Federal Register Vol. 83, No.114,

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 of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Title: Child Nutrition Program Operations Study-II (CN-OPS-II).

Form Number: N/A.

OMB Number: 0584-0607.

Expiration Date of Approval: 07/31/2020.

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

Abstract: The objective of the Child Nutrition Program Operations Study-II (CN-OPS-II) is to collect timely data on policies, administrative, and operational issues on the Child Nutrition Programs. The ultimate goal is to analyze these data and to provide input for new legislation on Child Nutrition Programs as well as to provide pertinent technical assistance and training to program implementation staff.

The CN-OPS-II will help the Food and Nutrition Service (FNS) better understand and address current policy issues related to Child Nutrition Programs (CNP) operations. The policy and operational issues include, but are not limited to, the preparation of the program budget, development and implementation of program policy and regulations, and identification of areas for technical assistance and training. Specifically, this study will help FNS obtain:

General descriptive data on the Child Nutrition (CN) program characteristics to help FNS respond to questions about the nutrition programs in schools;

Data related to program administration for designing and revising program regulations, managing resources, and reporting requirements; and

Data related to program operations to help FNS develop and provide training and technical assistance for School Food Authorities (SFAs) and State Agencies responsible for administering the CN programs.

The activities to be undertaken subject to this notice include:

Conducting a web survey of approximately 1,750 SFA Directors.

Conducting a web survey of all 55 State Agency CN Directors.

Affected Public: State, Local and Tribal Governments (SFA Directors for public schools and State CN Directors).

Estimated Number of Respondents: The total estimated number of respondents is 3,379 (1,814 respondents and 1,565 non-respondents). Three State CN Directors and six SFA Directors are expected to participate in the pre-test. The estimated number of respondents for each of the web surveys is as follows:

(1) State CN Director Web Survey: The sample for this collection includes all 55 State CN Directors (50 U.S. States, 4 U.S. Territories, and the District of Columbia), all of whom are expected to respond.

(2) SFA Director Web Survey: The sample for this collection includes 2,188 SFA Directors selected, using a stratified probability proportional-to-size (PPS) design, from the universe of SFAs operating in public school districts in the U.S. and outlying Territories that are required to submit the FNS-742 Verification Collection Report Summary form. Of the full sample, 1,750 SFA Directors are expected to respond for a response rate of 80 percent.

Estimated Frequency of Response per Respondent: SFA Director and State CN Director respondents will be asked to complete their respective web surveys one time. Each State CN Director may receive up to four follow-up/reminder emails and up to two reminder phone calls until the target of 55 respondents is reached. Each SFA Director may receive up to four follow-up/reminder emails and up to three reminder phone calls until the target number of 1,750 respondents is reached. FNS estimates that respondents will average 3.02 responses (5,479 responses/1,814 respondents) across the entire collection, with non-respondents averaging 4.38 responses (6,860 responses/1,565 non-respondents). Across all participants in the collection (respondents and non-respondents) the average number of responses is 3.65.

Estimated Total Annual Responses: The estimated total number of annual responses is 12,339. This includes 5,479 for all respondents and 6,860 for non-respondents.

Estimated Time per Response: The estimated time per response ranges from 2 minutes (0.03 hours) to 3 hours depending on the instrument. The average estimated time for all participants (respondents and non-respondents) in this collection is 20 minutes (0.33 hours) per response.

Estimated Total Annual Burden on Respondents: The annual reporting burden is estimated at 4,101.87 hours. See Table 1 for estimated total annual burden per respondent type.

This meeting is available to the public through the following toll-free call-in number: 877-719-9801, conference ID number: 4127448. 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 Ana Victoria Fortes 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 meetings at https://facadatabase.gov/committee/meetings.aspx?cid=235. Please click on the “Meeting Details” and “Documents” links. Records generated from these meetings may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meetings. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstance of this Committee voting on its advisory memorandum that will supplement the U.S. Commission on Civil Rights' 2018 statutory enforcement report.

Background

On December 6, 2017, Commerce published the Preliminary Results of the administrative review.1 We invited interested parties to comment on the Preliminary Results and received case and rebuttal briefs from interested parties.2

Commerce exercised its discretion to toll all deadlines affected by the closure of the Federal Government from January 20 through 22, 2018.3 On March 16, 2018, Commerce postponed the final results of this review until June 7, 2018.4

Commerce conducted this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).

The merchandise subject to the order is circular welded non-alloy steel pipe and tube. Imports of the product are currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 7306.30.1000, 7306.30.5025, 7306.30.5032, 7306.30.5040, 7306.30.5055, 7306.30.5085, and 7306.30.5090. While the HTSUS subheadings are provided for convenience and customs purposes, the written description is dispositive. A full description of the scope of the order is contained in the Issues and Decision Memorandum.5

All issues raised in the case and rebuttal briefs by parties in this review are addressed in the Issues and Decision Memorandum, which is hereby adopted by this notice. A list of the issues raised is attached in the Appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov and to all parties in the Central Records Unit, Room B-8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/index.html.

Based on our analysis of comments received, we revised the preliminary margin calculations for the two mandatory respondents, Husteel Co., Ltd. (Husteel) and Hyundai Steel Company (Hyundai Steel). These revisions resulted in changes to the margins for Husteel, Hyundai Steel, and the three respondents not selected for individual examination for the final results of this review.

We determine that the following weighted-average dumping margins exist for the respondents for the period November 1, 2015, through October 31, 2016.

We intend to disclose the calculations performed to parties in this proceeding within five days after public announcement of the final results in accordance with 19 CFR 351.224(b).

Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b)(1), Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review.

For Husteel and Hyundai Steel, we calculated importer-specific assessment rates on the basis of the ratio of the total amount of antidumping duties calculated for each importer's examined sales and the total entered value of the sales, in accordance with 19 CFR 351.212(b)(1).7 For entries of subject merchandise during the period of review produced by Husteel or Hyundai Steel for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

For the companies which were not selected for individual examination, AJU Besteel, NEXTEEL, and SeAH Steel Corporation, we will instruct CBP to apply the rates listed above to all entries of subject merchandise produced and/or exported by these firms. We intend to issue liquidation instructions to CBP 15 days after publication of the final results of these reviews.

The following deposit requirements will be effective upon publication of this notice for all shipments of CWP from Korea entered, or withdrawn from warehouse, for consumption on or after the date of publication, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the companies listed above will be equal to the weighted-average dumping margins established in these final results of administrative review; (2) for merchandise exported by producers or exporters not covered in this review but covered in a prior completed segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation but the producer has been covered in a prior complete segment of this proceeding, the cash deposit rate will be the rate established for the most recent period for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 4.80 percent,8 the all-others rate determined in the less-than-fair-value investigation. These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

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

This notice is published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5).

I. Abstract

In accordance with the Executive Order 12862, the National Institute of Standards and Technology (NIST), a non-regulatory agency of the Department of Commerce, proposes to conduct a number of data collection efforts—both quantitative and qualitative. The data collections will be designed to determine requirements and evaluate the usability and utility of NIST research for measurement and standardization work. These data collections efforts may include, but may not be limited to electronic methodologies, empirical studies, video and audio collections, interviews, and questionnaires. For example, data collection efforts may include the cryptography software survey and the password generation study. NIST will limit its inquiries to data collections that solicit strictly voluntary opinions or responses. NIST will not conduct individual data collections under this generic clearance that are mandatory, required, or regulated. The data collected will be used to guide NIST research. NIST will take steps to ensure anonymity of respondents in each activity covered under this request.

NIST will collect this information by electronic means when possible, as well as by mail, fax, telephone and person-to-person interviews. If an information collection is conducted in person, NIST will provide the respondent with a paper copy of the collection instrument that displays the “notwithstanding statement”, OMB Control # and current Expiration date.

OMB Control Number: 0693-0043.

Form Number: None.

Type of Review: Revision and extension of a currently approved information collection.

Affected Public: Individuals or households, State, local or tribal government, Federal government.

Estimated Number of Respondents: 15,000.

Estimated Time per Response: Varied, dependent upon the data collection method used. The estimated response time to complete a questionnaire is 15 minutes or 2 hours to participate in an empirical study.

Estimated Total Annual Burden Hours: 15,000.

Estimated Total Annual Cost to Public: $0.

NIST invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden (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.

Manufacturing Extension Partnership (MEP) is a national network of locally based manufacturing extension centers that assists small- and medium-sized manufacturers to improve their productivity, improve profitability, and enhance their economic competitiveness. The information collected will provide the MEP with information regarding MEP Center performance regarding the delivery of technology, and business solutions to U.S.-based manufacturers. The collected information will assist in determining the performance of the MEP Centers at both local and national levels, provide information critical to monitoring and reporting on MEP programmatic performance, and assist management in policy decisions. Responses to the collection of information are mandatory per the regulations governing the operation of the MEP Program (15 CFR parts 290, 291, 292, and H.R. 1274—section 2). The information collected will include center inputs and activities including services delivered, clients served, center staff, quarterly expenses and revenues, partners, strategic plan, operation plans, and client success stories. No confidentiality for information submitted is promised or provided. In order to reflect new initiatives and new data needs, NIST MEP has identified a need to revise its existing reporting processes by modifying existing reporting elements that will enable NIST MEP to better monitor and assess the extent to which the Centers are meeting program goals and milestones.

The information will be collected from the MEP Centers through the MEP Enterprise Information System (MEIS), https://meis.nist.gov.

OMB Control Number: 0693-0032.

Form Number(s): None.

Type of Review: Regular submission (revision of a currently approved information collection).

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 51.

Estimated Time per Response: 125 hours in year of Annual Review. 175 hours in year of Panel Review.

Estimated Total Annual Burden Hours: 6,375 hours in year of Annual Review. 8,925 hours in year of Panel Review.

Estimated Total Annual Cost to Public: $0.

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

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

The Committee was established in accordance with the requirements of Section 103 of the NEHRP Reauthorization Act of 2004 (Pub. L. 108-360). The Committee is composed of 15 members appointed by the Director of NIST, who were selected for their established records of distinguished service in their professional community, their knowledge of issues affecting NEHRP, and to reflect the wide diversity of technical disciplines, competencies, and communities involved in earthquake hazards reduction. In addition, the Chairperson of the U.S. Geological Survey Scientific Earthquake Studies Advisory Committee serves as an ex-officio member of the Committee. The Committee assesses:

• Trends and developments in the science and engineering of earthquake hazards reduction;

• The effectiveness of NEHRP in performing its statutory activities;

• Any need to revise NEHRP; and

• The management, coordination, implementation, and activities of NEHRP.

Background information on NEHRP and the Advisory Committee is available at http://nehrp.gov/.

Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the ACEHR will hold an open meeting on Wednesday, November 7, 2018, from 8:30 a.m. to 5:00 p.m. Mountain Time and Thursday, November 8, 2018, from 8:30 a.m. to 2:30 p.m. Mountain Time. The meeting will be held in the Katharine Blodgett Gebbie Laboratory Conference Room 1A106, Building 81, at NIST, 325 Broadway Street, Boulder, Colorado 80305. The meeting will be open to the public. The primary purpose of this meeting is to review the NEHRP agency updates on their latest activities and receive the NEHRP agency responses to the Committee's 2017 biennial and 2018 interim Reports on the Effectiveness of the NEHRP. The final agenda and any meeting materials will be posted on the NEHRP website at http://nehrp.gov/.

Individuals and representatives of organizations who would like to offer comments and suggestions related to the Committee's affairs are invited to request a place on the agenda. On November 8, 2018, approximately fifteen minutes will be reserved near the beginning of the meeting for public comments, and speaking times will be assigned on a first-come, first-serve basis. The amount of time per speaker will be determined by the number of requests received, but is likely to be about three minutes each. Questions from the public will not be considered during this period. All those wishing to speak must submit their request by email to the attention of Ms. Tina Faecke, [email protected], by 5:00 p.m. Eastern time, Wednesday, October 31, 2018.

Speakers who wish to expand upon their oral statements, those who had wished to speak but could not be accommodated on the agenda, and those who were unable to attend in person are invited to submit written statements to ACEHR, National Institute of Standards and Technology, 100 Bureau Drive, MS 8604, Gaithersburg, Maryland 20899-8604, via fax at (301) 975-4032, or electronically by email to [email protected].

All visitors to the NIST site are required to pre-register to be admitted. Anyone wishing to attend this meeting must register by 5:00 p.m. Eastern Time, Wednesday, October 24, 2018, in order to attend. Please submit your full name, email address, and phone number to Tina Faecke. Non-U.S. citizens must submit additional information; please contact Ms. Faecke. Ms. Faecke's email address is [email protected] and her phone number is (301) 975-5911. For participants attending in person, please note that federal agencies, including NIST, can only accept a state-issued driver's license or identification card for access to federal facilities if such license or identification card is issued by a state that is compliant with the REAL ID Act of 2005 (Pub. L. 109-13), or by a state that has an extension for REAL ID compliance. NIST currently accepts other forms of federal-issued identification in lieu of a state-issued driver's license. For detailed information please contact Ms. Faecke at (301) 975-5711 or visit: http://www.nist.gov/public_affairs/visitor/.

Notices were published in the Federal Register on the dates listed below that requests for a permit or permit amendment had been submitted by the below-named applicants. To locate the Federal Register notice that announced our receipt of the application and a complete description of the research, go to www.federalregister.gov and search on the permit number provided in the table below.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activities proposed are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

As required by the ESA, as applicable, issuance of these permit was based on a finding that such permits: (1) Were applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) are consistent with the purposes and policies set forth in Section 2 of the ESA.

Authority: The requested permits have been issued under the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), as applicable.

The workshop will review ensemble stock assessment modeling and evaluate how it fits in the NPFMC system. To also discuss considerations for potentially reducing an ABC from the maximum to account for observations and uncertainties not included in the assessment model or Tier system; and produce recommendations and a report to be considered by the September Joint Groundfish Plan Team. The Agenda is subject to change, and the latest version will be posted at http://www.npfmc.org/.

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

Agenda

The Fishery Data for Stock Assessment Working Group will present and discuss work to address the group's four main deliverables; begin discussions on working group recommendations and address other business as necessary.

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

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

The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. The product of the SEDAR webinar series will be a report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses, and describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: Data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.

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

Participants will identify who will be providing updated and/or new datasets.

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

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

This will be the first SaMTAAC meeting and its primary purpose is to orient the SaMTAAC and its advisors around to its charge, review information and alternatives already developed, and identify additional information that may be helpful to the committee for its first full meeting. The committee's charge is as follows: Identifying obstacles to achieving the goals and objectives of the catch share plan related to under attainment of non-sablefish trawl allocations and unharvested sablefish quota pounds (QP) south of 36° N latitude. As appropriate to overcome identified obstacles, the committee will discuss and develop options, including but not limited to, actions that may modify rules for gear switching by trawl permit holders and QP leasing to vessels using fixed gear, as well as options that may encourage increased utilization of sablefish QPs south of 36° N latitude.

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

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at [email protected] or (503) 820-2411 at least 10 days prior to the meeting date.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

On February 1, 2018, NMFS received a request from Chevron for an IHA to take marine mammals incidental to pile driving and pile removal associated with the WMEP in San Francisco Bay, California. Chevron's request is for take of seven species by Level A and Level B harassment. Neither Chevron nor NMFS expects serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.

NMFS has issued an IHA to Chevron authorizing the take of seven species by Level A and Level B harassment. Pile driving and removal will take 28 days and will be timed to occur within the work windows developed for Endangered Species Act (ESA)—listed fish species (June 1 through November 30). The IHA is effective from June 1, 2018 through May 31, 2019. This IHA would cover one year of a larger project for which Chevron intends to request additional take authorizations for subsequent facets of the project.

Chevron's Richmond Refinery Long Wharf (Long Wharf) located in San Francisco Bay, is the largest marine oil terminal in California. The Long Wharf has existed in its current location since the early 1900s (Figure 1-1 in Application). The existing configuration of these systems have limitations to accepting more modern, fuel efficient vessels with shorter parallel mid-body hulls and in some cases do not meet current Marine Oil Terminal Engineering and Maintenance Standards (MOTEMS). The purpose of the planned WMEP is to comply with current MOTEMS requirements and to improve safety and efficiency at the Long Wharf. The planned project will involve modifications at four berths (Berths 1, 2, 3, and 4). Modifications to the Long Wharf include replacing gangways and cranes, adding new mooring hooks and standoff fenders, adding new dolphins and catwalks, and modifying the fire water system at Berths 1, 2, 3 and/or 4, as well as the seismic retrofit to the Berth 4 loading platform. The type and numbers of piles to be installed, as well as those that will be removed during the 2018-2022 period are summarized in Table 1.

The combined modifications to Berths 1 to 4 would require the installation of 141 new concrete piles to support new and replacement equipment and their associated structures. The Berth 4 loading platform would add eight, 60-inch diameter steel piles as part of the seismic retrofit. The project would also add four clusters of 13 composite piles each (52 total) as markers and protection of the new batter (driven at an angle) piles on the east side of the Berth 4 retrofit. The project would remove 106 existing timber piles, three existing 22‐inch and two existing 24‐inch concrete piles. A total of 12 temporary piles would also be installed and removed during the seismic retrofit of Berth 4.

Note that the proposed IHA will only cover pile driving and removal that will occur during the 2018 work season, as provided in Table 2.

The Mil-Std-1553B decoder is written in the VHDL programming language and is vendor agnostic. This software is useful for implementation in technologies that need to passively collect, monitor or process existing Mil-Std-1553B bus interactions in real-time.

The purpose of this meeting is to update the public on GPS public document revisions and collect issues/comments for analysis and possible integration into future GPS public document revisions. All outstanding comments on the GPS public documents will be considered along with the comments received at this year's open forum in the next revision cycle. The 2018 Interface Control Working Group and Open Forum are open to the general public. For those who would like to attend and participate, we request that you register no later than August 30, 2018. Please send the registration information to [email protected], providing your name, organization, telephone number, email address, and country of citizenship.

Comments will be collected, catalogued, and discussed as potential inclusions to the version following the current release. If accepted, these changes will be processed through the formal directorate change process for IS-GPS-200, IS-GPS-705, IS-GPS-800, ICD-GPS-240, and ICD-GPS-870. All comments must be submitted in a Comments Resolution Matrix. This form along with current versions of the documents and the official meeting notice are posted at: http://www.gps.gov/technical/icwg/meetings/2018/.

Please submit comments to the SMC/GPS Requirements (SMC/GPER) mailbox at [email protected] by August 24, 2018. Special topics may also be considered for the Public Open Forum. If you wish to present a special topic, please submit any materials to SMC/GPER no later than August 1, 2018. For more information, please contact 1Lt Michael Telcide at 310-653-4191 or Mr. Daniel Godwin at 310-653-3640.

Full Text of Announcement I. Funding Opportunity Description

Purpose of Program: The FSCS program is newly authorized by sections 4621-4623 and 4625 of the Elementary and Secondary Education Act, as amended by the Every Student Succeeds Act (ESEA). This program provides support for the planning, implementation, and operation of full-service community schools that improve the coordination, integration, accessibility, and effectiveness of services for children and families, particularly for children attending high-poverty schools, including high-poverty rural schools.

Background: Community school strategies hold considerable promise for creating good schools for all students, but especially those living in poverty. This is of particular relevance in the face of growing achievement and opportunity gaps at a moment in which the Nation faces a decentralization of decision making about the use of Federal dollars.1

The growing interest in community schools, also known as full-service community schools, coupled with this competition, present an opportunity for nationwide school improvement. While earlier versions of the ESEA authorized community schools as a strategy and allowable activity, the reauthorized ESEA offers continued flexibilities at the State and district levels to implement strategies supported by community schools, such as coordination of school and community resources (ESEA sections 1114(b)(5) and 1115(b)(2)) and afterschool programming and support for a community school coordinator (ESEA section 4108(a)(5)(H)). If a State or district lacks the resources to implement community schools at scale, it can productively begin in neighborhoods where community schools are most needed and, therefore, students are most likely to benefit. The Department, through the FSCS program, provides catalytic support for the planning, implementation, operation, and coordination of effective services for children and families, particularly those in high-poverty urban and rural areas at the local level. According to a 2017 report, “a well-implemented community school leads to improvement in student and school outcomes and contributes to meeting the educational needs of low-achieving students in high-poverty schools. Strong research reinforces the efficacy of integrated student supports, expanded learning time and opportunities, and family and community engagement as intervention strategies.” 2

Over the last decade, the field has observed a wide range of practices coordinated and implemented in full-service community schools. Assuming stable leadership and a strong instructional program, full-service community schools have been associated with improved attendance and student achievement,3 increased family and community engagement,4 and improved student behavior and youth development.5 In addition, research suggests that system-wide support is critical to developing, implementing, and sustaining effective full-service community schools; full-service community schools have greater potential for impact when strong infrastructures are in place to support sustaining the overall effort and expanding the number of FSCS sites throughout a local educational agency (LEA) (as defined in this notice).

Priorities: This notice contains one absolute priority and four competitive preference priorities. In accordance with 34 CFR 75.105(b)(2)(iv), the absolute priority is from section 4625(b)(1)(A) of the ESEA. The competitive preference priorities are from sections 4625(b)(1)(B), 4625(b)(2), 4625(b)(3), and 8101(21)(A)(i) of the ESEA and 34 CFR 75.226(c).

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:

Eligible entities that will serve a minimum of two or more full-service community schools eligible for a schoolwide program (as defined in this notice) under section 1114(b) of the ESEA as part of a community- or district-wide strategy.

Competitive Preference Priorities: For FY 2018 and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2)(i) we award an additional two points to an application that meets Competitive Preference Priority 1 and we award an additional point to an application that meets any of Competitive Preference Priority 2, Competitive Preference Priority 3, or Competitive Preference Priority 4, for a maximum of five additional points under the competitive preference priorities. Applicants may apply under any, all, or none of the competitive preference priorities. Applicants must identify the priorities they are seeking points for in order to receive those points.

These priorities are:

Competitive Preference Priority 1—Rural Districts-Small and Rural or Rural and Low-Income. (0 or 2 points)

The Secretary gives priority to applicants that include a LEA that is currently eligible under the Small Rural School Achievement (SRSA) program or the Rural and Low-Income School (RLIS) program authorized under title V, part B (sections 5211 and 5221) of the ESEA. Applicants may determine whether a particular LEA is eligible for these programs by referring to information on the following Department websites: For the SRSA program, https://www2.ed.gov/programs/reapsrsa/eligible16/index.html and for the RLIS program, https://www2.ed.gov/programs/reaprlisp/eligibility.html.

Competitive Preference Priority 2—Broadly Representative Consortiums. (0 or 1 point)

The Secretary gives priority to an applicant that demonstrates that it is a consortium comprised of a broad representation of stakeholders.

Competitive Preference Priority 3—History of Effectiveness. (0 or 1 point)

The Secretary gives priority to an applicant that demonstrates that it is a consortium with a history of effectiveness.

Competitive Preference Priority 4—Evidence-Based Activities, Strategies, or Interventions. (0 or 1 point)

The Secretary gives priority to an application that is supported by promising evidence (as defined in this notice).

Definitions: The definitions for “Community-based organization,” “Eligible entity,” “Full-service community school,” “Local educational agency,” “Pipeline services,” and “State educational agency” are from sections 4622 and 8101 of the ESEA. The definitions for “Baseline,” “Experimental study,” “Nonprofit,” “Performance measure,” “Performance target,” “Project,” “Project component,” “Promising evidence,” “Relevant outcome,” “Quasi-experimental design study,” and “What Works Clearinghouse Handbook” are from 34 CFR 77.1. The definition of “School eligible for a schoolwide program” is from 34 CFR 200.25(b).

Baseline means the starting point from which performance is measured and targets are set.

Community-based organization means a public or private nonprofit (as defined in this notice) organization of demonstrated effectiveness that—

(a) Is representative of a community or significant segments of a community; and

(b) Provides educational or related services to individuals in the community.

Eligible entity means a consortium of one or more LEAs; or the Bureau of Indian Education; and one or more community-based organizations, nonprofit organizations, or other public or private entities.

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 (as defined in this notice):

(a) 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).

(b) 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.

(c) 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.

Full-service community school means a public elementary school or secondary school that—

(a) Participates in a community-based effort to coordinate and integrate educational, developmental, family, health, and other comprehensive services through community-based organizations and public and private partnerships; and

(b) Provides access to such services in school to students, families, and the community, such as access during the school year (including before- and after-school hours and weekends), as well as during the summer.

Local educational agency (LEA) means:

(a) In General. A public board of education or other public authority legally constituted within a State for either administrative control or direction of, or to perform a service function for, public elementary schools or secondary schools in a city, county, township, school district, or other political subdivision of a State, or of or for a combination of school districts or counties that is recognized in a State as an administrative agency for its public elementary schools or secondary schools.

(b) Administrative Control and Direction. The term includes any other public institution or agency having administrative control and direction of a public elementary school or secondary school.

(c) Bureau of Indian Education Schools. The term includes an elementary school or secondary school funded by the Bureau of Indian Education but only to the extent that including the school makes the school eligible for programs for which specific eligibility is not provided to the school in another provision of law and the school does not have a student population that is smaller than the student population of the local educational agency receiving assistance under the ESEA with the smallest student population, except that the school shall not be subject to the jurisdiction of any State educational agency (as defined in this notice) other than the Bureau of Indian Education.

(d) Educational Service Agencies. The term includes educational service agencies and consortia of those agencies.

(e) State Educational Agency. The term includes the State educational agency in a State in which the State educational agency is the sole educational agency for all public schools.

Nonprofit, as applied to an agency, organization, or institution, means that it is owned and operated by one or more corporations or associations whose net earnings do not benefit, and cannot lawfully benefit, any private shareholder or entity.

Performance measure means any quantitative indicator, statistic, or metric used to gauge program or project performance.

Performance target means a level of performance that an applicant would seek to meet during the course of a project or as a result of a project.

Pipeline services means a continuum of coordinated supports, services, and opportunities for children from birth through entry into and success in postsecondary education, and career attainment. Such services shall include, at a minimum, strategies to address through services or programs (including integrated student supports) the following:

(a) High-quality early childhood education programs.

(b) High-quality school and out-of-school-time programs and strategies.

(c) Support for a child's transition to elementary school, from elementary school to middle school, from middle school to high school, and from high school into and through postsecondary education and into the workforce, and including any comprehensive readiness assessment determined necessary.

(d) Family and community engagement and supports, which may include engaging or supporting families at school or at home.

(e) Activities that support postsecondary and workforce readiness, which may include job training, internship opportunities, and career counseling.

(f) Community-based support for students who have attended the schools in the area served by the pipeline, or students who are members of the community, facilitating their continued connection to the community and success in postsecondary education and the workforce.

(g) Social, health, nutrition, and mental health services and supports.

(h) Juvenile crime prevention and rehabilitation programs.

Project means the activity described in an application.

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:

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

(b) 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

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

(i) 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

(ii) 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.

School eligible for a schoolwide program means any school eligible under 34 CFR 200.25(b) to operate a school-wide program.

State educational agency (SEA) means the agency primarily responsible for the State supervision of public elementary schools and secondary schools.

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.

Application Requirements: The following requirements are from section 4625(a) of the ESEA. In order to receive funding, an applicant must include the following in its application:

(a) A description of the eligible entity.

(b) A memorandum of understanding among all partner entities in the eligible entity that will assist the eligible entity to coordinate and provide pipeline services and that describes the roles the partner entities will assume.

(c) A description of the capacity of the eligible entity to coordinate and provide pipeline services at two or more full-service community schools.

(d) A comprehensive plan that includes descriptions of the following:

(i) The student, family, and school community to be served, including demographic information.

(ii) A needs assessment that identifies the academic, physical, nonacademic, health, mental health, and other needs of students, families, and community residents.

(iii) Annual measurable performance objectives and outcomes, including an increase in the number and percentage of families and students targeted for services each year of the program, in order to ensure that children are—

(A) Prepared for kindergarten;

(B) Achieving academically; and

(C) Safe, healthy, and supported by engaged parents.

(iv) Pipeline services, including existing and additional pipeline services, to be coordinated and provided by the eligible entity and its partner entities, including an explanation of—

(A) Why such services have been selected;

(B) How such services will improve student academic achievement; and

(C) How such services will address the annual measurable performance objectives and outcomes described above.

(v) Plans to ensure that each full-service community school site has a full-time coordinator of pipeline services at such school, including a description of the applicable funding sources, plans for professional development for the personnel managing, coordinating, or delivering pipeline services, and plans for joint utilization and management of school facilities.

(vi) Plans for annual evaluation based upon attainment of the performance objectives and outcomes described above.

(vii) Plans for sustaining the programs and services described in the application after the grant period.

(e) An assurance that the eligible entity and its partner entities will focus services on schools eligible for a schoolwide program under section 1114(b) of the ESEA.

Applications that do not address the application requirements are not eligible for funding and will not be reviewed.

Program Authority: 20 U.S.C. 7275.

Applicable Regulations: (a) The Education Department General Administrative Regulations in 34 CFR parts 75, 77, 79, 81, 82, 84, 86, 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.

Type of Award: Discretionary grants.

Estimated Available Funds: $7,500,000.

Estimated Range of Awards: $275,000-$500,000 for each 12-month budget period; $1,375,000-$2,500,000 for the entire project period.

Estimated Average Size of Awards: $450,000 for each 12-month period.

Maximum Award: We will not make an award exceeding $2,500,000 for the entire project period.

Minimum Award: The Secretary may not award a grant under this subpart for activities described in this section to an eligible entity in an amount that is less than $75,000 for each year of the grant.

Estimated Number of Awards: 14-17.

Project Period: Up to 60 months.

1. Eligible Applicants: A consortium of—

(a) (i) One or more LEAs; or

(ii) The Bureau of Indian Education; and

(b) one or more community-based organizations, nonprofit organizations, or other public or private entities.

A consortium must comply with the provisions governing group applications in 34 CFR 75.127 through 75.129.

2. a. Cost Sharing or Matching: To be eligible for an award, a portion of the services provided by the applicant must be supported through non-Federal contributions, either in cash or in-kind donations. The applicant must propose the amount of cash or in-kind resources to be contributed for each year of the grant. The Bureau of Indian Education may meet the matching requirement using funds from other Federal sources.

b. Supplement not Supplant: This program is subject to supplement-not-supplant funding requirements. Grantees must use FSCS grant funds to supplement, and not supplant, any other Federal, State, and local funds that would otherwise have been available to carry out activities authorized under section 4625 of the ESEA.

3. Subgrantees: A grantee under this competition may not award subgrants to entities to directly carry out project activities described in its application.

4. Planning: Interagency collaborative efforts are highly complex undertakings that require extensive planning and communication among partners and key stakeholders. Partnerships should be based on identified needs and organized around a set of mutually defined results and outcomes. Applicants under this program may not use more than 10 percent of the total amount of grant funds for planning purposes during the first year of the grant. Funding received by grantees during the remainder of the project period must be devoted to program implementation.

5. Use of Funds: Grantees must use FSCS grant funds to: (1) Coordinate not less than three existing pipeline services, as of the date their grants are awarded, and provide not less than two additional pipeline services, at two or more public elementary schools or secondary schools; (2) to the extent practicable, integrate multiple pipeline services into a comprehensive and coordinated continuum to achieve the annual measurable performance objectives and outcomes under section 4625(a)(4)(C) of the ESEA to meet the holistic needs of children; and (3) if applicable, coordinate and integrate services provided by community-based organizations and government agencies with services provided by specialized instructional support personnel.

6. Evaluation: Grantees must conduct an annual evaluation of their project's progress in meeting the purpose of the FSCS program set out in section 4621(2) of the ESEA and use those evaluations to refine and improve activities carried out under the grant and the annual measurable achievement objectives and outcomes set out in section 4625(a)(4)(C). Grantees must make the results of their annual evaluation publicly available, including by providing public notice of the availability of such results.

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. Submission of Proprietary Information: Given the types of projects that may be proposed in applications for the FSCS program, your application may include business information that you consider proprietary. In 34 CFR 5.11 we define “business information” and describe the process we use in determining whether any of that information is proprietary and, thus, protected from disclosure under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552, as amended).

Because we plan to make successful applications available to the public, you may wish to request confidentiality of business information.

Consistent with Executive Order 12600, please designate in your application any information that you believe is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).

3. Intergovernmental Review: This program 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.

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

5. 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 150 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, references, and captions, as well as all text in charts, tables, figures, and graphs.

• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).

• 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 one-page abstract, the resumes, the bibliography, or the letters of support. However, the recommended page limit does apply to all of the application narrative.

6. Notice of Intent to Apply: The Department will be able to develop a more efficient process for reviewing grant applications if it has a better understanding of the number of entities that intend to apply for funding under this competition. Therefore, the Secretary strongly encourages each potential applicant to notify the Department of the applicant's intent to submit an application for funding by sending a short email message indicating the applicant's intent to submit an application for funding. The email need not include information regarding the content of the proposed application, only the applicant's intent to submit it. This email notification should be sent to [email protected] with “INTENT TO APPLY” in the subject line by June 28, 2018. Applicants that do not notify us of their intent to apply may still apply for funding.

1. Selection Criteria: The selection criteria for this competition are from 34 CFR 75.210. The maximum score for all of the selection criteria is 100 points. The maximum score for each criterion is included in parentheses following the title of the specific selection criterion. Each criterion also includes the factors that reviewers will consider in determining the extent to which an applicant meets the criterion.

Points awarded under these selection criteria are in addition to any points an applicant earns under the competitive preference priorities in this notice. The maximum score that an application may receive under the competitive preference priorities and the selection criteria is 105 points.

The selection criteria are as follows:

(a) Quality of the Project Design (up to 15 points).

The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers—

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

(2) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs.

(b) Quality of the Project Services (up to 25 points).

The Secretary considers the quality of the services to be provided by the proposed project. In determining the quality of project services, 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. In addition, the Secretary considers the following—

(1) The likely impact of the services to be provided by the proposed project on the intended recipients of those services.

(2) 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.

(c) Adequacy of Resources (up to 15 points).

The Secretary considers the adequacy of resources for the proposed project. In determining the adequacy of resources for the proposed project, the Secretary considers the following factors—

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

(2) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits.

(d) Quality of the Management Plan (up to 20 points).

The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers the following factors—

(1) 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.

(2) 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.

(e) Quality of the Project Evaluation (up to 25 points).

The Secretary considers the quality of the evaluation to be conducted of the proposed project. In determining the quality of the evaluation, the Secretary considers the following factors—

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

(2) 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.

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. 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.

4. 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. 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.

(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

5. Performance Measures: We have established one performance measure for the FSCS program: The percentage and number of individuals targeted for services and who receive services during each year of the project period.

6. 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) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

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

Full Text of Announcement I. Funding Opportunity Description

Purpose of Program: The purposes of this program are to (1) help address State-identified needs for personnel preparation in special education, early intervention, related services, and regular education to work with children, including infants and toddlers, with disabilities; and (2) ensure that those personnel have the necessary skills and knowledge, derived from practices that have been determined through scientifically based research and experience, to be successful in serving those children.

Priorities: This competition includes two absolute priorities and one competitive preference priority. In accordance with 34 CFR 75.105(b)(2)(v), Absolute Priority 1 is from allowable activities specified in the statute (see sections 662 and 681 of the Individuals with Disabilities Education Act (IDEA); 20 U.S.C. 1462 and 1481). Absolute Priority 2 and the competitive preference priority are from the Secretary's Final Supplemental Priorities and Definitions for Discretionary Grant Programs, published in the Federal Register on March 2, 2018 (83 FR 9096) (Supplemental Priorities).

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

These priorities are:

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 purpose of this Preparation of Special Education, Early Intervention, and Related Services Leadership Personnel competition is to support existing doctoral degree programs that prepare special education, early intervention, and related services personnel who are well-qualified for, and can act effectively in, leadership positions as researchers and preparers of special education, early intervention, and related services personnel in institutions of higher education (IHEs), or as leaders in national organizations, State educational agencies (SEAs), lead agencies (LAs), local educational agencies (LEAs), early intervention services programs (EIS programs), or schools. Absolute Priority 1 is consistent with the Supplemental Priorities, specifically, Supplemental Priority 5—Meeting the Unique Needs of Students and Children With Disabilities and/or Those with Unique Gifts and Talents; and Supplemental Priority 8—Promoting Effective Instruction in Classrooms and Schools.

There is a well-documented need for leadership personnel to fill faculty and leadership positions in special education, early intervention, and related services (Castillo, Curtis, & Tan, 2014; deBettencourt, Hoover, Rude, & Taylor, 2016; Montrosse & Young, 2012; Robb, Smith, & Montrosse, 2012; Smith, Montrosse, Robb, Tyler, & Young, 2011; Smith, Robb, West, & Tyler, 2010; Woods & Snyder, 2009). These leaders conduct research to increase the knowledge of effective interventions and services for children, including infants and toddlers, and youth with disabilities. These leaders also teach practices supported by evidence to future special education, early intervention, related services, and regular education professionals who will work in a variety of educational settings and provide services directly to these children (Robb et al., 2012; Smith et al., 2010; West & Hardman, 2012). Shortages in these leadership positions limit the field's capacity to generate new knowledge of effective interventions and to prepare future professionals to improve outcomes for children with disabilities (Smith et al., 2011). In addition, leadership shortages limit the field's capacity to ensure that children, including infants and toddlers, and youth with disabilities have the opportunity to meet challenging objectives and receive an educational program that is both meaningful and appropriately ambitious, which is essential for preparing them for future success.

Shortages of leadership personnel at State and local agencies to fill special education and early intervention administrator positions have also been noted (Billingsley, Crockett, & Kamman, 2014). These administrators supervise and evaluate the implementation of instructional programs supported by evidence to make sure that State or local agencies are meeting the needs of children with disabilities. Administrators also ensure that schools and programs meet Federal, State, and local requirements for special education, early intervention, and related services (Lashley & Boscardin, 2003).

Federal support can increase the supply of personnel who have the necessary knowledge and skills to assume leadership positions in special education, early intervention, and related services as researchers and preparers of special education, early intervention, related services, and regular education personnel in IHEs, or as leaders in national organizations, SEAs, LAs, LEAs, EIS programs, or schools. Critical competencies for special education, early intervention, and related services personnel vary depending on the type of leadership personnel and the requirements of the preparation program but can include, for example, skills needed for postsecondary instruction, administration, policy development, professional practice, leadership, or research. However, all leadership personnel need to have current knowledge of effective interventions and services that improve outcomes for children with disabilities, including high-need children with disabilities. This knowledge should be applicable to children served in a variety of educational settings (e.g., public schools, including charter schools, or private schools) or early childhood and early intervention settings (e.g., home, community-based, Early Head Start and Head Start, child care, or public and private preschools), and the interventions and services must include those that promote literacy development, literacy skills, or other skills critical for college and today's careers.

The purpose of this priority is to support existing doctoral degree programs that prepare special education, early intervention, and related services personnel at the doctoral degree level who are well qualified for, and can act effectively in, leadership positions as researchers and preparers of special education, early intervention, related services, and regular education personnel in IHEs, or as leaders in national organizations, SEAs, LAs, LEAs, or EIS programs. This priority supports two types of programs:

Type A programs are designed to prepare special education, early intervention, and related services personnel as researchers and preparers of personnel in IHEs. Type A programs culminate in a doctoral degree.

Type B programs are designed to prepare special education or early intervention administrators to work as leaders in national organizations, SEAs, LAs, LEAs, or EIS programs. Type B programs prepare personnel for positions such as SEA special education administrators, LEA or regional special education directors, school-based special education directors, preschool coordinators, and early intervention coordinators. Type B programs culminate in a doctoral degree.

To be considered for funding under this absolute priority, program applicants must meet the application requirements contained in the priority. All projects funded under this absolute priority also must meet the programmatic and administrative requirements specified in the priority.

The requirements of this priority are as follows:

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

(1) The project addresses the need for leadership personnel to provide, prepare others to provide, or supervise the provision of effective interventions and services that improve outcomes for children with disabilities, including high-need children with disabilities.1 These interventions should be applicable to children served in a variety of educational settings (e.g., public schools, including charter schools, or private schools) or early childhood and early intervention settings (e.g., home, community-based, Early Head Start and Head Start, child care, or public and private preschools), and the interventions and services must include those that promote literacy development, literacy skills, or other skills critical for college and today's careers. To address this requirement, the applicant must present—

(i) Appropriate and applicable data (e.g., national, State) demonstrating the need for the leadership personnel the applicant proposes to prepare; and

(ii) Data demonstrating the success of the doctoral program to date in producing leaders in special education, early intervention, or related services such as: The professional accomplishments of program graduates (e.g., public service, honors, or peer-reviewed publications (for Type A programs)) that demonstrate their leadership in special education, early intervention, or related services; the success of program graduates as educators of teachers, service providers, or administrators, including any results from evaluating the impact of those teachers, service providers, or administrators, on the outcomes of children with disabilities; the average amount of time it takes for program graduates to complete the program; The number of program graduates; and the percentage of program graduates finding employment directly related to their preparation.

(2) Scholar competencies to be acquired in the program relate to knowledge and skills needed by the leadership personnel the applicant proposes to prepare, including knowledge of technologies designed to provide instruction. To address this requirement, the applicant must—

(i) Identify the competencies needed by leadership personnel in postsecondary instruction, administration, policy development, professional practice, leadership, or research in order to provide, prepare others to provide, or supervise the provision of effective interventions and services that improve outcomes for children with disabilities, including high-need children with disabilities; and

(ii) Provide the conceptual framework of the leadership preparation program, including any empirical support, that will promote the acquisition of the identified competencies needed by leadership personnel, including knowledge of technologies designed to provide instruction, and, where applicable, how these competencies relate to the project's specialized preparation area.

(b) Demonstrate, in the narrative section of the application under “Quality of the Project Services,” how—

(1) The applicant will recruit and support high-quality scholars. The narrative must describe—

(i) The selection criteria the applicant will use to identify high-quality applicants for admission in the program;

(ii) The recruitment strategies the applicant will use to attract high-quality applicants and any specific recruitment strategies targeting high-quality applicants from groups that are underrepresented in the teaching profession, including individuals with disabilities; and

(iii) The approach the applicant will use to help all scholars, including individuals with disabilities, complete the program; and

(2) The project is designed to promote the acquisition of the competencies needed by leadership personnel to provide, prepare others to provide, or supervise the provision of effective interventions and services that improve outcomes for children with disabilities, including high-need children with disabilities. These interventions should be applicable to children served in a variety of educational settings (e.g., public schools, including charter schools, or private schools) or early childhood and early intervention settings (e.g., home, community-based, Early Head Start and Head Start, child care, or public and private preschools), and the interventions and services must include those that promote literacy development, literacy skills, or other skills critical for college and today's careers. To address this requirement, the applicant must—

(i) Describe how the components of the project, such as coursework, internship experiences, research requirements, and other opportunities provided to scholars to analyze data, critique research and methodologies, and practice newly acquired knowledge and skills, will enable the scholars to acquire the competencies needed by leadership personnel for postsecondary instruction, administration, policy development, professional practice, leadership, or research in special education, early intervention, or related services;

(ii) Describe how the components of the project are integrated in order to support the acquisition and enhancement of the identified competencies needed by leadership personnel in special education, early intervention, or related services, including knowledge of technologies designed to provide instruction;

(iii) Describe how the components of the project prepare scholars to provide, prepare others to provide, or supervise the provision of effective interventions and services that improve outcomes for children with disabilities, including high-need children with disabilities, in a variety of educational or early childhood and early intervention settings;

(iv) Demonstrate, through a letter of support from a partnering agency, school, or program, that it will provide scholars with a high-quality internship experience in a high-need LEA; 2 a high-poverty school; 3 a school identified for comprehensive support and improvement; 4 a school implementing a targeted support and improvement plan 5 for children with disabilities; an early childhood and early intervention program located within the geographical boundaries of a high-need LEA; or an early childhood and early intervention program located within the geographical boundaries of an LEA serving the highest percentage of schools identified for comprehensive support and improvement or implementing targeted support and improvement plans in the State;

(v) Describe how the project will use resources, as appropriate, available through technical assistance centers, which may include centers funded by the Department;

(vi) Describe the approach that faculty members will use to mentor scholars with the goal of helping them acquire competencies needed by leadership personnel and advancing their careers in special education, early intervention, or related services; and

(vii) Describe how the components of the project, mentoring, and other project opportunities will promote the acquisition of scholars' critical leadership skills, including communication, networking, and collaboration.

(c) Demonstrate, in the narrative section of the application under “Quality of the Project Evaluation,” how the applicant will—

(1) Evaluate how well the goals or objectives of the proposed leadership project have been met. The applicant must describe the outcomes to be measured for both the project and the scholars, particularly the acquisition of scholars' competencies and their impact on the services provided by future teachers, service providers, or administrators; and the evaluation methodologies to be employed, including proposed instruments, data collection methods, and possible analyses;

(2) Collect, analyze, and use data on current scholars and scholars who graduate from the program to improve the proposed program on an ongoing basis; and

(3) Report the evaluation results to OSEP in the applicant's annual and final performance reports.

(d) Demonstrate, in the narrative under “Required Project Assurances” or appendices as directed, that the following program requirements are met. The applicant must—

(1) Include in appendix B to the application—

(i) Course syllabi for all coursework in the major and any required coursework for a minor;

(ii) Course syllabi for all research methods, evaluation methods, or data analysis courses required by the degree program and elective research methods, evaluation methods, or data analysis courses that have been completed by more than one scholar enrolled in the program in the last five years; and

(iii) For new coursework, proposed syllabi;

(2) Ensure that the proposed number of scholars to be recruited into the program can graduate from the program by the end of the grant's project period. The described scholar recruitment strategies, including recruitment of individuals with disabilities, the program components and their sequence, and proposed budget must be consistent with this project requirement;

(3) Ensure scholars will not be selected based on race or national origin/ethnicity. Per the Supreme Court's decision in Adarand Constructors, Inc. v. Pena, 515 U.S. 200 (1995), the Department does not allow the selection of individuals on the basis of race or national origin/ethnicity. For this reason, grantees must ensure that any discussion of the recruitment of scholars based on race or national origin/ethnicity distinguishes between increasing the pool of applicants and actually selecting scholars;

(4) Ensure that the project will meet all requirements for grantees in disbursing scholarships as outlined in 34 CFR 304.23. Failure by a grantee to properly meet these requirements would be a violation of the grant award that could result in sanctions, including the grantee being liable for returning any misused funds to the Department. Specifically, before disbursement of scholarship assistance to an individual, a grantee must—

(i) Ensure that the scholar—

(A) Is a citizen or national of the United States;

(B) Is a permanent resident of—

(1) Puerto Rico, the United States Virgin Islands, Guam, American Samoa, or the Commonwealth of the Northern Mariana Islands; or

(2) The Republic of the Marshall Islands, the Federated States of Micronesia, or the Republic of Palau during the period in which these entities are eligible to receive an award under the Personnel Development to Improve Services and Results for Children with Disabilities program; or

(C) Provides evidence from the U.S. Department of Homeland Security that the individual is—

(1) A lawful permanent resident of the United States; or

(2) In the United States for other than a temporary purpose with the intention of becoming a citizen or permanent resident;

(ii) Limit the cost of attendance portion of the scholarship assistance (as discussed in 34 CFR 304.21(a)) to the amount by which the individual's cost of attendance at the institution exceeds the amount of grant assistance the scholar is to receive for the same academic year under title IV of the HEA; and

(iii) Obtain a Certification of Eligibility for Federal Assistance from each scholar, as prescribed in 34 CFR 75.60, 75.61, and 75.62.

(5) Ensure that the project will meet the requirements in 34 CFR 304.23, particularly those related to informing all scholarship recipients of their service obligation commitment. Failure by a grantee to properly meet these requirements is a violation of the grant award that may result in sanctions, including the grantee being liable for returning any misused funds to the Department. Specifically, the grantee must prepare, and ensure that each scholarship recipient signs, the following two documents:

(i) A Pre-Scholarship Agreement prior to the scholar receiving a scholarship for an eligible program (Office of Management and Budget (OMB) Control Number 1820-0686); and

(ii) An Exit Certification immediately upon the scholar leaving, completing, or otherwise exiting that program (OMB Control Number 1820-0686);

(6) Ensure that prior approval from the OSEP project officer will be obtained before admitting additional scholars beyond the number of scholars proposed in the application and before transferring a scholar to another preparation program funded by OSEP;

(7) Ensure that the project will meet the statutory requirements in section 662(e) through (h) of IDEA;

(8) Ensure that at least 65 percent of the total requested budget over the five years will be used for scholar support;

(9) Ensure that the IHE will not require scholars enrolled in the program to work (e.g., as graduate assistants) as a condition of receiving support (e.g., tuition, stipends) from the proposed project, unless the work is specifically related to the acquisition of scholars' competencies and the requirements for completion of their personnel preparation program. This prohibition on work as a condition of receiving support does not apply to the service obligation requirements in section 662(h) of IDEA;

(10) Ensure that the budget includes attendance of the project director at a three-day project directors' meeting in Washington, DC, during each year of the project. The budget may also provide for the attendance of scholars at the same three-day project directors' meetings in Washington, DC;

(11) Ensure that the project director, key personnel, and scholars will actively participate in the cross-project collaboration, advanced trainings, and cross-site learning opportunities (e.g., webinars, briefings) supported by OSEP. This network is intended to promote opportunities for participants to share resources and generate new knowledge by addressing topics of common interest to participants across projects including Department priorities and needs in the field;

(12) Ensure that if the project maintains a website, that it will be of high quality, with an easy-to-navigate design, that meets government or industry-recognized standards for accessibility;

(13) Ensure that scholar accomplishments (e.g., publications, awards) will be reported in annual and final performance reports; and

(14) Ensure that annual data will be submitted on each scholar who receives grant support (OMB Control Number 1820-0686). The primary purposes of the data collection are to track the service obligation fulfillment of scholars who receive funds from OSEP grants and to collect data for program performance measure reporting under the Government Performance and Results Act of 1993 (GPRA). Applicants are encouraged to visit the Personnel Development Program Data Collection System (DCS) website at https://pdp.ed.gov/osep for further information about this data collection requirement. Typically, data collection begins in January of each year, and grantees are notified by email about the data collection period for their grant, although grantees may submit data as needed, year round. This data collection must be submitted electronically by the grantee and does not supplant the annual grant performance report required of each grantee for continuation funding (see 34 CFR 75.590). Data collection includes the submission of a signed, completed Pre-Scholarship Agreement and Exit Certification for each scholar funded under an OSEP grant (see paragraph (4) of this section, subparagraphs (i) and (ii)).

The Department seeks to encourage grantees to leverage sources of support that may exist for their activities, beyond what is provided by the Department. Therefore, we have included an absolute priority for matching support through non-Federal contributions, either in cash or in-kind donations. Although the cash or in-kind resources to be contributed must be at least 10 percent of the total grant award, we encourage a higher percentage through the competitive preference priority included within this absolute priority.

Applicants must address this absolute priority, and the competitive preference priority, if applicable, in the budget information (ED Form 524, Section B) and budget narrative. The applicant must propose the amount of cash or in-kind resources to be contributed for each year of the grant.

Projects that are designed to demonstrate matching support 6 for the proposed project at 10 percent of the total amount of the grant.

Competitive Preference Priority: Within this absolute priority, we give competitive preference to applications that address the following priority. Under 34 CFR 75.105(c)(2)(i) we award an additional one point to an application that meets paragraph (i) of the competitive preference priority and an additional two points to an application that meets paragraph (ii) of the competitive preference priority.

This priority is:

Projects that are designed to demonstrate matching support for the proposed projects:

(i) 50 percent of the total amount of the grant (1 point); or

(ii) 100 percent of the total amount of the grant (2 points).

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. 1462 and 1481.

Applicable Regulations: (a) The Education Department General Administrative Regulations in 34 CFR parts 75, 77, 79, 81, 82, 84, 86, 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. (d) The regulations for this program in 34 CFR part 304.

Type of Award: Discretionary grants.

Estimated Available Funds: $4,250,000.

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: $225,000-$250,000 per year.

Estimated Average Size of Awards: $237,500 per year.

Maximum Award: We will not make an award exceeding $250,000 for a single budget period of 12 months.

Estimated Number of Awards: 17.

Project Period: Up to 60 months.

1. Eligible Applicants: IHEs, private nonprofit organizations.

2. Cost Sharing or Matching: Cost sharing or matching is required for this competition. See Absolute Priority 2.

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. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition.

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 of the Project (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 prepare personnel for fields in which shortages have been demonstrated;

(ii) The importance or magnitude of the results or outcomes likely to be attained by the proposed project; and

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

(b) Quality of Project Services (45 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 training or professional development services to be provided by the proposed project are of sufficient quality, intensity, and duration to lead to improvements in practice among the recipients of those services;

(ii) The extent to which the proposed activities constitute a coherent, sustained program of training in the field; and

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

(c) Quality of Project Evaluation (25 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 goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable;

(iii) 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; and

(iv) The extent to which the methods of evaluation will provide timely guidance for quality assurance.

(d) Quality of Management Plan and Resources (20 points).

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

(2) In determining the quality of the management plan and the adequacy of resources, the Secretary considers the following factors:

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

(ii) 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;

(iii) 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;

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

(v) The extent to which the budget is adequate to support the proposed project.

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. 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 GPRA, the Department has established a set of performance measures, including long-term measures, that are designed to yield information on the quality of the Personnel Development to Improve Services and Results for Children with Disabilities program. These measures include: (1) The percentage of preparation programs that incorporate scientifically or evidence-based practices into their curricula; (2) the percentage of scholars completing preparation programs who are knowledgeable and skilled in evidence-based practices for children with disabilities; (3) the percentage of scholars who exit preparation programs prior to completion due to poor academic performance; (4) the percentage of scholars completing preparation programs who are working in the area(s) in which they were prepared upon program completion; and (5) the Federal cost per scholar who completed the preparation program.

In addition, the Department will gather information on the following outcome measures: (1) The percentage of scholars who completed the preparation program and are employed in high-need districts; (2) the percentage of scholars who completed the preparation program and are employed in the field of special education for at least two years; and (3) the percentage of scholars who completed the preparation program and who are rated effective by their employers.

Grantees may be asked to participate in assessing and providing information on these aspects of program quality.

6. 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.

Full Text of Announcement I. Funding Opportunity Description

Purpose of Program: The purposes of this program are to (1) help address State-identified needs for personnel preparation in special education, early intervention, related services, and regular education to work with children, including infants and toddlers, and youth with disabilities; and (2) ensure that those personnel have the necessary skills and knowledge, derived from practices that have been determined through scientifically based research and experience, to be successful in serving those children.

Priority: In accordance with 34 CFR 75.105(b)(2)(v), this priority is from allowable activities specified in the statute (see sections 662 and 681 of the Individuals with Disabilities Education Act (IDEA); 20 U.S.C. 1462 and 1481).

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:

Interdisciplinary Preparation in Special Education, Early Intervention, and Related Services for Personnel Serving Children with Disabilities who have High-Intensity Needs.

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 purpose of this priority is to increase the number and improve the quality of personnel who are fully credentialed to serve children, including infants and toddlers, and youth with disabilities who have high-intensity needs,1 especially in areas of chronic personnel shortage. The priority will fund high-quality interdisciplinary 2 projects that prepare special education, early intervention, and related services 3 personnel at the master's degree, educational specialist degree, or clinical doctoral degree levels for professional practice in a variety of educational settings, including natural environments (including the home and community settings in which children without disabilities participate), early learning programs, classrooms, and school settings. This priority is consistent with the Secretary's Supplemental Priority 5—Meeting the Unique Needs of Students and Children With Disabilities and/or Those With Unique Gifts and Talents; and Supplemental Priority 8—Promoting Effective Instruction in Classrooms and Schools, which were published in the Federal Register on March 2, 2018 (83 FR 9096).

State demand for fully credentialed special education, early intervention, and related services personnel to serve children, including infants and toddlers, and youth with disabilities exceeds the available supply, particularly in high-need schools 4 (Boe, deBettencourt, Dewey, Rosenberg, Sindelar, & Leko, 2013). These shortages can negatively affect the quality of services provided to children, including infants and toddlers, and youth with disabilities and their families (Boe et al., 2013). These shortages limit the field's capacity in ensuring that children, including infants and toddlers, and youth with disabilities have the opportunity to meet challenging objectives and receive an individualized education program that is both meaningful and appropriately ambitious, which is essential for preparing them for the future.

The need for personnel with the knowledge and skills to serve children, including infants and toddlers, and youth with disabilities who have high-intensity needs is even greater because specialized or advanced preparation is required to collaboratively design and deliver evidence-based instruction and intensive individualized intervention(s) in natural environments, classrooms, and schools that address the needs of these individuals (Boe et al., 2013; Browder, Wood, Thompson, & Ribuffo, 2014; McLeskey & Brownell, 2015). Although children, including infants and toddlers, and youth with disabilities who have high-intensity needs may require the combined expertise of numerous professionals (including special education, early intervention, and related services providers), it is often difficult for personnel from varied professional backgrounds to work together because they lack shared information, understanding, and experience.

Interdisciplinary approaches to personnel preparation provide scholars with experience working and learning in team environments similar to those in which they are likely to work once employed (Smith, 2010). For example, under the IDEA, personnel serving children, including infants and toddlers, and youth with disabilities will work on interdisciplinary teams with parent(s), general and special education teachers, early interventionists, and related service providers with the expertise convened to design, implement, and evaluate intervention plans based on the unique learning and developmental needs of each individual child. To enable personnel to provide efficient, high-quality integrated services, personnel preparation programs need to embed content, practices, and clinical experience into preservice training that will match the interdisciplinary team-based approaches in which graduates are likely to work. This priority aims to fund interdisciplinary projects that will provide such preparation.

The purpose of this priority is to increase the number and improve the quality of personnel who are fully credentialed to serve children, including infants and toddlers, and youth with disabilities who have high-intensity needs—especially in areas of chronic personnel shortage. The priority will fund high-quality interdisciplinary projects that prepare special education, early intervention, and related services personnel at the master's degree, educational specialist degree, or clinical doctoral degree levels for professional practice in natural environments, early learning programs, classrooms, and school settings serving children, including infants and toddlers, and youth with disabilities.

Specifically, an applicant must propose an interdisciplinary project supporting scholars 5 from two or more graduate degree programs in either (a) special education or early intervention and one or more related services; or (b) two or more related services.

An interdisciplinary project is a project that delivers core content through shared coursework, group assignments, and coordinated clinical experiences as part of two or more master's degree, educational specialist degree, or clinical doctoral degree programs for scholars.

Not all requirements (e.g., courses and clinical experiences) of each participating graduate degree program must be shared across all degree programs participating in the interdisciplinary project, but the interdisciplinary project must: (a) Identify the competencies needed to address the individualized needs of children with disabilities who have high-intensity needs using an interdisciplinary approach to service delivery; (b) outline how the project will build capacity in those areas through shared coursework, group assignments, and coordinated clinical experiences for scholars supported by the proposed project; and (c) identify the aspects of each graduate degree program that are shared across all participating programs and those that remain unique to each.

Projects may include individuals who are in degree programs (e.g., general education, early childhood education, administration) and who are cooperating with, but not funded as scholars by, the applicant's proposed interdisciplinary project. These individuals may participate in interdisciplinary coursework, group assignments, coordinated field experiences, and other opportunities funded by the project (e.g., speaker series, monthly seminars) if doing so does not diminish the benefit for project-funded scholars (e.g., by reducing funds available for scholar support or limiting opportunities for scholars to participate in project activities).

Personnel preparation programs that prepare individuals to be educational interpreters for the deaf at the bachelor's degree level can qualify under this priority, and are exempted from (a) the interdisciplinary requirement; and (b) the requirement for two or more graduate degree programs. All other priority requirements specified for graduate programs will apply to the bachelor's program. While interdisciplinary projects are not required for educational interpreters, they are encouraged.

Within this absolute priority, the Secretary intends to support interdisciplinary projects under the following two focus areas: (A) Preparing Personnel to Serve Infants, Toddlers, and Preschool-Age Children with Disabilities who have High-Intensity Needs; and (B) Preparing Personnel to Serve School-Age Children with Disabilities who have High-Intensity Needs.

Applicants must identify the specific focus area (i.e., A or B) under which they are applying as part of the competition title on the application cover sheet (SF form 424, line 4). Applicants may not submit the same proposal under more than one focus area.

Focus Area A: Preparing Personnel to Serve Infants, Toddlers, and Preschool-Age Children with Disabilities who have High-Intensity Needs. This focus area is for interdisciplinary projects that deliver core content through shared coursework, group assignments, and coordinated clinical experiences for scholars across two or more graduate degree programs in either: (a) Early intervention or early childhood special education and related services for infants, toddlers, and preschool-age children with disabilities who have high-intensity needs; or (b) two or more related services to serve infants, toddlers, and preschool-age children with disabilities who have high-intensity needs.

Early intervention personnel are those who are prepared to provide services to infants and toddlers with disabilities ages birth to three, and early childhood personnel are those who are prepared to provide services to children with disabilities ages three through five (and in States where the age range is other than ages three through five, we defer to the State's certification for early childhood special education). In States where certification in early intervention is combined with certification in early childhood special education, applicants may propose a combined early intervention and early childhood special education personnel preparation project under this focus area.

Focus Area B: Preparing Personnel to Serve School-Age Children with Disabilities who have High-Intensity Needs. This focus area is for interdisciplinary projects that deliver core content through shared coursework, group assignments, and coordinated clinical experiences to scholars across two or more graduate degree programs in either: (a) Special education and related services for school-age children with disabilities who have high-intensity needs; or (b) two or more related services to serve school-age children with disabilities who have high-intensity needs.

Projects funded under Focus Area A or B may use up to 12 months during the first year of the project period and up to $100,000 of Federal funds for program planning without enrolling scholars. Applicants must provide sufficient justification for requesting program planning time and include the intended outcomes of program planning in Year 1, and a description of the proposed strategies and activities to be supported, such as—

(1) Outlining or updating coursework, group assignments, or coordinated clinical experience needed to support interdisciplinary preparation for special education, early intervention, or related services personnel serving children with disabilities who have high-intensity needs;

(2) Building capacity (e.g., hiring of a clinical practice supervisor, providing professional development for clinical field supervisors, and training for faculty);

(3) Purchasing needed resources (e.g., additional teaching supplies or specialized equipment to enhance instruction); or

(4) Negotiating agreements with programs or schools to serve as sites for coordinated clinical experience needed to support delivery of the proposed interdisciplinary project.

Remaining Year 1 Federal funds up to the maximum award available for one budget period of 12 months (i.e., $250,000) may be used for scholar support and other grant activities if included in the Year 1 budget request.

To be considered for funding under this absolute priority, all program applicants must meet the application requirements contained in the priority. All projects funded under this absolute priority also must meet the programmatic and administrative requirements specified in the priority.

The requirements of this priority are as follows:

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

(1) The project addresses national, State, regional, or district shortages of personnel who are fully qualified to serve children with disabilities, ages birth through 21, who have high-intensity needs. To address this requirement, the applicant must—

(i) Present data on the quality of each special education, early intervention, or related services personnel preparation degree program participating in the project in areas such as: The average amount of time it takes for scholars to complete the program; the percentage of program graduates who receive a license, endorsement, or certification related to special education, related services, or early intervention services; the percentage of program graduates finding employment related to their preparation after graduation; the success of program graduates in providing special education, early intervention, or related services, which could include data on the learning and developmental outcomes of children with disabilities they serve; the percentage of program graduates who maintain employment for two or more years in the area for which they were prepared; and the percentage of employers who rate the preparation of scholars who complete their degree program as adequate or higher; and

(ii) If available for the degree programs participating in the proposed project, present data on the quality of their interdisciplinary approaches to the preparation of special education, early intervention, or related services personnel.

(2) The project will increase the number of personnel who demonstrate the competencies needed to provide (a) differentiated instruction, and (b) intensive individualized intervention(s) in an interdisciplinary team-based approach to address the individualized needs of children with disabilities who have high-intensity needs, ages birth through 21, that result in improvements in learning or developmental outcomes (e.g., academic, social, emotional, behavioral), or successful transition to postsecondary education and the workforce. To address this requirement, the applicant must—

(i) Identify the competencies 7 that special education, early intervention, or related services personnel need in order to ensure delivery of (a) differentiated instruction, and (b) intense individualized intervention(s) in an interdisciplinary team-based approach that will: Lead to improved learning and developmental outcomes; ensure access to and progress in academic achievement standards or alternate academic achievement standards, as appropriate; lead to successful transition to college and career for children with disabilities, including children with disabilities who have high-intensity needs; and maximize the use of effective technology, including assistive technology, to deliver instruction, interventions, and services;

The Department is renaming the system of records from the “Office of the Student Loan Ombudsman Records” to the “Customer Engagement Management System (CEMS).” The system of records described in this notice maintains records on individuals who are, were, or may be participants in any of the Student Financial Assistance Programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA) who request assistance, directly or through a designated third party, from the Department. The CEMS maintains the information for a number of purposes related to the duties and responsibilities of the Ombudsman and the FSA Enforcement Office, including: Verifying the identities of individuals; recording complaints and comments; tracking individual cases through final resolution; reporting trends; analyzing the data to recommend improvements in student financial assistance programs; and assisting in the informal resolution of disputes. In addition, the system of records described in this notice maintains records on individuals who have asserted defenses to the repayment of their Federal student loans, also known as “borrower defenses,” pursuant to the Department's regulations at 34 CFR 685.206. These records are maintained to carry out the responsibilities of the Department to receive, review, evaluate, process, and render decisions on the eligibility of individuals for relief under the borrower defense regulations, which may include the discharge of a William D. Ford Federal Direct Loan (Direct Loan) Program loan and further relief as determined by the Secretary, as well as the initiation of appropriate proceedings to require schools whose acts or omissions resulted in successful defenses against repayment to pay the Department the amounts of the loans to which the defenses apply.

The CEMS consists of a variety of records that identify individuals' complaints, requests for assistance, or other inquiries. Records include, but are not limited to: Written documentation of an individual's complaint, request for assistance, or other comment or inquiry; and information pertaining to a student's or parent's student financial assistance program account(s) under title IV of the HEA, such as the individual's name, Social Security number, date of birth, address, telephone number(s), and FSA ID. Additionally, records may include the name, address, and phone numbers of school(s), lender(s), secondary holder(s) or lender(s), guaranty agency(ies), servicer(s), and private collection agency(ies), if applicable. The system of records also contains loan level information, and data submitted by individuals who have requested relief from Federal student loan repayment under the borrower defense to repayment regulations, as well as data that may be submitted by schools or other entities in connection with individuals' discharge requests.

The Department is modifying the section of the notice entitled “AUTHORITY FOR MAINTENANCE OF THE SYSTEM” to include 20 U.S.C. 1087e(h), which is the Department's authority to collect records on individuals who have requested relief under the borrower defense regulations.

The Department is modifying the section of the notice entitled “PURPOSE(S) OF THE SYSTEM” to include the duties and responsibilities of FSA to provide relief under the borrower defense regulations, including the receipt, review, evaluation, and processing of requests for relief under the borrower defense to repayment regulations, the rendering of decisions on the merits of such requests, and, where requests for borrower defense to repayment are successful, the determination of the relief that is appropriate to borrowers under the circumstances as well as the initiation of appropriate proceedings to require schools whose acts or omissions resulted in the successful defenses against repayment to pay the Department the amounts of the loans to which the defenses apply.

The Department is modifying the section of the notice entitled “CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM” to include individuals who request relief under borrower defense to repayment regulations from the Department.

The Department is modifying the section of the notice entitled “CATEGORIES OF RECORDS IN THE SYSTEM” to include individuals' requests for relief and related records under the borrower defense to repayment regulations and to indicate that records may contain other loan level data.

The Department is modifying the section of the notice entitled “RECORD SOURCE CATEGORIES” to include as record source categories third parties who provide data to the Department under the routine uses set forth below. The Department is also modifying this section to clarify that in addition to obtaining information from the individuals (e.g., borrowers), the Department also may obtain information from the individuals' counsel or representatives, or from students or their parents (if the individual is a borrower and depending on whether the individual is a parent or student). This Section also has been revised by adding that the Department may obtain information from accreditors in addition to the sources previously listed, which were Federal agencies, State agencies, schools, lenders, private collection agencies, and guaranty agencies.

The Department is making several modifications to routine use (1) entitled “Program Disclosure.” First, the Department is including requests for relief under the borrower defense regulations as one of the types of requests for which the Department may disclose records and clarifying that the Department may disclose records where a request for borrower defense to repayment is successful in order to determine the relief that is appropriate under the circumstances as well as to initiate the appropriate proceeding to require the school whose acts or omissions resulted in the successful defense against repayment to pay the Department the amount of the loan to which the defense applies. Disclosing records where a request for borrower defense to repayment is successful in order to determine the relief that is appropriate under the circumstances was previously authorized by “routine uses” published in the “Common Services for Borrowers (CSB)” system of records notice, see 81 FR 60,683-60,691 (Sep. 2, 2016), and the Department is making this more explicit now. Second, the Department is revising this routine use to permit the Department to make disclosures when further information “is relevant” to, rather than “is necessary to,” the Department's resolution of the complaint, request, or other inquiry. Third, the Department is adding accreditors.

The Department is removing former routine use (2) entitled “Disclosure for Use by Other Law Enforcement Agencies” because the Department no longer intends to disclose any records under this routine use.

The Department is modifying routine use (3) entitled “Litigation and Alternative Dispute Resolution (ADR) Disclosure” to insert the word “person” in place of the word “individual” to avoid any confusion to the public because we did not intend the word “individual” to have the meaning of this term as defined in the Privacy Act.

The Department is also modifying routine use (5) entitled “Contract Disclosure” to remove the reference to “Privacy Act safeguards as required under 5 U.S.C. 552a(m)” to now require that all contractors agree to maintain safeguards to protect the security and confidentiality of the records in the system. The Department also has clarified that such safeguards will be agreed to as part of the contract, rather than before the contract is entered into.

The Department is removing former routine use (7) entitled “Research Disclosure.” Consistent with our commitment to protect personal data, we do not anticipate releasing student, borrower, or applicant-level data for purposes other than program administration.

The Department is modifying routine use (7) entitled “Borrower Complaint Disclosure” to include “processing” and “reviewing” of a complaint as a course through which the Department may disclose a record to better align with the language of routine use (8) entitled “Borrower Defense to Repayment Disclosure”.

The Department is adding routine use (8) entitled “Borrower Defense to Repayment Disclosure” to clarify that disclosure of a record from this system of records is allowed in the course of reviewing, processing, investigating, fact-finding, or adjudicating a request for relief under the borrower defense regulations or in the course of the Department's enforcement activity to: Federal agencies, the student (if the student is not the borrower), the counsel or representative of the borrower or the student, or the school whose conduct is subject of the request for relief or the school's counsel or representative; a witness; or a designated fact-finder, mediator, or other person designated to resolve issues or decide the matter. The disclosure may only be made during the course of the review, processing, investigation, fact-finding, or adjudication of the request for relief.

Pursuant to the requirements in Office of Management and Budget Memorandum M-17-12 entitled “Preparing for and Responding to a Breach of Personally Identifiable Information,” the Department is also adding an additional routine use (11) in order to permit the Department to disclose records from this system of records in the course of assisting another Federal agency or entity in responding to a breach of data. Lastly, the Department is modifying routine use (10) (previously routine use (11)) so that the routine use conforms with the requirements set forth in OMB Memorandum M-17-12 entitled “Preparing for and Responding to a Breach of Personally Identifiable Information.”

The Department is updating the section entitled “POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS” to explain that the applicable Department records schedule is being amended, pending approval by the National Archives and Records Administration (NARA).

The sections entitled “RECORD ACCESS PROCEDURES,” “CONTESTING RECORD PROCEDURES,” and “NOTIFICATION PROCEDURES” are modified to define the “necessary particulars” needed to access, contest, or be notified of a record.

The Department has also added a section entitled “HISTORY.”

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., Braille, large print, audiotape, or compact disc) on request to the person listed under FOR FURTHER INFORMATION CONTACT.

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

For the reasons discussed in the preamble, the Acting Chief Operating Officer of Federal Student Aid (FSA) of the U.S. Department of Education (Department) publishes a notice of a modified system of records to read as follows:

DOE posted on its website an RFI to solicit feedback from industry, academia, research laboratories, government agencies, and other stakeholders on critical barriers to deployment of hydrogen infrastructure. The goal of the RFI is to identify these barriers and potential courses-of-action to address them to reduce deployment time and cost in implementing hydrogen technologies and to support the implementation of large-scale applications. Deployment of hydrogen station regulatory compliance costs and time for regulatory processing have been shown to be substantial. Courses-of-action may include areas such as: Identifying gaps in existing regulations, codes and standards; streamlining regulatory, permitting, and certification processes; reducing unneeded compliance actions; or consolidating regulatory requirements. The RFI [DE-FOA-0001948] is available at: https://eere-exchange.energy.gov/.

Because information received in response to this RFI may be used to structure future programs, funding and/or otherwise be made available to the public, respondents are strongly advised to not include any information in their responses that might be considered business sensitive, proprietary, or otherwise confidential. If, however, a respondent chooses to submit business sensitive, proprietary, or otherwise confidential information, it must be clearly and conspicuously marked as such in the response as detailed in the RFI [DE-FOA-0001948] at: https://eere-exchange.energy.gov/.

This information collection request contains: (1) OMB No. 1910-4100 (Renewal); (2) Information Collection Request Title: Procurement Information Collection; (3) Type of Request: Renewal; (4) Purpose: Under 48 CFR part 952 and Subpart 970.52, DOE must collect certain types of information from those seeking to do business with the Department or those awarded contracts by the Department. This information collection is necessary for the solicitation, award, administration, and closeout of DOE procurement contracts. (5) Annual Estimated Number of Respondents: 7,387; (6) Annual Estimated Total Burden Hours: 666,082; (7) Annual Estimated Reporting and Recordkeeping Cost Burden: $56,616,970.

This information collection request contains:

(1) OMB No.: 1905-0186;

(2) Information Collection Request Title: Generic Clearance for Questionnaire Testing, Evaluation, and Research;

(3) Type of Request: Renewal;

(4) Purpose: The U.S. Energy Information Administration (EIA) is requesting a three-year approval from the Office of Management and Budget (OMB) to utilize qualitative and quantitative methodologies to pretest questionnaires and validate the quality of the data that is collected on EIA and DOE survey forms. Through the use of these methodologies, EIA will conduct research studies to improve the quality of energy data being collected, reduce or minimize survey respondent burden, and increase agency efficiency. This authority would also allow EIA to improve data collection in order to meet the needs of EIA's customers while also staying current in the evolving nature of the energy industry.

The specific methods proposed for the coverage by this clearance are described below. Also outlined is the legal authority for these voluntary information gathering activities.

The following methods are proposed:

Pilot Surveys. Pilot surveys conducted under this clearance will generally be methodological studies, and will always employ statistically representative samples. The pilot surveys will replicate all components of the methodological design, sampling procedures (where possible), and questionnaires of the full scale survey. Pilot surveys will normally be utilized when EIA undertakes a complete redesign of a particular data collection methodology or when EIA undertakes data collection in new energy areas, such as HGL production, alternative fueled motor vehicles, and other emerging areas of the energy sector where data collection would provide utility to EIA.

Cognitive Interviews. Cognitive interviews are typically one-on-one interviews in which the respondent is usually asked to “think aloud” or is asked “retrospective questions” as he or she answers questions, reads survey materials, defines terminology, or completes other activities as part of a typical survey process. A number of different techniques may be involved including, asking respondents what specific words or phrases mean or asking respondents probing questions to determine how they estimate, calculate, or determine specific data elements on a survey. The objectives of these cognitive interviews are to identify problems of ambiguity or misunderstanding, examine the process that respondents follow for reporting information, assess survey respondents' ability to report new information, or identify other difficulties respondents have answering survey questions in order to reduce measurement error from estimates based on a survey.

Respondent Debriefings. Respondent debriefings conducted under this clearance will generally be methodological or cognitive research studies. The debriefing form is administered after a respondent completes a questionnaire either in paper format, electronically, or through in-person interviews. The debriefings contain probing questions to determine how respondents interpret the survey questions, how much time and effort was spent completing the questionnaire, and whether they have problems in completing the survey/questionnaire. Respondent debriefings also are useful in determining potential issues with data quality and in estimating respondent burden.

Usability Testing. Usability tests are similar to cognitive interviews in which a respondent is typically asked to “think aloud” or asked “retrospective questions” as he or she reviews an electronic questionnaire, website, visual aid, or hard copy survey form. The objective of usability testing is to check that respondents can easily and intuitively navigate electronic survey collection programs, websites, and other survey instruments to submit their data to EIA.

Focus Groups. Focus groups, in person or online, involve group sessions guided by a moderator who follows a topic guide containing questions or subjects focused on a particular issue rather than adhering to a standardized cognitive interview protocol. Focus groups are useful for exploring issues concerning the design of a form and the meaning of terms from a specific group of respondents, data users, or other stakeholders of EIA data.

(5) Annual Estimated Number of Respondents: 1,870;

(6) Annual Estimated Number of Total Responses: 1,870;

(7) Annual Estimated Number of Burden Hours: 1,915;

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: There are no additional costs associated with these survey methods other than the burden hours. The information is maintained in the normal course of business. The annual cost in burden hours to the respondents is estimated to be $144,946 (1,915 burden hours times $75.69 per hour), which represents a reduction of 85 burden hours from the prior renewal of this collection. Therefore, other than the cost of burden hours, EIA estimates that there are no additional costs for generating, maintaining, and providing the information.

Comments are invited on whether or not: (a) The proposed collection of information is necessary for the proper performance of agency functions, including whether the information will have a practical utility; (b) EIA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used, is accurate; (c) EIA can improve the quality, utility, and clarity of the information it will collect; and (d) EIA can minimize the burden of the collection of information on respondents, such as automated collection techniques or other forms of information technology.

Statutory Authority: Section 13(b) of the Federal Energy Administration Act of 1974, Pub. L. 93-275, codified as 15 U.S.C. 772(b) and the DOE Organization Act of 1977, Pub. L. 95-91, codified at 42 U.S.C. 7101 et seq.

The United States acquired the Olmsted Powerplant in 1990 through condemnation proceedings in order to secure the water rights associated with the Olmsted Powerplant deemed essential to the Central Utah Project (CUP). The CUP is a participating project of the Colorado River Storage Project. As part of the condemnation proceedings, PacifiCorp continued Olmsted operations until 2015; after that time, the operation of the facility became the responsibility of the Bureau of Reclamation.

The existing Olmsted Powerplant greatly exceeded its operational life, and a replacement facility was needed for the generation of power and preservation of associated non-consumptive water rights. On February 4, 2015, the Implementation Agreement (Agreement) for Olmsted was signed by Central Utah Water Conservancy District (District); the Department of the Interior, Bureau of Reclamation; and WAPA (Participants). The Agreement sets forth the responsibilities of the Participants and identifies funding of Olmsted. The District will construct, operate, maintain, and replace the Olmsted Powerplant and incidental facilities in connection with its CUP operations, including power generation.

WAPA is responsible for marketing the Olmsted energy, which is anticipated to be available in the late summer of 2018. Power production will be incidental to the delivery of water and will only be available when water is present. Therefore, only energy, without capacity, will be available for marketing. It is expected that the annual energy production from Olmsted will average around 27,000,000 kWh per year. The Final 2018 Olmsted Power Marketing Plan and Call for Applications was published on October 11, 2017 (82 FR 47201), and set forth that an application for an allocation of energy from Olmsted was due by December 11, 2017.

Pursuant to the Final Power Marketing Criteria, allocations of energy from Olmsted were made based on a percentage of annual generation rather than fixed quantities of energy. Olmsted is a “take all, pay all” project; the annual revenue requirement does not depend on the amount of energy available each year. Customers with an allocation will receive a share of the energy and will annually pay a proportional share of the operation, maintenance, and replacement (OM&R) expenses in 12 monthly installments.

Applications were received from four entities representing a total of 14 eligible applicants. In considering the Power Marketing Criteria, priority was given to the District due to its role in the construction, operation, maintenance, and replacement of Olmsted. The District will receive 30 percent of Olmsted's annual generation.

Olmsted will be electrically interconnected to Provo City's (Provo) distribution and transmission facilities. Provo is a participant of the Utah Municipal Power Agency (UMPA), a joint-action agency responsible for supplying the wholesale power needs to Provo and other municipal electric utilities in the area. UMPA, a long-term power customer of WAPA, has agreed to accept all Olmsted energy as it is generated and, under a scheduling and displacement agreement with WAPA, provide Olmsted customers with their respective Olmsted allocation amounts from a portion of UMPA's allocation of Salt Lake City Area Integrated Projects (SLCA/IP) resources, which is also marketed by WAPA. This arrangement will allow the Olmsted recipients more flexibility as it will be easier to schedule this SLCA/IP resource, which is essentially exchanged for Olmsted generation, and it allows the use of existing scheduling and transmission wheeling arrangements. In consideration for providing these arrangements, UMPA will receive a 30 percent allocation of Olmsted generation.

After consideration of the allocations to the District and UMPA, WAPA determined it would use the remaining Olmsted energy to increase the allocations of those applicants that have the lowest percentages of their current loads served by Federal power. Four of the applicants receive less than 10 percent of their energy resources from Federal power. All of the other applicants currently receive over 20 percent of their energy requirements from Federal allocations. Therefore, WAPA awarded 10 percent of the Olmsted generation to the four applicants receiving less than 10 percent of their energy from Federal sources. The following table shows the proposed allocation percentages of the annual energy production of Olmsted:

WAPA will respond to the comments received regarding the Olmsted Proposed Allocation of Energy and publish its final allocations after the public comment period ends. If any adjustments or corrections are necessary in a recipient's percentage allocation, the allocations of all other recipients may change. WAPA plans to enter into contracts with customers after publication of the Final Allocation of Power Federal Register notice.

Documents developed or retained by WAPA during this public process will be available, by appointment, for inspection and copying at the CRSP Management Center, 299 South Main Street, Suite 200, Salt Lake City, Utah. Any comments received during the 30-day comment period will be posted to WAPA's website at the following address: https://www.wapa.gov/regions/CRSP/PowerMarketing/Pages/power-marketing.aspx.

In compliance with the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321-4347), the Council on Environmental Quality Regulations (40 CFR parts 1500-1508), and DOE NEPA Regulations (10 CFR part 1021), WAPA issued a Finding of No Significant Impact (FONSI) on January 13, 2017. The FONSI and other NEPA compliance documentation may be found at https://www.wapa.gov/regions/CRSP/environment/Pages/environment.aspx.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601, et seq., requires a Federal agency to perform a regulatory flexibility analysis whenever the agency is required by law to publish a general notice of proposed rulemaking for any proposed rule unless the agency can certify that the rule will not have a significant economic impact on a substantial number of small entities. In defining the term “rule,” the RFA specifies that a “rule” does not include “a rule of particular applicability relating to rates [and] services . . . or to valuations, costs or accounting, or practices relating to such rates [and] services . . . .” 5 U.S.C. 601. WAPA has determined that this action relates to rates or services offered by WAPA and, therefore, is not a rule within the purview of the RFA.

WAPA has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this Federal Register notice by the Office of Management and Budget is required.

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

Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: Appropriate Government surveillance of contractor performance is required to give reasonable assurance that efficient methods and effective cost controls are being used for various cost-reimbursable and fixed-rate contracts. Per 48 CFR 1552.211 regulations, on a monthly basis the Agency requires contractors to provide the Contracting Officer's Representative (COR) with a report detailing: (a) What was accomplished on the contract for that period, (b) expenditures for the same period of time, and (c) what is expected to be accomplished on the contract for the next month. Responses to the information collection are mandatory for contractors and are required for the contractors to receive monthly payments.

Form Numbers: EPA Form 1900-68.

Respondents/Affected Entities: Private sector.

Respondent's Obligation to Respond: Mandatory per 48 CFR 1552.211.

Estimated Number of Respondents: 337 (total).

Frequency of Response: Monthly.

Total Estimated Burden: 97,056 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total Estimated Cost: $9,074,736 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in Estimates: There is an increase of 19,650 hours (97,056−77,406) in the total estimated respondent burden compared with the ICR currently approved by OMB because there are approximately 337 contracts and orders requiring response in 2018 instead of only 266 in 2014. This figure has increased to 337 due in part to shorter-value and shorter-length contracts being awarded due to budget uncertainty; e.g., continuing funding resolutions, sequestration budget cuts.

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

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

National Notifiable Diseases Surveillance System—Revision—Center for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC).

The Public Health Services Act (42 U.S.C. 241) authorizes CDC to disseminate nationally notifiable condition information. The National Notifiable Diseases Surveillance System (NNDSS) is based on data collected at the state, territorial and local levels as a result of legislation and regulations in those jurisdictions that require health care providers, medical laboratories, and other entities to submit health-related data on reportable conditions to public health departments. These reportable conditions, which include infectious and non-infectious diseases, vary by jurisdiction depending upon each jurisdiction's health priorities and needs. Each year, the Council of State and Territorial Disease Epidemiologists (CSTE), supported by CDC, determines which reportable conditions should be designated nationally notifiable or under standardized surveillance.

CDC requests a three-year approval for a Revision for the NNDSS, OMB Control No. 0920-0728, Expiration Date 02/28/2021. This Revision includes requests for approval to: (1) Receive case notification data for Salmonella enterica serotype Paratyphi (S. Paratyphi) A, B, or C Infections should they become nationally notifiable or be placed under standardized surveillance; (2) receive case notification data for Carbapenemase-Producing Carbapenem-Resistant Enterobacteriaceae (CP-CRE) which is now nationally notifiable; (3) receive case notification data for Candida auris (C. auris) which is now under standardized surveillance; and (4) receive disease-specific data elements for CP-CRE.

The NNDSS currently facilitates the submission and aggregation of case notification data voluntarily submitted to CDC from 60 jurisdictions: Public health departments in every U.S. state, New York City, Washington DC, 5 U.S. territories (American Samoa, the Commonwealth of Northern Mariana Islands, Guam, Puerto Rico, and the U.S. Virgin Islands), and 3 freely associated states (Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau). This information is shared across jurisdictional boundaries and both surveillance and prevention and control activities are coordinated at regional and national levels.

Approximately 90% of case notifications are encrypted and submitted to NNDSS electronically from already existing databases by automated electronic messages. When automated transmission is not possible, case notifications are faxed, emailed, uploaded to a secure network or entered into a secure website. All case notifications that are faxed, emailed, and uploaded are done so in the form of an aggregate weekly or annual report, not individual cases. These different mechanisms used to send case notifications to CDC vary by the jurisdiction and the disease or condition. Private personally identifiable information (PII) is collected from automated electronic messages and information can be retrieved by PII. In addition, some combinations of submitted data elements could potentially be used to identify individuals. Private information is not be disclosed unless otherwise compelled by law. All data are treated in a secure manner consistent with the technical, administrative, and operational controls required by the Federal Information Security Management Act of 2002 (FISMA) and the 2010 National Institute of Standards and Technology (NIST) Recommended Security Controls for Federal Information Systems and Organizations. Weekly tables of nationally notifiable diseases are available through CDC WONDER and data.cdc.gov. Annual summaries of finalized nationally notifiable disease data are published on CDC WONDER and data.cdc.gov and disease-specific data are published by individual CDC programs.

The burden estimates include the number of hours that the public health department uses to process and send case notification data from their jurisdiction to CDC. Specifically, the burden estimates include separate burden hours incurred for automated and non-automated transmissions, separate weekly burden hours incurred for modernizing surveillance systems as part of NNDSS Modernization Initiative (NMI) implementation, separate burden hours incurred for annual data reconciliation and submission, and separate one-time burden hours incurred for the addition of new diseases and data elements. The burden estimates also include the one-time burden for reporting jurisdictions for the addition of case notification data for CP-CRE and C. auris and disease-specific data elements for CP-CRE. The estimated annual burden for the 233 respondents is 18,619 hours. The cost of the information collection is $787,846. The total burden hours increased from 18,529 to 18,619 since the last revision because of the addition of diseases and disease-specific data elements.

I. Background

FDA is announcing the availability of a guidance for industry entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers.” This guidance provides information for firms about how FDA evaluates their medical product communications (that fall within the scope of FDA's regulatory authority) that present information that is not contained in the FDA-required labeling 1 for the product but that may be consistent with the FDA-required labeling for the product.

FDA determines whether a medical product is safe and effective for use under the conditions prescribed, recommended, or suggested in the proposed labeling submitted with the product's marketing application or submission (and for devices, also during the classification process). In making this determination, FDA evaluates whether the conditions of use in the proposed labeling are supported by the required levels and types of evidence of safety and effectiveness and whether the benefits of using the product under those specific conditions of use outweigh the risks of the product. After FDA approves, clears, or licenses a medical product, the FDA-required labeling sets forth the conditions of use under which the product has been shown to meet the relevant standard for marketing, and it provides directions and information on how to use the product safely and effectively under those conditions.

Medical product firms have told FDA that they are interested in communicating, including in their promotional materials, data and information about the approved/cleared/licensed uses of their products that are not contained in their products' FDA-required labeling. We are aware that firms have questions about how FDA determines whether such communications are consistent with the FDA-required labeling.

The guidance describes FDA's thinking when examining the consistency of a firm's product communications with that product's own FDA-required labeling. As explained in the guidance, if a firm communicates information that is not contained in its product's FDA-required labeling but that is determined to be consistent with the FDA-required labeling, FDA does not intend to rely on that communication to establish a new intended use, different from the use(s) for which the product is legally marketed. Establishing a product's intended uses is an element in establishing certain violations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Public Health Service Act. However, firms' communications about their products that are consistent with the products' FDA-required labeling but that are false or misleading may subject a firm to enforcement action under the FD&C Act. Thus, the guidance not only describes FDA's thinking on communications that are consistent with the FDA-required labeling, but also provides general recommendations intended to aid firms in complying with requirements in the FD&C Act and FDA's implementing regulations for conveying information that is consistent with the FDA-required labeling in a truthful and non-misleading way. The general recommendations provided in the guidance for conveying information in a truthful and non-misleading way are applicable only to drug and device labeling and prescription drug and restricted device advertising that are consistent with the FDA-required labeling. Communication of information that is not consistent with the FDA-required labeling is outside the scope of these recommendations.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on firms' communications for their medical products that may be consistent with the FDA-required labeling. 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.

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

Title: Recommended Content of Medical Product Communications That Are Consistent With the FDA-Required Labeling; OMB Control No. 0910—NEW.

The guidance includes third-party disclosure recommendations regarding information that firms should include in communications that contain information not found in the FDA-required labeling for their medical products but that are consistent with the FDA-required labeling (as explained in the guidance) if they choose to publicly disseminate such materials. The guidance recommends that various aspects of study design and methodology for studies relied on in such communications be disclosed to provide material contextual information (e.g., type of study, study objectives, product dosage/use regimens, control(s) used, patient population studied), and that material limitations related to the study design, methodology, and results also be disclosed in a clear and prominent manner to help ensure that the communications are not false or misleading. Additionally, the guidance recommends that firms accurately characterize and contextualize the relevant information about the product, including by disclosing unfavorable or inconsistent findings. Finally, the guidance recommends that firms disclose material contextual information from the FDA-required labeling in these communications, such as data and information from studies in the FDA-required labeling that are relevant to the data or information presented in the communication (e.g., if a communication provides post-market information about the types and rates of occurrence of adverse events that have been observed in practice, the communication should also include information from the FDA-required labeling about the types and rates of occurrence of adverse reactions observed in clinical trials to provide context).

In the Federal Register of January 19, 2017 (82 FR 6575), we published a notice announcing the availability of the draft guidance document and included an analysis under the PRA of the information collection burden associated with our recommendations. No comments were received in response to the four information collection topics solicited in the notice.

According to FDA data, approximately 162,000 FDA-regulated promotional materials are prepared by approximately 500 firms annually. Of these materials, we estimate approximately 5 percent contain unique presentations of information consistent with FDA-required labeling, as described in the guidance, submitted by approximately 64 percent (or 324) of the firms. Anticipating that the number of these FDA-regulated promotional materials will soon increase to 6 percent, we estimate the 324 firms will prepare and disseminate annually 9,720 FDA-regulated promotional materials that contain unique presentations of information that is consistent with the FDA-required labeling, as described in the guidance, and that therefore are recommended to include the proposed third party disclosures. Based on our experience reviewing FDA-regulated promotional materials for medical products, we estimate it will take respondents approximately 4 hours per unique presentation to prepare and incorporate the disclosures recommended in the guidance, if they choose to disseminate this information.

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

FDA is issuing this final guidance subject to OMB approval of the collection of information. Before implementing the information collection provisions of the guidance, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the collection of information, including OMB control number(s) for newly approved collections.

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov.

I. Background

FDA is announcing the availability of a guidance for industry and review staff entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers.” This guidance provides answers to common questions regarding firms' communications of HCEI about their approved prescription drugs to payors. The guidance also provides answers to common questions regarding firms' communications of HCEI about their approved or cleared medical devices to payors. In addition, the guidance addresses common questions relating to firms' dissemination to payors of information about medical products 1 that are not yet approved or cleared for any use and about unapproved uses of approved/cleared medical products. For purposes of this guidance, the term “payors” collectively refers to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis that are responsible for making product selection or acquisition, formulary management, and/or coverage and reimbursement decisions on a population basis regarding drugs and/or devices on behalf of health care organizations, which may include entities such as integrated health care delivery networks, hospitals, and hospital systems.

FDA is aware that payors seek a range of information on effectiveness, safety, and cost-effectiveness of approved/cleared medical products, including information from firms, to help support their medical product selection, formulary management, and/or coverage and reimbursement decisions on a population basis. This information may differ from and may be in addition to the information FDA reviews in order to make drug and device approval or clearance decisions. Because coverage and reimbursement decisions by payors impact many patients, FDA believes it is critical that HCEI provided by firms to payors about their approved drugs and approved/cleared devices be truthful and non-misleading.

With respect to HCEI regarding approved drugs, section 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352(a)), as amended by section 114 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and section 3037 of the 21st Century Cures Act (Pub. L. 114-255), includes a provision regarding communication of HCEI about such drugs to payors. Section 502(a) of the FD&C Act indicates that HCEI provided to payors carrying out their responsibilities for the selection of drugs for coverage or reimbursement shall not be considered to be false or misleading if the HCEI relates to an FDA-approved indication for the drug, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the FDA-approved labeling for the drug. Section III.A of this guidance provides FDA's current thinking on key concepts in section 502(a) of the FD&C Act and recommendations for how firms can communicate HCEI about approved drugs to payors in accordance with this section to help ensure that payors have information needed to make informed drug selection, formulary management, and/or coverage and reimbursement decisions and to help ensure that the information is not false or misleading. Section III.A also discusses how FDA's requirements for submission of promotional materials apply to HCEI about approved drugs disseminated by firms to payors. If a firm disseminates HCEI about an approved drug in accordance with this guidance, FDA does not intend to consider such information false or misleading. In addition, FDA does not intend to use HCEI about approved drugs disseminated consistent with this guidance as evidence of a new intended use.

When FDA published a notice announcing the availability of the draft guidance document in the Federal Register of January 19, 2017 (82 FR 6568), the Agency specifically requested comments from interested parties on the extent to which the principles provided in section III.A of the draft guidance could be applicable to communications of HCEI about approved/cleared devices (82 FR 6568 at 6571). We also stated that, to the extent that interested parties believe that different considerations should apply to medical devices or that guidance is needed on additional issues with respect to medical device firms' communications of HCEI about approved/cleared medical devices to payors, FDA is interested in input on those topics as well (Id.). FDA received 23 comments on the draft guidance; 3 comments expressed support for applying the recommendations in section III.A of the guidance to medical devices and no comments opposed applying these recommendations to medical devices. In response to this feedback, section III.B of the guidance provides FDA's recommendations for how firms can communicate HCEI about approved or cleared devices to payors to help ensure that device firms' communication of HCEI to payors is not false or misleading. These recommendations generally follow the recommendations in section III.A of the guidance. If a device firm disseminates HCEI about an approved or cleared device in accordance with this guidance, FDA does not intend to consider such information false or misleading. In addition, FDA does not intend to use HCEI about approved or cleared devices disseminated consistent with this guidance as evidence of a new intended use.

FDA also recognizes that due in part to their need, in some situations, to plan for and make coverage and reimbursement decisions far in advance of the effective date of such decisions, payors are also interested in receiving information from drug and device firms about medical products that are not yet approved or cleared by FDA for any use, and about unapproved uses of approved/cleared medical products. Section III.C of the guidance discusses FDA's thinking with respect to communication by firms to payors of information about unapproved products 2 and about unapproved uses of approved/cleared medical products. The draft guidance provided similar recommendations, but the relevant section only addressed communications related to unapproved products. As noted above, FDA received 23 comments on the draft guidance; 17 of these comments requested that the Agency also provide recommendations for firms' communications to payors of information about unapproved uses of approved/cleared medical products. No comments opposed providing recommendations on this topic. In response to these comments, section III.C of this guidance provides FDA's recommendations on firms' dissemination to payors of information about both unapproved products and about unapproved uses of approved/cleared medical products. As with firms' communications to payors of HCEI about approved prescription drugs and approved or cleared devices, it is essential that information provided by firms about their unapproved products and about unapproved uses of their approved/cleared medical products be truthful and non-misleading. Therefore, section III.C also lays out a series of recommendations to help achieve these goals.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on drug and device manufacturer communications with payors, formulary committees, and similar entities. 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.

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

Title: Recommendations for Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities; OMB Control No. 0910—NEW.

The information collection supports Agency guidance and includes Third-Party Disclosure recommendations regarding information that firms should include in HCEI for prescription drugs if they choose to disseminate such materials (“HCEI materials”) to payors, in accordance with section 502(a) of the FD&C Act. Specifically, FDA recommends that various aspects of study design and methodology of an economic analysis (i.e., type of analysis, modeling technique, patient population, perspective/viewpoint, treatment comparator, time horizon, outcome measures, cost estimates, and assumptions); factors that limit generalizability of an economic analysis; limitations to an economic analysis; and sensitivity analyses, if applicable, be included in HCEI materials disseminated to payors to allow for informed decision-making.

Furthermore, FDA recommends that firms include other information when disseminating HCEI materials, as applicable, to provide a balanced and complete presentation. Such information includes a statement of the FDA-approved indication of the drug and a copy of the most current FDA-approved labeling. Under section 502(a) of the FD&C Act, firms must also include a conspicuous and prominent statement to describe any material differences between the HCEI and the FDA-approved labeling. HCEI materials should also disclose whether certain studies or data sources were omitted from an economic analysis and how the omission of those studies or data sources may alter the conclusions presented in the analysis. Moreover, FDA recommends that HCEI materials disclose important risk information associated with the approved use of the drug, and pursuant to section 502(a) of the FD&C Act, must disclose any additional risk information related to assumptions that vary from the approved labeling. Finally, HCEI materials should disclose potential financial or affiliation biases to the extent reasonably known by firms at the time of dissemination.

The guidance provides similar recommendations for HCEI materials disseminated to payors about approved or cleared devices.

If firms choose to make communications to payors about unapproved products or unapproved uses of approved/cleared products, FDA recommends that firms include a clear statement with their communications that the product or use is not approved/cleared and that the safety or effectiveness of the product or use has not been established. In addition, FDA recommends providing information related to the stage of product development (e.g., the status of any study(ies) in which a product/new use is being investigated and how it relates to the overall product development plan; whether a marketing application for the product or new use has been submitted to FDA or when such a submission is planned). FDA also recommends that communications that include factual presentations of results from studies also describe material aspects of study design and methodology and disclose material limitations related to the study design, methodology, and results. Moreover, FDA recommends that firms provide followup information to payors if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status.

Description of Respondents: For information that should be included when HCEI about approved prescription drugs is disseminated to payors, respondents to this collection of information are firms that manufacture prescription human drugs products, including biological products; for information that should be included when HCEI about approved or cleared medical devices is disseminated to payors, respondents to this collection of information are firms that manufacture medical devices; for information that should be included in communications with payors about unapproved products and about unapproved uses of approved/cleared products, respondents to this collection of information are firms that manufacture prescription human drug products, including biological products, and medical devices.

As noted, in the Federal Register of January 19, 2017, we published a notice announcing the availability of the draft guidance document and included an analysis under the PRA of the information collection burden associated with recommendations found in the draft guidance. Although no comments were received in response to the four information collection topics solicited in the notice, we revised the guidance as discussed above. These revisions resulted in a significant increase to the number of respondents to the information collection and also recommended new data elements. However, because our estimate reflects the average burden of the information collection distributed among all respondents, we believe any increase resulting from revisions to the guidance would be nominal.

Based on the post-marketing submissions of promotional materials using Form FDA 2253 received in calendar year 2016 for approved human prescription drugs, including prescription biological products, FDA estimates that approximately 440 manufacturers will disseminate 4,400 distinct HCEI materials for approved human prescription drugs annually. FDA estimates that approximately 236 manufacturers will disseminate 2,360 distinct HCEI materials for approved/cleared devices annually. FDA estimates it will take firms approximately 20 hours to compile and draft the information that this final guidance recommends should be included when disseminating HCEI materials for approved human prescription drugs and approved/cleared devices. Based on the number of human prescription drugs and devices approved/cleared and the number of efficacy supplements approved/cleared (i.e., approving/clearing a new use for an approved/cleared product) in a calendar year, FDA estimates that approximately 717 manufacturers will prepare 1,434 distinct communications of information to payors about their unapproved products or unapproved uses of approved/cleared products annually. FDA estimates it will take firms approximately 0.5 hour to compile and draft the information that this final guidance recommends should be provided with communications to payors about unapproved products or unapproved uses of approved/cleared products. Additionally, FDA estimates that 50 percent of the firms will spend approximately 2 hours to compile and provide 718 distinct communications of followup information regarding previously communicated information to payors about their unapproved products or unapproved uses of approved/cleared products annually. We therefore estimate the burden of the information collection as follows:

This guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 314.81(b)(3)(i) (Form FDA 2253) have been approved under OMB control number 0910-0001.

FDA is issuing this final guidance subject to OMB approval of the collections of information. Before implementing the information collection provisions of the guidance, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the collections of information, including OMB control number(s) for newly approved collections.

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

I. Background

In December 2016, the Cures Act (Pub. L. 114-255) was signed into law. Section 3038(c) of the Cures Act mandated that FDA publish in the Federal Register a list identifying types of combination products and manufacturing processes for which “good manufacturing processes” may be adopted that vary from the requirements set forth in § 4.4 (21 CFR 4.4) or that FDA proposes can satisfy the requirements in § 4.4 through “alternative or streamlined mechanisms,” and to review this list periodically. In accordance with this statutory mandate, FDA is publishing a proposed list in section II of this document, which addresses processes for single-entity and co-packaged combination products that can satisfy requirements in § 4.4 through alternative or streamlined mechanisms (hereafter “mechanisms”).

On January 22, 2013, FDA issued a final rule on CGMP requirements for combination products (see 78 FR 4307 and part 4 (21 CFR part 4, subpart A)). Prior to issuance of the final rule, although CGMP regulations were in place to establish requirements for drugs, devices, biological products, and human cells, tissues, or cellular or tissue-based products (HCT/Ps), there were no regulations to clarify and explain the application of these CGMP requirements to combination products. The final rule clarified which CGMP requirements apply to combination products. It also established a transparent and streamlined regulatory framework for combination product manufacturers to use when demonstrating compliance with applicable CGMP requirements.

A combination product is a product composed of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product). The drugs, devices, and biological products included in combination products are referred to as “constituent parts” of the combination product. Combination products include “single-entity” combination products that are physically, chemically, or otherwise combined or mixed and produced as a single entity (§ 3.2(e)(1) (21 CFR 3.2(e)(1)) (e.g., prefilled syringes and drug-eluting stents) and “co-packaged” combination products where two or more separate products are packaged together in a single package or as a unit and composed of drug and device products, device and biological products, or biological and drug products (§ 3.2(e)(2)) (e.g., a surgical or first-aid kit).1 Section 4.4 outlines how manufacturers of single-entity and co-packaged combination products (hereafter “CP manufacturers”) can demonstrate compliance with applicable CGMP requirements, including through implementation of a streamlined approach to meet the requirements of both the drug CGMP and the device Quality System (QS) regulation by designing and implementing a CGMP operating system that demonstrates compliance with either of the following:

• The drug CGMP regulations in parts 210 and 211 (21 CFR parts 210 and 211) and the following specified provisions from the device QS regulation (§ 4.4(b)(1), “drug CGMP-based streamlined approach”): (1) § 820.20 (21 CFR 820.20) Management responsibility, (2) § 820.30 (21 CFR 820.30) Design controls, (3) § 820.50 (21 CFR 820.50) Purchasing controls, (4) § 820.100 (21 CFR 820.100) Corrective and preventive action, (5) § 820.170 (21 CFR 820.170) Installation, and (6) § 820.200 (21 CFR 820.200) Servicing; or

• The device QS regulation in part 820 (21 CFR part 820) and the following specified provisions from the drug CGMP regulations (§ 4.4(b)(2), “device QS regulation-based streamlined approach”): (1) § 211.84 (21 CFR 211.84) Testing and approval or rejection of components, drug product containers, and closures; (2) § 211.103 (21 CFR 211.103) Calculation of yield; (3) § 211.132 (21 CFR 211.132) Tamper-evident packaging requirements for over-the-counter (OTC) human drug products; (4) § 211.137 (21 CFR 211.137) Expiration dating; (5) § 211.165 (21 CFR 211.165) Testing and release for distribution; (6) § 211.166 (21 CFR 211.166) Stability testing; (7) § 211.167 (21 CFR 211.167) Special testing requirements; and (8) § 211.170 (21 CFR 211.170) Reserve samples.

If the combination product includes a biological product constituent part, the CGMP operating system must also demonstrate compliance with applicable CGMP requirements for biological products in parts 600 through 680 (21 CFR parts 600 through 680), and if the combination product includes an HCT/P, the CGMP operating system must also demonstrate compliance with the applicable current good tissue practice requirements in part 1271 (21 CFR part 1271).

Following publication of the final rule, FDA reviewed data and rationales provided by manufacturers who proposed various means of addressing CGMP considerations for combination products. FDA also considered feedback on its draft guidance on CGMP requirements for combination products, published in January 2015, in which stakeholders requested further guidance on circumstances in which flexible approaches may be available and how to engage with FDA on them. The final “Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products” includes discussion of existing mechanisms to comply with the final rule and of circumstances in which FDA did not intend to object to manufacturers applying practices that vary from the requirements set forth in the rule (Ref. 1). The Agency continues to apply a risk-based approach to evaluating methods for ensuring the quality of combination products and to welcome proposals from manufacturers for how to enhance the efficiency of development and manufacturing activities, while ensuring the safety and effectiveness of the combination products produced.

The following is a proposed list of mechanisms for demonstrating compliance with relevant combination product CGMP requirements, as described below. Where applicable, reference is made to sections of the “Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products” for additional information (Ref. 1). FDA will continue to evaluate this list in light of Agency experience and stakeholder input. Manufacturers are welcome to propose other approaches not described, and FDA continues to encourage dialogue with the Agency on various means of demonstrating CGMP compliance for combination products.

For each mechanism described below, CP manufacturers should consider what documentation would be sufficient to support that the mechanism, including the specific approach for implementing it, assures appropriate control of the manufacture of the combination product to ensure safety and effectiveness of the product. Appropriate evidence and an explanation of the rationale to support the approach should be accessible at the manufacturing facility for review during facility inspections. For additional discussion on how to interact with FDA regarding the mechanisms described below, see section III.

FDA interprets the mechanisms identified in the sections below as a means to demonstrate compliance with the specified part 211 requirements identified in § 4.4:

Use of product samples that are not finished combination products (but that are representative of the finished combination product with respect to the characteristics and attributes being tested) when performing testing required by § 211.165 to determine whether the drug constituent part meets final specifications. To meet the requirements of § 211.165, the CP manufacturer would need to establish, including where appropriate through bridging studies and other quantitative means, that any differences in the manufacturing process for the representative samples as compared to the finished combination product do not affect the drug constituent part. For example, as part of product release testing, drug-eluting lead manufacturers could perform release testing for identity, potency, or other quality attributes on a representative lead tip assembly that contains the drug constituent part, but does not contain the full electronic and mechanical assembly, so long as they can establish that the differences in the manufacturing process do not impact the drug constituent part and the sample is representative of the finished combination product with respect to the quality attributes being tested.

(See also Section IV.B.5 of Reference 1 for additional information on testing and release for combination products.)

Use of bracketing and matrixing approaches to stability studies for combination products. Principles for bracketing and matrixing approaches to meet the requirements of § 211.166 have already been addressed by the Agency with regard to drug products (Ref. 2), and such principles can also be applied to combination products. For example, when assessing stability for a prefilled syringe that is marketed in various fill volumes, one of the approaches that a CP manufacturer could utilize, if appropriate, is bracketing based on the smallest and the largest fill volume of product configurations. In determining the extremes for a bracketing approach and/or when justifying the use of a matrix design for single-entity combination products, it is important that the drug-device interactions and variations in the manufacturing processes are considered. For co-packaged combination products, such approaches can be applied to the drug constituent part of the product.

Leveraging stability data for an already marketed combination product. Such mechanisms can be considered when the new combination product is a modification of an already marketed product and the modification does not impact the stability of the drug constituent part. For example, when developing new lengths of a drug-coated catheter product for which the catheter materials, drug coating, manufacturing process, and packaging configurations are largely unchanged from existing marketed sizes, the CP manufacturer would generally be able to leverage existing stability data to establish initial product shelf life or to support reduced stability data requirements, so long as characteristics of the product that could impact stability (materials, packaging configuration, etc.) remain the same. However, if the device constituent part of a drug-coated catheter includes a new material that is in contact with the drug coating, for example, new stability studies would generally be needed under § 211.166.

(See also Section IV.B.6 of Reference 1 for additional information on stability requirements for combination products.)

Defining “batch” based on the drug constituent part rather than the finished combination product for purposes of special testing requirements for pyrogens and endotoxins. For example, a manufacturer of a combination product that has a sub-assembly coated with a drug, which is then incorporated into several “batches” or “lots” of the overall combination product, may be able to define a batch for purposes of pyrogen and endotoxin testing as a batch of that sub-assembly for purposes of meeting the requirements of § 211.167. As with the other mechanisms described in this list, this mechanism would only potentially be available if there would be no impact on the drug constituent part from subsequent manufacturing processes, including when the constituent parts are combined to produce the final combination product. CP manufacturers should consider whether such risks may be introduced later in the production process (after the batch has been defined). This approach will most frequently apply for co-packaged combination products or single-entity combination products for which only a component or sub-assembly of the overall product is in contact with the drug constituent part.

(See also Section IV.B.7 of Reference 1 for additional information on special testing requirements for combination products.)

Keeping reserve samples that are representative of the finished combination product. CP manufacturers may use validated surrogates as representative samples to meet the requirements of § 211.170, provided the surrogate is appropriate, both in terms of the manufacturing process and the characteristics of the container closure. For example, maintaining only a sub-assembly of a coated single-entity combination product or only the drug constituent part of a co-packaged combination product as a reserve sample would generally be permissible under the regulation when: (1) All manufacturing process steps after the coating step or the fill for the drug constituent part are shown not to affect the drug constituent part, (2) the immediate container closure has essentially the same characteristics as that for the drug constituent part as packaged in the combination product for distribution, and (3) the representative samples are suitable for all required testing of the drug constituent part for which the reserve samples are being kept.

Using samples from representative lots of a larger batch for retention of reserve samples. To meet the requirements of § 211.170, CP manufacturers may be able to use bracketing and matrixing approaches to retain reserve samples from certain lots to adequately represent the broadly defined batch of the combination product. For example, CP manufacturers might be able to retain reserve samples of appropriately varied sizes of a drug-coated combination product from within a broadly defined batch that includes multiple lots of different sizes.

(See also Section IV.B.8 of Reference 1 for additional information on reserve sample requirements for combination products.)

FDA interprets the mechanisms identified in the sections below as a means to demonstrate compliance with the specified part 820 requirements identified in § 4.4:

Using existing pharmaceutical development practices and documentation that align with the design control principles and requirements of § 820.30. Robust pharmaceutical development practices would address many design control requirements to assure compliance with § 820.30, where applicable. CP manufacturers need to demonstrate how development processes and terminology align with design control principles and requirements in § 820.30, when required, including, where necessary, developing additional design control elements. When evaluating the adequacy of existing pharmaceutical development processes, particular attention should be given to postmarket management of design changes to the combination product and the alignment of change control practices with the principles and requirements of § 820.30, as applicable.

Exemption of the combination product from all or certain provisions of the device QS regulation (part 820) if the device constituent part of the combination product is itself exempt from such requirements and use of the device constituent part falls within the scope of the relevant exemption, including with respect to the device constituent part's intended use. Some devices are exempt from all or certain provisions of the device QS regulation (see, for example, liquid medication dispensers such as cups and droppers that fall within the scope of § 880.6430 (21 CFR 880.6430), provided the use of the device is not a new intended use or does not otherwise raise different safety and effectiveness questions (see, for example, limitations to the exemption under 21 CFR 880.9). Consistent with this, for the combination product to be exempt from the associated provisions of the device QS regulation, we interpret this exemption to mean that the use of the device in the combination product must not be a new intended use or otherwise raise different safety and effectiveness questions for the device. This circumstance will most frequently apply to co-packaged combination products. For example, an oral dosing syringe (a liquid medication dispenser under § 880.6430) that is co-packaged with a drug may be exempt from certain provisions of the device QS regulation (and hence the combination product may also be exempt from such provisions); however, incorporation of such a dispenser into a primary container closure system or co-packaging of such a dispenser with an emergency-use product, for example, may constitute a new intended use for the dispenser or raise different safety and effectiveness questions for the dispenser, such that the relevant exemption would not apply.

(See also Section III.C.3 of Reference 1 for additional information on the exemption from provisions of the device QS regulation for combination products.)

In some cases, CP manufacturers may interact with FDA to gain approval or otherwise notify FDA of a manufacturing change. In other cases, although a submission or notification is not required, CP manufacturers may want to discuss potential use of CGMP mechanisms with FDA. CP manufacturers are encouraged to interact early with FDA on contemplated CGMP mechanisms.

• Pre-Submissions and Meeting Requests. CP manufacturers who want to obtain FDA feedback prior to submitting a premarket application or a postmarket supplement or who otherwise want to obtain feedback on their approach may interact with FDA via the existing established process applicable to the lead Center 3 for the combination product. For combination products reviewed under a new drug application (NDA) or a biologics license application (BLA), such interactions will generally be through Type C meetings (Ref. 3).4 For combination products reviewed under an abbreviated new drug application (ANDA), these interactions will generally be through pre-ANDA meetings (Ref. 4).5 For combination products reviewed under a device premarket submission (e.g., a premarket approval application (PMA), de novo classification, or premarket notification (510(k)), these interactions will generally be via the pre-submission process (Ref. 5).

Regardless of the type of submission, such interactions should be focused on a general discussion of the mechanism and CGMP approach the CP manufacturer wishes to pursue and associated justification to support the approach. Only representative data is typically appropriate in these interactions; complete data should be included in the subsequent premarket submission or postmarket supplement, if required, and/or be maintained at the manufacturing facility, as appropriate.6

• Premarket Review. CP manufacturers should include in their original submission for NDAs, BLAs, ANDAs, and PMAs information on any mechanisms for complying with CGMP requirements. For PMAs, this information should be included in the manufacturing section of the PMA. For information regarding where to place information in NDAs, BLAs, or ANDAs, refer to “eCTD Technical Conformance Guide” (Ref. 6).

• Postmarket Supplements or Notifications to FDA. Postmarket changes to implement a combination product CGMP mechanism for NDAs, ANDAs, BLAs, and PMAs, may require submission of a supplement or notification to FDA.7 CP manufacturers should consult related guidances relevant to the type of constituent part of the combination product (Refs. 7 to 9).8 If a CP manufacturer has questions on the appropriate submission type or the need for a submission, they can contact the lead Center for assistance.