Federal Register Vol. 81, No.143,

On February 17, 2016, the U.S. Office of Government Ethics (OGE) published a proposed rule in the Federal Register, 81 FR 8008, Feb. 17, 2016, proposing to amend subpart F of the Standards of Ethical Conduct for Employees of the Executive Branch regarding seeking other employment. These regulations combine the standards imposed by a criminal statute, 18 U.S.C. 208(a), with the standards imposed by Executive Order 12674, as modified by Executive Order 12731. Section 208(a) of Title 18 requires an employee to recuse from participating personally and substantially in any particular matter that, to the employee's knowledge, will have a direct and predictable effect on the financial interests of a person with whom the employee is negotiating or has any arrangement concerning prospective employment. Beyond this statutory requirement, subpart F incorporates the standards imposed by the Executive Order, addressing issues of lack of impartiality that require recusal from any particular matter that affects the financial interests of a prospective employer, even where the employee's actions in seeking employment may fall short of negotiating for employment. The final rule also implements the notification requirements under section 17 of the Stop Trading on Congressional Knowledge Act of 2012 (STOCK Act), Public Law 112-105, 126 Stat. 303, 5 U.S.C. app. 101 note, which apply to employees who file public financial disclosure reports.

The proposed rule was published on February 17, 2016. It provided a 60-day comment period, which ended on April 18, 2016. OGE did not receive any comments. The rationale for the proposed rule, which OGE is now adopting as final, is explained in the preamble at: https://www.thefederalregister.org/fdsys/pkg/FR-2016-02-17/pdf/2016-03214.pdf.

OGE has made nine technical changes in the final rule. First, OGE added the phrase “personally and substantially” in several places within the regulation. This phrase is consistent with the statutory language at 18 U.S.C. 208(a) and is parallel to the language that is currently within the regulation. Second, in 5 CFR 2635.602, Example 1 to paragraph (a), OGE removed the phrase “who is not a public filer” to better clarify the example. Third, OGE clarified in 5 CFR 2635.602, Example 2 to paragraph (a) that the employee is not currently participating in any particular matters affecting the University of Maryland. OGE further clarified that, if the employee is assigned to participate in a particular matter affecting the University of Maryland while she is seeking employment with the University, she must take whatever steps are necessary to avoid working on the grant, in accordance with § 2635.604. This revised language corresponds with 5 CFR 2635.602(a) in the proposed rule. Fourth, OGE added the citation for the Foreign Gifts and Decorations Act, 5 U.S.C. 7342, to 5 CFR 2635.602(b)(3). Fifth, OGE replaced the terms “person” and “potential employer” with the term “prospective employer” in 5 CFR 2635.603, Example 4 to paragraph (b) to use consistent defined terms. Sixth, OGE added the following to 5 CFR 2635.603, Example 10 to paragraph (b): Provided she does not receive a response indicating an interest in employment discussions. A letter merely acknowledging receipt of the resume is not an indication of interest in employment discussions. In addition, the clause “with a response indicating an interest in employment discussions” was added to 5 CFR 2635.604(a)(ii). This language parallels the discussion in the definition section of the previous regulation and corresponds with 5 CFR 2635.604, Example 3 to paragraph (a) in the proposed rule. Seventh, OGE made a grammatical correction in 5 CFR 2635.603, Example 2 to paragraph (c), replacing the word “they” with “it.” Eighth, OGE clarified in 5 CFR 2635.604, Example 2 to paragraph (b) that the employee is reviewing an application from the same pharmaceutical company, which is seeking FDA approval for a new drug product. This language parallels the discussion in the recusal section of the previous regulation and corresponds with 5 CFR 2635.604(b) in the proposed rule. Finally, OGE replaced the word “should” with the word “must” in 5 CFR 2635.604, Example 2 to paragraph (b): Once the employee makes a response that is not a rejection to the company's communication concerning possible employment, the employee must recuse from further participation in the review of the application. This language corresponds with 5 CFR 2635.604(b) in the proposed rule.

As Director of the Office of Government Ethics, I certify under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this final rule would not have a significant economic impact on a substantial number of small entities because it primarily affects current Federal executive branch employees.

The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply because this regulation does not contain information collection requirements that require approval of the Office of Management and Budget.

For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 5, subchapter II), this final rule would not significantly or uniquely affect small governments and will not result in increased expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year.

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select the regulatory approaches that maximize net benefits (including economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rulemaking has been designated as a “significant regulatory action” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this rule has been reviewed by the Office of Management and Budget.

As Director of the Office of Government Ethics, I have reviewed this final rule in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.

Accordingly, the Office of Government Ethics is amending 5 CFR part 2635 as set forth below:

On June 24, 2016, the FAA published a final rule titled, “Fuel Tank Vent Fire Protection” in the Federal Register (81 FR 41200).

The intent of that rule is to prevent fuel tank explosions caused by ignition from external ignition sources of fuel vapor either contained in vapor spaces 1 or exiting from vapor spaces through the fuel tank vent outlets. Potential external ignition sources include, but are not limited to, ground handling equipment, fuel fires that result from refueling spills, or ground fires that follow a survivable crash landing in which the fuel tank and the vent system remain intact. Means to prevent or delay the propagation of flame 2 from external sources into the fuel tank through the fuel tank vent system 3 would also prevent or delay fuel tank explosions following certain accidents. These means include flame arrestors or fuel tank inerting. This prevention or delay would provide additional time for the safe evacuation of passengers from the airplane and for emergency personnel to provide assistance.

The rule applies to applications for new type certificates and applications for amended or supplemental type certificates on significant product-level change projects in which title 14, Code of Federal Regulations (14 CFR) 25.975, “Fuel tank vents and carburetor vapor vents,” is applicable to a changed area. Additionally, a new operating requirement in both 14 CFR part 121, “Operating Requirements: Domestic, Flag, and Supplemental Operations,” and 14 CFR part 129, “Operations: Foreign Air Carriers and Foreign Operators of U.S.-Registered Aircraft Engaged in Common Carriage,” applies to airplanes that are issued an original airworthiness certificate after a specified date.

However, the rule published with incorrect amendment numbers, “25-142, 21-376, and 129-53.” Amendment number 25-142 is the same amendment number as the rule titled “Harmonization of Airworthiness Standards—Fire Extinguishers and Class B and F Cargo Compartments,” which published in the Federal Register on February 16, 2016 (81 FR 7698). Amendment numbers 21-376 and 129-53 are incorrect designations. The correct amendment numbers for this rule are “25-143, 121-375, and 129-52.”

In the same publication on page 41203 in footnote number 14, the Lockheed airplane model number referenced is “328.” The correct number should be “382.”

In FR Doc. 2016-14454, beginning on page 41200 in the Federal Register of June 24, 2016, make the following corrections:

1. On page 41200, in the second column, correct the 4th header paragraph to read as follows:

“[Docket No.: FAA-2014-0500; Amdt. Nos. 25-143, 121-375, and 129-52].”

2. On page 41203, in the second column, correct the text of footnote number 14 to read as follows:

“The previously approved Lockheed 382 and Embraer flame arrestors would not have met the 2 minute and 30 second requirement.”

Background

On December 15, 2011 the FAA published in the Federal Register a notice of proposed policy and request for comments (76 FR 77939) on the FAA's proposed strategy for gradually reducing the current VOR network to a Minimum Operational Network (MON) as the NAS transitions to performance-based navigation (PBN) as part of the Next Generation Air Transportation System (NextGen). The FAA announced that, as part of a NAS Efficient Streamlined Services Initiative, the number of conventional NAVAIDs would be reduced while more efficient Area Navigation (RNAV) routes and procedures are implemented throughout the NAS. The FAA noted its intention to convene a working group to assist in developing a candidate list of VORs for discontinuance using relevant operational, safety, cost, and economic criteria. Interested parties were invited to participate in the review of this policy and planning effort by submitting written comments on the proposal.

The FAA reviewed all 330 comments received and on August 21, 2012, published in the Federal Register the disposition of the comments on the notice of proposed policy (77 FR 50420). In considering and disposing of the comments, the FAA noted that it would develop an initial VOR MON Plan which would be made publicly available. The FAA renewed its intention to convene a working group that would assist in developing objective criteria which would be applied consistently nationally and regionally to help identify those VOR facilities that would remain operational.

After the FAA published the disposition of comments, stakeholders, industry, and military services provided further inputs to the FAA for consideration in developing the criteria used to select VORs that would need to be retained as a part of the MON. The FAA also sought recommendations from aviation industry stakeholders through the RTCA Tactical Operations Committee (TOC). With this collective input, the FAA developed the criteria to determine which VORs would be candidates for retention. VORs not meeting these criteria were considered as discontinuance candidates.

The following criteria were used by the FAA to determine which VORs would be retained as a part of the MON:

The following considerations were used to supplement the VOR MON criteria above:

Using the established criteria, the FAA convened an internal working group to develop a candidate list of VORs using the VOR MON criteria relevant to operational, safety, cost, and economic considerations. The group developed the VOR MON service by first selecting MON airports that met the criteria listed above. Airports with ILS approaches that met the criteria were selected in preference to VOR approaches. If two airports in close proximity had suitable approaches, then the airport whose ILS or VOR approach required the FAA to retain the fewest number of VORs (i.e., to identify initial, final, stepdown, and missed approach points) were generally selected. VORs necessary to fulfil other criteria were then selected to be retained. Additional VORs were retained to provide coverage at 5000 ft AGL. The effect of terrain blockage and unavailable radials from some VORs was considered, as was MON airport infrastructure, radar coverage, and training. The overall goal of the effort was to provide the VOR MON service according to the criteria while retaining the fewest number of VORs.

The working group also considered flight procedure development requirements and capabilities, non-rulemaking and rulemaking processing requirements and timelines, and geographic impacts to the NAS as it refined the candidate list of VORs for retention. Since some VORs are co-located with communications services, such as the Hazardous Inflight Weather Advisory Service (HIWAS) and Remote Communication Outlet (RCO), the working group also identified which services would be reconfigured or relocated in order to continue to provide those services. For VORs not listed as part of the MON, the FAA's working groups developed a candidate list of VORs for discontinuance arranged in two Phases (2016-2020 and 2021-2025) by Service Area based on Instrument Flight Procedure (IFP) mitigation complexity.

The FAA will follow its established policies and processes for VOR discontinuance according to FAA Order JO 7400.2, Procedures for Handling Airspace Matters. Prior to making any VOR discontinuance determinations, the geographically responsible Air Traffic Organization (ATO) service area office will publish a circular notice of the proposed discontinuance action to solicit comments from aviation interested persons and organizations. A brief description of the discontinuance effect on airspace and instrument procedures will be included in the circularization. Once a determination to discontinue a VOR has been made, the responsible service area office will initiate established part 71 and part 97 rulemaking processing procedures. The FAA will publish Notices of Proposed Rulemaking (NPRM) in the Federal Register to solicit public comments on all proposed part 71 airspace and ATS route amendments resulting from VOR discontinuance determinations prior to taking any amendment actions within the NAS. After consideration of all public comments received in response to published NPRMs, the FAA will determine whether to issue final rules announcing part 71 airspace and Air Traffic Service (ATS) route and part 97 standard instrument procedure amendment determinations in the Federal Register.

The FAA remains committed to the plan to retain an optimized network of VOR NAVAIDs. The MON will enable pilots to revert from Performance Based Navigation (PBN) to conventional navigation for approach, terminal and en route operations in the event of a GPS outage and supports the NAS transition from VOR-based routes to a more efficient PBN structure consistent with NextGen goals and the NAS Efficient Streamlined Services Initiative.

The FAA continues to plan the NAS transition from defining ATS routes and instrument procedures using VORs and other conventional NAVAIDs 1 to a point-to-point system based on RNAV and Required Navigation Performance (RNP). RNAV will generally be available throughout the NAS and RNP will be provided where beneficial. The FAA's network of DME NAVAIDs will provide a PBN-capable backup to GPS; however, for aircraft without scanning DME receivers (DD) or DD with Inertial Reference Unit aiding (DDI) equipment, the FAA will provide a conventional navigation backup service based on the proposed VOR MON. The VOR MON is designed to enable aircraft, having lost Global Navigation Satellite System (GNSS) service, to revert to conventional navigation procedures. The VOR MON is further designed to allow aircraft to proceed to a MON airport where an ILS or VOR approach procedure can be flown without the necessity of GPS, DME, ADF, or Surveillance. Of course, any airport with a suitable instrument approach may be used for landing, but the VOR MON assures that at least one airport will be within 100 NM.

Provided below is a candidate list of VORs being considered for discontinuance in Phase 1 (2016-2020) and Phase 2 (2021-2025) as the FAA works toward the establishment of a VOR MON. It is tentative and may be adjusted based on economic or other factors. As of June 21, 2016 the 45 facilities denoted with an asterisk (*) have completed the circularization public notice process and the FAA has made its determination for discontinuance:

DOL published a document in the Federal Register on July 1, 2016 (81 FR 43430), which made inadvertent revisions to the authority citation for part 655.

In FR Doc. 2016-15378, published on July 1, 2016, (81 FR 43430), make the following correction:

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has informed FDA that it has transferred ownership of, and all rights and interest in, the 71 approved NADAs and ANADAs in table 1 to Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140.

Accordingly, the Agency is amending the regulations in 21 CFR parts 520, 522, 524, and 558 to reflect these changes of sponsorship.

Following these changes of sponsorship, Elanco Animal Health, A Division of Eli Lilly & Co. is no longer the sponsor of any approved application. Accordingly, the regulations are being amended to remove this firm from the lists of sponsors of approved applications in 21 CFR 510.600(c).

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

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 520, 522, 524, and 558 are amended 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 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (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), among other amendments, established 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).

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.

A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification procedures (510(k)) to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a premarket approval application (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.

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).

On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device under that section from rulemaking to an administrative order.

Section 513(e) of the FD&C Act governs reclassification of classified devices. This section provides that FDA may, by administrative order, reclassify a device based on “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), 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 action where the reevaluation is made in light of newly available 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” (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 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Association 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 (21 U.S.C. 360j(c)).)

Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order to reclassify a device under that section. 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 presented the complete regulatory history of these devices in the proposed order to reclassify iontophoresis devices for any other purposes, published in the Federal Register of September 22, 2014 (79 FR 56532) (the “proposed order”). The following are the most relevant pieces of the regulatory history of these devices. On August 28, 1979, the Agency published a proposed rule (44 FR 50520) for classification of all iontophoresis devices. On November 23, 1983, FDA issued a final rule in the Federal Register (48 FR 53032 at 53045) classifying iontophoresis devices into two different classes based on the device's intended use. Specifically, the rule classified iontophoresis devices into class II when intended to induce sweating for use in the diagnosis of cystic fibrosis or for other uses only when the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug (§ 890.5525(a) (21 CFR 890.5525(a))). These devices are currently under product code KTB. The rule classified iontophoresis devices into class III when intended for any other purposes (§ 890.5525(b)), but did not establish an effective date of requirement for premarket approval. These devices are currently under product code EGJ. In 2009, FDA published an order under section 515(i) of the FD&C Act (the “515(i) Order”) requiring manufacturers of remaining class III devices for which regulations requiring PMAs had not been issued, including iontophoresis devices (§ 890.5525(b)), to submit a summary of information concerning those devices by August 7, 2009 (74 FR 16214, April 9, 2009).

As discussed in the proposed order, FDA considered the available information on iontophoresis devices intended for any other purposes and concluded that these devices, which are prescription devices, could be reclassified to class II, subject to the special controls identified in the proposed order, because there was sufficient information that these special controls, along with general controls, would provide reasonable assurance of safety and effectiveness. As required by section 513(e)(1) of the of the FD&C Act, FDA convened a meeting of a device classification panel described in section 513(b) of the FD&C Act, specifically the Orthopaedic and Rehabilitation Devices Panel (the 2014 Panel), to discuss whether iontophoresis devices intended for any other purposes should be reclassified or remain in class III on February 21, 2014 (Ref. 1). Please see the proposed order for additional information on the 2014 Panel. Ultimately, the panel concluded that sufficient information exists to establish special controls for these devices, and that special controls in combination with general controls could provide a reasonable assurance of safety and effectiveness; and thus, iontophoresis devices for any other purposes could be classified in class II.

FDA received and has considered three sets of comments on this proposed order, as discussed in section III of this document. Therefore, FDA has met the requirements for issuing a final order under section 513(e)(1) of the FD&C Act. FDA is not aware of new information since the 2014 Panel meeting that would provide a basis for a different recommendation or finding.

In response to the proposed order, FDA received three sets of comments from various stakeholders. The comments and FDA's responses to the comments are summarized as follows.

(Comment 1) One comment requested that iontophoresis devices intended for any other purposes remain classified in class III, and that FDA call for PMAs for these products. The commenter disagreed that general controls and special controls are sufficient to provide a reasonable assurance of safety and effectiveness because of, among other reasons, the commenter located, at the time of the 2014 Panel meeting, 40 adverse event reports for a 5-year period that implicated device malfunction, 12 of which include burns, in a search of the Manufacturer and User Facility Device Experience (MAUDE) database for iontophoresis devices intended for any other purposes. The commenter stated that manufacturing inspections during the PMA process would help ensure that iontophoresis devices are constructed properly and, therefore, be less likely to cause third degree burns and other injuries.

(Response) FDA disagrees that iontophoresis devices intended for any other purposes should remain in class III and require PMA approval. As discussed in section V, “Risks to Health,” of the proposed order, these devices have certain risks to health; however, the Agency believes that those risks can be mitigated by the special controls. For example, the special controls include performance testing that will mitigate the risks of burns, insufficient or excessive drug delivery, and/or infection. Performance testing using a drug approved for iontophoretic delivery, or a solution, identified in the labeling, will ensure that device malfunction or use error is minimized. Additionally, performance testing will ensure that iontophoresis devices intended for any other purposes maintain a safe pH level to minimize burns from a large electrical current density or highly acidic solution. Based on FDA's review of the MAUDE database, the number of adverse event reports identified for iontophoresis devices intended for any other purposes has decreased over the last several years, supporting that the risk of injury is low. Furthermore, in the past decade, there have been no recalls for iontophoresis devices intended for any other purposes.

(Comment 2) In addition, the commenter expressed concern that the special control requiring a labeling warning about adverse systemic effects was an insufficient safeguard because clinicians and patients may not see or read the label.

(Response) FDA takes issue with this statement. As stated in the proposed order, iontophoresis devices are restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device and the device identification in § 890.5525(b) has been revised to clarify that these are prescription devices in accordance with § 801.109 (21 CFR 801.109). Per § 801.109(c), a prescription device, including iontophoresis devices intended for any other purposes, must include labeling that describes the indications and other information for use, such as methods, frequency and duration of administration, any relevant hazards, contraindications, side effects, and precautions under which the practitioners can use the device safely. Accordingly, clinicians will have access to and be aware of the warnings and precautions in the labeling, and as such, clinicians should be adequately informed of the risks associated with these devices. The clinician can inform the patients of the relevant risks. Therefore, the warning and precaution statements are an appropriate mitigation. FDA believes, therefore, that the special controls identified in this final order, in combination with general controls, will adequately mitigate the risks identified for iontophoresis devices intended for any other purposes and will provide a reasonable assurance of safety and effectiveness. FDA believes that iontophoresis devices may benefit patients by improving the noninvasive transdermal delivery of drugs or other solutions intended to treat various medical ailments or issues. As such, it is appropriate to reclassify these devices from class III (PMA) to class II (special controls). This is also the conclusion supported by the 2014 Panel.

(Comment 3) Two comments supported the reclassification of iontophoresis from class III to class II when these devices are intended for any other purposes. One comment, although overall supportive of reclassification, disagreed with the modified identification language and special controls. This comment asserted that the special controls, by requiring testing using a drug approved for iontophoretic delivery and labeling that contains language referring the user of the device to approved drug labeling, would create different regulatory paradigms for § 890.5525(a) and (b), such that a new drug application (NDA) and 510(k) are needed for iontophoresis devices falling under paragraph (b) of the regulation, and that a 510(k) is needed for paragraph (a), although the devices are similar. The commenter uses iontophoresis devices that deliver pilocarpine for the diagnosis of cystic fibrosis, regulated under § 890.5525(a), as an example of this inconsistency.

(Response) To the extent the commenter is raising issues related to products regulated under § 890.5525(a), such products are not the subject of this reclassification; and as such, are not addressed here. However, we do note that the commenter's statement about two different regulatory paradigms is incorrect. As stated previously in this document and in the proposed order, whether an iontophoresis device falls into § 890.5525(a) or (b), any drug that is intended to be used with these devices is required to have marketing authorization for iontophoretic administration of that drug. FDA intends to consider addressing the regulation of iontophoresis devices under § 890.5525(a) through a separate process.

In addition, iontophoresis devices intended for any other purposes regulated under § 890.5525(b) will need to comply with the applicable special controls prior to entering the market. “Any other purposes” means that these devices are neither intended for use in the diagnosis of cystic fibrosis nor for use with a specific drug. Devices for any other purposes may include those intended for general iontophoretic delivery of drugs that are approved for that route of administration or intended for use with specific solutions. One example of an iontophoretic device for “any other purposes” is one indicated for use with tap water for treatment of hyperhidrosis.

(Comment 4) The commenter also requested clarification on the identified risk of infection and the special control that states the patient-contacting elements of the device must be assessed for sterility.

(Response) FDA believes that patient-contacting elements should be assessed for sterility if the device is labeled as sterile, and has clarified the special control in question (§ 890.5525(b)(2)(vi)) to specify such.

Based on the information discussed previously and in the preamble to the proposed order, the comments on the proposed order, a review of the MAUDE database, a review of current scientific literature, and panel deliberations (see the 2014 Panel transcript (Ref. 1)), FDA concludes that special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness of iontophoresis devices intended for any other purposes. Under section 513(e) of the FD&C Act, FDA is adopting its findings as published in the preamble to the proposed order, with the modification of the special control pertaining to sterility (§ 890.5525(b)(2)(vi)) to clarify that only devices labeled as sterile must have their patient-contacting elements assessed for sterility. FDA is issuing this final order to reclassify iontophoresis devices intended for any other purposes from class III to class II and establish special controls by revising § 890.5525(b).

As noted previously, the identification for § 890.5525(b) has been clarified to specify that devices intended to deliver specific drugs, including those drugs that may have adverse systemic effects, like fentanyl, are not considered part of this regulatory classification (§ 890.5525(b)(1)).

Following the effective date of this final order, firms submitting a premarket notification (510(k)) for iontophoresis devices intended for any other purposes must comply with the applicable mitigation measures set forth in the codified special controls. This includes firms who are required to submit a new 510(k) under § 807.81(a)(3) because the device is about to be significantly changed or modified. Additionally, a firm 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, must also comply with the special controls to remain legally on the market.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the devices. FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of iontophoresis devices intended for any other purposes, and therefore, this device type is not exempt from premarket notification requirements.

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

This final order refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, have been approved under OMB control number 0910-0120; and the collections of information under part 801 have been approved under OMB control number 0910-0485.

In addition, FDA concludes that the labeling statement codified in this order does not constitute a “collection of information” under the PRA. Rather, the labeling statement 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)).

Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously promulgated regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final order, we are revoking the requirements in § 890.5525(b) related to the classification of iontophoresis devices intended for any other purposes as class III devices and codifying the reclassification of iontophoresis device intended for any other purposes into class II (special controls).

The following reference is on display in the Division of Dockets Management (HFA-305) Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address, 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, part 890 is amended as follows:

Section 83 of the Internal Revenue Code (Code) addresses the tax consequences of a transfer of property in connection with the performance of services. Section 83(a) of the Code provides generally that the excess of the fair market value of the transferred property (determined without regard to any restriction other than a restriction which by its terms will never lapse) as of the first time that the transferee's rights in the property are transferable or are not subject to a substantial risk of forfeiture, whichever occurs earlier, over the amount (if any) paid for the property is included in the service provider's gross income for the taxable year which includes such time. Section 83(b) and § 1.83-2(a) permit the service provider to elect to include in gross income, as compensation for services, the excess (if any) of the fair market value of the property at the time of transfer over the amount (if any) paid for the property. Under section 83(b)(2), an election under section 83(b) must be made in accordance with the regulations thereunder. Under § 1.83-2(c), the election must be filed with the IRS no later than 30 days after the date on which the property is transferred, and a copy of the election must be submitted with the taxpayer's income tax return for the taxable year in which the property is transferred.

On July 17, 2015, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) published a notice of proposed rulemaking (REG-135524-14) in the Federal Register (137 FR 42439) under section 83 of the Code eliminating the requirement that a copy of a section 83(b) election be submitted with the taxpayer's income tax return for the taxable year in which the property is transferred. Treasury and the IRS received no comments responding to the notice of proposed rulemaking. No public hearing was requested and no public hearing was held. Treasury and the IRS now adopt the proposed regulations as final regulations without modification.

These final regulations remove the second sentence in § 1.83-2(c) of the existing regulations, which requires that a taxpayer submit a copy of a section 83(b) election with the taxpayer's tax return for the year in which the property subject to the election was transferred. Accordingly, under these final regulations, a taxpayer is no longer required to file a copy of a section 83(b) election with the taxpayer's income tax return.

Taxpayers are reminded of their general recordkeeping responsibilities pursuant to section 6001 of the Code, and more specifically of the need to keep records that show the basis of property owned by the taxpayer. Taxpayers must maintain sufficient records to show the original cost of the property and to support the tax treatment of the property transfer reported on the taxpayers' returns. Taxpayers must keep these records as long as they may be needed for the administration of any provision of the Code. Generally, this means records that support items shown on a return must be retained until the period of limitations for that return expires. See section 6501 of the Code. A copy of any section 83(b) election made with respect to property must be kept until the period of limitations expires for any return with respect to which the income inclusion or basis of the property is relevant.

These regulations apply to property transferred on or after January 1, 2016. For transfers of property on or after January 1, 2015 and prior to January 1, 2016, the preamble to the proposed regulations provides that taxpayers may rely on the guidance in the proposed regulations (which is identical to the guidance contained in these final regulations).

Rev. Proc. 2012-29 (IRB 2012-28, 49) states that a taxpayer making a section 83(b) election must submit a copy of the election with his or her tax return for the taxable year in which such property was transferred. Effective as of July 26, 2016, Rev. Proc. 2012-29 is revoked, in part, to the extent it requires, inconsistent with these final regulations, a taxpayer to submit a copy of a section 83(b) election with his or her income tax return.

Rev. Proc. 2012-29 is published in the Internal Revenue Bulletin (or Cumulative Bulletin) and is available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, or by visiting the IRS Web site at http://www.irs.gov.

Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, these regulations have been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.

The principal authors of these final regulations are Thomas Scholz and Michael Hughes, Office of the Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Treasury participated in their development.

Accordingly, 26 CFR part 1 is amended as follows:

OSHA published a final rule for the Occupational Exposure to Respirable Crystalline Silica standards on March 25, 2016 (81 FR 16286), after determining that employees exposed to respirable crystalline silica at the previous permissible exposure limits face a significant risk of material impairment to their health. The evidence in the record for this rulemaking indicates that workers exposed to respirable crystalline silica are at increased risk of developing silicosis and other nonmalignant respiratory diseases, lung cancer, and kidney disease. These requirements are necessary to provide protection from these hazards. The silica final rule becomes effective on June 23, 2016. Start-up dates for specific provisions are set in § 1910.1053(l) for general industry and maritime and in § 1926.1153(k) for construction.

Consistent with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3520), the Federal Register notice for the Occupational Exposure to Respirable Crystalline Silica final rule states that employers do not have to comply with the collections of information until OMB approves those collections of information and the Department of Labor publishes a notice in the Federal Register announcing this approval and the control number assigned by OMB to the final rule's collections of information. Under 5 CFR 1320.5(b), an agency may not conduct or sponsor a collection of information unless: (1) The collection of information displays a current valid OMB control number and (2) the agency informs members of the public required to respond to the collection of information that they are not required to do so unless the agency displays a currently valid OMB control number for the collection of information.

On March 25, 2016, the Department of Labor submitted an information collection request for the final rule to OMB for approval in accordance with the PRA. On June 27, 2016, OMB approved the collections of information contained in the final rule and assigned these collections of information OMB Control Number 1218-0266, titled “Respirable Crystalline Silica Standards for General Industry, Shipyard Employment and Marine Terminals (29 CFR 1910.1053) and Construction (29 CFR 1926.1053).” The approval for collecting the information expires on June 30, 2019.

This revision of § 1910.8, § 1915.8 and § 1926.5 is a technical amendment to increase public awareness of OMB's approval of the collections of information. Opportunity for public comment on this rule is therefore unnecessary. The Agency notes that the public has already had the opportunity to comment on the collections of information and OMB has approved them.

The final Occupational Exposure to Respirable Crystalline Silica standards impose new collections of information for purposes of the PRA. The collections of information in the rule are needed to assist employers in identifying and controlling exposures to respirable crystalline silica in the workplace, and to address adverse health effects related to respirable crystalline silica. OSHA will also use records developed in response to these standards to determine compliance with OSHA standards.

The table below identifies the new collections of information contained in the final rule.

Title: Respirable Crystalline Silica Standards for General Industry, Shipyard Employment and Marine Terminals and Construction.

Affected Public: Business or other for-profits.

Number of Respondents: 682,581 firms.

Frequency: Biennially; Once; Semi-annually; On occasion; Annually; Quarterly.

Average Time per Response: Varies from 5 minutes for the employer to make air-monitoring data, objective data and medical surveillance records available to employees to 16 hours for a large employer to develop a written exposure control plan.

Estimated Total Burden Hours: 12,118,364 hours.

Estimated Costs (Operation and Maintenance): $394 million.

David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this document. The authority for this document is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order 1-2012 (77 FR 3912 (January 25, 2012)).

For the reasons stated in the preamble, the Occupational Safety and Health Administration amends 29 CFR parts 1910, 1915, and 1926 as follows:

The Postal Service continues to seek opportunities to work with mailers to improve products and services. Therefore, we have established a method for commercial customers to pay for and manage their services online using a single account.

The U.S. Postal Service is upgrading its payment architecture for business customers. The new Enterprise Payment System (EPS) will replace the current product-centric payment system with a centralized account management system enabling commercial customers to pay for and manage their services online using a single account.

EPS has been designed to be part of USPS products and services offered through the existing Business Customer Gateway (BCG) portal. Commercial customers who want to use EPS will need to be a registered BCG user, request access to EPS and open an Enterprise Payment Account (EPA) to pay for their products and services. EPA requires that the customers fund the account via Electronic Funds Transfer—either Automated Clearing House (ACH) Debit or ACH Credit.

The first feature of EPS will allow business customers to open, close, and pay for their P.O. Boxes and Caller Service numbers (including reserved numbers) online using the new Enterprise P.O. Boxes Online (EPOBOL). EPS customers are required to have an EPA to pay for EPOBOL service. Future phases of EPS will provide commercial customers functionality to pay for additional services.

The Postal Service adopts the following changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

Accordingly, 39 CFR part 111 is amended as follows:

This document identifies updates to the product list, which appears as 39 CFR Appendix B to Subpart A of Part 3020—Competitive Product List. Publication of the updated product list in the Federal Register is addressed in the Postal Accountability and Enhancement Act (PAEA) of 2006.

Authorization. The Commission process for periodic publication of updates was established in Docket Nos. MC2010-21 and CP2010-36, Order No. 445, April 22, 2010, at 8.

Changes. The product list is being updated by publishing a replacement in its entirety of 39 CFR Appendix B to Subpart A of Part 3020—Competitive Product List. The following products are being added, removed, or moved within the product list:

1. Priority Mail Contract 201 (MC2016-108 and CP2016-136) (Order No. 3215), added April 6, 2016.

2. Priority Mail Contract 202 (MC2016-109 and CP2016-137) (Order No. 3217), added April 6, 2016.

3. First-Class Package Service Contract 48 (MC2016-111 and CP2016-139) (Order No. 3218), added April 6, 2016.

4. Priority Mail & First-Class Package Service Contract 17 (MC2016-112 and CP2016-140) (Order No. 3219), added April 6, 2016.

5. Priority Mail Contract 203 (MC2016-110 and CP2016-138) (Order No. 3221), added April 7, 2016.

6. Priority Mail & Parcel Select Contract 1 (MC2016-113 and CP2016-141) (Order No. 3222), added April 8, 2016.

7. Priority Mail Contract 205 (MC2016-115 and CP2016-146) (Order No. 3228), added April 11, 2016.

8. First-Class Package Service Contract 50 (MC2016-117 and CP2016-148) (Order No. 3229), added April 11, 2016.

9. Priority Mail Contract 204 (MC2016-114 and CP2016-145) (Order No. 3230), added April 11, 2016.

10. First-Class Package Service Contract 49 (MC2016-116 and CP2016-147) (Order No. 3232), added April 11, 2016.

11. First-Class Package Service Contract 51 (MC2016-119 and CP2016-149) (Order No. 3251), added April 19, 2016.

12. Priority Mail Express & Priority Mail Contract 29 (MC2016-120 and CP2016-150) (Order No. 3252), added April 19, 2016.

13. Priority Mail Contract 206 (MC2016-121 and CP2016-154) (Order No. 3262), added April 27, 2016.

14. Priority Mail Contract 207 (MC2016-122 and CP2016-155) (Order No. 3265), added April 27, 2016.

15. Priority Mail Contract 208 (MC2016-123 and CP2016-156) (Order No. 3267), added April 29, 2016.

16. Priority Mail Contract 211 (MC2016-126 and CP2016-160) (Order No. 3281), added May 10, 2016.

17. Priority Mail Contract 213 (MC2016-128 and CP2016-162) (Order No. 3283), added May 10, 2016.

18. Priority Mail Contract 209 (MC2016-124 and CP2016-158) (Order No. 3285), added May 10, 2016.

19. Priority Mail Contract 210 (MC2016-125 and CP2016-159) (Order No. 3286), added May 10, 2016.

20. Priority Mail Contract 212 (MC2016-127 and CP2016-161) (Order No. 3287), added May 10, 2016.

21. Priority Mail & First-Class Package Service Contract 18 (MC2016-129 and CP2016-163) (Order No. 3288), added May 10, 2016.

22. First-Class Package Service Contract 52 (MC2016-130 and CP2016-164) (Order No. 3289), added May 10, 2016.

23. Market Test of Global eCommerce Marketplace (GEM) Merchant (MT2016-1) (Order No. 3319), added May 25, 2016.

24. Priority Mail Contract 217 (MC2016-134 and CP2016-171) (Order No. 3336), added June 2, 2016.

25. Priority Mail Contract 218 (MC2016-135 and CP2016-172) (Order No. 3337), added June 2, 2016.

26. Priority Mail Contract 219 (MC2016-136 and CP2016-173) (Order No. 3338), added June 2, 2016.

27. Priority Mail Contract 216 (MC2016-133 and CP2016-170) (Order No. 3340), added June 2, 2016.

28. First-Class Package Service Contract 54 (MC2016-141 and CP2016-178) (Order No. 3341), added June 3, 2016.

29. Priority Mail & First-Class Package Service Contract 19 (MC2016-142 and CP2016-179) (Order No. 3342), added June 3, 2016.

30. Priority Mail Express Contract 37 (MC2016-139 and CP2016-176) (Order No. 3343), added June 3, 2016.

31. First-Class Package Service Contract 53 (MC2016-140 and CP2016-177) (Order No. 3344), added June 3, 2016.

32. Priority Mail Contract 215 (MC2016-132 and CP2016-169) (Order No. 3345), added June 3, 2016.

33. Priority Mail Express Contract 36 (MC2016-138 and CP2016-175) (Order No. 3346), added June 3, 2016.

34. Priority Mail Contract 221 (MC2016-144 and CP2016-181) (Order No. 3350), added June 6, 2016.

35. Priority Mail Contract 222 (MC2016-145 and CP2016-182) (Order No. 3351), added June 6, 2016.

36. First-Class Package Service Contract 55 (MC2016-148 and CP2016-185) (Order No. 3352), added June 6, 2016.

37. Priority Mail Contract 220 (MC2016-143 and CP2016-180) (Order No. 3353), added June 6, 2016.

38. Priority Mail Contract 223 (MC2016-146 and CP2016-183) (Order No. 3354), added June 6, 2016.

39. Parcel Select Contract 16 (MC2016-147 and CP2016-184) (Order No. 3355), added June 6, 2016.

40. Parcel Select Contract 15 (MC2016-137 and CP2016-174) (Order No. 3363), added June 8, 2016.

41. Global Expedited Package Services 6 Contracts (MC2016-149 and CP2016-188) (Order No. 3365), added June 14, 2016.

42. Priority Mail Contract 224 (MC2016-150 and CP2016-190) (Order No. 3367), added June 14, 2016.

43. Priority Mail Contract 225 (MC2016-151 and CP2016-191) (Order No. 3368), added June 14, 2016.

44. Global Plus 3 Contracts (MC2016-152 and CP2016-196) (Order No. 3378), added June 21, 2016.

45. First-Class Package Service Contract 57 (MC2016-155 and CP2016-218) (Order No. 3390), added June 28, 2016.

46. First-Class Package Service Contracts 56 (MC2016-154 and CP2016-217) (Order No. 3391), added June 28, 2016.

47. Global Plus 1D (CP2016-193) (Order No. 3395), added June 29, 2016.

48. Priority Mail Contract 227 (MC2016-156 and CP2016-219) (Order No. 3397), added June 29, 2016.

49. Priority Mail Contract 226 (MC2016-153 and CP2016-216) (Order No. 3399), added June 30, 2016.

The following negotiated service agreements have expired and are being deleted from the Competitive Product List:

1. Priority Mail Contract 29 (MC2011-3 and CP2011-4) (Order No. 574).

2. Priority Mail Contract 56 (MC2013-42 and CP2013-55) (Order No. 1695).

3. Priority Mail Contract 57 (MC2013-43 and CP2013-56) (Order No. 1696).

4. Priority Mail Contract 58 (MC2013-47 and CP2013-61) (Order No. 1712).

5. Priority Mail Express Contract 15 (MC2013-50 and CP2013-63) (Order No. 1729).

Updated product list. The referenced changes to the product list is incorporated into 39 CFR Appendix B to Subpart A of Part 3020—Competitive Product List.

For the reasons discussed in the preamble, the Postal Regulatory Commission amends chapter III of title 39 of the Code of Federal Regulations as follows:

USAID published a proposed rule in the Federal Register at 80 FR 69930 on November 12, 2015 soliciting public comments on the inclusion of several agency-specific clauses into the Agency for International Development Acquisition Regulation (AIDAR). The highlights of the changes are as follows:

• Sections 722.810 and 752.222-71 are added to encourage all USAID contractors performing and recruiting entirely outside the United States to develop and enforce employment nondiscrimination policies with regard to race, color, religion, sex (including pregnancy and gender identity), sexual orientation, marital status, parental status, political affiliation, national origin, disability, age, genetic information, veteran status or any other conduct that does not adversely affect the performance of the employee.

• New part 729, subpart 729.4, sections 729.204-70 and 752.229-70 require contractors to report the amounts of foreign taxes assessed by a foreign government on commodities financed with U.S. Foreign Assistance funds. The reporting is used to require the countries to reimburse the taxes or duties imposed on U.S. foreign assistance funds and for certain reporting to Congress.

• Sections 731.205-43 and 752.231-72 are added to mitigate the risk of inappropriate spending, as mandated by Executive Order 13589 “Promoting Efficient Spending” dated November 9, 2011. Contractors are required to obtain USAID written approval prior to committing costs related to USAID-funded conferences that meet the criteria provided in section 731.205-43.

• New section 752.7036 directs contractors to register with the Implementing Partner Notices (IPN) Portal, where USAID uploads contract modifications that affect multiple awards and provides notices to contractors.

• Section 752.7037 is added to promote child safeguarding when implementing USAID programs. The clause complements the USAID Counter Trafficking in Persons (C-TIP) Code of Conduct by expanding the range of actions prohibited by USAID to include abuse, exploitation, or neglect of children.

One comment was received in response to the proposed rule, which USAID reviewed in the development of the final rule. No other comments were received.

A discussion of the comment received and the resulting changes are provided as follows:

Comment: One respondent recommended that USAID clarify the impact of the transfer of the requirements for prior written approval of conference costs from Agency internal policies into the AIDAR section 731.205-43. The respondent correctly pointed out that the intent of including these requirements in section 731.205-43 was to make the costs associated with a conferences meeting the criteria in the subpart unallowable, if the contractor did not obtain the required prior written approval. To minimize potential disagreement between the contractors and the Government, and to mitigate the risk of litigations, the respondent recommended including a statement in the section 731.205-43 to clarify this point. Doing so would also ensure that such costs are expressly unallowable and thus subject to the penalties provided in FAR 42.709.

Response: We concur with the respondent's recommendation. Based on this public comment, USAID is revising section 731.205-43 to include a new paragraph stating that costs associated with a conference, meeting the criteria in the subpart, are unallowable, when the required prior written approval for such costs is not obtained.

In addition, the final rule includes the following minor editorial changes from the proposed rule, based on further Agency review and comments from OMB and other agencies:

• A new paragraph was added to section 731.205-43 to specify that contracting Officers or the contracting officer's representatives will provide conference cost approvals following Agency internal procedures in Automated Directive System (ADS) Chapter 580.

• The clause at 752.231-72 is revised to make clear that contractors must obtain the required approvals for conferences from the contracting officer or contracting officer's representative.

• The definition of the universal bilateral modification at 752.3036 has been slightly edited to conform to the plain language requirements.

• The clause at 752.222-71 is revised for clarity.

This rule has been determined to be “nonsignificant” under the Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993 and, therefore, is not subject to review. This rule is not a major rule under 5 U.S.C. 804.

The rule will not have an impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Therefore, an Initial Regulatory Flexibility Analysis has not been performed.

The proposed rule does not establish a new collection of information that requires the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

For the reasons discussed in the preamble, USAID amends 48 CFR chapter 7 as set forth below:

NMFS manages the Gulf reef fish fishery, which includes greater amberjack, under the Fishery Management Plan for the Reef Fish Resources of the Gulf (FMP). The Gulf of Mexico Fishery Management Council (Council) prepared the FMP and NMFS implements the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All greater amberjack weights discussed in this temporary rule are in round weight.

The 2016 recreational ACL for Gulf greater amberjack specified in 50 CFR 622.41(b)(2)(iii) is 1,255,600 lb (569,531 kg) and the recreational ACT specified in 50 CFR 622.39(a)(2)(ii) is 1,092,372 lb (495,492 kg). However, in 2015, the recreational harvest of greater amberjack exceeded the 2015 recreational ACL by 57,930 lb (26,277 kg). Therefore, consistent with the requirements specified in 50 CFR 622.41(a)(2)(ii), NMFS reduces the recreational ACL for greater amberjack in 2016 to 1,197,670 lb (543,254 kg) and the recreational ACT to 1,034,442 lb (469,215 kg).

Under 50 CFR 622.41(a)(2)(i), NMFS is required to close the recreational sector for greater amberjack when the recreational ACT is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined the 2016 recreational ACT was reached prior to the annual season closure, which is effective from June 1 through July 31 each year. Accordingly, the recreational sector for Gulf greater amberjack will not re-open on August 1, because NMFS is closing recreational harvest of greater amberjack for the rest of the 2016 fishing year effective at 12:01 a.m., local time, August 1, 2016, until 12:01 a.m., local time, January 1, 2017, the start of the next fishing year.

During the recreational closure, the bag and possession limits for greater amberjack in or from the Gulf EEZ are zero. The prohibition on possession in the Gulf on board a vessel for which a valid Federal charter vessel/headboat permit for Gulf reef fish has been issued applies regardless of whether greater amberjack were harvested in state or Federal waters.

The recreational sector for greater amberjack will reopen on January 1, 2017, the beginning of the 2017 recreational fishing year.

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of Gulf greater amberjack and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.41(a)(2)(i) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds that the need to immediately implement this action to close the recreational sector for greater amberjack constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule pursuant to the authority set forth in 5 U.S.C. 553(b)(B), because such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule establishing the closure provisions was subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect greater amberjack. Prior notice and opportunity for public comment would require time and would potentially allow the recreational sector to exceed the recreational ACL.

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

The U.S. Atlantic swordfish fishery is managed under the 2006 Consolidated Atlantic HMS FMP (October 2, 2006; 71 FR 58058). Implementing regulations at 50 CFR part 635 are issued under the authority of the Magnuson-Stevens Act, 16 U.S.C. 1801 et seq., and ATCA, 16 U.S.C. 971 et seq. ATCA authorizes the Secretary of Commerce (Secretary) to promulgate regulations as may be necessary and appropriate to implement ICCAT recommendations.

For North Atlantic swordfish, this final action maintains the U.S. baseline quota of 2,937.6 metric tons (mt) dressed weight (dw) and authorizes the transfer of 18.8 mt dw from the United States to Mauritania as required by ICCAT Recommendation 13-02. For South Atlantic swordfish, this action maintains the U.S. South Atlantic swordfish quota at 75.2 mt dw (100 mt whole weight (ww)), carries over 75.1 mt dw of 2015 underharvest, and authorizes the transfer of 50 mt ww (37.6 mt dw) to Namibia, 25 mt ww (18.8 mt dw) to Côte d'Ivoire, and 25 mt ww (18.8 mt dw) to Belize, consistent with ICCAT Recommendation 13-03. More specific information regarding the quota calculations can be found below. Additional details regarding the quotas and other actions in this rule and their impacts can be found in the proposed rule (81 FR 36511, June 7, 2016).

At the 2013 ICCAT annual meeting, Recommendation 13-02 was adopted, maintaining the North Atlantic swordfish total allowable catch (TAC) of 10,301 metric tons (mt) dressed weight (dw) (13,700 mt whole weight (ww)) through 2016. Of this TAC, the United States' baseline quota is 2,937.6 mt dw (3,907 mt ww) per year. ICCAT Recommendation 13-02 also includes an 18.8 mt dw (25 mt ww) annual quota transfer from the United States to Mauritania and limits underharvest carryover to 15 percent of a contracting party's baseline quota. Therefore, the United States may carry over a maximum of 440.6 mt dw (586.0 mt ww) of underharvest from 2015 to 2016. This final rule adjusts the U.S. baseline quota for the 2016 fishing year to account for the annual quota transfer to Mauritania and the 2015 underharvest.

The 2016 North Atlantic swordfish baseline quota is 2,937.6 mt dw (3,907 mt ww). The preliminary estimate of North Atlantic swordfish underharvest for 2015 was 2,181.6 mt dw as of December 31, 2015; therefore, NMFS is carrying forward 440.6 mt dw, the maximum carryover allowed under Recommendation 13-02. The 2,937.6 mt dw baseline quota is reduced by the 18.8 mt dw annual quota transfer to Mauritania and increased by the underharvest carryover of 440.6 mt dw, resulting in a final adjusted North Atlantic swordfish quota for the 2016 fishing year of 3,359.4 mt dw (2,937.6−18.8 + 440.6 = 3,359.4 mt dw). From that adjusted quota, 50 mt dw will be allocated to the reserve category for inseason adjustments and research, and 300 mt dw will be allocated to the incidental category, which includes recreational landings and landings by incidental swordfish permit holders, in accordance with regulations at 50 CFR 635.27(c)(1)(i). This would result in an allocation of 3,009.4 mt dw (3,359.4−50−300 = 3,009.4 mt dw) for the directed category, which would be split equally between two seasons in 2016 (January through June, and July through December) (Table 1).

For clarity, the final rule removes extraneous regulatory text about the percentage of the annual baseline quota allocation that may be carried over in a given year. Under prior ICCAT recommendations, 25 percent of the unused annual baseline could be carried over to the subsequent year. ICCAT Recommendation 13-02 changed the allowable carryover to 15 percent from 2015 on. This change simplifies the regulatory text by removing the reference to the 25-percent carryover allowance to avoid confusion.

In 2013, ICCAT Recommendation 13-03 established the South Atlantic swordfish TAC at 11,278.2 mt dw (15,000 mt ww) for 2014, 2015, and 2016. Of this, the United States receives 75.2 mt dw (100 mt ww). Recommendation 13-03 limits the amount of South Atlantic swordfish underharvest that can be carried forward, and the United States may carry forward up to 100 percent of its baseline quota (75.2 mt dw). Recommendation 13-03 also included a total of 75.2 mt dw (100 mt ww) of quota transfers from the United States to other countries. These transfers were 37.6 mt dw (50 mt ww) to Namibia, 18.8 mt dw (25 mt ww) to Côte d'Ivoire, and 18.8 mt dw (25 mt ww) to Belize.

In 2015, U.S. fishermen landed no South Atlantic swordfish according to data available as of December 31, 2015. The adjusted 2015 South Atlantic swordfish quota was 75.1 mt dw due to nominal landings in previous years. Therefore, 75.1 mt dw of underharvest is available to carry over to 2016. NMFS is carrying forward 75.1 mt dw to be added to the 75.2 mt dw baseline quota. The quota is then reduced by the 75.2 mt dw of annual international quota transfers outlined above, resulting in an adjusted South Atlantic swordfish quota of 75.1 mt dw for the 2016 fishing year.

In the past, NMFS has published proposed swordfish quota specifications annually, allowed for a public comment period, and then issued a final rule. NMFS has done this when adopting new quotas, altering conservation and management measures pursuant to an ICCAT recommendation, or when simply adjusting the swordfish quotas based on formulas or measures codified in regulations previously adopted through notice-and-comment rulemaking (see, e.g., regulatory text at 50 CFR 635.27(c)). Where NMFS is simply administering a pre-established formula that is already embodied in regulations, it has limited discretion over implementation. Inviting public notice and comment on these actions may have unnecessarily confused the regulated community, which has not understood the scope of these actions and NMFS' lack of discretion to make changes in these situations. Past public comments have included requests that go well beyond the scope of these actions, including suggestions to carry over underharvests in an amount exceeding the carryover limit, which would be inconsistent with ICCAT recommendations; requests not to carry over any underharvests, which would be inconsistent with the established regulatory formulas; and requests to shut down the commercial swordfish fishery.

To address public confusion and streamline the regulatory process, NMFS notifies the public that beginning in 2017, it will annually adjust the North and South Atlantic swordfish quotas through a final rule without an opportunity for public comment, as appropriate, when such adjustments simply apply a previously-adopted formula and are administrative in nature. NMFS takes such action consistent with requirements of the Administrative Procedure Act. NMFS would continue to undertake notice and comment rulemaking when adopting new quotas or otherwise altering conservation and management measures.

During the proposed rule comment period, NMFS received one written comment; however, it was not relevant to the proposed action.

The final rule contains no changes from the proposed rule.

Pursuant to the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that the final rule is consistent with the 2006 Consolidated HMS FMP and its amendments, other provisions of the Magnuson-Stevens Act, ATCA, and other applicable law.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

Previously, NMFS determined that proposed rules to implement the North Atlantic swordfish quota (77 FR 25669, May 1, 2012) and South Atlantic swordfish quota (75 FR 35432, June 22, 2010) were consistent to the maximum extent practicable with the enforceable policies of the approved coastal management program of coastal states on the Atlantic, including the Gulf of Mexico and the Caribbean Sea. Pursuant to 15 CFR 930.41(a), NMFS provided the Coastal Zone Management Program of each coastal state a 60-day period to review the consistency determination and to advise the Agency of their concurrence. NMFS received concurrence with the consistency determinations from several states and inferred consistency from those states that did not respond within the 60-day time period. This final action to establish the 2016 North and South Atlantic swordfish quotas does not change the framework previously consulted upon; therefore, no additional consultation is required.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.

For reasons set out in the preamble, 50 CFR part 635 is amended as follows:

NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands management area (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2016 flathead sole and rock sole CDQ reserves specified in the BSAI are 2,232 metric tons (mt), and 5,760 mt as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016) and following revision (81 FR 41253, June 24, 2016). The 2016 flathead sole and rock sole CDQ ABC reserves are 4,857 mt and 11,478 mt as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016) and following revision (81 FR 41253, June 24, 2016).

The Norton Sound Economic Development Corporation has requested that NMFS exchange 400 mt of flathead sole CDQ reserves for 400 mt of rock sole CDQ ABC reserves under § 679.31(d). Therefore, in accordance with § 679.31(d), NMFS exchanges 400 mt of flathead sole CDQ reserves for 400 mt of rock sole CDQ ABC reserves in the BSAI. This action also decreases and increases the TACs and CDQ ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016), and following revision (81 FR 41253, June 24, 2016), are revised as follows: