On November 14, 2011 (76 FR 70331), the NRC published a direct final rule amending its regulations at Title 10 of the Code of Federal Regulations Section 72.214 by revising the NAC MAGNASTOR® System listing within the “List of Approved Spent Fuel Storage Casks” to include Amendment No. 2 to CoC Number 1031. In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on January 30, 2012. The NRC did not receive any comments on the direct final rule. Therefore, this rule will become effective as scheduled.

This final rule incorporates by reference into Part 430 the following industry standard:

IESNA LM-49-01 (“IESNA LM-49”), IESNA Approved Method for Life Testing of Incandescent Filament Lamps, approved December 1, 2001.

Copies of IES standards can be purchased from the Illuminating Engineering Society (IES), 120 Wall Street, Floor 17, New York, NY 10005-4001, (212) 248-5000, orhttp://www.ies.org/store/.

You can also view copies of this standard at the U.S. Department of Energy, Building Technologies Program, 950 L'Enfant Plaza SW., 6th Floor, Washington, DC, 20024, (202) 586-2945, between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays. Please call Ms. Brenda Edwards at the above telephone number for additional information.

Title III of the Energy Policy and Conservation Act (42 U.S.C. 6291,et seq.;“EPCA” or, “the Act”) sets forth a variety of provisions designed to improve energy efficiency. (All references to EPCA refer to the statute as amended through the Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140 (Dec. 19, 2007)). Part B of title III, which for editorial reasons was redesignated as Part A upon incorporation into the U.S. Code (42 U.S.C. 6291-6309), establishes the “Energy Conservation Program for Consumer Products Other Than Automobiles.” These include general service fluorescent lamps (GSFLs), general service incandescent lamps (GSILs), and incandescent reflector lamps (IRLs), the subject of today's notice. (42 U.S.C. 6292(a)(14) and 6295(i))

Under EPCA, this program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products must use (1) as the basis for certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA, and (2) for making representations about the efficiency of those products, including on the Federal Trade Commission's EnergyGuide label. Similarly, DOE must use these test requirements to determine whether the products comply with any relevant standards promulgated under EPCA. However, to ensure that DOE is in full compliance with Section 315 of Public Law 112-74, DOE will not finalize in this document provisions related to certifying lamps subject to that provision of law. DOE may finalize those procedures at an appropriate time in the future.

Relevant to this rulemaking, EPCA, as codified, directs DOE to prescribe test procedures for GSFLs and IRLs, taking into consideration the applicable standards of the Illuminating Engineering Society of North America1 (IESNA) or the American National Standards Institute2 (ANSI). (42 U.S.C. 6293(b)(6))

In addition, on December 19, 2007, the Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140, was enacted. Section 321 of EISA 2007 amended EPCA, in relevant part, to prescribe energy conservation standards for GSILs that included maximum rated wattage and minimum rated lifetime requirements for several different lumen ranges; these standards will be phased in between 2012 and 2014. (42 U.S.C. 6295(i)) Section 302 of EISA 2007 also amended EPCA to require DOE to review test procedures for all covered products at least once every seven years. DOE must either amend the test procedures or publish notice in theFederal Registerof any determination not to amend a test procedure. (42 U.S.C. 6293(b)(1)(A))

In order to (1) fulfill the statutory requirements for periodic review of test procedures and (2) create for the first time a lifetime test procedure for GSILs, consistent with the minimum rated lifetime requirements set forth in EPCA, DOE published a notice of proposed rulemaking (NOPR) in theFederal Registeron September 14, 2011. DOE also invited comment on all aspects of the existing test procedures for GSFLs, GSILs, and IRLs that appear at Title 10 of the Code of Federal Regulations (CFR): 10 CFR 429.27 (“General service fluorescent lamps, general service incandescent lamps, and incandescent reflector lamps”), 10 CFR 430.2 (“Definitions”), 10 CFR 430.3(“Materials incorporated by reference”), 10 CFR 430.23 (“Test procedures for the measurement of energy and water consumption”), 10 CFR 430.25 (“Laboratory Accreditation Program”), and 10 CFR part 430 subpart B, Appendix R (“Uniform Test Method for Measuring Average Lamp Efficacy (LE), Color Rendering Index (CRI), and Correlated Color Temperature (CCT) of Electric Lamps”). 76 FR 56661, 56662 (September 14, 2011). DOE subsequently held a public meeting on October 4, 2011 to discuss the proposals in the NOPR and invited written comments through November 28, 2011.

To address prior EPCA requirements for GSFLs, GSILs, and IRLs, DOE has previously undertaken a number of rulemaking actions pertaining to the test procedures for these products. For further details refer to the NOPR. 76 FR 56661, 56662-63. Test procedures for GSFLs, GSILs, and IRLs are specified in various sections of the CFR and are based on the 1997 and 2009 final rules addressing test procedures for fluorescent and incandescent lamps. 62 FR 29221 (May 29, 1997); 74 FR 31829 (July 6, 2009); 74 FR 34080 (July 14, 2009). Prior to this final rule, DOE had no test procedure for measuring GSIL lifetime. Calculations for lamp efficacy of GSFLs, GSILs, and IRLs and for color rendering index of GSFLs are discussed in 10 CFR 430.23, which references 10 CFR part 430, subpart B, Appendix R. Appendix R specifies several IESNA and ANSI standards to use for test conditions and procedures. For GSFLs, it references measurement procedures set forth in IESNA LM-9-1999.3 Additionally, GSFLs are to be operated according to general procedures for taking electrical measurements described in ANSI C78.375-1997,4 and at the voltage and current conditions described in ANSI C78.81-2005 (double-based lamps)5 or ANSI C78.901-2005 (single-based lamps),6 and using the reference ballast at input voltage specified by the reference circuit in ANSI C82.3-2002.7 Appendix R also notes that the prior measurement procedures for GSILs and IRLs are set forth in IESNA LM-45-20008 and IESNA LM-20-1994,9 respectively.

Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. EPCA provides that any test procedures prescribed or amended under this section shall be reasonably designed to produce test results which measure energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle or period of use and shall not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6293(b)(2)) Finally, in any rulemaking to amend a test procedure, DOE must determine to what extent, if any, the proposed test procedure would alter the measured energy efficiency of any covered product as determined under the existing test procedure. (42 U.S.C. 6293(e)(1)). If DOE determines that the amended test procedure would alter the measured efficiency of a covered product, DOE must amend the applicable energy conservation standard accordingly. (42 U.S.C. 6293(e)(2))

With respect to today's rulemaking, DOE has determined that none of the amendments it is adopting will change the measured efficacy of the GSFLs, GSILs, or IRLs when compared to the previously existing test procedures.

Today's rule amends DOE's test procedures for GSFLs and GSILs. The amendments achieve two objectives: (1) Update test procedures by incorporating certain lighting industry standards by reference in order to adopt current best practices and technological developments and (2) establish a new test procedure for determining GSIL rated lifetime, consistent with the minimum rated lifetime requirements in set forth in EPCA.

Regarding the first objective, this final rule updates industry standards previously incorporated by reference to the latest versions of those documents. For GSFLs, DOE is updating dimensional and electrical characteristic-related references to ANSI C78.81-2003 as well as ANSI C78.81-2005 to ANSI C78.81-2010,10 and references to IESNA LM-9-199911 to IES LM-9-200912 for measuring electrical and photometric attributes. For GSILs, DOE is updating references of IESNA LM-45-2000 to IES LM-45-200913 for measuring electrical and photometric attributes. These changes will not, in DOE's view, significantly alter reported lamp efficacy values.14

Regarding the second objective, today's final rule establishes a GSIL test procedure for lifetime testing. As noted above, EISA 2007 amended EPCA, in part, by establishing energy conservation standards for GSILs which include for the first time minimum rated lifetime requirements that are to be phased in between January 2012 and January 2014. In order to meet these requirements, this final rule establishes a test procedure for GSIL lifetime that includes incorporation by reference of the industry standard “IESNA Approved Method for Life Testing of Incandescent Filament Lamps,” IESNA LM-49-2001;15 a definition for rated lifetime of GSILs; a sample size of 21 lamps for GSIL lifetime testing; and requirements for laboratory accreditation.

As indicated in greater detail below, these amendments and additions apply to the procedures in 10 CFR part 430, subpart B, Appendix R, and also to sections 10 CFR 429.27, 10 CFR 430.2, 10 CFR 430.23, 10 CFR 430.25. The changes do not affect measured efficacy of GSFLs, GSILs, and IRLs. The amendments to DOE's test procedures in this final rule will take effect 30 days after publication of this final rule.

After reviewing the current industry best practices and technological developments, DOE identified and proposed appropriate updates for the GSFL and GSIL test procedures, but no updates for the IRL test procedure. DOE proposed the following changes to the existing test procedures for GSFLs: (1) Updating references of ANSI C78.81-2003 and ANSI C78.81-2005 to ANSI C78.81-2010, which provides dimensional and electrical characteristics of fluorescent lamps; and, (2) updating references of IESNA LM-9-1999 to IES LM-9-2009 for measuring the electrical and photometric attributes of fluorescent lamps. In addition, DOE proposed modifying the existing test procedures for GSILs by updating references of IESNA LM-45-2000 to IES LM-45-2009 for measuring their electrical and photometric attributes of incandescent filament lamps.

As DOE's GSFL, GSIL, and IRL test procedures are based mainly on references to industry standards, when possible, DOE test procedures should reference the latest versions of these standards in order to be aligned with industry standards and practices. Periodic updates to these industry standards generally account for changes in product lines and/or developments in test methodology and equipment. Therefore, in the NOPR analysis, DOE reviewed relevant industry standards and compared versions. DOE found that the latest versions of these standards will increase the precision of measurements and provide clarifications of existing test setup and methodology. DOE determined that these revisions to DOE's regulations would not alter measured energy efficiency nor result in a test procedure that is unduly burdensome to conduct. (42 U.S.C. 6293(e)(1), 42 U.S.C. 6293(b)(3))

DOE received various comments on its proposed updates to those industry standards already incorporated by reference in DOE's test procedures. The sections below provide a brief summary of the key changes in the updated industry standards and DOE's responses to comments on these changes.

In the NOPR, DOE proposed updating all references to ANSI C78.81 in DOE's test procedures and definitions relating to GSFLs and fluorescent lamp ballasts from the 2003 and 2005 editions to the 2010 edition. ANSI C78.81 provides the dimensional and electrical specifications for fluorescent lamps. Adoption of the latest version of ANSI C78.81 will ensure that DOE test procedures reference updated lamp specifications.

DOE concluded in the NOPR analysis that updating to the 2010 version would not change the lamp specifications currently prescribed in DOE's test procedures. The main modification in the 2010 version is the addition of high-frequency and low-frequency lamp specifications for 25W, 28W, and 30W reduced-wattage 4-foot T8 medium bipin lamps. DOE requires testing GSFLs using low-frequency lamp specifications unless only high-frequency lamp specifications are available. The low-frequency ballast specifications for reduced-wattage lamps specified in the 2010 version are identical to those prescribed in the DOE test procedures for 4-foot T8 medium pin lamps.16 DOE's test procedures also prescribe low-frequency lamp specifications in ANSI C78.81-2003 for certain lamps, which are also identical to those specified in the 2010 version. Therefore, in this final rule, DOE concludes that neither measured efficacy nor testing burden would be affected by updating the references to ANSI C78.81-2010 in DOE test procedures.

The National Electrical Manufacturers Association (NEMA) commented that the low frequency reference ballast specifications included in ANSI C78.81 and C78.901 will be replaced with high frequency reference ballast specifications in the next revisions of these standards which are planned for publication in 2012. They added that as a result manufacturers will have to perform testing using low frequency reference ballasts for DOE certification and compliance reporting and high frequency reference ballasts for normative compliance using the updated standards. NEMA suggested coordinating the adoption of DOE's next test procedure with the updated ANSI standards in order to reduce dual testing burden. (NEMA, No. 8 at p. 2)17

Since the planned versions of ANSI C78.81-2010 and C78.901-2005 to which NEMA is referring were not available for DOE to assess and solicit comment on, DOE cannot reference these scheduled updated versions in this final rule. Therefore, because high-frequency testing specifications are still not yet available for all of DOE's covered fluorescent lamp types, DOE will maintain the requirement to test GSFLs using low-frequency reference lamp specifications unless only high-frequency lamp specifications are available as stated above. Regarding the possibility that manufacturers may have to conduct dual testing (low-frequency testing for DOE compliance and high-frequency testing for normative compliance), DOE is continually monitoring the development of testing standards of GSFLs and will consider amendments to future test procedures including testing on high-frequency reference ballasts as necessary.

In the NOPR, DOE proposed updating references to IESNA LM-9-1999 which specifies procedures for measuring the efficacy of GSFLs to the 2009 version. DOE's review indicated that incorporating the 2009 edition of IES LM-918 would align DOE's requirements with current industry standards; provide further clarification of the test procedure; and improve the test methodology and test instrumentation setup and specifications.

DOE identified the following four key updates to the 2009 edition of IES LM-9: (1) Additional information on conducting tests under high-frequency conditions; (2) modification of the lamp stabilization method; (3) added specification of temperature and orientation for stabilization of T5 lamps; and (4) added specification of impedance19 thresholds for the multipurpose volt, amperes, and watts (VAW) meter and power source. (More detail on these updates can be found in the NOPR. 76 FR 56661, 56665-66.) In the NOPR, DOE concluded that these updates would not significantly affect lamp efficacy or pose a significant testing burden. DOE did not receive any comments regarding the impacts of specific updates in the 2009 version of IES LM-9. DOE did however receive comments from interested partiesregarding potential issues with accreditation to the 2009 version of IES LM-9 as well as a request for clarification on the added specifications for T5 lamps and the existing CCT reporting requirement. DOE is also providing further guidance on the lamp stabilization method in this final rule.

NEMA, Osram Sylvania Inc. (OSI), and Philips Lighting (Philips) commented that many laboratories are not yet accredited to IES LM-9-2009 and would not be able to use the test procedure for compliance testing by the effective date of June 2012. They further noted that it was unclear whether the National Volunteer Laboratory Accreditation Program (NVLAP)20 had begun accrediting to the updated IES version. (NEMA, No. 8 at p. 2; OSI, Public Meeting Transcript, No. 7 at p. 34; Philips, Public Meeting Transcript, No. 7 at pp. 34-35) ICF Consulting on behalf of Energy Star (ICF) noted that there are several accrediting bodies that are already accrediting to IES LM-9-2009. (ICF, Public Meeting Transcript, No. 7 at p. 35)

Testing for GSFLs, IRLs, and GSILs must be conducted by a laboratory accredited by NVLAP or by an accrediting organization recognized by NVLAP. (10 CFR 430.25) At the time this final rule was written, there were ten laboratories accredited to IES LM-9 by NVLAP of which five were accredited to the most recent 2009 version.21 DOE has therefore concluded that because several laboratories are already accredited to IES LM-9-2009, compliance with updated test procedures established in this final rule is achievable by June 2012.

The People's Republic of China (P.R. China)22 requested clarification on the orientation of T5 lamps during the seasoning process at 35 °C. (P.R. China, No. 9 at p. 3) As stated in IES LM-9-2009, T5 lamps are to be seasoned in the vertical direction in 25 °C ambient air so as to obtain stable photometric results. IES LM-9-2009 also specifies that T5 lamps are to be measured horizontally, despite seasoning occurring in the vertical orientation.

NEMA also commented on an existing DOE GSFL test procedure requirement for reporting CCT. NEMA noted that ANSI C78.37623 guidance recognizes that CCT varies within the allowed chromaticity tolerance ellipse24 for fluorescent lamps and therefore assigns such lamps six separate nominal color temperature ellipses25 and designations. NEMA commented that since fluorescent lamps' chromaticity varies with lifetime, manufacturers design lamps to remain within a designated ellipse. Given these considerations, NEMA requested further clarification on why DOE proposed a requirement to report CCT to the nearest 10 degrees. (NEMA, No. 8 at p. 5)

In the NOPR stage of the 2009 test procedure rule for GSFLs, IRLs, and GSILs, DOE proposed test procedures that required CCT to be rounded to the nearest unit (measured in kelvin (K)). In response to DOE's proposal, NEMA recommended rounding CCT to the nearest 10 degrees because rounding to the nearest degree demonstrates a false level of accuracy. DOE consulted with the National Institute of Standards and Technology (NIST) and agreed with NEMA's conclusion that distinguishing between single digits in CCT is not meaningful. Therefore, because all laboratories were able to measure CCT to three significant figures, DOE required that manufacturers round CCT to the nearest 10 degrees in the July 2009 Test Procedure final rule. 74 FR 31829 (July 6, 2009). DOE finds no reason to modify this requirement.

Based on comments DOE received questioning whether or not the lamp stabilization method prescribed in IES LM-45-2009 was required, DOE is providing further clarification on the matter in this final rule (see section III.A.3). DOE is also providing this same clarification for the lamp stabilization method prescribed in IES LM-9-2009. The standard states that its prescribed stabilization method is strongly recommended but if not followed, the alternative methodology should be noted in the test report. Therefore, manufacturers should include in certification reports details of any variations from the lamp stabilization method prescribed in IES LM-9-2009.

In the NOPR, DOE proposed updating the 2000 version of IESNA LM-45 to the 2009 version. This new version specifies updated procedures for measuring GSIL efficacy. DOE's review indicated that incorporating the 2009 edition of IES LM-4526 would provide further clarification of the test procedure; and improve the test methodology and test instrumentation setup and specifications.

DOE identified the following five key updates in the 2009 edition of IES LM-45: (1) Modification of the lamp stabilization method; (2) modification of voltage and current regulation tolerances of the alternating current (AC) power source; (3) modification of instrument tolerance for AC voltage, current, and wattage; (4) establishment of impedance tolerances for instruments; and (5) establishment of a tolerance for the spectral response of the photo-detector. (More detail on these updates can be found in the NOPR. 76 FR 56661, 56666-67.) In the NOPR, DOE concluded that these updates will not significantly affect lamp efficacy or pose a significant testing burden. NEMA commented that it agreed with the incorporation of IES LM-45-2009. (NEMA, No. 8 at p. 2) DOE did, however, receive comments from interested parties regarding clarification on spectral match specifications and the lamp stabilization method.

At the October 2011 public meeting, Northwest Energy Efficiency Alliance (NEEA) asked for further clarification on the requirement in IES LM-45-2009 that the spectral match between the photo-detector and the V(λ) function be within five percent. (NEEA, Public Meeting Transcript, No. 7 at p. 30) The V(λ) function or the photopic luminous efficiency function27 is the response curve of a standard human observer. It is the visual sensitivity of the human eye to light at different wavelengths. Photodetectors can only approximate the standard V(λ) response due to limitations in the manufacturing process. The parameter f1′ describes the closeness of the spectral of the photodetector measurements and the V(λ) function. The parameter f1′ should be within a certain tolerance, but a spectral mismatch correction factor will be applied to the measured result regardless. Therefore in this final rule, DOE concludes that the inclusion of a specific tolerance for spectral match in IES LM-45-2009 would result in more consistent and precise measurementsbut would not significantly affect lamp efficacy measurements.

In the NOPR, DOE had indicated that industry commonly considers a value for f1′ of less than five percent good commercial quality and a value of less than three percent good laboratory/research quality. Earthjustice asked why the laboratory research quality tolerance of three percent for the f1′ parameter was not proposed as the required tolerance. (Earthjustice, Public Meeting Transcript, No. 7 at p. 37) ICF commented that NVLAP certified laboratories must have two percent tolerance and therefore, three and five percent tolerances would be outside the acceptable range to remain accredited. (ICF, Public Meeting Transcript, No. 7 at p. 38) Based on this information Earthjustice suggested the requirement should be a tolerance of two percent. (Earthjustice, Public Meeting Transcript, No. 7 at p. 38)

DOE has found no reason to lower the spectral match tolerance of five percent established in IES LM-45-2009, a standard based on industry consensus. First, DOE's research indicates that NVLAP does not require a spectral match tolerance different from that prescribed in IES LM-45-2009.28 DOE research shows that manufacturers already employ at least commercial-grade instruments and, therefore, this five percent specification would not pose an additional test burden. Additionally, in certain cases achieving a three percent spectral match is not possible. For example when using the integrating sphere measurement method29 to take photometric measurements, the spectral response of the whole sphere system involves factoring in the sphere paint and the cosine diffuser, rather than just the spectral response of the photodetector. Therefore, achieving a spectral match better than three percent may be too difficult under such circumstances. DOE has concluded that its test procedures do not need to establish a spectral match tolerance different from that prescribed in IES LM-45-2009.

With regards to lamp stabilization,30 NEMA commented that test lamps unable to meet the stabilization criteria as defined in IESNA LM-45-2009 after five measurement cycles should not be disqualified from the test group. Instead, NEMA suggested an analysis of the added uncertainty of the measured performance parameters be taken into account. (NEMA, No. 8 at p. 5) The lamp stabilization method specified in IES LM-45-2009 prescribes continuing sets of five measurements until the stabilization criterion is met. While the IES LM-45-2009 strongly recommends this stabilization method, it also states that a different method is permissible, but that its use should be noted in the test report. DOE is adopting these instructions in IES LM-45-2009. Therefore, as NEMA recommends in its comment, manufacturers can use a variation of the prescribed stabilization method as long any details of the variations from the prescribed methods are retained in the test reports required under 10 CFR 429.71.

As noted previously, in the NOPR, DOE did not propose updates to DOE's test procedure for IRLs, which incorporates by reference IESNA LM-20-1994.31 At the time of publication of the NOPR, a revised edition of this industry standard had not been published. DOE also had concluded in the NOPR analysis that there were no current best practices or technical developments that necessitate modifications to the existing test procedure. DOE did not receive any adverse comments regarding this conclusion. Therefore, no amendments to IRL test procedures have been adopted in this final rule.

Several interested parties noted that DOE will be evaluating the use of an application efficacy metric for IRLs as part of a rulemaking that is revising GSFL and IRL energy conservation standards. (76 FR 56678, September 14, 2011, see Framework Document available athttp://www1.eere.energy.gov/buildings/appliance_standards/pdfs/gsfl_irl_ecs_framework.pdf) NEMA commented that efficiency and economic comparisons across directional lamp technologies require the use of an application efficacy metric. NEMA added that replacing the lumens per watt metric with a new application efficacy metric for IRLs would affect lamp efficacy values. (NEMA, No. 8 at p. 3) Interested parties questioned whether the adoption of a new IRL metric would initiate amendments to the existing IRL test procedures. (CA Utilities, Public Meeting Transcript, No. 7 at p. 21, EEI, No. 7 at p. 36) If DOE decides to adopt such a metric, it also will update the IRL test procedure accordingly.

In the previous sections, DOE has addressed concerns raised regarding the impacts of updates to industry standards incorporated by reference relevant to this rulemaking. Based on its comparison of the updated and older versions of these industry standards, DOE has determined that the more recent versions do not make substantive changes to test setup and methodology, but are clearer and can potentially increase precision and consistency in measurements. Further, DOE has concluded that adopting the latest industry standards would not alter measured energy efficiency nor result in a test procedure that is unduly burdensome to conduct.

Therefore, in this final rule, for GSFLs, DOE is inserting updated references for ANSI C78.81-2003 and ANSI C78.81-2005 to ANSI C78.81-2010 and IESNA LM-9-1999 to IES LM-9-2009. For GSILs, DOE is inserting updated references for IESNA LM-45-2000 to IES LM-45-2009.

Section 321 of EISA 2007 amended EPCA by prescribing minimum rated lifetime32 requirements for GSILs, to be phased in between January 2012 and January 2014 (codified at 42 U.S.C. 6295(i)). Therefore, in the NOPR, DOE proposed a test procedure for GSIL lifetime testing, so that manufacturers can certify to DOE that their lamps meet these minimum rated lifetime requirements. DOE received comments on the following aspects of the proposed test procedure: (1) DOE's authority to establish a test procedure; (2) adoption of IESNA LM-49-2001 as an industry reference standard for DOE's GSIL lifetime test procedures; (3) disapproval of accelerated lifetime testing; (4) addressing lifetime measurement oflong-life lamps in a 12-month sampling period; (5) determination of rated lifetime definition and appropriateness of the proposed sample size; (6) certification requirements; (7) laboratory accreditation; and (8) cost of GSIL lifetime testing.

NEMA questioned the authority of DOE to require a test procedure for GSIL lifetime testing and opposed the expansion of GSIL test requirements. (NEMA, No. 8 at p. 4; NEMA, Public Meeting Transcript, No. 7 at pp. 60, 63-64) EPCA directs DOE to make a determination that a test procedure should be prescribed that measures energy efficiency, energy use, water use, or estimated annual operating cost of a covered product. (42 U.S.C. 6293(3)) In this case, however, the test is needed to calculate the minimum rated lifetime requirements set forth in ECPA. (42 U.S.C. 6295 (i))

DOE must establish those test procedures necessary to address all aspects of an energy conservation standard. Therefore, DOE has concluded that it has the authority to establish a test procedure for measuring lamp lifetime of GSILs.

NEMA objected to DOE regulating lamp lifetime which it considers a product reliability metric that has no bearing on efficiency or energy use and affects industry warranties. (NEMA, No. 8 at p. 3) DOE acknowledges NEMA's objection to the lifetime standard, however, as stated in section I, the minimum rated lifetime requirements for GSILs were established by Congress when it passed EISA 2007.

After conducting literature research and interviews with several GSIL lifetime testing facilities in the NOPR analysis, DOE concluded that IESNA LM-49-2001 is the appropriate industry standard for GSIL lifetime testing. IESNA LM-49-2001 is commonly used in industry and generally aligns with guidance in the IESNA Lighting Handbook. Additionally, IESNA LM-49-2001 is also the standard referenced by the Federal Trade Commission (FTC) in its regulations for product labeling of GSILs, which could minimize testing burden for manufacturers in terms of complying with both Federal energy conservation standards and labeling requirements. 16 CFR 305.5(b) (For further details regarding IESNA LM-49-2001 refer to the NOPR. 76 FR 56661, 56667-68.)

NEMA concurred with using IESNA LM-49-2001 as a reference. (NEMA, No. 7 at p. 3) DOE did not receive any adverse comments regarding adoption of IESNA LM-49-2001 as the industry reference standard for measuring GSIL lifetime.

In the NOPR, DOE proposed to disallow the use of accelerated lifetime testing in its test procedures. This method is permitted in IESNA LM-49-2001 only for non-halogen GSILs. Accelerated lifetime testing involves operating lamps at higher than rated voltage, thereby forcing the lamp to fail faster than it would under normal operating conditions. A scaling factor is then used to correlate the measured accelerated lifetime to the lifetime at the rated voltage. (For more details on DOE's analysis of accelerated lifetime testing refer to the NOPR. 76 FR 56661, 56668.) NEMA agreed with DOE's proposal to disallow accelerated lifetime testing. (NEMA, No. 8 at p. 3) Some interested parties, noted below, questioned DOE's reasoning for not allowing this method.

DOE proposed to disallow accelerated lifetime testing for several reasons including that IESNA LM-49-2001 prescribes this methodology only for non-halogen lamps, most of which will not meet January 2012 energy conservation standards. DOE did investigate the appropriateness of using accelerated lifetime testing for halogen lamps that would pass the January 2012 standards. DOE found the tungsten-halogen regenerative cycle to be incompatible with accelerated lifetime testing because it cannot achieve its purpose outside of a narrow range of temperatures. The regenerative cycle, intended to increase lamp lifetime by redepositing evaporated tungsten back onto the filament, must operate only at certain operating temperatures. Deviations from the rated voltage in accelerated testing would increase the operating temperature outside this operating range and potentially alter performance or introduce new modes of lamp failure. Therefore, DOE concluded that lifetimes determined by operating halogen lamps at higher than rated voltage would not reliably measure the actual lifetime.

In the October 2011 public meeting, however, Lutron and OSI commented that the halogen regenerative cycle is critical only at low voltages and temperatures, and is therefore not adversely affected by the high temperature and overvoltage requirements of accelerated lifetime testing. (Lutron, Public Meeting Transcript, No. 7 at p. 47; OSI, Public Meeting Transcript, No. 7 at p. 47) DOE acknowledges that the successful operation of the tungsten halogen regenerative cycle is dependent on low temperatures but has found that high temperatures attained when operating at higher than rated voltage as required in accelerated testing are also an important factor. Operating halogen lamps at higher than rated voltage increases filament temperature and the rate of tungsten evaporation, which results in blackening of the inside lamp wall. Subsequently, the glass temperature rises due to increased infrared absorption and eventually causes the lamp to bulge and leak. Therefore, DOE has concluded that operating halogen lamps at higher than rated voltages and subsequently higher temperatures could introduce modes of lamp failure and may invalidate any comparisons with lamps operating at rated voltage. Hence, in this final rule, DOE maintains the disallowance of accelerated lifetime testing for GSILs as part of DOE test procedures.

P.R. China commented that DOE should adopt the transformation accelerated lifetime testing requirements in IEC 60064-2007. P.R. China cited the stipulation in Article 2.4 of the Technical Barriers to Trade (TBT) agreement that the members should use international standards as the basis of technical rules and regulations. P.R. China also suggested that DOE employ a method similar to that of the International CFL Harmonization Initiative to make the accelerated lifetime testing standards for GSFLs, GSILs, and IRLs consistent across all countries. (P.R. China, No. 9 at pp. 3-4) Since DOE is disallowing the use of accelerated lifetime testing for GSILs, it will not be adopting any test procedures for this methodology. DOE also notes that there is no U.S. requirement for lifetime testing of GSFLs and IRLs.

For GSIL lifetime testing, DOE is requiring testing a minimum of three lamps per month each month of production for a minimum of seven months out of a 12-month period. In the October 2011 public meeting, Edison Electric Institute (EEI) expressed concerns that it would be difficult to complete non-accelerated lifetime testing in one year for halogen lamps that have rated lifetimes in the range of 4,000 and 6,000 hours. (EEI, Public Meeting Transcript, No. 7 at pp. 42-43) Measuring the full lifetime of a 6,000-hour lamp would require about 250 days.

In today's final rule, DOE is requiring measurement up to the minimum rated lifetime as prescribed by standardsspecified in 42 U.S.C. 6295(i). The standards currently require all GSILs to meet a minimum rated lifetime of 1,000 hours. For a model to be in compliance with the prescribed minimum rated lifetime standard, greater than 50 percent of the sample size must meet the minimum rated lifetime required. Manufacturers should follow the procedures set forth in IESNA LM-49-2001 (except for use of the accelerated lifetime testing method) to execute the minimum rated lifetime measurements described above.

In the NOPR, DOE proposed the following definition for rated lifetime of general service incandescent lamps: The length of operating time of a sample of lamps between first use and failure of 50 percent of the sample size in accordance with test procedures described in IESNA LM-49-2001. Interested parties voiced concern regarding the method of measuring lamp lifetime set forth in the proposed definition.

NEMA stated that the failure rate is a measure of how many lamps are failing per unit time at any given moment and that the 50 percent failure rate is not the definition of median lamp lifetime. NEMA also noted it was common industry practice to use distributional parametric fits such as Weibull or lognormal functions for determining the best estimate of median lifetime and recommended DOE allow the use of this methodology. (NEMA, No. 8 at p. 3)

DOE is using the 50 percent failure rate methodology as it is aligned with the general statutory definition of “life” or “lifetime” as the length of operating time of a statistically large group of lamps between first use and failure of 50 percent of the group (42 U.S.C. 6291(30)(P)). It also coincides with the definition in IESNA LM-49-2001 which states in Section 1.2g that for life rating, the applicable definition of median is the total operating time at which 50 percent of a large group of lamps is still expected to be operating. Therefore, DOE is only revising the definition of rated lifetime for GSILs to provide additional guidance. DOE is maintaining that the rated lifetime is the length of operating time of a sample of lamps between first use and failure of 50 percent of the sample size in accordance with test procedures described in IESNA LM-49-2001. It is also specifying that the operating time be based on the middle lamp operating time for an odd-numbered sample size and the average operating time of the two middle lamps for an even-numbered sample size.

While NEMA agreed with DOE's proposed minimum sample size of 20 lamps, it stated if DOE adopted the 50 percent failure rate determination for lifetime, the middle lamp of an odd number of samples should be used. (NEMA, No. 8 at p.3-4) In the NOPR, DOE had proposed the minimum sample size of 20 lamps in order to be consistent with the already existing 21-lamp minimum sample size requirement for GSIL performance testing. 10 CFR 429.27. DOE had chosen 20 samples (an even number) instead of 21 samples in order to facilitate the calculation of the 50 percent failure rate. DOE agrees, however, with NEMA that in terms of determining the 50 percent failure at the median lamp lifetime, an odd-numbered sample size is more appropriate. Therefore, DOE is revising the minimum required sample size of 20 lamps proposed in the NOPR to 21 lamps in this final rule.

As with the 21-sampling plan for GSIL performance testing, DOE will require a minimum of three lamps per month each month of production for a minimum of seven months out of a 12-month period. If lamp production occurs in fewer than seven months out of the year, three or more lamps will be selected for each month that production exists as evenly as possible to meet the minimum 21 sample requirement. These seven months do not need to be consecutive and can be any combination of seven months out of the 12.

With regards to the sampling plan, NEMA stated that the existing seven out of 12-month sampling requirement for performance testing should not be the basis for the lifetime sampling requirement. (NEMA, No. 8 at p. 4; Philips, No. 7 at p. 60) DOE notes that the seven out of 12-month sampling plan was developed with the input of interested parties in a previous test procedure rulemaking on incandescent and fluorescent performance testing. 62 FR 29221, 29229. This seven-month sampling minimum ensures manufacturers are consistently producing lamps that meet standards. DOE finds no reason to differentiate between the performance and lifetime testing sampling plans. Further, using the same sampling plan allows manufacturers the opportunity to test the same sample set for measurements of lumen output, wattage, and lifetime, thereby potentially reducing testing burden.

NEMA also recommended DOE require sampling from the initial production run and thereby prevent fractionated lifetime testing of 12-18 months' time. (NEMA, No. 8 at p. 4) Allowing testing up to the minimum rated lifetime should shorten the time required for lifetime testing. Hence, the continuation of lifetime tests for samples from the last month of production into the following production year should be limited. Therefore, DOE will not be requiring sampling from the initial production run.

As mentioned previously, to ensure that DOE is in full compliance with Section 315 of Public Law 112-74, DOE will not finalize in this document provisions related to certifying lamps subject to that provision of law. DOE may finalize those procedures at an appropriate time in the future. Described below are issues raised in public comment regarding certification. DOE would respond to these comments if it finalizes these provisions in the future.

In the NOPR, DOE proposed establishing new model filing requirements for GSIL testing similar to those in place for GSFLs and IRLs. These requirements take into account the 12-month sampling requirement for performance and lifetime testing of GSILs by allowing manufacturers to submit an initial certification report prior to or concurrent with distribution of the new model. This initial certification report filing, describing how the manufacturer has determined that the new model meets or exceeds energy conservation standards, will allow manufacturers to distribute new models while completing the 12-month sampling requirement for certification. This initial report is followed by a final certification report, based on the full sampling provisions, which is to be submitted one year after the first date of manufacture of the new model.

Interested parties commented on the proposed certification requirements for GSIL lifetime testing. NEMA requested that DOE accept product compliance at 40 percent of required lifetime. NEMA also stated that the testing should continue until completed and that any non-compliant products should be removed from the market. (NEMA, No. 8 at p. 3; NEMA, Public Meeting Transcript, No. 7 at p. 44-46) DOE finds that the certification process for GSIL lifetime should not cause delays in distribution since manufacturers can submit initial certification reports and are not required to measure the full lifetime of the lamp for compliance. DOE sees no reason to base certification on 40 percent compliance with the lifetime rating.

Instead of on an annual basis, which Phillips believed would pose asignificant burden, Philips stated that testing should be required only once for the product unless the product goes through major changes. (Philips, No. 7 at p. 51) NEMA also strongly recommended testing be required only once and not annually. (NEMA, No. 8 at p. 3)

Regarding certification reports, Lutron requested clarification on how DOE addresses discrepancies between the engineering analysis submitted for the initial certification report and testing conducted for the final certification reports. (Lutron, Public Meeting Transcript, No. 7 at p. 58)

In the NOPR, DOE proposed that facilities that conduct testing for GSIL lifetime be accredited to NVLAP or an organization recognized by NVLAP. DOE received several stakeholder comments regarding the burden such accreditation would pose on manufacturers. First, NEMA stated the NVLAP-accredited GSIL lifetime testing is a new requirement and manufacturers' accredited laboratories have limited resources for GSIL lifetime testing. Second, NEMA stated that most manufacturers test for lifetime at factory lifetime test facilities that are not NVLAP accredited. Further, these facilities would require significant investment in order to become NVLAP accredited. (NEMA, No. 8 at p. 4) NEMA noted that since NVLAP accredits to efficacy and lifetime standards separately, lifetime testing can be performed at laboratories at plant sites accredited only to the lifetime test standard. Photometry and colorimetry testing would then occur at accredited laboratories on sample sets taken from the same lots. NEMA, however, emphasized costs would still be significant as each plant would need to be accredited for lifetime testing. (NEMA, No. 8 at p. 5)

After further review, DOE has decided not to require NVLAP accreditation for laboratories conducting GSIL lifetime testing. NVLAP accreditation involves ensuring the laboratory is executing testing according to industry reference standards and practices that include an assessment of laboratory equipment and competency of personnel. DOE has not found evidence that NVLAP accreditation for incandescent lifetime testing, which does not require precise measurements, would provide significant value. Further, as noted in the NOPR, NVLAP imposes fees of $9,000 and $8,000 on years one and two of accreditation and subsequently, fees alternate between $5,000 and $8,000, with the $8,000 fee corresponding to the on-site evaluation required every other year. Based on the above comments, manufacturers plan to conduct performance testing and lifetime testing at different laboratories, with lifetime testing conducted at plant-level laboratories. These manufacturer-site laboratories have no previous NVLAP accreditations. Hence, manufacturers would have to obtain accreditation at each plant for lifetime testing. DOE has concluded, therefore, that NVLAP accreditation for GSIL lifetime testing would provide few benefits compared to the added costs. Therefore, in this final rule, DOE is not requiring manufacturers to conduct GSIL lifetime testing in a laboratory accredited to NVLAP or an organization recognized by NVLAP. DOE may, however, reevaluate the accreditation requirement for GSIL lifetime testing at a later time.

DOE does require NVLAP accreditation for facilities conducting GSIL energy performance measurements (e.g. lumen output, wattage, CRI) and will continue to do so. The accuracy of such performance measurements are highly dependent on precisely calibrated equipment and test execution that appropriately follows industry reference standards and practices. Further, manufacturers indicated they would be conducting GSIL performance testing at laboratories that either already have NVLAP accreditation for GSIL performance testing or NVLAP accreditation for other test procedures. In cases where a laboratory has a NVLAP accreditation, the cost of adding accreditation to another test procedure is incremental.

DOE also received several comments regarding the procedural aspects of NVLAP accreditation. ICF commented that IES withdraws test procedures after ten years and therefore, IESNA LM-49-2001 may be out of circulation at the end of 2011 posing a potential problem for laboratories that are not already accredited to the test procedure. (ICF, Public Meeting Transcript, No. 7 at p. 48) As indicated previously, DOE will no longer be requiring NVLAP accreditation to the GSIL lifetime test procedure. DOE notes that ten laboratories are currently accredited by NVLAP to IESNA LM-49-2001 in the United States and these laboratories will continue to be accredited to the test procedure even after it is withdrawn. DOE also verified with NVLAP that additional laboratories may become accredited to IESNA LM-49-2001 even after it is withdrawn.

P.R. China noted that NVLAP and the China National Accreditation Service (CNAS) signed the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement to accredit testing laboratories based on ISO/IEC 17025. P.R. China requested that DOE allow CNAS accredited laboratories for lifetime and efficiency testing in order to reduce the testing burden. (P.R. China, No. 9 at p. 3) As discussed above, DOE is removing the requirement that GSIL lifetime testing must be conducted at an NVLAP or NVLAP-recognized organization and therefore P.R. China's concerns are unwarranted. DOE does, however, continue to require GSIL performance testing be completed at a laboratory accredited by NVLAP or a NVLAP-recognized organization, which includes foreign laboratories accredited by foreign accrediting bodies that have mutual recognition agreements through ILAC with NVLAP. 62 FR 29221, 29235

P.R. China also stated that DOE's requirement for NVLAP certification on energy performance tests does not conform to relevant international agreements including Article 2.2 of the TBT which states that members should ensure that adopted technical rules and regulations do not cause unnecessary barriers to international trade. P.R. China suggested that DOE reconsider this certification requirement or provide the scientific basis for it. (P.R. China, No. 9 at p. 4) P.R. China also stated this final rule should become effective after DOE performs a review of the mutual laboratory qualification recognition procedures of World Trade Organization (WTO) member states. P.R. China suggested this approach as a way for DOE to comply with Article 6.3 of the TBT which encourages member states to come to an agreement on recognizing each other's qualification evaluation procedures. (P.R. China, No. 9 at pp. 3-4)

As stated previously, DOE's existing requirements necessitate test facilities that conduct performance testing be NVLAP-accredited or accredited by an organization recognized by NVLAP. This allows for other accreditation organizations that entered into mutual recognition agreements through ILAC with NVLAP to also perform testing. DOE has therefore concluded that the accreditation requirement is not causing trade barriers. Further, DOE finds any additional review of mutual qualification recognition procedures to be unnecessary due to the mutual recognition agreements with NVLAP.

DOE received several comments regarding the burden posed by the cost of GSIL lifetime testing on manufacturers. Philips commented that this cost would pose significant burdenon both small and large manufacturers. OSI added that for larger manufacturers the cost would be applicable at each manufacturing location. (Philips, Public Meeting Transcript, No. 7 at p. 62; OSI, Public Meeting Transcript, No. 7 at p. 62) NEMA contended DOE had underestimated GSIL lifetime testing costs in the NOPR. NEMA's own estimates suggest it would require a total initial investment of $133,000 and labor costs per year of $60,000 to test 100 basic models at an accredited lifetime test facility with a minimum of 2,000 lifetime test spaces. NEMA noted that most major manufacturers have a portfolio comprising more than 100 products. Additionally, NEMA emphasized preparation for lifetime testing was a significant investment that would have to be incurred in the near future for a mature technology that is being phased out in many areas. (NEMA, No. 8 at pp. 4-5). NEMA also stated that since these costs were not small for large manufacturers that they would pose a significant burden for smaller manufacturers. (NEMA, No. 8 at p. 4)

For this final rule, DOE conducted an independent calculation of GSIL lifetime testing costs. As in the NOPR, DOE based this estimate on the use of a still camera with a programmable snapshot system to record lamp operation. This is less labor intensive and costly than in person inspection. DOE's estimate of initial investment costs included installation labor and equipment for the lamp test racks, voltage regulator, and camera-based monitoring system. DOE also estimated labor costs for conducting the lifetime testing based on an hourly rate of $100. DOE then developed three separate cost estimates each for a manufacturer producing four, 50, and 100 models and adhering to the sampling requirement of 21 lamps per model. As mentioned in the NOPR, DOE had determined that small manufacturers of GSILs produce anywhere from four to 50 models. Further, DOE found that 100 models was a valid representation for large manufacturer production of general service incandescent lamps.

While NEMA's estimate assumed testing would be conducted for all models at once, DOE's calculations were based on a staggered test approach. DOE determined that over the course of a year, 1,000-hour lifetime tests for four models could be completed with one rack; 50 models with two racks; and 100 models with three racks. For comparison purposes, DOE scaled NEMA's estimates which were based on 20 racks (or testing 100 models at once) down to using one, two and three racks. For four models (one rack), NEMA's scaled-down estimate was about $10,000 while DOE's estimate was $13,000. NEMA's scaled-down estimate for 50 models (two racks) was about $20,000 and DOE's estimate was $63,000. NEMA's scaled-down estimate for 100 models (three racks) was $29,000 and DOE's estimate was $118,000.

Based on DOE's higher estimates, a small manufacturer producing 50 models would have to make an initial investment cost of about $20,000 and incur labor costs of about $40,000. In subsequent years, testing costs would be much smaller because only new products or substantially redesigned products would need to be tested. Assuming a conservative estimate of $1 million in revenue for a small business, initial testing costs would represent about six percent of revenue, but when amortized over subsequent years with little or no testing, testing costs would account for a smaller percentage of revenue. In addition, some businesses may already have lifetime data that could be used for representation purposes from previously completed FTC labeling testing. Based on these estimates, DOE has concluded that GSIL lifetime testing costs would not pose a substantial burden on small manufacturers. See section IV.B for further analysis of the impacts of this final rule on small manufacturers.

For a large manufacturer producing 100 models, DOE estimates an initial investment cost of $32,000 and about $86,000 for labor costs. This total cost is a negligible percentage of a large manufacturer's revenue. Therefore, based on these estimates, DOE has concluded that GSIL lifetime testing would not pose a substantial burden on large manufacturers.

With regards to testing burden, Philips also commented that when considering the products and testing requirements covered in the NOPR, DOE needed to either reduce the number of products that need to be tested or the testing requirements. (Philips, Public Meeting Transcript, No. 7 at p. 63-64) All products covered by standards must be tested for the purpose of compliance. (42 U.S.C. 6295(s)) DOE's test requirements ensure that compliance with these standards can be verified.

As specified in the sections above, DOE is incorporating IESNA LM-49-2001 as the industry reference standard in this lifetime test procedure, defining rated lifetime, prescribing a minimum sample size of 21, and establishing laboratory accreditation requirements.

The effective date for these test procedure amendments would be 30 days after publication of the test procedure final rule in theFederal Register. At that time, manufacturers and importers of covered GSFLs, IRLs, and GSILs may use the amended test procedure for making representations of the energy efficiency or energy consumption of each basic model. Additionally, for GSFLs and IRLs, manufacturers may use the amended test procedure or the existing test procedures to certify compliance with DOE's test procedure.

The compliance date for making any representations of the energy efficiency or energy consumption derived from the revised version of the test procedure for GSFLs, IRLs, and GSILs is 180 days from the date of publication of the test procedure final rule in theFederal Register. On or after that date, any manufacturer representations, including those made on marketing materials and product labels, must be based upon results generated under these new and amended test procedures and the applicable sampling plans.

The Office of Management and Budget has determined that test procedure rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). Accordingly, this action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB).

The Regulatory Flexibility Act (5 U.S.C. 601et seq.) requires preparation of an initial regulatory flexibility analysis (IFRA) for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (August 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the DOE rulemaking process. 68 FR 7990. DOEhas made its procedures and policies available on the Office of the General Counsel's Web site:www.gc.doe.gov.

Today's final rule will adopt test procedure provisions for GSFLs and GSILs, primarily through updates to industry testing standards, as well as specification of a procedure for testing GSIL lifetime. DOE has reviewed the final rule under the provisions of the Regulatory Flexibility Act and the policies and procedures published on February 19, 2003. For the reasons explained below, DOE certifies that the test procedure adopted in today's final rule would not have a significant economic impact on a substantial number of small entities.

The Small Business Administration (SBA) has set a size threshold for manufacturers of GSFLs, GSILs, and IRLs that defines those entities classified as “small businesses” for the purposes of the Regulatory Flexibility Analysis. DOE used the SBA's small business size standards to determine whether any small manufacturers of GSFLs, GSILs, and IRLs would be subject to the requirements of the rule. 65 FR 30836, 30849 (May 15, 2000), as amended at 65 FR 53533, 53545 (Sept. 5, 2000) and codified at 13 CFR part 121. The size standards are listed by North American Industry Classification System (NAICS) code and industry description and are available atwww.sba.gov/sites/default/files/Size_Standards_Table.pdf. GSFL, GSIL, and IRL manufacturing is classified under NAICS 335110, “Electric Lamp Bulb and Part Manufacturing.” The SBA sets a threshold of 1,000 employees or less for an entity to be considered as a small business for this category.

For this rulemaking, DOE determined the number of small business U.S. manufacturers of covered GSFLs, GSILs, and IRLs. First, DOE compiled a preliminary list of potential small business manufacturers of GSFLs, GSILs, and IRLs by searching the Hoover's and the SBA databases and also conducting general searches of the covered products. DOE then sought to determine if the companies identified actually manufactured the covered lamp types. From among the potential GSFL small business manufacturers initially identified, DOE was able to determine by reviewing the company Web sites that only one company qualified as a small business U.S. manufacturer of covered GSFLs. Similarly, DOE was also able to determine by reviewing company Web sites that there were no small business U.S. manufacturers of covered IRLs. These results for the number of GSFL and IRL small business U.S. manufacturers is the same as determined in the 2009 GSFL and IRL standards rulemaking. 74 FR 34080, 34174 (July 14, 2009). For GSILs, DOE reviewed company Web sites and contacted companies as necessary and identified six small business U.S. manufacturers of covered GSILs.

DOE has determined that the updated versions of the industry test methods for GSFLs and GSILs performance testing adopted in this final rule would not result in significant changes in test setup and methodology. The changes in these updated versions modify certain specifications such as impedance thresholds, voltage and current regulations and provide additional guidance on methods such as lamp stabilization. However, the updates are not making fundamental changes as to how GSFL or GSIL performance testing is conducted. Therefore, DOE has concluded that these changes will not add a significant amount of testing time or require additional test equipment. Further, DOE is not making any revisions to the IRL performance test procedure as there are no relevant updates to industry test methods, current best practices, or technical developments that necessitate modifications. Therefore, DOE has concluded that there will not be a significant economic impact on small business manufacturers of GSFLs, GSILs, and IRLs with regards to performance testing.

For the GSIL lifetime test procedure, DOE determined that GSIL small manufacturers are producing anywhere from four to 50 models of GSILs and provided cost estimates including labor for conducting the testing. DOE received several comments regarding these cost estimates and for this final rule reassessed these estimates for small business manufacturers.

Based on DOE's estimates for this final rule, a small manufacturer producing 50 models would have to make an initial investment cost of about $20,000 and incur labor costs of about $40,000. The details of this cost estimate are provided in section III.B.8. In subsequent years, testing costs would be much smaller because only new products or redesigned products would need to be tested. Assuming a conservative estimate of $1 million in revenue for a small business, initial testing costs would represent about six percent of revenue, but when amortized over subsequent years with little or no testing, testing costs would account for a lesser percentage of revenue. In addition, some businesses may already have lifetime data from previously completed FTC labeling testing. Based on these reassessed costs, DOE has concluded that the GSIL lifetime test procedure prescribed in this final rule will not result in a significant economic impact on small manufacturers.

Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE's certification and supporting statement of factual basis has been provided to the Chief Counsel for Advocacy of the SBA for review under 5 U.S.C. 605(b). DOE certifies that this rule would have no significant impact on a substantial number of small entities.

The collection-of-information requirement applicable to this rulemaking has been approved by OMB under OMB control number 1910-1400. Public reporting burden for the certification is estimated to average 20 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

In this final rule, DOE amends its test procedure for GSFLs, GSILs, and IRLs. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321et seq.) and DOE's implementing regulations at 10 CFR part 1021. Specifically, this rule amends an existing rule without affecting the amount, quality or distribution of energy usage, and, therefore, will not result in any environmental impacts. Thus, this rulemaking is covered by Categorical Exclusion A5 under 10 CFR part 1021, subpart D, which applies to any rulemaking that interprets or amends an existing rule without changing the environmental effect of that rule. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999) imposes certain requirements on agenciesformulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE examined this final rule and determined that it will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of today's final rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.

Regarding the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of Executive Order 12988.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a regulatory action resulting in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820; also available athttp://www.gc.doe.gov. DOE examined today's final rule according to UMRA and its statement of policy and determined that the rule contains neither an intergovernmental mandate, nor a mandate that may result in the expenditure of $100 million or more in any year, so these requirements do not apply.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. Today's final rule will not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988), that this regulation will not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed today's final rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use if the regulation is implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.

Today's regulatory action is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and,accordingly, DOE has not prepared a Statement of Energy Effects.

Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91; 42 U.S.C. 7101), DOE must comply with section 32 of the Federal Energy Administration Act of 1974, as amended by the Federal Energy Administration Authorization Act of 1977. (15 U.S.C. 788; FEAA) Section 32 essentially provides in relevant part that, where a proposed rule authorizes or requires use of commercial standards, the notice of proposed rulemaking must inform the public of the use and background of such standards. In addition, section 32(c) requires DOE to consult with the Attorney General and the Chairman of the Federal Trade Commission (FTC) concerning the impact of the commercial or industry standards on competition.

The final rule incorporates testing methods contained in the following commercial standards: IES LM-9-2009, “IES Approved Method for Electrical and Photometric Measurements of Fluorescent Lamps;” IES LM-45-2009, “IES Approved Method for Electrical and Photometric Measurement of General Service Incandescent Filament Lamps;” IESNA LM-49-2001, “IESNA Approved Method for Life Testing of Incandescent Filament Lamps;” and ANSI C78.81-2010, “American National Standard for Electric Lamps—Double-Capped Fluorescent Lamps—Dimensional and Electrical Characteristics.” DOE has consulted with both the Attorney General and the Chairman of the FTC about the impact on competition of using the methods contained in these standards and has received no comments objecting to their use.

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of today's rule before its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

The Secretary of Energy has approved publication of this final rule.

For the reasons stated in the preamble, DOE amends parts 429 and 430 of Chapter II of title 10 of the Code of Federal Regulations to read as set forth below:

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, issued EASA AD 2011-0087-E, dated May 12, 2011 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in theFederal Registeron October 18, 2011 (76 FR 64289). That NPRM was proposed to require on all TAE 125-02-99 and TAE 125-02-114 reciprocating engines, replacing the friction disk, P/N 05-7211-K010201.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (76 FR 64289, October 18, 2011).

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed.

Based on the service information, we estimate that this AD will affect about 206 TAE 125-02-99 and TAE 125-02-114 reciprocating engines installed on airplanes of U.S. registry. We also estimate that it will take about 3 work-hours per engine to comply with this AD. The average labor rate is $85 per work-hour. Required parts will cost about $1,500 per engine. Based on these figures, we estimate the cost of the AD on U.S. operators to be $361,530. Our cost estimate is exclusive of possible warranty coverage.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Background

On July 12, 2005, the FAA published SFAR 106, “Use of Certain Portable Oxygen Concentrator Devices Onboard Aircraft” (70 FR 40156). SFAR 106 permits passengers to carry on and use certain small portable oxygen concentrators (POCs) on board aircraft if the operator ensures compliance with conditions specified in the SFAR. Some of the devices determined acceptable for use in SFAR 106 are Delphi Medical Systems' RS-00400 (added to the SFAR in 74 FR 2351) and International Biophysics Corporation's LifeChoice (added to the SFAR in 75 FR 739).

As a result of business changes that took place after SFAR 106 was published, the LifeChoice POC is now manufactured by Inova Labs, Inc. and not by the International Biophysics Corporation. Similarly, the RS-00400 POC is now manufactured by Oxus, Inc. and not by Delphi Medical Systems.

The two companies currently manufacturing these POCs have petitioned the FAA to amend SFAR 106, Section 2 and section 3(a), of Title 14, Code of Federal Regulations (14 CFR). This amendment would update section 2 and section 3(a) of SFAR 106 with the names of the current manufacturers of the LifeChoice and RS-00400 POCs.

LifeChoice and RS-00400 are still the same products that were originally approved in SFAR 106—only the names of their manufacturers have changed. As such, this technical amendment makes two revisions to the final rule. First, the language in SFAR 106 section 2 and section 3(a) is revised to refer to LifeChoice as being manufactured by Inova Labs. Second, the reference to the RS-00400 POC is revised to refer to this device as being manufactured by Oxus, Inc.

Because the changes in this technical amendment result in no substantive change, we find good cause exists under 5 U.S.C. 553(d)(3) to make the amendment effective in less than 30 days.

In consideration of the foregoing, the Federal Aviation Administration amends chapter 1 of title 14, Code of Federal Regulations as follows:

Nycomed US, Inc., 60 Baylis Rd., Melville, NY 11747 has informed FDA of a change of name to Fougera Pharmaceuticals, Inc. Accordingly, the Agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is amended as follows:

Novartis Animal Health US, Inc., 3200 Northline Ave., Suite 300, Greensboro, NC 27408, filed NADA 141-333 that provides for the veterinary prescription use of SENTINEL SPECTRUM (milbemycin oxime/lufenuron/praziquantel) Tablets for the prevention of heartworm disease, for the prevention and control of flea populations, and for the treatment and control of adult roundworm, adult hookworm, adult whipworm, and adult tapeworm infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older. The NADA is approved as of December 8, 2011, and 21 CFR part 520 is amended by adding new § 520.1447 to reflect the approval.

A summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

The Agency has determined under 21 CFR 25.33 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.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:

Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200-494 for use of GENTAMED (gentamicin sulfate) Soluble Powder used to make medicated drinking water for swine. Cross Vetpharm Group's Gentamicin Soluble Powder is approved as a generic copy of GARACIN (gentamicin sulfate) Soluble Powder, sponsored by Intervet Inc., under NADA 133-836. The abbreviated application is approved as of December 14, 2011, and the regulations are amended in 21 CFR 520.1044c to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The Agency has determined under 21 CFR 25.33 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.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:

Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 141-207 for ADVOCIN (danofloxacin mesylate) Injectable Solution. The supplemental NADA provides for an additional dosage regimen for the treatment of bovine respiratory disease (BRD) associated withMannheimia haemolytica,andPasteurella multocidain beef cattle. The supplemental NADA is approved as of December 16, 2011, and 21 CFR 522.522 is amended to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

The Agency has determined under 21 CFR 25.33 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.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows:

Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 141-322 for IMPROVEST (gonadotropin releasing factor analog-diphtheria toxoid conjugate) Sterile Solution for Injection, administered as two doses 4 weeks apart to intact male pigs for the reduction of boar taint. The supplement extends the slaughter interval from 4 to 8 weeks after the second dose to 3 to 10 weeks. The supplemental NADA is approved as of November 30, 2011, and the regulations in 21 CFR 522.1083 are amended to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

The Agency has determined under 21 CFR 25.33 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.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows:

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 95-735 that provides for use of RUMENSIN 90 (monensin) Type A medicated article in free-choice feeds for growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers) for increased rate of weight gain and for prevention and control of coccidiosis. The supplemental NADA is approved as of November 18, 2011, and the regulations in 21 CFR 558.355 are amended to reflect the approval.

A summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The Agency has determined under 21 CFR 25.33 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.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:

Background

DEA implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 through 1321.

The Administrative Procedure Act (5 U.S.C. 553) does not require notice and the opportunity for public comment where the agency for good cause finds that notice and public comment are unnecessary, impracticable, or contrary to the public interest under 5 U.S.C. 553(b)(B) or on rules affecting agency organization, procedure, or practice under 5 U.S.C. 553(b)(A). This rule contains technical corrections and updates organizational changes in agency regulations; it imposes no new or substantive requirement on the public or DEA registrants. As such, DEA has determined that notice andopportunity for public comment on this rule are unnecessary. This rule is also exempt from notice and comment because these changes involve rules of agency organization, procedure, or practice. Because this is not a substantive rule and as DEA finds good cause under 5 U.S.C. 553(d)(3) for the above reasons, this final rule shall take effect upon date of publication in theFederal Register.

This rule removes the numbers for each definition in 21 CFR 1300.01 and 21 CFR 1300.02 and alphabetizes the definitions of each section so they can be easily referenced and so that additions and deletions can be made in future rulemakings without renumbering or causing confusion by placing definitions out of alphabetical order.

This rule also clarifies the regulations by correcting typographical errors and updating citation listings and organizational changes previously overlooked. Specifically, the changes are:

In § 1300.01(b), alphabetizing the definitions, italicization of defined terms, removing the numbered designations, standardization of subordinate definitions by placement in quotation marks, separating the term “manufacturer,” correcting the citation in “supplier” from 1305.08 to 1305.06, standardization of “a.k.a.” names for substances listed under “anabolic steroids,” and correcting the spelling of four of the chemical names for substances listed under “anabolic steroid”: boldenone, mesterolone, methyltrienolone, and 17α-methyl-Δ1-dihydrotestosterone;

In § 1300.02(b), alphabetizing the definitions, italicization of defined terms, removing the numbered designations, standardization of subordinate definitions by placement in quotation marks, and adding “Federal” at the beginning of “Food, Drug, and Cosmetic Act” in the definition of “Drug product”;

In the fifth sentence of § 1303.11(c), correcting the spelling of “nnt” to be “not”;

In the second sentence of § 1304.03(a), correcting the citation to be 1307.13 instead of 1307.15, and in the fifth sentence correcting the word “acquire” to be “require”;

In § 1305.03(d), updating the reference to reflect the new organization of § 1300.01;

In the heading for § 1306.24, correcting the spelling of “filing” to be “filling”;

In § 1308.11(d)(8), correcting the spelling of “mdthylenedioxy” to be“methylenedioxy”;

In § 1308.12(b)(4), correcting the spelling of “whhch” to be “which”;

In § 1308.13(b), correcting the spelling of “sxstem” to be “system” and correcting the term “position” to be “positional”;

In §§ 1309.21(a)(2), 1309.24(b)-(d), 1310.04(f)(1)(ii) and (g), 1310.05(d) and (f)(2), 1310.06(h)(5), 1310.09(b), 1310.10(a), 1310.14, 1313.21(c)(1), 1313.24(a), and 1314.115(a)(2), updating the references to reflect the new organization of § 1300.02;

In the second sentence of § 1309.62(a), correcting the spelling of “cases” to be “ceases”;

In the heading of § 1310.10, adding “Federal” at the beginning of “Food, Drug, and Cosmetic Act”;

In § 1312.18(d), correcting the citation from “paragraph (a)” to “paragraph (b)”;

In § 1312.21(c), correcting the spelling of “repuest” to be “request”;

In §§ 1312.25, 1312.28(c), 1313.12(d), and 1313.32(b)(2), updating the organizational listings of “Drug Operations Section,” “Drug Control Section,” and “Chemical Operations Section” to the correct “Import/Export Unit”;

In § 1313.14(c), correcting the spelling of “Sevice” to be “Service”;

In § 1313.31(b)(5), correcting the word “new” to be “net”;

In § 1314.45, correcting the citation from “1314.15” to “1314.30”;

In § 1316.03(d), correcting and updating the reference from “DEA Form 84” to “DEA Form 400”; and

In § 1316.42(g), correcting the spelling of “colmencing” to be “commencing.”

Finally, this rule would update sections of Parts 1310 and 1313 to accurately reflect how information is submitted to DEA by removing references to “telex number,” an outdated form of technology. This would occur by removing “telex” or “telex number” from 21 CFR 1310.06(e)(1), (e)(4), (f)(1) and (f)(4), 1313.13(c)(1), 1313.31(b)(11), and 1313.33(c)(1) and (c)(4).

The Administrative Procedure Act (5 U.S.C. 553) does not require notice and the opportunity for public comment where the agency for good cause finds that notice and public procedure thereon is unnecessary, impracticable, or contrary to the public interest under 5 U.S.C. 553(b)(B) or on rules affecting agency organization, procedure, or practice under 5 U.S.C. 553(b)(A). This rule contains technical corrections and updates organizational changes in agency regulations; it imposes no new or substantive requirement on the public or DEA registrants. As such, DEA finds good cause that notice and opportunity for public comment on this rule are unnecessary pursuant to 5 U.S.C. 553(b)(B). This rule is also exempt from notice and comment pursuant to 5 U.S.C. 553(b)(A) as these changes involve rules of agency organization, procedure, or practice.

Because this is not a substantive rule and as DEA finds good cause under 5 U.S.C. 553(d)(3) for the above reasons, this final rule is effective upon date of publication in theFederal Register.

This rule has been reviewed in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Deputy Assistant Administrator certifies that this regulation will have no economic impact on a substantial number of small entities. This rulemaking only makes technical amendments and imposes no new requirements.

The Deputy Assistant Administrator certifies that this is not a significant regulatory action within the meaning of Executive Order 12866 and the principles reaffirmed in Executive Order 13563, as it makes only technical amendments to the current regulations.

This proposed regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform to eliminate ambiguity, minimize litigation, establish clear legal standards and reduce burden.

This rulemaking does not preempt or modify any provision of State law, impose enforcement responsibilities on any State, or diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $136,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, noactions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C 1532.

This action does not impose a collection of information requirement under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.

This proposed rule will not have tribal implications and will not impose substantial direct compliance costs on Indian tribal governments.

This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

For the reasons set out above, 21 CFR Parts 1300, 1303, 1304, 1305, 1306, 1308, 1309, 1310, 1312, 1313, 1314, and 1316 are amended to read as follows:

Pursuant to Section 8(a) of the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix, agency heads are required to establish uniform administrative guidelines and management controls for advisory committees established by that agency.

The Department of State first finalized its rules, codified at 22 CFR Part 8, in 1975. Since then, GSA has promulgated comprehensive guidance at 41 CFR Part 102-3, and the Department recently published updated internal guidance that implements FACA and the GSA regulations. The Department guidance is in Volume 11 of the Foreign Affairs Manual, and can be found at:http://www.state.gov/documents/organization/176811.pdf. The provisions of Part 8 are obsolete and are hereby removed.

Removing 22 CFR part 8 is a decision regarding the Department's organization, procedure, or practice and is not subject to the notice-and-comment procedures of 5 U.S.C. 553(b).

The Department certifies that this rulemaking is not expected to have a significant impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act, 5 U.S.C. 601-612, and Executive Order 13272, section 3(b).

This rulemaking is not a major rule as defined by 5 U.S.C. 804, for purposes of congressional review of agency rulemaking under the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121. This rulemaking will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532, generally requires agencies to prepare a statement before proposing or adopting any rule that may result in an annual expenditure of $100 million or more by state, local, or tribal governments, or by the private sector. This rulemaking will not result in any such expenditure nor will it significantly or uniquely affect small governments.

This rulemaking will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Nor will the rule have federalism implications warranting the application of Executive Orders No. 12372 and No. 13132.

Although the Department of State is generally exempt from the provisions of Executive Order 12866, it has reviewed this rulemaking to ensure its consistency with the regulatory philosophy and principles set forth in that Executive Order, and has determined that the benefits of the regulation justify any costs. The Department does not consider this rulemaking to be a significant regulatory action within the scope of section 3(f)(1) of the Executive Order.

The Department of State has considered this rule in light of Executive Order 13563, dated January 18, 2011, and affirms that this regulation is consistent with the guidance therein.

The Department has reviewed this rulemaking in light of sections 3(a) and 3(b)(2) of Executive Order No. 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Section 5 of Executive Order 13175 do not apply to this rulemaking.

The Department of State has determined that this rulemaking does not require any collection of information under the Paperwork Reduction Act.

Accordingly, under the authority of 22 U.S.C. 2651a, for the reasons set forth in the preamble, the Department removes 22 CFR Part 8.

This rule is being published as an interim final rule to:

a. Implement DoD policy and assign responsibilities for the SAPR Program on prevention, response, and oversight to sexual assault.

b. Incorporate all applicable congressional mandates and all applicable recommendations from the Inspector General of the Department of Defense (IG, DoD), Government Accountability Office, and Defense Task Force on Sexual Assault in the Military Services, to include the new Defense Sexual Assault Incident Database (DSAID) that will give the Department a clear view of the number of incidents at the installation level;

c. Address vigorous congressional and public interest by publishing a revised and comprehensive DoD policy on the prevention of and response to sexual assaults involving members of the U.S. Armed Forces, which affords victims critical and unprecedented additional protections under this part; and

d. Provide field guidance and training requirements to the Military Components to ensure individual resilience and unit readiness in the U.S. Armed Forces, which may be degraded by sexual assault, and thus enableService member victims to become fully mission capable and engaged once again.

Additionally, until this rule is published as an interim final rule, adult spouses and other military dependents cannot elect Restricted Reporting or receive the services of a Sexual Assault Response Coordinator (SARC) or a Sexual Assault Prevention and Response VictimAdvocate (SAPR VA). Moreover, the rule and corresponding DoD policy mandate that all sexual assault victims are treated as emergency cases, regardless of visible physical injuries. Lastly, WHEN the Rule and corresponding DOD policy are published, DoD civilians outside of the continental United States (OCONUS) and DoD contractors (who are U.S. citizens and authorized to accompany U.S. military) will now be assured to receive emergency care for sexual assault (even when physical injuries are not present) and the services of a SARC and a SAPR VA during the emergency care.

This rule:

a. Incorporates all applicable congressional mandates from Section 113 of Title 10, United States Code (U.S.C.), and Public Laws 109-364, 109-163, 108-375, 106-65, 110-417, and 111-84; and all applicable recommendations from the IG, DoD; Government Accountability Office; and Defense Task Force on Sexual Assault in the Military Services;

b. Establishes the creation, implementation, maintenance, and function of DSAID, an integrated database that will meet congressional reporting requirements, support Military Service SAPR Program management, and inform DoD SAPRO oversight activities;

c. Increases the scope of applicability of this part by expanding the categories of persons covered by this part to include:

1. National Guard and Reserve Component members who are sexually assaulted when performing active service, as defined in section 101(d)(3) of Title 10, U.S.C., and inactive duty training. Refer to DoD Instruction (DoDI) 6495.02 for additional SAPR and medical services provided to such personnel and eligibility criteria for Restricted Reporting;

2. Military dependents 18 years of age and older who are eligible for treatment in the military healthcare system, at installations in the continental United States (CONUS) and outside of the continental United States (OCONUS), and who were victims of sexual assault perpetrated by someone other than a spouse or intimate partner. (The Family Advocacy Program (FAP), pursuant to DoD Directive (DoDD) 6400.1, covers military dependent sexual assault victims who are assaulted by a spouse or intimate partner and military dependent sexual assault victims who are 17 years of age and younger);

3. The following non-military personnel who are only eligible for limited medical services in the form of emergency care (see § 103.3 (g) of this rule), unless otherwise eligible to receive treatment in a military medical treatment facility. They will also be offered the limited SAPR services of a Sexual Assault Response Coordinator (SARC) and a SAPR Victim Advocate (VA) while undergoing emergency care OCONUS. Refer to DoDI 6495.02 for any additional SAPR and medical services provided. These limited medical and SAPR services shall be provided to:

i. DoD civilian employees and their family dependents 18 years of age and older when they are stationed or performing duties OCONUS and eligible for treatment in the military healthcare system at military installations or facilities OCONUS. Refer to DoDI 6495.02 for reporting options available to DoD civilians and their family dependents 18 years of age and older;

ii. U.S. citizen DoD contractor personnel when they are authorized to accompany the Armed Forces in a contingency operation OCONUS and their U.S. citizen employees per DoDI 3020.41. Refer to DoDI 6495.02 for reporting options available to DoD contractors; and

4. Service members who are on active duty but were victims of sexual assault prior to enlistment or commissioning. They are eligible to receive full SAPR services and either reporting option. The focus of this part and DoDI 6495.02 is on the victim of sexual assault. The DoD shall provide support to an active duty Service member regardless of when or where the sexual assault took place.

It has been determined that this rule is not a significant regulatory action. The rule does not:

1. Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a section of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities;

2. Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency;

3. Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or

4. Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.

It has been certified that this rule does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

It has been certified that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. This rule provides SAPR Program guidance only.

Section 103.5(a)(9) of this interim final rule contains information collection requirements. DoD has submitted the following proposal to the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35). Comments are invited on: a. Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility;

b. The accuracy of the estimate of the burden of the proposed information collection;

c. Ways to enhance the quality, utility, and clarity of the information to be collected; and

d. Ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology.

Title:DSAID.

Type of Request:New.

Number of Respondents:3,200.

Responses Per Respondent:1.

Annual Responses:3,200.

Average Burden Per Response:60 minutes.

Annual Burden Hours:1 hour.

Needs and Uses:A DoD database that captures uniform data provided by the Military Services and maintains all sexual assault data collected by the Military Services. This database shall be a centralized, case-level database for the uniform collection of data regardingincidence of sexual assaults involving persons covered by this part and DoDI 6495.02. DSAID will include information when available, or when not limited by Restricted Reporting, or otherwise prohibited by law, about the nature of the assault, the victim, the offender, and the disposition of reports associated with the assault. Information in the DSAID will be used to respond to congressional reporting requirements, support Military Service SAPR Program management, and inform DoD SAPRO oversight activities.

Affected Public:Federal Government; Individuals or Households; Business or Other For-Profit; Not-For-Profit Institutions; Farms; State, Local or Tribal Government.

Frequency:On occasion.

Respondent's Obligation:Voluntary.

OMB Desk Officer:

Written comments and recommendations on the proposed information collection should be sent to Ms. Jasmeet Seehra at the OMB, DoD Desk Officer, Room 10102, New Executive Office Building, Washington, DC 20503, with a copy to Ms. Darlene Sullivan at the DoD SAPRO, Oversight Program Manager, 1401 Wilson Boulevard, Suite 402, Arlington, VA 22209. Comments can be received from 30 to 60 days after the date of this notice, but comments to OMB will be most useful if received by OMB within 30 days after the date of this notice.

You may also submit comments, identified by docket number and title, by the following method: Federal eRulemaking Portal:http://www.regulations.gov.Follow the instructions for submitting comments.

Instructions:All submissions received must include the agency name, docket number and title for thisFederal Registerdocument. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet athttp://www.regulations.govas they are received without change, including any personal identifiers or contact information.

To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to DoD SAPRO, 1401 Wilson Boulevard, Suite 402, Arlington, VA 22209, ATTN: Ms. Darlene Sullivan, (703) 696-9422.

It has been certified that this rule does not have federalism implications, as set forth in Executive Order 13132. This rule does not have substantial direct effects on:

1. The States;

2. The relationship between the National Government and the States; or

3. The distribution of power and responsibilities among the various levels of Government.

Accordingly, 32 CFR Part 103 is added to read as follows:

The Miami International Boat Show Operations Manager has requested temporary modifications to the operating schedules of the Venetian Causeway Bridge (West) and the Venetian Causeway Bridge (East) in Miami, Florida. These deviations will result in the bridges being allowed to open only on the hour and half-hour from 7 a.m. to 9 p.m. daily, from February 13, 2012 through February 21, 2012.

The Miami International Boat Show generates a high volume of vessel and vehicle traffic. In previous years, opening these bridges on demand has resulted in significant vehicle congestion. By opening the bridges only on the hour and half-hour (rather than on demand) traffic congestion will be reduced. The temporary deviation will be effective from 7 a.m. on February 13, 2012 through 9 p.m. on February 21, 2012.

The details, regular operating schedule, and deviation period for each bridge are set forth below.

1.Venetian Causeway Bridge (West), mile 1088.6.The vertical clearance of the Venetian Causeway Bridge (West), across the Atlantic Intracoastal Waterway is 12 feet. The normal operating schedule for the Venetian Causeway Bridge (West) is set forth in 33 CFR 117.261(nn). 33 CFR 117.261(nn) requires the bridge to open on signal; except that from 7 a.m. to 7 p.m., Monday through Friday, except Federal holidays, the bridge need only open on the hour and half-hour.

2.Venetian Causeway Bridge (East).The vertical clearance of the Venetian Causeway Bridge (East), across Biscayne Bay is 6 feet. The normal operating schedule for the Venetian Causeway Bridge (East) is set forth in 33 CFR 117.269. 33 CFR 117.269 requires the bridge to open on signal; except that from 7 a.m. to 7 p.m., Monday through Friday, except Federal holidays, the bridge need only open on the hour and half-hour.

As a result of these temporary deviations, the Venetian Causeway Bridge (West) and the Venetian Causeway Bridge (East) will only open to navigation on the hour and half-hour from 7 a.m. until 9 p.m. daily, including weekend days, from February 13, 2012 through February 21, 2012. At all other times the bridges will open on demand. However, the drawspans will open as soon as possible at any time for the passage of public vessels of the United States, tugs, with tows, and vessels in distress.

In accordance with 33 CFR 117.35(e), the drawbridges must return to their regular operating schedules immediately at the end of the designated time period. These deviations from the operating regulations are authorized under 33 CFR 117.35.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in this document electronically, please go tohttp://www.epa.gov/ocsppand select “Test Methods and Guidelines.”

Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0697 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before March 27, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0697, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

•Mail:Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

•Delivery:OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr. Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for combined residues of the fungicide cyazofamid, in or on fresh basil at 12 parts per million (ppm), and on dried basil at 144 ppm. These time-limited tolerances expire on December 31, 2014.

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of section 408 of FFDCA and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The Illinois Department of Agriculture (IDA) submitted a Section 18 Specific Exemption request (10IL02). After having reviewed the submission, EPA determined that an emergency condition exists for this State, and that the criteria for approval of an emergency exemption were met. EPA has authorized a specific exemption under FIFRA section 18 for the use of cyazofamid on basil for control of downy mildew (Peronospora balbahrii) in Illinois. This new food use for cyazofamid triggered the requirement for the establishment of tolerances under FFDCA.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of cyazofamid in or on basil. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these time-limited tolerances expire on December 31, 2014, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on basil after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether cyazofamid meets FIFRA's registration requirements for use on basil or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of cyazofamid by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Illinois to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for cyazofamid, contact the Agency's Registration Division at the address provided underFOR FURTHER INFORMATION CONTACT.

Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerances for combined residues of cyazofamid on fresh basil at 12 ppm, and on dried basil at 144 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for cyazofamid used for human risk assessment is discussed in Unit III. B. of the final rule published in theFederal Registerof July 14, 2010 (75 FR 40745) (FRL-8833-1).

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to cyazofamid, EPA considered exposure under the time-limited tolerances established by this action as well as all existing cyazofamid tolerances in 40 CFR 180.601. EPA assessed dietary exposures from cyazofamid in food as follows:

i.Acute exposure.No acute toxicity endpoint was identified for cyazofamid for the general population including infants and children, because no acute effects were observed which could be attributed to a single-dose exposure. Nevertheless, EPA estimated acute exposure for the subpopulation, females 13-49 years, based on the developmental toxicity risk. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). Tolerance level residues and 100 percent crop treated (PCT) assumptions were used. Anticipated residues and PCT information were not used.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. Tolerance level residues and 100 PCT assumptions were used. Anticipated residues and PCT information were not used.

iii.Cancer.Based on the data summarized in Unit III.A., July 14, 2010, and athttp://www.regulation.govin document “Cyazofamid. Human Health Risk Assessment for Proposed Section 18 Use on Basil, item 4.4 Dietary Exposure and Risk,” p.14, EPA has concluded that cyazofamid does not pose a cancer risk to humans. Cyazofamid has been classified as “not likely to be carcinogenic in humans,” based on the absence of significant tumor increases in two rodent carcinogenic studies. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

2.Dietary exposure from drinking water.The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for cyazofamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyazofamid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), the estimated drinking water concentrations (EDWCs) of cyazofamid for acute exposures are estimated to be 136 parts per billion (ppb) for surface water and 2.18 ppb for ground water. For chronic exposures for non-cancer assessments EDWCs are estimated to be 133 ppb for surface water and 2.18 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 136 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 133 ppb was used to assess the contribution to drinking water.

3.Sources of non-dietary exposure.The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Cyazofamid is currently registered for the following uses that could result in residential exposures: Commercially-treated residential turf and ornamentals. EPA assessed residential exposure using the following assumptions: Non-occupational handler exposures are not expected; however, post-application exposure is possible for children and adults. Non-occupational/residential MOEs were estimated for “Day 0” exposure. The post-application children's aggregate MOE (including incidental oral exposures) is 1,600. The Agency is concerned when MOEs are <100. All MOEs, including the children's aggregate, are >100, and therefore not a risk concern.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at:http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4.Cumulative effects from substances with a common mechanism of toxicity.Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found cyazofamid to share a common mechanism of toxicity with any other substances, and cyazofamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyazofamid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site athttp://www.epa.gov/pesticides/cumulative.

1.In general.Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional SF when reliable data available to EPA support the choice of a different factor.

2.Prenatal and postnatal sensitivity.The prenatal and postnatal toxicology database for cyazofamid includes rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. There was some evidence of increased susceptibility followingin uteroexposure to rats in the prenatal developmental toxicity study; the increased incidence of bent ribs in the high dose fetuses was considered adverse and was used for setting the developmental NOAEL/LOAEL.

3.Conclusion.EPA has determined that reliable data show that the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for cyazofamid is sufficient to characterize the hazard, to conduct FQPA assessment, and to select toxicity endpoints for risk assessment. Under current data requirement guidelines, functional immunotoxicity data (OPPTS 780.7800) is a data gap. However, the cyazofamid toxicology database does not show any evidence of biologically relevant effects on the immune system that relate to this chemical. The Agency does not believe that conducting a functional immunotoxicity study will result in a lower NOAEL than the regulatory dose for this risk assessment, and an additional uncertainty factor (UF) for the data gap is unnecessary.

ii. There is no indication that cyazofamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account forneurotoxicity for this time-limited tolerance.

iii. There was some evidence of increased susceptibility followingin uteroexposure to rats in the prenatal developmental toxicity study. As described earlier, the increased incidence of bent ribs in the high dose fetuses was considered adverse and was used for setting the developmental NOAEL/LOAEL. EPA considers this approach conservative and highly protective because bent ribs are a reversible developmental anomaly rather than a malformation.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyazofamid in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by cyazofamid.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1.Acute risk.Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to cyazofamid will occupy 1.2% of the aPAD for females 13-49 years, the only subpopulation assessed. For the population of concern, the acute dietary (food and drinking water) risk assessment represents acute aggregate risk.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cyazofamid from food and water will utilize <1% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3. regarding residential use patterns, chronic residential exposure to residues of cyazofamid is not expected.

3.Short-term and intermediate term risk.Short-term and intermediate-term risks have been assessed together because both scenarios have the same endpoints and PODs. Short-intermediate term aggregate exposure takes into account short-intermediate term residential exposure plus chronic exposure to food and drinking water (considered to be a background exposure level). Cyazofamid is currently registered for uses that could result in short-term and/or intermediate term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-intermediate term residential exposures to cyazofamid.

Using the exposure assumptions described in this unit for short-intermediate term exposures, EPA has concluded the combined short-intermediate term food, water, and residential exposures result in aggregate MOEs of >100 for all scenarios. Because EPA's level of concern for cyazofamid is a MOE of 100 or below, these MOEs are not of concern.

4.Aggregate cancer risk for U.S. population.Based on the lack of evidence of carcinogenicity in two adequate rodent (both the rat and the mouse) carcinogenicity studies, cyazofamid is not expected to pose a cancer risk to humans.

5.Determination of safety.Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to cyazofamid residues.

Adequate enforcement methodologies are available to enforce the tolerance expression. Cyazofamid its and metabolite CCIM are completely recovered (>80% recovery) using FDA's Multiresidue Protocol D (without cleanup). In addition, an acceptable high performance liquid chromatography/ultraviolet/detector (HPLC/UV) method (“Independent Laboratory Validation of the Residue Method for IKF-916 and CCIM in Tomatoes”, Document Number 013033-0, Pyxant Labs Inc., with slight modification) is available for use as a single analyte confirmatory method.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for cyazofamid on basil.

Therefore, time-limited tolerances are established for residues of cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-sulfonamide,and its metabolites and degradates in or on basil, fresh, at 12 ppm, and basil, dried, at 144 ppm. These tolerances expire on December 31, 2014.

This final rule establishes time-limited tolerances under sections 408(e) and 408(l)(6) of FFDCA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory Planning and Review(58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-IncomePopulations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established in accordance with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation and Coordination with Indian Tribal Governments(65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq.,generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C.

Therefore, 40 CFR chapter I is amended as follows:

This is a summary of the Commission's Report and Order, ET Docket No. 09-36; RM 11404, FCC 11-176, adopted November 30, 2011 and released November 30, 2011. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, BestCopy and Printing, Inc., 445 12th Street SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at:www.fcc.gov.

People with disabilities:To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email tofcc504@fcc.govor call the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (tty).

1. In this Report and Order (R&O), the Commission expands the Medical Device Radiocommunication (MedRadio) Service under part 95 of the Commission's rules to permit the use of new wideband medical implant devices that employ neuromuscular microstimulation techniques to restore sensation, mobility, and other functions to paralyzed limbs and organs. These medical devices hold enormous promise to advance the state of medical care, lower health costs, and improve the quality of life for countless Americans. The rules adopted by the Commission will allow these new types of MedRadio devices to access 24 megahertz of spectrum in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands on a secondary basis.

2. The Commission's action is part of a larger effort to recognize and facilitate the significant advances in wireless medical technologies that are revolutionizing treatment for a wide variety of medical conditions and creating new health care models to benefit all Americans. Such advances have the potential to significantly improve the quality of life and sophistication of therapy for countless Americans living with a variety of medical conditions and, in turn, could result in lower medical costs and extend the time between hospital visits and surgical procedures. The devices that we expect to be deployed under the rules we adopt herein hold the promise of safer, less invasive, and more effective treatment options than those available under current medical practice.

3. The Wireless Medical Telemetry Service (WMTS) and MedRadio services, together with unlicensed medical applications developed and operated under our general part 15 rules, have supported countless vital therapeutic and diagnostic medical applications. The Commission recognizes, however, that the dynamic nature of medical technology means that our existing rules may need to evolve to keep pace with the newest cutting edge therapies. Thus, the Commission included in theMedRadio Proceedinga notice of inquiry seeking information in a broader context relating to future spectrum needs for wireless medical technologies. On September 5, 2007, the Alfred Mann Foundation for Scientific Research (AMF or Alfred Mann) filed a petition for rulemaking that serves as the basis of this proceeding.

4. In its petition, Alfred Mann asked the Commission to designate up to 24 megahertz of spectrum in the 413-457 MHz range to support new medical micro-power networks (MMNs) consisting of implantable neuromuscular microstimulation devices and associated external control units. Alfred Mann's petition was based on its research dating to 1989 on implantable medical devices to treat neurological injuries and disorders. Since 2005, AMF has conducted extensive work under the authority of an experimental license from the Commission to operate its devices in the 400-470 MHz band. Alfred Mann's wideband MMN equipment is designed to replace damaged nerve connections by performing functional electric stimulation (FES) to activate and monitor nerves and muscles in order to restore sensation, mobility, and other functions to nonfunctioning limbs and organs.

5. The work that AMF has done with the Veterans Administration and other hospitals under its experimental license has proven the potential benefits of MMNs. The Commission strongly believes that widespread MMN deployment can foster important advancements in medical care by, significantly improving the quality of life for the many Americans suffering from spinal cord injuries, traumatic brain injuries, and strokes. However, it also recognizes that MMNs represent a new type of radio communication which does not readily fit into any of the existing spectrum allocations. Because of the significant benefits that MMNs are poised to deliver, the Commission has concluded that the public interest warrants modifying its rules to allow their use. First, the Commission discussed the characteristics of MMN operations and concluded that this service is best accommodated by modifying and expanding our existing part 95 MedRadio rules. Second, it evaluated the frequency allocations necessary to support MMN operations and provide a secondary allocation in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands for use by MMNs as proposed. This means these devices cannot cause interference to and must accept interference from stations of a primary service. This restriction ensures that the potential for interference—i.e.,the only cost that would be imposed on other parties—is negligible. Finally, the Commission sets forth the service and technical rules that will allow MMNs operating on a secondary basis to share these bands with incumbent services.

7. The Commission's decision to allow MMNs to share spectrum with existing services supports the Commission's commitment to promoting efficient spectrum use to meet growing demand. In the March 2010National Broadband Plan,the Commission underscored the importance of expanding opportunities for innovative spectrum access models made possible by advanced technologies. The Commission sought to promote the development of such technologies through its dynamic spectrum use technologiesNotice of Inquiry.MMNs, which make use of advanced technology such as spectrum sensing, dynamic frequency selection, and notching out of interference signals to share spectrum with other services, demonstrate one such spectrum access model. These techniques will allow MMNs to use available spectrum to provide life-changing health benefits without impairing the ability of other licensed users in these frequency bands to continue providing service.

8. In theNPRM,the Commission sought comments on authorizing MMN devices to operate in the 413-457 MHz band as an extension of our existing part 95 MedRadio rules. As a part 95 MedRadio service, MMNs would qualify for license-by-rule operation pursuant to Section 307(e) of the Communications Act (Act). Under this approach, medical devices would operate in the band on a shared, non-exclusive basis with respect to each other. AMF supports the license-by-rule framework and no one objects to this approach or suggests alternative licensing methods.

9. As discussed in the NPRM, the Commission will authorize MMN operations under the existing part 95 MedRadio rules. For MedRadio devices, the Commission determined that the license-by-rule approach minimized regulatory procedures and would facilitate more expeditious deployment of new generations of beneficial wireless medical devices. Also, MMNs share many characteristics with devices that operate in the existing MedRadio service. The core MedRadio band from 402-405 MHz is restricted to communication between an implanted medical device and an externalprogrammer/controller. This is the same architecture employed for AMF's MMNs. As with MedRadio implant devices, the MMN implant devices are sophisticated medical devices that are intended to be deployed by or under the direction of a duly authorized health care professional. The power levels proposed by AMF for MMN devices are on par with the power levels used by MedRadio devices. Additionally, both MedRadio devices and MMN systems are designed to operate in the 400 MHz frequency range, although MMNs require greater bandwidth than is available under the existing MedRadio rules. For the reasons provided, the Commission believes that the MedRadio license-by-rule framework is the best way to structure our MMN rules.

10. In the NPRM the Commission sought comment on a number of definitions that AMF proposed be added to the part 95 MedRadio Service rules for devices operating in the 413-457 MHz band. These definitions were for a Medical Micropower Network (MMN), MMN control transmitter, MMN implant transmitter, and MMN transmitter. The Commission adopted a single definition for MMN, as follows:

11. The Commission declines to adopt the more expansive definitions proposed by Sienkiewicz and the Cleveland FES Center or to substantially deviate from the framework proposed in the NPRM. It recognizes that the existing programmer/control transmitter definition does not permit use of implanted programmer/control transmitters or the deployment of an MMN that functions without a programmer/control transmitter, as Sienkiewicz and the Cleveland FES Center have suggested should be permitted for MMNs. The record in this proceeding is largely based on AMF's MMN system, which uses an external programmer/control transmitter which implements a number of interference mitigation techniques to allow the MMN to share spectrum with other services in these bands and which has been subject to extensive testing. The Commission has no information at this time to determine whether an MMN without an external programmer/controller could mitigate the effects of interference and successfully coexist in these bands. Other use of these frequency bands such as for non-FES medical applications or allowing transmission of voice data is speculative at this point. No one has provided guidance on what alternative specifications would appropriately accommodate other uses while not compromising the potential of MMNs. Further modification to the rules may be readily sought if and when a need arises.

12. Based on this definition and the rules the Commission adopts under it, the Commission can be sure that all MMNs will be designed with sufficient interference mitigation techniques and design elements to be able to operate on a secondary basis under the Commission's part 95 rules. At the same time, and because it wants parties to be able to tap the vast potential MMN technologies have to transform lives and advance the state of medical care, the Commission rejected those comments that would have us bind our rules too tightly to AMF's specific equipment design. Because manufacturers may develop new MMN devices with different interference mitigation techniques, the Commission does not think it is appropriate to require that all MMN devices function in an identical fashion to AMF's devices. Future systems, may rely on technologies that have an even greater capability to reject interference than AMF's current design, and the Commission will evaluate individual devices as part of its equipment authorization process.

13. Finally, the Commission sought comments in theNPRMon the service and technical rules that would apply to medical devices in the 413-457 MHz band. The discussion generally followed the framework of the MedRadio Service rules with, for example, modified power and emission bandwidth requirements to accommodate the proposed MMNs. While the Commission did not include a separate appendix of proposed rules, the NPRM stated that the Commission was seeking comment on allowing additional spectrum to be used under the MedRadio Service in part 95 of the Commission's rules, referenced new rules that AMF had proposed in its filing, and discussed specific service and technical issues at length. For this reason parties have had ample opportunity to provide meaningful comments on the proposals, and the Commission rejected suggestions to the contrary. Because the Commission is including MMNs within the existing framework of the MedRadio Service, it will apply the existing MedRadio service and technical regulations to MMNs to the extent possible and only amend the rules in part 95, Subparts E and I, as necessary to distinguish between MMNs and other MedRadio devices. As observed in the NPRM, such an approach “is desirable as it would maintain consistency with rules applicable to wireless medical devices, particularly for implanted and related therapeutic devices.”

14. Although the Commission concluded that it is appropriate to license MMNs as a MedRadio service, it does not follow that it is feasible for MMNs to operate on the existing MedRadio frequencies. This is because MMNs are different from existing MedRadio applications in important technical and design elements. For example, a typical MMN is expected to contain multiple implant devices, which will require the transmission of much more data than the MedRadio devices operating under the existing rules. Moreover, due to their small size, MMN implant devices must be even more energy efficient than typical MedRadio implants. This efficiency is achieved by using short transmissions, which necessitate the use of much wider bandwidth signals than the 300 kHz currently permitted in the existing MedRadio bands. This limit was put in place to maximize the number of medical devices that can use the 5 megahertz available in the 401-406 MHz band and is consistent with the operational needs of existing MedRadio applications. By contrast, MMNs are designed to operate with a 5 megahertz emission bandwidth. Thus, the current MedRadio frequencies are insufficient to support MMN operation.

15.Decision.Consistent with our proposal, the Commission will allocate the 24 megahertz of spectrum in foursegments of the 413-457 MHz band for MMN use on a secondary basis,i.e.,413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz. As described by AMF, the propagation characteristics of the 400 MHz band make it particularly well suited to host MMN devices, and the band is already used for other MedRadio implanted devices. Further, because these four band segments will allow for the wide bandwidth signals required to transmit large amounts of data in a short amount of time, they will provide the emission bandwidth that MMNs require. As explained, the Commission does not believe operation on a secondary basis will detrimentally impact the development or deployment of MMNs as they are designed to be able to operate on a secondary basis.

16. The Commission also concluded that allocating four band segments for MMN use is necessary to ensure that an MMN has sufficient spectrum to operate while avoiding causing interference to or receiving interference from primary users in the band. An MMN will occupy only one band segment at any given time. By having a variety of authorized frequency bands available and employing protocols that will allow MMNs to quickly migrate from band to band, an MMN licensee will be able to make robust use of the available spectrum and respond to changing spectrum conditions. In addition, the four band segments serve a mix of Federal and non-Federal use. By permitting MMN use of all four segments, the Commission will give MMNs more flexibility to operate in differing RF interference environments. Commenters expressed concern that heavy band use situations could render a particular frequency band unavailable to MMNs for extended periods of time. However, the Commission does not believe that such a possibility should categorically preclude us from allocating the four proposed frequency bands. Similarly, the fact that certain interference mitigation techniques might work in some situations but not in others is not a reason to prevent MMNs from being authorized to operate in all four frequency bands. Even in a worst-case situation, the Commission can expect that many patients with MMN implants will still be able to make effective use of at least one of the allocated frequency segments.

17. The Commission will implement this allocation by modifying footnote US345 to the Table of Allocations for the MedRadio service to add a secondary mobile, except aeronautical mobile, allocation for the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz frequency bands and renumbering this footnote as US64. This allocation will be in addition to the existing allocations in these four frequency bands and will be limited to use solely by MedRadio operations. The Commission is making this allocation through a footnote rather than a direct entry in the Table for consistency with the existing MedRadio allocation and to emphasize the limited nature of this allocation.

18. The Commission will place this footnote in both the Federal Table and non-Federal Table for each of these four frequency bands to allow use in a variety of settings such as in health care facilities operated by the Department of Veterans Affairs or the United States military, as well as non-Federal health care facilities. Even though this allocation will be both a Federal and non-Federal allocation, the Commission does not expect any changes in the primary use of any of these frequency bands. The 413-419 MHz band will continue to be used primarily for Federal mobile and space research services. The 451-457 MHz band will continue to be used primarily for non-Federal land mobile services. The 426-432 MHz and 438-444 MHz bands will continue to be shared by the Federal radiolocation service and the non-Federal Amateur service. Because MedRadio use of these bands will be on a secondary basis, MedRadio stations will not be allowed to cause interference to and must accept interference from primary services sharing the bands. Consequently, there is no reason for any changes to the current coordination procedures between FCC and NTIA for these frequency bands. NTIA will continue to manage the 413-419 MHz band, the FCC will continue to manage the 451-457 MHz band, and both agencies will continue to share management responsibilities of the 426-432 MHz and 438-444 MHz bands.

19. The Commission also notes that the spectrum it is adding to the MedRadio Service is allocated to similar services in both the United States Table and in all regions of the world in the International Table. Thus, the Commission believes that MMN devices designed to be compatible with U.S. radiocommunications services will be equally compatible with the services found elsewhere in the world. However, it is not aware of any other administrations that have made provisions for MMNs. Although individuals using MMNs should not encounter significantly different electromagnetic environments when traveling abroad, the use of MMNs may be restricted in other countries. The Commission finds that the benefits promised by MMNs as well as the ability for MMNs to coexist with the radiocommunications services already allocated internationally in the bands under consideration support our decision to adopt the proposed allocation.

20. The Commission rejected other frequency band suggestions made by commenters and find that they would not be suitable for MMN use. It rejected suggestions by the National Association for Amateur Radio (ARRL), the Land Mobile Communications Council (LMCC), the Enterprise Wireless Alliance (EWA), and Motorola that the WMTS bands are more appropriate for MMNs. In the MedRadio proceeding, the Commission stated that frequencies below 216 MHz and above 470 MHz are “outside the range of spectrum generally considered to be the most suitable for propagation of radio signals within the human body.” Because implanted MMN devices must operate with minimal power, efficient propagation of signals through the human body is extremely important for their operation. The WMTS bands from 608-614 MHz, 1395-1400 MHz, and 1429-1432 MHz are far above the suitable range for signal propagation in the human body. While the use of additional power might overcome the decreased propagation of signals in the human body in these bands as compared to the 400 MHz band, it appears that it is not practical to substantially increase the size of batteries in the MMN implant devices. In addition, the 608-614 MHz WMTS band is heavily used in medical facilities and could complicate reliable MMN service in such close proximity. The Commission therefore concludes that the WMTS bands are not a practical alternative for use by MMNs.

21. The Commission's NPRM envisioned, and AMF has designed, MMNs that are capable of operating on a secondary basis in frequency bands with existing, established incumbent use. Through the use of harmful interference mitigation techniques, operations on multiple frequency bands, and pre-established shutdown protocols in the event that no frequency bands are available, MMNs will be able to operate successfully in the lower 400 MHz band. The Commission is further encouraged by the fact that the MMN concept is not just theoretical: AMF has engaged in prototype development under an experimental license that it has held since January 2005 and in actual evaluation and testing in cooperation with Federal stakeholders. AMF notes that it has developed prototype programmer/controllers thatimplement these interference mitigation techniques and points out that these techniques have been independently tested and shown to be effective against a wide range of potential interference signals.

22. AMF submitted interference analyses, test reports, and technical studies that it had commissioned to evaluate MMN use in the identified bands. These materials were the product of a process that began in August 2009, when AMF and the Joint Spectrum Center (JSC) (a field office within the U.S. Defense Spectrum Organization that provides spectrum planning and support for U.S. military interests) entered into a memorandum of agreement (MOA) for JSC to conduct a technical analysis to determine whether MMN devices could co-exist with incumbent government systems in the 413-457 MHz band.

23. Pursuant to the MOA, JSC directed a contractor, ITT, to collect, validate, and evaluate technical data regarding MMN devices and incumbent government systems. The resulting report (JSC Report) contained a theoretical analysis to evaluate the electromagnetic compatibility (EMC) of incumbent government system receivers in the presence of radiofrequency (RF) emissions from MMN transmitters and the EMC of MMN receivers of both the programmer/controller (P/C) and implanted microstimulator devices—in the presence of RFemissions from incumbent systems. The JSC reviewed the report and approved it for publication in October 2010.

24. The JSC Report concluded that, with respect to the MMN-to-government system interference potential, (1) “relatively small [required separation distances] result from the low EIRP and duty cycle of the MMN transmitters combined with the low antenna heights of the MMN,” and (2) MMN systems “should be operationally compatible and not cause unacceptable interference into [incumbent government] systems currently authorized to operate in the 410-450 MHz band.”

25. In addition, AMF commissioned Aerospace Corporation (the operator of a federally funded research and development center and provider of comprehensive technical service to national security space programs) to conduct laboratory tests to determine whether MMNs could successfully operate in the presence of incumbent users. To evaluate the performance of the MMN network in the 413-457 MHz band, the Aerospace testers conducted a wired simulation of the frequency bands. Specifically they tested signals representing Federal mobile radio (data and voice), radar (ground and airborne), and the Enhanced Position Location Reporting System, as well as non-Federal amateur television. The tests specifically targeted four MMN interference mitigation techniques: spectral excising of narrowband incumbent signals; changing frequency bands without suspending critical functions; shutting down in a communication link loss scenario; and incumbent signal level sensing to avoid interference. The resulting report (Aerospace Report) concluded that the AMF MMN System performs according to its specifications and can successfully operate in presence of incumbent users.

26. The JSC Report and Aerospace Report offer detailed evaluations of specific interference scenarios involving a broad spectrum of incumbent operations backed up by testing with actual equipment. Based on these reports, the Commission concluded that the recorddemonstrates that MMNs can operate on a compatible secondary basis with primary Federal operations in the 413-419 MHz, 426-432 MHz, and 438-444 MHz band segments.

27. The Commission is also convinced that MMNs can operate on a compatible secondary basis with primary non-Federal operations. The findings of the JSC Report, which focused on Federal systems, and the simulations conducted by AMF and the Aerospace Corporation, which looked at a wider variety of high-powered signals, support this conclusion. In this regard, non-Federal fixed and land mobile radio systems in the 451-457 MHz frequency band use the same technologies as Federal fixed and land mobile radio systems in the 420-450 MHz frequency band. Moreover, the mitigation techniques that the Aerospace Report examined have broad applicability. For example a P/C that incorporates “notching” techniques could filter out a 100 kHz RPU signal from a BAS operator.

28. The Commission believes that the JSC Report, Aerospace Report, and associated materials filed by AMF are responsive to these concerns. In addition, because these materials provide extensive technical details about the interference mitigation techniques employed by AMF's MMN devices, the Commission disagrees with the contention of the Engineers for the Integrity of the Broadcast Auxiliary Service Spectrum (EIBASS) that AMF has provided insufficient technical details about its interference mitigating protocols.

29. A number of parties claim that incumbent operators could receive harmful interference from MMN devices. The Commission disagrees. Several factors serve to reduce any risk that MMNs could cause harmful interference. First, the JSC Report concluded that the MMN systems would not cause unacceptable interference into government systems in the 413-419 MHz, 426-432 MHz, and 438-444 MHz bands. Again, because the non-Federal land mobile systems in the 451-457 MHz are virtually identical to the types of government systems considered in the JSC Report, there is no basis for us to expect interference to non-Federal land mobile systems. Such non-Federal land mobile systems must overcome interference caused by the high-powered operations of other incumbents in the band. For this reason, they are well equipped to tolerate the presence of any signals they might receive from an MMN system operating at a much lower power. The Aerospace Report, which tested actual prototype MMN devices and concluded that incumbent services would not receive significant interference, further bolsters our conclusion. The Commission further notes that some commenters have rejected the likelihood of interference from MMN devices to their services which, like land mobile systems, operate at much higher powers than MMNs. Finally, the Commission adopts service rules that will require an MMN to switch to another frequency if it appears that there is an incumbent operating in close proximity.

30. The studies commissioned by AMF show that MMNs are able to function with a significant amount of interference from incumbent operations. As such, the Commission is not persuaded by those comments that claim that MMNs are incompatible with incumbent non-Government licensees. Incumbent systems that operate in the bands under consideration share the same high-powered operational attributes that MMNs have been specifically designed to tolerate.

31. To the extent that objections from commenters focus on the fact that a transmitter of a particular service may cause interference when operating in close proximity to an MMN device, commenters fail to acknowledge that the MMN system design anticipates such a scenario. There is no dispute that MMN devices may not be able to function in one or more of the four bands at a particular moment because of interference. AMF's MMN devices are capable of switching among the four different bands and are designed to operate on one band at a time, and the Aerospace Report found that this design feature worked as planned. Moreover, because MMNs are designed to operate in a variety of bands with a diverse setof Government and non-Government users, a band that is rarely available for use in a particular place or at a specific time may be uncongested in other situations. Under this reasoning, the Commission is not troubled by EIBASS's claim that the tests submitted by AMF did not specifically consider RPU operations, a claim AMF refutes. EIBASS states that RPU broadcasts are distinct because they often employ a long duty cycle and postulates a scenario where extended RPU operations would take place at a health care facility. In such a case, the MMNs operating in that place and time would simply not be able to access the portion of the MedRadio band that is being used by the RPU operator.

32. Several parties argue that it would be inappropriate for us to permit medical devices—and MMNs in particular—to operate on a secondary basis. The Commission disagrees with parties that argue that it should never allocate spectrum to medical devices on a secondary basis. As a general matter, the Commission takes many factors into account in deciding whether a given service should operate with a primary or secondary status in a designated frequency band or even whether a device should operate on an unlicensed basis under part 15 of its rules. Each case is evaluated on its own merits. This is also true of our allocations for medical devices. At the present time, the Commission's rules allow medical devices to operate on a primary basis, on a secondary basis, and on an unlicensed basis. The Commission finds in this order that the characteristics of the MMN devices at issue here warrant operation on a secondary basis. The MMN devices that will be deployed under the rules that it adopted herein will be frequency agile and can switch to other frequency bands when interference occurs. Thus, the MMN devices will be designed with capabilities that enable them to share spectrum with primary services successfully. Rigorous testing has shown that MMN devices can perform as intended.

33. The Commission acknowledges that there may be instances when MMN devices cannot operate due to interference on all frequency bands. However, it also notes that AMF has accounted for this possibility by designing its MMN devices to shut down in a controlled, pre-planned manner that is designed to avoid harm to the patient or others if interference in all four frequency bands prevents successful reception of signals by the MMN system. The Commission rejects the notion that the potential for such a shutdown should categorically bar us from designating spectrum for MMNs and, thus, deny the benefits associated with these devices. The Food and Drug Administration (FDA), as part of its independent review process, will take into account these “graceful shutdowns” when it determines when and how MMN use can be prescribed. Further, the Commission will require that MMN devices be authorized under the direction of a duly authorized health care professional who will inform patients of the risks associated with MMN use, including “graceful shutdowns.”

34. The Commission must balance the cost of allowing MMNs to operate on a secondary basis in these bands against the benefits that patients could potentially receive from their use. Given the extremely low risk of incumbent services suffering interference from MMNs and the yet lower risk of a harmful result from any such interference, the potential benefits of establishing a secondary allocation and adopting rules to allow MMN operation outweigh the slight risk to incumbent services. Because of the great potential of MMNs to improve the lives of people who suffer from a range of illnesses such as spinal cord injuries, traumatic brain injuries, strokes, and various neuromusculoskeletal disorders, the Commission recognizes the enormous potential benefit of allowing MMNs to become a reality. The benefits of making this secondary allocation and adopting rules to facilitate MMN operations therefore far exceed any potential costs.

35. Lastly, the Commission addressed several commenters' overarching concerns that new MedRadio applications must remain truly secondary—neither interfering with incumbent operations nor creating an expectation that MMNs must be protected from the types of interference that higher-powered primary uses may legitimately cause. The Commission fully intends that MMN devices will operate within the constraints of their secondary status, and it does not adopt here any limitations on the operations of incumbent primary services in these bands for the benefit of MMN operation. Because AMF has designed its MMNs to anticipate interference and to operate in a challenging spectrum environment, the Commission is confident that they will remain secondary in both rule and practice. The Commission also clarified that MMNs, the Amateur Radio Service, and the non-Federal radiolocation service—all of which operate under a secondary allocation in the 426-432 MHz and 438-444 MHz bands—will have equal status. Given that MMN devices are expected to implement measures to mitigate the effects of interference, it is reasonable to expect the MMN devices to tolerate some interference from the Amateur Service or to move to another frequency band as needed. As ARRL concedes, MMN devices are “unlikely generally” to cause interference to Amateur Radio communications in these bands.

36. In the NPRM the Commission asked about the service and technical rules that should apply to medical devices in the 413-457 MHz band. The discussion generally followed the framework of the existing MedRadio Service rules and proposed to modify specific rules, such as those pertaining to power and emission bandwidth requirements, to accommodate the proposed MMNs. The Commission also noted that the service and technical rules discussed in the NPRM were essentially consistent with recommendations made in the Alfred Mann petition.

37. The Commission adopted the overall approach proposed in the NPRM. Thus, rather than creating a new rule subpart for MMNs, it will only amend the service and technical rules contained in part 95 subparts E and I of its rules to the extent necessary. The Commission also adopted service and technical rules that are based on the research undertaken for AMF's MMN devices. This approach offers incumbent operators greater certainty as to the types and characteristics of MedRadio devices that may be deployed in the band and, because it is backed by extensive testing, provides greater certainty that MMNs and other new medical technologies will be able to thrive on a secondary basis in these frequencies. The Commission is confident that the state of medical radiocommunication technology will evolve and improve over time, as will mitigation techniques that maximize sharing potential on a secondary basis. Further development and testing of future generations of MMNs may allow us to adopt service rules that provide even greater flexibility while still protecting incumbent services. However, the service and technical rules it adopts here are appropriate based on the record before us today.

38.Interference Mitigation.Because MMNs will operate under the secondary MedRadio Service, they must be designed to function in the presence of signals from other services operating in the same frequency bands. The interference analysis, test reports, and technical studies that AMF submittedhave demonstrated that it is possible to build MMNs that are highly resistant to interference, and as technology continues to advance, the Commission believes it will be possible to build MMN devices that are even more capable of functioning in the presence of interference. To ensure future flexibility for equipment designers, the Commission will not require that MMNs include all of the types of interference mitigation techniques that AMF has employed in its MMN devices. Instead, the Commission will adopt the general requirement that P/C transmitters have the ability to operate in the presence of other users in the 413-457 MHz band, and it will incorporate several basic interference mitigation provisions into its rules. The Commission expects that MMN technology developed in the future will be at least as capable of co-existing with other services as the system AMF has demonstrated.

39. Regardless of the interference mitigation techniques employed, the Commission expects that there will be instances where MMNs will not be able to function in a particular frequency band because of a high level of interference from other stations. To provide a greater probability that an MMN will continue to function in the presence of interference, the Commission adopted the requirement that all MMNs be capable of operating in any of the four frequency bands and that they be able to switch to another frequency band when the band on which they are operating becomes unavailable due to interference. The Commission concludes that these requirements will not increase the cost of equipment unreasonably or be burdensome for manufacturers to meet. As AMF has noted, these four bands are nearly adjacent in frequency and thus incorporation of a multi-channel operating capability requires no significant change in antenna or transmitter design and “imposes no undue economic burden.” Only a single transmitter and one antenna are necessary to cover these four bands. Components to enable manufacturers of MMNs to meet this requirement should be readily available since equipment is currently designed to operate across the Federal mobile bands between 406.1 MHz and 450 MHz and non-Federal mobile bands between 450 MHz and 512 MHz. Thus, the Commission concluded that the improved robustness of MMNs that will result from these requirements will more than offset the expected minimal cost of implementing them.

40. The Commission also notes that AMF has proposed several rules regarding interference mitigation techniques for MMNs. These suggested rules are based on AMF's experience in building and testing MMN systems. Because of AMF's expertise in this area and the lack of input from other parties on this issue, the Commission is adopting technical provisions to add assurance that any MMN technology developed in the future will be able to operate successfully in the heavily used 413-457 MHz frequency range.

41. To be able to switch to another frequency band when an existing band becomes unavailable due to high levels of interference, it will be necessary for an MMN to be aware of the potential for interference in all four frequency bands. To that end, the Commission adopted the requirement suggested by AMF that the programmer/controller (P/C) of an MMN monitor all four available frequency bands. For the band in which the MMN is operating, the P/C must check at least once a second for interference so as to be able to switch frequency bands to avoid disabling amounts of interference. Because most of the potential interferers in these bands such as land mobile, BAS, and amateur stations, typically transmit far longer than one second, a once-a-second monitoring interval should be sufficient to detect interfering signals. The P/C must be capable of determining when either direction of the communication link between the P/C and the implanted devices is being degraded to the extent that communication is likely to be lost for more than 45 milliseconds. The Commission will require the P/C to move the MMN to another frequency band upon making this determination. It will also require the P/C to monitor the other frequency bands often enough such that when it must switch frequency bands it has determined which frequency band is available based on monitoring of that band during the two second period prior to switching. According to AMF, incorporating a requirement to monitor MMN channels prior to executing a channel change “will not materially increase production costs.” This is not surprising considering that radios now operating in these bands also have a requirement to monitor channels prior to transmitting on them and that the technology and techniques to accomplish spectrum monitoring in these bands are well established. Thus, the Commission concludes that the benefits of these monitoring requirements far outweigh the expected costs to comply.

42. Because the MMN devices operate with such low power, the Commission does not believe that they will cause interference to other stations sharing the same frequency bands. However, out of an abundance of caution it adopted one additional monitoring requirement to further reduce the risk of interference. The Commission will require the P/C to switch to another frequency band if during the monitoring of the occupied frequency band it determines that there is a received signal with power greater than −60 dBm in any 12.5 kHz bandwidth being used by the MMN device that persists for at least fifty milliseconds. A received signal of this strength is likely to be caused by a station in close proximity to the P/C. The Commission is using a measurement bandwidth of 12.5 kHz for this determination because this is the signal bandwidth used by all Federal land mobile stations. Non-Federal land mobile operations are currently undergoing a migration from using 25 kHz channels to 12.5 kHz channels, and consequently, in the near future the majority of licensees will also be limited to signal bandwidths of 12.5 kHz. The Commission chose this measurement bandwidth based on land mobile stations because they are the most numerous stations that will share these frequency bands with MMNs. This requirement should prevent the unlikely occurrence of interference from an MMN device to another service sharing the same frequency band.

43. There may occasionally be instances when MMNs may not be able to function because of high levels of interference in all four frequency bands. To account for these infrequent occurrences, the rules the Commission adopted will require that all MMN transmitters incorporate a programmable means to implement a system shutdown process in the event of a communication failure or on command from the P/C. Because MMNs are used to provide therapeutic benefits to patients, such as providing them with a means to move muscles that they would not otherwise be able to move, it is important that the Commission require the MMNs to incorporate a means to implement a pre-defined system shutdown process. The Commission believes that this requirement offers vital benefits to patients and is integral to the success of the MMN system design. Because MMNs are sophisticated electronic devices and the programming necessary to implement a system shutdown process should represent only a portion of the overall design costs, the Commission concludes that the benefits of a system shutdown requirement far outweigh any associated costs. The Commission will require that this shutdown process commence within 45milliseconds after loss of the communication link or receipt of the shutdown command from the P/C.

44.Contention Protocol Requirement.In the NPRM, the Commission sought comment on a number of questions related to contention protocols, such as whether a contention protocol should be applied to MMN transmitting devices, what kinds of contention protocols should or should not be used, and how a contention protocol might be developed. A contention protocol would be aimed at allowing multiple MMN systems to share the specified frequency bands without causing interference to each other. This approach differs from the interference mitigation techniques that AMF's MMN devices employ. These techniques are designed to allow the MMNs to function in the presence of interference from other services sharing the same frequency bands. Commenters supported the idea of MMNs using a contention protocol, but no one specified a particular contention protocol that the Commission could adopt.

45. The Commission appreciates that requiring MMNs to use a common contention protocol would enable MMNs to more efficiently share the available spectrum. However, as no commenters have suggested a specific contention protocol, it cannot adopt a requirement for use of a specific contention protocol at this time. The Commission also will not require the development of a contention protocol by a particular date. Given the novelty of MMN technologies, the Commission is not able to predict when entities other than AMF will develop MMNs for use in these bands and therefore have no grounds to speculate on how and in what timeframe a contention protocol may be developed. The Commission does encourage manufacturers of MMN devices to cooperate in the development of a contention protocol so that the MMN devices may more effectively share the limited available spectrum. If, in the future, parties establish a specific contention protocol that they believe should be applied to these bands, they are welcome to file a Petition for Rulemaking to bring such information to our attention.

46. In the NPRM, the Commission also sought comment on using the listen-before-talk (LBT) approach of the existing MedRadio service rules to share spectrum between different MMNs. Under this approach, a transmitting device must monitor a frequency band for the presence of other MedRadio transmitters before beginning transmissions in that frequency band. If a signal with power above a certain threshold is detected, the transmitting device is not allowed to transmit in that frequency band. The Commission has adopted a similar requirement with a high power threshold (−60 dBm in a 12.5 kHz bandwidth) to help guard against the unlikely occurrence of interference from MMNs to other services sharing the same frequency band. Use of this high threshold will not be effective in facilitating MMN-to-MMN sharing because MMNs transmit such low power over a wide bandwidth. The Commission will not adopt a similar requirement with a lower LBT threshold because it would interfere with the functioning of the interference mitigation techniques employed by AMF's MMN devices. The MMN devices would not be able to determine whether a detected signal with a power above the LBT threshold is from another MMN or is a signal from another service sharing the same frequency band. Because MMNs should be designed to operate in the presence of a certain level of interference from other services operating in the same frequency band, not transmitting when signals above a lower LBT threshold are present would lead to MMNs not making use of the available spectrum effectively.

47.Permissible Communications and Operator Eligibility.In the NPRM, the Commission sought comment on restricting implant devices for use by persons only for diagnostic and therapeutic purposes and only to the extent that such devices have been provided to a human patient under the direction of a duly authorized health care professional. This requirement is present in our existing MedRadio rules and is consistent with how the Commission expects MMNs to be used. No one has raised an objection to this requirement. The Commission will therefore apply this restriction for MMNs.

48. The Commission also sought comment on prohibiting the medical implant programmer/controller (P/C) from relaying information to a receiver that is not included with a medical implant device. This prohibition is included in the existing MedRadio rules. The Commission will allow P/Cs in different MMNs to communicate with each other for the purposes of coordination of the use of the spectrum resource. This differs from our existing MedRadio rules, which prohibit controller-to-controller communication. The Commission expects that each MMN will use a spectrum band for short periods of time as is the case for AMF's MMNs. Because of this, multiple MMNs should be able to share a frequency band without causing interference to each other. If the P/Cs for different MMNs from the same manufacturer are able to communicate with each other, they can coordinate their networks' respective transmissions to avoid transmitting at the same time in the same frequency bands.

49. While the Commission will allow P/C-to-P/C communications to facilitate sharing of the scarce spectrum resource, it will not permit P/Cs to communicate with non-implanted devices for other purposes. This will prevent the 413-457 MHz spectrum from being used as backhaul to move data from an MMN to devices outside the network. This is the rule currently in place for MedRadio devices under our existing rules and is needed because the 413-457 MHz band remains reserved only for those medical applications that cannot be achieved in other spectrum and allowing other transmissions would cause undesirable spectrum congestion.

50. The Commission also sought comment in the NPRM on whether implant-to-implant communications should be allowed, whether each programmer/controller must always control the transmitters implanted in a single patient, and whether all implants in a patient must be controlled by a single programmer/controller.

51. The Commission will not permit implant-to-implant communications. In making the decision to allow MMNs to use spectrum in the 413-457 MHz band, it has been favorably impressed by the interference mitigation techniques that AMF has demonstrated in the independent test described in the Aerospace Report. The system tested relied on a P/C external to the body to schedule the implant transmissions in accordance with these mitigation techniques. The Commission has no evidence on the record that MMNs can successfully mitigate the effects of interference if implants are permitted to communicate with each other outside the control of a P/C. As a result, the Commission cannot reach the conclusion that such a network would be able to function in these bands with the incumbent services.

52. The Commission will allow multiple MMNs to exist within a single patient with each network having its own separate P/C. The configuration of the networks for a particular patient should be determined by the medical needs of the patient and the limits of existing technology. This may require the use of different networks to accomplish different functions. On the other hand, the Commission will not permit a P/C to control implanted devices in multiple patients. Given the power limits of the MMN devices, itexpects that the P/C will have to be within a few meters of the patient at all times. Allowing a single P/C to control implants in more than one patient would require the patients to remain in close proximity at all times, which does not appear to be practical. No commenter has suggested a scenario for which such an accommodation would be useful.

53.Emission Bandwidth.In the NPRM, the Commission sought comment on the maximum emission bandwidth that should be allowed for MMN devices. Each of the four segments of the 413-457 MHz band allocated in this proceeding for use by MMN devices occupies six megahertz of spectrum. Alternatively, it also sought comments on whether a smaller maximum emission bandwidth (e.g.,three megahertz) might be sufficient for MMN purposes and might further improve spectrum use and efficiency.

54. The Commission adopted a maximum emission bandwidth of six megahertz. It sees no reason to limit the emission bandwidth to three or five megahertz considering that we are allocating six megahertz bands for use by MMNs. This will provide flexibility for future, more efficient system design. The Commission notes that the maximum emission bandwidth of the MMN signals will also be constrained by the unwanted emission limits that it is adopting.

55.Channelization.In the NPRM, the Commission suggested that one approach to channelization would be to adopt rules that do not specify any particular channeling plan, thereby following the approach used with the existing MedRadio Service. The Commission sought comment on whether it should require a specific channel plan.

56. No parties suggested a channelization plan other than AMF's proposal for centering the signals in each of the four bands. Given that no parties suggest a channelization plan, the Commission has no grounds for adopting one, nor does it see any reason to specify that emissions be based around a center frequency in each of the four bands as AMF has proposed. Because MMN manufacturers will have to design equipment to operate on specific frequencies, the Commission recognizes that there would be little or no added equipment design cost if it were to specify a particular channel plan or center frequency. Nevertheless, the Commission sees no benefit in doing so, as it would limit the flexibility available for future system design. Accordingly, the Commission will not adopt rules specifying a channelization plan for MMN devices.

57.Transmitter Power.In the NPRM, the Commission sought comment on the appropriate transmitted power for MMNs. AMF suggested in its petition that each implantable microstimulator could be limited to a maximum EIRP of 200 microwatts and each P/C transmitter could be limited to a maximum EIRP of 1 milliwatt.

58. The Commission shall adopt the transmitter power limits in AMF's proposed rules with one minor change to reflect the fact that it is allowing MMNs to use a six megahertz maximum emission bandwidth instead of a five megahertz emission bandwidth as AMF proposed. The Commission will limit the maximum EIRP of any MMN transmitter to the lesser of 1 mW or (10 log B−7.782) dBm where B is the 20 dB emission bandwidth of the transmitted signal in MHz. The Commission believes that these devices transmitting at these power limits will not cause interference to other services in the 413-457 MHz band. The rules it adopted will apply the same transmitter power limits to both implanted transmitters and the P/C transmitter. The Commission sees no reason to apply a stricter power limit to implanted transmitters considering that the signals from these devices will be attenuated by body tissue. For this reason an implanted transmitter is even less likely to cause interference than a P/C transmitter operating at the same power level. The Commission will also not place a limit on the number of devices in an MMN network or aggregate the powers of the devices. No one has suggested a limit on the number of devices or how the power of multiple devices may be aggregated. The Commission notes that because the implant devices in an MMN will only transmit under the control of the P/C, as a practical matter only one implant device in an MMN would transmit at any one time. Consequently, it sees no need to aggregate the powers of the multiple devices in the MMN for purposes of establishing a transmitter power limit.

59.Duty Cycle.In the NPRM, the Commission sought comment on the appropriate duty cycle requirements for MMNs. In its petition AMF stated that “each implanted microstimulator transmits data for approximately5microseconds every 11 milliseconds and receives data for approximately 6 microseconds every 11 milliseconds (i.e.,less than 0.05 percent transmit duty cycle). For a system with 10 to 20 implanted microstimulators, the transmit duty cycle of the MCU is approximately 3 percent.” AMF made a similar statement in its comments filed subsequent to the NPRM when describing the operation of its prototype MMNs, but it did not include a duty cycle specification in the rules it concurrently proposed. In a recentex partesubmission, AMF indicated that it had reached agreement with the United States Department of Defense that a 3 percent maximum duty cycle for P/Cs would be appropriate.

60. The Commission finds that it is important to specify a maximum duty cycle for MMNs. Because each P/C will occupy a frequency band for a fraction of the time, other MMNs will be able to make use of the frequency band during the remainder of the time, thus facilitating sharing among multiple MMNs. Specifying a maximum duty cycle will also help the MMNs share the frequency bands with pulse radars with short duration signals that are present in the 426-432 MHz and 438-444 MHz bands. Based on the JSC Report and Aerospace Report, the Commission concluded that the record demonstrates that MMNs can operate on a compatible secondary basis with primary Federal systems in these bands. The JSC Report assumed a P/C duty cycle of 3 percent in conducting the analysis that concluded that MMNs would be operationally compatible and not cause interference to Federal systems. Because the Commission has no information on how the conclusions of the JSC Report would be affected if the P/C duty cycle were allowed to rise above 3 percent, and in recognition of the concurrence of AMF and the Department of Defense that a 3 percent maximum duty cycle is appropriate for MMNs, it adopted rules that specify a maximum duty cycle of 3 percent for P/Cs.

61.Unwanted Emissions.The existing MedRadio rules under part 95 set limits on unwanted emissions from medical transmitting devices operating in the 401-406 MHz band. As delineated therein, these provisions include limits on both in-band and out-of-band radiation. AMF has proposed emissions limits that are similar to the existing MedRadio rules. No parties commented on the unwanted emissions limits. The rule the Commission adopted applies these emissions limits to these frequency bands. Under this approach, in the first 2.5 megahertz beyond any of the frequency bands authorized for MMN operation, the EIRP level associated with any unwanted emission must be attenuated within a 1 megahertz bandwidth by at least 20 dB relative to the maximum EIRP level within any 1 megahertz of the fundamental emission. In addition, emissions more than 2.5megahertz outside of the authorized bandwidth must meet the frequency-dependent set of electric field strength limits of new § 95.635(d)(1)(iv) of the rules as set forth in Appendix A of the R&O.

62.Frequency Stability.In the NPRM, the Commission sought comment on whether each MMN transmitter should be required to maintain a frequency stability as specified in the current MedRadio rules of +/−100 ppm of the operating frequency over the range: (1) 25 °C to 45 °C in the case of MMN implant transmitters; and (2) 0 °C to 55 °C in the case of MMN programmer/control transmitters. AMF suggested extending this existing frequency stability criterion in its rulemaking petition. Sienkiewicz argues that a frequency stability requirement is unnecessary if there is no channelization scheme and that devices from different manufacturers do not need to talk to each other (i.e.,if there is no common contention protocol). Even if a frequency stability criterion is needed, he thinks that the criterion can be ten times more relaxed than the suggested standard, but he acknowledges that the +/−100 ppm standard is common in off-the-shelf oscillators.

63. The +/−100 ppm frequency stability criterion is the standard for MedRadio devices in the current rules and represents good engineering practice. As Sienkiewicz acknowledges, oscillators that meet this standard are readily available. AMF, which has built functioning equipment, believes it is an appropriate standard. The Commission agrees and sees no reason to depart from the current MedRadio frequency stability criterion. The Commission will apply this standard to MMN devices.

64.Antenna Locations.In the NRPM, the Commission sought comment on applying the existing MedRadio requirement that no antenna for a control transmitter be configured for permanent outdoor use. No one objected to this proposal, and the Commission will retain this rule for MMNs. Additionally, ARRL stated that only portable, body-worn MMN devices should be permitted and that no fixed antenna is appropriate in this frequency range. The rules adopted by the Commission will only permit MMNs that contain implanted devices and a programmer/controller transmitter to operate in the MedRadio Service in these frequency bands and the limited transmit power permitted under our rules will limit the programmer/controller to locations on or in close proximity to the patient. Because the rules will effectively restrict MMNs to portable body-worn devices and preclude the use of fixed antennas, the Commission concluded that it is unnecessary for us to adopt a new rule containing these restrictions.

65.RF Safety.In the NPRM, the Commission noted that portable devices are subject to § 2.1093 of its rules, pursuant to which an environmental assessment must be prepared under § 1.1307, and that these rule sections also govern existing MedRadio devices. The Commission further noted that its ongoing RF safety proceeding (ET Docket No. 03-137) anticipated dealing with proposed changes in the Commission's rules regarding human exposure to RF electromagnetic fields in a more comprehensive fashion. The NPRM only sought comment on whether MMN implant and programmer/controller transmitters should be deemed portable devices subject to §§ 2.1093 and 1.1307 of the existing rules. No commenters addressed this issue. Because existing MedRadio devices are considered portable devices and the Commission has no reason to treat MMN devices differently, it shall deem MMN devices to be portable devices subject to §§ 2.1093 and 1.1307 of its rules.

66. The ARRL stated that “no rules should be enacted without a comprehensive series of field tests that assure patient safety in the presence of typical RF fields in the bands at issue in this proceeding.” To the extent that these comments relate to RF safety matters, they are misplaced. Given the ongoing Commission proceeding on RF safety in ET Docket 03-137, the NPRM did not request duplicative comment in this proceeding. Rather, the only question we raised in the NPRM that implicated RF safety concerns was the categorization issue,i.e.,whether MMN devices should be subject to the RF exposure limits applicable to portable devices, as are other MedRadio devices, or the limits applicable to mobile devices. Consequently, because matters concerning RF safety are more appropriately addressed in ET Docket 03-137 and not here ARRL should raise any specific concerns it has regarding RF safety directly in ET Docket 03-137.

67.Miscellaneous Provisions.In the NPRM, the Commission sought comment on a number of provisions regarding equipment certification, authorized locations, station identification, station inspection, disclosure policy, labeling requirements, and marketing limitations that mirror the existing MedRadio rules.

68. As the Commission proposed in the NPRM, it will require each MMN transmitter authorized to operate in the 413-457 MHz band to be certificated. This requirement will not apply to transmitters that are not marketed for use in the United States, are being used in the United States by individuals who have traveled to the United States from abroad, and comply with the applicable technical requirements. The Commission also adopted the proposals in the NPRM that MedRadio devices in the 413-457 MHz band be authorized to operate anywhere CB station operation is authorized under § 95.405 and not be required to transmit a station identification announcement. In addition, it will apply the existing MedRadio rule that requires that all non-implanted MMN transmitters be made available for inspection upon request by an authorized FCC representative. Under this provision, persons operating implanted MMN transmitters are required to cooperate reasonably with duly authorized FCC representatives in the resolution of interference. These requirements are all the same as the existing MedRadio rules for the 401-406 MHz band.

69. In the NPRM, the Commission sought comment on whether to require the manufacturers of MMN transmitters to include with each transmitting device the following disclosure statement:

70. The Commission does not believe that the proposed labeling will be “useless” once the implanted MMN devices are placed within the body as claimed by SBE because only the P/C transmitter will bear a label, and it will not be implanted in the body. The proposed disclosure and labeling statements are based on the requirements for the MedRadio Services (and the MICS before that) that have been in place since 1999. These notices have served us well since that time, and it sees no reason to change them now. The Commission notes that MMN devices are medical devices which will be used only under the direction of knowledgeable medical personnel. As such, the notices are not aimed at consumers but instead at medical professionals who are in the best position to give appropriate patient advice. The Commission therefore believes that the notice and labeling requirements are sufficient and adopted them as proposed. These disclosure and labeling requirements provide an important benefit to medical professionals by warning of the secondary status of the MMN devices. These requirements are consistent with those that are in place for similar medical devices that are authorized under the Commission's rules, and so the costs should be similar. Therefore, the Commission sees no reason why disclosure and labeling requirements should be more burdensome in the case of MMNs.

71. No one commented on the proposal that implant transmitters be identified with a serial number. This is the same requirement that MedRadio devices must meet under our existing rules. The Commission therefore adopts this requirement. Doing so will make it easier to identify particular MMN implant devices, and this information is limited enough to be placed on tiny devices. As proposed, the Commission will allow the FCC ID number associated with the transmitter and the information required by § 2.925 of the FCC rules to be placed in the instruction manual for the transmitter in lieu of being placed directly on the transmitter.

72. In the NPRM the Commission also proposed to provide that MMN transmitters intended for operation in any portions of the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands may be marketed and sold only for those permissible uses described above. No one objected to this proposal, which currently is part of the existing MedRadio rules. Given our expressed intent to limit use of these frequency bands to MedRadio applications that cannot be achieved in other spectrum, the Commission believes that this requirement is necessary, and therefore adopts it.

73. As required by the Regulatory Flexibility Act of 1980, as amended (RFA),1 an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Notice of Proposed Rulemaking (NPRM).2 The Commission sought written public comment on the proposals in the NPRM, including comment on the IRFA. No comments were received addressing the IRFA. This present Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.3

74. The Report and Order (R&O) expands the Medical Device Radiocommunication (MedRadio) Service under part 95 of the Commission's rules to enable the operation of medical micro-power networks (MMNs) consisting of implantable medical devices and associated external programmer/controllers (P/C). These MMNs will employ functional electric stimulation (or FES) techniques to serve as an artificial nervous system to restore sensation, mobility, and function to paralyzed limbs and organs. The R&O establishes a secondary allocation in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands for MedRadio with use limited to MMNs.

75. TheR&Oadopts technical and service rules to govern the operation of MMNs in these four frequency bands. Because MMNs will operate on a secondary basis, they must accept interference from and not cause interference to primary services operating in these frequency bands. Consequently, these rules must prevent MMNs from causing interference to the other services operating in these bands. Since MMNs will be used for medical purposes, the rules must also provide assurance that they can reliably function in these frequency bands in the presence of signals from primary services operating these bands. For the most part the adopted rules mirror the existing rules that apply to MedRadio in the 401-406 MHz band in part 95 of the Commission's rules with modifications to account for the MMN's wider bandwidth, higher transmission power, and need to operate in the presence of other primary services.

76. The proposed action is authorized under sections 4(i), 301, 302, 303(e), 303(f), 303(r), and 307(e) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 301, 302, 303(e), 303(f), 303(r), and 307(e).

77. There were no comments filed that specifically addressed the rules and policies proposed in the IRFA.

78. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the rules and policies adopted herein.4 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.”5 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.6 A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.7 Nationwide, there are a total of approximately 27.5 million small businesses, according to the SBA.

79.Personal Radio Services.The Medical Device Radio Communications Services are being placed within part 95 of our rules (“Personal Radio Services”). The Commission has not developed a small business size standard specifically applicable to these services. Therefore, for purposes of this analysis, the Commission uses the SBA small business size standard for the categoryWireless Telecommunications Carriers (except Satellite), which is 1,500 or fewer employees.8 Census data for 2007 show that there were 1,383 firms that operated that year.9 Of those 1,368 had fewer than 100 employees. Personal radio services provide short-range, low power radio for personal communications, radio signaling, and business communications not provided for in other services. The Personal Radio Services include spectrum licensed under part 95 of our rules and cover a broad range of uses.10 Many of the licensees in these services are individuals and thus are not small entities. In addition, due to the fact that licensing of operation under part 95 is accomplished by rule (rather than by issuance of individual license), and due to the shared nature of the spectrum utilized by some of these services, the Commission lacks direct information other than the census data above upon which to base an estimation of the number of small entities under an SBA definition that might be directly affected by the proposed rules adopted herein.

80.Wireless Communications Equipment Manufacturers.The Census Bureau does not have a category specific to medical device radiocommunication manufacturing. The appropriate category is that for wireless communications equipment manufacturers. The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are: transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment.” The SBA has developed a small business size standard for Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing, which is: all such firms having 750 or fewer employees.11 According to Census bureau data for 2007, there were a total of 919 firms in this category that operated for the entire year. Of this total, 771 had fewer than 100 employees and 148 had more than 100 employees.12 Thus, under this size standard, the majority of firms can be considered small.

81. We do note, however, that the allocation for the twenty-four megahertz of spectrum in four frequency bands for the Medical Device Radio Communications Service would be limited to use by MMNs. To date no entities are producing MMNs on a commercial basis. However, one entity, the Alfred Mann Foundation (AMF), has produced prototype MMN devices. We have no data on the size of AMF in terms of number of employees or revenue, but we presume that AMF is a small entity. In general, there are only a small number of manufacturers who produce wireless implanted medical devices (less than ten), and FDA approval must be secured before such devices are brought to market. Due to the stringent FDA approval requirements, the small number of existing medical device manufacturers tend to focus very narrowly on this highly specialized niche market.

82. TheR&Oadopts no reporting or record keeping requirements. However, the R&O does adopt a number of service and technical rules that apply to all entities who manufacture and use MMN devices in the four frequency bands. Under the adopted rules the MMNs will not require individual licenses but instead will qualify for license-by-rule operation13 pursuant to section 307(e) of the Communications Act (Act).14 The rules generally require that MMNs be able to operate in the presence of other primary and secondary users in these frequency bands.15 MMNs must be capable of operating on any of the four allocated frequency bands.16 The programmer/controller (P/C) in the MMN will be required to monitor the frequency band in which the MMN is operating at least once a second and must monitor the other frequency bands often enough that when it does switch frequency bands it has monitored the band it is switching to in the two seconds prior to switching.17 The P/C must be capable of determining when either direction of the communication link between the P/C and the implanted devices is becoming degraded to the extent that communication is likely to be lost for more than 45 milliseconds. When the P/C makes this determination the MMN is required to move to another frequency band. The P/C will also be required to switch to another frequency band if during the monitoring of the occupied frequency band it determines that there is a received signal with power greater than −60 dBm in any 12.5 kHz bandwidth that persists for at least fifty milliseconds.18 The MMN transmitters must incorporate a programmable means to implement a system shutdown process within 45 milliseconds of a communication failure or on command from the P/C.19

83. MMN use shall be restricted for use by persons only for diagnostic and therapeutic purposes and only to the extent that such devices have been provided to a human patient under the direction of a duly authorized health care professional.20 P/Cs in different MMNs may communicate with each other for the purposes of coordination of the use of the spectrum resource.21 However, P/Cs may not communicate with non-implanted devices for other purposes.22 Implanted MMN devices may not communicate directly with other MMN implanted devices. Multiple MMNs may be present within one patient with each MMN having its own P/C.23 However, a P/C may not control implanted devices in multiple patients.

84. MMNs may transmit in a maximum emission bandwidth of six megahertz. MMN transmitters may transmit with a maximum EIRP of lesser of 1 mW or (10 log B − 7.782) dBm here B is the 20 dB emission bandwidth of the transmitted signal in MHz.24 The P/C of an MMN may transmit with a maximum duty cycle of 3 percent.25 The MMN must meet specific limits on both in-band and out-of-band emissions.26

85. MMN transmitters will be required to maintain a frequency stability as specified in the currentMedRadio rules of +/− 100 ppm of the operating frequency over the range: (1) 25 °C to 45 °C in the case of MMN implant transmitters; and (2) 0 °C to 55 °C in the case of MMN programmer/control transmitters.27

86. MMN transmitters must be certificated except for such transmitters that are not marketed for use in the United States, are being used in the United States by individuals who have traveled to the United States from abroad, and comply with the applicable technical requirements.28 MMNs may be operated anywhere that CB station operation is authorized under § 95.405 and not be required to transmit a station identification announcement.29 All non-implanted MMN transmitters must be made available for inspection upon request by an authorized FCC representative. Manufacturers of MMN transmitters must include with each transmitting device a disclosure statement and each MMN programmer/controller must be labeled with a statement.30 MMN transmitters must be labeled with a serial number, but this serial number may be placed in the instruction manual for the transmitter in lieu of being placed directly on the transmitter.31

87. The RFA requires an agency to describe any significant alternatives that it has considered in developing its approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”32

88. We are adopting a license-by-rule approach for MMN operations. This should decrease the cost of MMN use for small entities as compared to a licensing approach because they will not be subject to the expense of obtaining a license.

89. The Commission has adopted a requirement that MMNs be capable of operating in any of the four allocated frequency bands. It do not believe this requirement will increase the cost of equipment unreasonably or be burdensome for manufacturers to meet. We note that these four bands are relatively close in frequency and thus only a single transmitter and one antenna are necessary to cover these four bands. We believe that the components to enable manufacturers of MMNs to meet this requirement should be readily available since equipment is currently designed to operate across the Federal mobile bands between 406.1 MHz and 450 MHz and non-Federal mobile bands between 450 MHz and 512 MHz.

90. As described we have adopted requirements that the P/C of an MMN monitor the frequency bands and switch frequency bands under certain circumstances. We considered not imposing any frequency monitoring requirements on MMNs. However, we believe that this requirement is necessary because MMNs will operate in frequency bands where other services will operate on a primary basis. The MMNs must therefore be capable of detecting signals from these other services and taking steps to minimize the effects of these signals on MMN operations or switching frequency bands. Because MMNs will be used for medical purposes, they must be reliable and therefore these frequency monitoring requirements are necessary. We do not believe this monitoring requirement will add significant cost to MMN equipment since radios now operating in these bands also have a requirement to monitor channels prior to transmitting on them.33

91. The requirement that MMN transmitters maintain a frequency stability of +/−100 ppm will not impose significant costs on small entities because oscillators that meet this standard are readily available.

92. We have adopted various provisions regarding equipment certification, authorized locations, station identification, station inspection, disclosure policy, labeling requirements and marketing limitations that mirror the existing MedRadio rules. We note that the certification and inspection requirements apply to a broad range of wireless devices within the Commission's jurisdiction and are a necessary part of insuring that the Commission's technical rules are followed. We therefore did not consider alternatives to these requirements. The disclosure and labeling requirements inform interested parties about limitations on use of the MMN devices, such as the fact that they may not cause interference to and must accept interference from other stations operating on a primary basis in these bands. We therefore believe that the disclosure and labeling requirements are useful and that they will not have a significant cost. The marketing limitation permits MMNs to be marketed and sold only for the types of communication that are permitted under the rules the Commission has adopted. We do not believe this will impose significant costs on small entities.

93.Report to Congress:The Commission will send a copy of the Report and Order, including this FRFA, in a report to Congress pursuant to the Congressional Review Act.34 In addition, the Commission will send a copy of the Report and Order, including this FRFA, to the Chief Counsel for Advocacy of the SBA.

94. Pursuant to the authority contained in Sections 4(i), 301, 302, 303(e), 303(f), 303(r), and 307(e) of the Communications Act of 1934, as amended, 47 U.S.C. Sections 154(i), 301, 302, 303(e), 303(f), 303(r), and 307(e), this Report and Orderis adoptedand Parts 2 and 95 of the Commission's Rulesare amendedas set forth in the Appendix February 27, 2012.

For the reasons discussed above, the Federal Communications Commission amends title 47 of the Code of Federal Regulations, Parts 2 and 95, as follows:

(g)Shared access.The provisions of this section shall not be used to extend the range of spectrum occupied over space or time for the purpose of denying fair access to spectrum for other MedRadio systems.

(h)Measurement procedures.(1) MedRadio transmitters shall be tested for frequency stability, radiated emissions and EIRP limit compliance in accordance with paragraphs (h)(2) and (h)(3) of this section.

(2) Frequency stability testing shall be performed over the temperature range set forth in (f) of this section.

(3) Radiated emissions and EIRP limit measurements may be determined by measuring the radiated field from the equipment under test at 3 meters and calculating the EIRP. The equivalent radiated field strength at 3 meters for 1 milliwatt, 25 microwatts, 250 nanowatts, and 100 nanowatts EIRP is 115.1, 18.2, 1.8, or 1.2 mV/meter, respectively, when measured on an open area test site; or 57.55, 9.1, 0.9, or 0.6 mV/meter, respectively, when measured on a test site equivalent to free space such as a fully anechoic test chamber. Compliance with the maximum transmitter power requirements set forth in § 95.639(f) shall be based on measurements using a peak detector function and measured over an interval of time when transmission is continuous and at its maximum power level. In lieu of using a peak detector function, measurement procedures that have been found to be acceptable to the Commission in accordance with § 2.947 of this chapter may be used to demonstrate compliance. For a transmitter intended to be implanted in a human body, radiated emissions and EIRP measurements for transmissions by stations authorized under this section may be made in accordance with a Commission-approved human body simulator and test technique. A formula for a suitable tissue substitute material is defined in OET Bulletin 65 Supplement C (01-01).

Historically, the HMR, at 49 CFR 179.13, limited rail tank cars transporting hazardous materials to a GRL limitation of 263,000 pounds. Certain tank cars were able to operate in excess of that GRL limitation if permitted to do so via a Special Permit issued by PHMSA. However, on May 14, 2010, PHMSA published a final rule amending the HMR to incorporate provisions contained in several widely used or longstanding Special Permits that had an established safety record. 75 FR 27205. The final rule amended the HMR to allow, upon the approval of FRA, certain rail tank cars transporting hazardous materials to exceed the GRL limitation of 263,000 pounds without the need for a Special Permit. On January 25, 2011, FRA published aFederal Registernotice providing such approval for certain tank cars. 76 FR 4250. In that notice, FRA stated that all markings on tank cars subject to the GRL Special Permits that had been incorporated into the HMR by the final rule and approved by FRA were required to be removed or obliterated by January 25, 2012, or at the car's first shopping event, whichever date occurred first.1

As background, the requirement to mark Special Permit packagings is provided for in the HMR at 49 CFR 172.302(c). That section requires that a tank car operating under a Special Permit must have the permit number marked on the car (unless this requirement was waived under the terms of a Special Permit). These markings are typically applied to tank cars at the time of their qualification. Certain tank cars exceeding the GRL limitation of 263,000 pounds were previously required to operate under a Special Permit. Those tank cars were required to be marked with the appropriate Special Permit number. However, upon the PHMSA final rule incorporating the applicable GRL Special Permits into the HMR (and FRA's subsequent approval notice) those Special Permits and their corresponding Special Permit number markings on the subject tank cars became obsolete.

Since FRA's publication of the notice, FRA has received a number of requests to extend the deadline for removal of the Special Permit markings on tank cars subject to that notice. Such requests were based on the fact that owners of large fleets of tank cars would have to remove such cars from service in order to send them to an appropriate tank car facility or a loading/unloading facility to have the markings removed. Such a procedure could potentially be both costly to industry and inefficient. The requesters also pointed out that loading/unloading facilities may not be configured to allow for safe access to the location of the existing markings. Finally, personnel at loading/unloading facilities may not have the proper equipment or training to remove or obliterate the appropriate markings.

FRA recognizes the logistical and cost concerns regarding the ability of the railroad industry to comply with the pending January 25, 2012, deadline to remove these now obsolete GRL Special Permit markings. FRA also recognizes that markings are typically applied to tank cars at the time of qualification, and that tank car facilities performing such qualification inspections are equipped to safely access all areas of the tank car and properly remove and/or apply required markings. Also, the obsolete GRL Special Permit markings remaining on the tank cars subject to the FRA notice do not represent a safety or environmental risk. There is no risk as these cars were previously permitted to operate at a GRL of greater than 263,000 pounds via Special Permit, and the now obsolete markings merely reflected such. The PHMSA final rule incorporated the applicable Special Permits into the HMR, which alleviated the need for a Special Permit.

Based on the above discussion, the absence of any safety risk, and in order to avoid annual requests for the extension of the deadline listed in FRA's January 25, 2011,Federal Registernotice, FRA has decided to extend the deadline for the removal of the obsolete Special Permit markings to the date of each subject tank car's next required qualification pursuant to 49 CFR Part 180.

Each rail tank car subject to FRA's January 25, 2011,Federal Registernotice (76 FR 4250) may continue in transportation with the obsolete GRL Special Permit markings present until the date of each car's next required qualification pursuant to 49 CFR Part 180. If a subject tank car continues in transportation after the date of its next required qualification without such marking being removed, FRA reserves the right to take appropriate enforcement action.

The fishery for coastal migratory pelagic fish (king mackerel, Spanish mackerel, cero, cobia, little tunny, dolphin, and, in the Gulf of Mexico only, bluefish) is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils (Councils) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act by regulations at 50 CFR part 622.

Based on the Councils' recommended total allowable catch and the allocation ratios in the FMP, NMFS implemented a commercial quota of 3.87 million lb (1.76 million kg) for the Atlantic migratory group of Spanish mackerel (65 FR 41015, July 3, 2000). Atlantic migratory group Spanish mackerel are divided into a northern and southern zone for management purposes. The southern zone for Atlantic migratory group Spanish mackerel extends from 30°42′45.6″ N. lat., which is a line directly east from the Georgia/Florida boundary, to 25°20.4′ N. lat., which is a line directly east from the Miami-Dade/Monroe County, Florida, boundary.

For the southern zone, seasonally variable trip limits are based on an adjusted quota of 3.62 million lb (1.64 million kg). The adjusted quota is calculated to allow continued harvest in the southern zone at a set rate for the remainder of the fishing year, until February 29, 2012, in accordance with 50 CFR 622.44(b)(2).

Beginning December 1, the trip limit is unlimited on weekdays and limited to 1,500 lb (680 kg) of Spanish mackerel per day on weekends. After 75 percent of the adjusted quota of Atlantic migratory group Spanish mackerel is taken until 100 percent of the adjusted quota is taken, Spanish mackerel in or from the EEZ in the southern zone may not be possessed on board or landed from a permitted vessel in amounts exceeding 1,500 lb (680 kg) per day.

NMFS has determined that 75 percent of the adjusted quota for Atlantic group Spanish mackerel has been taken. Accordingly, the 1,500-lb (680-kg) per day commercial trip limit applies to Spanish mackerel in or from the EEZ in the southern zone effective 6 a.m., local time, January 27, 2012, until 12:01 a.m., local time, March 1, 2012, unless changed by further notification in theFederal Register.

This action responds to the best available information recently obtained regarding the status of the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds the need to immediately implement this commercial trip limit reduction constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself already has been subject to notice and comment, and all that remains is to notify the public of the trip limit reduction.

Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect the fishery resource because the capacity of the commercial fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment would require time and potentially result in a harvest well in excess of the established quota.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in effectiveness of this action under 5 U.S.C. 553(d)(3).

This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.