘‘the effective date of this AD.’’ Issued in Des Moines, Washington, on FD&C Act requires FDA to identify December 9, 2019. (i) Alternative Methods of Compliance through publication in the Federal (AMOCs) Michael Kaszycki, Register, any type of class I device that Acting Director, System Oversight Division, (1) The Manager, Seattle ACO Branch, the Agency determines no longer Aircraft Certification Service. FAA, has the authority to approve AMOCs requires a report under section 510(k) of for this AD, if requested using the procedures [FR Doc. 2019–28070 Filed 12–27–19; 8:45 am] the FD&C Act to provide reasonable found in 14 CFR 39.19. In accordance with BILLING CODE 4910–13–P assurance of safety and effectiveness. VerDate Sep<11>2014 16:33 Dec 27, 2019 Jkt 250001 PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 E:\FR\FM\30DER1.SGM 30DER1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Rules and Regulations 71795 FDA shall publish this determination Following publication of the notices, we exempted product code MNG, within 120 days of the date of FDA determined that it is unnecessary ‘‘External Urethral Occluder, Urinary enactment of the Cures Act and at least to update three classification regulations Incontinence-Control, Female’’ and once every 5 years thereafter, as FDA (21 CFR 872.4565, 21 CFR 878.4014, removed the current limitation language determines appropriate. Further, section and 21 CFR 880.6320) included in the regarding ‘‘use on females.’’ Therefore, 510(l)(2) provides that upon the date of class I notice, 82 FR 17841. Five product FDA is revising the name of the publication of the Agency’s codes corresponding to these three classification regulation to read determination in the Federal Register, a classification regulations (EGI and EIB ‘‘Urological clamp’’ to ensure clarity. 510(k) will no longer be required for (21 CFR 872.4565), OVR (21 CFR II. Criteria for Exemption these devices and the classification 878.4014), KZF and PEQ (21 CFR regulation applicable to each such type 880.6320)) were identified for As amended by the Cures Act, section of device shall be deemed amended to exemption in 82 FR 17841; however, the 510(l) now has two provisions, 510(l)(1) incorporate such exemption. corresponding classification regulations and (2). Under 510(1)(1), a class I device As amended, section 510(m)(1)(A) of were already class I, exempt from is exempt from the premarket the FD&C Act provides that, within 90 premarket notification procedures in notification requirements under section days after enactment of the Cures Act subpart E of part 807 (21 CFR part 807, 510(k) of the FD&C Act, unless the and at least once every 5 years subpart E) subject to the limitations in device is intended for a use which is of thereafter, FDA shall publish in the the corresponding ‘‘.9’’ regulations (i.e., substantial importance in preventing Federal Register a notice containing a 21 CFR 872.9, 21 CFR 878.9 or 21 CFR impairment of human health or it list of each type of class II device that 880.9); and, therefore, no revisions to presents a potential unreasonable risk of FDA determines no longer requires a the codified are necessary. Additionally, illness or injury. Based on these criteria, report under section 510(k) of the FD&C we determined that it is unnecessary to FDA evaluated all class I devices to Act to provide reasonable assurance of update 21 CFR 876.5820 included in the determine which device types should be safety and effectiveness.
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