Title: Annual State Report on Verification of SNAP Participation.

OMB Number: 0584-0605.

Expiration Date: March 30, 2019.

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

Abstract: SNAP regulations at 7 CFR 273.16 require that State agencies disqualify an individual who has committed an intentional program violation (IPV). Paragraph 7 CFR 273.16(e)(8) requires that these individuals “be disqualified in accordance with the disqualification periods and procedures in paragraph (b) of this section” (273.16(b)). Paragraph 7 CFR 273.16(i) requires State agencies to report information concerning each individual disqualified for an IPV to the disqualified recipient database, the electronic Disqualified Recipient System (eDRS), and to use eDRS data to determine the eligibility of individual applicants prior to certification. SNAP regulations at 7 CFR 272.14 require that each State agency establish a system to verify and ensure that benefits are not issued to individuals who are deceased, and that data source is the Social Security Administration's (SSA) Death Master File. The information required for the Annual State Report on Verification of SNAP Participation is obtained by validating that the State had the appropriate systems in place and followed procedures currently mandated at 7 CFR 272.14 and 7 CFR 273.16 for the preceding fiscal year. The burdens associated with establishing a system to verify and ensure that benefits are not issued to deceased individuals or those permanently disqualified from SNAP using both the SSA Death Master File and eDRS are already approved under OMB burden number 0584-0064, expiration date July 31, 2020.

In order to meet the reporting requirements specified in section 4032 of the Act, States are required to confirm via email to their FNS Regional SNAP Program Director that in the immediately preceding Federal fiscal year, they had the appropriate systems in place to meet the requirements of regulations at 7 CFR 272.14 and 273.16(i)(4) and that they conducted the matches required by these regulations. States are required to submit their section 4032 reports to the FNS Regional SNAP Director by March 31 each year for the preceding Federal fiscal year. The estimated annual burden for this collection is 57.41 hours. This estimate includes the time it takes each State agency to confirm that they have complied with FNS regulations for performing mandated checks against both eDRS and the SSA Death Master File, send an email to their FNS Regional Office SNAP Program Director to provide the verification, and any additional recordkeeping associated with this burden. States must perform this verification once a year and must retain these records for 3 years.

Affected Public: State, Local and Tribal Government Agencies.

Number of Respondents: 53 State Agencies.

Number of Responses per Respondent: 1.

Total Annual Responses: 53.

Reporting time per Response: 1 Hour.

Estimated Annual Reporting Burden Hours: 53.

Affected Public: State, Local and Tribal Government Agencies.

Number of Respondents: 53 State Agencies.

Number of Responses per Respondent: 1.

Total Annual Responses: 53.

Reporting time per Response: 0.08333 Hours or 5 minutes.

Estimated Annual Reporting Burden Hours: 4.41649.

Annual Grand Total Burden Estimates for Reporting and Recordkeeping: 57.41 hours.

Title: Volunteer Program—Earth Team.

OMB Number: 0578-0024.

Expiration Date of Approval: February 28, 2019.

Type of Request: Revision.

Abstract: NRCS is collecting information from individuals who are interested in volunteering to work with NRCS. The information will be used by NRCS to assign the volunteer to an appropriate position, and to track their volunteer time. Collection of this information is necessary to match volunteers with NRCS assignments as authorized by section 1526 of the Food and Agriculture Act of 1981 (Pub. L. 97-98). NRCS is authorized to recruit, train, and accept (following Civil Service classification laws, rules, or regulations) individuals to serve without compensation. Subject to certain conditions, most volunteers may assist in agency programs or projects, and may perform activities that the employees may perform. The two forms Volunteer Interest and Placement Summary Forms, NRCS-PER-002, and Timesheet Form, NRCS-PER-004, are used to collect information from the individuals.

The timesheet is an optional form and provides the volunteer or volunteer's supervisor a simplified method for tracking the volunteer's time. The form is placed in a volunteer “case file” and will be destroyed 3 years after the volunteer has completed service. In the event the volunteer is injured while engaged in volunteer activities and claims workman's compensation, the “case file” will be transferred to an Official Personnel Folder.

The information collection burden estimates have been updated. There were no other revisions required.

Estimate of Average Time to Respond: Public reporting burden for this collection of information is estimated to average 4 minutes per response.

Type of Respondents: Retirees, students, teachers, or senior citizens.

Estimated Annual Number of Respondents: 7,120.

Estimated Number of Responses per Respondent: 1.5.

Estimated Total Annual Responses: 14,440.

Estimated Total Annual Burden on Respondents: 1,010.80 hours.

We are requesting comments on all aspects of this information collection to help us to:

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

(2) Evaluate the accuracy of the estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

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

(4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All responses received in response to this notice, including names and addresses when provided, will be a matter of public records. Comments will be summarized and included in the submission for Office of Management and Budget approval.

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

Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Thomas P. Dickson, Rural Development Innovation Center—Regulatory Team 2, USDA, 1400 Independence Avenue SW, STOP 1522, Room 5164, South Building, Washington, DC 20250-1522. Telephone: (202) 690-4492. Email Thomas.dickson@usda.gov .

Title: Environmental Policies and Procedures.

OMB Number: 0575-0197.

Type of Request: Extension of currently approved information collection.

Abstract: The National Environmental Policy Act (NEPA) and other applicable environmental and historic preservation statutes require all Federal agencies to consider the potential environmental consequences of their actions on the quality of the human environment and historic properties before agency decisions are made and prior to it taking an action; in RD's case the “action” is the approval of financial assistance and obligation of Federal funds. To comply with NEPA and other environmental laws, regulations and Executive Orders, RD requires applicants submitting applications for financial assistance to include project-specific environmental information along with other underwriting requirements. The purpose of this information is to evaluate and document the environmental implications of applicant's proposals.

Estimate of Burden: Public reporting burden for this collection is estimated to average 60 hours per response.

Respondents: Cooperatives, local municipalities, private citizens, companies, not-for-profit companies.

Estimated Number of Respondents: 94,000.

Estimate Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 5,608,800 hours.

Copies of this information collections can be obtained from Diane M. Berger, Rural Development Innovation Center—Regulatory Team; phone—(715) 619-3124; or email diane.berger@usda.gov .

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

The U.S. Commission on Civil Rights will hold a public briefing to evaluate the civil rights of women in prison, including deprivations of women's medical needs that may violate the constitutional requirement to provide adequate medical care for all prisoners; implementation of the Prison Rape Elimination Act; and the sufficiency of programs to meet women's needs after release. The Commission will also examine consequences of discipline practices in women's prisons and the impact on families when women are placed far from home or parental rights are terminated despite their caregiving role. Commissioners will hear from state and federal corrections officials, women who have experienced incarceration, academic and legal experts, and advocates. Members of the public will be able to address the Commission in an open comment session (see below).

This briefing is open to the public; doors open at 8:30 a.m. ET. The event will also live-stream at https://www.youtube.com/user/USCCR/videos. (Streaming information subject to change.) If attending in person, we ask that you RSVP to publicaffairs@usccr.gov. Persons with disabilities who need accommodation should contact Pamela Dunston at 202-376-8105 or at access@usccr.gov at least seven (7) business days before the date of the meeting.

We will offer an open comment session in which members of the public will be able to address the Commission. Detailed information on this open comment session, including details on how to register for a speaking slot, will be announced on the Commission's website ( www.usccr.gov ), Twitter ( www.twitter.com/USCCRgov ), and Facebook page ( www.facebook.com/USCCRgov/ ) in advance of the briefing.

In addition, the Commission welcomes the submission of additional material for consideration as we prepare our report. Please submit such information no later than March 25, 2019 to womeninprison@usccr.gov or OCRE/Public Comments, U.S. Commission on Civil Rights, 1331 Pennsylvania Ave. NW, Suite 1150, Washington, DC 20425.

Schedule is subject to change.

Background

On September 11, 2018, Commerce published a notice of opportunity to request an administrative review of the antidumping duty order on certain oil country tubular goods (OCTG) from Turkey for the period of review (POR) September 1, 2017, through August 31, 2018. 1 On September 28, 2018, the petitioners, United States Steel Corporation, Maverick Tube Corporation, Tenaris Bay City, Inc., TMK IPSCO, Vallourec Star, L.P., and Welded Tube USA, requested an administrative review of the order with respect to Çayirova Boru San A.Ş., Çayirova Boru Sanayi ve Ticaret A.Ş. and Yücel Boru İthalat-İhracat ve Pazarlama A.Ş. (collectively, Yücel), HG Tubulars Canada Ltd., Tosçelik Profil ve Sac Endüstrisi A.Ş. and Tosyali Diş Ticaret A.Ş. (collectively, Tosçelik), and Yücelboru İhracat, Ithalat. 2 On November 15, 2018, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.221(c)(1)(i), we initiated an administrative review of the order on OCTG from Turkey with respect to these companies. 3 On December 13, 2018, the petitioners timely withdrew their request for an administrative review concerning these companies. 4 No other party requested a review.

Commerce exercised its discretion to toll all deadlines affected by the partial federal government closure from December 22, 2018, through the resumption of operations on January 29, 2019. 5 If the new deadline falls on a non-business day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the preliminary results in this review is now July 12, 2019.

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review “in whole or in part, if a party that requested a review withdraws the request within 90 days of the date of publication of notice of initiation of the requested review.” The petitioners withdrew their request for review before the 90-day deadline. Because we received no other requests for review of Çayirova Boru San A.Ş., Yücel, HG Tubulars Canada Ltd., Tosçelik, and Yücelboru İhracat, Ithalat, we are rescinding the administrative review of OCTG from Turkey covering the period September 1, 2017, through August 31, 2018, in full, in accordance with 19 CFR 351.213(d)(1).

Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of OCTG from Turkey during the POR at rates equal to the cash deposit rate of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP 15 days after publication of this notice in the Federal Register .

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

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

This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(d)(4).

This request is for a reinstatement of a previously approved information collection.

The National Marine Fisheries Service (NMFS) proposes to collect economic information from wreckfish landing commercial fishermen in the United States (U.S.) South Atlantic region. The data gathered will be used to evaluate the likely economic impacts of management proposals. In addition, the information will be used to satisfy legal mandates under Executive Order 12898, the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq. ), the Regulatory Flexibility Act, the Endangered Species Act, and the National Environmental Policy Act, and other pertinent statutes.

A standardized survey will be administered via in-person, telephone and/or mail to all fishermen participating in the fishery.

OMB Number: 0648-0670.

Form Number: None.

Type of Review: Regular submission (request for extension).

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 9.

Estimated Time per Response: 1 hr.

Estimated Total Annual Burden Hours: 9.

Estimated Total Annual Cost to Public: $0 in recordkeeping/reporting costs.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

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

The Mid-Atlantic Fishery Management Council's (MAFMC's) Surfclam and Ocean Quahog Committee will meet to review the Public Hearing Document for the Atlantic Surfclam and Ocean Quahog Excessive Shares Amendment to ensure the document is complete for Council review and approval. An agenda and background documents will be posted at 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 agenda for the meeting will include development of Committee recommendations for fulfilling Magnuson Stevens Act requirements on: Record keeping and reporting, standardized bycatch reporting methodology, and status determination criteria. Additionally, staff will present a work plan for the economic and community impacts analysis associated with the FMP amendment, and additional information.

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 at: Meetings.npfmc.org 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 purpose of the meeting is to provide background about the Council's current outreach and communication procedures and strategies for the committee to consider as they develop recommendations to the Council on whether and how to update the Council's communications with rural Alaska and Alaska Native communities. The CEC will develop their recommendations to the Council over a series of meetings the dates of which are to be discussed at this meeting on March 20, 2019. The Agenda is subject to change, and the latest version will be posted at https://www.npfmc.org/committees/cec/ prior to the meeting, along with meeting materials.

Public comment letters will be accepted and should be submitted either electronically via the eCommenting portal at meetings.npfmc.org 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.

February 15, 2019: “Review of 2018 Ocean Salmon Fisheries, Stock Assessment and Fishery Evaluation Document for the Pacific Coast Salmon Fishery Management Plan” is scheduled to be posted on the Pacific Council website at http://www.pcouncil.org.

March 1, 2019: “Preseason Report I-Stock Abundance Analysis and Environmental Assessment Part 1 for 2019 Ocean Salmon Fishery Regulations” is scheduled to be posted on the Pacific Council website at http://www.pcouncil.org.

March 21, 2019: “Preseason Report II-Proposed Alternatives and Environmental Assessment Part 2 for 2019 Ocean Salmon Fishery Regulations” and public hearing schedule is scheduled to be posted on the Pacific Council website at http://www.pcouncil.org. The report will include a description of the adopted salmon management alternatives and a summary of their biological and economic impacts.

April 23, 2019: “Preseason Report III—Council-Adopted Management Measures and Environmental Assessment Part 3 for 2019 Ocean Salmon Fishery Regulations” is scheduled to be posted on the Pacific Council website at http://www.pcouncil.org.

May 1, 2019: Federal regulations for 2019 ocean salmon regulations are published in the Federal Register and implemented.

January 22-25, 2019: The Salmon Technical Team (STT) will meet at the Council office in a public work session to draft “Review of 2018 Ocean Salmon Fisheries, Stock Assessment and Fishery Evaluation Document for the Pacific Coast Salmon Fishery Management Plan” and to consider any other estimation or methodology issues pertinent to the 2019 ocean salmon fisheries. The STT may also discuss and work on salmon rebuilding plans as time allows.

February 19-22, 2019: The STT will meet at the Council office in a public work session to draft “Preseason Report I-Stock Abundance Analysis and Environmental Assessment Part 1 for 2019 Ocean Salmon Fishery Regulations” and to consider any other estimation or methodology issues pertinent to the 2019 ocean salmon fisheries. The STT may also discuss and work on salmon rebuilding plans as time allows.

March 25-26, 2019: Public hearings will be held to receive comments on the proposed ocean salmon fishery management alternatives adopted by the Pacific Council. Written comments received at the public hearings and a summary of oral comments heard at the hearings will be provided to the Pacific Council at its April meeting.

All public hearings begin at 7 p.m. on the dates and locations specified below:

• March 25, 2019: Chateau Westport, Beach Room, 710 West Hancock, Westport, WA 98595, telephone: (360) 268-9101.

• March 25, 2019: Red Lion Hotel, South Umpqua Room, 1313 North Bayshore Drive, Coos Bay, OR 97420, telephone: (541) 267-4141.

• March 26, 2019: Hampton Inn, Grand Ballroom, 1160 Airport Park Blvd., Ukiah, CA 95482, telephone: (707) 462-6555.

Although non-emergency issues not contained in the STT meeting agendas may come before the STT for discussion, those issues may not be the subject of formal STT action during these meetings. STT action will be restricted to those issues specifically listed in this document and to any issues arising after publication of this document requiring emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the STT's intent to take final action to address the emergency.

These public meetings and hearings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2280 (voice), or (503) 820-2299 (fax) at least 10 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.

The items of discussion during the assessment scoping webinar are as follows: Panelists will review the data sets being considered for the assessment and discuss initial modeling efforts.

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.

Agenda Friday, March 8, 2019

The agenda will be to review the 2019 Norton Sound Red King Crab assessment and approve the final OFL and ABC for that stock.

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 will be limited to written comments only and should be submitted either electronically to meetings.npfmc.org or through the mail: North Pacific Fishery Management Council, 605 W 4th Ave., Suite 306, Anchorage, AK 99501-2252.

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 Council will begin its plenary session at 8 a.m. in the Aleutian Room on Wednesday, April 3, 2019 continuing through Tuesday, April 9, 2019. The Council's Scientific and Statistical Committee (SSC) will begin at 8 a.m. in the King Salmon/Iliamna Room on Monday, April 1, 2019 and continue through Wednesday, April 3, 2019. The Council's Advisory Panel (AP) will begin at 8 a.m.in the Dillingham/Katmai Room on Tuesday, April 2, 2019 and continue through Saturday, April 6, 2019. The IFQ Committee will meet on Monday, April 1, 2019, from 8 a.m. to 5 p.m. (room TBD). The Ecosystem Committee will meet on Monday, April 1, 2019, from 9 a.m. to 5 p.m. (room TBD). The Fishery Monitoring Advisory Committee (FMAC) will meet on Tuesday, April 2, 2019 from 8 a.m. to 5 p.m. (room TBD). The Enforcement Committee will meet on Tuesday, April 2, 2019 from 1 p.m. to 5 p.m. (room TBD). The Cook Inlet Salmon Committee will meet on Tuesday, April 2, 2019 from 9 a.m. to 5 p.m. (room TBD).

Council Plenary Session: The agenda for the Council's plenary session will include the following issues. The Council may take appropriate action on any of the issues identified.

The Advisory Panel will address Council agenda items (12) through (28).

The SSC agenda will include the following issues:

In addition to providing ongoing scientific advice for fishery management decisions, the SSC functions as the Council's primary peer review panel for scientific information, as described by the Magnuson-Stevens Act section 302(g)(1)(e), and the National Standard 2 guidelines (78 FR 43066). The peer review process is also deemed to satisfy the requirements of the Information Quality Act, including the OMB Peer Review Bulletin guidelines.

The Fishery Monitoring Advisory Committee will meet to discuss the Fee Analysis Initial Review document, partial coverage cost savings, and other business. The Enforcement Committee will discuss Sablefish discards and the progress on the trawl EM cooperative research plan, and other business. The Ecosystem Committee will discuss habitat issues, a report on the Alaska Ocean Acidification Network and other status updates, a workplan for upcoming items for committee consideration, and other business. The IFQ committee will review discussion papers on eligibility criteria, global examples, sablefish discards, fish up in 3A, prioritization of IFQ program tasks, and other business. The Cook Inlet Salmon Committee will finalize recommendations for the Council on the upcoming FMP amendment, and discuss other business.

The Agendas are subject to change, and the latest versions will be posted at http://www.npfmc.org/.

Public comment letters will be accepted and should be submitted either electronically at meetings.npfmc.org or through the mail: North Pacific Fishery Management Council, 605 W. 4th Ave., Suite 306, Anchorage, AK 99501-2252. Deadline for comments is March 29, 2019, at 12 p.m.

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.

Fort Benning's Maneuver Center of Excellence (MCoE), which includes the Army's Armor and Infantry Schools, supports training of Infantry and Armor Soldiers and leaders for a wide variety of situations that they can expect to encounter on the modern battlefield. Fort Benning is also home to several deployable units that conduct heavy off-road maneuver training, including the 1st Security Force Assistance Brigade, Task Force 1-28 Infantry, and elements of the 75th Ranger Regiment. Fort Benning must be able to train and develop highly skilled and cohesive units capable of conducting operations across the full spectrum of conflict. Inherent in and vital to this training is the requirement to provide sufficient heavy off-road mounted maneuver training area. Currently, the Good Hope Maneuver Training Area (GHMTA) is the only training area at Fort Benning suitable for this training. GHMTA maneuver boxes do not provide enough contiguous off-road maneuver space. Of the available 11,154 acres of the GHMTA, only 1,952 non-contiguous acres, with no more than 371 acres of open and maneuverable terrain in any section, can be used for heavy off-road mounted maneuver.

The purpose of the Proposed Action is to provide Fort Benning with a HOMMTA consistent with the current training requirements of the MCoE and Fort Benning's tenant units. The Proposed Action is needed to address the lack of sufficient contiguous off-road maneuver area to meet training requirements for heavy armor vehicle (tracked and wheeled) off-road maneuver training at Fort Benning. This lack of maneuver space has recently become more problematic since the Army's training strategy has changed and requires a more dispersed approach to movement and maneuver. The GHMTA does not have available area and time for both the required MCoE courses and deployable tenant units. Managing demand for the training area through scheduling is no longer a viable option.

In concert with the EIS, the Army will prepare studies, analyses, and permit applications to meet other Federal requirements, such as Section 7 of the Endangered Species Act, Sections 401 and 404 of the Clean Water Act, and Section 106 of the National Historic Preservation Act. Mitigation through avoidance and low-impact design would be used to avoid adverse impacts to sensitive environmental resources to the maximum extent practicable.

The EIS will analyze the No Action Alternative and three distinct location alternatives on Fort Benning. The following alternatives proposed for analysis have been initially determined to be feasible and to meet the purpose of and need for the Proposed Action. Some alternatives are larger than the minimum 2,400 acres to ensure they include enough contiguous areas suitable for heavy off-road mounted maneuver training.

Northern Mounted Maneuver Training Area (NMMTA) Alternative: This alternative includes approximately 4,723 acres and is located adjacent to and east of the current Northern Maneuver Training Area (NMTA) and west of the nearby Digital Multi-Purpose Range Complex (DMPRC).

Red Diamond Alternative: This alternative includes approximately 3,743 acres and is located south of the Southern Maneuver Training Area (SMTA) on the Installation's southern boundary.

Eastern Boundary Alternative: This alternative includes approximately 2,405 acres and is located between the Kilo dudded impact area and the Installation's eastern boundary.

Resource areas that will be analyzed in the EIS include: Land use, aesthetics, air quality, noise, geology and soils, water resources, biological resources, cultural resources, socioeconomics and environmental justice, traffic and transportation, utilities, and hazardous and toxic materials/waste. The EIS will also analyze potential cumulative environmental effects. Based on initial review by the Army, potentially significant adverse impacts to water, biological, and/or cultural resources could occur if no mitigation were included. Mitigation measures will be presented in the EIS to reduce potential adverse effects.

The public is invited to participate in the scoping process. The scoping process begins with the publication of this Notice of Intent in the Federal Register and will last for 30 days. The scoping process will include a public scoping meeting, which is an opportunity for the public to receive information about the Proposed Action and assist the Army in identifying issues related to the Proposed Action. This meeting will be held near Fort Benning; the specific details of the meeting will be announced in local media. The public will also be invited to review and comment on the Draft EIS when it is available for review. Comments from the public will be considered before any decision is made regarding implementation of the Proposed Action.

Title; Associated Form; and OMB Number: Militarily Critical Technical Data Agreement; DD Form 2345; OMB Control Number 0704-0207.

Needs and Uses: The information collection requirement is necessary as a basis for certifying enterprises or individuals to have access to DoD export-controlled militarily critical technical data subject to the provisions of 32 CFR 250. Enterprises and individuals that need access to unclassified DoD-controlled militarily critical technical data must certify on DD Form 2345, Militarily Critical Technical Data Agreement, that data will be used only in ways that will inhibit unauthorized access and maintain the protection afforded by U.S. export control laws. The information collected is disclosed only to the extent consistent with prudent business practices, current regulations, and statutory requirements and is so indicated on the Privacy Act Statement of DD Form 2345.

Affected Public: Individuals and households; businesses or other for-profit; not-for-profit institutions.

Annual Burden Hours: 2,666.

Number of Respondents: 8,000.

Responses per Respondent: 1.

Annual Responses: 8,000.

Average Burden per Response: 20 minutes.

Frequency: On Occasion.

Use of DD Form 2345 permits U.S. and Canada defense contractors to certify their eligibility to obtain certain unclassified technical data with military and space applications. Non-availability of this information prevents defense contractors from accessing certain restricted databases and obstructs conference attendance where restricted data will be discussed. The form is available on the Defense Technical Information Center (DTIC) web page and DLA Logistics Information Services web page.

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

Type of Request: New collection.

Number of Respondents: 100.

Responses per Respondent: 1.

Annual Responses: 100.

Average Burden per Response: 3 hours.

Annual Burden Hours: 300.

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.

Frequency: As required.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Mr. Frederick Licari.

Requests for copies of the information collection proposal should be sent to Mr. Licari at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: Project Time Record System; OMB Control Number 0704-0452.

Type of Request: Reinstatement without change.

Number of Respondents: 1,200.

Responses per Respondent: 52.

Annual Responses: 62,400.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 15,600.

Needs and Uses: This collection of information is for the purpose of tracking Defense Logistics Agency (DLA) contractor workload/project activity, time and attendance, and labor distribution and data for analysis and reporting, management, and planning purposes. Additionally, the data allows government supervisors to maintain management records associated with the operations of contracts and to evaluate and monitor contractor performance and other matters concerning contracts. Government supervisors are able to monitor all aspects of a contract and resolve any discrepancy in hours billed to DLA. Records devoid of personal identifiers are used for extraction or compilation of data and reports for management studies and statistical analyses for use internally as required by the Department of Defense (DoD).

Affected Public: Individuals or households.

Frequency: Weekly.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Mr. Frederick Licari.

Requests for copies of the information collection proposal should be sent to Mr. Licari at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.

Purpose of the Meeting: The purpose of the meeting is for the DACOWITS to receive briefings and updates relating to their current work.

Agenda: Tuesday, March 19, 2019, from 8:00 a.m. to 12:30 p.m.—Welcome, Introductions, and Announcements; Request for Information Status Update; Briefings and DACOWITS discussion on: Physics Fitness Training Programs; Women on Ships update; Domestic Violence Affecting Servicewomen; Marine Corps Recruit Training update; and a Public Comment period.

Meeting Accessibility: Pursuant to 5 U.S.C. 552b, as amended, and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public, subject to the availability of space.

Written Statements: Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the FACA, interested persons may submit a written statement to the DACOWITS. Individuals submitting a written statement must submit their statement no later than 5:00 p.m., Monday, March 11, 2019 to Mr. Robert Bowling (703) 697-2122 (Voice), 703-614-6233 (Facsimile), osd.pentagon.ousd-p-r.mbx.dacowits@mail.mil (Email) . Mailing address is 4800 Mark Center Drive, Suite 04J25-01, Alexandria, VA 22350. If members of the public are interested in making an oral statement, a written statement should be submitted. If a statement is not received by Monday, March 11, 2019, prior to the meeting, which is the subject of this notice, then it may not be provided to or considered by the DACOWITS during this quarterly business meeting. After reviewing the written statements, the Chair and the DFO will determine if the requesting persons are permitted to make an oral presentation of their issue during an open portion of this meeting or at a future meeting. The DFO will review all timely submissions with the DACOWITS Chair and ensure they are provided to the members of the Committee.

Title; Associated Form; and OMB Number: Outside Director/Proxy Holder for Private Contractors; (1) Outside Director/Proxy Holder Nominee Package, (2) Nominating Official Package, (3) Self-Assessment Form, (4) Peer Evaluation Form, (5) Group Assessment Form, (6) OD/PH Continuous Training Certificate; 0704-XXXX.

Needs and Uses: This information collection is necessary so that DSS can provide proper monitoring and oversight of companies with Foreign Ownership, Control, or Influence (FOCI), while those companies provide services on a U.S. government contract. In order to mitigate conflict of interest risks, DSS will designate Outside Director/Proxy Holder(s) (OD/PH) for the specified company. The OD/PH will be a cleared U.S. citizen who can ensure that the foreign owner is effectively insulated from the company in classified matters of the U.S. government. The overall intent of this collection is to prevent foreign interests from influencing the company's performance of classified contracts in matters of U.S. national security.

(1) Outside Director/Proxy Holder Nominee Package—This form is completed by the prospective OD/PH after being nominated to the position by the company board of directors. This form will provide DSS with the information necessary to assess whether the possible OD/PH possesses the qualifications and clearance level necessary to fulfill their role. This form consists of eight questions and must include the nominee's resume.

(2) Nominating Official Package—This form is completed by the company shareholder or proxy holder responsible for nominating the prospective OD/PH. It provides DSS with the information necessary to understand the particular reasons why an individual nominee was selected for placement on a FOCI Board. The form consists of five questions.

(3) Self-Assessment Form—This form is completed by OD/PH and Officer/Directors on an annual basis. It enables DSS to evaluate whether OD/PH and Officer/Directors are fulfilling the duties of his or her role effectively in accordance with the National Industrial Security Program. The form consists of six questions.

(4) Peer Evaluation Form—Every OD/PH and security advisor serving on a company's FOCI board completes this form on an annual basis to evaluate his or her peers (there are generally between one and seven personnel on a company's FOCI board). The information will assist DSS in evaluating whether an OD/PH is performing their duties in good faith and in a manner believed to be in the U.S. national interest and in the best interests of the company and company's shareholders. The form consists of six questions.

(5) Group Assessment Form—This form is completed by the company's Board of Directors and the Government Security Committee. It provides DSS with the information necessary to evaluate whether the collective group is acting in a manner consistent with a functioning corporate governance body, which is essential for the proper functioning and execution of corporate security controls and oversight. The form consists of three questions.

(6) OD/PH Continuous Training Certificate—provides DSS with information necessary to annually determine whether OD/PH have completed the necessary professional development units for continued approval to serve as an OD/PH.

Affected Public: Individuals or Households.

Annual Burden Hours: 4,050.

Number of Respondents: 1,800.

Responses per Respondent: 3.

Annual Responses: 5,400.

Average Burden per Response: 45 minutes.

Frequency: On occasion.

Due to circumstances beyond the control of the Department of Defense (DoD) and the Designated Federal Officer, the Defense Advisory Committee on Investigation, Prosecution, and Defense of Sexual Assault in the Armed Forces was unable to provide public notification required by 41 CFR 102-3.150(a) concerning the meeting on February 22, 2019 of the Defense Advisory Committee on Investigation, Prosecution, and Defense of Sexual Assault in the Armed Forces. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.

Purpose of the Meeting: In section 546 of the National Defense Authorization Act for Fiscal Year 2015 (Pub. L. 113-291), as modified by section 537 of the National Defense Authorization Act for Fiscal Year 2016 (Pub. L. 114-92), Congress tasked the DAC-IPAD to advise the Secretary of Defense on the investigation, prosecution, and defense of allegations of rape, forcible sodomy, sexual assault, and other sexual misconduct involving members of the Armed Forces. This will be the twelfth public meeting held by the DAC-IPAD. The purpose of the meeting is to gather information for the Committee to advise the Secretary of Defense on issues related to military sexual misconduct and the military justice process. For this meeting the Committee will conduct deliberations on its March 2019 Annual Report.

Agenda: 11:00 a.m.-11:10 a.m. Public Meeting Begins—Welcome and Introduction; 11:10 a.m.-2:00 p.m. Committee Deliberations on the DAC-IPAD March 2019 Draft Annual Report; 2:00 p.m.-2:15 p.m. Public Comment; 2:15 p.m. Public Meeting Adjourn.

Meeting Accessibility: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is limited and is on a first-come basis. Visitors are required to sign in at the One Liberty Center security desk and must leave government-issued photo identification on file and wear a visitor badge while in the building. Department of Defense Common Access Card (CAC) holders who do not have authorized access to One Liberty Center must provide an alternate form of government-issued photo identification to leave on file with security while in the building. All visitors must pass through a metal detection security screening. Individuals requiring special accommodations to access the public meeting should contact the DAC-IPAD at whs.pentagon.em.mbx.dacipad@mail.mil at least five (5) business days prior to the meeting so that appropriate arrangements can be made. In the event the Office of Personnel Management closes the government due to inclement weather or for any other reason, please consult the website for any changes to the public meeting date or time.

Written Statements: Pursuant to 41 CFR 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written comments to the Committee about its mission and topics pertaining to this public session. Written comments must be received by the DAC-IPAD at least five (5) business days prior to the meeting date so that they may be made available to the Committee members for their consideration prior to the meeting. Written comments should be submitted via email to the DAC-IPAD at whs.pentagon.em.mbx.dacipad@mail.mil in the following formats: Adobe Acrobat or Microsoft Word. Please note that since the DAC-IPAD operates under the provisions of the Federal Advisory Committee Act, as amended, all written comments will be treated as public documents and will be made available for public inspection. Oral statements from the public will be permitted, though the number and length of such oral statements may be limited based on the time available and the number of such requests. Oral presentations by members of the public will be permitted from 2:00 p.m. to 2:15 p.m. on February 22, 2019, in front of those Committee members physically present and telephonically to those Committee members participating remotely.

The following patents are available for licensing: Patent No. 10,189,117 (Navy Case No. 103030): ADHESION IMPROVEMENT VIA MATERIAL NANOSTRUCTURING OR TEXTURIZING// Patent No. 10,178,792 (Navy Case No. 200426): ONE-PERSON PORTABLE COMMAND AND CONTROL DATA CENTER// and Patent No. 10,173,784 (Navy Case No. 200328): MOBILE MULTI-MODE POWER GENERATION SYSTEM WITH MODE BASED ADJUSTABLE DRAG CONFIGURATION.

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

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Flexible Polyurethane Foam Product (40 CFR part 63, subpart III) apply to owners or operators of both new and existing facilities that engage in the manufacture of flexible polyurethane foam products which emit hazardous air pollutants (HAPs). This includes facilities making slabstock flexible polyurethane foam (slabstock foam), rebond flexible polyurethane foam (rebond foam), and/or molded flexible polyurethane foam (molded foam). In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. Owners or operators of flexible polyurethane foam production facilities to which this rule is applicable must choose one of the compliance options described in these standards or reduce HAP emissions to below the compliance level. Specifically, the rule requirements for slabstock foam producers include an initial notification, notification of compliance status, semiannual reports and annual compliance certifications. The rule requirements for molded and rebond foam producers include a notification of compliance status report and an annual compliance certification. These notifications, reports, and records are essential in determining compliance with 40 CFR part 63, subpart III.

Form Numbers: None.

Respondents/affected entities: Manufacturers of flexible polyurethane foam products.

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

Estimated number of respondents: 12 (total).

Frequency of response: Initially, annually, and semiannually.

Total estimated burden: 869 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $94,700 (per year), includes which $0 for annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is an adjustment decrease in the total estimated burden as currently identified in the OMB Inventory of Approved Burdens. The decrease is not due to any program changes. The change in burden hours and number of responses is a result of removing burden for reconstructed sources as no reconstructed sources are expected to occur during this ICR renewal period.

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

Abstract: The New Source Performance Standards (NSPS) for Beverage Can Surface Coating (40 CFR part 60, subpart WW) apply to each operation of the following surface coating lines in the Beverage Can Surface Coating industry: (1) Exterior base; (2) over-varnished; and (3) inside spray. New facilities include those that commenced construction, modification, or reconstruction after the date of proposal. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 60, subpart WW.

Form Numbers: None.

Respondents/Affected Entities: Beverage can surface coating facilities.

Respondent's Obligation to Respond: Mandatory (40 CFR part 60, subpart WW).

Estimated Number of Respondents: 48 (total).

Frequency of Response: Initially, occasionally, and semiannually.

Total Estimated Burden: 5,190 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total Estimated Cost: $669,000 (per year), which includes $101,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is no change in the labor hours in this ICR compared to the previous ICR. This is due to two considerations: (1) The regulations have not changed over the past three years and are not anticipated to change over the next three years; and (2) the growth rate for the industry is very low, negative or non-existent, so there is no significant change in the overall burden.

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

Abstract: The New Source Performance Standards (NSPS) for Metal Furniture Coating apply to each metal furniture surface coating operation in which organic coatings are applied (greater than 3,842 liters of coating per year), commencing construction, modification or reconstruction after November 28, 1980. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 60, subpart EE.

Form Numbers: None.

Respondents/affected entities: Metal furniture surface coating facilities.

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

Estimated number of respondents: 400 (total).

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

Total estimated burden: 56,500 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $7,280,000 (per year), which includes $840,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is no change in the burden in this ICR compared to the previous ICR. This is due to two considerations: (1) The regulations have not changed over the past three years and are not anticipated to change over the next three years; and (2) the growth rate for the industry is very low, negative or non-existent, so there is no significant change in the overall burden.

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

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Chromium Emissions from Hard and Decorative Chromium Electroplating and Chromium Anodizing Tanks (40 CFR part 63, subpart N) apply to both existing facilities and new facilities. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 63, subpart N.

Form Numbers: None.

Respondents/affected entities: Hard chromium electroplating, decorative chromium electroplating, and chromium anodizing facilities.

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

Estimated number of respondents: 1,343 (total).

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

Total estimated burden: 242,000 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $46,900,000 (per year), which includes $20,400,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There was no change in the labor hours in this ICR compared to the previous ICR for several reasons. First, the regulations have not changed over the past three years and are not anticipated to change over the next three years, plus there was no change in the capital or O&M costs.

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

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Printing, Coating and Dyeing of Fabrics and Other Textiles apply to each existing, new, or reconstructed source involved in printing, coating, slashing, dyeing or finishing of fabric and other textiles. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, with 40 CFR part 63, subpart OOOO.

Form Numbers: None.

Respondents/Affected Entities: Facilities involved in the printing, coating, slashing, dyeing or finishing of fabric and other textiles.

Respondent's Obligation to Respond: Mandatory (40 CFR part 63, subpart OOOO).

Estimated Number of Respondents: 43 (total).

Frequency of Response: Initially and semiannually.

Total Estimated Burden: 6,700 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total Estimated Cost: $760,000 (per year), which includes $1,120 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: The decrease in burden from the most-recently approved ICR is due to an adjustment that has more accurate estimates in the number of sources. There is a significant decrease in the number of respondents from the previously-approved ICR, as based on current Agency analyses. This decrease also results in a reduced number of responses. The decrease in the capital/startup vs. operation and maintenance (O&M) costs as calculated in section 6(b)(iii) is due to the decrease in the number of respondents and there being no additional sources projected over the next 3 years. The overall result is a decrease in burden hours and costs.

This proposed administrative settlement for recovery of past response costs concerning the Fletchers Paint Works Site, located in Milford, New Hampshire, is made in accordance with Section 122(h)(l) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). EPA covenants not to sue or take administrative action against the Settling Party, the General Electric Company, pursuant to Section 107(a) of CERCLA, 42 U.S.C. 9607(a), for Past Response Costs. In exchange, the Settling Party agrees to pay EPA $3,214,000. Payment of such amount shall be due within 30 days after the Effective Date. If payment is not paid as stipulated, interest shall accrue and continue to accrue on any unpaid amount until the total amount due has been received. For 30 days following the date of publication of this notice, the Agency will receive written comments relating to the settlement for recovery of response costs. The Effective Date of the Agreement is the date upon which EPA notifies the General Electric Company that the public comment period has closed and that such comments, if any, do not require that EPA modify or withdraw from the Agreement.

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

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Benzene Waste Operations (40 CFR part 61, subpart FF) apply to existing facilities and new facilities that generate waste containing benzene, such as chemical manufacturing plants, coke by-product recovery plants, petroleum refineries, and those owners and operators of hazardous waste treatment, storage, and disposal facilities (TSDF) that receive wastes from the above facilities. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 61, subpart FF.

Form Numbers: None.

Respondents/affected entities: Owners and operators of benzene waste facilities.

Respondent's obligation to respond: Mandatory (40 CFR part 61, subpart FF).

Estimated number of respondents: 270 (total).

Frequency of response: Quarterly and annually.

Total estimated burden: 19,500 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $2,130,000 (per year), which includes $0 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is an adjustment increase in the total estimated burden as currently identified in the OMB Inventory of Approved Burdens. This increase is not due to any program changes, but reflects the addition of burden hours to account for the time spent by existing facilities to re-familiarize themselves annually with the rule requirements.

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

Abstract: The New Source Performance Standards (NSPS) for New Residential Wood Heaters (40 CFR 60, Subpart AAA) apply to existing facilities and new facilities that contain wood heaters. A wood heater is defined as an enclosed, wood burning appliance capable of and intended for residential or space heating and domestic water heating. Unless otherwise specified, these devices include, but are not limited to, adjustable burn rate wood heaters, single burn rate wood heaters and pellet stoves. New facilities include those that commenced construction, modification or reconstruction after the date of proposal.

One feature of the NSPS requires emphasis at the outset, which is that the requirements of subpart AAA establish a certification program instead of the usual NSPS requirements, where each affected facility is required to demonstrate compliance through performance testing. Under the subpart AAA-required certification program, a single wood heater is tested to demonstrate compliance with particulate matter (PM) emission limits for an entire model line, which could consist of thousands of stoves. The use of a certification approach significantly reduces the compliance burden, including information collection, for the manufacturers of wood heating appliances. In order to minimize risks to the environment from intentional or accidental misuse of the certification approach, subpart AAA includes several safeguards, some of which entail reporting and recordkeeping.

Form Numbers: None.

Respondents/affected entities: Owners and operators of facilities that contain new residential wood heaters.

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

Estimated number of respondents: 45 (total).

Frequency of response: Initially, occasionally, and annually.

Total estimated burden: 4,320 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $1,210,000 (per year), which includes $740,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the estimates: There is an increase in the total estimated respondent annual burden as currently identified in the OMB Inventory of Approved Burdens due to an increase in the number of test laboratories and third-party certifiers subject to these standards. The number of sources has been adjusted in this ICR to reflect more current information obtained regarding the number of manufacturers certifying model lines in advance of Subpart AAA's Step 2 p.m. standards, which go into effect in 2020, as well as data that indicates a decline in the number of manufacturers based on ongoing industry consolidation and decreasing market size, and to reflect additional entities obtaining EPA approval as test laboratories or third-party certifiers.

There is a decrease in capital/startup costs as compared to the previous ICR. This change is due to a decrease in the number of manufacturers, and because initial compliance requirements for test laboratories and third-party certifiers within the standard occurred during the period of the previous ICR. The overall result is a decrease in costs to the industry.

The supporting statement for this information collection was revised to clarify and consolidate the information items requested (including notification, reporting, and recordkeeping requirements) and respondent activities in section 4(b), as well as for agency activities in section 5(a). These requirements were previously listed in Appendix A of the prior ICR and have been relocated in sections 4(b) and 5(a) to help more easily identify the relevant data items and activities that contribute to burden. There are no changes to these requirements from the prior ICR.

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

Abstract: The New Source Performance Standards (NSPS) for Nonmetallic Mineral Processing (40 CFR part 60, subpart OOO) apply to the following affected facilities in fixed or portable nonmetallic mineral processing plants: Each crusher, grinding mill, screening operation, bucket elevator, belt conveyor, bagging operation, storage bin, and enclosed truck or railcar loading station, which commenced construction, modification or reconstruction after August 31, 1983. Also, crushers and grinding mills at hot mix asphalt facilities that reduce the size of nonmetallic minerals embedded in recycled asphalt pavement and subsequent affected facilities up to, but not including, the first storage silo or bin are subject to the provisions of the subpart. New facilities include those that commenced construction, modification, or reconstruction after the date of proposal. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 60, subpart OOO.

Form Numbers: None.

Respondents/Affected Entities: Nonmetallic mineral processing facilities.

Respondent's Obligation to Respond: Mandatory (40 CFR part 60, subpart OOO).

Estimated Number of Respondents: 5,095 (total).

Frequency of Response: Initially and occasionally.

Total Estimated Burden: 20,200 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total Estimated Cost: $2,450,000 (per year), which includes $228,000 in annualized capital/setup and/or operation & maintenance costs.

Changes in the Estimates: The increase in burden for respondents from the most recently approved ICR is due to two adjustments. The first adjustment increase in burden is an increase in the number of new or modified sources. The second adjustment increase in burden from the most recently approved ICR is the addition of burden hours to account for the time spent by existing facilities to re-familiarize themselves annually with the rule requirements.

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

Abstract: Air Stationary Source Compliance and Enforcement Information Reporting is an activity whereby State, Local, Native American, Territorial, and Commonwealth governments (hereafter referred to as either “states/locals” or “state and local agencies”) make air stationary source compliance and enforcement information available to the U.S. Environmental Protection Agency (EPA or the Agency) on a cyclic basis via input to the Air component of the Integrated Compliance Information System (ICIS-Air).

ICIS-Air supports EPA and state and local agency efforts to ensure compliance with the nation's environmental laws pertaining to air, via the collection and management of important Clean Air Act (CAA or the “Act”) compliance and enforcement information. ICIS-Air is a sub-component of ICIS, which provides compliance and enforcement information on thousands of facilities regulated under numerous federal statutes. The information provided to EPA via ICIS-Air includes source information, compliance monitoring activities, violation determinations, and enforcement activities. EPA will use this information to assess the health of the compliance and enforcement program established under the CAA, and to protect and maintain air quality, public health, and the environment. Agencies receive delegation of the CAA through regulated grant authorities, and report compliance/enforcement activities undertaken at stationary sources pursuant to the Minimum Data Requirements (MDRs) as outlined in this ICR. The provisions of Section 114(a)(1) of the Clean Air Act, 42 U.S. C Section 7414(a)(1) provide the broad authority for the reporting of compliance monitoring and enforcement information, along with SubpartQ-Reports in 40 CFR 51: Sections 51.324(a) and (b), and 51.327. This renewal requires the continuation of reporting of previously established MDRs via either direct, on-line entry or electronic data transfer (EDT) to ICIS-Air.

Form Numbers: None.

Respondents/affected entities: State, Local, Territorial, Indian Nations, and Commonwealth governments.

Respondent's obligation to respond: Mandatory, see Section 114(a)(1) of the Clean Air Act, 42 U.S. C Section 7414(a)(1).

Estimated number of respondents: 99 (total).

Frequency of response: Every 60 days.

Total estimated burden: 26,100 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $1,280,000 (per year). There are no annualized capital or operation & maintenance costs.

Changes in the Estimates: There is a decrease of 25,313 hours compared to the currently approved ICR. The currently approved ICR includes burden for the use of ICIS-Air as well as the transition from the AFS to the ICIS-Air system. Additionally, the prior renewal relied on a time-study and limited consultations for burden. In this renewal, there is no change in the number of respondents or the number of responses from the prior ICR. The decrease in respondent burden occurred as a result of adjustments to the burden required for the gathering, review, quality assurance, and upload or submittal of data to ICIS-Air and any additional trainings, calls, or upkeep activities. This ICR includes no burden associated with AFS or the transition to ICIS-Air.

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

This notice serves to update and modify FCC/OWD-1 as a result of the various necessary changes and updates, including an increased use of information technology. The substantive changes and modifications to the previously published version of the FCC/OWD-1 system of records include:

1. Updating the language in the Security Classification to follow OMB guidance.

2. Adding information to the Purposes to note that the “request for reasonable accommodation” also includes access to other benefits and privileges of employment.

3. Minor changes to the language in the Categories of Individuals to be consistent with the language and phrasing now used in the FCC's SORNs.

4. Adding the new or revised information that OWD will obtain from FCC Forms 5626 and 5627 as well as minor changes to the language in the Categories of Records to be consistent with the language and phrasing now used in the FCC's SORNs.

5. Updating and/or revising language in five routine uses: (1) Adjudication and Litigation; (2) Law Enforcement and Investigation; (3) Congressional Inquiries; (4) Government-wide Program Management and Oversight; and (5) Labor Relations.

6. Adding three new routine uses: (6) Breach Notification to address the Commission's real or suspected data breach situations; (7) Assistance to Federal Agencies and Entities for assistance with other Federal agencies' data breach situations; and (8) For Non-Federal Personnel to allow contractors performing or working on a contract for the Federal Government access to information. Routine Uses (6) and (7) are required by OMB Memorandum m-17-12.

7. Adding two new sections: (a) Reporting to a Consumer Reporting Agency to address valid and overdue debts owed by individuals to the FCC under the Debt Collection Act, as recommended by OMB; and (b) History to reference the previous publication of this SORN in the Federal Register .

The system of records is also updated to reflect various administrative changes related to the system managers and system addresses; policy and practices for storage and retrieval of the information; administrative, technical, and physical safeguards; and updated notification, records access, and contesting records procedures.

This is a summary of the Commission's document in CC Docket No. 92-237, DA 19-38 released February 1, 2019. The complete text in this document is available for public inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW, Room CY-A257, Washington, DC 20554. The document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street SW, Room CY-B402, Washington, DC 20554, telephone (800) 378-3160 or (202) 863-2893, facsimile (202) 863-2898, or via the internet at http://www.bcpiweb.com. It is available on the Commission's website at http://www.fcc.gov.

This notice is being published less than 15 calendar days before the meeting for good cause and due to exigent circumstances. Specifically, this committee meeting was previously scheduled for February 5, 2019 but that meeting had to be cancelled due to uncertainty about when the Government shutdown would end. There is important committee business that needs to be completed expeditiously, and rescheduling the meeting for February 14 will ensure that the meeting is held during the period in which the agency will have appropriated funding.

*The Agenda may be modified at the discretion of the NANC Chairman with the approval of the Designated Federal Officer (DFO).

OMB Control Number: 3060-0856.

Title: Universal Service—Schools and Libraries Universal Service Support Program Reimbursement Forms.

Form Numbers: FCC Forms 472, 473, and 474.

Type of Review: Extension of a currently approved collection.

Respondents: Businesses or other for-profit institutions, Not-for-profit institutions, and State, Local or Tribal government.

Number of Respondents and Responses: 22,000 respondents; 158,000 responses.

Estimated Time per Response: 1 hour per form.

Frequency of Response: On occasion and annual reporting requirements and third-party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. The Commission's statutory authority to collect this information is derived from 47 U.S.C. Section 254.

Total Annual Burden: 158,000 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: If the Commission requests applicants to submit information that the respondents believe is confidential, respondents may request confidential treatment of such information under section 47 CFR 0.459 of the Commission's rules.

Needs and Uses: The Commission will submit this information collection to OMB, which is an extension of a currently approved collection, to obtain a full three-year clearance from OMB. FCC Forms 472, 473, and 474 have no revisions. The hourly burden will decrease by 165 hours for FCC Forms 472, 473, and 474. The public burden for the collection contained herein will decrease to 158,000 burden hours.

The FCC Form 472 is used by an eligible entity to seek reimbursement from the service provider for the discounts on services paid in full. After receiving an invoice from the service provider, together with an FCC Form 472, USAC is able to verify the eligible service and approved amounts that should be reimbursed and can make the appropriate payment to the service provider. The FCC Form 472 is also used to ensure that each service provider has provided discounted services within the current funding year for which it submits an invoice to USAC and that invoices submitted from service providers for the costs of discounted eligible services do not exceed the amount that has been approved.

The FCC Form 473 is used to verify that the service provider is eligible to participate in the schools and libraries universal service support program (E-Rate program) and to confirm that the invoice forms submitted by the service provider are in compliance with the Federal Communications Commission's E-Rate program rules. The FCC Form 473 is also used by USAC to assure that the dollars paid out by the universal service fund go to eligible providers.

The FCC Form 474 is used by an eligible service provider to seek payment for the discounted costs of services it provided to billed entities for eligible services. After receiving an invoice from the service provider, together with an FCC Form 474, USAC is able to verify that the eligible and approved amounts can be paid. The FCC Form 474 is also used to ensure that each service provider has provided discounted services within the current funding year for which it submits an invoice to USAC and that invoices submitted from service providers for the costs of discounted eligible services do not exceed the amount that has been approved.

All of the requirements contained in this information collection are necessary to implement the Congressional mandate for the E-Rate program and reimbursement process.

OMB Control Number: 3060-0537.

Title: Sections 13.9(c), 13.13(c), 13.17(b), 13.211(e) and 13.217, Commercial Operator License Examination Managers (COLEM) Records.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 659 respondents; 659 responses.

Estimated Time per Response: .44 hours to 30 hours.

Frequency of Response: Recordkeeping requirement and on occasion reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154 and 303 of the Communications Act of 1934.

Total Annual Burden: 14,796 hours.

Total Annual Cost: No cost.

Privacy Impact Assessment: No impact(s).

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

Needs and Uses: The Commission will submit this expiring information collection after this comment period to obtain the full, three year clearance from the Office of Management and Budget (OMB). The Commission is requesting approval for a three year extension. The rule sections approved under this collections are 47 CFR 13.9, 13.13, 13.17 13.211 and 13.217. If the information collection requirements were not kept or fulfilled it is conceivable that examinees could be overcharged and that fraud and deceit could be used for unjust enrichment of the examiners.

OMB Control Number: 3060-1185.

Title: Annual Report for Mobility Fund Phase I Support, FCC Form 690 and Record Retention Requirements.

Form Number: FCC Form 690.

Type of Review: Extension of a currently approved collection.

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

Number of Respondents and Responses: 34 respondents and 880 responses.

Time per Response: 1-18 hours.

Frequency of Response: Annual and on occasion reporting requirement; recordkeeping requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection 47 U.S.C. 154, 254 and 303(r) of the Communications Act of 1934, as amended.

Estimated Total Annual Burden: 15,874 hours.

Total Annual Costs: No Cost.

Nature and Extent of Confidentiality: There is no need for confidentiality. The information collected on FCC Form 690 will be made available for public inspection. To the extent that an applicant seeks to have information collected on FCC Form 690 withheld from public inspection, the applicant may request confidential treatment pursuant to 47 CFR 0.459.

Privacy Act Impact Assessment: No impact(s).

Needs and Uses: A request for extension of this information collection (no change in requirements) will be submitted to the Office of Management and Budget (OMB) after this 60-day comment period in order to obtain the full three year clearance from OMB. The Commission uses the information contained in this collection to ensure that each winning bidder is meeting its obligations for receiving Mobility Fund Phase I (MF-I) support. In its November 2011 USF/ICC Transformation Order (FCC 11-161), the Commission comprehensively reformed and modernized the high-cost program within the universal service fund and, among other things, established the Mobility Fund. The Commission adopted rules in the USF/ICC Transformation Order for MF-I, which provided up to $300 million in one-time universal service support payments to immediately accelerate deployment of mobile broadband services in unserved areas, including annual reporting and record retention requirements for MF-I support recipients. The Commission also established a separate and complementary one-time Tribal Mobility Fund Phase I (TMF-I) to award up to $50 million in additional universal service funding to Tribal Areas, including Alaska, to accelerate mobile broadband availability in these remote and underserved areas. In its May 2012 Third Order on Reconsideration (FCC 12-52), the Commission revised certain rules adopted in the USF/ICC Transformation Order, including the deadline by which MF-I and TMF-I support recipients must file their annual reports pursuant to 47 CFR 54.1009(a). The information being collected under this information collection will be used by the Commission to ensure that each MF-I support recipient is meeting the public interest obligations associated with receiving such support.

A state's federal fiscal year (FY) disproportionate share hospital (DSH) allotment represents the aggregate limit on the federal share amount of the state's DSH payments to DSH hospitals in the state for the FY. The amount of such allotment is determined in accordance with the provisions of section 1923(f)(3) of the Social Security Act (the Act), with some state-specific exceptions as specified in section 1923(f) of the Act. Under such provisions, in general a state's FY DSH allotment is calculated by increasing the amount of its DSH allotment for the preceding FY by the percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) for the previous FY.

The Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively, the Affordable Care Act), amended Medicaid DSH provisions, adding section 1923(f)(7) of the Act. Section 1923(f)(7) would have required reductions to states' FY DSH allotments from FY 2014 through FY 2020, the calculation of which was described in the Disproportionate Share Hospital Payment Reduction final rule published in the September 18, 2013 Federal Register (78 FR 57293). Subsequent legislation, most recently by the Bipartisan Budget Act of 2018 (Pub. L. 115-123, enacted February 9, 2018), delayed the start of these reductions until FY 2020. A proposed rule delineating a revised methodology for the calculation of DSH allotment reductions previously scheduled to begin in FY 2018 was published in the July 28, 2017 Federal Register (82 FR 35155).

Because there are no reductions to DSH allotments for FY 2017 and FY 2019 under section 1923(f)(7) of the Act, as amended, this notice contains only the state-specific final FY 2017 DSH allotments and preliminary FY 2019 DSH allotments, as calculated under the statute without application of the reductions that would have been imposed under the Affordable Care Act provisions beginning with FY 2014. This notice also provides information on the calculation of such FY DSH allotments, the calculation of the states' institutions for mental diseases (IMDs) DSH limits, and the amounts of states' final FY 2017 IMD DSH limits and preliminary FY 2019 IMD DSH limits.

Generally, in accordance with the methodology specified under section 1923(f)(3) of the Act, a state's FY DSH allotment is calculated by increasing the amount of its DSH allotment for the preceding FY by the percentage change in the CPI-U for the previous FY. Also in accordance with section 1923(f)(3) of the Act, a state's DSH allotment for a FY is subject to the limitation that an increase to a state's DSH allotment for a FY cannot result in the DSH allotment exceeding the greater of the state's DSH allotment for the previous FY or 12 percent of the state's total medical assistance expenditures for the allotment year (this is referred to as the 12 percent limit).

Furthermore, under section 1923(h) of the Act, federal financial participation (FFP) for DSH payments to IMDs and other mental health facilities is limited to state-specific aggregate amounts. Under this provision, the aggregate limit for DSH payments to IMDs and other mental health facilities is the lesser of a state's FY 1995 total computable (state and federal share) IMD and other mental health facility DSH expenditures applicable to the state's FY 1995 DSH allotment (as reported on the Form CMS-64 as of January 1, 1997), or the amount equal to the product of the state's current year total computable DSH allotment and the applicable percentage specified in section 1923(h) of the Act.

In general, we determine states' DSH allotments for a FY and the IMD DSH limits for the same FY using the most recent available estimates of or actual medical assistance expenditures, including DSH expenditures in their Medicaid programs and the most recent available change in the CPI-U used for the FY in accordance with the methodology prescribed in the statute. The indicated estimated or actual expenditures are obtained from states for each relevant FY from the most recent available quarterly Medicaid budget reports (Form CMS-37) or quarterly Medicaid expenditure reports (Form CMS-64), respectively, submitted by the states. For example, as part of the initial determination of a state's FY DSH allotment (referred to as the preliminary DSH allotments) that is determined before the beginning of the FY for which the DSH allotments and IMD DSH limits are being determined, we use estimated expenditures for the FY obtained from the August submission of the CMS-37 submitted by states prior to the beginning of the FY; such estimated expenditures are subject to update and revision during the FY before such actual expenditure data become available. We also use the most recent available estimated CPI-U percentage change that is available before the beginning of the FY for determining the states' preliminary FY DSH allotments; such estimated CPI-U percentage change is subject to update and revision during the FY before the actual CPI-U percentage change becomes available. In determining the final DSH allotments and IMD DSH limits for a FY we use the actual expenditures for the FY and actual CPI-U percentage change for the previous FY.

Addendum 1 to this notice provides the states' final FY 2017 DSH allotments determined in accordance with section 1923(f)(3) of the Act. As described in the background section, in general, the DSH allotment for a FY is calculated by increasing the FY DSH allotment for the preceding FY by the CPI-U increase for the previous fiscal year. For purposes of calculating the states' final FY 2017 DSH allotments, the preceding final fiscal year DSH allotments (for FY 2016) were published in the July 6, 2018 Federal Register (83 FR 31536). For purposes of calculating the states' final FY 2017 DSH allotments we are using the actual Medicaid expenditures for FY 2017. Finally, for purposes of calculating the states' final FY 2017 DSH allotments, the applicable historical percentage change in the CPI-U for the previous FY (FY 2016) was 0.9 percent; we note that this is the same as the estimated 0.9 percentage change in the CPI-U for FY 2016 that was available and used in the calculation of the preliminary FY 2017 DSH allotments which were published in the November 3, 2017 Federal Register (82 FR 51259).

Addendum 2 to this notice provides the preliminary FY 2019 DSH allotments determined in accordance with section 1923(f)(3) of the Act. The preliminary FY 2019 DSH allotments contained in this notice were determined based on the most recent available estimates from states of their FY 2019 total computable Medicaid expenditures. Also, the preliminary FY 2019 allotments contained in this notice were determined by increasing the preliminary FY 2018 DSH allotments. The estimated percentage increase in the CPI-U for FY 2018 was 2.4 percent (CMS originally published the preliminary FY 2018 DSH allotments in the July 6, 2018 Federal Register (83 FR 31536)).

We will publish states' final FY 2019 DSH allotments in a future notice based on the states' four quarterly Medicaid expenditure reports (Form CMS-64) for FY 2019 available following the end of FY 2019 utilizing the actual change in the CPI-U for FY 2018.

Section 1923(h) of the Act specifies the methodology to be used to establish the limits on the amount of DSH payments that a state can make to IMDs and other mental health facilities. FFP is not available for DSH payments to IMDs or other mental health facilities that exceed the IMD DSH limits. In this notice, we are publishing the final FY 2017 and the preliminary FY 2019 IMD DSH limits determined in accordance with the provisions discussed above.

Addendums 3 and 4 to this notice detail each state's final FY 2017 and preliminary FY 2019 IMD DSH limit, respectively, determined in accordance with section 1923(h) of the Act.

As it relates to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), this notice does not impose any new or revised collection of information requirements or burden. While discussed in section I.B. and in Addendums 3 and 4 of this notice, the requirements and burden associated with Form CMS-37 and Form CMS-64 are unaffected by this notice. Both forms are approved by the Office of Management and Budget (OMB) under control number 0938-1265. Since this notice will not impose any new or revised requirements/burden, we are not making any changes under that control number.

We have examined the impact of this notice as required by Executive Order 12866 on Regulatory Planning and Review (September 1993), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4; enacted on March 22, 1995) (UMRA `95), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This notice reaches the $100 million economic threshold and thus is considered a major rule under the Congressional Review Act.

The final FY 2017 DSH allotments being published in this notice are equal to the preliminary FY 2017 DSH allotments published in the November 3, 2017 Federal Register (82 FR 51259). This is due to the actual percentage change in the CPI-U for FY 2016 used in the calculation of the final FY 2017 allotments (0.9 percent) being equal to the estimated percentage change in the CPI-U for FY 2016 used in the calculation of the preliminary FY 2017 allotments (0.9 percent). The final FY 2017 IMD DSH limits being published in this notice are also equal to the preliminary FY 2017 IMD DSH limits published in the November 3, 2017 Federal Register (82 FR 51259). Since the final FY 2017 DSH allotments were equal to the preliminary FY 2017 DSH allotments, the associated FY 2017 IMD DSH limits also remained the same.

The preliminary FY 2019 DSH allotments being published in this notice have been increased by approximately $295 million more than the preliminary FY 2018 DSH allotments published in the July 6, 2018 Federal Register (83 FR 31536). The increase in the DSH allotments is due to the application of the statutory formula for calculating DSH allotments under which the prior fiscal year allotments are increased by the percentage increase in the CPI-U for the prior fiscal year. The preliminary FY 2019 IMD DSH limits being published in this notice are approximately $24 million more than the preliminary FY 2018 IMD DSH limits published in the July 6, 2018 Federal Register (83 FR 31536). The increases in the IMD DSH limits are because the DSH allotment for a FY is a factor in the determination of the IMD DSH limit for the FY. Since the preliminary FY 2019 DSH allotments are greater than the preliminary FY 2018 DSH allotments, the associated preliminary FY 2019 IMD DSH limits for some states also increased.

The RFA requires agencies to analyze options for regulatory relief of small businesses, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any one year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because the Secretary has determined that this notice will not have significant economic impact on a substantial number of small entities. Specifically, any impact on providers is due to the effect of the various controlling statutes; providers are not impacted as a result of the independent regulatory action in publishing this notice. The purpose of the notice is to announce the latest DSH allotments and IMD DSH limits, as required by the statute.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Core-Based Statistical Area for Medicaid payment regulations and has fewer than 100 beds. We are not preparing analysis for section 1102(b) of the Act because the Secretary has determined that this notice will not have a significant impact on the operations of a substantial number of small rural hospitals.

The Medicaid statute specifies the methodology for determining the amounts of states' DSH allotments and IMD DSH limits; and as described previously, the application of the methodology specified in statute results in the decreases or increases in states' DSH allotments and IMD DSH limits for the applicable FYs. The statute applicable to these allotments and limits does not apply to the determination of the amounts of DSH payments made to specific DSH hospitals; rather, these allotments and limits represent an overall limit on the total of such DSH payments. For this reason, we do not believe that this notice will have a significant economic impact on a substantial number of small entities.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $150 million. This notice will have no consequential effect on spending by state, local, or tribal governments, in the aggregate, or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this notice does not impose any costs on state or local governments or otherwise have Federalism implications, the requirements of E.O. 13132 are not applicable.

Executive Order 13771, titled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017. It has been determined that this notice is a transfer rule and is not a regulatory action for the purposes of Executive Order 13771.

The methodologies for determining the states' fiscal year DSH allotments and IMD DSH limits, as reflected in this notice, were established in accordance with the methodologies and formula for determining states' allotments and limits as specified in statute. This notice does not put forward any further discretionary administrative policies for determining such allotments and limits, or otherwise.

As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf ), in Table 1, we have prepared an accounting statement showing the classification of the estimated expenditures associated with the provisions of this notice. Table 1 provides our best estimate of the change (decrease) in the federal share of states' Medicaid DSH payments resulting from the application of the provisions of the Medicaid statute relating to the calculation of states' FY DSH allotments and the increase in the FY DSH allotments from FY 2018 to FY 2019.

Section 1877 of the Social Security Act (the Act), also known as the physician self-referral law—(1) prohibits a physician from making referrals for certain “designated health services” (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership or compensation), unless the requirements of an applicable exception are satisfied; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those DHS furnished as a result of a prohibited referral.

Section 1877(d)(2) of the Act provides an exception, known as the rural provider exception, for physician ownership or investment interests in rural providers. In order for an entity to qualify for the rural provider exception, the DHS must be furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act) and substantially all the DHS furnished by the entity must be furnished to individuals residing in a rural area.

Section 1877(d)(3) of the Act provides an exception, known as the hospital ownership exception, for physician ownership or investment interests held in a hospital located outside of Puerto Rico, provided that the referring physician is authorized to perform services at the hospital and the ownership or investment interest is in the hospital itself (and not merely in a subdivision of the hospital).

Section 6001(a)(3) of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (hereafter referred to together as “the Affordable Care Act”) amended the rural provider and hospital ownership exceptions to the physician self-referral prohibition to impose additional restrictions on physician ownership and investment in hospitals. Since March 23, 2010, a physician-owned hospital that seeks to avail itself of either exception is prohibited from expanding facility capacity unless it qualifies as an “applicable hospital” or “high Medicaid facility” (as defined in sections 1877(i)(3)(E), (F) of the Act and our regulations at 42 CFR 411.362(c)(2) and (3)) and has been granted an exception to the facility expansion prohibition by the Secretary of the Department of Health and Human Services (the Secretary). Section 1877(i)(3)(A)(ii) of the Act provides that individuals and entities in the community in which the provider requesting the exception is located must have an opportunity to provide input with respect to the provider's request for the exception. Section 1877(i)(3)(H) of the Act states that the Secretary shall publish in the Federal Register the final decision with respect to the request for an exception to the prohibition against facility expansion not later than 60 days after receiving a complete application.

On November 30, 2011, we published a final rule in the Federal Register (76 FR 74122, 74517-74525) that, among other things, finalized § 411.362(c), which specified the process for submitting, commenting on, and reviewing a request for an exception to the prohibition on expansion of facility capacity. We published a subsequent final rule in the Federal Register on November 10, 2014 (79 FR 66770) that made certain revisions. These revisions include, among other things, permitting the use of data from an external data source or data from the Hospital Cost Report Information System (HCRIS) for specific eligibility criteria.

Our regulations at § 411.362(c)(5) require us to solicit community input on the request for an exception by publishing a notice of the request in the Federal Register . Individuals and entities in the hospital's community will have 30 days to submit comments on the request. Community input must take the form of written comments and may include documentation demonstrating that the physician-owned hospital requesting the exception does or does not qualify as an applicable hospital or high Medicaid facility, as such terms are defined in § 411.362(c)(2) and (3). In the November 30, 2011 final rule (76 FR 74122), we gave examples of community input, such as documentation demonstrating that the hospital does not satisfy one or more of the data criteria or that the hospital discriminates against beneficiaries of Federal health programs; however, we noted that these were examples only and that we will not restrict the type of community input that may be submitted. If we receive timely comments from the community, we will notify the hospital, and the hospital will have 30 days after such notice to submit a rebuttal statement (§ 411.362(c)(5)(ii)).

A request for an exception to the facility expansion prohibition is considered complete as follows:

• If the request, any written comments, and any rebuttal statement include only HCRIS data: (1) The end of the 30-day comment period if the Centers for Medicare & Medicaid Services (CMS) receives no written comments from the community; or (2) the end of the 30-day rebuttal period if CMS receives written comments from the community, regardless of whether the physician-owned hospital submitting the request submits a rebuttal statement (§ 411.362(c)(5)(i)).

• If the request, any written comments, or any rebuttal statement include data from an external data source, no later than—(1) 180 days after the end of the 30-day comment period if CMS receives no written comments from the community; and (2) 180 days after the end of the 30-day rebuttal period if CMS receives written comments from the community, regardless of whether the physician-owned hospital submitting the request submits a rebuttal statement (§ 411.362(c)(5)(ii)).

If CMS grants the request for an exception to the prohibition on expansion of facility capacity, the expansion may occur only in facilities on the hospital's main campus and may not result in the number of operating rooms, procedure rooms, and beds for which the hospital is licensed to exceed 200 percent of the hospital's baseline number of operating rooms, procedure rooms, and beds (§ 411.362(c)(6)). The CMS decision to grant or deny a hospital's request for an exception to the prohibition on expansion of facility capacity must be published in the Federal Register in accordance with our regulations at § 411.362(c)(7).

On October 24, 2018, we published a notice in the Federal Register (83 FR 53634) entitled “Request for an Exception to the Prohibition on Expansion of Facility Capacity under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition”. In the notice, we stated that, as permitted by section 1877(i)(3) of the Act and our regulations at § 411.362(c), the following physician-owned hospital requested an exception to the prohibition on expansion of facility capacity:

Name of Facility: St. James Behavioral Health Hospital Inc.

Address: 3136 S Saint Landry Ave., Gonzales, Louisiana 70737-5801.

County: Ascension Parish.

Basis for Exception Request: High Medicaid Facility.

In the notice, we solicited comments from individuals and entities in the community in which St. James Behavioral Health Hospital Inc is located. During the 30-day public comment period, we received one comment. However, the comment was out of scope because it expressed only general views regarding the expansion exception process and was not community input on St. James Behavioral Health Hospital Inc's exception request.

This final notice announces our decision to approve St. James Behavioral Health Hospital Inc's request for an exception to the prohibition against expansion of facility capacity. St. James Behavioral Health Hospital Inc submitted the data and certifications necessary to demonstrate that it satisfies the criteria to qualify as a high Medicaid facility as specified in the November 30, 2011 final rule. In accordance with section 1877(i)(3) of the Act, we are granting St. James Behavioral Health Hospital Inc's request for an exception to the expansion of facility capacity prohibition based on the following criteria:

• St. James Behavioral Health Hospital Inc is not the sole hospital in the county in which the hospital is located;

• With respect to each of the 3 most recent 12-month periods for which data are available as of the date the hospital submitted its request, St. James Behavioral Health Hospital Inc had an annual percent of total inpatient admissions under Medicaid that is estimated to be greater than such percent with respect to such admissions for any other hospital located in the county in which the hospital is located; and

• St. James Behavioral Health Hospital Inc certified that it does not discriminate against beneficiaries of Federal health care programs and does not permit physicians practicing at the hospital to discriminate against such beneficiaries.

Our decision grants St. James Behavioral Health Hospital Inc's request to add a total of 28 operating rooms, procedure rooms, and beds. Under § 411.362(c)(6), the expansion may occur only in facilities on the hospital's main campus and may not result in the number of operating rooms, procedure rooms, and beds for which St. James Behavioral Health Hospital Inc is licensed to exceed 200 percent of its baseline number of operating rooms, procedure rooms, and beds. St. James Behavioral Health Hospital Inc certified that its baseline number of operating rooms, procedure rooms, and beds is 28. Accordingly, we find that granting an additional 28 operating rooms, procedure rooms, and beds will not exceed the limitation on a permitted expansion.

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

I. Background

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

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

FDA has approved for marketing the human drug product, EXONDYS 51 (eteplirsen) indicated for treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. This indication is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients treated with EXONDYS 51. A clinical benefit of EXONDYS 51 has not been established. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. Subsequent to this approval, the USPTO received patent term restoration applications for EXONDYS 51 (U.S. Patent Nos. 7,807,816 and 9,018,368) from the University of Western Australia and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated October 16, 2017, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of EXONDYS 51 represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for EXONDYS 51 is 2,280 days. Of this time, 1,828 days occurred during the testing phase of the regulatory review period, while 452 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: June 25, 2010. FDA has verified the applicant's claim that the date the investigational new drug application became effective was June 25, 2010.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: June 26, 2015. FDA has verified the applicant's claim that the new drug application (NDA) for EXONDYS 51 (NDA 206488) was initially submitted on June 26, 2015.

3. The date the application was approved: September 19, 2016. FDA has verified the applicant's claim that NDA 206488 was approved on September 19, 2016.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,314 or 481 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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 before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

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

On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law. This law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also gave FDA the authority to issue regulations deeming other products that meet the statutory definition of a tobacco product to be subject to chapter IX of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).

In accordance with that authority, on May 10, 2016, FDA issued a final rule deeming all products that meet the statutory definition of tobacco product, except accessories of newly deemed tobacco products, to be subject to FDA's tobacco product authority. The deemed products include electronic nicotine delivery systems, cigars, waterpipe (hookah), pipe tobacco, nicotine gels, dissolvables that were not already subject to the FD&C Act, and other tobacco products that may be developed in the future (final deeming rule) (81 FR 28973).

Among other requirements, section 904(e) of the FD&C Act (21 U.S.C. 387d(e)) requires FDA to establish, and periodically revise as appropriate, a list of HPHCs, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand. Section 904(d)(1) of the FD&C Act further requires that this list be published in a format that is understandable and not misleading to a lay person (the Section 904(d) list).

FDA has undertaken a rigorous science-based research approach to ensure that the Section 904(d) list is not misleading to lay persons. As part of this research, FDA is seeking to conduct an experimental/quantitative study (4,500 online surveys), consisting of adult and youth (aged 13-17) participants to evaluate the best way to convey information about HPHCs in tobacco products and tobacco smoke, by brand and by quantity in each brand and subbrand, in a format that is understandable and not misleading to a lay person. Participants will view sample formats and complete an online survey that will include questions regarding their understanding of the HPHC information presented to them. The purpose of the research is to gain insight on consumer comprehension of, and preferences regarding, HPHC presentations that will inform the Agency's efforts in connection with publishing the Section 904(d) list.

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

For this study, potential participants will be recruited by a market research firm that maintains an internet panel, and information will be collected through self-administered, online screening tests and surveys of youth aged 13-17 and adults aged 18 and older. Approximately 5,200 respondents (1,800 youth and 3,400 adults) will be requested to complete a screening test to determine eligibility for participation in the study, estimated to take approximately 3 minutes (0.05 hour) per screening test, for a total of 260 hours for screening activities. Respondents who qualify for the study will be directed to the survey. Approximately 4,500 participants (1,500 youth and 3,000 adults) will complete the survey, estimated to take 20 minutes (0.33 hour) per survey, for a total of 1,500 hours for completion of both adult and adolescent samples. The length of time to complete the screening test and survey are based on the research firm's experience that panel members answer approximately 2.5 questions per minute. This data collection will take place one time in 2019. Thus, the total estimated burden is estimated to be 1,760 hours.

I. Background

This public workshop is intended to meet one of the performance goals included in PDUFA VI. This PDUFA reauthorization is part of the FDA Reauthorization Act of 2017 signed by the President on August 18, 2017. The complete set of performance goals and procedures documented in the PDUFA Reauthorization Performance Goals And Procedures Fiscal Years 2018 Through 2022 (Goals Letter) is available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf. These goals were developed in consultation with patient and consumer advocates, health care professionals, and other public stakeholders, as part of negotiations with regulated industry. Section I.J.1 of the Goals Letter, “Enhancing the Incorporation of the Patient's Voice in Drug Development and Decision-Making,” outlines the requirement for FDA to conduct a public workshop.

This workshop will provide FDA the opportunity to better understand patients' perspectives on current barriers to participating in clinical trials and will discuss best practices and key considerations for enhancing the incorporation of patient perspectives into clinical trial development. At the workshop, patients (including patients with experience in participating in clinical trials and patients who have not participated in clinical trials but who are interested in doing so), caregivers, and other patient representatives will provide perspectives on several key topics related to clinical trials. These topics will include challenges and barriers patients face with access to trials, trial design, trial conduct, and trial followup. The meeting will also gather input from patients, caregivers, industry experts, academic researchers, and other external stakeholders on approaches and best practices to address these challenges and barriers. For more information on meeting topics and discussion questions, visit http://events.r20.constantcontact.com/register/event?llr=w8jl4kkab&oeidk=a07efuk61xm39d90653. FDA will also post the agenda and other workshop materials to this site approximately 5 business days before the workshop.

The format of the meeting will consist of a series of presentations, panel discussions, and audience Q&A. In addition to input generated through this public workshop, FDA is interested in receiving input through written comments, which can be submitted to the public docket (see ADDRESSES ).

Registration: To register for the public workshop, please visit the following website https://events.r20.constantcontact.com/register/eventReg?oeidk=a07efuk61xm39d90653&oseq=&c=&ch . Please register by March 11, 2019. Persons without access to the internet can call 919-668-5938 to register. If you are unable to attend the workshop in person, you can register to view a live webcast of the workshop. You will be asked to indicate in your registration if you plan to attend in person or via the webcast. 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. Persons interested in attending this public workshop must register by March 11, 2019, 11:59 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation once they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8 a.m. We will let registrants know if registration closes before the day of the public workshop.

If you need special accommodations due to a disability, please contact Graham Thompson (see FOR FURTHER INFORMATION CONTACT ) no later than March 11, 2019, 11:59 p.m. Eastern Time.

Streaming Webcast of the Public Workshop: This public workshop will also be webcast. Please register for the webcast by visiting https://events.r20.constantcontact.com/register/eventReg?oeidk=a07efuk61xm39d90653&oseq=&c=&ch=.

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.

If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview.

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 also may be viewed at the Dockets Management Staff (see ADDRESSES ).

The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

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

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

Section 502(x) of the FD&C Act (21 U.S.C. 352(x)), added by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462), requires the label of a nonprescription drug product marketed without an approved application in the United States to include a domestic address or domestic telephone number through which a manufacturer, packer, and distributor may receive a report of a serious adverse event associated with the product. The guidance document entitled, “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers,” explains how FDA interprets this requirement. The guidance discusses the meaning of “domestic address” for purposes of the labeling requirements of section 502(x) of the FD&C Act; FDA's recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x) of the FD&C Act; and FDA's intent regarding enforcing the labeling requirements of section 502(x) of the FD&C Act.

Description of Respondents: Respondents to this collection of information are manufacturers, packers, and distributors whose name (under section 502(b)(1) of the FD&C Act) appears on the label of a nonprescription drug product marketed in the United States without an approved application.

As indicated in table 1 of this document, we estimate that 300 manufacturers will revise approximately 900 labels to add a full domestic address or a domestic telephone number, and should they choose to adopt the guidance's recommendation, to add a statement identifying the purpose of the domestic address or telephone number. We believe that designing the label change should not take longer than 4 hours per label. Automated printing of the labels should only require a few seconds per label.

We estimate the burden of this collection of information as follows: