Page Range | 4875-4943 | |
FR Document |
Page and Subject | |
---|---|
81 FR 4942 - Sunshine Act Meeting | |
81 FR 4917 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommended Recordkeeping for Exempt Infant Formula Production | |
81 FR 4942 - Submission for OMB Review; Comment Request | |
81 FR 4914 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use | |
81 FR 4923 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping and Registration Provisions | |
81 FR 4921 - Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications | |
81 FR 4916 - Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability | |
81 FR 4913 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability | |
81 FR 4915 - Food and Drug Administration/Xavier Medical Device Conference | |
81 FR 4909 - Mid-Atlantic Fishery Management Council (MAFMC); Public Meetings | |
81 FR 4909 - North Pacific Fishery Management Council; Public Meeting | |
81 FR 4930 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Collection of Laboratory Analysis Data on Drug Samples Tested by Non-Federal (State and Local Government) Crime Laboratories | |
81 FR 4912 - Statement of Organization, Functions, and Delegations of Authority | |
81 FR 4907 - Agenda and Notice of Planning Meeting of the Wyoming Advisory Committee | |
81 FR 4908 - Notice of Public Meeting of the Indiana Advisory Committee to hear Testimony Regarding Civil Rights and the School to Prison Pipeline in Indiana | |
81 FR 4931 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Amendment No. 1 and Order Granting Accelerated Approval to a Proposed Rule Change, as Modified by Amendment No. 1, to Adopt the Funding Portal Rules and Related Forms and Rule 4518 | |
81 FR 4942 - RSL Railroad, LLC-Lease Exemption Containing Interchange Commitment-Norfolk Southern Railway Company | |
81 FR 4905 - Approval of Missouri's Air Quality Implementation Plans; Americold Logistics, LLC 24-Hour Particulate Matter (PM10 | |
81 FR 4886 - Approval of Missouri's Air Quality Implementation Plans; Americold Logistics, LLC 24-Hour Particulate Matter (PM10 | |
81 FR 4901 - Airworthiness Directives; Airbus Airplanes | |
81 FR 4884 - Air Plan Approval; Minnesota; Inver Hills SO2 | |
81 FR 4905 - Air Plan Approval; Minnesota; Inver Hills SO2 | |
81 FR 4889 - Disapproval of California Air Plan Revisions, South Coast Air Quality Management District | |
81 FR 4891 - Approval and Promulgation of Implementation Plans; Louisiana | |
81 FR 4896 - Air Plan Approval; KY; Emissions Statements for the 2008 8-Hour Ozone NAAQS | |
81 FR 4910 - National Coastal Condition Assessment 2010 | |
81 FR 4910 - Integrated Science Assessment for Oxides of Nitrogen-Health Criteria | |
81 FR 4926 - Changes in Certain Multifamily Mortgage Insurance Premiums | |
81 FR 4903 - Proposed Establishment of Class E Airspace, Shelton, WA | |
81 FR 4883 - Amendment of Class D and Class E Airspace, Revocation of Class E Airspace; Chico, CA | |
81 FR 4881 - Amendment of Class E Airspace; Boise, ID | |
81 FR 4900 - Noncompetitive Appointment of Certain Military Spouses | |
81 FR 4911 - Request for Medicare Payment Advisory Commission Nominations | |
81 FR 4907 - Notice of Public Information Collection; Requirements Submitted to OMB for Review; Partner Information Form | |
81 FR 4878 - Airworthiness Directives; Airbus Airplanes | |
81 FR 4875 - Airworthiness Directives; Airbus Airplanes |
National Oceanic and Atmospheric Administration
Centers for Disease Control and Prevention
Food and Drug Administration
Federal Aviation Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding Airworthiness Directive (AD) 98-20-27 for all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). AD 98-20-27 required repetitive inspections to detect fatigue cracking of the wing top skin at the front spar joint; and a follow-on eddy current inspection and repair, if necessary. This new AD reduces the inspection compliance time and intervals, and expands the inspection area of the wing top skin at the front spar joint. This AD was prompted by reports of cracking of the wing top skin in an area not required for inspection by AD 98-20-27. We are issuing this AD to detect and correct fatigue cracking of the wing top skin at the front spar joint; such fatigue cracking could result in reduced structural integrity of the airplane.
This AD becomes effective March 3, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 3, 2016.
The Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD as of October 29, 1998 (63 FR 50981, September 24, 1998).
You may examine the AD docket on the Internet at
For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 98-20-27, Amendment 39-10793 (63 FR 50981, September 24, 1998). AD 98-20-27 applied to all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2013-0232R1, dated October 2, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition.
The MCAI states:
During full-scale fatigue testing conducted in the early 1990's, cracks were found on the top skin of the wing between Ribs 1 and 7, starting at the front spar fastener holes.
This condition, if not detected and corrected, could adversely affect the structural integrity of the wing.
Consequently, Airbus issued Service Bulletin (SB) A300-57-6045 and DGAC [Direction Générale de l'Aviation Civile] France issued AD 97-374-238 [
After those [DGAC] ADs were issued, further cracks to the wing top skin were reported by operators, within an area not covered by the existing [DGAC] ADs. To address this potential unsafe condition, Airbus revised SB A300-57-6045 to extend the area to be inspected.
In addition, a fleet survey and updated Fatigue and Damage Tolerance analyses were performed in order to substantiate the second A300-600 Extended Service Goal (ESG2) exercise. The results of these analyses have determined that the inspection thresholds and intervals must be reduced to allow timely detection of these cracks and the accomplishment of applicable corrective action(s).
As the ESG2 exercise is only applicable to A300-600 aeroplanes, A300-600ST aeroplanes are now addressed through new Airbus SB A300-57-9026.
For the reasons described above, this [EASA] AD retains the requirements of DGAC France AD 97-374-238(B) [
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 19892, April 14, 2015) and the FAA's response to each comment.
United Parcel Service (UPS) stated that the proposed changes maintain the fleet airworthiness using the service experience and current certification maintenance programs for all airplanes in service.
UPS requested that we extend the interval for the repetitive inspections proposed in paragraph (j)(2) of the proposed AD (80 FR 19892, April 14, 2015). UPS stated that its Model A300 fleet and associated maintenance program is not certified to the ESG-2 limitations; therefore, the repetitive inspection interval should be based on the airplane certification design service goal (DSG). UPS explained that the repetitive interval extension request is due to the additional 12,000-flight-cycle service life to ensure any crack development is detected after an airplane operates beyond the 30,000-flight-cycle DSG. UPS stated that, with an extension of airplane operational life, more frequent inspections would be necessary for airplanes operating beyond the original DSG that are not necessary for an airplane operating to the airplane DSG values.
We disagree with UPS's request. UPS did not provide any data to substantiate that the changed compliance time for the repetitive inspection interval provides an equivalent level of safety. Under the provisions of paragraph (o)(1) of this AD, we will consider requests for approval of an alternative method of compliance (AMOC) if sufficient data are submitted to substantiate that a revised inspection interval would provide an equivalent level of safety. We have not changed this AD in this regard.
UPS requested that we correct the inadvertent omission of the corrective actions for the repetitive inspections in paragraph (j) of the proposed AD (80 FR 19892, April 14, 2015) by including a reference to paragraph (j) of the proposed AD in paragraphs (k)(1) and (k)(2) of the proposed AD, which specify the corrective actions.
We agree with UPS to correct the inadvertent omission. We have revised paragraphs (k)(1) and (k)(2) of this AD accordingly.
We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these changes:
• Are consistent with the intent that was proposed in the NPRM (80 FR 19892, April 14, 2015) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 19892, April 14, 2015).
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
Airbus has issued Service Bulletin A300-57-6045, Revision 10, dated November 13, 2013. The service information describes inspection procedures for fatigue cracking of the wing top skin at the front spar joint between ribs 1 and 7. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 130 airplanes of U.S. registry.
The actions that are required by AD 98-20-27, Amendment 39-10793 (63 FR 50981, September 24, 1998), and retained in this AD take about 2 work-hours per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the actions that are required by AD 98-20-27 is $170 per product.
We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $22,100, or $170 per product.
We have received no definitive data that will enable us to provide cost estimates for the on-condition actions specified in this AD.
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.
We determined that 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 the 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.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective March 3, 2016.
This AD replaces AD 98-20-27, Amendment 39-10793 (63 FR 50981, September 24, 1998).
This AD applies to the Airbus airplanes, certificated in any category, identified in paragraphs (c)(1) through (c)(4) of this AD, all manufacturer serial numbers.
(1) Airbus Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes.
(2) Airbus Model A300 B4-605R and B4-622R airplanes.
(3) Airbus Model A300 F4-605R and F4-622R airplanes.
(4) Airbus Model A300 C4-605R Variant F airplanes.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by reports of cracking of wing top skin in an area not required for inspection by AD 98-20-27, Amendment 39-10793 (63 FR 50981, September 24, 1998). We are issuing this AD to detect and correct fatigue cracking of the wing top skin at the front spar joint; such fatigue cracking could result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (a) of AD 98-20-27, Amendment 39-10793 (63 FR 50981, September 24, 1998), with revised service information. Prior to the accumulation of 22,000 total flight cycles, or within 2,000 flight cycles after October 29, 1998 (the effective date of AD 98-20-27), whichever occurs later: Perform a detailed visual inspection to detect fatigue cracking of the wing top skin at the front spar joint, in accordance with Airbus Service Bulletin A300-57-6045, Revision 1, dated August 3, 1994, including Appendix 1, Revision 1, dated August 3, 1994; Airbus Service Bulletin A300-57-6045, Revision 02, dated April 21, 1998, including Appendix 1, Revision 02, dated April 21, 1998; or Airbus Service Bulletin A300-57-6045, Revision 10, dated November 13, 2013. Repeat the detailed visual inspection thereafter at intervals not to exceed 8,000 flight cycles.
This paragraph restates the requirements of paragraph (b) of AD 98-20-27, Amendment 39-10793 (63 FR 50981, September 24, 1998), with revised service information. If any cracking is suspected or detected during any inspection required by paragraph (g) of this AD: Prior to further flight, perform an eddy current inspection to confirm the findings of the visual inspection, in accordance with Airbus Service Bulletin A300-57-6045, Revision 1, dated August 3, 1994, including Appendix 1, Revision 1, dated August 3, 1994; Airbus Service Bulletin A300-57-6045, Revision 02, dated April 21, 1998, including Appendix 1, Revision 02, dated April 21, 1998; or Airbus Service Bulletin A300-57-6045, Revision 10, dated November 13, 2013. If any cracking is detected during any eddy current inspection, prior to further flight, repair using a method approved by the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate; or the Direction Générale de l'Aviation Civile (or its delegated agent).
At the applicable time specified in paragraph (i)(1) or (i)(2) of this AD: Do a detailed inspection of the wing top skin between ribs 1 and 7 for cracking, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6045, Revision 10, dated November 13, 2013. Accomplishment of the initial inspection required by this paragraph terminates the requirements of paragraph (g) of this AD.
(1) For Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes; Model A300 B4-605R and B4-622R airplanes; and Model A300 C4-605R Variant F airplanes: At the later of the times specified in paragraphs (i)(1)(i) and (i)(1)(ii) of this AD.
(i) Before the accumulation of 17,100 total flight cycles or 38,400 total flight hours, whichever occurs first.
(ii) Within 1,000 flight cycles or 2,200 flight hours, whichever occurs first after the effective date of this AD.
(2) For Model A300 F4-605R and F4-622R airplanes: At the later of the times specified in paragraphs (i)(2)(i) and (i)(2)(ii) of this AD.
(i) Before the accumulation of 22,000 total flight cycles or 49,500 total flight hours, whichever occurs first.
(ii) Within 1,300 flight cycles or 2,800 flight hours, whichever occurs first after the effective date of this AD.
Repeat the inspection required by paragraph (i) of this AD thereafter at the applicable time and intervals specified in paragraphs (j)(1) and (j)(2) of this AD.
(1) For Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes; Model A300 B4-605R and B4-622R airplanes; and Model A300 C4-605R Variant F airplanes: Repeat the inspection at the applicable time specified in paragraph (j)(1)(i) or (j)(1)(ii) of this AD.
(i) For airplanes that have an average flight time (AFT) that is equal to or more than one and one-half hours: Repeat the inspection at intervals not to exceed 5,100 flight cycles or 11,000 flight hours, whichever occurs first.
(ii) For airplanes that have an AFT that is less than one and one-half hours: Repeat the inspection at intervals not to exceed 5,500 flight cycles or 8,300 flight hours, whichever occurs first.
(2) For Model A300 F4-605R and F4-622R airplanes: Repeat the inspection at the applicable time specified in paragraph (j)(2)(i) or (j)(2)(ii) of this AD.
(i) For airplanes that have an AFT that is equal to or more than one and one-half hours: Repeat the inspection at intervals not to exceed 6,500 flight cycles or 14,100 flight hours, whichever occurs first.
(ii) For airplanes that have an AFT that is less than one and one-half hours: Repeat the inspection at intervals not to exceed 7,000 flight cycles or 10,600 flight hours, whichever occurs first.
(1) If any crack in the top skin in the area forward of the front spar attachment is found during any inspection required by paragraph (i) or (j) of this AD: Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
(2) If any crack or sign of a crack is found in the top skin at or aft of the spar attachment during any inspection required by paragraph (i) or (j) of this AD: Before further flight, do an eddy current inspection of the cracks or of the signs of cracking to confirm the findings of the detailed inspection, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6045, Revision 10, dated November 13,
Accomplishment of any repair required by paragraph (k) this AD does not constitute terminating action for the repetitive inspections required by paragraph (j) of this AD.
Although Airbus Service Bulletin A300-57-6045, Revision 10, dated November 13, 2013, specifies to submit certain information to the manufacturer, this AD does not include that requirement.
This paragraph provides credit for actions required by paragraphs (i), (j) and (k) of this AD, if those actions were performed before the effective date of this AD using the Airbus service bulletins specified in paragraphs (n)(1) through (n)(8) of this AD, which are not incorporated by reference in this AD.
(1) Airbus Service Bulletin A300-57-6045, dated March 18, 1993.
(2) Airbus Service Bulletin A300-57-6045, Revision 03, dated October 25, 1999.
(3) Airbus Service Bulletin A300-57-6045, Revision 04, dated January 13, 2002.
(4) Airbus Service Bulletin A300-57-6045, Revision 05, dated June 13, 2003.
(5) Airbus Service Bulletin A300-57-6045, Revision 06, dated January 13, 2005.
(6) Airbus Service Bulletin A300-57-6045, Revision 07, dated August 14, 2008.
(7) Airbus Service Bulletin A300-57-6045, Revision 08, dated June 6, 2011.
(8) Airbus Service Bulletin A300-57-6045, Revision 09, dated May 21, 2013.
The following provisions also apply to this AD:
(i) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.
(ii) AMOCs approved previously for AD 98-20-27, Amendment 39-10793 (63 FR 50981, September 24, 1998), are approved as AMOCs for the corresponding provisions of this AD.
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2013-0232R1, dated October 2, 2013, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (q)(5) and (q)(6) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(3) The following service information was approved for IBR on March 3, 2016.
(i) Airbus Service Bulletin A300-57-6045, Revision 10, dated November 13, 2013.
(ii) Reserved.
(4) The following service information was approved for IBR on October 29, 1998 (63 FR 50981, September 24, 1998).
(i) Airbus Service Bulletin A300-57-6045, Revision 1, dated August 3, 1994, including Appendix 1, Revision 1, dated August 3, 1994, which contains the following list of effective pages: Page numbers 1 through 10, Revision 1, dated August 3, 1994; Appendix 1, pages 1 and 2, Revision 1, dated August 3, 1994; and Appendix 1, pages 3 through 6, dated March 18, 1993.
(ii) Airbus Service Bulletin A300-57-6045, Revision 02, dated April 21, 1998, including Appendix 1, Revision 02, dated April 21, 1998.
(5) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(6) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(7) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding Airworthiness Directive (AD) 96-18-06 for certain Airbus Model A320-211 and -231 airplanes. AD 96-18-06 required visual inspections to detect cracks of the pressurized floor fittings at frame 36, and renewal of the zone protective finish or replacement of fittings with new fittings if necessary. Since we issued AD 96-18-06, an extended service goal analysis by the manufacturer revealed that the compliance times and repetitive inspection intervals should be reduced to meet the design service goal. This AD retains the requirements of AD 96-18-06, with reduced compliance times and repetitive inspection intervals. This AD also adds Model A320-212 airplanes to the applicability. We are issuing this AD to detect and correct fatigue cracking in the pressurized floor fittings at frame 36, which could result in failure of a floor fitting and subsequent depressurization of the fuselage.
This AD becomes effective March 3, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of March 3, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of October 10, 1996.
You may examine the AD docket on the Internet at
For service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 96-18-06, Amendment 39-9730 (61 FR 46703, September 5, 1996). AD 96-18-06 applied to certain Airbus Model A320-111, -211, and -231 series airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agency for the Member States of the European Union, has issued EASA Airworthiness Directive 2013-0226, dated September 23, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for Airbus Model A320-211, -212, and -231 airplanes. The MCAI states:
During center fuselage certification full scale fatigue test, damage was found on the pressurized floor fittings at Frame 36, below the lower surface panel.
This condition, if not detected and corrected, could affect the structural integrity of the aeroplane.
To prevent such damage, Airbus developed modification 21282, which was introduced in production from [manufacturer serial number] MSN 0105, to reinforce the pressurized floor fitting lower surface by changing material. For affected in-service aeroplanes, Airbus issued Service Bulletin (SB) A320-57-1028, introducing repetitive inspections, and SB A320-57-1029, which provides modification instructions.
DGAC [Direction Générale de l'Aviation Civile] France issued [an] AD * * * [for Model A320-111, -211, and -231 airplanes] to require these repetitive inspections and, depending on findings, corrective action(s), while the modification was specified in that AD as optional terminating action for these inspections.
Following new analysis in the frame of ESG (Extended Service Goal) exercise, the inspection thresholds and intervals have been revised to meet the original DSG (Design Service Goal).
For the reasons described above, this [EASA] AD retains the requirements of [a] DGAC France AD * * *, which is superseded, but requires these actions within reduced compliance times. [This EASA AD also adds Model A320-212 airplanes to its applicability.]
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed except for the change described previously and minor editorial changes. We have determined that these changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
Airbus has issued Service Bulletin A320-57-1028, Revision 1, dated April 19, 1996; and Revision 02, dated June 3, 2013. The service information describes procedures for an inspection to detect cracks of the pressurized floor fittings at frame 36, renewal of the zone protective finish, and replacement of fittings with new fittings.
Airbus has also issued Service Bulletin A320-57-1029, Revision 02, dated June 16, 1999. The service information describes procedures for modification of the pressurized floor fittings at frame 36.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 13 airplanes of U.S. registry.
The actions required by AD 96-18-06, Amendment 39-9730 (61 FR 46703, September 5, 1996), and retained in this AD take about 3 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $0 per product. Based on these figures, the estimated cost of the actions that are required by AD 96-18-06 is $255 per product.
We also estimate that it will take about 11 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $12,155, or $935 per product.
We have received no definitive data that will enable us to provide cost estimates for the on-condition actions specified in this AD.
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.
We determined that 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 the 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.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective March 3, 2016.
This AD replaces AD 96-18-06, Amendment 39-9730 (61 FR 46703, September 5, 1996).
This AD applies to Airbus Model A320-211, -212, and -231 airplanes, certificated in any category, manufacturer serial numbers 0002 through 0104 inclusive.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by an extended service goal analysis by the manufacturer, which revealed that the compliance times and repetitive inspection intervals should be reduced to meet the design service goal. We are issuing this AD to detect and correct fatigue cracking in the pressurized floor fittings at frame 36, which could result in failure of a floor fitting and subsequent depressurization of the fuselage.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (a) of AD 96-18-06, Amendment 39-9730 (61 FR 46703, September 5, 1996), with revised service information for Airbus Model A320-211 and -231 airplanes. Prior to the accumulation of 16,000 total landings, or within 6 months after October 10, 1996 (the effective date of AD 96-18-06), whichever occurs later, perform a visual inspection to detect cracks of the 6 fittings of the pressurized floor at frame 36 under the lower surface panel, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1028, Revision 1, dated April 19, 1996; or Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013. As of the effective date of this AD, use only Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013, for accomplishing the actions required by this paragraph. Accomplishment of the initial inspection required by paragraph (i) of this AD terminates the actions required by this paragraph.
(1) If no cracking is found, prior to further flight, renew the zone protective finish, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1028, Revision 1, dated April 19, 1996; or Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013. As of the effective date of this AD, use only Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013, for accomplishing the actions required by this paragraph. Repeat the visual inspection thereafter at intervals not to exceed 12,000 landings.
(2) If only 1 of the 6 fittings is found to be cracked and that crack is less than or equal to 0.59 inch (15 mm) in length, prior to further flight, replace the cracked fitting with a new fitting, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1028, Revision 1, dated April 19, 1996; or Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013. Thereafter, prior to the accumulation of 500 landings following accomplishment of this replacement, replace the remaining 5 fittings with new fittings, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1028, Revision 1, dated April 19, 1996; or Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013. As of the effective date of this AD, use only Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013, for accomplishing the actions required by this paragraph.
(3) If only 1 of the 6 fittings is found to be cracked, and that crack is greater than 0.59 inch (15 mm) in length, prior to further flight, replace all six fittings with new fittings, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1028, Revision 1, dated April 19, 1996; or Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013. As of the effective date of this AD, use only Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013, for accomplishing the actions required by this paragraph.
(4) If 2 or more fittings are found to be cracked, prior to further flight, replace all 6 fittings with new fittings, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1028, Revision 1, dated April 19, 1996; or Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013. As of the effective date of this AD, use only Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013, for accomplishing the actions required by this paragraph.
This paragraph restates the provisions of paragraph (b) of AD 96-18-06, Amendment 39-9730 (61 FR 46703, September 5, 1996), with revised service information for Airbus Model A320-211 and -231 airplanes. Replacement of all 6 fittings with new fittings, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1028, Revision 1, dated April 19, 1996; or Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013; constitutes terminating action for the inspection requirements of paragraph (g) of this AD.
(1) At the latest of the times in paragraph (i)(1)(i), (i)(1)(ii), or (i)(1)(iii) of this AD: Do a detailed inspection of the pressurized floor fittings at frame 36, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013. Repeat the inspection thereafter, at intervals not to exceed 9,300 flight cycles or 18,600 flight hours, whichever occurs first. Accomplishment of the initial inspection required by this paragraph terminates the actions required by paragraph (g) of this AD.
(i) Prior to the accumulation of 20,900 total flight cycles or 41,800 total flight hours, whichever occurs first.
(ii) Prior to the accumulation of 9,300 flight cycles or 18,600 flight cycles since the most recent inspection required by paragraph (g) or (i) of this AD, whichever occurs first.
(iii) At the earlier of the times specified in paragraph (i)(1)(iii)(A) and (i)(1)(iii)(B) of this AD.
(A) Prior to the accumulation of 1,250 flight cycles or 2,500 flight hours after the effective date of this AD, whichever occurs first.
(B) Prior to the accumulation of 12,000 flight cycles since the most recent inspection required by paragraph (g) or (i) of this AD.
(2) If any crack is found during any inspection required by paragraph (i)(1) of this AD: Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).
Modification (replacement of aluminum fittings with titanium fittings) of the pressurized floor fittings at frame 36, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1029, Revision 02, dated June 16, 1999, is terminating action for the repetitive inspections required by paragraphs (g) and (i) of this AD.
The following provisions also apply to this AD:
(1)
(i) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.
(ii) AMOCs approved previously for AD 96-18-06, Amendment 39-9730 (61 FR 46703, September 5, 1996), are approved as AMOCs for the corresponding provisions of this AD.
(2)
Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2013-0226, dated September 23, 2013, for related information. This MCAI may be found in the AD docket on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(3) The following service information was approved for IBR on March 3, 2016.
(i) Airbus Service Bulletin A320-57-1028, Revision 02, dated June 3, 2013.
(ii) Airbus Service Bulletin A320-57-1029, Revision 02, dated June 16, 1999.
(4) The following service information was approved for IBR on October 10, 1996 (61 FR 46703, September 5, 1996).
(i) Airbus Service Bulletin A320-57-1028, Revision 1, dated April 19, 1996, which contains the following list of effective pages: Pages 1 through 3, Revision 1, dated April 19, 1996; Pages 4 through 15, dated August 12, 1991.
(ii) Reserved.
(5) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(6) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(7) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class E surface area airspace designated as an extension to Class C airspace, and Class E airspace extending upward from 700 feet above the surface at Boise Air Terminal/Gowen Field Airport, formerly Boise Air Terminal (Gowen Field), Boise, ID. After reviewing the airspace, the FAA found standard instrument approach procedures are not fully contained in controlled airspace, thereby necessitating airspace redesign for the safety and management of Instrument Flight Rules (IFR) operations at the airport. This action also corrects the name of the airport to match the FAAs aeronautical database.
Effective 0901 UTC, March 31, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4563.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the
On November 13, 2015, the FAA published in the
Class E airspace designations are published in paragraph 6003 and 6005, respectively, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace designated as an extension to Class C airspace, and Class E airspace extending upward from 700 feet above the surface at Boise Air Terminal/Gowen Field Airport, Boise, ID. Two segments are expanded from the 5-mile radius of the airport and extend to 12.8 miles southeast, and 11 miles northwest of the airport. Class E airspace extending upward from 700 feet above the surface at Boise Air Terminal/Gowen Field Airport is amended to accommodate standard instrument approach procedures for IFR operations at the airport. A review of the airspace found modification of the airspace necessary for the safety and management of standard instrument approach procedures for IFR operations at the airport. Also, the name of the airport is updated from Boise Air Terminal (Gowen Field), to Boise Air Terminal/Gowen Field Airport, to coincide with the FAA's aeronautical database.
Class E airspace extending upward from 700 feet above the surface is modified to within an 8.6-mile radius north of Boise Air Terminal/Gowen Field Airport, extending to 11.4 miles to the south, 17 miles to the east and 30 miles to the west.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (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); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface within 5 miles each side of the Boise Air Terminal/Gowen Field Airport 114° bearing extending from the 5-mile radius of the airport to 12.8 miles southeast of the airport; and within 5 miles each side of the Boise Air Terminal/Gowen Field Airport 295° bearing extending from the 5-mile radius of the airport to 11 miles northwest of the airport.
That airspace extending upward from 700 feet above the surface bounded by a line beginning at lat. 43°44′51″ N., long. 116°52′05″ W.; to lat. 43°52′31″ N., long. 116°38′57″ W.; to lat. 43°51′24″ N., long. 116°24′16″ W.; to lat. 43°31′33″ N., long. 115°50′14″ W.; to lat. 43°19′45″ N., long. 115°56′41″ W.; to lat. 43°25′11″ N., long. 116°32′39″ W.; to lat. 43°35′39″ N., long. 116°47′51″ W., thence to the point of beginning. That airspace extending upward from 1,200 feet above the surface within the 30.5-mile radius of the airport beginning at the 122° bearing of the airport, thence via a line to the intersection of the 34.8-mile radius of the airport and the 224° bearing of the airport, thence clockwise along the 34.8-mile radius of the airport to that airspace 7 miles each side of the 269° bearing of the airport extending from the 34.8-mile radius to 49.6 miles west of the airport, and within 7 miles northeast and 9.6 miles southwest of the 295° bearing of the airport extending from the 34.8-mile radius to 65.3 miles northwest of the airport, to lat. 44°00′27″ N., long. 117°10′58″ W., thence along the 042° bearing to V-253, thence south along V-253, thence along the 30.5-mile radius of the airport to the point of beginning. That airspace southeast of the airport extending upward from 9,000 feet MSL bounded on the north by V-444, on the east by V-293, on the south by V-330 and on the southwest by V-4. That airspace northeast of the airport extending upward from 11,500 feet MSL, bounded on the northeast by V-293, on the south by V-444, on the southwest by the 30.5-mile radius of the airport and on the west by V-253.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class D airspace, Class E airspace extending upward from 700 feet above the surface, and removes Class E surface area airspace designated as an extension at Chico Municipal Airport, Chico, CA. The FAA found it necessary to amend the airspace area by increasing the Class E airspace extending upward from 700 feet above the surface for the safety and management of Instrument Flight Rules (IFR) operations for arriving and departing aircraft at the airport. The FAA found no standard instrument approach procedures requiring Class E surface area airspace designated as an extension to Class D airspace. This action changes from navigation aids to geographic coordinate references in the legal description and updates the geographic coordinates of Chico Municipal and Ranchaero Airports for the Class D and E airspace areas noted above.
Effective 0901 UTC, March 31, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4563.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Chico, CA.
On November 13, 2015, the FAA published in the
Class D and Class E airspace designations are published in paragraph 5000, 6004, and 6005, respectively, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class D airspace, Class E airspace extending upward from 700 feet above the surface, and removes Class E surface area airspace as an extension at Chico Municipal Airport, Chico, CA. Class E airspace extending upward from 700 feet above the surface is modified to within a 4.1-mile radius east of Chico Municipal, extending to 6 miles from the southeast to the north, excluding that airspace within 1 NM of Ranchaero Airport, CA. This action removes reference to navigation aids and uses instead, geographic coordinate references in the legal descriptions. The geographic coordinates of the Chico Municipal and Ranchaero Airports are amended for the Class D and E airspace areas to coincide with the FAA's aeronautical database.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (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); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 2,700 feet MSL within a 4.1-mile radius of Chico Municipal Airport, excluding the portion within a 1-mile radius of Ranchaero Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from 700 feet above the surface bounded by a line beginning at lat. 39°43′57″ N., long. 121°45′28″ W., clockwise along the Chico Municipal Airport 6-mile radius to lat. 39°41′45″ N., long. 121°50′42″ W.; thence along the 174° bearing to lat. 39°43′38″ N., long. 121°51′05″ W., thence counter-clockwise along the Ranchaero Airport 1-mile radius to lat. 39°43′50″ N., long. 121°53′12″ W., thence along the 200° bearing to the Chico Municipal Airport 6-mile radius, thence clockwise to lat. 39°53′31″ N., long. 121°53′31″ W.; thence to lat. 39°51′48″ N., long. 121°52′04″ W., clockwise along the Chico Municipal Airport 4.1-mile radius to lat. 39°45′40″ N., long. 121°46′54″ W.; thence to the point of beginning.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is approving a revision to the Minnesota sulfur dioxide (SO
This rule is effective on March 28, 2016, unless EPA receives adverse written comments by February 29, 2016. If EPA receives adverse comments, EPA will publish a timely withdrawal of the rule in the
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2015-0366 at
Charles Hatten, Environmental Engineer, Control Strategies Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6031,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:
The Inver Hills facility is a 440 Megawatt peak demand electrical generation plant. The plant has six generation units, turbines EU 001-EU 006, which can burn both natural gas and distillate fuel oil. In 1980, Inver Hills was identified by the state of Minnesota as a culpable source in the Pine Bend portion of the Minneapolis-St. Paul SO
On June 8, 2004 (69 FR 31891), EPA approved a Minnesota SO
On May 1, 2015, MPCA submitted a request to EPA to revise the Title I SIP conditions in the SO
The Inver Hills SIP revision contains two methods for determining compliance with the sulfur limit for fuel oil. Method A requires Inver Hills to sample the fuel upon delivery to demonstrate compliance with the new lower fuel sulfur limit of 0.005 percent by weight. Method B requires the fuel supplier to provide a guarantee that the fuel oil has a sulfur content below a specific limit. If the fuel oil supplier provides that guarantee, Inver Hills is not required to conduct any additional sampling or analysis of the fuel oil. Since no sampling is required, the SIP revision reduces the sulfur content limit under Method B from 0.10 percent by weight to 0.0015 percent by weight.
The SIP revision submitted by Minnesota imposes more stringent limits on the sulfur content of the fuel used at the Inver Hills facility. In addition, the provisions for demonstrating compliance have been revised to reflect the more stringent fuel limits. A modeling analysis was not conducted for the Inver Hills because the SIP revision imposes more stringent SO
EPA is approving the request by Minnesota to revise the Title I SIP conditions in Minnesota's SO
We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Minnesota regulations described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through
Under the Clean Air Act (CAA), the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 28, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur dioxide.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(d) * * *
Environmental Protection Agency.
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the State Implementation Plan (SIP) submitted by the State of Missouri on June 2, 2014. This SIP revision incorporates a consent judgment to address violations of the 24-hour particulate matter (PM
This direct final rule will be effective March 28, 2016, without further notice, unless EPA receives adverse comment by February 29, 2016. If EPA receives adverse comment, we will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R07-OAR-2015-0644, to
Heather Hamilton, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at 913-551-7039 or by email at
Throughout this document “we,” “us,” or “our” refer to EPA. This section provides additional information by addressing the following:
EPA's current health-based PM
Exceedances and violations of the PM
There were no exceedances in 2009 and 2010; however, based on validated air quality data from 2011 to 2013, the Carthage monitor again experienced a number of exceedances as evidenced in the following table:
After an internal analysis to identify potential sources of emissions for the exceedances, the MDNR Air Pollution Control Program contacted CCL regarding their operations at the facility. On June 8, 2012, CCL proposed additional control measures that were necessary due to malfunctioning equipment and processing issues at the facility.
EPA is taking direct final action to approve a revision to the SIP submitted by the State of Missouri on June 2, 2014. Missouri requested that EPA approve Americold Logistics, LLC, Carthage Crushed Limestone (CCL) consent judgment for inclusion into the Missouri SIP. The consent judgment between the state of Missouri and CCL was entered on May 3, 2014, and effective May 13, 2014. The consent judgment requires CCL to apply specific measures and work practices to reduce PM
As a result, CCL worked cooperatively with MDNR who developed an enforceable consent judgment for implementing controls to further reduce PM
Control measures to reduce fugitive PM
The consent judgment also includes contingency measures in the event of an exceedance of the PM
In addition to the measures outlined in the consent judgment, CCL has voluntarily agreed to participate in a near-real-time PM
Since entering into the consent judgment with the MDNR, there was one exceedance of the PM
The control and contingency measures identified in the consent judgment, and included in MDNR's SIP revision request, is a significant strengthening of the current requirements applicable to this source to control fugitive PM emissions. EPA believes that these requirements will reduce or potentially eliminate future exceedances of the PM
The June 2, 2014, submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.
EPA is taking direct final action to approve this SIP revision. We are publishing this rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of this
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Missouri Source Specific Permits and Orders described in the direct final amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available electronically through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 28, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
For the reasons stated in the preamble, EPA amends 40 CFR part 52 as set forth below:
42 U.S.C. 7401
(d) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing disapproval of revisions to the South Coast Air Quality Management District (SCAQMD) portion of the California State Implementation Plan (SIP). This action was proposed in the
The EPA has established docket number EPA-R09-OAR-2015-0545 for this action. Generally, documents in the docket for this action are available electronically at
Idalia Pérez, EPA Region IX, (415) 972-3248,
Throughout this document, “we,” “us” and “our” refer to the EPA.
On November 24, 2015 (80 FR 73156), the EPA proposed to disapprove the following rules that were submitted for incorporation into the California SIP.
We proposed to disapprove these rules because some rule provisions do not satisfy the requirements of section 110 and part D of the Act.
We proposed to disapprove the SIP revision for Rule 1610 based at least in part on the following deficiencies:
1. The Section (e)(2) requirement that engines of scrapped vehicles be destroyed is insufficiently federally enforceable for various reasons.
2. The Section (f)(2)(A) requirement that the vehicle be registered for two years within SCAQMD is not fully enforceable by allowing the Executive Officer to approve different documentation.
3. The Section (g) requirement of a visual and functional inspection of the vehicle has no recordkeeping requirements.
4. There is no recordkeeping requirement to demonstrate compliance with the Section (g)(1) requirement that vehicles be driven under their own power to the scrapping site.
5. There is no requirement to maintain records for the life of Mobile Source Emission Reduction Credits.
We proposed to disapprove the SIP revision for Rule 2202 based at least in part on the following deficiencies:
1. Per Section (f)(1), the rule relies on Regulation XVI, which is not currently in the SIP.
2. Per Section (f)(3), the rule relies on the Air Quality Investment Program (Rule 2501), which is not currently in the SIP.
3. Per Section (f)(4), the rule relies on emission reduction strategies approved on a case-by-case basis by the Executive Officer.
4. Per Section (g)(4), the rule relies on vehicle miles travelled reduction programs approved on a case-by-case basis by the Executive Officer.
We proposed to disapprove the SIP revision for Rules 503.1 and 504 because they conflict with CAA sections 110(a) and (i) and fail to address that a state- or district-issued variance has no effect on enforcing the underlying federal requirement unless the variance is submitted to and approved by EPA as a SIP revision.
We proposed to disapprove the SIP revision for Rule 511.1 to avoid potential conflict with EPA's independent authorities provided in CAA section 113, section 114 and elsewhere.
Our proposed action contains more information on the basis for this rulemaking and on our evaluation of the submittal.
The EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.
No comments were submitted that change our assessment of the rules as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is finalizing a full disapproval of the submitted rules. This final disapproval does not trigger sanctions or a requirement for the EPA to issue a federal implementation plan (FIP). Sanctions will not be imposed under CAA 179(b) because the submittal of Rules 1610, 2202, 503.1, 504 and 511.1 is discretionary (
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose an information collection burden under the PRA, because this SIP disapproval does not in-and-of itself create any new information collection burdens, but simply disapproves certain State requirements for inclusion in the SIP.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This SIP disapproval does not in-and-of itself create any new requirements but simply disapproves certain State requirements for inclusion in the SIP.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action disapproves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.
This action does not have federalism implications. It 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.
This action does not have tribal implications, as specified in Executive Order 13175, because the SIP revision that the EPA is disapproving would not apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because this SIP disapproval does not in-and-of itself create any new regulations, but simply disapproves certain State requirements for inclusion in the SIP.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.
The EPA lacks the discretionary authority to address environmental justice in this rulemaking.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(a) * * *
(1) * * *
(iv) Rule 511.1, “Subpoenas,” submitted on February 7, 1989.
(v) Rule 503.1, “Ex Parte Petitions for Variances,” submitted on February 7, 1989.
(vi) Rule 504, “Rules from which Variances Are Not Allowed,” submitted on May 13, 1991.
(vii) Rule 1610, “Old-Vehicle Scrapping,” submitted on June 3, 1997.
(viii) Rule 2202, “On-Road Motor Vehicle Mitigation Options,” submitted on June 3, 1999.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing its proposal to approve revisions to the State Implementation Plan (SIP) for Louisiana. These rule revisions are the 2007 General Revisions, and 2008-2010 Miscellaneous Rule Revisions to the SIP that were submitted by the State of Louisiana. The overall intended outcome is to make the approved Louisiana SIP consistent with current Federal and State requirements. This action is in accordance with the federal Clean Air Act (the Act).
This rule is effective on February 29, 2016.
The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2012-0434. All documents in the docket are listed on the
Mr. Alan Shar (6MM-AA), telephone (214) 665-2164, email
Throughout this document “we,” “us,” and “our” refer to EPA.
On November 5, 2015 (80 FR 68481) we proposed to approve revision to the Louisiana SIP that the Louisiana Department of Environmental Quality (LDEQ) submitted to EPA on August 14, 2009, and August 29, 2013.
The Louisiana rule revisions submittals, corresponding Chapters, and type of action that we proposed are in Table 1 below.
On October 2, 2015 LDEQ submitted a letter withdrawing its revisions to Louisiana Administrative Code (LAC) 33:III, Chapter 15.
The revisions to rules adopt the most recent Particulate Matter standards and make numerous other administrative and ministerial changes. As discussed in our proposal, there is no increase in the amount of emissions or number of sources affected as a result of these ministerial or administrative rules revisions; therefore, section 110(l) of the Act has been complied with. Details of these submittals, their evaluation, and individual chapter-specific conclusions were explained in our proposal, and its corresponding Technical Supporting Document.
Certain provisions of the Louisiana SIP (§§ 1107(A), 1507(A)(1), 1507(B)(1), 2153(B)(1)(i), 2201(C)(8), 2307(C)(1), and 2307(C)(2)) are affected by EPA's June 12, 2015 National SIP Call (80 FR 33967). Approval of amendments to LAC 33:III, Chapters 11, 21, 22, and 23 here should not, in any way, be construed as explicitly or implicitly voiding or minimizing any concerns or inadequacies identified in EPA's National SIP Call with respect to the above referenced provisions. We continue to expect that issues raised within the context of the EPA's National SIP Call to be addressed in a timely fashion. See section 110(k)(5) of the Act.
The public comment period for the November 5, 2015 (80 FR 68481) proposal expired on December 7, 2015, and we did not receive any comments on the proposed actions during this period. Therefore, we are finalizing the November 5, 2015 (80 FR 68481) proposal without any changes into the Louisiana SIP.
We are approving rule revisions to LAC 33:III, Chapter 1, section 111; Chapter 7, sections 701, 703, and 711; Chapter 9, sections 918, and 919; Chapter 11, sections 1105, and 1107; Chapter 13, sections 1323, 1325, 1327,
In this rule, we are finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.4, we are finalizing the incorporation by reference of the revisions to the Louisiana regulations as described in the Final Action section above. We have made, and will continue to make, these documents generally available electronically through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. If a portion of the plan revision meets all the applicable requirements of this chapter and Federal regulations, the Administrator may approve the plan revision in part. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices that meet the criteria of the Act, and to disapprove state choices that do not meet the criteria of the Act. Accordingly, this final action approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this final action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act;
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994); and
• Does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 28, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposed of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Hydrocarbons, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Volatile organic compounds.
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
The revisions and additions read as follows:
(c) * * *
Environmental Protection Agency.
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve the state implementation plan (SIP) revision submitted by the Commonwealth of Kentucky, through the Kentucky Division of Air Quality (DAQ) on November 18, 2015, to address the emissions statements requirement for the Commonwealth's portion of the Cincinnati, Ohio-Kentucky-Indiana (Cincinnati, OH-KY-
This rule is effective February 29, 2016.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2015-0444. All documents in the docket are listed on the
Tiereny Bell, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms. Bell can be reached at (404) 562-9088 and via electronic mail at
On April 15, 2015, the Commonwealth of Kentucky submitted a draft SIP revision to EPA for parallel processing seeking to include the specific sections of 401 Kentucky Administrative Regulations (KAR) 52.020—
The details of Kentucky's submittal and the rationale for EPA's actions are explained in the NPR. Comments on the proposed rulemaking were due on or before October 22, 2015. No comments were received. On November 18, 2015, Kentucky submitted a final SIP revision that did not contain any substantive changes regarding emissions statements from the draft version submitted on April 15, 2015. EPA is now taking final action to approve the November 18, 2015, SIP revision as meeting the requirements of section 182(a)(3)(B) of the Clean Air Act (CAA or Act).
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporate by reference of 401 KAR 52.020—
EPA is approving the SIP revision submitted by Kentucky on November 18, 2015, as meeting the section 182(a)(3)(B) emissions statements requirement for the Kentucky portion of the Cincinnati, OH-KY-IN Area, and EPA is incorporating the regulatory text identified in Section II, above, into Kentucky's SIP. EPA has concluded that the Commonwealth's submission meets the requirements of the CAA.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 28, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
U.S. Office of Personnel Management.
Proposed rule with request for comments.
The U.S. Office of Personnel Management (OPM) is issuing a proposed regulation limiting to one the number of permanent appointments spouses of 100 percent disabled and spouses of deceased members of the Armed Forces may receive under these provisions. OPM is making this change based on a provision contained in the Fiscal Year (FY) 2013 National Defense Authorization Act (NDAA). The intended effect of this change is to conform our regulation with the statute.
Comments must be received on or before March 28, 2016.
You may submit comments, which are identified by RIN 3206-AM76, by any of the following methods:
•
•
•
Michelle Glynn, 202-606-1571, Fax: 202-606-2329 by TDD: 202-418-3134, or email:
On September 25, 2008, the President issued Executive Order (E.O.) 13473 allowing agencies to make noncompetitive appointments of certain military spouses of members of the Armed Forces. OPM implemented this E.O. via final regulations which were published in the
On January 2, 2013, the President signed the FY 13 NDAA. Section 566(a) of this Act codifies in statute, at 5 U.S.C. 3330d, the hiring authority previously created by E.O. 13743 and, in so doing, limits to one the number of permanent appointments the spouse of a disabled or deceased member of Armed Forces may receive under section 3330d. OPM is proposing to limit to one the number of permanent appointments an eligible spouse may receive under its regulatory provisions. We are making this change to conform our regulations to 5 U.S.C. 3330d(d)(2).
This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866 and Executive Order 13563.
I certify that this regulation will not have a significant economic impact on a substantial number of small entities because it affects only Federal agencies and employees.
Government employees.
U.S. Office of Personnel Management.
Accordingly, OPM is proposing to amend 5 CFR part 315 as follows:
5 U.S.C. 1302, 3301, and 3302; E.O. 10577, 3 CFR, 1954-1958 Comp. p. 218, unless otherwise noted; and E.O. 13162. Secs. 315.601 and 315.609 also issued under 22 U.S.C. 3651 and 3652. Secs. 315.602 and 315.604 also issued under 5 U.S.C. 1104. Sec. 315.603 also issued under 5 U.S.C. 8151. Sec. 315.605 also issued under E.O. 12034, 3 CFR, 1978 Comp. p. 111. Sec. 315.606 also issued under E.O. 11219, 3 CFR, 1964-1965 Comp. p. 303. Sec. 315.607 also issued under 22 U.S.C. 2560. Sec. 315.608 also issued under E.O. 12721, 3 CFR, 1990 Comp. p. 293. Sec. 315.610 also issued under 5 U.S.C. 3304(c). Sec. 315.611 also issued under 5 U.S.C. 3304(f). Sec. 315.612 also issued under E.O. 13473 and Pub. L. 112-239, Sec. 566. Sec. 315.708 also issued under E.O. 13318, 3 CFR, 2004 Comp. p. 265. Sec. 315.710 also issued under E.O. 12596, 3 CFR, 1978 Comp. p. 264.
(d) * * *
(3) Spouses of 100 percent disabled or deceased members of the armed forces may receive only one noncompetitive appointment under this section to a permanent position.
(4) Any law, Executive order, or regulation that disqualifies an applicant for appointment also disqualifies a spouse for appointment under this section.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Airbus Model A319, A320, and A321 series airplanes. This proposed AD was prompted by a report that a main landing gear (MLG) door could not be closed due to rupture of the actuator fitting. Later reports indicated that the forward monoblock fitting of the MLG door actuator (referred to as the nerve area) could be damaged after rupture of the actuator fitting. This proposed AD would require repetitive inspections of the MLG door actuator fitting and its components for cracking, and corrective actions if necessary. This proposed AD would also require eventual replacement of all affected MLG door actuator fittings with new monoblock fittings, which would terminate the repetitive inspections. We are proposing this AD to prevent rupture of the door actuator fittings, which could result in detachment of an MLG door and subsequent exterior damage and consequent reduced structural integrity of the airplane.
We must receive comments on this proposed AD by March 14, 2016.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0166, dated July 16, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A319, A320, and A321 series airplanes. The MCAI states:
On one A320 aeroplane, it was reported that one of the main landing gear (MLG) doors could not be closed. Investigations revealed the rupture of the actuator fitting at the actuator attachment area on the door side. The MLG door is attached to the aeroplane by 2 hinge fittings.
This condition, if not corrected, could, under certain circumstances, lead to detachment of a MLG door from the aeroplane, possibly resulting in damage to the aeroplane, and/or injury to persons on the ground.
Prompted by these findings, [Direction Générale de l'Aviation Civile] France issued * * * [an AD] * * *, to require a MLG door actuator fitting inspection for cracks and to check the grain direction on a batch of aeroplanes.
Subsequently, DGAC France issued * * * [an AD], retaining the requirements of DGAC France AD * * *, which was superseded, to require an inspection of the lower part of the MLG door actuator fitting.
After that [DGAC] AD was issued, additional investigations revealed that damage could also appear on the nerve area [of the forward monoblock fitting], in the upper part of the MLG door actuator fitting in the area of the hinge.
Consequently, DGAC France issued F2003-434, dated December 10, 2003 [
Since that [DGAC] AD was issued, in the framework of the extended service goal campaign, it has been decided to make replacement of the MLG door actuator fittings a required modification.
For the reasons described above, this AD retains the requirements of DGAC France AD F-2003-434, which is superseded, and requires replacement of the MLG door actuator fittings with new monoblock fittings, which constitutes terminating action for the repetitive inspections.
You may examine the MCAI in the AD docket on the Internet at
Airbus has issued Service Bulletins A320-52-1073, Revision 05, dated September 28, 2006; A320-52A1086, Revision 01, dated September 10, 1999; and A320-52-1096, Revision 02, dated July 12, 2006. This service information describes procedures for inspections of
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
Unlike the procedures described in Airbus Service Bulletin A320-52-1096, Revision 02, dated July 12, 2006, this proposed AD would not permit further flight if cracks are detected in the MLG door actuator fittings. We have determined that, because of the safety implications and consequences associated with that cracking, any cracked MLG door actuator fittings must be repaired or modified before further flight. This difference has been coordinated with the EASA.
We estimate that this proposed AD affects 71 airplanes of U.S. registry.
We also estimate that it would take about 38 work-hours per product to comply with the inspection requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost for the inspection specified in this proposed AD on U.S. operators to be $229,330, or $3,230 per product.
We estimate that it would take about 98 work-hours per product to comply with the MLG actuator replacement requirements of this proposed AD. Required parts would cost about $6,258 per product. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost for the actuator replacement specified in this proposed AD on U.S. operators to be $1,035,748, or $14,588 per product.
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.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by March 14, 2016.
None.
This AD applies to the Airbus airplanes, certificated in any category, identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, all manufacturer serial numbers.
(1) Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes.
(2) Model A320-211, -212, -214, -231, -232, and -233 airplanes.
(3) Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes.
Air Transport Association (ATA) of America Code 52, Doors.
This AD was prompted by a report that a main landing gear (MLG) door could not be closed due to rupture of the actuator fitting. Later reports indicated that the forward monoblock fitting of the MLG door actuator (referred to as the nerve area) could be damaged after rupture of the actuator fitting. We are issuing this AD to prevent rupture of the door actuator fittings, which could result in detachment of an MLG door and subsequent exterior damage and consequent reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For airplanes equipped with MLG door actuator fittings having part number (P/N) D52880224 000/001 that were installed before the first flight of the airplane on MLG doors identified in paragraphs (g)(1) and (g)(2) of this AD, as applicable: Within 500 flight hours since the most recent high frequency eddy current (HFEC) inspection done as specified in Airbus Service Bulletin A320-52A1086, Revision 01, dated September 10, 1999, or within 30 days after the effective date of this AD, whichever occurs later, perform an HFEC inspection for cracking of the MLG door fittings, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52A1086, Revision 01, dated September 10, 1999. Repeat the inspection thereafter at intervals not to exceed 500 flight hours, except as provided by paragraph (i)(1) of this AD.
(1) Left-hand MLG doors with S/Ns 1206 through 1237 inclusive, 1239 through 1247 inclusive, and 1249 through 1251 inclusive.
(2) Right-hand MLG doors with S/Ns 1208 through 1239 inclusive, 1241 through 1249 inclusive, and 1251.
For airplanes equipped with MLG door actuator fittings having P/N D52880224 000/001 or D52880235 000/001: Within 400 flight cycles after the effective date of this AD, or before the accumulation of 9,000 total flight cycles since first flight of the airplane, whichever occurs later, perform an HFEC inspection of both hinge and nerve areas of the MLG doors for cracking, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52-1096, Revision 02, dated July 12, 2006. Repeat the inspection thereafter at intervals not to exceed 800 flight cycles.
(1) If any cracking is found during any inspection required by paragraph (g) or (h) of this AD: Before further flight, replace the affected MLG door actuator fittings with new monoblock fittings, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52-1073, Revision 05, dated September 28, 2006. Accomplishing this replacement terminates the repetitive inspections required by paragraphs (g) and (h) of this AD.
(2) If, during any HFEC inspection required by paragraph (g) of this AD, no cracking is found: At the time specified in paragraph (g) of this AD, perform a low frequency eddy current (LFEC) inspection to determine the grain direction of the raw material of each MLG actuator fitting, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52A1086, Revision 01, dated September 10, 1999.
(i) If the grain direction of the raw material is correct, the repetitive inspections required by paragraph (g) of this AD may be terminated.
(ii) If the grain direction of the raw material is incorrect, repeat the HFEC inspection required by paragraph (g) of this AD at the time specified in paragraph (g) of this AD. Replacement of the MLG door actuator fittings with new monoblock fittings as specified in paragraph (i)(1) of this AD, terminates the repetitive inspections required by paragraphs (g) and (i) of this AD.
For airplanes equipped with any MLG door actuator fitting having P/N D52880102000 and P/N D52880102001, or P/N D52880220000 and P/N D52880220001, or P/N D52880224000 and P/N D52880224001, or P/N D52880235000 and P/N D52880235001: At the later of the times specified in paragraphs (j)(1) and (j)(2) of this AD, replace the MLG door actuator fittings with new monoblock fittings, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52-1073, Revision 05, dated September 28, 2006. Accomplishing this replacement terminates the repetitive inspections required by paragraphs (g) and (h) of this AD.
(1) Before the accumulation of 48,000 total flight cycles or 96,000 total flight hours, whichever occurs later since the first flight of the airplane; or
(2) Within 30 days after the effective date of this AD.
Replacement of the MLG door actuator fittings with new monoblock fittings, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52-1073, Revision 05, dated September 28, 2006, terminates the repetitive inspections required by paragraphs (g) and (h) of this AD.
For airplanes on which Airbus Modification 24903, 25372, or 36979 has been embodied in production, no action is required by this AD, provided that no MLG door actuator fitting having any part number identified in paragraph (j) of this AD has been reinstalled on the airplane since first flight.
As of the effective date of this AD, no person may install a MLG door actuator fitting having any part number identified in paragraph (j) of this AD on any airplane.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) European Aviation Safety Agency Airworthiness Directive 2014-0166, dated July 16, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Sanderson Field Airport, Shelton, WA, to accommodate new Standard Instrument Approach Procedures developed at the airport. Controlled airspace is necessary for the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Comments must be received on or before March 14, 2016.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2015-3994; Airspace Docket No. 15-ANM-23, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4563.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace at Sanderson Field Airport, Shelton, WA.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-3994; Airspace Docket No. 15-ANM-23.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This document would amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 feet above the surface at Sanderson Field Airport, Shelton, WA. Establishment of a GPS approach has made this action necessary for the safety and management of IFR operations at the airport. The Class E airspace area would be modified to a 4-mile radius of the Ed Carlson Memorial-South Lewis County Airport, with segments extending from the 4-mile radius to 5 miles northeast of the airport, and 9.5 miles southwest of the airport.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (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); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 4-mile radius of the Sanderson Field Airport, and that airspace 1.5 miles either side of the 068° bearing from airport extending from the 4-mile radius to 5 miles northeast of the airport, and that airspace 2.3 miles either side of the 248° bearing from airport extending from the 4-mile radius to 9.5 miles southwest of the airport.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Minnesota sulfur dioxide (SO
Comments must be received on or before February 29, 2016.
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2015-0366 at
Charles Hatten, Environmental Engineer, Control Strategies Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6031,
In the Final Rules section of this
Environmental Protection Agency.
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the State Implementation Plan (SIP) submitted by the State of Missouri on June 2, 2014. This proposed SIP revision will incorporate a consent judgment to address violations of the 24-hour particulate matter (PM
Comments on this proposed action must be received in writing by February 29, 2016.
Submit your comments, identified by Docket ID No. EPA-R07-OAR-2015-0644, to
Heather Hamilton, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at (913) 551-7039, or by email at
In the final rules section of this
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
U.S. Agency for International Development.
30-Day notice.
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the U.S. Agency for International Development (USAID) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the
Comments Due Date: February 29, 2016.
Written comments should be identified as Paperwork Reduction Act Comments, OMB Control Number 0412-0577. These comments should be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Desk Officer for USAID, by email at
Manuel A. Avendano, Management and Policy Analyst, USAID, RRB, 1300 Pennsylvania Avenue NW., Washington, DC 20523; (202) 7125-5785 or at
(1) Type of Information Collection: Reinstatement Collection.
(2) Title of the Form/Collection: Partner Information Form.
(3) Agency form number: AID500-13.
(4) Affected public who will be asked or required to respond, as well as a brief abstract: The U.S. Agency for International Development intends to continue collection of information from individuals and/or officers of for-profit and not-for-profit non-governmental organizations (NG0s) who apply for USAID contracts, grants, cooperative agreements, other funding from USAID, or who apply for registration with USAID as Private and Voluntary Organizations. The collection of this information will be used to conduct screening to help mitigate the risk that USAID funds or USAID-funded activities inadvertently provide support to entities or individuals associated with terrorism. Screening programs are being conducted in West Bank/Gaza, Afghanistan, and pilot countries under the Partner Vetting System Pilot Program (Guatemala, Kenya, Lebanon, Philippines, and Ukraine).
(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: USAID estimates that for pilot and non-pilot vetting programs, 3,800 PIFs will be completed in a calendar year and the additional requirements for partner vetting will add 1.25 hours (75 minutes) to an USAID acquisition or assistance award application.
(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 4,750 hours (3,800 forms multiplied by 75 minutes per form, divided by 60 minutes).
(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $217,740 (3,800 forms multiplied by $57.30 per submission cost)
Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the Wyoming Advisory Committee to the Commission will convene 10:00 a.m. (MST) on Friday, February 12, 2016, in the Cottonwood Room of the Wind River Hotel & Casino, 10269 State Highway 789, Riverton, WY 82501. The purpose of the meeting is to discuss civil rights issues affecting Native Americans in the state and other issues. The state advisory committee will review these issues in preparation to identify a topic for study.
The meeting is open to the public. In addition to in person attendance, this meeting is available to the public through the following toll-free call-in number: 1-888-572-7033, conference ID: 1243365. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS)
Persons who plan to attend the meeting and require other accommodations, please contact Evelyn Bohor at
Members of the public are invited to submit written comments; the comments must be received in the regional office by Monday, March 14, 2016. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1050, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
Friday, February 12, 2016 (MST).
Cottonwood Room of the Wind River Hotel & Casino, 10269 State Highway 789, Riverton, WY 82501.
Dial: 1-888-572-7033
Conference ID: 1243365
Malee V. Craft at
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) will hold a meeting on Wednesday, February 17, 2016, from 8:00 a.m.-5:00 p.m. EST. The Committee will hear testimony regarding school discipline policies and practices which may facilitate disparities in juvenile justice involvement and youth incarceration rates on the basis of race, color, disability, or sex, in what has become known as the “School to Prison Pipeline.”
This meeting is open to the public, and will take place at Ivy Tech Community College Event Center, 2820 North Meridian Street in Indianapolis, IN, 46208. Members of the public are invited to make statements during the open comment period beginning at 4:15 p.m. In addition, members of the public may submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records and documents discussed during the meeting will be available for public viewing prior to and following the meeting at
The meeting will be held on Wednesday February 17, 2016, from 8:00 a.m.—5:00 p.m. EST.
Melissa Wojnaroski, DFO, at 312-353-8311 or
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Mid-Atlantic Fishery Management Council's (Council) Tilefish Advisory Panel will hold a public meeting.
The meeting will be held Tuesday, February 16, 2016, from 9 a.m. until noon.
The meeting will be held via webinar with a telephone-only connection option.
Christopher M. Moore, Ph.D. Executive Director, Mid-Atlantic Fishery Management Council; telephone: (302) 526-5255. The Council's Web site,
The purpose of the meeting is to create a fishery performance report (FPR) by the Council's Golden Tilefish Advisory Panel (AP). The intent of this report is to facilitate a venue for structured input from the Advisory Panel members for the Golden Tilefish specifications process. The FPR will be used by the Council, its Scientific and Statistical Committee (SSC) and the Golden Tilefish Monitoring Committee (MC), when reviewing (at future meetings), and if necessary revising, the current measures designed to achieve the recommended Golden Tilefish catch and landings limits for 2017.
Although non-emergency issues not contained in this agenda may come before this group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during this meeting. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Center of Independent Experts will meet February 16 through February 19, 2016, in Seattle, WA.
The meeting will be held on Tuesday, February 16, 2016 through Friday, February 19, 2016 from 9 a.m. to 5 p.m.
The meeting will be held at the Alaska Fisheries Science Center (AFSC), in building 4, Room 2039 (Wednesday afternoon in Room 2143), 7600 Sand Point Way NE., Seattle, WA 98115.
Grant Thompson, AFSC staff; telephone: (541) 737-9318.
The CIE is to review the Eastern Bering Sea (EBS) and Aleutian Island (AI) Pacific Cod Stock Assessment Models.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The North Pacific Fishery Management Council's (Council) Scallop Plan Team will meet in Kodiak, AK.
The meeting will be held on Wednesday, February 17, 2016, from 9 a.m. to 5 p.m.
The meeting will be held at Fishermen's Hall, 403 Marine Way, Kodiak, AK 99615.
Jim Armstrong, Council staff; telephone: (907) 271-2809.
The agenda includes updating the status of the Statewide Scallop Stocks and Stock Assessment and Fishery Evaluation (SAFE) report-catch specifications, update on Alaska Pacific University's Fisheries, Aquatic Science and Technology lab projects, update on new scallop assessment programs and a review of research priorities. The Agenda is subject to change, and the latest version will be posted at
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
Environmental Protection Agency (EPA).
Notice of availability.
This notice announces the availability of the final National Coastal Condition Assessment (NCCA) 2010. The NCCA describes the results of a nationwide coastal probabilistic survey that was conducted in the summer of 2010 by the Environmental Protection Agency (EPA) and its state, tribal, and federal partners. Results include estimates of coastal area with good, fair, and poor biological quality, water quality, sediment quality, and ecological fish tissue quality. Results are presented nationally and regionally for the Northeast, Southeast, Gulf of Mexico, West, and Great Lakes coasts. The NCCA 2010 also includes information on how the survey was implemented, and future actions and challenges.
Hugh Sullivan, Office of Wetlands, Oceans and Watersheds, Office of Water, Washington DC Phone: 202-564-1763; email:
To better answer questions about the condition of waters across the country, EPA and its state and tribal partners have embarked on a series of surveys under the National Aquatic Resource Surveys (NARS) program. The NCCA 2010 is the most recent in this series of surveys. The key goals of the NCCA 2010 are to describe the ecological condition of the nation's coastal and Great Lakes nearshore waters, how those conditions are changing, and the key stressors affecting those waters. An important component of the NCCA is collaboration with state, tribal, and federal partners in developing new monitoring tools and analytical approaches and in advancing the science of coastal monitoring. The survey uses a statistical design to sample 1,104 randomly-selected sites that represent the condition of the larger population of coastal waters in the conterminous United States. This is the first time the nearshore waters of the Great Lakes have been included in a national statistically-based survey.
The report finds that more than half of the nation's coastal and Great Lakes nearshore waters are rated in good condition for biological and sediment quality, while about one third are rated in good condition for water quality and less than one percent are rated in good condition based on the potential harm that fish tissue contaminants pose to predator fish, birds, and wildlife. Excessive phosphorus is the greatest contributor to the poor water quality rating. Selenium is the greatest contributor to the poor rating for potential harm to predator fish, birds and wildlife from fish tissue contaminants. The draft report has undergone peer, state and EPA review.
You may access the NCCA 2010 from EPA's Web site at
Environmental Protection Agency (EPA).
Notice of availability.
The Environmental Protection Agency (EPA) is announcing the availability of a final document titled, “Integrated Science Assessment for Oxides of Nitrogen—Health Criteria” (EPA/600/R-15/068). The document was prepared by the National Center for Environmental Assessment National Center for Environmental Assessment (NCEA) within the EPA's Office of Research and Development (ORD) as part of the review of the primary (health-based) National Ambient Air Quality Standards (NAAQS) for nitrogen dioxide (NO
The document will be available on or around January 28, 2016.
The “Integrated Science Assessment for Oxides of Nitrogen—Health Criteria” will be available primarily via the Internet on the EPA's Integrated Science Assessment for Nitrogen Dioxide (Health Criteria) home page at
For technical information, contact Dr. Molini Patel, NCEA; telephone: 919-541-1492; fax: 919-541-1818; or email:
Section 108(a) of the Clean Air Act directs the Administrator to identify certain pollutants that, among other things, “cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare” and to issue air quality criteria for them. Further, section 108(a)(2) of the Act provides that these air quality criteria are to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [the] pollutant in the ambient air . . . .” Under section 109 of the Act, the EPA is then to establish National Ambient Air Quality Standards (NAAQS) for each pollutant for which the EPA has issued criteria. Section 109(d) of the Act subsequently requires periodic review and, if appropriate, revision of existing air quality criteria to reflect advances in scientific knowledge on the effects of the pollutant on public health or welfare. The EPA is also required to review and, if appropriate, revise the NAAQS, based on the revised air quality criteria (for more information on the NAAQS review process, see
Oxides of nitrogen are one of six criteria pollutants for which EPA has established NAAQS. Periodically, EPA reviews the scientific basis for these standards by preparing an ISA (formerly called an Air Quality Criteria Document). The ISA, in conjunction with additional technical and policy assessments, provides the scientific basis for decisions by EPA on the adequacy of the current NAAQS and the appropriateness of possible alternative standards. The Clean Air Scientific Advisory Committee (CASAC), an independent science advisory committee with review and advisory functions mandated by section 109(d)(2) of the Clean Air Act, is charged with, among other things, independent scientific review of the EPA's air quality criteria.
On February 10, 2012 (77 FR 7149), EPA formally initiated its current review of the air quality criteria for the health effects of oxides of nitrogen and the primary (health-based) nitrogen dioxide (NO
The discussions at this workshop guided the development of the EPA's “Draft Plan for Development of the Integrated Science Assessment for Nitrogen of Oxides—Health Criteria,” a draft “Integrated Review Plan for the Primary NAAQS for Nitrogen Dioxide” (EPA-452/R-14-003), and initial draft materials for the development of the ISA. The draft plan for the development of the ISA was made available for public comment on May 3, 2013 (78 FR 26026), and was discussed by the CASAC via a publicly accessible teleconference consultation on June 5, 2013 (78 FR 27234). On June 11, 2013, EPA held a workshop to discuss, with invited scientific experts, initial draft materials prepared for the development of the ISA (78 FR 27374). The draft Integrated Review Plan (IRP) was made available in February 2014 for comment by the public and review by the CASAC (79 FR 7184) and was reviewed by the CASAC at a public meeting on March 12, 2014 (79 FR 8701). The CASAC panel provided a consensus letter for their review of the draft IRP to the Administrator of the EPA on June 10, 2014 (
Comments on the draft plan for the ISA and discussion at the June 11, 2013, workshop guided development of the “First External Review Draft Integrated Science Assessment for Oxides of Nitrogen—Health Criteria,” which was released on November 22, 2013 (78 FR 70040), and is available at:
EPA has considered comments by the CASAC panel and by the public in preparing this final ISA.
Government Accountability Office (GAO).
Request for letters of nomination and resumes.
The Balanced Budget Act of 1997 established the Medicare Payment Advisory Commission (MedPAC) and gave the Comptroller General responsibility for appointing its members. For appointments to MedPAC that will be effective May 1, 2016, I am announcing the following: Letters of nomination and resumes will be accepted through March 9, 2016 to ensure adequate opportunity for review and consideration of nominees prior to appointment of new members. Acknowledgement of submissions will be provided within a week of submission. Please contact Mary Giffin at (202) 512-3710 if you do not receive an acknowledgment.
GAO: Office of Public Affairs, (202) 512-4800.
Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 80 FR 76493-76499, dated December 9, 2015) is amended to reflect the reorganization of the Division of Communication Services, Office of the Associate Director for Communication, Centers for Disease Control and Prevention.
Section C-B, Organization and Functions, is hereby amended as follows:
Delete in its entirety the title and the mission and function statements for the
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 28, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.
In the
As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that process, draft recommendations are posted on FDA's Web site and announced periodically in the
FDA is announcing the availability of new draft guidances for industry on product-specific BE recommendations for drug products containing the following active ingredients:
FDA is announcing the availability of a revised draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients:
For a complete history of previously published
These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On October 8, 2015, the Agency submitted a proposed collection of information entitled “Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0583. The approval expires on November 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice of public conference.
The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled “FDA/Xavier Medical Device Conference (MedCon).” This 3-day public conference includes presentations from key FDA officials and industry experts with small group break-out sessions. The conference is intended for companies of all sizes and employees at all levels.
The public conference will be held on May 4, 2016, from 8:30 a.m. to 5 p.m.; May 5, 2016, from 8:30 a.m. to 5 p.m.; and May 6, 2016, from 8:30 a.m. to 12:05 p.m.
The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3016.
The public conference helps fulfill the Department of Health and Human Services' and FDA's important mission to protect the public health. The conference will provide those engaged in FDA-regulated medical devices (for humans) with information on the following topics:
FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The conference helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The conference also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) by providing outreach activities by Government Agencies to small businesses.
To register online for the public conference, please visit the “Registration” link on the conference Web site at
To register by mail, please send your name, title, firm name, address, telephone, email, and payment information for the fee to Xavier University, Attn: Mason Rick, 3800 Victory Pkwy., Cincinnati, OH 45207-5471. An email will be sent confirming your registration.
Attendees are responsible for their own accommodations. The conference headquarter hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 W. 5th St., Cincinnati, OH 45202, 513-421-9100. Special conference block rates are available through April 11, 2016. To make reservations online, please visit the “Venue/Logistics” link at
If you need special accommodations due to a disability, please contact Mason Rick (see
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lamotrigine extended-release tablets entitled “Draft Guidance on Lamotrigine.” The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lamotrigine extended-release tablets.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 28, 2016.
You may submit comments as follows:
Submit electronic submissions in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.
In the
As described in that guidance, FDA adopted this process to develop and disseminate product-specific BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of revised draft BE recommendations for lamotrigine extended-release tablets.
On May 29, 2009, FDA initially approved new drug application 022115 for LAMICTAL (lamotrigine) extended-release tablets. There are eight approved ANDAs for this product. In April 2010, we issued a draft guidance for industry on BE recommendations for lamotrigine extended-release tablets, which we subsequently revised in May 2010; July 2010; and August 2010. We are now issuing a further revised draft guidance for industry on BE recommendations for generic lamotrigine extended-release tablets (“Draft Guidance on Lamotrigine”).
In October 2006, UCB, Inc., submitted a citizen petition requesting that FDA
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on the design of BE studies to support ANDAs for lamotrigine extended-release tablets. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the document at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by February 29, 2016.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 412(h)(1) (21 U.S.C. 350a(h)(1)) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) exempts an infant formula which is represented and labeled for use by an infant with an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem from the requirements of section 412(a), (b), and (c) of the FD&C Act (21 U.S.C. 350a(a), (b), and (c)). These formulas are customarily referred to as “exempt infant formulas.” In the
In the
The proposed information collection seeks OMB approval of the recordkeeping recommendations of the draft guidance. Our estimate of the burden of the recordkeeping recommendations includes the one-time burden of developing production and in-process control systems and the annual burdens of developing and maintaining production aggregate production and control records, records pertaining to the distribution of infant formula, and records pertaining to regularly scheduled audits. Included in the burden estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
In the
(Comment 1) One comment suggested that we clarify the action level for end-of-shelf-life verification testing and how this testing differs for exempt infant formulas as compared to non-exempt infant formulas.
(Response) We appreciate the concerns discussed in the comment.
To the extent that the comment requests us to engage in rulemaking, the comment is outside the scope of the comment request on the four collection of information topics as they relate to the provisions of the draft guidance document.
(Comment 2) One comment asserted that we may have underestimated the time it would take to test weekly for bacteriological contaminants, as reported in Table 1. The comment noted our estimate of 5 minutes per test, once a week, for each of three infant formula plants and added that including the performance of the test would significantly increase the time needed.
(Response) We appreciate the information provided in the comment. However, the comment did not provide us data or information to support a different estimate. In the absence of such data, we lack a basis on which to revise our estimates. In addition, we note that our estimate of 5 minutes per test, once a week, reflects the amount of time needed to fulfill the recordkeeping burdens associated with this requirement, not the time needed to conduct the testing that is subject to the recordkeeping requirement. In preparation for the next regular information collection request, we will consult with several establishments to obtain additional data on the recordkeeping burdens and reevaluate our estimates. We will then publish the revised estimates for comment and consider additional information submitted in response.
FDA estimates the burden of this collection of information as follows:
The total one-time estimated burden imposed by this collection of information is 19,320 hours. The total annual estimated burden imposed by this collection of information is 6,328.06 hours. There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated burden for the draft guidance is based on “Evaluation of Recordkeeping Costs for Food Manufacturers,” Eastern Research Group Task Order No. 5, Contract No. 223-01-2461. FDA estimates that firms will be able to fulfill recordkeeping requirements with existing record systems; that is, FDA estimates that it will not be necessary for infant formula firms to invest in new recordkeeping systems.
As of the beginning of 2015, five manufacturers produce exempt infant formulas that are marketed in the United States. Four out of these five infant formula manufacturers produce both exempt and non-exempt infant formulas, with both types of infant formula produced using the same production lines and equipment. Our experts believe that manufacturing practices are similar for both exempt and non-exempt infant formulas. Furthermore, given expert estimations of industry standard practices, it is estimated that the manufacturer that only produces exempt infant formula has practices comparable to those manufacturers producing both exempt and non-exempt infant formulas (Ref. 1). Together, these 5 manufacturers produce exempt infant formula at 12 plants.
The number of recordkeepers in column 3 of Table 1 is based on FDA's expert estimation of the number of plants that may not already be adhering to the relevant recordkeeping provisions of the final rule. The Regulatory Impact Analysis for the final rule (79 FR 33057) estimated that 25 percent of all infant formula plants manufacturing non-exempt infant formula were not currently adhering to the recordkeeping provisions under § 106.100 (21 CFR 106.100). Although such recordkeeping requirements are now effective for manufacturers of non-exempt infant formulas, and manufacturers of exempt infant formulas may have implemented similar procedures for their exempt infant formulas, it is estimated conservatively that this same proportion (25 percent, or 3 out of 12 plants that manufacture exempt infant formula) are not currently adhering to the recordkeeping provisions, and unless otherwise specified, burdens are estimated based on these 3 plants. Furthermore, we estimate that plants will collect the same information across the various exempt infant formulas produced by each firm.
For records pertaining to production and in-process controls, FDA estimates that, at most, three plants do not currently develop production records as specified under §§ 106.6(c)(5) and 106.100(e)(1) and (3). A team of two senior validation engineers (or other similarly skilled employees) per plant (2 workers per plant × 3 plants = 6 workers) would each need to work 20 hours to provide sufficient initial baseline records and documentation to develop records pertaining to production and in-process controls, for an industry total of 120 hours (2 workers per plant × 3 plants × 20 hours per worker = 120 hours), as presented in line 1 of Table 1.
For the recordkeeping specified under § 106.35(c), in accordance with § 106.100(f)(5), FDA estimates that a team of 10 senior validation engineers (or other similarly skilled employees) per plant would need to work full time for the 16 weeks (16 weeks/person × 40 work hours/week = 640 work hours per person) to provide sufficient initial records and documentation pertaining to controls intended to prevent adulteration due to automatic equipment. The total burden for 10 senior validation engineers each working 640 hours is 6,400 per plant in the first year (10 senior validation engineers × 640 hours = 6,400). For three plants, the total one-time hourly burden is 3 plants × 6,400 hours per plant = 19,200 hours, as presented in line 2 of Table 1.
For the testing specified under § 106.20(f)(3), manufacturers of exempt infant formulas should conduct water testing with appropriate frequency to meet Environmental Protection Agency primary standards for drinking water (40 CFR parts 9, 141, and 142), but shall conduct these tests at least annually for chemical contaminants, every 4 years for radiological contaminants, and weekly for bacteriological contaminants. FDA estimates that it is part of normal business practice for exempt infant formula plants to test for chemical contaminants and keep records of those tests on a regular basis; therefore, this is a new collection of information that does not present a burden (Ref. 1).
It is estimated that the recommendation to manufacturers of exempt infant formulas to test at least every 4 years for radiological contaminants would represent a new burden for all 12 infant formula plants (Ref. 1). In addition, it is estimated that collecting water for this testing takes between 1 and 2 hours (Ref. 1). For the purposes of this analysis, it is conservatively estimated that water collection takes, on average, 1.5 hours and that water collection occurs separately for each type of testing. It is estimated that performing the test (collecting the information) will take 1.5 hours per test, every 4 years. Therefore,
Furthermore, the draft guidance recommends that manufacturers of exempt infant formula make and retain records of the frequency and results of water testing as specified under §§ 106.20(f)(4) and 106.100(f)(1). For the 12 plants that are estimated not to currently test for radiological contaminants, this burden is estimated to be 5 minutes per record every 4 years. Therefore, 0.08 hour per record × 12 plants = 0.96 hour every four years for the maintenance of records of radiological testing, or 0.24 hours per year, as seen on line 4 of Table 1.
It is estimated that the recommendation to test weekly for bacteriological contaminants is a new burden for three infant formula plants. It is estimated that performing the test (collecting the information) will take 5 minutes per test once a week. Annually, this burden is 0.08 hour × 52 weeks = 4.16 hours per year per plant, and 4.16 hours per plant × 3 plants = 12.48 total annual hours, as seen on line 5 of Table 1. Furthermore, for the three plants that are estimated to not currently test weekly for bacteriological contaminants, this burden is estimated to be 5 minutes per record, every week. Therefore, 0.08 hour per record × 52 weeks = 4.16 hours per plant for the maintenance of records of bacteriological testing. Accordingly, 4.16 hours per plant × 3 plants = 12.48 annual hours, as seen on line 6 of Table 1.
The draft guidance recommends that manufacturers of exempt infant formulas calibrate certain instruments against a known reference standard and that records of these calibration activities be made and retained, as specified in §§ 106.30(d)(1) and 106.100(f)(2). FDA estimates that one senior validation engineer (or other similarly skilled employee) for each of the three (at most) plants would need to spend about 13 minutes per week to conduct the ongoing calibration recordkeeping. Therefore, 3 recordkeepers × 0.21 hours per week per recordkeeper = 0.63 hours per week; 0.63 hours per week × 52 weeks per year = 32.76 hours as the total industry annual burden, as presented in line 7 of Table 1.
The draft guidance recommends that manufacturers of exempt infant formula make and retain records of the temperatures of each cold storage compartment as specified in §§ 106.30(e)(3)(iii) and 106.100(f)(3). Based on expert opinion, FDA estimates that three (at most) plants are not currently conducting recordkeeping, and that at each of these three plants, conducting this recordkeeping would take one senior validation engineer (or other similarly skilled employee) about 13 minutes per week. Therefore, 3 recordkeepers × 0.21 hours per week per recordkeeper = 0.63 hours per week; 0.63 hours per week × 52 weeks = 32.76 hours as the total industry annual burden, as presented in line 8 of Table 1.
The draft guidance recommends the making and retention of records of ongoing sanitation efforts as specified under §§ 106.30(f)(2) and 106.100(f)(4). Based on expert opinion, FDA estimates that three (at most) plants are not currently making and retaining these records, and that at each of these three plants, it would take one senior validation engineer (or other similarly skilled employee) 0.19 hours per week to make and retain these records. Therefore, 3 recordkeepers × 0.19 hours per week per recordkeeper = 0.57 hours per week; 0.57 hours per week × 52 weeks = 29.64 hours as the total industry annual burden, as presented in line 9 of Table 1.
There will be annual recordkeeping associated with recommendations for preventing adulteration from equipment, as specified under §§ 106.35(c) and 106.100(f)(5). It is estimated that one senior validation engineer (or other similarly skilled employee) per plant would need to work 10 hours per week (520 work hours per year) to meet the ongoing recordkeeping recommendation. For the estimated three (at most) plants not conducting this recordkeeping, the total annual burden is 520 hours per plant × 3 plants = 1,560 annual hours, as shown in line 10 of Table 1. In addition, this guidance recommends that an infant formula manufacturer revalidate its systems when it makes changes to automatic equipment. FDA estimates that such changes are likely to occur twice a year to any aspect of the plant's system, and that on each of the two occasions, a team of four senior validation engineers (or other similarly skilled employees) per plant would need to work full time for 4 weeks (4 weeks × 40 hours per week = 160 work hours per person) to provide revalidation of the plant's automated systems sufficient to adhere to this section. The total annual burden for four senior validation engineers each working 160 hours twice a year is 1,280 hours ((160 hours × 2 revalidations) × 4 engineers = 1,280 total work hours) per plant. Therefore, 1,280 hours per plant × 3 plants = 3,840 annual hours, as shown on line 11 of Table 1.
The draft guidance recommends written specifications for ingredients, containers, and closures, as specified under §§ 106.40(g) and 106.100(f)(6). FDA estimates that the exempt infant formula industry already establishes written specifications for these components. However, the guidance regarding controls to prevent adulteration caused by ingredients, containers, and closures may represent new recordkeeping for three (at most) plants (Ref. 1). It is not possible to predict how often a specification will not be met or how often documented reviews of reconditioned ingredients, closures, or containers will occur. FDA estimates that, on average, one senior validation engineer per plant would work about 10 minutes a week to complete this recordkeeping. Therefore, 3 recordkeepers × 0.17 hours per week per recordkeeper = 0.51 hours per week; 0.51 hours per week × 52 weeks = 26.52 total annual hours, as presented in line 12 of Table 1.
This draft guidance recommends manufacturers of exempt infant formula to make and maintain records of controls to prevent adulteration during manufacturing, as specified in §§ 106.50 and 106.100(e). It is not possible to predict how often changes to the master manufacturing order would be made or how often deviations from the master manufacturing order would occur. Based on expert opinion, FDA estimates that each year, three (at most) plants would change a master manufacturing order and that, on average, one senior validation engineer for each of the three (at most) plants would spend about 14 minutes per week on recordkeeping pertaining to the master manufacturing order. Thus, 3 recordkeepers × 0.23 hours per recordkeeper per week = 0.69 hours per week; 0.69 hours per week × 52 weeks = 35.88 hours as the total annual industry burden, as presented in line 13 of Table 1.
The draft guidance recommends manufacturers of exempt infant formula make and retain records of the testing of infant formula for microorganisms, as specified in §§ 106.55(d) and 106.100(e)(5)(ii) and (f)(7). We estimate that this recordkeeping represents a new collection of information for, at most, three plants (Ref. 1) and that one senior validation engineer per plant would spend 15 minutes per week on recordkeeping pertaining to microbiological testing. Thus, 3 recordkeepers × 0.25 hours per recordkeeper per week = 0.75 hours; 0.75 hours per week × 52 weeks 39 hours as the total annual industry burden, as presented in line 14 of Table 1.
The draft guidance recommends that exempt infant formula manufacturers make and maintain records consistent with the requirements for the labeling of mixed-lot packages of infant formula that apply to non-exempt infant formula manufacturers, as specified under § 106.60(c). We estimate that the draft guidance will result in infant formula diverters labeling infant formula packaging (such as packing cases) to facilitate product tracing and to keep specific records of the distribution of these mixed lot cases. (A diverter is considered to be a business or individual that purchases food, including occasionally infant formula, in a geographic area where a special allowance or deal is being offered and then resells that food at a lower price to wholesale or retail grocery, drug and mass merchandise chains in an area where the deal is not being offered.) There will be some cost associated with this recordkeeping and labeling, but the Agency estimates that this burden would be minimal as it is estimated that less than 1 percent of infant formula is handled by diverters. For the purposes of this analysis, it is estimated that, for all plants combined, it may take one worker using manual methods 15 minutes, at most, to relabel one case of infant formula one time each month (0.25 hours per month × 12 months = 3 annual hours), as presented in line 15 of Table 1.
The draft guidance recommends nutrient testing for exempt infant formula manufacturers as specified in § 106.91(a)(1) through (4). It is estimated that the systems and processes of 100 percent of the exempt formula industry test in accordance with these provisions. Therefore, nutrient testing does not represent a new recordkeeping burden as nutrient testing is estimated to be common business practice in the exempt infant formula industry. Thus, no burden is estimated for these recommendations (Ref. 1).
The draft guidance also recommends on-going stability testing as specified under § 106.91(b)(1) through (3). It is estimated that the systems and processes of the infant formula industry partially adhere to this guidance in that 80 percent of infant formula plants (about 10 of 12 plants) conduct stability testing as recommended (Ref. 1). For the 20 percent of plants (2 of 12 plants) that do not conduct stability testing, it is estimated that these plants do conduct initial stability testing, but may not do so at the intervals specified in this provision (Ref. 1). For the purposes of this analysis, it is estimated that the stability testing guidance represents a new information collection burden of 2 annual hours, per plant. Therefore, 2 hours per plant × 2 plants = 4 annual hours as shown in line 16 of Table 1.
The draft guidance recommends recordkeeping for test results as specified under §§ 106.91(d) and 106.100(e)(5)(i). This represents new information collections for the two plants that are estimated not to be conducting all of the stability testing specified in § 106.91(b) (Ref. 1). For the purposes of this analysis, FDA estimates that one senior validation engineer per plant would spend about 9 minutes per week maintaining records related to testing. Thus, 2 recordkeepers × 0.15 hours per recordkeeper per week = 0.3 hours per week × 52 weeks = 15.6 hours as the annual total industry burden, as presented in lines 17, 18, and 19 of Table 1.
The draft guidance recommends the creation of audit plans and procedures, as specified under § 106.94. FDA estimates that all exempt infant formula manufacturers currently conduct audits, but that 25 percent of infant formula plants (3 of 12 plants) do not conduct audits that include all elements specified in § 106.94 (Ref. 1). It is estimated that the ongoing review and updating of audit plans would require a senior validation engineer 8 hours per year, per plant. Therefore, 8 hours per year per plant × 3 plants = 24 annual hours to regularly review and update audit plans as shown in line 20 of Table 1.
The infant formula final rule does not mandate a frequency of auditing, therefore, one is not recommended in the draft guidance. For the purposes of this analysis, FDA estimates that a manufacturer would choose to audit once per week. Each weekly audit is estimated to require a senior validation engineer 4 hours, or 52 weeks × 4 hours = 208 hours per plant per year. Therefore, the total annual burden for the estimated three plants not currently acting in accordance to this guidance to update audit plans is 208 hours × 3 plants = 624 hours, as shown in line 21 of Table 1.
The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by March 28, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This regulation relates to Agency management and organization and has two purposes. The first is to implement section 503(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)), as added by the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and amended by the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), by specifying how FDA will determine the organizational component within FDA assigned to have primary jurisdiction for the premarket review and regulation of products that are comprised of any combination of: (1) A drug and a device; (2) a device and a biological product; (3) a biological product and a drug; or (4) a drug, a device, and a biological product. The second purpose of this regulation is to enhance the efficiency of Agency management and operations by providing procedures for classifying and determining which Agency component is designated to have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute.
The regulation establishes a procedure by which an applicant may obtain an assignment or designation determination. The regulation requires that the request include the identity of the applicant, a comprehensive description of the product and its proposed use, and the applicant's recommendation as to which Agency component should have primary jurisdiction, with an accompanying statement of reasons. The information submitted would be used by FDA as the basis for making the assignment or designation decision. Most information required by the regulation is already required for premarket applications affecting drugs, devices, biological products, and combination products. The respondents will be businesses or other for-profit organizations.
FDA estimates the burden of this collection of information as follows:
These burden estimates are based on the number of applications FDA received over the past fiscal year.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by March 28, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined
With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Shell eggs contaminated with
Under part 118 (21 CFR part 118), shell egg producers are required to implement measures to prevent SE from contaminating eggs on the farm and from further growth during storage and transportation. Shell egg producers also are required to maintain records concerning their compliance with part 118 and to register with FDA. As described in more detail with regard to each information collection provision of part 118, each farm site with 3,000 or more egg laying hens that sells raw shell eggs to the table egg market, other than directly to the consumer, must refrigerate, register, and keep certain records. Farms that do not send all of their eggs to treatment are also required to have an SE prevention plan and to test for SE.
Section 118.10 of FDA's regulations requires recordkeeping for all measures the farm takes to prevent SE in its flocks. Since many existing farms participate in voluntary egg quality assurance programs, those respondents may not have to collect any additional information. Records are maintained on file at each farm site and examined there periodically by FDA inspectors.
Section 118.10 also requires each farm site with 3,000 or more egg laying hens that sells raw shell eggs to the table egg market, other than directly to the consumer, and does not have all of the shell eggs treated, to design and implement an SE prevention plan. Section 118.10 requires recordkeeping for each of the provisions included in the plan and for plan review and modifications if corrective actions are taken.
Finally, § 118.11 of FDA's regulations requires that each farm covered by § 118.1(a) register with FDA using Form FDA 3733. The term “Form FDA 3733” refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration Module, which is available at
Recordkeeping and registration are necessary for the success of the SE prevention measures. Written SE prevention plans and records of actions taken due to each provision are essential for farms to implement SE prevention plans effectively. Further, they are essential for us to be able to determine compliance. Information provided under these regulations helps us to notify quickly the facilities that might be affected by a deliberate or accidental contamination of the food supply. In addition, data collected through registration is used to support our enforcement activities.
We estimate the burden of this collection of information as follows:
We are basing our estimates for the recordkeeping burden and the reporting burden on our experience with similar recordkeeping activities and the number of registrations and cancellations received in the past 3 years.
The number of recordkeepers estimated in column 2 of table 1 is drawn from estimates of the total number of layer and pullet houses affected by part 118. We assume that those farms that are operating according to recognized industry or State quality assurance plans are already largely in compliance with the plan design and recordkeeping provisions discussed in this section, and therefore are not experiencing additional costs to comply with recordkeeping provisions. We found that 59 percent of farms with more than 50,000 layers are members of State or industry quality assurance plans. Fewer than 8 percent of farms with fewer than 50,000 layers are members of quality assurance plans. Thus, we estimate the number of layer farms incurring a new recordkeeping burden because of part 118 to be 2,600, and the number of houses affected to be 4,731.
Prevention plan design (§ 118.10(a)(1)) records are kept on a per farm basis, so we assume that new prevention plan design is only undertaken by new entrants to the industry. Refrigeration records (§ 118.10(a)(3)(iv)) are also kept on a per farm basis so the estimated number of recordkeepers for this provision is 2,600.
Records of chick and pullet procurement (§ 118.10(a)(2)), rodent and other pest control (§ 118.10(a)(3)(ii)), and biosecurity (§ 118.10(a)(3)(i)) are kept on a per house basis, so the estimated number of recordkeepers for these provisions is 4,731.
Records of cleaning and disinfection (§ 118.10(a)(3)(iii)) are also kept on a per house basis, but only need to be kept in the event that a layer house tests environmentally positive for SE. Prevention plan review and modifications (§ 118.10(a)(4)) also need to be performed every time a house tests positive, which we estimate that 7.0 percent tests positive. Therefore, the number of recordkeepers for these provisions is calculated to be 331 (4,731 houses × 0.070) annually.
Records of testing, diversion, and treatment (§ 118.10(a)(3)(v) through (viii)) are kept on a per house basis and include records on flocks from pullet houses. We estimate that there are one-third as many pullet houses as there are layer houses. Therefore the total number of recordkeepers for these provisions is 6,308 (4,731 + (4,731/3)). The number of annual records kept depends on whether or not houses test positive for SE. Annually, 343 layer and pullet houses ((4,731 layer houses × 0.070) + (4731/3 pullet houses) × 0.0075)) are expected to test positive and 5,965 are expected to test negative ((4,731 layer houses × 0.930) + (4731/3 pullet houses) × 0.9925)).
We assume that refrigeration records are kept on a weekly basis on a per farm basis under § 118.10(a)(3)(iv)). We estimate that 2,600 recordkeepers maintain 52 records each for a total of 135,200 records and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for refrigeration records is calculated to be 67,600 hours (135,200 × 0.5 hour).
We assume that records of testing, diversion, and treatment under § 118.10(a)(3)(v) through (viii) are kept weekly in the event a layer house tests environmentally positive for SE. We estimate that 343 layer and pullet houses test positive and thus 343 recordkeepers maintain 52 records each for a total of 17,836 records and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for testing, diversion, and treatment records in the event of a positive test result is calculated to be 8,918 hours (17,836 × 0.5 hour).
Given a positive environmental test for SE, we estimate the weighted average number of egg tests per house under § 118.10(a)(3)(vii)) to be 7. We estimate that 331 recordkeepers maintain 7 records each for a total of 2,317 records and that it takes approximately 8.3 hours per recordkeeping. Thus, the total annual burden for egg testing is calculated to be 19,231 hours (2,317 × 8.3 hours).
We estimate that all 1,577 pullet and 4,731 layer houses not currently testing (6,308 recordkeepers) incur the burden of a single environmental test annually under § 118.10(a)(3)(v)). The number of samples taken during the test depends on whether a farm employs the row based method (an average of 12 samples per house) or the random sampling method (32 samples per house). We estimate that roughly 50 percent of the houses affected employs a row based method and 50 percent employs a random sampling method, implying an average of 23 samples per house. Thus, we estimate that 6,308 recordkeepers take 23 samples each for a total of 145,084 samples. The time burden of sampling is estimated on a per swab sample basis. We estimate that it takes approximately 15 minutes to collect and pack each sample. Thus, the total annual burden for environmental testing is calculated to be 36,271 hours (145,084 × 0.25 hour).
We estimate that records of testing, diversion, and treatment under § 118.10(a)(3)(v) through (viii) are kept annually in the event a layer house tests environmentally negative for SE. We estimate that 5,965 layer and pullet houses test negative and thus 5,965 recordkeepers maintain one record of that testing that takes approximately 0.5 hour per record. Thus, the total annual burden for testing, diversion, and treatment records in the event of a negative test result is calculated to be 2,983 hours (5,965 × 0.5 hour).
Prevention plan review and modifications under § 118.10(a)(4)) need to be performed every time a house tests positive. We estimate that 331 layer houses test positive requiring plan
We estimate that chick and pullet procurement records under § 118.10(a)(2) is kept roughly once annually per layer house basis. We estimate that 4,731 layer houses maintain 1 record each and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for chick and pullet procurement recordkeeping is calculated to be 2,366 hours (4,731 × 0.5 hour).
We estimate that rodent and other pest control records under § 118.10(a)(3)(ii)) and biosecurity records under § 118.10(a)(3)(i) are kept weekly on a per layer house basis. We assume that 4,731 layer houses maintain a weekly record under each provision. Thus, we estimate 9,462 recordkeepers maintain 52 records each for a total of 492,024 records. We estimate a recordkeeping burden of 0.5 hours per record for a total of 246,012 burden hours (492,024 × 0.5 hour).
New prevention plan design required by § 118.10(a)(1) is only undertaken by new farms and records are kept on a per farm basis. We estimate that there are 300 new farm registrations annually and we assume that this reflects 300 new farms requiring prevention plan design. This is an increase from our previous estimate based on new registrations received. We estimate that it takes 20 hours to complete this work. Thus, the total annual burden for prevention plan design is calculated to be 6,000 hours (300 × 20 hours).
Cleaning and disinfection recordkeeping under § 118.10(a)(3)(iii) needs to be performed every time a house tests positive. We estimate that 331 layer houses test positive requiring 1 record each and that it takes approximately 0.5 hour per recordkeeping. Thus, the total annual burden for cleaning and disinfection recordkeeping in the event of a positive test result is calculated to be 166 hours (331 × 0.5 hour).
This estimate is based on the average number of new shell egg producer registrations and cancellations received in the past 3 years under § 118.11. We estimate that we will receive an average of 300 registrations or updates per year over the next 3 years. Based on the number of cancellations previously received, we estimate that we will receive approximately 30 cancellations per year over the next 3 years.
We estimate that it takes the average farm 2.3 hours to register taking into account that some respondents completing the registration may not have readily available Internet access. Thus, the total annual burden for new shell egg producer registrations or updates is calculated to be 690 hours (300 × 2.3 hours).
We estimate cancelling a registration, on average, requires a burden of approximately 1 hour, taking into account that some respondents may not have readily available Internet access. Thus, the total annual burden for cancelling shell egg producer registrations is calculated to be 30 hours (30 cancellations × 1 hour).
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
On October 2, 2015, HUD published a notice in the
Interested persons are invited to submit comments regarding this Notice to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500. Communications must refer to the above docket number and title and should contain the information specified in the “Request for Comments” section. There are two methods for submitting public comments.
1. Submission of Comments by Mail. Comments may be submitted by mail to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451
2. Electronic Submission of Comments. Interested persons may submit comments electronically through the Federal eRulemaking Portal at
To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the notice.
No Facsimile Comments. Facsimile (FAX) comments are not acceptable.
Public Inspection of Public Comments. All properly submitted comments and communications regarding this notice submitted to HUD will be available for public inspection and copying between 8 a.m. and 5 p.m. weekdays at the above address. Due to security measures at the HUD Headquarters building, an advance appointment to review the public comments must be scheduled by calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number through TTY by calling the Federal Relay Service at 800-877-8339. Copies of all comments submitted are available for inspection and downloading at
Theodore Toon, Director, Office of Multifamily Production, Office of Housing, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410-8000; telephone: 202-402-8386 (this is not a toll-free number). Hearing- or speech-impaired individuals may access these numbers through TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).
Section 203(c)(1) of the National Housing Act authorizes the Secretary to set the premium charge for insurance of mortgages under the various programs in Title II of the National Housing Act. The range within which the Secretary may set such charges must be between one-fourth of one percent per annum and one percent per annum of the amount of the principal obligation of the mortgage outstanding at any time. (See 12 U.S.C. 1709(c)(1)).
On October 2, 2015, HUD published a notice in the
HUD's Multifamily Housing Mortgage Insurance regulation at 24 CFR 207.254 provides as follows:
Notice of future premium changes will be published in the
Pursuant to this 30-day comment procedure, this Notice announces proposed changes for FY 2016 in the MIP for certain programs authorized under the National Housing Act (the Act) (12 U.S.C. 1709(c)(1)), and certain other multifamily programs. These changes would be effective on April 1, 2016.
HUD is proposing to change MIPs for FHA-insured loans on properties under specific Multifamily Mortgage Insurance programs. In FY 2013, FHA increased MIPs to compensate for increased risk to the FHA fund after the housing market crisis. Over the last several years, HUD has implemented underwriting standards for FHA insured mortgage insurance applications in an effort to mitigate risk to the FHA portfolio, and undertaken organizational changes to facilitate risk-based underwriting and asset management.
These proposed MIP changes reflect the health of the FHA Multifamily portfolio, an effort to simplify the rate structure, and HUD's commitment to promote its mission initiatives. The proposed annual multifamily mortgage insurance rates will be structured as four categories, as follows, and as illustrated on the table below. This Notice proposes MIP reductions focused on strategic mission areas: Affordable housing, and green and energy efficient housing. Under this proposed rate structure, portfolio and actuarial analysis demonstrates that premium revenues will exceed losses for the foreseeable future.
Upfront and annual MIP rates will remain unchanged for all FHA-insured multifamily loan types on market rate properties, except properties that meet the criteria for green and energy efficient housing, below.
Annual MIP will change from the current rates generally between 45 and 50 basis points,
All loans originated by Housing Finance Agencies under FHA's Section 542(c) Risk Share program, and by Qualified Participating Entities including Fannie Mae and Freddie Mac under FHA's Section 542(b) Risk Share program, will be eligible for this proposed 25 basis points rate, multiplied by the percentage risk assumed by FHA (see table below). For all others to qualify, the property must have Section 8 assistance or another
These projects must either:
• Have at least 90 percent of units covered by a Section 8 Project Based Rental Assistance (PBRA) contract or other federal rental assistance program contract serving very low income residents, with a remaining term of at least 15 years; or
• Have at least 90 percent of its units covered by an affordability use restriction under the Low Income Housing Tax Credit program or similar state or locally sponsored program, with achievable and underwritten tax credit rents at least 10 percent below comparable market rents, and with a recorded regulatory agreement in effect for at least 15 years after final endorsement and monitored by a public entity.
To ensure that the benefits of these MIP rates directly benefit the affordable housing properties and residents, lenders submitting applications for loans using this MIP rate are limited in the total loan fees they may charge on any loan greater than $2 million, to no more than 5 percent of the insured loan amount. Loan fees include (a) origination and placement fees as permitted by the Multifamily Accelerated Processing (MAP) Guide
Annual MIP will change from current rates generally between 45 and 70 basis points,
• Inclusionary Zoning, Density Bonus Set-asides, and Other Local Affordability Restrictions: Property owners shall submit with the FHA mortgage insurance application evidence of a deed covenant or housing ordinance on “inclusionary zoning” at the subject property to evidence the requirement for affordable unit set-asides. A minimum of 10 percent of the units must be affordable to, at most, a family at 80 percent AMI, with rents sized to be affordable at 30 percent of the income at that level. The affordability set-aside must be on site, in effect for at least 30 years after final endorsement of the FHA-insured mortgage, be monitored by public authority, and be recorded in a regulatory agreement; or
• Project has between 10 percent and 90 percent of units covered by a Section 8 PBRA contract or other state or federal rental assistance program contract serving very low income residents, with a remaining term of at least 15 years; or
• Project has between 10 percent and 90 percent of its units covered by an affordability use restriction under the Low Income Housing Tax Credit program or similar state or locally sponsored program, with rents sized at no greater than 30 percent of the income eligible for occupancy under the Low Income Housing Tax Credit program, with a recorded regulatory agreement in effect for at least 15 years after final endorsement and monitored by a public entity.
To qualify for this MIP rate:
• The project owner must also agree to accept voucher holders under the Section 8 Housing Choice Voucher program or other federal program voucher holders as residents for vacancies in units not covered by project based Section 8, and execute a Rider to the FHA regulatory agreement acceptable to HUD evidencing the owner's agreement to accept Section 8 vouchers for the life of the regulatory agreement.
Annual MIP will change from current rates generally between 45 and 70 basis points,
• Upon application for FHA mortgage insurance, the owner must evidence that the project has achieved, or the owner must certify that it will pursue, achieve and maintain, an industry-recognized standard for green building. Acceptable, independently verified standards include the Enterprise Green Communities Criteria, U.S. Green Building Council's LEED-H, LEED-H Midrise, LEED-NC, ENERGY STAR Certification, EarthCraft House, EarthCraft Multifamily, Earth Advantage New Homes, Greenpoint Rated New Home, Greenpoint Rated Existing Home (Whole House or Whole Building label), and the National Green Building Standard (NGBS), or other industry-recognized green building standards in HUD's sole discretion. Further, the owner must certify that it has achieved, or will pursue and achieve a score of 75 or better on the 1-100 ENERGY STAR score, using EPA's Portfolio Manager (the minimum score required to be recognized as ENERGY STAR). The reasonableness of achieving and maintaining the specified, independent green building standard, and the score of 75 or better in Portfolio Manager, must be verified by the independent conclusion of the qualified assessor preparing the physical condition assessment, and supported by the physical condition assessment report and recommendations, ASHRAE level II energy audit, and plans for new construction, or rehabilitation, repairs, and operations and maintenance. The physical condition assessment report submitted with the mortgage insurance application must include a certification from the architect, engineer, energy auditor, or CNA provider that the planned scope of work is reasonably sufficient to achieve and maintain the specified certification. Additionally, the owner must submit to HUD evidence that the specified, independent green building standard has been achieved, and provide a copy of the Portfolio Manager report showing building performance at or above 75, when those standards have been achieved, and no more than 12 months after completion of new construction, substantial rehabilitation or renovations. If not achieved, HUD may impose protocols to ensure the owner brings the property into compliance, similar to protocols
To ensure that the benefits of these MIP rates directly benefit the affordable housing properties and residents, lenders submitting applications for loans using this MIP rate are limited in the total loan fees they may charge on any loan greater than $2 million, to no more than 5 percent of the insured loan amount. Loan fees include (a) origination and placement fees as permitted by the MAP Guide,
HUD is proposing to change MIPs for FHA-insured loans on properties under specific Multifamily Mortgage Insurance programs. The chart below details the proposed MIP rates for each rate category, and each type of FHA multifamily mortgage insurance covered under this Notice. These programs are administered by FHA's Office of Multifamily Housing Programs. This Notice does not change MIP rates for programs under FHA's Office of Healthcare Programs, including health care facilities and the hospital insurance programs.
The proposed MIP rates would become effective for FHA firm commitments issued or reissued on or after April 1, 2016. MIP rates will not be modified for any loans that close or reach initial endorsement prior to March 31, 2016.
Drug Enforcement Administration, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until February 29, 2016.
If you have comments on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Barbara J. Boockholdt, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20530 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
1.
2.
3.
4.
Affected public (Primary): Business or other for-profit.
Affected public (Other): Not-for-profit institutions; Federal, State, local, and tribal governments.
Abstract: This collection provides the Drug Enforcement Administration (DEA) with a national database on analyzed drug evidence from non-federal laboratories. Information from this database is combined with the other existing databases to develop more accurate, up-to-date information on abused drugs. This database represents a voluntary, cooperative effort on the part of participating laboratories to provide a centralized source of analyzed drug data.
5.
6.
If additional information is required please contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Suite 3E.405B, Washington, DC 20530.
On October 9, 2015, the Financial Industry Regulatory Authority, Inc. (“FINRA”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”)
Amendment No. 1, on an accelerated basis.
On October 30, 2015, the Commission adopted Regulation Crowdfunding,
Funding Portal Rule 100 sets forth basic standards and definitions for purposes of the Funding Portal Rules. The rule provides that all funding portal members and persons associated with funding portal members shall be subject to the FINRA By-Laws and FINRA Regulation By-Laws, unless the context requires otherwise, and the Funding Portal Rules.
Funding Portal Rule 110(a) addresses the membership application process (“MAP”) for funding portal applicants (“FP Applicants”).
Funding Portal Rule 110(a)(3)(A) provides that an FP Applicant for FINRA membership must submit its application to FINRA's Department of Member Regulation (“Department”) by filing a Form FP-NMA
The rule requires a funding portal member to submit its application on Form FP-CMA
• In the equity ownership or partnership capital, LLC membership interest, or other ownership interest of the funding portal member that results in one person or entity directly or indirectly owning or controlling 25 percent or more of the equity or partnership capital, LLC membership interest, or other ownership interest; or
• of control persons of the funding portal member, other than the appointment or election of a natural person as an officer or director of the funding portal member in the normal course of business, regardless of whether such change occurred as a result of a direct or indirect change in the equity ownership, partnership capital, LLC membership interest, or other ownership interest in the funding portal member.
After receiving an application, the rules provide that FINRA may make requests for additional documents or information and will hold one or more membership interviews.
Funding Portal Rule 110(a)(10) requires the Department to consider the application for initial membership or change of ownership or control, other information and documents provided by the FP Applicant during the application process, other information and documents obtained by the Department, and the public interest and the protection of investors. After considering this information, the Department is required to determine whether the FP Applicant meets each of the following five standards, as applicable:
• The FP Applicant and its associated persons are capable of complying with applicable federal securities laws, the rules and regulations thereunder, and the Funding Portal Rules, including observing high standards of commercial honor and just and equitable principles of trade. In determining whether this standard is met, the Department is required to take into consideration all information in its possession, including information regarding whether an FP Applicant or its associated persons:
➢ is subject to an event described in Section 3(a)(39) of the Exchange Act; and
➢ is the subject of a pending, adjudicated, or settled regulatory action or investigation by the SEC, the Commodity Futures Trading Commission, a federal, state, or foreign regulatory agency, or a self-regulatory organization; an adjudicated or settled investment-related private civil action for damages or an injunction; or a criminal action (other than a minor traffic violation) that is pending, adjudicated, or that has resulted in a guilty or no contest plea of an FP Applicant or its associated persons.
• The FP Applicant has established all contractual or other arrangements and business relationships with banks, broker-dealers, clearing corporations, service bureaus, escrow agents, transfer agents, technology service providers, or others necessary to initiate the operations described in the FP Applicant's Form FP-NMA.
• The FP Applicant has a supervisory system that is reasonably designed to achieve compliance with applicable federal securities laws, the rules and regulations thereunder, and the Funding Portal Rules.
• The FP Applicant has fully disclosed and established through documentation all direct and indirect sources of funding.
• The FP Applicant has a recordkeeping system that enables the FP Applicant to comply with federal, state, and self-regulatory organization recordkeeping requirements.
Under the rules, if the Department determines that the FP Applicant meets each of the applicable standards set forth above, it is required to grant an application for initial membership or change of ownership or control.
Funding Portal Rule 110(a)(12) requires that the Department serve a written decision on the application for initial membership or change of ownership or control within 60 days after the filing of the application or such later date as the Department and the FP Applicant have agreed in writing. If the Department denies the application, it is required to explain in detail the reason for denial, referencing the applicable standard(s). A funding portal may appeal the Department's decision under the process set forth in Funding Portal Rule 110(a)(13), which is described in more detail in the Notice.
Funding Portal Rule 110(a)(14) provides that a person aggrieved by final action of FINRA under paragraph (a) of the rule may apply for review by the SEC pursuant to Section 19(d)(2) of the Exchange Act.
Funding Portal Rule 110(a)(15) provides that no funding portal member or person associated with a funding portal member shall file with FINRA information with respect to membership or registration that is incomplete or inaccurate so as to be misleading, or that could in any way tend to mislead, or shall fail to correct such filing after notice thereof.
Funding Portal Rule 200(a) is based in large part on FINRA Rule 2010 (Standards of Commercial Honor and Principles of Trade).
Funding Portal Rule 200(b) is based in large part on FINRA Rule 2020 (Use of Manipulative, Deceptive or Other Fraudulent Devices).
Funding Portal Rule 200(c) (Communications with the Public) is aimed at prohibiting false and misleading statements.
• Include any false, exaggerated, unwarranted, promissory or misleading statement or claim;
• Omit any material fact or qualification if the omission, in light of the context of the material presented, would cause the communication to be misleading; state or imply that FINRA, or any other corporate name or facility owned by FINRA, or any other regulatory organization endorses, indemnifies, or guarantees the funding portal member's business practices; or
• Predict or project performance, imply that past performance will recur or make any exaggerated or unwarranted claim, opinion or forecast. A hypothetical illustration of mathematical principles is permitted, provided that it does not predict or project the performance of an investment.
Further, paragraph (c)(2)(B) of the rule provides that all funding portal member communications must be based on principles of fair dealing and good faith and must be fair and balanced.
Funding Portal Rule 300(a) is a streamlined version of FINRA's supervision rules and is designed to permit funding portal members flexibility to tailor their supervisory systems to their business models.
• The establishment and maintenance of written procedures to supervise the activities of the funding portal and its associated persons;
• the designation of a person with authority to carry out the supervisory responsibilities of the funding portal member; and
• reasonable efforts to determine that all supervisory personnel are qualified by virtue of experience or training to carry out their assigned responsibilities.
Funding Portal Rule 300(a)(2) provides that a funding portal member must permit the examination and inspection of all of its businesses and business operations that relate to its activities as a funding portal, such as its premises, systems, platforms and records, by representatives of FINRA and the Commission, and must cooperate with the examination, inspection or investigation of any persons directly or indirectly using its platform.
Funding Portal Rule 300(c), which is discussed in further detail in the Notice, requires funding portal members to report to FINRA (and sets forth the obligations of such members' associated persons to report to the member) regulatory proceedings, disciplinary and other events.
Funding Portal Rule 300(e) requires each funding portal member each year to report to FINRA, in the manner prescribed by FINRA, the member's gross revenue on Form FP-Statement of Revenue, no later than 60 calendar days following each calendar year-end.
Funding Portal Rule 300(f) requires each funding portal member to make and keep current a record listing every associated person of the funding portal member that shows, for each such associated person, every office of the funding portal member where the associated person regularly conducts any business for the funding portal member, and any registration number, if any, to be prescribed by FINRA, and every identification number or code assigned to the associated person by the funding portal member.
FINRA is also proposing in Amendment No. 1 to include for purposes of FINRA Rule 8210 any other person listed in Schedule A of Form Funding Portal of a member to the definition of associated person.
Funding Portal Rule 800(a) is designed to provide that funding portal members will be subject to specified FINRA rules governing investigations and sanctions.
Funding Portal Rule 800(b) is a streamlined version of FINRA Rule 8312 (FINRA BrokerCheck Disclosure) and addresses specific information that FINRA is required to make available to the public.
The rule also requires FINRA to make available to the public information filed by a funding portal member, in a format to be prescribed by FINRA, indicating whether the funding portal member or any associated person of the funding portal member is subject to an event described in Section 3(a)(39) of the Exchange Act.
The rule also provides that, with respect to the information provided pursuant to paragraph (b)(2) of the rule, FINRA shall not make available information reported as a social security number, information that FINRA is otherwise prohibited from releasing under Federal law, or information that is provided solely for use by FINRA.
Funding Portal Rule 900(a) is designed to provide that funding portal members will be subject to specified FINRA rules setting forth FINRA's Code of Procedure.
• Failure to timely submit amendments to SEC Form Funding Portal;
• Funding Portal Rule 200(c) (Communications with the Public);
• Funding Portal Rule 300(a)—Failure to maintain adequate written supervisory procedures where the underlying conduct is subject to Rule 9217;
• Funding Portal Rule 300(c)—failure to timely file reports;
• failure to provide or update contact information as required by Funding Portal Rule 300(d);
• Rule 303(f) of SEC Regulation Crowdfunding—Confirmation of Transactions;
• Rule 404 of SEC Regulation Crowdfunding—failure to make and preserve records in conformance with all applicable laws, rules, regulations and statements of policy promulgated thereunder, and with the Funding Portal Rules.
The rule also provides that for purposes of FINRA Rule 9551(a),
Funding Portal Rule 900(b) is a streamlined version of the current FINRA Rule 9520 Series.
Funding Portal Rule 1200(a) provides that funding portal members will be subject to the FINRA Rule 12000 Series (Code of Arbitration Procedure for Customer Disputes), FINRA Rule 13000 Series (Code of Arbitration Procedure for Industry Disputes) and FINRA Rule 14000 Series (Code of Mediation Procedure), unless the context requires otherwise.
“This agreement contains a predispute arbitration clause. By signing an arbitration agreement the parties agree as follows:
(A) All parties to this agreement are giving up the right to sue each other in court, including the right to a trial by jury, except as provided by the rules of the arbitration forum in which a claim is filed.
(B) Arbitration awards are generally final and binding; a party's ability to have a court reverse or modify an arbitration award is very limited.
(C) The ability of the parties to obtain documents, witness statements and other discovery is generally more limited in arbitration than in court proceedings.
(D) The arbitrators do not have to explain the reason(s) for their award unless, in an eligible case, a joint request for an explained decision has been submitted by all parties to the panel at least 20 days prior to the first scheduled hearing date.
(E) The panel of arbitrators may include a minority of arbitrators who were or are affiliated with the securities industry.
(F) The rules of some arbitration forums may impose time limits for bringing a claim in arbitration. In some cases, a claim that is ineligible for arbitration may be brought in court.
(G) The rules of the arbitration forum in which the claim is filed, and any amendments thereto, shall be incorporated into this agreement.”
Paragraph (b)(2)(A) of the rule provides that, in any agreement
Paragraph (b)(3)(A) of the rule provides that, within ten business days of receipt of the investor's request, a funding portal member must provide an investor with a copy of any predispute arbitration clause or investor agreement executed between the investor and the funding portal member. Paragraph (b)(3)(B) provides that, upon request by an investor, a funding portal member must provide the investor with the names of, and information on how to contact or obtain the rules of, all arbitration forums in which a claim may be filed under the agreement.
Paragraph (b)(4) of the rule provides that no predispute arbitration agreement shall include any condition that:
• Limits or contradicts the rules of any self-regulatory organization;
• limits the ability of a party to file any claim in arbitration;
• limits the ability of a party to file any claim in court permitted to be filed in court under the rules of the forums in which a claim may be filed under the agreement;
• limits the ability of arbitrators to make any award.
Paragraph (b)(5) of the rule provides that, if an investor files a complaint in court against a funding portal member that contains claims that are subject to arbitration pursuant to a predispute arbitration agreement between the funding portal member and the investor, the funding portal member may seek to compel arbitration of the claims that are subject to arbitration. If the funding portal member seeks to compel arbitration of such claims, the funding portal member must agree to arbitrate all of the claims contained in the complaint if the investor so requests.
Paragraph (b)(6) of the rule provides that all agreements must include a statement that “No person shall bring a putative or certified class action to arbitration, nor seek to enforce any pre-dispute arbitration agreement against any person who has initiated in court a putative class action; or who is a member of a putative class who has not opted out of the class with respect to any claims encompassed by the putative class action until: (i) The class certification is denied; or (ii) the class is decertified; or (iii) the investor is excluded from the class by the court. Such forbearance to enforce an agreement to arbitrate shall not constitute a waiver of any rights under this agreement except to the extent stated herein.”
FINRA also proposed new FINRA Rule 4518. The rule, which would apply to registered broker members, provides that a FINRA member shall notify FINRA, in a manner prescribed by FINRA: Prior to engaging, for the first time, in a transaction involving the offer or sale of securities in reliance on Section 4(a)(6) of the Securities Act; or within 30 days of directly or indirectly controlling, or being controlled by or under common control with, a funding portal as defined pursuant to Rule 300(c)(2) of SEC Regulation Crowdfunding.
Commenters generally supported FINRA's proposal. As discussed below, some commenters recommended that the proposal be expanded and include additional requirements or explanations in certain aspects. One of these commenters, while not necessarily opposing the proposed rules, also suggested that the Commission reject, and require FINRA to resubmit, the rule proposal. One commenter, while appreciating FINRA's willingness to address potential issues through subsequent rulemakings, encouraged FINRA to address potential shortfalls now before any investors lose money.
One commenter suggested that FINRA and the public should review and evaluate FINRA's proposed Funding Portal Rules, related forms and Rule 4518 (the broker-dealer crowdfunding notification requirement) in light of Regulation Crowdfunding.
One commenter suggested omitting the language of “unless the context requires otherwise” in proposed Funding Portal Rule 100 regarding the application of FINRA by-Laws and FINRA Regulation By-Laws to funding portal members and their associated persons because the commenter believes it is unclear when the exception will apply.
As described above, Funding Portal Rule 110(a)(1)(A) includes a different definition of associated person solely for purposes of the MAP, which excludes persons whose functions are solely clerical or ministerial.
In response, FINRA notes that the two different definitions of associated person in the rules are tailored to different purposes.
FINRA further notes that, in contrast, it intended the definition under Funding Portal Rule 100(b)(1) to be for general application to funding portal members, in a similar manner to the definition of associated persons of broker-dealers under paragraph (rr) under Article I of the FINRA By-Laws.
As discussed in the Notice, FINRA has determined not to propose at this time a fidelity bond requirement for funding portals.
In response, FINRA indicates that it is not proposing a fidelity bond at this time, stating that as discussed in the proposal, it believes that this approach is appropriate in the interest of reducing potential burdens on prospective funding portal members given the limited nature of funding portal business and given that regulatory experience with funding portals is developing.
FINRA indicates that it noted in the proposal that the proposed rule is a streamlined version of FINRA Rule 2210 (Communications with the Public) and is aimed at prohibiting false and misleading statements.
One commenter suggested that funding portals should be required to report misconduct in 10 days rather than 30 days as proposed under Funding Portal Rules 300(c)(1) and 300 (c)(2).
In response, FINRA indicates that the 30 calendar day requirement, which is consistent with the corresponding requirement for broker-dealer members under FINRA Rule 4530, strikes the appropriate balance between prompt regulatory reporting for purpose of risk oversight and providing firms sufficient time to assess reportable events and submit complete and accurate reports.
In response to the comment about the types of written complaints that should be reported, FINRA notes its belief that the rule is consistent with its goal of tailoring the rule language to the limited permissible activities in which funding portals may engage.
As discussed in more detail above, Funding Portal Rule 800(b)(1) will allow FINRA to provide the public with access to a funding portal member's current SEC Form Funding Portal, including amendments and registration withdrawal requests via a link to the Commission's Web site. One commenter expressed concern about the permissive nature of Funding Portal Rule 800(b)(1).
One commenter suggested that funding portals should be required to use CRD to register and make ongoing disclosures.
In response, FINRA indicates that it is not at this time requiring funding portals to use CRD.
FINRA has not included any licensing or examination requirements in its Funding Portal Rules. One commenter expressed support for this approach, noting its belief that such an approach would result in cost savings for funding portals and would likely lead to greater flexibility and innovation in the roles and responsibilities of funding portal operators and employees.
In response, FINRA notes that it will consider whether additional rulemaking with respect to examination and licensing requirements is needed as it gains experience regulating funding portals.
Broker-dealers registered or required to be registered with the Commission are required to comply with anti-money laundering (“AML”) regulations promulgated by the Department of Treasury under the Bank Secrecy Act (“BSA”),
Two commenters suggested that crowdfunding investors should be able to opt out of arbitration agreements and pursue their claims in court.
In response, FINRA notes that the purpose of Funding Portal Rule 1200 is to ensure in part that funding portal members shall be subject to the existing rules in this area, unless the context requires otherwise.
One commenter suggested that the following conduct rules for FINRA's broker-dealer members should be applied to funding portal members: The prohibition against guarantees and sharing in accounts under FINRA Rule 2150 (Improper Use of Customers' Securities or Funds; Prohibition Against Guarantees and Sharing in Accounts); Rule 2210 (Communications with the Public); Rule 3220 (Influencing or Rewarding Employees of Others); Rule 3240 (Borrowing From or Lending to Customers); Rule 5230 (Payments Involving Publications that Influence the Market Price of a Security); and Rule 5110 (Corporate Financing Rule—Underwriting Terms and Arrangements).
In response, FINRA notes that it sought to streamline the Funding Portal Rules to the extent possible to reflect the limited scope of permissible funding portal activities while also maintaining investor protection.
One commenter suggested FINRA should require funding portals to make a current copy of the FINRA Manual available to customers for examination, which it requires of broker-dealers members.
One commenter requested additional guidance regarding Rule 4518, which as discussed in more detail above, requires broker-dealers members to provide a notification to FINRA prior to engaging in certain crowdfunding transactions or within 30 days of entering into certain control relationships with a funding portal.
One commenter requested guidance regarding whether offerings relying on the exemption under Section 4(a)(6) will be subject to the filing requirements of FINRA Rule 5123.
After careful review of the proposed rule change, the comment letters, and FINRA's response to the comments, the Commission finds that the proposal, as modified by Amendment No. 1, is consistent with the requirements of the Exchange Act and the rules and regulations thereunder that are applicable to a national securities association.
The Commission received three comment letters and FINRA's response to the comment letters. The Commission notes the commenters were generally supportive of the proposal but had suggestions regarding areas where certain aspects of the proposal could be expanded or further explained. The Commission has considered the commenters' suggestions and believes that FINRA has responded adequately to their concerns and that the rules are consistent with the Exchange Act.
As discussed above, some commenters expressed concern that FINRA has determined not to impose certain requirements that it imposes on its broker-dealer members to funding portal members.
Taking into consideration the comments and FINRA's response, we believe that the proposal is consistent with the Exchange Act. In particular, we believe that the Funding Portal Rules are appropriately designed to take into account the limited permissible activities of funding portals, while still maintaining investor protection. We believe that FINRA's response, as discussed in more detail above, appropriately addressed the reasons for not including certain requirements in the proposal. We note that FINRA, in its response, indicates that Rule 200(a), which requires funding portal members to observe high standards of commercial honor and just and equitable principles of trade in the conduct of their business, and Rule 200(b), which prohibits the use of manipulative, deceptive or other fraudulent devices, may be used to address misconduct by funding portals not specifically addressed in the rules. We also note that FINRA has represented that it will monitor how the funding portal business develops under the rules as well as other rules applicable to such entities, and assess whether changes to the rules are appropriate or necessary. Taken together, we believe that this approach is appropriate and designed to protect investors and the public interest, consistent with Section 15A(b)(6) of the Exchange Act.
The Commission also believes that FINRA's response, which is discussed in more detail above, appropriately addressed the commenter's concern regarding the timing of the proposal. In particular, FINRA notes that its rules have been in preparation for a considerable amount of time with public input, and the proposal is intended to provide the means for
In addition, the Commission also believes that the proposal is designed to provide for an appropriate amount of information to be reported to FINRA. FINRA stated that its goal is to develop rules for funding portal members that are tailored to the limited permissible activities in which funding portals may engage, and to minimize the initial potential costs and burdens to the development of the funding portal business. The Commission believes that FINRA's reporting rules are tailored to funding portal activities. For example, FINRA's Funding Portal Rule 300(c) requires funding portal members to report regulatory proceedings, disciplinary and other events.
Further, the Commission believes that the proposal is designed to provide for an appropriate level of public disclosure of information relating to funding portals. The Commission notes that FINRA indicates that it intends to exercise its authority under its rules and provide the public with access to a funding portal member's current SEC Form Funding Portal through a link to the Commission's Web site. Form Funding Portal, which is also publicly available through the Commission's EDGAR system, provides certain disclosure information about funding portals and their associated persons. In addition, FINRA stated its intention to make public information indicating whether the funding portal member or any associated person of the funding portal member is subject to a statutory disqualification event.
Accordingly, the Commission believes that the rule change is reasonably designed to designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest.
For the reasons stated above, the Commission finds that the rule change, as modified by Amendment No. 1, is consistent with the Exchange Act and the rules and regulations thereunder.
The Commission finds good cause, pursuant to Section 19(b)(2) of the Exchange Act
Amendment No. 1 revised the proposal to include “for purposes of FINRA Rule 8210 any other person listed in Schedule A of Form Funding Portal of a member” to the definition of “associated person of a funding portal member” or “person associated with a funding portal member” in Funding Portal Rule 100(b)(1). This change will help to ensure that FINRA is capable of using its Rule 8210 authority with regard to key persons controlling the funding portal. The Commission also believes the amendment is consistent with FINRA's obligation in Section 19(g) of the Exchange Act to effectively enforce its rules. The Commission also believes that Amendment No. 1's amended definition of associated person does not raise any novel regulatory issues because the change more closely aligns the definition with the definition of associated person applicable to FINRA's broker-dealer members.
Amendment No. 1 also revised the proposal to make technical changes to the language of Funding Portal Rules 300(a)(1)(A), 900(a)(4)(C), 900(a)(4)(F), 1200(a)(3), 1200(a)(4) and 1200(b)(4)(C). The Commission does not believe that these changes raise any novel regulatory issues, but rather are technical changes that do not change the substance of the rules.
Accordingly, the Commission finds that good cause exists to approve the proposal, as modified by Amendment No. 1, on an accelerated basis.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the rule change, as modified by Amendment No. 1, is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Robert W. Errett, Deputy Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission Equity Market Structure Advisory Committee will hold a public meeting on Tuesday, February 2, 2016, in the Multipurpose Room, LL-006 at the Commission's headquarters, 100 F Street NE., Washington, DC.
The meeting will begin at 9:30 a.m. (EST) and will be open to the public. Seating will be on a first-come, first-served basis. Doors will be open at 9 a.m. Visitors will be subject to security checks. The meeting will be webcast on the Commission's Web site at
On January 13, 2016, the Commission published notice of the Committee meeting (Release No. 34-76883), indicating that the meeting is open to the public and inviting the public to submit written comments to the Committee. This Sunshine Act notice is being issued because a majority of the Commission may attend the meeting.
The agenda for the meeting will focus on the events of August 24, 2015 and certain issues affecting customers in the current equity market structure.
For further information, please contact the Office of the Secretary at (202) 551-5400.
RSL Railroad, LLC (RSL), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to continue to lease and operate a rail line from Norfolk Southern Railway Company (NSR), known as the South Massillon IT (the Line). The Line extends between RSL's existing connection with NSR at milepost MT 1.4, and the proposed future interchange with NSR at milepost MT 0.0, in Massillon, OH.
RSL states that NSR and RSL have entered into an amendment to their prior lease agreement. RSL states that, at its request, the amendment modifies the lease rental provisions of the lease agreement to permit RSL to receive a lease credit against its fixed rental payment for each revenue carload it interchanges with NSR on the Line. RSL states that it requested the amendment to provide it the ability to earn a lower rental payment and to afford it the opportunity to invest in improvements on the Line to increase traffic levels.
RSL has certified that its projected annual revenues as a result of the proposed transaction will not result in RSL becoming a Class II or Class I rail carrier. RSL has further certified that its projected annual rail freight revenues, including the line to be operated pursuant to this notice, would not exceed $5 million.
The transaction may be consummated on or after February 11, 2016, the effective date of the exemption (30 days after the exemption was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than February 4, 2016 (at least 7 days before the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 35990, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Andy A. Ginella, 4096 Holiday St. NW., Canton, OH 44718.
According to RSL, this action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Board decisions and notices are available on our Web site at
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
The Department of the Treasury will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
Comments should be received on or before March 28, 2016 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained by emailing
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |