I. Abstract

In support of its development objectives and aim for self-reliance, USAID sponsors U.S.-based education and capacity strengthening programs for host country nationals, referred to as the Exchange Visitor (EV) Program. Exchange Visitors travel to the United States under a J-1 visa.

The USAID Bureau of Economic Growth, Education, and Environment, Office of Education (E3/ED) manages the Agency's J-1 visa designation and ensures the Agency's compliance with Department of Homeland Security (DHS) and Department of State (DoS) regulations contained in 22 CFR 62.1-90. The Office of Education collects Exchange Visitor data from USAID's overseas Missions and Implementers, and manages the Agency's EV approval process. USAID relies on data to fulfill a mandatory Agency function of providing the DHS, including Immigration and Customs Enforcement (ICE), and the DoS with information about host country nationals who study in the U.S. under USAID sponsorship. The referenced bio data forms are used to collect such data. The forms include a section for collecting data about the individuals': (a) Suitability for USAID sponsorship; (b) agreed upon commitment to return to the home country and use their newly acquired skills to help solve local development problems; (c) agreement to reimburse program costs if they fail to comply with USAID's and other U.S. Government Agencies Policy requirements; and (d) certification of dependents who accompany or visit EVs during their study in the U.S. USAID/Washington and Missions also use the data collected through these forms to monitor program performance and program completion, along with other management interventions. The main purpose is to enable the transfer of effective education and capacity interventions to host country governments while supporting U.S. national interests. The secondary purpose is to improve future planning and use of USAID resources. These objectives are aligned with Congressional requirements under the Foreign Assistance Act of 1961, as amended. They are also closely aligned with objectives of the Journey to Self-Reliance for countries where USAID operates.

Electronic.

Title: USAID program compliance and management information, including Conditions of Sponsorship for U.S. Activities; Exchange Visitors Biographical Data; Dependent Certification; Cost Repayment; and Conditions of Sponsorship for Third Country Training forms.

OMB Number: Not assigned.

Expiration Date: Three years from issuance date.

Type of Request: Forms Renewal.

Affected Public: Host country nationals whose study in the U.S. is funded by USAID.

Estimated Total Number of Affected Individual per Year: 1,500-2,000

Estimated Total Annual Burden: Less than 15 minutes per form, per person. Most forms are prepared only once at the inception of the EV's program and the form remains valid for the duration of the program. Note: The use of forms is situational, not all forms apply to every individual. For example, the Cost Repayment Form applies only to the small number of individuals who overstay their authorized time in the U.S. after completing their studies.

Comments are invited on: (1) Whether the proposed collection of information is necessary for the compliance and management of USAID-funded Exchange Visitor program; (2) the accuracy of USAID's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. The comments will also become a matter of public record.

When submitting comments or requesting information, please include the information request collection title for reference.

OMB No. ###

Information Collection Request Title: U.S. Government Feed the Future Initiative Audience Segmentation Survey.

Abstract: The “USAID National Survey of U.S. Adults about Global Food Security” is a 20-minute nationally-representative survey of U.S. adults conducted for USAID by a professional research company. The purpose of the research is to inform the communications strategy, education, and outreach efforts for the Feed the Future Initiative. The research contractor will gather information and feedback by telephone and online from 1,000 voluntary adult participants using a nationally representative survey sampling method. Using the information collected in the survey, the research consultant will measure opinions about global food security and hunger, program awareness, reasons for improving global food security and reducing hunger, questions and concerns about the initiative, as well as consumer segments and insights for each segment to more effectively hone communication, education and outreach efforts.

Likely Respondents: This study includes one respondent group, U.S. adults 18 years and older living in the fifty states and the District of Columbia.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions and survey screening criteria; to develop, acquire, install and utilize technology and systems for the purpose of providing opinions and feedback; to be able to respond to and complete the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated are summarized in the table below.

Estimated Annualized Burden Hours Form name Number of

USAID specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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

This agency information collection previously published at 84 FR 28000.

• Agency: U.S. Agency for International Development (USAID).

• Title of Information Collection: Partner Information Form.

• OMB Control Number: 0412-0577.

• Type of Request: Revision of a Currently Approved Collection.

• Originating Office: Bureau for Management, Office of Management Policy, Budget, and Performance (M/MPBP).

• Form Number: AID 500-13.

• Respondents: Potential awardees and subawardees.

• Estimated Annual Number of Responses: 5,800.

• Average Time per Response: 1 hour 30 minutes.

• Total Estimated Burden Time: 8,700 hours.

• Frequency: On occasion.

• Obligation to Respond: Voluntary.

USAID solicits public comments on the following:

• Evaluate whether the proposed information collection is necessary for the proper functions of the Agency.

• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.

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

• Minimize the reporting burden on respondents, including the use of automated collection techniques or other forms of information technology.

USAID collects information from individuals and organizations to conduct screening to help ensure that USAID funds, USAID-funded activities, or other resources will not be used to provide support to entities or individuals deemed to be a risk to national security.

USAID vets prospective awardees seeking funding from USAID to mitigate the risk that such funds might benefit entities or individuals who present a national security risk. To conduct vetting, USAID collects information from prospective awardees and subawardees regarding their directors, officers, and/or key employees. The information collected is compared to information gathered from commercial, public, and U.S. government databases to determine the risk that the applying organization or individual might use Agency funds or programs in a way that presents a threat to national security.

USAID collects information via mail or electronic submission.

The Federal Government's patent rights in this invention are assigned to the United States of America, as represented by the Secretary of Agriculture. It is in the public interest to so license this invention as Agrosource, Inc. of Tequesta, Florida has submitted a complete and sufficient application for a license. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published Notice, the Agricultural Research Service receives written evidence and argument which establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Members of the public can listen to the discussion. This meeting is available to the public through the above listed number, please use the call in number and the conference ID in order to fully access the meeting.

An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Advisory Committee Management Unit, U.S. Commission on Civil Rights, 230 S Dearborn St., Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324 or emailed to David Barreras at dbarreras@usccr.gov. Persons who desire additional information may contact the Advisory Committee Management Unit at (312) 353-8311.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Kansas Advisory Committee link ( http://www.facadatabase.gov/committee/meetings.aspx?cid=249 ). Click on “meeting details” and then “documents” to download. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-877-260-1479 and conference call ID number: 1929821. Please be advised that before placing them into the conference call, the conference call operator may 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 telephone number herein.

Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call number: 1-877-260-1479 and conference call ID number: 1929821.

Members of the public are invited to make statements during the Public Comments section of the meeting or to submit written comments. The comments must be received in the regional office by Monday, July 8, 2019. Comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425 or emailed to Evelyn Bohor at ero@usccr.gov. 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://gsageo.force.com/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzlKAAQ. Please 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 meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone numbers, email or street address.

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstances of the federal government shutdown.

Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-888-882-4478 and conference call ID number: 1071218. Please be advised that before being placed 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 1-888-364-3109 and providing the operator with the toll-free conference call-in number: 1-888-882-4478 and conference call ID number: 1071218.

Members of the public are invited to make statements during the Public Comments section of the Agenda. They are also invited to submit written comments, which must be received in the regional office approximately 30 days after the 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 or emailed to Corrine Sanders at ero@usccr.gov. 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://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzmCAAQ; 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 website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstances of the federal government shutdown.

The MEP Advisory Board is authorized under Section 3003(d) of the America COMPETES Act (Pub. L. 110-69), as amended by the American Innovation and Competitiveness Act, Public Law 114-329 sec. 501 (2017), and codified at 15 U.S.C. 278k(m), in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App. The Hollings Manufacturing Extension Partnership Program (Program) is a unique program, consisting of Centers in all 50 states and Puerto Rico with partnerships at the state, federal, and local levels. By statute, the MEP Advisory Board provides the NIST Director with: (1) Advice on the activities, plans, and policies of the Program; (2) assessments of the soundness of the plans and strategies of the Program; and (3) assessments of current performance against the plans of the Program.

Background information on the MEP Advisory Board is available at http://www.nist.gov/mep/about/advisory-board.cfm .

Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the MEP Advisory Board will hold an open meeting on Sunday, September 15, 2019, from 8:30 a.m. to 3:30 p.m. Eastern Time. The meeting agenda will include an update on the MEP programmatic operations, as well as provide guidance and advice on current activities related to the MEP National Network TM 2017-2022 Strategic Plan. The MEP Advisory Board will provide input to NIST on supply chain development with an emphasis on defense suppliers, in order to strengthen the defense industrial base. The final agenda will be posted on the MEP Advisory Board website at http://www.nist.gov/mep/about/advisory-board.cfm .

Individuals and representatives of organizations who would like to offer comments and suggestions related to the MEP Advisory Board's business are invited to request a place on the agenda. Approximately 15 minutes will be reserved for public comments at the end of the meeting. Speaking times will be assigned on a first-come, first-served basis. The amount of time per speaker will be determined by the number of requests received but is likely to be no more than three to five minutes each. Requests must be received in writing by September 6, 2019 to be considered. The exact time for public comments will be included in the final agenda that will be posted on the MEP Advisory Board website at http://www.nist.gov/mep/about/advisory-board.cfm . Questions from the public will not be considered during this period. Speakers who wish to expand upon their oral statements, those who wished to speak but could not be accommodated on the agenda, or those who are/were unable to attend in person are invited to submit written statements to the MEP Advisory Board, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 4800, Gaithersburg, Maryland 20899-4800, via fax at (301) 963-6556, or electronically by email to cheryl.gendron@nist.gov .

Admittance Instructions: Anyone wishing to attend the MEP Advisory Board meeting must submit their name, email address and phone number to Cheryl Gendron ( Cheryl.Gendron@nist.gov or 301-975-2785) no later than Friday, September 6, 2019, 5:00 p.m. Eastern Time.

The proposed revision of the standard has been developed and is being processed in accordance with Department of Commerce provisions in 15 CFR part 10, Procedures for the Development of Voluntary Product Standards, as amended (published June 20, 1986). The Committee for PS 1 is responsible for maintaining, revising, and interpreting the standard, and is comprised of producers, distributors, users, and others with an interest in the standard. Committee members voted on the revision and approved. The Committee then submitted a report to NIST along with the voting results and the draft revised standard. NIST has determined that the revised standard should be issued for public comment.

Voluntary Product Standard PS 1-09 establishes requirements for the principal types and grades of structural plywood and provides a basis for common understanding among producers, distributors, and users of the product. The standard covers the wood species, veneer grading, adhesive bonds, panel construction and workmanship, dimensions and tolerances, marking, moisture content, and packaging of structural plywood intended for construction and industrial uses. After conducting a review of the current standard, PS 1-09, the Committee for PS 1 determined that updates were needed to reflect current industry practices and developed the proposed revision to the standard. The proposed revision includes the following changes: editorial corrections, new and revised definitions, and updated references. A complete list of proposed changes can be found at https://www.nist.gov/standardsgov/voluntary-product-standards-program .

Written comments should be submitted in accordance with the DATES and ADDRESSES sections of this notice. Attachments will be accepted in plain text, Microsoft Word, or Adobe PDF formats. Comments containing references, studies, research, and other empirical data that are not widely published should include copies or electronic links of the referenced materials. All submissions, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. NIST reserves the right to publish comments publicly, unedited and in their entirety. Sensitive personal information, such as account numbers or Social Security numbers, or names of other individuals, should not be included. Submissions will not be edited to remove any identifying or contact information. Do not submit confidential business information, or otherwise sensitive or protected information. Comments that contain profanity, vulgarity, threats, or other inappropriate language or content will not be considered. The Committee for PS 1 and NIST will consider all other relevant comments received and may revise the standard accordingly.

Agenda Friday, September 20, 2019

The Council is hosting a webinar for the presentation of the draft Environmental Impact Statement for the BSAI Halibut abundance-based management (ABM) prohibited species catch limits. The purpose of the webinar is to provide the public with an understanding of the contents of the analysis and provide an opportunity for clarifying questions with the analysts. This will provide the public with a greater understanding of the analysis and help facilitate written public comments to the Council prior to the written comment deadline for the October Council meeting. Analysts will provide a presentation on the analysis, which will be web broadcast via Adobe Connect. Following the presentation, there will be a question and answer period via online submissions of the questions through meetings.npfmc.org/Meeting/Details/905, as well as in-person for public attending the meeting.

The Agenda is subject to change, and the latest version will be posted at meetings.npfmc.org/Meeting/Details/905 prior to the meeting, along with meeting materials.

Public comment will be limited to written comments only and should be submitted electronically to meetings.npfmc.org/Meeting/Details/905.

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

This notice announces our review of the status of the endangered Eastern Atlantic DPS, endangered Eastern Pacific DPS, threatened Central & Southwest Atlantic DPS, and threatened Indo-West Pacific DPS of scalloped hammerhead shark. Section 4(c)(2)(A) of the ESA requires that we conduct a review of listed species at least once every five years. The regulations in 50 CFR 424.21 require that we publish a notice in the Federal Register announcing species currently under active review. On the basis of such reviews under section 4(c)(2)(B), we determine whether a species should be delisted or reclassified from endangered to threatened or from threatened to endangered. As described by the regulations in 50 CFR 424.11(d), delisting a species must be supported by the best scientific and commercial data available and only considered if such data substantiates that the species is neither endangered nor threatened for one or more of the following reasons: (1) The species is considered extinct; (2) the species is considered to be recovered; or (3) the original data available when the species was listed, or the interpretation of such data, were in error. Any change in Federal classification would require a separate rulemaking process. The scalloped hammerhead shark DPSs were listed under the ESA on July 3, 2014 (79 FR 38214).

Background information on the scalloped hammerhead shark DPSs is available on the NMFS website at: https://www.fisheries.noaa.gov/species/scalloped-hammerhead-shark .

Section 4(a)(1) of the ESA requires that we determine whether a species is endangered or threatened based on one or more of the five following factors: (1) The present or threatened destruction, modification, or curtailment of its habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) the inadequacy of existing regulatory mechanisms; or (5) other natural or manmade factors affecting its continued existence. Section 4(b) also requires that our determination be made on the basis of the best scientific and commercial data available after conducting a review of the status of the species and after taking into account those efforts, if any, being made by any State or foreign nation, to protect such species.

To ensure that the 5-year review is complete and based on the best available scientific and commercial data, we are soliciting new information from the public, governmental agencies, Tribes, the scientific community, industry, environmental entities, and any other interested parties concerning the status of the listed scalloped hammerhead DPSs. Categories of requested information include: (1) Species biology including, but not limited to, population trends, distribution, abundance, demographics, and genetics; (2) habitat conditions including, but not limited to, amount, distribution, and important features for conservation; (3) status and trends of threats; (4) conservation measures that have been implemented that benefit the species, including monitoring data demonstrating effectiveness of such measures; (5) need for additional conservation measures; and (6) other new information, data, or corrections including, but not limited to, taxonomic or nomenclatural changes and improved analytical methods for evaluating extinction risk.

If you wish to provide information for the 5-year reviews, you may submit your information and materials electronically or via mail (see ADDRESSES section). We request that all information be accompanied by supporting documentation such as maps, bibliographic references, or reprints of pertinent publications. We also would appreciate the submitter's name, address, and any association, institution, or business that the person represents; however, anonymous submissions will also be accepted.

In accordance with the Western and Central Pacific Fisheries Convention Implementation Act (16 U.S.C. 6901 et seq. ), the Permanent Advisory Committee, or PAC, has been formed to advise the U.S. Commissioners to the WCPFC. The PAC is composed of: (i) Not less than 15 nor more than 20 individuals appointed by the Secretary of Commerce in consultation with the U.S. Commissioners to the WCPFC; (ii) the chair of the Western Pacific Fishery Management Council's Advisory Committee (or the chair's designee); and (iii) officials from the fisheries management authorities of American Samoa, Guam, and the Northern Mariana Islands (or their designees). The PAC supports the work of the U.S. National Section to the WCPFC in an advisory capacity. The U.S. National Section is made up of the U.S. Commissioners and the Department of State. NMFS Pacific Islands Regional Office provides administrative and technical support to the PAC in cooperation with the Department of State. More information on the WCPFC, established under the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean, can be found on the WCPFC website: http://www.wcpfc.int .

The PAC meeting topics may include the following: (1) Outcomes of the 2018 Annual Meeting and 2019 sessions of the WCPFC Scientific Committee, Northern Committee, and Technical and Compliance Committee; (2) conservation and management measures for bigeye tuna, yellowfin tuna, skipjack tuna and other species for 2019 and beyond; (3) potential U.S. proposals to WCPFC16; (4) input and advice from the PAC on issues that may arise at WCPFC16; (5) potential proposals from other WCPFC members; and (6) other issues.

The meeting location is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Emily Reynolds at 808-725-5039 by September 12, 2019.

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

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

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

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

Deletions

On 8/2/2019, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.

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

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

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

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

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

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

CPSC seeks to renew the following currently approved collection of information:

Title: Third Party Conformity Assessment Body Registration Form.

OMB Number: 3041-0143.

Type of Review: Renewal of collection.

Frequency of Response: On occasion.

Affected Public: Third party conformity assessment bodies seeking acceptance of accreditation or continuing accreditation.

General Description of Collection: The Consumer Product Safety Improvement Act of 2008 (CPSIA) requires third party testing be conducted by a third party conformity assessment body for any children's product, that is subject to a children's product safety rule, before importing for consumption or warehousing or distributing in commerce. The CPSIA allows accreditation of third party conformity assessment bodies to be conducted either by the Commission or by an independent accreditation organization designated by the Commission, and requires that the Commission maintain on its website an up-to-date list of entities that have been accredited to assess conformity with children's product safety rules. With the exception of firewalled third party conformity assessment bodies, the Commission has chosen to accept the accreditation of third party conformity assessment bodies that meet accreditation requirements of an independent accreditation organization.

To assess a third party conformity assessment body's qualifications for acceptance by CPSC, information related to location, accreditation, and ownership must be collected from third party conformity assessment bodies. The CPSC uses an online collection form, CPSC Form 223, to gather information from third party conformity assessment bodies voluntarily seeking acceptance by CPSC. The information collected relates to location, accreditation, and ownership. The Commission staff uses this information to assess:

• A third party conformity assessment body's status as either an independent third party conformity assessment body, a government-owned or government-controlled conformity assessment body, or a firewalled conformity assessment body;

• Qualifications for acceptance by CPSC to test for compliance to specified children's product safety rules; and

• Eligibility for acceptance on the CPSC website.

Part 1112 requires the collection of information in CPSC Form 223:

• Upon initial application by the third party conformity assessment body for acceptance by CPSC;

• Whenever there is a change to accreditation or ownership information; and

• At least every 2 years as part of a regular audit process.

Estimated Burden: The CPSC estimates the burden of the collection of information in CPSC Form 223 is as follows:

These estimates are based on the following information:

• Based on applications received from FY 2013 to date, we estimate the number of third party conformity assessment bodies who would register initially each year for the next three years would be 40.

• Under 16 CFR part 1112, third party conformity assessment bodies are required to resubmit CPSC Form 223 every two years. As all third party conformity assessment bodies have not submitted their first CPSC Form 223s at the same time, only about half would be expected to resubmit a CPSC Form 223 in any 1 year. As of

• August 2019, 581 third party conformity assessment bodies have registered with CPSC. Approximately half (291) of these firms would be required to re-register with CPSC each year.

• Under 16 CFR part 1112, third party conformity assessment bodies are required to ensure that the information submitted on CPSC Form 223 is current and to submit a new CPSC Form 223 whenever the information changes. Based on current experience with third party conformity assessment bodies, we estimate that two third party conformity assessment bodies will make revisions per year to update their information. A change in information is a change that does not require review of laboratory accreditation documents, such as scope or test methods. Examples of revised information include changes in the website URL, name of the laboratory, and name of point of contact.

The total burden, therefore, is 332.5 hours, which we will round up to 333 hours. We estimate that hourly compensation for the time required for recordkeeping is $34.61 per hour (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” Table 9, total compensation for sales, office, and related workers in goods-producing industries, March 2019: https://www.bls.gov/ect/data.htm ). The total cost burden to the respondents is approximately $11,525 ($34.61 × 333 hours = $11,525).

The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:

• Whether the collection of information described above is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility;

• Whether the estimated burden of the proposed collection of information is accurate;

• Whether the quality, utility, and clarity of the information to be collected could be enhanced; and

• Whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology.

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: Foreign Gifts and Contracts Disclosures.

OMB Control Number: 1801-NEW.

Type of Review: A new information collection.

Respondents/Affected Public: Private Sector.

Total Estimated Number of Annual Responses: 400.

Total Estimated Number of Annual Burden Hours: 4,000.

Abstract: Section 117 of the Higher Education Act of 1965 (HEA), as amended, provides that institutions of higher education must file a disclosure report with the Secretary of Education under the following circumstances:

Whenever any institution is owned or controlled by a foreign source or receives a gift from or enters into a contract with a foreign source, the value of which is $250,000 or more, considered alone or in combination with all other gifts from or contracts with that foreign source within a calendar year, the institution shall file a disclosure report with the Secretary on January 31 or July 31, whichever is sooner.

This collection of information is necessary to ensure that the Secretary receives sufficient information about gifts or contracts involving a foreign source, or about ownership or control of the institution by a foreign source, to be able to enforce 20 U.S.C. 1011f.

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: Program for the International Assessment of Adult Competencies (PIAAC) 2022 Cycle II Field Test.

OMB Control Number: 1850-0870.

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

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 5,662.

Total Estimated Number of Annual Burden Hours: 1,262.

Abstract: The Program for the International Assessment of Adult Competencies (PIAAC) is a cyclical, large-scale study of adult skills and life experiences focusing on education and employment. PIAAC is an international study designed to assess adults in different countries over a broad range of abilities, from simple reading to complex problem-solving skills, and to collect information on individuals' skill use and background. PIAAC is coordinated by the Organization for Economic Cooperation and Development (OECD) and developed by participating countries with the support of the OECD. In the United States, the National Center for Education Statistics (NCES), within the U.S. Department of Education (ED) conducts PIAAC. The U.S. participated in the PIAAC Main Study data collection in 2012 and conducted national supplement data collections in 2014 and 2017. All three of these collections are part of PIAAC Cycle I. A new PIAAC cycle is to be conducted every 10 years, and PIAAC Cycle II Main Study data collection will be conducted from August 2021 through March 2022. In preparation for the main study collection, PIAAC Cycle II will begin with a Field Test in 2020, in which 34 countries are expected to participate with the primary goal of evaluating newly developed assessment and questionnaire items and to test the PIAAC 2022 planned operations. PIAAC 2022 defines four core competency domains of adult cognitive skills that are seen as key to facilitating the social and economic participation of adults in advanced economies: (1) Literacy, (2) numeracy, (3) reading and numeracy components, and (4) adaptive problem solving. The U.S. will administer all four domains of the PIAAC 2022 assessment to a nationally representative sample of adults, along with a background questionnaire with questions about their education background, work history, the skills they use on the job and at home, their civic engagement, and sense of their health and well-being. The results are used to compare the skills capacities of the workforce-aged adults in participating countries, and to learn more about relationships between educational background, employment, and other outcomes. In addition, in PIAAC 2022, a set of financial literacy questions will be included in the background questionnaire. This request is to conduct the PIAAC Cycle II Field Test in April-June 2020.

Purpose: In accordance with the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. Appendix 2), the U.S. Election Assistance Commission (EAC) Technical Guidelines Development Committee will conduct an open meeting to discuss the Voluntary Voting System Guidelines and Technical Requirements.

Agenda: The Technical Guidelines Development Committee (TGDC) will discuss the Voluntary Voting System Guidelines 2.0 (VVSG 2.0) and all accompanying Technical Requirements. The TGDC will discuss the next TGDC meeting dates and the continuing steps to develop the Technical Requirements. There may be votes conducted at this meeting. Final Agenda will be published at www.eac.gov before the meeting.

The TGDC will discuss the Requirements of the VVSG 2.0. Draft VVSG Requirements can be found at the link below: https://collaborate.nist.gov/voting/bin/view/Voting/VVSG20DraftRequirements. The most current version of the draft VVSG 2.0 Requirements is clearly marked at the top of the page to ensure the latest version is the topic of discussion at the time of the meetings. As stated in the disclaimer (and in each document), the Requirements are in a draft state and are not yet ready for final posting in their current form. These are provided “as is” for facilitating on-going discussions, but do not yet represent an official or final version. Members of the public may submit relevant written statements about the meeting's content to the TGDC no later than 3:00 p.m. EDT on Wednesday, September 18, 2019.

Statements may be sent electronically via https://www.eac.gov/contact/, via standard mail addressed to the U.S. Election Assistance Commission, TGDC, 1335 East-West Highway, Suite 4300, Silver Spring, MD 20910, or by fax at 301-734-3108. This meeting is open to the public.

Title: FERC-725Z (Mandatory Reliability Standards: IRO Reliability Standards).

OMB Control No.: 1902-0276.

Type of Request: Revisions to the information collection, as discussed in Docket No. RD19-6-000.

Abstract: On July 11, 2019, the Commission issued a Delegated Letter Order, Docket No. RD19-6-000, approving proposed Reliability Standard IRO-002-6 (Reliability Coordination, Monitoring and Analysis), the associated violation risk factors and violation severity levels, and implementation plan. The Reliability Standard was submitted in a joint petition dated May 30, 2019, by the North American Electric Reliability Corporation (NERC) and Western Electricity Coordinating Council (WECC). NERC and WECC stated that the proposed Reliability Standard IRO-002-6 reflects the addition of a regional Variance containing additional requirements applicable to Reliability Coordinators providing service to entities in the Western Interconnection and none of the continent-wide requirements have been changed from currently effective Reliability Standard IRO-002-5. 1 According to the approved implementation plan, the effective date for Reliability Standard IRO-002-6 is January 1, 2020.

Type of Respondents: Reliability coordinators (RC) providing service to entities in the Western Interconnection.

Estimate of Annual Burden:   2 The Commission estimates the changes in the annual public reporting burden and cost  3 as follows.

Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Title: FERC-604 (Cash Management Agreements).

OMB Control No.: 1902-0267.

Type of Request: Three-year extension of the FERC-604 with no changes to the current reporting requirements.

Abstract: Cash management or “money pool” programs typically concentrate affiliates' cash assets in joint accounts for the purpose of providing financial flexibility and lowering the cost of borrowing. In a 2001 investigation, FERC staff found that balances in cash management programs affecting FERC-regulated entities totaled approximately $16 billion. Additionally, other investigations revealed large transfers of funds amounting to more than $1 billion) between regulated pipeline affiliates and non-regulated parents whose financial conditions were precarious. The Commission found that these and other fund transfers and the enormous (mostly unregulated) pools of money in cash management programs could detrimentally affect regulated rates.

To protect customers and promote transparency, the Commission issued Order 634-A (2003) requiring entities to formalize in writing and file with the Commission their cash management agreements. At that time, the Commission obtained OMB clearance for this new reporting requirement under the FERC-555 information collection (OMB Control No. 1902-0098). Now, the Commission includes these reporting requirements for cash management agreements under the FERC-604 information collection (OMB Control No. 1902-0267). The Commission implemented these reporting requirements in 18 CFR parts 141.500, 260.400, and 357.5.

Type of Respondents: Public utilities, natural gas companies, and oil pipeline companies.

Estimate of Annual Burden. 1 The Commission estimates the annual public reporting burden for the information collection as:

Comments: Comments are invited on: (1) Whether the collections of information are necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collections of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collections; and (4) ways to minimize the burden of the collections of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

The State of Mississippi has submitted a request that EPA approve a revision to the State's Safe Drinking Water Act Public Water System Supervision Program to include the authority to implement and enforce the Revised Total Coliform Rule. For the request to be approved, EPA must find the state regulations codified at 15 Miss. Admin. Code Pt. 20, Subpt. 72, Ch. 1, to be no less stringent than the federal rule codified at 40 CFR part 141. EPA reviewed Mississippi's application using the federal statutory provisions (Section 1413 of the Safe Drinking Water Act), federal regulations (at 40 CFR parts 141 and 142), state regulations, state policies and procedures for implementing the rule, regulatory crosswalk, and EPA regulatory guidance to determine whether the request for revision is approvable. EPA determined that the Mississippi regulations are no less stringent than the corresponding federal rule and the revision otherwise meets applicable Safe Drinking Water Act requirements. Therefore, EPA intends to approve this revision. If EPA does not receive a timely and appropriate request for a hearing and the Regional Administrator does not elect to hold a hearing on her own motion, this approval shall become final and effective on October 7, 2019.

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

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

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Health Reimbursement Arrangements and Other Account-Based Group Health Plans; Use: On June 20, 2019, the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (collectively, the Departments) issued final regulations titled “Health Reimbursement Arrangements and Other Account-Based Group Health Plans” (84 FR 28888) under section 2711 of the PHS Act and the health nondiscrimination provisions of HIPAA, Public Law 104-191 (HIPAA nondiscrimination provisions). The regulations expand the use of health reimbursement arrangements and other account-based group health plans (collectively referred to as HRAs). In general, the regulations expand the use of HRAs by eliminating the current prohibition on integrating HRAs with individual health insurance coverage, thereby permitting employers to offer individual coverage HRAs to employees that can be integrated with individual health insurance coverage or Medicare. Under the regulations employees will be permitted to use amounts in an individual coverage HRA to pay expenses for medical care (including premiums for individual health insurance coverage and Medicare), subject to certain requirements. This information collection includes provisions related to substantiation of individual health insurance coverage (45 CFR 146.123(c)(5)), the notice requirement for individual coverage HRAs (45 CFR 146.123(c)(6)), and notification of termination of coverage (45 CFR 146.123(c)(1)(iii)). Form Number: CMS-10704 (OMB control number 0938-1361); Frequency: Annually; Affected Public: Private Sector, State Governments; Number of Respondents: 2,005; Total Annual Responses: 273,492; Total Annual Hours: 6,016. (For policy questions regarding this collection contact Usree Bandyopadhyay at 410-786-6650.)

This Notice corrects a Federal Register Notice of Public Comment published on August 27, 2019, 84 FR 44899, page 44899-44900. The contact, title, email address, and fax number have been updated at page 44899, third column, lines 31-32, 37, and 39. (The deadline for submitting comments under the Dates section remains unchanged and is still September 26, 2019.) The corrected text is as follows for the Addresses section:

The additional funding will not be used to begin new projects, but to serve more CILs that are Subchapter C grantees with the same services and opportunities that Memorial Hermann Health System has been providing for some CILs that are Subchapter C grantees.

Program Name: Centers for Independent Living (Subchapter C) Training & Technical Assistance (T&TA) Center.

Recipient: Memorial Hermann Health System.

Period of Performance: The supplemental award will be issued for the third year of the three-year project period of September 30, 2019 through September 29, 2020.

Total Award Amount: $1,634,490 in FY 2019.

Award Type: Cooperative Agreement Supplement.

Statutory Authority: Rehabilitation Act of 1973, as amended, Public Law 114-95, Title 7, Section 721.

Basis for Award: The Memorial Hermann Health System is currently funded to provide T&TA to CILs for the period of September 30, 2017 through September 29, 2020. ACL is required to spend 1.8-2% of ACL's funds appropriated for CILs for FY 2020 on T&TA for CILs. Without this supplement, ACL would spend less than the 1.8% minimum required amount of funds on T&TA in FY 2020. This supplement will result in ACL complying with this minimum requirement of the statute. This additional funding will enable Memorial Hermann Health System to enhance its capacity to provide more trainings, technical assistance, peer mentoring, and referrals for more CILs.

Memorial Hermann Health System is uniquely positioned to complete the work called for under this project as Memorial Hermann Health System presently provides T&TA services to CILs. Many CILs have benefited from the T&TA provided by the Memorial Hermann Health System's many trainings and other resources.

Establishing another entity as a T&TA provider for CILs would probably be inefficient and disruptive. Another entity would not be able to promptly develop and implement a high-quality T&TA project for one year of funds. If this supplement were not provided, ACL would not meet the requirement that a minimum of 1.8% of funds appropriated for CILs be utilized to provide T&TA services to CILs.

I. Background

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

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

FDA has approved for marketing the human biologic product SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted). SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older. Subsequent to this approval, the USPTO received a patent term restoration application for SHINGRIX (U.S. Patent No. 7,939,084) from GlaxoSmithKline Biologicals SA, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 18, 2018, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of SHINGRIX represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for SHINGRIX is 3,257 days. Of this time, 2,892 days occurred during the testing phase of the regulatory review period, while 365 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: November 21, 2008. The applicant claims November 24, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 21, 2008, which was the first date after receipt of the IND that the investigational studies were allowed to proceed.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): October 21, 2016. FDA has verified the applicant's claim that the biologics license application (BLA) for SHINGRIX (BLA 125614) was initially submitted on October 21, 2016.

3. The date the application was approved: October 20, 2017. FDA has verified the applicant's claim that BLA 125614 was approved on October 20, 2017.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,361 days of patent term extension.

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

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

I. Background

FDA is announcing the availability of a final guidance for industry entitled “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older.” The guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of POS in pediatric patients. Specifically, this guidance addresses FDA's current thinking regarding clinical development programs that can support extrapolation of the efficacy of drugs approved for the treatment of POS in adults to pediatric patients 2 years of age and older. All the public comments received on the draft guidance have been considered and the guidance has been revised as appropriate, along with editorial changes. This guidance finalizes the draft guidance issued on February 16, 2018 (83 FR 7057).

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of Age and Older.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014, and the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001.

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will report the issuance of rare pediatric disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that RINVOQ (upadacitnib) approved August 16, 2019, meets the redemption criteria.

For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm . For further information about RINVOQ (upadacitnib) approved August 16, 2019, go to the “Drugs@FDA” website at https://www.accessdata.fda.gov/scripts/cder/daf/ .

I. Background

FDA developed this guidance to clarify to industry and FDA staff the current review practices for the HDE program. This guidance answers common questions about the HDE program and responds to a requirement in the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) to define the criteria for establishing “probable benefit” as that term is used in section 520(m)(2)(C) of the FD&C Act (21 U.S.C. 360j(m)(2)(C)).

This guidance reflects recent amendments to the FD&C Act that affect the HDE program. Specifically, section 3052 of the Cures Act modified the eligibility for an HDE by increasing the threshold number of patients affected by the disease or condition that a HUD is designed to treat or diagnose to “not more than 8,000 individuals in the United States.” Further, section 3056 of the Cures Act removed the requirement that institutional review committees, i.e., institutional review boards (IRBs), that supervise the clinical testing of HUDs or approve the use of HUDs in clinical care, be local. Additionally, the FDA Reauthorization Act of 2017 (Pub. L. 115-52) amended section 520(m) of the FD&C Act to provide that the use of a device under an HDE at a facility to treat or diagnose patients may be approved by an IRB or an appropriate local committee. Previously, section 520(m)(4) of the FD&C Act only allowed an IRB to perform this function.

FDA considered comments received on the draft guidance that appeared in the Federal Register of June 13, 2018 (83 FR 27614). FDA revised the guidance as appropriate in response to the comments. This guidance supersedes “Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff; Humanitarian Device Exemption (HDE) Regulation: Questions and Answers,” issued July 8, 2010 (available at: https://www.fda.gov/media/74307/download ).

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

Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to download an electronic copy of “Humanitarian Device Exemption Program” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 17040 and complete title of the guidance in the request.

This guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table:

ACHDNC provides advice and recommendations to the Secretary of HHS (Secretary) on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. ACHDNC's recommendations regarding inclusion of additional conditions for screening, following adoption by the Secretary, are evidence-informed preventive health services provided for in the comprehensive guidelines supported by HRSA through the Recommended Uniform Screening Panel (RUSP) pursuant to section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13). Under this provision, non-grandfathered group health plans and health insurance issuers offering group or individual health insurance are required to provide insurance coverage without cost-sharing (a co-payment, co-insurance, or deductible) for preventive services for plan years ( i.e., policy years) beginning on or after the date that is one year from the Secretary's adoption of the condition for screening.

During the September meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include a discussion of the role of health information technology within state newborn screening programs and general updates on ACHDNC projects focused on newborn screening. Agenda items are subject to changes as priorities dictate and the final meeting agenda will be available on ACHDNC's website: https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html. Information about the ACHDNC, a roster of members, as well as past meeting summaries are also available on the ACHDNC website.

Members of the public will have the opportunity to provide comments. Requests to offer oral comments will be accepted in the order they are requested and may be limited as time allows. Public participants may also submit written statements. To submit written comments or request time for an oral comment at the meeting, please register online by 12:00 p.m. ET on September 19, 2019. Visit the ACHDNC website for information on registration, https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html. Oral comments will be honored in the order they are requested and may be limited as time allows. Individuals associated with groups or who plan to provide comments on similar topics may be asked to combine their comments and present them through a single representative. No audiovisual presentations are permitted. Written comments should identify the individual's name, address, email, telephone number, professional or organization affiliation, background or area of expertise ( i.e., parent, family member, researcher, clinician, public health, etc.) and the topic/subject matter.

When submitting comments or requesting information, please include the ICR title for reference.

Information Collection Request Title: Drug Pricing Program Reporting Requirements (OMB No. 0915-0176)—[Extension].

Abstract: Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act “Limitation on Prices of Drugs Purchased by Covered Entities”), which instructs HHS to enter into a Pharmaceutical Pricing Agreement (PPA) with manufacturers of covered outpatient drugs. Manufacturers are required by section 1927(a)(5)(A) of the Social Security Act to enter into agreements with the Secretary of HHS that comply with section 340B of the PHS Act if they participate in the Medicaid Drug Rebate Program. When a drug manufacturer signs a PPA, it is opting into the 340B Drug Pricing Program (340B Program) and it agrees to the statutory requirement that prices charged for covered outpatient drugs to covered entities will not exceed defined 340B ceiling prices, which are based on quarterly pricing data reported by manufacturers to the Centers for Medicare & Medicaid Services. When an eligible covered entity voluntarily decides to enroll and participate in the 340B Program, it accepts responsibility for ensuring compliance with all provisions of the 340B Program, including all associated costs. Covered entities that choose to participate in the 340B Program must comply with the requirements of section 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the covered entity.

Section 340B(a)(5)(C) of the PHS Act permits the Secretary of HHS and manufacturers of a covered outpatient drug to conduct audits of covered entities in accordance with by procedures established the Secretary related to the number, duration, and scope of the audits. Manufacturers are permitted to conduct an audit only when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) has occurred. The manufacturer notifies the covered entity in writing when it believes the covered entity has violated these provisions of the 340B Program. If the problem cannot be resolved, the manufacturer will then submit an audit work plan describing the audit and evidence in support of the reasonable cause standard to HRSA, Healthcare Systems Bureau, Office of Pharmacy Affairs (OPA) for review. OPA will review the documentation to determine if reasonable cause exists. Once the audit is completed, the manufacturer will submit copies of the audit report to OPA for review and resolution of the findings, as appropriate. The manufacturer will also submit an informational copy of the audit report to the HHS Office of Inspector General (OIG).

In response to the statutory mandate of section 340B(a)(5)(C) to permit the Secretary or manufacturers to conduct audits of covered entities and because of the potential for disputes involving covered entities and participating drug manufacturers, OPA developed an informal voluntary dispute resolution process for manufacturers and covered entities. Prior to filing a request for resolution of a dispute with OPA, the parties involved should attempt in good faith to resolve the dispute. All parties involved in the dispute should maintain written documentation as evidence of a good faith attempt to resolve the dispute. To request voluntary dispute resolution of an unresolved dispute, a party submits a written request for a review of the dispute to OPA. A committee appointed to review the documentation will send a letter to the party alleged to have committed a violation. The party will be asked to provide a response to or a rebuttal of the allegations.

HRSA published a notice in 1996 and a policy release in 2011 on manufacturer audit guidelines and the informal dispute resolution process (61 FR 65406 (December 12, 1996) and “Clarification of Manufacturer Audits of 340B Covered Entities,” Release No. 2011-3).

Need and Proposed Use of the Information: HRSA is proposing the collection of information related to the manufacturer audit guidelines. These guidelines contain the following reporting/notification elements:

1. Manufacturers should notify the covered entity in writing when it believes a violation has occurred;

2. manufacturers should submit documentation to OPA as evidence of good faith in attempts to resolve a dispute;

3. manufacturers must submit an audit work plan to OPA;

4. manufacturers should submit the audit report to the OPA and informational copies to the HHS OIG; and

5. the covered entity should provide a written response to the audit report.

This information is necessary to ensure the orderly conduct of manufacturer audits. Also, the informal dispute resolution process requires the participating manufacturer or covered entity requesting dispute resolution to provide OPA with a written request. The party alleged to have committed a 340B Program violation may provide a response or rebuttal to OPA. This information is necessary to ensure that the dispute will be resolved in a fair and equitable manner.

A 60-day notice was published in the Federal Register on June 18, 2019, vol. 84, No. 117; pp. 28308-09. There was one public comment received. The comment received addressed a policy issue that is beyond the scope of this information collection request; therefore, HRSA will not be addressing the comment in this notice.

Likely Respondents: Drug manufacturers and 340B covered entities.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested during an audit. This includes the time needed to review instructions, to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information for both covered entities and manufacturers. The total annual burden hours estimated for this ICR are summarized in the table below.

Comments

The information collection notice was previously published in the Federal Register on June 6, 2019, at 84 FR 26422, allowing for a 60-day public comment period. USCIS did receive two comments in connection with the 60-day notice.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2007-0011 in the search box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

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

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

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

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

(1) Type of Information Collection Request: Revision of a Currently Approved Collection.

(2) Title of the Form/Collection: Application for Replacement/Initial Nonimmigrant Arrival-Departure Document.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-102; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. Nonimmigrants temporarily residing in the United States can use this form to request a replacement of a lost, stolen, or mutilated arrival-departure record, or to request a new arrival-departure record, if one was not issued when the nonimmigrant was last admitted but is now in need of such a record. U.S. Citizenship and Immigration Services (USCIS) uses the information provided by the requester to verify eligibility, as well as his or her status, process the request, and issue a new or replacement arrival-departure record.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection I-102 is 4,100 and the estimated hour burden per response is .75 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 3,075 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $1,182,440.

Comments

The information collection notice was previously published in the Federal Register on April 26, 2019, at 84 FR 17870, allowing for a 60-day public comment period. USCIS did receive one comment in connection with the 60-day notice.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2008-0021 in the search box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

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

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

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

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

(1) Type of Information Collection Request: Revision of a Currently Approved Collection.

(2) Title of the Form/Collection: Medical Certification for Disability Exception.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: Form N-648; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals and Households. USCIS uses the Form N-648 to substantiate a claim for an exception to the requirements of section 312(a) of the Immigration and Nationality Act. By certifying Form N-648, the doctor states that an applicant filing an Application for Naturalization, Form N-400, is unable to complete the English and/or civics requirements because of a physical or developmental disability or mental impairment(s).

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection N-648 is 4,138 and the estimated hour burden per response is 2.42 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 10,014 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $213,107.

We, the U.S. Fish and Wildlife Service (Service), announce the availability of documents related to an incidental take permit (ITP) application under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ). The final environmental impact statement (EIS) was developed in compliance with the Service's decision-making requirements per the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ), and is based on the HCP submitted by the Lower Colorado River Authority's Transmission Services Corporation (LCRA TSC, applicant). We described, fully evaluated, and analyzed three alternatives in detail in our 2019 final EIS.

Our proposed action is to issue an ITP to the applicant under section 10(a)(1)(B) of the ESA that authorizes incidental take of the following federally endangered species:

The ITP would also authorize incidental take of the following federally threatened species:

Also included is the following species, which is petitioned for listing:

Collectively, these are the covered species. The permit area for ITP implementation includes 241 Texas counties (see figure 1 in the HCP). Activities covered by the HCP include construction; operation; upgrade; decommissioning; and repair and maintenance of electrical transmission lines, substations, access roads, and related infrastructure and facilities (covered activities). LCRA TSC activities are classified as (1) new construction, (2) upgrading and decommissioning, (3) operations and maintenance, and (4) emergency responses. The applicant requested a term of 30 years, starting on the date of ITP issuance. The applicant will fully implement avoidance, minimization, and mitigation measures to offset impacts to the covered species according to the HCP and ITP. The applicant has agreed to include the following minimization measures:

1. Meet annually with the Service to discuss upcoming LCRA TSC activities, updated distribution or occurrence information for covered species, opportunities for mitigation, and other concerns;

2. Perform pre-construction natural resource assessments to avoid adverse effects on sensitive environmental features (including species);

3. Implement best practices and other measures to reduce environmental impacts before, during, and after construction;

4. Provide annual training to LCRA TSC staff and contractors working on covered activities regarding the implementation of the HCP and any covered species overlapping with covered activities;

5. Clear and manage vegetation within rights-of-way using aboveground means when practicable;

6. Mark those sections of transmission lines that cross major rivers and out 300 feet from either side;

7. Limit herbicide applications to woody vegetation that is a potential threat to the reliability of LCRA TSC facilities and observe the Service's Southwest Region guidance for pesticide applications;

8. Restore preconstruction contours and revegetate construction sites and any other places where soil is disturbed within rights-of-way;

9. Avoid causing subsurface disturbances to wetlands, riparian areas, and aquatic habitats;

10. Use erosion and sedimentation controls as required by the Texas Commission on Environmental Quality or local ordinances to address storm water discharges during construction;

11. Avoid causing subsurface disturbances to wetlands, riparian areas, and aquatic habitats; and

12. Disturb the least amount of habitat as possible for safely implementing the covered activities.

The mitigation measures include the following commitments:

1. Ratios will be applied at varying levels, depending on direct versus indirect effects, assumed occupied versus confirmed occupied habitat, and when designated critical habitat or conservation lands benefitting the species are impacted.

2. Mitigation will occur through one or more of the following:

a. A Service-approved conservation bank, with priority given to banks that have the covered activities within their service area;

b. Service-approved in-lieu fee programs;

c. Third-party conservation providers implementing Service-approved conservation actions; or

d. Permittee-implemented Service-approved conservation actions.

3. In the unlikely event that no practicable opportunities exist for carrying out mitigation obligations in connection with a covered activity, LCRA TSC will work with the Service to identify other types of practicable mitigation solutions for the covered species, which may include but are not limited to:

a. Approval of alternate means of mitigation delivery, such as translocating or repatriating covered species, enhancement of functional habitat for covered species, or restoration of degraded habitat for covered species;

b. Approval of methods to reduce or eliminate other threats to the covered species; and

c. Funding for research or studies regarding the covered species that further scientific understanding of how to manage and conserve those species.

4. If LCRA TSC starts a covered activity prior to mitigating, they will mitigate an additional 25 percent plus an additional 5 percent each year that mitigation is delayed.

5. The Service will review and approve all mitigation, except where covered activities occur within the service area of a conservation bank for the impacted covered species.

6. If a covered activity will take more than one covered species within the same location, then:

a. The mitigation can also count towards those species, if they are all present within the same location on the mitigation lands ( i.e. stacked); and

b. A stacked mitigation credit can only be used once, regardless whether all of the species within the mitigation were impacted by the covered activity.

In addition to this notice, the Environmental Protection Agency (EPA) is publishing a notice announcing the EIS, as required under the Clean Air Act, section 309 (42 U.S.C. 7401 et seq.; see EPA's Role in the EIS Process below).

The applicant has applied for an ITP under the ESA that would authorize incidental take of the covered species and would be in effect for a period of 30 years. The proposed incidental take of the covered species would occur from lawful non-Federal activities from the applicant's covered activities in the permit area. The HCP includes counties where LCRA TSC currently has facilities, counties LCRA TSC expects they may have future facilities, and a buffer around those counties. The final EIS considers the direct, indirect, and cumulative effects of implementing the HCP, including measures to minimize and mitigate such impacts to the maximum extent practicable.

Section 9 of the ESA and its implementing regulations in title 50 of the Code of Federal Regulations (CFR) prohibit “take” of fish and wildlife species listed as endangered or threatened under the ESA. The ESA defines “take” as “to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect listed animal species, or attempt to engage in such conduct” (16 U.S.C. 1533). The term “harm” is defined in the regulations as significant habitat modification or degradation that results in death or injury to listed species by significantly impairing essential behavioral patterns, including breeding, feeding, or sheltering (50 CFR 17.3). We may, however, under specified circumstances, issue permits that allow the take of federally listed species, provided the take is incidental to, and not the purpose of, otherwise lawful activities. Regulations governing ITPs for endangered and threatened species are at 50 CFR 17.22 and 17.32, respectively.

We published a notice of intent (NOI) in the Federal Register on July 11, 2017 (82 FR 35539), to determine the scope of issues and alternatives to be addressed in the EIS. Publication of the NOI initiated a 30-day scoping period, during which the Service solicited comments regarding potential impacts associated with and identification of alternatives to the proposed Federal action for the Service to address in their NEPA environmental review document. The Service held scoping meetings in Corpus Christi, Austin, Midland, and College Station, Texas, in August 2017. The scoping comment period closed on August 30, 2017.

Nine individuals attended scoping meetings, and the Katy Prairie Conservancy and National Park Service each submitted a comment letter. The Service considered the scoping comments and incorporated ideas into the environmental effects analysis, as applicable.

We published a notice of receipt of the application and availability of the HCP and a draft EIS in the Federal Register on April 29, 2019 (84 FR 18075). The public comment period closed on June 13, 2019. We received nine comments, one from the Texas Historical Commission with only minor editing suggestions, one from the Environmental Protection Agency (EPA) with no comment, four from tribes (three with no comments or concerns, and one requesting to be a consulting party), one from Texas Parks and Wildlife Department, and two comments that were not substantive. Appendix B of the final EIS provides the comments, responses, and information on where the Service made changes to the HCP/EIS.

We intend to issue an ITP allowing the applicant to implement the proposed HCP, identified as the preferred alternative in the final EIS. We determined that the preferred alternative best balances the protection and management of habitat for the covered species, while allowing for the covered activities to be authorized under a longer-term permit. Considerations used in this decision include: (1) Minimization and mitigation measures that will benefit the covered species by permanently preserving more acreage than is removed, (2) the focus of mitigation in single parcels when acreage impacted will likely come from patches spanning linear projects, (3) mitigation measures that will fully offset anticipated impacts to the covered species and will contribute to their recovery, and (4) that the HCP is consistent with species recovery plans or outlines, noting that some species do not have either.

In addition to this notice, EPA is publishing a notice in the Federal Register announcing the final EIS for LCRA TSC's final HCP, as required under the Clean Air Act, section 309. The EPA is charged with reviewing all Federal agencies' EISs and commenting on the adequacy and acceptability of the environmental impacts of proposed actions in EISs.

The EPA also serves as the repository (EIS database) for EISs that Federal agencies prepare. All EISs must be filed with EPA, which publishes a notice of availability on Fridays in the Federal Register . For more information, see https://www.epa.gov/nepa. You may search for EPA comments on EISs, along with EISs themselves, at https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

We provide this notice under section 10(c) of the ESA (16 U.S.C. 1531 et seq. ) and its implementing regulations (50 CFR 17.22 and 17.32) and NEPA (42 U.S.C. 4321 et seq. ) and its implementing regulations (40 CFR 1506.6).

The plats of survey of the following described lands are scheduled to be officially filed in the Bureau of Land Management, Oregon 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, Bureau of Land Management. 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 be untimely and 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 the 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.

HRDI has proposed an expansion to their operations at the existing Hycroft Mine, which is located approximately 55 miles west of Winnemucca, Nevada, in Humboldt and Pershing Counties. The Hycroft Mine Phase II Expansion proposed action proposes to increase the authorized Plan of Operations boundary to 27,835 acres, of which 26,082 acres would be on BLM-administered public lands. Under the project as proposed by HRDI, the surface disturbance would increase by 8,737 acres, from 6,144 acres to 14,881 acres, which includes 13,141 acres located on land administered by the BLM Black Rock Field Office. Surface disturbance on private land would decrease by 44 acres, from 1,784 acres to 1,740 acres. The proposed project would include the following activities: Expanding the authorized Plan of Operations boundary to the east; extending mining and ore processing activities to 2039; increasing the rate of process water pumping and extending until 2041; constructing and operating the Northeast Tailings Storage Facility (TSF) and associated pipeline corridor and haul road; constructing and operating the North Heap Leach Facility (HLF) East expansion and associated solution ponds; expanding the existing Brimstone Pit below the pre-mining groundwater table; conducting active dewatering of the Brimstone Pit through the installation and operation of dewatering wells; conducting passive dewatering within the expanded pit footprint; expanding the South Waste Rock Facility (WRF); modifying the approved land use in the South Processing Complex to allow for the option of constructing the Southwest WRF in place of the complex, if desired; modifying waste backfill plans with respect to the proposed mining plan; expanding haul and secondary roads around the pits, WRFs, HLFs, and TSF; modifying the milling operation to process ore in an ambient oxidation and leaching process; constructing and operating an oxygen plant; constructing stormwater diversions, installing culverts, and other stormwater controls; constructing growth media stockpiles; incorporating four HRDI rights-of-way (ROWs) (microwave repeater site and road [NVN046292], Floka access road [NVN054893], buried pipeline, wells, power distribution and access roads [NVN046564], and road and water pipeline [NVN039119]) that exist wholly within the authorized Plan boundary into the amendment to the Plan and relinquish the ROWs with the BLM; continuing use of the well field ROW; relocating rangeland improvement facilities within the footprint of the Northeast TSF; rerouting Rosebud Road around the Northeast TSF; reallocating 10 acres of exploration disturbance on private land to public land; and implementing the authorized and proposed additional applicant-committed Environmental Protection Measures to new facilities and activities. Alternative A would result in approximately 4,800 acres less surface disturbance, and the plan boundary would be nearly 7,800 acres less than the proposed action. Under Alternative A, all components of the proposed action would be the same except the Northeast TSF and all associated infrastructure would not be constructed, rather, the Southwest TSF would be constructed instead with all associated infrastructure. Alternative A would include an expansion to the authorized Plan of Operations boundary to accommodate the Southwest TSF (Alternative A Expansion). The Alternative A Expansion of the Plan of Operations boundary would encompass approximately 5,310 acres of public lands administered by the BLM. Alternative A would expand the authorized Project boundary, which encompasses 14,753 acres, by 5,310 acres of public lands administered by the BLM, for a combined total of 20,063 acres. Under Alternative A, HRDI would construct and operate an approximately 2,426-acre facility (dam and tails surface) known as the Southwest TSF to accommodate tailings generated by mining sulfide ore below the groundwater table and processed in the authorized mill facility located on private land.

The Winnemucca District, Black Rock Field Office has selected Alternative A, as outlined in Chapter 2 of the Draft EIS, including the applicant's committed EPMs specified in the Draft EIS Section 5.3 and all of the mitigation specified in the Draft EIS Section 5.2 for Alternative A. This aligns with the USFWS Eagle Take Permit Alternative A (USFWS Alternative A Eagle Permit Decision) as the Preferred Action based on the outcome of the Final EIS. HRDI's Eagle Conservation Plan contains commitments to avoid, minimize, and mitigate adverse effects on golden eagles resulting from the implementation of the Project. There are no new anticipated significant impacts on the cumulative effects of the area since a mine already exists in the area; impacting the air quality, visual resources, and the cultural viewshed of the area.

Ten alternatives addressing pit lake concerns, mine feature concerns, and eagle permit concerns were considered but eliminated from analysis for the inability meet the project's purpose and need, technical feasibility, the inability to reduce environmental impacts and for not being in compliance with regulatory and legal guidance.

In addition, HRDI has submitted an application to the USFWS requesting authorization to remove inactive golden eagle nests and for incidental take under the Eagle Act for operational activities associated with both the BLM's currently authorized mining activities and proposed expansion Project. The Project would also affect golden eagle nests and territories. HRDI's ECP is the foundation of the permit application and contains commitments to avoid, minimize, and mitigate adverse effects on golden eagles resulting from the implementation of the Project.

Through scoping the BLM has identified, and through the EIS the agencies have analyzed impacts to the following resources areas: Air and atmospheric resources; cultural resources (including National Historic Trails); noxious weeds, invasive species, and nonnative species; migratory birds; Native American religious concerns; wastes and materials (hazardous and solid); water quality (surface and ground); geology, minerals, and energy; golden eagles; lands and realty; paleontology; rangeland management; recreation; social values and economics; soils; special status species (plants and wildlife); transportation and access; vegetation; visual resources; and wildlife. The EIS describes and analyzes the proposed Project's direct, indirect, and cumulative impacts on all affected resources.

In addition to the Mine Expansion Proposed Action (BLM Decision) and the Eagle Take Permit Proposed Action (USFWS Eagle Permit Decision), the following alternatives are also analyzed in the EIS: The Mine Expansion Alternative A (BLM Alternative Decision), referred to as Alternative A; Eagle Take Permit Alternative A (USFWS Alternative A Eagle Permit Decision); the BLM No Action Alternative; and the USFWS No Action Alternative.

On December 30, 2014, an initial Notice of Intent (NOI) was published in the Federal Register inviting scoping comments on the proposed action. A total of 14 scoping comment letters were received for the December 20, 2014, through January 29, 2015, public scoping period. On September 22, 2017, a second NOI was published in the Federal Register inviting scoping comments on the requested eagle take permit as related to the Eagle Take Permit Proposed Action (USFWS Eagle Permit Decision) and the ECP. A total of nine scoping comment letters were received during the September 22, 2017, through November 21, 2017, public scoping period. Concerns raised included impacts to air quality, cultural resources, environmental justice, lands, realty and transportation, Native American religious concerns, rangeland management, recreation, soils, visual resources, wastes and materials (hazardous and solid), water resources, vegetation, and wildlife. A total of nine public comment letters were received during the May 17, 2019, through July 14, 2019, public comment period. Concerns raised included impacts to air quality, cultural resources, environmental justice, Native American religious concerns, rangeland management, recreation, soils, visual resources, wastes and materials (hazardous and solid), water resources, vegetation, and wildlife. Further clarification is provided in the Final EIS addressing these comments.

The BLM has utilized and coordinated the NEPA scoping and comment process to help fulfill the public involvement requirements under the National Historic Preservation Act (NHPA) (54 U.S.C. 306108) as provided in 36 CFR 800.2(d)(3)—and continues to do so. The information about historic and cultural resources within the area potentially affected by the proposed Project has assisted the BLM in identifying and evaluating impacts to such resources in the context of both NEPA and Title 54 of the NHPA.

The BLM and USFWS have consulted and continue to consult with numerous Native Indian tribes on a government-to-government basis in accordance with Executive Order 13175 and other policies. Tribal concerns, including impacts to Indian trust assets and potential impacts to cultural resources have been analyzed in the EIS.

Federal, State, and local agencies, along with tribes and other stakeholders that may be interested in or affected by the proposed Project that the BLM and USFWS have evaluated, are notified of the availability of the Final EIS. No ROD will issue for 30 days past the publication of this NOA.

The lands surveyed are:

A person or party who wishes to protest one or more plats of survey must file a written notice of protest within 30 calendar days from the date of this publication at the address listed in the ADDRESSES section of this notice. Any notice of protest received after the due date will be untimely and will not be considered. A written statement of reasons in support of a protest, if not filed with the notice of protest, must be filed at the same address within 30 calendar days after the notice of protest is filed. If a protest against the survey is received prior to the date of official filing, the filing will be stayed pending consideration of the protest. A plat will not be officially filed until the day after all protests have been dismissed or otherwise resolved.

Before including your address, phone number, email address, or other personal identifying information in your 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 at any time. While you can ask the BLM to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The Committee has been established by authority of the Secretary of the Interior (Secretary) under 54 U.S.C. 100906, and is regulated by the Federal Advisory Committee Act.

The Committee will convene its meeting at 9:00 a.m., and adjourn at 5:00 p.m. The Committee will meet to discuss topics related to public-private partnerships across all public lands, expanding access to and improving infrastructure on public lands and waterways, improving recreational visitor experiences, developing and deploying infrastructure improvements, and other business. The meeting agenda will be posted to the committee's website at: https://www.nps.gov/orgs/1892/made-in-america-rac.htm.

The meeting is open to the public, but preregistration is required due to security requirements in the building and limited seating. Any individual who wishes to attend the meeting should register via email at Joshua Winchell itmd_joshuawinchell@nps.gov, or telephone (202) 513-7053. Interested persons may choose to make a public comment at the meeting during the designated time for this purpose. Members of the public may also choose to submit written comments by mailing them to Joshua Winchell, Designated Federal Officer for the Made in America Outdoor Recreation Advisory Committee, Office of Policy, National Park Service, 1849 C Street NW, MS 2659, Washington, DC 20240, or via email at itmd_joshuawinchell@nps.gov. Individuals who plan to attend and need special assistance, such as sign language interpretation, should contact the NPS as provided above.

Public Disclosure of Comments: Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Correction: In the Federal Register of August 28, 2019, in FR Doc. 2019-18566, on page 45173, the DATES section is corrected to read as follows:

The information collection is listed below:

(1) Type of information collection: Extension of Currently Approved Collection.

(2) The title of the form/collection: Title of the Form/Collection: IER Charge Form.

(3) Agency form number: Form IER-1.

(3) Affected public who will be asked to respond, as well as a brief abstract: Primary: The Immigrant and Employee Rights Section (IER) enforces the anti-discrimination provision (§ 274B) of the Immigration and Nationality Act (INA), 8 U.S.C. 1324b. The statute prohibits: (1) Citizenship or immigration status discrimination in hiring, firing, or recruitment or referral for a fee, (2) national origin discrimination in hiring, firing, or recruitment or referral for a fee, (3) unfair documentary practices during the employment eligibility verification process (Form I-9 and E-Verify), and (4) retaliation or intimidation for asserting rights covered by the statute. IER, within the Department's Civil Rights Division, investigates and, where reasonable cause is found, litigates charges alleging discrimination. IER also initiates independent investigations, at times based on information developed during individual charge investigations. Independent investigations normally involve alleged discriminatory policies that potentially affect many employees or applicants. These investigations may result in complaints alleging a pattern or practice of discriminatory activity. If the Department lacks jurisdiction over a particular charge but believes another agency has jurisdiction over the claim, IER forwards the charge to the applicable Federal, state or local agency for any action deemed appropriate.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 340 individuals will complete each form annually; each response will be completed in approximately 30 minutes.

(6) An estimate of the total public burden (in hours) associated with the collection: There are an estimated 170 total annual burden hours associated with this collection.

This ICR seeks PRA authority for the TAA State Survey information collection. The Office of Trade Adjustment Assistance (OTAA) is seeking to establish the TAA State Survey to collect discrete data on how State Workforce Agencies (SWAs) organize the TAA program across eight (8) distinct categories. This data will allow OTAA to analyze which practices are best supporting TAA participants, identify areas where more technical assistance is needed, and determine opportunities for greater program integration. Section 239(c) of Title II, Chapter 2 of the Trade Act of 1974, as amended authorizes this information collection. See 19 U.S.C. 2271.

This proposed information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB, under the PRA, approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information if the collection of information does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. For additional information, see the related notice published in the Federal Register on April 5, 2019 (84 FR 13722).

Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register . In order to help ensure appropriate consideration, comments should mention OMB ICR Reference Number 201907-1205-014. The OMB is particularly interested in comments that:

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

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

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

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

Agency: DOL-ETA.

Title of Collection: TAA State Survey.

OMB ICR Reference Number: 201907-1205-014.

Affected Public: State Workforce Agencies.

Total Estimated Number of Respondents: 52.

Total Estimated Number of Responses: 52.

Total Estimated Annual Time Burden: 260 hours.

Total Estimated Annual Other Costs Burden: $0.

Authority: 44 U.S.C. 3507(a)(1)(D).

Please refer to Docket ID NRC-2019-0081 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2019-0081. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2019-0081 on this website.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ Begin Web-based ADAMS Search. ” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. A copy of the collection of information and related instructions may be obtained without charge by accessing ADAMS Accession No. ML19126A197. The supporting statement and title of documents are available in ADAMS under Accession No. ML19205A109.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

• NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting NRC's Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: Infocollects.Resource@nrc.gov.

The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS, and the NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled NRC Form 277, “Request for Visit.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The NRC published a Federal Register notice with a 60-day comment period on this information collection on May 16, 2019 (84 FR 22171).

1. The title of the information collection: NRC Form 277, Request for Visit.

2. OMB approval number: 3150-0051.

3. Type of submission: Extension.

4. The form number if applicable: NRC Form 277.

5. How often the collection is required or requested: As needed.

6. Who will be required or asked to respond: Licensees and NRC contractors.

7. The estimated number of annual responses: 60.

8. The estimated number of annual respondents: 60.

9. An estimate of the total number of hours needed annually to comply with the information collection requirement or request: 10 hours.

10. Abstract: NRC Form 277 is completed by NRC contractors and licensees who have been granted an NRC access authorization and require verification of that access authorization and need-to-know due to (1) a visit to NRC, (2) a visit to other contractors/licensees or government agencies in which access to classified information will be involved, or (3) unescorted area access is desired.

The Office of Management and Budget is particularly interested in comments that:

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

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

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

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

The Combined Federal Campaign (CFC) is the world's largest and most successful annual workplace philanthropic giving campaign, with 36 CFC Zones throughout the country and overseas raising millions of dollars each year. The mission of the CFC is to promote and support philanthropy through a program that is employee focused, cost-efficient, and effective in providing all federal employees the opportunity to improve the quality of life for all.

The CFC charity applications collect information from about 10,000 national, international, and local charities for inclusion on the CFC charity list. There are no recommended revisions to this ICR.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on September 3, 2019, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail Contract 547 to Competitive Product List . Documents are available at www.prc.gov, Docket Nos. MC2019-189, CP2019-212.