Federal Register Vol. 82, No.138,

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

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, Rural Utilities Service, U.S. Department of Agriculture, 1400 Independence Ave. SW., STOP 1522, Room 5164—South Building, Washington, DC 20250-1522 or email: [email protected]

Title: Servicing of Water Programs Loans and Grants.

OMB Control Number: 0572-0137.

Type of Request: Extension of a currently approved information collection.

Abstract: The Rural Utilities Service (RUS) Water and Environmental Programs (WEP) provide financing and technical assistance for development and operation of safe and affordable water supply systems and sewage and other waste disposal facilities. WEP provides loans, guaranteed loans and grants for water, sewer, storm water, and solid waste disposal facilities in rural areas and towns of up to 10,000 people. The recipients of the assistance covered by 7 CFR part 1782 must be public entities. These public entities can include municipalities, counties, special purpose districts, federally designated Indian tribes, and corporations not operated for profit, including cooperatives. The information, for the most part financial in nature, is needed by the Agency to determine if borrowers, based on their individual situations, qualify for the various servicing options.

Estimate of Burden: Public reporting for this collection of information is estimated to average 1.22 hours per response.

Respondents: Business or other for profit and non-profit institutions, and state and local governments.

Estimated Number of Respondents: 493.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 641 hours.

Copies of this information collection can be obtained from Thomas P. Dickson, Program Development and Regulatory Analysis, at (202) 690-4492. Email: [email protected]

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

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

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the 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, Acting Director, Program Development and Regulatory Analysis, Rural Utilities Service, U.S. Department of Agriculture, STOP 1522, 1400 Independence Ave. SW., Washington, DC 20250-1522. Telephone: (202) 690-4492 or email: [email protected]

Title: Electric System Emergency Restoration Plan.

OMB Control Number: 0572-0140.

Type of Request: Revision of a currently approved collection.

Abstract: USDA Rural Development administers rural utilities programs through the Rural Utilities Service (Agency). The Agency manages loan programs in accordance with the Rural Electrification Act (RE Act) of 1936, 7 U.S.C. 901 et sec., as amended. One of the Agency's main objectives is to safeguard loan security. An important part of safeguarding loan security is to make sure Agency financed facilities are utilized responsibly, adequately operated and adequately maintained. Accordingly, RUS borrowers have a duty to RUS to maintain their respective systems. In performing this duty, borrowers further the purposes of the RE Act while also preserving the value of electric systems to serve as collateral for repayment of RUS assistance.

A substantial portion of the electric infrastructure of the United States resides in rural America and is maintained by rural Americans. RUS is uniquely coupled with the electric infrastructure of rural America and its electric borrowers serving rural America. To ensure that the electric infrastructure in rural America is adequately protected, electric borrowers conduct a Vulnerability and Risk Assessment (VRA) of their respective systems and utilize the results of this assessment to enhance an existing Emergency Restoration Plan (ERP) or to create an ERP. The VRA is utilized to identify specific assets and infrastructure owned or served by the electric utility, to determine the criticality and the risk level associated with the assets and infrastructure including a risk versus cost analysis, to identify threats and vulnerabilities, if present, to review existing mitigation procedures and to assist in the development of new and additional mitigating procedures, if necessary. The ERP provides written procedures detailing response and restoration efforts in the event of a major system outage resulting from a natural or man-made disaster. The annual exercise of the ERP ensures operability and employee competency and serves to identify and correct deficiencies in the existing ERP. The exercise may be implemented individually by a single borrower, or by an individual borrower as a participant in a multi-party (to include utilities, government agencies and other participants or combination thereof) tabletop execution or actual implementation of the ERP.

Electric borrowers maintain ERPs as part of prudent utilities practices. These ERPs are essential to continuous operation of the electric systems. Each electric borrower provides RUS with an annual self-certification that an ERP exists for the system and that an initial VRA has been performed.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average .5 hour per response.

Respondents: Not-for-profit institutions.

Estimated Number of Respondents: 625.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 313 hours.

Copies of this information collection can be obtained from Thomas P. Dickson, Program Development and Regulatory Analysis, at (202) 690-4492, or email: [email protected]

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

Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-888-438-5448 and conference call 3640132. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-888-438-5448 and conference call 3640132.

Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://database.faca.gov/committee/meetings.aspx?cid=239; click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site, www.usccr.gov, or to contact the Eastern Regional Office at the above phone numbers, email or street address.

Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-888-267-6301 and conference call 1171256. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.

Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-977-8339 and providing the operator with the toll-free conference call-in number: 1-888-267-6301 and conference call 1171256.

Members of the public are invited to make statements during the open comment period of the meetings or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at [email protected] Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

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

Background

On May 31, 2017, the Department received an AD petition concerning imports of fine denier PSF from Vietnam, filed on behalf of the petitioners.1 On June 27, 2017, the Department published the initiation of the less-than-fair-value investigation of fine denier PSF from Vietnam.2 On June 29, 2017, the petitioners submitted a letter withdrawing the AD petition with respect to Vietnam.3 Section 351.207(b)(1) of the Department's regulations stipulates that the Secretary may terminate an investigation provided it has concluded that termination of the investigation is in the public interest.4 Because petitioners have withdrawn their May 31, 2017, petition with respect to Vietnam, and have requested that the Department terminate this investigation, we determine that termination of this investigation is in the public interest, pursuant to 19 CFR 351.207(b)(1).5 Accordingly, pursuant to section 734(a)(1)(A) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.207(b)(1), we are terminating the less-than-fair-value investigation with respect to Vietnam.

The merchandise covered by this investigation is fine denier polyester staple fiber (fine denier PSF), not carded or combed, measuring less than 3.3 decitex (3 denier) in diameter. The scope covers all fine denier PSF, whether coated or uncoated. The following products are excluded from the scope:

(1) PSF equal to or greater than 3.3 decitex (more than 3 denier, inclusive) currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 5503.20.0045 and 5503.20.0065.

(2) Low-melt PSF defined as a bi-component fiber with a polyester core and an outer, polyester sheath that melts at a significantly lower temperature than its inner polyester core currently classified under HTSUS subheading 5503.20.0015.

Fine denier PSF is classifiable under the HTSUS subheading 5503.20.0025. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigation is dispositive.

In accordance with section 734(a)(1)(A) of the Act and 19 CFR 351.207(b)(1), upon the petitioners' withdrawal of the petition, we are terminating the less-than-fair-value investigation of fine denier PSF with respect to Vietnam.

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) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report that compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment 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 assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a 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 in the Assessment Process webinars are as follows:

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

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

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

The meeting is 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 webinar.

In accordance with the Atlantic Coastal Fisheries Cooperative Management Act (Atlantic Coastal Act), 16 U.S.C. 5101 et seq., the Secretary of Commerce (Secretary) announces his determination that the State of New Jersey did not implement the measures required by the Atlantic States Marine Fishery Commission's Addendum XXVIII to the Flounder, Scup, and Black Sea Bass Interstate Fishery Management Plan (Addendum XXVIII). However, the Secretary finds that the management measures New Jersey failed to implement are not necessary for the conservation of summer flounder. Based on the analysis provided by the State, it is likely that New Jersey's measures will result in similar levels of total removals as the measures outlined in Addendum XXVIII. As a result, the Secretary is not imposing a moratorium in New Jersey state waters.

The Atlantic Coastal Act's noncompliance review and determination process was previously outlined in a notice that published in the Federal Register on June 22, 2017, (82 FR 28476) and is not repeated here.

The Q&A session and public hearings will be conducted via webinar. Registration for each webinar is required. Registration information and public hearing materials will be posted on the Council's Web site at http://safmc.net/safmc-meetings/public-hearing-and-scoping-meeting-schedule/ by July 27, 2017.

During the Q&A session Council staff will present an overview of the amendment and will be available for informal discussions and to answer questions via webinar. During the public hearings, Council staff will review the amendment and members of the public will have the opportunity to provide formal comments for consideration by the Council.

Written comments may be submitted online beginning July 27, 2017 at: http://safmc.net/safmc-meetings/public-hearing-and-scoping-meeting-schedule/. Written comments may also be submitted to the Council office (see ADDRESSES). Comments will be accepted until 5 p.m. on August 15, 2017.

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

Background information and additional details on NCA4 can be found at https://www.globalchange.gov/nca4.

This notice seeks nominations for Review Editors to NCA4 with pertinent subject matter expertise and scientific background. The roles of the Review Editor include: (a) Ensuring that all substantive comments submitted during the Public Comment Period and via a National Academies panel review (both currently scheduled for Autumn 2017-Winter 2018) are appropriately addressed, (b) advising Chapter Leads how to handle contentious issues, and (c) ensuring that significant scientific uncertainties are reflected adequately in the text of NCA4. Review Editors do not provide additional comments on assigned draft chapters; rather, they ensure each and every comment has been considered by the author team, and that the `annotation' (i.e., written responses to comments) is responsive to the comment and indicates any revision made to the chapter(s), including the scientific or logical rationale for said action.

Potential nominees should be accomplished scientists and/or science communicators with climate-related proficiency in at least one of the regions, sectors, or responses topics outlined in the NCA4 Outline, (described below in the Appendix and accessible via http://www.globalchange.gov/content/nca4-outline). Nominees must have demonstrated technical expertise such that the nominees could contribute to the development of a robust scientific, technical assessment as subject matter experts in one or more of the topics listed in the outline.

Responses to this request for nominations for Review Editors must be submitted by September 8, 2017. Users can access the nominations form via (https://contribute.globalchange.gov/). Interested persons may nominate themselves or third parties, and may nominate more than one person. Each nomination must include: (1) The nominee's full name, title, institutional affiliation, and contact information; (2) the desired chapter(s) the nominee wishes to serve as Review Editor on (i.e., area(s) of expertise); and (3) a short description of his/her qualifications relative to contributing to the report. Nominees are encouraged to submit a CV of no more than 4 pages for optimal consideration.

More information on the function of Review Editors, the tasks (including reporting) expected of them, as well as the tentative dates of commitment can be found at https://contribute.globalchange.gov.

The agenda will be to discuss progress on the items on the OAC subgroup's workplan, posted here: https://www.npfmc.org/wp-content/PDFdocuments/conservation_issues/Observer/OACSubgroupWorkplan617.pdf.

Meeting will be listening-only for those that are not on the OAC subgroup.

The meeting is via teleconference. Request for auxiliary aids should be directed to Maria Shawback at (907) 271-2809 at least 7 working days prior to the meeting date.

The SRWCW was formed in November 2015 and tasked with exploring and evaluating alternative fishery management frameworks for Sacramento River winter Chinook. The SRWCW first met in 2016 and identified three areas of focus: (1) Develop methods for forecasting abundance, (2) develop a suite of alternative control rules and (3) evaluate the performance of these control rules with regard to conservation benefits and fishery costs using a Management Strategy Evaluation (MSE) approach. Since 2016 the group has addressed these tasks and provided progress reports to the Council as information was available. At this webinar, the SRWCW will focus the discussion on the results of the MSE. The SAS will attend to provide input and feedback to the SRWCW. The SRWCW is tentatively scheduled to present preliminary MSE results to the Pacific Fishery Management Council in September 2017, and provide final MSE results in November 2017. The SRWCW may also discuss materials and reports for the Council's September 2017 meeting, and any future meeting plans.

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

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2411 at least 10 business 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. The product of the SEDAR webinar series will be a report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses, and describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species 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 non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.

The items of discussion in the Data Scoping webinar are as follows:

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.

This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see ADDRESSES) at least 5 business days prior to the meeting.

The Committee will discuss recent and planned work related to 2017 priorities, including development of a policy for monitoring commercial fisheries to address multiple information needs and a strategic approach to bycatch monitoring, and recommend appropriate next steps. The Committee will also discuss priorities for 2018; other business will be discussed as necessary.

This meeting is physically accessible to people with disabilities. This meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

Section 156 of title 35, United States Code, generally provides that the term of a patent may be extended for a period of up to five years if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review, and that the patent may be extended for interim periods of up to one year if the regulatory review is anticipated to extend beyond the expiration date of the patent.

On June 30, 2017, Kyowa Hakko Kirin Co., Ltd., the patent owner of record, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 7,179,464. The patent claims methods of using the human biological product benralizumab. The application for patent term extension indicates that a Biological License Application (BLA) 761070 was submitted to the Food and Drug Administration (FDA) on November 16, 2016.

Review of the patent term extension application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory review period will continue beyond the original expiration date of the patent, July 21, 2017, interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.

An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 7,179,464 is granted for a period of one year from the original expiration date of the patent.

The OMB is particularly interested in comments which:

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

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

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

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

A 60-day Notice requesting public comment was published in the Federal Register on July 1, 2016 at 81 FR 43192. This comment period ended August 30, 2016. No public comments were received from this Notice.

Description: The CNCS Grant Application is the information collection instrument used for grant competitions which CNCS sponsors when appropriations are available. This is a new information collection that replaces multiple application information collections used in the past. The information collection will otherwise be used in the same manner as the existing applications. CNCS also seeks to continue using the current applications until the revised application is approved by OMB. The current applications are due to expire at various times in the future and will be withdrawn once the new information collection request is approved and the new system is operational.

Type of Review: Renewal.

Agency: Corporation for National and Community Service.

Title: Grants and Member Management System.

OMB Number: TBD.

Agency Number: None.

Affected Public: Applicants for funding.

Total Respondents: 13,200.

Frequency: Depending on the availability of appropriations.

Average Time per Response: Six hours.

Estimated Total Burden Hours: 79,200.

Total Burden Cost (capital/startup): None.

Total Burden Cost (operating/maintenance): None.

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.

Availability of Materials for the Meeting: A copy of the agenda or any updates to the agenda for the August 10, 2017 meeting, is available at the Defense Health Board (DHB) Web site, https://health.mil/dhb. Any other materials presented in the meeting, may be obtained at the meeting.

Purpose of the Meeting: The Department of Defense is publishing this notice to announce a Federal Advisory Committee meeting of the DHB. The DHB provides independent advice and recommendations to maximize the safety and quality of, as well as access to, health care for DoD health care beneficiaries. The purpose of the meeting is to provide progress updates on specific taskings before the DHB. In addition, the DHB will receive information briefings on current issues related to military medicine.

Agenda: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165 and subject to availability of space, the meeting is open to the public from 9:15 a.m. to 12:45 p.m. and from 1:30 p.m. to 5:00 p.m. on August 10, 2017. The DHB anticipates receiving a decision brief from the Health Care Delivery and Neurological/Behavioral Health Subcommittees on a pediatric health care services tasking, a panel discussion on operational medicine from the Joint Staff Surgeon and two Combatant Command Surgeons, and a briefing from the Medical Officer of the Marine Corps. Any changes to the agenda can be found at the link provided in this SUPPLEMENTARY INFORMATION section.

Meeting Accessibility: Pursuant to 5 U.S.C. 552b, and 41 CFR 102-3.140 through 102-3.165 and subject to availability of space, this meeting is open to the public. Seating is limited and is on a first-come basis. All members of the public who wish to attend the public meeting must register by emailing their name, rank/title, and organization/company to [email protected] or by contacting Ms. Margaret Welsh at (703) 681-8007 or [email protected]

Special Accommodations: Individuals requiring special accommodations to access the public meeting should contact Ms. Margaret Welsh at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

Written Statements: Any member of the public wishing to provide comments to the DHB may do so in accordance with section 10(a)(3) of the Federal Advisory Committee Act, 41 CFR 102-3.105(j) and 102-3.140, and the procedures described in this notice. Written statements may be submitted to the DHB Designated Federal Officer (DFO), CAPT Juliann Althoff, at [email protected] and should be no longer than two type-written pages and include the issue, a short discussion, and a recommended course of action. Supporting documentation may also be included, to establish the appropriate historical context and to provide any necessary background information. If the written statement is not received at least five (5) business days prior to the meeting, the DFO may choose to postpone consideration of the statement until the next open meeting. The DFO will review all timely submissions with the DHB President and ensure they are provided to members of the DHB before the meeting that is subject to this notice. After reviewing the written comments, the President and the DFO may choose to invite the submitter to orally present their issue during an open portion of this meeting or at a future meeting. The DFO, in consultation with the DHB President, may allot time for members of the public to present their issues for review and discussion by the DHB.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Annual Progress Reporting Form for the American Indian Vocational Rehabilitation Services (AIVRS) Program.

OMB Control Number: 1820-0655.

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

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

Total Estimated Number of Annual Responses: 88.

Total Estimated Number of Annual Burden Hours: 968.

Abstract: The Rehabilitation Services Administration (RSA) of the U.S. Department of Education's (ED) Office of Special Education and Rehabilitative Services (OSERS) will use this data collection form to capture the performance data from grantees funded under the American Indian Vocational Rehabilitation Services (AIVRS) program (CFDA # 84.250). RSA and ED will use the information gathered annually to: (a) Comply with reporting requirements under the Education Department General Administration Regulations (EDGAR) 34 CFR part 75.118, (b) provide information annually to Congress on activities conducted under this program, and (c) measure performance on the program in accordance with the program indicators identified in the Government Performance Result Act (GPRA). The proposed changes to the existing form will improve user friendliness, clarity of data questions, and accuracy of data reported. Since the ED no longer collects data regarding common measures, the entire section of the report that collects this data is deleted, further reducing burden. These revisions are not significantly different from the original collection, but are proposed to provide clarity, consistency, and usability. In many areas, the data element language has been modified with direct language instead of passive terminology.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Quick Response Information System (QRIS) 2017-2020 System Clearance.

OMB Control Number: 1850-0733.

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

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

Total Estimated Number of Annual Responses: 104,004.

Total Estimated Number of Annual Burden Hours: 31,704.

Abstract: The National Center for Education Statistics (NCES) Quick Response Information System (QRIS) consists of the Fast Response Survey System (FRSS) and the Postsecondary Education Quick Information System (PEQIS). The QRIS currently conducts surveys under OMB generic clearance 1850-0733, which expires in February 2018. This submission requests approval to continue the current clearance conditions through the end of 2020. FRSS primarily conducts surveys of the elementary/secondary sector (districts, schools) and public libraries. PEQIS conducts surveys of the postsecondary education sector. FRSS and PEQIS surveys are cleared under the QRIS generic clearance. The QRIS clearance is subject to the regular clearance process at OMB with a 60-day notice and a 30-day notice as part of the 120-day review period. Each individual FRSS or PEQIS survey is then subject to clearance process with an abbreviated clearance package, justifying the particular content of the survey, describing the sample design, the timeline for the survey activities, and the questionnaire. The review period for each individual survey is 45 days, including a 30-day Federal Register notice period. OMB will provide comments as soon after the end of the 30-day notice period as possible. This generic clearance request is for surveys of state education agencies, school districts, schools, postsecondary institutions, and libraries.

Title: FERC Form No. 2 (Annual Report of Major Natural Gas Companies) and FERC Form No. 2-A (Annual Report of Non-major Natural Gas Companies).1

OMB Control Nos.: 1902-0028 (FERC Form No. 2) and 1902-0030 (FERC Form No. 2-A).

Type of Request: Three-year extension of the FERC Form No. 2 and FERC Form No. 2-A information collection requirements with no changes to the reporting requirements.

Abstract: Pursuant to sections 8, 10 and 14 of the National Gas Act (NGA), (15 U.S.C. 717g-717m, Pub. L. 75-688), the Commission is authorized to make investigations and collect and record data, to prescribe rules and regulations concerning accounts, records and memoranda as necessary or appropriate for purposes of administering the NGA. The Commission includes the filing requirements in 18 CFR parts 260.1 and 260.2.

The forms provide information concerning a company's past performance. The information is compiled using a standard chart of accounts contained in the Commission's Uniform System of Accounts (USofA).2 The forms contain schedules which include a basic set of financial statements: Comparative Balance Sheet, Statement of Income and Retained Earnings, Statement of Cash Flows, and the Statement of Comprehensive Income and Hedging Activities. Supporting schedules containing supplementary information are filed, including revenues and the related quantities of products sold or transported; account balances for various operating and maintenance expenses; selected plant cost data; and other information.

The information collected in the forms is used by Commission staff, state regulatory agencies and others in the review of the financial condition of regulated companies. The information is also used in various rate proceedings, industry analyses and in the Commission's audit programs and, as appropriate, for the computation of annual charges based on Page 520 of the forms. The Commission provides the information to the public, interveners and all interested parties to assist in the proceedings before the Commission.

Print versions of the Forms No. 2 and 2-A are located on the Commission's Web site at http://www.ferc.gov/docs-filing/forms.asp#2 and http://www.ferc.gov/docs-filing/forms.asp#2a respectively.

Type of Respondents: Each natural gas company whose combined gas transported or stored for a fee exceeds 50 million dekatherms in each of the previous three years must file the Form 2. Each natural gas company not meeting the filing threshold for the Form 2 but having total gas sales or volume transactions exceeding 200,000 dekatherms in each of the previous three calendar years must submit the Form 2-A.

Estimate of Annual Burden 3 : The Commission estimates the annual public reporting burden for the information collections as:

Final approval under OMB delegated authority of the extension for three years, without revision, of the following report:

Report title: Recordkeeping and Disclosure Requirements Associated with Regulation R.

Agency form number: FR 4025.

OMB Control number: 7100-0316.

Frequency: On occasion.

Respondents: Commercial banks and savings associations.

Estimated number of respondents: Section 701 disclosures to customers: 1,500; Section 701 disclosures to brokers: 1,500, Section 723 recordkeeping: 75; Section 741 disclosures to customers: 750.

Estimated average hours per response: Section 701 disclosures to customers: 5 minutes; Section 701 disclosures to brokers: 15 minutes, Section 723 recordkeeping: 15 minutes; Section 741 disclosures to customers: 5 minutes.

Estimated annual burden hours: 75,563.

General description of report: Sections 701, 723, and 741 contain information collection requirements. Details of the requirements for each section are provided below.

Section 701. Section 701(a)(2)(i) and (b) require banks (or their broker-dealer partners) that utilize the exemption provided in this section to make certain disclosures to high net worth or institutional customers. Specifically, these banks must clearly and conspicuously disclose (i) the name of the broker-dealer and (ii) that the bank employee participates in an incentive compensation program under which the bank employee may receive a fee of more than a nominal amount for referring the customer to the broker- dealer and payment of this fee may be contingent on whether the referral results in a transaction with the broker-dealer.

In addition, one of the conditions of the exemption is that the broker-dealer and the bank have a contractual or other written arrangement containing certain elements, including notification and information requirements. The bank must provide its broker-dealer partner with the name of the bank employee receiving a referral fee under the exemption and certain other identifying information relating to the bank employee.

Section 723. Section 723(e)(1) requires a bank that desires to exclude a trust or fiduciary account in determining its compliance with the chiefly compensated test in section 721, pursuant to a de minimis exclusion 5, to maintain records demonstrating that the securities transactions conducted by or on behalf of the account were undertaken by the bank in the exercise of its trust or fiduciary responsibilities with respect to the account.

Section 741. Section 741(a)(2)(ii)(A) requires a bank relying on this exemption, which permits banks to effect transactions in the shares of a money market fund, to provide customers with a prospectus for the money market fund securities, not later than the time the customer authorizes the bank to effect the transaction in such securities, if the class or series of securities are not no-load. In situations where a bank effects transactions under the exemption as part of a program for the investment or reinvestment of deposit funds of, or collected by, another bank, the Section permits either the effecting bank or the deposit-taking bank to provide the customer a prospectus for the money market fund securities.

Legal authorization and confidentiality: The Board's Legal Division has determined that section 3(a)(4)(F) of the Exchange Act (15 U.S.C. 78c(a)(4)(F)) authorizes the Board and the SEC to require the information collection. The FR 4025 is required to obtain a benefit because banks wishing to utilize exemptions provided by the rules 701, 723, and 741 are required to comply with the recordkeeping and disclosure requirements. If an institution considers the information to be trade secrets and/or privileged, such information could be withheld from the public under section (b)(4) of the Freedom of Information Act (5 U.S.C. 552(b)(4)). Additionally, to the extent that such information may be contained in an examination report, such information maybe also be withheld from the public under section (b)(8) of the Freedom of Information Act (5 U.S.C. 552 (b)(8)).

Current Actions: On April 3, 2017, the Board published a notice in the Federal Register (82 FR 16210) requesting public comment for 60 days on the extension, without revision, of the Recordkeeping and Disclosure Requirements Associated with Regulation R. The comment period for this notice expired on June 2, 2017. The Board did not receive any comments.

I. Background

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs as they are distributed within the United States. Section 202 of the DSCSA added the new sections 581 and 582 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360eee and 360eee-1, respectively). Under section 582(j) of the FD&C Act, FDA is required to establish one or more pilot projects, in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers, to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.

FDA will be establishing the DSCSA Pilot Project Program to implement section 582(j) of the FD&C Act. This program will assist the development of the interoperable electronic system to be established by 2023. The new system has the potential to reduce diversion of drugs distributed domestically as well as help reduce the influx of counterfeit drugs from foreign sources. The program will be designed to explore issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, identifying the system attributes that are necessary to implement the requirements established under the DSCSA, and any other issues identified by FDA (see section 582(j)(2)(B) of the FD&C Act). Particular program goals include assessing the ability of supply chain members to: Satisfy the requirements of section 582 of the FD&C Act; identify, manage, and prevent the distribution of suspect and illegitimate products as defined in section 581(21) and 581(8) of the FD&C Act, respectively; and demonstrate the electronic, interoperable exchange of product tracing information across the pharmaceutical distribution supply chain, in addition to identifying the system attributes needed to implement the requirements of section 582, particularly the requirement to utilize a product identifier for product tracing and verification purposes. FDA plans to coordinate with stakeholders who reflect the diversity of the pharmaceutical distribution supply chain, including large and small entities from all industry sectors. The pilot project is designed to allow industry to identify and evaluate the most efficient systems for their unique operational systems.

FDA will be seeking pilot project participants from the pharmaceutical distribution supply chain (authorized manufacturers, repackagers, wholesale distributors, and dispensers) and other stakeholders. FDA expects that participants will propose the design and execution of their pilot project in their submission to FDA; however, FDA intends to meet with all pilot project participants to ensure that the learnings from the pilot project(s) will be complementary in informing the direction of the development of the electronic, interoperable system that will go into effect in 2023. FDA encourages supply chain members to focus their proposed pilot project(s) on the DSCSA requirements related to the interoperable, electronic tracing of products at the package level. Specifically, the pilot project(s) should focus on the requirements for package-level tracing and verification that go into effect in 2023. Such pilot projects will be more useful than pilot projects dedicated to lot-level tracing. If there are adequate pilot project submissions, FDA may establish more than one pilot project to accomplish the goals of the DSCSA Pilot Project Program.

Proposed pilot projects may include any prescription drug that is a “product” within the meaning of section 581(13) of the FD&C Act. At its discretion, FDA may also consider proposed pilot projects involving product types outside the scope of section 581(13) of the FD&C Act (e.g., over-the-counter medicines) that could further the objectives of the DSCSA Pilot Project Program. Each package and homogenous case of product that is part of a pilot project should bear a “product identifier” as described in sections 581(14) and 582(a)(9) of the FD&C Act.

On April 5 and 6, 2016, FDA held a public workshop entitled “Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).” This public workshop provided a forum for members of the pharmaceutical distribution supply chain to discuss the design objectives of pilot projects established by FDA under section 582(j) of the FD&C Act. Based on the information gathered at that workshop and from the comments submitted to the public docket for the workshop (Docket No. FDA-2016-N-0407), FDA has identified several potential issues to examine, and evaluation methods to use, in pilot projects established under the DSCSA Pilot Project Program. These potential issues and evaluation methods are summarized in table 1. This table is intended only to assist in the design of potential pilot projects; it does not represent FDA's views or policies regarding the issues described in the table. For ease of reference, the potential issues to examine and evaluation methods have been grouped by focus areas for the pilot projects.

FDA also received input from the workshop participants and in the comments submitted to the public docket on factors that the Agency should take into consideration when establishing pilot projects. These factors described in the comments include the extent to which the pilot projects:

• Represent the mix of products and levels of packaging in the supply chain.

• Include a diverse set of supply chain stakeholders (types and sizes) and transaction types.

• Use adaptive design to make the pilot projects more efficient.

• Target known weaknesses in the supply chain.

• Can be completed in time to provide useful information for trading partners.

• Evaluate human factors that could present implementation challenges.

• Simulate illegitimate products/transactions to test a process or system.

• Document costs to implement, use, and maintain piloted solutions.

Although the Agency intends to take these factors into consideration when establishing pilot projects, FDA also recognizes that a single pilot project is unlikely to satisfy every factor. Accordingly, FDA may establish a pilot project based on a request to participate in the program that does not satisfy one or more of the factors listed in this document.

Once the DSCSA Pilot Project Program is established, volunteers interested in participating in the DSCSA Pilot Project Program will be able to submit a request to participate by email to a designated FDA email address for the program. For a group of entities that partner to participate in a pilot project, only one submission and one point-of-contact for the proposed pilot project should be provided in the request to participate. Requests to participate may also consider other ideas for a pilot project that are not included in this notice.

The following information should be included in the request:

• Contact information for the submitter or point of contact, if different from the submitter (name, mailing address, phone number, email address).

• Names of all partnering entities that would participate in such pilot project (name of company and name of company representative).

• Type(s) of each partnering entity participating in the pilot project (partnering entities include authorized trading partners or other supply chain stakeholders).

• Number of employees for each partnering entity that would participate in such pilot project.

• Proposed start and finish dates of the pilot project.

• Commitment to start the pilot project within 4 months of receiving a letter of acceptance from FDA.

• Product(s) that will be used in the pilot project.

• Location(s) where pilot project will be performed (facility address).

• Description of the proposed pilot project, including, but not limited to, the goals, objectives, processes that will be studied, and evaluation methods.

The selected participants should be ready to start their pilot project within 4 months of receiving a letter of acceptance from FDA into the program. The duration of a pilot project should not exceed 6 months. FDA may consider a pilot project with a later start date or longer duration depending on the proposed goal(s) and objective(s). Each pilot project is expected to be completed within the proposed duration time period. This time period does not include an additional 30-days for completion of a final report (see section G. Proposed Reports).

Prior to launching a pilot project, FDA will hold a design strategy meeting with the selected pilot participant(s) to review the goal(s) and objective(s) for the pilot project and discuss the plans and other pertinent details. The participant(s) will be responsible for conducting their pilot project. A group of entities (members of the pharmaceutical distribution supply chain and other stakeholders, including trade associations) that partner to conduct a pilot project may be considered a single participant for purposes of the DSCSA Pilot Project Program. The partners in any pilot project that is selected into the program will be responsible for the funding and resources necessary to conduct the pilot project, and for determining each partner's role and responsibility in their pilot project. Pilot project participants will also be expected to submit reports on the progress of their pilot projects to FDA (see section G. Proposed Reports). Participants should evaluate their pilot project using the evaluation methods they identified during the pilot project design process.

Each pilot project is expected to be completed within the proposed duration time period, and participants will be expected to report progress to FDA while the pilot project is being conducted, in addition to a final report within 30 days of completing the pilot project. These reports will provide insight into the systems and process needed to comply with certain DSCSA requirements for enhance drug distribution security.

Each pilot project program participant is expected to provide reports on the progress of their pilot project to FDA. The progress reports are intended to capture the ongoing work during the pilot project, including but not limited to, current status or results, changes, challenges, and/or lessons learned. FDA will work with participants to develop an appropriate schedule for the submission of progress reports based on the design and duration of the pilot project. Because the duration of a pilot project should not exceed 6 months, the frequency of progress reports will vary based on the length of the individual pilot project. Pilot projects of relatively shorter duration may result in shorter time intervals between progress reports. For example, FDA may ask for monthly progress reports for a 6-month pilot project, however for a one-month pilot project, FDA may ask for weekly progress reports.

Within 30 business days of completing a pilot project, each participant is expected to provide a final report to FDA that captures the description, objectives, methods, evaluation, costs and key findings and lessons learned from the project. Timely completion of pilot project and the final report will support FDA's DSCSA implementation, including the statutory requirements under section 582(j) to consider information from pilot projects in the development of guidances for unit-level tracing and standards for the interoperable data exchange in section 582(h)(3) and (4) of the FD&C Act. FDA may also request that the participants meet with the Agency upon the completion of their pilot project or the final report.

To ensure that all supply chain members benefit from the information generated by the DSCSA Pilot Project Program, FDA intends to make the following information about each of the program's pilot projects available to the public in a final program report: (1) The names and industry sector(s) of the pilot project participant(s); (2) the pilot project's objectives and evaluation methods; (3) the duration of the pilot project; and (4) the key findings and lessons learned from the pilot project. The information related to the DSCSA Pilot Project Program and the final program report will be posted on FDA's Web site.

Any records generated by a participant for conducting a pilot project should be maintained as an entity would as in a normal course of business. For participants that involve partnering entities, the partnering entities can decide who is responsible for the records generated by conducting a pilot project. FDA recommends that the progress reports and the final report that participants create and submit to FDA for a pilot project should be maintained for at least 1 year after completion of the pilot project.

FDA does not intend to begin the proposed DSCSA Pilot Project Program or accept requests to participate in the program until OMB has approved the proposed collection of information described in this notice.

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from OMB for each collection of information that they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal Agencies to provide a 60-day notice in the Federal Register to solicit comment for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the proposed collection of information set forth in this document.

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

The estimated burden for the information collection associated with the DSCSA Pilot Project Program consists of the following:

Submitting a request to participate and reporting activities. FDA estimates that no more than 10 respondents (i.e., the submitter or point of contact identified on the request to participate) will submit a request to participate, and that it will take approximately 80 hours to complete a request and submit the request to FDA. FDA estimates that certain respondents will coordinate with partnering entities to submit a request to participate; the burden estimate associated with that coordination follows. FDA estimates that it will select no more than eight participants for the pilot program. The estimated total time for respondents to submit a request to participate in the program is 800 hours. Once the request to participate is accepted, the submitter is now a participant of the DSCSA Pilot Project Program. FDA estimates that the eight respondents (i.e., participants) will submit an average of five progress reports to FDA. Because the duration of a pilot project should not exceed 6 months, the frequency of progress reports will vary based on the length of the individual pilot project. Pilot projects of relatively shorter duration may result in shorter time intervals between progress reports so that the reports will be sufficient to capture progress while the pilot project is ongoing. FDA estimates that it will take approximately 8 hours to compile and submit each progress report. The estimated total number of hours for submitting progress reports would be 320 hours. After completion of their pilot project, each respondent will provide one final report to FDA. FDA estimates that it will take the eight respondents approximately 40 hours to submit a final report. The estimated total number of hours for submitting the final report is 320 hours. The total hours for the estimated reporting burden are 1,440 hours (table 2).

Recordkeeping activities. Recordkeeping activities include storing and maintaining records related to submitting a request to participate in the program and compiling reports. Respondents can use current record retention capabilities for electronic or paper storage to achieve these activities. FDA estimates that no more than 10 respondents will have recordkeeping activities related to program participation. FDA believes that it will take 0.5 hour/year to ensure that the documents related to submitting a request to participate in the program are retained properly for a minimum of 1 year after the pilot project is completed (as recommended by FDA). The resulting total to maintain the records related to submitting a request is 5 hours annually. For retaining records related to progress reports and the final report properly for a minimum of 1 year after the pilot project is completed (as recommended by FDA), FDA estimates that it will take approximately 0.5 hour/year. As noted previously, FDA estimates that the eight respondents will submit an average of five progress reports and one final report to FDA. The estimated total for maintaining progress reports and the final report is 20 and 4 hours, respectively. The total recordkeeping burden is estimated to be 29 hours (table 3).

In developing its burden estimate for records associated with the proposed pilot projects, FDA has taken account of existing industry practices for keeping records in the normal course of their business. In particular, FDA is aware of various supply chain stakeholders that have conducted pilot projects over the past few years, including some pilot projects that occurred before the DSCSA was enacted. These pilot projects covered topics related to serialization, movement of product data, aggregation of data, and verification of product identifiers of returned products. Members of the supply chain who conduct pilot projects of their own accord created associated records as a matter of usual and customary business practice. Therefore, the burden estimates for like records associated with the proposed FDA pilot project program are not included in the calculation of the recordkeeping burden (see 5 CFR 1320.3(b)(2)). FDA welcomes comments on the activities identified for conducting a pilot project that FDA considers to be usual and customary business practice.

Third-party disclosure activities. For those pilot projects that involve a participant composed of partnering entities in the program, FDA is taking into consideration the time that partnering entities will spend coordinating with each other in a pilot project. For the initial request to participate, FDA estimates that eight respondents will work with their respective partnering entities, and the average number of partnering entities will be two. FDA estimates that each respondent will spend 8 hours coordinating with each partnering entity. Thus, for eight respondents with an average of two partnering entities, the estimated total burden for coordinating with partnering entities related to the submission of the request to participate in the program is 128 hours. FDA estimates that seven respondents will need to coordinate with an average of two partnering entities to create progress reports and the final report to submit to FDA. Earlier, FDA estimated that an average of five progress reports will be submitted to FDA per respondent. If a respondent has an average of 2 partners, it will coordinate 10 times with those partners on the progress reports. FDA estimates that for each progress report, it will take 4 hours to coordinate with each partner, resulting in a total of 280 hours. FDA estimates that for each final report, it will take approximately 20 hours to coordinate with each partner, resulting in a total of 280 hours. The total estimation for third-party disclosure burden is 688 hours (table 4).

I. Background on Patient-Focused Drug Development

FDA has selected HAE as the focus of a public meeting under the Patient-Focused Drug Development initiative. This initiative involves obtaining a better understanding of patients' perspectives on the challenges posed by HAE and the impact of current therapies for this condition. The Patient-Focused Drug Development initiative is being conducted to fulfill FDA performance commitments that are part of the PDUFA reauthorization under Title I of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144). The full set of performance commitments is available on the FDA Web site at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.

FDA committed to obtaining the patient perspective on 20 disease areas during the course of PDUFA V. For each disease area, the Agency is conducting a public meeting to discuss the disease and its impact on patients' daily lives, the types of treatment benefits that matter most to patients, and patients' perspectives on the adequacy of the available therapies. These meetings will include participation of FDA review divisions, the relevant patient communities, and other interested stakeholders.

On April 11, 2013, FDA published a notice in the Federal Register (78 FR 21613), announcing the disease areas for meetings in fiscal years (FYs) 2013-2015, the first 3 years of the 5-year PDUFA V time frame. The Agency used several criteria outlined in that notice to develop the list of disease areas. FDA obtained public comment on the Agency's proposed criteria and potential disease areas through a public docket and a public meeting that was convened on October 25, 2012. In selecting the set of disease areas, FDA carefully considered the public comments received and the perspectives of review divisions at FDA. FDA initiated a second public process for determining the disease areas for FY 2016-2017 and published a notice in the Federal Register on July 2, 2015 (80 FR 38216), announcing the selection of eight disease areas. More information, including the list of disease areas and a general schedule of meetings, is posted at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm.

As part of the Patient-Focused Drug Development, FDA will obtain input on the symptoms and other aspects of the disease that matter most to patients with HAE. FDA also intends to seek patients' perspectives on current approaches to treating HAE. FDA expects that this information will come directly from patients, caregivers, and patient advocates.

HAE is a rare genetic disorder that affects less than 200,000 individuals in the United States. It is associated with episodic recurrent attacks of swelling of the body caused by abnormalities in a protein called C1-Esterase Inhibitor. Most cases occur because there is either not enough of the protein or because the protein does not work normally to help prevent swelling of the body.

In individuals with HAE, the swelling attacks may involve various areas of the body, including the gastrointestinal tract, arms, legs, face, or throat and larynx (voice box). Symptoms of this condition often begin during childhood but may also appear in adulthood. The swelling episodes are usually self-limited; may or may not be associated with any triggering factors; and in severe cases involving the larynx, may be life-threatening. If not recognized early and left untreated, swelling of the larynx, called laryngeal edema, may acutely restrict airflow to the lungs and could result in death. Gastrointestinal tract swellings are often associated with nausea, vomiting, and abdominal pain, which can be severe and require hospitalization. Several FDA-approved therapies affecting different biological mechanisms are available to treat or prevent acute attacks of HAE.

The questions that will be asked of patients and patient representatives at the meeting are listed in this section and organized by topic. The two main topics for discussion are: (1) Symptoms and impact on activities of daily life that matter most to patients; and (2) perspectives on current approaches to treatment. For each topic, a brief patient/caregiver panel discussion will begin the dialogue. This will be followed by a facilitated discussion, inviting comments from other patient and caregiver participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through electronic or written comments, which can be submitted to the Dockets Management Staff (see ADDRESSES). For context, please indicate if you are commenting as a patient with HAE or on behalf of a child or loved one.

(1) Of all of the symptoms that you experience because of your condition, which one of these symptoms has the most significant impact on your life? Examples may include nausea, vomiting, abdominal pain, swelling of extremities, facial swelling, tongue swelling, hoarseness or loss of voice, shortness of breath, and difficulty urinating.

(2) Are there specific activities that are important to you that you cannot do at all or as well as you would like because of your condition? Please describe, using specific examples. Examples may include: Participating in physical activities; and attending work or school and family or social activities, during or between attacks.

(3) How have your condition and its symptoms changed over time?

(4) What worries you most about your condition?

(1) What are you currently doing to treat your condition and its symptoms?

• What, if anything, are you doing to prevent acute HAE attacks? Examples may include treatments with prescription medicines; over-the-counter products; and other therapies, including non-drug therapies.

• What, if anything, do you self-administer for acute HAE attacks?

• If you give yourself medication for acute HAE attacks, which types of attacks, with respect to body location(s), are you comfortable treating yourself?

• What treatment has your health professional used for your acute HAE attacks? Examples may include prescription medicines; over-the-counter products; and other therapies, including non-drug therapies.

(2) How well do these treatments work for you?

(3) What are the most significant disadvantages or complications of your current treatments, and how do they affect your daily life?

(4) How has your treatment regimen changed over time and why?

(5) What aspects of your condition are not improved by your current treatment regimen?

(6) What treatment has had the most positive impact on your quality of life?

(7) Short of a complete cure for your condition, what specific things would you look for in an ideal treatment for your condition?

(8) If you had the opportunity to consider participating in a clinical trial studying experimental treatments, what things would you consider when deciding whether or not to participate?

Registration: If you wish to attend this meeting, visit https://www.eventbrite.com/e/patient-focused-drug-development-for-hereditary-angioedema-public-meeting-tickets-32300298061. Persons interested in attending this public meeting must register by August 10, 2017. If you are unable to attend the meeting in person, you can register to view a live Webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations due to a disability, please contact Barbara Kass or Loni Warren Henderson (see FOR FURTHER INFORMATION CONTACT) no later than September 18, 2017.

Requests for Oral Presentations: Patients and patient representatives who are interested in presenting comments as part of the initial panel discussions will be asked to indicate in their registration which topic(s) they wish to address. These patients and patient representatives also must send to [email protected] a brief summary of responses to the topic questions by August 3, 2017. Panelists will be notified of their selection approximately 7 days before the public meeting. We will try to accommodate all patients and patient representatives who wish to speak, either through the panel discussion or audience participation; however, the duration of comments may be limited by time constraints.

Transcripts: Please be advised that, as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the Internet at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm542320.htm.

I. Background

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) (Title II, Pub. L. 113-54) was signed into law. The DSCSA outlines critical steps to build an electronic, interoperable system by 2023 to identify and trace certain prescription drugs as they are distributed within the United States. This system will enhance FDA's ability to protect U.S. consumers from exposure to drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain. Section 582(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360eee-1(i)), which was added by the DSCSA, directs FDA to hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain and provide opportunities for comment from stakeholders.

FDA will hold public meetings on August 23, 2017, December 5 and 6, 2017, and February 28, 2018, on enhanced drug distribution security. The purpose of these public meetings is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA, and provide input on, strategies and issues related to the enhanced drug distribution security provisions of the DSCSA. These public meetings will focus on the following topics for discussion:

FDA may include additional discussion topics. Materials for each public meeting will be provided on FDA's Web site at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm 10 days before each public meeting.

To request registration for the public meetings, provide your information including name, company or organization, address, telephone number, and email address to FDA at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. Registration requests for each meeting should be received during the time periods specified in table 1. FDA is limiting attendance due to restricted space. In addition, FDA may limit the number of participants from each organization based on space limitations. FDA recommends that each organization determine who should register for the public meeting to represent his/her organization. This will help ensure that the meeting will have broad and varied representation, including across the pharmaceutical distribution supply chain. Registrants will receive confirmation of participation for their chosen meeting from FDA within 14 days of the date of each meeting. There is no registration fee for the public meetings. There will be no onsite registration. If registration reaches maximum capacity, FDA will post a notice closing registration for the meeting on FDA's Web site at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. If you need special accommodations due to a disability, please contact Daniel Bellingham (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the public meeting.

Portions of each public meeting will be recorded and webcast on the day of the meeting. Information for how to access the webcast will be available at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm within 7 days prior to each public meeting. The webcast will be conducted in listening mode only.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species—21 CFR part 516 OMB Control Number 0910-0620—Extension

The Minor Use and Minor Species Animal Health Act of 2004 (the MUMS Act) (Pub. L. 108-282) added section 572 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360ccc-1), which authorizes FDA to establish new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats). In enacting the MUMS Act, Congress sought to encourage the development of these new animal drugs. Congress recognized that the markets for drugs intended to treat these species, diseases, or conditions are so small that there are often insufficient economic incentives to motivate drug companies to develop data to support approvals. Further, Congress recognized that some minor species populations are too small or their management systems too diverse to make it practical to conduct traditional studies to demonstrate safety and effectiveness of animal drugs for such uses. As a result of these limitations, drug companies have generally not been willing or able to collect data to support legal marketing of drugs for these species, diseases, or conditions. Consequently, Congress enacted the MUMS Act to provide incentives to develop new animal drugs for minor species, while still ensuring appropriate safeguards for animal and human health. Section 572 of the FD&C Act provides for a public index listing of legally marketed unapproved new animal drugs for minor species. FDA regulations in part 516 (21 CFR part 516) specify, among other things, the criteria and procedures for requesting eligibility for indexing and for requesting addition to the index, as well as the annual reporting requirements for index holders. The administrative procedures and criteria for indexing a new animal drug for use in a minor species are set forth in 21 CFR 516.111 through 516.171. Section 516.165 sets forth the annual reporting requirements for index holders. FDA needs the information to determine: (1) The eligibility of a new animal drug for indexing; (2) that a qualified expert panel proposed to review certain information regarding the new animal drug meets the selection criteria listed in the regulations; (3) whether the Agency agrees with the recommendation of a qualified expert panel that a drug be added to the index; and (4) whether there may be grounds for removing a drug from the index.

In the Federal Register of December 21, 2016 (81 FR 93689), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment, which was outside the scope of the comment requests in the notice.

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

FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.

The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.

Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.

The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at www.msc.fema.gov for comparison.

I. Watershed-based studies:

II. Non-watershed-based studies:

The plats of survey of the following described lands are scheduled to be officially filed in the BLM, Oregon/Washington State Office, Portland, Oregon:

A person or party who wishes to protest one or more plats of survey identified above must file a written notice of protest with the Chief Cadastral Surveyor for Oregon/Washington, BLM. The notice of protest must identify the plat(s) of survey that the person or party wishes to protest. The notice of protest must be filed before the scheduled date of official filing for the plat(s) of survey being protested. Any notice of protest filed after the scheduled date of official filing will not be considered. A notice of protest is considered filed on the date it is received by the Chief Cadastral Surveyor for Oregon/Washington during regular business hours; if received after regular business hours, a notice of protest will be considered filed the next business day. A written statement of reasons in support of a protest, if not filed with the notice of protest, must be filed with the Chief Cadastral Surveyor for Oregon/Washington within 30 calendar days after the notice of protest is filed. If a notice of protest against a plat of survey is received prior to the scheduled date of official filing, the official filing of the plat of survey identified in the notice of protest will be stayed pending consideration of the protest. A plat of survey will not be officially filed until the next business day following dismissal or resolution of all protests of the plat.

Before including your address, phone number, email address, or other personal identifying information in a notice of protest or statement of reasons, you should be aware that the documents you submit—including your personal identifying information—may be made publicly available in their entirety at any time. While you can ask us to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the correction of an inventory of human remains and associated funerary objects under the control of the U.S. Department of the Interior, National Park Service, Lake Meredith National Recreation Area, Fritch, TX. The human remains and associated funerary objects were removed from sites in Potter County, TX.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the Superintendent, Lake Meredith National Recreation Area.

This notice corrects the minimum number of individuals and number of associated funerary objects published in a Notice of Inventory Completion in the Federal Register (66 FR 32845-32846, June 18, 2001). A re-evaluation of the inventory resulted in an increase in the minimum number of individuals removed from the Footprint site. The total number of associated funerary objects has been found to be incorrectly calculated, though all funerary objects are accounted for. Transfer of control of the items in this correction notice has not occurred.

In the Federal Register (66 FR 32845, June 18, 2001), column 2, paragraph 2, sentence 1 is corrected by substituting the following sentence:

In the Federal Register (66 FR 32845, June 18, 2001), column 3, paragraph 2, sentences 1 and 2 are corrected by substituting the following sentences:

Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Robert Maguire, Superintendent, Lake Meredith National Recreation Area, P.O. Box 1460, Fritch, TX 79036, telephone (806) 857-3151, email [email protected], by August 21, 2017. After that date, if no additional requestors have come forward, transfer of control of the human remains and associated funerary objects to the Kiowa Indian Tribe of Oklahoma, and the Wichita & Affiliated Tribes (Wichita, Keechi, Waco & Tawakonie), Oklahoma, may proceed.

Lake Meredith National Recreation Area is responsible for notifying the Caddo Nation of Oklahoma; Cheyenne and Arapaho Tribes, Oklahoma (previously listed as the Cheyenne-Arapaho Tribes of Oklahoma); Comanche Nation, Oklahoma; Kiowa Indian Tribe of Oklahoma; Pawnee Nation of Oklahoma; Wichita and Affiliated Tribes (Wichita, Keechi, Waco & Tawakonie), Oklahoma; and the Cohuiltecan Nation, an Indian group that is not federally recognized, that this notice has been published.

The Commission instituted this investigation on March 14, 2016, based on a complaint filed by Nautilus Hyosung Inc. of Seoul, Republic of Korea and Nautilus Hyosung America Inc. of Irving, Texas (collectively, “Nautilus”). 81 FR 13149 (Mar. 14, 2016). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain automated teller machines, ATM modules, components thereof, and products containing the same by reason of infringement of one or more of claims 1-3 and 5 of U.S. Patent No. 7,891,551 (“the '551 patent”); claims 1 and 6 of U.S. Patent No. 7,950,655 (“the '655 patent”); claims 1-4, 6, and 7 of U.S. Patent No. 8,152,165 (“the '165 patent”); and claims 1-3, 6, 8, and 9 of U.S. Patent No. 8,523,235 (“the '235 patent”). Id. The notice of investigation named the following respondents: Diebold, Incorporated of North Canton, Ohio and Diebold Self-Service Systems of North Canton, Ohio (collectively, “Diebold”). Id. The Office of Unfair Import Investigations is not a party to the investigation.

On June 30, 2016, the ALJ granted a motion by Nautilus to terminate the investigation as to all asserted claims of the '551 patent and the '165 patent. See Order No. 11 (June 30, 2016). The Commission determined not to review Order No. 11. See Notice of non-review (July 27, 2016).

On July 21, 2016, the ALJ granted a motion by Nautilus to terminate the investigation as to all asserted claims of the '655 patent. See Order No. 17 (July 21, 2016). The Commission determined not to review Order No. 17. See Notice of non-review (Aug. 16, 2016).

On February 6, 2017, the ALJ granted a motion to amend the complaint and notice of investigation to reflect a corporate name change of Diebold, Incorporated to Diebold Nixdorf, Incorporated. See Order No. 32 (Feb. 6, 2017). The Commission determined not to review Order No. 32.

On March 13, 2017, the ALJ issued his final ID, finding a violation of section 337 by Diebold in connection with claims 1-3, 6, 8, and 9 of the '235 patent. Specifically, the ID finds that the Commission has subject matter jurisdiction, in rem jurisdiction over the accused products, and in personam jurisdiction over Diebold. ID at 9, 104-107. The ID finds that Nautilus satisfied the importation requirement of section 337 (19 U.S.C. 1337(a)(1)(B)). Id. The ID finds that the accused products directly infringe asserted claims 1-3, 6, 8, and 9 of the '235 patent, and that Diebold contributorily infringes those claims. See ID at 111-160, 163-172. The ID, however, finds that Diebold failed to establish that the asserted claims of the '235 patent are invalid for indefiniteness, anticipation, or obviousness. ID at 232-311. Finally, the ID finds that Nautilus established the existence of a domestic industry that practices the asserted patent under 19 U.S.C. 1337(a)(2). See ID at 212.

The ALJ's recommended determination on remedy and bonding issued concurrently with the final ID. RD at 330-40. The ALJ recommends that in the event the Commission finds a violation of section 337, the Commission should issue a limited exclusion order prohibiting the importation of Diebold's automated teller machines, ATM modules, components thereof, and products containing the same that infringe the asserted claims of the '235 patent. RD at 335. The ALJ also recommends issuance of cease and desist orders based on the presence of Diebold's commercially significant inventory in the United States. RD at 338. With respect to the amount of bond that should be posted during the period of Presidential review, the ALJ recommends that the Commission set a bond in the amount of zero (i.e., no bond) during the period of Presidential review because Nautilus “did not attempt any type of price comparison.” RD at 341.

On March 27, 2017, Diebold filed a petition for review of the ID. On April 4, 2017, Nautilus filed a response to Diebold's petition for review.

On May 15, 2017, the Commission determined to review the final ID in part and requested the parties to brief certain issues. See 82 FR 23064-66 (May 19, 2017). On May 25, 2017, the parties filed submissions to the Commission's question and on remedy, the public interest, and bonding. On June 1, 2017, the parties filed reply submissions.

Having examined the record of this investigation, including the final ID, and the parties' submissions, the Commission has determined to (1) affirm the ALJ's finding that the accused products and domestic industry products satisfy the claim limitation “horizontally transfer sheets along the main transfer path” and (2) reverse the ALJ's finding that certain prior art does not disclose the preamble to claim 1: “Automatic depositing apparatus for automatically depositing a bundle of banknotes including at least one cheque.” The Commission adopts the ID's findings to the extent they are not inconsistent with the Commission opinion issued herewith.

Having found a violation of section 337 in this investigation, the Commission has determined that the appropriate form of relief is: (1) A limited exclusion order prohibiting the unlicensed entry of automated teller machines, ATM modules, components thereof, and products containing the same that infringe one or more of claims 1-3, 6, 8, and 9 of the '235 patent that are manufactured on or behalf of, or imported on or behalf of Diebold or any of their affiliated companies, parents, subsidiaries, or other related business entities, or their successors or assigns, except under license of the patent owner or as provided by law, and except for service or repair articles imported for use in servicing or repairing automated teller machines, ATM modules, components thereof, and products containing the same, for identical articles that were imported as of the date of this Order. This exception does not permit the importation of automated teller machines to replace such articles that were previously imported; and (2) cease and desist orders prohibiting Diebold from conducting any of the following activities in the United States: Importing, selling, marketing, advertising, distributing, transferring (except for exportation), and soliciting U.S. agents or distributors for, automated teller machines, ATM modules, components thereof, and products containing the same covered by one or more of claims 1-3, 6, 8, and 9 of the '235 patent. The proposed cease and desist orders include the following exemptions: if in a written instrument, the owner of the patents authorizes or licenses such specific conduct, such specific conduct is related to the importation or sale of covered products by or for the United States, or such specific conduct is related to service or repair articles imported for use in servicing or repairing automated teller machines, ATM modules, components thereof, and products containing the same, for identical articles that were imported as of the date of this Order. This exception does not permit the importation of automated teller machines to replace such articles that were previously imported.

The Commission has also determined that the public interest factors enumerated in section 337(d) and (f) (19 U.S.C. 1337(d) and (f)) do not preclude issuance of the limited exclusion order or cease and desist orders. Finally, the Commission has determined that a bond in the amount of zero is required to permit temporary importation during the period of Presidential review (19 U.S.C. 1337(j)) of automated teller machines, ATM modules, components thereof, and products containing the same that are subject to the remedial orders. The Commission's orders and opinion were delivered to the President and to the United States Trade Representative on the day of their issuance.

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

Background.—These investigations are being instituted, pursuant to sections 703(a) and 733(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a) and 1673b(a)), in response to a petition filed on July 13, 2017, by the Cast Iron Soil Pipe Institute, Mundelein, IL.

For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).

Participation in the investigations and public service list.—Persons (other than petitioners) wishing to participate in the investigations as parties must file an entry of appearance with the Secretary to the Commission, as provided in sections 201.11 and 207.10 of the Commission's rules, not later than seven days after publication of this notice in the Federal Register. Industrial users and (if the merchandise under investigation is sold at the retail level) representative consumer organizations have the right to appear as parties in Commission antidumping duty and countervailing duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to these investigations upon the expiration of the period for filing entries of appearance.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list.—Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI gathered in these investigations available to authorized applicants representing interested parties (as defined in 19 U.S.C. 1677(9)) who are parties to the investigations under the APO issued in the investigations, provided that the application is made not later than seven days after the publication of this notice in the Federal Register. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Conference.—The Commission's Director of Investigations has scheduled a conference in connection with these investigations for 9:30 a.m. on Thursday, August 3, 2017, at the U.S. International Trade Commission Building, 500 E Street SW., Washington, DC. Requests to appear at the conference should be emailed to [email protected] and [email protected] (DO NOT FILE ON EDIS) on or before August 1, 2017. Parties in support of the imposition of countervailing and antidumping duties in these investigations and parties in opposition to the imposition of such duties will each be collectively allocated one hour within which to make an oral presentation at the conference. A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the conference.

Written submissions.—As provided in sections 201.8 and 207.15 of the Commission's rules, any person may submit to the Commission on or before August 8, 2017, a written brief containing information and arguments pertinent to the subject matter of the investigations. Parties may file written testimony in connection with their presentation at the conference. All written submissions must conform with the provisions of section 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on E-Filing, available on the Commission's Web site at https://www.usitc.gov/secretary/documents/handbook_on_filing_procedures.pdf, elaborates upon the Commission's rules with respect to electronic filing.

In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.

Certification.—Pursuant to section 207.3 of the Commission's rules, any person submitting information to the Commission in connection with these investigations must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will acknowledge that any information that it submits to the Commission during these investigations may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of these or related investigations or reviews, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

(1) Type of Information Collection: Revision of a currently approved collection.

(2) Title of the Form/Collection: Request for Registration Under the Gambling Devices Act of 1962.

(3) Agency form number, if any, and the applicable component of the Department sponsoring the collection: Agency form number: DOJ\CRM\OEO\GDR-1. Sponsoring component: Department of Justice, Criminal Division.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. Other: Not-for-profit institutions, individuals or households, and State, Local or Tribal Government. The form can be used by any entity required to register under the Gambling Devices Act of 1962 (15 U.S.C. 1171-1178).

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: It is estimated that 7,800 respondents will complete each form within approximately 5 minutes.

(6) An estimate of the total public burden (in hours) associated with the collection: There are an estimated 650 total annual burden hours associated with this collection.

If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530.

GRS Transmittal 28 announces changes to the General Records Schedules (GRS) made since NARA published GRS Transmittal 27 in January 2017. The GRS provide mandatory disposition instructions for records common to several or all Federal agencies. We are nearing the end of our five-year plan to completely rewrite the GRS. With Transmittal 28, 92% of old items are now superseded.

Transmittal 28 includes only schedules newly issued or updated since the last transmittal, those schedules' associated new-to-old crosswalks and FAQs, an update to the FAQs for GRS 6.1 (but not schedule 6.1 itself, which remains unchanged), and an update to the FAQs about Flexible Dispositions. This means that many current GRS schedules are not included in this Transmittal.

This means that many current GRS schedules are not included in this Transmittal. You can find all schedules (in Word, PDF, and CSV formats), crosswalks and FAQs for all schedules, and FAQs about the whole GRS at http://www.archives.gov/records-mgmt/grs.html. At the same location, you can also find the entire GRS (just schedules—no crosswalks or FAQs) in a single document (https: //www.archives.gov/files/records-mgmt/grs/trs28-sch-only.pdf).

GRS Transmittal 28 publishes nine new schedules:

It also publishes a new item in one schedule: GRS 1.1, Financial Management and Reporting Records (see question 3). In addition, it supersedes in its entirety GRS 4.3, Input Records, Output Records, and Electronic Copies (see question 4).

This transmittal also includes an updated table of contents that shows some alterations to the previously published schedule titles. Research led us to conclude that it is not possible at this time to write a GRS for legal records, so the number assigned to that anticipated schedule—GRS 6.3—has been assigned instead to Information Technology Records. A new schedule for rulemaking records is GRS 6.6. Both 6.3 and 6.6 should be published in Transmittal 29.

This transmittal publishes a revised Frequently Asked Questions (FAQs) for GRS 6.1. The revisions include adding new GRS citations where appropriate; removing unnecessary references to some CFR citations in Q3; clarifying Q4 text; clarifying culling in Q22; and clarifying how to report calendars, appointments, tasks, chat transcripts, and other communications on NA-1005 in Q27. Finally, this transmittal publishes updated FAQs on Flexible Dispositions, adding a new Q6 about batching records for disposal.

We added one new item (080) to cover administrative claims made by or against the Federal Government. We also added three new questions to the GRS 1.1 FAQs concerning travel receipts scanned into e-systems (question 9), audit records (question 16) and use of item 080 (question 18).

We deleted GRS 4.3, Input Records, Output Records, and Electronic Copies, because we have superseded its seven items with two new items in GRS 5.1 and 5.2. We superseded GRS 4.3, item 040, Non-recordkeeping copies of electronic records, with the closely parallel and identically titled GRS 5.1, item 020. We moved it to 5.1 to place it in context with other common office records. The new item is media-neutral. We superseded GRS 4.3, items 010, 011, 020, 030, 031, and 040 with GRS 5.2, item 020, Intermediary records. We found we could gather records of various formats from various sources into a single unit by recognizing this unifying trait: They are stopping points en route to a final record scheduled elsewhere.

Many old GRS items are superseded by new GRS items. A few old items, however, have outlived their usefulness and cannot be crosswalked to new items. The table below lists old items newly rescinded by GRS Transmittal 28.

Rescinded items are shown in context of their schedules in the old-to-new crosswalk.

When you send records to an FRC for storage, you should cite the records' legal authority—the “DAA” number—in the “Disposition Authority” column of the table. For informational purposes, please include schedule and item number. For example, “DAA-GRS-2013-0001-0004 (GRS 4.3, item 020).”

NARA regulations (36 CFR 1226.12(a)) require agencies to disseminate GRS changes within six months of receipt.

Per 36 CFR 1227.12(a)(1), you must follow GRS dispositions that state they must be followed without exception.

Per 36 CFR 1227.12(a)(3), if you have an existing schedule that differs from a new GRS item that does not require being followed without exception, and you wish to continue using your agency-specific authority rather than the GRS authority, you must notify NARA within 120 days of the date of this transmittal.

If you do not have an already existing agency-specific authority but wish to apply a retention period that differs from that specified in the GRS, you must submit a records schedule to NARA for approval via the Electronic Records Archives.

You can download the complete current GRS, in PDF format, from NARA's Web site at http://www.archives.gov/records-mgmt/grs.html.

Writing and maintaining the GRS is the responsibility of the GRS Team. You may contact the team with general questions about the GRS at [email protected] This team is part of Records Management Services in the National Records Management Program of the Office of the Chief Records Officer at NARA.

Your agency's records officer may contact the NARA appraiser or records analyst with whom your agency normally works for support in carrying out this transmittal. A list of the appraisal and scheduling work group and regional contacts is on the NARA Web site at http://www.archives.gov/records-mgmt/appraisal/index.html.

Pursuant to the Paperwork Reduction Act of 1995 (Public Law 104-13), NARA invites the public and other Federal agencies to comment on proposed information collections. The comments and suggestions should address one or more of the following points: (a) Whether the proposed information collection is necessary for NARA to properly perform its functions; (b) our estimate of the burden of the proposed information collection and its accuracy; (c) ways we could enhance the quality, utility, and clarity of the information we collect; (d) ways we could minimize the burden on respondents of collecting the information, including through information technology; and (e) whether this collection affects small businesses. We will summarize any comments you submit and include the summary in our request for OMB approval. All comments will become a matter of public record. In this notice, we solicit comments concerning the following information collection:

Title: National Archives Public Vaults Survey.

OMB number: 3095-0062.

Agency form number: N/A.

Type of review: Regular.

Affected public: Individuals who visit the National Archives' Public Vaults in Washington, DC.

Estimated number of respondents: 1,050.

Estimated time per response: 10 minutes.

Frequency of response: On occasion (when an individual visits the Public Vaults in Washington, DC).

Estimated total annual burden hours: 175 hours.

Abstract: The information collection is prescribed by EO 12862 issued September 11, 1993, which requires Federal agencies to survey their customers concerning customer service. The general purpose of this voluntary data collection is to measure customer satisfaction with the Public Vaults and identify additional opportunities for improving customers' experience.

By letter dated April 28, 2016, as supplemented on July 20, August 19, August 31, September 27, October 7, November 16, December 16, December 22, 2016, and March 16, 2017, WCS submitted an application for a specific license pursuant to part 72 of title 10 of the Code of Federal Regulations (10 CFR), “Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste.” In its letter, WCS requested authorization to store up to 5,000 metric tons of uranium for a period of 40 years in a CISF.

In addition, by letter dated July 21, 2016, WCS requested that the NRC initiate its environmental impact statement (EIS) process for the WCS CISF license application as soon as practicable. By letter dated October 7, 2016, the NRC informed WCS of its decision to start the EIS process in advance of making a decision on docketing the application. On November 14, 2016 (81 FR 79531), the NRC published a notice in the Federal Register announcing its intent to prepare an EIS and to open the scoping period for the EIS.

By letter dated January 26, 2017, the NRC informed WCS of its decision to accept the application and proceed with the technical review. Subsequently, on January 30, 2017 (82 FR 8773), the NRC published a notice in the Federal Register announcing the acceptance for docketing and opportunity to request a hearing and to petition for leave to intervene of the WCS application.

By letter dated March 16, 2017, WCS submitted Revision 1 to its license application. By letter dated April 18, 2017, WCS requested that the NRC temporarily suspend all safety and environmental review activities as well as public participation activities associated with WCS' license application. On April 19, 2017, WCS and the NRC staff jointly requested that the Commission withdraw the hearing notice, explaining that a new Federal Register notice to provide a fresh opportunity for interested persons to request a hearing would be issued if review of the application resumes. On May 10, 2017, the NRC staff granted WCS' request to temporarily suspend all safety and environmental review activities as well as public participation activities associated with its license application. On June 22, 2017, the Commission granted WCS's and the NRC staff's request and further directed that the NRC staff to publish a Federal Register notice withdrawing the opportunity to request a hearing on this license application and directed the NRC staff to publish a new notice of opportunity to request a hearing in the Federal Register if WCS requests that the NRC staff resume its review of WCS's application.

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.