Federal Register Vol. 83, No.210,

Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-877-260-1479 and conference ID# 6006921. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-877-260-1479 and conference ID# 6006921.

Members of the public are invited to make statements during the open comment period of the meetings or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Midwest Regional Office, U.S. Commission on Civil Rights, 230 S Dearborn Street, Suite 2120, Chicago, IL 60604, faxed to (312) 353-8324, or emailed to David Barreras at [email protected]. Persons who desire additional information may contact the Midwest Regional Office at (312) 353-8311.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=265; click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Midwest Regional Office at the above phone numbers, email or street address.

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstance of the rescheduling of a previously cancelled meeting.

In accordance with section 751(a)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.221(b)(5), on July 23, 2018, Commerce published its final results in the administrative review of the countervailing duty order on solar cells from China for the period of review (POR) January 1, 2015, through December 31, 2015.1 On August 2, 2018, Canadian Solar Inc. (Canadian Solar), a respondent in this administrative review, submitted timely ministerial error allegations concerning the Final Results.2 On August 7, 2018, SolarWorld Americas, Inc. timely filed rebuttal comments to Canadian Solar's allegations.3 No other parties submitted ministerial allegations or comments on Canadian Solar's allegations. Complaints were filed with the U.S. Court of International Trade (the Court, or CIT) challenging the Final Results. The United States sought leave from the Court to address these ministerial error allegations. The Court granted the United States' request and allowed until November 5, 2018, to issue any amended final results.

The merchandise covered by this order is crystalline silicon photovoltaic cells, and modules, laminates, and panels, consisting of crystalline silicon photovoltaic cells, whether or not partially or fully assembled into other products, including, but not limited to, modules, laminates, panels and building integrated materials. Merchandise covered by this order is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 8501.61.0000, 8507.20.80, 8541.40.6020, 8541.40.6030, and 8501.31.8000. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this order is dispositive. A full description of the scope of the order is contained in the Final Results Decision Memorandum.4

Section 751(h) of the Act and 19 CFR 351.224(f) define a “ministerial error” as an error in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any other similar type of unintentional error which the Secretary considers ministerial. Commerce finds that an error alleged by Canadian Solar regarding the calculation of the benchmark used to calculate benefits in the Aluminum Extrusions for Less Than Adequate Remuneration (LTAR) Program constitutes a ministerial error within the meaning of 19 CFR 351.224(f).5

In accordance with section 751(h) of the Act and 19 CFR 351.224(e), we are amending the Final Results to correct the ministerial error. Specifically, we are amending the net subsidy rates for the mandatory company respondents (i.e., Canadian Solar and Changzhou Trina Solar Energy Co., Ltd.) and for the companies for which a review was requested that were not selected as mandatory company respondents (i.e., the non-selected companies subject to this review).6 The revised net subsidy rates are provided below.

As a result of correcting the ministerial error, we determine the countervailable subsidy rates for the producers/exporters under review to be as follows:

Review-Specific Average Rate Applicable to the Non-Selected Companies Subject to this Review:

Normally, Commerce would issue appropriate assessment instructions to U.S. Customs and Border Protection (CBP) 15 days after the date of publication of these amended final results of review, to liquidate shipments of subject merchandise produced and/or exported by the companies listed above entered, or withdrawn from warehouse, for consumption on or after January 1, 2015, through December 31, 2015. However, on August 31, 2018, and on September 20 and 24, 2018, the CIT enjoined liquidation of certain entries that are subject to the Final Results.9 Accordingly, Commerce will not instruct CBP to assess countervailing duties on those enjoined entries pending resolution of the associated litigation.

Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties, in the amounts shown above for the companies listed above, on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after July 23, 2018, which is the date of publication of the Final Results. For all non-reviewed firms, we will instruct CBP to collect cash deposits at the most recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

We intend to disclose the calculations performed for these amended final results to interested parties within five business days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

We are issuing and publishing these results in accordance with section 751(h) and 777(i)(1) of the Act, and 19 CFR 351.224(e).

Background

This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on April 24, 2018.1 On August 20, 2018, Commerce postponed the preliminary determination of this investigation and the revised deadline is now October 23, 2018.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary 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 https://access.trade.gov, and it is available to all parties in the Central Records Unit, room B8024 of the main building of Commerce. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and the electronic versions of the Preliminary Decision Memorandum are identical in content.

The products covered by this investigation are steel wheels from China. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the preamble to Commerce's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).5 No interested party commented on the scope of the investigation as it appeared in the Initiation Notice. Commerce is not modifying the scope language as it appeared in the Initiation Notice. See the scope in Appendix I.

Commerce is conducting this investigation in accordance with section 731 of the Act. Pursuant to section 776(a) and (b) of the Act, we have preliminarily relied upon facts otherwise available, with adverse inferences, for the China-wide entity because it did not respond to our requests for information. Specifically, two mandatory respondents withdrew their participation, and no other companies have demonstrated their eligibility for a separate rate; thus, all companies are preliminarily found to be part of the China-wide entity. Furthermore, we find that the China-wide entity's lack of participation, including the failure of certain parts of the China-wide entity to respond to Commerce's questionnaires, constitute circumstances under which it is reasonable to conclude that the China-wide entity as a whole failed to cooperate to the best of its ability to comply with Commerce's requests for information. For a full description of the methodology underlying Commerce's preliminary determination, see the Preliminary Decision Memorandum.

Commerce preliminarily determines that the following estimated weighted-average dumping margins exist:

In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register, as discussed below. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the amount by which normal value exceeds U.S. price, adjusted, as appropriate, for export subsidies, as indicated in the chart above.

To determine the cash deposit rate, Commerce normally adjusts the estimated weighted-average dumping margin by the amount of domestic subsidy pass-through and export subsidies determined in a companion CVD proceeding when CVD provisional measures are in effect. Accordingly, where Commerce has made a preliminary affirmative determination for domestic subsidy pass-through or export subsidies, Commerce has offset the calculated estimated weighted-average dumping margin by the appropriate rate(s). As discussed in the Preliminary Decision Memorandum, we have made no adjustment for domestic subsidy pass-through. As further explained in the Preliminary Decision Memorandum, as an extension of our AFA finding for the China-wide entity, the appropriate export subsidy adjustment is the lowest amount of export subsidies found for any respondent in the companion CVD investigation, which is zero.

These suspension of liquidation instructions will remain in effect until further notice.

Normally, Commerce discloses to interested parties the calculations performed in connection with a preliminary determination within five days of its public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). However, because Commerce preliminarily applied total AFA to companies in this investigation in accordance with section 776 of the Act, and the applied AFA rate is based solely on the petition, there are no calculations to disclose.

Because the mandatory respondents withdrew their participation, Commerce preliminarily determines each of the mandatory respondents to have been uncooperative, and verification of Sunrise and Jingu will not be conducted.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 45 days after the date of publication of the preliminary determination, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.6 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

The applicant proposes to conduct research on and provide long-term care for one male beluga whale calf from the Cook Inlet DPS. The calf stranded alone as a neonate when he was less than a month old, and was rescued and rehabilitated by the Alaska marine mammal stranding network under the authority of the NMFS Marine Mammal Health and Stranding Response Program's (MMHSRP) scientific research and enhancement permit. Based on his young age, health conditions, and need for socialization with other beluga whales, NMFS determined him to be non-releasable and unable to survive in the wild, and chose SeaWorld of Texas to accept Tyonek into their beluga population, which was best suited for his needs. NMFS followed the standard placement process for non-releasable marine mammals as outlined in the NMFS Placement Process for Non-releasable Marine Mammals, No. 02-308-02, which is available at: http://www.nmfs.noaa.gov/op/pds/documents/02/308/02-308-02.pdf. The calf is currently held at SeaWorld of Texas under the authority of the MMHSRP permit (No. 18786-03). SeaWorld is now applying for their own scientific research and enhancement permit for the long-term care of this non-releasable animal and to conduct research to benefit the endangered wild population of Cook Inlet beluga whales.

SeaWorld's proposed research activities for this beluga whale include investigations of vocalizations (passive recordings) and hearing development (auditory evoked potential measurements). The proposed enhancement would include educational presentations on topics including the endangered status and current threats to the Cook Inlet DPS; continued daily husbandry care (feeding, training, and monitoring growth (measurements, weight, ultrasound)); veterinary care (exams and biological sampling including but not limited to blood, exhalate, swabs, urine, feces; and treatments as warranted); and behavioral observations and enrichment. This animal would be placed on public display incidental to the proposed activities but would not be used in interactive programs with the public or trained for performance. Presentations to educate the public may include demonstrations of trained husbandry and enrichment behaviors as well as natural behaviors. The permit is requested for a 5-year period, the maximum duration of a permit.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

NMFS has forwarded the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

The requested Letters of Confirmation have been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), and the regulations governing the taking and importing of marine mammals (50 CFR part 216). The General Authorization allows for bona fide scientific research that may result only in taking by Level B harassment of marine mammals. The following Letters of Confirmation (LOC) were issued in Fiscal Year 2018 (October 1, 2017—September 30, 2018).

File No. 19826-01: Issued to Tara Moll, Naval Undersea Warfare Center, Division Newport, 1176 Howell Street, Newport, RI, 02841 on November 6, 2017, to conduct ground and vessel surveys, photo-identification, and behavioral observations of gray (Halichoerus grypus), harbor (Phoca vitulina), and harp (Pagophilus groenlandicus) seals in lower Chesapeake Bay, VA and Narragansett Bay, RI. The amended LOC expands the location of research activities in Virginia to include the eastern Atlantic shore of Virginia, rather than just coastlines within the Chesapeake Bay. The LOC expires on January 31, 2021.

File No. 21363: Issued to David Johnston, Ph.D., Assistant Professor of the Practice, Duke University, Marine Science and Conservation, 135 Duke Marine Lab Rd., Beaufort, NC, 28516 on November 9, 2017, to use unmanned aircraft systems to count and photograph 11 pinniped species. Images will be used for photogrammetry, health assessments and habitat descriptions. Research may occur in three different areas: (1) Along the U.S. east coast from Maine to South Carolina; (2) along the U.S. West Coast from Alaska to California; and (3) along the Western Antarctic Peninsula. The objectives are to determine the density and distribution of non-listed pinnipeds using risk adverse and low impact technology. The LOC expires on November 15, 2022.

File No. 19826-02: Issued to Deanna Rees, Naval Undersea Warfare Center, Division Newport, 1176 Howell Street, Newport, RI 02841 on November 28, 2017, to conduct ground and vessel surveys, photo-identification, and behavioral observations of gray, harbor, and harp seals in Virginia and Narragansett Bay, RI. The amended LOC changes the Principal Investigator. The objectives do not change from those authorized under LOC No. 19826-01. The LOC expires on January 31, 2021.

File No. 19613: Issued to Eric Zolman, NOAA National Ocean Service, Hollings Marine Laboratory, 331 Ft. Johnson, Charleston, SC, 29412-9110 on December 21, 2017, to conduct research on bottlenose dolphins (Tursiops truncatus) within coastal waters of the southeastern United States (including the western North Atlantic and northern Gulf of Mexico). Dolphins may be closely approached during vessel surveys for the purposes of photo-identification and behavioral observations to address the following objectives: (1) To estimate abundance of specific inshore bottlenose dolphin stocks; (2) to better define stock boundaries in targeted regions; and (3) to assess the status and health of targeted dolphin populations. The LOC expires on January 1, 2023.

File No. 18101-03: Issued to Jens Currie, Pacific Whale Foundation, 300 Ma'alaea Rd., Suite 211, Wailuku, HI 96793 on March 23, 2018. The amended Letter of Confirmation changes the Principal Investigator and applicant, and extends the LOC by one year for vessel-based research activities on cetaceans within the Maui-4 islands area. The objectives do not change from those authorized under LOC No. 18101-02. The LOC expires on June 21, 2019.

File No. 21932: Issued to Jessica Taylor, Outer Banks Center for Dolphin Research, 310 West Eden St., Kill Devil Hills, NC 27948 on April 4, 2018, to conduct vessel surveys of bottlenose dolphins in the waters of northern North Carolina. Animals may be approached for photo-identification, behavioral observations, and focal follows. The objective of the research is to continue to monitor the presence, identity, ecology, and behavior of bottlenose dolphins in the area. The LOC expires on April 30, 2023.

File No. 21889: Issued to Lesley Thorne, Ph.D., School of Marine and Atmospheric Sciences, Stony Brook University, Stony Brook, NY, 11794 on April 23, 2018, to conduct vessel and unmanned aircraft system (UAS) surveys of 18 cetacean species. Animals may be approached for photo-identification, photogrammetry, behavioral observations, and abundance estimates. Research may occur in the New York Bight up to 120 nm offshore. The objective of the research is to provide detailed species-level information on the abundance, distribution, movements and body condition of cetaceans within the study area to the New York State Department of Environmental Conservation as part of an offshore monitoring program. The LOC expires on July 30, 2023.

File No. 21556: Issued to Stephen McCulloch, Dolphins Plus, 31 Corrine Place, Key Largo, FL 33037 on May 14, 2018 to conduct vessel surveys targeting bottlenose dolphins to include close approach for counts, photo-identification, video recording, and behavioral observations in the Upper Florida Keys, between North Key Largo to Islamorada, FL. The objectives of the research are to provide a contemporary account of common bottlenose dolphins utilizing the Upper Florida Keys. The LOC expires on May 15, 2023.

File No. 22198: Issued to Samuel Wasser, Ph.D., Center for Conservation Biology, University of Washington, Seattle, WA 98195 on May 22, 2018, to conduct boat-based vessel surveys targeting killer whales (Orcinus orca, West Coast Transient stock) within the inland waters of Washington State. Whales may be approached during focal follows for photo-identification, behavioral observations, and fecal sample collection. The objective of the research is to, through analysis of feces, address the physiologic measures of nutritional stress with variation in prey abundance, toxicant levels and boat traffic to endpoint measures such as successful birth outcomes and annual mortality. The LOC expires on July 15, 2019.

File No. 20519-01: Issued to Peggy Stap, Marine Life Studies, P.O. Box 884, Monterey, CA 93942-0884 on June 27, 2018. The amended LOC allows for the use of small UAS to determine the number of marine mammals in a group and for photogrammetry of Transient and Offshore killer whales. The objectives do not change from those authorized under LOC 20519. The LOC expires on December 31, 2021.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activities are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

The Tuna Conventions Act (16 U.S.C. 951 et seq.) (TCA) provides that the Secretary of Commerce, in consultation with the Secretary of State, shall appoint a “General Advisory Committee” (GAC) to advise the U.S. delegation to the Inter-American Tropical Tuna Commission (IATTC or Commission). The GAC shall be composed of no more than 25 individuals who shall be representative of the various groups concerned with the fisheries covered by the IATTC, including non-governmental conservation organizations, providing an equitable balance among such groups to the maximum extent practicable. Members of the GAC shall be invited to attend all non-executive meetings of the U.S. delegation to the IATTC and at such meetings shall be given the opportunity to examine and be heard on all proposed programs of investigation, reports, recommendations, and regulations of the Commission.

The Chair of the Pacific Fishery Management Council's (Pacific Council) Advisory Subpanel for Highly Migratory Fisheries and the Chair of the Western Pacific Fishery Management Council's (Western Pacific Council's) Advisory Committee shall be ex-officio members of the GAC by virtue of their positions advising those Councils. GAC members will be eligible to participate as members of the U.S. delegation to the Commission and its working groups to the extent that the Commission rules and space for delegations allow.

Meetings of the GAC, except when in executive session, shall be open to the public, and prior notice of meetings shall be made public in timely fashion. In accordance with Public Law 114-81, the GAC shall not be subject to the Federal Advisory Committee Act (5 U.S.C. App.).

Individuals appointed to serve as a member of the GAC shall serve without pay. While away from their homes or regular places of business to attend meetings of the GAC, they shall be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently by the Federal Government are allowed expenses under 5 U.S.C. 5703. In addition, individuals appointed to serve as a member of the GAC shall not be considered Federal employees except for the purposes of injury compensation or tort.

The TCA also provides that the Secretary of Commerce, in consultation with the Secretary of State, shall appoint persons to serve on the subcommittee of the GAC, referred to here as the “Scientific Advisory Subcommittee” (SAS). The SAS shall be composed of no fewer than 5 and no more than 15 qualified scientists with balanced representation from the public and private sectors, including non-governmental conservation organizations. In determining whether a person is a qualified scientist the Secretary may consider, among other things, advanced degrees and/or publications in fields such as fisheries or marine science.

The SAS shall also function as the National Scientific Advisory Committee which is required to be established pursuant to Article XI of the Agreement on the International Dolphin Conservation Program (AIDCP). In this regard, the SAS shall perform the functions of the National Scientific Advisory Committee as specified in Annex VI of the AIDCP. These functions include, but are not limited to: (1) Receiving and reviewing relevant data, including data provided to NMFS by IATTC staff; (2) advising and recommending measures and actions to the U.S. Government that should be undertaken to conserve and manage stocks of living marine resources in the eastern Pacific Ocean; (3) making recommendations to the U.S. Government regarding research needs related to the eastern Pacific Ocean tuna purse seine fishery; (4) promoting the regular and timely full exchange of data among the AIDCP Parties on a variety of matters related to the implementation of the AIDCP; and (5) consulting with other experts, as necessary, in order to achieve the objectives of the AIDCP.

Members of the SAS/National Scientific Advisory Committee shall receive no compensation for their service.

Each member of the GAC shall be appointed for a term of 3 years and may be reappointed. The Secretary of Commerce and the Secretary of State shall provide the GAC with relevant information concerning fisheries and international fishery agreements. The Secretary of Commerce shall provide to the GAC such administrative and technical support services that are necessary for its effective functioning in a timely manner.

Applications for the GAC and the SAS/National Scientific Advisory Committee should be submitted to NMFS West Coast Region (see ADDRESSES). This request for applications is for first time nominees, current members whose appointments will end in April 2019, and previous members. Self-nomination applications are acceptable. Applications should include all of the following information:

(1) Full name, address (home and business, if different), telephone, and email address of nominee;

(2) Specification about whether the application is for the GAC or the SAS/National Scientific Advisory Committee or both;

(3) Nominee's organization(s) or professional affiliation(s) serving as the basis for the nomination;

(4) Background statement describing the nominee's qualifications and experience, especially as related to fisheries for tuna and tuna-like species in the eastern Pacific Ocean or other factors relevant to the implementation of the Convention Establishing the IATTC or the AIDCP. Applications to the SAS should highlight advanced degrees and academic publications; and

(5) A written statement from the nominee of intent to participate actively and in good faith in the meetings and activities of either the GAC or the SAS/National Scientific Advisory Committee, or both.

Applicants who submitted material in response to the Federal Register Notice published by NMFS on January 20, 2016 (81 FR 3118), or prior, should resubmit their applications pursuant to this notice.

For a secondary source to request more information on this proposed information collection, please write to the U.S. Army Corps of Engineers Walla Walla District, ATTN: Karen Zelch, 201 N 3rd Ave, Walla Walla, WA 99362; call at 509-527-7251; or email at [email protected].

OMB Number: Pacific Northwest Households Recreation Use Surveys, OMB Control Number 0710-XXXX.

Needs and Uses: The U.S. Army Corps of Engineers, Bonneville Power Administration (BPA), and Bureau of Reclamation (BOR), are jointly developing an environmental impact statement (EIS), referred to as the Columbia River System Operations (CRSO) EIS. As part of the EIS, the Corps is tasked with evaluating changes in the economic value provided by water-based recreation.

The purpose of this survey effort is to gather information that will support development of a water-based recreational demand model for the Columbia River Basin in Washington, Oregon, Idaho, and western Montana. The proposed design involves a mail survey for preliminary screening to identify eligible recreators, followed by a telephone survey of eligible recreators to collect data on recreational trips and activities within the region. The model will be used to evaluate recreational impacts associated with alternatives identified within the CRSO EIS.

Affected Public: Individuals or households.

Annual Burden Hours: 1,150.

Number of Respondents: 11,500.

Responses per Respondent: 1.

Annual Responses: 11,500.

Average Burden per Response: 6 minutes.

Frequency: One-time.

Affected Public: Individuals or households.

Annual Burden Hours: 414.

Number of Respondents: 1,242.

Responses per Respondent: 1.

Annual Responses: 1,242.

Average Burden per Response: 20 minutes.

Frequency: One-time.

Annual Burden Hours: 1,564.

Number of Respondents: 11,500.

Responses per Respondent: 1.

Annual Responses: 11,500.

Average Burden per Response: 8.16 minutes.

Frequency: One-time.

We anticipate that approximately 11,500 households will complete the mail screener. Based on the results of a small pretest, we expect that it will take approximately 1 minute to read the screener letter and approximately 5 minutes to complete the screener questionnaire (total of 6 minutes per respondent). Approximately 1,242 eligible adults within those households will complete the follow-up telephone survey. Also based on the results of a small pretest, we expect that it will take approximately 20 minutes to complete the follow-up telephone survey. Based on that data, the burden for 10,258 households will be 6 minutes. The burden for 1,242 eligible adults will be a total of 26 minutes. This yields a total respondent burden estimate of 1,564 hours.

This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 18-34 with attached Policy Justification and Sensitivity of Technology.

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: Health Education Assistance Loan (HEAL) Program: Forms.

OMB Control Number: 1845-0128.

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

Respondents/Affected Public: Private Sector; Individuals or Households.

Total Estimated Number of Annual Responses: 69.

Total Estimated Number of Annual Burden Hours: 11.

Abstract: The HEAL forms are required for lenders to make application to the HEAL insurance program, to report accurately and timely on loan actions, including transfer of loans to a secondary agent, and to establish the repayment status of borrowers who qualify for deferment of payments using form 508. The reports assist in the diligent administration of the HEAL program, protecting the financial interest of the federal government.

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: Student Assistance General Provisions—Subpart K—Cash Management.

OMB Control Number: 1845-0106.

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

Respondents/Affected Public: Private Sector; State, Local, and Tribal Governments; Individuals or Households.

Total Estimated Number of Annual Responses: 3,037,182.

Total Estimated Number of Annual Burden Hours: 916,357.

Abstract: The Department of Education (the Department) is requesting an extension of the information collection for the requirements that are contained in the regulations § 668.164—Disbursing funds. The regulations require that an institution that makes direct payments to a student or parent by electronic funds transfer (EFT) and that chooses to enter into an arrangement described in 668.164(e) or (f), including an institution that uses a third-party servicer to make those payments, must establish a selection process under which the student chooses one of several options for receiving those Title IV, HEA fund payments. The Department amended the Student Assistance General Provisions regulations issued under the Higher Education Act of 1965, as amended (HEA), to implement the changes made to the Student Assistance General Provisions regulations—Subpart K—Cash Management § 668.164—Disbursing funds. These regulations are intended to ensure students and parents have convenient access to their Title IV, HEA program funds, do not incur unreasonable and uncommon financial account fees on these title IV funds and are not led to believe that they must open a particular financial account to receive their Federal student aid.

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: Income Based Repayment—Notifications.

OMB Control Number: 1845-0114.

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

Respondents/Affected Public: State, Local, and Tribal Governments; Private Sector.

Total Estimated Number of Annual Responses: 958,240.

Total Estimated Number of Annual Burden Hours: 76,665.

Abstract: The Higher Education Act of 1965, as amended (HEA), established the Federal Family Education Loan (FFEL) Program under Title IV, Part B. Section 493C [20 U.S.C. 1098e] of the HEA authorizes income based repayment for Part B borrowers who have a partial financial hardship. The regulations in 34 CFR 682.215(e)(2) require notifications to borrowers from the loan holders once a borrower establishes a partial financial hardship and is placed in an income based repayment (IBR) plan by the loan holder. The regulations identify information the loan holder must provide to the borrower to continue to participate in an IBR plan. This is a request for extension of the current information collection 1845-0114.

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: FY 2018 Child Care Access Means Parents in School Annual Performance Report Package 84.335A.

OMB Control Number: 1840-0763.

Type of Review: A reinstatement of a previously approved information collection.

Respondents/Affected Public: Private Sector.

Total Estimated Number of Annual Responses: 350.

Total Estimated Number of Annual Burden Hours: 9,800.

Abstract: The Child Care Access Means Parents In School (CCAMPIS) annual performance reports are used to collect programmatic data for purposes of annual reporting; budget submissions to OMB; Congressional hearings and testimonials; Congressional inquiries; and responding to inquiries from higher education interest groups and the general public.

Comments are invited on: (a) Whether the extended collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. This information collection request contains: (1) OMB No. 1910-5115; (2) Information Collection Request Title: Contractor Legal Management Requirements; (3) Type of Review: Extension; (4) Purpose: The information collection to be extended has been and will be used to form the basis for DOE actions on requests from the contractors for reimbursement of litigation and other legal expenses. The information collected related to annual legal budget, staffing and resource plans, and initiation or settlement of defensive or offensive litigation is and will be similarly used; (5) Annual Estimated Number of Respondents: 45; (6) Annual Estimated Number of Total Responses: 154; (7) Annual Estimated Number of Burden Hours: 1,150; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: 0.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Tentative Agenda:

Public Participation: The EM SSAB, Oak Ridge, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Melyssa P. Noe at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to the agenda item should contact Melyssa P. Noe at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available by writing or calling Melyssa P. Noe at the address and phone number listed above. Minutes will also be available at the following website: https://energy.gov/orem/listings/oak-ridge-site-specific-advisory-board-meetings.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management and related activities.

Tentative Agenda:

Breaks Taken As Appropriate.

Public Participation: The EM SSAB, Paducah, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Jennifer Woodard as soon as possible in advance of the meeting at the telephone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Jennifer Woodard at the telephone number listed above. Requests must be received as soon as possible prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments. The EM SSAB, Paducah, will hear public comments pertaining to its scope (clean-up standards and environmental restoration; waste management and disposition; stabilization and disposition of non-stockpile nuclear materials; excess facilities; future land use and long-term stewardship; risk assessment and management; and clean-up science and technology activities). Comments outside of the scope may be submitted via written statement as directed above.

Minutes: Minutes will be available by writing or calling Jennifer Woodard at the address and phone number listed above. Minutes will also be available at the following website: https://www.energy.gov/pppo/pgdp-cab/listings/meeting-materials.

On April 7, 2017, the Governor of North Dakota signed a bill into law mandating the creation of a new North Dakota Department of Environmental Quality. NDDEQ will be a cabinet-level agency that will implement all of the federally authorized or delegated environmental programs currently run by the Environmental Health Section of NDDOH. The law gives NDDOH until July 1, 2019, to obtain the necessary program authorizations and approvals from EPA to allow NDDEQ to implement the State's delegated and/or authorized environmental programs.

A state may revise its NPDES program. 40 CFR 123.62(a). In doing so, the State must submit a modified program description, Attorney General's statement, Memorandum of Agreement or other such documentation as EPA determines to be necessary under the circumstances. 40 CFR 123.62(b). States with approved programs are required to notify EPA whenever they propose to transfer all or part of the approved State agency to any other State agency and to identify any new division of responsibilities amongst the agencies involved. 40 CFR 123.62(c). Organizational charts required in the State's original authorization package must be revised and resubmitted. Id. The new agency is not authorized to administer the program until approved by the Regional Administrator.

On July 30, 2018, the EPA received a complete program revision package from the state of North Dakota. The EPA has determined the program revision package contains all the required elements. The full program revision package is available for inspection and copying at the addresses appearing in the ADDRESSES section of this notice.

Entities potentially affected by this action are: The EPA; and the regulated community and residents within the state of North Dakota (see Table 1). This table is not intended to be exhaustive; rather, it provides a guide for readers regarding entities that this action is likely to affect.

If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

With this action, the EPA is providing notice of a proposed program revision to the State of North Dakota's approved NPDES program to transfer authority to administer the NDPDES program from the NDDOH to the NDDEQ. This action is not changing the current scope of North Dakota's NDPDES program and is transferring authority to another agency to implement the state's current NPDES program as part of the larger effort to move all federally authorized or delegated environmental programs from the NDDOH to the NDDEQ. If the proposed program revision is approved, EPA will retain the authority to issue permits for facilities located in Indian country 1 and/or discharging to waters in Indian country.

This action is taken under the authority of section 402 of the Clean Water Act as amended, 33 U.S.C. 1342. Under 40 CFR 123.62(b)(2), the EPA is required to determine whether proposed program revisions are substantial and, if so, issue public notice and provide an opportunity to comment for a period of at least 30 days. The EPA considers this transfer of state authority to be substantial.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about the EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-Alone Semichemical Pulp Mills apply to new and existing chemical recovery combustion sources at kraft, soda, sulfite, and stand-alone semichemical pulp mills, for which the chemical recovery combustion sources emit greater than or equal to 10 tons per year (tpy) of any one hazardous air pollutant (HAP) or greater than or equal to 25 tpy of any combination of HAPs. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of any failures to meet applicable standards, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to 40 CFR part 63, subpart MM.

Form Numbers: None.

Respondents/affected entities: Chemical recovery combustion sources at kraft, soda, sulfite, and stand-alone semichemical pulp mills.

Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart MM).

Estimated number of respondents: 107 (total).

Frequency of response: Initially, occasionally, and semiannually.

Total estimated burden: 122,000 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $14,700,000 (per year), which includes $831,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is decrease in the total estimated respondent burden compared with the ICR currently approved by OMB. This ICR includes a more accurate estimate of the number of new respondents based on EPA's recent consultations with industry trade groups, which indicated that one new facility will start up in the third year of this information collection, in addition to the one new respondent per year that is an existing facility constructing new process units. This ICR also updates the burden associated with the October 11, 2017 RTR amendments, including removing first-year costs associated with the amendments, and accounting for the remaining one-time burden for facilities that applies through October 2020.

On August 20, 2018, the FDIC requested comment for 60 days on a proposal to renew the information collections described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these collections, and again invites comment on these renewals.

Proposal to renew the following currently approved collections of information:

1. Title: Certification of Compliance with Mandatory Bars to Employment.

OMB Number: 3064-00121.

Form Number: 2120/16.

Affected Public: Individuals seeking employment from the FDIC.

Burden Estimate:

General Description of Collection: There has been no change in the method or substance of this information collection. The change in estimates annual burden is due to a decrease in estimated number of new hires from an annual average of 600 in 2015 to an annual average of 500 currently. This information collection arises from the reporting requirements contained in 12 CFR part 336, subpart B of the FDIC Rules and Regulations entitled “Minimum Standards of Fitness for Employment with the Federal Deposit Insurance Corporation”. This rule implements Section 19 of the Resolution Trust Corporation Completion Act (“Completion Act”), Public Law 103-204, by (among other things) prescribing a certification, with attachments in some cases, relating to job applicants' fitness and integrity. More specifically, the statute provides that the FDIC shall issue regulations implementing provisions that prohibit any person from becoming employed by FDIC, who has been convicted of any felony; has been removed from, or prohibited from participating in the affairs of, any insured depository institution pursuant to any final enforcement action by any appropriate federal banking agency; has demonstrated a pattern or practice of defalcation regarding obligations to insured depository institutions; or has caused a substantial loss to federal deposit insurance funds. This collection of information implements these mandatory bars to employment through a certification, signed by job applicants prior to an offer of employment using form 2120/16.

2. Title: Purchaser Eligibility Certification.

OMB Number: 3064-0135.

Form Number: 7300-06.

Affected Public: Individuals and entities wishing to purchase receivership assets from the FDIC.

Burden Estimate: There has been no change in the method or substance of this information collection. The Subject Matter Experts (SMEs) from the FDIC's Division of Resolutions and Receiverships have estimated that this information collection will affect 600 respondents annually for the next three years. This estimate is unchanged from 2015. The SMEs reached this estimate by calculating the average number of Purchaser Eligibility Certifications (PECs) completed in the past three years and rounding up.

The number of PECs completed each year has been declining since 2009. If this trend were to continue, the number of respondents would be expected to continue to decrease from 369 over the next three years, which would imply that the estimated number of respondents should be lower for this collection compared to the one in 2015. The SMEs have acknowledged that 600 respondents may be a conservative estimate, but also believe that it is reasonable. This rationale stems from the fact that the current rate of bank failures is very low. The SMEs also point out that the PECs are collected from prospective purchasers and not just the winning bidders. As a result, the annual number of PECs could increase if there is an increase in the demand for the assets the FDIC sells even if the number of assets for sale decreases in line with the current trend of diminishing bank failures.

The estimated hourly burden for this information collection is 30 minutes per PEC form. The SMEs have arrived at this estimate through their personal observations of individuals completing these forms at open-outcry auction events. The table below contains estimates for the total estimated reporting burden for this information collection.

Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.

Under section 1861(p) of the Medicare statute, eligible beneficiaries may receive outpatient physical therapy and speech language pathology (OPT) services from a provider of services, a clinic, rehabilitation agency, a public health agency, or others, provided certain requirements are met. Section 1832(a)(2)(C) of the Social Security Act (the Act) permits payment for OPT services. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 485 subpart H specify the conditions that a clinic, rehabilitation agency or public health agency (“OPT providers”) must meet in order to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for OPT providers.

Generally, to enter into an agreement, an OPT provider must first be certified by a State survey agency as complying with the conditions of participation set forth in part 485, subpart H of our Medicare regulations. Thereafter, the OPT provider is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements.

Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by a Centers for Medicare & Medicaid Services (CMS) approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may deem those provider entities as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation.

If an AO is recognized by the Secretary of the Department of Health and Human Services as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions. An AO applying for approval of its accreditation program under part 488, subpart A, must provide CMS with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of AOs are set forth at § 488.5.

AAAASF's current term of approval for its OPT provider accreditation program expires April 4, 2019.

Section 1865(a)(2) of the Act and our regulations at § 488.5 require that our findings concerning review and approval of an AO's requirements consider, among other factors, the applying AO's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide CMS with the necessary data for validation.

Section 1865(a)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.

The purpose of this proposed notice is to inform the public of AAAASF's request for continued CMS approval of its OPT provider accreditation program. This proposed notice also solicits public comment on whether AAAASF's requirements meet or exceed the Medicare conditions of participation (CoPs) for OPT providers.

AAAASF submitted all the necessary materials to enable us to make a determination concerning its request for continued CMS-approval of its OPT provider accreditation program. This application was determined to be complete on September 6, 2018. Under Section 1865(a)(2) of the Act and our regulations at § 488.5, our review and evaluation of AAAASF will be conducted in accordance with, but not necessarily limited to, the following factors:

• The equivalency of AAAASF's standards for OPT providers as compared with Medicare's CoPs for OPT providers.

• AAAASF's survey process to determine the following:

++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.

++ The comparability of AAAASF's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.

++ AAAASF's processes and procedures for monitoring an OPT provider found out of compliance with AAAASF's program requirements. These monitoring procedures are used only when AAAASF identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the State survey agency monitors corrections as specified at § 488.9(c)(1).

++ AAAASF's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.

++ AAAASF's capacity to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.

++ The adequacy of AAAASF's staff and other resources, and its financial viability.

++ AAAASF's capacity to adequately fund required surveys.

++ AAAASF's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.

++ AAAASF's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans).

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

Upon completion of our evaluation, including evaluation of comments received as a result of this proposed notice, we will publish a final notice in the Federal Register announcing the result of our evaluation.

I. Background

Section 3011 of the 21st Century Cures Act established section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 357), which mandates that FDA publish a list of surrogate endpoints used as a basis to approve or license a drug or biological product under both accelerated and traditional approval provisions. The SE table fulfills this legislative requirement and is intended to provide valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs. FDA refers the public to the following web page for additional background information as well as the SE table: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm606684.htm.

Section 507(e)(9) of the FD&C Act defines the term “surrogate endpoint” to mean a marker, e.g., a laboratory measurement, radiographic image, physical sign, or other measure, that does not directly measure clinical benefit but (1) is known to predict clinical benefit and can potentially be used to support traditional approval of a drug or biological product or (2) is reasonably likely to predict clinical benefit and could be used to support accelerated approval in accordance with section 506(c) of the FD&C Act (21 U.S.C. 356(c)).

This SE table includes SEs that sponsors have used as primary efficacy clinical trial endpoints for approval of new drug applications (NDAs) or biologics license applications (BLAs). The table also includes SEs that may be appropriate for use as a primary efficacy clinical trial endpoint for drug or biologic approval, although the SEs have not necessarily been used to support an approved NDA or BLA. FDA believes that this table should facilitate discussions of potential SEs by sponsors when developers are designing their drug development programs.

To help FDA determine the utility of the SE table, develop future iterations of the SE table, and identify best methods for conveying this information on FDA's website, FDA is soliciting public suggestions and comments on the SE table listed on the following web page: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm606684.htm.

Specifically, FDA welcomes comments concerning: (1) The utility of the SE table; (2) suggestions on SEs that may not be reflected on the current SE table but that have been used for drug or biologic approvals; (3) the best approach for developing future iterations of the table, and (4) SE table questions you would like FDA to address in future communications. As required by section 507(c)(1) of the FD&C Act, FDA will update this table on the website every 6 months. The Agency will consider comments submitted to the docket as it revises the SE table.

I. Background

Food allergies occur when the body's immune system reacts to certain food proteins (Ref. 1). Allergic reactions to food due to immunoglobulin E (IgE) antibodies cause the body to release inflammatory chemicals and can be particularly severe, leading to symptoms such as hives, facial swelling, vomiting, wheezing, shock, and even death. Because there is no cure for food allergies, allergic consumers must use avoidance to prevent allergic reactions. Successful avoidance requires, among other things, that allergic consumers and their caregivers can read and understand the relevant information on packaged food labels and can identify food allergens in other settings, such as at retail or food service establishments.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that a food (other than a raw agricultural commodity) that bears or contains a “major food allergen” declare the allergen using its “common or usual name.” A food is misbranded if it contains a major food allergen and fails to declare that major food allergen on its label using the major food allergen's common or usual name (section 403(w) of the FD&C Act). The FD&C Act defines a “major food allergen,” in part, as any of the following:

• Milk,

• Eggs,

• Fish (e.g., bass, flounder, or cod),

• Crustacean shellfish (e.g., crab, lobster, or shrimp),

• Tree nuts (e.g., almonds, pecans, or walnuts),

• Wheat,

• Peanuts, and

• Soybeans.

See section 201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)). When Congress amended the FD&C Act regarding food allergens in 2004, these eight foods and food groups, out of more than 160 identified food allergens, accounted for 90 percent of serious food allergic reactions. We issued guidance in 2006 to help the public understand our implementation of the amendments, including what foods and manufacturers are subject to the amendments and labeling requirements (Ref. 2). We issued another guidance in 2014 to clarify the information we need when considering whether to exempt certain ingredients derived from major food allergens from the allergen labeling requirements (Ref. 3). These statutory requirements with respect to a label or labeling for major food allergens do not alter the authority of the Secretary of Health and Human Services under the FD&C Act to require a label or labeling for other food allergens (21 U.S.C. 343 note).

A common or usual name must accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients and can either be the name established by common use or the name required by a regulation (21 CFR 102.5). In addition to the specific requirement for allergen labeling, any food is misbranded unless its label uses: (1) The common or usual name of the food, if it has one, and (2) the common or usual name of each ingredient, if the food is made from two or more ingredients (section 403(i) of the FD&C Act). Thus, the FD&C Act includes other authorities that assist consumers with a food allergy or other reason for avoiding an ingredient. For example, the label of a food made with sugar must declare this ingredient by its common or usual name—“sugar”—rather than the chemical name “sucrose” (see section 403(i) of the FD&C Act (21 U.S.C. 343(i))).

In addition, section 403(x) of the FD&C Act gives us the authority to issue regulations requiring the disclosure of spices, flavorings, colorings, and incidental additives that are, or contain, allergens other than the eight major food allergens. We relied on this authority, in part, to require the labeling of carmine and cochineal in foods (see 74 FR 207).

In 2014, the Center for Science in the Public Interest, several medical professionals, and two consumer advocacy groups submitted a citizen petition (Ref. 4) requesting, in part, that we issue a rule to require that sesame seeds and sesame products be regulated in a manner similar to the manner in which major food allergens are regulated under the FD&C Act, and specifically to require sesame's disclosure by the common or usual name “sesame” in food labeling. The petition noted, among other things, that the European Union, Canada, Australia, and New Zealand require labeling of sesame and provided scientific information to support the petitioners' argument that sesame is an allergen of public health concern. The petition also requested that we add sesame to our list of allergens in our Compliance Policy Guide, which includes discussion of adulteration due to insufficient controls to prevent potential allergen cross-contact (the unintentional incorporation of allergens into foods that are not intended to include those allergens) (Ref. 5). Since the citizen petition was posted, more than 750 comments have been submitted to the docket.

We are interested in learning more about the prevalence and severity of sesame allergies in the United States, and the prevalence of sesame-containing foods sold in the United States that are not required to disclose sesame as an ingredient. We will consider the data and other information submitted, along with previously submitted information, to inform possible steps on sesame as an allergen in food to protect and promote the public health.

We invite comment, particularly scientific data and other evidence, about the following topics:

1. What is the prevalence of IgE-mediated sesame food allergies in the United States? Please provide any studies or data that support your conclusion, and provide your unit of measure (e.g., “1 in 10,000 adults”). What is the nature of the allergic response(s) to sesame in food and what are the impacts on consumers?

2. How does the prevalence of IgE-mediated sesame food allergies in the United States compare to the prevalence of IgE-mediated allergies to the major food allergens? Please provide any studies or data that support your conclusion.

3. What proportion of allergic reactions in the United States may be attributed specifically to exposure to undeclared sesame? Please provide any studies or data that support your conclusion.

4. What proportion of allergic reactions to undeclared sesame occur in response to sesame found in packaged food products versus sesame found in foods served at retail or food service establishments (e.g., restaurants, grocery stores, supermarkets, hospitals, nursing homes, childcare centers, and temporary food establishments)?

5. In packaged food products, what proportion of allergic reactions to sesame is due to:

a. Sesame in generically listed spices, flavorings, colorings, or incidental additives;

b. Sesame used as an ingredient and listed by some other name (e.g., “tahini” rather than “sesame”); or

c. Cross-contact?

1. What are examples of products or product categories that contain sesame as a spice, flavor, color, or incidental additive and that do not list “sesame” on the product labeling?

2. What amount or concentration of sesame is in products or product categories that contain sesame as a spice, flavor, color, or incidental additive and that do not list “sesame” on the product labeling? Please provide a unit of measure (e.g., “5 grams of sesame per kilogram of packaged food product” or “50 milligrams of sesame protein per serving”).

3. What are examples of products or product categories other than “spices” that contain sesame in one of the listed ingredients, but the common or usual name of that ingredient does not list “sesame,” specifically, on the product labeling? Please provide a copy of the labeling, if available.

4. What amount or concentration of sesame is in products or product categories that contain sesame in one of the listed ingredients, but the common or usual name of that ingredient does not list “sesame,” specifically, on the product labeling? Please provide a unit of measure (e.g., “5 grams of sesame per kilogram of packaged food product” or “50 milligrams of sesame protein per serving”).

5. What are examples of food products or product categories in which sesame has been found in a product because of cross-contact?

6. What amount or concentration of sesame has been found in products or product categories that contain sesame because of cross-contact? Please provide a unit of measure (e.g., “5 grams of sesame per kilogram of packaged food product” or “50 milligrams of sesame protein per serving”).

1. What would the costs be if we established disclosure requirements for sesame? We are interested in any costs, specifically those to manufacturers for labeling changes to reflect sesame as an ingredient, spice, flavor, color, or incidental additive.

2. What would the costs be to manufacturers to control allergen cross-contact from sesame and what would the costs be of educating food managers at retail or food establishments to control for sesame as an allergen?

3. What steps have manufacturers taken to eliminate or reduce cross-contact from sesame and/or sesame-containing ingredients?

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

I. Background

FDA is announcing the availability of a draft document entitled “Considerations for the Development of Dried Plasma Products Intended for Transfusion; Draft Guidance for Industry.” Plasma is a critical component of early transfusion therapy in the management of traumatic hemorrhage. Plasma can replenish various coagulation proteins that are consumed during the coagulopathy that can accompany traumatic injury. Because plasma products intended for transfusion such as fresh frozen plasma (FFP), plasma frozen within 24 hours after phlebotomy (PF24), and plasma frozen within 24 hours after phlebotomy held at room temperature up to 24 hours after phlebotomy (PF24, RT24) are stored frozen, these products need to be thawed prior to transfusion. This limits or prevents the use of plasma in settings where freezers and other support equipment are unavailable (e.g. battlefields, remote locations, and other austere settings) and may lead to delayed administration. Dried plasma (such as freeze-dried or spray-dried plasma) offers the potential to address these challenges by providing a product that is stable at ambient temperatures and can be rapidly reconstituted and transfused.

Recent clinical studies have demonstrated promising efficacy and safety of dried plasma, particularly in military applications, and dried plasma products are available for limited use in Germany, South Africa, and France. This guidance is intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma products in the United States.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on considerations for the development of dried plasma products intended for transfusion. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This draft guidance refers to previously approved collections of information subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 211 have been approved under OMB control number 0910-0139; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information in 21 CFR part 610 have been approved under OMB control numbers 0910-0116, 0910-0139, and 0910-0338; the collections of information in 21 CFR part 630 have been approved under OMB control number 0910-0116; the collections of information in 21 CFR part 640 have been approved under OMB control number 0910-0116; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; and the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

I. Procedural Background

PMRS submitted new drug application (NDA) 209155 for oxycodone HCl IR capsules, 5 mg, 15 mg, and 30 mg, under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)(2)), relying in part on the Agency's previous findings of safety and effectiveness for ROXICODONE (oxycodone HCl IR tablets (NDA 021011)) (Ref. 1).

PMRS's product contains excipients, including a dye blend, that have solubility in common solvents, including water and ethanol, similar to the solubility of the active pharmaceutical ingredient (API). PMRS contends that a solution prepared from its product for subcutaneous or intravenous injection will look relatively “impure” compared to a solution prepared from Roxicodone and will have a dark, opaque, “contaminated-looking” appearance, providing both a “visual deterrent” and a “chemical deterrent” to abuse by injection (Refs. 2 and 3).1 PMRS provided in vitro data intended to show that a solution prepared for injection would have these qualities but provided no data or literature supporting the conclusion that people who inject opioids would, in fact, be deterred from injecting such a solution (Ref. 2).

PMRS also provided in vitro data intended to demonstrate that its product would be more difficult to grind into particle sizes suitable for snorting compared to ROXICODONE but provided no data from studies in human subjects to evaluate the pharmacokinetic or pharmacodynamic properties of the product following abuse via the nasal route (Ref. 1).2 Nonetheless, PMRS proposed labeling for its product representing that it has abuse-deterrent properties (Ref. 4).

On November 16, 2017, CDER issued a complete response letter to PMRS under § 314.110(a) (21 CFR 314.110(a)) stating that the NDA could not be approved in its present form, describing the specific deficiencies, and, where possible, recommending ways PMRS might remedy these deficiencies (Ref. 5). The deficiencies cited include the following:

(1) The application in its present form is not approvable with the proposed labeling describing abuse-deterrent properties, for multiple reasons. In particular, (a) the oxycodone in the formulation can be readily extracted in commonly available solvents into a solution suitable for injection; (b) there were insufficient data showing the presence of excipients (including dye) in the formulation can be expected to deter abuse by injection; (c) the data submitted were insufficient to show the product was meaningfully resistant to manipulation for misuse or abuse; and (d) there were not data submitted, including data from pharmacokinetic and human abuse liability studies, fully characterizing the product's abuse potential by all relevant routes of abuse. Also, the data submitted were not sufficient to rule out the possibility that the proposed formulation could result in a greater proportion of abuse by injection of PMRS's product compared to a conventional oxycodone IR formulation. Abuse by injection carries greater risk of overdose and transmission of infectious disease than abuse by other routes.

(2) The safety and purity of the excipients intended (but not shown) to confer abuse-deterrent properties were not adequately characterized, either by the intended oral route of use or by expected routes of abuse, including injection.

(3) An overall evaluation of elemental impurities in the final formulation and a risk assessment for each heavy metal (taking into consideration the maximum daily dose) were not provided.

(4) The application did not fully comply with the patent certification requirements applicable to applications submitted under section 505(b)(2) of the FD&C Act.

The complete response letter describes additional deficiencies relating to the chemistry, manufacturing, and controls (CMCs) and current good manufacturing practice requirements that CDER determined precluded approval of the application in its present form (Ref. 5). The complete response letter also noted that satisfactory resolution of objectionable inspection observations was required before the application could be approved (Ref. 5).

In response to the complete response letter, on November 17, 2017, PMRS submitted a request for an opportunity for hearing under § 314.110(b)(3) on whether there are grounds under section 505(d) of the FD&C Act for denying approval of the NDA.

On February 13, 2018, FDA published a notice of opportunity for a hearing (NOOH) setting forth CDER's proposal to refuse to approve PMRS's NDA for oxycodone HCl IR capsules in 5-mg, 15-mg, and 30-mg strengths (83 FR 6196). The NOOH stated that, for the reasons described above and others described in the complete response letter, notice is given to PMRS and to all other interested persons that FDA proposes to issue an order refusing to approve the NDA because the application fails to meet the criteria for approval under section 505(d) of the FD&C Act, including that: (1) PMRS has not provided sufficient data to show that the product would be safe (section 505(d)(1)); (2) PMRS has not shown that the methods used in, and the facilities and controls used for, the manufacture, processing, or packing of the product are adequate to preserve its identity, strength, quality, and purity (section 505(d)(3)); and (3) the labeling PMRS proposed for the product is false or misleading (section 505(d)(7)).

PMRS submitted a request for a hearing on February 15, 2018. PMRS also submitted data, information, and analysis in support of its hearing request on April 13, 2018 (April Submission).3 CDER submitted a proposed order on June 13, 2018, and PMRS submitted a Response to CDER's Proposed Order on August 9, 2018 (August Submission), consistent with regulations at § 314.200(g)(3) (21 CFR 314.200(g)(3)), affording the hearing requestor 60 days to respond to a proposed order.

Under § 12.24(a)(2) (21 CFR 12.24(a)(2)), the Agency reviews a hearing request to determine whether a hearing has been justified. FDA has the authority to deny a hearing when it appears from the hearing request that there are no material disputes of fact. See Costle v. Pacific Legal Found., 445 U.S. 198, 214 (1980) (a party seeking a hearing is required to meet a “threshold burden of tendering evidence suggesting the need for a hearing”), reh'g denied, 446 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-21 (1973); Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 1085-86 (9th Cir. 1982) (holding that no hearing is necessary unless “material issues of fact” have been raised).

In determining whether there are material issues of fact suitable for a hearing, FDA considers the specific criteria set out in § 12.24(b) and grants a hearing only if the material submitted in support of the request shows the following: (1) There is a genuine and substantial factual issue for resolution at a hearing; a hearing will not be granted on issues of policy or law; 4 (2) the factual issue can be resolved by available and specifically identified reliable evidence; a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions; (3) the data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the requestor; a hearing will be denied if the Agency concludes that the data and information submitted are insufficient to justify the factual determination urged, even if accurate; 5 (4) resolution of the factual issue in the way sought by the person is adequate to justify the action requested; a hearing will not be granted on factual issues that are not determinative with respect to the action requested (e.g., if the Agency concludes that the action would be the same even if the factual issue were resolved in the way sought); 6 (5) the action requested is not inconsistent with any provision in the FD&C Act or any FDA regulation; and (6) the requirements in other applicable regulations, e.g., 21 CFR 10.20, 12.21, 12.22, and 314.200, and in the NOOH are met. Similarly, § 314.200(g) provides that a person requesting a hearing “may not rely upon allegations or denials but is required to set forth specific facts showing that there is a genuine and substantial issue of fact that requires a hearing with respect to a particular drug product specified in the request for hearing.”

Following review of the administrative record related to this proceeding, the Chief Scientist 7 finds that PMRS has not raised a genuine and substantial issue of fact justifying a hearing regarding CDER's proposal to refuse to approve the NDA in its present form.8 As further explained below, the Chief Scientist finds that a hearing would not otherwise be in the public interest. Accordingly, the Chief Scientist denies PMRS's hearing request under §§ 12.24(b) and 314.200(g) and orders approval denied under section 505(d) of the FD&C Act for PMRS's NDA in its present form.

Among other bases for proposing to deny PMRS's NDA, the NOOH cites the requirement that FDA deny approval to applications that propose labeling that is false or misleading in any particular (see section 505(d)(7) of the FD&C Act; 21 CFR 314.125(b)(6)). On this basis, the November 16, 2017, complete response letter explained that the NDA in its current form is not approvable with the proposed labeling describing abuse-deterrent properties. PMRS proposed labeling that includes multiple statements that the product has properties that make it more difficult to manipulate for purposes of abuse and misuse than a conventional formulation (Ref. 6). These statements include the assertion that the product “is formulated with inactive ingredients that make the capsule more difficult to manipulate for misuse and abuse” and that “the results of this testing demonstrated that [the product] capsules, in comparison to Roxicodone tablets, have increased resistance to physical and chemical extraction.” (Ref. 6).9

Specifically, the complete response letter explained that PMRS submitted “[n]o data . . . to support the proposed hypothesis that the presence of excipients or dye in the solution would create a deterrence to intravenous abuse” (Ref. 5). Generally, PMRS's hypothesis is that commonly used methods of preparing a solution for injection, if applied to its product, will result in a solution that will look “visually unappealing” compared to a solution prepared from Roxicodone, and will have a dark, opaque, “contaminated-looking” appearance that will serve as a “visual deterrent” to abuse (Ref. 2). PMRS's NDA provided in vitro data intended to show that a solution prepared for injection would have such an appearance (Refs. 2 and 3).10

As CDER informed PMRS during the application process, CDER considered this in vitro data unable to prove that PMRS's hypothesis is correct that individuals would actually be deterred by the appearance of a solution prepared from this formulation (Ref. 8). Although a solution prepared from PMRS's product may appear a certain way based on the in vitro data provided, PMRS has produced no scientific data or information to establish that people who inject opioids would be less likely to do so because of this appearance or based upon knowledge that the solution contains other components of the drug product in addition to the API. To demonstrate that this formulation deters abuse, and thus to support the proposed labeling for abuse-deterrent properties, CDER asked PMRS to provide evidence sufficient to prove that people who abuse opioids by injection would be deterred from doing so based on the solution's appearance.11

Critically, however, PMRS's NDA and subsequent submissions in this proceeding contain no such data or information on this critical question, either from PMRS's studies of its own product or from any potentially relevant scientific literature. In lieu of scientifically valid evidence for the proposition that appearance deters abuse, PMRS simply reiterates how the solution appears. PMRS states, variously, that the “dark, significant color is visually unappealing for potential intravenous abuse” (Ref. 2); that “PMRS considers this visual deterrent effective in classifying drug products as abuse deterrent” (id.); that “[t]he use of an FD&C dye was considered a deterrent to abuse as it provides a visual deterrent once introduced to aqueous solution” (id.); that “the ready solubility of the excipients matching the solubility profile of the API . . . maximiz[es] deterrence by rendering [the product] less attractive or rewarding for injection due to the inability to isolate the API from the inactive ingredients for injection” (Ref. 9); and that “it was very important that excipients for this formulation have same [solubility] in order to provide a chemical deterrent for abuse” (Ref. 2).12 Despite these assertions and the in vitro data related to how the product looks in solution, PMRS has offered no evidence to establish that opioid-abusers will be deterred by the color or appearance of a solution prepared from PMRS's formulation.

PMRS has also failed to offer evidence to establish its proposed conclusion related to another deficiency cited in the complete response letter (Ref. 5), specifically, PMRS's failure to establish that its product formulation deters abuse by snorting. Despite CDER's requests that human testing be conducted to establish whether this formulation deters abuse by snorting (see Refs. 5 and 8), PMRS declined to conduct such testing or to provide any other information to show that its product functions to deter abuse by snorting. Without human testing, or other appropriate data and information, it is not possible to evaluate whether PMRS's formulation has properties that render it more or less likely to be snorted.13 If the product were in fact less likely to be snorted, the product could result in shifting the pathway of abuse from snorting to injection. This shift would increase the product's overall risks associated with abuse compared to a conventional formulation, both because abuse by injection of any opioid carries additional risks particular to that route of abuse (Ref. 10) and because abuse by injection of PMRS's product in particular carries unknown additional risks associated with injection of the co-extracted excipients.14

The Chief Scientist concludes that PMRS has not created a genuine and substantial issue of fact justifying a hearing on this issue. As CDER informed PMRS during the review process and in the complete response letter, PMRS has not provided evidence that demonstrate its product deters abuse. Despite requesting a factual hearing and offering in vitro data intended to demonstrate how its product looks in solution, PMRS has not provided sufficient and reliable data or information that creates a genuine and substantial dispute of fact with respect to whether the appearance of such a solution deters abuse in the manner PMRS proposes to describe in its labeling. PMRS may have submitted evidence to show what the product looks like when prepared for injection but PMRS has not provided no clinical evidence—or indeed any evidence—that this appearance will deter abuse as PMRS's NDA represents in its proposed labeling. In addition, PMRS has failed to provide sufficient evidence to establish that the product formulation deters abuse by snorting. As a result, there exists no contested factual issue with respect to the information available to demonstrate whether PMRS's formulation possesses abuse-deterrent properties. Accordingly, the Chief Scientist denies PMRS's request for a factual hearing on this issue under §§ 12.24(b) and 314.200(g) because there exists no genuine and substantial issue of fact that would require such a hearing to resolve.

Having found that that is no genuine and substantial question of fact with respect to whether PMRS's proposed labeling is false or misleading, the Chief Scientist also finds that the Agency must therefore issue an order refusing to approve PMRS's NDA in its present form under section 505(d)(7) of the FD&C Act.

FDA makes approval decisions, including decisions regarding the content of FDA-approved prescription drug labeling, based on a comprehensive scientific evaluation of the available data and information, allowing only information for which there is a scientific basis to be included.15 As discussed above, no evidence establishes the proposition that this formulation has the abuse-deterrent properties PMRS proposes to include in its product labeling.16 The absence of such evidence in support of PMRS's assertions is particularly problematic in light of the novel and highly speculative nature of PMRS's abuse-deterrence hypothesis. It is well understood that people suffering from opioid use disorder—particularly people who abuse opioids by injection—routinely take extraordinary risks in connection with their opioid abuse. The individuals who abuse opioids by injection are known to be undeterred by such serious risks as disease transmission (including HIV and hepatitis C) associated with needle-sharing, injection-site infections, overdose, and even death (Ref. 10). Certain “street” opioids, such as black tar heroin, are commonly administered by injection despite their contaminated appearance (Ref. 11) and despite the real risks associated with the unknown composition and purity of such products (including, but not limited to, the presence of contaminants).

Against this backdrop, PMRS's unsupported assertions and in vitro data are insufficient to demonstrate that its product formulation will deter abuse. Given the lack of data establishing the effect of PMRS's formulation on its risks of abuse compared to a conventional formulation, the labeling statements PMRS has proposed suggesting that sufficient and reliable evidence exists and establishes that PMRS's formulation deters abuse would be false and misleading. Thus, the proposed labeling includes false and misleading statements suggesting that PMRS's product is expected to be safer than a conventional formulation with respect to the risks of abuse when this conclusion remains unproven.17 Accordingly, the Chief Scientist has determined that PMRS has not submitted data or information that can support a conclusion that its product would deter abuse by injection and that PMRS's proposed labeling is false and misleading under section 505(d)(7) in the absence of such evidence. As a result, the Chief Scientist accepts CDER's proposal to refuse approval for PMRS's NDA in its present form.

Instead of providing data and information addressing the absence of genuine and substantial issues of fact discussed in the previous sections, the PMRS's submissions consists largely of legal and policy objections to FDA's approach to evaluating, labeling, and approving opioids, as well as requests for the Agency to take specific actions regarding other drug products premised on PMRS's proposed alternative policies regarding opioids. These legal and policy arguments do not raise a genuine and substantial issue of fact justifying a hearing. See § 12.24(b)(1) (“A hearing will not be granted on issues of policy or law.”).18 Furthermore, a hearing will not be granted on the issue of whether FDA should take regulatory actions regarding other drug products which are not the subject of the NOOH.19 Accordingly, this order does not address the merits of FDA's policies regarding abuse-deterrent opioids or PMRS's objections to those policies, except as they apply to the question of whether PMRS has raised a genuine and substantial issue of fact which precludes CDER's proposal to refuse to approve PMRS's NDA.20 Instead, the Chief Scientist's order addresses only those aspects of the PMRS submissions that are at least potentially relevant to the question of whether PMRS has submitted data, information, or analysis that raises a genuine and substantial issue of fact justifying a hearing on the issue of whether PMRS's proposed abuse-deterrent labeling claims are false or misleading.

PMRS argues that CDER incorrectly proposed refusing to approve its NDA with the proposed abuse-deterrent labeling because CDER applied what PMRS considers the flawed approach to the evaluation and labeling of abuse-deterrent products contained in FDA's 2015 guidance for industry, “Abuse-Deterrent Opioids—Evaluation and Labeling” (Ref. 14) (the Guidance). Specifically, PMRS argues that the guidance's emphasis on premarket studies (i.e., laboratory studies and human testing) is scientifically invalid and that FDA should only approve abuse-deterrent formulations with abuse-deterrent labeling claims based on post-market epidemiological data. PMRS contends that data from premarket studies of abuse deterrence cannot constitute “substantial evidence” that a product deters abuse and therefore results in abuse-deterrent labeling claims that are false and misleading (April Submission at 2-5). PMRS further argues that CDER improperly treated compliance with the guidance approach as a requirement for approval of abuse-deterrent labeling, rather than merely as a set of recommendations, in violation of the Administrative Procedure Act (APA) (April Submission at 5-7). The Chief Scientist finds these arguments unconvincing and not relevant to the matter at hand.

First, PMRS makes a policy argument that FDA, by following the approach described in the Guidance, routinely approves abuse-deterrent labeling claims that are too strong or overly broad based on premarket data. But this argument does not raise an issue of fact regarding the approvability of an NDA for a product bearing a labeling claim that PMRS characterizes as a “more appropriately limited claim about abuse deterrence” (April Submission at 2). As stated above, PMRS has not presented data, information, or analysis that support a conclusion that its product is approvable with its own proposed labeling, rendering the question of whether “broader labeling statements” (April Submission at 2) should be withheld until supported by post-market epidemiological data irrelevant for purposes of this order.21 Even in its August submission, PMRS continues to suggest that its product should be labeled as possessing abuse-deterrent properties, even naming its product “ADF” or Abuse Deterrent Formulation, while simultaneously arguing that no evidence can demonstrate such properties pre-market (August Submission at 5).22 If PMRS is correct that such properties cannot be established pre-market, then labeling its product with abuse-deterrent properties becomes even more transparently false and misleading. PMRS cannot have it both ways without admitting that their proposed labeling lacks a scientific basis. Further, even if FDA were to agree with PMRS that only labeling claims of the type proposed by PMRS should be approved based on premarket studies, this policy change would not alter the conclusion that PMRS has not raised a genuine and substantial issue of fact justifying a hearing regarding CDER's proposal to refuse to approve PMRS's NDA with the labeling described in the NDA.23

The Chief Scientist finds PMRS's APA claim similarly irrelevant to the question of whether a hearing should be granted. PMRS contends that, by recommending that PMRS follow the approach to evaluating abuse-deterrent opioids described in the Guidance, and by referring to the guidance in the complete response letter and other documents, CDER “effectively converted a nonbinding guidance document into a requirement for abuse-deterrent labeling that has the force and effect of the law” (April Submission at 7). But challenging FDA's recommended approach for study design to measure abuse-deterrent effectiveness pre-market is immaterial to the proposal to refuse PMRS's specific NDA because PMRS has provided no evidence—either of the type FDA recommended or otherwise—that this formulation deters abuse. As a result and as discussed in the previous section, PMRS's proposed labeling remains false and misleading because it represents abuse-deterrent properties for a formulation that has not been shown to actually possess those properties.

In sum, the Chief Scientist concludes that PMRS has raised no legal or policy argument that alters the determinations discussed in the previous sections.

In its August Submission, PMRS argues that a Part 12 hearing would be “otherwise in the public interest” within the meaning of § 314.200(g)(6) in order to resolve broader policy issues related to opioid abuse. The Chief Scientist disagrees and finds in her discretion that a Part 12 hearing on this NDA would not otherwise be in the public interest.

As discussed above, PMRS's submissions raise arguments relevant to FDA's regulation of opioid products and to the crisis of opioid abuse, generally. For example, PMRS argues that the “emphasis on so-called abuse-deterrent formulations and labeling in response to the opioid epidemic has resulted in the market entry of additional misbranded products” and that “[s]uch false and misleading labeling serves only to confuse prescribers and patients about what the product is and . . . is not” (April Submission at 4). In its submissions, PMRS also requests that FDA take specific regulatory action regarding several other specific opioid products.

The Agency continues to take a variety of steps to address the public health crisis created by opioid abuse and the resulting addiction and death. For example, in May 2017, the Commissioner of Food and Drugs (the Commissioner) announced the establishment of an Opioid Policy Steering Committee to explore and develop additional approaches or strategies FDA could deploy to combat the opioid crisis.24 FDA has also held public hearings on topics relating to opioid abuse, including to receive stakeholder input on how FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics.25

The Agency is also working to enhance prescriber and patient awareness of the safe use of opioids. In 2017, FDA notified holders of approved applications for IR opioid analgesics of the Agency's determination that a REMS is necessary for IR opioid analgesics to ensure that the benefits of these drugs continue to outweigh the risks. Under this new policy, the IR opioid analgesics that are intended to be used in the outpatient setting will be subject to the same REMS requirements as the Extended-Release/Long-Acting opioid analgesics.

In addition, the Agency is undertaking a study to improve its understanding of prescriber beliefs relating to use of opioid products with abuse-deterrent properties.26 The Agency is evaluating currently-used nomenclature for such products, including by surveying doctors to better understand how they perceive these terms and to assess the clinical understanding that has developed around products with labeling for abuse-deterrent properties. Further, FDA is continuously monitoring the safety of approved opioid products based on post-market information, including through a focus on improving post-market data collection in this area.

As these examples show, the Agency is working to address the crisis of opioid addiction and abuse and recognizes the importance of seeking public comment and participation relevant to FDA's opioid-related policies. However, the Chief Scientist does not believe that a Part 12 hearing on the approvability of PMRS's NDA is an appropriate forum to address such concerns and finds in her discretion that such a hearing would not be in the public interest.

As described above, the Chief Scientist has determined that PMRS has not raised a genuine and substantial issue of fact that would warrant a hearing and that PMRS's proposed labeling containing abuse-deterrent representations would be false and misleading under section 505(d)(7) of the FD&C Act. Although the complete response letter and NOOH describe additional deficiencies in PMRS's NDA, it is not necessary to address these issues in this order because, even if resolved in PMRS's favor, PMRS's NDA would still be refused approval in its present form under section 505(d)(7) of the FD&C Act.27

For the reasons described above, the Chief Scientist finds that PMRS has not raised any genuine and substantial issue of fact that would justify a hearing (see §§ 12.24(b)(1) and 314.200(g)(1)). Accordingly, PMRS's request for a hearing is denied. The record conclusively shows that the approval criteria set forth in section 505(d)(7) of the FD&C Act have not been met. Therefore, under section 505(d) of the FD&C Act of the FD&C Act, the Chief Scientist hereby denies approval to PMRS's NDA in its present form.

The following references marked with an asterisk (*) are on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for reviewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. The reference without an asterisk is not on public display at https://www.regulations.gov because it has copyright restriction. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

NACNEP provides advice and recommendations to the Secretary of Health and Human Services (Secretary) and the U.S. Congress on policy matters arising in the administration of Title VIII of the Public Health Service (PHS) Act, as amended, including the range of issues relating to nurse supply, education, and practice improvements. NACNEP provides an annual report to the Secretary and Congress describing the activities of NACNEP, including findings and recommendations made by NACNEP concerning the activities under this title.

During the November 19, 2018, meeting, NACNEP will continue discussing areas where nursing can take the lead in the transition of the health care system to value-based care through improvements to nurse education and practice, to advance the development of its 15th Report. In addition, the members will discuss strategic priorities and future directions for the Council and discuss possible topics for its 16th Report. Agenda items are subject to change as priorities dictate. Refer to the NACNEP website for any updated information concerning the meeting.

Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written statements to NACNEP should be sent to Ms. Tracy L. Gray, Designated Federal Official, using the contact information above at least 3 business days prior to the meeting.

Technology description follows.

The invention includes compounds that inhibit c-Abl tyrosine kinase, and methods of making them which include administering (i) a therapeutically effective amount of the compound or a stereoisomer, tautomer, pharmaceutically acceptable salt, solvate, or prodrug thereof; or (ii) a therapeutically effective amount of the pharmaceutical compositions to a patient with the disease which involves c-Abl tyrosine kinase, including the overexpression of it. In some embodiments, the compound inhibits c-Abl tyrosine kinase by binding to an allosteric site of the c-Abl tyrosine kinase. In some embodiments, the compound binds to a myristate pocket of the c-Abl tyrosine kinase.

This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration.

• Novel therapeutics for neurodegenerative diseases AND other indications which involve c-Abl kinase (e.g., lysosomal storage disorders, cancers, etc.).

• Novel compounds that have a commercial advantage over those currently known because they are able to selectively bind to c-Abl at an allosteric site, can cross the blood-brain barrier, and show robust efficacy in several neurodegenerative models. All of this allows them to potentially treat neurodegenerative diseases, cancer etc.

• Pre-Clinical (in vivo validation).

• Juan Marugan, Marc Ferrer, Noel Southall, Andres Dulcey, Xin Hu, Christopher Dextras, Daniel Talley, Alejandra Alvarez, Silvana Zanlungo.

Intellectual Property: 1. C-ABL TYROSINE KINASE INHIBITORY COMPOUND EMBODIMENTS AND METHODS OF MAKING AND USING THE SAME” U.S. Provisional Patent Application NO. 62/641,126 filed on March 9, 2018 (HHS Ref. No. E-252-2017).

Licensing Contact: Ami Gadhia, JD, LL.M., CLP, 301-217-6098; [email protected].

Public Participation and Request for Comments

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2018-0879], and must be received by December 31, 2018.

We encourage you to submit comments through the Federal eRulemaking Portal at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

Title: Voyage Planning for Tank Barge Transits in the Northeast United States.

OMB Control Number: 1625-0088.

Summary: The information collection requirement for a voyage plan serves as a preventive measure and assists in ensuring the successful execution and completion of a voyage in the First Coast Guard District. This rule (33 CFR 165.100) applies to primary towing vessels engaged in towing tank barges carrying petroleum oil in bulk as cargo.

Need: Section 311 of the Coast Guard Authorization Act of 1998, Public Law 105-383, 33 U.S.C. 1231, and 46 U.S.C. 3719 authorize the Coast Guard to promulgate regulations for towing vessel and barge safety for the waters of the Northeast subject to the jurisdiction of the First Coast Guard District. The regulation is contained in 33 CFR 165.100. The information for a voyage plan will provide a mechanism for assisting vessels towing tank barges to identify those specific risks, potential equipment failures, or human errors that may lead to accidents.

Forms: None.

Respondents: Owners and operators of towing vessels.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has increased from 880 hours to 937 hours a year due to an increase in the estimated annual number of responses.

Public Participation and Request for Comments

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2018-0497], and must be received by November 29, 2018.

We encourage you to submit comments through the Federal eRulemaking Portal at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0015.

This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (83 FR 42522, August 22, 2018) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collections.

Title: Bridge Permit Application Guide.

OMB Control Number: 1625-0015.

Summary: The collection of information is a request for a bridge permit submitted as an application for approval by the Coast Guard of any proposed bridge project. An applicant must submit to the Coast Guard a letter of application along with letter-size drawings (plans) and maps showing the proposed project and its location.

Need: 33 U.S.C. 401, 491, and 525 authorize the Coast Guard to approve plans and locations for all bridges and causeways that go over navigable waters of the United States.

Forms: None.

Respondents: Public and private owners of bridges over navigable waters of the United States.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has increased from 12,354 hours to 17,607 hours a year due to the increase in the annual number of respondents.

This notice is to inform the interested public that BSEE, Oil Spill Preparedness Division (OSPD), Response Research Branch will be conducting a public meeting to discuss advancement of a low-emission spray combustion unit being designed to burn water-in-oil emissions. System integration including platform/barge configurations will be discussed to ready the unit towards use in oil spill cleanup operations.

The Commission instituted this investigation on August 1, 2017, based on a complaint and supplement, filed on behalf of Hologic, Inc. of Marlborough, Massachusetts (“Hologic”). 82 FR 35829-24 (Aug. 1, 2017). The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain x-ray breast imaging and components thereof by reason of infringement of certain claims of U.S. Patent No. 7,831,296 (“the '296 patent”); U.S. Patent No. 8,452,379 (“the '379 patent”); U.S. Patent No. 7,688,940 (“the '940 patent”); U.S. Patent No. 7,986,765 (“the '765 patent”); and U.S. Patent No. 7,123,684 (“the '684 patent”). The complaint further alleges that an industry in the United States exists as required by section 337. The Notice of Investigation named FUJIFILM Corporation of Tokyo, Japan; FUJIFILM Medical Systems USA, Inc. of Stamford, Connecticut; and FUJIFILM Techno Products Co., Ltd. of Hanamaki-Shi Iwate, Japan (collectively, “Fujifilm”) as respondents. The Office of Unfair Import Investigations (“OUII”) was named as a party. On January 18, 2018, the '765 patent was terminated in its entirety from the investigation. See Order No. 18 (Jan. 18, 2018) (unreviewed).

On July 26, 2018, the ALJ issued the final ID and found a violation of section 337 has occurred. On August 8, 2018, Fujifilm and OUII each filed petitions for review of the final ID. On August 16, 2018, OUII and Hologic filed responses to the petitions for review.

Having examined the record of this investigation, including the ALJ's final ID, the petitions for review, and the responses thereto, the Commission has determined to review the final ID in part. Specifically, the Commission has determined to review the ID's findings on (1) in rem jurisdiction and importation; (2) all findings concerning infringement; (3) claim construction of the “dose” limitations of the '379 and '296 patents; (3) claim construction of the limitations including terms of degree (i.e., similar, substantially less, much less, and substantially higher) in the '379 and '296 patents; (4) the “control”/“motion control” and “processor” limitations of the '379 and '296 patents; (5) the technical prong of domestic industry for the '379 and '296 patents; (6) claim construction of the “control” limitations of the '940 patent; (7) anticipation by the Kopans 2000 Army Report for the '379 and '296 patents; (8) anticipation by MGH/GE Prototype #2 for the '379 and '296 patents; (9) obviousness based on the publicly available MGH/GE References related to the MGH/GE Prototypes for the '379 and '296 patents; (10) anticipation by GE Senographe 2000D System and/or Manual for the '940 patent; (11) obviousness based on GE Senographe 2000D System and/or Manual with Dornheim for the '940 patent; (12) obviousness based on Niklason article, the GE Senographe DMR System and Dornheim for the '940 patent; and (13) indefiniteness under 35 U.S.C. 112 for the '940 patent.

In connection with its review, the Commission is interested in responses to the following questions:

The parties are requested to brief only the discrete issues above, with reference to the applicable law and evidentiary record. The parties are not to brief other issues on review, which are adequately presented in the parties' existing filings.

In connection with the final disposition of this investigation, the Commission may (1) issue an order that could result in the exclusion of the subject articles from entry into the United States, and/or (2) issue one or more cease and desist orders that could result in the respondents being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843 (December 1994) (Commission Opinion).

If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action. See Presidential Memorandum of July 21, 2005. 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered.

The Commission has also determined to extend the target date for completion of this investigation until January 25, 2019.

Written Submissions: The parties to the investigation are requested to file written submissions on the issues identified in this notice. Parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. Such submissions should address the recommended determination by the ALJ on public interest, remedy, and bonding. Complainant and the OUII are requested to submit proposed remedial orders for the Commission's consideration. Complainant is also requested to state the date that the subject patents expire and the HTSUS numbers under which the accused products are imported. Complainant is further requested to supply the names of known importers of the Respondents' products at issue in this investigation. Also specifically, with respect to the public interest, the Commission requests briefing on the following issue:

The written submissions and proposed remedial orders must be filed no later than close of business on November 5, 2018. Reply submissions must be filed no later than the close of business on November 13, 2018. Opening submissions are limited to 75 pages. Reply submissions are limited to 50 pages. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.

Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit eight 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 2.10.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-1063”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, http://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.pdf). 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 information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,1 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (“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 July 16, 2018, Cambrex High Point, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017 applied to be registered as an importer of the following basic class of controlled substance:

The company plans to import the listed controlled substance for clinical trial narcotic material for bulk manufacture.

The company listed below applied to be registered as an importer of various basic classes of controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for this notice.

The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrant to import the applicable basic classes of schedule I or II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.

Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule II controlled substances to the above listed company.

The companies listed below applied to be registered as bulk manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices.

The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each of the company's maintenance of effective controls against diversion by inspecting and testing each company's physical security systems, verifying each company's compliance with state and local laws, and reviewing each company's background and history.

Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed companies.

The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (“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 August 22, 2018, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock, Texas 78665-1019 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for these drug codes are authorized for this registration.

The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (“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 August 17, 2018, United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852-1717, applied to be registered as an importer of the following basic class of the controlled substance:

The company plans to import the bulk controlled substance for distribution of analytical reference standards to its customers for research and analytical purposes.

The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (“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 August 30, 2018, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020, applied to be registered as an importer of the following basic class of controlled substances:

The company plans to import dosage forms of the listed controlled substances to conduct clinical trials.

Approval of permit applications will occur only when the registrant's activity is consistent with what is authorized under to 21 U.S.C. 952 (a)(2).

Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.

The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (“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 August 17, 2018, Fisher Clinical Services Inc., 7554 Schantz Road, Allentown, Pennsylvania 18106, applied to be registered as an importer of the following basic classes of controlled substances:

The company plans to import the listed controlled substances for clinical trials.

The Attorney General has delegated his 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 delegated to the Assistant Administrator of the DEA Diversion Control Division (“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 June 14, 2018, Sigma Aldrich Research, 1-3 Strathmore Road, Natick, Massachusetts 01760-2447 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

The company plans to manufacture reference standards.

The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (“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 July 17, 2018, Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City, Missouri 64137-1418 applied to be registered as an importer of the following basic classes of controlled substances:

The company plans to import finished dosage unit products containing gamma-hydroxybutryic acid and marihuana extracts for clinical trial studies. These marihuana extracts compounds are listed under drug code 7350. No other activity for these drug codes is authorized for this registration. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a) (2). Authorization will not extend to the import of FDA-approved or non-approved finished dosage forms for commercial sale.

I. Introduction

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

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

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

• Docket Number: M-2016-033-C.

FR Notice: 81 FR 81811 (11/18/2016).

Petitioner: Mach Mining LLC, P.O. Box 300, Johnston City, Illinois 62951.

Mine: Mach No. 1 Mine, MSHA I.D. No. 11-03141, located in Williamson County, Illinois.

Regulation Affected: 30 CFR 75.503 (Permissible electric face equipment; maintenance) and 30 CFR 18.35(a)(5)(i) (Portable (trailing) cables and cords).

• Docket Number: M-2017-013-C.

FR Notice: 82 FR 34700 (7/26/2017).

Petitioner: Texas Westmoreland Coal Company, P.O. Box 915, Jewett, Texas 75846.

Mine: Jewett Mine, MSHA I.D. No. 41-03164, located in Leon County, Texas.

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

• Docket Number: M-2017-019-C.

FR Notice: 82 FR 49684 (10/26/2017).

Petitioner: Marfork Coal Company, LLC, 500 Lee Street East, Suite 701 (25301), Post Office Box 2548, Charleston, West Virginia 25329.

Mine: Slip Ridge Cedar Grove Mine, MSHA I.D. No. 46-09048, located in Raleigh County, West Virginia.

Regulation Affected: 30 CFR 75.360 (Preshift examination at fixed intervals).

• Docket Number: M-2017-021-C.

FR Notice: 82 FR 60045 (12/18/2017).

Petitioner: Rosebud Mining Company, 301 Market Street, Kittanning, Pennsylvania 16201.

Mines: Lowry Mine, MSHA I.D. No. 36-09287 and Heilwood Mine, MSHA I.D. No. 36-09407, located in Indiana County, Pennsylvania; Penfield Mine, MSHA I.D. No. 36-09355, located in Clearfield County, Pennsylvania; and Mine 78, MSHA I.D. No. 36-09371, located in Somerset County, Pennsylvania.

Regulation Affected: 30 CFR 75.503 (Permissible electric face equipment; maintenance) and 30 CFR 18.35(a)(5)(i) (Portable (trailing) cables and cords).

• Docket Number: M-2018-013-C.

FR Notice: 83 FR 17686 (4/23/2018).

Petitioner: The Coteau Properties Company, 204 County Road, Beulah, North Dakota 58523-9475.

Mine: Freedom Mine, MSHA I.D. No. 32-00595, located in Mercer County, North Dakota.

Regulation Affected: 30 CFR 77.1607(u) (Loading and haulage equipment; operation).

• Docket Number: M-2018-001-M.

FR Notice: 83 FR 4929 (2/2/2018).

Petitioner: Martin Marietta Kansas City, LLC, 1099 18th Street, Suite 2150, Denver, Colorado 80202.

Mines: Randolph Deep Mine, MSHA I.D. No. 23-02308, located in Clay County, Missouri; Stamper Underground Mine, MSHA I.D, No. 23-02232 and Parkville Quarry, MSHA I.D. No. 23-01883, located in Platte County, Missouri.

Regulation Affected: 30 CFR 49.6(a)(1) (Equipment and maintenance requirements).

• Docket Number: M-2018-002-M.

FR Notice: 83 FR 7780 (2/22/2018).

Petitioner: Central Plains Cement Company, 1801 Wewatta Street, Suite 1000, Denver, Colorado 80202.

Mine: Sugar Creek Underground Mine, MSHA I.D. No. 23-02171, located in Jackson County, Missouri.

Regulation Affected: 30 CFR 49.6(a)(1) (Equipment and maintenance requirements).

The OSHA Meeting: OSHA is hosting an open informal public meeting of the U.S. Interagency GHS Coordinating Group to provide interested groups and individuals with an update on GHS-related issues and an opportunity to express their views orally and in writing for consideration in developing U.S. Government positions for the upcoming UNSCEGHS meeting.

General topics on the agenda include:

• Review of Working Papers.

• Correspondence Group updates.

• Regulatory Cooperation Council (RCC) update.

Information on the work of the UNSCEGHS including meeting agendas, reports, and documents from previous sessions can be found on the United Nations Economic Commission for Europe (UNECE) Transport Division website located at the following web address: http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html.

The UNSCEGHS bases its decisions on Working papers. The Working Papers for the 36th session of the UNSCEGHS are located at: https://www.unece.org/trans/main/dgdb/dgsubc3/c32018.html.

Informal Papers submitted to the UNSCEGHS provide information for the Sub-Committee and are used either as a mechanism to provide information to the Sub-Committee or as the basis for future Working Papers. Informal Papers for the 36th session of the UNSCEGHS are located at: https://www.unece.org/trans/main/dgdb/dgsubc4/c4inf35.html.

In addition to participating at the public meeting, interested parties may submit comments on the Working and Informal Papers for the 36th session of the UNSCEGHS to the docket established for International/Globally Harmonized System (GHS) efforts at http://www.regulations.gov, Docket No. OSHA-2016-0005.

The PHMSA Meeting: The Federal Register notice and additional detailed information relating to PHMSA's public meeting will be available upon publication at: http://www.regulations.gov (Docket No. PHMSA-2018-0024; Notice No. 2018-11), and on the PHMSA website at: https://www.phmsa.dot.gov/international-program/international-program-overview.

The primary purpose of PHMSA's meeting is to prepare for the 54th session of the UNSCE TDG. This session represents the third meeting scheduled for the 2017-2018 biennium. UNSCOE will consider proposals for the 21st Revised Edition of the United Nations Recommendations on the Transport of Dangerous Goods (Model Regulations), which may be implemented into relevant domestic, regional, and international regulations from January 1, 2021. Copies of working documents, informal documents, and the meeting agenda may be obtained from the United Nations (UN) Transport Division's website at https://www.unece.org/trans/main/dgdb/dgsubc3/c32018.html.

During this meeting, PHMSA is also soliciting input relative to preparing for the 54th session of the UNSCE TDG as well as potential new work items which may be considered for inclusion in its international agenda. Following the 54th session of the UNSCE TDG, a copy of the Sub-Committee's report will be available at the UN Transport Division's website at http://www.unece.org/trans/main/dgdb/dgsubc3/c3rep.html.

Additional information regarding the UNSCE TDG and related matters can be found on PHMSA's website at https://www.phmsa.dot.gov/international-program/international-program-overview.

Authority and Signature: This document was prepared under the direction of Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, pursuant to sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657), and Secretary's Order 1-2012 (77 FR 3912), (Jan. 25, 2012).

I. Background

The Office of Workers' Compensation Programs (OWCP) administers the Longshore and Harbor Workers' Compensation Act (LHWCA). The Act provides benefits to workers' injured in maritime employment on the navigable waters of the United States or in an adjoining area customarily used by an employer in loading, unloading, repairing, or building a vessel. In addition, several acts extend the Longshore Act's coverage to certain other employees.

The Longshore and Harbor Workers' Compensation Act (LHWCA), at 33 U.S.C. 919(e), requires that any order rejecting or making an LHWCA award (a compensation order) be filed in the appropriate district director's office of the Office of Workers' Compensation Programs (OWCP), and that copies be sent by registered or certified mail to the claimant and the employer. The implementing regulations at 20 CFR 702.349(b) allow parties and their representatives to waive certified mail service and consent to electronic service instead. The compensation order notifies Employers/Carriers that payment of LHWCA compensation is due within 10 days of filing. If compensation is not paid within that time frame, an additional 20% in compensation must be paid [see LHWCA § 914(f)].

The information collected will be used by OWCP to more efficiently serve compensation orders by email instead of by registered or certified mail. Form LS-801 will be completed by the employer/insurance carrier and/or an authorized representative and forwarded to the District Director indicating waiver of service by registered or certified mail and designation of receipt by email instead. The LS-802 will be completed by the claimants and/or an authorized representative and forwarded to the District Director indicating waiver of service by registered or certified mail and designation of receipt by email instead. This information collection is currently approved for use through February 28, 2019.

The Department of Labor is particularly interested in comments which:

* 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.

The Department of Labor seeks the extension of approval of this information collection in order to carry out its responsibility to meet the statutory requirements to provide compensation or death benefits under the Act to workers and survivors covered by the Act.

Agency: Office of Workers' Compensation Programs.

Type of Review: Extension.

Title: Request for Electronic Service of Orders—Waiver of Certified Mail Requirements.

OMB Number: 1240-0053.

Agency Number: LS-801 and LS-802.

Affected Public: Claimants, employers, large insurance companies, and representatives.

Total Respondents: 9,240.

Total Annual Responses: 9,240.

Estimated Total Burden Hours: 770.

Estimated Time per Response: 5 minutes.

Frequency: On occasion.

Total Burden Cost (capital/startup): $0.

Total Burden Cost (operating/maintenance): $0.

Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chairman of July 5, 2016, these sessions will be closed to the public pursuant to subsection (c)(6) of section 552b of title 5, United States Code.

The upcoming meetings are:

The National Council on the Humanities is meeting pursuant to the National Foundation on the Arts and Humanities Act of 1965 (20 U.S.C. 951-960, as amended). The Committee meetings of the National Council on the Humanities will be held on November 15, 2018, as follows: The policy discussion session (open to the public) will convene at 9:00 a.m. until approximately 10:30 a.m., followed by the discussion of specific grant applications and programs before the Council (closed to the public) from 10:30 a.m. until 12:00 p.m. The following Committees will meet in the NEH offices:

Digital Humanities: Room 4085.

Education Programs: Room 2002.

Federal/State Partnership: Room 4089.

Preservation and Access: Room 4002.

Public Programs: Room P002.

Research Programs: Room P003.

The plenary session of the National Council on the Humanities will convene on November 16, 2018, at 9:00 a.m. in the Conference Center at Constitution Center. The agenda for the morning session (open to the public) will be as follows:

The remainder of the plenary session will be for consideration of specific applications and therefore will be closed to the public.

As identified above, portions of the meeting of the National Council on the Humanities will be closed to the public pursuant to sections 552b(c)(4), 552b(c)(6), and 552b(c)(9)(B) of Title 5 U.S.C., as amended. The closed sessions will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, and discussion of certain information, the premature disclosure of which could significantly frustrate implementation of proposed agency action. I have made this determination pursuant to the authority granted me by the Chairman's Delegation of Authority to Close Advisory Committee Meetings dated April 15, 2016.

Please note that individuals planning to attend the public sessions of the meeting are subject to security screening procedures. If you wish to attend any of the public sessions, please inform NEH as soon as possible by contacting Melanie Gaylord at (202) 606-8322 or [email protected]. Please also provide advance notice of any special needs or accommodations, including for a sign language interpreter.

Please refer to Docket ID NRC-2018-0155 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2018-0155.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. NUREG/BR-0204, Rev. 3, “Instructions for Completing NRC's Uniform Low-Level Radioactive Waste Manifest” is available in ADAMS under Accession No. ML18261A002. The NRC has prepared a draft regulatory analysis for this proposed guidance. The analysis examines the costs and benefits of the alternatives considered by the NRC. The NRC requests public comment on the draft regulatory analysis. The draft regulatory analysis can be found under ADAMS Accession No. ML18275A039. Comments on the draft analysis may be submitted to the NRC as indicated under Section I.B, “Submitting Comments.”

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

Please include Docket ID NRC-2018-0155 in your comment submission.

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

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

NUREG/BR-0204, Rev. 3, “Instructions for Completing the NRC's Uniform Low-Level Radioactive Waste Manifest,” provides guidance on completing NRC Forms 540, 541, and 542 (i.e., the NRC's Uniform Low-Level Waste Manifest). The last revision to this NUREG/BR, Rev. 2, was published in July 1998. In SECY-13-0001, “Staff Recommendations for Improving the Integration of the Ongoing 10 CFR part 61 Rulemaking Initiatives” (ADAMS Accession No. ML12199A412), staff noted that stakeholders suggested that NUREG/BR-0204 needs to be rewritten and that assumptions concerning the reporting of certain hard-to-detect isotopes (i.e., H-3, C-14, Tc-99 and I-129) on the Uniform Waste Manifest should be revisited. To address these stakeholder comments, the NRC staff held two public workshops in March and June of 2013 to collect comments specifically on NUREG/BR-0204. Comments received on the NUREG/BR-0204, Rev. 2, as a result of these workshops can be found on the Federal Rulemaking website (www.regulations.gov) under Docket ID NRC-2013-0035. Many of the comments received focused on the reporting of the hard-to-detect isotopes (i.e., H-3, C-14, Tc-99 and I-129) on the Uniform Low-Level Radioactive Waste Manifest.

In 2013, the NRC staff also identified additional changes that may be needed for the Uniform Low-Level Radioactive Waste Manifest forms and associated guidance in NUREG/BR-0204 as a part of the ongoing part 61 of title 10 of the Code of Federal Register (10 CFR) rulemaking (Docket ID NRC-2009-0257). The 10 CFR part 61 rulemaking, however, had not progressed far enough for the specific changes to the Uniform Low-Level Radioactive Waste Manifest forms and NUREG/BR-0204 to be known with certainty.

Therefore, staff developed Regulatory Information Summary (RIS-15-002) to address stakeholder concerns regarding the reporting of hard-to-detect radionuclides on the Uniform Low-Level Radioactive Waste Manifest. This RIS, titled “Reporting of H-3, C-14, Tc-99, and I-129 on the Uniform Waste Manifest” (ADAMS Accession No. ML14272A217), informs addressees of the option to use indirect methods to determine the activity of H-3, C-14, Tc-99, and I-129 reported on the Uniform Low-Level Radioactive Waste Manifest when the radionuclide is present at a concentration less than the lower limit of detection (LLD). The request for comments on draft RIS was published on in the Federal Register on June 2, 2014 (79 FR 31348), and the final RIS was published on February 18, 2015.

In September of 2017, the NRC received direction from the Commission on the part 61 rulemaking in SRM-SECY-16-0106 (ADAMS Accession No. ML17251B147), and the NRC staff determined that there was enough certainty in the portions of the part 61 rulemaking that affected the Uniform Low-Level Radioactive Waste Manifest to issue a draft of the manifest forms and the instructions in NUREG/BR-0204 for comment. The NRC staff considered the comments received in 2013 when revising these documents. Major areas of revision include: Updated references to Department of Transportation (DOT) regulations to reflect the current DOT regulations, additional discussion on the reporting of inventories based on LLD values, the potential use of indirect methods to determine these inventories, including the use of indirect methods in waste classification, clarification of the certification statement on Form 540, and overall improvements to the clarity of NUREG/BR-0204.

The NRC is requesting public comments on the draft revised Uniform Low-Level Radioactive Waste Manifest (NRC Forms 540, 541, and 542) and on the draft Rev. 3 to NUREG/BR-0204, and on the draft regulatory analysis. The NRC staff will consider any comments received in preparing the final version of Rev. 3 and the revised NRC Forms 540, 541, and 542. In responding, commenters are encouraged to provide specific suggestions and the basis for suggestions offered. Specifically, the NRC staff requests comment on the following questions:

1. Do the proposed revised Uniform Low-Level Radioactive Waste Manifest Forms 540, 541, and 542 request all of the information that is needed for the transport and disposal of low-level radioactive waste to be safely managed? Is there any additional information that should be collected?

2. Is any additional guidance or clarification needed in the instructions for filling out the Uniform Low-Level Radioactive Waste Manifest Forms in NUREG/BR-0204?

3. NRC Form 541 has lists of container description codes (note 1), waste descriptor codes (note 2), and sorption and solidification media (note 3) that have not been updated recently. Are there any items that should be added to these lists based on new technology or changes to industry practices? Are there any items on these lists that should be deleted because they are no longer in use or for any other reason? Should the items in the lists be combined in any way?

I. Introduction

The NRC is granting an exemption from paragraphs B.5.a, B.6.b, and B.6.c of section VIII, “Processes for Changes and Departures,” of Appendix D, of Part 52 of Title 10 of the Code of Federal Regulations (10 CFR), and issuing License Amendment No. to COLs, NPF-91 and NPF-92, to SNC. With the requested amendment, SNC sought proposed License Condition 2.D.13 and proposed changes that would revise the Updated Final Safety Analysis Report Tier 2 information.