Federal Register Vol. 80, No.83,

On behalf of CCC, FSA administers the Tobacco Transition Program (TTP), which includes TTPP and TTAP. The TTP regulations are located in 7 CFR part 1463, subpart B; TTAP regulations are located in subpart A. This notice does not change the regulations. TTPP was authorized by Title VI of the American Jobs Creation Act of 2004 (Pub. L. 108-357). Title VI is also known as FETRA (7 U.S.C. 518-519a). FETRA repealed the tobacco marketing quota and related price support programs authorized by Title III of the Agricultural Adjustment Act of 1938 and by the Agricultural Act of 1949, and provided for payments to persons who were owners of farms with tobacco quotas, or who were producers of quota tobacco. As specified in FETRA, TTPP used funds from assessments collected quarterly from domestic tobacco manufacturers and importers to make TTPP contract payments; those payments ended with fiscal year 2014. There will be no new TTPP contracts issued; the July 1, 2015 deadline is only for claims for payment under existing contracts.

FSA is clarifying a few final procedures and dates for both the orderly close-out of TTPP, and the effect of the former on the close-out of the TTAP. Accordingly, this notice clarifies how final payments will be handled after fiscal year 2014. Specifically, all claims for payments on existing contracts must be received in an FSA county office by July 1, 2015. This notice will also discuss the final “true-up” for TTAP.

FSA has already made every effort to pay in full existing TTPP contract holders. We believe that the only remaining pending payments are those that may be due to the surviving spouses, beneficiaries of an estate, or successors in interest of now-deceased contract holders.

In accordance with 7 CFR 1463.113, the TTPP payment can be transferred to the surviving spouse of a deceased TTPP contract holder upon presentation of a death certificate, without regard to any will or other document created on behalf of or by the deceased contract holder. If there is no surviving spouse of a deceased contract holder, the TTPP payment can be transferred to the estate of the deceased by any person authorized under State law to distribute assets of the deceased TTPP contract holder. The regulations for successor-in-interest contracts are found in 7 CFR 1463.112. This notice does not change those regulations. Evidence of authority to distribute assets of a deceased TTPP contract holder must be submitted to FSA by July 1, 2015.

Persons who are surviving spouses, beneficiaries of an estate, or successors in interest may not have received payment if contact information was not provided to FSA in a timely fashion, or if the right to receive such payments was not documented as required. Any such persons who wish to receive payments must provide contact information, present evidence of authority to distribute assets (if applicable), and submit a claim for payment, using form CCC-971, “Transfer of Tobacco Transition Payment Program Contracts Exempt From Maximum Discount Rate,” to a local FSA county office. The CCC-971 form must have an original signature. All of the above information and form CCC-971 must be submitted to any local FSA office either in person, or received by mail, no later than July 1, 2015. Form CCC-971 is available online at http://forms.sc.egov.usda.gov/efcommon/eFileServices/eForms/CCC971-971-A.PDF.

This notice does not change the final dates or procedures for assessments that were specified in the most recent final rule for TTAP, published on April 9, 2014 (79 FR 19462-19464). As specified in the preamble of that final rule, FSA will make any necessary final “trued up” revisions to the assessments for all 10 fiscal years of the Tobacco Transition Program and issue revised assessments on or before December 1, 2015. The final “trued up” assessment will include any adjustments needed to cover payments made for final claims for payments on existing TTPP contracts received by July 1, 2015. After December 1, 2015, there will be no revised assessments issued for any fiscal years. The final date for appeals of assessments is January 16, 2016, as specified in 7 CFR 1463.11; that date is not changing with this notice.

Background

On November 3, 2014, the Department initiated sunset reviews on the AD and CVD orders on commodity matchbooks from India pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).1 As a result of the reviews, the Department found that revocation of the AD order on commodity matchbooks from India would be likely to lead to the continuation or recurrence of dumping, and notified the ITC of the margins of dumping likely to prevail should the order be revoked.2 The Department also found that revocation of the CVD order on commodity matchbooks from India would be likely to lead to the continuation or recurrence of a countervailable subsidy, and notified the ITC of the net countervailable subsidy that is likely to prevail should the order be revoked.3

On April 17, 2015, the ITC published its determination, pursuant to sections 751(c) and 752(a) of the Act, that revocation of the AD and CVD orders on commodity matchbooks from India would be likely to lead to the continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.4

The scope of the orders covers commodity matchbooks, also known as commodity book matches, paper matches or booklet matches.5 Commodity matchbooks typically, but do not necessarily, consist of twenty match stems which are usually made from paperboard or similar material tipped with a match head composed of any chemical formula. The match stems may be stitched, stapled or otherwise fastened into a matchbook cover of any material, on which a striking strip composed of any chemical formula has been applied to assist in the ignition process.

Commodity matchbooks included in the scope of these orders may or may not contain printing. For example, they may have no printing other than the identification of the manufacturer or importer. Commodity matchbooks may also be printed with a generic message such as “Thank You” or a generic image such as the American Flag, with store brands (e.g., Kroger, 7-Eleven, Shurfine or Giant); product brands for national or regional advertisers such as cigarettes or alcoholic beverages; or with corporate brands for national or regional distributors (e.g., Penley Corp. or Diamond Brands). They all enter retail distribution channels. Regardless of the materials used for the stems of the matches and regardless of the way the match stems are fastened to the matchbook cover, all commodity matchbooks are included in the scope of these orders. All matchbooks, including commodity matchbooks, typically comply with the United States Consumer Product Safety Commission (CPSC) Safety Standard for Matchbooks, codified at 16 CFR 1202.1 et seq.

The scope of these orders excludes promotional matchbooks, often referred to as “not for resale,” or “specialty advertising” matchbooks, as they do not enter into retail channels and are sold to businesses that provide hospitality, dining, drinking or entertainment services to their customers, and are given away by these businesses as promotional items. Such promotional matchbooks are distinguished by the physical characteristic of having the name and/or logo of a bar, restaurant, resort, hotel, club, café/coffee shop, grill, pub, eatery, lounge, casino, barbecue or individual establishment printed prominently on the matchbook cover. Promotional matchbook cover printing also typically includes the address and the phone number of the business or establishment being promoted.6 Also excluded are all other matches that are not fastened into a matchbook cover such as wooden matches, stick matches, box matches, kitchen matches, pocket matches, penny matches, household matches, strike-anywhere matches (aka “SAW” matches), strike-on-box matches (aka “SOB” matches), fireplace matches, barbeque/grill matches, fire starters, and wax matches.

The merchandise subject to these orders is properly classified under subheading 3605.00.0060 of the Harmonized Tariff Schedule of the United States (HTSUS). Subject merchandise may also enter under subheading 3605.00.0030 of the HTSUS. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of these orders is dispositive.7

As a result of the determinations by the Department and the ITC that revocation of these AD and CVD duty orders would likely lead to the continuation or recurrence of dumping and a countervailable subsidy, as well as material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, the Department hereby orders the continuation of the AD and CVD orders on commodity matchbooks from India. U.S. Customs and Border Protection will continue to collect AD and CVD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise.

The effective date of the continuation of these orders will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act, the Department intends to initiate the next sunset review of these orders not later than 30 days prior to the fifth anniversary of the effective date of continuation.

These sunset reviews and this notice are in accordance with sections 751(c) and 751(d)(2) of the Act, and published pursuant to 777(i) of the Act and 19 CFR 351.218(f)(4).

Background

The Department has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping and countervailing duty orders and findings with March anniversary dates.

All deadlines for the submission of various types of information, certifications, or comments or actions by the Department discussed below refer to the number of calendar days from the applicable starting time.

If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (“POR”), it must notify the Department within 30 days of publication of this notice in the Federal Register. All submissions must be filed electronically at http://access.trade.gov in accordance with 19 CFR 351.303.1 Such submissions are subject to verification in accordance with section 782(i) of the Tariff Act of 1930, as amended (“the Act”). Further, in accordance with 19 CFR 351.303(f)(1)(i), a copy must be served on every party on the Department's service list.

In the event the Department limits the number of respondents for individual examination for administrative reviews, the Department intends to select respondents based on U.S. Customs and Border Protection (“CBP”) data for U.S. imports during the POR. We intend to release the CBP data under Administrative Protective Order (“APO”) to all parties having an APO within seven days of publication of this initiation notice and to make our decision regarding respondent selection within 21 days of publication of this Federal Register notice. The Department invites comments regarding the CBP data and respondent selection within five days of placement of the CBP data on the record of the applicable review. Rebuttal comments will be due five days after submission of initial comments.

In the event the Department decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:

In general, the Department has found that determinations concerning whether particular companies should be “collapsed” (i.e., treated as a single entity for purposes of calculating antidumping duty rates) require a substantial amount of detailed information and analysis, which often require follow-up questions and analysis. Accordingly, the Department will not conduct collapsing analyses at the respondent selection phase of this review and will not collapse companies at the respondent selection phase unless there has been a determination to collapse certain companies in a previous segment of this antidumping proceeding (i.e., investigation, administrative review, new shipper review or changed circumstances review). For any company subject to this review, if the Department determined, or continued to treat, that company as collapsed with others, the Department will assume that such companies continue to operate in the same manner and will collapse them for respondent selection purposes. Otherwise, the Department will not collapse companies for purposes of respondent selection. Parties are requested to (a) identify which companies subject to review previously were collapsed, and (b) provide a citation to the proceeding in which they were collapsed. Further, if companies are requested to complete the Quantity and Value (“Q&V”) Questionnaire for purposes of respondent selection, in general each company must report volume and value data separately for itself. Parties should not include data for any other party, even if they believe they should be treated as a single entity with that other party. If a company was collapsed with another company or companies in the most recently completed segment of this proceeding where the Department considered collapsing that entity, complete Q&V data for that collapsed entity must be submitted.

Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that the Department may extend this time if it is reasonable to do so. In order to provide parties additional certainty with respect to when the Department will exercise its discretion to extend this 90-day deadline, interested parties are advised that the Department does not intend to extend the 90-day deadline unless the requestor demonstrates that an extraordinary circumstance has prevented it from submitting a timely withdrawal request. Determinations by the Department to extend the 90-day deadline will be made on a case-by-case basis.

In proceedings involving non-market economy (“NME”) countries, the Department begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is the Department's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.

To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, the Department analyzes each entity exporting the subject merchandise under a test arising from the Final Determination of Sales at Less Than Fair Value: Sparklers from the People's Republic of China, 56 FR 20588 (May 6, 1991), as amplified by Final Determination of Sales at Less Than Fair Value: Silicon Carbide from the People's Republic of China, 59 FR 22585 (May 2, 1994). In accordance with the separate rates criteria, the Department assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both de jure and de facto government control over export activities.

All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification, as described below. For these administrative reviews, in order to demonstrate separate rate eligibility, the Department requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on the Department's Web site at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the certification, please follow the “Instructions for Filing the Certification” in the Separate Rate Certification. Separate Rate Certifications are due to the Department no later than 30 calendar days after publication of this Federal Register notice. The deadline and requirement for submitting a Certification applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers who purchase and export subject merchandise to the United States.

Entities that currently do not have a separate rate from a completed segment of the proceeding 2 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. In addition, companies that received a separate rate in a completed segment of the proceeding that have subsequently made changes, including, but not limited to, changes to corporate structure, acquisitions of new companies or facilities, or changes to their official company name, 3 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. The Separate Rate Status Application will be available on the Department's Web site at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the Separate Rate Status Application, refer to the instructions contained in the application. Separate Rate Status Applications are due to the Department no later than 30 calendar days of publication of this Federal Register notice. The deadline and requirement for submitting a Separate Rate Status Application applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers that purchase and export subject merchandise to the United States.

For exporters and producers who submit a separate-rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.

In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than March 31, 2016.

During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine, consistent with FAG Italia v. United States, 291 F.3d 806 (Fed Cir. 2002), as appropriate, whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.

For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period, of the order, if such a gap period is applicable to the POR.

Interested parties must submit applications for disclosure under administrative protective orders in accordance with 19 CFR 351.305. On January 22, 2008, the Department published Antidumping and Countervailing Duty Proceedings: Documents Submission Procedures; APO Procedures, 73 FR 3634 (January 22, 2008). Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures (e.g., the filing of separate letters of appearance as discussed at 19 CFR 351.103(d)).

On April 10, 2013, the Department published Definition of Factual Information and Time Limits for Submission of Factual Information: Final Rule, 78 FR 21246 (April 10, 2013), which modified two regulations related to antidumping and countervailing duty proceedings: the definition of factual information (19 CFR 351.102(b)(21)), and the time limits for the submission of factual information (19 CFR 351.301). The final rule identifies five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i)-(iv). The final rule requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. The final rule also modified 19 CFR 351.301 so that, rather than providing general time limits, there are specific time limits based on the type of factual information being submitted. These modifications are effective for all segments initiated on or after May 10, 2013. Please review the final rule, available at http://enforcement.trade.gov/frn/2013/1304frn/2013-08227.txt, prior to submitting factual information in this segment.

Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness of that information.5 Parties are hereby reminded that revised certification requirements are in effect for company/government officials as well as their representatives. All segments of any antidumping duty or countervailing duty proceedings initiated on or after August 16, 2013, should use the formats for the revised certifications provided at the end of the Final Rule. 6 The Department intends to reject factual submissions in any proceeding segments if the submitting party does not comply with applicable revised certification requirements.

On September 20, 2013, the Department modified its regulation concerning the extension of time limits for submissions in antidumping and countervailing duty proceedings: Final Rule, 78 FR 57790 (September 20, 2013). The modification clarifies that parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the time limit established under Part 351 expires. For submissions which are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Examples include, but are not limited to: (1) Case and rebuttal briefs, filed pursuant to 19 CFR 351.309; (2) factual information to value factors under 19 CFR 351.408(c), or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2), filed pursuant to 19 CFR 351.301(c)(3) and rebuttal, clarification and correction filed pursuant to 19 CFR 351.301(c)(3)(iv); (3) comments concerning the selection of a surrogate country and surrogate values and rebuttal; (4) comments concerning U.S. Customs and Border Protection data; and (5) quantity and value questionnaires. Under certain circumstances, the Department may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, the Department will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. This modification also requires that an extension request must be made in a separate, stand-alone submission, and clarifies the circumstances under which the Department will grant untimely-filed requests for the extension of time limits. These modifications are effective for all segments initiated on or after October 21, 2013. Please review the final rule, available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in these segments.

These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).

Availability

Electronic copies of SCWA's application and any supporting documents, as well as a list of the references cited in this document, may be obtained by visiting the Internet at: www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. In the case of problems accessing these documents, please call the contact listed above. NMFS' Environmental Assessment (2010) and associated Finding of No Significant Impact, prepared pursuant to the National Environmental Policy Act, and NMFS' Biological Opinion (2008) on the effects of Russian River management activities on salmonids, prepared pursuant to the Endangered Species Act, are also available at the same site.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361, et seq.) direct the Secretary of Commerce to allow, upon request by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified area, the incidental, but not intentional, taking of small numbers of marine mammals, providing that certain findings are made and the necessary prescriptions are established.

The incidental taking of small numbers of marine mammals may be allowed only if NMFS (through authority delegated by the Secretary) finds that the total taking by the specified activity during the specified time period will (i) have a negligible impact on the species or stock(s) and (ii) not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant). Further, the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such taking must be set forth.

The allowance of such incidental taking under section 101(a)(5)(A), by harassment, serious injury, death, or a combination thereof, requires that regulations be established. Subsequently, a Letter of Authorization may be issued pursuant to the prescriptions established in such regulations, providing that the level of taking will be consistent with the findings made for the total taking allowable under the specific regulations. Under section 101(a)(5)(D), NMFS may authorize such incidental taking by harassment only, for periods of not more than one year, pursuant to requirements and conditions contained within an IHA. The establishment of these prescriptions requires notice and opportunity for public comment.

NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: “. . . any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

On January 21, 2015, we received an adequate and complete request from SCWA for authorization of the taking of marine mammals incidental to Russian River estuary management activities in Sonoma County, California. SCWA plans to continue ongoing actions necessary to manage the naturally-formed barrier beach at the mouth of the Russian River in order to minimize potential for flooding adjacent to the estuary and to enhance habitat for juvenile salmonids, as well as to conduct biological and physical monitoring of the barrier beach and estuary. Flood control-related breaching of barrier beach at the mouth of the river may include artificial breaches, as well as construction and maintenance of a lagoon outlet channel. The latter activity, an alternative management technique conducted to mitigate impacts of flood control on rearing habitat for Endangered Species Act (ESA)-listed salmonids, occurs only from May 15 through October 15 (hereafter, the “lagoon management period”). Artificial breaching and monitoring activities may occur at any time during the one-year period of validity of the IHA.

Breaching of naturally-formed barrier beach at the mouth of the Russian River requires the use of heavy equipment (e.g., bulldozer, excavator) and increased human presence, and monitoring in the estuary requires the use of small boats. As a result, pinnipeds hauled out on the beach or at peripheral haul-outs in the estuary may exhibit behavioral responses that indicate incidental take by Level B harassment under the MMPA. Species known from the haul-out at the mouth of the Russian River or from peripheral haul-outs, and therefore anticipated to be taken incidental to the specified activity, include the harbor seal (Phoca vitulina richardii), California sea lion (Zalophus californianus), and northern elephant seal (Mirounga angustirostris).

This is the sixth such IHA issued to SCWA. SCWA was first issued an IHA, valid for a period of one year, effective on April 1, 2010 (75 FR 17382), and was subsequently issued one-year IHAs for incidental take associated with the same activities, effective on April 21, 2011 (76 FR 23306), April 21, 2012 (77 FR 24471), April 21, 2013 (78 FR 23746), and April 21, 2014 (79 FR 20180).

Additional detail regarding the specified activity was provided in our Federal Register notice of proposed authorization (80 FR 14073; March 18, 2015) and in past notices cited herein; please see those documents or SCWA's application for more information.

The planned action involves management of the estuary to prevent flooding while preventing adverse modification to critical habitat for ESA-listed salmonids. Requirements related to the ESA are described in further detail below. During the lagoon management period, this involves construction and maintenance of a lagoon outlet channel that would facilitate formation of a perched lagoon. A perched lagoon, which is an estuary closed to tidal influence in which water surface elevation is above mean high tide, reduces flooding while maintaining beneficial conditions for juvenile salmonids. Additional breaches of barrier beach may be conducted for the sole purpose of reducing flood risk. SCWA's planned activity was described in detail in our notice of proposed authorization prior to the 2011 IHA (76 FR 14924; March 18, 2011); please see that document for a detailed description of SCWA's estuary management activities. Aside from minor additions to SCWA's biological and physical estuary monitoring measures, the specified activity remains the same as that described in the 2011 document.

The specified activity may occur at any time during the one-year timeframe (April 21, 2015, through April 20, 2016) of the IHA, although construction and maintenance of a lagoon outlet channel will occur only during the lagoon management period. In addition, there are certain restrictions placed on SCWA during the harbor seal pupping season. These, as well as periodicity and frequency of the specified activities, are described in further detail below.

The estuary is located about 97 km (60 mi) northwest of San Francisco in Sonoma County, near Jenner, California (see Figure 1 of SCWA's application). The Russian River watershed encompasses 3,847 km2 (1,485 mi2) in Sonoma, Mendocino, and Lake Counties. The mouth of the Russian River is located at Goat Rock State Beach (see Figure 2 of SCWA's application); the estuary extends from the mouth upstream approximately 10 to 11 km (6-7 mi) between Austin Creek and the community of Duncans Mills (Heckel and McIver, 1994).

Within the Russian River watershed, the U.S. Army Corps of Engineers (Corps), SCWA and the Mendocino County Russian River Flood Control and Water Conservation Improvement District (District) operate and maintain federal facilities and conduct activities in addition to the estuary management, including flood control, water diversion and storage, instream flow releases, hydroelectric power generation, channel maintenance, and fish hatchery production. As described in the notice of proposed IHA, NMFS issued a 2008 Biological Opinion (BiOp) for Water Supply, Flood Control Operations, and Channel Maintenance conducted by the Corps, SCWA and the District in the Russian River watershed (NMFS, 2008). This BiOp found that the activities—including SCWA's estuary management activities prior to the BiOp—authorized by the Corps and undertaken by SCWA and the District, if continued in a manner similar to recent historic practices, were likely to jeopardize the continued existence of ESA-listed salmonids and were likely to adversely modify critical habitat. In part, therefore, the BiOp requires SCWA to collaborate with NMFS and modify their estuary water level management in order to reduce marine influence (i.e., high salinity and tidal inflow) and promote a higher water surface elevation in the estuary in order to enhance the quality of rearing habitat for juvenile salmonids. SCWA is also required to monitor the response of water quality, invertebrate production, and salmonids in and near the estuary to water surface elevation management in the estuary-lagoon system.

There are three components to SCWA's ongoing estuary management activities: (1) Lagoon outlet channel management, during the lagoon management period only, required to accomplish the dual purposes of flood risk abatement and maintenance of juvenile salmonid habitat; (2) traditional artificial breaching, with the sole objective of flood risk abatement; and (3) physical and biological monitoring in and near the estuary, required under the terms of the BiOp, to understand response to water surface elevation management in the estuary-lagoon system. The latter category (physical and biological monitoring) includes all ancillary beach and/or estuary monitoring activities, including topographic and geophysical beach surveys and biological and physical habitat monitoring in the estuary. Please see the previously referenced Federal Register notice (76 FR 14924; March 18, 2011) for detailed discussion of lagoon outlet channel management, artificial breaching, and other physical and biological monitoring activities, as well as our in our Federal Register notice of proposed authorization for this authorization (80 FR 14073; March 18, 2015) for descriptions of minor changes to physical and biological monitoring activities.

We published a notice of receipt of SCWA's application and proposed IHA in the Federal Register on March 18, 2015 (80 FR 14073). During the thirty-day comment period, we received a letter from the Marine Mammal Commission (Commission). The Commission recommends that we issue the requested authorization, subject to inclusion of the proposed mitigation and monitoring measures as described in our notice of proposed IHA and the application. All measures proposed in the initial Federal Register notice are included within the IHA.

The marine mammal species that may be harassed incidental to estuary management activities are the harbor seal, California sea lion, and the northern elephant seal. We presented a detailed discussion of the status of these stocks and their occurrence in the action area in the notice of the proposed IHA (80 FR 14073; March 18, 2015).

Ongoing monthly harbor seal counts at the Jenner haul-out were begun by J. Mortenson in January 1987, with additional nearby haul-outs added to the counts thereafter. In addition, local resident E. Twohy began daily observations of seals and people at the Jenner haul-out in November 1989. These datasets note whether the mouth at the Jenner haul-out was opened or closed at each observation, as well as various other daily and annual patterns of haul-out usage (Mortenson and Twohy, 1994). Recently, SCWA began regular baseline monitoring of the haul-out as a component of its estuary management activity. In the notice of proposed IHA, we presented average daily numbers of seals observed at the mouth of the Russian River from 1993-2005 and from 2009-14 (see Table 1; 80 FR 14073; March 18, 2015).

We provided a detailed discussion of the potential effects of the specified activity on marine mammals in the notice of the proposed IHA (79 FR 12472, March 5, 2013). A summary of anticipated effects is provided below.

A significant body of monitoring data exists for pinnipeds at the mouth of the Russian River. In addition, pinnipeds have co-existed with regular estuary management activity for decades as well as with regular human use activity at the beach, and are likely habituated to human presence and activity. Nevertheless, SCWA's estuary management activities have the potential to disturb pinnipeds present on the beach or at peripheral haul-outs in the estuary. During breaching operations, past monitoring has revealed that some or all of the seals present typically move or flush from the beach in response to the presence of crew and equipment, though some may remain hauled-out. No stampeding of seals—a potentially dangerous occurrence in which large numbers of animals succumb to mass panic and rush away from a stimulus—has been documented since SCWA developed protocols to prevent such events in 1999. While it is likely impossible to conduct required estuary management activities without provoking some response in hauled-out animals, precautionary mitigation measures, described later in this document, ensure that animals are gradually apprised of human approach. Under these conditions, seals typically exhibit a continuum of responses, beginning with alert movements (e.g., raising the head), which may then escalate to movement away from the stimulus and possible flushing into the water. Flushed seals typically re-occupy the haul-out within minutes to hours of the stimulus. In addition, eight other haul-outs exist nearby that may accommodate flushed seals. In the absence of appropriate mitigation measures, it is possible that pinnipeds could be subject to injury, serious injury, or mortality, likely through stampeding or abandonment of pups.

California sea lions and northern elephant seals, which have been noted only infrequently in the action area, have been observed as less sensitive to stimulus than harbor seals during monitoring at numerous other sites. For example, monitoring of pinniped disturbance as a result of abalone research in the Channel Islands showed that while harbor seals flushed at a rate of 69 percent, California sea lions flushed at a rate of only 21 percent. The rate for elephant seals declined to 0.1 percent (VanBlaricom, 2011). In the event that either of these species is present during management activities, they would be expected to display a minimal reaction to maintenance activities—less than that expected of harbor seals.

Although the Jenner haul-out is not known as a primary pupping beach, harbor seal pups have been observed during the pupping season; therefore, we have evaluated the potential for injury, serious injury or mortality to pups. There is a lack of published data regarding pupping at the mouth of the Russian River, but SCWA monitors have observed pups on the beach. No births were observed during recent monitoring, but were inferred based on signs indicating pupping (e.g., blood spots on the sand, birds consuming possible placental remains). Pup injury or mortality would be most likely to occur in the event of extended separation of a mother and pup, or trampling in a stampede. As discussed previously, no stampedes have been recorded since development of appropriate protocols in 1999. Any California sea lions or northern elephant seals present would be independent juveniles or adults; therefore, analysis of impacts on pups is not relevant for those species.

Similarly, the period of mother-pup bonding, critical time needed to ensure pup survival and maximize pup health, is not expected to be impacted by estuary management activities. Harbor seal pups are extremely precocious, swimming and diving immediately after birth and throughout the lactation period, unlike most other phocids which normally enter the sea only after weaning (Lawson and Renouf, 1985; Cottrell et al., 2002; Burns et al., 2005). Lawson and Renouf (1987) investigated harbor seal mother-pup bonding in response to natural and anthropogenic disturbance. In summary, they found that the most critical bonding time is within minutes after birth. Although pupping season is defined as March 15-June 30, the peak of pupping season is typically concluded by mid-May, when the lagoon management period begins. As such, it is expected that most mother-pup bonding would likely be concluded as well. The number of management events during the months of March and April has been relatively low in the past, and the breaching activities occur in a single day over several hours. In addition, mitigation measures described later in this document further reduce the likelihood of any impacts to pups, whether through injury or mortality or interruption of mother-pup bonding.

In summary, and based on extensive monitoring data, we believe that impacts to hauled-out pinnipeds during estuary management activities would be behavioral harassment of limited duration (i.e., less than one day) and limited intensity (i.e., temporary flushing at most). Stampeding, and therefore injury or mortality, is not expected—nor been documented—in the years since appropriate protocols were established (see Mitigation for more details). Further, the continued, and increasingly heavy (Figure 4; SCWA, 2015), use of the haul-out despite decades of breaching events indicates that abandonment of the haul-out is unlikely.

We provided a detailed discussion of the potential effects of this action on marine mammal habitat in the notice of the proposed IHA (80 FR 14073; March 18, 2015). SCWA's estuary management activities will result in temporary physical alteration of the Jenner haul-out. With barrier beach closure, seal usage of the beach haul-out declines, and the three nearby river haul-outs may not be available for usage due to rising water surface elevations. Breaching of the barrier beach, subsequent to the temporary habitat disturbance, will likely increase suitability and availability of habitat for pinnipeds. Biological and water quality monitoring will not physically alter pinniped habitat.

In summary, there will be temporary physical alteration of the beach. However, natural opening and closure of the beach results in the same impacts to habitat; therefore, seals are likely adapted to this cycle. In addition, the increase in rearing habitat quality has the goal of increasing salmonid abundance, ultimately providing more food for seals present within the action area. Thus, any impacts to marine mammal habitat are not expected to cause significant or long-term consequences for individual marine mammals or their populations.

In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses.

SCWA will continue the following mitigation measures, as implemented during the previous IHAs, designed to minimize impact to affected species and stocks:

• SCWA crews will cautiously approach the haul-out ahead of heavy equipment to minimize the potential for sudden flushes, which may result in a stampede—a particular concern during pupping season.

• SCWA staff will avoid walking or driving equipment through the seal haul-out.

• Crews on foot will make an effort to be seen by seals from a distance, if possible, rather than appearing suddenly at the top of the sandbar, again preventing sudden flushes.

• During breaching events, all monitoring will be conducted from the overlook on the bluff along Highway 1 adjacent to the haul-out in order to minimize potential for harassment.

• A water level management event may not occur for more than two consecutive days unless flooding threats cannot be controlled.

In addition, SCWA will continue mitigation measures specific to pupping season (March 15-June 30), as implemented in the previous IHA:

• SCWA will maintain a one-week no-work period between water level management events (unless flooding is an immediate threat) to allow for an adequate disturbance recovery period. During the no-work period, equipment must be removed from the beach.

• If a pup less than one week old is on the beach where heavy machinery will be used or on the path used to access the work location, the management action will be delayed until the pup has left the site or the latest day possible to prevent flooding while still maintaining suitable fish rearing habitat. In the event that a pup remains present on the beach in the presence of flood risk, SCWA will consult with NMFS to determine the appropriate course of action. SCWA will coordinate with the locally established seal monitoring program (Stewards' Seal Watch) to determine if pups less than one week old are on the beach prior to a breaching event.

• Physical and biological monitoring (including topographic and geophysical beach surveys) will not be conducted if a pup less than one week old is present at the monitoring site or on a path to the site.

• Any jetty study activities in the vicinity of the harbor seal haul-out will not occur during the pupping season.

Equipment will be driven slowly on the beach and care will be taken to minimize the number of shutdowns and start-ups when the equipment is on the beach. All work will be completed as efficiently as possible, with the smallest amount of heavy equipment possible, to minimize disturbance of seals at the haul-out. Boats operating near river haul-outs during monitoring will be kept within posted speed limits and driven as far from the haul-outs as safely possible to minimize flushing seals.

We have carefully evaluated SCWA's planned mitigation measures and considered their effectiveness in past implementation to determine whether they are likely to effect the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another: (1) The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals, (2) the proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and (3) the practicability of the measure for applicant implementation.

Any mitigation measure(s) we prescribe should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

• Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

• A reduction in the number (total number or number at biologically important time or location) of individual marine mammals exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only).

• A reduction in the number (total number or number at biologically important time or location) of times any individual marine mammal would be exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only).

• A reduction in the intensity of exposure to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing the severity of behavioral harassment only).

• Avoidance or minimization of adverse effects to marine mammal habitat, paying particular attention to the prey base, blockage or limitation of passage to or from biologically important areas, permanent destruction of habitat, or temporary disturbance of habitat during a biologically important time.

• For monitoring directly related to mitigation, an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

Based on our evaluation of SCWA's planned measures and on SCWA's record of management at the mouth of the Russian River including information from monitoring of SCWA's implementation of the mitigation measures as prescribed under the previous IHAs, we have determined that the planned mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking”. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for incidental take authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area.

Any monitoring requirement we prescribe should accomplish one or more of the following general goals:

1. An increase in the probability of detecting marine mammals, both within defined zones of effect (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;

2. An increase in our understanding of how many marine mammals are likely to be exposed to stimuli that we associate with specific adverse effects, such as behavioral harassment or hearing threshold shifts;

3. An increase in our understanding of how marine mammals respond to stimuli expected to result in incidental take and how anticipated adverse effects on individuals may impact the population, stock, or species (specifically through effects on annual rates of recruitment or survival) through any of the following methods:

• Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict pertinent information, e.g., received level, distance from source);

• Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict pertinent information, e.g., received level, distance from source);

• Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;

4. An increased knowledge of the affected species; or

5. An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.

SCWA submitted a marine mammal monitoring plan as part of the IHA application. It can be found on the Internet at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. The plan has been successfully implemented by SCWA under previous IHAs. The purpose of this monitoring plan, which is carried out collaboratively with the Stewards of the Coasts and Redwoods (Stewards) organization, is to detect the response of pinnipeds to estuary management activities at the Russian River estuary. SCWA has designed the plan both to satisfy the requirements of the IHA, and to address the following questions of interest:

1. Under what conditions do pinnipeds haul out at the Russian River estuary mouth at Jenner?

2. How do seals at the Jenner haul-out respond to activities associated with the construction and maintenance of the lagoon outlet channel and artificial breaching activities?

3. Does the number of seals at the Jenner haul-out significantly differ from historic averages with formation of a summer (May 15 to October 15) lagoon in the Russian River estuary?

4. Are seals at the Jenner haul-out displaced to nearby river and coastal haul-outs when the mouth remains closed in the summer?

In summary, monitoring includes the following:

Baseline Monitoring—Seals at the Jenner haul-out are counted twice monthly for the term of the IHA. This baseline information will provide SCWA with details that may help to plan estuary management activities in the future to minimize pinniped interaction. This census begins at local dawn and continues for eight hours. All seals hauled out on the beach are counted every thirty minutes from the overlook on the bluff along Highway 1 adjacent to the haul-out using spotting scopes. Monitoring may conclude for the day if weather conditions affect visibility (e.g., heavy fog in the afternoon). Counts are scheduled for two days out of each month, with the intention of capturing a low and high tide each in the morning and afternoon. Depending on how the sandbar is formed, seals may haul out in multiple groups at the mouth. At each thirty-minute count, the observer indicates where groups of seals are hauled out on the sandbar and provides a total count for each group. If possible, adults and pups are counted separately.

In addition to the census data, disturbances of the haul-out are recorded. The method for recording disturbances follows those in Mortenson (1996). Disturbances will be recorded on a three-point scale that represents an increasing seal response to the disturbance. The time, source, and duration of the disturbance, as well as an estimated distance between the source and haul-out, are recorded. It should be noted that only responses falling into Mortenson's Levels 2 and 3 (i.e., movement or flight) will be considered as harassment under the MMPA under the terms of the IHA. Weather conditions are recorded at the beginning of each census. These include temperature, percent cloud cover, and wind speed (Beaufort scale). Tide levels and estuary water surface elevations are correlated to the monitoring start and end times.

In an effort towards understanding possible relationships between use of the Jenner haul-out and nearby coastal and river haul-outs, several other haul-outs on the coast and in the Russian River estuary are monitored as well (see Figure 4 of SCWA's application). The peripheral haul-outs are visited for ten-minute counts twice during each baseline monitoring day. All pinnipeds hauled out were counted from the same vantage point(s) at each haul-out using a spotting scope or binoculars.

Estuary Management Event Monitoring—Activities associated with artificial breaching or initial construction of the outlet channel, as well as the maintenance of the channel that may be required, will be monitored for disturbances to the seals at the Jenner haul-out. A one-day pre-event channel survey will be made within one to three days prior to constructing the outlet channel. The haul-out will be monitored on the day the outlet channel is constructed and daily for up to the maximum two days allowed for channel excavation activities. Monitoring will also occur on each day that the outlet channel is maintained using heavy equipment for the duration of the lagoon management period. Monitoring will correspond with that described under the “Baseline” section previously, with the exception that management activity monitoring duration is defined by event duration, rather than being set at eight hours. On the day of the management event, pinniped monitoring begins at least one hour prior to the crew and equipment accessing the beach work area and continues through the duration of the event, until at least one hour after the crew and equipment leave the beach.

In an attempt to understand whether seals from the Jenner haul-out are displaced to coastal and river haul-outs nearby when management events occur, other nearby haul-outs are monitored concurrently with monitoring of outlet channel construction and maintenance activities. This provides an opportunity to qualitatively assess whether these haul-outs are being used by seals displaced from the Jenner haul-out. This monitoring will not provide definitive results regarding displacement to nearby coastal and river haul-outs, as individual seals are not marked, but is useful in tracking general trends in haul-out use during disturbance. As volunteers are required to monitor these peripheral haul-outs, haul-out locations may need to be prioritized if there are not enough volunteers available. In that case, priority will be assigned to the nearest haul-outs (North Jenner and Odin Cove), followed by the Russian River estuary haul-outs, and finally the more distant coastal haul-outs.

For all counts, the following information will be recorded in thirty-minute intervals: (1) Pinniped counts, by species; (2) behavior; (3) time, source and duration of any disturbance; (4) estimated distances between source of disturbance and pinnipeds; (5) weather conditions (e.g., temperature, wind); and (5) tide levels and estuary water surface elevation.

Monitoring During Pupping Season—As described previously, the pupping season is defined as March 15 to June 30. Baseline, lagoon outlet channel, and artificial breaching monitoring during the pupping season will include records of neonate (pups less than one week old) observations. Characteristics of a neonate pup include: Body weight less than 15 kg; thin for their body length; an umbilicus or natal pelage present; wrinkled skin; and awkward or jerky movements on land. SCWA will coordinate with the Seal Watch monitoring program to determine if pups less than one week old are on the beach prior to a water level management event.

If, during monitoring, observers sight any pup that might be abandoned, SCWA will contact the NMFS stranding response network immediately and also report the incident to NMFS' West Coast Regional Office and Office of Protected Resources within 48 hours. Observers will not approach or move the pup. Potential indications that a pup may be abandoned are no observed contact with adult seals, no movement of the pup, and the pup's attempts to nurse are rebuffed.

SCWA is required to submit a report on all activities and marine mammal monitoring results to the Office of Protected Resources, NMFS, and the West Coast Regional Administrator, NMFS, 90 days prior to the expiration of the IHA if a renewal is sought, or within 90 days of the expiration of the permit otherwise. This annual report will also be distributed to California State Parks and Stewards, and would be available to the public on SCWA's Web site. This report will contain the following information:

• The number of pinnipeds taken, by species and age class (if possible);

• Behavior prior to and during water level management events;

• Start and end time of activity;

• Estimated distances between source and pinnipeds when disturbance occurs;

• Weather conditions (e.g., temperature, wind);

• Haul-out reoccupation time of any pinnipeds based on post-activity monitoring;

• Tide levels and estuary water surface elevation; and

• Seal census from bi-monthly and nearby haul-out monitoring.

The annual report includes descriptions of monitoring methodology, tabulation of estuary management events, summary of monitoring results, and discussion of problems noted and proposed remedial measures. SCWA will report any injured or dead marine mammals to NMFS' West Coast Regional Office and Office of Protected Resources.

SCWA complied with the mitigation and monitoring required under all previous authorizations. In accordance with the 2014 IHA, SCWA submitted a Report of Activities and Monitoring Results, covering the period of January 1 through December 31, 2014. Previous monitoring reports (available at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm) provided additional analysis of monitoring results from 2009-13. A barrier beach was formed eleven times during 2014, but SCWA was required to implement artificial breaching for only six of these closure events. The Russian River outlet was closed to the ocean for a total of 110 days in 2014, including extended closures totaling 29 days during the lagoon management period. However, these closures all culminated in natural breaches and no outlet channel management events were required. During 2013, five artificial breaching events occurred (SCWA, 2014). In January 2012, the barrier beach was artificially breached after two days of breaching activity. There were also several periods over the course of the year where the barrier beach closed or became naturally perched and then subsequently breached naturally (SCWA, 2013). In 2011, no water level management activities occurred (SCWA, 2012). In 2010, one lagoon management event and two artificial breaching events occurred (SCWA, 2011). Pinniped monitoring occurred no more than 3 days before, the day of, and the day after each water level management activity. In addition, SCWA conducted biological and physical monitoring as described previously. During the course of these activities, SCWA did not exceed the take levels authorized under the relevant IHAs. We provided a detailed description of previous monitoring results in the notice of the proposed IHA (80 FR 14073; March 18, 2015).

Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: “. . . any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

We are authorizing SCWA to take harbor seals, California sea lions, and northern elephant seals, by Level B harassment only, incidental to estuary management activities. These activities, involving increased human presence and the use of heavy equipment and support vehicles, are expected to harass pinnipeds present at the haul-out through behavioral disturbance only. In addition, monitoring activities prescribed in the BiOp may result in harassment of additional individuals at the Jenner haul-out and at the three haul-outs located in the estuary. Estimates of the number of harbor seals, California sea lions, and northern elephant seals that may be harassed by the activities is based upon the number of potential events associated with Russian River estuary management activities and the average number of individuals of each species that are present during conditions appropriate to the activity. As described previously in this document, monitoring effort at the mouth of the Russian River has shown that the number of seals utilizing the haul-out declines during bar-closed conditions. Tables 1 and 2 detail the total number of authorized takes. Methodology of take estimation was discussed in detail in our notice of proposed IHA (80 FR 14073; March 18, 2015).

The MMPA, 16 U.S.C. 1361 et seq., allows for importation into the United States of yellowfin tuna harvested by purse seine vessels in the ETP under certain conditions. If requested by the harvesting nation, the Assistant Administrator will determine whether to make an affirmative finding based upon documentary evidence provided by the government of the harvesting nation, the IATTC, or the Department of State.

The affirmative finding process requires that the harvesting nation is meeting its obligations under the IDCP and obligations of membership in the IATTC. Every 5 years, the government of the harvesting nation must request a new affirmative finding and submit the required documentary evidence directly to the Assistant Administrator. On an annual basis, NMFS reviews the affirmative finding and determines whether the harvesting nation continues to meet the requirements. A nation may provide information related to compliance with IDCP and IATTC measures directly to NMFS on an annual basis or may authorize the IATTC to release the information to NMFS to annually renew an affirmative finding determination without an application from the harvesting nation.

An affirmative finding will be terminated, in consultation with the Secretary of State, if the Assistant Administrator determines that the requirements of 50 CFR 216.24(f) are no longer being met or that a nation is consistently failing to take enforcement actions on violations, thereby diminishing the effectiveness of the IDCP.

As a part of the affirmative finding process set forth in 50 CFR 216.24(f), the Assistant Administrator considered documentary evidence submitted by the Government of Spain and obtained from the IATTC and has determined that Spain has met the MMPA's requirements to receive an affirmative finding annual renewal.

After consultation with the Department of State, the Assistant Administrator issued an affirmative finding annual renewal to Spain, allowing the continued importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by Spanish-flag purse seine vessels or purse seine vessels operating under Spanish jurisdiction through March 31, 2015. Spain's 5-year affirmative finding will remain valid through March 31, 2015.

The primary purpose of the meeting is to review information on take of species listed under the Endangered Species Act (ESA) in the Pacific Coast groundfish fishery (other than salmonids) and provide recommendations to the Pacific Council on any additional mitigation measures needed, if any, to meet the requirements of the ESA as implemented through the terms and conditions in the most recent biological opinion for the fishery.

You may also join this meeting by conference line and webinar. To join by phone, participants should dial 888-790-6085, passcode 1730793. To join by webinar, each day of the meeting requires a different Web address. On May 19, participants can join Meeting ID: 544-685-613 at https://global.gotomeeting.com/join/544685613. On May 20, participants can join Meeting ID: 991-327-765 at https://global.gotomeeting.com/join/991327765. On May 21, participants can join Meeting ID: 845-869-013 at https://global.gotomeeting.com/join/845869013. Once you have joined the webinar, choose either your computer's audio or select “Use Telephone.” If you do not select “Use Telephone” you will be connected to audio using your computer's microphone and speakers (VolP). If you do not have a headset and speakers, you may use the conference line number by dialing 1-888-790-6085, and entering passcode 1730793 at the prompt.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

The meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2425 at least 5 days prior to the meeting date.

According to NOAA, in 2013, U.S. fishers landed 9.9 billion pounds of fish and shellfish worth $5.5 billion. Globally, illegal, unreported, and unregulated (IUU) fishing and seafood fraud undermine the sustainability of U.S. and global seafood stocks and negatively impact general ecosystem health. At the same time, IUU fishing and fraudulent seafood products distort legal markets and unfairly compete with the products of law-abiding fishers and seafood industries.

On March 15, 2015, the Presidential Task Force on Combating IUU Fishing and Seafood Fraud (Task Force), co-chaired by the Departments of Commerce and State, took an historic step to address these issues and published its action plan to implement Task Force recommendations (http://www.nmfs.noaa.gov/ia/iuu/taskforce.html).

This plan articulates the aggressive steps that Federal agencies will take to implement the recommendations the Task Force made to the President in December 2014 on a comprehensive framework of integrated programs to combat IUU fishing and seafood fraud. The plan identifies actions that will strengthen enforcement, create and expand partnerships with state and local governments, industry, and non-governmental organizations, and create a risk-based traceability program to track seafood from harvest to entry into U.S. commerce, including the use of existing traceability mechanisms. The work the Task Force began will continue under the oversight of the NOC Committee.

This notice is the first step in implementing Task Force Recommendations 14 and 15, “Identifying current at risk species threatened by IUU fishing and seafood fraud.” Once “at-risk” species have been determined, the NOC Committee will transmit the list to agencies for appropriate action. This list will form the basis for the species addressed in the first phase of the risk-based seafood traceability program, as described in the Task Force Action Plan.

With this notice, the NOC Committee is soliciting comment on what principles should be used to determine the seafood species “at risk” for IUU fishing and seafood fraud. Recommended principles should be measurable (i.e., there should be a reasonable amount of existing data to assess), and be applicable to domestic and/or international fisheries.

For example, possible principles could include assessing the extent to which species are known to have:

• significant domestic or international enforcement-related concerns, such as substantial numbers of violations of relevant regulations or conservation and management measures, significant challenges or limitations in existing enforcement regimes, or repeated reports of IUU activity;

• catches that are mis-reported or not reported according to the reporting procedures of the relevant international regional fisheries management organizations or national authorities, particularly when they are of high economic value;

• a human health risk when substituted for other species; and

• instances of being substituted for other species in order to avoid tariffs or to sell a lower value fish at a higher price.

Following the public comment period, the NOC Committee will take the input received into consideration as it develops a draft list of principles to be used in determining species “at risk” for IUU fishing and seafood fraud. The draft list of principles will then be used to create a draft list of “at-risk” species. Both the draft list of principles and the draft list of “at-risk” species will be published in the Federal Register for public comment in July 2015.

The items of discussion on the agenda are to discuss implementation of the Councils Risk Policy across all Council-managed species. The group will also continue work on development of the Risk Policy “operational handbook” to address the application of the Risk Policy. Additionally they will discuss the application of the Risk Policy in the Atlantic Herring FMP and develop related recommendations. The group will also plan for future work. They will discuss as other business as necessary.

Although non-emergency issues not contained in this agenda may come before these groups for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

The MMPA, 16 U.S.C. 1361 et seq., allows for importation into the United States of yellowfin tuna harvested by purse seine vessels in the ETP under certain conditions. If requested by the harvesting nation, the Assistant Administrator will determine whether to make an affirmative finding based upon documentary evidence provided by the government of the harvesting nation, the IATTC, or the Department of State.

The affirmative finding process requires that the harvesting nation is meeting its obligations under the IDCP and obligations of membership in the IATTC. Every 5 years, the government of the harvesting nation must request a new affirmative finding and submit the required documentary evidence directly to the Assistant Administrator. On an annual basis, NMFS reviews the affirmative finding and determines whether the harvesting nation continues to meet the requirements. A nation may provide information related to compliance with IDCP and IATTC measures directly to NMFS on an annual basis or may authorize the IATTC to release the information to NMFS to annually renew an affirmative finding determination without an application from the harvesting nation.

An affirmative finding will be terminated, in consultation with the Secretary of State, if the Assistant Administrator determines that the requirements of 50 CFR 216.24(f) are no longer being met or that a nation is consistently failing to take enforcement actions on violations, thereby diminishing the effectiveness of the IDCP.

As a part of the affirmative finding process set forth in 50 CFR 216.24(f), the Assistant Administrator considered documentary evidence submitted by the Government of Guatemala and obtained from the IATTC and has determined that Guatemala has met the MMPA's requirements to receive an affirmative finding annual renewal.

After consultation with the Department of State, the Assistant Administrator issued an affirmative finding annual renewal to Guatemala, allowing the continued importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by Guatemalan-flag purse seine vessels or purse seine vessels operating under Guatemalan jurisdiction through March 31, 2015. Guatemala's 5-year affirmative finding will remain valid through March 31, 2015.

The MMPA, 16 U.S.C. 1361 et seq., allows for importation into the United States of yellowfin tuna harvested by purse seine vessels in the ETP under certain conditions. If requested by the harvesting nation, the Assistant Administrator will determine whether to make an affirmative finding based upon documentary evidence provided by the government of the harvesting nation, the IATTC, or the Department of State.

The affirmative finding process requires that the harvesting nation is meeting its obligations under the IDCP and obligations of membership in the IATTC. Every 5 years, the government of the harvesting nation must request a new affirmative finding and submit the required documentary evidence directly to the Assistant Administrator. On an annual basis, NMFS reviews the affirmative finding and determines whether the harvesting nation continues to meet the requirements. A nation may provide information related to compliance with IDCP and IATTC measures directly to NMFS on an annual basis or may authorize the IATTC to release the information to NMFS to annually renew an affirmative finding determination without an application from the harvesting nation.

An affirmative finding will be terminated, in consultation with the Secretary of State, if the Assistant Administrator determines that the requirements of 50 CFR 216.24(f) are no longer being met or that a nation is consistently failing to take enforcement actions on violations, thereby diminishing the effectiveness of the IDCP.

As a part of the affirmative finding process set forth in 50 CFR 216.24(f), the Assistant Administrator considered documentary evidence submitted by the Government of Mexico and obtained from the IATTC and has determined that Mexico has met the MMPA's requirements to receive an affirmative finding 2-year renewal.

After consultation with the Department of State, the Assistant Administrator issued an affirmative finding 2-year renewal to Mexico, allowing the continued importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by Mexican-flag purse seine vessels or purse seine vessels operating under Mexican jurisdiction for the 2-year period of April 1, 2013 (retroactive) through March 31, 2015. Mexico's 5-year affirmative finding will remain valid through March 31, 2015.

The MMPA, 16 U.S.C. 1361 et seq., allows for importation into the United States of yellowfin tuna harvested by purse seine vessels in the ETP under certain conditions. If requested by the harvesting nation, the Assistant Administrator will determine whether to make an affirmative finding based upon documentary evidence provided by the government of the harvesting nation, the IATTC, or the Department of State.

The affirmative finding process requires that the harvesting nation is meeting its obligations under the IDCP and obligations of membership in the IATTC. Every 5 years, the government of the harvesting nation must request a new affirmative finding and submit the required documentary evidence directly to the Assistant Administrator. On an annual basis, NMFS reviews the affirmative finding and determines whether the harvesting nation continues to meet the requirements. A nation may provide information related to compliance with IDCP and IATTC measures directly to NMFS on an annual basis or may authorize the IATTC to release the information to NMFS to annually renew an affirmative finding determination without an application from the harvesting nation.

An affirmative finding will be terminated, in consultation with the Secretary of State, if the Assistant Administrator determines that the requirements of 50 CFR 216.24(f) are no longer being met or that a nation is consistently failing to take enforcement actions on violations, thereby diminishing the effectiveness of the IDCP.

As a part of the affirmative finding process set forth in 50 CFR 216.24(f), the Assistant Administrator considered documentary evidence submitted by the Government of Ecuador and obtained from the IATTC and has determined that Ecuador has met the MMPA's requirements to receive an affirmative finding 2-year renewal.

After consultation with the Department of State, the Assistant Administrator issued an affirmative finding 2-year renewal to Ecuador, allowing the continued importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by Ecuadorian-flag purse seine vessels or purse seine vessels operating under Ecuadorian jurisdiction for the 2-year period of April 1, 2013 (retroactive) through March 31, 2015. Ecuador's 5-year affirmative finding will remain valid through March 31, 2015.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Child Care Access Means Parents in School Program Annual Performance Report.

OMB Control Number: 1840-0763.

Type of Review: A revision of an existing information collection.

Respondents/Affected Public: Private Sector.

Total Estimated Number of Annual Responses: 89.

Total Estimated Number of Annual Burden Hours: 801.

Abstract: This is a revision of the Child Care Access Means Parent In School Program (CCAMPIS) Annual Performance Report (APR). This report provides the Department of Education with information needed to evaluate a grantee's performance and compliance with program requirements in accordance with the program authorizing statute. The data collected is aggregated to provide national information on project participants and the results demonstrated by program outcomes. The burden hours are increased due to additional queries that have been added to the APR that capture more specific data needed to enhance the understanding of results demonstrated by this program in accordance with OMB mandates.

Purpose of the Board: To make recommendations to the Assistant Secretary for the Office of Energy Efficiency and Renewable Energy regarding goals and objectives, programmatic and administrative policies, and to otherwise carry out the Board's responsibilities as designated in the State Energy Efficiency Programs Improvement Act of 1990 (Pub. L. 101-440).

Tentative Agenda: Receive STEAB Task Force updates on action items and revised objectives for FY 2015, discuss follow-up opportunities and engagement with EERE and other DOE staff as needed to keep Task Force work moving forward, continue engagement with DOE, EERE and EPSA staff regarding energy efficiency and renewable energy projects and initiatives, and receive updates on member activities within their states.

Public Participation: The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Members of the public who wish to make oral statements pertaining to agenda items should contact Monica Neukomm at the address or telephone number listed above. Requests to make oral comments must be received five days prior to the meeting; reasonable provision will be made to include requested topic(s) on the agenda. The Chair of the Board is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business.

Minutes: The minutes of the meeting will be available for public review and copying within 60 days on the STEAB Web site at: www.steab.org.

Purpose of Meeting: To provide advice and guidance that promotes research and development leading to the production of biobased fuels and biobased products.

Tentative Agenda: Agenda will include the following:

• Update on USDA Biomass R&D Activities

• Update on DOE Biomass R&D Activities

• Updated on the Biomass Research and Development Initiative

• Overview of the Biomass Interagency Working Groups

• Panel on International Bioenergy Activities

Public Participation: In keeping with procedures, members of the public are welcome to observe the business of the Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, you must contact Elliott Levine at 202-586-1476; Email: [email protected] and Roy Tiley at (410) 997-7778 ext. 220; Email: [email protected] at least 5 business days prior to the meeting. Members of the public will be heard in the order in which they sign up at the beginning of the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Co-chairs of the Committee will make every effort to hear the views of all interested parties. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. The Co-chairs will conduct the meeting to facilitate the orderly conduct of business.

Minutes: The minutes of the meeting will be available for public review and copying at http://biomassboard.gov/committee/meetings.html.

Purpose of the Committee: The purpose of the Methane Hydrate Advisory Committee is to provide advice on potential applications of methane hydrate to the Secretary of Energy, and assist in developing recommendations and priorities for the Department of Energy's Methane Hydrate Research and Development Program.

Tentative Agenda: The agenda will include: Welcome and Introduction by the Designated Federal Officer; Discussion of Committee Comments on Draft Letter to the Secretary of Energy; Discussion of Committee Recommendations; and Public Comments, if any.

Public Participation: The meeting is open to the public. The Designated Federal Officer and the Chair of the Committee will conduct the meeting to facilitate the orderly conduct of business. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of the items on the agenda, you should contact Lou Capitanio at the phone number listed above and provide your name, organization, citizenship, and contact information. Anyone attending the meeting will be required to present government issued identification. Space is limited. You must make your request for an oral statement at least five business days prior to the meeting, and reasonable provisions will be made to include the presentation on the agenda. Public comment will follow the three-minute rule.

Minutes: The minutes of this meeting will be available for public review and copying within 60 days at the following Web site: http://energy.gov/fe/services/advisory-committees/methane-hydrate-advisory-committee.

Background: The Commission was established to provide advice to the Secretary on the Department's national laboratories. The Commission will review the DOE national laboratories for alignment with the Department's strategic priorities, clear and balanced missions, unique capabilities to meet current energy and national security challenges, appropriate size to meet the Department's energy and national security missions, and support of other Federal agencies. The Commission will also look for opportunities to more effectively and efficiently use the capabilities of the national laboratories and review the use of laboratory directed research and development (LDRD) to meet the Department's science, energy, and national security goals.

Purpose of the Meeting: This meeting is the ninth meeting of the Commission.

Tentative Agenda: The meeting will start at 9:00 a.m. on May 22. The tentative meeting agenda include the impact of the National Laboratories on economic development and technology transfer, partnerships within the Bay Area, and the appropriate level of DOE oversight for its M&O contractor laboratories. Key presenters will address and discuss these topics with comments from the public. The meeting will conclude at 2:00 p.m. The agenda along with possible schedule adjustments will be posted when finalized and in advance of the meeting on the Lab Commission Web site (http://energy.gov/labcommission/commission-review-effectiveness-national-energy-laboratories).

Public Participation: The meeting is open to the public. Individuals who would like to attend must RSVP to Karen Gibson no later than 5:00 p.m. EDT on Tuesday, May 19, 2015 at email: [email protected]. Please provide your name, citizenship, organization, and contact information. Individuals and representatives of organizations who would like to offer comments and suggestions may do so at the end of the meeting. Approximately 30 minutes will be reserved for public comments. Time allotted per speaker will depend on the number who wish to speak but will not exceed 5 minutes. The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Those wishing to speak should register to do so beginning at 9:00 a.m. on May 22.

Those not able to attend the meeting or who have insufficient time to address the committee are invited to send a written statement to Karen Gibson, U.S. Department of Energy, 1000 Independence Avenue SW., Washington DC 20585, or to email: [email protected].

Minutes: The minutes of the meeting will be available on the Commission Web site at: http://energy.gov/labcommission.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Extension of the currently approved collection; Reinstatement with change of a previously approved collection; Title of Information Collection: Medicare and Medicaid Programs: Electronic Health Record Incentive Program; Use: The American Recovery and Reinvestment Act of 2009 (Recovery Act) (Pub. L. 111-5) was enacted on February 17, 2009. The Recovery Act includes many measures to modernize our nation's infrastructure, and improve affordable health care. Expanded use of health information technology (HIT) and certified electronic health record (EHR) technology will improve the quality and value of America's health care. Title IV of Division B of the Recovery Act amends Titles XVIII and XIX of the Social Security Act (the Act) by establishing incentive payments to eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs), and Medicare Advantage (MA) organizations participating in the Medicare and Medicaid programs that adopt and successfully demonstrate meaningful use of certified EHR technology. These Recovery Act provisions, together with Title XIII of Division A of the Recovery Act, may be cited as the “Health Information Technology for Economic and Clinical Health Act” or the “HITECH Act.”

The HITECH Act creates incentive programs for EPs and eligible hospitals, including CAHs, in the Medicare Fee-for-Service (FFS), MA, and Medicaid programs that successfully demonstrate meaningful use of certified EHR technology. In their first payment year, Medicaid EPs and eligible hospitals may adopt, implement or upgrade to certified EHR technology. It also, provides for payment adjustments in the Medicare FFS and MA programs starting in FY 2015 for EPs and eligible hospitals participating in Medicare that are not meaningful users of certified EHR technology. These payment adjustments do not pertain to Medicaid providers.

The first final rule for the Medicare and Medicaid EHR Incentive Program, which was published in the Federal Register on July 28, 2010 (CMS-0033-F), specified the initial criteria EPs, eligible hospitals and CAHs, and MA organizations must meet in order to qualify for incentive payments; calculation of incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs, eligible hospitals and CAHs failing to demonstrate meaningful use of certified EHR technology beginning in 2015; and other program participation requirements. On the same date, the Office of the National Coordinator of Health Information Technology (ONC) issued a closely related final rule (45 CFR part 170, RIN 0991-AB58) that specified the initial set of standards, implementation specifications, and certification criteria for certified EHR technology. ONC has also issued a separate final rule on the establishment of certification programs for health information technology (HIT) (45 CFR part 170, RIN 0991-AB59). The functionality of certified EHR technology should facilitate the implementation of meaningful use. Subsequently, final rules have been issued by CMS (77 FR 53968) and ONC (77 FR 72985) to create a Stage 2 of meaningful use criteria and other changes to the CMS EHR Incentive Programs and the 2014 Edition Certification Criteria for EHR technology.

The information collection requirements contained in this information collection request are needed to implement the HITECH Act. In order to avoid duplicate payments, all EPs are enumerated through their National Provider Identifier (NPI), while all eligible hospitals and CAHs are enumerated through their CMS Certification Number (CCN). State Medicaid agencies and CMS use the provider's tax identification number and NPI or CCN combination in order to make payment, validate payment eligibility and detect and prevent duplicate payments for EPs, eligible hospitals and CAHs. Form Number: CMS-10336 (OMB control number: 0938-1158); Frequency: Occasionally; Affected Public: Private sector; Number of Respondents: 214,694; Total Annual Responses: 214,694; Total Annual Hours: 2,034,740. (For policy questions regarding this collection contact Elisabeth Myers at 410-786-4751.)

I. Background

FDA is announcing the availability of a guidance for industry entitled “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product.” This guidance is intended to provide sponsors with an overview of analytical factors that are relevant to assessing whether a proposed product and the reference product are highly similar for the purpose of submitting a marketing application through the abbreviated licensure pathway under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). Although the 351(k) pathway applies generally to biological products, this guidance focuses on therapeutic protein products.

The Biologics Price Competition and Innovation Act of 2009 was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010, created an abbreviated licensure pathway under section 351(k) of the PHS Act for biological products demonstrated to be biosimilar to or interchangeable with a reference product. Under this abbreviated licensure pathway, FDA will license a proposed biological product submitted under section 351(k) of the PHS Act if FDA “determines that the information submitted in the application . . . is sufficient to show that the biological product . . . is biosimilar to the reference product . . .” and the 351(k) applicant (or other appropriate person) consents to an inspection of the facility that is the subject of the application (i.e., a facility in which the proposed biological product is manufactured, processed, packed, or held).1

All product applications should contain a complete and thorough chemistry, manufacturing, and controls section that provides the necessary and appropriate information, including, but not limited to, characterization, adventitious agent safety, process controls, and specifications, for the product to be adequately reviewed.2 This guidance describes important factors for consideration when assessing whether a proposed product and the reference product are highly similar, including:

• Expression System

• Manufacturing Process

• Assessment of Physiochemical Properties

• Functional Activities

• Receptor Binding and Immunochemical Properties

• Impurities

• Reference Product and Reference Standards

• Finished Drug Product

• Stability

In the Federal Register of February 15, 2012 (77 FR 8884), FDA announced the availability of the draft guidance entitled “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product” dated February 2012. FDA received a number of comments on the draft guidance. In response to these comments, this guidance provides further clarification on general principles on topics including, but not limited to, the use of comparative analytical data to provide the foundation for a biosimilar development program, the timing of submission of analytical similarity data, the appropriate number of lots needed, and the type of bridging data needed when sponsors use a non-U.S.-licensed comparator product in certain studies. The guidance provides additional clarification on the factors for consideration in assessing whether a proposed product is highly similar to the reference product. This guidance finalizes the draft guidance issued in February 2012.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

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). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

This guidance refers to previously approved collections of information found in FDA regulations, which are not expected to change as a result of the guidance. 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 related to the submission of: (1) An investigational new drug application, which is covered under 21 CFR part 312 and approved under OMB control number 0910-0014; (2) a new drug application, which is covered under 21 CFR 314.50 and approved under OMB control number 0910-0001; (3) a biologics license application (BLA) under section 351(a) of the PHS Act, which is covered under part 601 (21 CFR part 601) and approved under OMB control number 0910-0338; and (4) a BLA under section 351(k), which is covered under part 601 and approved under OMB control number 0910-0719.

Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

FDA is announcing the availability of a guidance for industry entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.” This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is “biosimilar” 1 to a reference product for the purpose of submitting a marketing application through the abbreviated licensure pathway under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)).

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act), enacted as part of the Affordable Care Act (Pub. L. 111-148) on March 23, 2010, created an abbreviated licensure pathway under section 351(k) of the PHS Act for biological products demonstrated to be biosimilar to, or interchangeable with, a reference product. Under this abbreviated licensure pathway, FDA will license a proposed biological product submitted under section 351(k) of the PHS Act if FDA “determines that the information submitted in the application . . . is sufficient to show that the biological product is biosimilar to the reference product. . . .” and the 351(k) applicant (or other appropriate person) consents to an inspection of the facility that is the subject of the application (i.e., a facility in which the proposed biological product is manufactured, processed, packed, or held).2 The guidance gives an overview of FDA's approach to determining biosimilarity. FDA intends to consider the totality of the evidence submitted in a 351(k) application and is recommending that sponsors use a stepwise approach in their development of biosimilar products. The guidance discusses important scientific considerations in demonstrating biosimilarity, including:

• A stepwise approach to demonstrating biosimilarity, which can include a comparison of the proposed product and the reference product with respect to structure, function, animal toxicity, human pharmacokinetics (PK) and pharmacodynamics (PD), clinical immunogenicity, and clinical safety and effectiveness;

• The totality-of-the-evidence approach that FDA will use to review applications for biosimilar products, consistent with a longstanding Agency approach to evaluation of scientific evidence; and

• General scientific principles in conducting comparative structural analyses, functional assays, animal testing, human PK and PD studies, clinical immunogenicity assessment, and comparative clinical trials (including clinical study design issues).

In the Federal Register of February 15, 2012 (77 FR 8883), FDA announced the availability of the draft guidance of the same title dated February 2012. FDA received a number of comments on the draft guidance. In response to these comments, FDA provides further clarification of the scientific considerations applicable to the conduct of comparative structural analysis, functional assays, animal studies, and clinical testing. The final guidance also provides additional information on clinical trial design and selection of study endpoint and population. It also explains FDA's current thinking on when a comparative clinical trial may not be needed. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes and replaces the draft guidance dated February 2012.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on scientific considerations in demonstrating biosimilarity to a reference product. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

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). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

This guidance describes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). This guidance references information collections that are already approved by OMB and are not expected to change as a result of the guidance. This includes information collections related to the submission of: (1) An investigational new drug application, which is covered under 21 CFR part 312 and approved under OMB Control No. 0910-0014; (2) a new drug application, which is covered under 21 CFR 314.50 and approved under OMB control number 0910-0001; (3) a biologics license application under section 351(a) of the PHS Act, which is covered under 21 CFR part 601 and approved under OMB control number 0910-0338; and (4) a biologics license application under section 351(k) of the PHS Act, which is covered under 21 CFR part 601 and approved under OMB control number 0910-0719.

Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

FDA is announcing the availability of a guidance for industry entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” This guidance provides answers to common questions from sponsors interested in developing proposed biosimilar products, BLA holders, and other interested parties regarding FDA's interpretation of the BPCI Act.

The BPCI Act, enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010, created an abbreviated licensure pathway under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)) for biological products demonstrated to be biosimilar to, or interchangeable with, an FDA-licensed reference product. This guidance describes FDA's current interpretation of certain statutory requirements added by the BPCI Act and includes Q&As in the following categories:

• Biosimilarity or Interchangeability

• Provisions Related to Requirement to Submit a BLA for a “Biological Product”

• Exclusivity

In the Federal Register of February 15, 2012 (77 FR 8885), FDA published a notice announcing the availability of a draft guidance entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” Although interested parties can comment on any guidance at any time, to ensure that the Agency considered comments on the draft guidance before beginning work on the final version of the guidance, FDA requested that interested parties submit comments by April 16, 2012. FDA's consideration of these comments, among other things, is reflected in a revised draft guidance and this final guidance. This guidance describes the status of the draft guidance Q&As provided in Revision 1 of the draft guidance entitled “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,” and the status of the final guidance Q&As that are included in this guidance. FDA intends to update these guidances to include additional Q&As as appropriate.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on “Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

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). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

This guidance refers to information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). The submission of an investigational new drug application is covered under 21 CFR part 312 and approved under OMB control number 0910-0014. The submission of an NDA is covered under 21 CFR 314.50 and approved under OMB control number 0910-0001. The submission of a BLA under section 351(a) of the PHS Act is covered under part 601 (21 CFR part 601) and approved under OMB control number 0910-0338. The submission of a BLA under section 351(k) of the PHS Act is covered under part 601 and approved under OMB control number 0910-0719. In the Federal Register of April 1, 2013 (78 FR 19492), FDA published a notice announcing the availability of a draft guidance for industry entitled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.” The notice contained an analysis of the information collection burden resulting from the draft guidance, and will be submitted to OMB for approval before issuance of the final guidance.

Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

I. Background

The NCIMS is a voluntary coalition that includes representatives from Federal and State governments, the dairy industry, academia, and consumer groups. FDA collaborates with the NCIMS under a memorandum of understanding between the two entities. The NCIMS requested that we conduct an assessment of animal drug residues in the milk supply to inform potential changes to milk testing program requirements. In response, we developed a multicriteria-based ranking model of selected animal drugs used in dairy cows. The risk assessment provides a science-based, analytical approach to collate and incorporate relevant available data and information (Ref. 1). It provides a decision-support tool to assist with reevaluating which animal drug residues should be included in milk testing programs. The risk assessment also may be used to identify and prioritize research needs. The risk assessment model approach has undergone an independent external peer review. FDA's response to the peer review is available electronically on the FDA Web site (Ref. 2).

The muticriteria-based ranking model is based on four overarching criteria that collectively contribute to a drug's score and rank within the group of drugs evaluated: (1) The likelihood that the drug will be administered to lactating dairy cows; (2) the likelihood that, following administration, drug residues would be present in milk (bulk tank or bulk milk pickup tanker); (3) the relative extent to which consumers could be exposed to the drug residue via consumption of milk and milk products; and (4) the potential for a human health hazard given exposure to the drug residue. The risk assessment describes the ranking model structure, the scientific data and assumptions used to inform scoring in the model, and the ranking results. The risk assessment also identifies data gaps and research needs.

FDA invites comments that can help improve:

• The ranking model approach, including the specific criteria, scoring, and weighting scheme;

• the scientific data and assumptions used to inform scoring used in the model;

• the selection of animal drugs evaluated; and

• the clarity and the transparency of the risk assessment.

Interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES) regarding the risk assessment. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Persons with access to the Internet may obtain the risk assessment at either http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm443549.htm or http://www.regulations.gov.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m. Monday through Friday, and are available electronically at http://www.regulations.gov. (We have verified the Web site addresses in this reference section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)

Technology descriptions follow.

Description of Technology: This invention is a novel T cell therapy against cancer mutations that are patient specific. Scientists at the National Institutes of Health have developed a method to identify T cells that specifically recognize immunogenic mutations expressed only by cancer cells. Human cancers contain genetic mutations that are unique to each patient. Some of the mutated peptides are immunogenic, can be recognized by T cells, and therefore, may serve as therapeutic targets. The inventors identified cancer-specific mutations from a patient with widely metastatic cholangiocarcinoma by sequencing tumor samples and comparing with normal cells. Using tandem minigene constructs encoding all of the mutations expressed by a patient's tumor, the inventors identified T cells that recognized the immunogenic mutations from the same patient. These mutation-reactive T cells have the potential to eliminate the cancer cells while sparing normal tissues since normal tissues do not express the mutations. The inventors expanded these mutation-reactive T cells in vitro, and infused a highly pure population of these T cells back into the same patient. The patient experienced tumor regression when she was treated with this approach.

• Personalized immunotherapy with mutation-reactive T cells for mediating tumor regression in patients with immunogenic mutations.

• Mutation-reactive T cell therapy especially beneficial for cancer patients refractory to other therapies.

• A research tool to identify patient-specific immunogenic mutations in the tumor.

• This patient-specific therapy has the potential application to most epithelial cancers, which account for about 90% of cancer deaths in the United States.

• Personalized mutation-specific T cells recognize mutations harboring tumor cells only and spare normal tissues. This therapy has no tissue toxicities comparing to traditional chemotherapy and radiotherapy.

• The infusion of a highly pure population of these mutation-specific T cells may maximize therapy and result in regression of all target lesions.

• Early-stage

• In vitro data available

• In vivo data available (human)

• Ex vivo data available

Inventors: Eric Tran, Yong-Chen W. Lu, Paul F. Robbins, Steven A. Rosenberg (all of NCI).

Intellectual Property: HHS Reference No. E-229-2014/0—PCT Application No. PCT/US2014/058805 filed October 2, 2014.

Related Technology: HHS Reference No. E-233-2014/0—PCT Application No. PCT/US2014/058796 filed October 2, 2014.

Licensing Contact: Whitney A. Hastings, Ph.D.; 301-451-7337; [email protected].

Collaborative Research Opportunity: The National Cancer Institute, Surgery Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize T-cell therapy against cancer mutations. For collaboration opportunities, please contact Steven A. Rosenberg, M.D., Ph.D. at [email protected].

Description of Technology: This invention is a novel T cell therapy against cancer mutations that are patient specific. Scientists at the National Institutes of Health have developed a method to identify and generate T-cell receptor (TCR) engineered T cells for personalized cancer therapy. The TCR is a complex of integral membrane proteins that recognizes antigens and activates T cells. Human cancers contain genetic mutations that are unique in each patient. The inventors found cancer-specific mutations by sequencing tumors and comparing with normal cells. Using tandem minigene constructs encoding all of the patient's tumor mutations, they first identified T cells that were reactive with the unique mutated antigens expressed only in the patient's tumors. Next, they isolated the mutation-reactive TCRs and engineered peripheral blood T cells from the same patient to express these mutation-reactive TCRs. These personalized TCR engineered T cells can be expanded and infused back into the same patient with the potential to induce tumor regression.

• Personalized immunotherapy to treat primary and recurrent epithelial cancer.

• A research tool to identify patient-specific immunogenic mutations in tumors.

• A research tool to identify and isolate mutation-specific T cell receptors.

• This patient-specific therapy has the potential application to most epithelial cancers, which account for about 90% of cancer deaths in the United States.

• Personalized TCR engineered T cells target tumor cells and spare normal tissues. This therapy has no tissue toxicities comparing to traditional chemotherapy and radiotherapy.

• The infusion of a highly pure population of these T cells expressing mutation-specific TCRs may maximize therapy and result in regression of all target lesions.

• Early-stage

• In vitro data available

• Ex vivo data available

Inventors: Eric Tran, Yong-Chen W. Lu, Paul F. Robbins, Steven A. Rosenberg (all of NCI).

Intellectual Property: HHS Reference No. E-233-2014/0—PCT Application No. PCT/US2014/058796 filed October 2, 2014.

Related Technology: HHS Reference No. E-229-2014/0—PCT Application No. PCT/US2014/058805 filed October 2, 2014.

Licensing Contact: Whitney A. Hastings, Ph.D.; 301-451-7337; [email protected].

Collaborative Research Opportunity: The National Cancer Institute, Surgery Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize TCRs reactive with tumor associated antigens. For collaboration opportunities, please contact Steven A. Rosenberg, M.D., Ph.D. at [email protected].

Description of Technology: The invention pertains to recombinant paramyxoviruses that express one or more heterologous antigens, such as the human respiratory syncytial virus (RSV) F protein, that have been optimized for increased expression and immunogenicity. The recombinant constructs induce a bivalent immune response to the paramyxovirus vectors and the heterologous antigen. Potential vectors include parainfluenza virus (PIV) serotype 1 and 3, Sendai virus, Newcastle disease virus, PIV2, and PIV5. An exemplary modified heterologous antigen includes the ectodomain of RSV F protein linked to the transmembrane and cytoplasmic domains of the F protein from the PIV vector, which results in efficient incorporation into the vector particle. The RSV F ectodomain can be engineered to be stabilized in an optimal conformation, such as the highly immunogenic prefusion conformation. Additionally, the exemplary heterologous RSV F ectodomain can include one or more amino acid substitutions to modify ectodomain expression, conformation, phenotype, or stability.

• RSV vaccine

• Paramyxovirus vaccines

• Prophylactic vaccines

• Multi-valence

• Immunogenicity

• Early-stage

• In vitro data available

Inventors: Peter Collins, Bo Liang Shirin Munir, Anne Schaap-Nutt, Ursula Buchholz, Natalie Mackow, Peter Kwong, Barney Graham, Jason McLellan (all of NIAID).

Intellectual Property: HHS Reference No. E-241-2014/0—US Provisional Patent Application 62/105,667 filed January 20, 2015.

Related Technologies: HHS Reference No. E-081-2013/0-/5—US Patent Application 14/207,372 filed March 12, 2014; International Patent Application PCT/US2014/026714 filed March 13, 2014. Priority documents as follows:

(1) US Provisional Application 61/780,910 filed March 13, 2013;

(2) US Provisional Application 61/798,389 filed March 15, 2013;

(3) US Provisional Application 61/857,613 filed July 23, 2013; and

(4) US Provisional Application 61/863,909 filed August 9, 2013.

Licensing Contact: Peter A. Soukas; 301-435-4646; [email protected].

Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize this technology. For collaboration opportunities, please contact Jenish Patel at [email protected].

Description of Technology: The invention pertains to a device and system for expediting the thawing of frozen specimens (e.g., cryopreserved cells) contained in cryo-vials. An adaptor support suspends cryo-vials over a centrifuge tube containing culture medium in an inverted position. The adaptor has an elongated tubular body. While relatively basic, the adaptor dramatically expedites the process of recovering viable cells from frozen specimens. It reduces the labor time for thawing from several minutes to a few seconds. There is virtually no labor involved and enables a single person to load hundreds of samples within minutes. The cells, once thawed, spend essentially no time in liquid cryopreservative, since they are diluted instantly into growth medium contained in the centrifuge tubes. This process ensures the highest viability as well as recovery from each specimen while dramatically increasing throughput. Importantly, the elimination of multiple labor-intensive steps minimizes variation in viability and yield.

• Sample preparation

• Cell culturing

• High throughput

• Low labor

• Speed

• Reduced variability

Development Stage: Prototype.

Inventors: Mario Roederer, Margaret Beddall, Pratip Chattopadhyay (all of NIAID).

Intellectual Property: HHS Reference No. E-080-2015/0—US Patent Application No. 14/661,449 filed March 18, 2015.

Licensing Contact: Vince Contreras, Ph.D.; 301-435-4711; [email protected].

Collaborative Research Opportunity: The National Institutes of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize this technology. For collaboration opportunities, please contact Barry Buchbinder at [email protected] or 240-627-3678.

Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that SGS North America, Inc., 900 Milik St., Carteret, NJ 07008, has been approved to gauge and accredited to test petroleum and petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. SGS North America, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):

SGS North America, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):

Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to [email protected]. Please reference the Web site listed below for a complete listing of CBP approved gaugers and accredited laboratories. http://www.cbp.gov/sites/default/files/documents/gaulist_3.pdf

CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The comments should address: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and (e) the annual cost burden to respondents or record keepers from the collection of information (total capital/startup costs and operations and maintenance costs). The comments that are submitted will be summarized and included in the CBP request for OMB approval. All comments will become a matter of public record. In this document, CBP is soliciting comments concerning the following information collection:

Title: Ship's Stores Declaration.

OMB Number: 1651-0018.

Form Number: CBP Form 1303.

Abstract: CBP Form 1303, Ship's Stores Declaration, is used by the carriers to declare articles to be retained on board the vessel, such as sea stores, ship's stores (e.g. alcohol and tobacco products), controlled narcotic drugs or bunker fuel in a format that can be readily audited and checked by CBP. This form collects information about the ship, the ports of arrival and departure, and the articles on the ship. CBP Form 1303 form is provided for by 19 CFR 4.7, 4.7a, 4.81, 4.85 and 4.87 and is accessible at: http://www.cbp.gov/sites/default/files/documents/CBP%20Form%201303.pdf.

Current Actions: CBP proposes to extend the expiration date of this information collection with no change to the burden hours or to CBP Form 1303.

Type of Review: Extension (without change).

Affected Public: Businesses.

Estimated Number of Respondents: 8,000.

Estimated Number of Responses per Respondent: 13.

Estimated Number of Total Annual Responses: 104,000.

Estimated Total Annual Burden Hours: 26,000.

I. Background

In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS) U.S. Immigration and Customs Enforcement (ICE) is updating and reissuing a current DHS system of records titled “DHS/ICE—011 Immigration and Enforcement Operational Records (ENFORCE) System of Records.” With this update, ICE is proposing new routine use II that will authorize disclosure of information from this system of records “to a domestic law enforcement agency for the purpose of providing notice of an individual's release from DHS custody or removal from the United States, when the individual has a conviction(s) for a violent or serious crime(s) and the agency receiving the notification has an interest in the individual due to: (1) A pending investigation or prosecution, (2) parole or other forms of supervision, or (3) the individual's intended residence or location of release falling within the agency's jurisdiction.”

ICE will share biographic and criminal history information as well as release conditions or restrictions with other domestic law enforcement agencies when an alien who has been convicted of a violent or serious crime is released from ICE custody or removed from the United States. Violent and serious crimes include certain firearms, national security, sex, and drug-related crimes that ICE has determined are most relevant to the safety of the community. For example, ICE will notify a local law enforcement agency of the release from ICE custody of an alien who has been convicted of aggravated assault with a deadly weapon and has parole requirements in the local jurisdiction. ICE will also notify a law enforcement agency when an alien who has been convicted of, for example, armed robbery and assault is released, to assist agency decisions concerning the allocation of public safety resources in the jurisdiction.

These notifications are intended as situational awareness messages to help inform agencies that have an interest in an alien for investigation, supervision, or public/officer safety purposes of the alien's whereabouts from the time the alien is released until the alien reaches his or her intended jurisdiction of residence or country of removal. Notifications also assist law enforcement agencies in narrowing the pool of potential suspects when a violent or serious crime is committed in their jurisdiction and there are few leads in the investigation, or if the particulars of a crime being investigated are similar to circumstances surrounding the violent or serious crime for which the individual was previously convicted. Notifications of removal of an alien from the United States will help ensure that law enforcement agencies with an interest in the alien do not deploy resources in an attempt to locate the alien.

The exemptions for the existing system of records notice will continue to be applicable for this system of records notice. This updated system will continue to be included in DHS's inventory of record systems.

The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which the federal government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.

Below is the description of the amended DHS/ICE-011 Immigration and Enforcement Operational Records (ENFORCE) System of Records.

In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.

The Act (16 U.S.C. 1531 et seq.) prohibits certain activities with respect to endangered and threatened species unless a Federal permit allows such activity. Along with our implementing regulations in the Code of Federal Regulations (CFR) at 50 CFR part 17, the Act provides for certain permits, and requires that we invite public comment before issuing these permits for endangered species.

A permit granted by us under section 10(a)(1)(A) of the Act authorizes the permittee to conduct activities (including take or interstate commerce) with respect to U.S. endangered or threatened species for scientific purposes or enhancement of propagation or survival. Our regulations implementing section 10(a)(1)(A) of the Act for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.

We invite local, State, and Federal agencies and the public to comment on the following applications. Please refer to the permit number for the application when submitting comments.

Documents and other information submitted with these applications are available for review by request from the Program Manager for Restoration and Endangered Species Classification at the address listed in the ADDRESSES section of this notice, subject to the requirements of the Privacy Act (5 U.S.C. 552a) and the Freedom of Information Act (5 U.S.C. 552).

The permittee requests a permit amendment to take (harass through captive propagation at two additional enclosure sites) the Columbia Basin distinct population segment of the pygmy rabbit (Brachylagus idahoensis) in Oregon and Washington, in conjunction with scientific research and recovery actions, for the purpose of enhancing the species' survival.

The applicant requests a new permit to take (survey, capture, handle, measure, mark, tag, weigh, collect biological samples, attach transmitters and accelerometers, photograph, release, monitor nests, inventory nests, excavate nests, and salvage) the green sea turtle (Chelonia mydas) and the hawksbill sea turtle (Eretmochelys imbricata), in conjunction with scientific research to characterize and monitor sea turtle nesting on Palmyra Atoll, for the purpose of enhancing the species' survival.

All comments and materials we receive in response to this request will be available for public inspection, by appointment, during normal business hours at the address listed in the ADDRESSES section.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The American Flat Mill is an abandoned mining feature located within the Virginia City National Historic Landmark. At the time of its completion in 1922, it was the largest concrete mill structure in the world utilizing cyanide extraction to process silver ore. Following a substantial decrease in silver prices in 1924, the operation never recovered and the mill was dismantled in 1927. Only the deteriorated concrete skeleton of the mill remains today. The BLM plans on abating the substantial physical safety hazard posed by the American Flat Mill by demolishing the remaining buildings. Public land surrounding and including the American Flat Mill will be closed to public entry for the duration of demolition and reclamation activities. The public land affected by this closure is described as follows:

The closure notice, communications plan and map of the closure area will be posted at the BLM Carson City District Office, 5665 Morgan Mill Road, Carson City, Nevada and on the BLM Web site: http://www.blm.gov/nv/st/en/fo/carson_city_field.html. Roads leading into the public lands under the closure will be posted to notify the public of the closure. Under the authority of Section 303(a) of the FLPMA (43 U.S.C. 1733(a)), 43 CFR 8360.0-7 and 43 CFR 8364.1, the BLM will enforce the following rules in the area described above: All public use, whether motorized, on foot, or otherwise, is prohibited.

Exceptions: Closure restrictions do not apply to demolition activities conducted under contract with the BLM; agency personnel monitoring the demolition; or mining activities conducted under an approved plan of operation. Authorized users must have in their possession, a written permit or contract from BLM signed by the authorized officer.

Penalties: Any person who fails to comply with the closure orders is subject to arrest and, upon conviction, may be fined not more than $1,000 and/or imprisonment for not more than 12 months under 43 CFR 8360.0-7. Violations may also be subject to the provisions of Title 18, U.S.C. 3571 and 3581.

Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2015).

Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on April 23, 2015, ORDERED THAT—

(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain protective cases for electronic devices and components thereof by reason of infringement of one or more of claims 9, 12, and 13 of the ’232 patent and claims 17 and 28 of the ’512 patent, and whether an industry in the United States exists or is in the process of being established as required by subsection (a)(2) of section 337;

(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:

(a) The complainant is:

(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:

(3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.

The Office of Unfair Import Investigations will not participate as a party in this investigation.

Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.

Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.

Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:

1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or

2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.

In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.

Docket Number: M-2015-007-C.

Petitioner: White Oak Resources, LLC, P.O. Box 339, McLeansboro, Illinois 62859.

Mine: White Oak Mine No. 1, MSHA I.D. No. 11-03203, located in Hamilton County, Illinois.

Regulation Affected: 30 CFR 75.1700 (Oil and gas wells).

Modification Request: The petitioner requests a modification of the existing standard to permit mining within a 300 foot diameter of abandoned oil and gas wells, and to allow mining through abandoned oil and gas wells.

1. A safety barrier of 300 feet diameter (150 feet between any mined area and a well) will be maintained around all oil and gas wells, to include all active, inactive, abandoned, shut-in, and previously plugged wells and including water injection wells until approval to proceed has been obtained from the District Manager (DM).

2. The petitioner proposes, prior to mining through any oil or gas well at its White Oak Mine No. 1, to provide the DM a sworn affidavit or declaration stating that all mandatory procedures for cleaning out, preparing, and plugging each gas or oil well have been completed. The declaration will be accompanied by down-hole logs and any other information that the DM may request.

(a) The petitioner proposes to use the following procedures when cleaning out and preparing oil and gas wells prior to plugging or replugging:

(1) Clean out the well from the surface to at least 200 feet below the base of the lowest mineable coal seam. The DM will be provided with all information it possesses concerning the geological nature of the strata and the pressure of the well. All material will be removed from the entire diameter of the well, wall to wall.

(2) Prepare down-hole logs for each well. The logs will consist of a caliper survey and be suitable for determining the top, bottom, and thickness of all coal seams and potential hydrocarbon-producing strata and the location for the bridge plug. In addition a journal will be maintained describing the depth and nature of each material encountered; bit size and type used to drill each portion of the hole; length and type of each material used to plug the well; length of casing(s) removed, perforated, or ripped, or left in place, any sections where casing was cut or milled; and other pertinent information concerning cleaning and sealing the well. Invoices, work-orders, and other records relating to all work on the well will be maintained as part of this journal and provided to MSHA on request.

(3) When cleaning out the well, a diligent effort will be made to remove all of the casing in the well or, if it is not possible to remove all of the casing, fill the annulus between the casings and the well walls with expanding cement (minimum 0.5 percent expansion on setting) and ensure that these areas contain no voids. If the casing cannot be removed it will be cut or milled at all mineable coal seam levels. Any remaining casings will be perforated or ripped at least every 50 feet from at least 200 feet below the base of the lowest mineable coal seam up to 100 feet above the uppermost mineable coal seam. When multiple casing and tubing strings are present in the coal horizon(s), perforate or rip any casing that remains and fill with expanding cement. Keep an acceptable casing bond log for each casing and tubing string used in lieu of ripping or perforating multiple strings.

(4) Place a mechanical bridge plug in the well, if a cleaned-out well emits excessive amounts of gas. Place the mechanical bridge plug in a competent stratum at least 200 feet below the base of the lowest mineable coal seam, but above the top of the uppermost hydrocarbon-producing stratum.

(5) If the uppermost hydrocarbon-producing stratum is within 300 feet of the base of the lowest mineable coal seam, properly place mechanical bridge plugs to isolate the hydrocarbon-producing stratum from the expanding cement plug. Place a minimum of 200 feet of expanding cement below the lowest mineable coal seam.

(b) The petitioner proposes to use the following procedures for plugging or replugging oil or gas wells to the surface:

(1) Pump expanding cement slurry down the well to form a plug that runs from at least 200 feet below the base of the lowest mineable coal seam to the surface. Place the expanding cement in the well under a pressure of at least 200 pounds per square inch. Portland cement or a lightweight cement mixture may be used to fill the area from 100 feet above the top of the uppermost mineable coal seam.

(2) Embed steel turnings or other small magnetic particles in the top of the cement near the surface to serve as a permanent magnetic monument of the well. In the alternative, extend a 41/2-inch or larger casing, set in cement, at least 36 inches above the ground level with the American Petroleum Institute (API) well number either engraved or welded on the casing. When the hole cannot be marked with a physical monument (i.e., prime farmland), use high-resolution GPS coordinates (one-half meter resolution) to locate the hole.

c. The petitioner proposes to use the following procedures for plugging or replugging oil and gas wells for subsequent use as degasification boreholes:

(1) Set a cement plug in the well by pumping expanding cement slurry down the tubing to provide at least 200 feet of expanding cement below the lowest mineable coal seam. Place the expanding cement in the well under a pressure of at least 200 pounds per square inch. Extend the top of the expanding cement at least 30 feet above the top of the coal seam being mined.

(2) Securely grout a suitable casing into the bedrock of the upper portion of the degasification well to protect it. The remainder of this well may be cased or uncased.

(3) Fit the top of the degasification casing with a wellhead, equipped as required by the DM in the approved ventilation plan. Such equipment may include check valves, shut-in valves, sampling ports, flame arrestor equipment, and security fencing.

(4) Operation of the degasification well will be addressed in the approved ventilation plan. This may include periodic tests of methane levels and limits on the minimum concentrations that may be extracted.

(5) After the area of the coal mine that is degassed by a well is sealed or the coal mine is abandoned, seal the degas holes using the following procedures:

(i) Insert a tube to the bottom of the drill hole or, if not possible, to at least 100 feet above the Herrin No. 6 coal seam. Remove any blockage to ensure that the tube is inserted to this depth.

(ii) Set a cement plug in the well by pumping Portland cement or a lightweight cement mixture down the tubing until the well is filled to the surface.

(iii) Embed steel turnings or other small magnetic particles in the top of the cement near the surface to serve as a permanent magnetic monument of the well. In the alternative, extend a 41/2-inch or larger casing, set in cement, at least 36 inches above the ground level with the API well number engraved or welded on the casing.

d. The petitioner proposes to use the following mandatory alternative procedures for preparing and plugging or replugging oil or gas wells that cannot be cleaned out:

(1) Drill a hole adjacent and parallel to the well to a depth of at least 200 feet below the lowest mineable coal seam.

(2) Locate any casing that may remain in the well using a geophysical sensing device.

(3) If the well contains casings, drill into the well from the parallel hole and perforate or rip all casings at intervals of at least 5 feet from 10 feet below the coal seam to 10 feet above the coal seam. Beyond that distance, perforate or rip all casings at least every 50 feet from at least 200 feet below the base of the lowest mineable coal seam up to 100 feet above the seam being mined. Fill the annulus between the casings and between the casings and the well wall with expanding cement (minimum of 0.5 percent expansion on setting), and ensure that these areas contain no voids. When multiple casing and tubing strings are present in the coal horizons, rip or perforate any casing that remains and fill with expanding cement. Provide an acceptable casing bond log for each casing and tubing used in lieu of ripping or perforating multiple strings.

(4) Use a horizontal hydraulic fracturing technique to intercept the original well. Fracture the original well in at least six places from at least 200 feet below the base of the lowest mineable coal seam to a point at least 50 feet above the seam being mined, at intervals to be agreed on by the petitioner and the DM after considering the geological strata and the pressure within the well. Pump expanding cement into the fractured well in sufficient quantities and in a manner that fills all intercepted voids.

(5) Prepare down-hole logs for each well. The logs will consist of a caliper survey and be suitable for determining the top, bottom, and thickness of all coal seams and potential hydrocarbon-producing strata and the location for the bridge plug. The operator may obtain the logs from the adjacent hole rather than the well if the condition of the well makes it impractical to insert the equipment necessary to obtain the log. Maintain a journal describing the depth of each material encountered; the nature of each material encountered; bit size and type used to drill each portion of the hole; length and type of each material used to plug the well; length of casing(s) removed, perforated, ripped, or left in place; and other pertinent information concerning sealing the well. Invoices, work orders, and other records relating to all work on the well will be maintained as part of the journal and provided to MSHA on request.

(6) After plugging the well, plug the open portions of both holes from the bottom to the surface with Portland cement or a lightweight cement mixture.

(7) Embed steel turnings or other small magnetic particles in the top of the cement near the surface to serve as a permanent magnetic monument of the well. In the alternative, extend a 41/2-inch or larger casing, set in cement, at least 36 inches above the ground level.

(8) A combination of the methods outlined in subparagraphs (d)(3) and (d)(4) may have to be used in a single well depending on the conditions of the hole and the presence of casings. The petitioner and DM would discuss the nature of each hole. The DM may require that more than one method be used.

e. The petitioner proposes to use the following procedures after approval has been granted by the DM to mine through a plugged or replugged well:

(1) Prior to cutting-through a plugged well, notify the DM or designee, representative of the miners, and the appropriate State agency in sufficient time for them to have a representative present.

(2) When using continuous mining machines, install drivage sites at the last open crosscut near the place to be mined to ensure intersection of the well. The drivage sites will not be more than 50 feet from the well. When using longwall mining methods, install drivage sites on 10-foot centers for a distance of 50 feet in advance of the well. The drivage sites will be installed in the headgate and tailgate.

(3) Firefighting equipment, including fire extinguishers, rock dust, and sufficient fire hose to reach the working face area of the mine-through (when either the conventional or continuous mining method is used), will be available and operable during each well mine-through. Locate the fire hose in the last open crosscut of the entry or room. Maintain the water line to the belt conveyor tailpiece along with a sufficient amount of fire hose to reach the farthest point of penetration on the section. When the longwall mining method is used, a hose to the longwall water supply is sufficient. All fire hoses will be connected and ready for use, but do not have to be charged with water during the cut-through.

(4) Keep available at the last open crosscut a supply of roof support and ventilation materials sufficient to ventilate and support around the well on cut-through. In addition, keep emergency plugs and suitable sealing materials available in the immediate area of the well intersection.

(5) Maintain minimum air quantities in the working face during the period from when mining within 50 feet of the well location until the post cut-through inspection, or mining progresses at least 50 feet past the well location will be specified in the approved ventilation plan.

(6) On the shift prior to mining through the well, service all equipment and check for permissibility.

(7) Calibrate the methane monitors on the longwall, continuous mining machine, or cutting machine and loading machine on the shift prior to mining through the well.

(8) When mining is in progress, test methane levels with a hand-held methane detector at least every 10 minutes from the time that mining with the continuous mining machine is within 30 feet of the well until the well is intersected and immediately prior to mining through it. No individual is allowed on the return side during the actual cutting process until the mine-through has been completed and the area examined and declared safe. All workplace examinations will be conducted on the return side of the shearer while the shearer is idle.

(9) Keep the working place free from accumulations of coal dust and coal spillages, and place rock dust on the roof, rib, and floor to within 20 feet of the face when mining through the well when using continuous or conventional mining methods. Conduct rock dusting on longwall sections on the roof, rib, and floor up to both the headgate and tailgate gob.

(10) Deenergize all equipment when the wellbore is intersected and thoroughly examine the place and determine it safe before resuming mining. After a well has been intersected and the working place determined safe, mining will continue inby the well a sufficient distance to permit adequate ventilation around the area of the well.

(11) In rare instances, torches may be used for inadequately or inaccurately cut or milled casings at the coal seam level. No open flame is permitted in the area until adequate ventilation has been established around the wellbore and methane levels are less than 1.0 percent in all areas that will be exposed to flames and sparks from the torch. Apply a thick layer of rock dust to the roof, face, floor, ribs, and any exposed coal within 20 feet of the casing prior to any use of torches.

(12) Non-sparkling (brass) tools will be located on the working section and will be used to expose and examine cased wells.

(13) No person will be permitted in the area of the cut-through operation except those actually engaged in the mining operation, including mine management, representatives of miners, personnel from MSHA, and personnel from the appropriate State agency.

(14) A certified official will directly supervise the cut-through operation and only the certified official in charge will issue instructions concerning the cut-through operation.

(15) Within 60 days after this petition becomes final, the petitioner will submit proposed revisions for its approved part 48 training plan to the DM. These proposed revisions will include initial and refresher training regarding compliance with the terms and conditions stated in the Order. The operator will provide all miners involved in the mine-through of a well with training regarding the requirements of this Order prior to mining within 150 feet of the next well intended to be mined through.

(16) The responsible person required in 30 CFR 75.1501 will be responsible for well intersection emergencies. The responsible person will review the well intersection procedures prior to any planned intersection.

(17) Within 60 days after this petition becomes final, the petitioner will submit proposed revisions for its approved mine emergency evacuation and firefighting plan required in 30 CFR 75.1501. The plan will include the hazards and evacuation procedures to be used for well intersections. All underground miners will be trained in this revised plan within 60 days of submittal of the revised evacuation plan.

The petitioner asserts that the proposed alternative method will at all times guarantee no less than the same measure or protection afforded by the existing standard.

Docket Number: M-2015-008-C.

Petitioner: Consolidation Coal Company, RD #1 Box 62A, Dallas, West Virginia 26036.

Mine: Shoemaker Mine, MSHA I.D. No. 46-01436, located in Marshall County, West Virginia.

Regulation Affected: 30 CFR 75.311(b)(2) and (3) (Main mine fan operation).

Modification Request: The petitioner requests a modification of the existing standard to allow the refuse belt to continue to operate during a fan outage other than the Dupont Fan. Management will monitor and prohibit the entrance of any miners or personnel underground at any time during the fan outages. The mine will follow the re-entry requirements in 30 CFR for examinations and re-entry by mine personnel once all fans are operational. The petitioner states that:

(1) The Shoemaker Mine operates in the Pittsburgh #8 coal seam. The seam thickness averages 84 inches. The overburden averages 850 feet. The continuous miner and longwall sections are used to mine this coal seam. The mine currently has 730 employees.

(2) Coal extraction from the mine is transported via conveyor belt to the coal processing plant located on the surface. Rock and other impurities are separated from the coal at this location. The separated rock and impurities are termed “refuse or refuse material”.

(3) The refuse material which has been separated from the coal is then loaded onto another conveyor belt, hereinafter known as the refuse belt, which carries the refuse material back into and through a small portion of the mine, before exiting to the surface again. The refuse is then trans-loaded onto rubber tired vehicles which distribute the refuse throughout the approved refuse disposal site.

(4) The belt consists of a 30-inch flame resistant material required in 30 CFR part 14. The belt travels from the preparation plant to the refuse site. The distance underground is approximately 4,000 feet.

(5) Removing the refuse belt from service due to a fan outage also prevents the coal processing plant from operating.

(6) The mine is ventilated with multiple main ventilation fans and the primary source of ventilation of the “refuse” belt is the Dupont main blowing fan. In the event of an outage of any or all ventilation fans, the Dupont fan will remain in operation to provide adequate ventilation to the petitioned area.

(7) The procedures below will be used to monitor the belt on the surface at manned locations.

(a) The following procedures will be used for operating the refuse belt during a fan outage:

(1) The refuse belt is ventilated by the Dupont main blowing fan. The air enters the mine and splits on the belt and exits the mine at the River Portal and top of the Refuse Slope at Browns Run. The blowing system provides positive pressure on the beltline and surrounding areas. Air measurements recorded at the two belt openings where air exits the mine will be monitored with a velometer. If at any time the Dupont main blowing fan becomes inoperative then the refuse belt will be deenergized by a remote system from a surface location.

(2) The beltline will be monitored on the surface at manned locations where audible and visual signals can be heard or seen. An intrinsically safe monitoring system capable of detection and monitoring of carbon monoxide, oxygen, methane and velocity will be installed and maintained along the refuse belt as indicated below:

(i) Carbon monoxide sensors will be installed near the center in the upper third of the entry, in a location that does not expose personnel working on the system to unsafe conditions. Sensors will not be located in abnormally high areas or in other locations where airflow patterns do not permit products of combustion to be carried to the sensors.

(ii) The carbon monoxide sensor location intervals will not exceed 1,000 feet along the belt entry and not more than 100 feet downwind of the belt tailpiece transfer.

(iii) Oxygen and methane sensors will be installed near the center of the entry, at least 12 inches from the roof, ribs, and floor, in a location that would not expose personnel working on the system to unsafe conditions. The sensor will be located where the ventilating current enters the refuse belt entry at Survey Station 12+50.

(iv) Velometers will be installed at the two locations where air used to ventilate the Refuse Belt exits the mine.

(v) The sensors will automatically provide visual and audible signals at the surface locations for any interruption of circuit continuity and any electrical malfunction of the system. These signals must be of sufficient magnitude to be seen or heard by the designated person at the surface locations.

(vi) The sensors will automatically provide visual and audible signals at the designated surface locations when carbon monoxide concentration levels reach alarm (10 PPM), (the Ambient CO Level for the entry will be zero); methane concentration levels reach alarm at 1.0 percent at any sensor; oxygen concentration levels drop below and reach alarm at 19.5 percent; or velocities drop under 50 FPM and reach alarm.

(vii) If at any time any segment of the monitoring system reaches alarm status the belt will be deenergized.

(8) The sensors will be installed and maintained by personnel trained in the installation and maintenance of the system. The system will be maintained in proper operating condition.

(9) Sensors used to monitor for carbon monoxide and methane will be of a type listed and installed in accordance with the recommendations of a nationally recognized testing laboratory approved by the Secretary, or will be of a type, and installed in a manner approved by the Secretary.

(10) At least once each shift when belts are operated as part of a production shift, sensors used to detect carbon monoxide will be visually examined.

(11) At least once every seven days alarms for the installed monitoring system will be functionally tested for proper operation.

(12) At intervals not to exceed 31 days, each carbon monoxide sensor will be calibrated in accordance with the manufacturer's calibration specifications. Calibration will be done with a known concentration of carbon monoxide in air sufficient to activate the alarm.

(13) Each methane sensor installed will be calibrated in accordance with the manufacturer's calibration specifications. Calibration will be done with a known concentration of methane in air sufficient to activate an alarm.

(14) If the alarm signals are activated during calibration of sensors, the designated person will be notified prior to and upon completion of calibration.

(15) Gases used for the testing and calibration of sensors will be traceable to the National Institute of Standards and Technology reference standard for the specific gas. When these reference standards are not available for a specific gas, calibration gases will be traceable to an analytical standard which is prepared using a method traceable to the National Institute of Standards and Technology. Calibration gases must be within ±2.0 percent of the indicated gas concentration.

(16) A record of the date, time, location and type of sensor, and the cause for the activation will be recorded if an alarm occurs.

(17) If a sensor malfunctions, the date, the extent and cause of the malfunction, and the corrective action taken to return the system to proper operation will be recorded.

(18) A record of the seven-day tests of alert and alarm signals, calibrations, and maintenance of the sensors will be made by the person(s) performing these tests.

(19) The person(s) entering the recordings will include their name, date, and signature in the record.

(20) The records required by this section will be kept either in a secure book that is not susceptible to alteration, or electronically in a computer system that is secure and not susceptible to alteration. These records will be maintained separately from other records and identifiable by a title, such as the “Sensor Log”.

(21) Records will be retained for at least one year at a surface location at the mine and made available for inspection by miners and authorized representatives of the Secretary.

(22) The Intrinsically Safe Fire Sensor and Warning System will be comprised of components from Conspec Controls, Inc., or equivalent parts or manufacture.

(23) The system will consist of intrinsically safe components. The following components will be the only electrical components present underground on the refuse belt:

(a) Belt Conveyor On/Off switches every 1,000 feet with an intrinsically safe system. A total of 6 switches are present along the beltline.

(b) The belt controls including belt switches and chute plug switch will be controlled by SMC C1570 IS Relays with diodes. The sequence switch will go through an IS barrier (BWI EAGLE 10-7072 IS Zenner Barrier) to an IS proximity switch (BWI EAGLE 10-7039 IS Prox Sensor).

(c) The refuse and slope belt drives and associated electrical components are located outside on the surface at Browns Run and the River Portal.

Within 60 days after this Petition is granted, the petitioner will submit proposed revisions for its approved part 48 training plan to the District Manager. The proposed revisions will specify initial and refresher training regarding the alternative method outlined in this petition and the terms and conditions stated in the Proposed Decision and Order.

Docket Number: M-2015-009-C.

Petitioner: Consolidation Coal Company, RD #1 Box 62A, Dallas, West Virginia 26036.

Mine: Shoemaker Mine, MSHA I.D. No. 46-01436, located in Marshall County, West Virginia.

Regulation Affected: 30 CFR 75.313(c)(2) and (3) (Main mine fan stoppage with persons underground).

Modification Request: The petitioner requests a modification of the existing standard to allow the refuse belt to continue to operate during a fan outage, other than the Dupont Fan. Management will monitor and prohibit the entrance of any miners or personnel underground at any time during the fan outages. The mine will follow the re-entry requirements in 30 CFR for examinations and re-entry by mine personnel once all fans are operational. The petitioner states that:

(1) The Shoemaker Mine operates in the Pittsburgh #8 coal seam. The seam thickness averages 84 inches. The overburden averages 850 feet. The continuous miner and longwall sections are used to mine this coal seam. The mine currently has 730 employees.

(2) Coal extraction from the mine is transported via conveyor belt to the coal processing plant located on the surface. Rock and other impurities are separated from the coal at this location. The separated rock and impurities and termed “refuse or refuse material”.

(3) The refuse material which has been separated from the coal is them loaded onto another conveyor belt, hereinafter known as the refuse belt, which carries the refuse material back into and through a small portion of the mine, before exiting to the surface again. The refuse is then trans-loaded onto rubber tired vehicles which distribute the refuse throughout the approved refuse disposal site.

(4) The belt consists of a 30-inch flame resistant material required in 30 CFR part 14. The belt travels from the preparation plant to the refuse site. The distance underground is approximately 4,000 feet.

(5) Removing the refuse belt from service due to a fan outage also prevents the coal processing plant from operating.

(6) The mine is ventilated with multiple main ventilation fans and the primary source of ventilation of the “refuse” belt is the Dupont main blowing fan. In the event of an outage of any or all ventilation fans, the Dupont fan will remain in operation to provide adequate ventilation to the petitioned area.

(7) The procedures below will be used to monitor the belt on the surface at manned locations.

(a) The following procedures will be used for operating the refuse belt during a fan outage:

(1) The refuse belt is ventilated by the Dupont main blowing fan. The air enters the mine and splits on the belt and exits the mine at the River Portal and top of the refuse slope at Browns Run. The blowing system provides positive pressure on the beltline and surrounding areas. Air measurements recorded at the two belt openings where air exits the mine will be monitored with a velometer. If at any time the Dupont main blowing fan becomes inoperative then the refuse belt will be deenergized by a remote system from a surface location.

(2) The beltline will be monitored on the surface at manned locations where audible and visual signals can be heard or seen. An intrinsically safe monitoring system capable of detection and monitoring of carbon monoxide, oxygen, methane and velocity will be installed and maintained along the refuse belt as indicated below:

(i) Carbon monoxide sensors will be installed near the center in the upper third of the entry, in a location that does not expose personnel working on the system to unsafe conditions. Sensors will not be located in abnormally high areas or in other locations where airflow patterns do not permit products of combustion to be carried to the sensors.

(ii) The carbon monoxide sensor location intervals will not exceed 1,000 feet along the belt entry and not more than 100 feet downwind of the belt tailpiece transfer.

(iii) Oxygen and methane sensors will be installed near the center of the entry, at least 12 inches from the roof, ribs, and floor, in a location that would not expose personnel working on the system to unsafe conditions. The sensor will be located where the ventilating current enters the refuse belt entry at Survey Station 12+50.

(iv) Velometers will be installed at the two locations where air used to ventilate the refuse belt exits the mine.

(v) The sensors will automatically provide visual and audible signals at the surface locations for any interruption of circuit continuity and any electrical malfunction of the system. These signals must be of sufficient magnitude to be seen or heard by the designated person at the surface locations.

(vi) The sensors will automatically provide visual and audible signals at the designated surface locations when carbon monoxide concentration levels reach alarm (10 PPM), (the Ambient CO Level for the entry will be zero); methane concentration levels reach alarm at 1.0 percent at any sensor; oxygen concentration levels drop below and reach alarm at 19.5 percent; or velocities drop under 50 FPM and reach alarm.

(vii) If at any time any segment of the monitoring system reaches alarm status the belt will be deenergized.

(8) The sensors will be installed and maintained by personnel trained in the installation and maintenance of the system. The system will be maintained in proper operating condition.

(9) Sensors used to monitor for carbon monoxide and methane will be of a type listed and installed in accordance with the recommendations of a nationally recognized testing laboratory approved by the Secretary, or will be of a type, and installed in a manner approved by the Secretary.

(10) At least once each shift when belts are operated as part of a production shift, sensors used to detect carbon monoxide must be visually examined.

(11) At least once every seven days alarms for the installed monitoring system will be functionally tested for proper operation.

(12) At intervals not to exceed 31 days, each carbon monoxide sensor will be calibrated in accordance with the manufacturer's calibration specifications. Calibration will be done with a known concentration of carbon monoxide in air sufficient to activate the alarm.

(13) Each methane sensor installed will be calibrated in accordance with the manufacturer's calibration specifications. Calibration will be done with a known concentration of methane in air sufficient to activate an alarm.

(14) If the alarm signals are activated during calibration of sensors, the designated person will be notified prior to and upon completion of calibration.

(15) Gases used for the testing and calibration of sensors will be traceable to the National Institute of Standards and Technology reference standard for the specific gas. When these reference standards are not available for a specific gas, calibration gases will be traceable to an analytical standard which is prepared using a method traceable to the National Institute of Standards and Technology. Calibration gases must be within ±2.0 percent of the indicated gas concentration.

(16) A record of the date, time, location and type of sensor, and the cause for the activation will be recorded if an alarm occurs.

(17) If a sensor malfunctions, the date, the extent and cause of the malfunction, and the corrective action taken to return the system to proper operation will be recorded.

(18) A record of the seven-day tests of alert and alarm signals, calibrations, and maintenance of the sensors will be made by the person(s) performing these actions.

(19) The person(s) entering the record must include their name, date, and signature in the record.

(20) The records required by this section will be kept either in a secure book that is not susceptible to alteration, or electronically in a computer system that is secure and not susceptible to alteration. These records will be maintained separately from other records and identifiable by a title, such as the “Sensor Log”.

(21) Records will be retained for at least one year at a surface location at the mine and made available for inspection by miners and authorized representatives of the Secretary.

(22) The Intrinsically Safe Fire Sensor and Warning System will be comprised of components from Conspec Controls, Inc., or equivalent parts or manufacture.

(23) The system will consist of intrinsically safe components. The following components will be the only electrical components present underground on the refuse belt:

(a) Belt conveyor on/off switches every 1,000 feet with an intrinsically safe system. A total of 6 switches are present along the beltline.

(b) The belt controls including belt switches and chute plug switch will be controlled by SMC C1570 IS Relays with diodes. The sequence switch will go through an IS barrier (BWI EAGLE 10-7072 IS Zenner Barrier) to an IS proximity switch (BWI EAGLE 10-7039 IS Prox Sensor).

(c) The refuse and slope belt drives and associated electrical components are located outside on the surface at Browns Run and the River Portal.

Within 60 days after this Petition is granted, the petitioner will submit proposed revisions for its approved part 48 training plan to the District Manager. The proposed revisions will specify initial and refresher training regarding the alternative method outlined in this petition and the terms and conditions stated in the Proposed Decision and Order.

Docket Number: M-2015-010-C.

Petitioner: Coyote Creek Mining Company, LLC, 6502 17th Street SW., Zap, North Dakota 58580.

Mine: Coyote Creek Mine, MSHA I.D. No. 32-01028, located in Mercer County, North Dakota.

Regulation Affected: 30 CFR 77.803 (Fail safe ground check circuits on high-voltage resistance grounded systems).

Modification Request: The petitioner requests a modification of the existing standard to permit an alternative method of compliance when the boom/mast is raised or lowered during necessary repairs. The petitioner states that:

(1) Some stages of assembly/disassembly of draglines require special consideration when the boom/mast is raised/lowered into position.

(2) The boom is raised/lowered utilizing the on-board VFD hoist drive and AC drive motors. This process is critical because power to the machine must not be interrupted. Power loss conditions may result in the boom becoming uncontrolled, falling, and possible injuries to workers. To address this condition, the petitioner proposes to use the following guidelines to help prevent loss of power to the machine. This procedure only addresses raising/lowering the boom on draglines utilizing the machine's electrical onboard VFD hoist drive and AC drive motors. It does not replace other mechanical precautions or the requirements of 30 CFR 77.405(b) that are necessary to safely secure booms/masts during construction or maintenance procedures.

The petitioner proposes to use the following procedure for “boom raising” or “boom lowering” at the Coyote Creek Mine. During this period of construction and maintenance the machine will not be performing mining operations. This procedure will also be applicable in instances of disassembly or major maintenance that require the boom to be raised/lowered. The following guidelines will be used to minimize the potential for electrical power loss during this critical boom procedure:

(1) The petitioner proposes to initially use the procedure to raise the boom on the Marion 8400 dragline, which is currently being reconstructed, and would most likely only use this procedure during disassembly or major maintenance in the future.

(2) Major maintenance requiring the raising/lowering of the boom/mast would only be performed on an as needed basis, which could span long periods of time. Therefore, training and review of the procedure would only be conducted prior to this need. At such time, all persons involved in the process would be trained and retrained.

The petitioner states that:

(1) Coyote Creek employees, its contractors, and affected persons will be trained on the requirements of the procedure at the mine.

(2) The procedure will be coordinated by a Coyote Creek Mine maintenance supervisor and, if present, the contractor's representative will assist. At least two MSHA qualified electricians will be present at all times during the procedure.

(3) The number of persons required on board the machine will be limited. An MSHA qualified electrician, dragline operator, and the dragline oiler will be permitted on the machine. The Coyote Creek maintenance supervisor and contractor's representative may either be on board or at a location on the ground to assist in the coordination.

(4) The affected area under the boom will be secured to prevent persons from entering and/or contacting the frame of the machine during the “boom raising/lowering”. The area will be secured and only those persons identified in Item #3 will be permitted inside the secured area. At no time will anyone be permitted under the boom or close to the boom.

(5) Communication between the dragline operator, the MSHA qualified electrician at the dragline, the MSHA qualified electrician at the substation, the Coyote Creek maintenance supervisor, and the contractor's representative, if present, will be a dedicated channel on the company's two-way radio.

(6) An MSHA qualified electrician will complete an examination of all electrical components that will be energized. The examination will be done within two hours prior to the boom raising/lowering process. A record of this examination will be made available to interested parties. The machine will be deenergized to perform this examination.

(7) After the examination is completed, the electrical components necessary to complete the boom raising/lowering process will be energized to assure they are operating properly as determined by an MSHA qualified electrician. When completed, the machine will be deenergized and locked out.

(8) The ground fault and ground check circuits will be disabled provided:

(a) The internal grounding conductor of the trailing cable has been tested and is continuous from the frame of the dragline to the grounding resistor located at the substation. Utilizing the ground check circuit and disconnecting the pilot circuit at the machine frame, and verifying the circuit breaker cannot be closed, will be an acceptable test. Resistance measurements will also be used to assure the ground conductor is continuous. The grounding resistor will be tested to assure it is properly connected, is not open, or is not shorted.

(b) Normal short circuit protection will be provided at all times. The over current relay setting may be increased up to 100 percent above its normal setting.

(9) During the boom raising/lowering procedure an MSHA qualified electrician will be positioned at the substation dedicated to monitor the grounding circuit. The MSHA qualified electrician will be able to detect a grounded phase condition or an open ground wire condition. The MSHA qualified electrician at the substation will at all times maintain communications with an MSHA qualified electrician at the dragline. If a grounded phase condition or an open ground wire should occur during the process, the MSHA qualified electrician at the substation will notify the MSHA qualified electrician at the dragline. All persons on board the machine must be aware of the condition and must remain on board the machine. The boom must be lowered to the ground or controlled and electrical circuit deenergized, locked and tagged out. The circuit must remain deenergized until the condition is corrected. The ground fault and ground check circuits will be reinstalled prior to reenergizing and testing the machine. Once circuits have been tested and no adverse conditions are present, the boom raising/lowering procedure, as outlined above, will be resumed.

(10) During the construction/maintenance procedure, persons cannot get on or off the dragline while the ground check ground fault circuits are disabled unless the circuit is deenergized, locked and tagged out as verified by the MSHA qualified electrician at the substation.

(11) After the boom raising/lowering is completed, the MSHA qualified electrician at the substation will restore all the protective devices to their normal state. When this has been completed, the MSHA qualified electrician at the substation will notify the dragline that all circuits are in their normal state. At this time normal work procedures can begin.

The petitioner asserts that this proposed alternative method of the existing standard will not result in a diminution of safety to the miners affected.

I. Introduction

Under section 101 of the Federal Mine Safety and Health Act of 1977, a mine operator may petition and the Secretary of Labor (Secretary) may modify the application of a mandatory safety standard to that mine if the Secretary determines that: (1) An alternative method exists that will guarantee no less protection for the miners affected than that provided by the standard; or (2) that the application of the standard will result in a diminution of safety to the affected miners.

MSHA bases the final decision on the petitioner's statements, any comments and information submitted by interested persons, and a field investigation of the conditions at the mine. In some instances, MSHA may approve a petition for modification on the condition that the mine operator complies with other requirements noted in the decision.

On the basis of the findings of MSHA's investigation, and as designee of the Secretary, MSHA has granted or partially granted the following petitions for modification:

• Docket Number: M-2014-026-C.

FR Notice: 79 FR 48256 (8/15/2014).

Petitioner: Covol Fuels No. 3, LLC, 10156 US Hwy 25 E, Pineville, Kentucky 40977.

Mine: Crockett, MSHA I.D. No. 15-12682, located in Bell County, Kentucky; Coarse Coal Refuse Fill #5, Site I.D. No. KY07-12682-05.

Regulation Affected: 30 CFR 77.214(a) (Refuse piles; general).

• Docket Number: M-2014-031-C.

FR Notice: 79 FR 64623 (10/30/2014).

Petitioner: Sunrise Coal LLC, 12661 Agricare Road, Oaktown, Indiana 47561.

Mine: Oaktown Fuels Mine No. 1, MSHA I.D. No. 12-02394, located in Knox County, Indiana.

Regulation Affected: 30 CFR 75.1700 (Oil and gas wells).

• Docket Number: M-2014-032-C.

FR Notice: 79 FR 64623 (10/30/2014).

Petitioner: Sunrise Coal LLC, 12661 Agricare Road, Oaktown, Indiana 47561.

Mine: Oaktown Fuels Mine No. 2, MSHA I.D. No. 12-02418, located in Knox County, Indiana.

Regulation Affected: 30 CFR 75.1700 (Oil and gas wells).

Title of Collection: Presidential Awards for Excellence in Mathematics and Science Teaching (PAEMST), State Coordinator (SC) Survey.

OMB Number: 3145—NEW.

Expiration Date of Approval: Not Applicable.

Type of request: NEW.

Abstract: The PAEMST is a White House program established by Congress in 1983 authorizing the President to bestow up to 108 awards each year to teachers of mathematics and science at the elementary and secondary levels. The NSF is the designated federal agency for administration of this Presidential program. Awards are given to mathematics and science (including computer science) teachers from each of the 50 states and four U.S. jurisdictions. The jurisdictions are Washington DC; Puerto Rico; Department of Defense Education Activity schools; and the U.S. territories as a group (American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the U.S. Virgin Islands). The award recognizes those teachers who develop and implement a high-quality instructional program that is informed by content knowledge and enhances student learning. Since the program's inception, more than 4,300 teachers have been recognized for their contributions in the classroom and to their profession. Awardees serve as models for their colleagues, inspiration to their communities, and leaders in the improvement of mathematics and science (including computer science) education.

The State Coordinator (SC) manages the PAEMST program within his or her state or jurisdiction. SCs recruit eligible nominees, select and assign mentors to nominees, coordinate the selection committee, and plan local recognition events within their State. They also carry out the responsibilities as noted in the “Operational Handbook for State-Level Science and Mathematics Coordinators.”

The purpose of this survey is to seek feedback from the 120 SCs regarding PAEMST management within their state or jurisdiction. The NSF, PAEMST support team will ask directed questions using the survey to gather information that may specifically address the methods and recruitment efforts that SCs use to support the attracting of prospective award nominees. Additional survey areas may also include:

• Applicant Mentoring

• Mentor Training

• State selection Committee

• State selection Process

• Applicant and State Finalist Notification and Recognition

• In-kind contributions

The survey will evaluate the impact SCs have on attracting prospective award nominees to PAEMST. This will be conducted as a Web-based survey.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 30-40 minutes for State Coordinators.

Respondents: Individuals.

Estimated Number of Responses per Form: 120 Coordinators.

Estimated Total Annual Burden on Respondents: 80 hours (120 Coordinators at 40 minutes per survey = 80 hours).

Frequency of Response: One per application cycle.

Comments: Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the PAEMST functions, including whether the information shall have practical utility; (b) the accuracy of the NSF's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information on respondents, including through the use of automated collection techniques or other forms of information technology; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology.

On November 7, 2014, NWMI filed with the NRC, pursuant to Section 103 of the Atomic Energy Act of 1954, as amended, and part 50 of Title 10 of the Code of Federal Regulations (10 CFR), a portion of an application for a construction permit for a medical radioisotope production facility in Columbia, Missouri. By letter dated February 5, 2015 (ADAMS Accession No. ML15086A262), NWMI withdrew and resubmitted this portion of their construction permit application (ADAMS Accession No. ML15086A261) to include a discussion of connected actions in their environmental report in response to a letter from the NRC (ADAMS Accession No. ML14349A501).

An exemption from certain requirements of 10 CFR 2.101(a)(5) granted by the Commission on October 7, 2013 (ADAMS Accession No. ML13238A333), in response to a letter from NWMI dated August 9, 2013 (ADAMS Accession No. ML13227A295), allowed for NWMI to submit its construction permit application in two parts. Specifically, the exemption allowed NWMI to submit a portion of its application for a construction permit up to 6 months prior to the remainder of the application regardless of whether or not an environmental impact statement or a supplement to an environmental impact statement is prepared during the review of its application. On February 5, 2015, in accordance with 10 CFR 2.101(a)(5), NWMI submitted the following in part one of the construction permit application:

• the description and safety assessment of the site required by 10 CFR 50.34(a)(1),

• the environmental report required by 10 CFR 50.30(f),

• the filing fee information required by 10 CFR 50.30(e) and 10 CFR 170.21,

• the general information required by 10 CFR 50.33, and

• the agreement limiting access to classified information required by 10 CFR 50.37.

As stated in NWMI's February 5, 2015, letter, part two of NWMI's application for a construction permit will contain the remainder of the preliminary safety analysis report required by 10 CFR 50.34(a) and will be submitted in accordance with the requirements of 10 CFR 2.101(a)(5).

Subsequent Federal Register notices will address the acceptability of this part of the tendered construction permit application for docketing and provisions for public participation in the construction permit application review process.

I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2015-0059 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0059.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in the SUPPLEMENTARY INFORMATION section. Draft NUREG—2178, “Refining and Characterizing Heat Release Rates from Electrical Enclosures During Fire (RACHELLE-FIRE), is available in ADAMS under Accession No. ML15056A144.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2015-0059 in the subject line of your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publically disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

The Refining and Characterizing Heat Release Rates From Electrical Enclosures During Fire (RACHELLE-FIRE) program involves a working group of experienced fire protection and fire probabilistic risk assessment researchers and practitioners focused on enhancing the methodology used to model electrical enclosure fires in nuclear power plants. This report documents the results from the working group's efforts to develop technical information in three areas: (1) Classification of electrical enclosures in terms of function, size, contents, and ventilation; (2) determination of peak heat release rate (HRR) probability distributions considering specific electrical enclosure characteristics;, and (3) development of a method to account for the impact of the enclosure on the vertical thermal zone of influence above the enclosure during fire. Electrical enclosures have been classified in groups based on their electrical function, contents, and size. Peak HRR distributions for the different classification groups have been developed. These distributions are based on the results of different experimental programs intended to measure the HRR associated with fires in electrical enclosures. In order to provide a comprehensive characterization of electrical enclosure fires, the working group evaluated the temperature characteristics of fire plumes associated with these events using the Fire Dynamics Simulator program. Computer simulations of various enclosure configurations were developed for evaluating the fire burning inside electrical enclosures and the fire plume temperature characteristics that would be generated. Based on this research, new fire plume temperature profiles reflecting the obstructed nature of fire plumes generated from fires inside electrical enclosures are provided. Finally, examples, consolidating the information described in this report, are provided to illustrate how to incorporate the information documented in this report into existing approaches for modeling fires in electrical enclosures.

Please refer to Docket ID NRC-2015-0111 when contacting the NRC about the availability of information regarding this this draft EA and FONSI. You may obtain publicly-available information related to this this draft EA and FONSI using any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0111.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. For the convenience of the reader, the ADAMS accession numbers are provided in a table in the “Availability of Documents” section of this document.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2015-0111 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

VY is a permanently shutdown and defueled nuclear power plant that is in the process of decommissioning. VY is located in Windham County, Vermont, 5 miles south of Brattleboro, Vermont. Entergy is the holder of the Renewed Facility Operating License No. DPR-28 for VY. VY has been shut down since December 29, 2014, and the final removal of fuel from the VY reactor vessel was completed on January 12, 2015. By letter dated January 12, 2015, Entergy submitted to the NRC a certification of the permanent cessation of power operations at VY and the permanent removal of fuel from the VY reactor vessel. As a permanently shutdown and defueled facility, and pursuant to section 50.82(a)(2) of Title 10 of the Code of Federal Regulations (10 CFR), VY is no longer authorized to be operated or to have fuel placed into its reactor vessel, but the licensee is still authorized to possess and store irradiated nuclear fuel. Irradiated nuclear fuel is currently stored onsite at VY in a spent fuel pool (SFP) and in an independent spent fuel storage installation (ISFSI).

The licensee has requested exemptions for VY from certain EP requirements in 10 CFR part 50, “Domestic Licensing of Production and Utilization Facilities.” The NRC regulations concerning EP do not recognize the reduced risks after a reactor is permanently shut down and defueled. As such, a permanently shutdown and defueled reactor, such as VY, must continue to maintain the same EP requirements as an operating power reactor under the existing regulatory requirements. To establish a level of EP commensurate with the reduced risks of a permanently shutdown and defueled reactor, Entergy requires exemptions from certain EP regulatory requirements before it can change its emergency plans.

The NRC is considering issuing to Entergy exemptions from portions of 10 CFR 50.47, “Emergency plans,” and 10 CFR part 50, appendix E, “Emergency Planning and Preparedness for Production and Utilization Facilities,” which would eliminate the requirements for Entergy to maintain offsite radiological emergency plans and reduce some of the onsite EP activities based on the reduced risks at VY, due to its permanently shutdown and defueled status. Based on the decision of the United States Court of Appeals for the Second Circuit in Brodsky v. NRC associated with a fire protection exemption for Indian Point Nuclear Generating Unit No. 3, and demonstrated public interest in this exemption request, particularly the State of Vermont, the NRC is issuing for public comment, pursuant to 10 CFR 51.33, this draft EA and FONSI associated with the exemption request. The NRC has concluded that the proposed action will have no significant environmental impact.

The proposed action would exempt Entergy from meeting certain requirements set forth in 10 CFR 50.47 and appendix E to 10 CFR part 50. More specifically, Entergy requested exemptions from: (1) Certain requirements in 10 CFR 50.47(b) regarding onsite and offsite emergency response plans for nuclear power reactors; (2) certain requirements in 10 CFR 50.47(c)(2) to establish plume exposure and ingestion pathway EP zones for nuclear power reactors; and (3) certain requirements in 10 CFR part 50, appendix E, section IV, which establishes the elements that make up the content of emergency plans. The proposed action of granting these exemptions would eliminate the requirements for Entergy to maintain offsite radiological emergency plans and reduce some of the onsite EP activities at VY, based on the reduced risks at the permanently shutdown and defueled reactor. However, requirements for certain onsite capabilities to communicate and coordinate with offsite response authorities would be retained. Additionally, if necessary, offsite protective actions could still be implemented using a comprehensive emergency management plan (CEMP) process. A CEMP in this context, also referred to as an emergency operations plan (EOP), is addressed in Federal Emergency Management Agency's (FEMA's) Comprehensive Preparedness Guide (CPG) 101. The CPG 101 is the foundation for State, territorial, tribal, and local EP in the United States. It promotes a common understanding of the fundamentals of risk-informed planning and decision making, and helps planners at all levels of government in their efforts to develop and maintain viable, all-hazards, all-threats emergency plans. An EOP is flexible enough for use in all emergencies. It describes how people and property will be protected; details who is responsible for carrying out specific actions; identifies the personnel, equipment, facilities, supplies, and other resources available; and outlines how all actions will be coordinated. A CEMP is often referred to as a synonym for “all-hazards” planning.

The proposed action is in accordance with the licensee's application dated March 14, 2014, as supplemented by letters dated August 29, 2014, and October 21, 2014. In its letters dated August 29, 2014, and October 21, 2014, Entergy provided responses to the NRC staff's requests for additional information concerning the proposed exemptions.

The proposed action is needed for Entergy to revise the VY emergency plan to reflect the permanently shutdown and defueled status of the facility. The EP requirements currently applicable to VY are for an operating power reactor. There are no explicit regulatory provisions distinguishing EP requirements for a power reactor that has been permanently shut down from those for an operating power reactor. Therefore, since the 10 CFR part 50 license for VY no longer authorizes operation of the reactor or emplacement or retention of fuel into the reactor vessel, as specified in 10 CFR 50.82(a)(2), the occurrence of postulated accidents associated with reactor operation is no longer credible.

In its exemption request, the licensee identified four possible radiological accidents at VY in its permanently shutdown and defueled condition. These are: (1) A fuel-handling accident; (2) a radioactive waste-handling accident; (3) a loss of SFP normal cooling (i.e., boil off); and (4) an adiabatic heat up of the hottest fuel assembly. The NRC staff evaluated these possible radiological accidents in the Commission Paper (SECY) 14-0125, “Request by Entergy Nuclear Operations, Inc., for Exemptions from Certain Emergency Planning Requirements,” dated November 14, 2014. In SECY-14-0125, the NRC staff verified that Entergy's analyses and calculations provided reasonable assurance that if the requested exemptions were granted, then: (1) For a design-basis accident (DBA), an offsite radiological release will not exceed the Environmental Protection Agency's (EPA) Protective Action Guides (PAGs) at the site boundary, as detailed in the EPA “PAG Manual, Protective Action Guides and Planning Guidance for Radiological Incidents,” dated March 2013, which was issued as Draft for Interim Use and Public Comment; and (2) in the unlikely event of a beyond DBA resulting in a loss of all SFP cooling, there is sufficient time to initiate appropriate mitigating actions, and if a release is projected to occur, there is sufficient time for offsite agencies to take protective actions using a CEMP to protect the health and safety of the public. The Commission approved the NRC staff's recommendation to grant the exemptions based on this evaluation in its Staff Requirements Memorandum to SECY-14-0125, dated March 2, 2015.

Based on these analyses, the licensee states that complete application of the EP rule to VY, in its particular circumstances as a permanently shutdown and defueled reactor would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule. Entergy also states that it would incur undue costs in the application of operating plant EP requirements for the maintenance of an emergency response organization in excess of that actually needed to respond to the diminished scope of credible accidents for a permanently shutdown and defueled reactor.

The NRC staff concluded that the exemptions, if granted, would not significantly increase the probability or consequences of accidents at VY in its permanently shutdown and defueled condition. There would be no significant change in the types of any effluents that may be released offsite. There would be no significant increase in the amounts of any effluents that may be released offsite. There would be no significant increase in individual or cumulative occupational or public radiation exposure. Therefore, there are no significant radiological environmental impacts associated with the proposed action.

With regard to potential non-radiological impacts, the proposed action does not have any foreseeable impacts to land, air, or water resources, including impacts to biota. In addition, there are also no known socioeconomic or environmental justice impacts associated with the proposed action. Therefore, there are no significant non-radiological environmental impacts associated with the proposed action.

Accordingly, the NRC concludes that there are no significant environmental impacts associated with the proposed action.

As an alternative to the proposed action, the NRC staff considered the denial of the proposed action (i.e., the “no-action” alternative). The denial of the application would result in no change in current environmental impacts. Therefore, the environmental impacts of the proposed action and the alternative action are similar.

The proposed action does not involve the use of any different resources than those previously considered in the Final Environmental Statement for VY, dated July 1972, as supplemented by NUREG-1437, Supplement 30, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants: Regarding Vermont Yankee Nuclear Power Station,” Volumes 1 and 2, published in August 2007.

The NRC staff did not enter into consultation with any other Federal agency or with the State of Vermont regarding the environmental impact of the proposed action. On April 24, 2015, the Vermont State representative was notified of this draft EA and FONSI.

The licensee has proposed exemptions from: (1) Certain requirements in 10 CFR 50.47(b) regarding onsite and offsite emergency response plans for nuclear power reactors; (2) certain requirements in 10 CFR 50.47(c)(2) to establish plume exposure and ingestion pathway EP zones for nuclear power reactors; and (3) certain requirements in 10 CFR part 50, appendix E, section IV, which establishes the elements that make up the content of emergency plans. The proposed action of granting these exemptions would eliminate the requirements for the licensee to maintain offsite radiological emergency plans and reduce some of the onsite EP activities at VY, based on the reduced risks at the permanently shutdown and defueled reactor. However, requirements for certain onsite capabilities to communicate and coordinate with offsite response authorities will be retained and offsite EP provisions will still exist through State and local government use of a CEMP.

Consistent with 10 CFR 51.21, the NRC conducted the EA for the proposed action included in Section III of this document, and incorporated by reference in this finding. On the basis of this EA, the NRC concludes that the proposed action will not have a significant effect on the quality of the human environment. Accordingly, the NRC has decided not to prepare an environmental impact statement for the proposed action.

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.