12083 Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Rules and Regulations 
CAUTION: Contains lead acetate. For external use only. Keep this product out of children’s reach. Do not use on cut or abraded scalp. If 
skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after each use. 
(e) Exemption for certification. 
Certification of this color additive for 
the prescribed use is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 721(c) of the Federal Food, Drug, and Cosmetic Act. 
Dated: March 27, 2019. 
Lowell J. Schiller, 
Acting Associate Commissioner for Policy. 
[FR Doc. 2019–06238 Filed 3–29–19; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 806 
[Docket No. FDA–2019–N–1345] 
Medical Devices; Technical 
Amendment 
AGENCY : Food and Drug Administration; 
HHS. 
ACTION : Final rule; technical 
amendment. 
SUMMARY : The Food and Drug 
Administration (FDA or Agency) is amending the medical device reports of corrections and removals regulation to correct three inaccurate cross- references. This action is editorial in nature and is intended to improve the accuracy of the Agency’s regulations. 
DATES : This rule is effective April 1, 
2019. 
FOR FURTHER INFORMATION CONTACT : 
Madhusoodana Nambiar, Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5518, Silver Spring, MD 20993–0002, 301–796–5837. 
SUPPLEMENTARY INFORMATION : FDA is 
amending 21 CFR 806.1 to correct three inaccurate cross-references to ensure accuracy and clarity in the Agency’s medical device regulations regarding medical device reports of corrections and removals. Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulation is nonsubstantive and provides only technical changes to 
correct inaccurate cross-references. 
In the Federal Register of September 
24, 2013 (78 FR 58821), FDA added the definition of ‘‘Human cells, tissues, or 
cellular or tissue-based product (HCT/P) regulated as a device’’ at § 806.2(f). The 
addition of this definition caused the paragraphs following paragraph (f) in § 806.2 to be redesignated alphabetically. Although the definitions of the terms were correct in § 806.2, the paragraphs in § 806.1(b) cross- referenced three of the definitions (market withdrawal, routine servicing, and stock recovery) from § 806.2 based on the previous designations. 
List of Subjects in 21 CFR Part 806 
Imports; Medical devices; Reporting 
and recordkeeping requirements. 
Therefore, under the Federal Food, 
Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 806 is amended as follows: 
PART 806—MEDICAL DEVICES; 
REPORTS OF CORRECTIONS AND REMOVALS 
■1. The authority citation for part 806 
continues to read as follows: 
Authority: 21 U.S.C. 352, 360, 360i, 360j, 
371, 374. 
■2. In § 806.1, revise paragraphs (b)(2) 
through (4) to read as follows: 
§ 806.1 Scope. 
* * * * * 
(b) * * * 
(2) Market withdrawal as defined in 
§ 806.2(i) 
(3) Routine servicing as defined in 
§ 806.2(l). 
(4) Stock recovery as defined in 
§ 806.2(m). 
Dated: March 26, 2019. 
Lowell J. Schiller, 
Acting Associate Commissioner for Policy. 
[FR Doc. 2019–06139 Filed 3–29–19; 8:45 am] 
BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 866 
[Docket No. FDA–2011–N–0103] 
RIN 0910–AH98 
Microbiology Devices; Classification of 
In Vitro Diagnostic Devices for Bacillus Species Detection 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final rule. 
SUMMARY : The Food and Drug 
Administration (FDA, the Agency, or we) is issuing a final rule to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. FDA is also establishing special controls in a special controls guideline in addition to restricting use and distribution of the devices. An in vitro diagnostic device for Bacillus spp. 
detection is a prescription device used to detect and differentiate among Bacillus spp. and presumptively 
identify B. anthracis and other Bacillus 
spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. 
DATES : This rule is effective May 1, 
2019. See further discussion in section V ‘‘Implementation Strategy’’. 
ADDRESSES : For access to the docket to 
read background documents or comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the 
heading of this final rule into the ‘‘Search’’ box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
FOR FURTHER INFORMATION CONTACT : 
Beena Puri, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4502, Silver Spring, MD 20993–0002, 301–796–6202. Beena.Puri@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
Table of Contents 
I. Executive Summary 
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A. Purpose of the Final Rule 
B. Summary of the Major Provisions of the 
Final Rule 
C. Legal Authority D. Costs and Benefits 
II. Background 
A. History of This Rulemaking B. Summary of Comments to the Proposed 
Rule 
III. Legal Authority IV. Comments on the Proposed Rule and FDA 
Response 
V. Implementation Strategy VI. Electronic Access VII. Economic Analysis of Impacts VIII. Analysis of Environmental Impact IX. Paperwork Reduction Act of 1995 X. Consultation and Coordination With 
Indian Tribal Governments 
XI. References 
I. Executive Summary 
A. Purpose of the Final Rule 
FDA is classifying in vitro diagnostic 
devices for Bacillus species (spp.) 
detection (product codes NVQ, NPO, 
NRL, NHT, and NWZ) into class II (special controls), establishing special controls in a special controls guideline entitled ‘‘Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection,’’ restricting 
the device to prescription use, and restricting distribution of these devices to laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities. 
This decision is based upon the 
recommendations from the Microbiology Devices Advisory Panel (the Panel), public comments received following the publication of the proposed rule, FDA’s experience with these devices. FDA believes that the special controls established and imposed by this final rule and special controls guideline, together with the general controls, will provide a reasonable assurance of safety and effectiveness of the device. Further, FDA believes that the restrictions on use and distribution are required for the safe and effective use of the device. 
B. Summary of the Major Provisions of 
the Final Rule 
This final rule classifies in vitro 
diagnostic devices for Bacillus spp. 
detection into class II (special controls), and establishes special controls in a special controls guideline entitled ‘‘Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection’’ which address: (1) Specific information relating to the devices’ intended use, components, testing procedures, specimen storage/ shipping conditions, and interpretation/ reporting; (2) detailed descriptive 
information regarding the studies required to demonstrate appropriate performance and control against assays that may otherwise fail to perform to acceptable standards; (3) specific labeling requirements; and (4) certain information that must be submitted for in vitro diagnostic devices for Bacillus spp. detection that use nucleic acid amplification. 
This rule also restricts the use and 
distribution of these devices. Because handling the quality control organisms and those potentially present in the specimen may pose a risk to laboratory workers, FDA is finalizing a restriction on distribution of these products to laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities. Further, FDA is restricting use of these devices to be a prescription device under the terms set forth in 21 CFR 866.3045(d). 
C. Legal Authority 
FDA is issuing this rule under the 
authority of the provisions of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to medical devices (21 U.S.C. 301 et seq.), including section 513(a) regarding device classes (21 U.S.C. 360c(a)), sections 513(b) and (c) regarding device classification panels (21 U.S.C. 360c(b) and (c)), section 513(d) regarding device classification (21 U.S.C. 360c(d)), and section 520(e) regarding restrictions on the sale, distribution, or use of a device (21 U.S.C. 360j(e)). 
D. Costs and Benefits 
Quantifiable benefits of this rule are 
annual cost savings resulting from a 
reduction in the time burden of inquiries manufacturers submit to FDA. The primary present value of the benefits, over a 20-year time horizon from 2018 to 2038 are estimated to be $258,054, at a 7 percent discount rate and $353,393, at a 3 percent discount rate. The primary estimate of the annual benefits is $22,258 a year. 
This rule has a one-time upfront cost 
for current manufacturers of these devices as they will need to spend time reading the rule and may need to develop new labeling. There is also an annual cost of reading the rule to firms who may submit inquiries in the future. The primary present value of the costs, over a 20-year time horizon, are estimated to be $12,659 at a 7 percent discount rate and $14,081 at a 3 percent discount rate. The primary annualized costs are $1,092 at a 7 percent discount rate and $887 at a 3 percent discount rate. The total net benefit of the rule is estimated to be $245,395 at a 7 percent discount rate and $339,312 at a 3 percent discount rate. The annualized net benefits of this rule are estimated to be $21,166 at a 7 percent discount rate and $21,371 at a 3 percent discount rate. 
II. Background A. History of This Rulemaking 
In the Federal Register of November 
17, 2015 (80 FR 71756), FDA issued a 
proposed rule to classify in vitro diagnostic devices for Bacillus spp. 
detection as class II with special controls, and proposed the draft special controls guideline entitled ‘‘Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. 
Detection; Draft Guideline for Industry and Food and Drug Administration Staff’’ (Ref. 1) and certain restrictions on its use and distribution. The proposed special controls and restrictions were based, in part, upon feedback received from the Panel on March 7, 2002 (Ref. 2). FDA invited interested persons to comment on the proposed regulation and the special controls guideline by February 16, 2016. 
B. Summary of Comments to the 
Proposed Rule 
FDA received one comment 
requesting an exclusive 510(k). This comment is outside the scope of the rule. No comments opposed the proposed classification for in vitro diagnostic devices for Bacillus spp. 
detection. 
III. Legal Authority 
The FD&C Act (21 U.S.C. 301 et seq.), 
as amended, established a 
comprehensive system for the regulation of medical devices intended for human use. The FD&C Act establishes three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness (section 513(a) of the FD&C Act). The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). 
Class I devices are those devices for 
which the general controls of the FD&C Act (controls authorized by or under the general controls sections of the FD&C Act (sections 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j), or any combination of such sections) are sufficient to provide a reasonable assurance of the safety and effectiveness of the device; or those devices for which insufficient information exists to determine that general controls are 
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sufficient to provide reasonable 
assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act). Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions as the Agency deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act). Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act). 
FDA refers to devices that were in 
commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), as ‘‘preamendments devices.’’ Pursuant to section 513(d)(1) of the FD&C Act, FDA classifies these devices after FDA: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel’s recommendation for comment, along with a proposed regulation classifying the device; and (3) publishes a final regulation classifying the device (section 513(d)(1) of the FD&C Act). FDA has classified most preamendments devices under these procedures and has followed these procedures to classify in vitro diagnostic devices for Bacillus spp. detection. 
Section 520(e) of the FD&C Act 
authorizes FDA to issue regulations imposing restrictions on the sale, distribution, or use of a device, if because of its potentiality for harmful effect or the collateral measures 
necessary to its use, FDA determines that absent such restrictions, there cannot be a reasonable assurance of its 
safety and effectiveness. Certain provisions of the FD&C Act related specifically to FDA’s authority over restricted devices. For example, section 502(q) and (r) of the FD&C Act provide that a restricted device distributed or offered for sale in any state shall be deemed to be misbranded if its advertising is false or misleading or fails to include certain information regarding the device, or it is sold, distributed, or used in violation of regulations prescribed under section 520(e) of the FD&C Act, and section 704(a) of the FD&C Act (21 U.S.C. 374(a)) authorizes FDA to inspect certain records relating 
to restricted devices. FDA continues to believe that the restrictions as provided in the final rule related to distribution and use are required for the safe and effective use of the device. 
IV. Comments on the Proposed Rule 
and FDA Response 
FDA received one comment on the 
proposed rule by the close of the comment period, requesting an exclusive 510(k). This comment is outside of the scope of the rule. No comments opposed the proposed classification for in vitro diagnostic devices for Bacillus spp. detection. In 
this final rule, FDA is adopting the classification, special controls and the restrictions on use and distribution from its proposed rule published on November 17, 2015 (80 FR 71756). 
V. Implementation Strategy 
This final rule will become effective 
30 days after its date of publication in 
the Federal Register. 
The implementation strategy is set 
forth below for these devices. 
•Devices that have not been legally 
marketed prior to the date of publication of this final rule, or devices that have been legally marketed, but are required to submit a new 510(k) under 21 CFR 807.81(a)(3) because the device is about to be significantly changed or modified: Manufacturers must obtain 510(k) clearance and comply with special controls before marketing the new or changed device. 
•Devices that have been legally 
marketed prior to the date of publication of this final rule, and devices for which 510(k) submissions have been submitted before the date of publication of this final rule: Manufacturers are not required to submit a 510(k) to demonstrate compliance with the special controls set forth in sections VI, VII, and IX of the special controls guideline. FDA had proposed that manufacturers of such devices must comply with the underlying requirements for those special controls, 
as well as the labeling special controls set forth in section VIII of the special controls guideline. FDA is finalizing our classification and is clarifying that for such devices, FDA does not expect submission of documentation to FDA demonstrating compliance with the special controls set forth in sections VI, VII, and IX of the special controls guideline. Further, FDA does not intend to enforce compliance with the labeling special controls set forth in section VIII of the special controls guideline until April 1, 2020. If a manufacturer markets such a device after April 1, 2020, and that device does not comply with the labeling special controls set forth in section VIII of the special controls guideline, then FDA would consider taking action against such a manufacturer under its usual enforcement policies. FDA believes that a period of 1 year from the publication date of this final rule is appropriate for manufacturers to come into compliance with such requirements. FDA believes this approach will help ensure the efficient and effective implementation of this final rule. 
VI. Electronic Access 
Persons interested in obtaining a copy 
of the final special controls guideline 
may do so by using the internet. A search capability for all Center for Devices and Radiological Health guidelines and guidance documents is available at https://www.fda.gov/ MedicalDevices/DeviceRegulationandGuidance/GuidanceDocumentsdefault.htm. The final special controls 
guideline is also available at https://www.regulations.gov. Persons unable to 
download an electronic copy of ‘‘Class 
II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. 
Detection,’’ may send an email request to CDRH-Guidance@fda.hhs.gov to 
receive an electronic copy of the document. Please use the document number 1400038 to identify the special controls guideline you are requesting. 
VII. Economic Analysis of Impacts 
We have examined the impacts of the 
final rule under Executive Order 12866, 
Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, 
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and other advantages; distributive 
impacts; and equity). Executive Order 13771 requires that the costs associated with significant new regulations ‘‘shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.’’ We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866. 
The Regulatory Flexibility Act 
requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because of the small impact expected from this rule, we certify that the final 
rule will not have a significant economic impact on a substantial number of small entities. 
The Unfunded Mandates Reform Act 
of 1995 (section 202(a)) requires us to prepare a written statement, which 
includes an assessment of anticipated costs and benefits, before proposing 
‘‘any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.’’ The current threshold after adjustment for inflation is $154 million, using the most current (2018) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount. 
Quantifiable benefits of this rule are 
cost savings resulting from a reduction in the time burden of inquiries manufacturers submit to FDA. The cost savings involve manufacturers, who no 
longer need to submit as many inquiries related to submissions for these devices, because much of the necessary information is provided by this rule and guideline, and FDA, who no longer needs to use resources to respond to these inquiries. A 20-year time horizon was chosen for this analysis because this industry has been stable and there is no reason to expect disruptions for the foreseeable future. The primary present value of the benefits, over a 20- year time horizon from 2018 to 2038 are 
estimated to be $258,054, at a 7 percent discount rate and $353,393, at a 3 percent discount rate. The primary estimate of the annual benefits, over a 20-year time horizon from 2018 to 2038, are estimated to be $22,258 a year. 
TABLE 1—S UMMARY OF BENEFITS , COSTS , ANDDISTRIBUTIONAL EFFECTS OF THE FINAL RULE IN 2017 D OLLARS OVER A  
20-Y EARTIMEHORIZON  
Category Primary 
estimate Low 
estimate High 
estimate Units 
Notes 
Year dollars Discount rate 
(%) Period 
covered 
Benefits: 
Annualized Monetized $/year .......... $22,258 
22,258 $7,419 
7,419 $37,096 
37,096 2017 
2017 7 
3 20 
........................
Annualized Quantified ..................... ........................
................................................
........................................................................................................................7 
3 ................................................
Qualitative. 
Costs: 
Annualized Monetized $/year .......... 1,092 
887 733 595 1,455 
1,183 2017 
2017 7 
3 20 
20 
Annualized Quantified ..................... ........................
........................................................................................................................................................................7 
3 ................................................
Qualitative. 
Transfers: 
Federal Annualized Monetized $/ 
year.................................................................................................................................................................................................7 
3 ................................................
From/To ........................................... From: To: 
Other Annualized Monetized $/year ........................
........................................................................................................................................................................7 3 ................................................
From/To ........................................... From: To: 
Effects: 
State, Local or Tribal Government: Small Business: Wages: Growth: 
This rule has a one-time upfront cost 
for current manufacturers of these 
devices as they may need to develop new labeling. There are seven total products on the market and each labeling redesign is estimated to cost $1,096. We estimate the total labeling cost to be $7,674. The six existing manufacturers (one firm has two products) also face a one-time upfront cost of having to read the rule and guideline which we estimate to be $1,138 for the manufacturers. Finally, there is an annual cost of reading the rule to firms who may submit inquiries in the future. We estimate this annual cost to be $332. The primary present value of the costs, over a 20-year time horizon from 2018 to 2038, are estimated to be $12,659 at a 7 percent discount rate and $14,081 at a 3 percent discount rate. The primary annualized costs, over a 20-year time horizon from 2018 to 2038, are estimated to be $1,092 at a 7 percent discount rate and $887 at a 3 percent discount rate. The total net benefit of the rule is estimated to be $245,395 at a 7 percent discount rate and $339,312 at a 3 percent discount rate. The annualized net benefits of this rule are estimated to be $21,166 at a 7 percent discount rate and $21,371 at a 3 percent discount rate. 
In line with Executive Order 13771, in 
table 2 we estimate present and annualized values of costs and cost savings over an infinite time horizon. Based on these cost savings this final 
rule would be considered a deregulatory action under Executive Order 13771. Our primary estimate for the present value of the net costs is ¥$319,974 (or a cost savings of $319,974) at a 7 percent discount rate and ¥$729,462 at a 3 percent discount rate in 2016 dollars. 
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TABLE 2—E XECUTIVE ORDER 13771 S UMMARY TABLE 
[In 2016 dollars, over an infinite time horizon] 
Primary 
(7%) Lower bound 
(7%) Upper bound 
(7%) Primary 
(3%) Lower bound 
(3%) Upper bound 
(3%) 
Present Value of Costs ............................ $13,614 $9,133 $18,094 $19,812 $13,265 $26,358 
Present Value of Cost Savings ................ 333,588 77,548 555,938 749,273 174,181 1,248,789 
Present Value of Net Costs ..................... (319,974) (68,415) (537,843) (729,462) (160,916) (1,222,430) 
Annualized Costs ..................................... 891 597 1,184 577 386 768 
Annualized Cost Savings ......................... 21,823 5,073 36,370 21,823 5,073 36,372 
Annualized Net Costs .............................. (20,933) (4,476) (35,186) (21,246) (4,687) (35,605) 
We have developed a comprehensive 
Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic impacts is available in the docket for this final rule (Ref. 3) and at https://www.fda.gov/ AboutFDA/ReportsManualsForms/ Reports/EconomicAnalyses/default.htm. 
VIII. Analysis of Environmental Impact 
We have 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. 
IX. Paperwork Reduction Act of 1995 
This final rule establishes special 
controls and restrictions that refer to 
currently 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 (the PRA) (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120 and the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910–0485. 
The labeling referenced in sections 
VI(A), VIII(A), and VIII(C) of the final special controls guideline do not constitute a ‘‘collection of information’’ under the PRA because the labeling is a ‘‘public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public’’ (5 CFR 1320.3(c)(2)). 
X. Consultation and Coordination With 
Indian Tribal Governments 
We have analyzed this rule in 
accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required. 
XI. References 
The following references marked with 
an asterisk (*) are on display at the 
Dockets Management Staff (see 
ADDRESSES ) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References 
without asterisks are not on public display at https://www.regulations.gov because they have a copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 
*1. Final Special Controls Guideline for 
Industry and Food and Drug 
Administration Staff, ‘‘Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection,’’ 
issued April 1, 2019, available at https:// 
www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM470760.pdf. 
*2. Transcript of the FDA Microbiology 
Devices Panel meeting, March 7, 2002 (available at https://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfAdvisory/details.cfm?mtg=348). 
*3. ‘‘Preliminary Regulatory Impact Analysis, 
Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection,’’ 
available at https://www.fda.gov/ downloads/AboutFDA/ReportsManualsForms/Reports/Economic
Analyses/UCM477856.pdf. 
4. Abshire, T.G., J.E. Brown, and J.W. Ezzell, 
‘‘Validation of the Use of Gamma Phage for Identifying Bacillus anthracis,’’ 102nd American Society for Microbiology Annual Meeting (poster #C122), 2001. 
*5. Abshire, T.G., et al., ‘‘Production and 
Validation of the Use of Gamma Phage for the Identification of Bacillus anthracis,’’ Journal of Clinical 
Microbiology, vol. 43(9), pp. 4780–8, 
2005, available at https://www.ncbi.nlm.nih.gov/pubmed/ 16145141. 
* 6. Brown, E.R. and W.B. Cherry, ‘‘Specific 
Identification of Bacillus anthracis by Means of a Variant Bacteriophage,’’ Journal of Infectious Diseases, vol. 96, p. 34, 1955, available at https://jid.oxfordjournals.org/content/96/1/ 34.long. 
* 7. Brown, E.R. et al., ‘‘Differential Diagnosis 
of Bacillus cereus, Bacillus anthracis, 
and Bacillus cereus var. mycoides,’’ 
Journal of Bacteriology, vol. 75, p. 499, 1958, available at https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC290100/pdf/jbacter00512-0024.pdf. 
* 8. Buck C.A., R.L. Anacker, F.S. Newman, 
et al., ‘‘Phage Isolated from Lysogenic Bacillus anthracis,’’ Journal of 
Bacteriology, vol. 85, p. 423, 1963, 
available at https://jb.asm.org/content/ 85/6/1423.full.pdf+html?sid=c14df35d- 1d7b-4cac-b55b-2097931a4623. 
9. Parry, J.M., P.C.B. Turnbull, and J.R. 
Gibson, ‘‘A Colour Atlas of Bacillus Species,’’ Wolfe Medical Publications Ltd., London, 1983. 
List of Subjects in 21 CFR Part 866 
Biologics, Laboratories, 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 866 is amended as follows: 
PART 866—IMMUNOLOGY AND 
MICROBIOLOGY DEVICES 
■1. The authority citation for part 866 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
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■2. Section 866.3045 is added to 
subpart D to read as follows: 
§ 866.3045 In vitro diagnostic device for 
Bacillus spp. detection. 
(a) Identification. An in vitro 
diagnostic device for Bacillus species 
(spp.) detection is a prescription device 
used to detect and differentiate among Bacillus spp. and presumptively 
identify B. anthracis and other Bacillus 
spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device may consist of 
Bacillus spp. antisera conjugated with a 
fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens; bacteriophage used for differentiating B. anthracis from other 
Bacillus spp. based on susceptibility to 
lysis by the phage; or antigens used to identify antibodies to B. anthracis (anti- toxin and anti-capsular) in serum. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, and gastrointestinal disease and non- gastrointestinal infections caused by B. cereus. 
(b) Classification. Class II (special 
controls). The special controls are set forth in FDA’s special controls guideline document entitled ‘‘In Vitro Diagnostic Devices for Bacillus spp. Detection; 
Class II Special Controls Guideline for Industry and Food and Drug Administration Staff.’’ For availability of the guideline document, see § 866.1(e). 
(c) Restriction on Distribution. The 
distribution of these devices is limited to laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities. 
(d) Restriction on Use. The use of this 
device is restricted to prescription use and must comply with the following: 
(1) The device must be in the 
possession of: 
(i)(A) A person, or his agents or 
employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or 
(B) A practitioner, such as a 
physician, licensed by law to use or order the use of such device; and 
(ii) The device must be sold only to 
or on the prescription or other order of such practitioner for use in the course of his professional practice. 
(2) The label of the device shall bear 
the statement ‘‘Caution: Federal law restricts this device to sale by or on the order of a ll ’’, the blank to be filled with the word ‘‘physician’’ or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device. 
(3) Any labeling, as defined in section 
201(m) of the Federal Food, Drug, and Cosmetic Act, whether or not it is on or within a package from which the device is to be dispensed, distributed by, or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications or other use information. 
(4) All labeling, except labels and 
cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling. 
Dated: March 22, 2019. 
Scott Gottlieb, 
Commissioner of Food and Drugs. 
[FR Doc. 2019–06026 Filed 3–29–19; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 888 
[Docket No. FDA–2015–N–3785] 
RIN 0910–AI00 
Medical Devices; Orthopedic Devices; 
Classification of Posterior Cervical Screw Systems 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final rule. 
SUMMARY : The Food and Drug 
Administration (FDA, the Agency, or we) is issuing a final rule to classify posterior cervical screw systems into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. The term ‘‘posterior cervical screw systems’’ is used to distinguish these devices from currently classified thoracolumbosacral pedicle screw systems for use in other spinal regions. 
DATES : This rule is effective May 1, 
2019. 
ADDRESSES : For access to the docket to 
read background documents or comments received, go to http://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
FOR FURTHER INFORMATION CONTACT : 
Genevieve McRae, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1457, Silver Spring, MD 20993–0002, 301–796–6423, genevieve.mcrae@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
Table of Contents 
I. Executive Summary 
A. Purpose of the Final Rule 
B. Summary of the Major Provisions of the 
Final Rule 
C. Legal Authority D. Costs and Benefits 
II. Background 
A. History of This Rulemaking B. Summary of Comments to the Proposed 
Rule 
III. Legal Authority IV. Comments on the Proposed Rule and FDA 
Response 
A. Introduction 
B. Description of General Comments and 
FDA Response 
C. Specific Comments and FDA Response 
V. Effective Date VI. Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Consultation and Coordination With 
Indian Tribal Governments 
X. Reference 
I. Executive Summary 
A. Purpose of the Final Rule 
Through this final rule, FDA is 
classifying posterior cervical screw 
systems (product code NKG) into class II (special controls). This decision was based upon the recommendation of the Orthopaedic and Rehabilitation Devices Panel (the Panel) and our consideration and analysis of the public comments received following the publication of the proposed rule. FDA believes that the special controls established and imposed by this final rule, together with 
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