Federal Register Vol. 83, No.49,

USDA is committed to operating efficiently, effectively, and with integrity, and minimizing the burdens on individuals, businesses, and communities for participation in and compliance with USDA programs. USDA works to support the American agricultural economy to strengthen rural communities; to protect and conserve our natural resources; and to provide a safe, sufficient, and nutritious food supply for the American people. The Department's wide range of programs and responsibilities touches the lives of every American every day.

Executive Order 13781, “Comprehensive Plan for Reorganizing the Executive Branch”, is intended to improve the efficiency, effectiveness, and accountability of the executive branch. The principles in the Executive Order provide the basis for taking actions to enhance and strengthen the delivery of USDA programs.

On March 9, 2018, Secretary Perdue will be announcing his intent to take actions to strengthen civil rights and customer service at USDA by taking the following actions to ensure integrity, consistency, and fairness:

• USDA will eliminate inefficiencies in delivering civil rights services at the agency and staff office level, thereby resulting in improved civil rights management. Under the realignment, a Civil Rights Director and appropriate Equal Opportunity staff will be aligned as follows:

(1) Departmental Administration, staff offices, and Trade and Foreign Agricultural Affairs will share civil rights resources;

(2) Each remaining Departmental Mission Area will consolidate its sub-agency resources at the Mission Area level; and

(3) The Office of the Inspector General (OIG) shall have an independent Civil Rights Director.

• OASCR will direct all Departmental civil rights activities, including those of the Mission Areas, Departmental Administration, staff offices, and to the extent appropriate and lawful, OIG. The delegations for the Assistant Secretary for Civil Rights shall be revised as necessary to reflect OASCR's direct responsibility in providing civil rights policy direction to Mission Area and other Civil Rights Directors and Civil Rights staff and conveying the clear guidance of the Office of the Secretary on all civil rights issues.

• OASCR will implement a timely, fair, transparent, and consistent approach to addressing all Equal Employment Opportunity or program complaints, including those based on discrimination, harassment, and retaliation that shall be adopted by all Mission Areas, Departmental Administration, staff offices and, to the extent appropriate and lawful, OIG.

• OASCR will direct an effective, robust, and compliant mandatory civil rights training program for all staff, including Mission Areas, Departmental Administration, staff offices and, to the extent appropriate and lawful, OIG.

• OASCR will monitor and evaluate the implementation of the reasonable accommodation process by the Mission Areas, Departmental Management, staff offices and, to the extent appropriate and lawful, OIG.

• OASCR will not address matters that Office of Human Resource Management (OHRM) handles exclusively, such as setting human resources policy, investigating and evaluating harassment allegations for misconduct, and reviewing and advising on requests for reasonable accommodations, but will serve as a collaborative partner with OHRM on all appropriate issues affecting civil rights policy, implementation, and compliance.

• OASCR will request the Mission Areas to provide a list of all civil rights positions on-board (full-time, part-time, or collateral duty) within 30 days from issuance of this Memorandum to determine staff needs to effectuate the purpose of this Memorandum.

• Mission Areas, Departmental Administration, and the Staff Offices will implement all organizational changes necessary to effectuate the civil rights staff realignments indicated above based upon the direction of OASCR. When conducting any reorganizations, the Mission Areas, Departmental Administration, and Staff Offices will adhere to all relevant Departmental Directives, including Departmental Regulation 1010 and the corresponding Congressional notification requirements.

• OASCR will eliminate the position of Deputy Assistant Secretary for Civil Rights (ASCR), so as to flatten the organization with the Associate Assistant Secretary for Civil Rights assuming the responsibilities of the Deputy ASCR.

• OASCR will eliminate its Policy Division, which is no longer necessary in an era of decreased regulations, and will perform reduced policy functions with staff from other areas of the organization.

• OASCR will eliminate its Training and Cultural Transformation Division and will develop training with staff from other areas of the organization.

• OASCR will eliminate its Early Resolution and Complaint Division, and the Department will carry out informal counseling within each Mission Area, with coordination from a Mission Area Liaison within OASCR.

• OASCR's career Senior Executive Service (SES) Director for the Office of Compliance, Policy, Training and Cultural Transformation will be reclassified as the career SES Executive Director for Civil Rights Operations, a position responsible for managing the Mission Area Liaison, the Compliance Division, and the Data and Records Management Division over customer service, data, and information technology. The largest component in this part of the OASCR organization is the Compliance Division, which will continue addressing compliance reporting to oversight entities as well as limited regulatory and policy review.

• OASCR's career SES Director for the Office of Adjudication will be reclassified as the career SES Executive Director for Civil Rights Enforcement, a position responsible for leading not only the Office of Adjudication, but also the Program Planning, and Accountability Division over budget, contracting and procurement, human resources management, facilities management, strategic planning, and Continuity of Operations for OASCR. The largest component of this part of the OASCR organization is the Office of Adjudication is responsible for intake, investigation, and adjudication of employment discrimination complaints from USDA employees and program complaints of discrimination arising within any program conducted or assisted by USDA.

USDA is seeking public comment on these actions and notes that this notice is issued solely for information and program-planning purposes. While responses to this notice do not bind USDA to any further actions, all submissions will be reviewed by the appropriate program office, and made publicly available on http://www.regulations.gov.

Title: Generic Clearance for Social Science and Economics Data Collections on Natural Disasters and Disturbances

OMB Number: 0596—NEW.

Expiration Date of Approval: NEW.

Type of Request: NEW.

Abstract: The USDA Forest Service has broad responsibilities for caring for the forests and grasslands of the nation. This includes managing wildland fires and responding to many other threats such as droughts, floods, tree pests and diseases, invasive species, extreme weather events, effects of climate change, and other natural disasters and disturbances. The frequency, type, duration, and intensity of disturbances and disasters shape our forests and other natural ecosystems and impact people's lives. In any given year, a wide range of people living in all types of communities across the nation—rural, suburban, and urban; forested, industrical, and agricultural—are affected by natural disasters and disturbances.

This Generic Information Collection Request (ICR) seeks Office of Management and Budget (OMB) approval to collect information that will help the Forest Service understand how individuals, communities, and organizations prepare for, respond and adapt to, and recover from natural disturbances and disasters, as well as build resilience. This information is critical to supporting the Forest Service's mission of both managing national forests and grasslands and collaborating with others to develop useful guidelines for management of the nation's forests. Under this Generic ICR, social science research methods such as surveys, interviews, and focus groups will collect information from individuals and groups who are preparing for, responding to, and/or recovering from natural disasters and disturbances. Results from the proposed research and data collections can inform prediction, preparation, response, and recovery strategies and efforts by the Forest Service and other Federal agencies, as well as related local government, civil society, and community efforts. In the long term, such knowledge can contribute to fewer societal costs from disturbance processes, more cost-effective management efforts, and more resilient communities and economies. Any specific study conducted under this Generic ICR will be posted for public comment in The Federal Register for 30 days by the USDA Forest Service.

Estimate of Annual Burden on Respondents: 15,533 hours/year.

Type of Respondents: Participants/respondents will be individuals, not specific entities.

Estimated Annual Number of Respondents: 100,500 year.

Estimated Annual Number of Responses per Respondent: 1 response/respondent is anticipated.

Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden 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 to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. The Forest Service will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval.

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

I. Program Description

The Rural Energy for America Program (REAP) helps agricultural producers and rural small businesses reduce energy costs and consumption and helps meet the Nation's critical energy needs. REAP has two types of funding assistance: (1) Renewable Energy Systems and Energy Efficiency Improvements Assistance and (2) Energy Audit and Renewable Energy Development Assistance Grants.

The Renewable Energy Systems and Energy Efficiency Improvements Assistance provides grants and guaranteed loans to agricultural producers and rural small businesses for renewable energy systems and energy efficiency improvements. Eligible renewable energy systems for REAP provide energy from: Wind, solar, renewable biomass (including anaerobic digesters), small hydro-electric, ocean, geothermal, or hydrogen derived from these renewable resources.

The Energy Audit and Renewable Energy Development Assistance Grant is available to a unit of State, Tribal, or local government; instrumentality of a State, Tribal, or local government; institution of higher education; rural electric cooperative; a public power entity; or a council, as defined in 16 U.S.C. 3451. The recipient of grant funds, grantee, will establish a program to assist agricultural producers and rural small businesses with evaluating the energy efficiency and the potential to incorporate renewable energy technologies into their operations.

A. General. Applications for REAP can be submitted any time throughout the year. This Notice announces the deadline times and dates that applications have to be received in order to be considered for REAP funds provided by the Agricultural Act of 2014, (2014 Farm Bill), and any appropriated funds that REAP may receive from the appropriation for Federal FY 2018 for grants, guaranteed loans, and combined grants and guaranteed loans to purchase and install renewable energy systems, and make energy efficiency improvements; and for grants to conduct energy audits and renewable energy development assistance.

The Notice of Solicitation of Applications (NOSA) announces the acceptance of applications under REAP for Federal FY 2018 for grants, guaranteed loans, and combined grants and guaranteed loans for the development of renewable energy systems and energy efficiency projects as provided by the Agricultural Act of 2014 (2014 Farm Bill). The Notice also announces the acceptance of applications under REAP for Federal FY 2018 for energy audit and renewable energy development assistance grants as provided by the 2014 Farm Bill.

The administrative requirements in effect at the time the application window closes for a competition will be applicable to each type of funding available under REAP and are described in 7 CFR part 4280, subpart B. In addition to the other provisions of this Notice:

(1) The provisions specified in 7 CFR 4280.101 through 4280.111 apply to each funding type described in this Notice.

(2) The requirements specified in 7 CFR 4280.112 through 4280.124 apply to renewable energy system and energy efficiency improvements project grants.

(3) The requirements specified in 7 CFR 4280.125 through 4280.152 apply to guaranteed loans for renewable energy system and energy efficiency improvements projects. For Federal FY 2018, the guarantee fee amount is one percent of the guaranteed portion of the loan, and the annual renewal fee is one-quarter of 1 percent (0.250 percent) of the guaranteed portion of the loan.

(4) The requirements specified in 7 CFR 4280.165 apply to a combined grant and guaranteed loan for renewable energy system and energy efficiency improvements projects.

(5) The requirements specified in 7 CFR 4280.186 through 4280.196 apply to energy audit and renewable energy development assistance grants.

A. Statutory Authority. This program is authorized under 7 U.S.C. 8107.

B. Catalog of Federal Domestic Assistance (CFDA) Number. 10.868.

C. Funds Available. This Notice is announcing deadline times and dates for applications to be submitted for REAP funds provided by the 2014 Farm Bill and any appropriated funds that REAP may receive from the congressional enactment of a full-year appropriation for Federal FY 2018. This Notice is being published prior to the congressional enactment of a full-year appropriation for Federal FY 2018. The Agency will continue to process applications received under this announcement and should REAP receive appropriated funds, these funds will be announced on the following website: https://www.rd.usda.gov/programs-services/rural-energy-america-program-renewable-energy-systems-energy-efficiency, and are subject to the same provisions in this Notice.

To ensure that small projects have a fair opportunity to compete for the funding and are consistent with the priorities set forth in the statute, the Agency will set-aside not less than 20 percent of the Federal FY 2018 funds until June 29, 2018, to fund grants of $20,000 or less.

(1) Renewable energy system and energy efficiency improvements grant-funds. There will be allocations of grant funds to each Rural Development State Office for renewable energy system and energy efficiency improvements applications. The State allocations will include an allocation for grants of $20,000 or less funds and an allocation of grant funds that can be used to fund renewable energy system and energy efficiency improvements applications for either grants of $20,000 or less or grants of more than $20,000, as well as the grant portion of a combination grant and guaranteed loan. These funds are commonly referred to as unrestricted grant funds. The funds for grants of $20,000 or less can only be used to fund grants requesting $20,000 or less, which includes the grant portion of combination requests when applicable.

(2) Renewable energy system and energy efficiency improvements loan guarantee funds. Rural Development's National Office will maintain a reserve of guaranteed loan funds.

(3) Renewable energy system and energy efficiency improvements combined grant and guaranteed loan funds. Funding availability for combined grant and guaranteed loan applications are outlined in paragraphs II.(C)(1) and II.(C)(2) of this Notice.

(4) Energy audit and renewable energy development assistance grant funds. The amount of funds available for energy audits and renewable energy development assistance in Federal FY 2018 will be 4 percent of Federal FY 2018 mandatory funds and will be maintained in a National Office reserve. Obligations of these funds will take place through March 30, 2018. Any unobligated balances will be moved to the renewable energy budget authority account, and may be utilized in any of the renewable energy system and energy efficiency improvements national competitions.

D. Approximate Number of Awards. The estimated number of awards is 1,000 based on the historical average grant size and the anticipated mandatory funding of $50 million for Federal FY 2018, but will depend on the actual amount of funds made available and on the number of eligible applicants participating in this program.

E. Type of Instrument. Grant, guaranteed loan, and grant/guaranteed loan combinations.

The eligibility requirements for the applicant, borrower, lender, and project (as applicable) are clarified in 7 CFR part 4280 subpart B, and are summarized in this Notice. Failure to meet the eligibility criteria by the time of the competition window may result in the Agency reviewing an application, but will preclude the application from receiving funding until all eligibility criteria have been met.

A. Eligible Applicants. This solicitation is for applications from agricultural producers and rural small businesses for grants or guaranteed loans, or a combination grant and guaranteed loan, for the purpose of purchasing and installing renewable energy systems and energy efficiency improvements. This solicitation is also for applications for Energy Audit or a Renewable Development Assistance grants from units of State, Tribal, or local government; instrumentalities of a State, Tribal, or local government; institutions of higher education; rural electric cooperatives; public power entities; and councils, as defined in 16 U.S.C. 3451, which serve agricultural producers and rural small businesses. To be eligible for the grant portion of the program, an applicant must meet the requirements specified in 7 CFR 4280.110, and 7 CFR 4280.112, or 7 CFR 4280.186, as applicable.

B. Eligible Lenders and Borrowers. To be eligible for the guaranteed loan portion of the program, lenders and borrowers must meet the eligibility requirements in 7 CFR 4280.125 and 7 CFR 4280.127, as applicable.

C. Eligible Projects. To be eligible for this program, a project must meet the eligibility requirements specified in 7 CFR 4280.113, 7 CFR 4280.128, and 7 CFR 4280.187, as applicable.

D. Cost Sharing or Matching. The 2014 Farm Bill mandates the maximum percentages of funding that REAP can provide. Additional clarification is provided in paragraphs IV.E. (1) through (3) of this Notice.

(1) Renewable energy system and energy efficiency improvements funding. Requests for guaranteed loan and combined grant and guaranteed loan will not exceed 75 percent of total eligible project costs, with any Federal grant portion not to exceed 25 percent of total eligible project costs, whether the grant is part of a combination request or is a grant-only.

(2) Energy audit and renewable energy development funds. Requests for the energy audit and renewable energy development assistance grants, will indicate that the grantee that conducts energy audits must require that, as a condition of providing the energy audit, the agricultural producer or rural small business pay at least 25 percent of the cost of the energy audit. The Agency recommended practice for on farm energy audits, audits for agricultural producers, ranchers, and farmers is the American Society of Agricultural and Biological Engineers S612 Level II audit. This audit conforms to program standards used by the Natural Resource Conservation Service. As per 7 CFR 4280.110(a), an applicant who has received one or more grants under this program must have made satisfactory progress towards completion of any previously funded projects before being considered for subsequent funding. The Agency interprets satisfactory progress as at least 50 percent of previous awards expended by January 31, 2018. Those who cannot meet this requirement will be determined to be a “risk” pursuant to 2 CFR 200.205 and may be determined in-eligible for a subsequent grant or have special conditions imposed.

E. Other. Ineligible project costs can be found in 7 CFR 4280.114(d), 7 CFR 4280.129(f), and 7 CFR 4280.188(c), as applicable. The U.S. Department of Agriculture Departmental Regulations and Laws that contain other compliance requirements are referenced in paragraphs VI.B.(1) through (3), and IV.F of this Notice. Applicants who have been found to be in violation of applicable Federal statutes will be ineligible.

A. Address to Request Application Package. Application materials may be obtained by contacting one of Rural Development's Energy Coordinators, as identified via the following link: https://www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf. In addition, for grant applications, applicants may obtain electronic grant applications for REAP from www.grants.gov.

B. Content and Form of Application Submission. Applicants seeking to participate in this program must submit applications in accordance with this Notice and 7 CFR part 4280, subpart B. Applicants must submit complete applications by the dates identified in Section IV.C., of this Notice, containing all parts necessary for the Agency to determine applicant and project eligibility, to score the application, and to conduct the technical evaluation, as applicable, in order to be considered.

(1) Renewable energy system and energy efficiency improvements grant application.

(a) Information for the required content of a grant application to be considered complete is found in 7 CFR part 4280, subpart B.

(i) Grant applications for renewable energy systems and energy efficiency improvements projects with total project costs of $80,000 or less must provide information required by 7 CFR 4280.119.

(ii) Grant applications for renewable energy systems and energy efficiency improvements projects with total project costs of $200,000 or less, but more than $80,000, must provide information required by 7 CFR 4280.118.

(iii) Grant applications for renewable energy systems and energy efficiency improvements projects with total project costs of greater than $200,000 must provide information required by 7 CFR 4280.117.

(iv) Grant applications for energy audits or renewable energy development assistance grant applications must provide information required by 7 CFR 4280.190.

(b) All grant applications must be submitted either as hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located, or electronically using the Government-wide www.grants.gov website.

(i) Applicants submitting a grant application as a hard copy must submit one original to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located. A list of USDA Rural Development Energy Coordinators is available via the following link: https://www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf.

(ii) Applicants submitting a grant application to the Agency via www.grants.gov (website) will find information about submitting an application electronically through the website, and may download a copy of the application package to complete it off line, upload and submit the completed application, including all necessary assurances and certifications, via www.grants.gov. After electronically submitting an application through the website, the applicant will receive an automated acknowledgement from www.grants.gov that contains a www.grants.gov tracking number. USDA Rural Development strongly recommends that applicants do not wait until the application deadline date to begin the application process through www.grants.gov.

(c) After successful applicants are notified of the intent to make a Federal award, applicants must meet the requirements of 7 CFR 4280.122 (a) through (h) for the grant agreement to be executed.

(2) Renewable energy system and energy efficiency improvements guaranteed loan application.

(a) Information for the content required for a guaranteed loan application to be considered complete is found in 7 CFR 4280.137.

(b) All guaranteed loan applications must be submitted as a hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located. A list of USDA Rural Development Energy Coordinators is available via the following link: https://www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf.

(c) After successful applicants are notified of the intent to make a Federal award, borrowers must meet the conditions prior to issuance of loan note guarantee as outlined in of 7 CFR 4280.142.

(3) Renewable energy system and energy efficiency improvements combined guaranteed loan and grant application.

(a) Information for the content required for a combined guaranteed loan and grant application to be considered complete is found in 7 CFR 4280.165(c).

(b) All combined guaranteed loan and grant applications must be submitted as hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located. A list of USDA Rural Development Energy Coordinators is available via the following link: www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf.

(c) After successful applicants are notified of the intent to make a Federal award, applicants must meet the requirements, including the requisite forms and certifications, specified in 7 CFR 4280.117, 4280.118, 4280.119, and 4280.137, as applicable, for the issuance of a grant agreement and loan note guarantee.

(4) Energy audits or renewable development assistance grant applications.

(a) Grant applications for energy audits or renewable energy development assistance must provide the information required by 7 CFR 4280.190 to be considered a complete application.

(b) All energy audits or renewable development assistance grant applications must be submitted either as hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located, electronically using the Government-wide www.grants.gov website, or via an alternative electronic format with electronic signature followed up by providing original signatures to the appropriate Rural Development office. Instructions for submission of the application can be found at section IV.B. of this Notice.

(c) After successful applicants are notified of the intent to make a Federal award, applicants must meet the requirements of 7 CFR 4280.195 for the grant agreement to be executed.

5. Dun and Bradstreet Universal Numbering System (DUNS) Number and System for Award Management (SAM). Unless exempt under 2 CFR 25.110, or who have an exception approved by the Federal awarding agency under 2 CFR 25.110 (d), applicants as applicable are required to:

(a) Be registered in SAM prior to submitting a grant application; which can be obtained at no cost via a toll-free request line at (866) 705-5711 or online at fedgov.dnb.com/webform.

(b) Provide a valid DUNS number in its grant or loan application.

(c) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal grant award or a grant application under consideration by the Agency.

(d) If an applicant has not fully complied with the requirements of IV.C. (1) through (3) at the time the Agency is ready to make an award, the Agency may determine the applicant is not eligible to receive the award.

C. Submission Dates and Times. Grant applications, guaranteed loan-only applications, and combined grant and guaranteed loan applications for financial assistance provided by the 2014 Farm Bill for Federal FY 2018, and for appropriated funds that REAP may receive from the appropriation for Federal FY 2018, may be submitted at any time on an ongoing basis. When an application window closes, the next application window opens on the following day. This Notice establishes the deadline dates for the applications to be received in order to be considered for funding. If an application window falls on a Saturday, Sunday, or Federal holiday, the application package is due the next business day. An application received after these dates will be considered with other applications received in the next application window. In order to be considered for funds under this Notice, complete applications must be received by the appropriate USDA Rural Development State Office or via www.grants.gov. The deadline for applications to be received to be considered for funding in Federal FY 2018 are outlined in the following paragraphs and also summarized in a table at the end of this section:

(1) Renewable energy system and energy efficiency improvements grant applications and combination grant and guaranteed loan applications. As per RD Instruction 4280-B Application deadlines for Federal FY 2018 grant funds are:

(a) For applicants requesting a grant only of $20,000 or less or a combination grant and guaranteed loan where the grant request is $20,000 or less, that wish to have their grant application compete for the “Grants of $20,000 or less set aside,” complete applications must be received no later than:

(i) 4:30 p.m. local time on October 31, 2017, or

(ii) 4:30 p.m. local time on April 30, 2018.

(b) For applicants requesting a grant only of over $20,000 (unrestricted) or a combination grant and guaranteed loan where the grant request is greater than $20,000, complete applications must be received no later than 4:30 p.m. local time on April 30, 2018.

(2) Renewable energy system and energy efficiency improvements guaranteed loan-only applications. Eligible applications will be reviewed and processed when received for periodic competitions.

(3) Energy audits and renewable energy development assistance grant applications. Applications must be received no later than 4:30 p.m. local time on January 31, 2018.

D. Intergovernmental Review. REAP is not subject to Executive Order 12372, Intergovernmental Review of Federal Programs.

E. Funding Restrictions. The following funding limitations apply to applications submitted under this Notice.

(1) Renewable energy system and energy efficiency improvements projects.

(a) Applicants can be awarded only one renewable energy system grant and one energy efficiency improvement grant in Federal FY 2018.

(b) For renewable energy system grants, the minimum grant is $2,500 and the maximum is $500,000. For energy efficiency improvements grants, the minimum grant is $1,500 and the maximum grant is $250,000.

(c) For renewable energy system and energy efficiency improvements loan guarantees, the minimum REAP guaranteed loan amount is $5,000 and the maximum amount of a guaranteed loan to be provided to a borrower is $25 million.

(d) Renewable energy system and energy efficiency improvements guaranteed loan and grant combination applications. Paragraphs IV.E.(1)(b) and (c) of this Notice contain the applicable maximum amounts and minimum amounts for grants and guaranteed loans. Requests for guaranteed loan and combined grant and guaranteed loan will not exceed 75 percent of eligible project costs, with any Federal grant portion not to exceed 25 percent of the eligible project costs, whether the grant is part of a combination request or is a grant-only.

(2) Energy audit and renewable energy development assistance grants.

(a) Applicants may submit only one energy audit grant application and one renewable energy development assistance grant application for Federal FY 2018 funds.

(b) The maximum aggregate amount of energy audit and renewable energy development assistance grants awarded to any one recipient under this Notice cannot exceed $100,000 for Federal FY 2018.

(c) The 2014 Farm Bill mandates that the recipient of a grant that conducts an energy audit for an agricultural producer or a rural small business must require the agricultural producer or rural small business to pay at least 25 percent of the cost of the energy audit, which shall be retained by the eligible entity for the cost of the audit.

(3) Maximum grant assistance to an entity. For the purposes of this Notice, the maximum amount of grant assistance to an entity will not exceed $750,000 for Federal FY 2018 based on the total amount of the renewable energy system, energy efficiency improvements, energy audit, and renewable energy development assistance grants awarded to an entity under REAP.

F. Other Submission Requirements.

(1) Environmental information. For the Agency to consider an application, the application must include all environmental review documents with supporting documentation in accordance with 7 CFR part 1970. Any required environmental review must be completed prior to obligation of funds or the approval of the application. Applicants are advised to contact the Agency to determine environmental requirements as soon as practicable to ensure adequate review time.

(2) Felony conviction and tax delinquent status. Corporate applicants submitting applications under this Notice must include Form AD 3030, “Representations Regarding Felony Conviction and Tax Delinquent Status for Corporate Applicants.” Corporate applicants who receive an award under this Notice will be required to sign Form AD 3031, “Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants.” Both forms can be found online at http://www.ocio.usda.gov/document/ad3030, and http://www.ocio.usda.gov/document/ad3031.

(3) Original signatures. USDA Rural Development may request that the applicant provide original signatures on forms submitted through www.grants.gov at a later date.

(4) Transparency Act Reporting. All recipients of Federal financial assistance are required to report information about first-tier sub-awards and executive compensation in accordance with 2 CFR part 170. If an applicant does not have an exception under 2 CFR 170.110(b), the applicant must then ensure that they have the necessary processes and systems in place to comply with the reporting requirements to receive funding.

(5) Race, ethnicity, and gender. The Agency is requesting that each applicant provide race, ethnicity, and gender information about the applicant. The information will allow the Agency to evaluate its outreach efforts to under-served and under-represented populations. Applicants are encouraged to furnish this information with their applications, but are not required to do so. An applicant's eligibility or the likelihood of receiving an award will not be impacted by furnishing or not furnishing this information. However, failure to furnish this information may preclude the awarding of State Director and Administrator points in Section V.E.(3) of this Notice.

A. Criteria. In accordance with 7 CFR part 4280 subpart B, the application dates published in Section IV.C. of this Notice identify the times and dates by which complete applications must be received in order to compete for the funds available.

(1) Renewable energy systems and energy efficiency improvements grant applications. Complete renewable energy systems and energy efficiency improvements grant applications are eligible to compete in competitions as described in 7 CFR 4280.121.

(a) Complete renewable energy systems and energy efficiency improvements grant applications requesting $20,000 or less are eligible to compete in up to five competitions within the Federal FY as described in 7 CFR 4280.121(b). If the application remains unfunded after the final national office competition for the Federal FY it must be withdrawn. Pursuant to the publication of this announcement, all complete and eligible applications will be limited to competing in the Federal FY that the application was received, versus rolling into the following Federal FY, which may result in less than five total competitions. This was effective for any application submitted on or after April 1, 2017.

(b) Complete renewable energy systems and energy efficiency improvements grant applications, regardless of the amount of funding requested are eligible to compete in two competitions a Federal FY—a State competition and a national competition as described in 7 CFR 4280.121(a).

(2) Renewable energy systems and energy efficiency improvements guaranteed loan applications. Complete guaranteed loan applications are eligible for periodic competitions as described in 7 CFR 4280.139(a).

(3) Renewable energy systems and energy efficiency improvements combined guaranteed loan and grant applications. Complete combined guaranteed loan and grant applications with requests of $20,000 or less are eligible to compete in up to five competitions within the Federal FY as described in 7 CFR 4280.121(b). Combination applications where the grant request is greater than $20,000, are eligible to compete in two competitions a Federal FY—a State competition and a national competition as described in 7 CFR 4280.121(a).

(4) Energy audit and renewable energy development assistance grant applications. Complete energy audit and renewable energy development assistance grants applications are eligible to compete in one national competition per Federal FY as described in 7 CFR 4280.193.

B. Review and Selection Process. All complete applications will be scored in accordance with 7 CFR part 4280 subpart B and this section of the Notice. Specifically, sections C and D below outline revisions to the scoring criteria found in 7 CFR 4280.120.

(1) Renewable energy systems and energy efficiency improvements grant applications. Renewable energy system and energy efficiency grant applications will be scored in accordance with 7 CFR 4280.120 and selections will be made in accordance with 7 CFR 4280.121. For grant applications requesting greater than $250,000 for renewable energy systems, and/or greater than $125,000 for energy efficiency improvements a maximum score of 90 points is possible. For grant applications requesting $250,000 or less for renewable energy systems and/or $125,000 or less for energy efficiency improvements, an additional 10 points may be awarded such that a maximum score of 100 points is possible. Due to the competitive nature of this program, applications are competed based on submittal date. The submittal date is the date the Agency receives a complete application. The complete application date is the date the Agency receives the last piece of information that allows the Agency to determine eligibility and to score, rank, and compete the application for funding.

(a) Funds for renewable energy system and energy efficiency improvements grants of $20,000 or less will be allocated to the States. Eligible applications must be submitted by April 30, 2018, in order to be considered for these set-aside funds. Approximately 50 percent of these funds will be made available for those complete applications the Agency receives by October 31, 2017, and approximately 50 percent of the funds for those complete applications the Agency receives by April 30, 2018. All unused State allocated funds for grants of $20,000 or less will be pooled to the National Office.

(b) Eligible applications received by April 30, 2018, for renewable energy system and energy efficiency improvements grants of $20,000 or less, that are not funded by State allocations can be submitted to the National Office to compete against grant applications of $20,000 or less from other States at a national competition. Obligations of these funds will take place prior to June 29, 2018.

(c) Eligible applications for renewable energy system and energy efficiency improvements, regardless of the amount of the funding request, received by April 30, 2018, can compete for unrestricted grant funds. Unrestricted grant funds will be allocated to the States. All unused State allocated unrestricted grant funds will be pooled to the National Office.

(d) National unrestricted grant funds for all eligible renewable energy system and energy efficiency improvements grant applications received by April 30, 2018, which include grants of $20,000 or less, that are not funded by State allocations can be submitted to the National Office to compete against grant applications from other States at a final national competition.

(2) Renewable energy systems and energy efficiency improvements guaranteed loan applications. Renewable energy systems and energy efficiency improvements guaranteed loan applications will be scored in accordance with 7 CFR 4280.135 and selections will be made in accordance with 7 CFR 4280.139. The National Office will maintain a reserve for renewable energy system and energy efficiency improvements guaranteed loan funds. Applications will be reviewed and processed when received. Those applications that meet the Agency's underwriting requirements, are credit worthy, and score a minimum of 40 points will compete in national competitions for guaranteed loan funds periodically. All unfunded eligible guaranteed loan-only applications received that do not score at least 40 points will be competed against other guaranteed loan-only applications from other States at a final national competition, if the guaranteed loan reserves have not been completely depleted, on September 3, 2018. If funds remain after the final guaranteed loan-only national competition, the Agency may elect to utilize budget authority to fund additional grant-only applications.

(3) Renewable energy systems and energy efficiency improvements combined grant and guaranteed loan applications. Renewable energy systems and energy efficiency improvements combined grant and guaranteed loan applications will be scored in accordance with 7 CFR 4280.120 and selections will be made in accordance with 7 CFR 4280.121. For combined grant and guaranteed loan applications requesting grant funds of $250,000 or less for renewable energy systems, or $125,000 or less for energy efficiency improvements, a maximum score of 100 points is possible. For combined grant and guaranteed loan applications requesting grant funds of more than $250,000 for renewable energy systems, or more than $125,000 for energy efficiency improvements, a maximum score of 90 points is possible.

Renewable energy system and energy efficiency improvements combined grant and guaranteed loan applications will compete with grant-only applications for grant funds allocated to their State. If the application is ranked high enough to receive State allocated grant funds, the State will request funding for the guaranteed loan portion of any combined grant and guaranteed loan applications from the National Office guaranteed loan reserve, and no further competition will be required. All unfunded eligible applications for combined grant and guaranteed loan applications that are received by April 30, 2018, and that are not funded by State allocations can be submitted to the National Office to compete against other grant and combined grant and guaranteed loan applications from other States at a final national competition.

(4) Energy audit and renewable energy development assistance grant applications. Energy audit and renewable energy development assistance grants will be scored in accordance with 7 CFR 4280.192 and selections will be made in accordance with 7 CFR 4280.193. Energy audit and renewable energy development assistance grant funds will be maintained in a reserve at the National Office. Applications received by January 31, 2018 will compete for funding at a national competition, based on the scoring criteria established under 7 CFR 4280.192. If funds remain after the energy audit and renewable energy development assistance national competition, the Agency may elect to transfer budget authority to fund additional renewable energy system and energy efficiency improvements grants from the National Office reserve after pooling.

C. Size of Agricultural Producer or Rural Small Business.

The criterion noted in 7 CFR 4280.120 (d) which allows for a maximum of 10 points to be awarded based on the size of the Applicant's agricultural operation or business concern, as applicable, compared to the SBA Small Business size standards categorized by NAICS found in 13 CFR 121.201, is being removed for applications for renewable energy systems or energy efficiency improvements effective as of the date of this publication.

D. State Director and Administrator Points. The criterion noted in 7 CFR 4280.120(g) allows for the State Director and the Administrator to take into consideration paragraphs V.D.(1) through (5) below in the awarding of up to 10 points for eligible renewable energy systems and energy efficiency improvement grant applications submitted in Federal FY 2018:

(1) May allow for applications for an under-represented technology to receive additional points.

(2) May allow for applications that help achieve geographic diversity to receive additional points. This may include priority points for smaller grant requests which enhances geographic diversity.

(3) May allow for applicants who are members of unserved or under-served populations to receive additional points if one of the following criteria are met:

(a) Owned by a veteran, including but not limited to individuals as sole proprietors, members, partners, stockholders, etc., of not less than 20 percent. In order to receive points, applicants must provide a statement in their applications to indicate that owners of the project have veteran status; or

(b) Owned by a member of a socially-disadvantaged group, which are groups whose members have been subjected to racial, ethnic, or gender prejudice because of their identity as members of a group without regard to their individual qualities. In order to receive points, the application must include a statement to indicate that the owners of the project are members of a socially-disadvantaged group.

(4) May allow for applications that further a Presidential initiative, or a Secretary of Agriculture priority, including Federally declared disaster areas, to receive additional points.

(5) The proposed project is located in an impoverished area, has experienced long-term population decline, or loss of employment.

E. Other Submission Requirements. Grant-only applications, guaranteed loan-only applications, and combined grant and guaranteed loan applications for financial assistance may be submitted at any time. In order to be considered for funds, complete applications must be received by the appropriate USDA Rural Development State Office in which the applicant's proposed project is located, or via www.grants.gov, as identified in Section IV.C., of this Notice.

(1) Insufficient funds. If funds are not sufficient to fund the total amount of an application:

(a) For State allocated funds:

(i) The applicant must be notified that they may accept the remaining funds or submit the total request for National Office reserve funds available after pooling. If the applicant agrees to lower its grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project.

(ii) If two or more grant or combination applications have the same score and remaining funds in the State allocation are insufficient to fully award them, the Agency will notify the applicants that they may either accept the proportional amount of funds or submit their total request for National Office reserve funds available after pooling. If the applicant agrees to lower its grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project.

(b) The applicant notification for national funds will depend on the competition as follows:

(i) For an application requesting a grant of $20,000 or less or a combination application where the grant amount is $20,000 or less from set-aside pooled funds, the applicant must be notified that they may accept the remaining funds, or submit the total request to compete in the unrestricted state competition. If the applicant agrees to lower the grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project. A declined partial award counts as a competition.

(ii) For an application requesting a grant of $20,000 or less or a combination application where the grant amount is $20,000 or less from unrestricted pooled funds, in which this is the final competition or for those applications requesting grants of over $20,000 and combined grant and guaranteed loan application, the applicant must be notified that they may accept the remaining funds or their grant application will be withdrawn. If the applicant agrees to lower the grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project.

(iii) If two or more grant or combination applications have the same score and remaining funds are insufficient to fully award them, the Agency will notify the applicants that they may either accept the proportional amount of funds or be notified in accordance with V.D.(1)(b)(i) or (ii), as applicable.

(iv) At its discretion, the Agency may instead allow the remaining funds to be carried over to the next Federal FY rather than selecting a lower scoring application(s) or distributing funds on a pro-rata basis.

(2) Award considerations. All award considerations will be on a discretionary basis. In determining the amount of a renewable energy system or energy efficiency improvements grant or loan guarantee, the Agency will consider the six criteria specified in 7 CFR 4280.114(e) or 7 CFR 4280.129(g), as applicable.

(3) Notification of funding determination. As per 7 CFR 4280.111(c) all applicants will be informed in writing by the Agency as to the funding determination of the application.

A. Federal Award Notices. The Agency will award and administer renewable energy system and energy efficiency improvements grants, guaranteed loans in accordance with 7 CFR 4280.122, and 7 CFR 4280.139, as applicable. The Agency will award and administer the energy audit and renewable energy development assistance grants in accordance with 7 CFR 4280.195. Notification requirements of 7 CFR 4280.111, apply to this Notice.

B. Administrative and National Policy Requirements.

(1) Equal Opportunity and Nondiscrimination. The Agency will ensure that equal opportunity and nondiscrimination requirements are met in accordance with the Equal Credit Opportunity Act, 15 U.S.C. 1691 et seq. and 7 CFR part 15d, Nondiscrimination in Programs and Activities Conducted by the U.S. Department of Agriculture. The Agency will not discriminate against applicants on the basis of race, color, religion, national origin, sex, marital status, or age (provided that the applicant has the capacity to contract); because all or part of the applicant's income derives from any public assistance program; or because the applicant has in good faith exercised any right under the Consumer Credit Protection Act, 15 U.S.C. 1601 et seq.

(2) Civil Rights Compliance. Recipients of grants must comply with the Americans with Disabilities Act of 1990, 42 U.S.C. 12101 et seq., Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d et seq., and Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794. This may include collection and maintenance of data on the race, sex, and national origin of the recipient's membership/ownership and employees. These data must be available to conduct compliance reviews in accordance with 7 CFR 1901.204.

(3) Environmental Analysis. Environmental procedures and requirements for this subpart are specified in 7 CFR part 1970. Prospective applicants are advised to contact the Agency to determine environmental requirements as soon as practicable after they decide to pursue any form of financial assistance directly or indirectly available through the Agency.

(4) Appeals. A person may seek a review of an Agency decision or appeal to the National Appeals Division in accordance with 7 CFR 4280.105.

(5) Reporting. Grants, guaranteed loans, combination guaranteed loans and grants, and energy audit and energy audit and renewable energy development assistance grants that are awarded are required to fulfill the reporting requirements as specified in Departmental Regulations, the Grant Agreement, and in 7 CFR part 4280 subpart B and paragraphs VI.B.(5)(a) through (d) of this Notice.

(a) Renewable energy system and energy efficiency improvements grants that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.123.

(b) Guaranteed loan applications that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.143.

(c) Combined guaranteed loan and grant applications that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.165(f).

(d) Energy audit and renewable energy development assistance grants grant applications that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.196.

For further information contact the applicable USDA Rural Development Energy Coordinator for your respective State, as identified via the following link: http://www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf.

For information about this Notice, please contact Maureen Hessel, Business Loan and Grant Analyst, USDA Rural Development, Energy Division, 1400 Independence Avenue SW, Stop 3225, Room 6866, Washington, DC 20250. Telephone: (202) 401-0142. Email: [email protected].

In accordance with the Paperwork Reduction Act of 1995, the information collection requirements associated with renewable energy system and energy efficiency improvements grants and guaranteed loans, as covered in this Notice, have been approved by the Office of Management and Budget (OMB) under OMB Control Number 0570-0050. The information collection requirements associated with energy audit and renewable energy development assistance grants have also been approved by OMB under OMB Control Number 0570-0059.

In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at http://www.ascr.usda.gov/complaint_filing_cust.html and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by:

(1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410;

(2) Fax: (202) 690-7442; or

(3) Email: [email protected].

USDA is an equal opportunity provider, employer, and lender.

This meeting is available to the public through the following toll-free call-in number: 888-516-2447, conference ID number: 8154017. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

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

Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://facadatabase.gov/committee/meetings.aspx?cid=259.

Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above 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 circumstance of this Committee preparing for its upcoming public meeting to hear testimony.

Members of the public may also listen to the discussion through the above listed toll free number. As well as attending in person, any interested member of the public may call the above listed number and listen to 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.

Time will be set aside at the community forum from 4:00 p.m.-5:00 p.m. so that members of the public may address the Committee after the formal presentations have been completed. Persons interested in the issue are also invited to submit written comments; the comments must be received in the regional office by Monday, April 30, 2018. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012, faxed to (213) 894-0508, or emailed to Angelica Trevino at [email protected]. Persons who desire additional information may contact the Western Regional Office at (213) 894-3437. Persons who plan to attend the community forum and require other accommodations, please contact Evelyn Bohor at ebohor @usccr.gov at the Rocky Mountain Regional Office at least ten (10) working days before the scheduled date of the meeting.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://facadatabase.gov/committee/committee.aspx?cid=259&aid=17 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Western 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 Western Regional Office at the above phone number, email or street address.

Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 877-879-6207, conference ID: 2611734. Any interested member of the public may call this number and listen to 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 1-800-977-8339 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 Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to David Barreras at [email protected]. Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311.

Records generated from this meeting may be inspected and reproduced at the Midwestern Regional 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, Alabama Advisory Committee link (http://www.facadatabase.gov/committee/committee.aspx?cid=233&aid=17). Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.

Background

On April 10, 2017, Commerce published in the Federal Register the notice of initiation of an administrative review of the AD order on stainless steel butt-weld pipe fittings (SSBW pipe fittings) from Italy for the period February 1, 2016, through January 31, 2017.1 Commerce initiated a review with respect to one company, Filmag. On October 31, 2017, Commerce extended the preliminary results of review until January 2, 2018.2 On December 28, 2017, Commerce extended the preliminary results of review until February 28, 2018.3

Commerce exercised its discretion to toll all deadlines affected by the closure of the Federal Government from January 20 through 22, 2018. If the new deadline falls on a non-business day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the final results of this review is now March 5, 2018.4

The merchandise covered by the order is certain stainless steel butt-weld pipe fittings from Italy.5 Stainless steel butt-weld pipe fittings are under 14 inches in outside diameter (based on nominal pipe size), whether finished or unfinished. The product encompasses all grades of stainless steel and “commodity” and “specialty” fittings. Specifically excluded from the definition are threaded, grooved, and bolted fittings, and fittings made from any material other than stainless steel.

The butt-weld fittings subject to the order are currently classifiable under subheading 7307.23.0000 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of the order is dispositive. A full description of the scope of the order is contained in the memorandum from Christian Marsh, Deputy Assistant Secretary for Enforcement and Compliance, to Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, titled “Decision Memorandum for Preliminary Results of Antidumping Duty Administrative Review: Stainless Steel Butt-Weld Pipe Fittings from Italy; 2016-2017” (Preliminary Decision Memorandum), which is issued concurrent with these results and hereby adopted by this notice.

Commerce is conducting this review in accordance with sections 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). Export price has been calculated in accordance with section 772 of the Act. Normal value has been calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.

The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). Access to ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. A list of topics discussed in the Preliminary Decision Memorandum is attached as an Appendix to this notice. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

We preliminarily determine that, for the period February 1, 2016, through January 31, 2017, the following dumping margin exists:

Commerce intends to disclose to parties to the proceeding any calculations performed in connection with these preliminary results of review within five days after the date of publication of this notice.6 Interested parties may submit case briefs to Commerce in response to these preliminary results no later than 30 days after the publication of these preliminary results.7 Rebuttal briefs, the content of which is limited to the issues raised in the case briefs, must be filed within five days from the deadline date for the submission of case briefs.8

Parties who submit arguments in this proceeding are requested to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.9 Case and rebuttal briefs should be filed using ACCESS.10 Case and rebuttal briefs must be served on interested parties.11 Executive summaries should be limited to five pages total, including footnotes.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a date and time to be determined.12 Parties should confirm the date, time, and location of the hearing by telephone two days before the scheduled date.

Commerce intends to publish the final results of this administrative review, including the results of its analysis of issues addressed in any case or rebuttal brief, no later than 120 days after publication of these preliminary results, unless extended.13

Upon issuance of the final results in this administrative review, Commerce shall determine, and Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries.14 If Filmag's weighted-average dumping margin is not zero or de minimis in the final results of this review, we will calculate importer- or customer-specific ad valorem assessment rates for the merchandise based on the ratio of the total amount of antidumping duties calculated for the examined sales made during the period of review to the total customs value of the sales used to calculate those duties in accordance with 19 CFR 351.212(b)(1). Where an importer-specific ad valorem assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties in accordance with 19 CFR 351.106(c)(2). If the respondent's weighted-average dumping margin is zero or de minimis in the final results of review, we will instruct CBP liquidate the appropriate entries without regard to duties in accordance with the Final Modification for Reviews, i.e., “{w}here the weighted-average margin of dumping for the exporter is determined to be zero or de minimis, no antidumping duties will be assessed.” 15

We intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review.

The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Filmag will be that established in the final results of this administrative review; (2) for previously reviewed or investigated companies, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or in the investigation but the manufacturer is, the cash deposit rate will be the rate established for the most recent review period for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be the all-others rate of 26.59 percent, the rate established in the investigation of this proceeding.16 These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

This notice is relevant to the following species and evolutionarily significant unit (ESU)/distinct population segment (DPS):

Steelhead (O. mykiss): Threatened, naturally produced and artificially propagated Upper Columbia River.

Title; Associated Form; and OMB Number: Evaluation of Health Status of an Infantry Battalion Following Deployment in Support of Operation Iraqi Freedom in 2004-2005; OMB Control Number 0702-XXXX.

Needs and Uses: The information collection requirement is necessary to assess and evaluate the self-reported post-deployment health status of selected soldiers who operated in the vicinity of Mosul, Iraq in 2004 (e.g., 1-24 Infantry Battalion). The data collected from the survey will be used to compare the health of current and former U.S. Army personnel after their initial deployment in support of Operation Iraqi Freedom (OIF) to that of a subset of Millennium Cohort Study participants. This evaluation is being conducted at the request of the Army Chief of Staff.

Affected public: Individuals or Households.

Annual burden hours: 3,500.

Number of respondents: 3,500.

Responses per respondent: 1.

Annual responses: 3,500.

Average burden per response: 60 minutes.

Frequency: One time.

Respondents are former soldiers who deployed in support of OIF. The post-deployment health survey will record self-reported health topics, including medical conditions, health behaviors, and exposures that may have affected the health of soldiers and veterans. The data from the completed survey will be used to compare the health status of members of the 1-24 Infantry Battalion (1-24 IN) who deployed to Mosul, Iraq in 2004-2005 and a similar exposure group consisting of other personnel in the 1st Stryker Brigade Combat Team (SBCT) to a comparable set of soldiers and veterans participating in a separate and not related Millennium Cohort Study. A deployment and environmental health surveillance investigation conducted by the APHC in 2014 was unable to discern etiologic elements connecting the multitude of health conditions and symptoms experienced by a small subset of the 1-24 IN. Deployment-associated environmental exposures which may have increased the risk of developing these conditions were not identified; however, a comprehensive comparative evaluation that includes self-reported data and all former members of the 1-24 IN who served in Mosul has not been conducted.

The EA was prepared as required under the National Environmental Policy Act (NEPA) of 1969. In addition, the EA complied with DLA Regulation 1000.22. DLA completed an EA to address the potential environmental consequences associated with the Proposed Action at Defense Supply Center Richmond. This FONSI incorporates the EA by reference and summarizes the results of the analyses in the EA. Additionally, this FONSI documents the decision of DLA to implement the Proposed Action at Defense Supply Center Richmond. DLA has determined that the Proposed Action is not a major federal action significantly affecting the quality of the human environment within the context of NEPA and that no significant impacts on the human environment are associated with this decision.

DLA received two comments during the 30-day public comment period. An anonymous comment, dated September 13, 2016, concurred with DLA that the Proposed Action would not result in a significant impact. The Virginia Department of Environmental Quality (DEQ) coordinated review of the EA by state agencies, planning district commissions, and Chesterfield County and provided a consolidated comment letter dated September 15, 2016. The Virginia DEQ consolidated comment letter noted the EA did not address potential impacts to land analogous to Chesapeake Bay Preservation Areas. On September 22, 2017, DLA responded to the Virginia DEQ consolidated comment letter. DLA's response letter noted that DLA conducted a wetland delineation, stream assessment, and resource protection area (RPA) delineation and submitted a RPA Designation Application to Chesterfield County requesting redesignation of the RPA within a portion of the proposed 18.2-acre outdoor storage area on March 31, 2017. Chesterfield County confirmed DLA's perennial stream flow determination and RPA designations on April 14, 2017.

DLA determined that the Proposed Action would be consistent, to the maximum extent practicable, with the enforceable policies of Virginia's Coastal Zone Management Program and submitted a coastal zone consistency determination for Virginia DEQ review on June 9, 2016. On August 16, 2016, Virginia DEQ concurred that the Proposed Action would be consistent with Virginia's Coastal Zone Management Program provided DLA obtains all applicable permits and approvals.

The Proposed Action would take place within the Bellwood-Richmond Quartermaster Depot Historic District, which is eligible for listing in the National Register of Historic Places. Pursuant to the National Historic Preservation Act, DLA contacted the State Historic Preservation Officer to conduct Section 106 consultation for the Proposed Action on September 25, 2015. In a letter dated November 2, 2015, the State Historic Preservation Office concurred that the Proposed Action would not adversely affect historic properties.

The EA includes an appendix with the public's comments and DLA's response, coastal zone consistency documentation, and State Historic Preservation Office consultation documents. The revised EA is available electronically at the Federal eRulemaking Portal at http://www.regulations.gov within Docket ID: DOD-2016-OS-0086.

Purpose and Need for Action: The purpose of the Proposed Action is to improve the efficiency of DLA Disposition Services operations in the Eastern United States. The Proposed Action is necessary, because the DLA Disposition Services disposal network in the Eastern United States has experienced increased customer wait times, insufficient loading bays, workload and productivity imbalances between sites, aging facilities, and a lack of process optimization since DLA Distribution and DLA Disposition Services merged materiel receipt, storage, and distribution functions.

Proposed Action and Alternatives: Under the Proposed Action, DLA would: (1) Redesign the DLA Disposition Services mid-Atlantic disposal network. This will divert incoming excess military property from DLA Disposition Services at Fort Meade, Fort Bragg, Norfolk, and Susquehanna to DLA Disposition Services at Richmond. (2) Expand DLA Disposition Services at Richmond to a full-service operation (i.e., receive, store, distribute, and sell excess military equipment; documentation of hazardous materials management; demilitarization; and scrap operations). The expansion increases the warehouse footprint from 60,000 to 340,000 square feet (an addition of 280,000 square feet) and increases the outdoor storage area footprint from 34 to 60 acres (an addition of 26 acres). (3) Create an operational test bed for research, development, testing, and evaluation of standardized disposal practices at DLA Disposition Services at Richmond.

Description of the No Action Alternative: The No Action Alternative avoids relocation, or expansion of DLA Disposition Services at Richmond. DLA Disposition Services would continue to operate with extensive customer wait times, insufficient loading bays, workload and productivity imbalances between sites, aging facilities, and a lack of process optimization. The No Action Alternative would not meet the purpose of and need for the Proposed Action.

Potential Environmental Impacts: No significant effects on environmental resources are expected from the Proposed Action. Insignificant, adverse effects on land use, e.g., noise, air quality, geological resources, water resources, biological resources, cultural resources, infrastructure and transportation, hazardous materials and wastes, and health and safety are to be expected. Insignificant and beneficial effects on infrastructure and socioeconomics are also to be expected. The EA covers details of the environmental consequences, which is hereby incorporated by reference.

Determination: DLA has determined that implementation of the Proposed Action will not have a significant effect on the human environment. DLA interprets the human environment as the natural and physical environment and the relationship of people with that environment. DLA based this determination on an analysis of uncertain or controversial impacts; unique or unknown risks; and cumulative impacts of the proposed action. Implementation of the Proposed Action will not violate any Federal, State, or local laws.

Mr. Phillip R. Dawson, Acting Director, DLA Installation Management, concludes that implementing the Proposed Action at the Defense Supply Center Richmond does not constitute a major federal action that would significantly affect the quality of the environment within the context of NEPA. This decision is based on the results of the analyses performed during the EA preparation as well as comments received from the public.

Therefore, an environmental impact statement for the Proposed Action is not required.

This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-79 with attached Policy Justification and Sensitivity of Technology.

(i) Prospective Purchaser: Government of Japan

(ii) Total Estimated Value:

(iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

Major Defense Equipment (MDE):

Twenty-four (24) MK 15 Phalanx Close-in Weapon System (CIWS) Block IB Baseline 1 to MK 15 Phalanx Block IB Baseline 2 Conversion Kits.

Non-MDE:

Also included is support equipment, spare parts, publications, software and associated support, and logistical support services, and other related elements of logistical and program support.

(iv) Military Department: Navy (JA-P-NBE)

(v) Prior Related Cases, if any: None

(vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

(vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: See Attached Annex

(viii) Date Report Delivered to Congress: March 2, 2018

* As defined in Section 47(6) of the Arms Export Control Act.

The Government of Japan has requested to buy twenty-four (24) MK 15 Phalanx Close-in Weapon System (CIWS) Block IB Baseline 1 to MK 15 Phalanx Block IB Baseline 2 conversion kits. Also included is support equipment, spare parts, publications, software and associated support, and logistical support services, and other related elements of logistical and program support. The estimated total case value is $45 million.

This proposed sale will contribute to the foreign policy and national security of the United States by improving the security of a major ally that has been, and continues to be, a force for political stability and economic progress in the Asia-Pacific region.

The proposed sale will improve Japan's capability in current and future defensive efforts. Japan will use the enhanced capability as a deterrent to regional threats and to strengthen homeland defense.

The proposed sale of this equipment and support will not alter the basic military balance in the region.

The principal contractor will be Raytheon Missile Systems, Tucson, AZ. There are no known offset agreements proposed in connection with this potential sale.

Implementation of this proposed sale will not require the permanent assignment of additional U.S. Government or contractor representatives in Japan.

There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

(vii) Sensitivity of Technology:

1. The CIWS Block IB Baseline 2 represents an increase in threat acquisition and firepower accuracy over previous Block 1 Baseline configurations. The Baseline 2 variant includes a radar improvement upgrade and an electro-optical sensor to improve weapon system performance against low-observable, sea-skimming threats, and provides improved capability to concentrate hard-kill ordnance in a tighter pattern on the threat. The CIWS mount and spare hardware are UNCLASSIFIED. The radar improvement/upgrade is the most sensitive portion of the Baseline 2 configuration.

2. The CIWS Block 1B Baseline 2 systems and upgrade kits will result in the transfer of a highly accurate close-in engagement technology and ship self-defense capability. The equipment, hardware, and the majority of documentation are UNCLASSIFIED. The embedded software and operational performance are classified CONFIDENTIAL. The seeker/electro-optical control section and the target detector are UNCLASSIFIED, but contain a sensitive state-of-the-art technology. Technical Manuals used to support the operation and provisioning of organizational-level maintenance are CONFIDENTIAL. The technical and operational data identified above is classified to protect vulnerabilities, design and performance parameters, and similar critical information.

3. If a technologically advanced adversary were to obtain knowledge of specific hardware, the information could be used to develop countermeasures which might reduce weapons system effectiveness or be used in the development of a system with similar or advanced capabilities.

4. A determination has been made that Japan can provide substantially the same degree of protection for sensitive technology being released as the U.S. Government. This proposed sustainment program is necessary to the furtherance of the U.S. foreign policy and national security objectives outlined in the policy justification.

5. All defense articles and services listed in this transmittal are authorized for release and export to the Government of Japan.

On March 2, 2018, we published in the Federal Register a notice inviting applications for new awards for FY 2018 for CSP—Grants to Charter School Developers for the Opening of New Charter Schools and for the Replication and Expansion of High-Quality Charter Schools (83 FR 8974). This correction notice provides a direct link to the application submission instructions.

In FR Doc. 2018-04294, we are revising the paragraph beginning on page 8979 in the second column, at the bottom of the page, under the heading “IV. Application and Submission Information,” to provide the link to the application submission instructions: 1. Application Submission Instructions: For information on how to submit an application please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the Federal Register on February 12, 2018 (83 FR 6003) and available at www.thefederalregister.org/fdsys/pkg/FR-2018-02-12/pdf/2018-02558.pdf.

Program Authority: Title IV, part C of the ESEA (20 U.S.C. 7221-7221j).

Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

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

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

On December 28, 2017, the FDIC requested comment for 60 days on a proposal to renew the information collections described below. One comment was received and was generally supportive of the requirements in the rule but did not address the paperwork burden for this information collection. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.

Proposal to renew the following currently approved collections of information:

1. Title: Uniform Application and Termination Notice for Municipal Securities Principal or Representative Associated with a Bank Municipal Securities Dealer.

OMB Number: 3064-0022.

Form Number: MSD-4 and MSD-5

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

Burden Estimate:

Total Estimated Annual Burden: 2.5 Hours.

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

General Description of Collection: The 1975 Amendments to the Securities Exchange Act of 1934 established a comprehensive framework for the regulation of the activities of municipal securities dealers. Under Section 15B(a) of the Securities Exchange Act, municipal securities dealers which are banks, or separately identifiable departments or divisions of banks engaging in municipal securities activities, are required to be registered with the Securities and Exchange Commission in accordance with such rules as the Municipal Securities Rulemaking Board (MSRB), a rulemaking authority established by the 1975 Amendments, may prescribe as necessary or appropriate in the public interest or for the protection of investors.

One of the areas in which the Act directed the MSRB to promulgate rules is the qualifications of persons associated with municipal securities dealers as municipal securities principals and municipal securities representatives. The MSRB Rules require persons who are or seek to be associated with municipal securities dealers as municipal securities principals or municipal securities representatives to provide certain background information and conversely, require the municipal securities dealers to obtain the information from such persons. Generally, the information required to be furnished relates to employment history and professional background including any disciplinary sanctions and any claimed bases for exemption from MSRB examination requirements.

The FDIC and the other two Federal bank regulatory agencies, the Comptroller of the Currency, and the Federal Reserve Board, have prescribed Forms MSD-4 to satisfy these requirements and have prescribed Form MSD-5 for notification by a bank municipal securities dealer that a municipal securities principal's or a municipal securities representative's association with the dealer has terminated and the reason for such termination. State nonmember banks and state savings associations that are municipal security dealers submit these forms, as applicable, to the FDIC as their appropriate regulatory agency for each person associated with the dealer as a municipal securities principal or municipal securities representative.

2. Title: Request for Deregistration for Registered Transfer Agents.

OMB Number: 3064-0027.

Form Number: 6342/12.

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

Burden Estimate:

There is no change in the method or substance of the collection. There is an overall reduction in burden hours which is the result of (1) economic fluctuation reflected by a decrease in the number of FDIC-supervised institutions and (2) a decrease in the number of requests for deregistration of a registered transfer agent forms submitted to the FDIC.

General Description of Collection: Under the Securities Exchange Act of 1934 (15 U.S.C. 78q-1), an insured nonmember bank (or a subsidiary of such a bank) that functions as a transfer agent may withdraw from registration as a transfer agent by filing a written notice of withdrawal with the FDIC. The FDIC requires such banks to file FDIC Form 6342/12 as the written notice of withdrawal.

Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

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

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Using Qualitative Methods to Understand Issues in HIV Prevention, Care and Treatment in the United States (OMB Control Number 0920-1091; expires 12/31/2018)—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC).

The CDC's National Center on HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Division of HIV/AIDS Prevention (DHAP) seeks a three-year extension to conduct qualitative studies to quickly identify barriers and facilitators to HIV prevention, care and treatment in specific regions with high HIV burden in the US. Proposed activities remain consistent with the national HIV prevention goals, the CDC Division of HIV/AIDS Prevention (DHAP) Strategic Plan, and DHAP's High-impact HIV Prevention approach.

The purposes for each data collection study supported under this umbrella generic information collection plan will be to understand specific barriers and facilitators to local HIV prevention, care and treatment in the United States and territories. For example, each study will seek to identify ways to improve programmatic activities along the continuum of HIV prevention, treatment and care for different populations residing in different geographic settings with greatest burden of HIV.

The target populations for the studies include, but are not limited to: (1) Persons living with HIV who are in treatment; (2) persons living with HIV who are out of treatment and who may or may not be seeking treatment at healthcare facilities; (3) persons at high risk for HIV acquisition (HIV negative) and HIV transmission (HIV positive); (4) persons from groups at high risk for HIV including gay, bisexual and other MSM, transgender persons, and injection and non-injection drug users; (5) persons from racial and ethnic minorities; and (6) healthcare providers or other professionals who provide HIV prevention, care and treatment services. Other populations may include individuals who provide non-HIV services or otherwise interact with persons living with HIV or persons at risk for HIV acquisition.

Studies will only provide local contextual information about the barriers and facilitators to HIV prevention, care, and treatment experienced by specific communities at risk for acquiring HIV infection, by HIV-positive persons across the HIV care continuum, and by organizations or individuals providing HIV prevention, care, treatment, and related support services.

Data collection methods used in any of the specific studies primarily will consist of rapid qualitative assessment methodologies, such as semi-structured and in-depth qualitative interviews, focus groups; direct observations; document reviews; and short structured surveys. Data will be analyzed using well-established qualitative analysis methods, such as coding interviews for themes about barriers and successes to HIV prevention, care, and treatment. Structured response surveys will be analyzed using descriptive statistics and other appropriate statistical methods.

CDC will use the results from each specific data collection study to help identify ways to improve local programmatic activities for specific communities along the continuum of HIV prevention, treatment and care for populations and areas with the greatest HIV burden. CDC will communicate study outcomes to local stakeholders and organizations in positions to consider and implement site-specific improvements in HIV prevention, care, and treatment for each of the study sites examined. For stakeholders, organizations, or agencies outside the local affected communities, all communications will include clear discussion of the limitations of the region-specific, qualitative methods and the non-generalizability of the study outcomes.

For a given year, each separate data collection will range from 30 (minimum) to 200 (maximum) respondents, based on the nature and scope of the research purposes. For example, if there are three data collections, the maximum combined number of expected respondents is 600. In a given year, CDC anticipates the need to screen 1,600 persons to identify 800 eligible persons, of which 600 persons will agree to participate.

CDC anticipates that screener forms will take 5 minutes to complete each, contact information forms will take 1 minute to complete each, and consent forms will take 5 minutes to complete each. CDC anticipates study eligibility for 50 percent of the targeted populations screened. Of eligible persons, 75% will agree to participate.

Brief structured surveys will take 15 minutes to complete. In-depth interviews or focus groups with respondents are expected to take 60 minutes (1 hour) to complete. In-depth interviews or focus groups with healthcare providers are expected to take 45 minutes to complete.

The total annual response burden, based on an average of 600 study respondents per year (assuming three large data collections involving 200 participants each), is 918 hours.

On December 1, 2017, NIOSH published a request for public review in the Federal Register [82 FR 56973] of the draft version of the National Occupational Research Agenda for Transportation, Warehousing and Utilities. No comments were received.

I. Background

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act.

Prescription drug advertising regulations require that broadcast advertisements containing product claims present the product's major side effects and contraindications in either audio or audio and visual parts of the advertisement (21 CFR 202.1(e)(1)); this is often called the major statement. The regulations also require that broadcast advertisements contain a brief summary of all necessary information related to side effects and contraindications or that “adequate provision” be made for dissemination of the approved package labeling in connection with the broadcast (§ 202.1(e)(1)). The requirement for adequate provision is generally fulfilled when a firm gives consumers the option of obtaining FDA-required labeling or other information via a toll-free telephone number, through print advertisements or product brochures, through information disseminated at health care provider offices or pharmacies, and through the internet (Ref. 1). The purpose of including all four elements is to ensure that most of a potentially diverse audience can access the information.

Internet accessibility is increasing, but many members of certain demographic groups (e.g., older adults, low socioeconomic status individuals) nonetheless report that the internet is inaccessible to them either as a resource or due to limited knowledge, and so a website alone may not adequately serve all potential audiences (Refs. 2 and 3). Similarly, some consumers may prefer to consult sources other than a health care provider to conduct initial research, for privacy reasons or otherwise (Refs. 1, 4, and 5). In light of these considerations, the toll-free number and print ad may provide special value to consumers who are low to non-internet users and/or those who value privacy when conducting initial research on a medication, though not necessarily unique value relative to one another. As such, a primary purpose of this research is to examine the value of including both the toll-free number and print ad as part of adequate provision in direct-to-consumer (DTC) prescription drug broadcast ads. We will also investigate the ability and willingness of low to non-internet users to make use of internet resources if other options were unavailable. These questions will be assessed using a survey methodology administered via telephone.

In addition, building on concurrent FDA research regarding drug risk information,1 we will assess risk perceptions as influenced by opening statements that could be used to introduce risks in DTC prescription drug broadcast ads. Opening statements may be used to frame risk information that follows. As such, consumers may interpret the likelihood, magnitude, and duration of risks differently depending on how those risks are introduced (Refs. 6-9). The intended outcome of this component of the research is to evaluate the influence of these opening statements within a sample of low to non-internet users. This research question will be addressed using a 1 × 3 between-subjects experimental design embedded in the previously mentioned survey. This particular component of the research will serve as an exploratory test intended to inform FDA's future research efforts.

Sampling Frame. Given that older adults (i.e., those aged 65 and older) are among the largest consumers of prescription drugs (Ref. 10) and that approximately 41 percent of older adults do not use the internet (Ref. 2), investigating use of adequate provision in this population is especially important. Also of concern, 34 percent of those with less than a high school education do not use the internet, 23 percent of individuals with household incomes lower than $30,000 per year do not use the internet, and 22 percent of individuals living in rural areas do not use the internet (Ref. 2). These estimates capture non-internet users, and so consideration of low-internet users warrants additional concern. Consistent with these citations, the present research will utilize a nationally representative sample of low to non-internet users from these and other relevant demographic groups.

Data collection will utilize a random digit dialing (RDD) sample that has been pre-identified as being a non-internet household, or having at least one non-internet using member. This sample solution is ideal because it relies on a dual-frame (landline and cell phone) probability sample, yet has the advantage of prior knowledge of those who are likely to be low to non-internet users (re-screening will verify this). The Social Science Research Solutions (SSRS) Omnibus, within which this survey will be embedded, utilizes a sample designed to represent the entire adult U.S. population, including Hawaii and Alaska, and including bilingual (Spanish-speaking) respondents. As reflected in the overall population of low to non-internet users, we intend to collect a small sample of Spanish-speaking individuals, which comprise a subsample of the regular landline and cell phone RDD sampling frames. We will also screen for past and present prescription drug use in order to ensure a motivated sample.

Survey Protocol. This survey will be conducted by telephone on landline and cell phones, with an expected 50 to 60 percent of interviews conducted on cell phones. Interviewing for the pretest and main study will be conducted via SSRS's computer-assisted telephone interviewing system. We expect to achieve a roughly 40 percent survey completion rate from the pre-identified respondents to be sampled in this study, given an 8-week field period and a maximum of 10 attempts to reach respondents. The original SSRS Omnibus from which this sample is derived receives an approximately 8 to 12 percent response rate. These are not uncommon response rates for high-quality surveys and have been found to yield accurate estimates (Refs. 11 and 12).

As communicated earlier, the primary focus of interview questions concern the ability and willingness of low to non-internet users to utilize the various components of adequate provision, particularly the toll-free number and print ad components. In addition to these questions, experimental manipulations will be embedded in the survey as an exploratory test to assess the impact of opening statements that could be used to introduce risks in DTC prescription drug broadcast ads, which is a related concept. To form the experimental manipulations, participants will be presented with a statement of major risks and side effects (“the major statement”) drawn from a real prescription drug product, but modified to include only serious and actionable risks. Preceding this description of major risks will be one of three opening statements: (1) “[Drug] can cause severe, life threatening reactions. These include . . .”; (2) “[Drug] can cause serious reactions. These include . . .”; or (3) “[Drug] can cause reactions. These include . . .” All risk statements will conclude with the following language: “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information.” Participants will be randomly assigned to experimental condition, and all manipulations will be pre-recorded to allow for consistent administration. Following exposure to these manipulations, participants will respond to several questions designed to assess risk perceptions.

Before the main study, we will execute a pretest with a sample of 25 participants from the same sampling frame as outlined. The pretest questionnaire will take approximately 15 minutes to complete. The goal of the pretest will be to assess the questionnaire's format and the general protocol to ensure that the main study is ready for execution. To test the protocol among the target groups, we will seek to recruit a mix of participants based on demographic and other characteristics of interest. We do not plan to use incentives for the pretest or main study portions of this survey. However, upon request, cell phone respondents may be offered $5 to cover the cost of their cell phone minutes.

Questionnaire development is an iterative process and so the main study questionnaire will include any changes from pretesting, as well as other outcomes, such as OMB and public comments. Like pretesting, the main study questionnaire should take approximately 15 minutes to complete. Based on a power analyses, the main study sample will include approximately 1,996 participants. This sample size will allow us to draw statistical comparisons between the various demographic groups in the sample.

Measurement and Planned Analyses. Consistent with the larger purpose of the study, survey questions will examine access, technical ability, and willingness to use adequate provision options; preference for and experience using adequate provision options; privacy concerns; and potentially other secondary questions of interest. In addition, to assess the impact of the experimental manipulations, survey questions will assess perceived risk likelihood, perceived risk magnitude, and perceived risk duration. Demographic information will also be collected. To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. A copy of the draft questionnaire is available upon request.

In the Federal Register of June 12, 2017 (82 FR 26934), FDA published a 60-day notice requesting public comment on the proposed collection of information. Comments received along with our responses to the comments are provided below. For brevity, some public comments are paraphrased and therefore may not reflect the exact language used by the commenter. We assure commenters that the entirety of their comments was considered even if not fully captured by our paraphrasing. The following acronyms are used here: FRN = Federal Register Notice; DTC = direct-to-consumer; FDA and “The Agency” = Food and Drug Administration; OPDP = FDA's Office of Prescription Drug Promotion.

Comment 1a, regulations.gov tracking number 1k1-8y16-3nqx (summarized): The commenter expresses support for FDA's collective research and welcomes the Agency's current proposed survey examining adequate provision.

Response to Comment 1a: We appreciate and thank the commenter for their support.

Comment 1b (verbatim): Throughout the main survey questionnaire, some questions ask about ability to obtain information on prescription drugs after seeing an advertisement on television. These questions presume access to a television. If understanding this process of first seeing an ad on TV then searching for information is the key objective, we suggest in the screening criteria ensuring all respondents have access to a TV and/or watch television on a regular basis.

Response to Comment 1b: We have added a screening question to confirm that participants watch television at least occasionally.

Comment 1c (verbatim): As currently outlined, the sample frame is relatively broad in that it includes those who possibly do not have experience with prescription medications or experience searching for prescription medication information. Respondents without experience in this area could provide speculative responses to many questions, and thus, [the commenter] suggests that they are outside of the scope. To address this, we recommend adding a screening question or questions to include only those who have had at least one medical condition which has required prescription medication within the last 12 months.

Response to Comment 1c: To ensure a motivated sample, we included a question to screen for past or present prescription drug use.

Comment 1d (verbatim): The purpose of the secondary objective of the study pertaining to risk statements is not entirely clear. Since the sample frame is not restricted to those who suffer from a condition which could be helped by the mock drug, responses have the possibility to be speculative and reflect bias of people coming in to the study rather than what is intended. For instance, respondents who happen to be within a population targeted by the major statements are reasonably more likely to report a higher likelihood of experiencing a stated side effect and reporting a higher seriousness of them, biasing experiment responses.

Response to Comment 1d: The secondary objective of the study is designed to assess the impact of opening statements that could be used to introduce risks in DTC prescription drug broadcast ads. This objective complements previously published research and adds value by newly investigating the impact of framing statements among a sample of low to non-internet users. Our approach involves random assignment to experimental conditions which should lead to approximately equal numbers of diagnosed versus undiagnosed individuals in each of the conditions, lessening any concern about bias. Nonetheless, please understand that this secondary objective is intended to provide a preliminary assessment of the stated research questions for development purposes. Procedurally, this objective will involve only a brief presentation of a short audio broadcast followed by three questions, allowing us to gather this valuable information with very low burden to participants who are already engaged in our larger survey regarding adequate provision.

Comment 1e (verbatim): Additionally, information gained from the experimental manipulations (E-1 through E-3) will only be applicable to hearing the opening and major statement presented over the phone, rather than versus being read through print or online. Interpretations and understanding of this info could differ between the media. While this could possibly be a useful supplement to current knowledge, the learnings will likely not be directly applicable to the other media. If comparison of interpretation between the media is the goal of this section, [the commenter] suggests a stand-alone study would better address that goal rather than an addendum to this one.

Response to Comment 1e: We appreciate this limitation of our preliminary assessment and intend to take it into consideration when interpreting results.

Comment 1f (verbatim): Screener: The current screener terminates cell phone users who have not browsed the internet in the past month (S I). It is not readily apparent why this group should not participate in the survey. We would suggest that the termination criteria be removed from this question as it may make incremental improvement to response rates.

Response to Comment 1f: The screener only excludes cell phone users (T1 = 2) who choose “don't know”(− 98) or refuse the question(− 99) (S1 < 0).

Comment 1g (verbatim): As is, it is unclear what an independent variable for the questionnaire is intended to be. One possibility [the commenter] suggests is including a question aimed at understanding the overall preference for source of information, which would serve as the independent variable in the study or could be combined with the ability and access questions to make a composite variable. (e.g., “What is your preferred medium in which to receive prescription drug information: Print ads for the drug; the manufacturer's phone number or website; or asking your healthcare provider?”)

Response to Comment 1g: Please refer to the instruction set preceding question 3. Our questionnaire attempts to learn about patient preferences through questions about participant likelihood to seek information via the various available sources, as well as past use, ability, and willingness, among other constructs. We believe these constructs to provide adequate assessment of consumer preference to obtain additional information via the various available sources. Moreover, we note that another commenter (see Comment 3n) takes the position that we should not inquire about patient preferences. We have considered both of the perspectives when deciding upon potential revisions.

Comment 1h (verbatim): Throughout the survey, [the commenter] suggests defining each point on the 5 point scales used to avoid confusion by respondents. In our consumer research efforts, we customarily use 5 point scales that are defined at each point, such as ‘Excellent, Very Good, Good, Poor, and Very Poor'.

Response to Comment 1h: We concur that defining each point on 5 point scales helps mitigate confusion and have revised the questionnaire to define each point of scales.

Comment 1i (verbatim): It seems inappropriate to use a Likert scale to answer “Q1: Access to sources of information”, as it would seem access could be defined more narrowly—No access, some access, or complete access. We suggest using the pre-test to examine this question in particular to ensure either that the current scale is interpreted correctly or determine an appropriate re-wording. Additionally, it could be helpful to include the more specific options as distinct answer choices (e.g. an option for internet at a public library and a separate option for internet at a coffee shop) in order to provide more granular information which could be useful to the FDA as well as industry as a whole. We suggest using the pre-test to produce a full list of options as well as any appropriate re-wordings.

Response to Comment 1i: We agree that defining access more narrowly may be sufficient for this question and so we have adopted this approach in our revised survey. We will also evaluate responses to this narrowed scale in our analysis of pretest data. We also appreciate the value of assessing locations of access; however, we consider such questions to be of lesser relevance to our key objectives, and we have sought to limit the duration of the survey to less than 15 minutes. Consequently, we do not adopt this recommendation.

Comment 1j (verbatim): Throughout the survey, we suggest adding in “Talked with your doctor” as an answer choice among the options for sources of information. Physicians are a major source of product information and “talking with a doctor” are what drug advertisements generally suggest to consumers, so inclusion of this option is appropriate.

Response to Comment 1j: We agree that health care providers are one important source for adequate provision. Nonetheless, the current investigation is designed to assess the utility of the various options for disseminating additional product risk information, and speaking with a health care provider is not under reevaluation. Consequently, we ask participants to respond under the premise that they are seeking information prior to approaching a health care professional.

Comment 1k (verbatim): As currently worded, question 13 has the possibility to lead the respondent by stating that “Some people change their approach . . .” The current wording could bias respondents to be overly critical. [The commenter] would suggest either changing the question or adding in a new question prior to the current Q 13 to ascertain a rating of the level of privacy offered by each information source. This new question would provide the respondents current perceptions of privacy, something which the survey omits. For example, a newly worded question could be as follows: “On a 5-point scale, in which 1 is Very Low Privacy and 5 is Very High Privacy, what is the level of privacy offered by each of the following information sources when getting full prescription-drug product information?” The current question 13 could then follow this question.

Response to Comment 1k: Our intention with this question (and its wording) is to facilitate comparisons between baseline likelihood to use the various sources of adequate provision (see Q3) and likelihood to use the various options in cases where privacy is a concern. By stating “Some people change their approach . . . ” we hoped to give participants permission to respond differently than they had in the earlier question, if they felt a change in their response was appropriate. Nonetheless, we recognize that this language could be leading and so we have eliminated it from our revised questionnaire. We are hopeful that the revised question will still allow us to draw the intended comparisons.

Comment 1l (verbatim): In addition to our concerns regarding the goal of the experiment questions (E 1-E2), the purpose in the variations of the major statements is unclear. The objectives state that varying opening statements (E I) are the secondary focus of this research, not major statements. We suggest choosing an appropriate major statement in the pre-tests and then using that in the broader fielding of the study.

Response to Comment 1l: The purpose of varying the major statements was to add to the generalizability of our findings. The revised version of our survey adopts this commenter's recommendation and includes only one version of the major statement.

Comment 1m (verbatim): We suggest adding a “Don't know” option for EI-E3 as respondents might not be able to assess how long lasting, serious, or likely the side effects would be. The current range of answer choices may force inaccurate or speculative responses; a “Don't Know” answer would be a legitimate choice and informative for the study. Our standard practice is to provide a “Don't Know” option whenever it could be a valid answer.

Response to Comment 1m: The items used in this section were developed through scale validation research and thus we prefer to retain them in their original form. Nonetheless, we have added labels to each point on the scales in response to Comment 1h, and the midpoint (“neutral”) of these scales may be treated similarly to a “Don't Know” option.

Comment 2a, regulations.gov tracking number 1k1-8xz6-t7bj (verbatim): The practical utility of this study is unclear. Currently, industry is broadly executing on making labeling available via both IN [internet] and non-IN based options to a diverse audience. Historically, there were many options available to enable patients to locate drug-related labeling, even before the IN became available. When added to the three options mentioned above, the IN provides patients with a fourth option, one that is increasingly at a patient's fingertip via tablet, cell phone, or laptop. Hence, it is unclear how results from this study will enhance consumer access to information or be applied to modify current practices.

Response to Comment 2a: As stated in the 60-day FRN (82 FR 26934), our intention is to assess the utility of the various sources of adequate provision among a sample of low to non-internet users. For example, it may not be necessary to include both a print ad reference and toll free number reference. We have received inquiries along these lines from stakeholders. Additionally, we may find that low to non-internet users would be willing to use the internet themselves or with the help of a friend or family member if non-internet options were unavailable. This research will provide insights to inform our approach to the adequate provision requirement.

Comment 2b (verbatim): The sampling frame focuses on those “not likely to have IN access” as defined by FDA and includes older adults, with less than a high school education, who make less than $30,000/year, and live in rural areas; it also includes bilingual Spanish speakers. Yet it is not clear how persons not likely to have IN access would be able to inform FDA about how they would behave if they had access to the IN and other options were not available. Rather than speculate about how their behavior might change if faced with IN access and no other options, it would be better to design a study that focuses on understanding the effectiveness of non-IN options to provide information in general.

Response to Comment 2b: To be clear, we intend to sample from the above referenced populations separately, as opposed to sampling from one population with all these attributes.

As indicated in the 60-day FRN (82 FR 26934), we do intend to assess the effectiveness of non-internet options. However, as a secondary objective, it seems to us worthwhile to also consider how low to non-internet users may respond if non-internet options were unavailable. As another commenter indicates (see Comment 3b), internet use is widespread and technological sources of adequate provision may suffice (when combined with recommendation to speak to a health care professional). We hope to shed light on this question through our research.

Comment 2c (verbatim): Questions 1-5 and 13: The current choices do not assess the respondent's willingness or ability to visit their healthcare provider to obtain the approved package labeling. This option should be added.

Response to Comment 2c: Please refer to Comment 1j and our associated response.

Comment 2d (verbatim): Question 15: Given the length of the package labeling making it impractical to receive the information verbally, it would be likely that callers would prefer an option, Mail the prescription drug product information to me, even when faced with privacy concerns.

Response to Comment 2d: This response option has been added to our revised questionnaire.

Comment 2e (verbatim): Instructions for Experimental Manipulations, E1/E2: E2 includes three different versions of the major statements. If the intended outcome of this component of the research is to evaluate the influence of these opening statements within a sample of low to non-IN users, and risk perceptions will be assessed as influenced by opening statements that could be used to introduce risks, it is unclear why the major statements (E2: A, B, C) differ when assessing whether or not opening statements (E1: 1, 2, 3) influence risk perceptions.

Response to Comment 2e: Please refer to Comment 1l and our associated response.

Comment 3a, regulations.gov tracking number 1k1-8y13-m7td: FDA is conducting too much research without “articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health.” “The Agency should publish a comprehensive list of its prescription drug advertising and promotion studies from the past five years and articulate a clear vision for its research priorities for the near future.”

Response to Comment 3a: OPDP's mission is to protect the public health by helping to ensure that prescription drug information is truthful, balanced, and accurately communicated, so that patients and health care providers can make informed decisions about treatment options. OPDP's research program supports this mission by providing scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that we believe are most central to our mission, focusing in particular on three main topic areas: Advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits; focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience; and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues.

Because we recognize the strength of data and the confidence in the robust nature of the findings is improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our homepage, which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website includes links to the latest FRNs and peer-reviewed publications produced by our office. The website maintains information on all studies we have conducted, dating back to a DTC survey conducted in 1999.

Comment 3b; the commenter provided a summary of their comments followed by a more detailed description of the same comments. For brevity, only the summary of comments (verbatim) is provided below. Full comments may be accessed at regulations.gov via tracking number 1k1-8y13-m7td.

First, FDA's proposed research appears to offer limited practical utility in several ways:

• The Agency proposes research based on an outdated, 18-year-old guidance document that fails to recognize adequately the societal and technological changes of the last two decades, including the many options now available to satisfy the adequate provision requirement.

• FDA regulations require adequate, not complete, provision. Given the prevalence of the internet and smartphones across all U.S. demographic groups, we believe that biopharmaceutical manufacturers can satisfy adequate provision simply through information dissemination at health care provider offices or pharmacies, a 1-800 number, and/or the internet.

• FDA fails to recognize existing research that demonstrates the pervasiveness of the internet and smartphones in the United States. This research limits any potential utility of the proposed study. The Agency's proposal mainly relies on data from six to 16 years ago. The smartphone is dramatically increasing internet connectivity for traditionally low to non-internet use demographic groups. Further, FDA does not acknowledge that older adults (with or without internet access) tend to rely on others, including family and health care personnel, for drug information.

Response to Comment 3b: FDA recognizes that a large proportion of the U.S. population utilizes the internet. It is specifically for this reason that we are conducting research to inform our current guidance recommendations. Nonetheless, as indicated in the 60-day FRN (82 FR 26934), certain segments of the U.S. population are unlikely to use the internet. For example, 41 percent of individuals aged 65 and older do not use the internet, yet are the largest consumers of prescription drugs. As the commenter states, some individuals from this demographic rely on others to obtain drug information, but this perspective does not take into account the desire for privacy in obtaining such information, or the availability of these other individuals. The proposed research will provide empirical assessment of how vulnerable populations such as older adults may be impacted by changes to regulatory policy.

The assertion that the requirement for “adequate” provision can be fulfilled by disseminating information through “health care provider offices or pharmacies, a 1-800 number, and/or the internet” may be correct, and FDA invites the commenter to submit data supportive of this perspective. FDA maintains a science-based approach to its regulatory decisionmaking, and as such, the current research is designed to inform our thinking in this area.

We disagree with the assertion that our proposal relied mainly on data from 6 to 16 years ago. A more careful review of the FRN will show that our key citations range from 2013 to the present. By necessity, we also cite the relevant 1999 guidance, as well as a few other references which speak to general patterns of human behavior.

Comment 3c (summarized): The commenter recommends removal of the second proposed study concerning opening statements to frame risk information on the grounds that (a) questions regarding adequate provision may impact responding in the second proposed study and (b) a low to non-internet user sample is not sufficiently diverse.

Response to Comment 3c: Please refer to Comment 1d and our associated response.

Comment 3d (summarized): The commenter provides several recommendations pertaining to subject enrollment. The first comment on this topic “recommends that FDA ensure that the subject sample includes representative portions of alleged subpopulations of low to non-internet users, including older adults, low socioeconomic status individuals, people with less than a high school education, and individuals living in rural areas.”

Response to Comment 3d: To obtain a nationally representative sample of the target population of adult low to non-internet users who are also prescription drug users, the research team will use a sample sourced from a dual frame. This approach involves using a random digit dialing sample that has been pre-identified as being a non-internet household (or having at least one non-internet using member). The demographics within this frame of low to non-internet users fall within the expected range of subpopulations with respect to older adults, low socioeconomic status, and people with less than a high school education or some college. The sample is designed to represent the adult U.S. population (including Hawaii and Alaska) and will include rural areas. This sample solution is ideal because it relies on a dual-frame probability-sample, yet has the advantage of already knowing who are likely to be low to non-internet users.

Comment 3e (summarized): In the second comment pertaining to subject enrollment, the commenter recommends that participants reached via smartphone not be included in the sample.

Response to Comment 3e: We agree that smartphone use is increasing internet access for traditionally low to non-internet use demographics and appreciate the importance of confirming our sample are low to non-internet users. Notwithstanding, we are screening based on self-reported internet browsing, such that individuals who report browsing the internet three or more times in the past month—regardless of medium—will not be asked to participate in the survey. Further, the current approach supports that only households which have been pre-identified as having at least one non-internet using member will be screened for participation, adding an additional layer of assurance that only low to non-internet users will be asked to participate in the questionnaire.

Comment 3f (summarized): In the third comment pertaining to subject enrollment, the commenter recommends collecting data in-person because data collection via phone may impact responses regarding the 1-800 number.

Response to Comment 3f: We acknowledge that in-person data collection would add value to the proposed research but cost implications bar us from pursuing it. We will consider implications of our protocol for survey administration when interpreting results.

Comment 3g (summarized): In the final comment pertaining to subject enrollment, the commenter indicates agreement with the proposed approach to screen for past and present prescription drug use in order to ensure a motivated sample.

Response to Comment 3g: We appreciate the support for this planned approach.

Comment 3h: Remaining comments pertain to the draft study questionnaire. The first comment on this topic suggests that certain items may lead participants to respond in certain ways. Examples (abbreviated for brevity) include:

• The instructions for Q3 of the Main Study Survey state: “Prescription drugs advertised on television provide only limited product information. For example, not all of the product's risks and side effects are described. Imagine you wanted to obtain additional product information before seeing your health care provider.” As previously mentioned, while research “reveal[s] consumers engage in some prescription drug information seeking . . . most takes place after visiting a doctor, not before” (emphasis added [by commenter]). The question prompt does not reflect common practice and may lead to a misleading answer. Both the prompt and question itself should be revised to reflect that subjects may look specifically to their healthcare provider for this information.

• Further, the Main Study Survey introduces questions about privacy by stating: “Next, I will ask about privacy concerns you might have when getting full prescription-drug product information.” Such phrasing suggests that a subject should have “concerns” in this context. Q12 asks subjects to “rate the extent to which you value privacy . . . ” (emphasis added [by commenter]). Such language suggests subjects should indeed “value” privacy.

• The prompt for Q13 is also leading by introducing the question with: “Some people change their approach to getting information about prescription drugs when privacy is a concern.”

Response to Comment 3h: As the commenter indicates in the first comment, there is evidence to suggest that consumers seek information both before and after visiting with a health care professional. Moreover, the ubiquity of DTC prescription drug advertising suggests that pharmaceutical companies are well aware of the advantages of introducing products to consumers prior to the consumer-health care provider interaction. The proposed research is concerned with how low to non-internet users access full product information prior to approaching a health care professional. As such, we need to provide this context to participants before they can respond regarding their interest and experiences within this context. We disagree that our presentation here is leading as the commenter describes, and consequently, we retain our current approach with these questions.

Likewise, in response to the second comment, we cannot inquire about privacy concerns without referencing privacy concerns. Nonetheless, we have revised Q12 to read “How much value do you place on privacy . . .”

In response to the third comment, please see Comment 1k and our associated response.

Comment 3i (summarized): The second comment pertaining to the study questionnaire concerned definitions and terms. The commenter states, “The questionnaires do not define certain key terms (e.g., side effect, risk, serious, reference, full product information, partial information). Subjects may interpret these terms based on different standards. For example, for Q16 of the Main Study Survey, FDA may wish to provide context for what could constitute “complete prescription-drug product information. FDA should consider providing user-friendly definitions or terms throughout the questionnaires.”

Response to Comment 3i: We appreciate the importance of ensuring uniform interpretation of terms. In cognitive interviews preceding this work, we assessed whether individuals interpret key terms similarly and made revisions where necessary. We have also considered the additional time (burden) that would be required to complete the survey if every term were defined in the pretest and main study. We have targeted to keep the current information collection to under 15 minutes per respondent. With these factors in mind, we have chosen not to provide additional definitions.

Comment 3j (summarized): The third comment pertaining to the study questionnaire concerned the sliding scale format of certain questions: “FDA should consider replacing the sliding scale format (especially for Q1-Q3 of the Main Study Survey) with a binary or “Yes-No-Neutral” scheme. The sliding-scale format is at times confusing in form, inappropriately frames certain questions, and could potentially introduce error.”

Response to Comment 3j: Please see Comment 1i and our associated response.

Comment 3k: The final comments pertaining to the questionnaire were characterized by the commenter as miscellany. The first comment read, “As previously mentioned in Section II.A, E1-E3 of the Main Study Survey should be eliminated. (reference omitted) Similarly, we would also recommend that elimination of “Other Questions of Interest” (Q16-Q20) of the Main Study Survey, which appear to have limited applicability to the study of adequate provision.”

Response to Comment 3k: In regards to E1-E3, please see Comment 1d and our associated response. In regards to Q16-Q20, all these items provide potentially valuable information relevant to the topic of interest, and therefore we prefer to retain them.

Comment 3l: The next comment characterized as miscellany read: “The Study Screener introduction should not state that the survey is being conducted “on behalf of the Food and Drug Administration” and that study results “will be used in the consideration of important policy decisions.” These statements could potentially influence subjects' responses to study questions. Instead, this information might be provided at the conclusion of the study.”

Response to Comment 3l: Such statements are intended to communicate the legitimacy of the study to potential participants, and thus validate participation. Upon further consideration, we concur that these statements may potentially influence responses, and we have removed them.

Comment 3m: The next comment characterized as miscellany read: “The Main Study Survey should include a similar question to Q5, inquiring about if a toll-free number was not available.”

Response to Comment 3m: We acknowledge the potential value of this question, but given the key objectives of the research, and concerns about participant burden, we decline to adopt this recommendation. We have targeted to keep the current information collection to under 15 minutes per respondent.

Comment 3n: Continuing under the miscellany category: “There are several questions of the Main Study Survey (e.g., questions associated with Instructions_2) that inquire about a subject's preferences regarding the provision of product labeling. We do not understand the utility of these questions. Again, FDA's regulation concerns adequate, not preferred, provision.”

Response to Comment 3n: In deciding upon potential revisions, we have considered both this commenter's views and those of another commenter (see Comment 1g) which recommend utilizing consumer preferences as an independent variable. We agree with the first commenter that consumer preferences are crucial for understanding the issues at hand as articulated in the 60-day FRN (82 FR 26934). Consequently, we have retained these questions.

Comment 3o: The next miscellany comment read: “Certain questions, like Q4 and Q5 of the Main Study Survey, should include the option of asking a health care provider. Such a choice is part of FDA's adequate provision recommendation in the Guidance Document.”

Response to Comment 3o: Please see Comment 1j and our associated response.

Comment 3p: The next miscellany comment read: “The ordering of the questions (web page, toll-free number, print ad) of the Main Study Survey could potentially introduce bias. FDA may want to randomize the ordering of questions (e.g., Q6-Q11) to eliminate such bias.”

Response to Comment 3p: We accept this recommendation and will randomize the ordering of questions Q6 to Q11 pertaining to web page, toll-free number, and print ad.

Comment 3q: The final comment characterized as miscellany read: “Q15 of the Main Study Survey should include an option of mailing information to the customer.”

Response to Comment 3q: Please see Comment 2d and our associated response.

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

The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

The draft guidance “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” is intended to provide information on how to notify FDA of the transfer of a 510(k) clearance from one person to another, and the procedures FDA and industry should use to ensure public information in FDA's databases about the current 510(k) holder for a specific device(s) is accurate and up-to-date. The proposed information collection seeks to provide information to notify FDA of the transfer of a premarket notification (510(k)) clearance.

The respondents to this collection of information are 510(k) holders and parties claiming to be 510(k) holders.

In the Federal Register of December 22, 2014 (79 FR 76331), FDA published a 60-day notice requesting public comment on the proposed collection of information. While FDA received comments on the draft guidance document, none were related to the information collection.

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

FDA estimates that 78 percent of 510(k)s are listed outside of the annual registration cycle based on numbers in the FURLS database from fiscal year 2009 through fiscal year 2014. Fiscal year 2008 was left out of this cohort as it was the first year that registrants were required to report the 510(k) number on their listings and, therefore, an unusually high number of listings were created. An average of 5,231 510(k)s have been listed each year since 2008. Because listing outside of the annual requirement is voluntary, FDA estimates that annually 78 percent of 510(k)s will continue to be listed outside of the annual requirement. FDA estimates that 4,080 510(k)s may be listed outside of the annual registration cycle. FDA estimates that it will take approximately 15 minutes for each listing, for a total reporting burden of 1,020 hours.

FDA estimates it will have 2,033 instances of more than one party claiming to be a 510(k) holder for a specific device as part of annual registration and listing. FDA reached this estimate by identifying the number of unique 510(k) device listings entered in FURLS between fiscal years 2009 and 2014 that conflict with a listing already entered by another party (5,304), dividing that number by the number of years (6), and multiplying by the average number of parties claiming to be the 510(k) holder when there is a conflict in the current FURLS database (2.3). The draft guidance identifies potential documentation a party could submit to FDA to establish the transfer of a 510(k) clearance. FDA estimates it will take a party approximately 4 hours to locate and submit information to establish the transfer of the 510(k) clearance, resulting in 8,132 burden hours for those 2,033 parties claiming to be 510(k) holders. FDA reached this estimate based on its expectation of the amount of time it will take a party to locate the information, copy it, and submit a copy to FDA.

The burden estimate does not include the maintenance of records used to document transferring a premarket notification (510(k)) clearance. Based on available information, FDA believes that the maintenance of these records is a usual and customary part of normal business activities. For example, in the ordinary course of business, supporting documents should be kept to verify asset information for calculating the annual depreciation or calculating gain or loss on sale of an asset on a businesses' tax return. Therefore, this recordkeeping requirement creates no additional paperwork burden.

The draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 807 (registration and listing) are approved under OMB control number 0910-0625; the collections of information in 21 CFR part 807 subpart E (premarket notification submission) have been approved under OMB control number 0910-0120, and collections of information in 42 CFR 493.17 have been approved under OMB control number 0910-0607.

This package is a revision to the collection titled THIRA/SPR, OMB Control Number: 1660-0131. Although initially titled the State Preparedness Report (SPR), FEMA changed the name of the collection to the THIRA/SPR Unified Reporting Tool to more accurately reflect the information gathered and method of collection. The Post-Katrina Emergency Management Reform Act of 2006 (PKEMRA), as amended by the Implementing Recommendations of the 9/11 Commission Act of 2007, established an annual requirement for the 56 States and Territories to submit a State Preparedness Report. Because this reporting now includes States, Territories, urban areas, and Tribes, FEMA has revised the name of the report as the Stakeholder Preparedness Review (SPR). States, Territories, urban areas and Tribes receiving non-disaster preparedness grant funds administered by DHS submit the SPR annually, and this encompasses the requirements of the State Preparedness Report while also reflecting the updated reporting needs. The legislation requires a report on current capability levels and a description of targeted capability levels from all States, Territories, urban areas and Tribes receiving non-disaster preparedness grant funds administered by DHS. Each report must also include a discussion of the extent to which target capabilities identified in the applicable State homeland security plan and other applicable plans are unmet, and an assessment of resources needed to meet the preparedness priorities established under PKEMRA Section 646(e), including: (i) An estimate of the amount of expenditures required to attain the preparedness priorities; and (ii) the extent to which the use of Federal assistance during the preceding fiscal year achieved the preparedness priorities. To meet this requirement, States, Territories, Tribes, and urban areas first identify capability targets through the Threat and Hazard Identification and Risk Assessment (THIRA) and then assess against these targets in the SPR. Through the SPR, these jurisdictions estimate their current capabilities, identify and describe gaps between current capabilities and targets, indicate their intended approach for addressing gaps in the future, and report on the impact of Federal grant dollars in building and sustaining capabilities. It is also important to note that completing the THIRA and SPR are allowable expenses under the grant awards.

Title: Threat and Hazard Identification and Risk Assessment (THIRA)—Stakeholder Preparedness Review (SPR) Reporting Tool.

Type of Information Collection: Revision of a currently approved information collection.

OMB Number: 1660-0131.

FEMA Forms: FEMA Form 008-0-19 (THIRA), Threat and Hazard Identification and Risk Assessment (THIRA) Reporting Tool; FEMA Form 008-0-20 (SPR), Stakeholder Preparedness Review (SPR) Reporting Tool; FEMA Form 008-0-23, THIRA/SPR After-Action Call Questions.

Abstract: The assessment is structured by the 32 core capabilities from the 2015 National Preparedness Goal. States, Territories, urban areas, and Tribes provide information on capability targets, their current capability levels and capability gaps for each core capability. Respondent States, Territories, Tribes and urban areas gather the information and complete the THIRA and SPR following the “Comprehensive Preparedness Guide (CPG) 201, Third Edition.”

Affected Public: State, Local or Tribal Government.

Estimated Number of Respondents: 113.

Estimated Number of Responses: 113.

Estimated Total Annual Burden Hours: 84,414.

Estimated Total Annual Respondent Cost: $4,328,749.92.

Estimated Respondents' Operation and Maintenance Costs: $12,404,962.

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

Estimated Total Annual Cost to the Federal Government: $2,648,063.63.

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

DHS collects information, when necessary, when inviting firms to submit bids, proposals, and offers for public contracts for supplies and service. Using solicitation methods such as requests for proposals (RFP), requests for information (RFI), and broad agency announcements (BAA), the Government requests information from prospective offerors such as pricing information, delivery schedule compliance, and evidence that the offeror has the resources (both human and financial) to accomplish requirements. The information collection is necessary for compliance with the HSAR, 48 CFR Chapter 30, and the SBIR and STTR programs, 15 U.S.C. 628. The collections under the HSAR include:

• 3052.209-70 Prohibition on Contracts with Corporate Expatriates (Required in all solicitations and contracts). The offeror must disclose whether it is a foreign incorporated entity that should be treated as an inverted domestic corporation.

• 3052.209-71 Reserve Officer Training Corps and Military Recruiting on Campus (Required in all solicitations and contracts with institutions of higher education) Requires that the Contractor represent that it does not now have, and agrees that during performance of the contract that it will not adopt, any policy or practice described in paragraph (b) of the clause.

• 3052.209-72 Organizational Conflict of Interest, paragraphs (c), (d) and (e) (Required in all solicitations and contracts where a potential organizational conflict of interest exists and mitigation may be possible). The offeror must disclose whether it is aware of any facts which create any actual or potential organizational conflicts of interest; and, provide information as required by the Government and a mitigation plan relating to the conflict, if applicable.

• 3052.209-74 Limitations on Contractors Acting as Lead System Integrators (Required in solicitations for the acquisition of a major system when the acquisition strategy envisions the use of a lead system integrator). The offeror must disclose whether it proposes to perform this contract as a lead system integrator with system responsibility, and whether it has a direct financial interest in the system that is the subject of the solicitation; and, provide evidence, as needed.

• 3052.209-76 Prohibition on Federal Protective Service (FPS) Guard Services Contracts with Business Concerns Owned, Controlled, or Operated by an Individual Convicted of a Felony, paragraphs (a) through (g) (Required in in all solicitations and contracts for FPS guard services). The offeror must disclose whether it is owned, operated or controlled by an individual convicted of any felony. A business concern owned, operated or controlled by an individual convicted of any felony may submit an award request to the Government. The request must include information that is considered personally identifiable information, and any additional information the Government deems necessary.

• 3052.215-70 Key Personnel and Facilities (Required in solicitations and contracts when the selection for award is substantially based on the offeror's possession of special capabilities regarding personnel or facilities). Before removing or replacing any of the specified individuals or facilities, the offeror must notify the Government, in writing, before the change becomes effective.

• 3052.219-72 Evaluation of Prime Contractor Participation in the DHS Mentor-Protégé Program (Required in all solicitations containing (HSAR) 48 CFR 3052.219-71, DHS Mentor-Protégé Program and (FAR) 48 CFR 52.219-9 Small Business Subcontracting Plan). The offeror must provide a signed letter of mentor-protégé agreement, if it wishes to receive credit under the source selection factor.

• 3052.247-70 F.o.b. Origin Information (Required in solicitations as appropriate) the offeror must provide information related to the offeror's shipping point.

The DHS Science and Technology (S&T) Directorate issues BAAs soliciting when white papers and proposals from the public. DHS S&T evaluates white papers and proposals received in response to a DHS S&T BAA using the evaluation criteria specified in the BAA through a peer or scientific review process in accordance with FAR 35.016(d). Unclassified white papers and proposals are typically collected via the DHS S&T BAA secure website, while classified white papers and proposals must be submitted via proper classified courier or proper classified mailing procedures as described in the National Industrial Security Program Operating Manual (NSPOM).

Federal agencies with an annual extramural research and development (R&D) budget exceeding $100 million are required to participate in the SBIR Program. Similarly, Federal agencies with an extramural R&D budget exceeding $1 billion are required to participate in the STTR Program. Federal agencies who participate in the SBIR and STTR programs must collect information from the public to meet:

1. Applicable reporting requirements under 15 U.S.C. 638 (b)(7), (g)(8), (i), (j)(1)(E), (j)(3)(C), (l), (o)(10), and (v);

2. The requirement to maintain both a publicly accessible database of SBIR/STTR award information and a government database of SBIR/STTR award information for SBIR and STTR program evaluation under 15 U.S.C. 638 g(10), (k), (o)(9), and (o)(15); and

3. Requirements for public outreach under 15 U.S.C. 638 (j)(2)(F), (o)(14), and (s).

The prior information collection request for OMB No. 1600-0005 was approved through June 30, 2018 by OMB in a Notice of OMB Action.

The information being collected is used by the Government's contracting officers and other acquisition personnel, including technical and legal staff to determine the adequacy of technical and management approach, experience, responsibility, responsiveness, and expertise of the firms submitting offers; the identification of members of the public (i.e., small businesses) who qualify for and are interested in participating in the DHS SBIR Program; and, provide the DHS SBIR Program Office necessary and sufficient information to determine whether proposals submitted by the public to the DHS SBIR Program meet the criteria for consideration under the program.

Failure to collect this information would adversely affect the quality of products and services DHS receives from contractors. Potentially, contracts would be awarded to firms without sufficient experience and expertise, thereby placing the Department's operations in jeopardy. Defective and inadequate contractor deliverables would adversely affect DHS's fulfillment of the mission requirements in all areas. Additionally, the Department would be unsuccessful in identifying small businesses with R&D capabilities, which would adversely affect the mission requirements in this area.

Many sources of the requested information use automated word processing systems, databases, and web portals to facilitate preparation of material to be submitted and to post and collect information. It is common place within many of DHS's Components for submissions to be electronic as a result of implementation of e-Government initiatives.

Information technology (i.e., electronic web portal) is used in the collection of information to reduce the data gathering and records management burden. DHS uses a secure website the public can use to propose SBIR research topics and submit proposals in response to SBIR solicitations. In addition, DHS uses a web portal to review RFIs and register to submit a white paper or proposal in response to a specific BAA. The data collection forms standardize the collection of information that is necessary and sufficient for the DHS SBIR Program Office to meet its requirements under 15 U.S.C. 638.

DHS/ALL/PIA-006 General Contact Lists dated June15, 2007 covers the basic contact information that must be collected for DHS. Other information collected will typically pertain to the contract itself, and not individuals. All information for this information collection is submitted voluntarily. However, sensitive information (e.g., felony conviction information) may also be collected through this information collection. Due to this sensitivity, and the sensitivities regarding the procurement process as a whole, a new PIA is required to document and identify any potential risks associated with collecting this information. There is no assurance of confidentiality provided to the respondents.

The burden estimates provided in response to Item 12 above are based upon definitive proposals reported by DHS and its Components to the Federal Procurement Data System (FPDS) for Fiscal Year 2016. No program changes occurred and there have been no changes to the information being collected. However, the burden was adjusted to reflect an agency adjustment increase of 103,600 in the number of respondents within DHS for Fiscal Year 2016, as well as an increase in the average hourly wage rate. In addition, the average response per respondent went from 7 to 3.5 per response, a difference of 3.5 hours. The change is a result of the DHS Heads of Contracting Activities' reassessment of the response time required for each of the applicable clauses.

This is an extension of a currently approved collection, 1600-0005. OMB is particularly interested in comments which:

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.

Agency: Office of the Chief Procurement Officer, DHS.

Title: Agency Information Collection Activities: Homeland Security Acquisition Regulation (HSAR) Solicitation of Proposal Information for Award of Public Contracts.

OMB Number: 1600-0005.

Frequency: Annually.

Affected Public: Private and Public Sector.

Number of Respondents: 117,212.

Estimated Time per Respondent: 3.5 hours.

Total Burden Hours: 1,230,726.

The information collection notice was previously published in the Federal Register on December 6, 2017, at 82 FR 57604, allowing for a 60-day public comment period. USCIS did receive 6 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-2008-0037 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: Notice of Entry of Appearance as Attorney or Accredited Representative; Notice of Entry of Appearance as Attorney in Matters Outside the Geographical Confines of the United States.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: G-28, G-28I; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. The data collected on Forms G-28 and G-28I is used by DHS to determine eligibility of the individual to appear as a representative. Form G-28 is used by attorneys admitted to practice in the United States and accredited representatives of certain non-profit organizations recognized by the Department of Justice. Form G-28I is used by attorneys admitted to the practice of law in countries other than the United States and only in matters in DHS offices outside the geographical confines of the United States. If the representative is eligible, the form is filed with the case and the information is entered into DHS systems for whatever type of application or petition it may be.

(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 G-28 is 2,778,700 and the estimated hour burden per response is 0.833 hours. The estimated total number of respondents for the information collection G-28 online filing is 281,950 and the estimated hour burden per response is 0.667 hours. The estimated total number of respondents for the information collection G-28I is 25,057 and the estimated hour burden per response is 0.700 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 of information is 2,520,258.

(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 $0. Any costs associated with this collection of information would be included in the forms that provide the catalyst for the filing of Forms G-28 or G-28I.

Comments

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-2015-0004 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

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.

Overview of this information collection:

(1) Type of Information Collection: Extension, Without Change, of a Currently Approved Collection.

(2) Title of the Form/Collection: Application for Travel Document (Carrier Documentation).

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-131A; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. USCIS uses the information provided on Form I-131A to verify the status of permanent or conditional residents, and determine whether the applicant is eligible for the requested travel document.

(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 Form I-131A is 4,110 and the estimated hour burden per response is .92 hours; biometrics processing is 4,110 and the estimated hour burden per response is 1.17 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 8,590 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 $704,620.

The following applicants have applied for scientific research permits to conduct certain activities with endangered species under section 10(a)(1)(A) of the Act (16 U.S.C. 1531 et seq.). We seek review and comment from local, State, and Federal agencies and the public on the following permit requests.

The applicant requests a permit renewal to take (harass by survey, capture, handle, photograph, and release) the arroyo toad (arroyo southwestern) (Anaxyrus californicus) in conjunction with survey and scientific research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a new permit to take (harass by survey, capture, handle, and release) the Fresno kangaroo rat (Dipodomys nitratoides exilis), Tipton kangaroo rat (Dipodomys nitratoides nitratoides), and giant kangaroo rat (Dipodomys ingens) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit amendment to take (harass by survey) the California Clapper rail (California Ridgway's rail) the California Ridgway's rail, formerly known as the California Clapper rail (Rallus longirostris obsoletus, or R. obsoletus o.) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a new permit to take (harass by survey, locate and monitor nests, capture, band, and release) the California least tern (Sternula antillarum browni) (Sterna a. browni) in conjunction with survey, population monitoring, and research activities throughout the range of the species for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (pursuit by survey) the Quino checkerspot butterfly (Euphydryas editha quino) in conjunction with survey activities throughout the range of the species for the purpose of enhancing the species' survival.

The applicant requests a permit renewal and amendment to take (harass by survey, capture, handle, mark, collect tissues samples, photograph, release, collect a limited number of voucher specimens, and conduct habitat restoration for) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense) and take (harass by survey, capture, handle, mark, photograph, release, collect a limited number of voucher specimens, and conduct habitat restoration for) the Santa Cruz long-toed salamander (Ambystoma macrodactylum croceum) in conjunction with survey, population monitoring, genetic sampling, research, and habitat restoration activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal and amendment to take (locate and monitor nests) the least Bell's vireo (Vireo bellii pusillus) and take (harass by survey, and locate and monitor nests) the southwestern willow flycatcher (Empidonax traillii extimus) in conjunction with survey and population monitoring activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey) the California Clapper rail (California Ridgway's rail) (Rallus longirostris obsoletus) (R. obsoletus o.) and take (harass by survey, capture, handle, and release) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey, capture, handle, mark, and release) the Stephens' kangaroo rat (Dipodomys stephensi) in conjunction with survey and research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

Applicant: Karl Fairchild, Fullerton, California.

The applicant requests a permit amendment to take (harass by survey) the southwestern willow flycatcher (Empidonax traillii extimus) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

Applicant: Michael Hobbs, San Jose, California.

The applicant requests a permit amendment to take (harass by survey, capture, handle, and release) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

Applicant: University of California Merced, Merced, California.

The applicant requests a new permit to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio) and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey and educational activities in Merced County, California, for the purpose of enhancing the species' survival.

The applicant requests a new permit to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); and take (pursuit by survey) the Quino checkerspot butterfly (Euphydryas editha quino) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey and research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey, capture, handle, and release) the Pacific pocket mouse (Perognathus longimembris pacificus) and arroyo toad (arroyo southwestern) (Anaxyrus californicus) and take (pursue by survey) the Delhi Sands flower-loving fly (Rhaphiomidas terminatus abdominalis) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit amendment to take (harass by survey, capture, mark, and release) the Mohave tui chub (Gila bicolor mohavensis), in conjunction with survey and population monitoring activities on Naval Air Weapons Station China Lake, in California, for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a new permit to take (harass by survey, capture, handle, and release) the San Bernardino Merriam's kangaroo rat (Dipodomys merriami parvus), Stephens' kangaroo rat (Dipodomys stephensi), and Pacific pocket mouse (Perognathus longimembris pacificus) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey, capture, handle, and release) the San Bernardino Merriam's kangaroo rat (Dipodomys merriami parvus), Stephens' kangaroo rat (Dipodomys stephensi), and Pacific pocket mouse (Perognathus longimembris pacificus) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a new permit to take (harass by survey, capture, and release) the Ohlone tiger beetle (Cicindela ohlone) in conjunction with survey and habitat enhancement activities in Santa Cruz County, California, for the purpose of enhancing the species' survival.

The applicant requests a permit renewal and amendment to take (harass by survey, capture, handle, and conduct instructional workshops involving field survey methods) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense) and take (harass by survey, capture, handle, release, collect vouchers, collect branchiopod cysts, process vernal pool soil samples, and conduct instructional workshops involving field survey methods) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey and educational activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, collect branchiopod cysts, and process vernal pool soil samples) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); take (harass by survey, capture, handle, and release) the San Francisco garter snake (Thamnophis sirtalis tetrataenia) and California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense); and take (harass by survey) the California Clapper rail (California Ridgway's rail) (Rallus longirostris obsoletus) (R. obsoletus o.) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal and amendment to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey activities throughout the range of the species in California and Oregon for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); take (harass by survey, capture, handle, take tissue samples, remove hybrids from the wild, temporarily keep hybrids in captivity, euthanize hybrids, and release) the California tiger salamander (Santa Barbara County Distinct Population Segment) (Ambystoma californiense); and take (pursuit by survey) the El Segundo blue butterfly (Euphilotes battoides allyni) in conjunction with survey and research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); take (harass by locating and monitoring nests) the least Bell's vireo (Vireo bellii pusillus); and take (harass by survey, capture, handle, and release) the San Bernardino Merriam's kangaroo rat (Dipodomys merriami parvus) and Stephens' kangaroo rat (Dipodomys stephensi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a new permit to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the San Diego fairy shrimp (Branchinecta sandiegonensis), and Riverside fairy shrimp (Streptocephalus woottoni) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by survey, capture, handle, and release) the San Bernardino Merriam's kangaroo rat (Dipodomys merriami parvus) and take (harass by survey) the southwestern willow flycatcher (Empidonax traillii extimus) in conjunction with survey activities in San Bernardino County, California, for the purpose of enhancing the species' survival.

The applicant requests a permit amendment and renewal to take (harass by survey, capture, handle, release, collect adult vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); take (pursuit by survey) the Quino checkerspot butterfly (Euphydryas editha quino) and mission blue butterfly (Icaricia icarioides missionensis); and take (harass by survey, capture, handle, release) the Casey's june beetle (Dinacoma caseyi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal and amendment to take (harass by survey, capture, handle, take tissue samples, conduct habitat restoration for, and release) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense) in conjunction with survey, research, and habitat enhancement activities throughout the range of the species in California for the purpose of enhancing the species' survival.

The applicant requests a permit renewal to take (harass by locating and monitoring nests, capture, handle, band, and remove brown-headed cowbird (Molothrus ater) eggs and chicks from parasitized nests) the least Bell's vireo (Vireo bellii pusillus), take (harass by survey, locate and monitor nests, capture, handle, band, and remove brown-headed cowbird (Molothrus ater) eggs and chicks from parasitized nests) the southwestern willow flycatcher (Empidonax traillii extimus), take (harass by survey) the light-footed clapper rail (light-footed Ridgway's rail) (Rallus longirostris levipes) (R. obsoletus l.) and Yuma clapper rail (Yuma Ridgway's rail) (Rallus longirostris yumanensis) (R. obsoletus y.), take (harass by survey, locate and monitor nests, capture, handle, and band) the California least tern (Sternula antillarum browni) (Sterna a. browni), and take (harass by survey, capture, handle, and release) the arroyo toad (arroyo southwestern) (Anaxyrus californicus) in conjunction with survey and population monitoring activities throughout the range of the species in California and Nevada for the purpose of enhancing the species' survival.

We invite public review and comment on each of these recovery permit applications. Comments and materials we receive will be available for public inspection, by appointment, during normal business hours at the address listed in the ADDRESSES section of this notice.

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.