82_FR_48613 82 FR 48413 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System

82 FR 48413 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 200 (October 18, 2017)

Page Range48413-48415
FR Document2017-22590

The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Federal Register, Volume 82 Issue 200 (Wednesday, October 18, 2017)
[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Rules and Regulations]
[Pages 48413-48415]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22590]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. FDA-2017-N-5160]


Medical Devices; Clinical Chemistry and Clinical Toxicology 
Devices; Classification of the Organophosphate Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the organophosphate test system into class II (special controls). The 
special controls that apply to the device type are identified in this 
order and will be part of the codified language for the organophosphate 
test system's classification. We are taking this action because we have 
determined that classifying the device into class II (special controls) 
will provide a reasonable assurance of safety and effectiveness of the 
device. We believe this action will also enhance patients' access to 
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective October 18, 2017. The classification was 
applicable on August 8, 2013.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD, 20993-0002, 301-796-5866.

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the organophosphate test system as 
class II (special controls), which we have determined will provide a 
reasonable assurance of safety and effectiveness. In addition, we 
believe this action will enhance patients' access to beneficial 
innovation, in part by reducing regulatory burdens by placing the 
device into a lower device class than the automatic class III 
assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to

[[Page 48414]]

these devices as ``postamendments devices'' because they were not in 
commercial distribution prior to the date of enactment of the Medical 
Device Amendments of 1976, which amended the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k) and 21 CFR part 807.
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically within 
class III, the De Novo classification is considered to be the initial 
classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval (PMA) application in order to market a 
substantially equivalent device (see 21 U.S.C. 360c(i), defining 
``substantial equivalence'').
    Instead, sponsors can use the less burdensome 510(k) process, when 
necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on May 2, 2013, finding the 
Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS 
(liquid chromatography-tandem mass spectrometry (the two ``MS'' next to 
each other denote ``tandem'')) not substantially equivalent to a 
predicate not subject to PMA. Thus, the device remained in class III in 
accordance with section 513(f)(1) of the FD&C Act when we issued the 
order.
    On May 31, 2013, Elizabeth Hamelin, on behalf of the Centers for 
Disease Control and Prevention, Division of Laboratory Sciences/
National Center for Environmental Health, submitted a request for 
classification of the Quantitation of Organophosphate Metabolites in 
Urine by LC/MS/MS. FDA reviewed the request in order to classify the 
device under the criteria for classification set forth in section 
513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves 
are insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on August 8, 2013, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 862.3652. We have named 
the generic type of device organophosphate test system, and it is 
identified as a device intended to measure organophosphate metabolites 
quantitatively in human urine from individuals who have signs and 
symptoms consistent with cholinesterase poisoning. The data obtained by 
this device is intended to aid in the confirmation and investigation of 
organophosphate exposure.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

   Table 1--Organophosphate Test System Risks and Mitigation Measures
------------------------------------------------------------------------
         Identified risks                    Mitigation measures
------------------------------------------------------------------------
False Positive....................  (1) The distribution of these
                                     devices is limited to laboratories
                                     with experienced personnel who are
                                     trained to measure and evaluate
                                     organophosphate exposure and guide
                                     public health response.
                                    (2) Analytical testing must
                                     demonstrate the device has
                                     appropriate performance
                                     characteristics, including adequate
                                     precision and accuracy across the
                                     measuring range and near medical
                                     decision points.
False Negative....................  (1) The distribution of these
                                     devices is limited to laboratories
                                     with experienced personnel who are
                                     trained to measure and evaluate
                                     organophosphate exposure and guide
                                     public health response.
                                    (2) Analytical testing must
                                     demonstrate the device has
                                     appropriate performance
                                     characteristics, including adequate
                                     precision and accuracy across the
                                     measuring range and near medical
                                     decision points.
Public Health Risk from Incorrect   (1) The distribution of these
 Test Results.                       devices is limited to laboratories
                                     with experienced personnel who are
                                     trained to measure and evaluate
                                     organophosphate exposure and guide
                                     public health response.
                                    (2) Analytical testing must
                                     demonstrate the device has
                                     appropriate performance
                                     characteristics, including adequate
                                     precision and accuracy across the
                                     measuring range and near medical
                                     decision points.
------------------------------------------------------------------------


[[Page 48415]]

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. In order for a device to fall 
within this classification, and thus avoid automatic classification in 
class III, it would have to comply with the special controls named in 
this final order. The necessary special controls appear in the 
regulation codified by this order. This device is subject to premarket 
notification requirements under section 510(k).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
part 807, subpart E, regarding premarket notification submissions have 
been approved under OMB control number 0910-0120.

List of Subjects in 21 CFR Part 862

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

0
1. The authority citation for part 862 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  862.3652 to subpart D to read as follows:


Sec.  862.3652  Organophosphate test system.

    (a) Identification. An organophosphate test system is a device 
intended to measure organophosphate metabolites quantitatively in human 
urine from individuals who have signs and symptoms consistent with 
cholinesterase poisoning. The data obtained by this device is intended 
to aid in the confirmation and investigation of organophosphate 
exposure.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The distribution of these devices is limited to laboratories 
with experienced personnel who are trained to measure and evaluate 
organophosphate exposure and guide public health response.
    (2) Analytical testing must demonstrate the device has appropriate 
performance characteristics, including adequate precision and accuracy 
across the measuring range and near medical decision points.

    Dated: October 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22590 Filed 10-17-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                              Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations                                         48413

                                             authorities, as noted above, are                         margin requirements; the treatment of                  DEPARTMENT OF HEALTH AND
                                             responsible for supervising FCs as part                  inter-affiliate derivative transactions;               HUMAN SERVICES
                                             of their ongoing prudential regulation                   the methodologies for calculating the
                                             and supervision of such FCs, will                        amounts of initial and variation margin;               Food and Drug Administration
                                             enforce the RTS, which are directly                      the process and standards for approving
                                             applicable in the Member States, and                     models for calculating initial and                     21 CFR Part 862
                                             will take all measures necessary to                      variation margin models; the timing and                [Docket No. FDA–2017–N–5160]
                                             ensure that those rules are                              manner in which initial and variation
                                             implemented. Thus, the Commission                        margin must be collected and/or paid;                  Medical Devices; Clinical Chemistry
                                             finds that the EC, through the competent                 any threshold levels or amounts; risk                  and Clinical Toxicology Devices;
                                             authorities, has the necessary powers to                 management controls for the calculation                Classification of the Organophosphate
                                             supervise, investigate, and discipline                   of initial and variation margin; eligible              Test System
                                             entities for compliance with its margin                  collateral for initial and variation
                                             requirements and recognizes the                          margin; the requirements of custodial                  AGENCY:    Food and Drug Administration,
                                             relevant competent authorities’ ongoing                  arrangements, including segregation of                 HHS.
                                             efforts to detect and deter violations of,               margin and rehypothecation; margin                     ACTION:   Final order.
                                             and ensure compliance with, the margin                   documentation requirements; and the
                                             requirements applicable in the EU.                       cross-border application of the EU’s                   SUMMARY:    The Food and Drug
                                                                                                      margin regime. Finally, based on the                   Administration (FDA or we) is
                                             V. Conclusion                                                                                                   classifying the organophosphate test
                                                                                                      long history of regulatory cooperation
                                               As detailed above, the Commission                      between the Commission and Member                      system into class II (special controls).
                                             has noted several differences between                    State competent authorities with                       The special controls that apply to the
                                             the Final Margin Rule and the EU                         supervisory and enforcement authority                  device type are identified in this order
                                             margin rules. However, having                            under the RTS, the Commission finds                    and will be part of the codified language
                                             considered the scope and objectives of                   that the EC, through the competent                     for the organophosphate test system’s
                                             the margin requirements for uncleared                    authorities, has the necessary powers to               classification. We are taking this action
                                             swaps under the laws of the EU,202                       supervise, investigate, and discipline                 because we have determined that
                                             whether such margin requirements                         entities for compliance with its margin                classifying the device into class II
                                             achieve comparable outcomes to the                       requirements, and recognizes the                       (special controls) will provide a
                                             Commission’s corresponding margin                        relevant authorities’ ongoing efforts to               reasonable assurance of safety and
                                             requirements,203 and the ability of the                  detect and deter violations of, and                    effectiveness of the device. We believe
                                             Member State competent authorities to                    ensure compliance with, the margin                     this action will also enhance patients’
                                             supervise and enforce compliance with                    requirements applicable in the EU.                     access to beneficial innovative devices,
                                             the margin requirements for non-                           Accordingly, a CSE that is subject to                in part by reducing regulatory burdens.
                                             centrally cleared OTC derivatives under                  both the Final Margin Rule and the EU’s                DATES: This order is effective October
                                             the laws of the EU,204 the Commission                    margin rules with respect to an                        18, 2017. The classification was
                                             has determined that the EU margin rules                  uncleared swap that is also a non-                     applicable on August 8, 2013.
                                             are comparable in outcome to the Final                   centrally cleared OTC derivative may                   FOR FURTHER INFORMATION CONTACT:
                                             Margin Rule.                                             rely on substituted compliance for all                 Steven Tjoe, Center for Devices and
                                               As noted above, the Final Margin                       aspects of the Final Margin Rule and the               Radiological Health, Food and Drug
                                             Rule’s regulatory objective is to ensure                 Cross-Border Margin Rule. Any such                     Administration, 10903 New Hampshire
                                             the safety and soundness of CSEs in                      CSE that, in accordance with this                      Ave., Bldg. 66, Rm. 4550, Silver Spring,
                                             order to offset the greater risk to CSEs                 comparability determination, complies                  MD, 20993–0002, 301–796–5866.
                                             and the financial system arising from                    with the EU margin rules, would be                     SUPPLEMENTARY INFORMATION:
                                             the use of swaps that are not cleared.                   deemed to be in compliance with the
                                             The EU margin rules require                              Final Margin Rule but would remain                     I. Background
                                             counterparties to apply robust risk-                     subject to the Commission’s                              Upon request, FDA has classified the
                                             mitigation techniques to their bilateral                 examination and enforcement                            organophosphate test system as class II
                                             relationships to reduce counterparty                     authority.205                                          (special controls), which we have
                                             credit risk and to mitigate the potential
                                                                                                        Issued in Washington, DC, on October 13,             determined will provide a reasonable
                                             systemic risk that could arise. Moreover,
                                                                                                      2017, by the Commission.                               assurance of safety and effectiveness. In
                                             the EU margin rules achieve comparable
                                                                                                      Christopher J. Kirkpatrick,                            addition, we believe this action will
                                             outcomes to the Final Margin Rule in
                                                                                                      Secretary of the Commission.                           enhance patients’ access to beneficial
                                             the following specific areas: The
                                                                                                                                                             innovation, in part by reducing
                                             products and entities subject to the EU’s                Appendix to Comparability                              regulatory burdens by placing the
                                                                                                      Determination for the European Union:                  device into a lower device class than the
                                             International/MemorandaofUnderstanding/                  Margin Requirements for Uncleared
                                             index.htm.                                                                                                      automatic class III assignment.
                                                202 See § 23.160(c)(3)(i).
                                                                                                      Swaps for Swap Dealers and Major                         The automatic assignment of class III
                                                203 See § 23.160(c)(3)(ii). As discussed above, the   Swap Participants—Commission Voting                    occurs by operation of law and without
                                             Commission’s Final Margin Rule is based on the           Summary                                                any action by FDA, regardless of the
                                             BCBS/IOSCO Framework; therefore, the                                                                            level of risk posed by the new device.
                                             Commission expects that the relevant foreign
                                                                                                        On this matter, Chairman Giancarlo and
                                                                                                                                                             Any device that was not in commercial
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                                             margin requirements would conform to such                Commissioners Quintenz and Behnam voted
                                             Framework at minimum in order to be deemed               in the affirmative. No Commissioner voted in           distribution before May 28, 1976, is
                                             comparable in outcome to the Commission’s                the negative.                                          automatically classified as, and remains
                                             corresponding margin requirements.                       [FR Doc. 2017–22616 Filed 10–17–17; 8:45 am]           within, class III and requires premarket
                                                204 See § 23.160(c)(3)(iii). See also

                                             § 23.160(c)(3)(iv) (indicating the Commission would      BILLING CODE 6351–01–P                                 approval unless and until FDA takes an
                                             also consider any other relevant facts and                                                                      action to classify or reclassify the device
                                             circumstances).                                            205 See   § 23.160(c)(4).                            (see 21 U.S.C. 360c(f)(1)). We refer to


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                                             48414             Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations

                                             these devices as ‘‘postamendments                             equivalence, that person requests a                   request for classification of the
                                             devices’’ because they were not in                            classification under section 513(f)(2) of             Quantitation of Organophosphate
                                             commercial distribution prior to the                          the FD&C Act.                                         Metabolites in Urine by LC/MS/MS.
                                             date of enactment of the Medical Device                          Under either procedure for De Novo                 FDA reviewed the request in order to
                                             Amendments of 1976, which amended                             classification, FDA is required to                    classify the device under the criteria for
                                             the Federal Food, Drug, and Cosmetic                          classify the device by written order                  classification set forth in section
                                             Act (the FD&C Act).                                           within 120 days. The classification will              513(a)(1) of the FD&C Act.
                                                FDA may take a variety of actions in                       be according to the criteria under
                                                                                                                                                                    We classify devices into class II if
                                             appropriate circumstances to classify or                      section 513(a)(1) of the FD&C Act.
                                                                                                                                                                 general controls by themselves are
                                             reclassify a device into class I or II. We                    Although the device was automatically
                                             may issue an order finding a new device                       within class III, the De Novo                         insufficient to provide reasonable
                                             to be substantially equivalent under                          classification is considered to be the                assurance of safety and effectiveness,
                                             section 513(i) of the FD&C Act to a                           initial classification of the device.                 but there is sufficient information to
                                             predicate device that does not require                           We believe this De Novo classification             establish special controls that, in
                                             premarket approval (see 21 U.S.C.                             will enhance patients’ access to                      combination with the general controls,
                                             360c(i)). We determine whether a new                          beneficial innovation, in part by                     provide reasonable assurance of the
                                             device is substantially equivalent to a                       reducing regulatory burdens. When FDA                 safety and effectiveness of the device for
                                             predicate by means of the procedures                          classifies a device into class I or II via            its intended use (see 21 U.S.C.
                                             for premarket notification under section                      the De Novo process, the device can                   360c(a)(1)(B)). After review of the
                                             510(k) of the FD&C Act (21 U.S.C. 360(k)                      serve as a predicate for future devices of            information submitted in the request,
                                             and 21 CFR part 807.                                          that type, including for 510(k)s (see 21              we determined that the device can be
                                                FDA may also classify a device                             U.S.C. 360c(f)(2)(B)(i)). As a result, other          classified into class II with the
                                             through ‘‘De Novo’’ classification, a                         device sponsors do not have to submit                 establishment of special controls. FDA
                                             common name for the process                                   a De Novo request or premarket                        has determined that these special
                                             authorized under section 513(f)(2) of the                     approval (PMA) application in order to                controls, in addition to general controls,
                                             FD&C Act. Section 207 of the Food and                         market a substantially equivalent device              will provide reasonable assurance of the
                                             Drug Administration Modernization Act                         (see 21 U.S.C. 360c(i), defining                      safety and effectiveness of the device.
                                             of 1997 established the first procedure                       ‘‘substantial equivalence’’).                            Therefore, on August 8, 2013, FDA
                                             for De Novo classification (Pub. L. 105–                         Instead, sponsors can use the less                 issued an order to the requestor
                                             115). Section 607 of the Food and Drug                        burdensome 510(k) process, when                       classifying the device into class II. FDA
                                             Administration Safety and Innovation                          necessary, to market their device.                    is codifying the classification of the
                                             Act modified the De Novo application                                                                                device by adding 21 CFR 862.3652. We
                                                                                                           II. De Novo Classification
                                             process by adding a second procedure                                                                                have named the generic type of device
                                             (Pub. L. 112–144). A device sponsor                              For this device, FDA issued an order
                                                                                                           on May 2, 2013, finding the                           organophosphate test system, and it is
                                             may utilize either procedure for De                                                                                 identified as a device intended to
                                             Novo classification.                                          Quantitation of Organophosphate
                                                                                                           Metabolites in Urine by LC/MS/MS                      measure organophosphate metabolites
                                                Under the first procedure, the person
                                                                                                           (liquid chromatography-tandem mass                    quantitatively in human urine from
                                             submits a 510(k) for a device that has
                                             not previously been classified. After                         spectrometry (the two ‘‘MS’’ next to                  individuals who have signs and
                                             receiving an order from FDA classifying                       each other denote ‘‘tandem’’)) not                    symptoms consistent with
                                             the device into class III under section                       substantially equivalent to a predicate               cholinesterase poisoning. The data
                                             513(f)(1) of the FD&C Act, the person                         not subject to PMA. Thus, the device                  obtained by this device is intended to
                                             then requests a classification under                          remained in class III in accordance with              aid in the confirmation and
                                             section 513(f)(2).                                            section 513(f)(1) of the FD&C Act when                investigation of organophosphate
                                                Under the second procedure, rather                         we issued the order.                                  exposure.
                                             than first submitting a 510(k) and then                          On May 31, 2013, Elizabeth Hamelin,                   FDA has identified the following risks
                                             a request for classification, if the person                   on behalf of the Centers for Disease                  to health associated specifically with
                                             determines that there is no legally                           Control and Prevention, Division of                   this type of device and the measures
                                             marketed device upon which to base a                          Laboratory Sciences/National Center for               required to mitigate these risks in table
                                             determination of substantial                                  Environmental Health, submitted a                     1.

                                                                              TABLE 1—ORGANOPHOSPHATE TEST SYSTEM RISKS AND MITIGATION MEASURES
                                                           Identified risks                                                                     Mitigation measures

                                             False Positive ..................................   (1) The distribution of these devices is limited to laboratories with experienced personnel who are trained
                                                                                                   to measure and evaluate organophosphate exposure and guide public health response.
                                                                                                 (2) Analytical testing must demonstrate the device has appropriate performance characteristics, including
                                                                                                   adequate precision and accuracy across the measuring range and near medical decision points.
                                             False Negative ................................     (1) The distribution of these devices is limited to laboratories with experienced personnel who are trained
                                                                                                   to measure and evaluate organophosphate exposure and guide public health response.
                                                                                                 (2) Analytical testing must demonstrate the device has appropriate performance characteristics, including
                                                                                                   adequate precision and accuracy across the measuring range and near medical decision points.
                                             Public Health Risk from Incorrect                   (1) The distribution of these devices is limited to laboratories with experienced personnel who are trained
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                                               Test Results.                                       to measure and evaluate organophosphate exposure and guide public health response.
                                                                                                 (2) Analytical testing must demonstrate the device has appropriate performance characteristics, including
                                                                                                   adequate precision and accuracy across the measuring range and near medical decision points.




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                                                              Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations                                        48415

                                                FDA has determined that special                       investigation of organophosphate                      Law), under authority delegated by the
                                             controls, in combination with the                        exposure.                                             Secretary of the Navy, has certified that
                                             general controls, address these risks to                   (b) Classification. Class II (special               USS MICHAEL MONSOOR (DDG 1001)
                                             health and provide reasonable assurance                  controls). The special controls for this              is a vessel of the Navy which, due to its
                                             of safety and effectiveness. In order for                device are:                                           special construction and purpose,
                                             a device to fall within this classification,               (1) The distribution of these devices is            cannot fully comply with the following
                                             and thus avoid automatic classification                  limited to laboratories with experienced              specific provisions of 72 COLREGS
                                             in class III, it would have to comply                    personnel who are trained to measure                  without interfering with its special
                                             with the special controls named in this                  and evaluate organophosphate exposure                 function as a naval ship: Annex I
                                             final order. The necessary special                       and guide public health response.                     paragraph 2(a)(i), pertaining to the
                                             controls appear in the regulation                          (2) Analytical testing must                         location of the forward masthead light at
                                             codified by this order. This device is                   demonstrate the device has appropriate                a height not less than 6 meters above the
                                             subject to premarket notification                        performance characteristics, including                hull; Annex I, paragraph 2(g) pertaining
                                             requirements under section 510(k).                       adequate precision and accuracy across                to the placement of sidelights above the
                                                                                                      the measuring range and near medical                  hull of the vessel; Rule 30(a)(i) and
                                             III. Analysis of Environmental Impact                    decision points.                                      Annex I, paragraph 2(k) pertaining to
                                                The Agency has determined under 21                      Dated: October 13, 2017.                            the vertical separation between anchor
                                             CFR 25.34(b) that this action is of a type               Leslie Kux,                                           lights, and the location of the forward
                                             that does not individually or                            Associate Commissioner for Policy.                    anchor light at a height of not less than
                                             cumulatively have a significant effect on                [FR Doc. 2017–22590 Filed 10–17–17; 8:45 am]          6 meters above the hull; Annex I,
                                             the human environment. Therefore,                                                                              paragraph 3(a), pertaining to the
                                                                                                      BILLING CODE 4164–01–P
                                             neither an environmental assessment                                                                            horizontal separation between the
                                             nor an environmental impact statement                                                                          forward and after masthead lights;
                                             is required.                                                                                                   Annex I, paragraph 2(i)(iii), pertaining
                                                                                                      DEPARTMENT OF DEFENSE
                                             IV. Paperwork Reduction Act of 1995                                                                            to the vertical spacing of task lights; and
                                                                                                      Department of the Navy                                Annex I, paragraph 3(c), pertaining to
                                               This final order establishes special                                                                         the task lights placed at a horizontal
                                             controls that refer to previously                                                                              distance of not less than 2 meters from
                                                                                                      32 CFR Part 706
                                             approved collections of information                                                                            the fore and aft centerline of the vessel.
                                             found in other FDA regulations. These                    Certifications and Exemptions Under                   The DAJAG (Admiralty and Maritime
                                             collections of information are subject to                the International Regulations for                     Law) has also certified that the lights
                                             review by the Office of Management and                   Preventing Collisions at Sea, 1972                    involved are located in closest possible
                                             Budget (OMB) under the Paperwork                                                                               compliance with the applicable 72
                                             Reduction Act of 1995 (44 U.S.C. 3501–                   AGENCY:    Department of the Navy, DoD.
                                                                                                                                                            COLREGS requirements.
                                             3520). The collections of information in                 ACTION:   Final rule.
                                                                                                                                                               Moreover, it has been determined, in
                                             part 807, subpart E, regarding premarket                                                                       accordance with 32 CFR parts 296 and
                                                                                                      SUMMARY:    The Department of the Navy
                                             notification submissions have been                                                                             701, that publication of this amendment
                                                                                                      (DoN) is amending its certifications and
                                             approved under OMB control number                                                                              for public comment prior to adoption is
                                                                                                      exemptions under the International
                                             0910–0120.                                                                                                     impracticable, unnecessary, and
                                                                                                      Regulations for Preventing Collisions at
                                             List of Subjects in 21 CFR Part 862                      Sea, 1972, as amended (72 COLREGS),                   contrary to public interest since it is
                                               Medical devices.                                       to reflect that the Deputy Assistant                  based on technical findings that the
                                                                                                      Judge Advocate General                                placement of lights on this vessel in a
                                               Therefore, under the Federal Food,
                                                                                                      (DAJAG)(Admiralty and Maritime Law)                   manner differently from that prescribed
                                             Drug, and Cosmetic Act and under
                                                                                                      has determined that USS MICHAEL                       herein will adversely affect the vessel’s
                                             authority delegated to the Commissioner
                                                                                                      MONSOOR (DDG 1001) is a vessel of                     ability to perform its military functions.
                                             of Food and Drugs, 21 CFR part 862 is
                                                                                                      the Navy which, due to its special
                                             amended as follows:                                                                                            List of Subjects in 32 CFR Part 706
                                                                                                      construction and purpose, cannot fully
                                             PART 862—CLINICAL CHEMISTRY                              comply with certain provisions of the 72                 Marine safety, Navigation (water),
                                             AND CLINICAL TOXICOLOGY                                  COLREGS without interfering with its                  Vessels.
                                             DEVICES                                                  special function as a naval ship. The                    For the reasons set forth in the
                                                                                                      intended effect of this rule is to warn               preamble, the DoN amends part 706 of
                                             ■ 1. The authority citation for part 862                 mariners in waters where 72 COLREGS                   title 32 of the Code of Federal
                                             continues to read as follows:                            apply.                                                Regulations as follows:
                                               Authority: 21 U.S.C. 351, 360, 360c, 360e,             DATES: This rule is effective October 18,
                                             360j, 360l, 371.                                         2017 and is applicable beginning                      PART 706—CERTIFICATIONS AND
                                                                                                      October 3, 2017.                                      EXEMPTIONS UNDER THE
                                             ■ 2. Add § 862.3652 to subpart D to read                                                                       INTERNATIONAL REGULATIONS FOR
                                             as follows:                                              FOR FURTHER INFORMATION CONTACT:
                                                                                                      Lieutenant Commander Kyle Fralick,                    PREVENTING COLLISIONS AT SEA,
                                             § 862.3652       Organophosphate test system.            (Admiralty and Maritime Law), Office of               1972
                                               (a) Identification. An                                 the Judge Advocate General, Department
                                                                                                                                                            ■ 1. The authority citation for part 706
                                             organophosphate test system is a device                  of the Navy, 1322 Patterson Ave. SE.,
                                                                                                                                                            continues to read as follows:
                                                                                                      Suite 3000, Washington Navy Yard, DC
ethrower on DSK3G9T082PROD with RULES




                                             intended to measure organophosphate
                                             metabolites quantitatively in human                      20374–5066, telephone 202–685–5040.                       Authority: 33 U.S.C. 1605.
                                             urine from individuals who have signs                    SUPPLEMENTARY INFORMATION: Pursuant                   ■ 2. Section 706.2 is amended by:
                                             and symptoms consistent with                             to the authority granted in 33 U.S.C.                 ■ a. In Table One, adding in
                                             cholinesterase poisoning. The data                       1605, the DoN amends 32 CFR part 706.                 alphanumerical order by vessel number,
                                             obtained by this device is intended to                     This amendment provides notice that                 an entry for USS MICHAEL MONSOOR
                                             aid in the confirmation and                              the DAJAG (Admiralty and Maritime                     (DDG 1001);


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Document Created: 2017-10-18 01:37:39
Document Modified: 2017-10-18 01:37:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal order.
DatesThis order is effective October 18, 2017. The classification was applicable on August 8, 2013.
ContactSteven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD, 20993-0002, 301-796-5866.
FR Citation82 FR 48413 

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