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§ 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.

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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. This notice class II notice, 82 FR 13609. The exempt from premarket notification shall provide at least a 60-day comment product code within this classification requirements. For class II devices, there are a period. Within 210 days of enactment of regulation (FKI) was identified for number of factors FDA may consider to the Cures Act, FDA shall publish in the exemption in 82 FR 13609. However, determine whether a 510(k) is necessary Federal Register a list representing its this device type is specifically identified to provide reasonable assurance of the final determination regarding exemption within the class I paragraph of this safety and effectiveness of a class II of devices that were contained in the classification regulation (21 CFR device. These factors are discussed in proposed list published under 876.5820(b)(2)) and already exempt 510(m)(1)(A) of the FD&C Act. Further, the January 21, 1998, Federal Register from premarket notification procedures notice (63 FR 3142) and subsequently in section 510(m)(3) of the FD&C Act in subpart E of part 807 subject to the provides that upon the date of the guidance we issued on February 19, limitations in 21 CFR 876.9. Therefore, 1998, entitled ‘‘Procedures for Class II publication of the final list in the no revisions to the codified are Federal Register, a 510(k) will no longer Device Exemptions From Premarket necessary. Notification, Guidance for Industry and be required for these devices and the We are also making a revision to CDRH Staff ’’.2 classification regulation applicable to correct a misidentified classification each such device shall be deemed regulation in 82 FR 31976. The notice III. Limitations on Exemptions amended to incorporate such incorrectly listed the classification exemption. Although FDA exempted the types of regulation 21 CFR 868.1400 ‘‘Carbon class I and class II devices from the In the Federal Register of April 13, dioxide gas analyzer’’ as corresponding 2017 (82 FR 17841), in accordance with premarket notification requirements with product code LLK; however, the under section 510(k) of the FD&C Act in the amendments to 510(l)(2), FDA correct classification regulation issued a notice of final determination to accordance with the provisions under associated with product code LLK is 21 510(l) and (m), an exemption from the exempt a list of class I devices from CFR 880.5780 ‘‘Medical Support premarket notification requirements requirement of premarket notification Stocking’’. Therefore, 21 CFR 868.1400 does not mean the device is exempt under section 510(k) of the FD&C Act, remains unchanged, and 21 CFR subject to certain limitations. In the from any other statutory or regulatory 880.5780(a)(2) is revised to reflect the requirements, unless such exemption is Federal Register of March 14, 2017 (82 exemption. FR 13609), in accordance with the explicitly provided by order or We are revising the name of one regulation. FDA’s determination that amendments to 510(m)(1)(A), FDA classification regulation, currently issued a notice proposing to exempt a premarket notification is unnecessary to entitled ‘‘Urological clamp for males’’, provide a reasonable assurance of safety list of class II devices from premarket in response to FDA’s exemption in 82 notification requirements under section and effectiveness is based, in part, on FR 17841. Part 876.5160 is currently the assurance of safety and effectiveness 510(k) of the FD&C Act, subject to entitled ‘‘Urological clamp for males,’’ that other regulatory controls, such as certain limitations. After a 60-day which was previously exempt from current good manufacturing practice comment period, in the Federal Register premarket notification procedures ‘‘. . . requirements, provide. of July 11, 2017 (82 FR 31976), FDA Except when intended for internal use In addition to being subject to the issued a notice of final determination to or use on females . . .’’. In 82 FR 17841, general limitations to the exemptions exempt class II devices provided in the found in 21 CFR 862.9 to 892.9, FDA proposed list. Through this action, FDA order,’’ rather than ‘‘Final order.’’ Beginning in has also partially limited some is now amending the codified language December 2019, this editorial change was made to exemptions from premarket notification for each listed classification regulation indicate that the document ‘‘amends’’ the Code of requirements to specific devices within to reflect final determinations for these Federal Regulations. The change was made in 1 accordance with the Office of Federal Register’s class I and class II exemptions. (OFR) interpretations of the Federal Register Act (44 2 Available at: https://www.fda.gov/regulatory- U.S.C. chapter 15), its implementing regulations (1 information/search-fda-guidance-documents/ 1 FDA notes that the ‘‘ACTION’’ caption for this CFR 5.9 and parts 21 and 22), and the Document procedures-class-ii-device-exemptions-premarket- final order is styled as ‘‘Final amendment; final Drafting Handbook. notification-guidance-industry-and-cdrh-staff.

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the listed device type. In such situations PART 862—CLINICAL CHEMISTRY premarket notification procedures in where a partial exemption limitation AND CLINICAL TOXICOLOGY subpart E of part 807 of this chapter has been identified, FDA has DEVICES subject to the limitations in § 862.9. The determined that premarket notification special controls for this device are: ■ is necessary to provide a reasonable 1. The authority citation for part 862 * * * * * continues to read as follows: assurance of safety and effectiveness for ■ 8. In § 862.1410, revise paragraph (b) these devices. Authority: 21 U.S.C. 351, 360, 360c, 360e, to read as follows: IV. Analysis of Environmental Impact 360j, 360l, 371. ■ 2. In § 862.1020, revise paragraph (b) § 862.1410 Iron (non-heme) test system. The Agency has determined under 21 to read as follows: * * * * * CFR 25.30(h) that this action is of a type (b) Classification. Class I (general that does not individually or § 862.1020 Acid phosphatase (total or controls). The device is exempt from the cumulatively have a significant effect on prostatic) test system. premarket notification procedures in the human environment. Therefore, * * * * * subpart E of part 807 of this chapter neither an environmental assessment (b) Classification. Class II (special subject to the limitations in § 862.9. nor an environmental impact statement controls). The device is exempt from the ■ 9. In § 862.1415, revise paragraph (b) is required. premarket notification procedures in to read as follows: subpart E of part 807 of this chapter V. Paperwork Reduction Act of 1995 subject to the limitations in § 862.9. § 862.1415 Iron-binding capacity test This final order refers to previously ■ 3. In § 862.1090, revise paragraph (b) system. approved FDA collections of to read as follows: * * * * * information. These collections of (b) Classification. Class I (general information are subject to review by the § 862.1090 Angiotensin converting enzyme controls). The device is exempt from the Office of Management and Budget (A.C.E.) test system. premarket notification procedures in (OMB) under the Paperwork Reduction * * * * * subpart E of part 807 of this chapter Act of 1995 (44 U.S.C. 3501–3521). The (b) Classification. Class II (special subject to the limitations in § 862.9. collections of information in part 807, controls). The device is exempt from the ■ 10. In § 862.1445, revise paragraph (b) subpart E, regarding premarket premarket notification procedures in to read as follows: notification submissions, have been subpart E of part 807 of this chapter approved under OMB control number subject to the limitations in § 862.9. § 862.1445 Lactate dehydrogenase isoenzymes test system. 0910–0120; the collections of ■ 4. In § 862.1100, revise paragraph (b) information in 21 CFR parts 801 and to read as follows: * * * * * 809, regarding labeling, have been (b) Classification. Class II (special § 862.1100 Aspartate amino transferase controls). The device is exempt from the approved under OMB control number (AST/SGOT) test system. 0910–0485; and the collections of premarket notification procedures in information in 21 CFR part 820, * * * * * subpart E of part 807 of this chapter (b) Classification. Class II (special regarding quality system regulation, subject to the limitations in § 862.9. controls). The device is exempt from the have been approved under OMB control ■ 11. In § 862.1509, revise paragraph (b) premarket notification procedures in number 0910–0073. to read as follows: subpart E of part 807 of this chapter List of Subjects subject to the limitations in § 862.9. § 862.1509 Methylmalonic acid ■ (nonquantitative) test system. 21 CFR Parts 862, 868, 870, 872, 874, 5. In § 862.1150, revise paragraph (b) * * * * * 876, 878, 880, 882, 884, 888, and 890 to read as follows: (b) Classification. Class II (special Medical devices. § 862.1150 Calibrator. controls). The device is exempt from the * * * * * premarket notification procedures in 21 CFR Part 864 (b) Classification. Class II (special subpart E of part 807 of this chapter Blood, Medical devices, Packaging controls). The device is exempt from the subject to the limitations in § 862.9. and Containers. premarket notification procedures in ■ 12. In § 862.1580, revise paragraph (b) subpart E of part 807 of this chapter to read as follows: 21 CFR Part 866 subject to the limitations in § 862.9. Biologics, Laboratories, Medical ■ 6. In § 862.1345, revise paragraph (b) § 862.1580 Phosphorous (inorganic) test system. devices. to read as follows: * * * * * 21 CFR Part 886 § 862.1345 Glucose test system. (b) Classification. Class I (general Medical devices, Ophthalmic goods * * * * * controls). The device is exempt from the and services. (b) Classification. Class II (special premarket notification procedures in controls). The device is exempt from the subpart E of part 807 of this chapter 21 CFR Part 892 premarket notification procedures in subject to the limitations in § 862.9. Medical devices, Radiation subpart E of part 807 of this chapter ■ 13. In § 862.1660, revise paragraph (b) protection, X-rays. subject to the limitations in § 862.9. to read as follows: ■ 7. In § 862.1350, revise paragraph (b) Therefore, under the Federal Food, introductory text to read as follows: § 862.1660 Quality control material Drug, and Cosmetic Act and under (assayed and unassayed). authority delegated to the Commissioner § 862.1350 Continuous glucose monitor * * * * * of Food and Drugs, 21 CFR parts 862, secondary display. (b) Classification. Class I (general 864, 866, 868, 870, 872, 874, 876, 878, * * * * * controls). Except when intended for use 880, 882, 884, 886, 888, 890, and 892 are (b) Classification. Class II (special in donor screening tests, quality control amended as follow: controls). The device is exempt from the materials (assayed and unassayed) are

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exempt from the premarket notification § 862.3050 Breath-alcohol test system. testing programs. The device is exempt procedures in subpart E of part 807 of * * * * * from the premarket notification this chapter subject to the limitations in (b) Classification. Class I (general procedures in subpart E of part 807 of § 862.9. controls). The device is exempt from the this chapter subject to the limitations in ■ 14. In § 862.1685, revise paragraph (b) premarket notification procedures in § 862.9, provided the test system is as follows: subpart E of part 807 of this chapter intended for employment and insurance subject to the limitations in § 862.9. testing and includes a statement in the § 862.1685 Thyroxine-binding globulin test ■ 20. In § 862.3100, revise paragraph (b) labeling that the device is intended system. to read as follows: solely for use in employment and * * * * * insurance testing, and does not include § 862.3100 Amphetamine test system. (b) Classification. Class II (special devices intended for Federal drug controls). The device is exempt from the * * * * * testing programs (e.g., programs run by premarket notification procedures in (b) Classification. Class II (special the Substance Abuse and Mental Health subpart E of part 807 of this chapter controls). An amphetamine test system Services Administration (SAMHSA), the subject to the limitations in § 862.9. is not exempt if it is intended for any Department of Transportation (DOT), use other than employment or insurance and the U.S. military). ■ 15. In § 862.1700, revise paragraph (b) testing or is intended for Federal drug as follows: ■ 23. In § 862.3200, revise paragraph (b) testing programs. The device is exempt to read as follows: § 862.1700 Total thyroxine test system. from the premarket notification procedures in subpart E of part 807 of § 862.3200 Clinical toxicology calibrator. * * * * * this chapter subject to the limitations in (b) Classification. Class II (special * * * * * § 862.9, provided the test system is (b) Classification. Class II (special controls). The device is exempt from the intended for employment and insurance controls). The device is exempt from the premarket notification procedures in testing and includes a statement in the premarket notification procedures in subpart E of part 807 of this chapter labeling that the device is intended subpart E of part 807 of this chapter subject to the limitations in § 862.9. solely for use in employment and subject to the limitations in § 862.9. ■ 16. In § 862.1775, revise paragraph (b) insurance testing, and does not include ■ 24. In § 862.3220, revise paragraph (b) to read as follows: devices intended for Federal drug to read as follows: testing programs (e.g., programs run by § 862.1775 Uric acid test system. the Substance Abuse and Mental Health § 862.3220 Carbon monoxide test system. * * * * * Services Administration (SAMHSA), the * * * * * (b) Classification. Class I (general Department of Transportation (DOT), (b) Classification. Class I (general controls). The device is exempt from the and the U.S. military). controls). The device is exempt from the premarket notification procedures in ■ 21. In § 862.3150, revise paragraph (b) premarket notification procedures in subpart E of part 807 of this chapter to read as follows: subpart E of part 807 of this chapter subject to the limitations in § 862.9. subject to the limitations in § 862.9. § 862.3150 Barbiturate test system. ■ 17. In § 862.2265, revise paragraph (b) ■ 25. In § 862.3240, revise paragraph (b) introductory text to read as follows: * * * * * to read as follows: (b) Classification. Class II (special § 862.2265 High throughput genomic controls). A barbiturate test system is § 862.3240 Cholinesterase test system. sequence analyzer for clinical use. not exempt if it is intended for any use * * * * * * * * * * other than employment or insurance (b) Classification. Class I (general (b) Classification. Class II (special testing or is intended for Federal drug controls). The device is exempt from the controls). The device is exempt from the testing programs. The device is exempt premarket notification procedures in premarket notification procedures in from the premarket notification subpart E of part 807 of this chapter subpart E of part 807 of this chapter procedures in subpart E of part 807 of subject to the limitations in § 862.9. subject to the limitations in § 862.9. The this chapter subject to the limitations in ■ 26. In § 862.3250, revise paragraph (b) special controls for this device are: § 862.9, provided the test system is to read as follows: * * * * * intended for employment and insurance testing and includes a statement in the § 862.3250 Cocaine and cocaine ■ 18. In § 862.2570, revise paragraph (b) labeling that the device is intended metabolite test system. to read as follows: solely for use in employment and * * * * * (b) Classification. Class II (special § 862.2570 Instrumentation for clinical insurance testing, and does not include multiplex test systems. devices intended for Federal drug controls). A cocaine and cocaine metabolite test system is not exempt if * * * * * testing programs (e.g., programs run by the Substance Abuse and Mental Health it is intended for any use other than (b) Classification. Class II (special Services Administration (SAMHSA), the employment or insurance testing or is controls). The device is exempt from the Department of Transportation (DOT), intended for Federal drug testing premarket notification procedures in and the U.S. military). programs. The device is exempt from subpart E of part 807 of this chapter ■ the premarket notification procedures in subject to the limitations in § 862.9. The 22. In § 862.3170, revise paragraph (b) to read as follows: subpart E of part 807 of this chapter special control is FDA’s guidance subject to the limitations in § 862.9, document entitled ‘‘Class II Special § 862.3170 Benzodiazepine test system. provided the test system is intended for Controls Guidance Document: * * * * * employment and insurance testing and Instrumentation for Clinical Multiplex (b) Classification. Class II (special includes a statement in the labeling that Test Systems.’’ See § 862.1(d) for the controls). A benzodiazepine test system the device is intended solely for use in availability of this guidance document. is not exempt if it is intended for any employment and insurance testing, and ■ 19. In § 862.3050, revise paragraph (b) use other than employment or insurance does not include devices intended for to read as follows: testing or is intended for Federal drug Federal drug testing programs (e.g.,

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programs run by the Substance Abuse Department of Transportation (DOT), § 862.9, provided the test system is and Mental Health Services and the U.S. military). intended for employment and insurance Administration (SAMHSA), the ■ 30. In § 862.3610, revise paragraph (b) testing and includes a statement in the Department of Transportation (DOT), to read as follows: labeling that the device is intended and the U.S. military). solely for use in employment and § 862.3610 Methamphetamine test system. ■ 27. In § 862.3270, revise paragraph (b) insurance testing, and does not include to read as follows: * * * * * devices intended for Federal drug (b) Classification. Class II (special testing programs (e.g., programs run by § 862.3270 Codeine test system. controls). A methamphetamine test the Substance Abuse and Mental Health * * * * * system is not exempt if it is intended for Services Administration (SAMHSA), the (b) Classification. Class II (special any use other than employment or Department of Transportation (DOT), controls). A codeine test system is not insurance testing or is intended for and the U.S. military). exempt if it is intended for any use Federal drug testing programs. The ■ 33. In § 862.3640, revise paragraph (b) other than employment or insurance device is exempt from the premarket to read as follows: notification procedures in subpart E of testing or is intended for Federal drug § 862.3640 Morphine test system. testing programs. The device is exempt part 807 of this chapter subject to the from the premarket notification limitations in § 862.9, provided the test * * * * * system is intended for employment and (b) Classification. Class II (special procedures in subpart E of part 807 of insurance testing and includes a controls). A morphine test system is not this chapter subject to the limitations in statement in the labeling that the device exempt if it is intended for any use § 862.9, provided the test system is is intended solely for use in other than employment or insurance intended for employment and insurance employment and insurance testing, and testing or is intended for Federal drug testing and includes a statement in the does not include devices intended for testing programs. The device is exempt labeling that the device is intended Federal drug testing programs (e.g., from the premarket notification solely for use in employment and programs run by the Substance Abuse procedures in subpart E of part 807 of insurance testing, and does not include and Mental Health Services this chapter subject to the limitations in devices intended for Federal drug Administration (SAMHSA), the § 862.9, provided the test system is testing programs (e.g., programs run by Department of Transportation (DOT), intended for employment and insurance the Substance Abuse and Mental Health and the U.S. military). testing and includes a statement in the Services Administration (SAMHSA), the ■ labeling that the device is intended Department of Transportation (DOT), 31. In § 862.3620, revise paragraph (b) to read as follows: solely for use in employment and and the U.S. military). insurance testing, and does not include ■ 28. In § 862.3280, revise paragraph (b) § 862.3620 Methadone test system. devices intended for Federal drug to read as follows: * * * * * testing programs (e.g., programs run by (b) Classification. Class II (special the Substance Abuse and Mental Health § 862.3280 Clinical toxicology control controls). A methadone test system is material. Services Administration (SAMHSA), the not exempt if it is intended for any use Department of Transportation (DOT), * * * * * other than employment or insurance and the U.S. military). (b) Classification. Class I (general testing or is intended for Federal drug ■ 34. In § 862.3650, revise paragraph (b) controls). The device is exempt from the testing programs. The device is exempt to read as follows: premarket notification procedures in from the premarket notification subpart E of part 807 of this chapter procedures in subpart E of part 807 of § 862.3650 Opiate test system. subject to the limitations in § 862.9. this chapter subject to the limitations in * * * * * ■ 29. In § 862.3580, revise paragraph (b) § 862.9, provided the test system is (b) Classification. Class II (special to read as follows: intended for employment and insurance controls). An opiate test system is not testing and includes a statement in the exempt if it is intended for any use § 862.3580 Lysergic acid diethylamide labeling that the device is intended other than employment or insurance (LSD) test system. solely for use in employment and testing or is intended for Federal drug * * * * * insurance testing, and does not include testing programs. The device is exempt (b) Classification. Class II (special devices intended for Federal drug from the premarket notification controls). A lysergic acid diethylamide testing programs (e.g., programs run by procedures in subpart E of part 807 of (LSD) test system is not exempt if it is the Substance Abuse and Mental Health this chapter subject to the limitations in intended for any use other than Services Administration (SAMHSA), the § 862.9, provided the test system is employment or insurance testing or is Department of Transportation (DOT), intended for employment and insurance intended for Federal drug testing and the U.S. military). testing and includes a statement in the programs. The device is exempt from ■ 32. In § 862.3630, revise paragraph (b) labeling that the device is intended the premarket notification procedures in to read as follows: solely for use in employment and subpart E of part 807 of this chapter insurance testing, and does not include subject to the limitations in § 862.9, § 862.3630 Methaqualone test system. devices intended for Federal drug provided the test system is intended for * * * * * testing programs (e.g., programs run by employment and insurance testing and (b) Classification. Class II (special the Substance Abuse and Mental Health includes a statement in the labeling that controls). A methaqualone test system is Services Administration (SAMHSA), the the device is intended solely for use in not exempt if it is intended for any use Department of Transportation (DOT), employment and insurance testing, and other than employment or insurance and the U.S. military). does not include devices intended for testing or is intended for Federal drug ■ 35. In § 862.3700, revise paragraph (b) Federal drug testing programs (e.g., testing programs. The device is exempt to read as follows: programs run by the Substance Abuse from the premarket notification and Mental Health Services procedures in subpart E of part 807 of § 862.3700 Propoxyphene test system. Administration (SAMHSA), the this chapter subject to the limitations in * * * * *

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(b) Classification. Class II (special Federal drug testing programs (e.g., subpart E of part 807 of this chapter controls). A propoxyphene test system programs run by the Substance Abuse subject to the limitations in § 864.9. is not exempt if it is intended for any and Mental Health Services ■ 44. In § 864.7300, revise paragraph (b) use other than employment or insurance Administration (SAMHSA), the to read as follows: testing or is intended for Federal drug Department of Transportation (DOT), testing programs. The device is exempt and the U.S. military). § 864.7300 Fibrin monomer from the premarket notification paracoagulation test. procedures in subpart E of part 807 of PART 864—HEMATOLOGY AND * * * * * this chapter subject to the limitations in PATHOLOGY DEVICES (b) Classification. Class II (special § 862.9, provided the test system is ■ controls). The device is exempt from the intended for employment and insurance 38. The authority citation for part 864 continues to read as follows: premarket notification procedures in testing and includes a statement in the subpart E of part 807 of this chapter labeling that the device is intended Authority: 21 U.S.C. 351, 360, 360c, 360e, subject to the limitations in § 864.9. The solely for use in employment and 360j, 360l, 371. special control for this device is FDA’s insurance testing, and does not include ■ 39. In § 864.5400, revise paragraph (b) ‘‘In Vitro Diagnostic Fibrin Monomer devices intended for Federal drug to read as follows: Paracoagulation Test.’’ See § 864.1(d) for testing programs (e.g., programs run by information on obtaining this document. the Substance Abuse and Mental Health § 864.5400 Coagulation instrument. ■ Services Administration (SAMHSA), the * * * * * 45. In § 864.7340, revise paragraph (b) Department of Transportation (DOT), (b) Classification. Class II (special to read as follows: and the U.S. military). controls). A fibrometer or coagulation § 864.7340 Fibrinogen determination ■ 36. In § 862.3870, revise paragraph (b) timer intended for use with a system. to read as follows: coagulation instrument is exempt from * * * * * the premarket notification procedures in § 862.3870 Cannabinoid test system. (b) Classification. Class II (special subpart E of part 807 of this chapter controls). A control or fibrinogen * * * * * subject to the limitations in § 864.9. (b) Classification. Class II (special standard intended for use with a ■ 40. In § 864.5425, revise paragraph (b) fibrinogen determination system is controls). A cannabinoid test system is to read as follows: not exempt if it is intended for any use exempt from the premarket notification other than employment or insurance § 864.5425 Multipurpose system for in procedures in subpart E of part 807 of testing or is intended for Federal drug vitro coagulation studies. this chapter subject to the limitations in testing programs. The device is exempt * * * * * § 864.9. from the premarket notification (b) Classification. Class II (special ■ 46. In § 864.7375, revise paragraph (b) procedures in subpart E of part 807 of controls). A control intended for use to read as follows: this chapter subject to the limitations in with a multipurpose system for in vitro § 864.7375 Glutathione reductase assay. § 862.9, provided the test system is coagulation studies is exempt from the intended for employment and insurance premarket notification procedures in * * * * * testing and includes a statement in the subpart E of part 807 of this chapter (b) Classification. Class II (special labeling that the device is intended subject to the limitations in § 864.9. controls). The device is exempt from the solely for use in employment and ■ 41. In § 864.6550, revise paragraph (b) premarket notification procedures in insurance testing, and does not include to read as follows: subpart E of part 807 of this chapter devices intended for Federal drug subject to the limitations in § 864.9. testing programs (e.g., programs run by § 864.6550 Occult blood test. ■ 47. In § 864.7415, revise paragraph (b) the Substance Abuse and Mental Health * * * * * to read as follows: Services Administration (SAMHSA), the (b) Classification. Class II (special Department of Transportation (DOT), controls). A control intended for use § 864.7415 Abnormal hemoglobin assay. and the U.S. military). with an occult blood test is exempt from * * * * * ■ 37. In § 862.3910, revise paragraph (b) the premarket notification procedures in (b) Classification. Class II (special to read as follows: subpart E of part 807 of this chapter controls). A control intended for use subject to the limitations in § 864.9. with an abnormal hemoglobin assay is § 862.3910 Tricyclic antidepressant drugs ■ test system. 42. In § 864.7040, revise paragraph (b) exempt from the premarket notification to read as follows: procedures in subpart E of part 807 of * * * * * this chapter subject to the limitations in (b) Classification. Class II (special § 864.7040 Adenosine triphosphate § 864.9. controls). A tricyclic antidepressant release assay. ■ drugs test system is not exempt if it is * * * * * 48. In § 864.7455, revise paragraph (b) intended for any use other than (b) Classification. Class I (general to read as follows: employment or insurance testing or is controls). The device is exempt from the § 864.7455 Fetal hemoglobin assay. intended for Federal drug testing premarket notification procedures in * * * * * programs. The device is exempt from subpart E of part 807 of this chapter the premarket notification procedures in subject to the limitations in § 864.9. (b) Classification. Class II (special subpart E of part 807 of this chapter ■ controls). A fetal hemoglobin stain 43. In § 864.7275, revise paragraph (b) intended for use with a fetal hemoglobin subject to the limitations in § 862.9, to read as follows: provided the test system is intended for assay is exempt from the premarket employment and insurance testing and § 864.7275 Euglobulin lysis time tests. notification procedures in subpart E of includes a statement in the labeling that * * * * * part 807 of this chapter subject to the the device is intended solely for use in (b) Classification. Class II (special limitations in § 864.9. employment and insurance testing, and controls). The device is exempt from the ■ 49. In § 864.7500, revise paragraph (b) does not include devices intended for premarket notification procedures in to read as follows:

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§ 864.7500 Whole blood hemoglobin ■ 55. In § 864.8185, revise paragraph (b) document entitled ‘‘Class II Special assays. to read as follows: Controls Guidance Document: * * * * * Norovirus Serological Reagents.’’ See § 864.8185 Calibrator for red cell and white § 866.1(e) for the availability of this (b) Classification. Class II (special cell counting. controls). An acid hematin intended for guidance document. * * * * * use with whole blood hemoglobin ■ (b) Classification. Class II (special 61. In § 866.5210, revise paragraph (b) assays is exempt from the premarket controls). The device is exempt from the to read as follows: notification procedures in subpart E of premarket notification procedures in part 807 of this chapter subject to the § 866.5210 Ceruloplasmin immunological subpart E of part 807 of this chapter limitations in § 864.9. test system. subject to the limitations in § 864.9. ■ * * * * * 50. In § 864.7720, revise paragraph (b) ■ 56. In § 864.8625, revise paragraph (b) to read as follows: (b) Classification. Class II (special to read as follows: controls). The device is exempt from the § 864.7720 Prothrombin consumption test. § 864.8625 Hematology quality control premarket notification procedures in * * * * * mixture. subpart E of part 807 of this chapter subject to the limitations in § 866.9. (b) Classification. Class II (special * * * * * controls). The device is exempt from the (b) Classification. Class II (special ■ 62. In § 866.5470, revise paragraph (b) premarket notification procedures in controls). Except when intended for use to read as follows: subpart E of part 807 of this chapter in blood components, the device is § 866.5470 Hemoglobin immunological subject to the limitations in § 864.9. exempt from the premarket notification test system. ■ procedures in subpart E of part 807 of 51. In § 864.7735, revise paragraph (b) * * * * * to read as follows: this chapter subject to the limitations in § 864.9. (b) Classification. Class II (special controls). The device is exempt from the § 864.7735 Prothrombin-proconvertin test ■ 57. In § 864.9400, revise paragraph (b) and thrombotest. premarket notification procedures in to read as follows: * * * * * subpart E of part 807 of this chapter subject to the limitations in § 866.9. (b) Classification. Class II (special § 864.9400 Stabilized enzyme solution. controls). The device is exempt from the * * * * * ■ 63. In § 866.5620, revise paragraph (b) premarket notification procedures in (b) Classification. Class II (special to read as follows: controls). The device is exempt from the subpart E of part 807 of this chapter § 866.5620 Alpha-2-macroglobulin subject to the limitations in § 864.9. premarket notification procedures in immunological test system. ■ 52. In § 864.8150, revise paragraph (b) subpart E of part 807 of this chapter subject to the limitations in § 864.9. * * * * * to read as follows: (b) Classification. Class II (special § 864.8150 Calibrator for cell indices. PART 866—IMMUNOLOGY AND controls). The device is exempt from the MICROBIOLOGY DEVICES premarket notification procedures in * * * * * subpart E of part 807 of this chapter (b) Classification. Class II (special ■ 58. The authority citation for part 866 subject to the limitations in § 866.9. controls). The device is exempt from the continues to read as follows: ■ premarket notification procedures in 64. In § 866.5630, revise paragraph (b) Authority: 21 U.S.C. 351, 360, 360c, 360e, to read as follows: subpart E of part 807 of this chapter 360j, 360l, 371. subject to the limitations in § 864.9. § 866.5630 Beta-2-microglobulin ■ 59. In § 866.2900, revise paragraph (b) ■ 53. In § 864.8165, revise paragraph (b) immunological test system. to read as follows: to read as follows: * * * * * § 866.2900 Microbiological specimen (b) Classification. Class II (special § 864.8165 Calibrator for hemoglobin or collection and transport device. controls). The device is exempt from the hematocrit measurement. * * * * * premarket notification procedures in * * * * * (b) Classification. Class I (general subpart E of part 807 of this chapter (b) Classification. Class II (special controls). The device is exempt from the subject to the limitations in § 866.9. controls). The device is exempt from the premarket notification procedures in ■ 65. In § 866.5750, revise paragraph (b) premarket notification procedures in subpart E of part 807 of this chapter to read as follows: subpart E of part 807 of this chapter subject to the limitations in § 866.9. subject to the limitations in § 864.9. ■ 60. In § 866.3395, revise paragraph (b) § 866.5750 Radioallergosorbent (RAST) immunological test system. ■ 54. In § 864.8175, revise paragraph (b) to read as follows: to read as follows: * * * * * § 866.3395 Norovirus serological reagents. (b) Classification. Class II (special § 864.8175 Calibrator for platelet counting. * * * * * controls). The device, when intended to * * * * * (b) Classification. Class II (special detect any of the allergens included in (b) Classification. Class II (special controls). The device is exempt from the Table 1 in this paragraph, is exempt controls). The device is exempt from the premarket notification procedures in from the premarket notification premarket notification procedures in subpart E of part 807 of this chapter procedures in subpart E of part 807 of subpart E of part 807 of this chapter subject to the limitations in § 866.9. The this chapter subject to the limitations in subject to the limitations in § 864.9. special control is FDA’s guidance § 866.9.

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS

Source Allergen code Allergen product (taxonomical name)

Grass Pollens

g1 ...... Sweet vernal grass ...... Anthoxanthum odoratum. g3 ...... Cocksfoot grass, Orchard grass ...... Dactylis glomerata. g4 ...... Meadow fescue ...... Festuca elatior. g5 ...... Rye-grass (perennial rye grass) ...... Lolium perenne. g7 ...... Common reed (common reed grass) ...... Phragmites communis. g8 ...... Meadow grass, Kentucky blue (June grass) ...... Poa pratensis. g9 ...... Redtop, Bentgrass ...... Agrostis stolonifera, Agrostis gigantea (Agrostis alba). g11 ...... Brome grass ...... Bromus inermis. g12 ...... Cultivated rye (cultivated rye grass) ...... Secale cereale. g13 ...... Velvet grass ...... Holcus lanatus. g14 ...... Cultivated oat (cultivated oat grass) ...... Avena sativa. g15 ...... Cultivated wheat (cultivated wheat grass) ...... Triticum aestivum (Triticum spp.). g16 ...... Meadow foxtail (meadow foxtail grass) ...... Alopecurus pratensis. g17 ...... Bahia grass ...... Paspalum notatum. g24 ...... Wheat grass, Western ...... Agropyron smithii (Elymus smithii). g30 ...... Bluegrass, annual ...... Poa annua. g70 ...... Wild rye grass ...... Elymus triticoides Elymus condensatus. g71 ...... Canary grass ...... Phalaris arundinacea. g201 ...... Barley, cultivated ...... Hordeum vulgare. g202 ...... Maize, corn (cultivated corn) ...... Zea mays. g203 ...... Salt grass ...... Distichlis spicata. g204 ...... False oat-grass ...... Arrhenatherum elatius. g216 ...... Cyn d 1 ...... Cynodon dactylon. g701 ...... Phl p 1.0102, Phl p 5.0101 ...... Phleum pratense. g702 ...... Phl p 7.0101 ...... Phleum pratense. g703 ...... Phl p 12.0101 ...... Phleum pratense.

Weed Pollens

w2 ...... Western ragweed ...... Ambrosia psilostachya. w4 ...... False ragweed ...... Ambrosia acanthicarpa (Franseria acanthicarpa). w5 ...... Wormwood ...... Artemisia absinthium Artemisia annua. w6 ...... Mugwort ...... Artemisia vulgaris. w7 ...... Marguerite, ox-eye daisy ...... Chrysanthemum leucanthemum. w8 ...... Dandelion ...... Taraxacum vulgare, Taraxacum officinale. w9 ...... Plantain (English), Ribwort ...... Plantago lanceolata. w10 ...... Goosefoot, lamb’s quarters ...... Chenopodium album. w11 ...... Saltwort (prickly), Russian thistle ...... Salsola kali (Salsola pestifer). w12 ...... Goldenrod ...... Solidago virgaurea (Solidago spp.). w13 ...... Cocklebur, common ...... Xanthium commune. w14 ...... Common pigweed (rough pigweed) ...... Amaranthus retroflexus. w15 ...... Scale, Lenscale ...... Atriplex lentiformis. w16 ...... Rough marsh elder ...... Iva ciliate, Iva annua. w17 ...... Firebush (Kochia) ...... Kochia scoparia. w18 ...... Sheep sorrel ...... Rumex acetosella. w19 ...... Wall pellitory ...... Parietaria officinalis. w20 ...... Nettle (Common stinging nettle) ...... Urtica dioica. w21 ...... Wall pellitory ...... Parietaria judaica. w22 ...... Japanese hop (careless weed) ...... Humulus japonicas (Humulus scandens). w23 ...... Yellow dock, Yellow dockweed ...... Rumex crispus. w24 ...... Spiny pigweed ...... Amaranthus spinosus. w27 ...... Carnation ...... Dianthus spp. w28 ...... Rose ...... Rosa rugosa. w33 ...... Clover ...... Trifolium pratense. w35 ...... Mexican tea ...... Chenopodium ambrosioides. w36 ...... Rabbit bush ...... Ambrosia deltoidea (Franseria deltoides). w37 ...... Salt bush, annual ...... Atriplex wrightii. w39 ...... Water hemp, Western ...... Amaranthus rudis (Acnida tamariscina). w41 ...... Burrobrush ...... Hymenoclea salsola. w42 ...... Poverty weed ...... Baccharis neglecta. w43 ...... Common sagebrush ...... Artemisia tridentata. w45 ...... Alfalfa ...... Medicago sativa. w46 ...... Dog fennel ...... Eupatorium capillifolium. w53 ...... Geranium ...... Geranium spp. w67 ...... Groundsel bush ...... Baccharis halimifolia. w69 ...... Iodine bush ...... Allenrolfea occidentalis. w70 ...... Ragweed, slender ...... Ambrosia confertiflora. w75 ...... Wing scale (wingscale) ...... Atriplex canescens.

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS—Continued

Source Allergen code Allergen product (taxonomical name)

w82 ...... Careless weed ...... Amaranthus palmeri, Amaranthus hybridus. w90 ...... Japanese hop ...... Humulus japonicas (Humulus scandens). w203 ...... Rape (rape pollen) ...... Brassica napus. w204 ...... Sunflower ...... Helianthus annuus. w206 ...... Camomile ...... Matricaria chamomilla. w207 ...... Lupin ...... Lupinus spp. w210 ...... Sugar-beet ...... Beta vulgaris. w211 ...... Par j 2.0101 ...... Parietaria judaica. w231 ...... Art v 1 ...... Artemisia vulgaris (Mugwort). w232 ...... Sal k 1 ...... Salsola kali. w233 ...... Art v 3 ...... Artemisa vulgaris (LTP, Mugwort). w234 ...... Pla l 1 ...... Plantago lanceolata. w235 ...... Che a 1.0101 ...... Chenopodium album. w236 ...... Mer a 1.0101 ...... Mercurialis annua. a753 ...... Art v 1 ...... Artemisia vulgaris (Mugwort weed).

Tree Pollens

t1 ...... Box-elder (Maple) ...... Acer negundo, Acer saccharum. t2 ...... Gray alder, speckled alder (alder) ...... Alnus incana. t4 ...... Hazel, hazelnut ...... Corylus avellana, Corylus americana. t5 ...... American beech (beech) ...... Fagus grandifolia (Fagus americana). t6 ...... Mountain juniper, Mountain cedar ...... Juniperus ashei (Juniperus sabinoides). t8 ...... Elm ...... Ulmus americana. t9 ...... Olive ...... Olea europaea. t10 ...... Walnut ...... Juglans californica, Juglans nigra. t11 ...... Maple leaf sycamore, London plane, Plane tree ...... Platanus acerifolia. t61 ...... Sycamore ...... Platanus occidentalis. t12 ...... Willow ...... Salix caprea, Salix nigra. t14 ...... Cottonwood (Eastern Cottonwood/Black Cottonwood) ...... Populus deltoides. t15 ...... White ash ...... Fraxinus americana. t16 ...... White pine ...... Pinus strobus. t18 ...... Eucalyptus, gum-tree ...... Eucalyptus globulus (Eucalyptus spp.). t19/t26 ...... Acacia ...... Acacia longifolia (Acacia spp.). t20 ...... Mesquite ...... Prosopis glandulosa/Prosopis juliflora. t21 ...... Melaleuca, cajeput tree ...... Melaleuca quinquenervia (Melaleuca leucadendron). t22 ...... Pecan, hickory ...... Carya illinoinensis (Carya pecan). t23 ...... Italian/Mediterranean/funeral cypress ...... Cupressus sempervirens. t24 ...... Japanese cypress ...... Chamaecyparis obtusa (Chamaecyparis spp.). t25 ...... Ash ...... Fraxinus excelsior. t27 ...... Maple, red ...... Acer rubrum. t29 ...... Acacia ...... Acacia spp. t30 ...... Birch, white ...... Betula populifolia. t32 ...... Willow, black ...... Salix nigra. t33 ...... Ash, Arizona ...... Fraxinus velutina. t35 ...... Cedar, salt ...... Tamarix gallica. t37 ...... Bald cypress (white bald cypress) ...... Taxodium distichum. t38 ...... Elm, Chinese/Siberian ...... Ulmus pumila. t40 ...... Hazelnut tree ...... Corylus americana. t41 ...... White hickory ...... Carya alba (Carya tomentosa). t42 ...... Oak, red ...... Quercus rubra. t43 ...... Loblolly pine ...... Pinus taeda. t44 ...... Hackberry ...... Celtis occidentalis. t45 ...... Cedar elm ...... Ulmus crassifolia. t47 ...... Juniper, one seed ...... Juniperus monosperma. t48 ...... Pine, lodgepole ...... Pinus contorta. t49 ...... Pine, ponderosa ...... Pinus ponderosa. t50 ...... Beech, European ...... Fagus sylvatica. t51 ...... Tree of Heaven ...... Ailanthus altissima. t52 ...... Western white pine ...... Pinus monticola. t54 ...... Russian olive ...... Elaeagnus angustifolia. t55 ...... Scotch broom ...... Cytisus scoparius. t56 ...... Bayberry ...... Myrica cerifera. t57 ...... Red cedar ...... Juniperus virginiana. t60 ...... Western juniper ...... Juniperus occidentalis. t61 ...... Sycamore ...... Platanus occidentalis. t70 ...... Mulberry (white mulberry) ...... Morus alba. t71 ...... Red mulberry ...... Morus rubra. t72 ...... Queen palm ...... Arecastrum romanzoffiamon. t73 ...... Australian pine ...... Casuarina equisetifolia.

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS—Continued

Source Allergen code Allergen product (taxonomical name)

t77 ...... Oak mix (red, white, black) ...... Quercus spp. t80 ...... Japanese cypress ...... Chamaecyparis obtusa. t81 ...... Japanese alder ...... Alnus japonica. t83 ...... Mango tree ...... Mangifera indica. t90 ...... Walnut, black ...... Juglans nigra. t96 ...... Poplar, white (poplar) ...... Populus alba. t103/t218 ...... Virginia live oak (live oak) ...... Quercus virginiana. t105 ...... Pepper tree ...... Schinus molle. t110 ...... Orange tree ...... Citrus sinensis. t201 ...... Spruce, Norway spruce ...... Picea abies (Picea excelsa). t202 ...... Alder, smooth ...... Alnus incana spp. Rugosa (Alnus rugosa). t203 ...... Horse chestnut ...... Aesculus hippocastanum. t205 ...... Elder ...... Sambucus nigra. t206 ...... Chestnut ...... Castanea sativa. t207 ...... Douglas fir ...... Pseudotsuga menziesii (Pseudotsuga taxifolia). t208 ...... Linden ...... Tilia cordata. t209 ...... Horn beam ...... Carpinus betulus. t210 ...... Privet ...... Ligustrum vulgare. t211 ...... Sweet gum ...... Liquidambar styraciflua. t212 ...... Cedar ...... Libocedrus decurrens. t213 ...... Pine ...... Pinus radiata. t214 ...... Date palm ...... Phoenix canariensis. t215 ...... Lilac ...... Syringa vulgaris. t217 ...... Pepper tree ...... Schinus molle. t217 ...... Red alder ...... Alnus rubra. t218 ...... Virginia live oak ...... Quercus virginiana. t218 ...... Bayberry (bayberry/sweet gale) ...... Myrica gale. t219 ...... Palo verde ...... Cercidium floridum. t219 ...... Red cedar ...... Juniperus virginiana. t220 ...... Bet v 4 ...... Betula verrucosa (Birch). t221 ...... Bet v 2.0101, Bet v 4 ...... Betula verrucosa (Birch). t222 ...... Cypress (Arizona cypress) ...... Cupressus arizonica. t223 ...... Oil palm ...... Elaeis guineensis. t224 ...... Ole e 1 ...... Olea europaea. t225 ...... Bet v 6 ...... Betula verrucosa (Birch). t226 ...... Cup a 1 ...... Cupressus arizonica. t227 ...... Ole e 7 ...... Olea Europaea. t228 ...... Aspen, quaking ...... Populus tremuloides. t229 ...... Eastern hemlock ...... Tsuga canadensis. t230 ...... Redwood (sequoia) ...... Sequoia sempervirens. t232 ...... Pussy willow ...... Salix discolor. t240 ...... Ole e 9.0101 ...... Olea Europaea. t241 ...... Pla a 1.0101 ...... Platanus acerifolia. t242 ...... Pla a 2 ...... Platanus acerifolia. t243 ...... Pla a 3.0101 ...... Platanus acerifolia. t244 ...... Cor a 1.0103 ...... Corylus avellana. t245 ...... Aln g 1.0101 ...... Alnus glutinosa. t246 ...... Cry j 1 ...... Cryptomeria japonica. t280 ...... Locust tree ...... Robinia pseudoacacia. t401 ...... Brazilian peppertree ...... Schinus terebinthifolius. t402 ...... Mastic tree ...... Pistacia lentiscus. t404 ...... Tree of heaven ...... Ailanthus altissima. t406 ...... Date palm ...... Phoenix dactylifera. a482 ...... Ole e 1 ...... Olea europaea (Olive Oil).

Mites

d207 ...... Blo t 5.0101 ...... Blomia tropicalis. d208 ...... Lep d 2.0101 ...... Lepidoglyphus destructor.

Microorganisms, Molds, Yeast

m1 ...... Penicillium chrysogenum (Penicillium notatum) ...... Penicillium chrysogenum (Penicillium notatum). m2 ...... Cladosporium herbarum (Hormodendrum) ...... Cladosporium herbarum (Hormodendrum). m3 ...... Aspergillus fumigatus ...... Aspergillus fumigatus. m4 ...... Mucor racemosus ...... Mucor racemosus. m5 ...... Candida albicans ...... Candida albicans. m7 ...... Botrytis cinerea ...... Botrytis cinerea. m8 ...... Drechslera halodes (Setomelanomma rostrata, Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium Helminthosporium halodes. interseminatum).

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS—Continued

Source Allergen code Allergen product (taxonomical name)

m9 ...... Fusarium moniliforme (Fusarium proliferatum) ...... Fusarium moniliforme (Fusarium proliferatum). m10 ...... Stemphylium botryosum ...... Stemphylium herbarum (Stemphylium botryosum). m11 ...... Rhizopus nigricans ...... Rhizopus nigricans. m12 ...... Aureobasidium pullulans ...... Aureobasidium pullulans. m13 ...... Phoma betae ...... Phoma betae. m14 ...... Epicoccum purpurascens ...... Epicoccum purpurascens (Epicoccum nigrum). m15 ...... Trichoderma viride ...... Trichoderma viride. m16 ...... Curvularia lunata ...... Curvularia lunata, Curvularia specifera (K923044). m17 ...... Cladosporium fulvum ...... Cladosporium fulvum. m18 ...... Fusarium culmorum ...... Fusarium culmorum. m19 ...... Aspergillus versicolor ...... Aspergillus versicolor. m20 ...... Mucor mucedo ...... Mucor mucedo. m21 ...... Aspergillus clavatus ...... Aspergillus clavatus. m22 ...... Micropolyspora faeni ...... Saccharopolyspora rectivirgula (Micropolyspora faeni). m23 ...... Thermoactinomyces vulgaris ...... Thermoactinomyces vulgaris. m24 ...... Stachybotrys atra ...... Stachybotrys chartarum (Stachybotrys atra). m24 ...... Paecilomyces spp ...... Paecilomyces spp. m25 ...... Aspergillus versicolor ...... Aspergillus versicolor. m25 ...... Penicillium brevicompactum ...... Penicillium brevicompactum. m26 ...... Cladosporium cladosporioides ...... Cladosporium cladosporioides. m26 ...... Penicillium citrinum ...... Penicillium citrinum. m27 ...... Penicillium spp ...... Penicillium spp. m29 ...... Aspergillus repens ...... Aspergillus repens. m30 ...... Penicillium roqueforti ...... Penicillium roqueforti. m32 ...... Cladosporium cladosporioides ...... Cladosporium cladosporioides. m34 ...... Serpula lacrymans ...... Serpula lacrymans. m36 ...... Aspergillus terreus ...... Aspergillus terreus. m37 ...... Trichophyton mentagrophytes ...... Trichophyton mentagrophytes. m40 ...... Aspergillus amstelodami ...... Aspergillus amstelodami. m43 ...... Saccharomyces Carlsberg ...... Saccharomyces carlsbergensis. m44 ...... Saccharomyces cerevisiae ...... Saccharomyces cerevisiae. m45 ...... Hormodendrum hordei ...... Hormodendrum hordei. m46 ...... Bipolaris spicifera ...... Bipolaris spicifera. m47 ...... Aspergillus nidulans ...... Aspergillus nidulans. m48 ...... Aspergillus oryzae ...... Aspergillus oryzae. m49 ...... Fusarium oxysporum ...... Fusarium oxysporum. m50 ...... Micropolyspora faeni ...... Saccharopolyspora rectivirgula (Micropolyspora faeni). m51 ...... Thermoactinomyces vulgaris ...... Thermoactinomyces vulgaris. m53 ...... Microspora canis ...... Microsporum canis (Microspora canis). m54 ...... Aspergillus flavus ...... Aspergillus flavus. m63 ...... Helminthosporium intersemin ...... Helminthosporium intersemin. m66 ...... Mucor plumbeus ...... Mucor plumbeus. m67 ...... Mycogone ...... Mycogone perniciosa. m68 ...... Nigrospora oryzae ...... Nigrospora oryzae. m69 ...... Rhodotorula ...... Rhodotorula rubra (Rhodotorula mucilaginosa). m70 ...... Malassezia furfur (Pityrosporum orbiculare) ...... Malassezia furfur (Pityrosporum orbiculare). m71 ...... Spondylocladium ...... Spondylocladium spp. m72 ...... Epidermophyton ...... Epidermophyton floccosum. m73 ...... Epicoccum nigrum ...... Epicoccum purpurascens (Epicoccum nigrum). m80 ...... Staphylococcal enterotoxin A (Sta a SEA) ...... Staphylococcus aureus. m80 ...... Helminthosporium spp ...... Helminthosporium spp. m81 ...... Staphylococcal enterotoxin B (Sta a SEB) ...... Staphylococcus aureus. m88 ...... Stemphylium solani ...... Stemphylium solani. m93 ...... Gliocladium fimbriatum ...... Gliocladium fimbriatum. m94 ...... Phycomyces blakesleeanus ...... Phycomyces blakesleeanus. m201 ...... Tilletia tritici (Ustilago nuda, Ustilago tritici) (Barley smut) .... Tilletia tritici (Ustilago nuda, Ustilago tritici). m202 ...... Acremonium kiliense (Cephalosporium acremonium) ...... Acremonium kiliense (Cephalosporium acremonium). m203 ...... Trichosporon pullulans ...... Trichosporon pullulans. m204 ...... Ulocladium chartarum ...... Ulocladium chartarum. m205 ...... Trichophyton rubrum ...... Trichophyton rubrum. m207 ...... Aspergillus niger ...... Aspergillus niger. m208 ...... Chaetomium globosum ...... Chaetomium globosum. m209 ...... Penicillium frequentans ...... Penicillium glabrum (Penicillium frequentans). m209 ...... Stachybotrys chartarum ...... Stachybotrys chartarum (Stachybotrys atra). m210 ...... Trichophyton mentagrophytes var. goetzii ...... Trichophyton mentagrophytes var. goetzii. m211 ...... Trichophyton mentagrophytes var. interdigitale ...... Trichophyton mentagrophytes var. interdigitale. m211 ...... Oat smut ...... Ustilago avenae. m212 ...... Micropolyspora faeni ...... Saccharopolyspora rectivirgula (Micropolyspora faeni). m212 ...... Geotrichum candidum ...... Geotrichum candidum. m213 ...... Bermuda grass smut ...... Ustilago cynodontis.

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS—Continued

Source Allergen code Allergen product (taxonomical name)

m214 ...... Johnson grass smut ...... Sphacelotheca cruenta. m215 ...... Corn smut ...... Ustilago maydis. m218 ...... Asp f 1.0101 ...... Aspergillus fumigatus. a3050 ...... Asp r 1 ...... Aspergillus restrictus. m219 ...... Asp f 2 ...... Aspergillus fumigatus. m220 ...... Asp f 3.0101 ...... Aspergillus fumigatus. m221 ...... Asp f 4 ...... Aspergillus fumigatus. m222 ...... Asp f 6.0101 ...... Aspergillus fumigatus. m223 ...... Staphylococcal enterotoxin C (Sta a SEC) ...... Staphylococcus aureus. m224 ...... Staphylococcal enterotoxin D (Sta a SED) ...... Staphylococcus aureus. m226 ...... Staphylococcal enterotoxin TSST (Sta a TSST) ...... Staphylococcus aureus. m227 ...... Malassezia spp. (Pityrosporum spp.) ...... Malassezia spp. (Pityrosporum spp.). m228 ...... Aspergillus flavus.. m229 ...... Alt a 1.0101 ...... Alternaria alternata (Alternaria tenuis). m230 ...... Alt a 6.0101 ...... Alternaria alternata (Alternaria tenuis). m231 ...... Cla h 8.0101 ...... Cladosporium herbarum (Hormodendrum). m300 ...... Eurotium spp ...... Eurotium spp. m304 ...... Aspergillus oryzae ...... Aspergillus oryzae. m305 ...... Penicillium brevicompactum ...... Penicillium brevicompactum. m309 ...... Aspergillus terreus ...... Aspergillus terreus. m310 ...... Aspergillus nidulans ...... Aspergillus nidulans. m311 ...... Aspergillus flavus ...... Aspergillus flavus. m312 ...... Aspergillus clavatus ...... Aspergillus clavatus.

Epidermal & Animal

e6 ...... Guinea pig epithelium ...... Cavia porcellus. e7 ...... Pigeon droppings ...... Columba palumbus, Columba livia. e25 ...... Chicken serum ...... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e26 ...... Parrot serum ...... Psittacoidea spp. e62 ...... Camel ...... Camelus dromedaries. e70 ...... Goose feathers ...... Anser anser. e71 ...... Mouse epithelium ...... Mus musculus (Mus spp.). e73 ...... Rat epithelium ...... Rattus norvegicus. e74 ...... Rat urine proteins ...... Rattus norvegicus, Rattus rattus. e75 ...... Rat serum proteins ...... Rattus norvegicus, Rattus rattus. e76 ...... Mouse serum proteins ...... Mus musculus (Mus spp.). e77 ...... Budgerigar droppings ...... Melopsittacus undulatus. e78 ...... Budgerigar feathers ...... Melopsittacus undulatus. e79 ...... Budgerigar serum proteins ...... Melopsittacus undulatus. e80 ...... Goat epithelium ...... Capra hircus. e81 ...... Sheep epithelium ...... Ovis aries (Ovis spp.). e82 ...... Rabbit epithelium ...... Oryctolagus cuniculus (Oryctolagus spp.). e83 ...... Swine epithelium ...... Sus scrofa (Sus scrofa domesticus; Sus spp.). e84 ...... Hamster epithelium ...... Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus. e85 ...... Chicken feathers ...... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e86 ...... Duck feathers ...... Anas platyrhynchos. e87 ...... Rat epithelium, serum proteins, and urine proteins ...... Rattus norvegicus Rattus rattus. e88 ...... Mouse epithelium, serum proteins, and urine proteins Mus musculus (Mus spp.). (mouse). e89 ...... Turkey feathers ...... Meleagris gallopavo. e90 ...... Budgerigar serum proteins, feathers, and droppings ...... Melopsittacus undulatus. e91 ...... Pigeon serum proteins, feathers, and droppings ...... Streptopelia roseogrisea, Psittacidae spp. e92 ...... Parrot serum proteins, feathers, and droppings ...... Ara spp. e93 ...... Pigeon serum proteins ...... Streptopelia roseogrisea. e94 ...... Fel d 1.0101 ...... Felis domesticus. a345 ...... Fel d 1 ...... Felis domesticus. e98 ...... Parrot droppings ...... Psittacoidea spp. e101 ...... Can f 1.0101 ...... Canis familiaris (Canis domesticus). a174 ...... Can f 1 ...... Canis familiaris (Canis domesticus). e102 ...... Can f 2.0101 ...... Canis familiaris (Canis domesticus). e196 ...... Parakeet feathers ...... Nymphicus hollandicus. e197 ...... Parakeet droppings ...... Nymphicus hollandicus. e198 ...... Parakeet serum ...... Nymphicus hollandicus. e199 ...... Canary bird serum ...... Serinus canarius. e200 ...... Canary bird droppings ...... Serinus canarius. e201 ...... Canary bird feathers (Canary feathers) ...... Serinus canarius. e202 ...... Reindeer epithelium ...... Rangifer tarandus. e203 ...... Mink epithelium ...... Mustela spp.

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS—Continued

Source Allergen code Allergen product (taxonomical name)

e204 ...... Bos d 6 ...... Bos domesticus (Bos taurus; Bos spp.). e205 ...... Horse, serum proteins ...... Equus caballus (Equus spp.). e206 ...... Rabbit, serum proteins ...... Oryctolagus cuniculus (Oryctolagus spp.). e208 ...... Chinchilla epithelium ...... Chinchilla laniger. e209 ...... Gerbil epithelium ...... Meriones unguiculatus. e210 ...... Fox epithelium ...... Vulpes vulpes. e211 ...... Rabbit, urine proteins ...... Oryctolagus cuniculus (Oryctolagus spp.). e212 ...... Swine, urine proteins ...... Sus scrofa (Sus scrofa domesticus; Sus spp.). e213 ...... Parrot feathers ...... Ara spp. e214 ...... Finch feathers ...... Lonchura domestica. e215 ...... Pigeon feathers ...... Streptopelia roseogrisea (Streptopelia spp.), Columbia spp. e216 ...... Deer epithelium ...... Dama dama. e217 ...... Ferret epithelium ...... Mustela putorius. e218 ...... Chicken droppings ...... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e219 ...... Chicken, serum proteins ...... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e220 ...... Fel d 2, Cat serum albumin ...... Felis domesticus. e221 ...... Can f 3 ...... Canis familiaris (Canis domesticus) (Dog serum albumin). e222 ...... Swine serum albumin (Sus s PSA) ...... Sus scrofa (Sus scrofa domesticus; Sus spp.). e225 ...... Lovebird feathers ...... Psittacoidea agapomis. e226 ...... Can f 5.0101 ...... Canis familiaris. e227 ...... Equ c 1.0101 ...... Equus caballus. e228 ...... Fel d 4.0101 ...... Felis domesticus. e230 ...... Equ c 3 ...... Equus caballus. e231 ...... Mus m 1 ...... Mus musculus.

Food

f9 ...... Rice ...... Oryza sativa. f12 ...... Pea (green pea) ...... Pisum sativum. f15 ...... White bean ...... Phaseolus vulgaris. f19 ...... Cayenne pepper ...... Capsicum frutescens (Capsicum annum). f21 ...... Sugar cane ...... Saccharum officinarum. f22 ...... Raspberry ...... Rubus idaeus. f26 ...... Pork ...... Sus scrofa (Sus scrofa domesticus; Sus spp.). f29 ...... Watermelon ...... Citrullus lanatus (Citrullus vulgaris). f31 ...... Carrot ...... Daucus carota. f32 ...... Oyster mushroom ...... Pleurotus ostreatus. f33 ...... Orange ...... Citrus sinensis. f35 ...... Potato ...... Solanum tuberosum. f43 ...... Mother’s milk ...... Homo sapiens. f44 ...... Strawberry ...... Fragaria vesca (Fragaria spp.). f45 ...... Yeast, baker’s ...... Saccharomyces cerevisiae. f46 ...... Pepper, Red ...... Capsicum annuum. f47 ...... Garlic ...... Allium sativum. f48 ...... Onion ...... Allium cepa. f49 ...... Apple ...... Malus x domestica (Malus spp.). f51 ...... Bamboo shoot ...... Phyllostachys pubescens. f52 ...... Cacao/chocolate ...... Theobroma cacao. f54 ...... Sweet potato ...... Ipomoea batatas. f55 ...... Common millet ...... Panicum miliaceum. f56 ...... Foxtail millet ...... Setaria italica. f57 ...... Japanese millet ...... Echinochloa crus-galli. f58 ...... Pacific squid ...... Todarodes pacificus. f59 ...... Octopus ...... Octopus vulgaris (Octopus spp.). f63 ...... Kefir ...... NA. f67 ...... Parmesan cheese ...... NA. f81 ...... Cheese, cheddar type ...... NA. f82 ...... Cheese, mold type ...... NA. f83 ...... Chicken ...... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). f86 ...... Parsley ...... Petroselinum crispum. f87 ...... Melon ...... Cucumis melo Cucumis melo + Citrullus lanatus. f88 ...... Mutton (lamb) ...... Ovis aries (Ovis spp.). f90 ...... Malt ...... Hordeum vulgare. f92 ...... Banana ...... Musa spp. f93 ...... Cacao ...... Theobroma cacao. f94 ...... Pear ...... Pyrus communis (Pyrus spp.). f97 ...... Yam ...... Dioscorea spp. Dioscorea opposita. f97 ...... Chamomile tea ...... Matricaria chamomilla. f98 ...... Gliadin ...... Triticum aestivum (Triticum spp.). f102 ...... Cantaloupe ...... Cucumis melo var. cantalupensis.

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS—Continued

Source Allergen code Allergen product (taxonomical name)

f105 ...... Chocolate ...... Theobroma cacao. f109 ...... Cottonseed ...... Gossypium hirsutum. f110 ...... Giant radish ...... Raphanus sativus. f118 ...... Zucchini ...... Cucurbita pepo. f119 ...... Radish ...... Raphanus sativus. f120 ...... Venison ...... Capreolus capeolus. f121 ...... Pinto bean ...... Phaseolus vulgaris. f122 ...... Cheese, American ...... NA. f127 ...... Black-eyed pea ...... Vigna unguiculata. f131 ...... Black Olive ...... Olea europaea. f136 ...... Red beet ...... Beta vulgaris var. conditiva. f139 ...... Goat’s Cheese ...... Capra aegagrus. f140 ...... Bran ...... NA. f141 ...... Corn (vegetables) ...... Zea mays. f152 ...... Green bell pepper ...... Capsicum annuum. f155 ...... Brewer’s yeast ...... Saccharomyces carlsbergensis. f157 ...... Duck ...... Anas domesticus. f158 ...... Goose ...... Anser anser. f160 ...... Camembert cheese ...... NA. f162 ...... Nectarine ...... Prunus persica var. nucipersica. f163 ...... Kohlrabi ...... Brassica oleracea var. gongylodes. f65 ...... Perch. f166 ...... Leek ...... Allium porrum. f170 ...... Cheese (Switzerland) (Swiss cheese) ...... NA. f174 ...... Fig ...... Ficus carica. f177 ...... Cranberry ...... Vaccinium macrocarpon. f179 ...... Raisin ...... Vitis spp. f182 ...... Lima bean ...... Phaseolus lunatus. f198 ...... Flaxseed (bruised grain) ...... Linum usitatissimum. f199 ...... Untreated native milk ...... Bos domesticus (Bos taurus; Bos spp.). f208 ...... Lemon ...... Citrus limon. f209 ...... Grapefruit ...... Citrus paradisi. f210 ...... Pineapple ...... Ananas comosus. f211 ...... Blackberry ...... Rubus fruticosus. f212 ...... Mushroom (champignon) ...... Agaricus hortensis (Agaricus spp.). f213 ...... Rabbit ...... Oryctolagus cuniculus (Oryctolagus spp.). f214 ...... Spinach ...... Spinacia oleracea. f215 ...... Lettuce ...... Lactuca sativa. f216 ...... Cabbage ...... Brassica oleracea var. capitata. f217 ...... Brussels sprouts ...... Brassica oleracea var. gem. f218 ...... Paprika, sweet pepper ...... Capsicum annuum. f219 ...... Fennel seed ...... Foeniculum vulgare. f219 ...... Sage ...... Salvia officinalis. f220 ...... Cinnamon ...... Cinnamomum spp. f221 ...... Coffee ...... Coffea spp. f222 ...... Tea ...... Camellia sinensis. f223 ...... Green olive ...... Olea europaea. f225 ...... Summer squash, pumpkin ...... Cucurbita pepo. f225 ...... Pumpkin ...... Cucurbita maxima. f226 ...... Pumpkin seed ...... Cucurbita pepo. f227 ...... Sugar-beet seed ...... Beta vulgaris. f229 ...... Safflower Seed ...... Carthamus tinctorius. f231 ...... Milk, boiled ...... Bos domesticus (Bos taurus; Bos spp.). f234 ...... Vanilla ...... Vanilla planifolia. f237 ...... Apricot ...... Prunus armeniaca. f241 ...... Gouda cheese ...... NA. f242 ...... Cherry ...... Prunus avium. f244 ...... Cucumber ...... Cucumis sativus. f246 ...... Guar, guar gum ...... Cyamopsis tetragonoloba. f247 ...... Honey ...... NA. f248 ...... Rosemary ...... Rosmarinus officinalis. f254 ...... Plaice ...... Pleuronectes platessa. f255 ...... Plum ...... Prunus domestica, Prunus americana. f258 ...... Squid ...... Loligo spp. f259 ...... Grape ...... Vitis vinifera (Vitis spp.). f260 ...... Broccoli ...... Brassica oleracea var. italica (Brassica oleracea var. cultivar). f261 ...... Asparagus ...... Asparagus officinalis. f262 ...... Aubergine, eggplant ...... Solanum melongena. f263 ...... Green pepper ...... Piper nigrum, Capsicum annuum.

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS—Continued

Source Allergen code Allergen product (taxonomical name)

f264 ...... Eel ...... Anguilla anguilla. f265 ...... Caraway ...... Carum carvi. f265 ...... Cumin ...... Cuminum cyminum. f266 ...... Mace ...... Myristica fragrans. f267 ...... Cardamon ...... Elettaria cardamomum. f268 ...... Clove ...... Syzygium aromaticum. f269 ...... Basil ...... Ocimum basilicum. f270 ...... Ginger ...... Zingiber officinale. f271 ...... Anise ...... Pimpinella anisum. f272 ...... Tarragon ...... Artemisia dracunculus. f273 ...... Thyme ...... Thymus vulgaris. f274 ...... Marjoram ...... Origanum majorana. f275 ...... Lovage ...... Levisticum officinale. f276 ...... Fennel, fresh ...... Foeniculum vulgare. f277 ...... Dill ...... Anethum graveolens. f278 ...... Bay leaf ...... Laurus nobilis. f279 ...... Chili pepper ...... Capsicum frutescens. f280 ...... Black pepper ...... Piper nigrum. f281 ...... Curry (Santa Maria) ...... NA. f282 ...... Nutmeg ...... Myristica fragrans. f283 ...... Oregano ...... Origanum vulgare. f284 ...... Turkey meat ...... Meleagris gallopavo. f285 ...... Elk/moose meat ...... Alces spp. f286 ...... Mare’s milk ...... Equus caballus (Equus spp.). f287 ...... Red kidney bean ...... Phaseolus vulgaris. f288 ...... Blueberry ...... Vaccinium myrtillus (Vaccinium spp.). f289 ...... Date ...... Phoenix dactylifera. f291 ...... Cauliflower ...... Brassica oleracea var. botrytis. f292 ...... Guava ...... Psidium guajava. f293 ...... Papaya ...... Carica papaya. f294 ...... Passion fruit, Maracuja ...... Passiflora edulis (Passiflora spp.). f295 ...... Carambola ...... Averrhoa carambola. f296 ...... Carob ...... Ceratonia siliqua. f297 ...... Gum Arabic ...... Acacia senegal (Acacia spp.). f298 ...... Tragacanth ...... Astragalus spp. f299 ...... Sweet chestnut (chestnut) ...... Castanea sativa. f300 ...... Pinto bean ...... Phaseolus spp. f301 ...... Persimmon (kaki fruit, sharon) ...... Diospyros kaki. f302 ...... Mandarin (tangerine, clementine, satsumas) ...... Citrus reticulata. f305 ...... Fenugreek ...... Trigonella foenum-graecum. f306 ...... Lime ...... Citrus aurantifolia. f307 ...... Hake ...... Merluccius merluccius. f308 ...... Sardine (pilchard) ...... Sardina pilchardus. f310 ...... Blue vetch ...... Lathyrus sativus. f311 ...... Megrim ...... Lepidorhombus whiffiagonis. f315 ...... Green bean ...... Phaseolus vulgaris. f316 ...... Rape seed ...... Brassica napus. f317 ...... Coriander ...... Coriandrum sativum. f318 ...... Jack fruit ...... Artocarpus heterophyllus. f319 ...... Beetroot ...... Beta vulgaris. f320 ...... Crayfish ...... Astacus astacus. f321 ...... Horse meat ...... Equus caballus (Equus spp.). f322 ...... Red currant ...... Ribes sylvestre. f324 ...... Hop (fruit cone) ...... Humulus lupulus. f325 ...... Saffron ...... Colchicum autumnale. f328 ...... Fig ...... Ficus carica. f329 ...... Watermelon ...... Citrullus lanatus. f330 ...... Rose hip ...... Rosa spp. f331 ...... Saffron ...... Crocus sativus. f332 ...... Mint ...... Mentha piperita. f333 ...... Linseed ...... Linum usitatissimum. f336 ...... Jujube ...... Ziziphus jujuba. f336 ...... Wine vinegar ...... Vitis vinifera (Vitis spp.). f337 ...... Sole ...... Solea solea. f337 ...... English sole ...... Parophrys vetulus. f338 ...... Wine, white ...... Vitis vinifera (Vitis spp.). f339 ...... Allspice ...... Pimenta dioica. f339 ...... Wine, red ...... Vitis vinifera (Vitis spp.). f341 ...... Cranberry ...... Vaccinium oxycoccus, Vaccinium macrocarpon. f342 ...... Olive (black, fresh) ...... Olea europaea.

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS—Continued

Source Allergen code Allergen product (taxonomical name)

f343 ...... Raspberry ...... Rubus idaeus. f344 ...... Sage ...... Salvia officinalis. f346 ...... Chives ...... Allium schoenoprasum. f347 ...... Quinoa ...... Chenopodium quinoa. f348 ...... Litchi ...... Litchi chinensis. f349 ...... Chum salmon roe ...... Oncorhynchus keta. f358 ...... Artichoke ...... Cynara scolymus. f360 ...... Yogurt ...... NA. f368 ...... Black bass ...... Micropterus dolomieu (Micropterus dolomieui). f374 ...... Karaya gum ...... Sterculia urens. f375 ...... Horseradish ...... Armoracia rusticana. f377 ...... Maple syrup ...... NA. f379 ...... Okra ...... Abelmoschus esculentus. f382 ...... Beet, sugar ...... Beta vulgaris var. altissima. f401 ...... Loquat ...... Eriobotrya japonica. f402 ...... Fig ...... Ficus carica. f403 ...... Brewer’s yeast ...... Saccharomyces cerevisiae. f405 ...... Mint ...... Mentha spp. f406 ...... Arugula ...... Eruca vesicaria.

House Dust

h1 ...... Greer Labs., Inc ...... NA. h2 ...... Hollister-Stier Labs ...... NA. h6 ...... Japan ...... NA.

Venoms & Insects

i7 ...... Midge ...... Chironomus yoshimatsui. i8 ...... Moth ...... Bombyx mori, Heterocera spp. i47 ...... Water flea ...... Daphnia spp. i49 ...... Deer fly ...... Chrysops spp. i51 ...... Black ant ...... Camponotus pennsylvanicus. i54 ...... Flea mix (dog/cat), common flea ...... Ctenocephalides spp. i71 ...... Mosquito ...... Aedes communis, Aedes spp. and Culex spp. i72 ...... Green nimitti ...... Cladotanytarsus lewisi. i73 ...... Blood worm ...... Chironomus thummi, Chironomusri parius, Chironomus spp. i75 ...... European hornet ...... Vespa crabro. i76 ...... Berlin beetle ...... Trogoderma angustum. i77 ...... European paper wasp ...... Polistes dominulus. i78 ...... Fly ...... Musca domestica. i80 ...... Bumblebee ...... Bombus pennsylvanicus. i201 ...... Horse bot fly ...... Gasterophilus intestinalis. i202 ...... Grain weevil ...... Sitophilus granarius. i203 ...... Mediterranean flour moth ...... Ephestia kuehniella (Anagasta kuehniella). i204 ...... Horse fly ...... Tabanus spp. i205 ...... Bumblebee ...... Bombus terrestris. i208 ...... Api m 1.0101 ...... Apis mellifera. a45 ...... Api m 1 ...... Apis mellifera. i209 ...... Ves v 5.0101 ...... Vespula vulgaris. a670 ...... Ves v 5 ...... Vespula vulgaris. i210 ...... Pol d 5.0101 ...... Polistes dominulus. i211 ...... Ves v 1.0101 ...... Vespula vulgaris. i213 ...... Api m 4 ...... Apis mellifera. i214 ...... Api m 2 ...... Apis mellifera. i215 ...... Api m 3 ...... Apis mellifera. i216 ...... Api m 5 ...... Apis mellifera. i217 ...... Api m 10 ...... Apis mellifera. i220 ...... Bla g 1.0101 ...... Blattella germanica. i221 ...... Bla g 2.0101 ...... Blattella germanica. i222 ...... Bla g 5.0101 ...... Blattella germanica. i223 ...... Bla g 7 ...... Blattella germanica. a46 ...... Api m 2 ...... Apis mellifera.

Miscellaneous

o1 ...... Cotton, crude fibers ...... Gossypium spp. o3 ...... Cotton (treated) ...... Gossypium spp. o70 ...... Seminal fluid ...... Homo sapiens. o71 ...... Staphylococcus aureus ...... Staphylococcus aureus.

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS—Continued

Source Allergen code Allergen product (taxonomical name)

o72 ...... Pichia pastoris crude extract customer specific ...... Pichia pastoris. o72 ...... Sperm-sediment ...... Homo sapiens. o73 ...... Pichia pastoris crude extr. vector customer specific ...... Pichia pastoris. o74 ...... Pichia pastoris with vector customer specific ...... Pichia pastoris. o201 ...... Tobacco leaf, tobacco dust ...... Nicotiana tabacum. o202 ...... Artemia salina, fish feed ...... Artemia salina. o203 ...... Tetramin, fish feed ...... NA. o207 ...... Daphnia, fish feed ...... Daphnia spp. o211 ...... Mealworm ...... Tenebrio molitor. o212 ...... Streptavidin ...... Streptomyces avidini. o213 ...... MBP (maltose binding protein) ...... Escherichia coli. o214 ...... CCD; MUXF3 from bromelain ...... Ananas comosus. o72 ...... Enterotoxin A (Sta a SEA) ...... Staphylococcus aureus. o73 ...... Enterotoxin B (Sta a SEB) ...... Staphylococcus aureus.

Parasites

p1 ...... Ascaris ...... Ascaris suum. p2 ...... Echinococcus ...... Echinococcus granulosus. p3 ...... Schistosoma ...... Schistosoma mansoni. p4 ...... Anisakis (Herring Worm) ...... Anisakis simplex (Anisakis spp.). p5 ...... Toxocara canis ...... Toxocara canis. p10 ...... Ani s 3.0101 ...... Anisakis simplex (Anisakis spp.). p11 ...... Ani s 1 ...... Anisakis simplex (Anisakis spp.).

Occupational

k4 ...... Threshing dust ...... NA. k5 ...... Flax ...... NA. k7 ...... Hay Dust ...... NA. k8 ...... Hop (hops) ...... Humulus lupulus. k12 ...... Grain mill dust ...... NA. k14 ...... Kapok ...... NA. k20 ...... Sheep’s wool (treated) (wool) ...... Ovis aries (Ovis spp.). k21 ...... Sheep’s wool (Untreated) ...... Ovis aries (Ovis spp.). k23 ...... Straw Dust ...... NA. k33 ...... Oak ...... NA. k70 ...... Green coffee bean ...... Coffea spp. k71 ...... Castor bean ...... Ricinus communis. k72 ...... Ispaghula ...... Plantago psyllium/Plantago ovata. k73 ...... Silk waste ...... NA. k74 ...... Silk ...... Bombyx mori. k75 ...... Isocyanate TDI (Toluene diisocyanate) ...... NA. k76 ...... Isocyanate MDI (Diphenylmethane diisocyanate) ...... NA. k77 ...... Isocyanate HDI (Hexamethylen diisocyanate) ...... NA. k78 ...... Ethylene oxide ...... NA. k79 ...... Phthalic anhydride ...... NA. k80 ...... Formaldehyde/Formalin ...... NA. k81 ...... Ficus ...... Ficus benjamina (Ficus spp.). k83 ...... Cotton seed ...... Gossypium hirsutum. k84 ...... Sunflower seed ...... Helianthus annuus. k85 ...... Chloramin T ...... NA. k86 ...... Trimellitic anhydride, TMA ...... NA. k87 ...... Asp o 21, alpha-amylase ...... Aspergillus oryzae. k89 ...... Orris root ...... Iris florentina. k99 ...... HSA (Human Serum Albumin) (Hom s HSA) ...... Homo sapiens. k201 ...... Car p 1, Papain ...... Carica papaya. k202 ...... Ana c 2, Bromelain ...... Ananas comosus. k204 ...... Maxatase ...... Bacillus licheniformis. k205 ...... Alcalase ...... Bacillus spp. k206 ...... Savinase, Protease 1 (Bac l Subtilisin) ...... Bacillus spp. k208 ...... Gal d 4, Lysozyme ...... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). k209 ...... Hexahydrophtalic anhydrid ...... NA. k210 ...... Maleic anhydride ...... NA. k211 ...... Methyltetrahydrophtalic anhydrid ...... NA. k212 ...... Abachi wood dust ...... Triplochiton scleroxylon. k213 ...... Pepsin (Sus s Pepsin) ...... Sus scrofa (Sus scrofa domesticus; Sus spp.). k213 ...... TCPA ...... NA. k214 ...... Bougainvillea ...... Bougainvillea spp. k225 ...... Horse radish peroxidase (Arm r HRP) ...... Armoracia rusticana.

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TABLE 1—CLASS II EXEMPT ALLERGENS UNDER § 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS—Continued

Source Allergen code Allergen product (taxonomical name)

k226 ...... Ascorbate oxidase (Cuc p ascorbate oxidase) ...... Cucurbita pepo. k301 ...... Flour dust ...... Triticum spp. k501 ...... Savinase customer specific ...... Proprietary knowledge of customer. k502 ...... Lipolase customer specific ...... Proprietary knowledge of customer. k503 ...... Termamyl customer specific ...... Proprietary knowledge of customer. k504 ...... Clazinase customer specific ...... Proprietary knowledge of customer.

■ 66. In § 866.5910, revise paragraph (b) Analyzer.’’ See § 868.1(e) for the Authority: 21 U.S.C. 351, 360, 360c, 360e, to read as follows: availability of this guidance document. 360j, 360l, 371. ■ ■ § 866.5910 Quality control material for 70. In § 868.2500, revise paragraph (b) 75. In § 870.1330, revise paragraph (b) cystic fibrosis nucleic acid assays. to read as follows: to read as follows: * * * * * § 868.2500 Cutaneous oxygen (PcO2) § 870.1330 Catheter guide wire. (b) Classification. Class II (special monitor. * * * * * controls). The device is exempt from the * * * * * (b) Classification. Class II (special premarket notification procedures in (b) Classification. Class II (special controls). The device, when it is a subpart E of part 807 of this chapter controls). The device is exempt from the torque device that is manually operated, subject to the limitations in § 866.9. The premarket notification procedures in non-patient contacting, and intended to special control is FDA’s guidance subpart E of part 807 of this chapter manipulate non-cerebral vascular guide document entitled ‘‘Class II Special subject to the limitations in § 868.9. The wires, is exempt from the premarket Controls Guidance Document: Quality special control is FDA’s ‘‘Class II notification procedures in subpart E of Control Material for Cystic Fibrosis Special Controls Guidance Document: part 807 of this chapter subject to the Nucleic Acid Assays.’’ See § 866.1(e) for Cutaneous Carbon Dioxide (PcCO2) and limitations in § 870.9. the availability of this guidance Oxygen (PcO2) Monitors; Guidance for document. ■ 76. In § 870.1390, revise paragraph (b) Industry and FDA.’’ See § 868.1(e) for to read as follows: the availability of this guidance PART 868—ANESTHESIOLOGY document. § 870.1390 Trocar. DEVICES ■ 71. In § 868.2550, revise paragraph (b) * * * * * ■ 67. The authority citation for part 868 to read as follows: (b) Classification. Class II (special continues to read as follows: controls). Except for trocars that are § 868.2550 Pneumotachometer. reprocessed for multiple use, the device Authority: 21 U.S.C. 351, 360, 360c, 360e, * * * * * 360j, 360l, 371. is exempt from the premarket (b) Classification. Class II (special notification procedures in subpart E of ■ 68. In § 868.1040, revise paragraph (b) controls). The device is exempt from the part 807 of this chapter subject to the to read as follows: premarket notification procedures in limitations in § 870.9. § 868.1040 Powered algesimeter. subpart E of part 807 of this chapter ■ subject to the limitations in § 868.9. 77. In § 870.1650, revise paragraph (b) * * * * * ■ to read as follows: (b) Classification. Class II (special 72. In § 868.5180, revise paragraph (b) controls). The device is exempt from the to read as follows: § 870.1650 Angiographic injector and syringe. premarket notification procedures in § 868.5180 Rocking bed. * * * * * subpart E of part 807 of this chapter * * * * * subject to the limitations in § 868.9. (b) Classification. Class II (special (b) Classification. Class II (special controls). The device, when it is a non- ■ 69. In § 868.2385, revise paragraph (b) controls). The device is exempt from the to read as follows: patient contacting balloon inflation premarket notification procedures in syringe intended only to inflate/deflate § 868.2385 Nitrogen dioxide analyzer. subpart E of part 807 of this chapter balloon catheters and monitor pressure subject to the limitations in § 868.9. * * * * * within the balloon, is exempt from the (b) Classification. Class II (special ■ 73. In § 868.6250, revise paragraph (b) premarket notification procedures in controls). The device, when it is a to read as follows: subpart E of part 807 of this chapter standalone nitrogen dioxide analyzer § 868.6250 Portable air compressor. subject to the limitations in § 870.9. and not those that are components of ■ * * * * * 78. In § 870.1875, revise paragraph nitric oxide delivery systems intended (b) Classification. Class II (special (b)(2) to read as follows: to monitor nitrogen dioxide levels controls). The device is exempt from the during inhaled nitric oxide therapy, is § 870.1875 Stethoscope. premarket notification procedures in exempt from the premarket notification * * * * * subpart E of part 807 of this chapter procedures in subpart E of part 807 of (b) * * * subject to the limitations in § 868.9. this chapter subject to the limitations in (2) Classification. Class II (special § 868.9. The special control is FDA’s PART 870—CARDIOVASCULAR controls). The device, when it is a lung ‘‘Guidance Document for Premarket DEVICES sound monitor, is exempt from the Notification Submissions for Nitric premarket notification procedures in Oxide Administration Apparatus, Nitric ■ 74. The authority citation for part 870 subpart E of part 807 of this chapter Oxide Analyzer, and Nitrogen Dioxide continues to read as follows: subject to the limitations in § 870.9.

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■ 79. In § 870.2675, revise paragraph (b) blood filters, is exempt from the § 872.3540 OTC denture cushion or pad. to read as follows: premarket notification procedures in * * * * * subpart E of part 807 of this chapter (b) * * * § 870.2675 Oscillometer. subject to the limitations in § 870.9. (2) Class II (special controls) if the * * * * * ■ 85. In § 870.4420, revise paragraph (b) OTC denture cushion or pad is made of (b) Classification. Class II (special to read as follows: a material other than wax-impregnated controls). The device is exempt from the cotton cloth or if the intended use of the premarket notification procedures in § 870.4420 Cardiopulmonary bypass device differs from that described in subpart E of part 807 of this chapter cardiotomy return sucker. paragraph (b)(1) of this section. The subject to the limitations in § 870.9. * * * * * device is exempt from the premarket ■ 80. In § 870.2770, revise paragraph (b) (b) Classification. Class II (special notification procedures in subpart E of to read as follows: controls). The device is exempt from the part 807 of this chapter subject to the premarket notification procedures in limitations in § 872.9. The special § 870.2770 Impedance plethysmograph. subpart E of part 807 of this chapter controls for this device are FDA’s: * * * * * subject to the limitations in § 870.9. * * * * * (b) Classification. Class II (special ■ 86. In § 870.4430, revise paragraph (b) ■ 92. In § 872.3560, revise paragraph (b) controls). The device, when it is a body to read as follows: composition analyzer which is not introductory text to read as follows: § 870.4430 Cardiopulmonary bypass intended to diagnose or treat any § 872.3560 OTC denture reliner. intracardiac suction control. medical condition, is exempt from the * * * * * premarket notification procedures in * * * * * (b) Classification. Class II (special (b) Classification. Class II (special subpart E of part 807 of this chapter controls). The device is exempt from the subject to the limitations in § 870.9. controls). The device is exempt from the premarket notification procedures in premarket notification procedures in ■ 81. In § 870.4280, revise paragraph (b) subpart E of part 807 of this chapter to read as follows: subpart E of part 807 of this chapter subject to the limitations in § 870.9. subject to the limitations in § 872.9. The § 870.4280 Cardiopulmonary prebypass special controls for this device are filter. PART 872—DENTAL DEVICES FDA’s: * * * * * * * * * * ■ 87. The authority citation for part 872 (b) Classification. Class II (special ■ 93. In § 872.3590, revise paragraph (b) continues to read as follows: controls). The device is exempt from the to read as follows: premarket notification procedures in Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. § 872.3590 Preformed plastic denture subpart E of part 807 of this chapter tooth. subject to the limitations in § 870.9. ■ 88. In § 872.1720, revise paragraph (b) * * * * * ■ to read as follows: 82. In § 870.4290, revise paragraph (b) (b) Classification. Class II (special to read as follows: § 872.1720 Pulp tester. controls). The device is exempt from the § 870.4290 Cardiopulmonary bypass * * * * * premarket notification procedures in adaptor, stopcock, manifold, or fitting. (b) Classification. Class II (special subpart E of part 807 of this chapter * * * * * controls). The device is exempt from the subject to the limitations in § 872.9. (b) Classification. Class II (special premarket notification procedures in ■ 94. In § 872.3600, revise paragraph (b) controls). The device is exempt from the subpart E of part 807 of this chapter introductory text to read as follows: premarket notification procedures in subject to the limitations in § 872.9. § 872.3600 Partially fabricated denture kit. subpart E of part 807 of this chapter ■ 89. In § 872.3260, revise paragraph (b) subject to the limitations in § 870.9. to read as follows: * * * * * (b) Classification. Class II (special ■ 83. In § 870.4340, revise paragraph (b) § 872.3260 Cavity varnish. controls). The device is exempt from the to read as follows: * * * * * premarket notification procedures in § 870.4340 Cardiopulmonary bypass level (b) Classification. Class II (special subpart E of part 807 of this chapter sensing monitor and/or control. controls). The device, when it is an subject to the limitations in § 872.9. The * * * * * external cleaning solution, is exempt special controls for this device are (b) Classification. Class II (special from the premarket notification FDA’s: controls). The device is exempt from the procedures in subpart E of part 807 of * * * * * premarket notification procedures in this chapter subject to the limitations in ■ 95. In § 872.3890, revise paragraph (b) subpart E of part 807 of this chapter § 872.9. to read as follows: subject to the limitations in § 870.9. ■ 90. In § 872.3300, revise paragraph (b) ■ 84. In § 870.4400, revise paragraph (b) to read as follows: § 872.3890 Endodontic stabilizing splint. to read as follows: * * * * * § 872.3300 Hydrophilic resin coating for (b) Classification. Class II (special § 870.4400 Cardiopulmonary bypass blood dentures. controls). The device is exempt from the reservoir. * * * * * premarket notification procedures in * * * * * (b) Classification. Class II (special subpart E of part 807 of this chapter (b) Classification. Class II (special controls). The device is exempt from the subject to the limitations in § 872.9. controls), except that a reservoir that premarket notification procedures in ■ 96. In § 872.5550, revise paragraph contains a defoamer or filter is classified subpart E of part 807 of this chapter (b)(2) to read as follows: into the same class as the defoamer or subject to the limitations in § 872.9. filter. The device, when it is a ■ 91. In § 872.3540, revise paragraph § 872.5550 Teething ring. cardiopulmonary bypass blood reservoir (b)(2) introductory text to read as * * * * * that does not contain defoamers or follows: (b) * * *

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(2) Class II (special controls) if the subpart E of part 807 of this chapter for single use; a diagnostic incandescent teething ring contains a fluid, such as subject to the limitations in § 874.9. light source; a fiberoptic photographic water. The device is exempt from the ■ 103. In § 874.3320, revise paragraph light source; a routine fiberoptic light premarket notification procedures in (b) to read as follows: source; an endoscopic sponge carrier; a subpart E of part 807 of this chapter xenon arc endoscope light source; an subject to the limitations in § 872.9. § 874.3320 Group hearing aid or group endoscope transformer; an LED light auditory trainer. ■ 97. In § 872.6770, revise paragraph (b) source; or a gastroenterology-urology to read as follows: * * * * * endoscopic guidewire, is exempt from (b) Classification. Class II (special the premarket notification procedures in § 872.6770 Cartridge syringe. controls). The device is exempt from the subpart E of part 807 of this chapter * * * * * premarket notification procedures in subject to the limitations in § 876.9. (b) Classification. Class II (special subpart E of part 807 of this chapter * * * * * subject to the limitations in § 874.9. controls). The device is exempt from the ■ ■ 109. In § 876.4020, revise paragraph premarket notification procedures in 104. In § 874.3330, revise paragraph (b) to read as follows: subpart E of part 807 of this chapter (b) to read as follows: subject to the limitations in § 872.9. § 876.4020 Fiberoptic light ureteral § 874.3330 Master hearing aid. catheter. PART 874—EAR, NOSE, AND THROAT * * * * * * * * * * DEVICES (b) Classification. Class II (special (b) Classification. Class II (special controls). The device is exempt from the controls). The device is exempt from the ■ 98. The authority citation for part 874 premarket notification procedures in premarket notification procedures in continues to read as follows: subpart E of part 807 of this chapter subpart E of part 807 of this chapter Authority: 21 U.S.C. 351, 360, 360c, 360e, subject to the limitations in § 874.9. subject to the limitations in § 876.9. ■ 360j, 360l, 371. 105. In § 874.3430, revise paragraph ■ 110. In § 876.4270, revise paragraph (b) to read as follows: ■ 99. In § 874.1090, revise paragraph (b) (b) to read as follows: § 874.3430 Middle ear mold. to read as follows: § 876.4270 Colostomy rod. § 874.1090 Auditory impedance tester. * * * * * * * * * * (b) Classification. Class II (special (b) Classification. Class II (special * * * * * controls). The device is exempt from the controls). The device is exempt from the (b) Classification. Class II (special premarket notification procedures in premarket notification procedures in controls). The device, when it is a subpart E of part 807 of this chapter subpart E of part 807 of this chapter tympanometer or auditory impedance subject to the limitations in § 874.9. tester that complies with FDA- subject to the limitations in § 876.9. ■ 106. In § 874.3730, revise paragraph recognized consensus standard ANSI ■ 111. In § 876.4400, revise paragraph (b) to read as follows: S3.39, is exempt from the premarket (b) to read as follows: notification procedures in subpart E of § 874.3730 Laryngeal prosthesis (Taub § 876.4400 Hemorrhoidal ligator. part 807 of this chapter subject to the design). limitations in § 874.9. * * * * * * * * * * ■ 100. In § 874.1120, revise paragraph (b) Classification. Class II (special (b) Classification. Class II (special (b) to read as follows: controls). The device, when it is a voice controls). Except for a hemostatic metal amplification device, is exempt from the clip intended for use in the § 874.1120 Electronic noise generator for premarket notification procedures in gastrointestinal tract, the device is audiometric testing. subpart E of part 807 of this chapter exempt from the premarket notification * * * * * subject to the limitations in § 874.9. procedures in subpart E of part 807 of (b) Classification. Class II (special this chapter subject to the limitations in controls). The device is exempt from the PART 876—GASTROENTEROLOGY– § 876.9. premarket notification procedures in UROLOGY DEVICES ■ 112. In § 876.4500, revise paragraph subpart E of part 807 of this chapter (b) to read as follows: subject to the limitations in § 874.9. ■ 107. The authority citation for part § 876.4500 Mechanical lithotriptor. ■ 101. In § 874.1325, revise paragraph 876 continues to read as follows: (b) to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, * * * * * 360j, 360l, 371. (b) Classification. Class II (special § 874.1325 Electroglottograph. ■ 108. In § 876.1500, revise paragraph controls). The device, when it is a * * * * * (b)(1) to read as follows: biliary mechanical lithotripter, is (b) Classification. Class II (special exempt from the premarket notification controls). The device is exempt from the § 876.1500 Endoscope and accessories. procedures in subpart E of part 807 of premarket notification procedures in * * * * * this chapter subject to the limitations in subpart E of part 807 of this chapter (b) * * * § 876.9. subject to the limitations in § 874.9. (1) Class II (special controls). The ■ 113. In § 876.4770, revise paragraph ■ 102. In § 874.3310, revise paragraph device, when it is an endoscope (b) to read as follows: (b) to read as follows: disinfectant basin, which consists solely of a container that holds disinfectant § 876.4770 Urethrotome. § 874.3310 Hearing aid calibrator and and endoscopes and accessories; an * * * * * analysis system. endoscopic magnetic retriever intended (b) Classification. Class II (special * * * * * for single use; sterile scissors for controls). The device is exempt from the (b) Classification. Class II (special cystoscope intended for single use; a premarket notification procedures in controls). The device is exempt from the disposable, non-powered endoscopic subpart E of part 807 of this chapter premarket notification procedures in grasping/cutting instrument intended subject to the limitations in § 876.9.

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■ 114. In § 876.5010, revise paragraph (b) Classification. Class II (special sheet drape with self-retaining finger (b) to read as follows: controls). The following accessories are cot, a disposable urological drape, a exempt from the premarket notification Kelly pad, an ophthalmic patient drape, § 876.5010 Biliary catheter and procedures in subpart E of part 807 of an ophthalmic microscope drape, an accessories. this chapter subject to the limitations in internal drape retention ring (wound * * * * * § 876.9: A catheter finger grip that is protector), or a surgical drape that does (b) Classification. Class II (special non-patient contacting and intended for not include an antimicrobial agent, is controls). The device, when it is a bile single use with a peritoneal catheter; a exempt from the premarket notification collecting bag or a surgical biliary continuous ambulatory peritoneal procedures in subpart E of part 807 of catheter that does not include a balloon dialysis (CAPD) belt; and a catheter this chapter subject to the limitations in component, is exempt from the stand that does not include weigh § 878.9. premarket notification procedures in scales. ■ 125. In § 878.4495, revise paragraph subpart E of part 807 of this chapter ■ 120. In § 876.5665, revise paragraph (b) to read as follows: subject to the limitations in § 876.9. (b) to read as follows: ■ 115. In § 876.5025, revise paragraph § 878.4495 Stainless steel suture. (b) introductory text to read as follows: § 876.5665 Water purification system for * * * * * hemodialysis. (b) Classification. Class II (special § 876.5025 Vibrator for climax control of * * * * * controls). The device, when it is a steel premature ejaculation. (b) Classification. Class II (special monofilament suture that is uncoated * * * * * controls). The device, when it is a water and does not incorporate barbs, is (b) Classification. Class II (special purification subsystem disinfectant, is exempt from the premarket notification controls). The device is exempt from the exempt from the premarket notification procedures in subpart E of part 807 of premarket notification procedures in procedures in subpart E of part 807 of this chapter subject to the limitations in subpart E of part 807 of this chapter this chapter subject to the limitations in § 878.9. The special control for this subject to the limitations in § 876.9. The § 876.9. device is FDA’s ‘‘Class II Special special controls for this device are: ■ 121. In § 876.5895, revise paragraph Controls Guidance Document: Surgical * * * * * (b) to read as follows: Sutures; Guidance for Industry and ■ FDA.’’ See § 878.1(e) for the availability 116. In § 876.5160, revise the section § 876.5895 Ostomy irrigator. heading and paragraph (b) to read as of this guidance document. * * * * * ■ 126. In § 878.4580, revise paragraph follows: (b) Classification. Class II (special (b) to read as follows: § 876.5160 Urological clamp. controls). The device is exempt from the * * * * * premarket notification procedures in § 878.4580 Surgical lamp. (b) Classification. Class I (general subpart E of part 807 of this chapter * * * * * controls). Except when intended for subject to the limitations in § 876.9. (b) Classification. Class II (special internal use, the device is exempt from ■ 122. In § 876.5980, revise paragraph controls). The device, when it is an the premarket notification procedures in (b)(1) to read as follows: operating room lamp, a surgical subpart E of part 807 of this chapter § 876.5980 Gastrointestinal tube and instrument light, a surgical floor subject to the limitations in § 876.9. accessories. standing light, an endoscopic surgical light, a surgical light connector, a ■ 117. In § 876.5365, revise paragraph * * * * * (b) to read as follows: (b) * * * ceiling mounted surgical light, a (1) Class II (special controls). The surgical light carrier, surgical light § 876.5365 Esophageal dilator. barium enema retention catheter and tip accessories, a surgical lamp, a remote * * * * * with or without a bag that is a illuminator, or an incandescent surgical (b) Classification. Class II (special gastrointestinal tube and accessory or a lamp, is exempt from the premarket controls). The device is exempt from the gastronomy tube holder accessory is notification procedures in subpart E of premarket notification procedures in exempt from the premarket notification part 807 of this chapter subject to the subpart E of part 807 of this chapter procedures in subpart E of part 807 of limitations in § 878.9. subject to the limitations in § 876.9. this chapter subject to the limitations in ■ 127. In § 878.5070, revise paragraph ■ 118. In § 876.5520, revise paragraph § 876.9. (b) to read as follows: (b)(1) to read as follows: * * * * * § 878.5070 Air-handling apparatus for a surgical operating room. § 876.5520 Urethral dilator. PART 878—GENERAL AND PLASTIC * * * * * SURGERY DEVICES * * * * * (b) * * * (b) Classification. Class II (special (1) Class II (special controls). Except ■ 123. The authority citation for part controls). The device, when it is an air when it is a mechanical urethral dilator, 878 continues to read as follows: handling bench apparatus, an air the device is exempt from the premarket handling room apparatus, or an air Authority: 21 U.S.C. 351, 360, 360c, 360e, handling enclosure apparatus, is exempt notification procedures in subpart E of 360j, 360l, 371. part 807 of this chapter subject to the from the premarket notification ■ 124. In § 878.4370, revise paragraph limitations in § 876.9. procedures in subpart E of part 807 of (b) to read as follows: this chapter subject to the limitations in * * * * * § 878.9. ■ 119. In § 876.5630, revise paragraph § 878.4370 Surgical drape and drape (b) to read as follows: accessories. PART 880—GENERAL HOSPITAL AND * * * * * PERSONAL USE DEVICES § 876.5630 Peritoneal dialysis system and (b) Classification. Class II (special accessories. controls). The device, when it is an ear, ■ 128. The authority citation for part * * * * * nose, and throat surgical drape, a latex 880 continues to read as follows:

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Authority: 21 U.S.C. 351, 360, 360c, 360e, lubricant, it is exempt from the (b) Classification. Class II (special 360j, 360l, 371. premarket notification procedures in controls). The device is exempt from the ■ 129. In § 880.5580, revise paragraph subpart E of part 807 of this chapter premarket notification procedures in (b) introductory text to read as follows: subject to the limitations in § 880.9. subpart E of part 807 of this chapter ■ 134. In § 880.6760, revise paragraph subject to the limitations in § 882.9. § 880.5580 Acupuncture needle. (b) to read as follows: ■ 140. In § 882.1560, revise paragraph * * * * * (b) to read as follows: § 880.6760 Protective restraint. (b) Classification. Class II (special controls). The device, when it is an * * * * * § 882.1560 Skin potential measurement device. acupuncture point locator or a single (b) Classification. Class I (general use acupuncture needle, is exempt from controls). The device is exempt from the * * * * * the premarket notification procedures in premarket notification procedures in (b) Classification. Class II (special subpart E of part 807 of this chapter subpart E of part 807 of this chapter controls). The device is exempt from the subject to the limitations in § 880.9. subject to the limitations in § 880.9. premarket notification procedures in subpart E of part 807 of this chapter Acupuncture needles must comply with PART 882—NEUROLOGICAL DEVICES the following special controls: subject to the limitations in § 882.9. ■ * * * * * ■ 135. The authority citation for part 141. In § 882.1855, revise paragraph (b) to read as follows: ■ 130. In § 880.5680, revise paragraph 882 continues to read as follows: (b) to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, § 882.1855 Electroencephalogram (EEG) 360j, 360l, 371. telemetry system. § 880.5680 Pediatric position holder. ■ * * * * * * * * * * 136. In § 882.1020, revise paragraph (b) to read as follows: (b) Classification. Class II (special (b) Classification. Class I (general controls). The device is exempt from the controls). Except when the device is an § 882.1020 Rigidity analyzer. premarket notification procedures in infant positioner for prescription use in * * * * * subpart E of part 807 of this chapter highly monitored settings or an infant (b) Classification. Class II (special subject to the limitations in § 882.9. sleep position holder, it is exempt from controls). The device is exempt from the ■ 142. In § 882.4060, revise paragraph the premarket notification procedures in premarket notification procedures in (b) to read as follows: subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 880.9. The subject to the limitations in § 882.9. § 882.4060 Ventricular cannula. device is exempt from the good ■ 137. In § 882.1030, revise paragraph * * * * * manufacturing practice regulation in (b) to read as follows: (b) Classification. Class I (general part 820 of this chapter, with the controls). The device is exempt from the exception of § 820.180, with respect to § 882.1030 Ataxiagraph. premarket notification procedures in general requirements concerning * * * * * subpart E of part 807 of this chapter records, and § 820.198, with respect to (b) Classification. Class I (general subject to the limitations in § 882.9. complaint files. controls). Except when the device is ■ 143. In § 882.4545, revise paragraph ■ 131. In § 880.5780, revise paragraph intended to provide an interpretation or (b) to read as follows: (a)(2) to read as follows: a clinical implication of the measurement, it is exempt from the § 882.4545 Shunt system implantation § 880.5780 Medical support stocking. premarket notification procedures in instrument. (a) * * * subpart E of part 807 of this chapter * * * * * (2) Classification. Class II (special subject to the limitations in § 882.9. (b) Classification. Class I (general controls). The device is exempt from the ■ 138. In § 882.1470, revise paragraph controls). The device is exempt from the premarket notification procedures in (b) introductory text to read as follows: premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 880.9. § 882.1470 Computerized cognitive subject to the limitations in § 882.9. assessment aid. * * * * * ■ 144. In § 882.5895, revise paragraph ■ 132. In § 880.6250, revise paragraph * * * * * (b) introductory text to read as follows: (b) to read as follows: (b) Classification. Class II (special controls). Except when the § 882.5895 Vibratory counter-stimulation § 880.6250 Non-powdered patient computerized cognitive assessment aid device. examination glove. is intended for diagnostic assessment of * * * * * * * * * * specific diseases or conditions and (b) Classification. Class II (special (b) Classification. Class I (general relies on inputs from visual cues, controls). The device is exempt from the controls). The device, when it is a finger auditory cues, and/or functional use of premarket notification procedures in cot, is exempt from the premarket the hand, the device is exempt from the subpart E of part 807 of this chapter notification procedures in subpart E of premarket notification procedures in subject to the limitations in § 882.9. The part 807 of this chapter subject to the subpart E of part 807 of this chapter special controls for this device are: limitations in § 880.9. subject to the limitations in § 882.9. The * * * * * ■ 133. In § 880.6375, revise paragraph special control(s) for this device are: (b) to read as follows: * * * * * PART 884—OBSTETRICAL AND ■ 139. In § 882.1540, revise paragraph GYNECOLOGICAL DEVICES § 880.6375 Patient lubricant. (b) to read as follows: * * * * * ■ 145. The authority citation for part (b) Classification. Class I (general § 882.1540 Galvanic skin response 884 continues to read as follows: controls). Except when the device is a measurement device. Authority: 21 U.S.C. 351, 360, 360c, 360e, vaginal patient lubricant or an oral * * * * * 360j, 360l, 371.

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■ 146. In § 884.1630, revise paragraph notification procedures in subpart E of (b) Classification. Class I (general (b) to read as follows: part 807 of this chapter subject to the controls). The device is exempt from the limitations in § 884.9. premarket notification procedures in § 884.1630 Colposcope. * * * * * subpart E of part 807 of this chapter * * * * * ■ subject to the limitations in § 884.9 only (b) Classification. Class II (special 151. In § 884.4900, revise paragraph (b) to read as follows: when the device is made of common controls). The device, when it is a cellulosic and synthetic material with standard colposcope (or § 884.4900 Obstetric table and an established safety profile. colpomicroscope) that uses only a white accessories. ■ 157. In § 884.6120, revise paragraph light source, does not use filters other * * * * * (b) to read as follows: than a green filter, does not include (b) Classification. Class II (special image analysis software, and is not controls). The device is exempt from the § 884.6120 Assisted reproduction accessories. smartphone-based, is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter * * * * * subpart E of part 807 of this chapter subject to the limitations in § 884.9. (b) Classification. Class II (special subject to the limitations in § 884.9. controls) (design specifications, labeling ■ 152. In § 884.5200, revise paragraph ■ requirements, and clinical testing). The 147. In § 884.2990, revise paragraph (b) introductory text to read as follows: (b) to read as follows: device, when it is a simple embryo § 884.5200 Hemorrhoid prevention incubator with only temperature, gas, § 884.2990 Breast lesion documentation pressure wedge. and humidity control; a syringe pump; system. * * * * * a collection tube warmer; a dish/plate/ * * * * * (b) Classification. Class II (special microscope stage warmer; or a (b) Classification. Class II (special controls). The device is exempt from the controlled-rate cryopreservation freezer, controls). The device, when it is a breast premarket notification procedures in is exempt from the premarket examination recording sheet, is exempt subpart E of part 807 of this chapter notification procedures in subpart E of from the premarket notification subject to the limitations in § 884.9. The part 807 of this chapter subject to the procedures in subpart E of part 807 of special controls for this device are: limitations in § 884.9. this chapter subject to the limitations in ■ * * * * * 158. In § 884.6130, revise paragraph § 884.9. The special control is FDA’s (b) to read as follows: guidance entitled ‘‘Class II Special ■ 153. In § 884.5390, revise paragraph Controls Guidance Document: Breast (b) to read as follows: § 884.6130 Assisted reproduction Lesion Documentation System.’’ See microtools. § 884.5390 Perineal heater. § 884.1(e) for the availability of this * * * * * guidance document. * * * * * (b) Classification. Class II (special (b) Classification. Class II (special ■ 148. In § 884.3200, revise paragraph controls) (mouse embryo assay controls). The device is exempt from the (b) to read as follows: information, endotoxin testing, premarket notification procedures in sterilization validation, design § 884.3200 Cervical drain. subpart E of part 807 of this chapter specifications, labeling requirements, * * * * * subject to the limitations in § 884.9. and clinical testing). The device, when (b) Classification. Class II (special ■ 154. In § 884.5400, revise paragraph the assisted reproduction microtools controls). The device is exempt from the (b) to read as follows: (pipettes) are manufactured from glass, premarket notification procedures in is exempt from the premarket § 884.5400 Menstrual cup. subpart E of part 807 of this chapter notification procedures in subpart E of subject to the limitations in § 884.9. * * * * * part 807 of this chapter subject to the ■ 149. In § 884.4400, revise paragraph (b) Classification. Class II (special limitations in § 884.9. (b) to read as follows: controls). The device is exempt from the ■ 159. In § 884.6150, revise paragraph premarket notification procedures in (b) to read as follows: § 884.4400 Obstetric forceps. subpart E of part 807 of this chapter * * * * * subject to the limitations in § 884.9. § 884.6150 Assisted reproduction (b) Classification. Class II (special ■ 155. In § 884.5425, revise paragraph micromanipulators and microinjectors. controls). The device is exempt from the (b)(2) to read as follows: * * * * * premarket notification procedures in (b) Classification. Class II (special subpart E of part 807 of this chapter § 884.5425 Scented or scented deodorized controls) (design specifications, labeling subject to the limitations in § 884.9. menstrual pad. requirements, and clinical testing). The ■ 150. In § 884.4530, revise paragraph * * * * * device is exempt from the premarket (b)(1) to read as follows: (b) * * * notification procedures in subpart E of (2) Class II (special controls) for part 807 of this chapter subject to the § 884.4530 Obstetric-gynecologic scented or scented deodorized limitations in § 884.9. specialized manual instrument. menstrual pads made of materials not ■ 160. In § 884.6160, revise paragraph * * * * * described in paragraph (b)(1). The (b) to read as follows: (b) * * * device is exempt from the premarket (1) Class II (special controls). The notification procedures in subpart E of § 884.6160 Assisted reproduction labware. device, when it is an umbilical clamp part 807 of this chapter subject to the * * * * * with or without a cutter, a uterine limitations in § 884.9. (b) Classification. Class II (special tenaculum which is sterile and does not ■ 156. In § 884.5435, revise paragraph controls) (mouse embryo assay use suction and is intended for single (b) to read as follows: information, endotoxin testing, use, a nonmetal vaginal speculum, or a sterilization validation, design fiberoptic nonmetal vaginal speculum, § 884.5435 Unscented menstrual pad. specifications, labeling requirements, is exempt from the premarket * * * * * and clinical testing). The device, when

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it is a dish or plate intended for general this chapter subject to the limitations in (b) Classification. Class II (special assisted reproduction technology § 886.9. controls). The device, when it is procedures, is exempt from the * * * * * phacofragmentation unit replacement premarket notification procedures in ■ 166. In § 886.1850, revise paragraph tubing, is exempt from the premarket subpart E of part 807 of this chapter (b) to read as follows: notification procedures in subpart E of subject to the limitations in § 884.9. part 807 of this chapter subject to the § 886.1850 AC-powered slitlamp limitations in § 886.9. PART 886—OPHTHALMIC DEVICES biomicroscope. ■ 171. In § 886.4250, revise paragraph * * * * * ■ (b) to read as follows: 161. The authority citation for part (b) Classification. Class II (special 886 continues to read as follows: controls). The device, when it is § 886.4250 Ophthalmic electrolysis unit. Authority: 21 U.S.C. 351, 360, 360c, 360e, intended only for the visual * * * * * 360j, 360l, 371. examination of the anterior segment of (b) Classification. (1) Class I (general the eye, is classified as Group 1 per controls) for the battery-powered device. ■ 162. In § 886.1120, revise paragraph FDA-recognized consensus standard The battery-powered device is exempt (b) to read as follows: ANSI Z80.36, does not provide any from the premarket notification § 886.1120 Ophthalmic camera. quantitative output, and is not intended procedures in subpart E of part 807 of * * * * * for screening or automated diagnostic this chapter subject to the limitations in (b) Classification. Class II (special indications, is exempt from the § 886.9. controls). The device, when it is a premarket notification procedures in (2) Class II (special controls) for the photorefractor or a general-use subpart E of part 807 of this chapter AC-powered device. The AC-powered ophthalmic camera, is exempt from the subject to the limitations in § 886.9. device is exempt from the premarket premarket notification procedures in ■ 167. In § 886.1945, revise paragraph notification procedures in subpart E of subpart E of part 807 of this chapter (b) to read as follows: part 807 of this chapter subject to the subject to the limitations in § 886.9. limitations in § 886.9. § 886.1945 Transilluminator. ■ 172. In § 886.4335, revise paragraph ■ 163. In § 886.1250, revise paragraph * * * * * (b) to read as follows: (b) to read as follows: (b) Classification. (1) Class I (general § 886.4335 Operating headlamp. § 886.1250 Euthyscope. controls) for the battery-powered device. * * * * * * * * * * The battery-powered device is exempt from the premarket notification (b) Classification. (1) Class I (general (b) Classification. (1) Class I (general procedures in subpart E of part 807 of controls) for the battery-powered device. controls) for the battery-powered device. this chapter subject to the limitations in The battery-powered device is exempt The battery-powered device is exempt § 886.9. from the premarket notification from the premarket notification (2) Class II (special controls) for the procedures in subpart E of part 807 of procedures in subpart E of part 807 of AC-powered device. The AC-powered this chapter subject to the limitations in this chapter subject to the limitations in device is exempt from the premarket § 886.9. § 886.9. notification procedures in subpart E of (2) Class II (special controls) for the (2) Class II (special controls) for the part 807 of this chapter subject to the AC-powered device. The AC-powered AC-powered device. The AC-powered limitations in § 886.9. device is exempt from the premarket device is exempt from the premarket ■ notification procedures in subpart E of notification procedures in subpart E of 168. In § 886.3320, revise paragraph (b) to read as follows: part 807 of this chapter subject to the part 807 of this chapter subject to the limitations in § 886.9. limitations in § 886.9. § 886.3320 Eye sphere implant. ■ 173. In § 886.4400, revise paragraph ■ 164. In § 886.1570, revise paragraph * * * * * (b) to read as follows: (b) to read as follows: (b) Classification. Class II (special § 886.4400 Electronic metal locator. § 886.1570 Ophthalmoscope. controls). The device, when it is an ocular peg which is supplied sterile * * * * * * * * * * only, is exempt from the premarket (b) Classification. Class II (special (b) Classification. Class II (special notification procedures in subpart E of controls). The device is exempt from the controls). The device, when it is an AC- part 807 of this chapter subject to the premarket notification procedures in powered opthalmoscope, a battery- limitations in § 886.9. subpart E of part 807 of this chapter powered opthalmoscope, or a hand-held ■ 169. In § 886.4070, revise paragraph subject to the limitations in § 886.9. ophthalmoscope replacement battery, is (b) to read as follows: ■ 174. In § 886.4440, revise paragraph exempt from the premarket notification (b) to read as follows: procedures in subpart E of part 807 of § 886.4070 Powered corneal burr. this chapter subject to the limitations in * * * * * § 886.4440 AC-powered magnet. § 886.9. (b) Classification. Class I (general * * * * * ■ 165. In § 886.1780, revise paragraph controls). The device is exempt from the (b) Classification. Class II (special (b)(1) to read as follows: premarket notification procedures in controls). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in § 886.1780 Retinoscope. subject to the limitations in § 886.9. subpart E of part 807 of this chapter * * * * * ■ 170. In § 886.4150, revise paragraph subject to the limitations in § 886.9. (b) * * * (b) to read as follows: ■ 175. In § 886.4790, revise paragraph (1) Class II (special controls) for the (b) to read as follows: AC-powered device. The device is § 886.4150 Vitreous aspiration and cutting exempt from the premarket notification instrument. § 886.4790 Ophthalmic sponge. procedures in subpart E of part 807 of * * * * * * * * * *

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(b) Classification. Class II (special (b) Classification. Class II (special part 807 of this chapter subject to the controls). The device is exempt from the controls). The device is exempt from the limitations in § 892.9. premarket notification procedures in premarket notification procedures in ■ 189. In § 892.1560, revise paragraph subpart E of part 807 of this chapter subpart E of part 807 of this chapter (b) to read as follows: subject to the limitations in § 886.9. subject to the limitations in § 890.9. § 892.1560 Ultrasonic pulsed echo imaging ■ 183. In § 890.5250, revise paragraph PART 888—ORTHOPEDIC DEVICES system. (b) to read as follows: * * * * * ■ 176. The authority citation for part § 890.5250 Moist steam cabinet. (b) Classification. Class II (special 888 continues to read as follows: * * * * * controls). A biopsy needle guide kit Authority: 21 U.S.C. 351, 360, 360c, 360e, (b) Classification. Class II (special intended for use with an ultrasonic 360j, 360l, 371. controls). The device is exempt from the pulsed echo imaging system only is exempt from the premarket notification ■ premarket notification procedures in 177. In § 888.1240, revise paragraph procedures in subpart E of part 807 of (b) to read as follows: subpart E of part 807 of this chapter subject to the limitations in § 890.9. this chapter subject to the limitations in § 892.9. § 888.1240 AC-powered dynamometer. ■ 184. In § 890.5360, revise paragraph * * * * * (b) to read as follows: ■ 190. In § 892.1610, revise paragraph (b) Classification. Class II (special (b) to read as follows: § 890.5360 Measuring exercise equipment. controls). The device is exempt from the § 892.1610 Diagnostic x-ray beam-limiting premarket notification procedures in * * * * * device. subpart E of part 807 of this chapter (b) Classification. Class II (special controls). The device, when it is a * * * * * subject to the limitations in § 888.9. (b) Classification. Class II (special measuring exerciser, is exempt from the ■ 178. In § 888.4580, revise paragraph controls). The device is exempt from the premarket notification procedures in (b) to read as follows: premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter § 888.4580 Sonic surgical instrument and subject to the limitations in § 890.9. accessories/attachments. subject to the limitations in § 892.9. ■ 185. In § 890.5500, revise paragraph ■ 191. In § 892.1650, revise paragraph * * * * * (b) to read as follows: (b) Classification. Class II (special (b) to read as follows: § 890.5500 Infrared lamp. controls). The device is exempt from the § 892.1650 Image-intensified fluoroscopic premarket notification procedures in * * * * * x-ray system. subpart E of part 807 of this chapter (b) Classification. Class II (special * * * * * subject to the limitations in § 888.9. controls). The device, when it is an (b) Classification. Class II (special infrared therapeutic heating lamp, is controls). An anthrogram tray or PART 890—PHYSICAL MEDICINE exempt from the premarket notification DEVICES radiology dental tray intended for use procedures in subpart E of part 807 of with an image-intensified fluoroscopic this chapter subject to the limitations in ■ 179. The authority citation for part x-ray system only is exempt from the § 890.9. 890 continues to read as follows: premarket notification procedures in ■ 186. In § 890.5575, revise paragraph subpart E of part 807 of this chapter Authority: 21 U.S.C. 351, 360, 360c, 360e, (b) to read as follows: subject to the limitations in § 892.9. In 360j, 360l, 371. addition, when intended as an accessory ■ § 890.5575 Powered external limb overload 180. In § 890.1450, revise paragraph warning device. to the device described in paragraph (a) (b) to read as follows: of this section, the fluoroscopic * * * * * compression device is exempt from the § 890.1450 Powered reflex hammer. (b) Classification. Class II (special premarket notification procedures in * * * * * controls). The device is exempt from the subpart E of part 807 of this chapter (b) Classification. Class II (special premarket notification procedures in subject to the limitations in § 892.9. subpart E of part 807 of this chapter controls). The device is exempt from the ■ 192. In § 892.1670, revise paragraph subject to the limitations in § 890.9. premarket notification procedures in (b) to read as follows: subpart E of part 807 of this chapter subject to the limitations in § 890.9. PART 892—RADIOLOGY DEVICES § 892.1670 Spot-film device. ■ 181. In § 890.5100, revise paragraph ■ 187. The authority citation for part * * * * * (b) to read as follows: 892 continues to read as follows: (b) Classification. Class II (special controls). The device is exempt from the § 890.5100 Immersion hydrobath. Authority: 21 U.S.C. 351, 360, 360c, 360e, premarket notification procedures in * * * * * 360j, 360l, 371. subpart E of part 807 of this chapter (b) Classification. Class II (special ■ 188. In § 892.1000, revise paragraph subject to the limitations in § 892.9. controls). The device, when it is a (b) to read as follows: ■ 193. In § 892.1680, revise paragraph hydromassage bath or a powered sitz (b) to read as follows: bath, is exempt from the premarket § 892.1000 Magnetic resonance diagnostic notification procedures in subpart E of device. § 892.1680 Stationary x-ray system. part 807 of this chapter subject to the * * * * * * * * * * limitations in § 890.9. (b) Classification. Class II (special (b) Classification. Class II (special ■ 182. In § 890.5110, revise paragraph controls). A magnetic resonance imaging controls). A radiographic contrast tray (b) to read as follows: disposable kit intended for use with a or radiology diagnostic kit intended for magnetic resonance diagnostic device use with a stationary x-ray system only § 890.5110 Paraffin bath. only is exempt from the premarket is exempt from the premarket * * * * * notification procedures in subpart E of notification procedures in subpart E of

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part 807 of this chapter subject to the ■ 200. In § 892.2030, revise paragraph Defense Authorization Act for Fiscal limitations in § 892.9. (b) to read as follows: Year 2019 expanding patronage for ■ commissary, exchange, and revenue- 194. In § 892.1730, revise paragraph § 892.2030 Medical image digitizer. (b) to read as follows: generating morale, welfare, and * * * * * recreation (MWR) facilities. As part of § 892.1730 Photofluorographic x-ray (b) Classification. Class II (special DOD’s implementation the Department system. controls; voluntary standards—Digital is required to collect a user fee when * * * * * Imaging and Communications in these new populations utilize a credit or (b) Classification. Class II (special Medicine (DICOM) Std., Joint debit card that creates a cost to the controls). A discography kit intended Photographic Experts Group (JPEG) Department of the Treasury for for use with a photofluorographic x-ray Std.). The device is exempt from the processing these transactions. As it system only is exempt from the premarket notification procedures in related to this Section, such costs are premarket notification procedures in subpart E of part 807 of this chapter only generated by credit or debit card subpart E of part 807 of this chapter subject to the limitations in § 892.9. transactions at Defense Commissary subject to the limitations in § 892.9. ■ 201. In § 892.2040, revise paragraph Agency (DeCA) facilities. ■ 195. In § 892.1820, revise paragraph (b) to read as follows: DATES: Effective date: This interim final (b) to read as follows: § 892.2040 Medical image hardcopy rule is effective on December 30, 2019. § 892.1820 Pneumoencephalographic device. Comment date: Comments will be chair. * * * * * received by February 28, 2020. * * * * * (b) Classification. Class II (special Applicability date: Per the deadline in (b) Classification. Class II (special controls; voluntary standards—Digital the statute and as implemented in this controls). The device is exempt from the Imaging and Communications in rule, these user fees go into effect on premarket notification procedures in Medicine (DICOM) Std., Joint January 1, 2020. subpart E of part 807 of this chapter Photographic Experts Group (JPEG) Std., ADDRESSES: You may submit comments, subject to the limitations in § 892.9. Society of Motion Picture and identified by docket number and or ■ 196. In § 892.1850, revise paragraph Television Engineers (SMPTE) Test Regulatory Information Number (RIN) (b) to read as follows: Pattern). The device is exempt from the and title, by any of the following premarket notification procedures in methods: § 892.1850 Radiographic film cassette. subpart E of part 807 of this chapter • Federal Rulemaking Portal: http:// * * * * * subject to the limitations in § 892.9. www.regulations.gov. Follow the (b) Classification. Class II (special ■ 202. In § 892.5730, revise paragraph instructions for submitting comments. controls). The device is exempt from the (b) to read as follows: • Mail: Department of Defense, Office premarket notification procedures in of the Chief Management Officer, subpart E of part 807 of this chapter § 892.5730 Radionuclide brachytherapy Directorate for Oversight and subject to the limitations in § 892.9. source. Compliance, 4800 Mark Center Drive, ■ 197. In § 892.1860, revise paragraph * * * * * Mailbox #24, Suite 08D09, Alexandria, (b) to read as follows: (b) Classification. Class II (special VA 22350–1700. controls). A prostate seeding kit Instructions: All submissions received § 892.1860 Radiographic film/cassette intended for use with a radionuclide must include the agency name and changer. brachytherapy source only is exempt docket number or RIN. The general * * * * * from the premarket notification policy for comments and other (b) Classification. Class II (special procedures in subpart E of part 807 of submissions from members of the public controls). The device is exempt from the this chapter subject to the limitations in is to make these submissions available premarket notification procedures in § 892.9. at http://www.regulations.gov as they subpart E of part 807 of this chapter Dated: December 13, 2019. are received without change, including subject to the limitations in § 892.9. Lowell J. Schiller, any personal identifiers or contact ■ 198. In § 892.1870, revise paragraph Principal Associate Commissioner for Policy. information. (b) to read as follows: [FR Doc. 2019–27394 Filed 12–27–19; 8:45 am] FOR FURTHER INFORMATION CONTACT: Jane § 892.1870 Radiographic film/cassette BILLING CODE 4164–01–P Westbay, (571) 372–6579, changer programmer. [email protected]. * * * * * SUPPLEMENTARY INFORMATION: DEPARTMENT OF DEFENSE (b) Classification. Class II (special Summary of New and Amendatory controls). The device is exempt from the Office of the Secretary Regulatory Provisions and Their premarket notification procedures in Impact subpart E of part 807 of this chapter subject to the limitations in § 892.9. 32 CFR Part 225 This rule implements Section 621 of ■ 199. In § 892.1900, revise paragraph [Docket ID: DOD–2019–OS–0131] the John S. McCain National Defense (b) to read as follows: Authorization Act for Fiscal Year 2019 RIN 0790–AK92 (Purple Heart and Disabled Veterans § 892.1900 Automatic radiographic film Equal Access Act of 2018), codified at Commissary Credit and Debit Card processor. Section 1065 of Title 10, United States User Fee * * * * * Code. Section 621 expands patronage (b) Classification. Class II (special AGENCY: Department of Defense (DoD). for commissary, exchange, and revenue- controls). The device is exempt from the ACTION: Interim final rule. generating morale, welfare, and premarket notification procedures in recreation (MWR) facilities. By January subpart E of part 807 of this chapter SUMMARY: This rule implements Section 1, 2020, the Department of Defense is subject to the limitations in § 892.9. 621 of the John S. McCain National directed to:

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