Federal Register Vol. 83, No.173,

Authority and Purpose: Under Section 301 of Public Law 101-445 (7 U.S.C. 5341, the National Nutrition Monitoring and Related Research Act of 1990, Title III) the Secretaries of the U.S. Departments of Agriculture (USDA) and Health and Human Services (HHS) are directed to publish the Dietary Guidelines for Americans jointly at least every five years. The law instructs that this publication shall contain nutritional and dietary information and guidelines for the general public, shall be based on the preponderance of scientific and medical knowledge current at the time of publication, and shall be promoted by each Federal agency in carrying out any Federal food, nutrition, or health program. Recent editions of the Dietary Guidelines provide dietary advice for Americans ages 2 years and older. The Agricultural Act of 2014 mandates the addition of dietary guidance for women who are pregnant and infants and toddlers from birth to 24 months of age beginning with the 2020 edition.

The 2020 Dietary Guidelines Advisory Committee (the Committee) shall be formed and governed under the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C., App), which sets forth standards for the formation and use of advisory committees. The Committee is established to provide independent, science-based advice and recommendations to be considered by USDA and HHS in the development of the 2020-2025 Dietary Guidelines for Americans. Formation of the Committee is necessary and in the public interest.

The Committee is expected to begin meeting during the Fall/Winter of 2018/2019; the Committee will meet approximately five times during the course of its operation. Pursuant to the FACA, all Committee meetings will be open to the public. The Committee will be established to accomplish a single, time-limited task. The Committee will develop a report of its recommendations that will be submitted to the Secretaries of USDA and HHS. Upon delivery of its report to the Secretaries or when the charter expires, the activities of the Committee will be terminated.

Structure: The Committee will consist of 13 to 20 members, including the Chair and Vice-Chairperson. Factors to be considered in selecting individuals to serve on the Committee include educational background, professional experience, and demonstrated scientific expertise in the issues to be examined by the Committee, as well as statutory obligations under FACA and requirements regarding a balanced membership.

Expertise in human nutrition related to disease prevention and health promotion during different stages of life, such as pediatrics, obstetrics, and geriatrics, will be sought. Expertise in the topics and scientific questions identified by the Departments to be examined by the Committee also will be sought. Information on the topics and scientific questions is available at www.dietaryguidelines.gov.

Equal opportunity practices regarding membership appointments to the Committee will be aligned with USDA and HHS policies. To ensure that recommendations of the Committee take into account the needs of the diverse groups served by USDA and HHS, membership shall include, to the extent practicable, individuals who are minorities, women, and persons with disabilities.

Individuals will be appointed to serve as members of the Committee to represent balanced viewpoints of the scientific evidence, not to represent the viewpoints of any specific group.

Members of the Committee will be classified as Special Government Employees (SGEs) during their term of appointment on the Committee and, as such, are subject to the ethical standards of conduct for Federal employees. Upon entering the position and annually throughout the approximate 2-year term of appointment, members of the Committee will be required to complete and submit a report of their financial holdings.

Nominations and Appointments for Memberships: Nominees, including self-nominees, will be considered for appointment as members of the Committee. To be considered for an appointment requires submission of the following for each nominee: (1) A cover letter that clearly states the name and affiliation of the nominee, the rationale for the nomination (i.e., specific attributes which qualify the nominee for service in this capacity), and a statement that the nominee would be willing to serve as a member of the Committee, if selected; (2) the name, address, telephone number, and electronic mail address of the nominator and the individual being nominated; (3) a copy of the nominee's curriculum vitae, which should be limited to no more than 15 pages; and (4) the following administrative form: AD-755 (Advisory Committee Membership Background Information, OMB Number 0505-0001), available on the internet at: https://www.ocio.usda.gov/document/ad-755. Where prohibited by Federal law or regulations, nominations will not be accepted directly from USDA research and promotion boards. Self-nominations and nominations by members of research and promotion boards in their individual capacity will be considered.

The curriculum vitae should include the following information: (a) Education; (b) experience (current and former); (c) affiliations (food, nutrition, public health, and/or other relevant associations, including positions held); (d) memberships (expert panels, committees, or other relevant groups, including positions held); (e) peer-reviewed publications (for past 10 years); (f) oral presentations (for past 5 years); (g) editorials, opinion pieces, and blogs (for past 5 years); (h) grant funding (for past 15 years); (i) name of any corporation, professional society, association, panel, company, firm, government agency (Federal, state, and local), research organization, educational institution, or other organization or institution (government, private, and not-for-profit; domestic and foreign) in which the nominee's services have been, will be, or are expected to be provided, with or without compensation, including on a part-time or seasonal basis as an officer, medical staff, board member, owner, trustee, director, expert advisor, consultant, official spokesperson, member of speakers bureau, or expert witness (for past 5 years and upcoming); (j) other paid travel or honoraria received, not included above (for past 5 years). Web links to publications, presentations, and other materials available online are requested, when available. In all cases, a limited selection of earlier publications, presentations, affiliations, etc. applicable to the qualifications may also be included.

Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.

The CCFICS is responsible for:

(a) Developing principles and guidelines for food import and export inspection and certification systems, with a view to harmonizing methods and procedures that protect the health of consumers, ensure fair trading practices, and facilitate international trade in foodstuffs;

(b) Developing principles and guidelines for the application of measures by the competent authorities of exporting and importing countries to provide assurance, where necessary, that foodstuffs comply with requirements, especially statutory health requirements;

(c) Developing guidelines for the utilization, as and when appropriate, of quality assurance systems to ensure that foodstuffs conform with requirements and to promote the recognition of these systems in facilitating trade in food products under bilateral/multilateral arrangements by countries;

(d) Developing guidelines and criteria with respect to format, declarations and language of such official certificates as countries may require with a view towards international harmonization;

(e) Making recommendations for information exchange in relation to food import/export control;

(f) Consulting as necessary with other international groups working on matters related to food inspection and certification systems; and

(g) Considering other matters assigned to it by the Commission in relation to food inspection and certification systems.

The CCFICS is hosted by Australia. The United States attends CCFICS as a member country of Codex.

The following items on the Agenda for the 24th Session of the CCFICS will be discussed during the public meeting:

Each issue listed will be fully described in documents distributed, or to be distributed by the Secretariat before to the Committee Meeting. Members of the public may access or request copies of these documents (see ADDRESSES).

At the September 26, 2018, public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Mary Stanley, U.S. Delegate for the 24th Session of the CCFICS (see ADDRESSES). Written comments should state that they relate to activities of the 24th Session of the CCFICS.

Public awareness of all segments of rulemaking and policy development is important. Consequently, the U.S. Codex Office will announce this Federal Register publication on-line through the FSIS web page located at: http://www.fsis.usda.gov/federal-register. The U.S. Codex Office also offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

Send your completed complaint form or letter to USDA by mail, fax, or email.

Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.

Fax: (202) 690-7442, Email: [email protected].

Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

In FR Doc. 2018-17765 appearing on page 41046 in the Federal Register of August 16, 2018, make the following correction:

On page 41052 in the second column, third paragraph, section d. reads “The applicant will demonstrate how their proposal will utilize partnerships outside of RD . . . (10 points),” replace with “The applicant will demonstrate how their proposal will utilize partnerships outside of RD . . . (5 points).”

The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies information collections that USDA Rural Development is submitting to OMB for extension.

Comments are invited on: (a) Whether this collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the 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 appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology. Comments may be sent to: Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5162, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email [email protected].

Title: Mergers and Consolidations of Electric Borrowers, 7 CFR 1717,subpart D.

OMB Control Number: 0572-0114.

Type of Request: Extension of a currently approved collection.

Abstract: The Rural Electrification Act of 1936 (7 U.S.C. 901 et seq.), as amended (RE Act) authorizes and empowers the administration of RUS to make and guarantee loans to furnish and improve electric service in rural areas. Due to deregulation and restructuring activities in the electric industry, RUS borrowers may find it advantageous to merge or consolidate to meet the challenges of industry change. This information collection addresses the requirements of RUS policies and procedures for mergers and consolidations of electric program borrowers.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 1.32 hours per response.

Respondents: Not for profit institutions; business or other for-profit entities.

Estimated Number of Respondents: 10.

Estimated Number of Responses per Respondent: 10.6.

Estimated Total Annual Burden on Respondents: 140 hours.

Copies of this information collection can be obtained from Kimble Brown, Innovation Center, at (202) 692-0043, or email: [email protected]. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that will be submitted to OMB for approval. 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 will 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 those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Michele Brooks, Team Lead, Rural Development Innovation Center—Regulatory Team, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5162, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Email [email protected].

Title: RUS Form 675, Certification of Authority.

OMB Control Number: 0572-0074.

Type of Request: Extension of a currently approved collection.

Abstract: The Rural Utilities Service (RUS) manages loan programs in accordance with the Rural Electrification Act of 1936, as amended (7 U.S.C. 901 et seq.) (RE Act). A major factor in managing loan programs is controlling the advance funds, including assuring that actual borrowers receive their funds. OMB Circular A-123, Management Accountability and Control, provides that information should be maintained on a current basis and that funds should be protected from unauthorized use. The use of RUS Form 675 allows effective control against unauthorized release of funds by providing a list of authorized borrower signatures against which signatures requesting funds are compared. Form 675 allows borrowers to keep RUS up to-date of changes in signature authority and controls release of funds only to authorized borrower representatives.

Estimate of Burden: Public reporting for this collection of information is estimated to average .10 hours per response.

Respondents: Not-for-profit institutions; Business or other for-profit.

Estimated Number of Respondents: 163.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 16.0 hours.

Copies of this information collection can be obtained from Robin M. Jones, Innovation Center, at (202) 772-1172. Email: [email protected].

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

This business meeting is open to the public. There will also be a call-in line for individuals who desire to listen to the presentations: 800-682-0995; Conference ID 4872955. The event will also live-stream at https://www.youtube.com/user/USCCR/videos. (Please note that streaming information is subject to change.) Persons with disabilities who need accommodation should contact Pamela Dunston at (202) 376-8105 or at [email protected] at least seven (7) business days before the scheduled date of the meeting.

List of Petitions Received by EDA for Certification of Eligibility To Apply for Trade Adjustment Assistance [08/08/2018 through 08/29/2018] Firm name Firm address Date

Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice. These petitions are received pursuant to section 251 of the Trade Act of 1974, as amended.

Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.

Background

On October 16, 2017, we published the notice of initiation for this administrative review.1 For a complete description of the events that followed the initiation of the review, see the Preliminary Decision Memorandum.2 Commerce exercised its discretion to toll deadlines for the duration of the closure of the Federal Government from January 20 through 22, 2018,3 moving the deadline for the preliminary results to May 6, 2018.4 On April 5, 2018, we extended the time limit for completion of the preliminary results of the review to no later than August 31, 2018.5 A list of topics included in the Preliminary Decision Memorandum is included in the 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 https://access.trade.gov and to all parties in the Central Records Unit, located in room B8094 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed and the electronic versions of the Preliminary Decision Memorandum are identical in content.

The scope of this order covers certain welded carbon-quality light-walled steel pipe and tube, of rectangular (including square) cross section, having a wall thickness of less than 4 mm. The term carbon-quality steel includes both carbon steel and alloy steel which contains only small amounts of alloying elements. Specifically, the term carbon-quality includes products in which none of the elements listed below exceeds the quantity by weight respectively indicated; 1.80 percent of manganese, or 2.25 percent of silicon, or 1.00 percent of copper, or 0.50 percent of aluminum, or 1.25 percent of chromium, or 0.30 percent of cobalt, or 0.40 percent of lead, or 1.25 percent of nickel, or 0.30 percent of tungsten, or 0.10 percent of molybdenum, or 0.10 percent of niobium, or 0.15 percent of vanadium, or 0.15 percent of zirconium.

The description of carbon-quality is intended to identify carbon-quality products within the scope. The welded-carbon quality rectangular pipe and tube subject to the order is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7306.61.50.00 and 7306.61.70.60. This tariff classification is provided for convenience and Customs purposes; however, the written description of the scope of the order is dispositive.

Commerce is conducting this review in accordance with sections 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). Export price was calculated in accordance with section 772 of the Act. Normal value 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.

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

We will disclose to parties to the proceeding any calculations performed in connection with these preliminary results of review within five days after the date of publication of this notice.7 Interested parties may submit case briefs not later than 30 days after the date of publication of this notice in the Federal Register.8 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.9 Parties who submit case 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.10 Case and rebuttal briefs should be filed using ACCESS.11

Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice.12 Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) 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, we intend to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a date and time to be determined.13 Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

Unless extended, we intend to issue the final results of this administrative review, which will include the results of our analysis of all issues raised in the case and rebuttal briefs, within 120 days of publication of these preliminary results in the Federal Register, pursuant to section 751(a)(3)(A) of the Act.

Upon issuance of the final results, Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.14 If a respondent's weighted-average dumping margin is not zero or de minimis in the final results of this review and the respondent reported reliable entered values, we will calculate importer-specific ad valorem assessment rates for the merchandise based on the ratio of the total amount of dumping calculated for the examined sales made during the period of review to each importer to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). If the respondent has not reported reliable entered values, we will calculate a per-unit assessment rate for each importer by dividing the total amount of dumping for the examined sales made during the period of review to that importer by the total sales quantity associated with those transactions. Where an importer-specific ad valorem assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties in accordance with 19 CFR 351.106(c)(2). If the respondent's weighted-average dumping margin is zero or de minimis in the final results of review, we will instruct CBP not to assess duties on any of its entries in accordance with the Final Modification for Reviews, i.e., “ {w}here the weighted-average margin of dumping for the exporter is determined to be zero or de minimis, no antidumping duties will be assessed.” 15

Regarding entries of subject merchandise during the period of review that were produced by Maquilacero and Regiopytsa and for which they did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate un-reviewed entries at the all-others rate of 3.76 percent, as established in the less-than-fair-value investigation of the order, if there is no rate for the intermediate company(ies) involved in the transaction.16 For a full discussion of this matter, see Assessment Policy Notice. 17

For the firms covered by this review, we intend to issue liquidation instructions 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 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 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 Maquilacero and Regiopytsa and other companies listed above will be equal to the weighted-average dumping margin established in the final results of this administrative review; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which they were reviewed; (3) if the exporter is not a firm covered in this review, a prior review, or in the investigation but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be the all-others rate of 3.76 percent. These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as a 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 Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

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)(4).

This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). We published the notice of initiation of this investigation on February 27, 2018.1 On June 26, 2018, we postponed the preliminary determination of this investigation. The revised deadline is now August 29, 2018.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and 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 directly at http://enforcement.trade.gov/frn/. The signed and the electronic versions of the Preliminary Decision Memorandum are identical in content.

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

In accordance with the preamble to Commerce's regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).5 Certain interested parties provided comments on the scope of the investigation as it appeared in the Initiation Notice. 6 For a summary of the product coverage comments and rebuttal responses submitted to the record for this preliminary determination, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.7 We are preliminarily modifying the scope language as it appeared in the Initiation Notice. See the revised scope in Appendix I to this notice.

We are conducting this investigation in accordance with section 731 of the Act. Pursuant to section 776(a) and (b) of the Act, we have preliminarily relied upon facts otherwise available, with adverse inferences, for the China-wide entity because it did not respond to our requests for information. Specifically, all companies to which Commerce issued quantity and value (Q&V) questionnaires failed to respond.8 Thus, no companies have demonstrated their eligibility for a separate rate and are preliminarily found to be part of the China-wide entity. Furthermore, we find that the China-wide entity's lack of participation, including the failure of certain parts of the China-wide entity to submit Q&V information, constitutes circumstances under which it is reasonable to conclude that the China-wide entity as a whole failed to cooperate to the best of its ability to comply with Commerce's request for information. For a full description of the methodology underlying Commerce's preliminary determination, see the Preliminary Decision Memorandum.

On June 11, 2018, as revised on August 7, 2018, the petitioner timely filed a critical circumstances allegation, pursuant to section 733(e)(1) of the Act and 19 CFR 351.206, alleging that critical circumstances exist with respect to imports of rubber bands from China.9 Based on the failure of all respondents, and thus the China-wide entity, to cooperate to the best of their ability to comply with Commerce's requests for information, we preliminarily determine that massive imports of rubber bands from China existed for the China-wide entity, based on adverse facts available, pursuant to section 733(e)(1)(B) of the Act. In addition, we have preliminarily determined that there is a reasonable basis to believe or suspect that importers knew, or should have known, that merchandise was being sold for less than fair value and that those sales were likely to cause material injury in accordance with section 733(e)(1)(A)(ii) of the Act.

For a full description of the methodology and the results of Commerce's analysis, see the Preliminary Decision Memorandum.

We preliminarily determine that the following estimated weighted-average dumping margin exists:

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

Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. Commerce preliminarily finds that critical circumstances exist for all imports of subject merchandise from China. In accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to all unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice.

To determine the cash deposit rate, Commerce normally adjusts the estimated weighted-average dumping margin by the amount of domestic subsidy pass-through and export subsidies determined in a companion countervailing duty (CVD) proceeding when CVD provisional measures are in effect. Accordingly, where Commerce has made a preliminary affirmative determination for export subsidies, Commerce has offset the calculated estimated weighted-average dumping margin by the appropriate rate(s). Any such cash deposit rates may be found in the Preliminary Determination Section's chart of estimated weighted-average dumping margins above.

Should provisional measures in the companion CVD investigation expire prior to the expiration of provisional measures in this LTFV investigation, Commerce will direct CBP to begin collecting cash deposits at a rate equal to the estimated weighted-average dumping margin calculated in this preliminary determination unadjusted for the export subsidies at the time the CVD provisional measures expire. These suspension of liquidation instructions will remain in effect until further notice.

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

Because all respondents did not provide information requested by Commerce and we preliminarily determine that all respondents to have been uncooperative, verification will not be conducted.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 30 days after the date of publication of the preliminary determination, unless the Secretary alters the time limit. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.10 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, we intend 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. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

In accordance with section 733(f) of the Act, we notified the ITC of our preliminary affirmative determination of sales at LTFV and preliminary determination of critical circumstances. If the Commerce final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether imports of the subject merchandise are materially injuring, or threaten material injury to, the U.S. industry and whether critical circumstances exist.

This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

On June 22, 2018, Commerce published in the Federal Register the preliminary determination of the CVD investigation of plastic ribbon.1 On August 2, 2018, Commerce placed on the record of this investigation a preliminary decision memorandum addressing all comments received in this proceeding and the companion antidumping proceeding regarding the scope of the investigations.2 In accordance with the comments discussed in the memorandum, we made certain changes to the scope of these investigations. The changes include a revision to part b) of clause 4 in paragraph 5, and the exclusion of certain shredded plastic film or shredded plastic strip from the investigations. The revised scope is printed in its entirety below.

The merchandise covered by this investigation is certain plastic decorative ribbon having a width (measured at the narrowest span of the ribbon) of less than or equal to four (4) inches in actual measurement, including but not limited to ribbon wound onto itself; a spool, a core or a tube (with or without flanges); attached to a card or strip; wound into a keg- or egg-shaped configuration; made into bows, bow-like items, or other shapes or configurations; and whether or not packaged or labeled for retail sale. The subject merchandise is typically made of substrates of polypropylene, but may be made in whole or in part of any type of plastic, including without limitation, plastic derived from petroleum products and plastic derived from cellulose products. Unless the context otherwise clearly indicates, the word “ribbon” used in the singular includes the plural and the plural “ribbons” includes the singular.

The subject merchandise includes ribbons comprised of one or more layers of substrates made, in whole or in part, of plastics adhered to each other, regardless of the method used to adhere the layers together, including without limitation, ribbons comprised of layers of substrates adhered to each other through a lamination process. Subject merchandise also includes ribbons comprised of (a) one or more layers of substrates made, in whole or in part, of plastics adhered to (b) one or more layers of substrates made, in whole or in part, of non-plastic materials, including, without limitation, substrates made, in whole or in part, of fabric.

The ribbons subject to this investigation may be of any color or combination of colors (including without limitation, ribbons that are transparent, translucent or opaque) and may or may not bear words or images, including without limitation, those of a holiday motif. The subject merchandise includes ribbons with embellishments and/or treatments, including, without limitation, ribbons that are printed, hot-stamped, coated, laminated, flocked, crimped, die-cut, embossed (or that otherwise have impressed designs, images, words or patterns), and ribbons with holographic, metallic, glitter or iridescent finishes.

Subject merchandise includes “pull-bows” an assemblage of ribbons connected to one another, folded flat, and equipped with a means to form such ribbons into the shape of a bow by pulling on a length of material affixed to such assemblage, and “pre-notched” bows, an assemblage of notched ribbon loops arranged one inside the other with the notches in alignment and affixed to each other where notched, and which the end user forms into a bow by separating and spreading the loops circularly around the notches, which form the center of the bow. Subject merchandise includes ribbons that are packaged with non-subject merchandise, including ensembles that include ribbons and other products, such as gift wrap, gift bags, gift tags and/or other gift packaging products. The ribbons are covered by the scope of this investigation; the “other products” (i.e., the other, non-subject merchandise included in the ensemble) are not covered by the scope of this investigation.

Excluded from the scope of this investigation are the following: (1) Ribbons formed exclusively by weaving plastic threads together; (2) ribbons that have metal wire in, on, or along the entirety of each of the longitudinal edges of the ribbon; (3) ribbons with an adhesive coating covering the entire span between the longitudinal edges of the ribbon for the entire length of the ribbon; (4) ribbon formed into a bow without a tab or other means for attaching the bow to an object using adhesives, where the bow has: (a) An outer layer that is either flocked or made of fabric, and (b) a flexible metal wire at the base which permits attachment to an object by twist-tying; (5) elastic ribbons, meaning ribbons that elongate when stretched and return to their original dimension when the stretching load is removed; (6) ribbons affixed as a decorative detail to non-subject merchandise, such as a gift bag, gift box, gift tin, greeting card or plush toy, or affixed (including by tying) as a decorative detail to packaging containing non-subject merchandise; (7) ribbons that are (a) affixed to non-subject merchandise as a working component of such non-subject merchandise, such as where the ribbon comprises a book marker, bag cinch, or part of an identity card holder, or (b) affixed (including by tying) to non-subject merchandise as a working component that holds or packages such non-subject merchandise or attaches packaging or labeling to such non-subject merchandise, such as a “belly band” around a pair of pajamas, a pair of socks or a blanket; (8) imitation raffia made of plastics having a thickness not more than one (1) mil when measured in an unfolded/untwisted state; and (9) ribbons in the form of bows having a diameter of less than seven-eighths (7/8) of an inch, or having a diameter of more than 16 inches, based on actual measurement. For purposes of this exclusion, the diameter of a bow is equal to the diameter of the smallest circular ring through which the bow will pass without compressing the bow.

The scope of the investigation is not intended to include shredded plastic film or shredded plastic strip, in each case where the shred does not exceed 5 mm in width and does not exceed 18 inches in length, imported in bags.

Further, excluded from the scope of the antidumping duty investigation are any products covered by the existing antidumping duty order on polyethylene terephthalate film, sheet, and strip (PET Film) from the People's Republic of China (China). See Polyethylene Terephthalate Film, Sheet, and Strip from Brazil, the People's Republic of China and the United Arab Emirates: Antidumping Duty Orders and Amended Final Determination of Sales at Less Than Fair Value for the United Arab Emirates, 73 FR 66595 (November 10, 2008).

Merchandise covered by this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 3920.20.0015 and 3926.40.0010. Merchandise covered by this investigation also may enter under subheadings 3920.10.0000; 3920.20.0055; 3920.30.0000; 3920.43.5000; 3920.49.0000; 3920.62.0050; 3920.62.0090; 3920.69.0000; 3921.90.1100; 3921.90.1500; 3921.90.1910; 3921.90.1950; 3921.90.4010; 3921.90.4090; 3926.90.9996; 5404.90.0000; 9505.90.4000; 4601.99.9000; 4602.90.0000; 5609.00.3000; 5609.00.4000; and 6307.90.9889. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this investigation is dispositive.

Pursuant to the Preliminary CVD Determination, Commerce previously suspended liquidation of certain plastic decorative ribbon from China entered, or withdrawn from warehouse, for consumption on or after June 22, 2018 (the publication of the Preliminary CVD Determination in the Federal Register). Commerce will now instruct Customs and Border Protection (CBP) to suspend liquidation of certain plastic decorative ribbon from China, as defined by the revised scope language included above, entered, or withdrawn from warehouse, for consumption on or after the publication of this amended preliminary determination in the Federal Register. Commerce will also instruct CBP to lift suspension of certain shredded plastic film or shredded plastic strip, as defined above, now excluded from the investigation.

Commerce has previously set August 13, 2018, as the deadline for case briefs and August 20, 2018 as the deadline for rebuttal briefs regarding the CVD preliminary determination.3 Commerce has set a separate deadline for scope comments for both the antidumping and CVD proceedings.4 The current deadline for case briefs regarding scope issues is August 30, 2018, and the current deadline for rebuttal briefs regarding scope issues is September 4, 2018. Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its amended preliminary determination. If Commerce's final determination is affirmative, the ITC will make its final determination before the later of 120 days after the date of this preliminary determination or 45 days after Commerce's final determination.

This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.

Background: The Council was established on November 4, 2014, to advise the President, through the Secretary of Commerce, on strengthening commercial engagement between the United States and Africa. The Council's charter was renewed for a second, two-year term in September 2017. The Council was established in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

Public Submissions: The public is invited to submit written statements to the Council. Statements must be received by 5:00 p.m. September 19, 2018 by either of the following methods:

Submit statements electronically to Giancarlo Cavallo and Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, via email: [email protected].

Send paper statements to Giancarlo Cavallo and Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, Department of Commerce, 1401 Constitution Ave. NW, Room 22004, Washington, DC, 20230.

Statements will be provided to the members in advance of the meeting for consideration and also will be posted on the Council website (http://trade.gov/pac-dbia). Any business proprietary information should be clearly designated as such. All statements received, including attachments and other supporting materials, are part of the public record and subject to public disclosure.

Meeting minutes: Copies of the Council's meeting minutes will be available within ninety (90) days of the meeting on the Council's website at http://trade.gov/pac-dbia.

On January 30, 2018, Commerce received a CVD petition concerning imports of rubber bands from China filed in proper form on behalf of Alliance Rubber Co. (the petitioner).1 The investigation was initiated on February 20, 2018,2 and the affirmative Preliminary Determination was published on July 9, 2018.3

Commerce selected Graceful Imp. & Exp. Co., Ltd. (Graceful), Moyoung Trading Co., Ltd. (Moyoung), and Ningbo Syloon Imp & Exp Co., Ltd. (Ningbo Syloon) (collectively, the mandatory respondents) as the individually-examined respondents in this investigation. Because neither the Government of China (GOC) nor the three mandatory respondents responded to Commerce's CVD questionnaire and, thus, are not cooperating in this investigation, Commerce's preliminary determination was based on the application of adverse facts available (AFA) in accordance with section 776(a) and (b) of the Tariff Act of 1930, as amended (the Act).4

On June 11, 2018, the petitioner alleged that critical circumstances exist with respect to imports of rubber bands from China, pursuant to section 703(e)(1) of the Act and 19 CFR 351.206.5 On June 27, 2018, we notified the petitioner that additional information was needed to support the allegation, in particular monthly import data and an explanation for the proposed base period.6 On August 7, 2018, the petitioner submitted an amended allegation of critical circumstances.7

In accordance with 19 CFR 351.206(c)(1), if the petitioner submits an allegation of critical circumstances 30 days or more before the scheduled date of the final determination,8 Commerce will make a preliminary finding whether there is a reasonable basis to believe or suspect that critical circumstances exist. Commerce will issue its preliminary finding of critical circumstances within 30 days after the petitioner submits the allegation.9

The POI is January 1, 2017, through December 31, 2017.

The products covered by this investigation are rubber bands from China. For a complete description of the scope of this investigation, see the Appendix to this notice.

In accordance with the preamble to Commerce's regulations,10 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).11 Certain interested parties provided comments on the scope of the investigation as it appeared in the Initiation Notice. 12 For a summary of the product coverage comments and rebuttal responses submitted to the record of this CVD investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.13 We are preliminarily modifying the scope language as it appeared in the Initiation Notice and Preliminary Determination. See the revised scope in the Appendix to this notice.

The petitioner alleges a massive increase of imports of rubber bands from China and provided monthly import data, sourced from the U.S. International Trade Commission's (ITC) Tariff and Trade DataWeb (DataWeb) for the period January 2017 through April 2018.14 The petitioner states that a comparison of total imports (by value) 15 for the period February 2017 through April 2017, to the period February 2018 through April 2018, shows that imports of rubber bands from China increased by 17.22 percent,16 which is considered “massive” under 19 CFR 351.206(h)(2).

The petitioner also alleges that there is a reasonable basis to believe that there are subsidies in this investigation which are inconsistent with the Subsidies and Countervailing Measures Agreement (SCM Agreement).17

Section 703(e)(1) of the Act provides that Commerce will preliminarily determine that critical circumstances exist if there is a reasonable basis to believe or suspect that: (A) The alleged countervailable subsidy is inconsistent with the SCM Agreement,18 and (B) there have been massive imports of the subject merchandise over a relatively short period.

In determining whether there are “massive imports” over a “relatively short period,” pursuant to section 703(e)(1)(B) of the Act and 19 CFR 351.206(h) and (i), Commerce normally compares the import volumes of the subject merchandise for at least three months immediately preceding the filing of the petition (i.e., the base period) to a comparable period of at least three months following the filing of the petition (i.e., the comparison period). The regulations also provide, however, that if Commerce finds that importers, or exporters or producers, had reason to believe, at some time prior to the beginning of the proceeding, that a proceeding was likely, Commerce may consider a period of not less than three months from the earlier time.19 Imports must increase by at least 15 percent during the comparison period to be considered massive.20

Sections 776(a)(1) and (2) of the Act provide that Commerce shall, subject to section 782(d) of the Act, apply “facts otherwise available” if necessary information is not on the record or an interested party or any other person: (A) Withholds information that has been requested; (B) fails to provide information within the deadlines established, or in the form and manner requested by Commerce, subject to subsections (c)(1) and (e) of section 782 of the Act; (C) significantly impedes a proceeding; or (D) provides information that cannot be verified as provided by section 782(i) of the Act. Because the mandatory respondents decided to not participate in this investigation, we have made this preliminary determination with respect to critical circumstances on the basis of facts otherwise available, pursuant to section 776(a)(2)(A), (B), and (C) of the Act.

Section 776(b) of the Act provides that Commerce may use an adverse inference in selecting from among the facts otherwise available when a party fails to cooperate by not acting to the best of its ability to comply with a request for information. Further, section 776(b)(2) of the Act states that an adverse inference may include reliance on information derived from the petition, the final determination from the investigation, a previous administrative review, or other information placed on the record. Because Graceful, Moyoung, and Ningbo Syloon did not cooperate to the best of their ability in this investigation, in selecting from the facts available, we find that an adverse inference is warranted, pursuant to section 776(b) of the Act, with respect to critical circumstances. As such, we are making an adverse inference that Graceful, Moyoung, and Ningbo Syloon each benefited from countervailable subsidies under the “Export Assistance Grants” program. As determined in Commerce's Initiation Checklist, the “Export Assistance Grants” program, alleged in the Petition and supported by information reasonably available to the petitioner, appears to be export contingent and thus inconsistent with the SCM Agreement.21 Also, based on AFA, we preliminarily determine that Graceful, Moyoung, and Ningbo Syloon had massive imports of subject merchandise over a relatively short period. Thus, we preliminarily determine that critical circumstances exist regarding imports of rubber bands shipped by Graceful, Moyoung, and Ningbo Syloon, pursuant to sections 703(e)(1) and 776(a) and (b) of the Act and 19 CFR 351.206.

Consistent with prior determinations, we have not imputed the adverse inference of massive imports that we applied to the mandatory respondents to the non-individually examined companies receiving the all-others rate.22 Rather, we examined data for total imports of subject merchandise during the comparison period relative to a base period to determine whether or not imports were massive with respect to these companies.

The petitioner stated that it is not aware of any seasonal or consumption trends.23 The petitioner did not provide, pursuant to 19 CFR 351.206(i), any argument or evidence that importers, exporters, or producers had reason to believe, at some point prior to the filing of the Petition that a proceeding was likely.24 Therefore, to determine whether or not there has been a massive surge of imports with respect to all other exporters or producers, we used a comparison period starting with February 2018, because the Petition was filed on January 30, 2018,25 and ending with the most recent month for which we have import data on the record (i.e., June 2018).

We obtained U.S. import value data from DataWeb for each month from January 2017 through June 2018.26 It is Commerce's practice to base its critical circumstances analysis on all available data, using base and comparison periods of no less than three months. Therefore, we selected a five-month base period of September 2017 through January 2018, to compare to the comparison period of February 2018 through June 2018, to determine whether or not imports of subject merchandise were massive over a relatively short period. Our analysis of the data, which indicate a 9.1 percent decrease in imports of rubber bands from China, leads us to conclude that there was not a massive increase in imports, as defined by 19 CFR 351.206(h)(2).27 Therefore, we preliminarily determine that critical circumstances do not exist with respect to all other exporters or producers.

We will make a final determination concerning critical circumstances for rubber bands from China when we make our final determination in this investigation, which is currently scheduled to be signed no later than November 13, 2018.

Interested parties may submit case briefs or other written comments with regard to this preliminary affirmative critical circumstances determination and the preliminary scope decision. Such submissions must be submitted to the Assistant Secretary for Enforcement and Compliance via ACCESS 28 no later than 30 days after the date on which this notice is published in the Federal Register.29 Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.30 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.31

Electronically filed documents must be received successfully in their entirety by 5:00 p.m. Eastern Time,32 on the due dates established above.

In accordance with section 703(e)(2)(A) of the Act, we are directing U.S. Customs and Border Protection (CBP) to suspend liquidation, with regard to Graceful, Moyoung, and Ningbo Syloon, of any unliquidated entries of subject merchandise from the China entered, or withdrawn from warehouse for consumption, on or after April 10, 2018, which is 90 days prior to the date of publication of the Preliminary Determination in the Federal Register. For such entries, CBP shall require a cash deposit equal to the estimated preliminary subsidy rates established for Graceful, Moyoung, and Ningbo Syloon in the Preliminary Determination. This suspension of liquidation will remain in effect until further notice. Further, as a result of the changes to the scope of the investigation in the Preliminary Scope Decision Memorandum, we are amending the scope of the investigation as published in the Preliminary Determination. We will send appropriate instructions to CBP to reflect these changes to the scope of the investigation.

In accordance with section 703(f) of the Act, we will notify the ITC of this preliminary determination of critical circumstances.

This determination is issued and published pursuant to sections 703(f) and 777(i)(1) of the Act.

Background

This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). We published the notice of initiation of this investigation on February 27, 2018.1 On June 26, 2018, we postponed the preliminary determination of this investigation. The revised deadline is now August 29, 2018.2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.3 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov, and 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 directly at http://enforcement.trade.gov/frn/. The signed and the electronic versions of the Preliminary Decision Memorandum are identical in content.

The products covered by this investigation are rubber bands from Thailand. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the preamble to our regulations,4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage (i.e., scope).5 Certain interested parties provided comments on the scope of the investigation as it appeared in the Initiation Notice. 6 For a summary of the product coverage comments and rebuttal responses submitted to the record for this preliminary determination, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum.7 We are preliminarily modifying the scope language as it appeared in the Initiation Notice. See the revised scope in Appendix I to this notice.

We are conducting this investigation in accordance with section 731 of the Act. We have calculated export prices in accordance with section 772(a) of the Act. Normal value (NV) is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination we shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely under section 776 of the Act.

In this investigation, we preliminarily determined a zero rate for Liang Hah Heng International Rubber Co., Ltd. (Liang Hah Heng).8 Therefore, the only rate that is not zero, de minimis or based entirely on facts otherwise available is the rate calculated for U. Yong Industry Co., Ltd. (U. Yong).9 Consequently, the rate calculated for U. Yong is also assigned as the rate for all-other producers and exporters.

We preliminarily determine that the following estimated weighted-average dumping margins exist:

Consistent with section 733(b)(3) of the Act, we disregard de minimis rates and preliminarily determine that individually examined respondents with de minimis rates have not made sales of subject merchandise at LTFV.

In accordance with section 733(d)(2) of the Act, we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), we will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondents listed above will be equal to the company-specific estimated weighted-average dumping margins determined in this preliminary determination, except if that rate is zero or de minimis, no cash deposit will be required; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all-other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

We normally adjust cash deposits for estimated antidumping duties by the amount of export subsidies countervailed in a companion countervailing duty (CVD) proceeding, when CVD provisional measures are in effect. Accordingly, where we preliminarily make an affirmative determination for countervailable export subsidies, we offset the estimated weighted-average dumping margin by the appropriate CVD rate.

However, in the companion CVD preliminary determination, we have preliminarily determined that no countervailable subsidies are being provided to the production or exportation of subject merchandise, and therefore, we did not direct CBP to suspend liquidation of any such entries.11 Accordingly, we made no adjustment for the prohibited subsidy offset to the estimated weighted-average dumping margin. These suspension of liquidation instructions will remain in effect until further notice.

We intend to disclose to interested parties the calculations and analysis performed in connection with this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

As provided in section 782(i)(1) of the Act, we intend to verify information relied upon in making our final determination.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.12 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, we intend 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. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioner. Section 351.210(e)(2) of our regulations requires that a request by exporters for postponement of the final determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.

On July 31, 2018, and August 1, 2018, in accordance with 19 CFR 351.210(b)(2)(ii), Liang Hah Heng and U. Yong requested to postpone the final determination for a maximum of 135 days after the date of publication of the preliminary determination in the Federal Register, in the event that we issued an affirmative preliminary determination.13 Liang Hah Heng and U. Yong, pursuant to 19 CFR 351.210(e)(2), also requested an extension of provisional measures from a four-month period to a period not more than six months in duration.14 In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because: (1) The preliminary determination is affirmative; (2) the requesting exporters account for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, we are postponing the final determination and extending the provisional measures from a four-month period to a period not greater than six months. Accordingly, we will make our final determination no later than 135 days after the date of publication of this preliminary determination.

In accordance with section 733(f) of the Act, we will notify the International Trade Commission (ITC) of our preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

The Mid-Atlantic Fishery Management Council's Mackerel, Squid, and Butterfish Advisory Panel and Committee will meet on Monday, September 24, 2018 (see DATES and ADDRESSES). The purpose of this meeting is to review and provide comments on a draft public hearing document for the Mid-Atlantic Fishery Management Council's Chub Mackerel Amendment. This amendment will consider adding Atlantic chub mackerel (Scomber colias) to the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan. The amendment will consider potential catch limits, accountability measures, and other conservation and management measures required for stocks “in the fishery.”

Background documents can be found on the Council's website (www.mafmc.org).

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

Three natural coho stocks (Queets coho, Strait of Juan de Fuca coho, and Snohomish coho) and two Chinook stocks (Sacramento River fall Chinook and Klamath River fall Chinook) were found to meet the criteria for being classified as overfished in the PFMC Review of 2017 Ocean Salmon Fisheries. Under the tenets of the Salmon Fishery Management Plan, the STT is required to develop a salmon rebuilding plan for each of these stocks and propose them to the Council within one year.

The STT, tribal, state, Federal, and other management entities are working together to develop the salmon rebuilding plans. These meetings are the third of a series of meetings, and will focus on the development of potential recommendations to be included in each rebuilding plan. Additional topics for discussion may include, but are not limited to, outstanding data needs, data analysis, and economic aspects to be included in each plan. One meeting will occur for each of the five stocks; additional meetings will be scheduled as needed. These meetings are open to the public. All meetings will have the same webinar ID and access code.

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

The meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt ([email protected]; phone: (503) 820-2411) at least 10 days prior to the meeting date.

The Council created a Citizen Science Advisory Panel Pool in June 2017. The Council appointed members of the Citizen Science Advisory Panel Pool to five Action Teams in the areas of Volunteers, Data Management, Projects/Topics Management, Finance, and Communication/Outreach/Education to develop program policies and operations for the Council's Citizen Science Program.

Each Action Team will meet to continue work on developing recommendations on program policies and operations to be reviewed by the Council's Citizen Science Committee. Public comment will be accepted at the beginning of the meeting.

Items to be addressed during these meetings:

These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see ADDRESSES) 3 days prior to the meeting.

This action is authorized by the Pacific Coast Groundfish Fishery Management Plan and the regulations implementing the Magnuson-Stevens Fishery Conservation and Management Act at 50 CFR 600.745, which state that EFPs may be used to authorize fishing activities that would otherwise be prohibited.

At its June 2018 meeting, the Pacific Fishery Management Council (Council) made its final recommendation to NMFS on three EFP applications. The Council considered the EFP applications concurrently with the 2019-2020 biennial harvest specifications and management process because expected catch under each EFP is included in the catch limits for groundfish stocks. All three EFP applicants request to test hook-and-line gear that selectively targets underutilized, midwater rockfish species (e.g., yellowtail rockfish) while avoiding overfished, bottom-dwelling rockfish species (e.g., yelloweye rockfish). An EFP is necessary for these activities because they will all occur in the non-trawl RCA, which is closed to fishing with non-trawl fixed gear to protect overfished groundfish stocks. A summary of each EFP application is provided below:

• Yellowtail Rockfish Jig Fishing for the 2019-2020 Fishing Seasons: The San Francisco Community Fishing Association (SFCFA) and Daniel Platt submitted a renewal request for EFP activities that have been conducted since 2013. This EFP would authorize seven vessels to test the potential for a new commercial jig gear configured to target underutilized, midwater yellowtail and shelf rockfish species while avoiding overfished, bottom-dwelling yelloweye and canary rockfish. These EFP activities would take place within the non-trawl RCA off the California coast—specifically between Point Conception and the Oregon/California border at depths ranging from 35 to 150 fathoms (64 to 274 meters (m)).

• Commercial Midwater Hook-and-Line Rockfish Fishing in the RCA off the Oregon Coast: Scott Cook of Coos Bay, Oregon submitted an EFP to authorize 3-5 vessels to test a modified, midwater trolled longline gear configured to target underutilized, midwater yellowtail, widow, and canary rockfish while avoiding overfished, bottom-dwelling yelloweye rockfish. Alongside 100 percent observer coverage, this EFP would also test a new electronic monitoring (EM) device tailored to small vessels that are difficult to observe with human observers. These EFP activities will take place within the non-trawl RCA (referred to as Fixed Gear RCA in the EFP application) off the Oregon Coast—specifically in the rocky reef habitat at depths ranging from 30 to 100 fathoms (55 to 183 m). The Council approved this EFP application for final recommendation to NMFS with the understanding that the applicant will: (1) Harvest no more than 5 metric tons (mt) of canary rockfish as opposed to the requested 10 mt; (2) use artificial fishing lures; and, (3) limit the number of hooks per individual line to 40 or less with a maximum of 125 hooks total. The Council recommended the use of artificial fishing lures and a maximum hook limitation in order to minimize potential seabird interactions.

• Monterey Bay Regional Exempted Fishing Permit—Chilipepper Rockfish: Real Good Fish of Moss Landing, California submitted an EFP to authorize 5-10 vessels to: (1) Test a trolled hook-and-line gear configured to target underutilized, midwater chilipepper rockfish and avoid overfished, bottom-dwelling yelloweye rockfish; (2) determine areas that are abundant with chilipepper rockfish and that correspond to low densities of overfished yelloweye rockfish; and, (3) to test a new EM and vessel monitoring system intended to provide a cost-effective alternative to observer coverage on small vessels. These EFP activities will take place in the non-trawl RCA off the California coast—specifically in areas with canyon edges and walls that have historically produced high volumes of chilipepper rockfish catch and at depths ranging from 40 to 150 fathoms (73 to 274 m).

During the two-year period of EFP activities from 2019 to 2020, all applicants will adhere to EFP set-asides for targeted and incidental groundfish and other species, which were considered and approved by the Council at their June 2018 meeting. These EFP set-asides are off the top deductions from the 2019-2020 applicable annual catch limits (ACLs), meaning any landings and discards that occur under these EFPs would be accounted for within the applicable ACLs.

NMFS does not expect any impacts to the environment, essential fish habitat, or protected or prohibited species from this EFP beyond those analyzed for the groundfish fishery as a whole in applicable biological opinions 1 2 or the draft Environmental Assessment for the Pacific Coast Groundfish Fishery 2019-2020 Harvest Specifications and Management Measures.3 During Council deliberations, Council members expressed concern regarding seabird and canary rockfish impacts from the Scott Cook EFP, and salmon bycatch impacts from all three EFPs. To address seabird concerns, the Council requested modifications to the Scott Cook EFP, which included requiring participating vessels to use artificial fishing lures (as opposed to live bait) and limiting hooks to a maximum of 40 hooks per line with a maximum of 125 hooks total. NMFS will require additional mitigation measures if necessary to ensure that all potential seabird impacts fall within the scope of the 2017 United States Fish and Wildlife Biological Opinion 2 for Pacific Coast Groundfish Fishery impacts on seabirds. To address canary rockfish concerns, the Council requested a reduction in the Scott Cook EFP set-aside from 10 mt to 5 mt in order to take a precautionary approach in providing opportunities to target canary rockfish. To address the possibility of salmon bycatch, the Council requested that NMFS consider precautionary limits for bycatch of endangered salmon that may occur during EFP fishing activities. NMFS requested that the applicants estimate their expected bycatch of Chinook and coho salmon, and will present this information at the September 2018 Council meeting. NMFS will request that the Council provide additional input on the proposed salmon bycatch limits or additional considerations for approving these EFPs based on the expected salmon encounter rates and any public comments received during the comment period for the EFPs. The salmon bycatch limits that the Council approves would be counted against the non-whiting salmon bycatch guidelines for Chinook (5,500) and coho (560) salmon bycatch in NMFS's 2017 Biological Opinion. The terms and conditions of the EFP would state that EFP fishing will cease if vessels reach the expected salmon bycatch levels specified in the EFP.

The OMB is particularly interested in comments which:

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

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

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

• Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

A 60-day Notice requesting public comment was published in the Federal Register on Thursday, February 1, 2018 at Vol. 83, No. 22 Pg. 4644. This comment period ended April 2, 2018. No public comments were received from this Notice.

Description: Day of Service project promotion tool. Individuals organizing a volunteer event will be able to register their projects. This group includes national service grantees, corporations, volunteer organizations, and individuals. CNCS wants to help promote activities across the country and also to be able to assess impact of the CNCS's initiatives. Information provided is purely voluntary and will not be used for any grant or funding support. CNCS seeks to renew the current information collection. The information collection will otherwise be used in the same manner as the existing application. CNCS also seeks to continue using the current application until the revised application is approved by OMB. The current application expired March 31, 2018.

Type of Review: Renewal.

Agency: Corporation for National and Community Service.

Title: Day of Service Project Collection Tool.

OMB Number: 3045-0122.

Agency Number: None.

Affected Public: Any person or group organizing a service project in conjunction with a CNCS initiative.

Total Respondents: 60,000.

Frequency: Six times annually.

Average Time per Response: 10 minutes.

Estimated Total Burden Hours: 60,000 hours.

Total Burden Cost (capital/startup): None.

Total Burden Cost (operating/maintenance): None.

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

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

Minutes: Minutes will be available by writing or calling Amy Boyette at the address or phone number listed above. Minutes will also be available at the following website: http://cab.srs.gov/srs-cab.html.

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

Public Participation: The EM SSAB, Nevada, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Barbara Ulmer at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral presentations pertaining to agenda items should contact Barbara Ulmer at the telephone number listed above. The request must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments can do so during the 15 minutes allotted for public comments.

Minutes: Minutes will be available by writing to Barbara Ulmer at the address listed above or at the following website: http://www.nnss.gov/NSSAB/pages/MM_FY18.html.

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

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

Minutes: Minutes will be available by writing or calling Menice Santistevan at the address or phone number listed above. Minutes and other Board documents are on the internet at: https://energy.gov/em/nnmcab/meeting-materials.

The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act (ERDDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical advice to the Administrator on the scientific and technical basis for Agency positions and regulations. The SAB is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. Pursuant to FACA and EPA policy, notice is hereby given that the SAB will hold a public teleconference to discuss and deliberate on the topics below.

Quality Review of the draft SAB Review of EPA's Draft Assessments titled Toxicological Review of Ethyl Tertiary Butyl Ether and Toxicological Review of tert-Butyl Alcohol (tert-Butanol): National Center for Environmental Assessment (NCEA) in the EPA's Office of Research and Development (ORD) develops toxicological reviews/assessments for various chemicals for the Integrated Risk Information System and requested that the SAB conduct a peer review of the two EPA draft assessments. NCEA is developing a draft Toxicological Review of tert-Butyl Alcohol (tert-butanol) and Toxicological Review of Ethyl Tertiary Butyl Ether (ETBE). These two draft EPA documents represent new IRIS assessments of tert-butanol and ETBE. Experimental animal data and other relevant data from studies of the noncancer and cancer effects of tert-butanol and ETBE are evaluated in these assessments. These assessments include an oral reference dose (RfD) and inhalation reference concentration (RfC) for noncancer effects as well as a cancer assessment. The cancer assessments characterize tert-butanol and ETBE as having suggestive evidence of carcinogenic potential to humans and include oral cancer slope factors for both compounds and an inhalation unit risk for ETBE. The EPA SAB Staff Office augmented the SAB CAAC with subject matter experts, to provide advice to the Administrator through the chartered SAB regarding these assessments. Background on the current advisory activity can be found on the SAB website at: https://yosemite.epa.gov/sab/sabpeople.nsf/WebCommittees/BOARD.

Quality review of a draft SAB review report on the Framework for Assessing Biogenic CO2 Emissions from Stationary Sources: In 2012, the SAB completed a review of the first draft accounting framework addressing scientific and technical issues associated with biogenic carbon dioxide (CO2) emissions, Accounting Framework for Biogenic CO 2 Emissions from Stationary Sources (September 2011). The EPA subsequently revised the 2011 framework and requested the SAB to conduct a review of the Framework for Assessing Biogenic CO 2 Emissions from Stationary Sources (November 2014). The purpose of the 2014 framework is to develop a method for calculating the adjustment, or Biogenic Assessment Factor (BAF), for carbon emissions associated with the combustion of biogenic feedstocks considering the biological carbon cycle effects associated with their growth, harvest and processing. The SAB conducted two previous quality reviews and identified revisions to the draft reports in order to clarify the recommendations and in some cases to reframe them to ensure they are not policy prescriptive. This report is a product of SAB's direct efforts and utilizes portions of the draft reports. Previous drafts of the panel's report are retained on the SAB website. Background on the current advisory activity, Biogenic Carbon Dioxide Emissions from Stationary Sources—Assessment Framework can be found on the SAB website at http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/Biogenic%20CO2%20Framework?OpenDocument.

Briefings and updates. The SAB will receive updates from SAB members on the current activities of committees and panels developing advisory reports and briefings on future topics from the EPA staff.

Pursuant to FACA and EPA policy, notice is hereby given that the Chartered SAB will hold a public teleconference to discuss information provided by the EPA on these topics. The Chartered SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies.

Availability of Meeting Materials: Prior to the meeting, the review documents, agenda and other materials will be accessible on the SAB website at http://www.epa.gov/sab/.

Procedures for Providing Public Input: Public comment for consideration by the EPA's federal advisory committees and panels has a different purpose from public comment provided to the EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office.

Federal advisory committees and panels, including scientific advisory committees, provide independent advice to the EPA. Members of the public can submit comments for a federal advisory committee to consider as it develops advice for the EPA. Interested members of the public may submit relevant written or oral information on the topic of this advisory activity, and/or the group conducting the activity, for the SAB to consider during the advisory process. Input from the public to the SAB will have the most impact if it provides specific scientific or technical information or analysis for SAB to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should follow the instructions below to submit comments. Oral Statements: In general, individuals or groups requesting an oral presentation on a public teleconference will be limited to three minutes. Each person making an oral statement should consider providing written comments as well as their oral statement so that the points presented orally can be expanded upon in writing. Interested parties should contact Mr. Thomas Carpenter, DFO, in writing (preferably via email) at the contact information noted above by September 19, 2018, to be placed on the list of public speakers. Written Statements: Written statements should be supplied to the DFO via email at the contact information noted above by September 19, 2018, so that the information may be made available to the SAB members for their consideration. It is the SAB Staff Office general policy to post written comments on the web page for the advisory meeting or teleconference. Members of the public should be aware that their personal contact information, if included in any written comments, may be posted to the SAB website. Copyrighted material will not be posted without explicit permission of the copyright holder.

Accessibility: For information on access or services for individuals with disabilities, please contact Mr. Thomas Carpenter at the contact information provided above. To request accommodation of a disability, please contact Mr. Carpenter preferably at least ten days prior to each meeting to give the EPA as much time as possible to process your request.

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.

Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: On December 15, 1989, pursuant to Section 112 of the Clean Air Act as amended in 1977 (42 U.S.C. 1857), the Environmental Protection Agency (EPA) promulgated National Emission Standards for Hazardous Air Pollutants (NESHAP) to control radionuclide emissions from several source categories. The regulations are codified at 40 CFR part 61. Of the seven subparts (B, H, I, K, R, T and W) included in the 1989 rule, as currently amended, four apply to privately-operated facilities. In addition to requiring operational practices that limit emissions, Subparts B, K, R, and W impose radionuclide dose and/or emission limits, respectively, to underground uranium mines, elemental phosphorous plants, phosphogypsum stacks, and uranium mill tailings impoundments. Facilities must measure their radionuclide emissions, perform analysis or calculations per EPA procedure, and report the results to the EPA.

Information collected is used by the EPA to ensure that public health continues to be protected from the hazards of airborne radionuclides by compliance with these standards. Compliance is demonstrated through emissions testing and dose calculation when appropriate.

Form Numbers: None.

Respondents/affected entities: The North American Industry Classification System (NAICS) codes of facilities associated with the activity of the respondents are: (1) Elemental Phosphorous—325180, (2) Phosphogypsum Stacks—212392, (3) Underground Uranium Mines—212291, and (4) Uranium Mill Tailings—212291.

Respondent's obligation to respond: Mandatory (CAA, Sec, 112; 40 CFR part 61).

Estimated number of respondents: 17 (total).

Frequency of response: Annual, or one-time depending on the source category and respondent activity.

Total estimated burden: 1,880 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $447,850 (per year), which includes $328,000 annualized capital or operation and maintenance costs.

Changes in estimates: There is a decrease of 1,898 hours in the total estimated respondent burden compared with the 3,778 hours in the ICR currently approved by OMB. This decrease is due to a combination of factors. Fewer facilities, particularly uranium mines, are currently active. The only operating elemental phosphorus plant has obtained a waiver from annual testing and reporting. Compared to previous estimates, the current calculation assumes that fewer phosphogypsum stacks will require radon tests in any given year. The current assumption represents an upper bound on costs due to radon testing and reporting, compared to the actual observed activities of these facilities.

Parts of this meeting of the Board will be open to the public (limited space available) and parts will be closed to the public. Please send an email to [email protected] at least 24 hours before the meeting. In your email include: name, postal address, entity you are representing (if applicable), and telephone number. You will receive an email confirmation from us. Please be prepared to show a photo identification when you arrive. If you need assistance for accessibility reasons, or if you have any questions, contact Dale L. Aultman, Secretary to the Farm Credit Administration Board, at (703) 883-4009. The matters to be considered at the meeting are:

This meeting is open to members of the general public. The meeting will be webcast with open captioning at: www.fcc.gov/live. In addition, a reserved amount of time will be available on the agenda for comments and inquiries from the public. Members of the public may comment or ask questions of presenters via the email address [email protected]. The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations or for materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format) should be submitted via email to: [email protected] or by calling the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). Such requests should include a detailed description of the accommodation needed and a way for the FCC to contact the requester if more information is needed to fill the request. Requests should be made as early as possible; last minute requests will be accepted but may not be possible to accommodate.

Proposed Agenda: At this meeting, the DAC is expected to receive and consider reports and recommendations from its subcommittees. The DAC may also receive briefings from Commission staff on issues of interest to the Committee and may discuss topics of interest to the committee, including, but not limited to, matters concerning communications transitions, telecommunications relay services, emergency access, and video programming accessibility.

(1) Oral Argument in In the Matter of Impax Laboratories, Inc., Docket No. 9373.

(2) Executive Session to follow the Oral Argument in In the Matter of Impax Laboratories, Inc., Docket No. 9373.

On August 22, 2018, Commissioners Simons, Phillips, Chopra, and Slaughter were recorded as voting in the affirmative to conduct Matter Number One in open session, and to close Matter Number Two, and to withhold from this meeting notice such information as is exempt from disclosure under 5 U.S.C. 552b(c). Commissioner Ohlhausen was recorded as not participating.

The Commission has determined that Matter Number Two may be closed under 5 U.S.C. 552b(c)(10), and that the public interest does not require the matter to be open.

The General Counsel has certified that Matter Number Two may properly be closed, citing the following relevant exemptive provision: 5 U.S.C. 552b(c)(10).

Expected to attend the closed meeting are the Commissioners themselves, an advisor to one of the Commissioners, and such other Commission staff as may be appropriate.

A. Federal Acquisition Regulation (FAR) Subpart 4.11 prescribes policies and procedures for requiring contractor registration in the System for Award Management (SAM) database to: (1) Increase visibility of vendor sources (including their geographical locations) for specific supplies and services; and (2) establish a common source of vendor data for the Government.

In the past, the GSA Office of Inspector General (OIG) conducted an investigation into fraudulent activities discovered within SAM. Certain bad actors have, through electronic means, used public information to impersonate legitimate entities and established new entity registrations for those entities in SAM. By establishing fraudulent entity registrations, bad actors submitted bids in certain U.S. Government procurement systems or shipped deficient or counterfeit goods to the U.S. Government.

GSA established a new Information Collection Request (ICR) to collect additional information to support increased validation of entities registered and registering in the System for Award Management (SAM). This additional information is contained in a notarized letter in which an officer or other signatory authority of the entity formally appoints the Entity Administrator for the entity registering or recertifying in SAM. The original, signed letter is mailed to the Federal Service Desk for SAM prior to the registration's activation or re-registration.

The new ICR expires September 30, 2018, without authority for an extension. GSA is actively pursuing technical alternatives to the collection of this information for all non-federal entities. GSA seeks to refine the requirement and adopt a risk-based approach. This notice for an extension of the ICR lays the groundwork for the authority to continue collection of the information provided GSA is still pursuing the technical alternative beyond the ICR expiration date. In the interim, the collection of the notarized letter information is essential to GSA's acquisition mission to meet the needs of all federal agencies, as well as the needs of the grant community. A key element of GSA's mission is to provide efficient and effective acquisition solutions across the Federal Government. SAM is essential to the accomplishment of that mission. In addition to federal contracts, federal assistance programs also rely upon the integrity and security of the information in SAM. Without assurances that the information in SAM is protected and, is at minimal risk of compromise, GSA would risk losing the confidence of the federal acquisition and assistance communities which is serves. As a result, some entities may prefer not to do business with the Federal Government.

A 60-day notice was published in the Federal Register at 83 FR 24312 on May 25, 2018. Two comments were received.

Comments: One respondent stated that it is already time-consuming and frustrating for our grantees to use the SAM registration process. If the process was simple, it would not be a problem; however, having to submit notarized documents in addition to an already difficult process affects our ability to nimbly respond to programmatic initiatives through small grants to organizations or individuals who we know and want to partner with to achieve our goals. The other respondent stated that the new procedure creates another challenge for our grantees in that mailing the notarized document requires extra effort, but also finding a reliable courier service will be costly and requires a considerable amount of time to complete the registration process.

Response: GSA has taken several actions to address alleged fraudulent activity in the System for Award Management (SAM). The measures GSA has put in place to help prevent improper activity in SAM include masking specific data elements in the entity registration even for authorized entity users; requiring “parent” approval of new registrations for their “child” entities; multi-factor authentication using login.gov and notifying Entity Administrators when there is a change in the entity's bank account information. Requiring the formal appointment of the Entity Administrator by original, signed notarized letter ensures that the individual(s) reporting for their entity are associated with the entity and provides a validation of the letter submitter's identity by the notary. GSA is actively pursuing technical alternatives to replace and/or supplement the collection of notarized letters.

Respondents: 686,400.

Responses per Respondent: 1.

Total Annual Responses: 686,400.

Hours per Response: 2.25.

Total Burden Hours: 1,544,400.

The information collection allows GSA to request the notarized letter, and apply this approach to new registrants (an average of 7,200 per month) and to existing SAM registrants (an average of 50,000 re-register per month).

Entities registered and registering in SAM are provided the template for the requirements of the notarized letter. It is estimated that the Entity Administrator will take on average 0.5 hour to create the letter and 0.25 hour to mail the hard copy letter. GSA proposes that an Entity Administrator equivalent to a GS-5, Step 5 Administrative Support person within the Government would perform these tasks. The estimated hourly rate of $24.70 (Base + Locality + Fringe) was used for the calculation.

Based on historical data of the ratio of small entities to other than small entities registering in SAM, GSA approximates 32,200 of the 57,200 new and existing entities (re-registrants) will have in-house resources to notarize documents. GSA proposes that the entities with in-house notaries will typically be large businesses where the projected salary of the executive or officer responsible for signing the notarized letter is on average approximately $150 per hour. The projected time for signature and notarizing the letter internally is 0.5 hour.

The other remaining 25,000 new and existing entities (re-registrants) per month are estimated to be small entities where the projected salary of the executive or officer responsible signing the notarized letter is on average approximately $100 per hour. These entities will more than likely have to obtain notary services from an outside source. The projected time for signature and notarizing the letter externally is 1 hour. The estimate includes a nominal fee ($5.00) usually charged by third- party notaries.

Public comments are particularly invited on: Whether this collection of information is necessary, whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405. ATTN: Information Collection 3090-0317; Notarized Document Submittal for System for Award Management Registration. Please cite OMB Control No. 3090-0317; Notarized Document Submittal for System for Award Management Registration, in all correspondence.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Many environmental chemicals absorbed or ingested by pregnant women can cross the placenta to the fetus. The scientific evidence over the last 10 to 15 years has shown that exposure to toxic environmental agents before conception and during pregnancy can have significant and long-lasting adverse effects on the reproductive health of mothers, and on the long-term health of mothers and babies. Reducing exposure to toxic environmental agents is a critical area of intervention for reproductive health care professionals in the United States and worldwide. In 2013, the American College of Obstetricians and Gynecologists (ACOG) and other obstetrician-gynecologist professional societies called for timely action to identify and reduce exposure to toxic environmental agents while addressing the consequences of such exposure (ACOG, 2013; FIGO, 2105).

In support of this call to action, the Agency for Toxic Substances and Disease Registry (ATSDR) is requesting a three-year Paperwork Reduction Act (PRA) clearance for a new information collection request (ICR) entitled “Prenatal Assessment of Environmental Risk (PAER)”.

The long-term goal is for the PAER web-based information collection system to be widely adopted by obstetricians, gynecologists, and other reproductive health care professionals. Through PAER, practicing clinicians will have readily accessible and reliable information, and educational resources to counsel mothers-to-be on their potential environmental exposures and associated risks. This will facilitate reduction in harm to mothers-to-be and their babies. PAER environmental exposure assessment results will be suitable for incorporation into patients' electronic health records and maintenance within health care provider organizations.

Data collected will also establish an ongoing public health surveillance system that will provide an improved understanding of behaviors in daily life that put women of reproductive age and their babies at higher risk of exposure to environmental hazards. ATSDR will maintain only anonymous patient PAER survey responses and registration variables, including the PAER unique survey ID number, age, and zip code. Age and zip code will serve as the two variables for data analysis. Reported risk-based aggregate data will be at the zip code or higher geographic level, excluding zip code tabulation areas (ZTCAs) with 20,000 or fewer persons.

ATSDR plans to analyze the exposure risk data by geographic regions and over time. This data analysis will allow clinician and patient education on the most prevalent region-specific environmental exposures. ATSDR and partner organizations can use this information to shape educational initiatives and counseling guidance on ways women can lower environmental exposure risk.

The PAER survey is web-based, and includes 17 multiple-choice questions and one open-ended question. These questions are divided into five topic areas: Lifestyle; home; food and water; cans, bottles, and containers; and getting ready for the baby. The PAER survey focuses on 11 common types of environmental exposures: Air pollution, benzene, bisphenol A (BPA), flame retardants, lead, mercury, polychlorinated biphenyls (PCBs), pesticides, phthalates, smoking, and volatile organic compounds (VOCs).

There are two types of respondents who will participate in the PAER data collection, reproductive health care clinicians (RHCCs), and women of reproductive age who are seeking preconception or prenatal care. RHCCs will include obstetricians/gynecologists, family medicine physicians, nurse practitioners and physician assistants, and nurse midwives who are involved in the care of these women.

RHCCs (the first type of respondent) who choose to participate in the PAER process will be required to register with ATSDR, and gain approval to participate and establish credentials through CDC's Secure Access Management Services (SAMS). ATSDR will provide online training resources to instruct RHCCs how to register themselves and their clinic for PAER, to recruit patients, to utilize environmental histories and PAER resources for patient counseling, and to link PAER results to their patient health records. Online registration and training module components are estimated to take 30 minutes per RHCC.

Each RHCC who participates in PAER will also invite their patients to complete the environmental exposure survey by email or text, link their patients' survey response data with the invitations sent and health records, and provide counseling to individual patients to aid in modifying behavior to lower environmental exposure risks. These components are estimated to take RHCCs 30 minutes per patient.

Of note, ATSDR will not receive any information from the patients' electronic health records. RHCCs will invite their patients to participate outside of the PAER application, and will be responsible for protecting the patient information provided to them within PAER in accordance with the 1996 Health Insurance Portability and Accountability (HIPAA) guidelines.

Based on ACOG estimates, the number of practicing RHCCs in the U.S. is approximately 35,586. On average over the next three years, ATSDR estimates that up to 15 percent (n = 5,338) of these clinicians will participate in the PAER process each year through online registration and training. For purposes of estimation, ATSDR assumes the RHCCs represent the full effort of clinic staff. The annualized frequency of response (12 per RHCC) is based on ATSDR assumptions about the number of patients who will take part in the PAER survey as described below.

Women who receive preconception or prenatal care (the second type of respondents) may respond to the PAER environmental exposure history by accessing the online PAER survey through the application internet home page or through their RHCC's email/text invitation. ATSDR assumes that 5 percent of these women will participate in PAER over the next three years (or 1.67 percent per year). Using the 3,978,497 births reported in the 2015 U.S. Vital Statistics to represent the number women who receive preconception or prenatal care, 1.67 percent equals to 66,441 women who will take part in the PAER survey each year. Thus, each RHCCH is assumed to interact with 12 such patients per year (66,441/5,338 = 12). The time for women to respond to the survey is estimated at 10 minutes per patient.

Participation in the PAER process and survey is voluntary. There is no cost to respondents other than their time. The total annualized time burden requested is 45,772 hours. A summary of the estimated annualized burden hours is shown in the table that follows.

Public Participation

Interested persons or organizations are invited to submit written views, recommendations, and data about how investing in communities can improve health and prosperity. Examples may include:

(1) Available data, evidence and/or experience(s) (a) that suggest private sector investments in community health have (directly or indirectly) improved health and prosperity of the workforce and communities; (b) that healthier communities help private sector businesses to be more efficient, profitable, successful, or competitive; (c) description of data systems and evaluation frameworks that might contribute to supporting community health investment decisions, evaluating success and impact; and (d) case studies, examples, reviews and meta-analyses, data linkages, promising and emerging ideas, and best practices;

(2) Types of investments the private sector and local policy makers can consider to improve health and wellness of employees and families, and community well-being and prosperity;

(3) Types of partners or coalitions that have invested in community health and the scope of their collaborations contributions;

(4) Descriptions of important barriers to and facilitators of success;

(5) Private sector and local policy maker rationales for making investments in community health; and

(6) Successful efforts by local policy makers to promote and sustain private sector investments in community health.

Please note that comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Comments will be posted at https://www.regulations.gov. Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. CDC will review all submissions and may choose to redact or withhold submissions containing private or proprietary information, such as Social Security numbers, medical information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted and may include relevant information in the Call to Action.

America's prosperity is being hampered by preventable chronic diseases and behavioral health issues. Life expectancy at birth dropped in the United States for a second consecutive year in 2016. Preliminary data indicate that age-adjusted death rates continued to rise in 2017, which is likely to mark a third straight year of declining life expectancy. The U.S. lags behind comparable high-income countries on a range of health outcomes including life expectancy despite spending more on health care. About 6 in 10 American adults have at least one chronic health condition, and these people account for 90% of total health care spending. While chronic diseases affect all populations, they are not evenly distributed. Disease rates vary by race, ethnicity, education, geography and income level, with the most disadvantaged Americans often suffering the highest burden of disease.

However, only about 20% of the factors that influence a person's health can be addressed by health care and the remaining 80% reflect socioeconomic, environmental or behavioral factors. Focusing on strategies that address the social and community conditions could improve health, life expectancy, and quality of life, while also reducing related health care costs and productivity losses. Investing in communities to improve the health and well-being of people could also revitalize and improve economic opportunity, enhancing prosperity in the community and for its residents and businesses.

Although there are published literature and several ongoing public, private and philanthropic initiatives examining how investments in community health can enhance well-being and economic prosperity, there has not been a thorough assessment that compiles the evidence and best practices to illustrate benefits for the private sector and local policy makers. The Surgeon General's Call to Action is expected to bridge that gap and inspire more investments by the private sector and local policy makers in community health.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

5. Assess information collection costs.

Capacity Building Assistance Program: Assessment and Quality Control—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

The CDC is requesting the Office of Management and Budget (OMB) to grant a one year revision to collect data that comprises the Health Professional Application for Training, Training Follow-up Instrument, and the Technical Assistance Satisfaction Instrument. For this one year revision we will not collect any qualitative data (interviews) since we have gleaned valuable information that has been used to improve our service delivery and processes. The purpose of this information collection is to assess how well the CDC's Capacity Building Assistance (CBA) program meets the needs of its consumers in order to enhance its capacity building strategy over time. The PTCs and CBA providers are funded by CDC/Division of STD Prevention (DSTDP) and Division of HIV/AIDS Prevention (DHAP) over a five-year period to provide capacity building services that includes information, training, and technical assistance. CBA means the provision of free (not for fee) information, training, technical assistance, and technology transfer to individuals, organizations, and communities to improve their capacity in the delivery and effectiveness of evidence-based interventions and core public health strategies for HIV prevention. CBA is provided to support health departments, community-based organizations, and healthcare organizations in the implementation, monitoring and evaluation of evidence-based HIV prevention interventions and programs; building organizational infrastructure; and community mobilization to decrease stigma and increase HIV testing in high risk communities. CBA services are requested by health departments, community-based organizations, and healthcare organizations and also offered proactively. Under this project, there will be no duplication of information collection, because it builds on existing, OMB approved data collection activities. The PTCs and CBA providers offer classroom and experiential training, web-based training, clinical consultation, and capacity building assistance to maintain and enhance the capacity of healthcare professionals to control and prevent STDs and HIV. The CBA service recipients are healthcare professionals who work at community-based organizations (CBOs), health departments, and healthcare organizations, most of whom are funded directly or indirectly by the CDC, involved in HIV prevention service delivery. Their positions include HIV educator, clinical supervisor, HIV prevention specialist, clinician, outreach worker, case manager director, program coordinator, program manager, disease intervention specialist, partner services provider, physicians, nurses, and health educators, etc. CDC is requesting to use two web-based assessments that will be administered to recipients of CBA services: (1) Training Follow-Up Instrument and (2) Technical Assistance Satisfaction Instrument. The first quantitative assessment will be disseminated 90 days after a training event to agency staff who participated in a training activity. It takes approximately 12 minutes to complete. The purpose of this web-based assessment is to determine the training participants' satisfaction with the trainers, training materials, and the course pace, benefits from the training, and CBA needs, how relevant the training was to their work, and whether they were able to utilize the information gained from the training. The second quantitative assessment will be disseminated 45 days after a technical assistance event to agency staff who participated in a technical assistance. This instrument takes approximately 12 minutes to complete. The purpose of the second assessment is to assess participants' satisfaction with the technical assistance they received, intended or actual use of enhanced capacity, barriers and facilitators to use, and benefits of the technical assistance. The 7,400 respondents represent an average of the number of health professionals who receive training and technical assistance from the CBA and PTC grantees during the years 2010 and 2011. The data collection is necessary (a) to assess CBA consumers' (community-based organizations, health departments, and healthcare organizations) satisfaction with and short-term outcomes from the overall CBA program as well as specific elements of the CBA program; (b) to improve CBA services and enhance the Capacity Building Branch's national capacity building strategy over time; (c) to assess the performance of the grantees in delivering training and technical assistance and to standardize the registration processes across the two CBA programs (i.e., the PTC program and the CBA program) and multiple grantees funded by each program. There are no costs to respondents. The estimated annualized burden hours for this data collection activity are 8,633 hours.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

5. Assess information collection costs.

Assessment of Outcomes Associated with the Preventive Health and Health Services Block Grant—New—Office for State, Tribal, Local and Territorial Support (OSTLTS), Centers for Disease Control and Prevention (CDC).

For more than 35 years, the Preventive Health and Health Services Block Grant (PHHS Block Grant) has provided flexible funding for all 50 states, the District of Columbia, two American Indian tribes, five U.S. territories, and three freely associated states to address the unique public health needs of their jurisdictions in innovative and locally defined ways. First authorized by Congress in 1981 through the Public Health Service Act (Pub. L. 102-531), the fundamental and enduring purpose of the grant has been to provide grantees with flexibility and control to address their priority public health needs. In 1992, Congress amended the law to align PHHS Block Grant funding priorities with the 22 chapters specified in Healthy People (HP) 2000, a set of national objectives designed to guide health promotion and disease prevention efforts. Additional amendments included set-aside funds specifically dedicated to sex offense prevention and victim services, thus requiring grantees receiving this support to include related HP objectives and activities as part of their PHHS Block Grant-funded local programs.

CDC is establishing a comprehensive, standardized method to collect data to describe select outputs and outcomes and ensure the accountability of the PHHS Block Grant. The CDC PHHS Block Grant Measurement Framework is an innovative approach to assessing cross-cutting outputs and outcomes resulting from grantees' use of flexible grant funds. The framework defines four measures that enable CDC to standardize the collection of data on grantee achievements. The measures capture data on public health infrastructure improved (i.e., information systems improved and quality improved—efficiency and effectiveness improvements achieved in programs, services, and operations), emerging public health needs addressed, and evidence-based public health interventions implemented.

The purpose of this information collection request (ICR) is to collect data that assess select cross-cutting outputs and outcomes of the grant (as defined by the framework measures) and that demonstrate the utility of the grant on a national level. This data collection will describe the outcomes of the PHHS Block Grant as a whole—not individual grantee activities or outcomes. Findings from this data collection will be used to: (1) Describe the outcomes and achievements of grantees' public health efforts and identify how the use of PHHS Block Grant funds contributed to those results, and (2) help assess how the PHHS Block Grant advances work of the public health system and provides evidence to support future budgetary requests.

The respondent universe consists of 61 PHHS Block Grant coordinators, or their designees, across 61 health departments (50 states, the District of Columbia, two tribes, five US territories, and three freely associated states). The assessment will be administered to PHHS Block Grant coordinators electronically via a web-based questionnaire. A link to the assessment will be provided by email invitation. The survey will be completed once every two years. The total annualized estimated burden is 46 hours.

The Medical Device Amendments of 1976 (Pub. L. 94-295) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) established a risk-based framework for the regulation of medical devices. The law established a three-tiered risk classification system based on the risk posed to patients should the device fail to perform as intended. Under this system, devices that pose greater risks to patients are subject to more regulatory controls and requirements. Generally, in premarket decision-making for devices, there exists some uncertainty around benefits and risks. The Agency generally provides marketing authorization for a device when it meets the applicable standards, including that its benefits outweigh its risks.

In 2015, following pilots conducted over 4 years, FDA established the Expedited Access Pathway Program as a voluntary program for certain medical devices that address an unmet need in the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under this program, an eligible device subject to a PMA could be approved with greater uncertainty about the product's benefits and risks, provided that, among other requirements, the data still support a reasonable assurance of safety and effectiveness, including that the probable benefits of the device outweigh its risks for a patient population with unmet medical needs. For devices subject to PMA, the Agency has the authority to impose, when warranted, postmarket requirements, including post-approval studies and postmarket surveillance, as a condition of approval, which could be used to address this greater uncertainty.1 In the Breakthrough Device provisions of the FD&C Act, as added by the 21st Century Cures Act (Cures Act) and amended by the FDA Reauthorization Act of 2017 (FDARA), Congress codified and expanded this program to include devices reviewed through a 510(k) notification.2

This draft guidance provides further information on how FDA considers uncertainty in benefit-risk determinations for PMAs, De Novo requests, and HDE applications.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, De Novo classifications, and humanitarian device exemptions. 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.

Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food and Drug Administration Staff” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 17039 to identify the guidance you are requesting.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; the collections of information for De Novo classification requests have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H, have been approved under OMB control number 0910-0332; and the collections of information in 21 CFR part 822 have been approved under OMB control number 0910-0449.

FDA is requesting nominations for voting members on TEPRSSC that include three general public representatives.

The committee provides advice and consultation to the Commissioner of Food and Drugs (Commissioner) on the technical feasibility, reasonableness, and practicability of performance standards for electronic products to control the emission of radiation from such products, and may recommend electronic product radiation safety standards to the Commissioner for consideration.

The committee consists of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of science or engineering, applicable to electronic product radiation safety. Members will be invited to serve for overlapping terms of up to 4 years. Terms of more than 2 years are contingent upon the renewal of the committee by appropriate action prior to its expiration.

Any interested person may nominate one or more qualified individuals for membership on the committee. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee, including current business address and/or home address, telephone number, and email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must also specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

I. Background

In the Federal Register of July 12, 2018, FDA published notices of availability with a 90-day comment period for six draft guidance documents listed in the following table. Three of the six draft guidance documents provide recommendations to stakeholders developing gene therapies for retinal disorders, hemophilia, and rare diseases. The remaining three guidance documents provide recommendations to sponsors manufacturing gene therapies; namely, how to provide chemistry, manufacturing and controls information for gene therapy products, additional recommendations regarding the testing for replication competent retrovirus during the manufacture of retroviral vector-based gene therapy products and during the follow-up monitoring of patients who received retroviral vector-based gene therapy products, and recommendations regarding the design of long-term follow-up observational studies for the collection of data on delayed adverse events following administration of a gene therapy product. Comments were requested on these draft guidances by October 10, 2018.

The Agency has received requests for a 60-day extension of the comment period for the six draft guidance documents. These requests conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the draft guidance documents.

FDA has considered these requests and is extending the comment period for the six draft guidance documents for 60 days, until December 10, 2018. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments.

The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov.

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

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

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding, among other things, a chapter granting FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.

The FD&C Act, as amended by the Tobacco Control Act, requires that before a new tobacco product may be introduced or delivered for introduction into interstate commerce, the new tobacco product must undergo premarket review by FDA. FDA must issue an order authorizing the commercial distribution of the new tobacco product or find the product exempt from the requirements of substantial equivalence under section 910(a)(2)(A) of the FD&C Act, before the product may be introduced into commercial distribution (section 910 of the FD&C Act (21 U.S.C. 387j)).

FDA has issued a guidance document containing recommendations for preparing substantial equivalence reports (SE Reports) under section 905(j)(1)(A)(i). A tobacco product manufacturer must show that a new tobacco product is substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that it is in compliance with the requirements of the FD&C Act. The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product.

The guidance document associated with this collection of information contains recommendations on preparing reports intended to demonstrate substantial equivalence to a predicate tobacco product and compliance with the FD&C Act as required under section 905(j)(1)(A)(i). Submission of a section 905(j)(1)(A)(i) report intended to demonstrate substantial equivalence and, in response, an order from the Agency finding that the new tobacco product is substantially equivalent to a predicate tobacco product and in compliance with the requirements of the FD& C Act, is one means for a new tobacco product to legally enter the market. FDA's guidance entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” (December 2016). This guidance may be accessed at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm). In that guidance, FDA recommends that certain modifications might be addressed in a “Product Quantity Change Report,” which is a more streamlined SE Reports for certain modifications that should be easier for manufacturers to prepare.

The Tobacco Control Act also gave FDA the authority to issue a regulation deeming all other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the FD&C Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10, 2016, FDA issued that rule, extending FDA's tobacco product authority to all products that meet the definition of tobacco product in the law (except for accessories of newly regulated tobacco products), including electronic nicotine delivery systems, cigars, hookah, pipe tobacco, nicotine gels, dissolvables that were not already subject to the FD&C Act, and other tobacco products that may be developed in the future (81 FR 28974 at 28976) (“the Deeming final rule”).

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

FDA's estimates are based on experience with SE Reports, initial updated deemed registration and listing data, interactions with the industry, and information related to other regulated products. The estimated number of SE Reports is expected to increase from an annual average of 979 to 1,570.

When groups of full or product quantity change SE Reports have identical content, they may be bundled; when a group of similar reports are bundled, the subsequent bundled reports are expected to take less time to prepare than the initial report.

FDA has based these estimates on information it now has available from interactions with the industry, information related to other regulated products, and FDA expectations regarding the tobacco industry's use of the section 905(j) pathway to market their products. Table 1 describes the annual reporting burden as a result of the implementation of the substantial equivalence requirements of sections 905(j)(1)(A)(i) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)) for an SE application.

FDA estimates that 683 respondents will prepare and submit 683 section 905(j)(1)(A)(i) SE Reports each year. In addition, anyone submitting an SE Report is required to submit an environmental assessment (EA) under 21 CFR 25.40. The burden for environmental reports has been included in the burden per response for each type of SE report. Based on FDA's experience with EAs for currently regulated tobacco products, we expect industry to spend 80 hours to prepare an environmental assessment for a SE Report. Thus, FDA estimates that it will take a manufacturer approximately 300 hours per report to prepare an SE Report and the EA for a new tobacco product, which is a total of 204,900 hours.

In addition, we estimate receiving 456 Full SE Bundled Reports at 90 hours per submission for a total of 41,040 hours.

FDA estimates that it will receive 239 Product Quantity Change SE Reports and that it will take a manufacturer approximately 87 hours to prepare this report for a total of 20,793 hours. This includes time to prepare the environmental assessment, which FDA believes will take less time due to the typically more limited modification(s) included in a Product Quantity Change SE Report. We estimate receiving 192 Product Quantity Change Bundled SE Reports at approximately 62 hours per submission for a total of 11,904 hours, this number excludes the time for the initial SE Report which was previously account for.

Therefore, FDA estimates the burden for submission of SE information will be 278,637 hours. This is an increase of 106,759 hours from the currently approved burden. We attribute this increase to an increase in the number of SE Reports we expect related to Deemed products (e.g., based on the initial registration and listing information).

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

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

This information collection supports the previously captioned Agency guidance and associated Form FDA 3911. The Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113-54) added new section 582(h)(2) to the Federal Food, Drug, and Cosmetic Act (FD&C Act), requiring FDA to issue guidance to aid trading partners in identifying a suspect product and terminating a notification regarding an illegitimate product and, for a manufacturer, a product with a high risk of illegitimacy. Suspect product is defined in section 581(21) of the FD&C Act as a product for which there is reason to believe it: (1) Is potentially counterfeit, diverted, or stolen; (2) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; (3) is potentially the subject of a fraudulent transaction; or (4) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

Beginning January 1, 2015, section 582 of the FD&C Act requires certain trading partners, upon determining that a product in their possession or control is a suspect product, to quarantine the product while they promptly conduct an investigation to determine whether the product is an illegitimate product. Illegitimate product is defined in section 581(8) of the FD&C Act as a product for which credible evidence shows that it: (1) Is counterfeit, diverted, or stolen; (2) is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; (3) is the subject of a fraudulent transaction; or (4) appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans. Also beginning January 1, 2015, trading partners must, upon determining that a product in their possession or control is illegitimate, notify FDA and all immediate trading partners that they have reason to believe they may have received the illegitimate product not later than 24 hours after making the determination. Under section 582(b)(4)(B)(ii)(II) of the FD&C Act, manufacturers are additionally required to notify FDA and any immediate trading partners that they believe may possess a product manufactured by or purportedly manufactured by the manufacturer not later than 24 hours after the determination is made or being notified by FDA or a trading partner that the product has a high risk of illegitimacy.

Under section 202 of the DSCSA, manufacturers, repackagers, wholesale distributors, and dispensers (e.g., pharmacies) must: (1) Notify FDA when they have determined that a product in their possession or control is illegitimate (and, for manufacturers, when they have determined or been notified by FDA or a trading partner that a product has a high risk of illegitimacy); (2) notify certain immediate trading partners about an illegitimate product that they may have received (and, for manufacturers, that a product has a high risk of illegitimacy); (3) terminate notifications regarding illegitimate products (and, for manufacturers, a product with a high risk of illegitimacy), in consultation with FDA, when the notifications are no longer necessary; and (4) notify immediate trading partners when the notifications are terminated. Trading partners should use Form FDA 3911 to submit notifications and requests for terminations of notifications to FDA. Form FDA 3911 is available on FDA's web page (https://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm).

Under section 582(b)(4)(B)(ii)(I), (c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii) of the FD&C Act, as amended by the DSCSA, and beginning not later than January 1, 2015, a manufacturer, repackager, wholesale distributor, or dispenser who determines that a product in its possession or control is illegitimate must notify FDA of that determination not later than 24 hours after the determination is made. In addition, section 582(b)(4)(B)(ii)(II) of the FD&C Act requires manufacturers to notify FDA when a manufacturer determines that a product poses a high risk of illegitimacy.

We originally estimated that all manufacturers, repackagers, wholesale distributors, and dispensers would collectively submit 5,000 notifications per year. This estimate included the notifications by trading partners that have determined that illegitimate product is in their possession or control, as well as notifications by manufacturers that have determined a product poses a high risk of illegitimacy. As discussed in our Federal Register notice of June 11, 2014 (79 FR 33564), the estimate was based on our experience with field alert reports (FARs) (Form FDA 3331) that holders of approved drug applications are required to submit for certain drug quality issues (21 CFR 314.81(b)(1)) and with reports of the falsification of drug sample records, diversion, loss, and known theft of prescription drug samples as currently required under § 203.37 (21 CFR 203.37). Upon evaluation of the number of notifications we received for fiscal years 2016 and 2017, however, we are lowering our estimate to 150 notifications.

We are also combining the estimates for manufacturers and repackagers because FDA's establishment and drug product listing database indicates that many companies perform activities of both manufacturers and repackagers. Although the DSCSA specifically defines dispensers, for estimation purposes, we are using estimates for pharmacies in general terms based on those that must comply with the new requirements under section 582(d) of the FD&C Act.

Because manufacturers, repackagers, and wholesale distributors are collectively responsible for prescription drugs from the point of manufacturing through distribution in the drug supply chain, we assume that most notifications of illegitimate products are submitted by these three trading partners. The total number of respondents is comprised of 80 percent manufacturers (120), 15 percent wholesale distributors (22), and 5 percent pharmacies (8).

We estimate that the number of annual notifications will vary from 0 to 2 for manufacturers/repackagers, as well as from pharmacies, with the vast majority of companies making no notifications. Although FDA's establishment and drug product listing database currently contains registrations for approximately 6,500 manufacturers and repackagers, we estimate that approximately 120 manufacturers/repackagers will notify us of illegitimate products an average of one time per year. Although we estimate approximately 69,000 pharmacy sites in the United States, based on data from the National Association of Chain Drug Stores, the National Community Pharmacists Association, and the American Hospital Association, we estimate that approximately 8 pharmacies will notify FDA of illegitimate product an average of one time per year. According to the Healthcare Distribution Alliance (formerly known as Healthcare Distribution Management Association), approximately 30 wholesale distributors are responsible for over 90 percent of drug distributions; based on sales and because FDA is estimating that over 2,200 small wholesale distributors might be responsible for the remaining 10 percent of drug sales, we estimate that wholesale distributors will be responsible for making about an average of 1 notification per year to account for the estimated 22 notifications that FDA will receive regarding illegitimate product. Each notification should include information about the person or entity initiating the notification, the product determined to be illegitimate or having a high risk of illegitimacy, and a description of the circumstances surrounding the event that prompted the notification. We estimate that each notification will take about 1 hour, as reflected in table 1.

Under section 582(b)(4)(B)(ii)(I), (c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii) of the FD&C Act, a trading partner who determines that a product in its possession is illegitimate must also notify all immediate trading partners that they believe may have received such illegitimate product not later than 24 hours after the determination is made. In addition, under section 582(b)(4)(B)(ii)(II) of the FD&C Act, a manufacturer is required to notify all immediate trading partners that the manufacturer believes may possess a product manufactured by or purported to be manufactured by the manufacturer not later than 24 hours after the determination is made or being notified by FDA or a trading partner that the product has a high risk of illegitimacy.

Because the extent of distribution of any illegitimate product is likely to vary from one situation to another, we assume a wide distribution of each illegitimate product. We estimate that, for each notification made by a manufacturer or repackager to FDA, approximately 30 trading partners (based on the number of distributors) will also be notified. This results in approximately 3,600 notifications annually to trading partners of manufacturers/repackagers. This estimate includes the notifications by manufacturers and repackagers who have determined that illegitimate product is in their possession or control, as well as notifications by manufacturers that have determined that a product poses a high risk of illegitimacy.

We estimate that a large wholesale distributor may have up to 4,500 trading partners, but a small wholesale distributor may have 200 trading partners, for an average of approximately 2,350. We originally estimated that a wholesale distributor would notify all 2,350 trading partners for each of the illegitimate products identified. However, we are lowering our estimate as a result of our experience with the collection and informal feedback from industry to reflect that 22 respondents will make 1,175 disclosures for a total of 25,850 disclosures annually; and that each disclosure will require approximately 12 minutes, for a total of 5,170 hours annually.

We estimate that a pharmacy purchases prescription drugs from an average of two wholesale distributors. Therefore, a pharmacy would notify 2 trading partners for each of the 8 illegitimate products identified, resulting in approximately 16 notifications annually to pharmacy trading partners.

Manufacturers/repackagers, wholesale distributors, and pharmacies may notify their trading partners using existing systems and processes used for similar types of communications. Such communications may include, but are not limited to, posting notifications on a company website, sending an email, telephoning, or mailing or faxing a letter or notification. The information contained in the notification to the immediate trading partner should be the same as or based on the notification that was already submitted to FDA. We estimate that, for all trading partners, each notification of immediate trading partners will take approximately 0.2 hours (12 minutes). The estimated total burden hours that manufacturers/repackagers, wholesale distributors, and pharmacies will take to notify trading partners is approximately 5,893 hours annually, as reflected in table 2.

Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and (e)(4)(B)(iv) of the FD&C Act requires that a trading partner who determines, in consultation with FDA, that a notification made under section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), or (e)(4)(B)(ii) is no longer necessary must terminate the notification. The guidance for industry sets forth the process by which trading partners should consult with FDA to terminate notifications that are no longer necessary.

Each request for termination of notification must include information about the person or entity initiating the request for termination, the illegitimate product or product with a high risk of illegitimacy, the notification that was issued, and an explanation about what actions have taken place or what information has become available that make the notification no longer necessary. Trading partners should also include the FDA-assigned incident number associated with the initial notification on the request for termination. The request for a termination will be viewed as a request for consultation with FDA. We estimate that the same amount of time will be required to provide the information necessary to request termination as is required to make the notification. The time required to investigate and resolve an illegitimate product notification will vary, but we assume that each notification will eventually be terminated. We assume that the number of requests for termination of a notification per year will be the same as the original number of notifications for a given year. The estimated total burden hours of making requests for termination of notifications to FDA is 150 hours annually, as reflected in table 3.

Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and (e)(4)(B)(iv) of the FD&C Act requires that a trading partner who, in consultation with FDA, terminates a notification made under section 582(b)(4)(B)(ii)(I) or (II), (c)(4)(B)(ii), (d)(4)(B)(ii), or (e)(4)(B)(ii) must also promptly inform previously-notified immediate trading partners that the notification has been terminated. We estimate that the burden for notifying trading partners of an illegitimate product and the number of trading partners notified will be the same as the estimates for notification of termination. The estimated total burden hours of notifying trading partners that the notification is terminated is approximately 5,893 hours annually, as reflected in table 4.

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

Cumulatively, the total estimated burden is 12,086 annual hours, which reflects a significant decrease. We base this adjustment on our experience with the information collection since its establishment and implementation.

FDA is requesting nominations for voting members to fill upcoming vacancies on the National Mammography Quality Assurance Advisory Committee.

The National Mammography Quality Assurance Advisory Committee advises the Commissioner of Food and Drugs (the Commissioner) or designee on: (1) Developing appropriate quality standards and regulations for mammography facilities; (2) developing appropriate standards and regulations for bodies accrediting mammography facilities under this program; (3) developing regulations with respect to sanctions; (4) developing procedures for monitoring compliance with standards; (5) establishing a mechanism to investigate consumer complaints; (6) reporting new developments concerning breast imaging that should be considered in the oversight of mammography facilities; (7) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; (8) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (9) determining the costs and benefits of compliance with these requirements.

The committee consists of a core of 15 members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years.

Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee, including current business address, telephone number, and email address if available and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

FDA is announcing the availability of a guidance for industry entitled “Allergic Rhinitis: Developing Drug Products for Treatment.” The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of SAR and PAR. This guidance finalizes the draft guidance of the same name issued on February 16, 2016. All the public comments received on the draft guidance have been considered and the guidance has been revised as appropriate along with a few editorial changes.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Allergic Rhinitis: Developing Drug Products for Treatment. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.

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

I. Background

FDA is announcing the availability of a guidance for industry entitled “Nonallergic Rhinitis: Developing Drug Products for Treatment.” The purpose of this guidance is to assist applicants of new drug applications and biologics license applications in developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults. This guidance incorporates the comments received and finalizes the draft guidance of the same name issued on February 16, 2016 (81 FR 7811). All the public comments received on the draft guidance have been considered and the guidance has been revised primarily to update references and to clarify.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on developing drug products for treatment of nonallergic rhinitis. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.

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

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

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

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2018-0789], and must be received by November 5, 2018.

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

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

Title: Ballast Water Management Reporting and Recordkeeping.

OMB Control Number: 1625-0069.

Summary:This collection requires the master of a vessel to provide information that details the vessel operator's ballast water management efforts.

Need: The information is needed to ensure compliance with 16 U.S.C. 4711 and the requirements in 33 CFR part 151, subparts C and D regarding the management of ballast water, to prevent the introduction and spread of aquatic nuisance species into U.S. waters. The information is also used for research and periodic reporting to Congress.

Forms: Ballast Water Management Report and Ballast Water Management (BWM) Equivalent Reporting Program Application.

Respondents: Owners and operators of certain vessels.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has increased from 61,819 hours to 83,337 hours a year due to an increase in the estimated annual number of responses.

Public Participation and Request for Comments

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

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

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2018-0792], and must be received by November 5, 2018.

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

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

Title: Title 46 CFR Subchapter Q: Lifesaving, Electrical, Engineering and Navigation Equipment, Construction and Materials & Marine Sanitation Devices (33 CFR part 159).

OMB Control Number: 1625-0035.

Summary: This information is used by the Coast Guard to ensure that regulations governing specific types of safety equipment, material and Marine Sanitation Devices (MSDs) installed on commercial vessels and pleasure craft are met. Manufacturers are required to submit drawings, specifications, and laboratory test reports to the Coast Guard before any approval is given.

Need: Tile 46 U.S.C. 2103, 3306, 3703, and 4302 authorize the Coast Guard to establish safety equipment and material regulations. Title 46 CFR parts 159 to 164 prescribe these requirements. Title 33 U.S.C. 1322 authorizes the Coast Guard to establish MSD regulations. Title 33 CFR part 159 prescribes these rules. NVIC 8-01 (Chg 2) prescribes the standards for navigation equipment. This information is used to determine whether manufacturers are in compliance with Coast Guard regulations. When the Coast Guard approves any safety equipment, material or MSD for use on a commercial vessel or pleasure craft, the manufacturer is issued a Certificate or Approval.

Forms: CGHQ-10030, Certificate of Approval.

Respondents: Manufacturers of safety equipment, materials and marine sanitation devices.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has decreased from 118,594 hours to 114,586 hours a year due to a decrease in the estimated annual number of responses.

This proposed information collection previously published in the Federal Register on June 29, 2018 at 83 FR 30159 with a 60 day public comment period. FEMA received 12 unrelated comments. The number of respondents, responses, and total annual burden hours for this collection changed from the previously published Federal Register notice because the Commonwealth of Puerto Rico were added as a respondent. The purpose of this notice is to notify the public that FEMA will submit the information collection abstracted below to the Office of Management and Budget for review and clearance.

Title: Application for Community Disaster Loan (CDL) Program.

Type of Information Collection: Extension, without change, of a currently approved information collection.

OMB Number: 1660-0083.

Form Titles and Numbers: FEMA Form 090-0-1, Certification Of Eligibility For Community Disaster Loans; FEMA Form 116-0-1, Promissory Note; FEMA Form 116-0-1A, Promissory Note; FEMA Form 116-0-1B, Promissory Note; FEMA Form 116-0-1C, Promissory Note; FEMA Form 085-0-1, Local Government Resolution—Collateral Security; FEMA Form 112-0-3C, Certifications Regarding Lobbying; Debarment, Suspension and Other Responsibility Matters; and Drug-Free Workplace Requirements; FEMA Form 090-0-4, Letter of Application through the GAR. The respondent will only complete each form once and each response will require 4.0 hours.

Abstract: The loan package for the CDL Program provides Local and Tribal governments that have suffered substantial loss of tax or other revenues as a result of a major disaster or emergency, the opportunity to obtain financial assistance in order to perform their governmental functions. The loan must be justified on the basis of need and actual expenses.

Affected Public: State, local or Tribal Government.

Estimated Number of Respondents: 144.

Estimated Number of Responses: 144.

Estimated Total Annual Burden Hours: 518.13.13.

Estimated Total Annual Respondent Cost: $27,761.41.

Estimated Respondents' Operation and Maintenance Costs: $0.

Estimated Respondents' Capital and Start-Up Costs: $0.

Estimated Total Annual Cost to the Federal Government: $1,012,699.66.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.

The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).

This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.

This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are used to calculate the appropriate flood insurance premium rates for new buildings, and for the contents in those buildings. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.

Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at https://msc.fema.gov.