Federal Register Vol. 83, No.213,

This meeting is available to the public through the number listed above. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Alejandro Ventura at [email protected]. Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at http://facadatabase.gov/committee/meetings.aspx?cid=245. Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

On April 16, 2018, Commerce published in the Federal Register a notice of initiation of an administrative review of the antidumping duty order on uncovered innerspring units from the People's Republic of China.1 Commerce initiated a review with respect to two companies: Comfort Coil Technology Sdn. Bhd. (Comfort Coil) and Foshan Nanhai Jolyspring (Foshan Nanhai).2 On May 11, 2018, Commerce issued its questionnaire to Comfort Coil and Foshan Nanhai.3 The questionnaire for Comfort Coil was undeliverable,4 and based on an alternate address provided by the petitioner,5 on July 5, 2018, we resent the questionnaire to Comfort Coil.6 We confirmed delivery of the questionnaires to both respondents.7

On July 11, 2018, Comfort Coil stated it had “no sales, exports, or entries of subject merchandise during the period of review.” 8 On July 30, 2018, Commerce issued a no shipment inquiry to U.S. Customs and Border Protection (CBP) with respect to Comfort Coil, and CBP reported no entries for the company during the POR.9 Foshan Nanhai never responded to the questionnaire, nor did it contact Commerce to state that it was unable to respond or to request an extension of time to do so.

The merchandise subject to the order is uncovered innerspring units composed of a series of individual metal springs joined together in sizes corresponding to the sizes of adult mattresses (e.g., twin, twin long, full, full long, queen, California king, and king) and units used in smaller constructions, such as crib and youth mattresses. The product is currently classified under subheading 9404.29.9010 and has also been classified under subheadings 9404.10.0000, 9404.29.9005, 9404.29.9011, 7326.20.0070, 7326.20.0090, 7320.20.5010, 7320.90.5010, or 7326.20.0071 of the Harmonized Tariff Schedule of the United States (HTSUS). The HTSUS subheadings are provided for convenience and customs purposes only; the written description of the scope of the order is dispositive.10

Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). For a full description of the methodology underlying our conclusions, please see the Preliminary Decision Memo. The Preliminary Decision Memo is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit, Room B8024 of the main Commerce building. In addition, a complete version of the Preliminary Decision Memo can be accessed directly on the internet at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memo and the electronic version are identical in content.

On July 11, 2018, Comfort Coil filed a no shipment certification, indicating that it did not export subject merchandise to the United States during the POR. During the course of this review, Commerce examined this no shipments claim and provides its analysis in the Preliminary Decision Memo. Based on the record evidence, we preliminarily determine that Comfort Coil had no shipments during the POR. In addition, consistent with our practice in non-market economy cases, Commerce is not rescinding this review for Comfort Coil, but intends to complete the review with respect to Comfort Coil and issue appropriate instructions to CBP based on the final results of the review.11 Should evidence contrary to Comfort Coil's no-shipments claims arise, we will address the issue in the final results.

Because Foshan Nanhai did not respond to the questionnaire, Commerce preliminarily determines that Foshan Nanhai is not eligible for a separate rate and is a part of the China-wide entity. We are not conducting a review of the China-wide entity. Thus, the weighted-average dumping margin for the China-wide entity (234.51 percent) 12 is not subject to change as a result of this review. Accordingly, the pre-existing China-wide rate of 234.51 percent will apply to entries of Foshan Nanhai's subject merchandise into the United States during the POR.

Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs not later than 30 days after the date of publication of this notice in the Federal Register. 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.14 Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.15 Case and rebuttal briefs should be filed using ACCESS.16 An electronically filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Standard Time on the due dates set forth in this notice.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice. 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, Commerce intends 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.17 Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

Unless extended, Commerce intends 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 CBP shall assess, antidumping duties on all appropriate entries covered by this review.18 Commerce intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review. We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review if any assessment rate calculated in the final results of this review is above de minimis. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable. Assessment of duties resulting from the final results of this review will pertain only to entries of subject merchandise (i.e., innerspring units from China).

If we continue to find that Comfort Coil had no shipments during the period of review in the final results, Commerce will direct CBP to liquidate and assess antidumping duties on all entries made during the period of review claiming Comfort Coil as the exporter or producer in accordance with the Reseller Policy, i.e., at the rate for the China-wide entity.19

The following cash deposit requirements will be effective upon publication of the final results of this administrative review for shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date of this notice, as provided by section 751(a)(2)(C) of the Act: (1) For previously investigated or reviewed Chinese and non-Chinese exporters of subject merchandise that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate published for the most recently completed period; (2) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, i.e., Foshan Nanhai, the cash deposit rate will be the China-wide rate of 234.51 percent; and (3) for all non-Chinese exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Chinese exporter that supplied that non-Chinese exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

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

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

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), and the Fur Seal Act of 1966, as amended (16 U.S.C. 1151 et seq.).

The applicant proposes to import, export, and receive biological samples from up to 100 cetaceans and 100 pinnipeds, excluding walrus, annually for scientific research to study the mechanisms of cancer resistance in marine mammals. The requested duration of the permit is 5 years.

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

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

The agenda will include: drafting additional recommendations for how to potentially lower costs and increase observer coverage rates in the partial coverage category while maintaining the data sufficient for managing the fisheries; randomized deployment; and, cost equity considerations among participants. This may include providing input of differential deployment base levels by gear type.

The Agenda is subject to change, and the latest version will be posted at www.npfmc.org prior to the meeting, along with meeting materials.

Public comment letters will be accepted and should be submitted either electronically to Elizabeth Figus, Council staff: [email protected] or through the mail: North Pacific Fishery Management Council, 605 W 4th Ave., Suite 306, Anchorage, AK 99501-2252. In-person oral public testimony will be accepted at the discretion of the chair.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216).

Research activities will take place between October 1 and March 31 for the five austral summer seasons. Each season will encompass two sampling periods: one during the lactation period (October to November) and one at the end of the molt (January to March). During the first period, up to 25 adult females will be given a health exam and dive recorders/transmitters will be recovered from females handled the previous molt period. At the end of the molt, up to 25 adult females will undergo a health and pregnancy status assessment and will be outfitted with a satellite-relay dive recorder. Unmanned aircraft system surveys will be used for photogrammetry of handled animals, as well as unhandled seals in larger area surveys. Up to 500 crabeater seals (Lobodon carcinophagus) may also be taken by incidental harassment. Research activities will conducted as part of a larger assessment of Weddell seals in the Ross Sea Marine Protected Area, led by the New Zealand Antarctic Program.

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

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

Agenda Monday, November 19, 2018 to Tuesday, November 20, 2018

The agenda will include: Updates since the last meeting in August 2018; staff presentations about the updated Alaska Regional Electronic Technologies Implementation Plan, biological sampling needs, electronic monitoring in other regions, and automation; reviewing a white paper on retention, a data streams draft document, and research plans for tender issues in the western Gulf of Alaska; discussing funding opportunities; finalizing a cooperative research plan document; and, scheduling and other issues.

The Agenda is subject to change, and the latest version will be posted at www.npfmc.org prior to the meeting, along with meeting materials.

Public comment letters will be accepted and should be submitted either electronically to Elizabeth Figus, Council staff: [email protected] or through the mail: North Pacific Fishery Management Council, 605 W 4th Ave., Suite 306, Anchorage, AK 99501-2252. In-person oral public testimony will be accepted at the discretion of the chair.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.

The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a multi-step process including: (1) Data Workshop, (2) a series of assessment webinars, and (3) A Review Workshop. The product of the Data Workshop is a report that compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The assessment webinars produce a report that describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The product of the Review Workshop is an Assessment Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, HMS Management Division, and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and state and federal agencies.

1. Using datasets and initial assessment analysis recommended from the Data Webinar, panelists will employ assessment models to evaluate stock status, estimate population benchmarks and management criteria, and project future conditions.

2. Participants will recommend the most appropriate methods and configurations for determining stock status and estimating population parameters.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice 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.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see ADDRESSES) at least 5 business days prior to each workshop.

The Mid-Atlantic Fishery Management Council's Summer Flounder, Scup, and Black Sea Bass Advisory Panel, together with the Atlantic States Marine Fisheries Commission's Summer Flounder, Scup, and Black Sea Bass Advisory Panel, will meet on Monday, November 19, 2018 (see DATES and ADDRESSES). The purpose of this meeting is to Provide comments and recommendations on recreational management measures for summer flounder, scup, and black sea bass in 2019. A detailed agenda and background documents will be made available on the Council's website (www.mafmc.org) prior to the meeting.

The meeting is 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.

The purpose of this Working Group meeting is to: (1) Review the status of the wingspread performance analyses and gear performance (door) evaluations, (2) discuss the twin trawl survey design and door testing with considerations given to species of interest, timing, experimental design and analyses, (3) discuss other business and next steps for the NTAP.

The meeting is 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.

Addition

On 5/25/2018 (83 FR 102), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed addition to the Procurement List.

After consideration of the material presented to it concerning capability of a qualified nonprofit agency to provide the product and impact of the addition on the current or most recent contractors, the Committee has determined that the product listed below is suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organization that will furnish the product to the Government.

2. The action will result in authorizing a small entity to furnish the product to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product proposed for addition to the Procurement List.

Accordingly, the following product is added to the Procurement List:

On 9/28/2018 (83 FR 189), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.

After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action may result in authorizing small entities to furnish the products to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products deleted from the Procurement List.

Accordingly, the following products are deleted from the Procurement List:

This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products and service listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

The following products and service are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

The following products and services are proposed for deletion from the Procurement List:

Title; Associated Form; and OMB Number: Tender of Service for Personal Property Household Goods and Unaccompanied Baggage Shipments, DD Form 619; OMB Control Number 0704-0531.

Needs and Uses: The information collection requirement is necessary to private sector commercial Transportation Service Providers, who are under contract with the DOD for shipment/storage of personal property, to identify ownership, schedule pickup and delivery of personal property, to include privately owned vehicles, motorcycles, and house trailers/motor homes, Bill of Lading for services rendered, personal property counseling checklist.

To U.S. Customs and Border Protection Declaration for personal property shipments, re-weigh of personal property, shipment evaluation and inspection reports, receipt for unaccompanied baggage, mobile home inspection record, temporary commercial storage at Government expense, accessorial services-mobile home, report of contractor services, and claims for loss and damage; to manifest individuals and personal property being transported in the Defense Travel System (DTS); to provide emergency contact information to the designated authorized carrier under DoD contract and DoD authorizing activity, emergency contact information in the event of an emergency; to disclose information to other Federal agencies in order to manage an optimize DoD transportation resources, and to provide customs, immigration, and transportation security screening; to the designated authorized carrier under DoD contract and DoD authorizing activity, emergency contact information in the event of an emergency; to the Department of State to locate individuals in the DTS; to General Service Administration and Defense Government Accounting Activities for processing government Bills of Lading, and post-payment audits as required.

Affected Public: Business of Other For-Profit.

Annual Burden Hours: 18,980 hours.

Number of Respondents: 876.

Responses per Respondent: 260.

Annual Responses: 227,760.

Average Burden per Response: 5 minutes.

Frequency: On occasion.

The Tender of Service is the contractual agreement between the DOD and the Transportation Service Provider (TSP), under which the TSP agrees to provide services in accordance with the conditions cited in the Tender of Service. In accordance with the provisions of DOD 4500.9-R, the DD Form 619 is used by the household goods TSP industry to itemize accessorial services and other charges for billing purposes on household goods and unaccompanied baggage shipments.

Title; Associated Form; and OMB Number: Exchange Employee Travel Files; OMB Control Number 0702-0131.

Needs and Uses: The information collection requirement is necessary to process official travel requests for civilian employees of the Army and Air Force Exchange Service; to determine eligibility of the individual's dependents to travel; to obtain the necessary clearance where foreign travel is involved, including assisting individuals in applying for passports and visas and counseling where proposed travel involves visiting/transiting communist countries and danger zones.

Affected Public: Individuals or Households.

Annual Burden Hours: 262.5.

Number of Respondents: 350.

Responses per Respondent: 1.

Annual Responses: 350.

Average Burden per Response: 45 Minutes.

Frequency: On occasion.

Respondents are Exchange employees, family members, and dependents that are authorized to make Exchange government travel. The completed forms are necessary to obtain this authorization and to provide the employee and their dependents with assistance to obtain visas, passports, security clearances and other travel documents as required.

Title; Associated Form; and OMB Number: Army Sex Offender Information; Department of the Army Form 190-45-SG (Army Law Enforcement Reporting and Tracking System (ALERTS)); OMB Control Number 0702-0128.

Needs and Uses: The information collection requirement is necessary to obtain and record the sex offender registration information of those sex offenders who live, work or go to school on Army installations. Respondents are any convicted sex offender required to register pursuant to any DOD, Army, State government, law, regulation, or policy where they are employed, reside, or are a student and live, work, or go to school on an Army installation. The information collected is used by Army law enforcement to ensure the sex offender is compliant with any court order restrictions.

Affected Public: Business or other for profit; Not-for-profit institutions and Individuals and Households.

Annual Burden Hours: 40.

Number of Respondents: 120.

Responses per Respondent: 1.

Annual Responses: 120.

Average Burden per Response: 20 minutes.

Frequency: On occasion.

Respondents are sex offenders required to register with the state and live, work or go to school on an Army Installation. The information collected is used by Army law enforcement and the Garrison Commander to ensure the sex offender is compliant with any specific court ordered restrictions on Army installations. Data from members of the public is collected only by Army Law Enforcement authorized personnel. The frequency of sex offender registration with the Provost Marshall Office (PMO) is not under the control of any Army Law Enforcement personnel, it is the responsibility of the sex offender who lives or works on the Army installations to follow Army policy and report to the PMO within 3 working days of assignment to the installation. Sex Offenders could live or work on an Army installation and live in government housing near schools or daycare without Army Law Enforcement's knowledge. Army Law Enforcement would be less able to complete its mission to provide security and law enforcement to safeguard personnel living and working on Army installations.

Title; Associated Form; and OMB Number: Community Member Application for Innovative Readiness Training; OMB Control Number 0704-XXXX.

Needs and Uses: This information collection is necessary to support the Department of Defense's Innovative Readiness Training (IRT) program. Each year the military collects voluntary applications from communities to participate in IRT missions. Communities respond to the collection because they will have a chance to receive incidental support and services from the DoD during a conduct of an IRT mission and training. Currently the majority of missions are in the form of civil engineering projects or medical care. IRT however, is not limited to this only and any application is considered for its potential training value and incidental community benefit.

Affected Public: State, local, or tribal government; not-for-profit institutions.

Annual Burden Hours: 300.

Number of Respondents: 100.

Responses per Respondent: 1.

Annual Responses: 100.

Average Burden per Response: 3 hours.

Frequency: As required.

On October 17, 2018, we published in the Federal Register a notice inviting applications from parties to implement a Pilot of a Payment Vehicle Account Program (83 FR 52427). This notice amends the deadline for transmittal of applications, the dates of the in-person presentations for applicants selected to present and discussion session, and the intended award date. All other information in the original notice remains the same.

In FR Doc. 2018-22646, we make the following amendments:

(a) On page 52427 in the first column, under the heading DATES, after the words “Deadline for Transmittal of Applications:” We are removing the date “November 7, 2018” and replacing it with the date “November 30, 2018.”

(b) On page 52427 in the first column, under the heading DATES, after the words “In-Person Presentations for Applicants selected to Present (45 minutes) and Discussion Session (45 minutes):” We are removing the dates “November 21, 2018 to November 28, 2018” and replacing them with the dates “December 18, 2018 to December 20, 2018.”

(c) On page 52427 in the first column, under the heading DATES, after the words “Intended Award Date:” We are removing the date “December 5, 2018” and replacing it with “On or before December 31, 2018.”

(d) On page 52435 in the second column, under the heading Electronic Submission of Applications, we are revising the sentence following the first bullet point to read, “You must complete the electronic submission of your Application by 4:30 p.m., Eastern Time, on November 30, 2018.”

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the Project Advisors listed under FOR FURTHER INFORMATION CONTACT in this Notice.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register. You may access the official edition of the Federal Register and the Code of Federal Regulations via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Public notice of the section 229 boundary of the Paducah Gaseous Diffusion Plant was initially made in the Federal Register notice published October 19, 1965 (30 FR 13287). The boundary was revised on May 7, 1980 (45 FR 30106). The boundary was revised in its entirety on January 23, 2012 (77 FR 3255).

Pursuant to section 229 of the Atomic Energy Act, as implemented by DOE regulations at 10 CFR part 860 (28 FR 8400, Aug. 26, 1963), the amendment by substitution of the following description language for the entirety of the former descriptions are made. DOE regulations prohibit the unauthorized entry (10 CFR 860.3) and the unauthorized introduction of weapons or dangerous materials (10 CFR 860.4) into or upon the facilities.

1. The DOE installation known as the Paducah Gaseous Diffusion Plant located in McCracken County, KY, approximately 6,000 feet North of Woodville Road (State Route 725) and approximately 6,300 feet West of Metropolis Lake Road. The primary security interest area, including a buffer area, totals approximately 1,223 acres with boundary coordinates as follows:

2. The DOE landfill installation located North of Item 1 above and consisting of approximately 106 acres with boundary coordinates as follows:

This revised boundary replaces the property description contained in the Federal Register notice published January 23, 2012 (77 FR 3255).

Title: FERC-546, Certificated Rate Filings: Gas Pipeline Rates.

OMB Control No.: 1902-0155.

Type of Request: Three-year extension of the FERC-546 information collection requirements with no changes to the current reporting requirements.

Abstract: The requirements of the FERC-546 information collection are contained within the Commission's regulations in 18 CFR parts 154.7, 154.202, 154.204-154.208, 154.602-154.603, 284.501-284.505, and 154.4. The Commission reviews the FERC-546 materials to decide whether to approve rates and tariff changes associated with an application for a certificate under Natural Gas Act (NGA) section 7(c). Additionally, FERC reviews FERC-546 materials in NGA section 4(f), storage applications, to evaluate an applicant's market power and determine whether to grant market-based rate authority to the applicant. The Commission uses the information in FERC-546 to monitor jurisdictional transportation, natural gas storage, and unbundled sales activities of interstate natural gas pipelines and Hinshaw 1 pipelines. In addition to fulfilling the Commission's obligations under the NGA, the FERC-546 enables the Commission to monitor the activities and evaluate transactions of the natural gas industry, ensure competitiveness, and improve efficiency of the industry's operations. In summary, the Commission uses the information to:

• Ensure adequate customer protections under NGA section 4(f);

• Review rate and tariff changes filed under NGA section 7(c) for certification of natural gas pipeline transportation and storage services;

• Provide general industry oversight; and

• Supplement documentation during the pipeline audits process.

Failure to collect this information would prevent the Commission from monitoring and evaluating transactions and operations of jurisdictional pipelines and performing its regulatory functions.

Type of Respondents: Jurisdictional pipeline companies and storage operators.

Estimate of Annual Burden: 2 The Commission estimates the annual reporting burden and cost for the information collection as:

1. Submitting CBI. Do not submit this information to the EPA through https://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, mark the outside of the digital storage media as CBI and then identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media clearly that it does not contain CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2. Send or deliver information identified as CBI only to the following address: OAQPS Document Control Officer (C404-02), OAQPS, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, 27711, Attention Docket ID No. EPA-HQ-OAR-2018-0279.

2. Tips for Preparing your Comments. When submitting comments, remember to:

• Identify the notice by docket number and other identifying information (subject heading, Federal Register date and page number).

• Follow directions. The agency may ask you to respond to specific questions or organize comments by referencing a CFR part or section number.

• Explain why you agree or disagree; suggest alternative and substitute language for your requested changes.

• Describe any assumption and provide any technical information and/or data that you used.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples to illustrate your concerns and suggest alternatives.

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

• Make sure to submit your comments by the comment period deadline identified.

Two sections of the Clean Air Act (CAA or the Act) govern the establishment and revision of the NAAQS. Section 108 directs the Administrator to identify and list certain air pollutants and then issue “air quality criteria” for those pollutants. The air quality criteria are to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air . . .” (CAA section 108(a)(2)). Under section 109 of the Act, the EPA is then to establish primary (health-based) and secondary (welfare-based) NAAQS for each pollutant for which the EPA has issued air quality criteria. Section 109(d)(1) of the Act requires periodic review and, if appropriate, revision of existing air quality criteria. Revised air quality criteria are to reflect advances in scientific knowledge on the effects of the pollutant on public health and welfare. Under the same provision, the EPA is also to periodically review and, if appropriate, revise the NAAQS, based on the revised air quality criteria.

The Act additionally requires appointment of an independent scientific review committee that is to periodically review the existing air quality criteria and NAAQS and to recommend any new standards and revisions of existing criteria and standards as may be appropriate (CAA section 109(d)(2)(A)-(B)). Since the early 1980s, the requirement for an independent scientific review committee has been fulfilled by the Clean Air Scientific Advisory Committee (CASAC).

Presently the EPA is reviewing the air quality criteria and NAAQS for photochemical oxidants and O3.1 The draft document announced in this notice is being developed as part of the planning phase for the review. The draft IRP has been prepared jointly by the EPA's National Center for Environmental Assessment, within the Office of Research and Development, and the Office of Air Quality Planning and Standards, within the Office of Air and Radiation. This document will be available on the EPA's website at https://www.epa.gov/naaqs/ozone-o3-air-quality-standards. The document will be accessible under “Planning Documents” from the current review.

The draft IRP is being made available for consultation with CASAC and for public comment. Comments should be submitted to the docket, as described above, by December 3, 2018. A separate Federal Register notice will provide details about this meeting and the process for participation. The final IRP will be prepared in consideration of CASAC and public comments. The draft document announced in this notice presents the draft plan for this review, including the anticipated timeline for the review, the expected process for conducting the review, and the key policy-relevant science issues that are expected to guide the review. This draft document does not represent and should not be construed to represent any final EPA policy, viewpoint, or determination.

I. General Information A. Does this action apply to me?

This action is directed to the public in general. This action may be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

1. Submitting CBI. Do not submit CBI information to EPA through regulations.gov or email. If your comments contain any information that you consider to be CBI or otherwise protected, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT to obtain special instructions before submitting your comments.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

You may participate in this meeting by following the instructions in this unit. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA-HQ-OPP-2018-0517 in the subject line on the first page of your request.

1. Written comments. Written comments on the experts currently under consideration as ad hoc participants in this review should be submitted, using the instructions in FOR FURTHER INFORMATION CONTACT, on or before November 9, 2018

2. Oral comments. Registration is required to participate in the preparatory virtual meeting. Please visit: http://www.epa.gov.sap to register. Each individual or group wishing to make brief oral comments to FIFRA SAP during the virtual meeting should submit their request by registering with the DFO listed under FOR FURTHER INFORMATION CONTACT on or before noon November 9, 2018. Oral comments before FIFRA SAP are limited to approximately 5 minutes due to the time constraints of this virtual meeting.

During the preparatory virtual meeting scheduled for November 14, 2018, the FIFRA SAP will review and consider the draft Charge Questions for the Panel's December 4-7, 2018 Meeting on Evaluation of a Proposed Approach to Refine Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a NAM. The SAP will receive a short background briefing including the EPA's history and current position on the methodology being considered. In addition, the panel members will have the opportunity to comment on the scope and clarity of the draft charge questions. Subsequent to this virtual meeting, final charge questions will be provided for the FIFRA SAP's deliberation on the methodology and supplemental information during the in-person meeting to be held December 4-7, 2018.

FIFRA SAP serves as a primary scientific peer review mechanism of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. FIFRA SAP is a Federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act (5 U.S.C. Appendix). FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. The FIFRA SAP is assisted in their reviews by ad hoc participation from the Science Review Board (SRB). As a scientific peer review mechanism, FIFRA SAP provides comments, evaluations, and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. The FIFRA SAP is not required to reach consensus in its recommendations to the Agency.

EPA's background paper, charge/questions to FIFRA SAP, and related supporting materials were made available on September 7, 2018. You may obtain electronic copies of most meeting documents, including the list of experts currently under consideration as ad hoc participants in this review, at http://www.regulations.gov and the FIFRA SAP website at http://www.epa.gov/sap.

OMB Control Number: 3060-XXXX.

Title: Broadcast Incubator Program.

Form Number: N/A.

Type of Review: New information collection.

Respondents: Business or other for-profit entities; not-for-profit institutions; Tribal Governments.

Number of Respondents: 20 respondents; 123 responses.

Estimated Time per Response: 4 to 16 hours.

Frequency of Response: On occasion reporting requirement; annual reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for these collections are contained in 47 U.S.C. 151, 152(a), 154(i), 257, 303, 307-310, and 403.

Total Annual Burden: 1,179 hours.

Total Annual Cost: $326,700.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: The need for confidentiality for this collection of information is not anticipated; however, when submitting an incubation proposal (including the underlying contract and certified statements), applicants may, upon request, redact confidential or proprietary terms.

Needs and Uses: On August 3, 2018, the Commission released a Report and Order (Order), Rules and Policies to Promote New Entry and Ownership Diversity in the Broadcasting Services, FCC 18-114, in MB Docket No. 17-289, establishing the requirements that will govern the incubator program that the Commission previously decided to adopt to support the entry of new and diverse voices into the radio broadcast industry. The Commission recognized the need for more innovative approaches to encourage access to capital, as well as technical, operational, and management training for use by new entrants and small businesses, that without assistance, would not be able to own broadcast stations. The incubator program is designed for small businesses, struggling station owners, and new entrants that do not have any other means to access the financial assistance and operational support necessary for success in the broadcast industry. The goal is the pairing of these small aspiring, or struggling, broadcast station owners with established broadcasters. These incubation relationships will provide new entrants and struggling small broadcasters access to the financing, mentoring, and industry connections that are necessary for success in the industry, but to date have been unavailable to many. In return for successfully incubating a small aspiring, or struggling, broadcast station owner as part of the incubator program, an incumbent broadcaster will be eligible to receive a waiver of the Commission's Local Radio Ownership Rule following the conclusion of a successful qualifying incubation relationship. Commission staff will use the initial incubator applications, certification statements, contracts, and any responses to Commission requests for additional information to determine qualifications for participation in the incubator program. Commission staff will use the periodic reports to determine whether ongoing incubation relationships are proceeding in a manner consistent with the parties' initial filings and are likely to result in a successful incubation relationship. In the event the parties seek to extend the duration of their incubation relationship, the filing of a request for such an extension will enable Commission staff to gauge the types of problems incubating parties are experiencing. Information provided by the parties to the Commission no later than six months before the contract termination date will allow Commission staff to evaluate which option for station ownership the incubating parties plan to pursue at the conclusion of the relationship. Additionally, Commission staff will review documentation submitted to seek a reward waiver to assess whether the market where the reward waiver is sought is a comparable market to where the incubated station was located.

As part of its continuing effort to reduce paperwork burdens, and as required by the PRA, 44 U.S.C. 3501-3520, the FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control Number: 3060-0984.

Title: 90.175(b)(1), Frequency Coordinator Requirements, Industrial/Business Pool frequencies.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities, and State, local, or tribal government.

Number of Respondents and Responses: 2,700 respondents; 2,700 responses.

Estimated Time per Response: 1 hour.

Frequency of Response: One-time reporting requirement, and third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this collection of information is contained in Sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161, 301, 302(a), 303(g), 303(r), 309, 332(c)(7), 336 and 337.

Total Annual Burden: 2,700 hours.

Total Annual Cost: No cost.

Privacy Impact Assessment: No impact(s).

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

Needs and Uses: Section 90.175 requires third party disclosures by applicants proposing to operate a land mobile radio station. If they are requesting a frequency that formerly was coordinated exclusively by one industry-specific frequency coordinator, they are required to obtain written concurrence of that frequency coordinator.

On August 18, 2016, the Commission adopted a Notice of Proposed Rulemaking, FCC 16-110, in WP Docket No. 16-261, RM-11719 and RM-11722 (2016 Notice of Proposed Rulemaking), which proposed to amend Part 90 of the Commission's Rules to expand access to private land mobile radio (PLMR) spectrum. Among the many actions taken in the 2016 Spectrum Access NPRM, the Commission proposed to make certain frequencies that are designated for central station alarm operations available for other PLMR uses.

Specifically, the Commission proposed to modify section 95.35(c)(63) to remove the use limitation in the urbanized areas where the frequencies designated for alarm use in urban areas are not in use. The Commission tentatively concluded that it would be in the public interest to make these frequencies available for other PLMR operations in those areas and sought comment on this proposal, including its costs and benefits. The Commission also sought comment on other ways to expand PLMR users' access to frequencies that are designated, but no longer needed, for central station commercial protection services, including by making available channels in urbanized areas where some of the urban frequencies are in use, including: Related costs and benefits associated with such proposals; current and expected future need for central station commercial protection service channels in the 460-470 MHz band; and how to protect incumbent central station commercial protection service operations from harmful interference if eliminating the use restriction on any frequency in any area where it currently is in use.

On October 22, 2018, the Commission issued a Report and Order and Order, FCC 18-143, in WP Docket No. 15-32, RM-11572, WP Docket No. 16-261, RM-11719 and RM-11722 (800/PLMR Access Order), in which it revised certain rules to require applicants for channels currently designated for central station alarm use to obtain the concurrence of the central station alarm frequency coordinator in order to use the channels for uses other than central station alarm operations. This requirement is similar to existing requirements pertaining to certain other channels. The Report and Order and Order did not revise any of the information collection requirements that are contained in this collection but rather added additional frequencies to the list. Therefore, this essentially is adding an additional 200 respondents to this collection.

Proposal to renew the following currently approved collection of information:

1. Title: Activities and Investments of Insured State Banks.

OMB Number: 3064-0111.

Form Number: None.

Affected Public: Insured state nonmember banks and insured state savings associations.

Burden Estimate:

General Description of Collection: Section 24 of the Federal Deposit Insurance (FDI Act), 12 U.S.C. 1831a, limits investments and other activities in which state banks may engage as principal to those permissible for national banks and those approved by the FDIC under procedures set forth in Part 362 of the FDIC's Rules and Regulations, 12 CFR part 362. With certain exceptions, section 24 of the FDI Act limits the direct equity investments of state chartered banks to equity investments that are permissible for national banks. In addition, the statute prohibits an insured state bank from directly engaging, as a principal, in any activity that is not permissible for a national bank, or indirectly through a subsidiary in an activity that is not permissible for a subsidiary of a national bank, unless such bank meets its minimum capital requirements and the FDIC determines that the activity does not pose significant risk to the Deposit Insurance Fund. The FDIC can make such a determination for exception by regulation or by order. The FDIC's implementing regulation for section 24 is 12 CFR part 362. This regulation details the activities that insured state nonmember banks or their subsidiaries may engage in, under certain criteria and conditions, and identifies the information that banks must furnish to the FDIC in order to obtain the FDIC's approval or non-objection. Section 28(a), 12 U.S.C. 1831e, similarly limits the investments and activities of state savings associations and their service corporations to those permitted by federal savings associations and their service corporations, absent FDIC approval.

There is no change in the method or substance of the collection. The overall reduction in burden hours is the result of economic fluctuation. In particular, the number of respondents has decreased while the hours per response and frequency of responses have remained the same.

2. Title: Privacy of Consumer Information.

OMB Number: 3064-0136.

Form Number: None.

Affected Public: Insured state nonmember banks and consumers.

Burden Estimate:

General Description of Collection: The elements of this collection are required under sections 503 and 504 of the Gramm-Leach-Bliley Act, 15 U.S.C. 6803, 6804. The collection mandates notice requirements and restrictions on a financial institution's ability to disclose nonpublic personal information about consumers to nonaffiliated third parties.

There is no change in the method or substance of the collection. The hours per response and frequency of responses have remained the same.

3. Title: Registration of Mortgage Loan Originators (SAFE Act).

OMB Number: 3064-0171.

Form Number: None.

Affected Public: FDIC Supervised Institutions and Employee Mortgage Loan Originators.

Burden Estimate:

General Description of Collection: This information collection implements the Secure and Fair Enforcement for Mortgage Licensing Act of 2008 (SAFE Act) requirement that employees of Federally-regulated institutions who engage in the business of a mortgage loan originator to register with the Nationwide Mortgage Licensing System and Registry and establishes national licensing and registration requirements. It also directs Federally-regulated institutions to have written policies and procedures in place to ensure that their employees who perform mortgage loan originations comply with the registration and other SAFE Act requirements.

There is no change in the method or substance of the collection. The overall reduction in burden hours is the result of economic fluctuation. In particular, the number of respondents has decreased while the hours per response and frequency of responses have remained the same.

Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collections, 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 collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

Background: The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the development of probability of causation guidelines which have been promulgated by the Department of Health and Human Services (HHS) as a final rule, advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule, advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program, and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC.

The Advisory Board's charter was issued on August 3, 2001, renewed at appropriate intervals, rechartered under Executive Order 13811 on February 12, 2018, and will terminate on September 30, 2019.

Purpose: This Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class.

Matters to be Considered: The agenda will include discussions on the following: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; SEC Petitions Update; possible discussion of a site profile review (dose reconstruction methods) for Carborundum Company (Niagara Falls, New York); SEC Petitions for: Y-12 Plant (Oak Ridge, Tennessee), Metals and Controls Corporation (Attleboro, Massachusetts, Area IV Santa Susanna Field Laboratory (Ventura County, California), DeSoto Avenue Facility (Los Angeles, California), Superior Steel Company (Carnegie, Pennsylvania), and Los Alamos National Laboratory (Los Alamos, New Mexico); and a Board Work Session. Agenda items are subject to change as priorities dictate.

The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

Purpose: The Board will: (1) Conduct, encourage, cooperate with, and assist other appropriate public health authorities, scientific institutions, and scientists in the conduct of research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases, and other impairments; (2) assist States and their political subdivisions in preventing and suppressing communicable and non-communicable diseases and other preventable conditions and in promoting health and well-being; and (3) conduct and assist in research and control activities related to injury. The Board of Scientific Counselors makes recommendations regarding policies, strategies, objectives, and priorities; and reviews progress toward injury prevention goals and provides evidence in injury prevention-related research and programs. The Board also provides advice on the appropriate balance of intramural and extramural research, the structure, progress and performance of intramural programs. The Board is designed to provide guidance on extramural scientific program matters, including the: (1) Review of extramural research concepts for funding opportunity announcements; (2) conduct of Secondary Peer Review of extramural research grants, cooperative agreements, and contracts applications received in response to the funding opportunity announcements as it relates to the Center's programmatic balance and mission; (3) submission of secondary review recommendations to the Center Director of applications to be considered for funding support; (4) review of research portfolios, and (5) review of program proposals.

Matters to be Considered: The Board of Scientific Counselors will discuss science matters to include research strategies needed to guide the Center's focus on reducing opioid overdose and to review the recommendations from the opioid prescribing for acute and chronic pain workgroup. Agenda items are subject to change as priorities dictate.

The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

Purpose: This Council advises and makes recommendations to the Secretary of Health and Human Services, the Assistant Secretary for Health, and the Director, CDC, regarding the elimination of tuberculosis. Specifically, the Council makes recommendations regarding policies, strategies, objectives, and priorities; addresses the development and application of new technologies; and reviews the extent to which progress has been made toward eliminating tuberculosis.

Matters to be Considered: The agenda will include discussions on (1) Division of Tuberculosis Elimination (DTBE) funded Demonstration Project on Latent Tuberculosis Infection (LTBI) Testing and Treatment; (2) DTBE Communications Messaging and Campaigns; (3) Update on LTBI Treatment Guidelines; (4) Update on Drug Resistant Tuberculosis Guidelines; and (5) Update from ACET workgroups. Agenda items are subject to change as priorities dictate.

The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

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

Under the Medicare program, eligible beneficiaries may receive covered services from an end-stage renal disease (ESRD) facility provided the facility meets the requirements established by the Secretary of the Department of Health and Human Services (the Secretary). Section 1881(b) of the Social Security Act (the Act) establishes distinct requirements for facilities seeking designation as an ESRD facility under Medicare. Regulations concerning provider agreements and supplier approval are at 42 CFR part 489 and those pertaining to activities relating to the survey, certification, and enforcement procedures of suppliers which include ESRD facilities are at 42 CFR part 488. The regulations at 42 CFR part 494 subparts A through D implement section 1881(b) of the Act, which specify the conditions that an ESRD facility must meet in order to participate in the Medicare program and the conditions for Medicare payment for ESRD facilities.

Generally, to enter into a Medicare agreement, an ESRD facility must first be certified by a State survey agency (SA) as complying with the conditions or requirements set forth in part 494 subparts A through D of our Medicare regulations. Thereafter, the ESRD facility is subject to regular surveys by a SA to determine whether it continues to meet these requirements.

Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by a Centers for Medicare & Medicaid Services (CMS) approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may deem those provider entities as having met the requirements. Section 1865(a)(1) of the Act had historically excluded dialysis facilities from participating in Medicare via a CMS-approved accreditation program; however, section 50404 of the Bipartisan Budget Act of 2018 amended section 1865(a) of the Act to include renal dialysis facilities as provider entities allowed to participate in Medicare through a CMS-approved accreditation program. Accreditation by an AO is voluntary and is not required for Medicare participation.

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

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

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

The purpose of this proposed notice is to inform the public of Accreditation Commission for Health Care, Inc.'s (ACHC's) request for CMS-approval of its ESRD facility accreditation program. This notice also solicits public comment on whether ACHC's requirements meet or exceed the Medicare conditions for coverage (CfCs) for ESRD facilities.

ACHC submitted all the necessary materials to enable us to make a determination concerning its request for CMS-approval of its ESRD facility accreditation program. This application was determined to be complete on September 13, 2018. Under section 1865(a)(2) of the Act and regulations at § 488.5, our review and evaluation of ACHC will be conducted in accordance with, but not necessarily limited to, the following factors:

• The equivalency of ACHC's standards for ESRD facilities as compared with Medicare's CfCs for ESRD facilities.

• ACHC's survey process to determine the following:

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

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

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

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

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

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

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

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

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

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

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

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

I. Background

The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently.

Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register.

This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS website or the appropriate data registries that are used as our resources. This is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the website list provides more timely access for beneficiaries, providers, and suppliers. We also believe the website offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and “real time” accessibility. In addition, many of the websites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the website. These listservs avoid the need to check the website, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a website proves to be difficult, the contact person listed can provide information.

This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at http://www.cms.gov/manuals.

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, ACL is publishing a notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:

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

(2) the accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates;

(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.

ACL, the Centers for Medicare and Medicaid Services (CMS), and the Veterans Health Administration (VHA) have partnered to support states' efforts in developing coordinated systems of access, or No Wrong Door (NWD) Systems, to make it easier for people to learn about and access long-term services and supports (LTSS). When seeking services and supports, individuals and caregivers often face multiple, fragmented processes that are complex and confusing. States' access systems have been built over time as programs and funding streams have been added, creating duplicative eligibility and intake processes that are difficult for individuals and their caregivers to use. To address these issues, the NWD System model supports state efforts to streamline access to LTSS options for all populations and provides the infrastructure to promote the collaboration of local service organizations, making service delivery more efficient and person-centered. Examples of coordinated efforts include processes where individuals are assessed once via a common or standardized data collection method that captures a core set of individual level data relevant for determining the range of necessary LTSS.

The federal vision for the NWD System gives states flexibility in determining how best to organize, structure and operate the various functions of their NWD System. States continue to integrate, in some cases restructure, and over time strengthen their existing programs in order to realize the joint ACL/CMS/VHA vision for a fully coordinated and integrated system of access. These efforts are supported by a variety of initiatives, including the VHA's Veteran Directed Care (VDC) program, an evidence-based self-directed program where person-centered counselors from aging and disability network agencies within a state's NWD System provide facilitated assessment and care planning, arrange fiscal management services and provide ongoing counseling and support to Veterans, their families and caregivers.

The NWD System Management Tool (NWD MT) provides a platform for data collection necessary to evaluate the four primary functions of a NWD System: State Governance and Administration, Public Outreach and Coordination with Key Referral Sources, Person Centered Counseling, and Streamlined Access to Public LTSS Programs. In addition, this tool will include data collection for the VDC program to collect qualitative and quantitative data elements necessary to evaluate the impact of the VDC program. The VDC tool will track key performance measures and identify best practices and technical assistance needs.

The NWD MT and the VDC tool will enable ACL and its partners to collect and analyze data elements necessary to assess the progress of the NWD System model, track performance measures, and identify gaps and best practices. These tools have been designed in close collaboration with states and are intended to simplify grant reporting requirements to reduce burden on local and state entities and will provide a consistent, streamlined and coordinated statewide approach to help states govern their NWD System and manage their programs efficiently.

The proposed data collection tools may be found on the ACL website for review at: https://www.acl.gov/about-acl/public-input.

Estimated Program Burden:

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

Fifty-six lead NWD System state and territorial agencies will respond to the NWD MT bi-annually and it will take approximately half an hour to collect the data and an additional half hour to input the data into a web-based system. Additionally, an estimated 996 local agencies will take approximately three hours to collect the data and one hour to submit the data to their lead NWD System state agency. If all state and local agencies respond bi-annually, the national burden estimate for the NWD MT would be a total of 8,080 hours annually. This burden estimate is calculated based upon a sample of three states that tested a demonstration of the NWD MT as a part of the grantee requirements under the NWD System Implementation grant, a competitive funding opportunity funded in 2016 through 2018. Each state entity submitting data will receive local-level data from designated NWD System entities. The estimated response burden includes time to review the instructions, gather existing information, and complete and review the data entries in a web-based system.

An estimated 400 VDC program entities will respond to the VDC Tool on a monthly basis, all of which are also NWD local-level entities, for an annual burden of 2,400 hours. This burden estimate is calculated based upon information provided by a current VDC program provider testing a demonstration of the VDC tool. The NWD MT and the VDC tool have been developed to increase ease and uniformity of reporting and improve the ability of ACL to manage and analyze data.

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of drugs and biologics for the treatment of chronic HBV infection from the initial IND through the NDA/BLA and postmarketing phases. The guidance includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and phase 3 safety and efficacy trials. The guidance discusses phase 3 trial design considerations and efficacy endpoints for the development of combination therapies for the treatment of chronic HBV infection. Drug development considerations for specific subpopulations such as patients coinfected with hepatitis D virus or human immunodeficiency virus and pediatric HBV-infected patients are also included.

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 “Chronic Hepatitis B Virus Infection: Developing Drugs 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 (PRA) (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. The submission of prescription drug labeling under 21 CFR 201.56 and 201.57 has been approved under OMB control number 0910-0572.

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

I. Background

Hemophilia is a bleeding disorder caused by deficiency of coagulation factor VIII (hemophilia A) or coagulation factor IX (hemophilia B). Hemophilia treatment strategies are intended to prevent or control bleeding and the attendant complications. Recently, hemophilia treatment strategies have led to the development of factor concentrates, recombinant DNA technology products, antibodies, and potential curative strategies such as gene therapy. These new emerging technologies raise new considerations about trial design, novel endpoints, patient-reported outcomes, and long-term safety collection.

This public workshop is intended to provide a platform for engaging in a discussion with experts in hemophilia treatment, patients, and caregivers. The purpose of this workshop is to advance further development of patient-experience and patient-reported outcomes for use in clinical trials, facilitate reliable and interpretable measurements of factor VIII/IX activity levels for gene therapy products, discuss the need for long-term safety assessments in gene therapy clinical trials, and discern when to enroll pediatric patients in gene therapy trials.

The workshop will feature presentations and panel discussions on hemophilia product development. The presentations will include an overview of product development in hemophilia, and the regulatory challenges in the development of novel hemophilia therapies. Five sessions include presentations to frame panel discussions to cover the following topics:

1. Overview of product development in hemophilia;

2. Efficacy endpoints related to bleeding outcomes and considerations for factor activity as a surrogate endpoint;

3. Patient and caregiver perspectives on developing outcomes for clinical trials;

4. Discrepancies in the factor activity measurements by different assays observed in gene therapy trials and root causes for the discrepancies; and

5. Clinical trial design considerations for follow up on safety, efficacy, enrollment of pediatric patients in gene therapy trials, and the applicability of on-demand treatment as a control group in the evolving landscape of treatment options in hemophilia.

Registration: Persons interested in attending this public workshop must register online at https://fdaoce.formstack.com/forms/pdh120618 before 5 p.m. on December 3, 2018. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted.

If you need special accommodations due to a disability, please contact Joan Ferlo Todd at [email protected] no later than 5 p.m., on November 21, 2018.

Streaming Webcast of the Public Workshop: This public workshop will also be web-streamed on the day of the workshop.

If you have never attended a webcast event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Adobe webcast program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will be available on the internet at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm620602.htm.

Recipient of the Award: The National Center for Farmworker Health, Inc.

Amount of Non-Competitive Awards: $150,000.

Period of Supplemental Funding: Fiscal years 2018 and 2019 (contingent upon available funding and satisfactory performance).

CFDA Number: 93.129.

Authority: Section 330(l) of the Public Health Service Act, as amended.

The primary purpose of this meeting is to prepare for the upcoming one hundred twenty first session of IMO Council (C 120). The agenda items for this session include:

Members of the public may attend this meeting up to the seating capacity of the room. To facilitate the building security process, and to request reasonable accommodation, those who plan to attend should contact the meeting coordinator, Lieutenant Commander Staci Weist, not later than November 7, 2018. Requests made after November 7, 2018, may not be able to be accommodated. It is recommended that attendees arrive to Coast Guard Headquarters no later than 30 minutes ahead of the scheduled meeting for the security screening process. Parking in the vicinity of the building is extremely limited. Additional information regarding this and other IMO public meetings may be found at: www.uscg.mil/imo.

Notice is hereby given that, in a letter dated October 18, 2018, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”), as follows:

The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration.

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Steven W. Johnson, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.

The following areas of the State of Wisconsin have been designated as adversely affected by this major disaster:

The notice of a major disaster declaration for the State of North Carolina is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of September 14, 2018.

Notice is hereby given that, in a letter dated October 10, 2018, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Manny J. Toro, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.

The following areas of the State of Georgia have been designated as adversely affected by this declared emergency:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes 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.

This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at https://msc.fema.gov.

The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.

Notice is hereby given that, in a letter dated October 14, 2018, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”), as follows:

The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration.

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Manny J. Toro, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.

The following areas of the State of Georgia have been designated as adversely affected by this major disaster:

The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.

Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.

The modifications are made pursuant to section 201 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.

The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

These flood hazard determinations, 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. The flood hazard determinations are in accordance with 44 CFR 65.4.

The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.