Federal Register Vol. 83, No.142,

This meeting is available to the public through the following toll-free call-in number: 800-231-9012, conference ID number: 7840110. 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 staffing limitations that require immediate action.

The Census Bureau plans to request a three-year extension of Form C-404, “Report of Building or Zoning Permits Issued for New Privately-Owned Housing Units”, otherwise known as the Building Permits Survey. The Census Bureau uses this survey to produce statistics to monitor activity in the large and dynamic construction industry. For New Residential Construction (which includes Housing Units Authorized by Building Permits, Housing Starts, and Housing Completions), form C-404 is used to collect the estimate for Housing Units Authorized by Building Permits. For New Residential Construction and Sales, the number of housing units authorized by building permits is a key component utilized in the estimation of housing units started, completed, and sold.

These statistics help state and local governments, the Federal Government, and private industry, analyze the housing and construction industry sector of the economy. Building permits for new private housing units also are a component of The Conference Board's Leading Economic Index.

The Census Bureau uses Form C-404 to collect information on changes to the geographic coverage of permit-issuing places, the number and valuation of new residential housing units authorized by building permits, and additional information on residential permits valued at $1 million or more, including, but not limited to, site address and type of building. The Census Bureau uses these data to estimate the number of housing units started, the number of housing units completed, the number of single-family houses sold, and to select samples for the Census Bureau's demographic surveys. The Building Permits Survey is the only source of statistics on residential construction for states and smaller geographic areas. The Census Bureau uses the detailed geographic data collected from state and local officials on new residential construction authorized by building permits in the development of annual population estimates that are used by government agencies to allocate funding and other resources to local areas. Policymakers, planners, businesses, and others also use the detailed geographic data to monitor growth, plan for local services, and to develop production and marketing plans.

Respondents may submit their data via internet or a mailed or faxed form. Some respondents choose to email proprietary electronic files or mail proprietary printouts of permit information in lieu of returning the form.

The survey universe is comprised of approximately 20,325 local governments that issue building permits. Due to resource availability and the time required to complete the data review and analysis, the Census Bureau collects data from a sample of permit-issuing jurisdictions monthly, and the remainder of the jurisdictions annually. We collect this information monthly for about 7,850 permit-issuing jurisdictions who respond via internet or who mail or fax the provided form. Another 325 jurisdictions have established reporting arrangements that allow them to submit their responses monthly via proprietary electronic files or mailed printouts using their own file format. We collect this information annually for about 11,700 permit-issuing jurisdictions who respond via internet or who mail or fax the provided form. Another 450 jurisdictions have established reporting arrangements that allow them to submit their responses annually via proprietary electronic files or mailed printouts using their own file format.

OMB Control Number: 0607-0094.

Form Number(s): C-404.

Type of Review: Regular submission.

Affected Public: State and Local Governments.

Estimated Number of Respondents: 20,325.

Estimated Time per Response: 8 minutes for monthly respondents who report via internet, mail or faxing the form, 23 minutes for annual respondents who report via internet, mail or faxing the form and 3 minutes for monthly and annual respondents who send electronic files or mail printouts.

Estimated Total Annual Burden Hours: 17,263.

Estimated Total Annual Cost to Public: $0. (This is not the cost of respondents' time, but the indirect costs respondents may incur for such things as purchases of specialized software or hardware needed to report, or expenditures for accounting or records maintenance services required specifically by the collection.)

Respondent's Obligation: Voluntary.

Legal Authority: Title 13, United States Code, Sections 131 and 182.

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

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

Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. The regulations implementing Title III are found at 15 CFR part 325 (2014). The U.S. Department of Commerce, International Trade Administration, Office of Trade and Economic Analysis (“OTEA”) is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Secretary of Commerce to publish a summary of the issuance in the Federal Register. Under Section 305(a) of the Export Trading Company Act (15 U.S.C. 4012(b)(1)) and 15 CFR 325.11(a), any person aggrieved by the Secretary's determination may, within 30 days of the date of this notice, bring an action in any appropriate district court of the United States to set aside the determination on the ground that the determination is erroneous.

AIA's Export Trade Certificate of Review has been amended to:

1. Add the following companies as new Members of the Certificate within the meaning of section 325.2(l) of the Regulations (15 CFR 325.2(l)):

2. Delete the following companies as Members of AIA's Certificate:

3. Change in name or address for the following Members:

AIA's amendment of its Export Trade Certificate of Review results in the following membership list:

The effective date of the amendment is April 4, 2018, the date on which AIA's application to amend was deemed submitted.

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

Title: Information Management Requirements for Derivatives Clearing Organizations (OMB Control No. 3038-0069). This is a request for extension of a currently approved information collection.

Abstract: Part 39 of the Commission's regulations establishes information management requirements for registered DCOs. The Commission will use the information in this collection to assess compliance of DCOs with requirements for DCOs prescribed in the Commodity Exchange Act and Commission regulations.

With respect to the collection of information, the CFTC invites comments on:

• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;

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

• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

• Ways to minimize the burden of 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.

You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.1

The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from http://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the information collection requirements will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.

In accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i), announcement is made of the intent to grant an exclusive, non-royalty-bearing, revocable license to United States Patent Application US 15/723,448, filed October 3, 2017, entitled, “Aerosol Concentrating Apparatus for Use with Aerosol Aging Drum,” and Patent Cooperation Treaty Patent Application PCT/US2017/016845, filed February 7, 2017, entitled, “Oro-Nasal Inhalation Plethysmography Mask Exposure System,” and Patent Cooperation Treaty Patent Application PCT/US2017/016811, filed February 7, 2017, entitled, “Head-Only and/or Whole Body Inhalation Exposure Chamber” to PneumoDose, LLC, having its principal place of business at 112 Lynhaven Drive, Alexandria, VA 22305.

Anyone wishing to object to grant of this license can file written objections along with supporting evidence, if any, within 15 days from the date of this publication. Written objections are to be filed with the Command Judge Advocate (see ADDRESSES).

Purpose of Program: The purpose of this program is to ensure that parents of children with disabilities receive impartial training and information to help improve outcomes for their children.

Priority: In accordance with 34 CFR 75.105(b)(2)(v), this priority is from allowable activities specified in the statute (see sections 671, 672, 673, and 681(d) of the Individuals with Disabilities Education Act (IDEA); 20 U.S.C. 1471, 1472, 1473, and 1481(d)).

Absolute Priority: For FY 2018 and any subsequent year in which we make awards from the list of unfunded applications from this competition, this priority is an absolute priority. Under 34 CFR 75.105(c)(3), we consider only applications that meet this priority.

This priority is:

Technical Assistance for Parent Centers.

Background: The mission of the Office of Special Education and Rehabilitative Services (OSERS) is to improve early childhood, educational, and employment outcomes and raise expectations for all people with disabilities, their families, their communities, and the Nation. The work of the centers we are proposing to fund is generally consistent with the following priorities included in the Secretary's Supplemental Priorities, which were published in the Federal Register on March 2, 2018 (83 FR 9096): Priority 1—Empowering Families and Individuals to Choose a High-Quality Education That Meets Their Unique Needs; Priority 5—Meeting the Unique Needs of Students and Children With Disabilities and/or Those With Unique Gifts and Talents; and Priority 9—Promoting Economic Opportunity. The purpose of this priority is to fund five cooperative agreements to establish and operate five technical assistance centers for parent centers across two focus areas. A center for parent information and resources (CPIR) will focus on developing products for parent centers (Focus Area 1). Four regional parent training and technical assistance centers (regional PTACs) will focus on providing capacity-building technical assistance (TA) to the parent centers in their regions (Focus Area 2). Section 673 of IDEA authorizes TA for developing, assisting, and coordinating parent training and information programs carried out by parent training and information centers (PTIs) that receive assistance under section 671 of IDEA and community parent resource centers (CPRCs) that receive assistance under section 672 of IDEA (collectively, “parent centers”).

The 93 parent centers (www.parentcenterhub.org/find-your-center/) currently funded by the Department promote the effective education of infants, toddlers, children, and youth with disabilities by “strengthening the role and responsibility of parents and ensuring that families of such children have meaningful opportunities to participate in the education of their children at school and at home” (section 601(c)(5)(B) of IDEA). For the past 30 years, parent centers, consistent with section 671(b) of IDEA, have helped parents navigate systems providing early intervention, special education and related services, general education, and postsecondary options; understand the nature of their children's disabilities; learn about their rights and responsibilities under IDEA; expand their knowledge of practices based on evidence to help their children succeed; strengthen their collaboration with professionals; locate resources for themselves and their children; and advocate for improved child outcomes and student achievement, increased graduation rates, and improved postsecondary outcomes for all children through participation in program and school reform activities. In addition, parent centers have helped youth with disabilities understand their rights and responsibilities and learn self-advocacy skills.

PTACs provide support to parent centers to carry out these statutorily required activities and thereby help parents participate in the education of their children to improve their children's outcomes. In addition, section 673(b) of IDEA lists areas in which parent centers may also need TA from PTACs: (1) Coordinating parent training efforts; (2) disseminating scientifically based research and information; (3) promoting the use of technology, including assistive technology devices and services; (4) reaching underserved populations, including parents of low-income and limited English proficient children with disabilities; (5) including children with disabilities in general education programs; (6) facilitating all transitions from early intervention through postsecondary environments; and (7) promoting alternative methods of dispute resolution, including mediation.

PTACs provide needed support to parent centers on other topics as well, including current information on laws and policies; evidence-based (as defined in this notice) practices (EBPs) that impact children with disabilities and their families; how to help parents learn about and access high-quality education options that meet their children's unique needs; and ways to effectively engage in school reform activities, including Federal, State, and local initiatives. Ongoing TA, responsive to the individual needs of parent centers, can increase parent center staff knowledge and expertise on these topics. In addition, since many parent centers are grassroots organizations with small budgets, they often benefit from TA on managing a Federal grant, maximizing efficiencies, meeting complex statutory and regulatory requirements for nonprofits, and providing professional development to staff.

Parent centers also need support to increase their capacity to reach and provide services to youth with disabilities and to all parents of children with disabilities, particularly parents of infants, toddlers, preschool children and transition-age youth; and underserved parents with additional needs or unique circumstances, including low income-parents, parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents.

In order to ensure that parent centers receive the TA they need to increase their knowledge and capacity to provide services to parents and youth effectively and efficiently, the Department plans to fund five technical assistance centers for parent centers. The Department will fund a CPIR that will, in coordination with the regional PTACs, develop and disseminate resources for all parent centers to use when working with parents of children with disabilities and youth with disabilities. CPIR will also develop and disseminate materials that all parent centers can use to train staff to effectively reach and serve all parents and youth. The Department will also fund four regional PTACs that will provide TA to parent centers to effectively manage their centers and reach and serve all parents and youth within their region. The CPIR and regional PTACs will coordinate their efforts in order to maximize resources and avoid duplication. The following website provides more information on the current parent centers, including links to each grantee's website: www.parentcenterhub.org.

Priority: Under this priority, we will fund five cooperative agreements to establish and operate one CPIR and four regional PTACs across two focus areas. An applicant may submit separate applications in more than one focus area; however, an applicant is limited to only one application in each focus area.

Focus Area 1: Under Focus Area 1, the Department intends to fund one CPIR to achieve at a minimum, the following expected outcomes:

(a) Increased parent centers' knowledge, through the development and dissemination of high-quality, accurate, and impartial information and products, of:

(1) Early intervention and educational EBPs, and current Federal and State laws and policies, that impact children with disabilities and their families;

(2) The range of educational options that may be available in States to families of children with disabilities;

(3) Effective practices in carrying out parent center activities including outreach, family-centered services, and self-advocacy skill building;

(4) Effective and appropriate practices in outreach and service provision to underserved parents, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; and

(5) Effective nonprofit management practices;

(b) Increased parent centers' use of, high-quality, accurate, and impartial materials and approaches to train:

(1) Staff in reaching all parents and youth, including underserved parents of children with disabilities, which includes parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; and

(2) Multilingual staff in their native languages and assure the accuracy of the information the staff provide in languages other than English.

In addition to these programmatic requirements, to be considered for funding under Focus Area 1 of this priority, applicants must meet the application and administrative requirements in this priority, which are:

(a) Demonstrate, in the narrative section of the application under “Significance,” how the proposed project will—

(1) Address parent centers' needs both for resources to effectively reach and serve all parents of children with disabilities and youth with disabilities, including underserved parents, which includes parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents, and for materials to train staff to effectively reach and serve all parents and youth. To meet this requirement, the applicant must—

(i) Present applicable information on the needs of parent centers nationally; and

(ii) Demonstrate knowledge of—

(A) Current educational issues and policy initiatives relating to early childhood (ages birth through five), general and special education, secondary transition services, and postsecondary options; and

(B) Best practices in:

(1) Outreach; family-centered services; and self-advocacy skill building, including effective and appropriate outreach and service provision to underserved parents of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents;

(2) Staff training, including multilingual staff; and

(3) Nonprofit management; and

(2) Increase the knowledge of parent centers on how to reach and provide services to all parents and youth, train staff using high-quality, accurate, and impartial training materials, and manage their projects; and indicate the likely magnitude or importance of the improvements.

(b) Demonstrate, in the narrative section of the application under “Quality of project services,” how the proposed project will—

(1) Ensure equal access and treatment for members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. To meet this requirement, the applicant must describe how it will—

(i) Identify the informational and TA needs of the parent centers.

Note: The methods and tools to identify needs will be finalized in consultation with the regional PTACs and the OSEP project officer in order to assure coordination and avoid duplication; and

(ii) Ensure that services and products meet the needs of the parent centers;

(2) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—

(i) Measurable intended project outcomes; and

(ii) In Appendix A, the logic model (as defined in this notice) by which the proposed project will achieve its intended outcomes that depicts, at a minimum, the goals, activities, outputs, and intended outcomes of the proposed project;

(3) Use a conceptual framework (and provide a copy in Appendix A) to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework;

Note: The following websites provide more information on logic models and conceptual frameworks: www.osepideasthatwork.org/logicModel and www.osepideasthatwork.org/resources-grantees/program-areas/ta-ta/tad-project-logic-model-and-conceptual-framework.

(4) Be based on current research and make use of EBPs. To meet this requirement, the applicant must describe—

(i) The current research on outreach, family-centered services, and self-advocacy skill building, including effective and appropriate outreach and service provision to underserved parents of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; staff training, including multilingual staff; and nonprofit management;

(ii) The current research about adult learning principles and implementation science that will inform the proposed TA; and

(iii) How the proposed project will incorporate current research and EBPs in the development and delivery of its products and services;

(5) Develop products and provide services that are of high quality and sufficient intensity and duration to achieve the intended outcomes of the proposed project. To address this requirement, the applicant must describe—

(i) How it proposes to identify how knowledgeable the parent centers are of: Outreach, family-centered services, and self-advocacy skill building, including effective and appropriate outreach and service provision to underserved parents of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; staff training, including multilingual staff; and nonprofit management;

(ii) Its proposed approach to universal, general TA,1 which must identify the intended recipients within the parent centers, including the type and number of recipients, that will receive the products and services under this approach, and should, at minimum, include how the project will—

(A) Create, update, and maintain an online, annotated repository of high-quality, accurate, and impartial resources,2 including translations of materials as needed, produced by the CPIR, the previously funded Military and Native American PTACs, parent centers, OSEP-funded projects, and other federally funded projects for parent centers' use with families, youth, staff members, and members of the boards of directors;

(B) Develop up-to-date, family-centered resources as needed that parent centers can use with parents in a variety of languages, formats, and reading levels; disseminate and modify, as needed, family-centered resources developed by OSEP and other federally funded centers to provide families with strategies to enhance their children's literacy, numeracy, and scientific reasoning at home; and revise materials developed by the previously funded Military PTAC and the Native American PTAC as necessary;

(C) Compile and create materials to train staff, including multilingual staff, to provide effective, appropriate, and impartial outreach and service provision to underserved parents of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents;

(D) Compile and create materials on nonprofit management, as necessary, and develop a process for an annual orientation of new parent center directors and other key personnel and members of the boards of directors that provides the new personnel with the information and resources they need to carry out their responsibilities; and

(6) Develop products and implement services that maximize efficiency. To address this requirement, the applicant must describe—

(i) How the proposed project will use technology to achieve the intended project outcomes;

(ii) With whom the proposed project will collaborate and the intended outcomes of this collaboration;

(iii) How the proposed project will use existing knowledge and expertise within parent centers to achieve intended project outcomes; and

(v) How the proposed project will use non-project resources to achieve the intended project outcomes; and

(7) Assist parent centers in the collection of annual performance data required under section 671(b)(12) of IDEA, in consultation with the OSEP project officer.

(c) In the narrative section of the application under “Quality of the project evaluation,” include an evaluation plan for the project as described in the following paragraphs. The evaluation plan must describe: Measures for evaluating the quality, accuracy, and impartiality of project services and products; measures of progress in implementation, including the criteria for determining the extent to which the project's products and services have met the goals for reaching its target population; measures of intended outcomes or results of the project's activities in order to evaluate those activities; and how well the goals or objectives of the proposed project, as described in its logic model, have been met.

The applicant must provide an assurance that, in designing the evaluation plan, it will—

(1) Designate, with the approval of the OSEP project officer, a project liaison staff person with sufficient dedicated time, experience in evaluation, and knowledge of the project to work in collaboration with the TA Center to Improve Program and Project Performance (CIP3),3 the project director, and the OSEP project officer on the following tasks:

(i) Revise, as needed, the logic model submitted in the grant application to provide for a more comprehensive measurement of implementation and outcomes and to reflect any changes or clarifications to the model discussed at the kick-off meeting;

(ii) Refine the evaluation design and instrumentation proposed in the grant application consistent with the logic model (e.g., prepare evaluation questions about significant program processes and outcomes; develop quantitative or qualitative data collections that permit both the collection of progress data, including fidelity of implementation, as appropriate, and the assessment of project outcomes; and identify analytic strategies); and

(iii) Revise, as needed, the evaluation plan submitted in the grant application such that it clearly—

(A) Specifies the measures and associated instruments or sources for data appropriate to the evaluation questions, suggests analytic strategies for those data, provides a timeline for conducting the evaluation, and includes staff assignments for completion of the plan;

(B) Delineates the data expected to be available by the end of the second project year for use during the project's evaluation (3+2 review) for continued funding described under the heading Fourth and Fifth Years of the Project; and

(C) Can be used to assist the project director and the OSEP project officer, with the assistance of CIP3, as needed, to specify the performance measures to be addressed in the project's Annual Performance Report;

(2) Cooperate with CIP3 staff in order to accomplish the tasks described in paragraph (1) of this section; and

(3) Dedicate sufficient funds in each budget year to cover the costs of carrying out the tasks described in paragraphs (1) and (2) of this section and implementing the evaluation plan.

(d) Demonstrate, in the narrative section of the application under “Adequacy of resources,” how—

(1) The proposed project will encourage applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate;

(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to carry out the proposed activities and achieve the project's intended outcomes;

(3) The applicant and any key partners have adequate resources to carry out the proposed activities; and

(4) The proposed costs are reasonable in relation to the anticipated results and benefits.

(e) Demonstrate, in the narrative section of the application under “Quality of the management plan,” how—

(1) The proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—

(i) Clearly defined responsibilities for key project personnel, consultants, and subcontractors, as applicable; and

(ii) Timelines and milestones for accomplishing the project tasks;

(2) Key project personnel and any consultants and subcontractors will be allocated and how these allocations are appropriate and adequate to achieve the project's intended outcomes;

(3) The proposed management plan will ensure that the products and services provided are of high quality, impartial, relevant, and useful to recipients; and

(4) The proposed project will benefit from a diversity of perspectives, including those of families using a variety of education options, youth, educators, TA providers, researchers, and policy makers, among others, in its development and operation.

(f) Address the following application requirements. The applicant must—

(1) Include, in Appendix A, personnel-loading charts and timelines, as applicable, to illustrate the management plan described in the narrative;

(2) Include, in the budget, attendance at the following:

(i) A one and one-half day kick-off meeting in Washington, DC, after receipt of the award, and an annual planning meeting in Washington, DC, with the OSEP project officer and other relevant staff during each subsequent year of the project period;

Note: Within 30 days of receipt of the award, a post-award teleconference must be held between the OSEP project officer and the grantee's project director or other authorized representative;

(ii) A two and one-half day project directors' conference in Washington, DC, during each year of the project period;

(iii) Two annual two-day trips to attend Department briefings, Department-sponsored conferences, and other meetings, as requested by OSEP; and

(iv) A one-day intensive 3+2 review meeting in Washington, DC, during the last half of the second year of the project period;

(3) Include, in the budget, a line item for an annual set-aside of five percent of the grant amount to support emerging needs that are consistent with the proposed project's intended outcomes, as those needs are identified in consultation with, and approved by, the OSEP project officer. With approval from the OSEP project officer, the project must reallocate any remaining funds from this annual set-aside no later than the end of the third quarter of each budget period;

(4) Ensure that the budget allocates at least $200,000 annually to carry out the project services described in paragraphs (b)(5)(ii)(A) through (C) of this focus area;

(5) Maintain a high-quality website, with an easy-to-navigate design, including the repository described in paragraph (b)(5)(ii)(A) of this focus area, that meets government or industry-recognized standards for accessibility; and

(6) Include, in Appendix A, an assurance to assist OSEP with the transfer of pertinent resources and products and to maintain the continuity of services to parent centers during the transition to this new award period, as appropriate.

Fourth and Fifth Years of the Project: In deciding whether to continue funding the project for the fourth and fifth years, the Secretary will consider the requirements of 34 CFR 75.253(a), as well as—

(a) The recommendation of a 3+2 review team consisting of experts selected by the Secretary. This review will be conducted during a one-day intensive meeting that will be held during the last half of the second year of the project period;

(b) The timeliness with which, and how well, the requirements of the negotiated cooperative agreement have been or are being met by the project; and

(c) The quality, relevance, and usefulness of the project's products and services and the extent to which the project's products and services are aligned with the project's objectives and likely to result in the project achieving its intended outcomes.

Focus Area 2: Under Focus Area 2, the Department intends to fund four regional PTACs to meet the unique needs of parent centers in their region and to achieve, at a minimum, the following expected outcomes:

(a) Increased parent center capacity to accurately and impartially train parents on, and inform them about:

(1) Early intervention and educational EBPs;

(2) Their rights and responsibilities under Federal, State, and local laws and policies that impact children with disabilities and their families; and

(3) The range of education options that may be available to families of children with disabilities in the area served by the parent center.

(b) Increased parent center capacity to reach more parents and youth; and effectively provide parent center services to help more parents improve outcomes for their children, and youth build their self-advocacy skills;

(c) Increased parent center capacity to provide effective and appropriate outreach and service provision to underserved parents of children with disabilities including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; and

(d) Increased parent center capacity to effectively manage their projects and provide high-quality training to staff, including multilingual staff, to reach and serve all parents and youth in their region.

The geographic regions served by the four regional PTACs are generally aligned with the States served by the Equity Assistance Centers funded under Title IV of the 1964 Civil Rights Act, while also balancing the number of centers each regional PTAC will have in their region. This alignment will help the regional PTACs meet the requirement in section 673(c) of IDEA that the regional PTACs develop collaborative agreements with the geographically appropriate centers. The four regional PTACs will be awarded to represent the following geographic regions:

Region A PTAC: CT, DC, DE, ME, MA, MD, NH, NJ, NY, PA, Puerto Rico, RI, U.S. Virgin Islands, VT.

Region B PTAC: AL, AR, FL, GA, LA, MS, NC, OK, SC, TN, TX, VA.

Region C PTAC: IL, IN, IA, KS, KY, MI, MN, MO, MT, NE, ND, OH, SD, WI, WV, WY.

Region D PTAC: AK, AZ, CA, CO, HI, ID, NM, NV, OR, UT, WA, and the outlying areas of the Pacific Basin, and the Freely Associated States.

In addition to these programmatic requirements, to be considered for funding under Focus Area 2 of this priority, applicants must meet the application and administrative requirements in this priority, which are:

(a) Demonstrate, in the narrative section of the application under “Significance,” how the proposed project will—

(1) Address the needs of parent centers in its region for TA to increase their capacity to reach and provide services to parents and youth in their areas, including underserved parents of children with disabilities, which includes parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; build youth's self-advocacy skills; train staff; and effectively manage their centers. To meet this requirement the applicant must—

(i) Present applicable information on the needs of parent centers in the region; and

(ii) Demonstrate knowledge of—

(A) Current early intervention and educational issues and policy initiatives relating to early childhood, general and special education, secondary transition services, and postsecondary options; and

(B) Best practices in:

(1) Outreach, family-centered services, and self-advocacy skill building, including effective and appropriate outreach and service provision to underserved parents of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents;

(2) Staff training, including multilingual staff; and

(3) Nonprofit management; and

(2) Increase the capacity of parent centers to reach and provide services to all parents and youth, train staff, and manage their projects; and indicate the likely magnitude or importance of the improvements.

(b) Demonstrate, in the narrative section of the application under “Quality of project services,” how the proposed project will—

(1) Ensure equal access and treatment for members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. To meet this requirement, the applicant must describe how it will—

(i) Identify the needs of the parent centers in the proposed region for TA and information.

Note: The methods and tools to identify needs will be finalized in consultation with the CPIR, other regional PTACs, and the OSEP project officer in order to assure coordination and avoid duplication; and

(ii) Ensure that services and products meet the needs of the parent centers;

(2) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—

(i) Measurable intended project outcomes; and

(ii) In Appendix A, the logic model (as defined in this notice) by which the proposed project will achieve its intended outcomes that depicts, at a minimum, the goals, activities, outputs, and intended outcomes of the proposed project;

(3) Use a conceptual framework (and provide a copy in Appendix A) to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework;

Note: The following websites provide more information on logic models and conceptual frameworks: www.osepideasthatwork.org/logicModel and www.osepideasthatwork.org/resources-grantees/program-areas/ta-ta/tad-project-logic-model-and-conceptual-framework.

(4) Be based on current research and make use of EBPs. To meet this requirement, the applicant must describe—

(i) The current research on: Outreach, family-centered services, and self-advocacy skill building, including effective and appropriate outreach and service provision to underserved parents of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; staff training, including multilingual staff; and nonprofit management;

(ii) The current research about adult learning principles and implementation science that will inform the proposed TA; and

(iii) How the proposed project will incorporate current research and EBPs in the development and delivery of its products and services;

(5) Develop products and provide services that are of high quality and sufficient intensity and duration to achieve the intended outcomes of the proposed project. To address this requirement, the applicant must describe—

(i) How it proposes to work with the CPIR to identify the knowledge base for parent centers': Outreach, family-centered services, and self-advocacy skill building, including effective and appropriate outreach and service provision to underserved families of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; staff training, including multilingual staff; and nonprofit management;

(ii) Its proposed approach to targeted, specialized TA,4 which must identify the intended recipients within the parent centers, including the type and number of recipients, that will receive the products and services under this approach, and how the project will—

(A) Conduct at least one in-person, on-site visit to each parent center in the region during the course of the five-year project period;

(B) Increase parent centers' capacity to reach and provide services to all parents with children with disabilities and youth, including underserved parents, which includes parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents;

(C) Increase parent centers' capacity to train staff, including multilingual staff, to provide effective and appropriate outreach and service provision to underserved families of children with disabilities, including parents with limited English proficiency, parents with low literacy levels, parents who themselves experience disability, parents of youth involved in the juvenile justice system, foster parents, military-connected parents, and Native American parents; and

(D) Increase parent centers' capacity to effectively manage nonprofit organizations, including developing the board of directors so that parent centers have the organizational policies, procedures, and a structure in place to manage their grants effectively;

(iii) Its proposed approach to intensive, sustained TA,5 which must identify—

(A) The intended recipients, including the type and number of recipients, that will receive the products and services under this approach;

(B) Its proposed approach to measure the readiness of the parent centers to work with the project, including their commitment to the initiative, current infrastructure, and available resources;

(C) Its proposed plan for assisting parent centers to build or enhance their staff training and professional development based on adult learning principles and coaching; and

(D) Its proposed approach to providing intensive TA when requested by OSEP project officers; and

(6) Develop products and implement services that maximize efficiency. To address this requirement, the applicant must describe—

(i) How the proposed project will use technology to achieve the intended project outcomes;

(ii) With whom the proposed project will collaborate and the intended outcomes of this collaboration;

(iii) How the proposed project will use existing knowledge and expertise within parent centers to achieve intended project outcomes;

(iv) How the proposed project will use the resources housed in and developed by the CPIR—including family-centered resources that provide families with strategies to enhance their children's literacy, numeracy, and scientific reasoning at home—and build on the CPIR's universal TA; and

(v) How the proposed project will use non-project resources to achieve the intended project outcomes.

(c) In the narrative section of the application under “Quality of the project evaluation,” include an evaluation plan for the project. The evaluation plan must describe: Measures for evaluating the quality, accuracy, and impartiality of project services and products; measures of progress in implementation, including the criteria for determining the extent to which the project's products and services have met the goals for reaching its target population; measures of intended outcomes or results of the project's activities in order to evaluate those activities; and how well the goals or objectives of the proposed project, as described in its logic model, have been met.

Note: The evaluations for all the regional PTACs will be developed in consultation with the regional PTACs and OSEP project officers for the regional PTACs.

(d) Demonstrate, in the narrative section of the application under “Adequacy of resources,” how—

(1) The proposed project will encourage applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate;

(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to carry out the proposed activities and achieve the project's intended outcomes;

(3) The applicant and any key partners have adequate resources to carry out the proposed activities; and

(4) The proposed costs are reasonable in relation to the anticipated results and benefits.

(e) Demonstrate, in the narrative section of the application under “Quality of the management plan,” how—

(1) The proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—

(i) Clearly defined responsibilities for key project personnel, consultants, and subcontractors, as applicable; and

(ii) Timelines and milestones for accomplishing the project tasks;

(2) Key project personnel and any consultants and subcontractors will be allocated and how these allocations are appropriate and adequate to achieve the project's intended outcomes;

(3) The proposed management plan will ensure that the products and services provided are of high quality, impartial, relevant, and useful to recipients; and

(4) The proposed project will benefit from a diversity of perspectives, including those of families using a variety of education options, youth, educators, TA providers, researchers, and policy makers, among others, in its development and operation.

(f) Address the following application requirements. The applicant must—

(1) Include, in Appendix A, personnel-loading charts and timelines, as applicable, to illustrate the management plan described in the narrative;

(2) Include, in the budget, attendance at the following:

(i) A one and one-half day kick-off meeting in Washington, DC, after receipt of the award, and an annual planning meeting in Washington, DC, with the OSEP project officer and other relevant staff during each subsequent year of the project period.

Note: Within 30 days of receipt of the award, a post-award teleconference must be held between the OSEP project officer and the grantee's project director or other authorized representative;

(ii) A two and one-half day project directors' conference in Washington, DC, during each year of the project period; and

(iii) Two annual two-day trips to attend Department briefings, Department-sponsored conferences, and other meetings, as requested by OSEP;

(5) Ensure that the budget allocates $75,000 annually to carry out the project services described in paragraphs (b)(5)(ii)(B) and (C) (military connected and native American parents and youth) of this focus area.

(6) Include, in the budget, a line item for an annual set-aside of five percent of the grant amount to support emerging needs that are consistent with the proposed project's intended outcomes, as those needs are identified in consultation with, and approved by, the OSEP project officer. With approval from the OSEP project officer, the project must reallocate any remaining funds from this annual set-aside no later than the end of the third quarter of each budget period; and

(7) Maintain a presence on a high-quality website, with an easy-to-navigate design, that meets government or industry-recognized standards for accessibility.

Competitive Preference Priorities: Within this absolute priority, we give competitive preference to applications that address the following priorities. Under 34 CFR 75.105(c)(2)(i), we will award five additional points to an application for Focus Area 2 that meets each of these priorities, for a total of no more than 10 points, as follows.

These priorities are:

Competitive Preference Priority 1—Applicants that are parent organizations (5 Points).

Section 671(a)(2) of IDEA defines a “parent organization” as a private nonprofit organization (other than an institution of higher education) that—

(A) Has a board of directors—

(i) The majority of whom are parents of children with disabilities ages birth through 26;

(ii) That includes—

(I) Individuals working in the fields of special education, related services, and early intervention;

(II) Individuals with disabilities; and

(iii) The parent and professional members of which are broadly representative of the population to be served, including low-income parents and parents of limited English proficient children; and

(B) Has as its mission serving families of children with disabilities who—

(i) Are ages birth through 26; and

(ii) Have the full range of disabilities described in section 602(3) of IDEA.

Competitive Preference Priority 2—Location (5 Points).

Applicants under Focus Area 2 that are located in the region they propose to serve.

Definitions: The following definitions are from 34 CFR 77.1:

Demonstrates a rationale means a key project component included in the project's logic model is informed by research or evaluation findings that suggest the project component is likely to improve relevant outcomes.

Evidence-based means the proposed project component is supported by one or more of strong evidence, moderate evidence, promising evidence, or evidence that demonstrates a rationale.

Experimental study means a study that is designed to compare outcomes between two groups of individuals (such as students) that are otherwise equivalent except for their assignment to either a treatment group receiving a project component or a control group that does not. Randomized controlled trials, regression discontinuity design studies, and single-case design studies are the specific types of experimental studies that, depending on their design and implementation (e.g., sample attrition in randomized controlled trials and regression discontinuity design studies), can meet What Works Clearinghouse (WWC) standards without reservations as described in the WWC Handbook:

(i) A randomized controlled trial employs random assignment of, for example, students, teachers, classrooms, or schools to receive the project component being evaluated (the treatment group) or not to receive the project component (the control group).

(ii) A regression discontinuity design study assigns the project component being evaluated using a measured variable (e.g., assigning students reading below a cutoff score to tutoring or developmental education classes) and controls for that variable in the analysis of outcomes.

(iii) A single-case design study uses observations of a single case (e.g., a student eligible for a behavioral intervention) over time in the absence and presence of a controlled treatment manipulation to determine whether the outcome is systematically related to the treatment.

Logic model (also referred to as a theory of action) means a framework that identifies key project components of the proposed project (i.e., the active “ingredients” that are hypothesized to be critical to achieving the relevant outcomes) and describes the theoretical and operational relationships among the key project components and relevant outcomes.

Moderate evidence means that there is evidence of effectiveness of a key project component in improving a relevant outcome for a sample that overlaps with the populations or settings proposed to receive that component, based on a relevant finding from one of the following:

(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;

(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” or “potentially positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

(iii) A single experimental study or quasi-experimental design study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—

(A) Meets WWC standards with or without reservations;

(B) Includes at least one statistically significant and positive (i.e., favorable) effect on a relevant outcome;

(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and

(D) Is based on a sample from more than one site (e.g., State, county, city, school district, or postsecondary campus) and includes at least 350 students or other individuals across sites. Multiple studies of the same project component that each meet requirements in paragraphs (iii)(A), (B), and (C) of this definition may together satisfy this requirement.

Project component means an activity, strategy, intervention, process, product, practice, or policy included in a project. Evidence may pertain to an individual project component or to a combination of project components (e.g., training teachers on instructional practices for English learners and follow-on coaching for these teachers).

Promising evidence means that there is evidence of the effectiveness of a key project component in improving a relevant outcome, based on a relevant finding from one of the following:

(i) A practice guide prepared by WWC reporting a “strong evidence base” or “moderate evidence base” for the corresponding practice guide recommendation;

(ii) An intervention report prepared by the WWC reporting a “positive effect” or “potentially positive effect” on a relevant outcome with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

(iii) A single study assessed by the Department, as appropriate, that—

(A) Is an experimental study, a quasi-experimental design study, or a well-designed and well-implemented correlational study with statistical controls for selection bias (e.g., a study using regression methods to account for differences between a treatment group and a comparison group); and

(B) Includes at least one statistically significant and positive (i.e., favorable) effect on a relevant outcome.

Quasi-experimental design study means a study using a design that attempts to approximate an experimental study by identifying a comparison group that is similar to the treatment group in important respects. This type of study, depending on design and implementation (e.g., establishment of baseline equivalence of the groups being compared), can meet WWC standards with reservations, but cannot meet WWC standards without reservations, as described in the WWC Handbook.

Relevant outcome means the student outcome(s) or other outcome(s) the key project component is designed to improve, consistent with the specific goals of the program.

Strong evidence means that there is evidence of the effectiveness of a key project component in improving a relevant outcome for a sample that overlaps with the populations and settings proposed to receive that component, based on a relevant finding from one of the following:

(i) A practice guide prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “strong evidence base” for the corresponding practice guide recommendation;

(ii) An intervention report prepared by the WWC using version 2.1 or 3.0 of the WWC Handbook reporting a “positive effect” on a relevant outcome based on a “medium to large” extent of evidence, with no reporting of a “negative effect” or “potentially negative effect” on a relevant outcome; or

(iii) A single experimental study reviewed and reported by the WWC using version 2.1 or 3.0 of the WWC Handbook, or otherwise assessed by the Department using version 3.0 of the WWC Handbook, as appropriate, and that—

(A) Meets WWC standards without reservations;

(B) Includes at least one statistically significant and positive (i.e., favorable) effect on a relevant outcome;

(C) Includes no overriding statistically significant and negative effects on relevant outcomes reported in the study or in a corresponding WWC intervention report prepared under version 2.1 or 3.0 of the WWC Handbook; and

(D) Is based on a sample from more than one site (e.g., State, county, city, school district, or postsecondary campus) and includes at least 350 students or other individuals across sites. Multiple studies of the same project component that each meet requirements in paragraphs (iii)(A), (B), and (C) of this definition may together satisfy this requirement.

What Works Clearinghouse Handbook (WWC Handbook) means the standards and procedures set forth in the WWC Procedures and Standards Handbook, Version 3.0 or Version 2.1 (incorporated by reference, see 34 CFR 77.2). Study findings eligible for review under WWC standards can meet WWC standards without reservations, meet WWC standards with reservations, or not meet WWC standards. WWC practice guides and intervention reports include findings from systematic reviews of evidence as described in the Handbook documentation.

Waiver of Proposed Rulemaking: Under the Administrative Procedure Act (APA) (5 U.S.C. 553) the Department generally offers interested parties the opportunity to comment on proposed priorities and requirements. Section 681(d) of IDEA, however, makes the public comment requirements of the APA inapplicable to the priority in this notice.

Program Authority: 20 U.S.C. 1471, 1472, 1473, and 1481.

Applicable Regulations: (a) The Education Department General Administrative Regulations in 34 CFR parts 75, 77, 79, 81, 82, 84, 97, 98, and 99. (b) The Office of Management and Budget Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474.

Note: The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian Tribes.

Type of Award: Cooperative agreements.

Estimated Available Funds: $2,800,000.

Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2019 from the list of unfunded applications from this competition.

Estimated Range of Awards: $500,000-$800,000.

Estimated Average Size of Awards: 4 awards at $500,000 for the regional PTACs; 1 award of $800,000 for the CPIR.

Maximum Award: We will not make an award exceeding $500,000 for each of the regional PTACs or $800,000 for the CPIR for a single budget period of 12 months.

Estimated Number of Awards: 5.

Note: The Department is not bound by any estimates in this notice.

Project Period: Up to 60 months.

1. Eligible Applicants: Nonprofit private organizations.

2. Cost Sharing or Matching: This program does not require cost sharing or matching.

3. Subgrantees: Under 34 CFR 75.708(b) and (c), a grantee under this competition may award subgrants—to directly carry out project activities described in its application—to the following types of entities: IHEs and private nonprofit organizations suitable to carry out the activities proposed in the application The grantee may award subgrants to entities it has identified in an approved application.

4. Other General Requirements: (a) Recipients of funding under this competition must make positive efforts to employ and advance in employment qualified individuals with disabilities (see section 606 of IDEA).

(b) Applicants for, and recipients of, funding must, with respect to the aspects of their proposed project relating to the absolute priority, involve individuals with disabilities, or parents of individuals with disabilities ages birth through 26, in planning, implementing, and evaluating the project (see section 682(a)(1)(A) of IDEA).

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.

2. Intergovernmental Review: This competition is subject to Executive Order 12372 and the regulations in 34 CFR part 79. However, under 34 CFR 79.8(a), we waive intergovernmental review in order to make awards by the end of FY 2018.

3. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

4. Recommended Page Limit: The application narrative (Part III of the application) is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. We recommend that you (1) limit the application narrative to no more than 50 pages, and (2) use the following standards:

• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.

• Double-space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, reference citations, and captions, as well as all text in charts, tables, figures, graphs, and screen shots.

• Use a font that is 12 point or larger.

• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.

The recommended page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the abstract (follow the guidance provided in the application package for completing the abstract), the table of contents, the list of priority requirements, the resumes, the reference list, the letters of support, or the appendices. However, the recommended page limit does apply to all of the application narrative, including all text in charts, tables, figures, graphs, and screen shots.

1. Selection Criteria: The selection criteria for this competition are from 34 CFR 75.210 and are as follows:

(a) Significance (10 points).

(1) The Secretary considers the significance of the proposed project.

(2) In determining the significance of the proposed project, the Secretary considers the following factors:

(i) The extent to which the proposed project will focus on serving or otherwise addressing the needs of disadvantaged individuals;

(ii) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses; and

(iii) The importance or magnitude of the results or outcomes likely to be attained by the proposed project.

(b) Quality of the project services (35 points).

(1) The Secretary considers the quality of the services to be provided by the proposed project.

(2) In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.

(3) In addition, the Secretary considers the following factors:

(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable;

(ii) The extent to which there is a conceptual framework underlying the proposed research or demonstration activities and the quality of that framework;

(iii) The extent to which the services to be provided by the proposed project reflect up-to-date knowledge from research and effective practice;

(iv) The extent to which the services to be provided by the proposed project are appropriate to the needs of the intended recipients or beneficiaries of those services;

(v) The extent to which the services to be provided by the proposed project involve the collaboration of appropriate partners for maximizing the effectiveness of project services; and

(vi) The extent to which the technical assistance services to be provided by the proposed project involve the use of efficient strategies, including the use of technology, as appropriate, and the leveraging of non-project resources.

(c) Quality of project evaluation (20 points).

(1) The Secretary considers the quality of the evaluation to be conducted of the proposed project.

(2) In determining the quality of the evaluation, the Secretary considers the following factors:

(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project;

(ii) The extent to which the methods of evaluation are appropriate to the context within which the project operates;

(iii) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes; and

(iv) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible.

(d) Adequacy of resources and Quality of Project Personnel (15 points).

(1) The Secretary considers the adequacy of resources and quality of project personnel for the proposed project.

(2) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.

(3) In determining the adequacy of resources and quality of project personnel for the proposed project, the Secretary considers the following factors:

(i) The qualifications, including relevant training and experience, of the project director or principal investigator;

(ii) The qualifications, including relevant training and experience, of key project personnel;

(iii) The qualifications, including relevant training and experience, of project consultants or subcontractors;

(iv) The adequacy of support, including facilities, equipment, supplies, and other resources, from the applicant organization or the lead applicant organization;

(v) The relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project; and

(vi) The extent to which the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project.

(e) Quality of the management plan (20 points).

(1) The Secretary considers the quality of the management plan for the proposed project.

(2) In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:

(i) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks;

(ii) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project;

(iii) The adequacy of mechanisms for ensuring high-quality products and services from the proposed project; and

(iv) How the applicant will ensure that a diversity of perspectives are brought to bear in the operation of the proposed project, including those of parents, teachers, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate.

2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

In addition, in making a competitive grant award, the Secretary requires various assurances, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

3. Additional Review and Selection Process Factors: In the past, the Department has had difficulty finding peer reviewers for certain competitions because so many individuals who are eligible to serve as peer reviewers have conflicts of interest. The standing panel requirements under section 682(b) of IDEA also have placed additional constraints on the availability of reviewers. Therefore, the Department has determined that for some discretionary grant competitions, applications may be separated into two or more groups and ranked and selected for funding within specific groups. This procedure will make it easier for the Department to find peer reviewers by ensuring that greater numbers of individuals who are eligible to serve as reviewers for any particular group of applicants will not have conflicts of interest. It also will increase the quality, independence, and fairness of the review process, while permitting panel members to review applications under discretionary grant competitions for which they also have submitted applications.

4. Risk Assessment and Specific Conditions: Consistent with 2 CFR 200.205, before awarding grants under this competition the Department conducts a review of the risks posed by applicants. Under 2 CFR 3474.10, the Secretary may impose specific conditions and, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

5. Integrity and Performance System: If you are selected under this competition to receive an award that over the course of the project period may exceed the simplified acquisition threshold (currently $150,000), under 2 CFR 200.205(a)(2) we must make a judgment about your integrity, business ethics, and record of performance under Federal awards—that is, the risk posed by you as an applicant—before we make an award. In doing so, we must consider any information about you that is in the integrity and performance system (currently referred to as the Federal Awardee Performance and Integrity Information System (FAPIIS)), accessible through the System for Award Management (SAM) at https://www.sam.gov. You may review and comment on any information about yourself that a Federal agency previously entered and that is currently in FAPIIS.

Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.

1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN); or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

If your application is not evaluated or not selected for funding, we notify you.

2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

3. Open Licensing Requirements: Unless an exception applies, if you are awarded a grant under this competition, you will be required to openly license to the public grant deliverables created in whole, or in part, with Department grant funds. When the deliverable consists of modifications to pre-existing works, the license extends only to those modifications that can be separately identified and only to the extent that open licensing is permitted under the terms of any licenses or other legal restrictions on the use of pre-existing works. Additionally, a grantee or subgrantee that is awarded competitive grant funds must have a plan to disseminate these public grant deliverables. This dissemination plan can be developed and submitted after your application has been reviewed and selected for funding. For additional information on the open licensing requirements please refer to 2 CFR 3474.20.

4. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

5. Performance Measures: Under the Government Performance and Results Act of 1993 (GPRA), the Department has established a set of performance measures, including long-term measures, that are designed to yield information on the quality, relevance, and usefulness of the materials, products, and services of the Parent Training and Information Centers program. These measures are:

• Program Performance Measure #1: The percentage of materials used by projects that are deemed to be of high quality;

• Program Performance Measure #2: The percentage of products and services deemed to be of high relevance to educational and early intervention policy and practice; and

• Program Performance Measure #3: The percentage of all products and services deemed to be useful by target audiences to improve educational or early intervention policy or practice.

Grantees will be required to report information on their project's performance in annual reports to the Department (34 CFR 75.590).

5. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: Whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, the performance targets in the grantee's approved application.

In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

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) by contacting the Management Support Services Team, U.S. Department of Education, 400 Maryland Avenue SW, Room 5113, Potomac Center Plaza, Washington, DC 20202-2500. Telephone: (202) 245-7363. If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.

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

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

This information collection request contains: (1) OMB No.: 1910-5143; (2) Information Collection Request Title: Labor Relations Report; (3) Type of Request: Renewal; (4) Purpose: The proposed collection will request information from the Department of Energy M&O and Facilities Management Contractors for contract administration, management oversight, and cost control. This information is used to ensure that Department contractors maintain good labor relations and retain a workforce in accordance with the terms of their contract and in compliance with statutory and regulatory requirements as identified by contract. The respondents are Department M&O and Facility Management Contractors; (5) Annual Estimated Number of Respondents: 35; (6) Annual Estimated Number of Total Responses: 35; (7) Annual Estimated Number of Burden Hours: 1.84 per respondent for total of 64.4 per year; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: $3,316.60.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control Number: 3060-0876.

Title: Sections 54.703, USAC Board of Directors Nomination Process and Sections 54.719 through 54.725, Review of the Administrator's Decision.

Form Number(s): N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities and Not-for-profit institutions, and State, Local or Tribal Governments.

Number of Respondents and Responses: 557 respondents; 557 responses.

Estimated Time per Response: 20-32 hours.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Voluntary. Statutory authority for this information collection is contained in 47 U.S.C. 151 through 154, 201 through 205, 218 through 220, 254, 303(r), 403 and 405.

Total Annual Burden: 17,680 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No Impact(s).

Nature and Extent of Confidentiality: The Commission is not requesting that respondents submit confidential information to the FCC. However, respondents may request confidential treatment of their information under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: The information in this collection is used by the Commission to select Universal Service Administrative Company (USAC) Board of Directors and to ensure that requests for review are filed properly to the Commission.

Section 54.703 states that industry and non-industry groups may submit to the Commission for approval nominations for individuals to be appointed to the USAC Board of Directors.

Sections 54.719 through 54.725 describes the procedures for Commission review of USAC decisions including the general filing requirements pursuant to which parties may file requests for review.

OMB Control Number: 3060-1085.

Title: Section 9.5, Interconnected Voice Over internet Protocol (VoIP) E911 Compliance.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Individuals or Households; Business or other for-profit entities; Not-for-profit institutions; State, Local or Tribal government.

Number of Respondents and Responses: 12 respondents; 16,927,624 responses.

Estimated Time per Response: 0.09 hours.

Frequency of Response: Recordkeeping requirement and third party disclosure requirements.

Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47. U.S.C. Sections 1, 4(i), and 251 (e)(3) of the Communications Act of 1934, as amended.

Total Annual Burden: 1,543,284 hours.

Total Annual Cost: $253,280,000.

Privacy Act Impact Assessment: No impact(s).

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

Needs and Uses: The Commission is obligated by statute to promote “safety of life and property” and to “encourage and facilitate the prompt deployment throughout the United States of a seamless, ubiquitous, and reliable end-to-end infrastructure” for public safety. Congress has established 911 as the national emergency number to enable all citizens to reach emergency services directly and efficiently, irrespective of whether a citizen uses wireline or wireless technology when calling for help by dialing 911. Efforts by federal, state and local government, along with the significant efforts of wireline and wireless service providers, have resulted in the nearly ubiquitous deployment of this life-saving service.

The Order the Commission adopted on May 19, 2005, sets forth rules requiring providers of VoIP services that interconnect with the nation's existing public switched telephone network (interconnected VoIP services) to supply E911 capabilities to their customers.

To ensure E911 functionality for customers of VoIP service providers the Commission requires the following information collections:

A. Location Registration. Requires providers to interconnected VoIP services to obtain location information from their customers for use in the routing of 911 calls and the provision of location information to emergency answering points.

B. Provision of Automatic Location Information (ALI). Interconnected VoIP service providers will place the location information for their customers into, or make that information available through, specialized databases maintained by local exchange carriers (and, in at least one case, a state government) across the country.

C. Customer Notification. Requires that all providers of interconnected VoIP are aware of their interconnected VoIP service's actual E911 capabilities. That all providers of interconnected VoIP service specifically advise every subscriber, both new and existing, prominently and in plain language, the circumstances under which E911 service may not be available through the interconnected VoIP service or may be in some way limited by comparison to traditional E911 service.

D. Record of Customer Notification. Requires VoIP providers to obtain and keep a record of affirmative acknowledgement by every subscriber, both new and existing, of having received and understood this advisory.

E. User Notification. In addition, in order to ensure to the extent possible that the advisory is available to all potential users of an interconnected VoIP service, interconnected VoIP service providers must distribute to all subscribers, both new and existing, warning stickers or other appropriate labels warning subscribers if E911 service may be limited or not available and instructing the subscriber to place them on or near the customer premises equipment used in conjunction with the interconnected VoIP service.

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in health care, AHRQ developed and pilot tested the Medical Office Survey on Patient Safety Culture with OMB approval (OMB No. 0935-0131; Approved July 5, 2007).

The survey is designed to enable medical offices to assess provider and staff perspectives about patient safety issues, medical error, and error reporting. The survey includes 38 items that measure 10 composites of patient safety culture. In addition to the composite items, 14 items measure staff perceptions of how often medical offices have problems exchanging information with other settings as well as other patient safety and quality issues. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in December, 2008 on the AHRQ website (located at https://www.ahrq.gov/sops/quality-patient-safety/patientsafetyculture/medical-office/index.html).

The AHRQ Medical Office SOPS Database consists of data from the AHRQ Medical Office Survey on Patient Safety Culture and may include reportable, non-required supplemental items. Medical offices in the U.S. can voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Medical Office SOPS Database (OMB No. 0935-0196, last approved on August 25, 2015) was developed by AHRQ in 2011 in response to requests from medical offices interested in tracking their own survey results. Those organizations submitting data receive a feedback report, as well as a report of the aggregated, de-identified findings of the other medical offices submitting data. These reports are used to assist medical office staff in their efforts to improve patient safety culture in their organizations.

Rationale for the information collection. The Medical Office SOPS and the Medical Office SOPS Database support AHRQ's goals of promoting improvements in the quality and safety of health care in medical office settings. The survey, toolkit materials, and database results are all made publicly available on AHRQ's website. Technical assistance is provided by AHRQ through its contractor at no charge to medical offices, to facilitate the use of these materials for medical office patient safety and quality improvement.

Request for information collection approval. The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) reapprove, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Medical Office SOPS Database; OMB No. 0935-0196, last approved on August, 25, 2015.

This database will:

(1) Present results from medical offices that voluntarily submit their data,

(2) Provide data to medical offices to facilitate internal assessment and learning in the patient safety improvement process, and

(3) Provide supplemental information to help medical offices identify their strengths and areas with potential for improvement in patient safety culture.

This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to: The quality, effectiveness, efficiency, appropriateness and value of health care services; quality measurement and improvement; and database development. 42 U.S.C. 299a(a)(1), (2), and (8).

To achieve the goal of this project the following activities and data collections will be implemented:

(1) Eligibility and Registration Form—The medical office point-of-contact (POC) completes a number of data submission steps and forms, beginning with the completion of an online Eligibility and Registration Form. The purpose of this form is to collect basic demographic information about the medical office and initiate the registration process.

(2) Data Use Agreement—The purpose of the data use agreement, completed by the medical office POC, is to state how data submitted by medical offices will be used and provide privacy assurances.

(3) Medical Office Site Information Form—The purpose of the site information form, also completed by the medical office POC, is to collect background characteristics of the medical office. This information will be used to analyze data collected with the Medical Office SOPS survey.

(4) Data Files Submission—POCs upload their data file(s), using the medical office data file specifications, to ensure that users submit standardized and consistent data in the way variables are named, coded, and formatted. The number of submissions to the database is likely to vary each year because medical offices do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either an office manager or a survey vendor who contracts with a medical office to collect their data. POCs submit data on behalf of 35 medical offices, on average, because many medical offices are part of a health system that includes many medical office sites, or the POC is a vendor that is submitting data for multiple medical offices.

Survey data from the AHRQ Medical Office Survey on Patient Safety Culture are used to produce three types of products:

(1) A Medical Office SOPS Database Report that is made publicly available on the AHRQ website (see Medical Office User Database Report);

(2) Individual Medical Office Survey Feedback Reports that are customized for each medical office that submits data to the database; and

(3) Research data sets of individual-level and medical office-level de-identified data to enable researchers to conduct analyses. All data released in a data set are de-identified at the individual-level and the medical office-level.

Medical offices will be invited to voluntarily submit their Medical Office SOPS survey data to the database. AHRQ's contractor, Westat, then cleans and aggregates the data to produce a PDF-formatted Database Report displaying averages, standard deviations, and percentile scores on the survey's 38 items and 10 patient safety culture composites of patient safety culture, and 14 items measuring how often medical offices have problems exchanging information with other settings and other patient safety and quality issues. The report also displays these results by medical office characteristics (size of office, specialty, geographic region, etc.) and respondent characteristics (staff position).

The Database Report includes a section on data limitations, emphasizing that the report does not reflect a representative sampling of the U.S. medical office population. Because participating medical offices will choose to voluntarily submit their data into the database and therefore are not a random or national sample of medical offices, estimates based on this self-selected group might be biased estimates. We recommend that users review the database results with these caveats in mind.

Each medical office that submits its data receives a customized survey feedback report that presents their results alongside the aggregated results from other participating medical offices.

Medical offices use the Medical Office SOPS, Database Reports, and Individual Medical Office Survey Feedback Reports for a number of purposes, to:

• Raise staff awareness about patient safety;

• Elucidate and assess the current status of patient safety culture in their medical office;

• Identify strengths and areas for patient safety culture improvement;

• Evaluate trends in patient safety culture change over time; and

• Evaluate the cultural impact of patient safety initiatives and interventions.

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 70 POCs, each representing an average of 35 individual medical offices each, will complete the database submission steps and forms. Each POC will submit the following:

• Eligibility and registration form (completion is estimated to take about 3 minutes).

• Data Use Agreement (completion is estimated to take about 3 minutes).

• Medical Office Information Form (completion is estimated to take about 5 minutes).

• Survey data submission will take an average of one hour.

The total burden is estimated to be 283 hours.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $14,880 annually.

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

On September 27, 2017, NIOSH published a request for public review in the Federal Register [82 FR 45027] of the draft version of the National Occupational Research Agenda for Construction. All comments received were reviewed and addressed where appropriate.

Purpose: This Board is charged with providing advice and guidance to the Secretary, Department of Health and Human Services (HHS), the Assistant Secretary for Health (ASH), the Director, Centers for Disease Control and Prevention (CDC), and the Director, Office of Public Health Preparedness and Response (OPHPR), concerning strategies and goals for the programs and research within OPHPR, monitoring the overall strategic direction and focus of the OPHPR Divisions and Offices, and administration and oversight of peer review for OPHPR scientific programs. For additional information about the Board, please visit: http://www.cdc.gov/phpr/science/counselors.htm.

Matters to be considered: The agenda will include briefings and BSC deliberation on the following topics: Interval updates from OPHPR Divisions and Offices including responses to issues raised by the Board during the May 2018 in-person BSC meeting; updates from the Biological Agent Containment working group; and proposed agenda items for the October 29-30 2018 in-person BSC meeting. Agenda items are subject to change as priorities dictate.

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

Although multiple drugs are known to cause hearing loss, otic and vestibular toxicities remain a neglected component in routine drug development. In drug safety evaluations, comparative clinical assessments for auditory and vestibular systems between animals and humans remain largely unexplored. The objective of this public workshop is to identify the challenges involved in the translation of toxicities from animal toxicology studies to clinical trials, to highlight potential endpoints that can be used in nonclinical and clinical phases of drug development, and to provide a platform for engaging discussions to improve safety assessments for ototoxic drugs. This public workshop will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular endpoints.

A regulatory perspective of drug development and the occurrence of otic and vestibular toxicity will be presented, with a focus on the current regulatory recommendations on assessment of the auditory and vestibular systems in clinical and nonclinical studies. Relevant endpoints of vestibular and auditory function (clinical evaluation, non-invasive electrophysiological measurements, and histopathology) will be discussed from a clinical and nonclinical perspective. The public workshop will end with an open platform discussion between the audience and panelists regarding the adequacy of the current evaluation and potential future approaches towards improving safety assessments for agents impacting auditory and vestibular functions. We support the principles of the “3Rs,” to reduce, refine, and replace animal use in testing when feasible. We encourage sponsors to consult with us if it they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method.

Registration: To register for the public workshop, please visit the following website to register: https://www.eventbrite.com/e/fda-public-workshop-regulatory-perspectives-on-otic-vestibular-toxicity-tickets-47223962142. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by August 20, 2018, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization.

For any participant in need of sign language interpretation, please send an email request to [email protected]. For all other reasonable accommodations, please contact FDA's Office of Equal Employment Opportunity at 301-796-9400.

Streaming webcast of the public workshop: This public workshop will also be webcast at https://collaboration.fda.gov/ovtw/.

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

Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FDA is announcing the availability of a draft guidance for industry entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” This draft guidance describes FDA's current recommendations regarding how to optimize and standardize dietary management in clinical trials for the development of drugs treating IEM for which dietary management is a key component of patients' metabolic control. Optimizing dietary management in these patients before entry into and during the clinical trial(s) is essential to providing an accurate evaluation of the efficacy of new drug products.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on how sponsors can optimize and standardize dietary management for clinical trials in the development of drugs for inborn errors of metabolism that use dietary management. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

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

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

Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, to be exempt from the following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications or abbreviated new drug applications).

One of the conditions that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that a bulk drug substance (active pharmaceutical ingredient) used in a compounded drug product must meet one of the following criteria: (1) Complies with the standards of an applicable United States Pharmacopoeia (USP) or National Formulary monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if an applicable monograph does not exist, is a component of a drug approved by the Secretary of Health and Human Services (the Secretary); or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary (the “503A Bulks List”) (see section 503A(b)(1)(A)(i) of the FD&C Act).

Agenda: The committee will receive information on the following two issues to follow up on discussions from previous PCAC meetings: Balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the committee will discuss six bulk drug substances nominated for inclusion on the 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin. The chart below identifies the use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before August 28, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 9:40 a.m., 10:45 a.m. and 10:55 a.m., 11:50 a.m. and 12 noon, 1:50 p.m. and 2 p.m., 3:05 p.m. and 3:15 p.m., and 4:10 p.m. and 4:20 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 20, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 21, 2018.

Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jay Fajiculay (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

FDA is announcing the availability of a draft GFI #257 entitled “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species” (VICH GL57). In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based, harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.

The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency, International Federation for Animal Health—Europe; FDA; the U.S. Department of Agriculture; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry, and Fisheries; and the Japanese Veterinary Products Association. Six observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, one representative from the industry in Canada, one representative from the government of South Africa, and one representative from the industry in South Africa. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health.

The VICH Steering Committee held a meeting in November 2017 and agreed that the draft guidance document entitled “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species” (VICH GL 57) should be made available for public comment. This draft guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements. This draft guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.

FDA and the VICH Expert Working Group will consider comments about the draft guidance document.

This level 1 draft guidance, developed under the VICH process, is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents do not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement.

The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910-0032.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.

The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.

A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.

Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register.” Set forth below is a list of petitions received by HRSA on June 1, 2018, through June 30, 2018. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction.

Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:

1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and

2. Any allegation in a petition that the petitioner either:

a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or

b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.

In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading FOR FURTHER INFORMATION CONTACT), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.

The IHS participated in a strategic planning process informed by feedback received from Tribes, Urban Indian Organizations, and staff, as described in more detail below, to develop the Draft IHS Strategic Plan FY 2018-2022 for consideration. The IHS is committed to improving health care delivery services and enhancing critical public health services to strengthen the health status of American Indian and Alaska Native people throughout the health system.

The Draft IHS Strategic Plan FY 2018-2022 includes a revised IHS Mission statement, a new IHS Vision statement, and articulates how the IHS will achieve its mission through three strategic goals. The three strategic goals are: (1) To ensure that comprehensive, culturally acceptable personal and public health services are available and accessible to American Indian and Alaska Native people; (2) To promote excellence and quality through innovation of the Indian health system into an optimally performing organization; and (3) To strengthen IHS program management and operations. Each goal is supported by objectives and strategies. To review the current IHS Mission statement and priorities, please visit: https://www.ihs.gov/aboutihs/overview/.

The strategic planning Consultation and Confer process is an opportunity for the IHS to further refine and strengthen the Draft IHS Strategic Plan FY 2018-2022. The IHS appreciates the invaluable feedback received to date on the Draft IHS Strategic Plan FY 2018-2022 and seeks to ensure all Agency stakeholders have the opportunity to comment. As we build on the current Draft IHS Strategic Plan FY 2018-2022, we look forward to receiving your comments by August 23, 2018.

The Urban Indian Confer on August 3, 2018, and the Tribal Consultation on August 6, 2018, will be held telephonically and by webinar. A letter will be sent to Urban Indian Organization Leaders and Tribal Leaders to notify them about details associated with conference call and webinar schedules and call-in information.

To develop the Draft IHS Strategic Plan FY 2018-2022, the IHS used a process similar to the U.S. Department of Health and Human Services (HHS) Strategic Plan FY 2018-2022, including use of goals; objectives and strategies; environmental scans; Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis; and workgroup participation. The environmental scan reviewed several IHS Areas, Headquarters Offices, and other available documents, and the SWOT exercise was conducted with IHS staff. Informed by these documents and analysis, the IHS developed an initial framework for review and comment by Tribes, Urban Indian Organizations, and IHS staff. The IHS first initiated Tribal Consultation and Urban Indian Confer on the IHS Strategic Plan initial framework on September 15, 2017, and formed an IHS Federal-Tribal Strategic Planning Workgroup (workgroup) to review all comments and recommend a list of final goals and objectives for IHS leadership review and approval.

During the initial framework comment period (September 15, 2017-October 31, 2017), the IHS held listening sessions, presented at Tribal meetings, and held conference calls with Tribal and Urban Indian Organization leaders. The workgroup membership included IHS staff at the Area, Service Unit, and Headquarters levels (including a representative from the IHS Office of Urban Indian Health Programs); Tribal leaders or their designees. The workgroup reviewed the comments received from 150 Tribes, Tribal Organizations, Urban Indian Organizations and IHS staff on the initial framework and suggested strategies during six meetings over a 3-month period, resulting in final recommendations on the IHS Mission, Vision, Goals, Objectives, and Strategies. These recommendations are the basis of the Draft IHS Strategic Plan FY 2018-2022.

Since initiating Tribal Consultation and Urban Indian Confer on the IHS Strategic Plan initial framework, the IHS has issued four letters to Tribal Leaders and Urban Indian Organization Leaders to update Tribes and Urban Indian Organizations on progress. Additionally, the IHS issued several communications stating that comments on the Draft IHS Strategic Plan FY 2018-2022 will be accepted throughout the strategic planning process. The IHS strategic planning Web site includes more information about the IHS strategic plan timeline, as well as links to the Tribal Leader letters, Urban Indian Organization Leader letters, and workgroup activities.

The IHS values all feedback and input regarding the Draft IHS Strategic Plan FY 2018-2022 and invites Tribes, Tribal Leaders, and/or their designees to Consult and Urban Indian Organization Leaders to Confer on the Draft IHS Strategic Plan FY 2018-2022. Tribal Consultation will be conducted with elected or appointed leaders of Tribal Governments and their designated representatives. Those wishing to participate in the Tribal Consultation as a designee must have a copy of a letter signed by an elected or appointed Tribal official or their designee that authorizes them to serve as the representative of the Tribe. Urban Indian Confer will be conducted with recognized representatives from Urban Indian Organizations, as defined by 25 U.S.C. 1603(29). Representatives from other Tribal Organizations and Native non-profit organizations are welcome as observers. Those wishing to be recognized representatives from Urban Indian Organizations should provide documentation that their organization meets the definition at 25 U.S.C. 1603(29) and that the selected participant has the official capacity to represent the organization. This documentation should be submitted by e-mail no later than 3 days in advance of the Tribal Consultation and Urban Indian Confer session to the address that follows: [email protected].

The text of the Draft IHS Strategic Plan FY 2018-2022 is available at the IHS Web site at: https://www.ihs.gov/strategicplan/and below.

The IHS will publish an additional Federal Register Notice with the final IHS Strategic Plan FY 2018-2022 after all comments are received and considered.

This proposed information collection was previously published in the Federal Register on May 1, 2018, Volume 83, Number 50, page 19073-19074 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Proposed Collection: DERT Extramural Grantee Data Collection, 0925-0657, Expiration Date 06/30/2015—Revision, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH).

Need and Use of Information Collection: In order to make informed management decisions about its research programs and to demonstrate the outputs, outcomes and impacts of its research programs NIEHS will collect, analyze and report on data from extramural grantees who are currently receiving funding or who have received funding in the past on topics such as: (1) Key scientific outcomes achieved through the research and the impact on the field of environmental health science; (2) Contribution of research findings to program goals and objectives; (3) Satisfaction with the program support received; (4) Challenges and benefits of the funding mechanism used to support the science; and (5) Emerging research areas and gaps in the research.

Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research. Satisfaction information to be collected includes measures of satisfaction with the type of funding or program management mechanism used, challenges and benefits with the program support received, and gaps in the research. Frequency of Response: Once per grantee, per research portfolio. Affected Public: Current or past grantees from:

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);

• National Institute on Deafness and Other Communication Disorders (NIDCD);

• National Institute of Mental Health (NIMH);

• National Institute of Neurological Disorders and Stroke (NINDS);

• National Institute of Environmental Health Sciences (NIEHS);

• National Cancer Institute (NCI); and

• Environmental Protection Agency (EPA).

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 800.

CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (83 FR 16895) on April 17, 2018, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) 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) 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) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

Title: Entry/Immediate Delivery Application and ACE Cargo Release.

OMB Number: 1651-0024.

Form Number: 3461 and 3461 ALT.

Current Actions: This submission is being made to extend the expiration date with no change in the data collected. There is an increase to the annual burden hours based on updated agency estimates. CBP previously submitted a 60 day Federal Register Notice with a change for this OMB control number. That change was an error and has been corrected. There is no change in the data collected under this submission.

Type of Review: Extension (without change).

Abstract: All items imported into the United States are subject to examination before entering the commerce of the United States. There are two procedures available to effect the release of imported merchandise, including “entry” pursuant to 19 U.S.C. 1484, and “immediate delivery” pursuant to 19 U.S.C. 1448(b). Under both procedures, CBP Forms 3461, Entry/Immediate Delivery, and 3461 ALT are the source documents in the packages presented to Customs and Border Protection (CBP). The information collected on CBP Forms 3461 and 3461 ALT allow CBP officers to verify that the information regarding the consignee and shipment is correct and that a bond is on file with CBP. CBP also uses these forms to close out the manifest and to establish the obligation to pay estimated duties in the time period prescribed by law or regulation. CBP Form 3461 is also a delivery authorization document and is given to the importing carrier to authorize the release of the merchandise.

CBP Forms 3461 and 3461 ALT are provided for by 19 CFR 141 and 142. These forms and instructions for Form 3461 are accessible at: https://www.cbp.gov/newsroom/publications/forms?title=3461&=Apply.

ACE Cargo Release is a program for ACE entry summary filers in which importers or brokers may file Simplified Entry data in lieu of filing the CBP Form 3461. This data consists of 12 required elements: Importer of record; buyer name and address; buyer employer identification number (consignee number), seller name and address; manufacturer/supplier name and address; Harmonized Tariff Schedule 10-digit number; country of origin; bill of lading; house air waybill number; bill of lading issuer code; entry number; entry type; and estimated shipment value. Three optional data elements are the container stuffing location; consolidator name and address, and ship to party name and address. The data collected under the ACE Cargo Release program is intended to reduce transaction costs, expedite cargo release, and enhance cargo security. ACE Cargo Release filing minimizes the redundancy of data submitted by the filer to CBP through receiving carrier data from the carrier. This design allows the participants to file earlier in the transportation flow. Guidance on using ACE Cargo Release may be found at http://www.cbp.gov/trade/ace/features.

Affected Public: Businesses.

CBP Form 3461 paper form only:

Estimated Number of Respondents: 12,307.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Responses: 12,307.

Estimated Time per Response: 15 minutes.

Estimated Total Annual Burden Hours: 3,077.

ACE Cargo Release to include electronic submission for 3461/3461ALT:

Estimated Number of Respondents: 9,810.

Estimated Number of Responses per Respondent: 2,994.

Estimated Total Annual Responses: 29,371,140.

Estimated Time per Response: 10 minutes.

Estimated Total Annual Burden Hours: 4,875,609.

We, the USGS, in accordance with the Paperwork Reduction Act of 1995, provide the general public and other Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on March 5th, 2018 at 83 FR 9336. No comments were received.

We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the USGS; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the USGS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the USGS minimize the burden of this collection on the respondents, including through the use of information technology.

Comments that you submit in response to this notice are a matter of public record. 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 may 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.

Abstract: The USGS is working with the Federal Advisory Committee on Water Information (ACWI) and its Subcommittee on Ground Water (SOGW) to develop and administer a National Ground-Water Monitoring Network (NGWMN). This network is required as part of Public Law 111-11, Subtitle F—Secure Water: Section 9507, 42 U.S.C. 10367, “Water Data Enhancement by United States Geological Survey.” The NGWMN will consist of an aggregation of wells from existing Federal, State, Tribal, and local groundwater monitoring networks. To support data providers for the NGWMN, the USGS will be providing funding through cooperative agreements to water-resource agencies that collect groundwater data. The USGS will be soliciting applications for funding that will request information from the Agency collecting the data. Elements will include contact information (phone number and email address), and a proposal describing their proposed work in support of the NGWMN. The proposal will describe the groundwater networks to be included in the NGWMN, the purpose of the networks, and the Principal aquifers that are monitored. Proposals may include work to become a new data provider to the NGWMN, support for maintaining connections to agency databases, and work to enhance NGWMN sites (updating metadata, performing well maintenance, and well drilling). The proposal would also require estimates of costs to complete the above tasks and a timeline for planned completion. The proposal will be reviewed by the USGS and the NGWMN Program Board who will make funding recommendations.

Title of Collection: National Ground-Water Monitoring Network Cooperative Funding Application.

OMB Control Number: 1028-0114.

Form Number: None.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Multi-state, state, or local water-resources agencies who operate groundwater monitoring networks.

Total Estimated Number of Annual Respondents: 30 applicants, 25 awardees.

Total Estimated Number of Annual Responses: 55.

Estimated Completion Time per Response: 40 hours for applicants, 80 hours for final report.

Total Estimated Number of Annual Burden Hours: 3,200 hours.

Respondent's Obligation: Mandatory to be considered for funding.

Frequency of Collection: Annually.

Total Estimated Annual Non-hour Burden Cost: None.

An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.).

In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on March 21, 2018 (83 FR 12404). No comments were received.

We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIA IHSP; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIA IHSP enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIA IHSP minimize the burden of this collection on the respondents, including through the use of information technology.

Comments that you submit in response to this notice are a matter of public record. 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.

Abstract: Information collected from tribal entities concerning, population, land base, highway miles and statistical data concerning vehicle fatalities, crashes, traffic enforcement actions and proposed financial data. This data collected is a requirement for the BIA IHSP to fulfil the data obligations of 23 CFR 1300.11 and will be used for review and consideration by the IHSP Selection Committee for consideration of grant awards.

Title of Collection: Indian Highway Safety Grants.

OMB Control Number: 1076-NEW.

Form Number: None.

Type of Review: New.

Respondents/Affected Public: Tribal governments.

Total Estimated Number of Annual Respondents: 483 per year, on average.

Total Estimated Number of Annual Responses: 2,254 per year, on average.

Estimated Completion Time per Response: For applications, 4 hours, on average; for monthly reports, 3-11 hours, on average; and for annual reports, 5-9 hours, on average.

Total Estimated Number of Annual Burden Hours: 15,312 hours.

Respondent's Obligation: Required to Obtain a Benefit.

Frequency of Collection: Annually if elect to apply for the grant(s).

Total Estimated Annual Nonhour Burden Cost: None.

An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq).

The Cold War Advisory Committee was established by Title VII, Subtitle C, Section 7210(c) of Public Law 111-11, the Omnibus Public Land Management Act of 2009, March 30, 2009 (16 U.S.C. 1a-5 note). The purpose of the Committee is to assist the Secretary of the Interior in the preparation of a national historic landmark theme study to identify sites and resources significant to the Cold War.

The Committee will be composed of nine members, to be appointed by the Secretary, of whom: (1) Three shall have expertise in Cold War history; (2) two shall have expertise in historic preservation; (3) one shall have expertise in the history of the United States; and (4) three shall represent the general public.

We are currently seeking members to represent all categories.

Nominations should be typed and should include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Committee and permit the Department to contact a potential member. All documentation, including letters of recommendation, must be compiled and submitted in one complete package.

Members of the Committee may serve as special Government employees and be required on an annual basis to complete ethics training and file a Confidential Financial Disclosure Report. Members of the Committee serve without compensation. However, while away from their homes or regular places of business in the performance of services for the Committee as approved by the NPS, members may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in Government service are allowed such expenses under section 5703 of title 5 of the United States Code.

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

The Occupational Safety and Health Administration is providing notice that TUV SUD America, Inc. (TUVAM), is applying for expansion of its current recognition as a NRTL. TUVAM requests the addition of two test standards to its NRTL scope of recognition.

OSHA recognition of a NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by its applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.

The Agency processes applications by a NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A of 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the Federal Register in processing an application. In the first notice, OSHA announces the application and provides its preliminary finding. In the second notice, the Agency provides its final decision on the application. These notices set forth the NRTL's scope of recognition or modifications of that scope. OSHA maintains an informational web page for each NRTL, including TUVAM, which details the NRTL's scope of recognition. These pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.

TUVAM currently has six facilities (sites) recognized by OSHA for product testing and certification, with its headquarters located at: TUV SUD America, Inc., 10 Technology Drive, Peabody, MA 01960. A complete list of TUVAM's scope of recognition (including sites) recognized by OSHA is available at https://www.osha.gov/dts/otpca/nrtl/tuvam.html.

TUVAM submitted an application, dated June 12, 2017 (OSHA-2007-0043-0023), to expand its recognition to include two additional test standards. OSHA staff performed a detailed analysis of the application packet and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to this application.

Table 1 below lists the appropriate test standards found in TUVAM's application for expansion for testing and certification of products under the NRTL Program.

TUVAM submitted an acceptable application for expansion of its scope of recognition. OSHA's review of the application file, and pertinent documentation, indicates that TUVAM can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of these two test standards for NRTL testing and certification listed above. This preliminary finding does not constitute an interim or temporary approval of TUVAM's application.

OSHA welcomes public comment as to whether TUVAM meets the requirements of 29 CFR 1910.7 for expansion of its recognition as a NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, at the above address. These materials also are available online at http://www.regulations.gov under Docket No. OSHA-2007-0043.

OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will make a recommendation to the Assistant Secretary for Occupational Safety and Health whether to grant TUVAM's application for expansion of its scope of recognition. The Assistant Secretary will make the final decision on granting the application. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.

OSHA will publish a public notice of its final decision in the Federal Register.

Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.

The NRTL Program recognizes organizations that provide product safety testing and certification services to manufacturers. These organizations perform testing and certification, for purposes of the Program, to U.S. consensus-based product safety test standards. The products covered by the NRTL Program consist of those items for which OSHA safety standards require “certification” by a NRTL. The requirements affect electrical products and 38 other types of products. OSHA does not develop or issue these test standards, but generally relies on standards development organizations (SDOs) which develop and maintain the standards using a method that provides input and consideration of views of industry groups, experts, users, consumers, governmental authorities and others having broad experience in the safety field involved.

OSHA may propose to remove a test standard from the NRTL list of appropriate test standards based on an internal review in which NRTL Program staff review the NRTL list of appropriate test standards to determine if the test standard conforms to the definition of appropriate test standard defined in NRTL Program regulations and policy. There are several reasons for removing a test standard based on the internal review by NRTL Program staff. First, a document that provides the methodology for a single test is a test method rather than an appropriate test standard. A test standard must specify the safety requirements for a specific type of product(s) (29 CFR 1910.7(c)). A test method, however, is a “specified technical procedure for performing a test” (CPL 1-0.3, App. B). As such, a test method is not an appropriate test standard. While a NRTL may use a test method to determine if certain safety requirements are met, a test method is not itself a safety requirement for a specific product category.

Second, a document that focuses primarily on usage, installation, or maintenance requirements would also not be considered an appropriate test standard (CPL 1-0.3, App. D.IV.B). In some cases, however, a document may also provide safety test specifications in addition to usage, installation, and maintenance requirements. In such cases, the document would be retained as an appropriate test standard based on the safety test specifications.

Finally, a document may not be considered an appropriate test standard if the document covers products for which OSHA does not require testing and certification (CPL 1-0.3, App. D.IV.A).

Similarly, a document that covers electrical product components would not be considered an appropriate test standard. These documents apply to types of components that have limitation(s) or condition(s) on their use, in that they are not appropriate for use as end-use products. These documents also specify that these types of components are for use only as part of an end-use product. NRTLs, however, evaluate such components only in the context of evaluating whether end-use products requiring NRTL approval are safe for use in the workplace. Testing such components alone would not indicate that the end-use products containing the components are safe for use. Accordingly, as a matter of policy, OSHA considers that documents covering such components are not appropriate test standards under the NRTL Program. OSHA notes, however, that it is not proposing to delete from NRTLs' scopes of recognition any test standards covering end-use products that contain such components.

OSHA may additionally propose to remove a test standard from the NRTL list of appropriate test standards if it has been withdrawn by a SDO. However, OSHA will recognize a NRTL for an appropriate replacement test standard if the NRTL has the requisite testing and evaluation capability for implementing the replacement test standard, and the replacement standard does not require an additional or different technical capability than an existing test standard. OSHA can add the replacement test standard to affected NRTLs' scopes of recognition.

In this notice, OSHA proposes to delete three test standards from the NRTL Program's list of appropriate test standards.

Table 1 lists the test standards that OSHA proposes to delete from the NRTL Program's list of appropriate test standards, as well as an abbreviated rationale for OSHA's proposed actions. For a full discussion of the rationale, see, above, Section I of this notice.

In this notice, OSHA proposes to update the scopes of recognition of several NRTLs. The tables in this section (Table 2 thru Table 5) list, for each affected NRTL, the test standard(s) that OSHA proposes to delete from the scope of recognition of the NRTL and the proposed appropriate replacement test standard. OSHA's analysis shows that the proposed replacement standards do not require additional or different technical capability than the proposed deleted standards so that the proposed replacement standards are comparable to the proposed deleted standards. These proposed replacement standards are already on the NRTL List of Appropriate Test Standards.

OSHA seeks comment on whether its proposed deletions are appropriate, and whether individual tables omit any appropriate replacement test standard that is comparable to a withdrawn test standard. If OSHA determines any appropriate replacement test standard that is comparable to a withdrawn test standard was omitted, then the final determination will incorporate that replacement test standard into the scope of recognition of each affected NRTL.

Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request, by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer time period. OSHA may deny a request for an extension if it is not adequately justified.

The Occupational Safety and Health Administration is providing notice that MET Laboratories, Inc. (MET), is applying for expansion of its current recognition as a NRTL. MET requests the addition of one test standard to its NRTL scope of recognition.

OSHA recognition of a NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by its applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.

The Agency processes applications by a NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the Federal Register in processing an application. In the first notice, OSHA announces the application and provides a preliminary finding. In the second notice, the Agency provides a final decision on the application. These notices set forth the NRTL's scope of recognition or modifications of that scope. OSHA maintains an informational web page for each NRTL, including MET, which details the NRTL's scope of recognition. These pages are available from the OSHA website at http://www.osha.gov/dts/otpca/nrtl/index.html.

MET currently has one facility (site) recognized by OSHA for product testing and certification, with its headquarters located at: MET Laboratories, Inc., 914 West Patapsco Avenue, Baltimore, Maryland 21230. A complete list of MET's scope of recognition is available at https://www.osha.gov/dts/otpca/nrtl/met.html.

MET submitted an application, dated January 29, 2016 (OSHA-2006-0028-0046), to expand its recognition to include one additional test standard. OSHA staff performed a detailed analysis of the application packet and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to this application.

Table 1, below, lists the appropriate test standard found in MET's application for expansion for testing and certification of products under the NRTL Program.

Periodically, OSHA will propose to add new test standards to the NRTL list of appropriate test standards following an evaluation of the test standard document. To qualify as an appropriate test standard, the Agency evaluates the document to (1) verify it represents a product category for which OSHA requires certification by a NRTL, (2) verify the document represents an end product and not a component, and (3) verify the document defines safety test specifications (not installation or operational performance specifications). OSHA becomes aware of new test standards through various avenues. For example, OSHA may become aware of new test standards by: (1) Monitoring notifications issued by certain Standards Development Organizations; (2) reviewing applications by NRTLs or applicants seeking recognition to include new test standards in their scopes of recognition; and (3) obtaining notification from manufacturers, manufacturing organizations, government agencies, or other parties. OSHA may determine to include a new test standard in the list, for example, if the test standard is for a particular type of product that another test standard also covers or it covers a type of product that no standard previously covered.

In this notice, OSHA proposes to add one new test standard to the NRTL Program's List of Appropriate Test Standards. Table 2, below, lists the test standard that is new to the NRTL Program. OSHA preliminarily determined that this test standard is an appropriate test standard and proposes to include it in the NRTL Program's List of Appropriate Test Standards. OSHA seeks public comment on this preliminary determination.

MET submitted an acceptable application for expansion of its scope of recognition. OSHA's review of the application file, and pertinent documentation, indicate that MET can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of this one test standard for NRTL testing and certification listed in Table 2. This preliminary finding does not constitute an interim or temporary approval of MET's application.

OSHA welcomes public comment as to whether MET meets the requirements of 29 CFR 1910.7 for expansion of its recognition as a NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, at the above address. These materials also are available online at http://www.regulations.gov under Docket No. OSHA-2006-0028.

OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will make a recommendation to the Assistant Secretary for Occupational Safety and Health whether to grant MET's application for expansion of its scope of recognition. The Assistant Secretary will make the final decision on granting the application. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.

OSHA will publish a public notice of its final decision in the Federal Register.

Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.

This meeting will be open to the public telephonically and by WebEx. Any interested person may call the USA toll free conference call number at 1-844-467-4685 or the USA local toll number at 1-720-259-7012 passcode: 106724 to participate in this meeting by telephone. The WebEx link is https://nasa.webex.com/, meeting number is 995 034 805, password is uuU7bDX* (case sensitive). This meeting was agreed to at the 21st session of the National Space-Based PNT Advisory Board, held May 16-17, 2018, in Baltimore, Maryland. The public may follow the discussions by dial-in and/or the web link provided. The agenda includes the following topics:

OMB Number: 3133-0117.

Type of Review: Revision of a currently approved collection.

Title: Designation of Low Income Status, 12 CFR 701.34(a).

Abstract: The Federal Credit Union Act (12 U.S.C. 1752(5)) authorizes the NCUA Board to define low-income members so that credit unions with a membership serving predominantly low-income members can benefit from certain statutory relief and receive assistance from the Community Development Revolving Loan Fund. To utilize this authority a credit union must receive a low-income designation from NCUA as defined in NCUA's regulations at 12 CFR 701.34. NCUA uses the information from credit unions to determine whether they meet the criteria for the low-income designation.

Affected Public: Private Sector: Not-for-profit institutions.

Estimated Number of Respondents: 252.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Reponses: 252.

Estimated Burden Hours per Response: 1.20.

Estimated Total Annual Burden Hours: 303.

Reason for Change: The burden associated with the appeals process has been consolidate under 12 CFR 746-B and has been removed from this information collection.

OMB Number: 3133-0121.

Type of Review: Extension of a currently approved collection.

Title: Notice of Change of Officials and Senior Executive Officers.

Forms: NCUA Form 4063 and 4063a.

Abstract: In order to comply with statutory requirements, the agency must obtain sufficient information from new officials or senior executive officers of troubled or newly chartered credit unions to determine their fitness for the position. This is established by the Financial Institutions Reform, Recovery, and Enforcement Act of 1989 (FIRREA) (Pub. L. 101-73). The forms provide a standardize format to collect the information needed.

Affected Public: Private Sector: Not-for-profit institutions; Individual or Household.

Estimated Number of Respondents: 219.

Estimated Number of Responses per Respondent: Individual 1; Credit Union 1.21.

Estimated Total Annual Reponses: 483.

Estimated Burden Hours per Response: 1.83.

Estimated Total Annual Burden Hours: 884.

OMB Number: 3133-0154.

Type of Review: Extension of a currently approved collection.

Title: Prompt Corrective Action, 12 CFR 702 (Subparts A-D).

Abstract: Section 216 of the Federal Credit Union Act (12 U.S.C. 1790d) mandates prompt corrective action (PCA) requirements for federally insured credit unions (FICUs) that become less than well capitalized. Section 216 requires the NCUA Board to (1) adopt, by regulation, a system of prompt corrective action to restore the net worth of inadequately capitalized FICUs; and (2) develop an alternative system of prompt corrective action for new credit unions that carries out the purpose of PCA while allowing an FICU reasonable time to build its net worth to an adequately capitalized level. Part 702 implements the statutory requirements. The purpose of PCA is to resolve the problems of FICUs at the least possible long-term loss to the National Credit Union Share Insurance Fund (NCUSIF).

Affected Public: Private Sector: Not-for-profit institutions.

Estimated Number of Respondents: 642.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Reponses: 642.

Estimated Burden Hours per Response: 5.99.

Estimated Total Annual Burden Hours: 3,847.

OMB Number: 3133-0192.

Type of Review: Extension of a currently approved collection.

Title: Involuntary Liquidation Proof of Claim Form.

Form: NCUA Form 7250.

Abstract: In accordance with 12 CFR part 709, the NCUA is appointed liquidating agent of a credit union when the credit union is placed into involuntary liquidation. Section 709.6 instructs creditors to present a written claim to the liquidating agent by the date specified in the notice to creditors. Those creditors making a claim must document their claim in writing and submit a form to the liquidating agent. In addition, the liquidating agent may require a claimant to submit supplemental evidence to support its claim. This collection of information is necessary to protect the National Credit Union Share Insurance Fund in determining valid claims.

Affected Public: Private Sector: Not-for-profit institutions.

Estimated Number of Respondents: 200.

Estimated Number of Responses per Respondent: 1.10.

Estimated Total Annual Responses: 220.

Estimated Burden Hours per Response: 1.

Estimated Total Annual Burden Hours: 220.

Request for Comments: Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will become a matter of public record. The public is invited to submit comments concerning: (a) Whether the collection of information is necessary for the proper execution of the function of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of the information on the respondents, including the use of automated collection techniques or other forms of information technology.

The NRC is granting an exemption from paragraph B of section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the Code of Federal Regulations (10 CFR), and issuing License Amendment Nos. 128 and 127 to COL Nos. NPF-91 and NPF-92, respectively, to the licensee. The exemption is required by paragraph A.4 of section VIII, “Processes for Changes and Departures,” appendix D, to 10 CFR part 52 to allow the licensee to depart from Tier 1 information. With the requested amendment, the licensee sought proposed changes to plant-specific DCD Tier 2 and Tier 2* information and related changes to plant-specific Tier 1 information, with corresponding changes to Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC) in COL Appendix C. Specifically, the proposed changes clarify the thickness of the Nuclear Island Basemat, revise wall thicknesses and descriptions in the Auxiliary Building, and clarify floor thicknesses in the Annex Building.

Part of the justification for granting the exemption was provided by the review of the amendment. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemption met all applicable regulatory criteria set forth in sections 50.12, 52.7, and section VIII.A.4 of appendix D to 10 CFR part 52. The license amendment was found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML18138A252.

Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COL Nos. NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML18138A246 and ML18138A247, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COL Nos. NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML18138A248 and ML18138A250, respectively. A summary of the amendment documents is provided in Section III of this document.

Reproduced below is the exemption document issued to VEGP Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:

1. In a letter dated December 15, 2017, as supplemented by letter dated April 6, 2018, the Southern Nuclear Operating Company (SNC) requested from the Commission an exemption to allow departures from Tier 1 information in the certified DCD incorporated by reference in 10 CFR part 52, Appendix D, as part of license amendment request 17-040, “Consistency and Clarification Changes to Annex Building, Auxiliary Building and Basemat ITAAC.”

For the reasons set forth in Section 3.2 of the NRC staff's Safety Evaluation, which can be found in ADAMS under Accession No. ML18138A252, the Commission finds that:

A. The exemption is authorized by law;

B. the exemption presents no undue risk to public health and safety;

C. the exemption is consistent with the common defense and security;

D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;

E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and

F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.

2. Accordingly, SNC is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendix C of the Facility Combined License, as described in the licensee's request dated December 15, 2017, as supplemented by letter dated April 6, 2018. This exemption is related to, and necessary for the granting of License Amendment No. 128 (Unit 3) and No. 127 (Unit 4), which is being issued concurrently with this exemption.

3. As explained in Section 5.0 of the NRC staff's Safety Evaluation (ADAMS Accession No. ML18138A252), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.

4. This exemption is effective as of the date of its issuance.

By letter dated December 15, 2017 (ADAMS Accession No. ML17349A924), as supplemented by letter dated April 6, 2018 (ADAMS Accession No. ML18096A718), the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COL Nos. NPF-91 and NPF-92. The proposed amendment is described in Section I of this Federal Register notice.

The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.

A notice of consideration of issuance of amendment to facility operating license or COL, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the Federal Register on March 6, 2018 (83 FR 9555). No comments were received during the 30-day comment period.

The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.

Using the reasons set forth in the combined safety evaluation, the staff granted the exemptions and issued the amendments that the licensee requested on December 15, 2017, as supplemented by letter dated April 6, 2018.

The exemptions and amendments were issued on June 27, 2018, as part of a combined package to the licensee (ADAMS Accession No. ML18138A244).

Section 4043 of the Employee Retirement Income Security Act of 1974 (ERISA) requires plan administrators and plan sponsors to report certain plan and employer events to PBGC. The reporting requirements give PBGC notice of events that indicate plan or employer financial problems. PBGC uses the information provided in determining what, if any, action it needs to take. For example, PBGC might need to institute proceedings to terminate a plan (placing it in trusteeship) under section 4042 of ERISA to ensure the continued payment of benefits to plan participants and their beneficiaries or to prevent unreasonable increases in PBGC's losses.

The provisions of section 4043 of ERISA have been implemented in PBGC's regulation on Reportable Events and Certain Other Notification Requirements (29 CFR part 4043). Subparts B and C of the regulation deal with reportable events.

PBGC has issued Forms 10 and 10-Advance and related instructions under subparts B and C (approved under OMB control number 1212-0013). OMB approval of this collection of information expires November 30, 2018. PBGC intends to request that OMB extend its approval for three years, with modifications. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

PBGC estimates that it will receive 590 reportable event notices per year under subparts B and C of the reportable events regulation using Forms 10 and 10-Advance and that the average annual burden of this collection of information is 1,770 hours and $439,500.

Section 303(k) of the Employee Retirement Income Security Act of 1974 (ERISA) and section 430(k) of the Internal Revenue Code of 1986 (Code) impose a lien in favor of an underfunded single-employer plan that is covered by PBGC's termination insurance program if (1) any person fails to make a required payment when due, and (2) the unpaid balance of that payment (including interest), when added to the aggregate unpaid balance of all preceding payments for which payment was not made when due (including interest), exceeds $1 million. (For this purpose, a plan is underfunded if its funding target attainment percentage is less than 100 percent.) The lien is upon all property and rights to property belonging to the person or persons that are liable for required contributions (i.e., a contributing sponsor and each member of the controlled group of which that contributing sponsor is a member).

Only PBGC (or, at its direction, the plan's contributing sponsor or a member of the same controlled group) may perfect and enforce this lien. ERISA and the Code require persons that fail to make payments to notify PBGC within 10 days of the due date whenever there is a failure to make a required payment and the total of the unpaid balances (including interest) exceeds $1 million.

PBGC Form 200, Notice of Failure to Make Required Contributions, and related instructions implement the statutory notification requirement. Submission of Form 200 is required by 29 CFR 4043.81 (Subpart D of PBGC's regulation on Reportable Events and Other Notification Requirements, 29 CFR part 4043).

OMB has approved this collection of information under OMB control number 1212-0041, which expires November 30, 2018. PBGC intends to request that OMB extend its approval for three years, with modifications. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

PBGC estimates that it will receive 100 Form 200 filings per year and that the average annual burden of this collection of information is 100 hours and $72,500.

PBGC is soliciting public comments to—

• evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

• evaluate the accuracy of the agency's estimate of the burden of the proposed collections of information, including the validity of the methodologies and assumptions used;

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

• minimize the burden of the collections 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.