Federal Register Vol. 80, No.249,

Title III, Part B 1 of the Energy Policy and Conservation Act of 1975 (EPCA or the Act), Public Law 94-163 (codified at 42 U.S.C. 6291-6317) sets forth a variety of provisions designed to improve energy efficiency and established the Energy Conservation Program for Consumer Products Other Than Automobiles.2 Part C 3 of title III (42 U.S.C. 6311-6317) establishes an energy conservation program for certain industrial and commercial equipment. The Act provides DOE authority to enforce certain prohibited acts listed in section 6302(a), including EPCA's prohibition on the importation of covered products and equipment that do not conform to applicable energy conservation standards. (42 U.S.C. 6302(a)(5), 6303, 6316(a),(b)) 4

Comments Invited

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 ADDRESSES section. Include “Docket No. FAA-2015-7533; Directorate Identifier 2015-NM-080-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The European Aviation Safety Agency, which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0082, dated May 11, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain Airbus Model A330-200 and -300 series airplanes, Model A330-200 Freighter series airplanes, and Airbus Model A340-541 and A340-642 airplanes. The MCAI states:

Findings (or discrepancies) include one bolt that is loose or able to rotate, two or more bolts that are loose or able to rotate, or one or more pylon bolts that are fully broken. Corrective actions include re-torqueing the affected bolt(s), and replacing all bolts and associated nuts with new bolts and nuts on the engine where the loose or fully broken bolt(s) were detected. This proposed AD specifies reporting of all findings (including no discrepancies). The corrective actions include re-torqueing loose bolts before further flight. The compliance times for replacing loose or fully broken bolts ranges, depend on airplane configuration, and range from before further flight if more than one bolt rotates or is fully broken to no later than 2,350 flight cycles or 24,320 flight hours since first flight of the airplane, if only one bolt rotates. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7533.

We have reviewed the following service information.

• Airbus AOT A71L004-14, Revision 01, dated April 7, 2014. The service information describes procedures for doing a one-time torque check to determine if there are any loose or fully broken engine mount pylon bolts at four positions at the forward engine pylon 1 and pylon 2 of Airbus Model A330 series airplanes having Pratt and Whitney engines, doing corrective actions, and reporting all findings.

• Airbus AOT A71L005-14, Revision 01, dated December 11, 2014. The service information describes procedures for doing a one-time torque check to determine if there are any loose or fully broken engine mount pylon bolts at four positions at the forward engine pylon 1 and pylon 2 of Airbus Model A330 series airplanes having Trent 700 engines, doing corrective actions, and reporting all findings.

• Airbus AOT A71L006-14, dated July 22, 2014. The service information describes procedures for doing a one-time torque check to determine if there are any loose or fully broken engine mount pylon bolts at five FWD and four AFT positions at the forward engine pylon 1 and pylon 2 of Airbus Model A330 series airplanes having GE engines, doing corrective actions, and reporting all findings.

• Airbus AOT A71L008-14, Revision 01, dated December 18, 2014. The service information describes procedures for doing a one-time torque check to determine if there are any loose or fully broken engine mount pylon bolts at four positions at the forward engine pylon 1 and pylon 2 of Airbus Model A340 series airplanes having Trent 500 engines, doing corrective actions, and reporting all findings.

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 ADDRESSES section of this NPRM.

On June 21, 2013, we issued AD 2013-14-04, Amendment 39-17509 (78 FR 68352, November 14, 2013). AD 2013-14-04 requires a torque check of forward engine mount bolts, and replacement if necessary on all Airbus Model A330-223F, -223, -321, -322, and -323 airplanes. AD 2013-14-04 was prompted by a fatigue load analysis that determined that the inspection interval for certain pylon bolts must be reduced. We issued AD 2013-04-04 to detect and correct loose or broken bolts, which could lead to engine detachment in-flight, and damage to the airplane.

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.

We estimate that this proposed AD affects 55 airplanes of U.S. registry.

We also estimate that it would take about 12 work-hours per product to comply with the basic requirements of this proposed AD, and 1 work-hour per product to report torque check findings. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $60,755, or $1,105 per product.

In addition, we estimate that any necessary follow-on actions would take about 20 work-hours and require parts costing $90,200 for a cost of $91,900 per product. We have no way of determining the number of aircraft that might need these actions.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this proposed AD is 2120-0056. The paperwork cost associated with this proposed AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this proposed AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

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.

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

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2015-7531; Directorate Identifier 2015-NM-052-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

We received reports of electrical shorts of the motor stator wiring burning a hole through the housing of the motor of the CAC. The pack bay is classified as a flammable fluid leakage zone and the burn-through would be classified as an ignition source. This condition, if not corrected, could result in a fire in the pack bay, and consequent reduced controllability of the airplane.

We reviewed Boeing Alert Service Bulletin B787-81205-SB210055-00, Issue 001, dated March 12, 2015. This service information describes procedures for installing modified inboard and outboard CAC modules on the left side and right side CACTCS packs. 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 ADDRESSES section of this NPRM.

We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This proposed AD would require accomplishing the actions specified in the service information described previously. For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7531.

The FAA worked in conjunction with industry, under the Airworthiness Directive Implementation Aviation Rulemaking Committee (ARC), to enhance the AD system. One enhancement was a new process for annotating which steps in the service information are required for compliance with an AD. Differentiating these steps from other tasks in the service information is expected to improve an owner's/operator's understanding of crucial AD requirements and help provide consistent judgment in AD compliance. The steps identified as RC in any service information identified previously have a direct effect on detecting, preventing, resolving, or eliminating an identified unsafe condition.

For service information that contains steps that are labeled as RC, the following provisions apply: (1) the steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD, and an AMOC is required for any deviations to RC steps, including substeps and identified figures; and (2) steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

We estimate that this proposed AD affects 22 airplanes of U.S. registry.

We estimate the following costs to comply with this proposed AD:

According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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.

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

I. Background—Regulatory Authorities

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629), Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). One type of general control provided by the FD&C Act is a restriction on the sale, distribution, or use of a device under section 520(e) of the FD&C Act (21 U.S.C. 360j(e)). A restriction under section 520(e) of the FD&C Act must be implemented through rulemaking procedures, unlike the administrative order procedures that apply to this proposed reclassification under section 513(e) of the FD&C Act, as amended by FDASIA.

Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type may be marketed without submission of a PMA until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval or until the device is subsequently reclassified into class I or class II.

Although, under the FD&C Act, the manufacturer of a class III preamendments device may respond to the call for PMAs by filing a PMA or a notice of completion of a PDP, in practice, the option of filing a notice of completion of a PDP has not been used. For simplicity, although corresponding requirements for PDPs remain available to manufacturers in response to a final order under section 515(b) of the FD&C Act, this document will refer only to the requirement for the filing and receiving approval of a PMA.

On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126 Stat. 1056) amended section 513(e) of the FD&C Act, changing the process for reclassifying a device from rulemaking to an administrative order. Section 608(b) of FDASIA amended section 515(b) of the FD&C Act changing the process for requiring premarket approval for a preamendments class III device from rulemaking to an administrative order.

FDA is publishing this document to propose the reclassification of ECT devices for use in treating severe MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition from class III to class II.

Section 513(e) of the FD&C Act governs reclassification of classified preamendments devices. This section provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify a preamendments device. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., Holland Rantos Co. v. United States Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)

Reevaluation of the data previously before the Agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see Bell, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F. Supp. 382, 388-391 (D.D.C. 1991)) or in light of changes in “medical science” (see Upjohn, 422 F.2d at 951). Whether data before the Agency are old or new data, the “new information” to support reclassification under section 513(e) must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and § 860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)

FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA. (See section 520(c) of the FD&C Act .) Section 520(h)(4) of the FD&C Act, added by FDAMA, provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety or effectiveness of the device but does not include descriptions of methods of manufacture or product composition and other trade secrets.

Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order for reclassifying a device. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments to a public docket. FDA has held a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to ECT devices, and therefore, has met this requirement under section 515(b)(1) of the FD&C Act.

FDAMA added a section 510(m) to the FD&C Act. Section 510(m) of the FD&C Act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the FD&C Act if the Agency determines that premarket notification is not necessary to assure the safety and effectiveness of the device.

FDA is proposing to require PMAs for ECT devices for the intended uses listed in section IX of this proposed order. For the purposes of this proposed order, the term, “Certain Specified Intended Uses,” refers to the listing of the intended uses in section IX of this proposed order and includes the following: schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia.

Section 515(b)(1) of the FD&C Act sets forth the process for issuing a final order requiring PMAs. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments from all affected stakeholders, including patients, payors, and providers. FDA has held a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to ECT devices, and therefore, has met this requirement under section 515(b)(1) of the FD&C Act.

Section 515(b)(2) of the FD&C Act provides that a proposed order to require premarket approval shall contain: (1) The proposed order, (2) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved PMA or a declared completed PDP and the benefit to the public from the use of the device, (3) an opportunity for the submission of comments on the proposed order and the proposed findings, and (4) an opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.

Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification panel described in section 513(b) of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f).

Under section 501(f) of the FD&C Act (21 U.S.C. 351(f)), a preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order (or a final rule issued under section 515(b) of the FD&C Act prior to the enactment of FDASIA) requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD&C Act, whichever is later. For ECT devices, the preamendments class III devices that are the subject of this proposal, the later of these two time periods is the 90-day period. Since these devices were classified in 1979, the 30-month period has expired (44 FR 51776, September 4, 1979). Therefore, if the proposal to require premarket approval for ECT devices for Certain Specified Intended Uses is finalized, section 501(f)(2)(B) of the FD&C Act requires that a PMA for such device be filed within 90 days of the date of issuance of the final order. If a PMA is not filed for such device within 90 days after the issuance of a final order, the device would be deemed adulterated under section 501(f) of the FD&C Act.

Also, a preamendments device subject to the order process under section 515(b) of the FD&C Act is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous with its interstate distribution until the date identified by FDA in the final order requiring the filing of a PMA for the device. At that time, an IDE is required only if a PMA has not been filed. If the manufacturer, importer, or other sponsor of the device submits an IDE application and FDA approves it, the device may be distributed for investigational use. If a PMA is not filed by the later of the two dates, and the device is not distributed for investigational use under an IDE, the device is deemed to be adulterated within the meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if its distribution continues. Other enforcement actions include, but are not limited to, the following: Shipment of devices in interstate commerce will be subject to injunction under section 302 of the FD&C Act (21 U.S.C. 332), and the individuals responsible for such shipment will be subject to prosecution under section 303 of the FD&C Act (21 U.S.C. 333). In the past, FDA has requested that manufacturers take action to prevent the further use of devices for which no PMA has been filed and may determine that such a request is appropriate for the class III devices that are the subject of this proposed order, if finalized.

In accordance with section 515(b)(2)(D) of the FD&C Act, interested persons are being offered the opportunity to request reclassification of ECT devices for Certain Specified Intended Uses.

In the preamble to the proposed rule (43 FR 55729, November 28, 1978), FDA described the recommendation of the Neurological Device Classification Panel (the Panel) that ECT be classified into class II because: “Although the use of this device involves a substantial risk to the patient, the Panel believes that the benefit of the treatment outweighs the risks involved if the patients are selected carefully and the devices are designed and used properly. The Panel believes that a standard will provide reasonable assurance of the safety and effectiveness of the device and that there is sufficient information to establish a standard to provide such assurance.” However, in 1979 (44 FR 51776, September 4, 1979), FDA classified ECT into class III after receiving several comments on the proposed rule, and reconvening the Panel to discuss these comments (May 29, 1979). The Panel discussed whether there was sufficient evidence to establish a performance standard for ECT. Several panel members expressed doubt that such information was available, and the Panel voted to recommend that ECT be classified into class III. FDA agreed with the Panel stating that FDA did not believe that the characteristics of ECT devices had been identified precisely enough such that special controls could be established that would provide reasonable assurance of the safety and effectiveness of the device.

On August 13, 1982, the American Psychiatric Association (APA) submitted a reclassification petition to FDA requesting that ECT be classified into class II. The reclassification petition was discussed at a Panel meeting on November 4, 1982 (47 FR 44611, October 8, 1982). The Panel recommended that ECT be reclassified from class III to class II. FDA tentatively agreed that there was sufficient evidence to reclassify to class II for severe depression and schizophrenia and published a notice of intent to reclassify (48 FR 14758, April 5, 1983). Several comments received by the Agency argued that research and data did not support that ECT is an effective therapy for schizophrenia, and after careful review of the scientific literature and the APA's petition, FDA agreed with the comments. In the subsequent proposed rule (55 FR 36578, September 5, 1990), FDA determined that the evidence of effectiveness for schizophrenia was inconclusive, and proposed that ECT be reclassified to class II only for severe depression and remain class III for all other indications. In 1995, FDA published an order for the submission of safety and effectiveness information on ECT devices (60 FR 41986, August 14, 1995). In 2003, FDA published an intent to withdraw the 1990 proposed rule (68 FR 19766, April 22, 2003) followed by withdrawal in 2004 (69 FR 68831, November 26, 2004) of the proposed rule for reclassification of ECT, along with other FDA proposed rules that had been outstanding for more than 5 years because the proposals were no longer considered viable candidates for final action. Thus, ECT devices remain in class III for all indications.

In 2009, FDA published an order for the submission of safety and effectiveness information on ECT devices by August 7, 2009 (74 FR 16214, April 9, 2009). In response to that order, FDA received two submissions from ECT manufacturers suggesting that ECT devices could be reclassified to class II. The manufacturers stated that safety and effectiveness of these devices may be assured by reducing the frequency of treatments, temporary or permanent interruption of treatments, reduction of stimulus dose, electrode placement, dosage or type of anesthetic (or other) medications, including minimizing psychotropic medications, brief pulse or ultra-brief pulse waveform stimulus, EEG monitoring, proper preparation (including conductive gel) and contact of the electrodes to the skin, changing anesthetic medications or doses, and changing concurrent medications.

In 2009, FDA also opened a public docket to receive information and comments regarding the current classification process for ECT by January 8, 2010 (74 FR 46607, September 10, 2009). FDA received over 3,000 submissions to the docket, with the majority of respondents, approximately 80 percent, opposing reclassification of ECT. The majority of those opposing reclassification of ECT cited adverse events from ECT treatment as the basis for their opposition. The most common type of adverse event mentioned in the public docket were memory adverse events, followed by other cognitive complaints, brain damage, and death.

On January 27-28, 2011, a meeting of the Neurological Devices Panel was held to discuss the classification of ECT devices for treatment of several disorders. There was panel consensus recommending class III for Schizophrenia, Bipolar manic states, Schizoaffective, and Schizophreniform disorder. The Panel did not reach consensus on the classification of ECT for depression (unipolar and bipolar) and catatonia. The Panel transcript and other meeting materials are available on FDA's Web site (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/ucm240924.htm).

The ECT device consists of an electrical generator and a pair of electrodes that apply a brief intense electrical current to the head in order to induce a generalized seizure. In addition to generating and modulating the electrical functions of the stimulus, the box enclosing the generator also has capabilities and displays for physiological monitoring. The device parameters such as voltage, pulse width, frequency, and treatment (train) duration are adjustable. The typical display may provide information such as Electroencephalograph (EEG) activity, stimulus administration, total charge, energy, and impedance. These devices are currently regulated under § 882.5940 (21 CFR 882.5940), product code GXC.

FDA is proposing in this order to modify the identification language from how it is presently written in § 882.5940(a). FDA is clarifying in the identification that these are prescription devices and clarifying that this device type includes the ECT pulse generator and its stimulation electrodes and accessories.

FDA is proposing that ECT devices intended for treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition be reclassified from class III to class II. In this proposed order, the Agency has identified special controls under section 513(a)(1)(B) of the FD&C Act that, together with general controls applicable to the devices, would provide reasonable assurance of safety and effectiveness. Absent the special controls identified in this proposed order, general controls applicable to the device are insufficient to provide reasonable assurance of the safety and effectiveness of the device.

Therefore, in accordance with sections 513(e) and 515(i) of the FD&C Act and21 CFR 860.130, based on new information with respect to the devices and taking into account the public health benefit of the use of the device and the nature and known incidence of the risk of the device, FDA, on its own initiative, is proposing to reclassify this preamendments class III device into class II when the device is intended to treat severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. FDA believes that this new information is sufficient to demonstrate that the proposed special controls can effectively mitigate the risks to health identified in the next section, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for ECT devices intended for treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

Section 510(m) of the FD&C Act authorizes the Agency to exempt class II devices from premarket notification (510(k)) submission. FDA has considered ECT devices intended for treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition and decided that the device does require premarket notification. Therefore, the Agency does not intend to exempt this proposed class II device from premarket notification (510(k)) submission.

After considering the available information from the reports and recommendations of the advisory committees (panels) for the classification of these devices, FDA has evaluated the risks to health associated with the use of ECT devices and determined that the following risks to health are associated with its use:

• Adverse reaction to anesthetic agents/neuromuscular blocking agents. The muscle relaxing and sedating (or sleep inducing) drugs that are a part of the procedure may hamper the patient's ability to breathe spontaneously.

• Adverse skin reactions. The patient-contacting materials of the device may cause an adverse immunological or allergic reaction in a patient.

• Cardiovascular complications. The therapeutic convulsions may be accompanied by arrhythmias (irregular heartbeat) or ischemia/infarction (i.e., heart attack). Hypertension (high blood pressure) as well as hypotension (low blood pressure) may be associated with ECT treatment. ECT treatment may also result in stroke (impairment of blood flow to the brain or bleeding in the brain).

• Cognition and memory impairment. ECT treatment may result in memory impairment, specifically immediate post-treatment disorientation, anterograde memory impairment and retrograde personal (autobiographical) memory impairment.

• Death. Death may result from various complications of ECT such as reactions to anesthesia, cardiovascular complications, pulmonary complications, or stroke.

• Dental/oral trauma. Dental fractures, dislocations, lacerations, and prosthetic damage may occur as a result of strong muscle contractions during treatment.

• Device malfunction. Faulty hardware, software or accessories (electrodes) or improper use may cause electrical hazards, such as the risk of excessive dose administration, prolonged seizures, and skin burns.

• Manic symptoms. ECT treatment may result in the development of hypomanic or manic symptoms.

• Pain/discomfort. The patient may experience mild to moderate pain following the motor seizure induced by ECT treatment.

• Physical trauma. Inadequate supportive drug treatment may allow the patient to be injured from unconscious violent movements during convulsions.

• Prolonged or tardive seizures. ECT treatment may result in prolonged or delayed seizures, and status epilepticus (continuous unremittent seizure) may ensue if prolonged seizures are not properly treated.

• Pulmonary complications. ECT treatment may result in prolonged apnea (no breathing) or inhalation of foreign material, such as regurgitated stomach contents.

• Skin burns. Excessive electrical current or improperly designed electrodes may cause the patient's skin under the electrodes to be burned.

• Worsening of psychiatric symptoms. ECT treatment may be ineffective and therefore may result in worsening psychiatric symptoms.

FDA believes that ECT devices indicated for severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition should be reclassified from class III to class II because, in light of new information about the effectiveness of these devices, special controls, in addition to general controls, can be established to provide reasonable assurance of safety and effectiveness of the device, and because general controls themselves are insufficient to provide reasonable assurance of its safety and effectiveness. FDA believes that in the specified patient population, and with the application of general and special controls as described in this document, the probable benefit to health from use of the device outweighs the probable injury or illness from such use. FDA acknowledges significant risks associated with ECT but believes that for the specified population—patients age 18 years of age and older experiencing a severe MDE associated with MDD or BPD for whom other treatment options have not been successful or for whom rapid, definitive response is needed due the severity of a psychiatric or medical condition—the probable benefit of ECT outweighs these risks. FDA is inviting comments on whether the term “treatment resistant” and the phrase “require rapid response” provide sufficient clarity to the population for which ECT benefits outweigh risks.

Since the time of the original ECT device classification, sufficient evidence has been developed to support a reclassification of ECT to class II with special controls for severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. FDA's review of the clinical literature has been previously summarized in the Executive Summary to the January 27-28, 2011, Neurological Device Panel meeting to discuss ECT classification (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM240933.pdf). The largest body of evidence for ECT effectiveness exists for MDE associated with MDD and BPD in patients 18 years of age and older. Based on this review, FDA concluded that ECT demonstrated effectiveness in the acute phase (less than 3 months after treatment); however, the Panel members had various scientific opinions regarding the long-term effectiveness of ECT for the treatment of depression, but agreed that it was effective in the acute phase. Panel members indicated that controlled clinical trials are lacking regarding the effectiveness of ECT beyond the acute phase, in part, due to the fact that many patients have an initial improvement in the depressive symptoms following an acute course of ECT and are able to return to alternative treatments for managing depression such as medications and psychotherapy. The findings from FDA's review are consistent with other recently conducted, comprehensive, high quality systematic reviews, including the American Psychiatric Association (APA) recommendations/guidelines (Ref. 1), the Third report of the Royal College of Psychiatrists' Special Committee on ECT (2004) (Ref. 2), the United Kingdom National Institute for Health and Clinical Excellence (NICE 2003; NICE 2009) (Refs. 3, 4), the Surgeon General's report on mental health (Ref. 5), systematic reviews by Semkovska and McLoughlin (Ref. 6), and Greenhalgh et al (Ref. 7). These findings from the FDA review included examining the results of over 60 randomized controlled clinical trials comparing ECT with either placebo (sham) or antidepressant therapy in which ECT was superior for patients with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. In addition, FDA conducted a systematic meta-analysis of these studies which supported a robust effect of ECT in the short-term (e.g. 3 months) (Ref. 11).

FDA also examined other conditions, including bipolar mania, schizophrenia, schizoaffective disorder, schizophreniform disorder, and catatonia, but there were insufficient clinical data to support effectiveness for these conditions. FDA relied upon literature describing clinical study data collected largely in patients age 18 and older. Data on the use of ECT in children and adolescents is limited and hence the recommended reclassification is limited to patients 18 years of age and older. Most of the published literature FDA is aware of and reviewed focused on subject populations that did not receive benefit from prior treatments; therefore, the recommended reclassification is limited to treatment resistant populations as well as those patients who require a rapid response due to the severity of their psychiatric or medical condition. Further, practice guidelines published by the APA task force on ECT and the NICE in the United Kingdom recommend that ECT be considered for primary use (i.e., prior to medications) when there is a need for rapid, definitive response due to the severity of a psychiatric or medical condition. Conventional treatments such as medications and psychotherapy are likely to be less effective for a rapid definitive response, thus the recommended reclassification for ECT includes patients who require a rapid response because of the severity of their psychiatric or medical condition.

Panel deliberations focused heavily on ECT versus sham meta-analysis for treatment of depression. Discussion focused on the clinical meaningfulness of the effect size, the wide confidence interval which included 0 (i.e., the possibility of no effect), and the sources of variability in the dataset. Compared with other approved treatments for depression, the data suggest that the effect size of ECT is at least as large as, or larger than, that of other treatments (i.e., antidepressant medications) (Refs. 8, 9). In addition, other sources of evidence supported the effectiveness claim of ECT, including the FDA effectiveness systematic review, the meta-analysis demonstrating ECT favorability over placebo, and meta-analyses demonstrating ECT effectiveness being equal to or better than some antidepressant medications (see FDA Executive Summary from the panel meeting, Ref. 11).

While medical/physical risks may occur with ECT, they vary in frequency, with the most severe risks being quite rare. Death associated with ECT appears to occur at a very low rate comparable to that of minor surgical procedures. Recent estimates of the mortality rate associated with ECT treatment are 1 per 10,000 patients or 1 per 80,000 treatments (Refs. 1, 10).

The risks of greatest concern to clinicians and patients remain cognitive and memory impairment. Both the FDA review of literature and the meta-analyses of the randomized controlled studies indicate that while post-procedure disorientation occurs frequently, it is transient, typically resolving within minutes after the procedure is complete. The systematic meta-analyses of the randomized controlled clinical trials data by FDA revealed that there is no evidence that disorientation following ECT is long-term or persistent. The primary areas of concern for persistent changes are anterograde and retrograde autobiographical memory. While rates of occurrence are difficult to estimate, it appears that both types of memory impairment are not uncommon. The literature review suggests that anterograde memory declines immediately post-ECT and then returns to baseline within 3 months post-ECT. Retrograde autobiographical memory declines immediately post-ECT and then appears to improve over time. It is important to note that while improvement is seen, impairment may persist past 6 months post-ECT. Data on persistent retrograde autobiographical memory deficits beyond 6 months is lacking in the scientific literature. Therefore, it cannot be concluded that retrograde autobiographical memory returns to baseline over time. (See tables 6 and 7 and Figures 2-24 from FDA's Executive Summary, Ref. 11.)

Despite the occurrence and uncertainty of duration of memory impairment, FDA believes that the potential benefits of ECT outweigh the risks in patients 18 years of age or older for MDE associated with MDD or BPD in patients who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

FDA believes that special controls, in addition to the general controls, are necessary to provide a reasonable assurance of safety and effectiveness for ECT devices indicated for severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. FDA believes that the risks to health identified in section V associated with ECT devices indicated for severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition can be mitigated with general and special controls.

Several of the risks associated with ECT, including adverse reaction to anesthetic agents/neuromuscular blocking agents, cardiovascular complications, death, and pulmonary complications, are medical/physical risks related to the procedure involving use of the device. For these risks, safe use of the device is based on appropriate directions for use. FDA believes that labeling provisions are adequate to mitigate these risks, including:

• Disclosure of contraindications, precautions, warnings, and potential adverse effects/complications in both physician and patient labeling so that users and patients can be advised of conditions under which ECT treatment should not proceed, and

• Specific device use instructions including information regarding conduct of pre-ECT patient assessments; and information on appropriate patient monitoring during an ECT procedure) to minimize potential ECT procedural complications.

Other ECT risks are specific to the medical/physical effects of the induced seizure and potentially severe muscle contractions that result from use of the device (dental/oral trauma, physical trauma, prolonged or tardive seizures, pain/discomfort). FDA believes that appropriate labeling provisions are adequate to mitigate these risks, including:

• Disclosure of contraindications, precautions, warnings, and adverse effects/complications in both physician and patient labeling so that users and patients can be advised of conditions under which ECT treatment should not proceed and are aware of potential adverse effects associated with ECT treatment, and

• Specific device use instructions including information regarding conduct of pre-ECT assessments, use of mouth protection during the procedure, use of general anesthetic agents and neuromuscular blocking agents, and information on appropriate patient monitoring during the procedure to minimize potential post-ECT complications.

The risks of skin burns can be mitigated by performance testing of the device to demonstrate safe electrical performance, adhesive integrity, and physical and chemical stability of the stimulation electrodes. This risk is further mitigated by providing specific user instructions regarding proper electrode placement, including instructions for adequate skin preparation and use of conductivity gel in placing the electrodes.

The risk of cognitive and memory impairment can be mitigated by establishing the technical parameters for the device along with non-clinical testing data to confirm the electrical characteristics of the output waveform to ensure that the device performance characteristics are consistent with existing clinical performance data that supports a reasonable assurance of safety and effectiveness (see information on review of clinical performance data in section VII). This risk is further mitigated by providing information to both the user and patient on the potential adverse effects of the device, alternative treatments, and a prominent warning that ECT device use may be associated with: Disorientation, confusion, and memory problems and limited in its long-term effectiveness (greater than 3 months). These risks can also be mitigated by providing instructions to the user that include recommendations on cognitive status monitoring prior to beginning ECT and during the course of treatment. Providing this information helps patients and providers to make informed choices about how and when to use ECT to maximize benefits and minimize potential adverse effects.

The risks associated with malfunction of the device can be mitigated by data demonstrating electrical and mechanical safety and the functioning of all safety features built into the device (including the static and dynamic impedance monitoring system); appropriate analysis/testing of electromagnetic compatibility such that electromagnetic interference does not cause device malfunction; and appropriate software verification, validation, and hazard analysis to ensure that any device software has been adequately designed.

The potential for manic symptoms or worsening of the condition being treated can be mitigated by labeling provisions, including:

• The clinical training needed by users of the device to ensure appropriate use of ECT and appropriate ongoing medical management of the patient, and

• Information on the patient population in which the device is intended to be used, including a detailed summary of the clinical testing pertinent to use of the device, information on the potential adverse effects of treatment, and information on the typical course of treatment such that users and patients can make informed decisions regarding the appropriate use of ECT.

The risks of adverse skin reactions can be mitigated with biocompatibility testing to ensure that the materials used in patient-contacting components of the device are safe for skin contact as well as labeling that provides information on validated methods for reprocessing any reusable components between uses.

Specifically, FDA believes that special controls in § 882.5940(b)(1), together with general controls, are sufficient to mitigate the risks to health described in section V:

Table 1 shows how FDA believes that the risks to health identified in section V can be mitigated by the proposed special controls.

In addition, FDA is proposing to limit this reclassification to prescription use devices under 21 CFR 801.109. Under 21 CFR 807.81, the device would continue to be subject to 510(k) notification requirements. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document entitled “Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses,” that, when finalized, would provide recommendations on how to comply with the special controls proposed in this order, if FDA reclassifies this device.

In accordance with section 515(b) of the FD&C Act, FDA is proposing to require that a PMA be filed with the Agency within 90 days after issuance of any final order based on this proposal for ECT devices intended for Certain Specified Intended Uses. An applicant whose device was legally in commercial distribution before May 28, 1976, or whose device has been found to be substantially equivalent to such a device, will be permitted to continue marketing such class III devices during FDA's review of the PMA provided that the PMA is timely filed. FDA intends to review any PMA for the device within 180 days of the date of filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days unless the Agency finds that “the continued availability of the device is necessary for the public health.”

FDA intends that under § 812.2(d), the preamble to any final order based on this proposal will state that, as of the date on which the filing of a PMA or a notice of completion of a PDP is required to be filed, the exemptions from the requirements of the IDE regulations for preamendments class III devices in § 812.2(c)(1) and (2) will cease to apply to any device that is: (1) Not legally on the market on or before that date or (2) legally on the market on or before that date but for which a PMA or notice of completion of a PDP is not filed by that date, or for which PMA approval has been denied or withdrawn.

If a PMA for a class III device is not filed with FDA within 90 days after the date of issuance of any final order requiring premarket approval for the device, the device would be deemed adulterated under section 501(f) of the FD&C Act (21 U.S.C. 351(f)). The device may be distributed for investigational use only if the requirements of the IDE regulations are met. The requirements for significant risk devices include submitting an IDE application to FDA for its review and approval. An approved IDE is required to be in effect before an investigation of the device may be initiated or continued under § 812.30. FDA, therefore, cautions that IDE applications should be submitted to FDA at least 30 days before the end of the 90-day period after the issuance of the final order to avoid interrupting investigations.

FDA proposes that following the effective date of any final order, ECT devices intended for use in treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition must comply with the special controls. FDA notes that a firm whose ECT device was legally in commercial distribution before May 28, 1976, or whose device was found to be substantially equivalent to such a device and who does not intend to market such device for uses other than use in treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, may remove such intended uses from the device's labeling. FDA proposes that such ECT devices must comply with the special controls, and, as part of the special controls, anyone who wishes to continue to market an ECT device for these uses must submit an amendment to their previously cleared premarket notification (510(k)) that demonstrates compliance with the special controls within 60 days after the effective date of the final order. Such amendment will be added to the 510(k) file but will not serve as a basis for a new substantial equivalence review. A submitted 510(k) amendment in this context will be used solely to demonstrate to FDA that an ECT device is in compliance with the special controls. If a 510(k) amendment is not submitted within 60 days after the effective date or if FDA determines that the amendment does not demonstrate compliance with the special controls, the device may be considered adulterated under section 501(f)(1)(B) of the FD&C

As required by section 515(b) of the FD&C Act, FDA is publishing its proposed findings regarding: (1) The degree of risk of illness or injury designed to be eliminated or reduced by requiring that this device have an approved PMA or a declared completed PDP when intended for use in treating any condition other than MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition and (2) the benefits to the public from the use of ECT devices for other specified intended uses.

These findings are based on the reports and recommendations of the advisory committees (panels) for the classification of these devices along with information submitted in response to the 515(i) Order (74 FR 16214), the public docket (74 FR 46607) and any additional information that FDA has obtained. Additional information regarding the risks as well as classification associated with this device type can be found in 43 FR 55729, 44 FR 51776, 48 FR 14758, and 55 FR 36578.

An electroconvulsive therapy device is a device used for treating severe psychiatric disturbances by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head.

For intended uses other than the treatment of MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, FDA concludes that the safety and effectiveness of ECT devices have not been established by adequate scientific evidence. Given the FDA analysis and the advisory panel deliberations (see http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/ucm240924.htm), there is insufficient evidence of effectiveness for indications including: schizophrenia, bipolar mania (and mixed states), schizoaffective disorder, schizophreniform disorder, and catatonia. The panel recommended Class III designation for schizophrenia, bipolar mania (and mixed states), schizoaffective disorder, and schizophreniform disorder; however, the panel did not reach consensus on the classification of ECT in treatment of catatonia and a review of the literature for use of ECT in catatonia yielded only one randomized control trial (Ref. 11). The body of evidence is not sufficiently robust for FDA to determine that there is a reasonable assurance of safety and effectiveness for ECT treatment of catatonia. Catatonia is a potentially life-threatening condition for patients unresponsive to the current standard of care treatment. FDA encourages collection of additional data that may support future reclassification of ECT for this use.

FDA believes that insufficient information exists regarding the risks and benefits of the device in order for FDA to determine that general and/or special controls will provide reasonable assurance of the safety and effectiveness of ECT for Certain Specified Intended Uses. As established in section 513(a)(1)(C) of the FD&C Act and 21 CFR 860.3(c)(3), a device is in class III if insufficient information exists to determine that general controls and/or special controls are sufficient to provide reasonable assurance of its safety and effectiveness and the device is purported or represented to be for a use that is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury. FDA believes that the risks to health identified in section V for the use of ECT devices for Certain Specified Intended Uses, in the absence of an established positive benefit-risk profile, presents a potential unreasonable risk of illness or injury.

The risks to health for ECT devices for intended uses other than the treatment of MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition are the same as outlined in section V.

As discussed previously, there is limited scientific evidence regarding the effectiveness of ECT devices for intended uses other than the treatment of MDE associated with MDD or BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. Because the benefits of these devices for such uses are unknown, it is impossible to estimate the direct effect of the devices on patient outcomes. However, based on claims made about the devices, the devices have the potential to benefit the public by providing additional treatment options for schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia.

A PMA for ECT devices Certain Specified Intended Uses must include the information required by section 515(c)(1) of the FD&C Act. Such a PMA should also include a detailed discussion of the risks identified previously, as well as a discussion of the effectiveness of the device for which premarket approval is sought. In addition, a PMA must include all data and information on: (1) Any risks known, or that should be reasonably known, to the applicant that have not been identified in this document; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all preclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.

A PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use (see § 860.7(c)(1)). Valid scientific evidence is evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use. Isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness. (§ 860.7(c)(2)).

Before requiring the filing of a PMA or notice of completion of a PDP for a device, FDA is required by section 515(b)(2)(D) of the FD&C Act to provide an opportunity for interested persons to request a change in the classification of the device based on new information relevant to the classification. Any proceeding to reclassify the device will be under the authority of section 513(e) of the FD&C Act.

A request for a change in the classification of ECT devices is to be in the form of a reclassification petition containing the information required by 21 CFR 860.123, including new information relevant to the classification of the device.

Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices and section 515(b) of the FD&C Act provided for FDA to issue regulations to require approval of an application for premarket approval for preamendments devices or devices found to be substantially equivalent to preamendments devices. Because sections 513(e) and 515(b) of the FD&C Act as amended require FDA to issue final orders rather than regulations, FDA will continue to codify reclassifications and requirements for approval of an application for premarket approval, resulting from changes issued in final orders, in the Code of Federal Regulations (CFR). Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this proposed order, we are proposing to codify the reclassification of ECT devices for use in treating severe Major Depressive Episode (MDE) associated with Major Depressive Disorder (MDD) or Bipolar Disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition into class II by amending § 882.5940.

The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This proposed order refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120. The collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078. The collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231.

The device and patient warning labeling provisions in this proposed rule are not subject to review by OMB because they do not constitute a “collection of information” under the PRA. Rather, the recommended labeling is a “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).

FDA is proposing that any final order based on this proposal become effective 90 days after the date of publication in the Federal Register.

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). FDA is explicitly seeking comments on whether: (1) The term “treatment resistant” and the phrase “require rapid response” provide sufficient clarity to the population for which ECT benefits outweigh risks and (2) if 60 days is an appropriate time to allow existing manufacturers who do not intend to market their ECT device(s) for uses other than use in treating severe MDE associated with MDD and BPD in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition to prepare and submit 510(k) amendments for ECT devices.

The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 882 be amended as follows:

In FR Doc. 2015-27703, appearing on pages 66845 and 66847 in the Federal Register of Friday, October 30, 2015, the following corrections are made:

1. On page 66845, in the third column under DATES, the third sentence is revised to read: “Persons seeking to attend (including FDA employees) or to present at the public hearing must register by January 8, 2016.”

2. On page 66847, in the first column under section IV. Attendance and Registration, the third sentence is revised to read: “Individuals who wish to attend (including FDA employees) or present at the public hearing must register by sending an email to [email protected] on or before January 8, 2016, and provide complete contact information, including name, title, affiliation, address, email, and phone number.”

I. General Information A. How is this Federal Register notice organized?

The information presented in this document is organized as follows:

Entities potentially affected by this proposed rule include air agencies responsible for the permitting of stationary and OCS sources of air pollution or for determining COA designation for implementation of the OCS Air Regulations. This includes the EPA Regions, and both EPA-delegated air programs and EPA-approved air programs that are operated by state, local and tribal governments. Entities also potentially affected by this proposed rule include owners and operators of stationary and OCS sources that are subject to air pollution permitting under the CAA, as well as the general public who would have an interest in knowing about permitting actions, public hearings and other agency actions.

1. Submitting CBI. Do not submit this information to the EPA through http://www.regulations.gov or email. Clearly mark the specific information that you claim to be CBI. For CBI in a disk or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing comments. When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

• Follow directions. The proposed rule may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

• Explain why you agree or disagree, suggest alternatives and substitute language for your requested changes.

• Describe any assumptions and provide any technical information and/or data that you used to support your comment.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples to illustrate your concerns wherever possible, and suggest alternatives.

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

• Make sure to submit your comments by the comment period deadline identified.

To request a public hearing or information pertaining to a public hearing on this document, contact Ms. Pamela Long, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, by phone at (919) 541-0641 or by email at [email protected].

In addition to being available in the docket, an electronic copy of this Federal Register document will be posted at http://www3.epa.gov/nsr/actions.html and http://www3.epa.gov/airquality/permits/actions.html.

The CAA authorizes the EPA to administer and oversee the permitting of stationary and other sources of air pollution. To accomplish this obligation, the EPA has promulgated permitting regulations for construction of sources pursuant to NSR under title I of the CAA, for operation of major and certain other sources of air pollutants under title V of the CAA; and for OCS sources under CAA § 328. These regulations are contained in 40 CFR parts 51, 52, 55, 70, 71 and 124, and cover the requirements for federal permit actions (i.e., when the EPA or a delegated air agency is the permitting authority 1 ) and minimum permitting requirements under an approved state implementation plan (SIP) and title V program.2 These rules contain, among other things, requirements for public notice and availability of supporting information to allow for informed public participation in permit actions. These regulatory requirements for public participation in permit and other actions are the subject of this proposed rule.

In general, prior to issuing a permit to a major stationary source 3 of air pollution, the permitting authority prepares a draft permit, provides notice to the public of the draft permit, and provides the public reasonable access to the draft permit, the application, and supporting information. The permitting authority must provide an opportunity for public comment, as well as an opportunity to request a public hearing on the draft permit. See, e.g., 40 CFR 70.7(h). In addition, the information that supports the permit decisions—referred to in some cases as the “permit record” or “administrative record”—must be made available to the public for inspection. Id. Under the title V programs, these procedures apply to permits for all covered sources, including certain non-major sources. See 40 CFR 70.3.4

This action addresses the method by which the permitting agency provides the required notice of the permitting action and access to the information supporting the action. We specifically propose to remove from the EPA rules the mandatory requirement that draft permits under CAA permitting programs for major sources be noticed in a newspaper of general circulation and instead allow—and, in some cases, require (as explained below)—the use of electronic methods to provide notice of and access to these draft permits. We are not changing the majority of the existing procedural requirements for processing permit applications and the requirement to keep a record of the materials that support the permit decisions. We also are not changing existing requirements as to the substance of the information that must be made available when the permitting agency notifies the public of the draft permitting action.

We are also not proposing to revise the federal rules for public notice that apply to minor NSR permits under 40 CFR part 51.161, which require “notice by prominent advertisement.” See § 51.161(b)(3). In 2012, the EPA clarified through guidance that the § 51.161 term “prominent advertisement” is media neutral, and therefore newspaper notice of minor NSR actions is not required. (“EPA's 2012 Memorandum”) 5 The guidance memorandum did not, however, address notice requirements for synthetic minor source permits.6 In this action, we are proposing to extend the media neutrality policy of the EPA's 2012 Memorandum to all permit actions governed by § 51.161, including synthetic minor source permits, and to ensure that e-access methods are available for minor NSR permit actions.

We are also not proposing to revise the public participation requirements for permits that establish a Plantwide Applicability Limitation (PAL), which cross reference the public participation procedures at § 51.161. See §§ 51.165(f)(5), 51.166(w)(5), and 52.21(aa), and Appendix S to part 51, Section IV.K.5. As discussed in the preamble to the PAL regulations (“PAL preamble”), “[t]he reviewing authority must establish a PAL in a federally enforceable permit (for example, a “minor” NSR construction permit, a major NSR permit, or a SIP-approved operating permit program).” 67 FR 80208; December 31, 2002. The PAL preamble further explains that “the reviewing authority must provide an opportunity for public participation when issuing a PAL permit . . . consistent with the requirements at § 51.161 and include a minimum of a 30-day period for public notice and opportunity for public comment.” Id. As explained above, in EPA's 2012 Memorandum we clarified that the term “prominent advertisement” in § 51.161 is media neutral for minor NSR permits, and in this action we are proposing to extend the applicability of the policy in that memorandum to all permit actions governed by § 51.161. In addition, the PAL preamble explains “[w]here the PAL is established in a major NSR permit, major NSR public participation procedures apply.” Id. In this rule action, we propose to amend the public participation requirements for major source permits under CAA permitting programs to allow or require the use of electronic methods to provide notice of these permits. Therefore, since this proposed action along with our previous rules and guidance would collectively ensure that § 51.161 and the major source specific regulations allow for e-notice in lieu of newspaper notice, and these public notice requirements would apply as well to all of the types of permits that may be used to establish a PAL, we believe that it is unnecessary to propose any revisions to the PAL-specific provisions of EPA's air permitting rules.

In addition, these proposed revisions would not change the requirements for nonattainment NSR (NNSR), minor NSR, and synthetic minor NSR permits in Indian country, which are contained in 40 CFR part 49 and allow for other means of public noticing beyond a newspaper of general circulation. See §§ 49.157 (minor NSR and synthetic minor NSR permits) and 49.171 (nonattainment major NSR permits). However, these proposed revisions would change the requirements for PSD permits that the EPA issues in Indian country, as well as Prevention of Significant Deterioration (PSD) permits that are issued by a tribe through a delegation agreement or by a tribe that has an approved tribal implementation plan (TIP) that incorporates by reference the public noticing requirements in the federal PSD rules at 40 CFR 52.21. Also, since this proposal would revise the noticing requirements in 40 CFR 71, which apply to Indian country absent an approved part 70 program, the revisions would affect the public notice procedures for the majority of title V operating permits in tribal lands.7 Also, the tribal agency with an approved part 70 program would have the option to implement e-notice under the same terms that apply to other approved part 70 programs.

This action addresses the public notice requirements for all air agencies. For the noticing of major source permits by the EPA and other air agencies that implement the federal permitting rules, e-notice would be required under this proposed rule. For major source permits issued by air agencies that implement their own rules approved by EPA, this proposed rule would allow additional flexibility such that these permitting authorities would have the option to provide e-notice or to continue to provide traditional newspaper notice, although they must adopt a single, “consistent noticing method” to be used for all of their major source permits. Thus, where an agency opts to post notices of draft permits on a Web site in lieu of newspaper publication, it must post all notices to this Web site in order to ensure that the public has a consistent and reliable location to turn to for all permit notices. If the agency does not maintain a consistent noticing method (i.e., if the state posts some notices to a Web site and others in the newspaper), the public may not know where to look for information regarding a permit for a source of interest to them. We are taking comment on this proposed approach of requiring a consistent noticing method for these approved state programs, as well as the option of not requiring a consistent noticing method.

In addition, to satisfy the proposed requirements for e-notice, except for programs that implement part 51 regulations for PSD and NNSR permits and states that issue OCS permits, the air agency must maintain a mailing list that will notify any person on the list of any new public notice. This approach is consistent with the current noticing requirements in the federal rules for NSR and EPA-issued OCS permits, and for federal and state operating permits under parts 70 and 71 (and OCS permits subject to these requirements), which all require that a copy of the notice be mailed to persons who have subscribed to the appropriate mailing list. The EPA believes that continuing with this approach will maintain the current efforts to reach communities through a variety of methods. This proposed rule clarifies that distributing the public notice information to the persons on the mailing list can be by way of email or the more traditional mailing methods (e.g., postal service, courier).

This proposed action also requires that, when a permitting authority adopts the e-notice approach, it also must provide e-access. For the purpose of this proposed rule, e-access means that the permitting authority must make the draft permit available electronically (i.e., on the agency's public Web site or on a Web site identified by the permitting agency, which could be an online document management system) for the duration of the public comment period. It is important to note that, while e-access in this proposed rule only pertains to the availability of and access to the draft permit during the public comment period, nothing in this rule alters the requirement for the permitting authority to maintain a record of the permit action and to make it available to the public. Thus, a permitting authority that is satisfying the proposed conditions of e-access by posting the draft permit on a Web site must also provide the public with reasonable access to the other materials that support the permit decision (as it has always been required to do). Access to the other materials can be provided either electronically, or at a physical location, or a combination of both.

In addition to the proposed approach described above for EPA-approved permitting programs, we are requesting comment on an alternative approach. In the alternative approach, permitting programs that implement 40 CFR part 51 or 70 and that select e-notice as their consistent noticing method would have the option, but would not be required to, provide e-access. This approach could be of benefit to some agencies that may notice permits using an online permits register—which would qualify for e-notice under this rule proposal—but do not have the Web site capabilities to satisfy the e-access requirement of making the draft permit available electronically.

Additionally, we are soliciting comment on including a provision in the regulations to allow air agencies to temporarily use an alternative noticing method if their Web site is unavailable for a period of time. This may be necessary during periods when a Web site is temporarily offline due to, for example, malfunctions, transitions to a different Web site platform, or emergency situations that result in prolonged electrical system outages. As with the Web site noticing method, the permitting agency would need to assure that the alternative noticing method provides adequate notice to the affected public. We specifically seek comment on the criteria for determining when the alternative method should be available, the length of time it could be used, and how the transition to the method would be conveyed to the public.

Finally, we are proposing to extend the use of e-notice methods to three non-permitting actions. In each case, the regulatory provision currently requires notice of the action by way of newspaper publication. We briefly describe each provision below.

• The “OCS Air Regulations” at 40 CFR part 55 apply to more than just OCS permitting actions. Specifically, when the EPA makes a COA designation determination, it must do so by way of a process that allows for public comment on the draft determination. Through this action, we are proposing to require electronic notice of the COA designation.

• The existing federal PSD regulations contain a provision for “permit rescission” that only refers to newspaper notification. Specifically, paragraph 40 CFR 52.21(w)(4) requires that, if an agency rescinds a permit, it shall give “adequate notice of the rescission,” and that newspaper publication “shall be considered adequate notice.” We are proposing in this action to revise the provision to specifically require that the Administrator notify the public of a permit rescission by e-notice.

• Paragraph 40 CFR 71.4(g) provides that, when the EPA takes action to administer and enforce, or to delegate, a federal operating permits program, it will publish a notice in the Federal Register and, “to the extent practicable, publish notice in a newspaper of general circulation within the area subject to the part 71 program effectiveness or delegation.” We are proposing to revise this provision to require the additional notice of the program effectiveness or delegation by way of posting on a public Web site identified by the EPA.

• It is important to note that the EPA is not proposing additional public participation where existing rules do not require public participation. Thus, the minimum notice and access requirements being proposed in this rule would apply to the public participation procedures of air quality permits issued by EPA and other air agencies in cases where the current rules require public participation in a permitting decision.

While the CAA requires permitting authorities to offer the opportunity for public participation in the processing of air permits, it does not specify the best or preferred method for providing notice to the public. See, e.g., CAA 165(a)(2). The EPA's air permitting regulations also address the issue of public participation, and in those rules there is more specificity regarding the methods of meeting the public notice obligations. The EPA's regulations are intended to ensure that the EPA and other permitting authorities provide adequate public notice of their permitting actions. Among the procedural requirements for public notice, the current regulations for the major NSR, title V and OCS programs include (or cross reference to) specific language that requires agencies to notify the public of pending permitting actions and the opportunity to comment on those permitting actions by advertisement in a newspaper of general circulation.8

When the EPA first developed public notice provisions for the major NSR program in the late 1970s and early 1980s, newspaper advertisement was the most commonly accepted method for providing notice of permits and other agency actions in the community. The EPA, therefore, finalized rules that contained, among other things, requirements for newspaper notice of permitting and other actions. When the title V rules were first issued in 1992, the EPA considered the public notice requirements for PSD permits and similarly required in part that the public be notified of a permitting action by way of “a newspaper of general circulation in the area where the source is located or in a State publication designed to give general public notice.” 40 CFR 70.7(h)(1).9 OCS regulations, also promulgated in 1992, included this same approach of requiring public notice via newspaper publication, by requiring that the applicable requirements for federal PSD permits in 40 CFR part 124 also apply to the processing of OCS permit applications.10 The EPA also added specific language within the OCS rules that require COA designation determinations to be announced by way of a newspaper of general circulation. Consequently, in promulgating the rules for NSR, title V and OCS air programs, the EPA determined that it was most appropriate for permitting actions, COA designations, and public hearings to be announced to the public by a newspaper notice. The public notice procedures in the regulations for each of these programs have not changed with respect to newspaper notification since they were first developed and issued.

Permitting authorities typically have met the required newspaper notice provision by publishing a single-day legal notice of availability of the draft permit action in a local newspaper. In some cases, depending on the location of the source and the demographics of the affected community, some permitting agencies may publish the notice in multiple newspapers to reach the intended audience, or may provide bilingual newspaper notices of their permitting actions. The specific contents of the newspaper notice are specified for some programs, and they tend to vary with different permitting authorities. Most notices typically contain basic information about the draft permit, such as the permit number, the name and physical address of the facility, and the name and contact information of a person from whom interested persons may obtain additional information on the draft permit. Depending on the permitting authority, the notice may include more detailed information on the draft permit, such as the anticipated emissions increase from the proposed project. The public notice for the permit also informs interested parties on how to request and/or attend a public hearing and how to access additional information relevant to the draft permit. This additional information is typically housed in a designated public reading room near the source or in a library at the permitting agency with specified hours of operation for viewing the documents. In the case of title V permits, as well as PSD and OCS permits that follow 40 CFR part 124, the regulations also provide for mailing lists for permit actions and, as a result, notice may also occur for these draft permits (in addition to the mandatory newspaper notice) via direct mail or other communication to those persons included on a mailing list.

Over the years, however, availability of and access to the basic forms of electronic media—namely, the Internet and email—have increased significantly across the United States. More recently, sophisticated mobile devices and high-speed wireless networks are transforming the Internet and how our society interacts with it.11 One effect of this electronic media development is that circulation of newspapers and other print media is declining, making printed newspaper notice less effective in providing widespread public notice of permit actions. Over the same time period, many permitting authorities developed their own Internet Web sites and began using email for the purpose of communicating with the public. In doing so, many of these agencies began to supplement the required one-time newspaper publication with the posting of electronic notices of availability of draft permits via their agency Web sites. Once the permitting agency develops its Web site and formats it to post permitting notices, the agency has an effective and convenient way to communicate permitting-related information to the majority of the public. In addition, the effort and cost to post a notice on an already-established Web site is generally lower than the expense of purchasing a newspaper advertisement, and it generally enables broader and faster dissemination of information to interested and affected parties as compared to newspaper noticing.

The EPA believes that having the notice of availability and the draft permit remain electronically available on an agency's Web site for an extended period of time, as compared to a one-time publication in an area newspaper that directs the public to a reading room at the permitting agency, or at a library or other location near the source, results in a significant increase in public awareness of the proposed permitting action and access to the draft permit. Even without this additional electronic access to the draft permit, posting the notice for the duration of the public comment period provides more widespread public notice than a single-day publication in a newspaper of general circulation.

We note that, in some instances, communities that are potentially affected by a proposed permitting action may have limited access to the Internet, and therefore may rely more on newspapers for receiving their information. In these cases, newspaper publication can still provide a means to convey permitting information to these communities. However, we expect that in many cases these communities would have access to a public library with Internet access that would provide access to the online permit notices and draft permits. Furthermore, because many permitting authorities are now supplementing their newspaper notices with electronic posting of the notice on their agency Web site, it seems unlikely that the public would continue to seek out permitting announcements in newspapers in the future. As discussed later in this preamble, a report issued by the National Environmental Justice Advisory Council (NEJAC) found that publication in the legal section of a newspaper is antiquated and ineffective and is not ideal for providing notice to affected environmental justice (EJ) communities. Given this significant shift away from the public's reliance on traditional newspapers for information, and the corresponding increased reliance on the Internet, the EPA recognizes that newspaper notice is no longer the only, or most effective, method of announcing permitting actions to reach the public.

To this end, the EPA has identified the need to allow for more noticing options than just newspaper publication. In 2011, the EPA issued the Tribal NSR Rules that contained, among other things, requirements for noticing of permits in Indian country that allowed for options other than newspaper and print media.12 The July 2011 rule provides options such as web posting and email lists among the methods that the permitting authority may use to provide adequate public notice in agreement with the prominent advertisement goal. See 76 FR 38764. Then, through guidance issued in 2012, the EPA clarified its position on what constitutes public notice for minor NSR permit programs and is adequate to meet the requirement of “notice by prominent advertisement.” 40 CFR 51.161(b)(3). As noted above, the EPA's 2012 Memorandum explained, “. . . as the public continues to increase the use of web based sources of information and states experience decreases in budgets allocated for public noticing of permits, we believe that for the purposes of minor NSR programs and permits, the `prominent advertisement' requirement at 40 CFR 51.161(b)(3) is media neutral.” The guidance further explains that the EPA believes “it is appropriate to give state and local programs the flexibility to determine what constitutes prominent advertisement for purposes of minor NSR programs and permits, consistent with the overarching requirement that the public have routine and ready access to the alternative publishing venues.”

This action proposes to remove the mandatory requirement that draft permits for sources subject to the major NSR, title V or OCS programs be noticed in a newspaper of general circulation and instead allow the use of electronic methods to provide notice of draft permits. This action also proposes these same revisions for COA designations in the OCS program, permit rescissions under the federal PSD program, and noticing of federal operating permits programs. In the case of permits issued by the EPA or other agencies implementing 40 CFR parts 52 or 71, we are proposing to require that the EPA provide e-notice for all draft permits. For permits issued by other air agencies—specifically, agencies that implement 40 CFR parts 51 or 70—we are proposing that those permitting authorities would have the option to adopt either e-notice or traditional newspaper notice; however, they must select one of the noticing methods as their consistent noticing method to be used to notice all of their draft permits and their rules must reflect this selection.

This proposed action also requires that, if the permitting authority adopts the e-notice approach, it would also provide e-access as described in this rule. Specifically, the agency would make the draft permit available electronically for the duration of the public comment period. Furthermore, this rule proposes specific minimum requirements for satisfying the meaning of the terms “e-notice” and “e-access.” While e-access in this rule pertains only to the availability and access to the draft permit, nothing in this rule nullifies the requirement for the permitting authority to maintain a record of the permit decisions and to make it available to the public. Hence, a permitting authority that is satisfying the proposed terms of e-access by posting the draft permit on its Web site must also maintain the other materials that support the permit decision and make them publicly available—either electronically, or at a physical location, or a combination of both. This proposed action does not affect any of the record retention or CBI policies of agencies.

More specifically, this proposed action includes revisions to 40 CFR part 51.166 (state/local PSD permits), part 52.21 (EPA/delegated agency-issued PSD permits), part 70 (state/local/tribal operating permits), part 71 (EPA/delegated agency-issued operating permits), part 55 (EPA-issued OCS permits and COA designations), and part 124 (EPA-issued permits applying generally to a number of media programs, including EPA-issued PSD and OCS permits). In addition, this action proposes to add specific public notice provisions in 40 CFR 51.165 (for state/local major NNSR permits), which currently does not contain section-specific public notification requirements (except for PAL permits).13 However, since the PSD program rules under 40 CFR 51.166 contain specific newspaper public notice provisions at § 51.166(q)(2)(iii), for clarity and consistency purposes we are proposing to add parallel noticing provisions to § 51.165 to avoid any possible confusion as to the methods for providing notice under approved state and local NNSR programs.

It is important to note that some of the rule sections that we are proposing to amend have existing noticing and access requirements that are specific to the section and may not appear in other sections. We are not proposing to alter these specific rule provisions in this action. For example, the notice requirements in § 51.166(q) relate to the “degree of increment consumption” that is expected from the source or modification, but these requirements are not in other sections. Similarly, parts 70 and 71 have differing requirements for what information the notice should identify. In the federal PSD and the OCS permitting sections, there are currently no specific provisions for permit noticing—nor are we proposing specific requirements through this action—but these sections cross reference the procedural requirements in part 124 for which amendments are being proposed in this action. Consequently, the proposed rule revisions that would allow for e-notice and e-access appear differently in each rule section, but the basic effect of the changes is the same across all of the sections being revised.14

In specifying that an agency electronically post the notice and draft permit “for the duration of the public comment period,” we note that there may be instances during the comment period when the Web site is unavailable. This may occur due to, among other things, Web site failures or power outages. While we expect that these situations would be infrequent and short in duration, they would nonetheless temporarily interrupt the noticing of the draft permit and the electronic posting would be less than “the duration of the comment period.” We do not interpret “the duration of the comment period” to be a requirement for uninterrupted web access, but rather to mean that, to the extent that interruptions to the accessibility of the posted notice and draft permit occur, they would be short and infrequent. Further, we expect that the permitting authority or webmaster would be in a good position to make a reasonable assessment, based on experience, regarding unusual interruptions that would significantly affect the noticing of the permit. In general, we do not expect that short interruptions would significantly affect the noticing of the permit, and we do not expect these situations to result in a need for the comment period to be extended to account for the time during which the Web site is unavailable. On the other hand, for an agency that is providing only electronic access to the permit record (i.e., no physical access options), Web site interruptions could present larger problems for anyone who is attempting to understand the draft permit and provide timely comments. In such cases, the air agency should evaluate the degree of limitation that the interruption has on the public's access to the permit record. For any interruption that impacts public access for an extended period, we recommend that the agency provide hard copies of the permit record at appropriate locations. In addition to taking comment on this proposed approach for the phrase “for the duration of the public comment period,” we are soliciting comment on whether we should include a provision in the regulations that allows a permitting authority to use an alternative noticing (and/or access) method to reach the affected public while the Web site is unavailable.

In addition to the proposed rule approach, we are taking comment on an alternative approach for air agencies that implement 40 CFR parts 51 and 70 that would not require these agencies to couple e-notice with e-access. In other words, if an agency adopts e-notice as its consistent noticing method, it would not be required to provide e-access (although the agency could provide e-access at its discretion—e.g., to supplement its physical access of the draft permit). This alternative approach may be of benefit to some agencies that notice permits using an online permits register—which would qualify for e-notice—but do not have the technical capabilities to satisfy the e-access requirement of making the draft permit electronically available.

These proposed rules provide flexibility to air agencies with EPA-approved programs, such that they are no longer required to use newspaper noticing, although they can continue to use the newspaper method for noticing if they choose. In the case of EPA and other air agencies that implement the federal permitting rules, we are proposing that these programs are required to use e-notice and e-access, but these terms are limited in scope to require only minimal electronic noticing and access and to allow the agency the flexibility to use either its own Web site or another publicly available Web site that it identifies. We believe the proposed rule revisions, once final, will lead to more effective noticing of air permitting actions and will likely promote additional public participation in the permitting process, while also avoiding the higher costs of newspaper advertisement.

For the purpose of this proposed rule, the term “e-notice” means the notice of availability of the draft permitting action is provided on the permitting agency's Web site or another public Web site identified by the permitting agency for the purpose of noticing permits. The Web site should be easily accessible by the public, and the noticing section of the Web site should be “user friendly”—i.e., organized in such a way that it directs the public to the entire notice in a clear and straightforward manner. In some cases, the Web site may be characterized as a “portal” or it can be some other publicly accessible Web site that is identified by the permitting authority and allows for the noticing of draft permits (e.g., a state permits register).

In some of the rule sections proposed for revision, the permitting authority must maintain a mailing list that will be used to notify persons on the list of any new public notice of a draft permit. This requirement exists in part 124 for EPA-issued PSD and OCS permits and in parts 70 and 71 for title V permits. We are proposing that the mailing list requirement would continue to apply for the noticing of these permits, and we are proposing that the mailing list requirement would not apply to programs that currently do not have a mailing list requirement—namely, agencies that follow part 51 regulations for PSD and NNSR permits and for state-issued OCS permits. Although the mailing list provisions were originally created with the idea that authorities would use the postal service to physically convey the notice to the recipients on the list, it has evolved over time such that many agencies that maintain a mailing list use electronic notification rather than mailing the notice through the postal service. In general, email notification has become a common practice among air agencies that currently provide supplemental notice via their agency Web site. Furthermore, many of these agencies' Web sites are equipped with a hyperlink or a radio button that facilitates convenient and easy sign up for interested persons to subscribe to the mailing list. Thus, we are not changing the current rule sections that require mailing lists, but we are updating the provisions to also allow agencies to use electronic methods to administer the activities of the mailing list, to include subscribing to the list, maintaining the list, and distributing the required information to the parties on the list. We expect that some agencies may use both electronic methods and more traditional methods (e.g., a mailing list sign-up sheet posted at a public hearing) to administer their permits mailing lists.

Part 71.11(d)(3) currently requires the EPA and delegated agencies to affirmatively solicit for their mailing lists. As part of this proposed rulemaking, we are proposing revised language for part 71 to explain that the permitting authority will notify the public via Web site of the opportunity to be included or removed from its mailing list. We expect that many agencies will add a generally accepted method (e.g., hyperlink sign up function, radio button) to their Web sites that will facilitate easy and convenient sign-up for their mailing list, as well as methods for unsubscribing. As noted above, many air agencies maintain a Web site that currently supplements the newspaper noticing of their permits with online noticing of their permits. Furthermore, some of these agencies rely on a variety of methods, beyond mailing lists, to alert the affected community that their Web site has been updated with a new draft permit or new information about a permit. Though not required under this proposed rule, we encourage air agencies to continue the practice of providing appropriate additional outreach to the general public for permits of interest. These outreach efforts may consist of opportunities presented by social media services (e.g., RSS feed, Twitter, Facebook) where appropriate, or more traditional techniques such as online community bulletin boards or community newspapers. We are proposing that use of these additional outreach methods is not required, but is discretionary for the permitting authority.

Also, it is important to reiterate that we are not proposing to alter any existing requirements regarding the content of the public notice. We are, however, expressly requiring that the notice direct interested parties to information on how to request and/or attend a public hearing and how to access additional information relevant to the draft permit. Requirements regarding additional information in the notice vary across the different sections of the permitting rules, and may further vary among different individual permitting authorities. Most notices of availability will contain, at a minimum, the permit number, name and physical address of the facility, and the name and contact information of a person from whom interested persons may obtain additional information on the draft permit.

We request comment on this approach to defining e-notice as it applies to this proposed rule. In particular, we request comment on whether this approach and the corresponding rule text preclude some forms of electronic noticing that are currently being used or under development.

To clarify what this action is proposing for e-notice, in the following section we provide a summary of the proposed rule requirements. In addition, we are providing recommended “best practices” for electronic notice. These best practices recommendations are intended to foster improved communication and outreach of permit notices beyond the minimum requirements being proposed in this action.

In order to satisfy the requirement for e-notice of a permit, the permitting authority shall electronically post, for the duration of the public comment period, the following information on a public Web site identified by the permitting authority:

(1) notice of availability of the draft permit for public comment;

(2) information on how to access the permit record (either electronically and/or physically);

(3) information on how to request and/or attend a public hearing on the draft permit; and

(4) all other information currently required to be included in the public notice under the existing regulations.

In addition, where already required by the current rules, the permitting authority shall maintain a mailing list of persons who request to be notified of permitting activity and shall distribute (e.g., by email) the above information to these persons.

While not proposed as a requirement of this rule, the EPA is recommending best practices that can be used to augment the above requirements for electronic notice. These best practice methods are not required to satisfy the e-notice requirements for this proposed rule, but may be helpful in the course of providing the fullest communication to the public on permitting actions. The recommended best practices of e-notice include:

• Providing notice of the final permit issuance on the Web site.

• Soliciting actively for the mailing list on the Web site (e.g., Web site equipped with radio button, hyperlink, or “click here” function to subscribe).

• Providing options for email notification that enable subscribers to tailor the types of notifications they receive (e.g., a person can request notification of only draft permit notices for major source actions, rather than receiving notice of all permitting activity by the agency).

For the purpose of this proposed rule, the term “e-access” means the permitting authority shall post on its Web site (or a Web site identified by the permitting authority) the draft permit for the duration of the public comment period. As with e-notice, the posting of the draft permit should be in a prominent location on the Web site, and the Web site should allow user-friendly access to the draft permit. Access to all other relevant materials that represent the record for the permit shall also be available to the public during the public comment period, but these other materials can be accessible either electronically or at a physical location, or in both locations. In this action, we are proposing that if the permitting authority provides e-notice, then it must also provide e-access.

In defining the requirements for e-access and authorizing the use of e-access for major source permits that are undergoing public notice, we are proposing to add new paragraphs to certain program rules and specifically revise other program rules that have draft permit access requirements containing language that could be read to suggest that access requirements could not be met through electronic availability of the permit materials. See, e.g., 40 CFR 51.166(q)(2)(ii), 55.5(f)(1)(i). These revised rule paragraphs would expressly allow for electronic availability of permit documents.

As noted above, nothing in this proposed rule affects the requirement for an agency to maintain a record to support the decisions of the permitting actions and to make it available to the public. Furthermore, nothing in this proposed rule affects the record retention policies and requirements of governmental agencies that provide schedules for retention and disposal of paper and electronic records. Finally, the electronic posting of draft and final permits, including information supporting the permit decisions (e.g., permit applications), would be subject to the applicable CBI policies and requirements of the air agency and, consequently, some permit-related documents may be redacted or otherwise withheld from viewing on a Web site or public reading room if it is determined that the document contains CBI.

We request comment on this approach to defining e-access as it applies to this proposed rule. In particular, we request comment on whether this approach and the corresponding regulatory text preclude some forms of electronic access that are currently being used or under development. Also, as noted above, we are requesting comment on an alternative proposal that does not require air agencies with EPA-approved programs to electronically post the draft permit (i.e., e-access) if they choose e-notice as their consistent noticing method.

To clarify what this action is proposing for e-access, in the following section we provide a summary of the proposed rule requirements. As we provided in the preceding section on e-notice, we are also sharing what we consider to be recommended best practices for electronic access.

In order to satisfy the requirement for electronic access, the permitting authority shall electronically post, for the duration of the public comment period, the draft permit on a public Web site identified by the permitting authority, which may include the permitting authority's public Web site, an online state permits register, or a publicly-available electronic document management Web site that allows for downloading documents. The draft permit file should be in a format that can be opened and viewed by the public using commonly accepted computer software (e.g., portable document format that can be opened with Adobe Acrobat Reader). We request comment on whether our rules should require that the electronic format of the draft permit be viewable by software that is “free” (i.e., available without charge) to the user.

The Federal Docket Management System (FDMS) at http://www.regulations.gov is a web-based docket system used for, among other things, federal permitting actions that require public notice and comment. This searchable docket system allows for public access and downloading of the draft permit and permit related documents. The http://www.regulations.gov Web site also allows the public to register to receive email alerts to track activity on selected dockets. Similar online data management systems exist in a number of states and allow agencies to provide digital access to permits and other records.

While not proposed as a requirement of this rule, the EPA is recommending best practices that can be used to augment the above requirement for electronic access. These best practice methods are not required to satisfy the e-access provision for this proposed rule, but may be helpful in the course of providing the fullest communication to the public on permitting actions. The recommended best practices of e-access include:

• Continued posting of the draft permit on the Web site past the public comment period (e.g., until issuance of the final permit or until the permit application has been denied or withdrawn).

• Posting the final permit on the Web site for a specified period of time after issuance of the permit (e.g., through the permit appeal period or petition period).

• Posting (or hyperlinking to) other key permit support documents on the agency Web site or on a publicly-available online document management site (e.g., FDMS), such as the permit application, Statement of Basis, fact sheet, preliminary determination, final determination, and response to comments.15

For programs in which the permits are issued by the EPA or by an air agency that implements the EPA's federal permitting rules (i.e., 40 CFR parts 52, 55, 71 or 124), the EPA is proposing specific changes to the public notice and permit access methods. We are proposing to remove the mandatory newspaper notice requirement and mandatory access to the permit information at a physical address, and to replace these requirements with mandatory e-notice and mandatory e-access, as those terms are outlined in this rule, as the consistent noticing method for major source permits issued under the federal rules for NSR and title V, and for all EPA-issued OCS permits.16 While each of these programs currently has specific rule provisions for noticing that may be worded differently depending on the program, we are proposing to replace the existing rule provisions with consistently worded provisions that describe the requirements for mandatory e-notice and e-access.

As noted in the above sections of this preamble, if an agency is satisfying the requirements of e-notice and e-access, the permitting authority would retain the discretion to supplement the e-notice with any other noticing method (e.g., newspaper publication, announcement through social media) depending on the specific circumstances of the permit application, such as the location of the proposed project and the accessibility of information sources by the affected community and other stakeholders. Moreover, the EPA recommends that agencies supplement their Web site postings with notices in newspapers and other forms of print media when noticing draft permits for facilities that are in areas where the agency believes such print media may enhance noticing efforts for certain audiences among the interested public. The EPA specifically encourages agency practices that consider the input and special needs (such as social, economic and geographic factors at the location) of the particular communities that may be affected by a permit action in order to provide public notice by methods that would better reach particular communities.17 Thus, we are not proposing to require that the permitting agency provide additional noticing methods beyond e-notice. At the same time, nothing in the proposed rule revisions prevents the permitting agency from also providing additional notice by a method other than e-notice.

With respect to title V in particular, the rule revisions include additional changes in order to support the movement to e-notice. Currently, the title V regulations in part 71 include the use of a mailing list for public notice purposes. This proposal includes regulatory revisions to amend the EPA's solicitation obligations associated with the mailing list, but it otherwise keeps the mailing list in place. The EPA interprets its rules, and understands that many air agencies do as well, to allow for the mailing list to be maintained in an electronic format. Further, the EPA recognizes that many air agencies also maintain their part 70 mailing lists in an electronic format and that such a format is generally supported by stakeholders as well. See, e.g., Clean Air Act Advisory Committee (CAAAC) Task Force Report at 202, 206-207.18 With respect to the EPA's mailing list obligations for the federal program, we are proposing to remove the specific language within 40 CFR 71.11(d)(3)(E) and 71.27(d)(3)(E) that requires the EPA to solicit mailing list membership through “area lists” and “periodic publication in the public press.”

Similar changes are proposed for 40 CFR part 124, which are “general program requirements” that apply to federally-issued PSD and OCS permits, as well as permits issued for other media programs. 40 CFR 52.21(q), 40 CFR 55.6(a)(3). Due to the existing language in part 124 covering a number of permit programs other than air permitting, the EPA is proposing minor revisions to part 124 in order to maintain the current provisions for the other permit programs and to specifically clarify public notice requirements associated with EPA-issued PSD permits (and PSD permits issued by any program that implements 40 CFR 52.21). In this action, we are proposing to establish a new paragraph within paragraph 124.10(c)(2) that applies exclusively to PSD permits (and OCS permits, which use the PSD provisions) with clearly identified public notice requirements that will require e-notice rather than newspaper notice. The part 124 provisions would continue to require the agency to solicit the public to be added to a mailing list and to provide specific notifications (e.g., state, local governments, resource agencies). However, the proposed new provision would allow that in lieu of the existing requirement in part 124 regarding soliciting persons for “area lists” and notifying the public of the opportunity to be on a mailing list, the agency may use generally accepted methods (e.g., hyperlink sign up function or radio button on agency Web site, sign-up sheet at public hearing) that enable interested parties to subscribe to the mailing list.

The OCS regulations specify that EPA will use the applicable administrative and procedural requirements in 40 CFR part 124 and the federal title V rules (part 71 is incorporated by reference), and that the Administrator will follow the procedures used to issue PSD permits when using 40 CFR part 124. 40 CFR 55.6(a)(3), 40 CFR 55.13(f), 40 CFR 55.14(c)(5). Hence, as e-notice flexibility is added to parts 71 and 124, it will be incorporated by reference into the OCS regulations for EPA-issued OCS permits. In addition, specific language referencing the administrative procedures of 40 CFR 71 is proposed to be added to the Administrative Procedures and Public Participation requirements provisions of the OCS regulations to clarify that EPA may use either the applicable administrative procedures of 40 CFR 71 or 40 CFR 124 when issuing OCS permits.

We note that some air programs with EPA-approved plans for implementing the PSD program incorporate by reference the federal rule provisions—e.g., 40 CFR part 52.21. Furthermore, some of these program rules automatically update whenever the EPA revises its rules and the revisions become effective. These agencies would not have the option to continue with newspaper notice as their noticing method (unless they revise their rules and undertake a SIP revision to remove the referencing of the federal rules). These agencies would be required to provide e-notice and e-access according to this rule. This same scenario would apply to programs that are delegated by the EPA to implement 40 CFR 52.21 and issue PSD permits on behalf of the EPA. We specifically solicit comment on whether any air program that incorporates by reference the federal permitting rules would have difficulty meeting the e-notice and e-access requirements of this proposed rule if the revisions become effective immediately upon finalizing the rule. We also solicit suggestions for addressing such difficulties.

In addition, we are proposing to delete a superfluous provision from 40 CFR 52.21(q) “Public participation.” The second sentence reads “[t]he Administrator shall follow the procedures at 40 CFR 52.21(r) as in effect on June 19, 1979, to the extent that the procedures of 40 CFR part 124 do not apply.” The preamble to the 1980 NSR rules explained the transition from the previous regulations to the consolidated permitting regulations at part 124: “. . . the procedures of the 1978 Part 52 regulations continue to apply to the extent that the new procedures have not yet displaced them. In time, the new procedures will displace the old ones entirely.” See 45 FR 52686, August 7, 1980. Since the procedures of 40 CFR 124 have displaced the old procedures, this sentence is no longer necessary.

We solicit comment on this “mandatory e-notice and e-access” approach for permit programs implemented by the EPA and by other agencies implementing the federal air permitting rules.

For the noticing of major source permits issued pursuant to EPA-approved air agency programs under 40 CFR part 51 or 70, we are proposing to remove the mandatory newspaper notice requirement and provide these agencies with the option to select either e-notice or newspaper notice. A required element of these programs is to provide adequate notice and informed public participation, and this program element is not changing. However, a key aspect of this proposed approach is that the agency would be required to adopt one noticing method—known as the “consistent noticing method”—to be used for all of its notices. Thus, if an agency selects e-notice, it must provide e-notice for all of its draft permit notices. If a consistent noticing approach is not adhered to (i.e., if the agency posted some notices to its Web site and others in the newspaper), it could lead to confusion for the public, who may not know where to look for permitting information regarding a source proposing to locate in the community. Accordingly, if the agency elects e-notice as its consistent noticing method (and e-notice is not available in its approved SIP), it must implement its choice of noticing method through a change in its program rules. As discussed later in this preamble, we are requesting comment on whether there are air agencies that believe they can implement e-notice and e-access in lieu of newspaper notice without contravening their state rules.

As with the proposed mandatory requirements for e-notice for the federal programs, if the e-notice option is chosen as the consistent noticing method for a particular state program, the state must use e-notice to provide the information required under existing public notification regulations and must provide e-access to the draft permit. All other permit documents required under existing regulations can be accessible either electronically or physically (i.e., in a designated reading room). However, if the agency chooses newspaper notice as the consistent noticing method, then the agency can either provide electronic access or physical access (or both) to the additional materials that existing regulations require be made publicly available.

We are aware that many states already have Web sites that are actively used for permitting purposes—e.g., permit application instructions, form downloads, online permit applications. Consequently, we anticipate that most of these state agencies will opt for the e-notice approach, since it may mirror what they are already doing to supplement their newspaper notice. For these agencies, we believe this change would be minimally burdensome and would relieve them of the additional burden of providing newspaper notice. At the same time, we recognize that some air agencies do not have an established Web site, or they may have a Web site but they would need to invest in significant infrastructure to increase their Web site capability in order to accommodate the posting of permit information that existing regulations require be included in a newspaper notice. These agencies may opt to continue with the newspaper notice as their consistent noticing method.

With regard to part 70, the proposed revisions would affect only the mandatory newspaper language, and would not change any other obligations such as the requirement to have or maintain a mailing list. The EPA interprets the existing mailing list obligations to include either electronic or hardcopy mailing list, or both, at the reasonable discretion of the air agency.

Furthermore, nothing in these proposed revisions to parts 51 and 70 prevents the air agency from also providing public notice through other methods including, but not limited to, a newspaper notice. As with our proposal for noticing of permitting actions under the federal rules, under this proposed option, agencies would have the discretion to provide public notice through other methods—in addition to their consistent noticing method—if a particular permit action warrants it and ensure that the notice of the draft permit reaches the affected community and stakeholders. We encourage all air agencies to consider facility- and permit-specific facts in determining the appropriate methods of public notice, such as expected public interest, location and type of source being permitted, environmental justice considerations, including the language that will be understood by the affected community.

To summarize, we propose that for air agencies that implement 40 CFR part 51 or 70, for the noticing of their major source draft permits, they either provide: (1) Mandatory e-notice and e-access, as these terms are used in the context of this proposed rule, or (2) newspaper notice with either electronic access (e.g., Web site) and/or physical access (e.g., reading room) to the draft permit. In choosing (1) or (2), they must use a consistent method of noticing. These air agencies can continue to supplement the consistent noticing method with other noticing methods at their discretion or as currently required under part 70. We specifically request comment on this approach for EPA-approved NSR and title V permit programs to establish either “e-notice” or newspaper notice as the single, consistent noticing method.

As noted above, since many air agencies with EPA approved programs currently have a Web site and notice draft permits and provide permit documents on their Web sites, we do not believe that the e-notice requirement would impose any additional burden on most agencies. We are specifically seeking comment on whether (and how significantly) this rule imposes additional burden on air agencies that already provide postings of permits on their Web sites and those air agencies that do not already use a Web site for permit postings.

Finally, the EPA is requesting comment on two alternative approaches to the ones being proposed in this rule and described above, one for providing notice and the other for providing access. In the first alternative approach, an agency implementing rules pursuant to either part 51 or 70 would not be required to choose a consistent noticing method. Thus, the agency could potentially provide one noticing method for some permits (or some types of permits) and another noticing method for other permits. This approach is analogous to the “media neutral” approach that is available under § 51.161 for the noticing of minor NSR permits, as well as the approach adopted in the Tribal NSR Rule. See 40 CFR 49.157(b)(1). Neither of these other program rules requires a consistent noticing method. Thus, under such an approach for this rule, we would amend the part 51 and 70 rules that currently require “newspaper” notice to require use of Web site or newspaper notice, but without specifying a consistent noticing method. Alternatively, to provide additional flexibility to the agency, we could simply require that they provide notice via “a method reasonably likely to provide routine and ready access to the public” without imposing any more specific requirements. The EPA requests comment on whether to allow such an approach, how likely it is that this approach could lead to confusion (e.g., if the permitting agency regularly or frequently changed its noticing method from one permitting action to another), and whether EPA should require the permitting agency to specify the circumstances under which it will use a particular method or articulate criteria for doing so. The EPA also requests comment on whether it is reasonable to assume that permitting authorities would try to avoid such problems because each agency is ultimately responsible to ensure that it provides adequate notice on each of its permits and access to the permit information. In other words, does the suggested requirement for the agency to notice via “a method reasonably likely to provide routine and ready access to the public,” in and of itself ensure that some level of noticing consistency is achieved?

The EPA also requests comments on a second alternative approach to providing access, under which e-notice would not need to be coupled with e-access for state agency programs implementing approved rules pursuant to parts 51 and 70. This may help some states that notice permits using an online permits register (which would qualify for e-notice), but where the state may not have its own Web site to satisfy the “e-access” requirement of making the draft permit available electronically. As noted elsewhere in this preamble, the state would still be required to provide access to the draft permit, as well as any other documents that are part of the permit record.

We are requesting comments on adding a provision to each of the program rules that would allow an agency that is relying on e-notice (and/or e-access) to temporarily use another noticing medium for a reasonable period of time during which its Web site is unavailable. This may be necessary during planned Web site outages (e.g., a transition to a different Web site platform) or unforeseen circumstances, such as Web site malfunctions or emergency situations (e.g., hurricanes) that result in prolonged electrical system outages. We do not believe this same problem existed under the current regulations that require newspaper notice. This is based on the assumption that, in the event that a problem occurs with a newspaper that the agency plans to use, the agency can notice the permit in another newspaper in the area that it determines would provide adequate notice.

If an alternative noticing method is used, it would need to be publicly announced in some way before they occur, so that the public has reasonable notice of where to look for permit notices during such outages. It would also need to assure adequate notice to the affected public. Noticing either in the newspaper or State Register could be an agency's alternative noticing method, since each method is generally presumed to provide adequate notice to the public.

Given the broad range of situations that could lead to problems with a Web site, it may be difficult to specify the limits of the duration of the “temporary” period. We expect that most agencies would generally have an incentive to restore operations to their Web site as soon as possible for cost purposes and to ensure that they continue to provide the most effective notice of their permitting actions. We request comment as to whether providing specific boundaries around the use of the alternative noticing method should be required, and how those boundaries should be established and what criteria should be used to judge their adequacy. We specifically seek comment on the appropriate criteria for invoking the alternative noticing method, the length of time it could be used, and how the transition to the alternative method would be conveyed to the public.

As noted earlier in this preamble, this rule proposal is not revising any regulatory requirements for minor NSR permits. Notably, this rule proposal is not revising the requirement for “notice by prominent advertisement” in 40 CFR 51.161(b)(3), because the prominent advertisement term, as discussed in the EPA's 2012 Memorandum, is sufficiently broad to allow for e-notice. However, while we are reaffirming the guidance provided in the EPA's 2012 Memorandum, we are proposing to amplify its policy guidance in two respects.

This rule is proposing to clarify that the EPA's 2012 Memorandum's interpretation of “prominent advertisement” in paragraph 51.161(b)(3) as “media neutral” also applies to paragraph 51.161(b)(1). The provision currently reads: “[a]vailability for public inspection in at least one location in the area affected of the information submitted by the owner or operator and of the State or local agency's analysis of the effect on air quality.” Thus, paragraph 51.161(b)(1) does not expressly require that permitting information be made available in the form of paper records, and we are proposing to clarify that it allow for electronic access to the permitting information. More specifically, we are proposing that allowing electronic access to the information submitted by the owner or operator and to the agency's analysis of the effect on air quality by way of a Web site identified by the permitting authority would satisfy the requirement of “availability for public inspection in at least one location in the area affected . . .” We believe this approach is consistent with the memorandum with respect to allowing use of electronic and other methods to provide notice of minor NSR actions, and it is reasonable for the same reasons discussed in this preamble for allowing electronic access to permit documents for major source permits. We specifically request comment on this clarification for the minor NSR program rules.

In addition, in issuing the EPA's 2012 Memorandum, the EPA indicated that our guidance on the meaning of the term “prominent advertisement” in 40 CFR part 51.161(b)(3) applies only to minor sources and not to synthetic minor sources. See Footnote 1. Given the statement in the memorandum, which raises uncertainty about the flexibility to use media neutral methods for synthetic minor programs, the EPA has now determined that it is not appropriate to exclude synthetic minor permits in this regard, and that this action should propose to clarify that the limitation established in the footnote is no longer appropriate. In this action, we are proposing to treat minor and synthetic minor sources identically in this regard by extending the EPA's media neutrality policy to synthetic minor sources. In addition, we propose to extend this policy to any permit action that relies on the public notice requirements of § 51.161.

We seek comment on these two proposed revisions to the policy guidance provided by the EPA's 2012 Memorandum. Through the preamble to the final rule for this action, we intend to provide amplifying guidance with regard to the EPA's noticing policies for permits subject to 40 CFR 51.161.

In addition to the existing mandatory newspaper notice required for draft permits, part 71 permits programs and COA designations, the permitting program rules contain another regulatory provision that provides for newspaper notification. In the federal PSD regulations, a provision titled “permit rescission” requires that “[i]f the Administrator rescinds a permit under this paragraph, the public shall be given adequate notice of the rescission” and that notice “in a newspaper of general circulation in the affected region . . .” is considered adequate. 40 CFR 52.21(w)(4). While this language does not foreclose the notion that another type of noticing method could also be “adequate,” we are proposing to revise the rule provision to specifically require that the permitting authority notify the public of a permit rescission electronically—i.e., on a Web site identified by the permitting authority. This “mandatory e-notice” approach for permit rescissions under 40 CFR 52.21(w) is consistent with our approach for the noticing of other actions that implement the federal program rules. We specifically request comment on whether this is an appropriate approach for the noticing of a permit rescission.

This proposal to revise these CFRs to allow permitting authorities to provide public notice of permits and other actions on a publicly available Web site in lieu of the newspaper publication requirement, when final and effective, would reduce burden to all air agencies. In addition, the proposed requirements are consistent with practices some permitting agencies currently follow to supplement existing requirements for noticing permits, and they would provide flexibility for agencies to use the noticing methods that they determine are appropriate, reasonable and effective without the need for newspaper notice. These proposed changes are consistent with the approaches taken in EPA's permitting rule for Indian country and in EPA's minor NSR regulations, and with broad stakeholder input regarding more effective advertisement of permitting actions.

As noted earlier in this preamble, Internet Web sites have become an increasingly effective and widely employed avenue for broadly disseminating information to the public and many agencies currently supplement the required newspaper publication by posting draft and final permits on their agency Web sites. Since the Internet is generally available at all times, it allows for the noticing of a permit, and for the information that supports the permit, to be available and accessible over a longer period of time, rather than a one-day newspaper publication of the notice. As noted above, most states are already using the Internet (to varying degrees) for noticing permitting actions, so we do not anticipate many agencies having to spend a lot of time or funding on upgrading their existing Web sites to meet the proposed requirements. For agencies currently without a Web site for noticing permits and hearings, the use of e-notice and other applicable alternatives may allow the permitting authority to redirect funds that were being used for newspaper publication in order to establish and maintain a Web site where permit information could be posted. Thus, the EPA anticipates these proposed rule revisions, when finalized, would result in more effective dissemination of permitting and hearing information to the surrounding communities (including the underserved and environmental justice (EJ) communities) and possibly substantial cost savings for both the EPA and for state and local program permitting authorities.

We believe these proposed requirements are consistent with CAA goals of providing public notice and promoting access to information in permitting, and they would enhance the permitting process. With respect to preconstruction permit actions, CAA § 160(1) establishes a statutory policy of providing for informed public participation in the permitting process, and CAA § 165(a)(2) precludes issuing a PSD permit without an opportunity for the public to review the decision and submit comments. These proposed revisions enable the use of e-notice and e-access for both EPA-issued and other agency-issued permits and further the statutory policies these provisions establish. With respect to operating permits, the 1990 CAA Amendments require that the EPA rules for permitting programs provide “adequate, streamlined and reasonable procedures” including an opportunity for the general public to have informed participation in the air permitting process in the areas affected by a proposed permit. CAA § 502(b)(6). Also, § 502(b)(8) provides that procedures to make information available should be consistent with the need for expeditious action on permit applications or related matters. The proposed revisions, which enable the use of e-notice for both EPA-issued and other agency-issued permits, would improve implementation of the statutory policy of ensuring public notice of title V permits by providing more effective noticing procedures in affected areas across the country.

Another basis for, and benefit from, the proposed action would come from the cost savings associated with the move to electronic notification instead of legal notice advertisements in newspapers. The EPA's annual costs for publishing notices in newspapers is a significant annual expenditure, and it is the EPA's understanding that the newspaper publication for noticing permits has become costly for states as well. The EPA's proposal intends to reduce those costs by allowing the permitting authority to notice draft permits using a publicly available Web site in lieu of newspaper publication. While e-notice may pose a burden for certain states that do not already have a permitting Web site, the EPA is not mandating that permitting authorities that implement 40 CFR part 51 or 70 adopt the e-notice and e-access approaches, so these agencies can continue with the current program of newspaper publication if they prefer. In addition, permitting authorities that incorporate by reference the federal PSD rules at 40 CFR 52.21 that wish to continue to use newspaper notice as their primary method of notice can undertake a SIP revision to remove the reference to the federal provisions and adopt their own noticing rules that conform to § 51.166.

As an example of the approximate costs for publishing permit and hearing notices in the newspaper, in Fiscal Year 2013, the EPA Regions incurred a cost of over $40,000 to publish newspaper notices for NSR, title V and OCS permits. In Fiscal Year 2014, newspaper notice for the EPA regional permits exceeded $35,000. Newspaper publication costs vary widely depending on a number of factors, but for most permits the cost to notice averages between $600 and $1,000 per notice. While these costs vary on a yearly basis in each EPA Region, the overall annual costs are significant for the EPA. Moreover, given that state and local air agencies generally process more air permits than the EPA, it is reasonable to expect that the annual costs incurred for newspaper publication by state and local permitting agencies exceed the annual costs incurred by the EPA. (We note, however, that some air agencies require that the applicant bear the cost of newspaper publication.)

While we recognize that there is a cost associated with developing and maintaining an agency Web site for the purpose of noticing permits, the incremental cost to upload permit notices is expected to be very low, and we expect the overall burden would be less than that of the existing rules that mandate newspaper publication. This is because most agencies already have their own Web sites (or some other means to electronically notice draft permits and hearings) and they will continue to have their Web sites regardless of the requirements that are being proposed by this action. Thus, even though the costs of creating, upgrading and maintaining a Web site and providing web security may very well be many times higher than the cost of an agency's annual newspaper notice, states are choosing to continue to have a Web site due to the convenience of noticing and the ability to level out the overall costs of the Web site across all of the program areas of the agency. Furthermore, for agencies that already do web postings and posting of the draft permit, the newspaper requirement is duplicative and consequently the removal of the requirement would result in savings. The EPA specifically seeks comments on the potential cost savings, and the possibility of increased burden, from the specific noticing requirements in this rule proposal.

A broad range of stakeholders has identified e-notice as a more efficient, more prominent, less costly and more cost-effective, and more reasonable approach to public notice of permitting actions, as compared to newspaper notice. For example, e-notice is responsive to recommendations from the CAAAC's Title V Task Force Report, which includes a number of recommendations for implementation improvements, such as public notice. Importantly, task force members agreed unanimously on two recommendations related to the means of providing public notice. First, task force members recommended that state program rules should be allowed to include alternatives to newspaper notification, provided the alternative is more effective in informing a cross section of the affected public. (A remaining concern mentioned was that members of the public may lack routine access to the Internet.) See Recommendation #1 at 210. Second, task force members agreed that states should improve their title V Web sites to provide better notice and access to relevant documents in a permit proceeding. Accordingly, the Final Report recommended that the EPA should encourage permitting authorities to provide the option to receive notification by email instead of traditional mail, and to maintain their Web sites with information, documents, and dates helpful for public participation, including how to sign up to be included on a mailing list. See Recommendation #3 at 210. While these recommendations were focused on permitting under title V, the EPA believes that the same concepts and concerns would also apply to NSR and OCS permits.

As noted in the previous sections, providing e-notice is consistent with noticing requirements of the EPA's Tribal NSR Rule issued in 2011 and with the EPA's 2012 Memorandum that clarified the term “prominent advertisement” is media neutral for the minor NSR program. This action also supports Executive Orders 13563 and 13610 (issued in 2011 and 2012, respectively), which direct the Agency to modernize its rules periodically in order to achieve regulatory objectives more effectively, considering the agency resources and priorities.

Once this rule becomes final, it will become effective within 30 days for air permitting programs that implement the federal program rules at 40 CFR parts 52, 55 and 124. This includes EPA Regions, air agencies that are delegated authority by the EPA to issue permits on behalf of the EPA (via a delegation agreement), and air agencies that have their own rules approved by EPA in a SIP and the SIP incorporates by reference the federal program rules and automatically updates when EPA's rules are amended. Under this rule proposal, these programs would be required to implement e-notice and e-access, with the exception of states that are delegated authority to issue permits under part 55 (as described earlier in this preamble).

While we expect that most programs that implement the federal permitting rules are in a position to comply with the proposed requirements for e-notice and e-access once this rule is finalized, some programs may need more time. More time may be necessary if, for example, a delegated air program needs to upgrade or improve its Web site to allow for e-notice and/or e-access. We request comment on whether any air programs that would be required to immediately implement 40 CFR 52.21 would need a “phase in” period, beyond the 30 days, in order to implement e-notice and e-access.

For an air agency with an approved SIP that implements 40 CFR part 51 and that chooses e-notice and e-access as its consistent noticing method, it may need to revise its applicable program rules and seek the EPA's approval of a SIP revision in order to begin to implement e-notice in lieu of newspaper notice. (However, NNSR programs under § 51.165 are subject to the public participation requirements at § 51.161 and may be able to interpret their state rules and SIP to currently allow for implementing e-notice in lieu of newspaper notice.) Similarly, for an agency that implements rules that incorporate by reference our federal program regulations (40 CFR 52), and if its rules do not automatically update upon the EPA amending its federal rules, it may need to amend its regulations and seek the EPA's approval of a SIP revision in order to implement e-notice and e-access in lieu of newspaper notice.

Under this proposed rule it is voluntary for these programs to move to e-notice and e-access, and we are not proposing to impose a deadline for submission of SIP revisions for those programs that are choosing to adopt e-notice and e-access instead of newspaper notice. Furthermore, nothing in the current or proposed 40 CFR part 51 rules prevents an agency from beginning to implement e-notice and e-access methods once the agency is ready, but depending on the air agency's rules there may be ongoing obligations to continue with newspaper notices until the agency revises its rules. We request comment on whether agencies believe they have the ability to implement e-notice and e-access in lieu of newspaper notice without amending their state rules.

Consistent with title V and the part 70 regulations for initial program submittals, approved part 70 programs must provide for implementation of 40 CFR 70.7, including subsection “h” which sets forth the public participation obligations including “adequate procedures for public notice.” See, e.g., 40 CFR 70.4(b)(16). A program revision may be necessary when the relevant federal regulations are modified or supplemented. 40 CFR 70.4(i). When part 70 is revised after the air agency program is approved, the EPA determines the need for conforming revisions, but the approved program may initiate a program revision on its own initiative. See, e.g., 40 CFR 70.4(a) and (i). Under the proposed rulemaking, air agencies implementing part 70 have a choice as to whether or not to adopt e-notice as their consistent method of public notice of air permits. If an air agency chooses that approach and a program revision is necessary (e.g., additional authority is needed), then the agency should initiate a program revision by undergoing a rule change and submitting a program revision package to the EPA for review and approval consistent with § 70.4(i)(2).

As previously noted in this preamble, this proposal would not change the requirement to provide “adequate procedures for public notice.” Consequently, we believe that a program revision will not necessarily be required for all approved programs and that certain agency programs could implement e-notice and e-access upon approval of the rules at the state level. We propose that, for an agency that needs only to revise the agency program rules to clarify its implementation of e-notice and e-access but does not otherwise require a program change because the current program practice includes electronic posting of public notices and the draft permit and has adequate authority and resources for maintaining the practice, that such agency does not need a program revision for implementing the revised part 70 notice requirements. We request comment on our proposed determination that certain approved programs will not need a program revision for implementing e-notice. Alternatively, the EPA proposes that these program revisions are non-substantial. Accordingly, the EPA Regional offices would issue direct approvals of these program revisions concurrent with their notice of proposed approval. We request comment on our interpretation that the program revisions are non-substantial.

With regard to the proposed part 71 program revisions, once the rules are finalized, an air agency that is delegated the part 71 program would likely need to update its delegation agreement to update its notice procedures consistent with the e-notice requirement in the federal rules.

The 1990 CAA Amendments generally require that the EPA or the permitting authority provide for adequate procedural opportunity for the general public to have informed participation in the air permitting process in the areas affected by a proposed permit. These areas include EJ communities.

The effectiveness of noticing methods for reaching underserved and EJ communities is a substantial concern to the EPA. A 2011 report issued by NEJAC found that publication in the legal section of a regional newspaper is antiquated and ineffective, and is not ideal for providing notice to affected EJ communities.19 Regarding public participation, the report recommends to the EPA: “To ensure meaningful public participation, the public notice and outreach process must include direct communication in appropriate languages through telephone calls and mailings to EJ and tribal communities, press releases, radio announcements, electronic and regular mail, Web site postings and the posting of signs.” Thus, the NEJAC specifically listed Web site postings as a method to ensure meaningful public participation. The EPA concludes that notice via the Internet would be a viable and effective means of making information widely available to the public. We encourage permitting authorities to provide additional notice where they determine that a specific jurisdiction or population would be better served with notice by traditional newspaper or another noticing method.

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 any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control numbers 2060-0003 (for PSD and NNSR permit programs) and 2060-0243 and 2060-0336 (for operating permit programs).

In this action, the EPA is proposing to revise regulations to address public noticing method requirements for permits for major sources of air pollution. It is important to note that the proposed rule revisions would not require air agencies that implement the permitting program through an EPA-approved title V program or SIP to use e-notice. These agencies may continue to provide notice by newspaper publication or they can adopt e-notice as their consistent noticing method. Only in the latter case would an agency be required to revise the title V program rules or undertake a SIP revision. For EPA-delegated agencies, and for agencies that incorporate by reference the federal rules and their rules automatically update when the EPA revises its rules, no rulemaking action would be required by the agency to adopt the e-notice requirements. In addition, an agency delegated a part 71 program may need to update its delegation agreement. However, if any of these agencies desire to continue to provide notice by way of newspaper publication, they could request removal of delegation, revise their program rules consistent with the rules for state programs (e.g., 40 CFR 51.166), and undertake a SIP revision. An agency delegated the part 71 program may have to choose between implementing e-notice, obtaining approval for implementing a part 70 program, or relinquishing their title V program. Given that many air agencies already are providing various forms of electronic notice as a supplement to their newspaper notices, we anticipate that many agencies will cease to notice permits by way of newspaper. However, to the extent that a SIP revision or a title V program revision is necessary to effect the changes being proposed, we believe that the burden is already accounted for under the approved information collection requests noted above.

In addition, the proposed rule would not create any new requirements for regulated entities, since air agencies are responsible for the noticing of permits. Some industry sources could experience a reduction in costs for permitting in cases where the permitting agency requires that the cost of the newspaper public notice be incurred by the permit applicant.

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. Entities potentially affected directly by this proposal include state, local and tribal governments, and none of these governments would qualify as a small entity. Other types of small entities are not directly subject to the requirements of this action.

This action does not contain any unfunded federal mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

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. Specifically, these proposed public notice revisions do not affect the relationship or distribution of power and responsibilities between the federal government and Indian tribes. Elsewhere in this preamble we specifically describe the interaction of this proposed rule with tribal air agencies. 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 it does not concern an environmental health risk or safety risk.

This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations because it does not affect the level of protection provided to human health or the environment. The results of this evaluation are contained in Section VII of this preamble titled, “Environmental Justice Considerations.”

The statutory authority for this action is provided by 23 U.S.C. 101; 42 U.S.C. 6901, et seq.; 42 U.S.C. 300f, et seq. 33 U.S.C. 1251, et seq.; 42 U.S.C. 7401, et seq.

For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is proposed to be amended as follows:

This document extends the public comment period for the proposed Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS (80 FR 75706, December 3, 2015) in order to ensure that the public has sufficient time to review and comment on the proposal.

The Security and Accountability For Every Port Act of 2006 (SAFE Port Act, Pub. L. 109-347) requires all Federal agencies with a role in import admissibility decisions to collect information electronically through the ITDS. The Department of the Treasury has the U.S. Government lead on ITDS development and Federal agency integration. CBP developed Automated Commercial Environment (ACE) as an internet-based system for the collection and dissemination of information for ITDS. The Office of Management and Budget (OMB), through its e-government initiative, oversees Federal agency participation in ITDS, with a focus on reducing duplicate reporting across agencies and migrating paper-based reporting systems to electronic information collection.

The term ITDS refers to the integrated, government-wide project for the electronic collection, use, and dissemination of the international trade and transportation data Federal agencies need to perform their missions, while the term ACE refers to the “single window” system through which the trade community will submit data related to imports and exports. Detailed information on ITDS is available at: http://www.itds.gov.

Numerous Federal agencies are involved in the regulation of international trade and many of these agencies participate in the import, export and transportation-related decision-making process. Agencies also use trade data to monitor and report on trade activity. NMFS is a partner government agency in the ITDS project because of its role in monitoring the trade of certain fishery products. Electronic collection of seafood trade data through a single portal will result in an overall reduction of the public reporting burden and the agency's data collection costs, will improve the timeliness and accuracy of admissibility decisions, and increase the effectiveness of applicable trade restrictive measures.

NMFS is responsible for implementation of trade measures and monitoring programs for fishery products subject to RFMO documentation requirements and/or documentation requirements under domestic laws. RFMOs are international fisheries organizations, established by treaties, to promote international cooperation to achieve effective and responsible marine stewardship and ensure sustainable fisheries management. The United States is a signatory to many RFMO treaties, and Congress has passed implementing legislation to carry out U.S. obligations under those treaties. Trade measures and monitoring programs enable the United States to exclude products that do not meet the criteria for admissibility to U.S. markets.

NMFS notes that the MSA defines “import” to mean “land on, bring into, or introduce into, or attempt to land on, bring into, or introduce into, any place subject to the jurisdiction of the United States, whether or not such landing, bringing or introduction constitutes an importation within the meaning of the customs laws of the United States; but . . . does not include any activity described [above] with respect to fish caught in the exclusive economic zone or by a vessel of the United States.” 16 U.S.C. 1802(22). This definition of “import” covers a broad range of activities, including but not limited to, customs entry for consumption, withdrawal from warehouse for consumption, or entry for consumption from a foreign trade zone. The following sections outline NMFS authorities for the various trade measures and trade monitoring programs that apply to fishery products.

The High Seas Driftnet Fishing Moratorium Protection Act (HSDFMPA) (16 U.S.C. 1826d-k) requires U.S. actions to address IUU fishing activity, bycatch of protected living marine resources (PLMR) and shark catch. Specifically, the HSDFMPA requires the Secretary of Commerce (Secretary) to identify in a biennial report to Congress foreign nations whose vessels engaged in IUU fishing or fishing practices that result in PLMR bycatch or shark catch on the high seas without a regulatory program comparable to that of the United States. The Secretary has established procedures to certify whether nations identified in the biennial report are taking appropriate corrective actions to address the activities for which they were identified (50 CFR 300, Subpart N). Certain fish and fish products from identified nations that do not receive positive certifications could be subject to import prohibitions under the authority provided in the High Seas Driftnet Fisheries Enforcement Act (HSDFEA) (16 U.S.C. 1826a-c).

Additionally, there are identification and/or certification procedures in other statutes, including the Pelly Amendment to the Fishermen's Protective Act (22 U.S.C. 1978) and the Atlantic Tunas Convention Act (ATCA) (16 U.S.C. 971 et seq.). These procedures may result in trade restrictive measures for a country for those fishery products associated with the activity that raised concerns. Further, import prohibitions for certain fishery products could also be applied under provisions of the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361 et seq.) and other statutes, depending on the circumstances of the fish harvest and the conservation concerns of the United States. Trade monitoring authority is also provided by the Dolphin Protection Consumer Information Act (DPCIA) (16 U.S.C. 1385) which specifies the conditions under which tuna products, eligible to be labeled dolphin-safe, may be imported into the United States.

Multilateral efforts to combat IUU fishing may also result in requirements to take trade action. The United States is a member or contracting party to several RFMOs. Many of these RFMOs have established procedures to identify nations and/or vessels whose fishing activities undermine the effectiveness of the conservation and management measures adopted by the organization. Fishery products exported by such nations or harvested by such vessels may be subject to import or sale prohibitions specified by the RFMO as a means to address the activity of concern. In these cases, the United States is obligated to deny entry of the designated products into its markets, unless it has lodged a timely objection to the RFMO measure establishing the import or sale prohibition. Relevant RFMO statutes include the ATCA, the Antarctic Marine Living Resources Convention Act (AMLRCA) (16 U.S.C. 2431 et seq.), the Western and Central Pacific Fisheries Convention Implementation Act (WCPFCIA) (16 U.S.C. 6901 et seq.), and the Tuna Conventions Act (TCA) (16 U.S.C. 951 et seq.).

Although the proposed rule would not amend existing regulations pertaining to any of the above trade measure authorities, import filing through ACE will facilitate U.S. Government implementation of trade measures when and if imposed. ITDS will facilitate sharing of data between agencies and allow for improved targeting of suspected illegal (or embargoed) shipments.

Pursuant to domestic statutory authorities and/or multilateral agreements, NMFS has implemented a number of monitoring programs to collect information from the seafood industry regarding the origin of certain fishery products. The purpose of these programs is to determine the admissibility of the products in accordance with the specific criteria of the trade measure or documentation requirements in effect. The three NMFS trade monitoring programs subject to this proposed rule are the HMS ITP program which regulates trade in specified commodities of tuna, swordfish, billfish, and shark fins; the AMLR trade program which regulates trade in Antarctic and Patagonian toothfish and other fishery products caught in the area where the Convention on the Conservation of Antarctic Marine Living Resources (CCAMLR) applies; and the TTVP, which regulates trade in frozen and/or processed tuna products, as well as certain other fishery products under the authority of the HSDFEA (refer to 50 CFR 216.24(f)(2)(iii) for a complete list). Generally, these trade monitoring programs require anyone who intends to import, export, and/or re-export regulated species to: Obtain a permit from NMFS; obtain documentation on the flag-nation authorization for the harvest from the foreign exporter; and submit this information to NMFS. Depending on the commodity, specific information may also be required, for example the flag state of the harvesting vessel, the ocean area of catch, the fishing gear used, the harvesting vessel name, and details and authorizations related to harvest, landing, transshipment and export.

In most cases, these trade monitoring programs require the importer to submit documentation that provides catch and/or other statistical information to NMFS, while other relevant information on the inbound shipments is provided by the dealer, importer, shipper, carrier, or customs broker to CBP by electronic means. NMFS reviews and reconciles the information reported by importers with the information obtained from CBP and, where applicable, from the relevant RFMO or harvesting or exporting/re-exporting nation to determine if the admissibility requirements have been satisfied. If documentation is incomplete, fraudulent or missing, or if the shipment is not admissible given its ocean area of harvest, flag country of the harvesting vessel, harvesting vessel or the circumstances under which it was harvested, entry into U.S. commerce may be prohibited for that shipment and the shipment may be subject to forfeiture. In addition, the importer or other responsible party may be subject to enforcement action. Likewise, U.S. exporters must provide similar documentation for use by other importing nations.

As an ITDS partner government agency, access to the ACE system and ITDS data has improved NMFS' ability to evaluate trends and identify potential problems with seafood imports, including potential cases of seafood fraud (e.g., tariff code misspecification) or imports lacking proper documentation. ACE has helped NMFS communicate with the seafood industry to educate importers and brokers on documentation requirements. It has also helped NMFS target enforcement resources using a risk management approach and has improved the Agency's ability to intercept illegal shipments by providing access to real time information on shipments coming into U.S. ports of entry. NMFS anticipates that efficiencies derived from ITDS integration would better enable the agency to implement potential future trade measures taken by RFMOs or under domestic statutes, as well as enhance the implementation of NMFS' three current trade monitoring and documentation programs (AMLR, HMS ITP, and TTVP). NMFS believes implementation of ITDS would result in reduced reporting burdens for the seafood industry, reduced data processing time for government, increased compliance with product admissibility requirements, faster admissibility decisions and more effective enforcement.

Under the proposed rule (50 CFR 300.320), an IFTP would be established which would consolidate existing international trade permits for regulated seafood products under the AMLR and HMS ITP programs and expand the scope of the permit requirement to include regulated seafood products under the TTVP. To obtain the IFTP, U.S. importers, exporters, and re-exporters of seafood products covered under the TTVP, AMLR, and HMS ITP programs would be required to electronically submit their application and fee for the IFTP via a Web site designated by NMFS. As explained above, currently, the TTVP, AMLR and HMS ITP regulations require submission of specific information and documentation for trade monitoring. Under this proposed rule, the IFTP holder, or his or her representative, would need to electronically provide CBP via ACE with certain data sets (i.e., a subset of the information required to be submitted under the TTVP, AMLR or HMS ITP) and scanned images of documentation for each applicable trade transaction. NMFS would provide detailed information regarding submission of such data sets and documentation in a compliance guide for industry that will be prepared in advance of NMFS' implementation of a final rule. The format for the data sets would be designated for each of the three programs and specified in the following documents that would be jointly developed by NMFS and CBP and made available to entry filers by CBP (http://www.cbp.gov/trade/ace/catair):

While this proposed rule only applies to the three programs described above, proposed § 300.320 provides that the IFTP and ACE requirements may be incorporated by reference in other regulations pertaining to documentation and reporting of imports and/or exports.

Because NMFS will have access to the ITDS, importers, exporters, re-exporters and/or their customs agents would no longer be required to provide NMFS with paper copies of trade documentation. However, they would still need to maintain, and make available for inspection, electronic or paper versions of said records at their place of business for a period of two years after the transaction. Biweekly dealer reports, or other documents not required for import/export admissibility decisions, will not be affected by this proposed rule and will continue to be submitted to NMFS as paper copies. Currently, a trade permit is not required for trade of TTVP fishery commodities. Under this proposed rule, however, those who trade in TTVP fishery commodities would need to obtain an IFTP and individuals or business entities trading in fishery commodities covered by the current HMS ITP and AMLR trade programs would need to obtain an IFTP rather than the program-specific permits required currently. The IFTP would authorize import, export and re-export of fishery commodities covered by the TTVP, AMLR or HMS ITP programs, provided that the permit holder complies with the specific requirements of each program. The amount of the fee charged for the IFTP would be calculated, at least annually, in accordance with procedures of the NOAA Finance Handbook (http://www.corporateservices.noaa.gov/finance/Finance%20Handbook.html) for determining the costs for administering the IFTP program; the fee would not exceed such costs.

When deliberating how best to implement ITDS, NMFS also considered several alternatives to the proposed action described above. Under the first alternative, rather than require entry filers to submit scanned images of documentation and a limited data set, such filers would be required to enter all data elements necessary for the authentication and authorization of each shipment into the CBP's automated ACE system. Although this alternative would not require the submission of scanned images of documentation for two of the three trade monitoring programs (scanned images would still be required for the TTVP), it would require entry filers to provide most of the data contained in such documentation at the time of import or export rather than providing a data set limited to only those elements absolutely necessary to determine admissibility. NMFS considers this alternative to be too burdensome for entry filers in terms of the additional time that would be required to enter such data into ACE.

A second alternative would involve the submission of a limited electronic data set with no scanned documentation provided electronically. In this scenario, NMFS would require entry filers to submit a limited message set into ACE, but entry filers would also need to separately provide NMFS with any additional documentation and data necessary for NMFS to complete dolphin-safe tuna verification at the time of, or in advance of, importation and periodic reports for RFMOs. This alternative is not preferred as it would create an unnecessary burden on both NMFS and the trade since it would require entry filers to both complete ACE entry procedures and also submit admissibility documents to NMFS outside of ACE, the ITDS single window.

A third alternative would be for NMFS to require an electronic data set consisting solely of the international fisheries trade permit number with scanned documentation provided electronically via ITDS. This alternative would not be preferred as it would place a significant burden on NMFS to manually convert scanned document images to data sets so that NMFS could make decisions regarding product admissibility. Such an approach would require considerable NMFS staff time and would inevitably create burdens on industry as such an alternative would result in post-release seizures or re-delivery orders to the trade for products later determined by NMFS to be inadmissible.

A fourth alternative would be to implement the IFTP requirement for the HMS ITP and AMLR trade program but not for the TTVP which currently has no permit requirement. The rationale for instituting the IFTP for the TTVP is to identify the business entities that are engaged in the trade activities subject to monitoring, for the purposes of informing them of requirements and any changes thereto. Lack of education/notification could increase noncompliance, resulting in delayed release, seizures or other enforcement actions, and/or blocked shipments when requirements are not met at the border. In addition, not requiring an IFTP for the TTVP participants, would preclude the imposition of permit sanctions in the event of serious infractions of reporting or recordkeeping requirements in the TTVP. For all the above-stated reasons, this alternative is not preferred.

As a Member of the Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR), the United States is obligated to implement conservation measures adopted by CCAMLR, unless the United States objects, pursuant to Article IX of the CCAMLR Convention. NMFS has implemented CCAMLR-adopted conservation measures in 50 CFR part 300, subpart G. Under these regulations, a person that intends to import or re-export AMLR must obtain a dealer permit. To integrate the collection of information on the trade of AMLR within the ITDS, NMFS proposes to revise the AMLR regulations to require a dealer importing or exporting AMLR to possess a valid IFTP issued under the proposed § 300.322 discussed below. These proposed revisions to 50 CFR part 300 subpart G would replace the AMLR dealer permit procedures with a reference to the proposed IFTP procedures (see below). Where appropriate, the term “AMLR dealer permit” and references to that permit would be replaced with “IFTP.” Section 300.114(k) of the AMLR regulations regarding registered agents would be removed because § 300.322 provides for the designation of resident agents who would be authorized to act on behalf of foreign entities.

NMFS established permitting, reporting, and recordkeeping regulations to implement various RFMO trade monitoring programs under the HMS ITP program in 50 CFR part 300 subpart M. As noted above, a person trading in fishery commodities covered by the current HMS ITP program would need to obtain the newly established IFTP and the program-specific HMS ITP permit will be retired. Submission of consignment documents such as the International Commission for the Conservation of Atlantic Tuna (ICCAT) bluefin tuna catch document would be through ACE and the CBP Document Imaging System (DIS). Using the ACE system rather than submitting hardcopy documents to NMFS would result in reduced reporting burdens for the seafood industry and reduced data processing time for the government as documents would be submitted only once, to CBP, instead of to both CBP and NMFS.

As noted above, a person trading in fishery commodities covered under the TTVP would need to obtain an IFTP. Such a trade permit is currently not a requirement under the TTVP. NMFS believes the benefits and efficiencies resulting from ITDS implementation and establishing a single consolidated IFTP covering all three of the NMFS trade monitoring programs would greatly exceed the fee charged to cover administrative costs associated with NMFS issuance of the IFTP.

In addition, under current regulations at 50 CFR 216.24(f)(3)(ii), TTVP importers are able to submit documents electronically in Portable Document Format (PDF) using a secure file transfer protocol site. This proposed rule would eliminate that document submission option in favor of document submission through the ACE system. Such a change would result in reduced reporting burdens for the seafood industry and reduced data processing time for the government as documents would be submitted only once, to CBP, instead of to both CBP and the TTVP. The proposed rule would also allow for a reduced data set to be filed via ACE in certain circumstances. The reduced data set is limited to importations by domestic canners and to processors other than canners that label any tuna product dolphin-safe, and which are required to submit the monthly reports required under 50 CFR 216.93(d)(2) or (e) to the TTVP. The reduced data set pertains to importations of: 1) frozen cooked tuna loins used in cannery operations and 2) tuna products in airtight containers manufactured in American Samoa and imported into the United States or Puerto Rico that originated from the tuna receipts listed on those monthly reports. The reduced data set is intended to prevent duplicative reporting for the companies that import the tuna products described above and that already submit required information to the TTVP via the monthly reports.

This proposed rule also makes minor edits to the regulatory text in order to update an internet Web site address, harmonize regulatory text in part 216, Subpart H, Dolphin Safe Tuna Labeling, with the regulatory text being revised as part of ITDS implementation in 50 CFR 216.24(f), and allow importers to submit documentation to the ACE system at the time of, or in advance of, importation. Revisions to the tables in § 216.24(f)(2)(i) through (iii) have been made to reflect the latest updates to harmonized tariff codes.

This current rulemaking does not propose measures to implement recommendations 14 and 15 (seafood traceability) of the Presidential Task Force on Combatting Illegal, Unreported, and Unregulated (IUU) Fishing and Seafood Fraud (Task Force). There will be a separate opportunity for public comment on the proposed regulations pertaining to these Task Force recommendations.

This proposed rule is published under the authority of AMLRCA of 1984, 16 U.S.C. 2431 et seq.; ATCA of 1975, 16 U.S.C. 971 et seq.; TCA of 1950, 16 U.S.C. 951-961; MSA, 16 U.S.C. 1801 et seq.; MMPA of 1972, 16 U.S.C. 1361-1407; DPCIA, 16 U.S.C. 1385; HSDFMPA, 16 U.S.C. 1826d-k; and HSDFEA, 16 U.S.C. 1826a-c. Other relevant authorities include the Pelly Amendment to the Fishermen's Protective Act, 22 U.S.C. 1978, and the Lacey Act, 16 U.S.C. 3371.

The NMFS Assistant Administrator has determined that this proposed rule is consistent with the provisions of these and other applicable laws, subject to further consideration after public comment.

This proposed rule has been determined to be not significant for the purposes of Executive Order 12866. NMFS has prepared a regulatory impact review of this action, which is available from NMFS (see ADDRESSES). This analysis describes the economic impact this proposed action, if adopted, would have on the United States. NMFS invites the public to comment on this proposal and the supporting analysis.

An initial regulatory flexibility analysis was not prepared because this proposed rule is not expected to have a significant economic impact on U.S. small entities. Thus, the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have any significant economic impact on a substantial number of small entities.

The regulatory action being considered, and its legal basis, is described in detail earlier in the preamble. Although a new IFTP is proposed to be established for the import, export or re-export of regulated products under the AMLR, HMS ITP and TTVP programs, this new permit generally represents a consolidation of information contained in existing permits and should actually result in fewer reporting or recordkeeping requirements. Data sets to be entered electronically to determine product admissibility are already required to be submitted in paper form under the respective trade programs. Thus, NMFS anticipates that U.S. entities would not be significantly affected by this action because it generally does not pose new or additional burdens with regard to the collection and submission of information necessary to determine product admissibility.

With regard to the possible economic effects of this action, per the response to Question 13 of the supporting statement prepared for the Paperwork Reduction Act analysis (available from www.reginfo.gov/public/do/PRAMain), NMFS estimates there will be 751 applicants for the new IFTP with an estimated net increase in annual costs of $16,255 for obtaining those permits, based on the combined number of permit holders and respondents under NMFS' existing trade monitoring programs. Although NMFS does not have access to data about the business sizes of importers and receivers that would be impacted by this proposed rule, it is likely that the majority may be classified as small entities. However, when overall total new burdens for the three requirements proposed under this rule (IFTP, data set submission, and admissibility document(s) submission) are compared to current burdens, the new consolidated burdens are estimated to result in an overall net burden decrease of 4,225 hours and $63,650. A no-action alternative, where NMFS would not promulgate the proposed rule, was not considered as all applicable U.S. government agencies are required to implement ITDS under the authority of section 405 of the SAFE Port Act and Executive Order 13659 on Streamlining the Export/Import Process, dated February 19, 2014.

The proposed action would not affect the volume of seafood trade or alter trade flows in the U.S. market. Although the proposed rule would require traders under the TTVP to obtain an IFTP, which they are not currently required to do, NMFS expects that the consolidated IFTP would have no impact on, or would actually reduce, the overall administrative burden on the public; those parties currently required to obtain two separate permits under the AMLR and HMS ITP programs would be required to obtain only one consolidated permit under this proposed rule.

The consolidated permitting and electronic reporting program proposed by this rulemaking would not have significant adverse or long-term economic impacts on small U.S. entities. This proposed rule has also been determined not to duplicate, overlap, or conflict with any other Federal rules. Thus, the requirements and prohibitions in the proposed rule would not have a significant economic impact on a substantial number of small entities. Consequently, an initial regulatory flexibility analysis is not required and none has been prepared.

This proposed rule contains a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been submitted to OMB for approval. When overall total new burdens for the three requirements proposed under this rule (IFTP, data set submission, and admissibility document(s) submission) are compared to current burdens, the new burdens are estimated to result in an overall net burden decrease of 4,225 hours and $63,650.

Public comment is sought regarding: whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to the Office for International Affairs and Seafood Inspection at the FOR FURTHER INFORMATION CONTACT above, or to the Office of Information and Regulatory Affairs by email to [email protected] or fax to (202) 395-7285.

Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.

For the reasons set out in the preamble, 50 CFR parts 216 and 300 are proposed to be amended as follows:

The revision and addition read as follows:

The revisions read as follows:

The additions and revisions read as follows: