Federal Register Vol. 83, No.237,

Members of the public are invited to come in and listen to the discussion. Written comments will be accepted until February 8, 2019 and may be mailed to the Regional Program Unit Office, U.S. Commission on Civil Rights, 230 S Dearborn, Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324 or may be emailed to Jeff Hinton at [email protected]. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Tennessee Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Southern Regional Office at the above email or street address.

This notice informs the public that the FirstNet Board and the Board Committees will convene an open public meeting on December 13, 2018.

Background: The Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96, Title VI, 126 Stat. 256 (codified at 47 U.S.C. 1401 et seq.)) (Act) established FirstNet as an independent authority within the National Telecommunications and Information Administration that is headed by a Board. The Act directs FirstNet to ensure the building, deployment, and operation of a nationwide, interoperable public safety broadband network. The FirstNet Board is responsible for making strategic decisions regarding FirstNet's operations. The FirstNet Board held its first public meeting on September 25, 2012.

Matters to be Considered: FirstNet will post a detailed agenda for the Combined Board Committees and Board Meeting on its website, http://www.firstnet.gov, prior to the meetings. The agenda topics are subject to change. Please note that the subjects that will be discussed by the Committees and the Board may involve commercial or financial information that is privileged or confidential or other legal matters affecting FirstNet. As such, the Committee Chairs and Board Chair may call for a vote to close the meetings only for the time necessary to preserve the confidentiality of such information, pursuant to 47 U.S.C. 1424(e)(2).

Times and Dates of Meeting: A combined meeting of the FirstNet Board and FirstNet Board Committees will be held on December 13, 2018 between 11:00 a.m. and 2:30 p.m. (ET). The meeting of the FirstNet Board and the Governance and Personnel, Technology, Consultation and Outreach, and Finance Committees will be open to the public from 11:00 a.m. to 2:30 p.m. (ET). The times listed above are subject to change. Please refer to FirstNet's website at www.firstnet.gov for the most up-to-date information.

Place: The meetings on December 13, 2018 will be held at the Hyatt Regency Tysons Corner Center, 7901 Tysons One Place, McLean, VA 22102. Members of the public may listen to the meeting by dialing toll free 1-888-469-2980 and entering participant code 4810197#.

Other Information: These meetings are open to the public and press on a first-come, first-served basis. Space is limited. To ensure an accurate headcount, all expected attendees are asked to provide notice of intent to attend by sending an email to [email protected]. If the number of RSVPs indicates that expected attendance has reached its capacity, FirstNet will respond to all subsequent notices indicating that capacity has been reached and that in-person viewing may no longer be available but that the meeting may still be viewed by webcast as detailed below. For access to the meetings, valid government issued photo identification may be requested for security reasons.

The Combined Committee and Board Meetings are accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Ms. Miller-Kuwana by telephone (571) 665-6177 or email at [email protected] at least five (5) business days before the applicable meeting.

The meeting will also be webcast. Please refer to FirstNet's website at www.firstnet.gov for webcast instructions and other information. Viewers experiencing any issues with the live webcast may email [email protected] or call 202-684-3361 x3 for support. A variety of automated troubleshooting tests are also available via the “Troubleshooting Tips” button on the webcast player. The meetings will also be available to interested parties by phone. To be connected to the meetings in listen-only mode by telephone, please dial toll free 1-888-469-2980 and enter participant code 4810197#. If you experience technical difficulty, please contact the Conferencing Center customer service at 1-866-900-1011.

Records: FirstNet maintains records of all Board proceedings. Minutes of the Board Meeting and the Committee meetings will be available at www.firstnet.gov.

Background

In providing its advice and consent to the ratification of the Convention on the Prohibition of the Development, Production, Stockpiling, and Use of Chemical Weapons and Their Destruction, commonly called the Chemical Weapons Convention (CWC or “the Convention”), the Senate included, in Senate Resolution 75 (S. Res. 75, April 24, 1997), several conditions to its ratification. Condition 9, titled “Protection of Advanced Biotechnology,” calls for the President to certify to Congress on an annual basis that “the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms in the United States are not being significantly harmed by the limitations of the Convention on access to, and production of, those chemicals and toxins listed in Schedule 1.” On July 8, 2004, President Bush, by Executive Order 13346, delegated his authority to make the annual certification to the Secretary of Commerce.

The CWC is an international arms control treaty that contains certain verification provisions. In order to implement these verification provisions, the CWC established the Organization for the Prohibition of Chemical Weapons (OPCW). The CWC imposes certain obligations on countries that have ratified the Convention (i.e., States Parties), among which are the enactment of legislation to prohibit the production, storage, and use of chemical weapons, and the establishment of a National Authority to serve as the national focal point for effective liaison with the OPCW and other States Parties in order to achieve the object and purpose of the Convention and the implementation of its provisions. The CWC also requires each State Party to implement a comprehensive data declaration and inspection regime to provide transparency and to verify that both the public and private sectors of the State Party are not engaged in activities prohibited under the CWC.

“Schedule 1” chemicals consist of those toxic chemicals and precursors set forth in the CWC “Annex on Chemicals” and in “Supplement No. 1 to part 712—SCHEDULE 1 CHEMICALS” of the Chemical Weapons Convention Regulations (CWCR) (15 CFR parts 710-722). The CWC identified these toxic chemicals and precursors as posing a high risk to the object and purpose of the Convention.

The CWC (Part VI of the “Verification Annex”) restricts the production of “Schedule 1” chemicals for protective purposes to two facilities per State Party: A single small-scale facility (SSSF) and a facility for production in quantities not exceeding 10 kg per year. The CWC Article-by-Article Analysis submitted to the Senate in Treaty Doc. 103-21 defined the term “protective purposes” to mean “used for determining the adequacy of defense equipment and measures.” Consistent with this definition and as authorized by Presidential Decision Directive (PDD) 70 (December 17, 1999), which specifies agency and departmental responsibilities as part of the U.S. implementation of the CWC, the Department of Defense (DOD) was assigned the responsibility to operate these two facilities. Although this assignment of responsibility to DOD under PDD-70 effectively precluded commercial production of “Schedule 1” chemicals for protective purposes in the United States, it did not establish any limitations on “Schedule 1” chemical activities that are not prohibited by the CWC. However, DOD does maintain strict controls on “Schedule 1” chemicals produced at its facilities in order to ensure accountability for such chemicals, as well as their proper use, consistent with the object and purpose of the Convention.

The provisions of the CWC that affect commercial activities involving “Schedule 1” chemicals are implemented in the CWCR (see 15 CFR 712) and in the Export Administration Regulations (EAR) (see 15 CFR 742.18 and 15 CFR 745), both of which are administered by the Bureau of Industry and Security (BIS). Pursuant to CWC requirements, the CWCR restrict commercial production of “Schedule 1” chemicals to research, medical, or pharmaceutical purposes. The CWCR prohibit commercial production of “Schedule 1” chemicals for “protective purposes” because such production is effectively precluded per PDD-70, as described above—see 15 CFR 712.2(a). The CWCR also contain other requirements and prohibitions that apply to “Schedule 1” chemicals and/or “Schedule 1” facilities. Specifically, the CWCR:

(1) Prohibit the import of “Schedule 1” chemicals from States not Party to the Convention (15 CFR 712.2(b));

(2) Require annual declarations by certain facilities engaged in the production of “Schedule 1” chemicals in excess of 100 grams aggregate per calendar year (i.e., declared “Schedule 1” facilities) for purposes not prohibited by the Convention (15 CFR 712.5(a)(1) and (a)(2));

(3) Provide for government approval of “declared Schedule 1” facilities (15 CFR 712.5(f));

(4) Provide that “declared Schedule 1” facilities are subject to initial and routine inspection by the OPCW (15 CFR 712.5(e) and 716.1(b)(1));

(5) Require 200 days advance notification of establishment of new “Schedule 1” production facilities producing greater than 100 grams aggregate of “Schedule 1” chemicals per calendar year (15 CFR 712.4);

(6) Require advance notification and annual reporting of all imports and exports of “Schedule 1” chemicals to, or from, other States Parties to the Convention (15 CFR 712.6, 742.18(a)(1) and 745.1); and

(7) Prohibit the export of “Schedule 1” chemicals to States not Party to the Convention (15 CFR 742.18(a)(1) and (b)(1)(ii)).

For purposes of the CWCR (see 15 CFR 710.1), “production of a Schedule 1 chemical” means the formation of “Schedule 1” chemicals through chemical synthesis, as well as processing to extract and isolate “Schedule 1” chemicals produced by a biochemical or biologically mediated reaction. Such production is understood, for CWCR declaration purposes, to include intermediates, by-products, or waste products that are produced and consumed within a defined chemical manufacturing sequence, where such intermediates, by-products, or waste products are chemically stable and therefore exist for a sufficient time to make isolation from the manufacturing stream possible, but where, under normal or design operating conditions, isolation does not occur.

In order to assist in determining whether the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms in the United States are significantly harmed by the limitations of the Convention on access to, and production of, “Schedule 1” chemicals as described in this notice, BIS is seeking public comments on any effects that implementation of the CWC, through the Chemical Weapons Convention Implementation Act and the CWCR, has had on commercial activities involving “Schedule 1” chemicals during calendar year 2018. To allow BIS to properly evaluate the significance of any harm to commercial activities involving “Schedule 1” chemicals, public comments submitted in response to this notice of inquiry should include both a quantitative and qualitative assessment of the impact of the CWC on such activities.

All comments must be submitted to one of the addresses indicated in this notice. The Department requires that all comments be submitted in written form. BIS will consider all comments received on or before January 10, 2019. All comments (including any personally identifying information or information for which a claim of confidentially is asserted either in those comments or their transmittal emails) will be made available for public inspection and copying. Parties who wish to comment anonymously may do so by submitting their comments via Regulations.gov, leaving the fields that would identify the commenter blank and including no identifying information in the comment itself.

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

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

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

In the event Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review. We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 30 days of publication of the initiation Federal Register notice. Comments regarding the CBP data and respondent selection should be submitted seven days after the placement of the CBP data on the record of this review. Parties wishing to submit rebuttal comments should submit those comments five days after the deadline for the initial comments.

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

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

Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.

Section 504 of the Trade Preferences Extension Act of 2015 amended the Act by adding the concept of particular market situation (PMS) for purposes of constructed value under section 773(e) of the Act.2 Section 773(e) of the Act states that “if a particular market situation exists such that the cost of materials and fabrication or other processing of any kind does not accurately reflect the cost of production in the ordinary course of trade, the administering authority may use another calculation methodology under this subtitle or any other calculation methodology.” When an interested party submits a PMS allegation pursuant to section 773(e) of the Act, Commerce will respond to such a submission consistent with 19 CFR 351.301(c)(v). If Commerce finds that a PMS exists under section 773(e) of the Act, then it will modify its dumping calculations appropriately.

Neither section 773(e) of the Act nor 19 CFR 351.301(c)(v) set a deadline for the submission of PMS allegations and supporting factual information. However, in order to administer section 773(e) of the Act, Commerce must receive PMS allegations and supporting factual information with enough time to consider the submission. Thus, should an interested party wish to submit a PMS allegation and supporting new factual information pursuant to section 773(e) of the Act, it must do so no later than 20 days after submission of initial responses to section D of the questionnaire.

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

To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, Commerce analyzes each entity exporting the subject merchandise. In accordance with the separate rates criteria, Commerce assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both de jure and de facto government control over export activities.

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

Entities that currently do not have a separate rate from a completed segment of the proceeding 3 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. In addition, companies that received a separate rate in a completed segment of the proceeding that have subsequently made changes, including, but not limited to, changes to corporate structure, acquisitions of new companies or facilities, or changes to their official company name,4 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. The Separate Rate Status Application will be available on Commerce's website at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the Separate Rate Status Application, refer to the instructions contained in the application. Separate Rate Status Applications are due to Commerce no later than 30 calendar days of publication of this Federal Register notice. The deadline and requirement for submitting a Separate Rate Status Application applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers that purchase and export subject merchandise to the United States.

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

Initiation of Reviews:

In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than October 31, 2019.

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

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

Interested parties must submit applications for disclosure under administrative protective orders in accordance with the procedures outlined in Commerce's regulations at 19 CFR 351.305. Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures (e.g., the filing of separate letters of appearance as discussed at 19 CFR 351.103(d)).

Commerce's regulations identify five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). These regulations require any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. The regulations, at 19 CFR 351.301, also provide specific time limits for such factual submissions based on the type of factual information being submitted. Please review the final rule, available at http://enforcement.trade.gov/frn/2013/1304frn/2013-08227.txt, prior to submitting factual information in this segment.

Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness of that information.10 Parties are hereby reminded that revised certification requirements are in effect for company/government officials as well as their representatives. All segments of any antidumping duty or countervailing duty proceedings initiated on or after August 16, 2013, should use the formats for the revised certifications provided at the end of the Final Rule.11 Commerce intends to reject factual submissions in any proceeding segments if the submitting party does not comply with applicable revised certification requirements.

Parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by the Secretary. See 19 CFR 351.302. In general, an extension request will be considered untimely if it is filed after the time limit established under Part 351 expires. For submissions which are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Examples include, but are not limited to: (1) Case and rebuttal briefs, filed pursuant to 19 CFR 351.309; (2) factual information to value factors under 19 CFR 351.408(c), or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2), filed pursuant to 19 CFR 351.301(c)(3) and rebuttal, clarification and correction filed pursuant to 19 CFR 351.301(c)(3)(iv); (3) comments concerning the selection of a surrogate country and surrogate values and rebuttal; (4) comments concerning U.S. Customs and Border Protection data; and (5) quantity and value questionnaires. Under certain circumstances, Commerce may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, Commerce will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. This modification also requires that an extension request must be made in a separate, stand-alone submission, and clarifies the circumstances under which Commerce will grant untimely-filed requests for the extension of time limits. These modifications are effective for all segments initiated on or after October 21, 2013. Please review the final rule, available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in these segments.

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

The merchandise subject to the order is circular welded non-alloy steel pipe and tube. Imports of the product are currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 7306.30.1000, 7306.30.5025, 7306.30.5032, 7306.30.5040, 7306.30.5055, 7306.30.5085, and 7306.30.5090. While the HTSUS subheadings are provided for convenience and customs purposes, the written description is dispositive. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.1

Commerce conducted this review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act). Constructed export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.

For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and to all parties in Commerce's Central Records Unit, located at Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be found at http://enforcement.trade.gov/frn/index.html.

We preliminarily determine that the following weighted-average dumping margins exist for the respondents for the period November 1, 2016, through October 31, 2017:

We intend to disclose the calculations performed for these preliminary results to the parties within five days after public announcement of the preliminary results in accordance with 19 CFR 351.224(b). Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.2 Parties who submit case briefs or rebuttal briefs in this proceeding 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.3

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice.4 Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. Commerce will issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act.

If a respondent's weighted-average dumping margin is above de minimis in the final results of this review, we will calculate an importer-specific assessment rate on the basis of the ratio of the total amount of antidumping duties calculated for the importer's examined sales and the total entered value of the sales in accordance with 19 CFR 351.212(b)(1).5 If the respondent's weighted-average dumping margin is zero or de minimis in the final results of reviews, we will instruct U.S. Customs and Border Protection (CBP) not to assess duties on any of its entries in accordance with the Final Modification for Reviews.6

For entries of subject merchandise during the POR produced by Husteel Co., Ltd. or Hyundai Steel Company for which they did not know their merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

For the 23 companies which were not selected for individual examination, we will instruct CBP to apply the rates listed above to all entries of subject merchandise produced and/or exported by these firms.

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

The following deposit requirements will be effective upon publication of the notice of final results of this review for all shipments of CWP from Korea entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for companies subject to this review will be the rates established in the final results of the review; (2) for merchandise exported by producers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation but the producer is, the cash deposit rate will be the rate established for the most recent period for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 4.80 percent,7 the all-others rate established in the less-than-fair-value investigation, adjusted for the export-subsidy rate in the companion countervailing duty investigation. These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

Commerce is issuing and publishing these results in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.221(b)(4).

On February 23, 2018, Commerce initiated the antidumping duty administrative review on circular welded carbon-quality steel pipe from the Sultanate of Oman.1 This review covers one producer/exporter of the subject merchandise, Al Jazeera Steel Products Co. SAOG (Al Jazeera). For a detailed description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum, dated concurrently with these preliminary results and hereby adopted by this notice.2

The merchandise subject to the Order 3 is CWP from Oman. A full description of the scope of the Order is contained in the Preliminary Decision Memorandum.

Commerce is conducting this review in accordance with section 751(a)(1)(B) and (a)(2) of the Tariff Act of 1930, as amended (the Act). Export price was calculated in accordance with section 772 of the Act. NV was calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. A list of the topics included in the Preliminary Decision Memorandum is included as an appendix 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 http://access.trade.gov, and to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content.

We preliminarily determine that, for the period of June 8, 2016, through November 30, 2017, the following weighted-average dumping margin exists:

We intend to disclose the calculations performed for these preliminary results of review to interested parties within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs to Commerce no later than 30 days after the date of publication of this notice.4 Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.5 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this proceeding 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.6 Case and rebuttal briefs should be filed using ACCESS.7

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically-filed document must be received successfully in its entirety by ACCESS by 5 p.m. Eastern Standard Time within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; (3) whether any participant is a foreign national; and (4) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined.8 Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

We intend to issue the final results of this administrative review, including the results of its analysis of issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless the deadline is extended.9

Upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.10

Pursuant to 19 CFR 351.212(b)(1), as Al Jazeera reported the entered value for its U.S. sales, we calculated importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the examined sales to the total entered value of the sales. Where the respondent's weighted-average dumping margin is zero or de minimis within the meaning of 19 CFR 351.106(c)(1), or an importer-specific rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. We intend to instruct CBP to take into account the “provisional measures deposit cap,” in accordance with 19 CFR 351.212(d).

The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable.

In accordance with our “automatic assessment” practice, for entries of subject merchandise during the POR produced by Al Jazeera for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate.11

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

The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Al Jazeera will be the rate established in the final results of this review; (2) for previously reviewed or investigated companies not participating in this review, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment of this proceeding in which the company was reviewed; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair value (LTFV) investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently-completed segment of this proceeding for the manufacturer of subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 7.36 percent, the all-others rate established in the LTFV investigation.12 These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

Notification To Interested Parties

The preliminary results of review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).

On January 11, 2018, pursuant to section 751(a)(1) of the Tariff Act of 1930, as amended (the Act), Commerce initiated an administrative review of the antidumping duty order on steel concrete reinforcing bar (rebar) from Mexico.1

On August 10, 2018, Commerce published the preliminary results for this administrative review.1 We invited interested parties to comment on the Preliminary Results. We received no comments nor requests for a hearing from any party.2 Commerce conducted this administrative review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act).

The products covered by the antidumping duty order are all gauges of raw, pretreated, or primed polyethylene terephthalate film, sheet, and strip (PET film), whether extruded or coextruded. Excluded are metalized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer of more than 0.00001 inches thick. Imports of PET film are currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under item number 3920.62.00.90. HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of the antidumping duty order is dispositive.

Based on our analysis of U.S. Customs and Border Protection (CBP) information and information provided by Shinkong Materials Technology Corporation (SMTC) and its affiliate Shinkong Synthetic Fibers Corporation (SSFC), we determine that SMTC had no shipments of the subject merchandise during the POR.

As there are no changes from, or comments upon, the Preliminary Results, Commerce has not modified its analysis or calculations. Accordingly, no decision memorandum accompanies this Federal Register notice. We continue to find that Nan Ya did not make sales of subject merchandise at less than normal value during the POR.

Commerce determines that the weighted-average dumping margin exists for the period July 1, 2016, through June 30, 2017:

Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries in this review, in accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1). Commerce intends to issue assessment instructions directly to CBP 15 days after publication of these final results of review. Because we calculated a zero margin in the final results of this review for Nan Ya, in accordance with 19 CFR 351.212, we will instruct CBP to liquidate the appropriate entries without regard to dumping duties.

In accordance with Commerce's practice, for entries of subject merchandise during the POR that SMTC or its affiliate, SSFC, did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate such entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Nan Ya will be 0.00 percent, the rate established in the final results of this review; (2) for previously reviewed or investigated companies not covered in this review, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this or any previous review or in the original less-than-fair-value (LTFV) investigation but the manufacturer is, the cash-deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) if neither the exporter nor the manufacturer is a firm covered in this or any previous review or the investigation, the cash-deposit rate will continue to be the all-others rate of 2.40 percent, which is the all-others rate established by Commerce in the LTFV investigation.3 These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the 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 terms of an APO is a violation, which is subject to sanction.

We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).

On January 11, 2018, based on requests from interested parties, Commerce initiated the administrative review on monosodium glutamate (MSG) from the Republic of Indonesia (Indonesia) covering Miwon and CJ Indonesia.1 A detailed description of the events that followed the initiation of this review can be found in the Preliminary Decision Memorandum.2 This administrative review is being conducted in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).

The product covered by this review is MSG from Indonesia. A complete description of the scope of the order can be found in the Preliminary Decision Memorandum.

Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the date of publication of the notice of initiation of the requested review. The notice initiating the instant administrative review was published on January 11, 2018. On April 4, 2018, Daesang America, Inc. (Daesang), a U.S. importer of MSG from Indonesia, timely withdrew its request for an administrative review with respect to Miwon.3 Because Daesang timely withdrew its request for an administrative review of Miwon within 90 days of the date of publication of the Initiation Notice, and as there are no remaining requests to review Miwon, Commerce is rescinding this review with respect to Miwon, in accordance with 19 CFR 351.213(d)(1).

Commerce is conducting this administrative review in accordance with sections 751(a)(1)(B) and (2) of the Act. Export price and constructed export price are calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. A full description of the methodology underlying these preliminary results can be found in the Preliminary Determination Memorandum. A list of the topics included in the Preliminary Decision Memorandum is included as an appendix 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 Duty Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and its electronic version are identical in content.

Commerce preliminarily determines that a weighted-average margin of 24.68 percent exists for CJ Indonesia for the period November 1, 2016, through October 31, 2017.

Upon issuance of the final results of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.4

If the weighted-average dumping margin for CJ Indonesia is not zero or de minimis (i.e., less than 0.5 percent), we will calculate importer-specific ad valorem antidumping duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific assessment rate calculated in the final results of this review is above de minimis (i.e., 0.5 percent). If the respondent's (i.e., CJ Indonesia's) weighted-average dumping margin is zero or de minimis, or an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review where applicable.

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by CJ Indonesia for which the producer did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate entries not reviewed at the all-others rate if there is no rate for the intermediate company (or companies) involved in the transaction.5 We intend to issue appropriate instructions to CBP 15 days after the date of publication of the final results of this review.

For the company for which this review is rescinded (i.e., Miwon), antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions with respect to the company for which this review is being rescinded to CBP 15 days after the publication of this notice.

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for CJ Indonesia will be the rate established in the final results of this review, except if the rate is less than 0.5 percent and, therefore, de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rate will be zero; (2) for previously reviewed or investigated companies not participating in this review, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value (LTFV) investigation, but the manufacturer is covered in this review, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 6.19 percent, the all-others rate established in the LTFV investigation.6 These deposit requirements, when imposed, shall remain in effect until further notice.

Commerce intends to disclose to interested parties the calculations performed in reaching these preliminary results within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit written comments (case briefs) at a date to be determined by Commerce and rebuttal comments (rebuttal briefs) within five days after the time limit for filing case briefs.7 Rebuttal briefs must be limited to issues raised in the case briefs.8 Commerce will notify interested parties when it has determined a deadline for case briefs. Parties who submit case or rebuttal briefs are requested to submit with the argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.9

Interested parties who wish to request a hearing must do so within 30 days of publication of these preliminary results by submitting a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, using Enforcement and Compliance's ACCESS system.10 Hearing requests should contain the party's name, address, and telephone number, the number of participants, and a list of the issues to be discussed. If a request for a hearing is made, we will inform parties of the scheduled date for the hearing, which will be held at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230, at a time and location to be determined.11 Parties should confirm by telephone the date, time, and location of the hearing. Issues addressed at the hearing will be limited to those raised in the briefs.12 All briefs and hearing requests must be filed electronically and received successfully in their entirety through ACCESS by 5:00 p.m. Eastern Time by their respective deadlines.

Commerce intends to issue the final results of this administrative review, including the results of its analysis of issues raised in any written briefs, not later than 120 days after the date of publication of this notice, unless otherwise extended.13

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

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

Commerce published the Preliminary Results on August 10, 2018.1 For events subsequent to the Preliminary Results, see Commerce's Issues and Decision Memorandum.2

Imports covered by the order are shipments of certain non-egg dry pasta. The merchandise subject to review is currently classifiable under items 1901.90.90.95 and 1902.19.20 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive.3

In the Issues and Decision Memorandum, we addressed all issues raised in parties' case and rebuttal briefs. In the Appendix to this notice, we provide a list of the issues raised by parties. The Issues and Decision Memorandum is a public document and is on-file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and in the Central Records Unit (CRU), Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. The signed Issues and Decision Memorandum and the electronic versions of the Issues and Decision Memorandum are identical in content.

Based on our review of the record and comments received from interested parties, these final results do not differ from the Preliminary Results with respect to Ghigi/Zara, Indalco, and the seven firms not subject to individual review.4

As a result of this review, Commerce calculated a weighted-average dumping margin that is above de minimis for Ghigi/Zara and a zero margin for Indalco for the POR. Therefore, consistent with its practice and the methodology set forth in section 735(c)(5)(A) of the Tariff Act of 1930, as amended (the Act), Commerce assigned the weighted-average dumping margin calculated for Ghigi/Zara to the seven non-selected companies in these final results, as referenced below.

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce shall determine and Customs and Border Protection (CBP) shall assess antidumping duties on all appropriate entries.5 For any individually examined respondent whose weighted-average dumping margin is above de minimis, we calculated importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). Upon issuance of the final results of this administrative review, if any importer-specific assessment rates calculated in the final results are above de minimis (i.e., at or above 0.5 percent), Commerce will issue instructions directly to CBP to assess antidumping duties on appropriate entries. Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

In accordance with Commerce's “automatic assessment” practice,6 for entries of subject merchandise during the POR produced by each respondent for which it did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

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

The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication of the final results of this administrative review, as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for respondents noted above will be the rate established in the final results of this administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the manufacturer of the subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 15.45 percent, the all-others rate established in the antidumping investigation as modified by the section 129 determination. These cash deposit requirements, when imposed, shall remain in effect until further notice.

We intend to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

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

This notice also serves as a reminder to parties subject to administrative protective orders (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 are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5).

Chinook salmon (Oncorhynchus tshawytscha): threatened, naturally produced and artificially propagated Snake River Spring/Summer and Snake River Fall.

Steelhead (O. mykiss): threatened, naturally produced and artificially propagated Snake River Basin.

Sockeye salmon (O. nerka): endangered, naturally produced and artificially propagated Snake River.

IDFG submitted the FMEP to NMFS describing fisheries targeting adult adipose-fin-clipped, hatchery-origin steelhead within the State of Idaho and in boundary waters with Oregon and Washington. The plan was submitted under ESA limit 4 of the 4(d) Rule. These fisheries were designed to support fishing opportunities while minimizing potential risks to ESA-listed species. The FMEP describes timing, location, harvest impact limits, licensing, and gear requirements, and requires that all fish caught with an intact adipose fin be released unharmed. A variety of monitoring and evaluation is included in the FMEP.

This reopening is in place of a planned extension of the comment period. NMFS had previously considered extending the comment period by seven days, until December 13. However, extensions may only occur while the comment period is ongoing, and NMFS could not be certain that a public notice of an extension would be published before December 6. Therefore, to avoid potential confusion, we are executing a reopening of the comment period to accept comments until December 13, so that the result is identical to the planned extension. This additional period for public comment will not affect NMFS's overall schedule for completing our ESA review.

As specified in the July 10, 2000, ESA 4(d) rule for salmon and steelhead (65 FR 42422) and updated June 28, 2005 (70 FR 37160), NMFS may approve an FMEP if it meets criteria set forth in 50 CFR 223.203(b)(4)(i)(A) through (I). Prior to final approval of an FMEP, NMFS must publish notification announcing the FMEP's availability for public review and comment.

Under section 4 of the ESA, the Secretary of Commerce is required to adopt such regulations as he deems necessary and advisable for the conservation of species listed as threatened. The ESA salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005) specifies categories of activities that contribute to the conservation of listed salmonids and sets out the criteria for such activities. Limit 4 of the updated 4(d) rule (50 CFR 223.203(b)(4)) further provides that the prohibitions of paragraph (a) of the updated 4(d) rule (50 CFR 223.203(a)) do not apply to fisheries provided that an FMEP has been approved by NMFS to be in accordance with the salmon and steelhead 4(d) rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005).

The subject amendment to Permit No. 20532 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).

Permit No. 20532, issued on October 26, 2016 (81 FR 70100), authorizes the permit holder to receive, import, and export biological samples from seven species of cetaceans from museum holdings, stranded animals, or legally subsistence hunted animals worldwide for scientific research to chronologically profile anthropogenic and physiological data including hormones and pesticides to record exposure and stress. The permit holder is requesting the permit be amended to include authorization to import earwax and baleen samples from additional cetacean species including: 50 each of Bryde's (Balaenoptera edeni), all species of right (Eubalaena spp.), and sei (Balaenoptera borealis) whales, and up to 100 individual unidentified cetaceans.

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 activities proposed are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding copies of the applications to the Marine Mammal Commission and its Committee of Scientific Advisors.

The NOAA Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.

Matters to be Considered: The meeting will include the following topics: (1) Climate Working Group Review of the Climate Program Office Climate and Global Change Post-Doctoral Program; (2) Environmental Information Services Working Group Interim Report on the Use of Observing System Simulation Experiments (OSSEs); (3) Input on the draft NOAA Strategic Aquaculture Science Plan; and (4) Discussion of the NOAA Research and Development Plan. Meeting materials, including work products will be made available on the SAB website: http://sab.noaa.gov/SABMeetings.aspx.

Status: The meeting will be open to public participation with a 5-minute public comment period on February 27th from 3:50-3:55 p.m. EST (check website to confirm time). The SAB expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of one (1) minute. Written comments for the meeting should be received in the SAB Executive Director's Office by February 20, 2019 to provide sufficient time for SAB review. Written comments received after February 20 will be distributed to the SAB, but may not be reviewed prior to the meeting date. Seating at the meeting will be available on a first-come, first served basis.

Special Accommodations: These meetings are physically accessible to people with disabilities. Requests for special accommodations may be directed no later than 12:00 p.m. on February 20, 2019, to Dr. Cynthia Decker, SAB Executive Director, SSMC3, Room 11230, 1315 East-West Highway, Silver Spring, MC 20910; Email: [email protected].

The Department of the Army plans to grant an exclusive license to H2 Power, LLC related to “Aluminum based nanogalvanic compositions useful for generating hydrogen gas and low temperature processing thereof”, U.S. Patent Application No.: 16/042632, Filing Date July, 2018 in the fields of use related to;

The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the U.S. Army Research Laboratory receives written objections including evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). Competing applications completed and received by the U.S. Army Research Laboratory within fifteen (15) days from the date of this published notice will also be treated as objections to the grant of the contemplated exclusive license.

Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Public Comments: The JSC solicited public comments for these supplementary materials via the Federal Register on July 11, 2017 (82 FR 31952-31953, Docket ID: DoD-2017-OS-0032), held a public meeting on August 3, 2017, and published the JSC response to public comments via the Federal Register on May 23, 2018 (83 FR 23907-23908, Docket ID: DoD-DoD-2018-OS-0024).

Due to the length of the changes, they are being made available on the internet rather than being printed in the Federal Register. The supplementary materials are available at http://jsc.defense.gov.

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: State Charter School Facilities Incentive Grants Program (1894-0001).

OMB Control Number: 1855-0012.

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

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

Total Estimated Number of Annual Responses: 12.

Total Estimated Number of Annual Burden Hours: 480.

Abstract: The State Charter School Facilities Incentive Grants Program allows States to apply for Federal assistance. These grants are made to States to provide them with an incentive to create new or enhance existing per-pupil facilities aid programs for charter schools. The applicants will provide a description of their proposed activities and provide information necessary to determine which grant applications should be funded. An additional part of the application consists of assurances regarding the applicant's compliance with applicable Federal laws and regulations. The information provided in the application will allow field readers and the Department of Education to determine if applicants are eligible and identify which applications most merit funding.

This information collection request contains:

(1) 1910-NEW;

(2) Information Collection Request Title: Combined Heat and Power (CHP) Packaged System e-Catalog (e-Catalog);

(3) Type of Request: New.

(4) Purpose: DOE's “CHP Technical Potential in the U.S.” shows significant technical potential in commercial buildings and industrial facilities in the < 10MW size range. Due to building characteristic similarities, this size range is particularly disposed to standardization of CHP systems. The e-Catalog creates a mechanism to take advantage of this standardization including the risk and cost reduction that are expected to ensue. This request for information consists of a voluntary data collection process for e-Catalog participation: to enroll CHP packagers and CHP solutions providers; develop an e-Catalog of packaged CHP systems; and relay the benefits of packaged CHP system performance to industry. Typical respondents are expected to be CHP project developers, CHP designers and packagers, and state and local energy program offices. Each respondent should have experience with compiling the data requested. Participation in the e-Catalog is voluntary, and it is expected that respondents would already have access to the information requested in this collection.

There are four types of information to be collected from primary participants: (1) Background data, including contact information and basic information about the CHP packager's experience with CHP design, durability and performance testing—collected in the CHP Packager Enrollment Form; (2) Background data, including contact information and basic information about the CHP solutions provider's experience with CHP design, durability and performance testing, installation, operation and maintenance—collected in the CHP Solutions Provider Enrolment Form; (3) contact information and program description of market engagement programs that support Packaged CHP systems—collected in the Market Engagement Registration Form; and (4) Information, including packaged system component descriptions, design data, full-load and part-load performance data at three ambient conditions—collected in Packaged CHP System Application Form; Background data will primarily be used as a means to recognize CHP packers and solution providers, and establish the e-Catalog.

(5) Annual Estimated Number of Respondents: 50;

(6) Annual Estimated Number of Total Responses: 177;

(7) Annual Estimated Number of Burden Hours: 739;

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: $30,506.

Comments are invited on: (a) Whether the proposed 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.

Summary of Change in Control

The Notice was filed under section 3 of the Natural Gas Act (NGA), 15 U.S.C. 717b. Pieridae US filed a Notice of Change in Control in the above-referenced docket on August 31, 2018.1 In the Notice, Pieridae US states that it is wholly-owned by Pieridae Energy Limited (Pieridae). Pieridae US further states that, during July 2018, Electron Capital Partners, LLC (a Delaware corporation), either alone or together with Electron Global Master Fund, L.P. (collectively, Electron) acquired beneficial ownership of, or exercised control or direction over, 10% or more of all issued and outstanding common shares of Pieridae. As of July 31, 2018, Electron beneficially owned, or exercised control or direction over, 7,127,775 common shares of Pieridae, representing approximately 14.1% of Pieridae's issued and outstanding common shares.2

Additional details can be found in the Notice, posted on the DOE/FE website at: https://www.energy.gov/sites/prod/files/2018/09/f55/CIC%2008_31_18.pdf.

DOE/FE will review Pieridae US's Notice in accordance with its Procedures for Changes in Control Affecting Applications and Authorizations to Import or Export Natural Gas (CIC Procedures).3 Consistent with the CIC Procedures, this notice addresses only the proceeding in which Pieridae US has been granted final authorization to export liquefied natural gas (LNG) to countries with which the United States has not entered into a free trade agreement (FTA) requiring national treatment for trade in natural gas (non-FTA countries). The affected proceeding is FE Docket No. 14-179-LNG. If no interested person protests the change in control and DOE takes no action on its own motion, the change in control will be deemed granted 30 days after publication in the Federal Register. If one or more protests are submitted, DOE will review any motions to intervene, protests, and answers, and will issue a determination as to whether the proposed change in control has been demonstrated to render the underlying authorization inconsistent with the public interest.

Interested persons will be provided 15 days from the date of publication of this notice in the Federal Register in order to move to intervene, protest, and answer Pieridae US's Notice. Protests, motions to intervene, notices of intervention, and written comments are invited only as to the change in control described in the Notice.4 All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by DOE's regulations in 10 CFR part 590.

Filings may be submitted using one of the following methods: (1) Preferred method: emailing the filing to [email protected], with the individual FE Docket Number(s) in the title line, or Pieridae Change in Control in the title line to include all applicable dockets in this Notice; (2) mailing an original and three paper copies of the filing to the Office of Regulation, Analysis, and Engagement at the address listed in ADDRESSES; or (3) hand delivering an original and three paper copies of the filing to the Office of Regulation, Analysis, and Engagement at the address listed in ADDRESSES. All filings must include a reference to the individual FE Docket Number(s) in the title line, or Pieridae Change in Control in the title line to include all applicable dockets in this Notice. Please Note: If submitting a filing via email, please include all related documents and attachments (e.g., exhibits) in the original email correspondence. Please do not include any active hyperlinks or password protection in any of the documents or attachments related to the filing. All electronic filings submitted to DOE must follow these guidelines to ensure that all documents are filed in a timely manner. Any hardcopy filing submitted greater in length than 50 pages must also include, at the time of the filing, a digital copy on disk of the entire submission.

The Notice and any filed protests, motions to intervene or notice of interventions, and comments are available for inspection and copying in the Office of Regulation, Analysis, and Engagement docket room, Room 3E-042, 1000 Independence Avenue SW, Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

The Notice and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address: http://www.fe.doe.gov/programs/gasregulation/index.html.

On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the Federal Register (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

On September 11, 2018, the Kansas Department of Health and Environment (KDHE) submitted an application titled “Kansas Environmental Information Management System” for revisions/modifications to its EPA-approved programs under title 40 CFR to allow new electronic reporting. EPA reviewed KDHE's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Kansas' request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 50-52, 60-65, and 70, is being published in the Federal Register:

Part 52—Approval and Promulgation of Implementation Plans;

Part 60—Standards of Performance For New Stationary Sources;

Part 62—Approval and Promulgation of State Plans for Designated Facilities and Pollutants;

Part 63—National Emission Standards for Hazardous Air Pollutants for Source Categories; and

Part 70—State Operating Permit Programs.

KDHE was notified of EPA's determination to approve its application with respect to the authorized programs listed above.

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 EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The New Source Performance Standards (NSPS) for Metallic Mineral Processing Plants (40 CFR part 60, subpart LL) apply to the following facilities at metallic mineral processing plants: Each crusher and screen at open-pit mines and each crusher, screen, bucket elevator, conveyor belt transfer point, thermal dryer, product packaging station, storage bin, enclosed storage area, and truck loading and unloading station at mills or concentrators commencing construction, modification or reconstruction after the date of proposal. The NSPS does not apply to facilities located in underground mines or uranium ore beneficiation processing plants.

In general, all NSPS 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 the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 60, subpart LL.

Form numbers: None.

Respondents/affected entities: Metallic mineral processing plants.

Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart LL).

Estimated number of respondents: 20 (total).

Frequency of response: Initially, occasionally, and semiannually.

Total estimated burden: 2,330 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $268,000 (per year), which includes $13,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is an adjustment increase of 24 labor hours due to a change in assumption. This ICR assumes all existing sources will spend time each year to re-familiarize with the regulations. There are no other changes in burden in this ICR compared to the previous ICR. This is due to two considerations: (1) The regulations have not changed over the past three years, and are not anticipated to change over the next three years; and (2) the growth rate for the industry is very low, negative or non-existent, so there is no significant change in the overall burden.

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 EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The New Source Performance Standards (NSPS) for Kraft Pulp Mills apply to the following facilities at kraft pulp mills: Recovery furnaces, smelt dissolving tanks, lime kilns, digester systems, brown stock washer systems, black liquor oxidation systems, multiple effect evaporator systems and condensate stripper systems that were constructed, modified or reconstructed after the date of proposal. In pulp mills where kraft pulping is combined with neutral sulfite semi-chemical pulping, the provisions of this Subpart are applicable when any portion of the material charged to an affected facility is produced by the kraft pulping operation. Facilities may be exempt from the total reduced sulfur (TRS) standard if the facility can demonstrate that TRS emissions from a new, modified, or reconstructed brown stock washer can be neither technically nor economically feasible to control.

In general, all NSPS 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 the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 60, subpart BB.

Form numbers: None.

Respondents/affected entities: Kraft pulp mills.

Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart BB).

Estimated number of respondents: 97 (total).

Frequency of response: Initially, occasionally and semiannually.

Total estimated burden: 13,900 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $5,020,000 (per year), which includes $3,510,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the estimates: There is an adjustment decrease in the estimated burden and cost as currently identified in the OMB Inventory of Approved Burdens. The decrease is not due to any program changes. The change in burden is due to an industry decline since the last ICR renewal, resulting in a decrease in the number of respondent subject to the standard.

Notice of Final Action

On April 25, 2018, EPA Region IX initially issued PSD Permit No. SE 17-01 to Palmdale Energy, LLC under 40 CFR 124.15, authorizing the construction and operation of the PEP. By its own terms, and consistent with 40 CFR 124.15(b), the effective date of the permit was delayed as the result of the filing of a petition for review of the Region's permit decision with the EAB.

On October 23, 2018, the EAB denied review of the permit decision. See In re Palmdale Energy LLC, PSD Appeal No. 18-01 (EAB Oct. 23, 2018), 17 E.A.D. __ (Order Denying Review). Following the EAB's action, pursuant to 40 CFR 124.19(l)(2), EPA Region IX issued a final permit decision on October 25, 2018. All conditions of the PEP PSD permit, as initially issued by EPA Region IX on April 25, 2018, were final and effective as of October 25, 2018.

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 EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The NESHAP for Ferroalloys Production: Ferromanganese and Silicomanganese applies to new and existing ferroalloy production facilities that manufacture ferromanganese and silicomanganese, and that are either major sources of hazardous air pollutant (HAP) emissions or are co-located at major sources of HAPs. The following affected facilities at ferroalloy production plants are subject to this NESHAP rule: Submerged arc furnaces; metal oxygen refining processes; crushing and screening operations; and fugitive dust sources. New facilities include those that commenced construction or reconstruction after the date of proposal.

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 the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 63, subpart XXX.

Form numbers: None.

Respondents/affected entities: Ferroalloy production facilities.

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

Estimated number of respondents: 2 (total).

Frequency of response: Initially, quarterly, semiannually, and annually.

Total estimated burden: 1,170 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $133,000 (per year); there are no annualized capital/startup and operation & maintenance costs.

Changes in the estimates: There is an increase in the total estimated respondent burden compared with the ICR currently-approved by OMB. The adjustment increase in burden is due to more accurate estimates of existing and anticipated new sources, as identified during the development of the final rule amendments.

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 either 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 EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Pesticide Active Ingredient Production (40 CFR part 63, subpart MMM) apply to existing and new facilities engaged in the production of pesticide active ingredients (PAIs) that emit HAPs. New facilities include those that commenced construction, modification or reconstruction after the date of proposal.

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 the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 63, subpart MMM.

Form numbers: None.

Respondents/affected entities: Owners and operators of pesticides active ingredient production operations.

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

Estimated number of respondents: 18.

Frequency of response: Initially, quarterly, and semiannually.

Total estimated burden: 12,100 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $1,350,000 (per year), which includes $26,500 in annualized capital/startup and/or operation & maintenance costs.

Changes in the estimates: There is a decrease in the total capital/startup cost and O&M cost due to a correction. This ICR corrects an error in the capital/startup cost calculation in the previous ICR, as existing sources are not expected to incur capital/startup costs associated with purchasing PRD electronic indicators. There is also a small adjustment increase in the estimated labor hours due to a change in assumption. This ICR assumes all existing sources will take some time to re-familiarize with the regulations each year.

OMB Control Number: 3060-1207.

Title: Sections 25.701, Other DBS Public Interest Obligations, and 25.702, Other SDARS Public Interest Obligations.

Form Number: None.

Type of Review: Extension of an existing collection.

Respondents: Business or other for profit entities.

Number of Respondents and Responses: 3 respondents and 3 responses.

Estimated Hours per Response: 18 hrs.

Frequency of Response: On occasion reporting requirement, Recordkeeping requirement, Third party disclosure requirement.

Total Annual Burden: 54 hours.

Total Annual Cost: $592.

Obligation to Respond: Required to be obtained or retained for benefits. The statutory authority for this information collection is contained in sections 154, 301, 302, 303, 307, 309, 319, 332, 605, and 721 of the Communications Act of 1934, as amended.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Privacy Act Assessment: The Commission prepared a system of records notice (SORN), FCC/MB-2, “Broadcast Station Public Inspection Files,” that covers the PII contained in the broadcast station public inspection files located on the Commission's website. The Commission will revise appropriate privacy requirements as necessary to include any entities and information added to the online public file in this proceeding.

Needs and Uses: In 2012, the Commission replaced the decades-old requirement that commercial and noncommercial television stations maintain public files at their main studios with a requirement to post most of the documents in those files to a central, online public file hosted by the Commission. On January 28, 2016, the Commission adopted a Report and Order (“R&O”) in MB Docket No. 14-127, FCC 16-4, In the Matter of Expansion of Online Public File Obligations to Cable and Satellite TV Operators and Broadcast and Satellite Radio Licensees, expanding the requirement that public inspection files be posted to the FCC-hosted online public file database to satellite TV (also referred to as “Direct Broadcast Satellite” or “DBS”) providers and to satellite radio (also referred to as “satellite Digital Audio Radio Services” or “SDARS”) licensees, among other entities. The Commission stated that its goal is to make information that these entities are already required to make publicly available more accessible while also reducing costs both for the government and the public sector. The Commission took the same general approach to transitioning these entities to the online file that it took with television broadcasters in 2012, tailoring the requirements as necessary to the different services. The Commission also took similar measures to minimize the effort and cost entities must undertake to move their public files online. Specifically, the Commission required entities to upload to the online public file only documents that are not already on file with the Commission or that the Commission maintains in its own database. The Commission also exempted existing political file material from the online file requirement and required that political file documents be uploaded only on a going-forward basis.

The Commission first adopted a public inspection file requirement for broadcasters more than 40 years ago. The public file requirement grew out of Congress' 1960 amendment of Sections 309 and 311 of the Communications Act of 1934. Finding that Congress, in enacting these provisions, was guarding “the right of the general public to be informed, not merely the rights of those who have special interests,” the Commission adopted the public inspection file requirement to “make information to which the public already has a right more readily available, so that the public will be encouraged to play a more active part in dialogue with broadcast licensees.” The information provided in the public file enables citizens to engage in an informed dialog with their local video provider or to file complaints regarding provider operations. Satellite TV (also known as “Direct Broadcast Satellite” or “DBS”) providers and satellite radio (also referred to as “Satellite Digital Audio Radio Services” or “SDARS”) licensees have public and political file requirements modeled, in large part, on the longstanding broadcast requirements. With respect to DBS providers, the Commission adopted public and political inspection file requirements in 1998 in conjunction with the imposition of certain public interest obligations, including political broadcasting requirements, on those entities. DBS providers were required to “abide by political file obligations similar to those requirements placed on terrestrial broadcasters and cable systems” and were also required to maintain a public file with records relating to other DBS public interest obligations. The Commission imposed equal employment opportunity and political broadcast requirements on SDARS licensees in 1997, noting that the rationale behind imposing these requirements on broadcasters also applies to satellite radio.

The information collection requirements contained in 47 CFR 25.701(d) require each DBS provider to keep and permit public inspection of a complete and orderly record (political file) of all requests for DBS origination time made by or on behalf of candidates for public office, together with an appropriate notation showing the disposition made by the provider of such requests, and the charges made, if any, if the request is granted. The disposition includes the schedule of time purchased, when the spots actually aired, the rates charged, and the classes of time purchased. Also, when free time is provided for use by or on behalf of candidates, a record of the free time provided is to be placed in the political file. All records required to be retained by this section must be placed in the political file as soon as possible and retained for a period of two years. DBS providers must make available, by fax, email, or by mail upon telephone request, copies of documents in their political files and assist callers by answering questions about the contents of their political files. If a requester prefers access by mail, the DBS provider must pay for postage but may require individuals requesting documents to pay for photocopying. If a DBS provider places its political file on its website, it may refer the public to the website in lieu of mailing copies.

Any material required to be maintained in the political file must be made available to the public by either mailing or website access or both.

The information collection requirements contained in 47 CFR 25.701(d) require DBS providers to place all new political file material required to be retained by this section in the online file hosted by the Commission.

47 CFR 25.701(f)(6) information collection requirements require each DBS provider to maintain a public file containing a complete and orderly record of quarterly measurements of: Channel capacity and yearly average calculations on which it bases its four percent reservation, as well as its responses to any capacity changes; a record of entities to whom noncommercial capacity is being provided, the amount of capacity being provided to each entity, the conditions under which it is being provided and the rates, if any, being paid by the entity; and a record of entities that have requested capacity, disposition of those requests and reasons for the disposition. All records required by this provision must be placed in a file available to the public as soon as possible and be retained for a period of two years.

47 CFR 25.701(f)(6) to require DBS providers to place all public file material required to be retained by this section in the online file hosted by the Commission. Each DBS provider must place in the online file the records required to be placed in the public inspection file by 47 CFR 25.701(e)(commercial limits in children's programs) and by 47 CFR 25.601 and Part 76, Subpart E (equal employment opportunity requirements) and retain those records for the period required by those rules. In addition, each DBS provider is required to provide a link to the public inspection file hosted on the Commission's website from the home page of its own website, if the provider has a website, and provide on its website contact information for a representative who can assist any person with disabilities with issues related to the content of the public files. Each DBS provider is also required to include in the online public file the name, phone number, and email address of the licensee's designated contact for questions about the public file. In addition, each DBS provider must place the address of the provider's local public file in the Commission's online file unless the provider has fully transitioned to the FCC's online public file (e.g., posts to the FCC's online file database all public and political file material required to be maintained in the public inspection file) and also provides online access via the provider's own website to back-up political file material in the event the online file becomes temporarily unavailable.

47 CFR 25.702(b) requires each SDARS licensee to maintain a complete and orderly record (political file) of all requests for SDARS origination time made by or on behalf of candidates for public office, together with the disposition made by the provider of such requests, and the charges made, if any, if the request is granted. The disposition must include the schedule of time purchased, when the spots actually aired, the rates charged, and the classes of time purchased. Also, when free time is provided for use by or on behalf of candidates, a record of the free time provided is to be placed in the political file. SDARS licensees are required to place all records required by this section in the political file as soon as possible and retain the record for a period of two years.

The information collection requirements contained in 47 CFR 25.702(c) require each SDARS applicant or licensee to place in the online file hosted by the Commission the records required to be placed in the public inspection file by 47 CFR 25.601 and 73.2080 (equal employment opportunities) and to retain those records for the period required by those rules. Each SDARS licensee must provide a link to the public inspection file hosted on the Commission's website from the home page of its own website, if the licensee has a website, and provide on its website contact information for a representative who can assist any person with disabilities with issues related to the content of the public files. Each SDARS licensee is also required to include in the online public file the name, phone number, and email address of the licensee's designated contact for questions about the public file. In addition, each SDARS licensee must place the address of the provider's local public file in the Commission's online file unless the provider has fully transitioned to the FCC's online public file (i.e., posts to the Commission's online public file all public and political file material required to be maintained in the public inspection file) and also provides online access via the licensee's own website to back-up political file material in the event the online file becomes temporarily unavailable.

OMB Control Number: 3060-0265.

Title: Section 80.868, Card of Instructions.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities, not-for-profit institutions and state, local or tribal government.

Number of Respondents: 4,506 respondents; 4,506 responses.

Estimated Time per Response: 10 minutes (0.167 hours).

Frequency of Response: Third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154, 303, 307(e), 309 and 332.

Total Annual Burden: 753 hours.

Total Annual Cost: No cost.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Needs and Uses: The third party disclosure requirement contained in 47 CFR 80.868 of the Commission's rules is necessary to ensure that radiotelephone distress procedures must be securely mounted and displayed in full view of the principal operating position on board certain vessels (300 gross tons) required by the Communications Act or the International Convention for Safety of Life at Sea to be equipped with a radiotelephone station.

The information is used by a vessel radio operator during an emergency situation, and is designed to assist the radio operator to utilize proper distress procedures during a time when he or she may be subject to considerable stress or confusion.

FRTIB is proposing to establish a new system of records entitled, “FRTIB-20, Communications, Education, and Outreach Materials.” The proposed system of records is necessary to assist FRTIB's Office of Communications and Education in effectively educating and communicating with Thrift Savings Plan (TSP) participants and other individuals.

Files maintained as part of FRTIB-20 include: Information about TSP participants and other individuals who receive educational messages from FRTIB or who have otherwise corresponded with FRTIB, including names, personal and business phone numbers, mailing addresses, email addresses, and social media handles; aggregated data and FRTIB analysis of participant behavior; incoming feedback and other correspondence; FRTIB's response; the FRTIB responder's name and business information; additional unsolicited personal information provided by individuals; video recordings of volunteer participants; and related materials. FRTIB is proposing to add sixteen routine uses to apply to FRTIB-20.

Tobacco use is the leading cause of preventable disease, disability, and death in the United States.1 The burden of death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other combusted tobacco products; therefore, rapid elimination of their use will dramatically reduce this burden.1

Cigarette smoking alone causes more than 480,000 deaths each year, including more than 41,000 secondhand smoke related deaths, and costs the country over $300 billion annually in health care spending and lost productivity.1 2 Cigarette smoking is causally linked to numerous types of cancer, respiratory and cardiovascular diseases, diabetes, eye disease, complications to pregnancy and reproduction, and compromises the immune system.

Any form of tobacco product use is unsafe for youth, irrespective of whether it is smoked, smokeless, or electronic. Since brain development continues through the early to mid-20s, the use of products containing nicotine, including e-cigarettes, can be harmful to youth and young adults. Specifically, the use of these products can disrupt the growth of brain circuits that control attention, learning, and susceptibility to addiction.3 In 2018, nearly 4.9 million United States middle and high school students currently used (≥1 day in past 30 days) at least one type of tobacco product, with e-cigarettes being the most commonly used tobacco product.4 Flavors are a major factor contributing to the use of these products among young people; 85% of youth e-cigarette users report using flavors.5 The use of e-cigarettes may also lead to future cigarette smoking among some youth.6 In addition to e-cigarettes, youth also use several other types of tobacco products, and disparities in use of these products exist across population groups.14

The U.S. Surgeon General has concluded that there is no risk-free level of secondhand smoke exposure; even brief exposure can be harmful to health.7 8 During 2011-2012, about 58 million nonsmokers in the United States were exposed to secondhand smoke, and exposure remains higher among children, non-Hispanic blacks, those living in poverty, and those who rent their housing.9 Secondhand smoke exposure can cause heart disease, lung cancer, and stroke among adults, as well as the following in children: 1 7 8

Although progress has been made in reducing tobacco use in the general population, disparities persist across population groups.1 These disparities can affect populations on the basis of certain factors, including but not limited to: 10 11

Addressing the social and environmental factors that influence tobacco use can advance equity in tobacco prevention and control, and reduce tobacco-related disparities among populations disproportionately impacted by tobacco use.12 These efforts can help reduce the overall prevalence of tobacco use.13

Approach: CDC is seeking input to inform future activities to advance tobacco control practices to prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities. The information gathered will be used to inform activities that encompass technical assistance and guidance to state tobacco control programs and collaborative work with national governmental and nongovernmental partners, who share CDC's goals to prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities.

CDC is specifically interested in receiving information on the following issues:

(1) What innovative strategies are working in communities to prevent tobacco use among youth, especially in terms of flavored tobacco products and e-cigarettes?

(2) How can CDC best educate all community members about the harmful effects of secondhand smoke exposure?

(3) How can CDC support state and local health departments and their partners to improve community engagement with populations most at risk for tobacco use?

(4) What innovative strategies are effective in communities to decrease tobacco use in population groups that have the greatest burden of tobacco use and secondhand smoke exposure?

(5) What science, tools, or resources does the public health sector need CDC to develop in order to enhance and sustain tobacco prevention and control efforts?

Contents

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

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

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: National Implementation of the Hospital CAHPS Survey; Use: The HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) Survey, also known as the CAHPS® Hospital Survey or Hospital CAHPS®, is a standardized survey instrument and data collection methodology that has been in use since 2006 to measure patients' perspectives of hospital care. While many hospitals collect information on patient satisfaction, HCAHPS created a national standard for the collection and public reporting of information that enables valid comparisons to be made across all hospitals to support consumer choice.

In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38328 through 38342), out of an abundance of caution, in the face of a nationwide epidemic of opioid over prescription, we finalized a refinement to the HCAHPS Survey measure as used in the Hospital Inpatient Quality Reporting Program by removing the previously adopted Pain Management questions and incorporating new Communication About Pain questions beginning with patients discharged in January 2018. As discussed in the CY 2019 OPPS/ASC proposed rule (83 FR 37218), since finalization of the Communication About Pain questions, we have received feedback that some stakeholders are concerned that, although the revised questions focus on communications with patients about their pain and treatment of that pain, rather than how well their pain was controlled, the questions still could potentially impose pressure on hospital staff to prescribe more opioids in order to achieve higher scores on the HCAHPS Survey.

In response to stakeholder feedback, recommendations from the President's Commission on Combatting Drug Addiction and the Opioid Crisis, to comply with the requirements of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (Pub. L. 115-271), and to avoid any potential unintended consequences under the Hospital Inpatient Quality Reporting (IQR) Program, CMS is revising the HCAHPS survey by removing the three recently revised pain communication questions. The removal of these questions is effective with October 2019 discharges. At that point, the HCAHPS Survey will consist of 29 questions which will decrease the burden hours. Form Number: CMS-10102 (OMB control number 0938-0981); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 4,200; Total Annual Responses: 3,104,200; Total Annual Hours: 379,290. (For policy questions regarding this collection contact William Lehrman at 410-786-1037.)

2. Type of Information Collection Request: Extension; Title of Information Collection: Student Health Insurance Coverage; Use: Under the Student Health Insurance Coverage Final Rule published March 21, 2012 (77 FR 16453), student health insurance coverage is a type of individual health insurance coverage provided pursuant to a written agreement between an institution of higher education (as defined in the Higher Education Act of 1965) and a health insurance issuer, and provided to students who are enrolled in that institution and their dependents. The Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017 Final Rule provided that, for policy years beginning on or after July 1, 2016, student health insurance coverage is exempt from the actuarial value (AV) requirements under section 1302(d) of the Affordable Care Act, but must provide coverage with an AV of at least 60 percent. This provision also requires issuers of student health insurance coverage to specify in any plan materials summarizing the terms of the coverage the AV of the coverage and the metal level (or the next lowest metal level) the coverage would otherwise satisfy under § 156.140. This disclosure will provide students with information that allows them to compare the student health coverage with other available coverage options. Form Number: CMS-10377 (OMB control number 0938-1157); Frequency: Annually; Affected Public: Private Sector; Number of Respondents: 52; Total Annual Responses: 1,176,235; Total Annual Hours: 52. (For policy questions regarding this collection contact Russell Tipps at 301-492-4371.)

I. Background A. Drug Compounding

Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounded drug products serve an important role for patients whose clinical needs cannot be met by an FDA-approved drug product, such as for a patient who has an allergy to a certain dye contained in an FDA-approved drug product and needs a medication compounded without that dye, or an elderly patient or a child who cannot swallow a pill and needs a medicine in a liquid form that is not available in an approved product. Drug products can be compounded consistent with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) by licensed pharmacists in State-licensed pharmacies and Federal facilities, or by licensed physicians, or consistent with section 503B of the FD&C Act (21 U.S.C. 353b) by compounders known as outsourcing facilities.

Sometimes, it is necessary for HCPs in hospitals, clinics, offices, or other settings to have a certain compounded drug product on hand, so they can administer it to a patient who presents with an immediate need for the compounded drug product. Such drug products are often known as “office stock,” and outsourcing facilities are uniquely permitted to supply these compounded products in accordance with the law.

For example, if a patient presents at an ophthalmologist's office with a fungal eye infection, timely administration of a compounded antifungal medication may be critical to preventing vision loss. In such a case, the ophthalmologist may need to inject the patient with a compounded drug product immediately, rather than writing a prescription and waiting for the drug product to be compounded and shipped to the prescriber. In other cases, compounded drug products may need to be administered by a healthcare practitioner in his or her office because it would not be safe for the patient to take the drug home for self-administration, and it would be preferable for the physician to have the drug in his or her office to administer immediately upon diagnosis, rather than asking the physician to order the drug and have the patient return to the healthcare practitioner for administration.

Although compounded drugs can serve an important role for certain patients in cases such as these, they also can pose a higher risk to patients than FDA-approved drugs. Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. Because compounded drug products are subject to a lower regulatory standard than FDA-approved drug products, they present a greater risk to patients and should not be administered to patients unless their medical needs cannot be met by FDA-approved drug products.

Sections 503A and 503B of the FD&C Act address human drug compounding. Section 503A, added to the FD&C Act by the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act:

• Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning CGMP requirements);

• section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and

• section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications).

A compounded drug product may be eligible for the exemptions under section 503A of the FD&C Act only if it is, among other things, compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient. Among other conditions, to qualify for the exemptions under section 503A, the drug product must be compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician (section 503A(a)).

New section 503B, added to the FD&C Act by the Drug Quality and Security Act in 2013, created a new category of compounders called outsourcing facilities. Section 503B defines outsourcing facility, in part, as a facility that is engaged in the compounding of sterile drugs (section 503B(d)(4)(A)(i)). An outsourcing facility may engage in nonsterile compounding provided that it also engages in the compounding of sterile drugs, and provided that it compounds all of its drugs (both sterile and nonsterile) in accordance with the conditions of section 503B.

Section 503B of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility to qualify for exemptions from three sections of the FD&C Act:

• Section 502(f)(1);

• section 505; and

• section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements).

In contrast to compounders compounding in accordance with section 503A of the FD&C Act, outsourcing facilities may, but need not, obtain prescriptions for identified individual patients for their compounded drug products (section 503B(d)(4)(C)). Outsourcing facilities are subject to CGMP requirements in section 501(a)(2)(B). They must also be inspected by FDA according to a risk-based schedule and are subject to specific adverse event reporting requirements and other conditions that help to mitigate the risks of the drug products they compound.

Elsewhere in this issue of the Federal Register, FDA announced the availability of a revised draft guidance for industry entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” (revised draft guidance). FDA previously issued a draft guidance for industry on this subject in July 2014 (79 FR 37743). This guidance, once final, will provide for conditions under which FDA generally does not intend to take regulatory action against an outsourcing facility regarding certain CGMP requirements in 21 CFR parts 210 and 211 during the interim period before FDA issues regulations specific to outsourcing facilities. In developing policies pertaining to CGMP requirements for outsourcing facilities, FDA seeks to recognize the differences between outsourcing facilities and conventional drug manufacturers and to develop policies that reflect the specific compounding operations conducted by outsourcing facilities. The revised draft guidance proposes a risk-based approach to enforcement of CGMP requirements, tailored to the size and scope of outsourcing facilities' operations. The policies are aimed at making it more feasible for entities to register as outsourcing facilities to compound drugs for office stock in accordance with CGMP requirements, while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.

In the revised draft guidance, FDA made a number of revisions to address comments submitted on the 2014 draft. For example, the revised draft guidance differentiates between CGMP requirements applicable to sterile drug products and nonsterile drug products where appropriate. Among other changes, FDA made revisions to address comments on (1) stability testing, including the assignment of a beyond use date (BUD) as an expiration date; (2) a clear definition of “in-use time,” distinguishing it from “BUD” and “expiration date”; (3) testing batches before release for distribution; and (4) collection and use of samples retained from distributed batches, known as reserve samples. For a more comprehensive discussion of the policies proposed in the revised draft guidance, please see the revised draft guidance (available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov) and associated notice of availability, which FDA is publishing elsewhere in this issue of the Federal Register. In the docket for the revised draft guidance, FDA is seeking comment on whether the conditions outlined appropriately balance the risks and needs associated with compounded drugs produced for office stock.

FDA is seeking public input regarding outsourcing facilities supplying compounded drugs for office stock in light of the CGMP policies described in the revised draft guidance, if finalized as written. FDA has developed a list of topics to facilitate a productive discussion at the public meeting. This list is not intended to be exhaustive, and FDA encourages comments on the potential implications of the policies pertaining to compliance with CGMP requirements described in the revised draft CGMP guidance, if finalized as written, for outsourcing facilities supplying drugs compounded for office stock. Policies include, but are not limited to, those related to stability studies, beyond use dating, and release testing. Issues that are of specific interest to the Agency include the following:

• Perspectives related to demand and supply of office stock, including:

○ Ways in which HCPs seek to identify outsourcing facilities that compound the drugs they want for office stock, as well as issues, if any, with this process.

○ Communications between HCPs and outsourcing facilities to address potential issues related to requested formulations, timing, and order size.

○ Coordination or consolidation of orders among providers for same or similar compounded drug products.

○ HCPs' experiences with the availability of office stock products from outsourcing facilities.

• Perspectives related to orders for drug products that an outsourcing facility has not made or does not routinely make.

○ Factors outsourcing facilities consider before deciding whether to fill an order for a requested compounded drug product that it has not previously made or does not routinely make.

○ The impact that FDA's policies proposed in the revised draft guidance would have on outsourcing facilities filling orders for requested products not previously or routinely made.

• Perspectives related to small volume orders of office stock products, including:

○ HCPs' experiences seeking small volume orders from outsourcing facilities.

○ Factors outsourcing facilities consider before determining whether to produce small batches of compounded drug products for office stock.

○ The impact that FDA's policies proposed in the revised draft guidance would have on outsourcing facilities' decisions regarding filling small volume orders and/or producing small batches of compounded drug products for office stock.

○ Whether/how the revisions proposed in the revised draft guidance would affect registration of compounders engaged in smaller-scale production as outsourcing facilities.

• Perspectives related to beyond use dating for office stock products, including:

○ How long HCPs seek to keep office stock drug products before use.

○ The impact that FDA's policies proposed in the revised draft guidance would have on outsourcing facilities' production of compounded drug products for office stock with beyond use dating desired by HCPs.

FDA will post the agenda and other meeting materials at least 5 days before the meeting on the public meeting website. More information regarding the meeting, including the public meeting website address, will be posted at: https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm.

Registration: Persons interested in attending this public meeting must register online by May 7, 2019. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. More information regarding the meeting, including the public meeting website address and registration instructions, will be posted at: https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm.

Registration is free and in-person attendance is based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 8:30 a.m. We will post information at https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm if registration closes before the day of the public meeting.

If you need special accommodations due to a disability, please contact [email protected] no later than May 14, 2019.

Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session and which topic(s) you wish to address. All requests to make oral presentations must be received by March 1, 2019. You will also be asked to send [email protected] a brief summary your comments by March 1, 2019. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to present. For more information on oral presentation requests, visit https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin. We will do our best to accommodate all stakeholders who wish to speak; however, the duration of comments may be limited by time constraints, including time allowances for each topic. Presenters will be notified of their selection no later than May 7, 2019. If selected for presentation, any presentation materials must be emailed to the [email protected] no later than May 14, 2019. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

Streaming Webcast of the Public Meeting: This public meeting will also be webcast. Further information regarding the webcast, including the address for the webcast, will be made available at least 2 days in advance of the meeting on the public meeting website. More information regarding the meeting, including the public meeting website address, will be posted at: https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm. FDA has verified the website addresses in this document, 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 revised draft guidance for industry entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” Under section 503B(b) of the FD&C Act (21 U.S.C. 353b(b)), a compounder can register as an outsourcing facility with FDA. Drug products compounded in an outsourcing facility can qualify for exemptions from FDA approval requirements in section 505 of the FD&C Act (21 U.S.C. 355), the requirement to label products with adequate directions for use under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), and the drug supply chain security requirements in section 582 of the FD&C Act (21 U.S.C. 360eee-1), if the requirements in section 503B are met. Outsourcing facilities are inspected by FDA according to a risk-based schedule and must comply with other provisions of the FD&C Act, including CGMP requirements under section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)). FDA intends to issue CGMP regulations specific to outsourcing facilities. Until final regulations are issued, this draft guidance describes FDA's policies regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211.

This draft guidance revises the draft guidance for industry entitled “Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act,” which published in July 2014 (79 FR 37743). This revised draft guidance applies to drugs compounded in accordance with section 503B. In addition, this guidance generally applies to drugs that outsourcing facilities repackage and biological products that outsourcing facilities mix, dilute, or repackage in accordance with relevant guidance for outsourcing facilities. This revised draft guidance reflects FDA's intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products.

The comment period on the initial draft guidance ended on September 2, 2014. FDA received 26 comments on the draft guidance. In response to received comments or on its own initiative, FDA made changes and updates in the revised draft guidance as follows.

FDA received a number of comments regarding the requirements in FDA regulations applicable to nonsterile drug products because the draft guidance focused primarily on sterile compounding. To address these comments, the revised draft guidance differentiates between requirements applicable to sterile drug products and nonsterile drug products where appropriate. The revised draft guidance also distinguishes the risks presented by using sterile and nonsterile components in producing sterile drug products and offers recommendations and policies on quality control commensurate with the risk. Further, the revised draft guidance addresses concerns raised regarding FDA's policies in several other areas. FDA made significant revisions to address comments on (1) stability testing, including the assignment of a beyond use date (BUD) as an expiration date; (2) release testing; (3) the potential use of a drug master file to address contract laboratory testing arrangements and testing of component quality before use in compounding; (4) the use of accredited third-party laboratories to perform testing; (5) a clear definition of “in-use time,” distinguishing it from “BUD” and “expiration date”; and (6) reserve samples.

We note that the default BUDs and storage conditions associated with nonsterile drug products described in this revised draft guidance differ from those described for nonsterile repackaged drug products in FDA's guidance for industry entitled “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities” (Repackaging guidance). FDA believes that the BUDs described in this revised draft CGMP guidance are also relevant to nonsterile drug products repackaged by outsourcing facilities. When this guidance is finalized, we intend to make conforming revisions to the BUDs for repackaged nonsterile drug products in the Repackaging guidance, as appropriate.

Finally, this revised draft contains revisions to the conditions under which the Agency generally would not intend to take regulatory action regarding the requirement to test the finished product before release (see § 211.165 (21 CFR 211.165)). These revisions make a broader range of production volumes eligible for the relevant enforcement policy, which we believe would encourage additional compounders to register as outsourcing facilities. Compared to compounders that are not registered under section 503B of the FD&C Act, outsourcing facilities are subject to increased Federal oversight through FDA inspection on a risk-based schedule, as well as to additional standards that help to assure the quality of their compounded drug products. Outsourcing facilities produce drug products for hospitals, clinics, or healthcare practitioners to keep on hand as “office stock” for patients who present with an immediate need for them. The revised draft guidance addresses standards critical to reducing the risk of patient harm while balancing appropriate flexibility. FDA is seeking public comment on whether the conditions outlined in the revised draft appropriately balance the risks and needs associated with drugs produced for office stock, including comments on the production volumes specified in the guidance.

This revised 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 “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” 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.

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

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

A quality control unit must be established by outsourcing facilities to oversee various aspects of drug production and to monitor quality assurance (see, e.g., § 211.22 (21 CFR 211.22)). The responsibilities of the quality control unit must be established in procedures (§ 211.22(d)) and should include investigations and development and oversight of appropriate corrective and preventive actions regarding results of tests and examinations, unexpected results or trends, failures that occur during validation or revalidation of sterilization or depyrogenation processes, stability failures, environmental and personnel monitoring results that exceed alert or action limits, process deviations or equipment malfunctions that involve critical equipment, and complaints that indicate possible drug product contamination or other risks to patients. The quality control unit must periodically (at least annually) review records of compounding operations to evaluate the quality standards for each drug product to determine the need for changes in specifications or control procedures (21 CFR 211.180(e)).

FDA estimates that annually approximately 74 outsourcing facilities 1 (“No. of Recordkeepers” in table 1, row 1) will individually establish approximately 13 procedures on the responsibilities of the quality control unit (“No. of Records per Recordkeeper” in table 1, row 1) as described in section III.A of the guidance. FDA also estimates that preparing and maintaining these procedures will take approximately 3 hours for each record (“Average Burden per Recordkeeping” in table 1, row 1).

The revised draft guidance describes those elements of facility design of outsourcing facilities that are considered critical to assuring the quality of sterile drug products at those facilities. For example, the draft guidance states that sterile drugs should be produced only in ISO 5 (International Organization for Standardization) or better air quality and that the ISO 5 zone or critical area must be qualified (i.e., shown to meet the specifications) (see §§ 211.42 and 211.113(b) (21 CFR 211.42 and 211.113(b))). The revised draft guidance lists certain studies and tests that should be successfully performed for outsourcing facilities and states that the results of these studies and tests should be documented.

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 2) will individually document approximately 20 studies and tests (“No. of Records per Recordkeeper” in table 1, row 2) that are critical to assuring the quality of sterile drug products. FDA also estimates that preparing and maintaining each record as described in the guidance will take on average approximately 1.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 2).

The revised draft guidance describes procedures that should be established and followed that assign responsibility for sanitation and describe the cleaning schedules, methods, equipment, and materials to be used in cleaning buildings and facilities. For multiuse facilities and nondedicated equipment, changeover and cleaning procedures for equipment and utensils must be established and followed to prevent contamination (see §§ 211.42 and 211.67). Procedures for cleaning and disinfecting must also be established (see §§ 211.42, 211.56, and 211.67). If powder drugs are handled, procedures must be established and followed to appropriately manage cross-contamination risk (§ 211.100 (21 CFR 211.100)). Processes and procedures should minimize contamination risks posed by the number and complexity of manipulations, number of simultaneous operations and workstations, and staging of materials used in the process. Temperature and humidity must be maintained in cleanrooms; such controls are critical to reduce microbial growth (see 21 CFR 211.46). In addition, the guidance describes that procedures should ensure recording of instances when there is a loss of positive pressure in the cleanroom during production.

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 3) will individually establish and maintain approximately 6 records (procedures and documentation) for maintaining suitable outsourcing facilities (“No. of Records per Recordkeeper” in table 1, row 3). FDA also estimates that preparing and maintaining each record as described in the guidance will take on average approximately 5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 3).

The revised draft guidance states that operations and appropriate written procedures designed to prevent microbial contamination include a well-defined and documented program for environmental monitoring that evaluates the potential routes of microbial contamination of the human drug that could arise from the air, surfaces, process, operation, and personnel practices (see §§ 211.42(c)(10)(iv), 211.100, and 211.113(b)). Personnel monitoring should include a routine program for daily/shift monitoring of operators' gloves and an appropriate schedule for monitoring other critical sites of the gown (e.g., gown sleeves for hood work) during or immediately after completion of aseptic operations; establish and justify limits that are based on the criticality of the operation relative to the contamination risk to the product; and call for an investigation of results that exceed the established levels or demonstrate an adverse trend, a determination of the impact on the sterility assurance of finished products intended to be sterile, and the development and execution of appropriate corrective actions. This monitoring should take place before planned disinfection so that actual operating conditions are being assessed. In addition, an outsourcing facility or its contract laboratory should establish procedures for establishing the validity of media if microbiological media used in performing tests, including environmental and personnel monitoring, are not purchased from a qualified supplier.

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 4) will individually establish approximately 1,200 environmental and personnel monitoring procedures and records to document test results (“No. of Records per Recordkeeper” in table 1, row 4) for aseptic processing areas. FDA also estimates that preparing and maintaining the environmental and personnel monitoring procedures as described in the guidance will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 4).

Scientifically sound and appropriate criteria for containers and closures must be established to ensure that containers and closures used for drug products are suitable for each drug product for which they will be used (see § 211.160(b) (21 CFR 211.160(b))). Appropriate procedures must be established for testing the containers and closures to determine whether they meet the criteria for use, and the tests and results must be documented (see 21 CFR 211.84(d)(3) and 211.184). Procedures for storage, if appropriate, of sterilized containers or closures must be established in a manner to prevent contamination and to maintain sterility (see 21 CFR 211.80(a) and (b)).

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 5) will individually establish and maintain approximately 300 procedures and pieces of documentation for testing containers and closures (“No. of Records per Recordkeeper” in table 1, row 5) in the aseptic processing areas. FDA also estimates that preparing and maintaining these procedures and documentation as described in the guidance will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 5).

Procedures should be established and records maintained for routine calibration and maintenance of equipment (mechanical, electronic, or automated).

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 6) will individually establish and maintain approximately 150 procedures and pieces of documentation for the calibration and maintenance of equipment (“No. of Records per Recordkeeper” in table 1, row 6). FDA also estimates that preparing and maintaining these records will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 6).

Procedures should be established and records maintained concerning the source and quality of components such as raw materials or ingredients used in producing nonsterile and sterile drug products at outsourcing facilities. The revised draft guidance also states that FDA generally does not intend to take regulatory action against an outsourcing facility regarding testing components if an adequate supplier quality agreement is in place and maintained appropriately.

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 7) will individually establish and maintain approximately 150 records of testing to ensure the quality of components used in producing drug products, as recommended in the guidance (“No. of Records per Recordkeeper” in table 1, row 7). FDA also estimates that preparing and maintaining these records will take on average approximately 4 hours for each record (“Average Burden per Recordkeeping” in table 1, row 7).

Production and process documentation and procedures, such as batch records, must be established to assure the quality of drug products at outsourcing facilities (see § 211.100). Training on aseptic technique, cleanroom behavior, gowning, and procedures covering aseptic manufacturing area operations must be established (see 21 CFR 211.25(a)). The validation of sterilization operations (e.g., holding vessels, filling equipment, lyophilizers) and periodic verification activities and results must be documented (see § 211.113(b)).

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 8) will individually establish and maintain approximately 1,325 records pertaining to production and process controls, such as validation procedures and training, to ensure the quality of sterile drug products (“No. of Records per Recordkeeper” in table 1, row 8). FDA also estimates that preparing and maintaining these records, as described in the guidance, will take on average approximately 0.25 hours for each record (“Average Burden per Recordkeeping” in table 1, row 8).

Drug products produced at outsourcing facilities must be tested to determine whether they meet final product specifications before release for distribution, and procedures for final release testing must be established and followed (§§ 211.165 and 211.167).

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 9) will individually establish and maintain approximately 1,725 records pertaining to final release testing of drug products, including release testing procedures and documentation (“No. of Records per Recordkeeper” in table 1, row 9). FDA also estimates that preparing and maintaining these records, as described in the guidance, will take on average approximately 1.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 9).

If sterility testing is not completed before release under certain conditions described in Appendix A of the guidance, procedures should be established that specify that if the product fails to meet a criterion for sterility, all healthcare and other facilities that received the product should be immediately notified of the test results and provided with any appropriate information and recommendations to aid in the treatment of patients; the notification should be documented; and FDA should be notified in writing.

FDA estimates that annually approximately 10 outsourcing facilities (“No. of Respondents” in table 2, row 1) will individually send approximately 1 notification of test results to all healthcare and other facilities that received the drug product and provide them with any appropriate information and recommendations to aid in the treatment of patients (No. of Disclosures per Respondent” in table 2, row 1). FDA also estimates that preparing and sending each notification will take approximately 5 hours (“Average Burden per Disclosure” in table 2,row 1).

FDA also estimates that annually approximately 10 outsourcing facilities (“No. of Respondents” in table 3) will individually submit to FDA 1 notification of the test results for any drug product that fails to meet a sterility criterion (“No. of Responses per Respondent” in table 3). Preparing and submitting this information will take approximately 5 hours per notification (“Average Burden per Response” in table 3).

Each laboratory used to conduct testing of components, in-process materials, and finished drug products for outsourcing facilities must follow written procedures for the conduct of each test and must document the results; establish sampling and testing procedures to ensure that components, in-process materials, and drug products conform to the product specifications; keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays; and, if using a validated or an established compendial test, verify and document that the test procedure works under the conditions of actual use (see §§ 211.160 and 211.194).

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 10) will individually establish and maintain approximately 200 laboratory records as described in the guidance (“No. of Records per Recordkeeper” in table 1, row 10). FDA also estimates that preparing and maintaining these records will take on average approximately 0.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 10).

Stability testing is used to ensure that a drug product will retain its quality (e.g., strength) and remain sterile, if applicable, through the labeled expiration date. The draft guidance states that procedures established by outsourcing facilities for assessing the stability of drug products must include the following: Using stability-indicating test methods that are reliable, meaningful, and specific; evaluating samples of the drug product in the same container-closure system in which the drug product will be marketed; evaluating samples for stability that are representative of the lot or batch from which they were obtained and are stored under suitable conditions; and testing to evaluate antimicrobial effectiveness for drug products labeled or intended to be multiple dose (see §§ 211.122, 211.160, and 211.166). The guidance states that regardless of whether an expiration date or BUD to be used as an expiration date is used, container-closure integrity testing and antimicrobial effectiveness testing (for products labeled as multiple dose) are required to be completed before a batch is released (see §§ 211.166 and 211.167). Each of these studies only needs to be conducted once for each formulation and container-closure system, and a bracketing or matrixing approach can be considered to minimize the amount of testing needed. Outsourcing facilities are also responsible for including appropriate labeled directions for use for drug products, which may include in-use time if the product requires additional manipulation before administration. Appropriate studies, including stability studies, would need to support the stated in-use time.

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 11) will individually establish and maintain approximately 75 procedures for stability studies to determine an expiration date (“No. of Records per Recordkeeper” in table 1, row 11) for drug products. FDA also estimates that preparing and maintaining these procedures as described in the guidance will take approximately 5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 11).

FDA also estimates that annually approximately 74 outsourcing facilities (“No. of Respondents” in table 2, row 2) will add approximately 540 expiration dates to the labeling of drug products (“No. of Disclosures per Respondent” in table 2, row 2). FDA also estimates that preparing the labeling will take approximately 0.25 hours (“Average Burden per Disclosure” in table 2, row 2).

Packaging of drugs must ensure the sterility, if applicable, and integrity of the product until it is administered to a patient, product labels must contain required information, and labeling operations must include controls to prevent mixups (see §§ 211.94, 211.122, 211.125, 211.130, and 211.134). The following must be implemented by outsourcing facilities for packaging and labeling operations to ensure the quality of drug products: The container, closure, and packaging systems adequately protect against foreseeable external factors in storage, shipment, and use that can cause contamination or deterioration; packaging records include specimens or copies of all labels used; adequate controls are established for issuing labels, examining issued labels, and reconciling used labels to prevent mixups; different labeling and packaging operations are adequately separated to prevent mixups; and controls are established that ensure proper identification of any filled containers of products that are stored unlabeled for any period of time (see §§ 211.94, 211.122, 211.125, 211.130, 211.134, and 211.188).

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 12) will individually establish and maintain approximately 20 procedures for packaging and labeling operations (“Records per Recordkeeper” in table 1, row 12) for drug products. FDA also estimates that preparing and maintaining these procedures as described in the guidance will take approximately 5.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 12).

An appropriately identified reserve sample that is representative of each lot or batch of drug product must be retained and stored under conditions consistent with product labeling (21 CFR 211.170).

FDA estimates that annually approximately 74 outsourcing facilities (“No. of Recordkeepers” in table 1, row 13) will individually establish and maintain approximately 12 procedures and records for reserve samples (“Records per Recordkeeper” in table 1, row 13) for drug products. FDA also estimates that preparing and maintaining these procedures and records as described in the guidance will take approximately 0.5 hours for each record (“Average Burden per Recordkeeping” in table 1, row 13).

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

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