Federal Register Vol. 80, No.237,

During the period of August 3 through August 14, 2015, pursuant to Section 8(c)(1) of the Act, USDA provided an opportunity for eligible cotton producers and importers to request a continuance referendum regarding the 1991 amendments to the Order provided for in the Act. Sign-up period results showed that USDA received 46 valid requests from eligible producers and importers. The following table depicts the number of requests for a continuance referendum.

Section 8(c)(2) of the Act, provides that following a sign-up period, USDA shall conduct a referendum upon the request of 10 percent or more of the number of cotton producers and importers voting in the most recent referendum (1991). This would require 10 percent or 4,622 (46,220 × .10 = 4,622) of the 46,220 valid ballots cast by cotton producers and importers in the July 1991 referendum. It is further provided that, in counting such request not more than 20 percent or 924 may be from producers from any one state or importers of cotton.

USDA finds that the results of the sign-up period did not meet the criteria requiring a continuance referendum by the Act. USDA bases this determination on the fact that the 46 requests received during the sign-up period is less than the 4,622 required.

The 1991 amendments to the Order (7 CFR 1205 et seq.) were implemented following the July 1991 referendum. The 1990 amendments were provided for in the Act (7 U.S.C. 2101-2118). These amendments provided for: (1) Importer representation on the Cotton Board by an appropriate number of persons, to be determined by USDA, who import cotton or cotton products into the U.S. and whom USDA selects from nominations submitted by importer organization certified by USDA; (2) assessments levied on imported cotton and cotton products at a rate determined in the same manner as for U.S. cotton; (3) increasing the amount USDA can be reimbursed for the conduct of a referendum from $200,000 to $300,000; (4) reimbursing government agencies that assist in administering the collection of assessments on imported cotton and cotton products; and (5) terminating the right of producers to demand a refund of assessments.

On July 9, 1991, (56 FR 31289) AMS issued a proposal to amend the Order to determine if a majority, 50 percent or more, of producers and importers favored implementation of the proposed amendments to the Order. USDA conducted a referendum (July 1991) among persons who had been cotton producers or cotton importers during a representative period. Results of the July 1991 referendum showed that of the 46,220 valid ballots received; 27,879 or 60 percent of the persons voting favored the amendments to the Order and 18,341 or 40 percent opposed the amendments.

Following the July 1991 referendum, AMS implemented the amendments. In addition to the previously discussed amendments to the Act and Order, USDA is required by Section 8(c)(1) to: (1) Conduct a review once every 5 years after the anniversary date of the referendum implementing the 1990 Act amendments to determine whether a referendum is necessary and (2) make public the results of such a review within 60 days after each fifth anniversary date of the 1991 implementing referendum. Should the review indicate that a referendum is needed USDA is directed to conduct the referendum within 12 months after a public announcement of review results. Should the review indicate that a referendum is not warranted, Section 8(c)(2) includes provisions for producers and importers to request a continuance referendum through a sign-up period.

In 2011-2012, the Department prepared a 5-year report that described the impact of the Cotton Research and Promotion Program on the cotton industry. The review report is available upon written request to the Chief of the Cotton Research and Promotion Staff at the address provided above. Comments were solicited from all interested parties, including persons who pay the assessments as well as from organizations representing cotton producers and importers (76 FR 31573). Five comments, including comments from four certified producer organizations that nominate producers to the Cotton Board, claimed strong support for the continuance of the program, noting that the administration of the Act has been proper, carries out the intent and purpose in a timely and superior manner, and requires no changes or adjustment.

USDA reviewed the Cotton Research and Promotion Program major program activities and accomplishments, including third-party evaluations of advertising and marketing activities and other functional areas; the results of producer and importer awareness and satisfaction surveys; and data from the Foreign Agricultural Service. USDA also reviewed the results of the Cotton Board's 2011 independent program evaluation, which assessed the effectiveness of the Cotton Research and Promotion Program; the strength of cotton's competitive position; the ability to maintain and expand domestic and foreign markets; increases in the number of uses for cotton; and estimates of a return on investment for stakeholders and qualitative benefits and returns associated with the Cotton Research and Promotion Program. The review report concluded that the 1990 amendments to the Act were successfully implemented and are operating as intended. The report also noted that there is a general consensus within the cotton industry that the Cotton Research and Promotion Program and the 1990 amendments to the Act are operating as intended. Written comments, economic data, and results from independent evaluations support this conclusion.

USDA found no compelling reason to conduct a referendum regarding the 1990 Act amendments to the Cotton Research and Promotion Order although some program participants support a referendum. In 2013, USDA announced its view not to conduct a referendum regarding the 1991 amendments to the Order (78 FR 32228). Therefore, USDA allowed all eligible persons to request the conduct of a continuance referendum on the 1990 amendments through a sign-up period. The results of this sign-up period did not meet the criteria as established by the Act for a continuance referendum and, therefore, referenda were not conducted.

With this announcement of the results of the sign-up period, USDA has completed all requirements set forth in Section 8(c) (1) and (2) of the Act regarding the review of the Cotton Research and Promotion Program to determine if a continuance referendum is warranted. A referendum will not be conducted, and no further actions are planned in connection with this review.

The purpose of the meeting is:

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by December 30, 2015 to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Olga Troxel, RAC Coordinator, 808 Meadow Lane, Cody, WY; or by email to [email protected], or via facsimile to 307-578-5112.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

Title III of the Export Trading Company Act of 1982 (15 U.S.C. Sections 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions.

The regulations implementing Title III are found at 15 CFR part 325 (2015).

OTEA is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Secretary of Commerce to publish a summary of the certification in the Federal Register. Under Section 305(a) of the Act and 15 CFR 325.11(a), any person aggrieved by the Secretary's determination may, within 30 days of the date of this notice, bring an action in any appropriate district court of the United States to set aside the determination on the ground that the determination is erroneous.

CAEA's Export Trade Certificate of Review has been amended to:

Add the following new Member of the Certificate within the meaning of section 325.2(1) of the Regulations (15 CFR 325.2(1)): California Gold Almonds, Modesto, CA.

CAEA's Export Trade Certificate of Review complete amended Membership is listed below:

Schedule Sunday, September 18 U.S. Industry Delegation Welcome Reception and Program Orientation/Major Nuclear Markets Overview. Monday, September 19 Industry Program breakfast meeting begins. U.S. Policymakers Roundtable. Break. USG Dialogue with Industry. IAEA Side Events. Break. Industry Program Meetings: one-on-one meetings with ITA Commercial Service staff and Ex-Im Bank staff over lunch. Country & IAEA Briefings for Industry Delegation (foreign delegates & IAEA staff). IAEA Director General Reception. U.S. Mission to the IAEA Reception. Tuesday, September 20 USG Industry Roundtable briefings. Country & IAEA Briefings for Industry (presented by foreign delegates & IAEA staff). IAEA Side Event Meetings. U.S. Industry Reception (America Lounge). Wednesday, September 21 Country & IAEA Briefings for Industry (presented by foreign delegates & IAEA staff). IAEA Side Events.

Web site: Please visit our official mission Web site for more information: http://www.export.gov/trademissions/.

U.S. companies, U.S. trade associations, and U.S. academic and research institutions interested in participating in the trade mission must complete and submit an application package for consideration by the DOC. All applicants will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria as outlined below. Applications will be reviewed on a rolling basis in the order that they are received. A minimum of 15 and maximum of 50 companies and/or trade associations and/or U.S. academic and research institutions will be selected to participate in the mission from the applicant pool.

After a company or organization has been selected to participate on the mission, a payment to the DOC in the form of a participation fee is required. Participants will be able to take advantage of U.S. Embassy rates for hotel rooms.

The fee to participate in the event is $3,500 for a large, small or medium-sized company (SME), a trade association, or a U.S. university or research institution. The fee for each additional representative (large company, trade association, university/research institution, or SME) is $2,400.

All interested firms and associations may register via the following link: http://emenuapps.ita.doc.gov/ePublic/TM/6R0R.

The mission fee does not include any personal travel expenses such as lodging, most meals, local ground transportation, except as stated in the proposed agenda, and air transportation from the United States to the mission site and return to the United States.

Recruitment for participation in the U.S. Industry Program as a representative of the U.S. nuclear industry will be conducted in an open and public manner, including publication in the Federal Register, posting on the DOC trade mission calendar, notices to industry trade associations and other multiplier groups. Recruitment will begin 2 weeks after publication in the Federal Register and conclude no later than June 24, 2016. The ITA will review applications and make selection decisions on a rolling basis. Applications received after June 24, 2016, will be considered only if space and scheduling permit.

Applicants must submit a completed mission application signed by a company, trade association, or academic or research institution official, together with supplemental application materials, including adequate information on the organization's products and/or services, primary market objectives, and goals for participation. If the DOC receives an incomplete application, the DOC may reject the application, request additional information, or take the lack of information into account in its evaluation.

Each applicant also must certify that the products or services it seeks to export through the mission are either produced in the United States, or, if not, marketed under the name of a U.S. firm and have demonstrable U.S. content as a percentage of the value of the finished product or service. In the case of a trade association, the applicant must certify that, for each company to be represented by the trade association or trade organization, the products and services the represented company seeks to export are either produced in the United States, or, if not, marketed under the name of a U.S. firm and have demonstrable U.S. content. In the case of an academic or research institution, the applicant must certify that as part of its activities at the event, it will represent the interests of constituents that meet the criteria above.

Applicants from a company, organization or institution that is majority owned or controlled by a foreign government entity will not be considered for participation in the U.S. Industry Program.

On October 20, 2015, the Department published its final affirmative determination in the countervailing duty investigation of SC paper from Canada.1 On December 3, 2015, the ITC notified the Department of its final determination pursuant to section 705(b)(1)(A)(i) of the Tariff Act of 1930, as amended (Act), that an industry in the United States is materially injured by reason of subsidized imports of subject merchandise from Canada.2

The product covered by this order is SC paper. For a complete description of the scope of the order, see Appendix 1 to this notice.

In accordance with sections 705(b)(1)(A)(i) and 705(d) of the Act, the ITC has notified the Department of its final determination that the industry in the United States producing SC paper is materially injured by reason of subsidized imports of SC paper from Canada. Therefore, in accordance with section 705(c)(2) of the Act, we are publishing this countervailing duty order.

As a result of the ITC's final determination, in accordance with section 706(a) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by the Department, countervailing duties on unliquidated entries of SC paper from Canada entered, or withdrawn from warehouse, for consumption on or after August 3, 2015, the date on which the Department published its preliminary countervailing duty determination in the Federal Register, 3 and before December 1, 2015, the date on which the Department instructed CBP to discontinue the suspension of liquidation in accordance with section 703(d) of the Act. Section 703(d) of the Act states that the suspension of liquidation pursuant to a preliminary determination may not remain in effect for more than four months. Therefore, entries of SC paper made on or after December 1, 2015, and prior to the date of publication of the ITC's final determination in the Federal Register are not liable for the assessment of countervailing duties due to the Department's discontinuation, effective December 1, 2015, of the suspension of liquidation.

In accordance with section 706 of the Act, the Department will direct CBP to reinstitute the suspension of liquidation of SC paper from Canada, effective the date of publication of the ITC's notice of final determination in the Federal Register, and to assess, upon further instruction by the Department pursuant to section 706(a)(1) of the Act, countervailing duties for each entry of the subject merchandise in an amount based on the net countervailable subsidy rates for the subject merchandise. On or after the date of publication of the ITC's final injury determination in the Federal Register, CBP must require, at the same time as importers would normally deposit estimated duties on this merchandise, a cash deposit equal to the rates noted below:

This notice constitutes the countervailing duty order with respect to SC paper from Canada pursuant to section 706(a) of the Act. Interested parties may contact the Department's Central Records Unit, Room B8024 of the main Commerce Building, for copies of an updated list of countervailing duty orders currently in effect.

This order is issued and published in accordance with section 706(a) of the Act and 19 CFR 351.211(b).

On June 5, 2015, the Department published the Preliminary Results of this review in the Federal Register. We invited parties to comment on the Preliminary Results. On July 26, 2015, we received a case brief from Toscelik. On July 27, 2015, we received case briefs from Allied Tube & Conduit and TMK IPSCO (petitioner) and from Borusan. On August 10, 2015, we received rebuttal briefs from petitioner, Borusan, and Toscelik. The Department conducted this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act).

The merchandise subject to the order is welded pipe and tube. The welded pipe and tube subject to the order is currently classifiable under subheading 7306.30.1000, 7306.30.5025, 7306.30.5032, 7306.30.5040, 7306.30.5055, 7306.30.5085, and 7306.30.5090 of the Harmonized Tariff Schedule of the United States (HTSUS). The HTSUS subheadings are provided for convenience and customs purposes only. The written description is dispositive.4

In the Preliminary Results, the Department preliminarily determined that Erbosan had no shipments during the POR.5 Following publication of the Preliminary Results, we received no comments from interested parties regarding this company. As a consequence, and because the record contains no evidence to the contrary, we continue to find that Erbosan made no shipments during the POR. Accordingly, consistent with the Department's practice, we intend to instruct U.S. Customs and Border Protection (CBP) to liquidate any existing entries of merchandise produced by Erbosan, but exported by other parties without their own rate, at the all-others rate.6

All issues raised in the case and rebuttal briefs submitted in this review are addressed in the Issues and Decision Memorandum, which is hereby adopted with this notice. A list of the issues raised is attached as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and it is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/index.html. The signed Issues and Decision Memorandum and the electronic versions of the Issues Decision Memorandum are identical in content.

Based on our analysis of the comments received, we made certain changes to the Preliminary Results. For a discussion of these changes, see Issues and Decision Memorandum.

As a result of this review, we determine that the following weighted-average dumping margins exist for the period May 1, 2013 through April 30, 2014:

We intend to disclose the calculations performed for these final results of review within five days of the date of publication of this notice in the Federal Register, in accordance with 19 CFR 351.224(b).

The Department shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b).

For Borusan, because its weighted-average dumping margin is not zero or de minimis (i.e., less than 0.5 percent), the Department has calculated importer-specific antidumping duty assessment rates. We calculated importer-specific ad valorem antidumping duty assessment rates by aggregating the total amount of dumping calculated for the examined sales of each importer and dividing each of these amounts by the total entered value associated with those sales. We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review where an importer-specific assessment rate is not zero or de minimis. Pursuant to 19 CFR 351.106(c)(2), we will instruct CBP to liquidate without regard to antidumping duties any entries for which the importer-specific assessment rate is zero or de minimis.

For Toscelik, we will instruct CBP to liquidate its entries during the POR imported by the importers identified in its questionnaire responses without regard to antidumping duties because its weighted-average dumping margin in these final results is zero.9 Consistent with the Department's assessment practice, for entries of subject merchandise during the POR produced by Borusan, Erbosan, or Toscelik for which they did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.10

We intend to issue instructions to CBP 15 days after publication of the final results of this review.

The following cash deposit requirements will be effective for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2) of the Act: (1) The cash deposit rates for Borusan and Toscelik will be equal to the weighted-average dumping margins established in the final results of this review; (2) for previously reviewed or investigated companies not participating in this review, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the company was reviewed; (3) if the exporter is not a firm covered in this review, a previous review, or the original less-than-fair-value (LTFV) investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the manufacturer of subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 14.74 percent, the all-others rate established in the LTFV investigation.11 These deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

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: Evaluation of Effectiveness of the Scholarships for Opportunity and Results (SOAR) Program.

OMB Control Number: 1850-0800.

Type of Review: An extension of an existing information collection.

Respondents/Affected Public: Individuals or households.

Total Estimated Number of Annual Responses: 3,666.

Total Estimated Number of Annual Burden Hours: 867.

Abstract: The foundation of this evaluation is a randomized control trial (RCT) comparing outcomes of eligible applicants (students and their parents) assigned by lottery to receive or not receive a scholarship. This design is consistent with the requirement for a rigorous evaluation as well as the need to fairly allocate the scholarships if the program is oversubscribed. Because the law also specified other kinds of comparisons and analyses, the planned evaluation study includes both quantitative and qualitative components.

In order for the evaluation to have sufficient statistical power to detect policy relevant impacts, the sample consists of 1,771 eligible program applicants in spring 2012 (cohort 1; n=536), spring 2013 (cohort 2; n=718), and in spring 2014 (cohort 3, n=517. This is an extension of an approved information collection. The extension is requested to cover follow up data collection for cohort 2 as well as the addition of cohort 3 needed to obtain the sample size needed for the evaluation. There are no changes to the study design, data collection plans and instruments from what is approved by OMB in the current collection.

Evaluation data will be collected for the three cohorts of program applicants from a variety of sources listed below. Each cohort will have baseline data as well as three years of follow up (post-lottery) data collection; 2013-2015 for cohort 1, 2014-2016 for cohort 2, and 2015-2017 for cohort 3. In addition to estimating program impact, we will use this experimental study to conducted research about interim outcomes.

Data sources include:

Student surveys: The surveys will be administered to each evaluation sample student in grades four and above in each of the follow up years at the same time (and place) as the student assessments.

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: Enterprise Complaint System.

OMB Control Number: 1845-NEW.

Type of Review: A new information collection.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 43,200.

Total Estimated Number of Annual Burden Hours: 7,344.

Abstract: This is a request for a new information collection. On March 10, 2015, the White House issued a Student Aid Bill of Rights. Among the objectives identified was the creation of a centralized complaint system. The purpose of the Enterprise Complaint System is to meet the objective: “Create a Responsive Student Feedback System: The Secretary of Education will create a new Web site by July 1, 2016, to give students and borrowers a simple and straightforward way to file complaints and provide feedback about federal student loan lenders, servicers, collections agencies, and institutions of higher education. Students and borrowers will be able to ensure that their complaints will be directed to the right party for timely resolution, and the Department of Education will be able to more quickly respond to issues and strengthen its efforts to protect the integrity of the student financial aid programs.” The Department of Education has charged Federal Student Aid with the development and oversight of this new collection.

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: Client Assistance Program (CAP).

OMB Control Number: 1820-0520.

Type of Review: An extension of an existing information collection.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 57.

Total Estimated Number of Annual Burden Hours: 9.

Abstract: This form is used by states to request funds to establish and carry out Client Assistance Programs (CAP). CAP is mandated by the Rehabilitation Act of 1973, as amended (Rehabilitation Act), to assist consumers and applicants in their relationships with projects, programs and services provided under the Rehabilitation Act including the Vocational Rehabilitation program.

California initially adopted its Portable Engine regulations on February 26, 2004 as part of a broad California program to reduce emissions of diesel particulate matter. The regulations applied to in-use, portable, off-road diesel-fueled engines rated 50 brake horsepower (bhp) and greater. “Portable engines” are engines that may be moved easily from location to location.2 Subject engines were required to be certified to certain emission standards by January 1, 2010, unless the engines were designated as low-use engines or as engines exclusively used in emergency applications. Fleets of in-use diesel-fueled portable engines were required to meet fleet-average standards for diesel PM emissions that become increasingly more stringent in 2013, 2017, and 2020. The initial Portable Engine air toxic control measure (ATCM) became operative under state law on March 11, 2005 3 and EPA authorized the regulations on November 29, 2012.4

CARB adopted the 2007 amendments on July 31, 2007, and they became effective on September 12, 2007. The 2007 amendments were designed to extend temporary, emergency provisions CARB had adopted to address the inability of owners and operators to permit or register older engines that did not satisfy the Portable Engine certification requirement to meet the most stringent federal or California emission standards. The 2007 amendments addressed this issue by (i) granting discretion to local air districts to permit or register uncertified portable engines that were operated in California within a designated time period prior to October 1, 2006, or that were low-use engines or used exclusively in emergency applications, (ii) allowing Tier 1 and Tier 2 engines that were in operation within a designated time period prior to October 1, 2006, but did not meet the most stringent emission requirements, to be permitted or registered until December 31, 2009, and (iii) otherwise providing additional compliance flexibility.

In 2008, CARB adopted an In-Use Off-Road regulation 5 and a Truck and Bus regulation.6 CARB then amended the Portable Engine regulations to exempt certain engines (viz., secondary engines on two-engine cranes and two-engine sweepers, and on lattice boom cranes) that instead became subject to either the In-Use Off-Road regulation or the Truck and Bus regulation. CARB formally adopted the amendments to the Portable Engine ATCM on October 19, 2009 (the 2009 amendments).

California formally approved the 2010 amendments to the Portable Engine ATCM regulations on October 19, 2010 and January 20, 2011. The 2010 amendments became operative under state law on February 19, 2011. The 2010 amendments provided further compliance flexibility, and clarified or modified other aspects of the regulations. For example, some entities were allowed to operate a limited number of non-certified engines for an additional year, through December 31, 2010. Additional regulatory relief was provided for engines that were permitted or registered prior to January 1, 2010. The amendments provided for permitting of portable engines that were certified to standards for new on-road engines. Auxiliary deck engines on water well drilling rigs were exempted and instead made subject to CARB's In-Use Off-Road Regulation. Portable engines used exclusively on dedicated snow removal vehicles were also exempted. Low-use and emergency use engines were required to be removed or replaced with a current tier engine by January 1, 2017. The 2010 amendments also deleted the provision that had allowed local air districts, in their discretion, to permit non-certified engines that had operated between March 1, 2004 and October 1, 2006. The amendments specified particulate matter (PM) emission factors for certain engines, which are used to help determine fleet average standards. Finally, the 2010 amendments provided relief for certified engines that lost their permit exemption due to changes in local air district rules.

By letter dated September 15, 2014, CARB submitted a request to EPA pursuant to section 209(e) of the Act for confirmation that the 2007, 2009, and 2010 amendments fall within the scope of EPA's previous authorization, or, in the alternative, that EPA grant a full authorization for those amendments.

Section 209(e)(1) of the Act permanently preempts any state, or political subdivision thereof, from adopting or attempting to enforce any standard or other requirement relating to the control of emissions for certain new nonroad engines or vehicles.7 For all other nonroad engines (including “non-new” engines), states generally are preempted from adopting and enforcing standards and other requirements relating to the control of emissions, except that section 209(e)(2)(A) of the Act requires EPA, after notice and opportunity for public hearing, to authorize California to adopt and enforce such regulations unless EPA makes one of three enumerated findings. Specifically, EPA must deny authorization if the Administrator finds that (1) California's protectiveness determination (i.e., that California standards will be, in the aggregate, as protective of public health and welfare as applicable federal standards) is arbitrary and capricious, (2) California does not need such standards to meet compelling and extraordinary conditions, or (3) the California standards and accompanying enforcement procedures are not consistent with section 209 of the Act.

On July 20, 1994, EPA promulgated a rule interpreting the three criteria set forth in section 209(e)(2)(A) that EPA must consider before granting any California authorization request for nonroad engine or vehicle emission standards.8 EPA revised these regulations in 1997.9 As stated in the preamble to the 1994 rule, EPA historically has interpreted the consistency inquiry under the third criterion, outlined above and set forth in section 209(e)(2)(A)(iii), to require, at minimum, that California standards and enforcement procedures be consistent with section 209(a), section 209(e)(1), and section 209(b)(1)(C) of the Act.10

In order to be consistent with section 209(a), California's nonroad standards and enforcement procedures must not apply to new motor vehicles or new motor vehicle engines. To be consistent with section 209(e)(1), California's nonroad standards and enforcement procedures must not attempt to regulate engine categories that are permanently preempted from state regulation. To determine consistency with section 209(b)(1)(C), EPA typically reviews nonroad authorization requests under the same “consistency” criteria that are applied to motor vehicle waiver requests under section 209(b)(1)(C). That provision provides that the Administrator shall not grant California a motor vehicle waiver if she finds that California “standards and accompanying enforcement procedures are not consistent with section 202(a)” of the Act. Previous decisions granting waivers and authorizations have noted that state standards and enforcement procedures will be found to be inconsistent with section 202(a) if (1) there is inadequate lead time to permit the development of the necessary technology, giving appropriate consideration to the cost of compliance within that time, or (2) the federal and state testing procedures impose inconsistent certification requirements.

In light of the similar language of sections 209(b) and 209(e)(2)(A), EPA has reviewed California's requests for authorization of nonroad vehicle or engine standards under section 209(e)(2)(A) using the same principles that it has historically applied in reviewing requests for waivers of preemption for new motor vehicle or new motor vehicle engine standards under section 209(b).11 These principles include, among other things, that EPA should limit its inquiry to the three specific authorization criteria identified in section 209(e)(2)(A),12 and that EPA should give substantial deference to the policy judgments California has made in adopting its regulations. In previous waiver decisions, EPA has stated that Congress intended EPA's review of California's decision-making be narrow. EPA has rejected arguments that are not specified in the statute as grounds for denying a waiver:

This principle of narrow EPA review has been upheld by the U.S. Court of Appeals for the District of Columbia Circuit.14 Thus, EPA's consideration of all the evidence submitted concerning an authorization decision is circumscribed by its relevance to those questions that may be considered under section 209(e)(2)(A).

If California amends regulations that were previously authorized by EPA, California may ask EPA to determine that the amendments are within the scope of the earlier authorization. A within-the-scope determination for such amendments is permissible without a full authorization review if three conditions are met. First, the amended regulations must not undermine California's previous determination that its standards, in the aggregate, are as protective of public health and welfare as applicable federal standards. Second, the amended regulations must not affect consistency with section 209 of the Act, following the same criteria discussed above in the context of full authorizations. Third, the amended regulations must not raise any “new issues” affecting EPA's prior authorizations.15

In previous waiver and authorization decisions, EPA has recognized that the intent of Congress in creating a limited review based on the section 209(b)(1) criteria was to ensure that the federal government did not second-guess state policy choices. As the agency explained in one prior waiver decision:

Similarly, EPA has stated that the text, structure, and history of the California waiver provision clearly indicate both a congressional intent and appropriate EPA practice of leaving the decision on “ambiguous and controversial matters of public policy” to California's judgment.17 This interpretation is supported by relevant discussion in the House Committee Report for the 1977 amendments to the Clean Air Act.18 Congress had the opportunity through the 1977 amendments to restrict the preexisting waiver provision, but elected instead to expand California's flexibility to adopt a complete program of motor vehicle emission controls. The report explains that the amendment is intended to ratify and strengthen the preexisting California waiver provision and to affirm the underlying intent of that provision, that is, to afford California the broadest possible discretion in selecting the best means to protect the health of its citizens and the public welfare.19

As the U.S. Court of Appeals for the DC Circuit has made clear in MEMA I, opponents of a waiver request by California bear the burden of showing that the statutory criteria for a denial of the request have been met:

The same logic applies to authorization requests. The Administrator's burden, on the other hand, is to make a reasonable evaluation of the information in the record in coming to the waiver decision. As the court in MEMA I stated: “here, too, if the Administrator ignores evidence demonstrating that the waiver should not be granted, or if he seeks to overcome that evidence with unsupported assumptions of his own, he runs the risk of having his waiver decision set aside as ‘arbitrary and capricious.’ ”21 Therefore, the Administrator's burden is to act “reasonably.” 22

With regard to the standard of proof, the court in MEMA I explained that the Administrator's role in a section 209 proceeding is to:

With regard to the protectiveness finding, the court upheld the Administrator's position that, to deny a waiver, there must be “clear and compelling evidence” to show that proposed enforcement procedures undermine the protectiveness of California's standards.24 The court noted that this standard of proof also accords with the congressional intent to provide California with the broadest possible discretion in setting regulations it finds protective of the public health and welfare.25

With respect to the consistency finding, the court did not articulate a standard of proof applicable to all proceedings, but found that the opponents of the waiver were unable to meet their burden of proof even if the standard were a mere preponderance of the evidence. EPA's past waiver decisions have consistently made clear that: “[E]ven in the two areas concededly reserved for Federal judgment by this legislation—the existence of `compelling and extraordinary' conditions and whether the standards are technologically feasible—Congress intended that the standards of EPA review of the State decision to be a narrow one.” 26

On November 21, 2014, EPA published a Federal Register notice announcing its receipt of California's authorization request. In that notice, EPA invited public comment on each of the Portable Engine ATCM amendments and an opportunity to request a public hearing.27

First, EPA requested comments on whether California's 2007, 2009, or 2010 Portable Engine ATCM amendments: (1) Undermine California's previous determination that its standards, in the aggregate, are at least as protective of public health and welfare as comparable federal standards; (2) affect the consistency of California's requirements with section 209 of the Act; or (3) raise any other new issues affecting EPA's previous authorization determinations. EPA also requested comments on whether the 2007, 2009, or 2010 Portable Engine ATCM amendments meet the criteria for a full authorization should any party believe that the amendments are not within the scope of the previous authorization.

EPA received no comments and no requests for a public hearing. Consequently, EPA did not hold a public hearing.

CARB maintains that the amendments noted above meet all three within-the-scope criteria, i.e., that the amendments: (1) Do not undermine the original protectiveness determination underlying California's Portable Engine ATCM regulations; (2) do not affect the consistency of the Portable Engine ATCM regulations with section 209, and (3) do not raise any new issues affecting the prior authorization.28 We received no adverse comments or evidence suggesting a within-the-scope analysis is inappropriate, or that these Portable Engine ATCM amendments fail to meet any of the three criteria for within-the-scope confirmation.

With regard to the first within-the-scope prong, CARB maintains that the stringency of its emission standards is, in the aggregate, at least as protective of public health and welfare as applicable federal standards, especially since there are no federally applicable standards regulating in-use nonroad engines.29 No comments presented otherwise, and EPA agrees that there are no federally applicable standards for in-use nonroad engines and that no evidence exists in the record to demonstrate that CARB's Portable Engine ATCM regulations, in the aggregate, are less protective than applicable federal standards. Therefore, we find that the Portable Engine ATCM amendments, as noted, do not undermine the protectiveness determination made with regard to the original Portable Engine ATCM authorization.

With regard to the second within-the-scope prong (consistency with section 209), CARB first maintains that the Portable Engine ATCM amendments do not regulate new motor vehicles or motor vehicle engines and so are consistent with section 209(a).30 Likewise the Portable Engine ATCM amendments do not regulate any of the permanently preempted categories of engines or vehicles (e.g., new locomotives, engines for new locomotives, or new nonroad engines less than 175 horsepower used in farm and construction equipment and vehicles), and so are consistent with section 209(e)(1).31 CARB maintains that the Portable Engine ATCM amendments do not cause any technological feasibility issues or cause inconsistency between state and federal test procedures, per section 209(b)(1)(C). Finally, CARB maintains that none of the 2007, 2009 or 2010 Amendments alter the test procedures specified for certifying engines, so there is no effect on the consistency with federal test procedures.32 As mentioned above, no comments were received showing otherwise on any of these contentions. Because there is no evidence in the record to indicate that CARB's Portable Engine amendments are inconsistent with section 209, we cannot find that the noted Portable Engine amendments are inconsistent with section 209.

Regarding the third prong, California states that it is “not aware of any new issues affecting the previously granted authorization for the Portable Engine ATCM.” 33 There were also no comments arguing that any new issues have been raised affecting the previously granted authorization. CARB's 2007 Amendments and 2009 Amendments provide compliance flexibilities and regulatory relief that would not appear to raise any new issues affecting the previously granted authorization. Thus, we cannot find that the 2007 or 2009 Amendments raise any new issues affecting the previously granted authorization.

CARB's 2010 Amendments, however, include some new or stricter regulatory requirements, such as (i) requiring low-use and emergency use engines to be removed or replaced with a current tier engine by January 1, 2017 (which is earlier than originally required for some engine sizes), (ii) no longer allowing local air districts to permit non-certified engines that had operated between March 1, 2004 and October 1, 2006, and (iii) specifying PM emission factors for certain engines in order to help determine fleet average standards. These amendments will be referred to herein as the “New 2010 Requirements.” Because these New 2010 Requirements raise new issues affecting the authorization previously granted for the Portable Engine ATCM, the New 2010 Requirements are not considered within the scope of the prior authorization, and will need to be evaluated for a full authorization.34

In summary, for the 2007 and 2009 Amendments, we find that California has met the three criteria for a within-the-scope authorization approval, and these amendments are thus confirmed as within the scope of the previous EPA authorization of California's Portable Engine ATCM regulations. For the 2010 Amendments, while most of the 2010 amendments are within the scope of the previous authorization, the New 2010 Requirements are not within the scope of the prior authorization, and we will proceed to determine whether the New 2010 Requirements qualify for full authorization.

As described in the background section, the CAA directs EPA to grant authorization, unless EPA makes one of three possible findings: (1) That California's protectiveness determination is arbitrary and capricious, (2) that California does not need state standards to meet compelling and extraordinary conditions, or (3) that the California standards and accompanying enforcement procedures are not consistent with section 209 of the Act. As mentioned above, the New 2010 Requirements to be evaluated for full authorization include the amendments requiring low-use and emergency use engines to be removed or replaced with a current tier engine by January 1, 2017, the amendments no longer allowing local air districts to permit non-certified engines that had operated between March 1, 2004 and October 1, 2006, and the amendments specifying PM emission factors for certain engines in order to help determine fleet average standards.

Regarding the first possible finding, it is clear that California's standards are at least as protective of public health and welfare as applicable federal standards, especially since there are no federally applicable standards to regulate in-use nonroad engines.35 No comments presented otherwise, and the New 2010 Requirements at issue make the standards more protective, not less. Therefore, we find that California's protectiveness determination is not arbitrary and capricious.

Regarding the second possible finding, California reasserts its longstanding position that the State continues to need its own nonroad engine program to meet serious air pollution problems.36 CARB points out that California, particularly in the South Coast and San Joaquin Valley Air Basins, continues to experience some of the worst air quality in the nation.37 We further note that the relevant inquiry under section 209(e)(2)(A)(ii) is whether California needs its own emission control program to meet compelling and extraordinary conditions, not whether any given standard is necessary to meet such conditions.38 CARB's emission control program is a central part of California's efforts to improve its air quality, to meet its air quality goals and satisfy its State Implementation Plan obligations. No comments were submitted otherwise. Therefore, we cannot find that California does not need its state standards to meet compelling and extraordinary conditions in California.

The third and final possible finding upon which authorization could be denied is if the New 2010 Requirements are not consistent with “this section.” As discussed above, this requires evaluation of consistency with sections 209(a), 209(e)(1), and 209(b)(1)(C). To be consistent with section 209(a), the amendments must not apply to new motor vehicles or motor vehicle engines. CARB states that none of its Portable Engine ATCM requirements apply to new motor vehicles or motor vehicle engines.39 No evidence has been received to the contrary. Second, to be consistent with section 209(e)(1) of the Act, the regulations must not attempt to regulate vehicles and engines permanently preempted from state regulation by section 209(e)(1), including new nonroad engines below 175 horsepower used in farm and construction equipment and vehicles, or new locomotives or locomotive engines. CARB states that none of its Portable Engine ATCM requirements apply to these preempted vehicles or engines.40 Again, we received no evidence to the contrary. We therefore cannot find that the New 2010 Requirements are inconsistent with sections 209(a) and 209(e)(1).

Third, to be consistent with section 209(b)(1)(c), there must be adequate lead time to permit technological development for compliance with the new standards, and the state test procedures must not be made inconsistent with federal test procedures.

Regarding test procedures, CARB maintains that the amendments do not alter any test procedures, and EPA does not have comparable in-use standards and test procedures; thus, by definition, there is no inconsistency with federal test procedures.41 No comments were received otherwise. We therefore cannot find that the New 2010 Requirements are inconsistent with federal test procedures.

Regarding the existence of adequate lead time, CARB maintains that the New 2010 Requirements do not require development of new technologies, and that EPA has already previously determined that California's applicable Tier 1 through Tier 4 off-road compression ignition engine standards are technically feasible,42 thus there is no consistency issue presented with regard to lead time. As mentioned above, we received no comment or evidence contesting California's positions regarding the consistency criterion under section 209(b)(1)(c).The compliance date for low use and emergency use engines is nearly the same as the original compliance date, and the two other changes (i.e., elimination of discretionary permits by local air districts, and specification of PM emission factors used to calculate fleet average standards) likewise do not raise feasibility issues. Thus, we cannot find any evidence indicating that the New 2010 Requirements do not provide adequate lead time or are otherwise not technically feasible. We therefore cannot find that the New 2010 Requirements that we analyzed under the full authorization criteria are inconsistent with section 209 of the Act.

Having found that the New 2010 Requirements satisfy each of the criteria for full authorization, and having received no contrary evidence to contradict this finding, we cannot deny authorization of the amendments.

The Administrator has delegated the authority to grant California section 209(e) authorizations to the Assistant Administrator for Air and Radiation. After evaluating CARB's amendments to its Portable Engine ATCM regulations described above and CARB's submissions for EPA review, EPA is granting a within-the-scope authorization for the Portable Engine ATCM 2007, 2009, and 2010 Amendments, other than the New 2010 Requirements (as specified above). In addition, EPA is granting a full authorization for the New 2010 Requirements.

This decision will affect persons in California and those manufacturers and/or owners/operators nationwide who must comply with California's requirements. In addition, because other states may adopt California's standards for which a section 209(e)(2)(A) authorization has been granted if certain criteria are met, this decision would also affect those states and those persons in such states. See CAA section 209(e)(2)(B). For these reasons, EPA determines and finds that this is a final action of national applicability, and also a final action of nationwide scope or effect for purposes of section 307(b)(1) of the Act. Pursuant to section 307(b)(1) of the Act, judicial review of this final action may be sought only in the United States Court of Appeals for the District of Columbia Circuit. Petitions for review must be filed by February 8, 2016. Judicial review of this final action may not be obtained in subsequent enforcement proceedings, pursuant to section 307(b)(2) of the Act.

As with past authorization and waiver decisions, this action is not a rule as defined by Executive Order 12866. Therefore, it is exempt from review by the Office of Management and Budget as required for rules and regulations by Executive Order 12866.

In addition, this action is not a rule as defined in the Regulatory Flexibility Act, 5 U.S.C. 601(2). Therefore, EPA has not prepared a supporting regulatory flexibility analysis addressing the impact of this action on small business entities.

Further, the Congressional Review Act, 5 U.S.C. 801, et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule for purposes of 5 U.S.C. 804(3).

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product FULYZAQ (crofelemer). FULYZAQ is indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. Subsequent to this approval, the USPTO received a patent term restoration application for FULYZAQ (U.S. Patent No. 7,323,195) from Napo Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 23, 2014, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of FULYZAQ represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for FULYZAQ is 7,784 days. Of this time, 7,391 days occurred during the testing phase of the regulatory review period, while 393 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: September 11, 1991. The applicant claims August 14, 1991, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was September 11, 1991, which was 30 days after FDA receipt of the first IND from the sponsor for this new drug.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: December 5, 2011. The applicant claims December 16, 2011, as the date the new drug application (NDA) for FULYZAQ (NDA 202292) was initially submitted. However, FDA records indicate that NDA 202292 was submitted on December 5, 2011.

3. The date the application was approved: December 31, 2012. FDA has verified the applicant's claim that NDA 202292 was approved on December 31, 2012.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product SIRTURO (bedaquiline). SIRTURO is indicated for combination therapy in adults (≥18 years) with pulmonary multi-drug resistant tuberculosis. Subsequent to this approval, the USPTO received a patent term restoration application for SIRTURO (U.S. Patent No. 7,498,343) from Janssen Pharmaceutica, N.V., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 27, 2014, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of SIRTURO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for SIRTURO is 2,213 days. Of this time, 2,030 days occurred during the testing phase of the regulatory review period, while 183 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: December 9, 2006. The applicant claims November 9, 2006, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was December 9, 2006, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: June 29, 2012. FDA has verified the applicant's claim that the new drug application (NDA) for SIRTURO (NDA 204384) was initially submitted on June 29, 2012.

3. The date the application was approved: December 28, 2012. FDA has verified the applicant's claim that NDA 204384 was approved on December 28, 2012.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 741 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product ELIQUIS (apixaban). ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Subsequent to this approval, the USPTO received a patent term restoration application for ELIQUIS (U.S. Patent No. 6,967,208) from Bristol-Myers Squibb Company, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 27, 2014, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ELIQUIS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for ELIQUIS is 3,685 days. Of this time, 3,227 days occurred during the testing phase of the regulatory review period, while 458 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: November 28, 2002. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on November 28, 2002.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: September 28, 2011. FDA has verified the applicant's claim that the new drug application (NDA) for ELIQUIS (NDA 202155) was initially submitted on September 28, 2011.

3. The date the application was approved: December 28, 2012. FDA has verified the applicant's claim that NDA 202155 was approved on December 28, 2012.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,424 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).

FDA has approved for marketing the medical device ARGUS II VISUAL STIMULATION SYSTEM. ARGUS II VISUAL STIMULATION SYSTEM is indicated for patients aged 25 years and older with bare or no light perception vision caused by advanced retinitis pigmentosa. Subsequent to this approval, the USPTO received a patent term restoration application for ARGUS II VISUAL STIMULATION SYSTEM (U.S. Patent No. 7,668,599) from Second Sight Medical Products, Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 22, 2014, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of ARGUS II VISUAL STIMULATION SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for ARGUS II VISUAL STIMULATION SYSTEM is 2,282 days. Of this time, 1,630 days occurred during the testing phase of the regulatory review period, while 652 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: November 17, 2006. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the FD&C act for human tests to begin became effective on December 31, 2004. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on November 17, 2006, which represents the IDE effective date.

2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): May 4, 2011. The applicant claims May 3, 2011, as the date the humanitarian device exemption (HDE) for Argus II Visual Stimulation System (HDE H110002) was initially submitted. However, FDA records indicate that HDE H110002 was submitted on May 4, 2011.

3. The date the application was approved: February 13, 2013. The applicant claims that HDE H110002 was approved on February 14, 2013. However, FDA records indicate that ARGUS II VISUAL STIMULATION SYSTEM was approved on February 13, 2013.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,735 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Under the PRA, 44 U.S.C. 3501-3520, Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

As part of its commitments in PDUFA V, FDA established a new review Program to promote greater transparency and increased communication between the FDA review team and the applicant on the most innovative products reviewed by the Agency. The Program applies to all NMEs, NDAs, and original BLAs that are received from October 1, 2012, through September 30, 2017. The Program is described in detail in section II.B of the document entitled “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017” (the Commitment Letter) (available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.

The goals of the Program are to increase the efficiency and effectiveness of the first review cycle and decrease the number of review cycles necessary for approval so that patients have timely access to safe, effective, and high-quality new drugs and biologics. A key aspect of the Program is an interim and final assessment that will evaluate how well the parameters of the Program have achieved the intended goals. The PDUFA V Commitment Letter specifies that the assessments be conducted by an independent contractor and that they include interviews of pharmaceutical manufacturers who submit NMEs, NDAs, and original BLAs to the Program in PDUFA V. The contractor for the assessments of the Program is Eastern Research Group, Inc. (ERG), and the statement of work for the assessments is available at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM304793.pdf.

In accordance with the PDUFA V Commitment Letter, FDA contracted with ERG to conduct independent interviews of applicants after FDA issues a first-cycle action for applications reviewed under the Program. The purpose of these interviews is to collect feedback from applicants on the success of the Program in increasing review transparency and communication during the review process. ERG will anonymize and aggregate sponsor responses prior to inclusion in the assessments and any presentation materials at public meetings. FDA will publish ERG's assessments (with interview results and findings) in the Federal Register for public comment.

FDA typically reviews approximately 40 to 45 NMEs, NDAs, and original BLAs per year. ERG interviews 1 to 3 sponsor representatives at a time for each application that receives a first-cycle action from FDA, up to 135 sponsor representatives per year. ERG conducts a pretest of the interview protocol with five respondents. FDA estimates that it will take 1.0 to 1.5 hours to complete the pretest, for a total of a maximum of 7.5 hours. We estimate that up to 135 respondents will take part in the post-action interviews each year, with each interview lasting 1.0 to 1.5 hours, for a total of a maximum of 202.5 hours. Thus, the total estimated annual burden is 210 hours. FDA's burden estimate is based on prior experience with similar interviews with the regulated community.

Thus, FDA estimates the burden of this collection of information as follows:

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for an animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B).

FDA has approved for marketing the animal drug product VERAFLOX (pradofloxacin). VERAFLOX is indicated for treatment of skin infections in cats caused by susceptible strains of Pasteurella multocide, Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, and Staphylococcus pseudintermedius. Subsequent to this approval, the USPTO received a patent term restoration application for VERAFLOX (U.S. Patent No. 6,323,213) from Bayer Animal Health GmbH, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 26, 2014, FDA advised the USPTO that this animal drug product had undergone a regulatory review period and that the approval of VERAFLOX represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for VERAFLOX is 3,285 days. Of this time, 3,235 days occurred during the testing phase of the regulatory review period, while 50 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the FD&C Act (21 U.S.C. 355(i)) became effective: November 12, 2003. The applicant claims July 31, 2002, as the date the investigational new animal drug application (INAD) became effective. However, FDA records indicate that the INAD effective date was November 12, 2003, which was the date on which the agency acknowledges the filing of a notice of claimed investigational exemption for a new animal drug.

2. The date the application was initially submitted with respect to the animal drug product under section 512 of the FD&C Act (21 U.S.C. 360b): September 19, 2012. FDA has verified the applicant's claim that the new animal drug Application (NADA) for VERAFLOX (NADA 141-344) was submitted on September 19, 2012.

3. The date the application was approved: November 7, 2012. FDA has verified the applicant's claim that NADA 141-344 was approved on November 7, 2012.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,901 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The updated comprehensive national action plan, Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention, Care, & Treatment of Viral Hepatitis 2014-2016, details more than 150 actions to be undertaken between 2014 and 2016 by 20 federal agencies and offices from across the U.S. Departments of Health and Human Services (HHS), Housing and Urban Development (HUD), Justice (DOJ), and Veterans Affairs (VA). While the Viral Hepatitis Action Plan describes efforts to be undertaken by federal stakeholders, many of the successes our nation has seen in the fight against viral hepatitis have resulted from non-federal efforts including those of health departments, academic researchers, community-based organizations, professional organizations, education and advocacy groups, private industry, and other stakeholders. The Viral Hepatitis Action Plan provides a framework around which all stakeholders can engage to strengthen the nation's response to viral hepatitis and envisions active involvement of and innovation by a broad mix of partners from both public and private sectors.

The updated Action Plan describes four main goals to be achieved by 2020:

• Increase in the proportion of persons who are aware of their hepatitis B virus (HBV) infection, from 33% to 66%.

• Increase in the proportion of persons who are aware of their hepatitis C virus (HCV) infection, from 45% to 66%.

• Reduce by 25% the number of new cases of HCV infection.

• Eliminate mother-to-child transmission of HBV.

This request for information seeks public comment on several key areas with respect to non-federal efforts undertaken throughout calendar years 2014-2015 that are consistent with the four main goals of the Viral Hepatitis Action Plan. Comments are sought on (but not limited to) the following:

1. Describe the type of organization or group with which you are affiliated (e.g., advocacy, private industry, health care, local, or state government, etc.).

2. What is the most significant need your community/clients experience with respect to combating viral hepatitis?

3. What activities conducted in 2014 and 2015 demonstrated the greatest advances toward reaching the goals of the Viral Hepatitis Action Plan? Responses are invited (but not limited to) viral hepatitis activities in the following areas:

a. Raising awareness about viral hepatitis among the general public, specific targeted populations, and/or community leaders;

b. Training and/or increasing capacity of health care providers to prevent, diagnose, treat viral hepatitis;

c. Developing strategies to promote timely viral hepatitis diagnosis and linkage to care;

d. Developing/implementing clinical decision support tools and/or improved protocols in clinical settings that improve viral hepatitis health outcomes;

e. Implementing strategies to educate women of child-bearing age and high risk groups about mother-to-infant transmission of hepatitis B;

f. Reaching people who inject drugs with viral hepatitis information and services;

g. Improving viral hepatitis infection prevention awareness and initiatives in medical settings;

h. Developing strategies to foster stakeholder collaboration and sustainable programs; and

i. Other (please specify).

4. Please include relevant information such as the dates of implementation; names of collaborating organizational partners; related Action Plan goal(s); geographic area and populations served, quantitative findings and outcomes such as number of tests done, proportion of positives identified; and links to online tools, resources, and publications.

Please limit responses to four pages, single-sided, double spaced, 10 point font.

Selected activities will be compiled and made available to federal partners, stakeholders, and the public in order to foster further expansion, innovation, and collaboration toward achieving the goals of the Viral Hepatitis Action Plan. Reponses to this RFI will also be used to inform future HHS strategic planning and implementation.

This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

Title of Information Collection: Multifamily Family Self-Sufficiency Program Escrow Credit Data.

OMB Approval Number: Pending.

Type of Request: This is a new collection.

Form Number: Sample attached: Sample MF FSS Reporting Tool

Description of the need for the information and proposed use:

Multifamily Family Self-Sufficiency (MF FSS) is a HUD program that enables families living in multifamily assisted housing to increase their earned income and reduce their dependence on public assistance programs. MF FSS promotes the development of local strategies to coordinate the use of HUD rental assistance programs with public and private resources, to enable eligible families to achieve economic independence and self-sufficiency.

HUD's Appropriations Act of 2015 allows owners of privately owned multifamily properties with a Section 8 contract to voluntarily make a Family Self-Sufficiency program available to assisted tenants in accordance with procedures established by the Secretary, including those procedures permitting tenants to accrue escrow funds in accordance with section 23(d)(2) of the U.S. Housing Act of 1937. Owners of privately-owned HUD assisted multifamily housing can voluntarily establish and operate a MF FSS program at their housing sites. Participation in the MF FSS program is voluntary for families living in these properties.

FSS families are referred to services and educational opportunities that can lead to improved employment and earned income. Such services might include child care, transportation, education, job training, employment counseling, financial literacy, and homeownership counseling.

Families entering the FSS program work with a case manager to develop goals that will lead to self-sufficiency within a 5-year period. These goals may include education, specialized training, and job readiness, placement, and career advancement activities. Families sign a five year contract of participation (CoP) with the owner. Goals for each participating family member are set out in Individual Training and Services plans (ITSP) that are part of the CoP. When the family meets its goals and completes its FSS contract, the family becomes eligible to receive funds deposited in an escrow account.

The owner establishes an interest-bearing escrow account for each participating family. If a family's earned income and rental payments increase as a result of participation in the FSS, the owner will credit the incremental earned income amount to the family's escrow account. Once a family successfully graduates from the program, they may access the escrow funds and use them for any purpose.

Owners of privately-owned HUD assisted multifamily housing who voluntarily establish and operate a MF FSS program at their housing sites.

Estimated Number of Respondents: 2,000.

Estimated Number of Responses: 8,000.

Frequency of Response: Quarterly.

Average Hours per Response: 1 hour.

Total Estimated Burdens: 8,000.

This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and

(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

HUD encourages interested parties to submit comment in response to these questions.

Section 604(a) of the National Manufactured Housing Construction and Safety Standards Act of 1974, as amended by the Manufactured Housing Improvement Act of 2000 (42 U.S.C. 5401 et seq.) (the Act) establishes the MHCC. Among other things, the MHCC is responsible for providing periodic recommendations to HUD to adopt, revise, and interpret the manufactured housing construction and safety standards. HUD's Manufactured Home Construction and Safety Standards are codified at 24 CFR part 3280. According to Section 604(a)(4) of the Act, the MHCC is required to consider revisions not less than once during each 2-year period.

Today's notice requests that interested persons provide proposed changes for revising or updating HUD's Manufactured Home Construction and Safety Standards. Consistent with the Act, recommendations are requested that further HUD's efforts to increase the quality, durability, safety and affordability of manufactured homes; facilitate the availability of affordable manufactured homes and increase homeownership for all Americans; and encourage cost-effective and innovative construction techniques for manufactured homes. To permit the MHCC to fully consider the proposed changes, commenters are encouraged to provide at least the following information:

• The specific section of the current Manufactured Home Construction and Safety Standards that require revision or update; or whether the recommendation would require a new standard;

• Specific detail regarding the recommendation including a statement of the problem intended to be corrected or addressed by the recommendation, how the recommendation would resolve or address the problem, and the basis of the recommendation; and

• Information regarding whether the recommendation would result in increased costs to manufacturers or consumers and the value of the benefits derived from HUD's implementation of the recommendation, should be provided and discussed to the extent feasible.

The Act requires that an administering organization administer the process for the MHCC's development and interpretation of the Federal Standards and Procedural and Enforcement Regulations. The administering organization that has been selected by HUD to administer this process is Home Innovation Research Labs, Inc. This Notice requests that proposed revisions to the Federal standards be submitted to the MHCC for consideration through the administering organization, Home Innovation Research Labs, Inc. at the following URL address: mhcc.homeinnovation.com. This organization will be responsible for ensuring delivery of all appropriately prepared proposed changes to the MHCC for its review and consideration.

The information collection requirements contained in this notice have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), and assigned OMB Control Number 2535-0116. In accordance with the Paperwork Reduction Act, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number.

National Historic Landmarks (NHLs) are nationally significant historic places (buildings, sites, structures, objects, or districts) designated by the Secretary of the Interior, because they possess exceptional value or quality in illustrating or interpreting the heritage of the United States. Today, just over 2,500 historic places bear this national distinction. All NHLs are also listed in the National Register of Historic Places.

The Historic Sites Act of 1935 (16 U.S.C. 461-467) directs the Secretary of the Interior (Secretary), through the National Park Service, to survey historic and archeological sites, buildings, and objects to determine those that possess exceptional value in commemorating or illustrating the history of the United States. Designation as an NHL:

• Ensures that stories of nationally important historic events, places, or persons are recognized and preserved for the benefit of all citizens.

• May provide the property's historic character with a measure of protection against any project initiated by the Federal Government.

• May ensure eligibility for grants, tax credits, and other opportunities to maintain a property's historic character.

In accordance with the law and 36 CFR part 65, private citizens, businesses, Federal agencies, State and local public agencies, and Indian tribes may submit nominations for NHL designation. Instructions for submitting a letter of inquiry and completing NPS Form 10-934 are available on the NHL Web site at http://www.nps.gov/nhl/index.htm. We collect the following information:

Prior to nominating a property for NHL designation, respondents must send a letter of inquiry to the NPS. The letter introduces the property to the NHL Program staff and serves as a formal, written record of initiating the NHL designation process. It provides an overview of the property, its historic significance, and its historic integrity, including, but not limited to:

• Historic importance of the property. What nationally significant story does the property tell?

• Current condition and integrity of the property. Has the property undergone major alterations since the historic period? If so, how extensive are these alterations?

• Support of the property owner. Is the property already listed in the National Register of Historic Places?

• Supporting documents, such as photographs or brochures.

• Name and Location of Property.

• Significance Data (NHL criteria, criteria exceptions, NHL themes, period(s) of significance, significant person(s), cultural affiliation, historic contexts, designer/creator/architect/builder, etc.).

• Sensitive Information (resources, such as archeological sites, that would be adversely affected by amateur excavation or vandalism by the general public if the location were disclosed).

• Geographical Data (acreage, Universal Transverse Mercator (UTM) grid references or latitude/longitude coordinates, and boundaries for the property).

• Significance Statement and Discussion (narrative statement based on documentary research of the property and the specific assessment of how the property qualifies for designation as an NHL).

• Property Description and Statement of Integrity (classifies the property by ownership of the property, type of property, and the number and nature of resources comprising the property).

• Major Bibliographic References (sources from which the documentation given on the form was compiled and the assessment of the property's significance was made).

• Contact Information for Form Preparer.

We review the forms to evaluate the eligibility of the property being nominated and submit them to the Secretary of the Interior's National Park System Advisory Board. The Board recommends those properties that meet the criteria for NHL designation to the Secretary of the Interior. The Secretary decides whether or not to designate a property as an NHL.

OMB Control Number: 1024-New.

Title: Nomination of Properties for Designation as National Historic Landmarks, 36 CFR 65.

Service Form Number(s): 10-934.

Type of Request: Existing collection in use without an OMB control number.

Description of Respondents: Individuals; State, tribal, and local governments; businesses; educational institutions; and nonprofit organizations.

Respondent's Obligation: Required to obtain or retain a benefit.

Frequency of Collection: On occasion.

Estimated Annual Nonhour Burden Cost: None.

On July 30, 2012, we published in the Federal Register (77 FR 44669) a notice of our intent to request that OMB approve this information collection. In that notice, we solicited comments for 60 days, ending on September 28, 2012. We did not receive any comments.

We again invite comments concerning this information collection on:

• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;

• The accuracy of our estimate of the burden for this collection of information;

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

• Ways to minimize the burden of the collection of information on respondents.

Comments that you submit in response to this notice are a matter of public record. 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 OMB and us in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.

The Commission has received a complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Neology, Inc. on December 4, 2015. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain radio frequency identification (“RFID”) products and components thereof. The complaint names as respondents Kapsch TrafficCom IVHS, Inc. of McLean, VA; Kapsch TrafficCom IVHS Holding Corp.of McLean, VA; Kapsch TrafficCom IVHS Technologies of McLean, VA; Kapsch TrafficCom U.S. Corp. of McLean, VA; Kapsch TrafficCom Holding Corp. of McLean, VA; Kapsch TrafficCom Canada, Inc. of Canada; Star Systems International, Ltd. of Hong Kong and STAR RFID Co., Ltd. of Thailand. The complainant requests that the Commission issue a limited exclusion order and cease and desist orders.

Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

In particular, the Commission is interested in comments that:

(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

(v) explain how the requested remedial orders would impact United States consumers.

Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register. There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation.

Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3104”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures 4 ). Persons with questions regarding filing should contact the Secretary (202-205-2000).

Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR. 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.5

This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

In accordance with 21 CFR 1301.33(a), this is notice that on September 3, 2015, Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

The company plans to manufacture the listed controlled substances in bulk for sale to its customers.

The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

In accordance with 21 CFR 1301.34(a), this is notice that on October 19, 2015, Mylan Pharmaceuticals, Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505 applied to be registered as an importer of the following basic classes of controlled substances:

The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company's own domestically-manufactured FDF. This analysis is required to allow the company to export domestically-manufactured FDF to foreign markets.

The information collection (IC) is required by sections 203(b)(3); 212(a)(5)(A); 212(m), (n), (p), (t); and 214(c) of the Immigration and Nationality Act (INA) (8 U.S.C. 1153(b)(3); 1182(a)(5)(A); 1182(m), (n), (p), (t); and 1184(c)) and 8 CFR 214.2(h). The INA requires the Secretary of Labor to certify, among other things, that any foreign worker seeking to enter the United States (U.S.) for the purpose of performing certain skilled or unskilled labor temporarily or permanently will not, by doing so, adversely affect wages and working conditions of U.S. workers similarly employed. Before the Secretary of Labor can certify that wages for U.S. workers have not been adversely affected, he must ensure that the wages being paid the foreign workers are the same as those being offered and paid to U.S. workers.

The information contained in the Form ETA-9141 is the basis for the Secretary's determination of the wage employers must pay foreign workers to protect against an adverse effect on wages as a result of the employment of a foreign worker. Prior to submitting requests for most labor certifications or a labor condition applications to the Secretary of Labor, employers must obtain a prevailing wage for the job opportunity based on the place of employment in order to ensure that U.S. workers' wages are not being adversely affected by paying foreign workers less than the prevailing wage. Form ETA-9141, Application for Prevailing Wage Determination, is used to collect the necessary information from employers to enable the Department to issue a prevailing wage for the occupation and location of the job offer. The Form ETA-9141 is used in the H-2B, H-1B, H-1B1, E-3, and PERM programs administered by the Department. The Department is not proposing any changes to the collection and is requesting a three year extension.

DOL is particularly interested in comments that:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

• evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• enhance the quality, utility, and clarity of the information to be collected; and

• 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, e.g., permitting electronic submissions of responses.

Type of Review: Extension.

Title: Application for Prevailing Wage Determination.

OMB Number: 1205-0508.

Affected Public: Individuals or Households, Private Sector—businesses or other for profits, Government, State, Local and Tribal Governments.

Form(s): ETA-9141, Application for Prevailing Wage Determination.

Total Annual Respondents: 520,452.

Annual Frequency: On Occasion.

Total Annual Responses: 996,585.

Average Time per Response: Various.

Estimated Total Annual Burden Hours: 448,349.

Total Annual Burden Cost for Respondents: $0.

Comments submitted in response to this comment request will be summarized and/or included in the request for OMB approval of the ICR; they will also become a matter of public record. Commenters are encouraged not to submit sensitive information (e.g., confidential business information or personally identifiable information such as a social security number).

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (i.e., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accord with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information collection burden is accurate. The Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651 et seq.) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of efforts in obtaining information (29 U.S.C. 657).

Subpart I specifies several paperwork requirements which are described below.

Section 1915.152(b) requires the employer to assess work activities to determine whether there are hazards present, or likely to be present, which necessitate the worker's use of PPE. If such hazards are present, or likely to be present, the employer must: (1) Select the type of PPE that will protect the affected workers from the hazards identified in the occupational hazard assessment; (2) communicate PPE selection decisions to the affected workers; (3) select PPE that properly fits each affected worker; and (4) maintain documentation to verify that the required occupational hazard assessment has been performed. The verification must contain the following information: Occupation or trade assessed, the date(s) of the hazard assessment, and the name of the person performing the hazard assessment.

OSHA has a particular interest in comments on the following issues:

• Whether the proposed information collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;

• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;

• The quality, utility, and clarity of the information collected; and

• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.

OSHA is requesting that OMB extend its approval of the collection of information requirements contained in the Standard on Personal Protective Equipment (PPE) for Shipyard Employment (29 CFR part 1915, subpart I). The Agency is requesting an adjustment increase of 120 burden hours (from 52 hours to 172 hours). This increase is the result of identifying additional establishments that have been covered by the Shipyard Employment PPE Standard.

OSHA will summarize the comments submitted in response to this notice, and will include this summary in its request to OMB to extend the approval of the information collection requirements contained in the Standard on Personal Protective Equipment (PPE) for Shipyard Employment (29 CFR part 1915, subpart I).

Type of Review: Extension of a currently approved collection.

Title: Personal Protective Equipment Standard for Shipyard Employment (29 CFR part 1915, subpart I).

OMB Control Number: 1218-0215.

Affected Public: Business or other for-profits.

Number of Respondents: 2,759.

Total Responses: 2,144.

Frequency of Response: On Occasion.

Average Time per Response: An estimated 5 minutes (.08 hour) for employers to record the hazard assessment.

Estimated Burden Hours: 172.

Estimated Cost (Operation and Maintenance): $0.

You may submit comments in response to this document as follows: (1) Electronically at http://www.regulations.gov, which is the Federal e-Rulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All comments, attachments, and other material must identify the Agency name and the OSHA docket number (Docket No. OSHA-2012-0038) for the ICR. You may supplement electronic submissions by uploading document files electronically. If you wish to mail additional materials in reference to an electronic or facsimile submission, you must submit them to the OSHA Docket Office (see the section of this notice titled ADDRESSES). The additional materials must clearly identify your electronic comments by your name, date, and the docket number so the Agency can attach them to your comments.

Because of security procedures, the use of regular mail may cause a significant delay in the receipt of comments. For information about security procedures concerning the delivery of materials by hand, express delivery, messenger, or courier service, please contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627).

Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about submitting personal information such as social security numbers and date of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted material) is not publically available to read or download from this Web site. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Information on using the http://www.regulations.gov Web site to submit comments and access the docket is available through the Web site's “User Tips” link. Contact the OSHA Docket Office for information about materials not available from the Web site, and for assistance in using the Internet to locate docket submissions.

David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012 (77 FR 3912).

Title of Collection: Grantee Reporting Requirements for the Graduate Research Fellowship Program.

OMB Control No.: 3145-0223.

Type of Request: Intent to seek approval to renew an information collection.

Abstract:

Proposed Project: The purpose of the NSF Graduate Research Fellowship Program is to help ensure the vitality and diversity of the scientific and engineering workforce of the United States. The program recognizes and supports outstanding graduate students who are pursuing research-based master's and doctoral degrees in science, technology, engineering, and mathematics (STEM) and in STEM education. The GRFP provides three years of support, to be used during a five-year fellowship period, for the graduate education of individuals who have demonstrated their potential for significant research achievements in STEM and STEM education.

The Graduate Research Fellowship Program uses several sources of information in assessing and documenting program performance and impact. These sources include reports from program evaluation, the GRFP Committee of Visitors, and data compiled from the applications. In addition, GRFP Fellows submit annual activity reports to NSF.

The GRFP Completion report is proposed as a continuing component of the annual reporting requirement for the program. This report, submitted by the GRFP Institution, certifies the completion status of Fellows at the institution (e.g., in progress, completed, graduated, transferred, or withdrawn). The existing Completion Report, Grants Roster Report, and the Program Expense Report comprise the GRFP Annual Reporting requirements from the Grantee GRFP institution. Through submission of the Completion Report to NSF GRFP institutions certify the current status of all GRFP Fellows at the institution as either: In Progress, Graduated, Transferred, or Withdrawn. For Graduate Fellows with Graduated status, the graduation date is a required reporting element. Collection of this information allows the program to obtain information on the current status of Fellows, the number and/or percentage of Graduate Fellowship recipients who complete a science or engineering graduate degree, and an estimate of time to degree completion. The report must be certified and submitted by the institution's designated Coordinating Official (CO) annually.

Use of the Information: The completion report data provides NSF with accurate Fellow information regarding completion of the Fellows' graduate programs. The data is used by NSF in its assessment of the impact of its investments in the GRFP, and informs its program management.

Estimate of Burden: Overall average time will be 15 minutes per Fellow (8,500 Fellows) for a total of 2,215 hours for all institutions with Fellows. An estimate for institutions with 12 or fewer Fellows will be 1 hour, institutions with 12-48 fellows will be 4 hours, and institutions over 48 Fellows will be 10 hours.

Respondents: Academic institutions with NSF Graduate Fellows (GRFP Institutions).

Estimated Number of Responses per Report: One from each of the 271 current GRFP institutions.

To better serve the Returned Volunteer Population, Peace Corps Office of Third Goal and Returned Volunteer Services (3GL) has developed a Returned Peace Corps Volunteer (RPCV) Portal. This Portal will allow RPCVs to update their contact information, share stories, request official documentation, view their service history, and enroll in outreach and marketing campaigns.

OMB Control Number: 0420-xxxx.

Title: Returned Peace Corps Volunteer Portal (RPCV Portal).

Type of Review: New.

Affected Public: Individuals.

Respondents' Obligation to Reply: Voluntary.

Burden to the Public:

a. Number of Respondents (first year): 50,000.

b. Number of Respondents (annually): 3,000.

c. Frequency of response: 2 times.

d. Completion time: 5 minutes.

e. Annual burden hours (first year): 8,333 hours.

f. Annual burden hours (annually): 500 hours.

General Description of Collection: To build a robust alumni network it is essential that Peace Corps maintains accurate and up-to-date contact information for RPCVs. By logging into the RPCV Portal, RPCVs access their record in the database directly, and are able to make changes and submit requests at their convenience. The updated contact information collected in the RPCV Portal will be used for outreach and support purposes, along with managing subscriptions for Peace Corps newsletters.

Request for Comment: Peace Corps invites comments on whether the proposed collection of information is necessary for proper performance of the functions of the Peace Corps, including whether the information will have practical use; the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the information to be collected; and ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30 et seq., the Postal Service filed a formal request and associated supporting information to add Priority Mail Contract 156 to the competitive product list.1

The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.

To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.

The Commission establishes Docket Nos. MC2016-22 and CP2016-28 to consider the Request pertaining to the proposed Priority Mail Contract 156 product and the related contract, respectively.

The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than December 14, 2015. The public portions of these filings can be accessed via the Commission's Web site (http://www.prc.gov).

The Commission appoints Katalin K. Clendenin to serve as Public Representative in these dockets.

It is ordered:

1. The Commission establishes Docket Nos. MC2016-22 and CP2016-28 to consider the matters raised in each docket.

2. Pursuant to 39 U.S.C. 505, Katalin K. Clendenin is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).

3. Comments are due no later than December 14, 2015.

4. The Secretary shall arrange for publication of this order in the Federal Register.

In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30 et seq., the Postal Service filed a formal request and associated supporting information to add Priority Mail Express & Priority Mail Contract 23 to the competitive product list.1

The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.

To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.

The Commission establishes Docket Nos. MC2016-26 and CP2016-32 to consider the Request pertaining to the proposed Priority Mail Express & Priority Mail Contract 23 product and the related contract, respectively.

The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than December 14, 2015. The public portions of these filings can be accessed via the Commission's Web site (http://www.prc.gov).

The Commission appoints James F. Callow to serve as Public Representative in these dockets.

It is ordered:

1. The Commission establishes Docket Nos. MC2016-26 and CP2016-32 to consider the matters raised in each docket.

2. Pursuant to 39 U.S.C. 505, James F. Callow is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).

3. Comments are due no later than December 14, 2015.

4. The Secretary shall arrange for publication of this order in the Federal Register.

The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling (202) 551-8090.

1. The Existing Regulated Funds were each organized as a corporation under the General Corporate Laws of the State of Maryland. The Company operates as an externally-managed, non-diversified, closed-end management investment company that has elected to be regulated as a business development company (“BDC”) under the Act.1 BAMSCF is a non-diversified, closed-end management investment company registered under the Act. The Company's investment objective is to generate both current income and capital appreciation primarily by making direct investments in lower middle-market companies in the form of subordinated debt and, to a lesser extent, senior debt and minority equity investments. BAMSCF's investment objective is to seek total return consisting of capital appreciation and income. A majority of the board of directors (“Board”) 2 of the Company are persons who are not “interested persons,” as defined in section 2(a)(19) of the Act (the “Independent Directors”). It is anticipated that the BAMSCF Board will be comprised entirely of Independent Directors.

2. The Subsidiary is a Wholly-Owned Investment Sub (as defined below), the sole business purpose of which is to hold one or more investments on behalf of the Company. The Subsidiary is a Delaware entity.

3. The Existing Co-Investment Affiliate is a Delaware limited partnership. In reliance on the exclusion from the definition of “investment company” provided by section 3(c)(1) or 3(c)(7) of the Act, none of the Co-Investment Affiliates (as defined below) will be registered under the Act.

4. Alcentra NY is a Delaware limited liable company that is registered as an investment adviser under the Investment Advisers Act of 1940 (the “Advisers Act”). Alcentra NY serves as investment adviser to the Company pursuant to an investment advisory agreement and also serves as investment adviser to the Existing Co-Investment Affiliate. Alcentra Limited is incorporated in the United Kingdom and Wales and is registered as an investment adviser under the Advisers Act. Alcentra Limited is proposed to serve as a sub-adviser to BAMSCF. Dreyfus is a corporation organized under the laws of the State of New York that is registered as an investment adviser under the Advisers Act. Dreyfus is proposed to serve as investment manager to BAMSCF.

5. Applicants seek an order (“Order”) to permit a Regulated Fund 3 (or a Wholly-Owned Investment Sub) (as defined below) and one or more other Regulated Funds (or a Wholly-Owned Investment Sub) and/or one or more Co-Investment Affiliates 4 to participate in the same investment opportunities through a proposed co-investment program (the “Co-Investment Program”) where such participation would otherwise be prohibited under sections 17(d) and 57(a)(4) and rule 17d-1. “Co-Investment Transaction” means any transaction in which a Regulated Fund (or a Wholly-Owned Investment Sub) participated together with one or more other Regulated Funds (or a Wholly-Owned Investment Sub) and/or one or more Co-Investment Affiliates in reliance on the requested Order. “Potential Co-Investment Transaction” means any investment opportunity in which a Regulated Fund (or a Wholly-Owned Investment Sub) could not participate together with one or more other Regulated Funds (or a Wholly-Owned Investment Sub) and/or one or more Co-Investment Affiliates without obtaining and relying on the Order.5