Direct Grant Programs and Definitions That Apply to Department Regulations, 63062-63066 [2014-24929]

Download as PDF 63062 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Proposed Rules Issued in Washington, DC, on October 10, 2014. John Barbagallo, Deputy Director, FAA Flight Standards Service. Dated: October 16, 2014. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2014–25060 Filed 10–21–14; 8:45 am] BILLING CODE 4164–01–P [FR Doc. 2014–25089 Filed 10–21–14; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF EDUCATION DEPARTMENT OF HEALTH AND HUMAN SERVICES 34 CFR Parts 75 and 77 Food and Drug Administration [Docket ID ED–2014–OII–0116] 21 CFR Part 73 Direct Grant Programs and Definitions That Apply to Department Regulations [Docket No. FDA–2014–C–1552] AGENCY: RIN 1855–AA10 Colorcon, Inc.; Filing of Color Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules. SUMMARY: The color additive petition was filed on September 22, 2014. DATES: FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740– 3835, 240–402–1075. Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 4C0300), submitted by Colorcon, Inc., 275 Ruth Rd., Harleysville, PA 19438. The petition proposes to amend the color additive regulations in 21 CFR part 73 Listing of Color Additives Exempt From Certification to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules. We have determined under 21 CFR 25.32(r) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. tkelley on DSK3SPTVN1PROD with PROPOSALS SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:12 Oct 21, 2014 Jkt 235001 Office of Innovation and Improvement, Department of Education. ACTION: Notice of proposed rulemaking. On August 13, 2013, the Department of Education (the Department) published a notice of final regulations in the Federal Register to amend our Education Department General Administrative Regulations (EDGAR). In this document, the Department proposes to further amend EDGAR to add a definition of ‘‘What Works Clearinghouse Evidence Standards’’ (WWC Evidence Standards) in our regulations to standardize references to this term. In addition, the Department proposes to amend the definition of ‘‘large sample’’ in our regulation. We also propose technical edits to our regulations to improve the consistency and clarity of the regulations. Finally, we propose to redesignate our regulations and to include in that redesignated section an additional provision that would allow the Secretary to give special consideration to projects supported by evidence of promise. DATES: We must receive your comments on or before December 8, 2014. ADDRESSES: Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments. • Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under ‘‘Are you new to the site?’’ SUMMARY: PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 • Postal Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments about these proposed regulations, address them to Alli Moss, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W319, Washington, DC 20202. Privacy Note: The Department’s policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available. FOR FURTHER INFORMATION CONTACT: Allison Moss, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W319, Washington, DC 20202. Telephone: (202) 205–7726 or by email: allison.moss@ed.gov. If you use a telecommunications device for the deaf (TDD) or text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1–800–877– 8339. SUPPLEMENTARY INFORMATION: The Department published a notice of final regulations in the Federal Register (78 FR 49338) on August 13, 2013 to amend EDGAR. In this document, we propose further amendments to EDGAR to standardize a term and make other amendments to improve the consistency and clarity of these regulations. Invitation to Comment: We invite you to submit comments regarding these proposed regulations. To ensure that your comments have maximum effect in developing the final regulations, we urge you to identify clearly the specific section or sections of the proposed regulations that each of your comments addresses and to arrange your comments in the same order as the proposed regulations. We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from these proposed regulations. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the Department’s programs and activities. During and after the comment period, you may inspect all public comments about these proposed regulations by accessing Regulations.gov. You may also inspect the comments in person in Room 4W335, 400 Maryland Avenue SW., Washington, DC, between 8:30 a.m. and 4:00 p.m., Washington, DC E:\FR\FM\22OCP1.SGM 22OCP1 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Proposed Rules time, Monday through Friday of each week except Federal holidays. Please contact the person listed under FOR FURTHER INFORMATION CONTACT. Assistance to Individuals with Disabilities in Reviewing the Rulemaking Record: On request we will provide an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for these proposed regulations. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT. tkelley on DSK3SPTVN1PROD with PROPOSALS Background References to the WWC Handbook The Department proposes to add a definition of ‘‘What Works Clearinghouse Evidence Standards’’ to 34 CFR part 77. This definition would incorporate the most recent version of the What Works Clearinghouse (WWC) Procedures and Standards Handbook (WWC Handbook), Version 3.0, which was made public in March 2014. Instead of continuing to separately cite the WWC Handbook in various provisions of parts 75 and 77, we propose to add, to part 77, a single definition of the WWC Evidence Standards that incorporates the current version of the WWC Handbook, and then to use that defined term, as applicable, throughout parts 75 and 77. The WWC Handbook, first published in 2008, documents the systematic review process and the standards by which the WWC reviews studies. Version 3.0 of the WWC Handbook significantly expands the examples used to illustrate how the WWC Evidence Standards are applied in various contexts. Although previous versions of the WWC Handbook focused on only one WWC product—the intervention report—Version 3.0 includes information on several additional WWC products, including practice guides, single-study reviews, and quick reviews. By adding a definition of ‘‘WWC Evidence Standards’’ and updating the applicable references throughout 34 CFR parts 75 and 77 to incorporate the most recent version of the WWC Handbook, the Department will provide more effective guidance to applicants and grantees as they design and implement rigorous evaluations of their projects. Because Version 3.0 of the WWC Handbook provides further clarification, and does not introduce new requirements, on evaluation- and evidence-related concepts, updating the VerDate Sep<11>2014 17:12 Oct 21, 2014 Jkt 235001 citations does not substantively change the regulations in 34 CFR parts 75 or 77. Special Consideration for Discretionary Grant Applications Demonstrating ‘‘Evidence of Promise’’ Section 75.266 currently provides that the Secretary may give special consideration, through establishing a separate competition or awarding competitive preference, to discretionary grant applications supported by strong evidence of effectiveness or moderate evidence of effectiveness. In our experience using evidence in discretionary grant competitions, we think it may be beneficial to also include in 34 CFR 75.266 (which we propose to redesignate as 34 CFR 75.226) a provision for giving special consideration to applications supported by evidence of promise, which is a less rigorous standard, because evidence of effectiveness in the education field continues to develop. By including evidence of promise in newly redesignated 34 CFR 75.226, we would allow more flexibility to discretionary grant programs oriented towards supporting evidence-based projects. Definition of ‘‘Large Sample’’ The Department proposes to modify the definition of ‘‘large sample’’ in 34 CFR part 77.1 to remove the requirement that analysis units be randomly assigned to treatment or control groups. In implementing our discretionary grant programs, we discovered a discrepancy between the existing definition, specifically its references to random assignment of students, teachers, classrooms, schools, or other single analysis units to treatment or control groups, and the definition of ‘‘moderate evidence of effectiveness’’ in 34 CFR 77.1. Under the definition of ‘‘moderate evidence of effectiveness,’’ a quasi-experimental design study (as defined in 34 CFR 77.1) that includes a large sample could meet the standard, but many such studies do not randomly assign units of analysis to treatment or control groups. We propose to revise the definition of ‘‘large sample’’ to eliminate the random assignment of analysis units into treatment or control groups as a mandatory element. Therefore, for instance, a quasi-experimental design study with a sample of 350 or more students (or other single analysis units), or 50 or more groups (such as classrooms or schools) that contains 10 or more students, could meet the definition of ‘‘moderate evidence of effectiveness’’ in 34 CFR 77.1. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 63063 Significant Proposed Regulations We group major issues according to subject, with appropriate sections of the proposed regulations referenced in parentheses. We discuss other substantive issues under the sections of the proposed regulations to which they pertain. Generally, we do not address proposed regulatory changes that are technical or otherwise minor in effect. I. WWC Evidence Standards (34 CFR Parts 75 and 77) Current Regulations: The current regulations include multiple references to the WWC Evidence Standards, in each case accompanied by a footnote citing the WWC Handbook, throughout 34 CFR parts 75 and 77, as follows: 1. Factors (viii) and (ix) of the selection criterion ‘‘Quality of the project evaluation’’ in 34 CFR 75.210(h); and 2. Definitions in 34 CFR 77.1(c) of ‘‘evidence of promise,’’ ‘‘moderate evidence of effectiveness,’’ ‘‘quasiexperimental design study,’’ ‘‘randomized controlled trial,’’ and ‘‘strong evidence of effectiveness.’’ Proposed Regulations: In each provision of 34 CFR parts 75 and 77 that references the WWC Evidence Standards, we propose to update the reference to use a common term, and to define that term in part 77 with reference to Version 3.0 of the WWC Handbook. Reasons: By updating all references to WWC Evidence Standards in 34 CFR parts 75 and 77, and adding a common definition that references Version 3.0 of the WWC Handbook, we would: (1) Help ensure that applicants and grantees are aware of the most accurate and appropriate resources that are available relating to the WWC Evidence Standards; (2) no longer need the multiple footnotes that reference the current version of the WWC Handbook; and (3) streamline the process for updating our regulations to reflect future versions of the WWC Handbook. II. Special Consideration of Applications Supported by ‘‘Evidence of Promise’’ and Clarification of That Definition (34 CFR 77.1(c)) Current Regulations: Under 34 CFR 75.266, the Secretary may give special consideration to applications supported by strong or moderate evidence of effectiveness, by establishing a separate competition or awarding competitive preference. In 34 CFR 77.1(c), the definition of ‘‘evidence of promise’’ references ‘‘quasi-experimental study’’ instead of ‘‘quasi-experimental design E:\FR\FM\22OCP1.SGM 22OCP1 63064 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Proposed Rules study,’’ a term defined later in the section. Proposed Regulations: We propose to amend 34 CFR 75.266 to provide that the Secretary may give special consideration to applications supported by evidence of promise, and to redesignate that section as 34 CFR 75.226. We also propose to amend the definition of ‘‘evidence of promise’’ to replace the reference to ‘‘quasiexperimental study’’ with ‘‘quasiexperimental design study,’’ to clarify that the term used in the definition of ‘‘evidence of promise’’ is ‘‘quasiexperimental design study,’’ which is defined in 34 CFR 77.1(c). We also propose to change the paragraph designations in this definition for consistency. Reasons: We propose these changes in order to provide greater flexibility to discretionary grant programs that reward evidence-based projects in their competitions, to correct the definition of ‘‘evidence of promise,’’ and to provide applicants and grantees consistent and clear information when referencing that definition. We propose to redesignate 34 CFR 75.266 as 34 CFR 75.226 so that the section will be included under the subheading ‘‘Selection Procedures’’ in subpart D of part 75 instead of under the subheading ‘‘Miscellaneous.’’ tkelley on DSK3SPTVN1PROD with PROPOSALS III. Definition of ‘‘Large Sample’’ (34 CFR 77.1(c)) Current Regulations: In 34 CFR 77.1(c), the definition of ‘‘large sample’’ currently refers to students, classrooms, schools, groups, or other single analysis units that ‘‘were randomly assigned to a treatment or control group.’’ Proposed Regulations: We propose to remove the reference to random assignment to treatment or control groups in the definition of ‘‘large sample.’’ Reasons: We propose this change to eliminate inconsistencies between the definition of ‘‘large sample’’ and the definition of ‘‘moderate evidence of effectiveness.’’ We do not believe that random assignment to a treatment or control group is necessary because the concept of random assignment is embedded within the definition of randomized controlled trial (as defined in 34 CFR 77.1(c)). In order for the ‘‘large sample’’ definition to align fully with the ‘‘moderate evidence of effectiveness’’ definition, the ‘‘large sample’’ definition must not require that units of analysis be randomly assigned into treatment or control groups. VerDate Sep<11>2014 17:12 Oct 21, 2014 Jkt 235001 Executive Orders 12866 and 13563 Regulatory Impact Analysis Under Executive Order 12866, the Secretary must determine whether this regulatory action is ‘‘significant’’ and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a ‘‘significant regulatory action’’ as an action likely to result in a rule that may— (1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an ‘‘economically significant’’ rule); (2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles stated in the Executive order. This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866. We have also reviewed these regulations under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency— (1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify); (2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations; (3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 (5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices. Executive Order 13563 also requires an agency ‘‘to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.’’ The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include ‘‘identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.’’ We are issuing these proposed regulations only on a reasoned determination that their benefits would justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that these proposed regulations are consistent with the principles in Executive Order 13563. We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions. In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs associated with this regulatory action are those resulting from statutory requirements and those we have determined to be necessary for administering the Department’s programs and activities. Clarity of the Regulations Executive Order 12866 and the Presidential memorandum ‘‘Plain Language in Government Writing’’ require each agency to write regulations that are easy to understand. The Secretary invites comments on how to make these proposed regulations easier to understand, including answers to questions such as the following: • Are the requirements in the proposed regulations clearly stated? • Do the proposed regulations contain technical terms or other wording that interferes with their clarity? • Does the format of the proposed regulations (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce their clarity? • Would the proposed regulations be easier to understand if we divided them into more (but shorter) sections? (A E:\FR\FM\22OCP1.SGM 22OCP1 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Proposed Rules ‘‘section’’ is preceded by the symbol ‘‘§ ’’ and a numbered heading; for example, § 77.1 Definitions that apply to Department regulations.) • Could the description of the proposed regulations in the SUPPLEMENTARY INFORMATION section of this preamble be more helpful in making the proposed regulations easier to understand? If so, how? • What else could we do to make the proposed regulations easier to understand? To send any comments that concern how the Department could make these proposed regulations easier to understand, see the instructions in the ADDRESSES section. Regulatory Flexibility Act Certification The Secretary certifies that these proposed regulations would not have a significant economic impact on a substantial number of small entities because the proposed regulations primarily clarify and update regulations previously published in the Federal Register. Paperwork Reduction Act of 1995 These proposed regulations do not contain any changes to the Department’s current information collection requirements. Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/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 Adobe 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. (Catalog of Federal Domestic Assistance Number does not apply.) List of Subjects 34 CFR Part 75 Accounting, Copyright, Education, Grant programs-education, Inventions and patents, Private schools, Reporting and recordkeeping requirements. 34 CFR Part 77 Education, Grant programs-education. Intergovernmental Review These proposed regulations affect direct grant programs of the Department that are subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance. This document provides early notification of our specific plans and actions for these programs. tkelley on DSK3SPTVN1PROD with PROPOSALS In accordance with section 411 of the General Education Provisions Act, 20 U.S.C. 1221e–4, the Secretary particularly requests comments on whether these proposed regulations would require transmission of information that any other agency or authority of the United States gathers or makes available. 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. 17:12 Oct 21, 2014 Jkt 235001 For the reasons discussed in the preamble, the Secretary proposes to amend parts 75 and 77 of title 34 of the Code of Federal Regulations as follows: PART 75—DIRECT GRANT PROGRAMS 1. The authority citation for part 75 continues to read as follows: ■ Authority: 20 U.S.C. 1221e–3 and 3474, unless otherwise noted. 2. Section 75.210 is amended by revising paragraphs (h)(2)(viii) and (ix) to read as follows. ■ Assessment of Educational Impact VerDate Sep<11>2014 Dated: October 15, 2014. Arne Duncan, Secretary of Education. § 75.210 General selection criteria. * * * * * (h) * * * (2) * * * (viii) The extent to which the methods of evaluation will, if well-implemented, produce evidence about the project’s effectiveness that would meet the What Works Clearinghouse Evidence Standards without reservations. * * * (ix) The extent to which the methods of evaluation will, if well-implemented, produce evidence about the project’s PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 63065 effectiveness that would meet the What Works Clearinghouse Evidence Standards with reservations. * * * * * ■ 3. Section 75.266 is redesignated as § 75.226 and the newly redesignated section is revised to read as follows: § 75.226 What procedures does the Secretary use if the Secretary decides to give special consideration to applications supported by strong evidence of effectiveness, moderate evidence of effectiveness, or evidence of promise? (a) As used in this section, ‘‘strong evidence of effectiveness’’ is defined in 34 CFR 77.1(c); (b) As used in this section, ‘‘moderate evidence of effectiveness’’ is defined in 34 CFR 77.1(c); (c) As used in this section, ‘‘evidence of promise’’ is defined in 34 CFR 77.1(c); and (d) If the Secretary determines that special consideration of applications supported by strong evidence of effectiveness, moderate evidence of effectiveness, or evidence of promise is appropriate, the Secretary may establish a separate competition under the procedures in 34 CFR 75.105(c)(3), or provide competitive preference under the procedures in 34 CFR 75.105(c)(2), for applications supported by: (1) Evidence of effectiveness that meets the conditions set out in paragraph (a) of the definition of ‘‘strong evidence of effectiveness’’ in 34 CFR 77.1(c); (2) Evidence of effectiveness that meets the conditions set out in either paragraph (a) or (b) of the definition of ‘‘strong evidence of effectiveness’’ in 34 CFR 77.1(c); (3) Evidence of effectiveness that meets the conditions set out in the definition of ‘‘moderate evidence of effectiveness;’’ or (4) Evidence of effectiveness that meets the conditions set out in the definition of ‘‘evidence of promise.’’ (Authority: 20 U.S.C. 1221e–3 and 3474.) PART 77—DEFINITIONS THAT APPLY TO DEPARTMENT REGULATIONS 4. The authority citation for part 77 continues to read as follows: ■ Authority: 20 U.S.C. 1221e–3 and 3474, unless otherwise noted. 5. In § 77.1 paragraph(c) is amended by: ■ A. Revising the definitions of Evidence of promise, Large sample, Moderate evidence of effectiveness, Quasi-experimental design study, Randomized controlled trial, and Strong evidence of effectiveness. ■ E:\FR\FM\22OCP1.SGM 22OCP1 63066 Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Proposed Rules B. Adding, in alphabetical order, the definition of What Works Clearinghouse Evidence Standards. The revisions and addition read as follows: ■ § 77.1 Definitions that apply to all Department programs. tkelley on DSK3SPTVN1PROD with PROPOSALS * * * * * (c) * * * * * * * * Evidence of promise means there is empirical evidence to support the theoretical linkage(s) between at least one critical component and at least one relevant outcome presented in the logic model for the proposed process, product, strategy, or practice. Specifically, evidence of promise means the conditions in paragraphs (a) and (b) of this section are met: (a) There is at least one study that is a— (1) Correlational study with statistical controls for selection bias; (2) Quasi-experimental design study that meets the What Works Clearinghouse Evidence Standards with reservations; or (3) Randomized controlled trial that meets the What Works Clearinghouse Evidence Standards with or without reservations. (b) The study referenced in paragraph (a) found a statistically significant or substantively important (defined as a difference of 0.25 standard deviations or larger) favorable association between at least one critical component and one relevant outcome presented in the logic model for the proposed process, product, strategy, or practice. * * * * * Large sample means an analytic sample of 350 or more students (or other single analysis units), or 50 or more groups (such as classrooms or schools) that contain 10 or more students (or other single analysis units). * * * * * Moderate evidence of effectiveness means one of the following conditions is met: (a) There is at least one study of the effectiveness of the process, product, strategy, or practice being proposed that meets the What Works Clearinghouse Evidence Standards without reservations, found a statistically significant favorable impact on a relevant outcome (with no statistically significant and overriding unfavorable impacts on that outcome for relevant populations in the study or in other studies of the intervention reviewed by and reported on by the What Works Clearinghouse), and includes a sample that overlaps with the populations or VerDate Sep<11>2014 17:12 Oct 21, 2014 Jkt 235001 settings proposed to receive the process, product, strategy, or practice. (b) There is at least one study of the effectiveness of the process, product, strategy, or practice being proposed that meets the What Works Clearinghouse Evidence Standards with reservations, found a statistically significant favorable impact on a relevant outcome (with no statistically significant and overriding unfavorable impacts on that outcome for relevant populations in the study or in other studies of the intervention reviewed by and reported on by the What Works Clearinghouse), includes a sample that overlaps with the populations or settings proposed to receive the process, product, strategy, or practice, and includes a large sample and a multi-site sample. (Note: multiple studies can cumulatively meet the large and multi-site sample requirements as long as each study meets the other requirements in this paragraph.) * * * * * Quasi-experimental design study means a study using a design that attempts to approximate an experimental design by identifying a comparison group that is similar to the treatment group in important respects. These studies, depending on design and implementation, can meet What Works Clearinghouse Evidence Standards with reservations (but not What Works Clearinghouse Evidence Standards without reservations). * * * * * Randomized controlled trial means a study that employs random assignment of, for example, students, teachers, classrooms, schools, or districts to receive the intervention being evaluated (the treatment group) or not to receive the intervention (the control group). The estimated effectiveness of the intervention is the difference between the average outcomes for the treatment group and for the control group. These studies, depending on design and implementation, can meet What Works Clearinghouse Evidence Standards without reservations. * * * * * Strong evidence of effectiveness means one of the following conditions is met: (a) There is at least one study of the effectiveness of the process, product, strategy, or practice being proposed that meets the What Works Clearinghouse Evidence Standards without reservations, found a statistically significant favorable impact on a relevant outcome (with no statistically significant and overriding unfavorable impacts on that outcome for relevant populations in the study or in other PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 studies of the intervention reviewed by and reported on by the What Works Clearinghouse), includes a sample that overlaps with the populations and settings proposed to receive the process, product, strategy, or practice, and includes a large sample and a multi-site sample. (Note: multiple studies can cumulatively meet the large and multisite sample requirements as long as each study meets the other requirements in this paragraph.) (b) There are at least two studies of the effectiveness of the process, product, strategy, or practice being proposed, each of which: Meets the What Works Clearinghouse Evidence Standards with reservations, found a statistically significant favorable impact on a relevant outcome (with no statistically significant and overriding unfavorable impacts on that outcome for relevant populations in the studies or in other studies of the intervention reviewed by and reported on by the What Works Clearinghouse), includes a sample that overlaps with the populations and settings proposed to receive the process, product, strategy, or practice, and includes a large sample and a multi-site sample. * * * * * What Works Clearinghouse Evidence Standards means the standards set forth in the What Works Clearinghouse Procedures and Standards Handbook (Version 3.0, March 2014), which can be found at the following link: https:// ies.ed.gov/ncee/wwc/ DocumentSum.aspx?sid=19. * * * * * [FR Doc. 2014–24929 Filed 10–21–14; 8:45 am] BILLING CODE 4000–01–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 222 [Docket No. 140829733–4733–01] RIN 0648–BE35 2015 Annual Determination To Implement the Sea Turtle Observer Requirement National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Proposed rule. AGENCY: The National Marine Fisheries Service (NMFS) publishes a proposed Annual Determination (AD) for 2015, pursuant to its authority under SUMMARY: E:\FR\FM\22OCP1.SGM 22OCP1

Agencies

[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Proposed Rules]
[Pages 63062-63066]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24929]


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DEPARTMENT OF EDUCATION

34 CFR Parts 75 and 77

RIN 1855-AA10
[Docket ID ED-2014-OII-0116]


Direct Grant Programs and Definitions That Apply to Department 
Regulations

AGENCY: Office of Innovation and Improvement, Department of Education.

ACTION: Notice of proposed rulemaking.

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SUMMARY: On August 13, 2013, the Department of Education (the 
Department) published a notice of final regulations in the Federal 
Register to amend our Education Department General Administrative 
Regulations (EDGAR).
    In this document, the Department proposes to further amend EDGAR to 
add a definition of ``What Works Clearinghouse Evidence Standards'' 
(WWC Evidence Standards) in our regulations to standardize references 
to this term. In addition, the Department proposes to amend the 
definition of ``large sample'' in our regulation. We also propose 
technical edits to our regulations to improve the consistency and 
clarity of the regulations. Finally, we propose to redesignate our 
regulations and to include in that redesignated section an additional 
provision that would allow the Secretary to give special consideration 
to projects supported by evidence of promise.

DATES: We must receive your comments on or before December 8, 2014.

ADDRESSES: Submit your comments through the Federal eRulemaking Portal 
or via postal mail, commercial delivery, or hand delivery. We will not 
accept comments submitted by fax or by email or those submitted after 
the comment period. To ensure that we do not receive duplicate copies, 
please submit your comments only once. In addition, please include the 
Docket ID at the top of your comments.
     Federal eRulemaking Portal: Go to www.regulations.gov to 
submit your comments electronically. Information on using 
Regulations.gov, including instructions for accessing agency documents, 
submitting comments, and viewing the docket, is available on the site 
under ``Are you new to the site?''
     Postal Mail, Commercial Delivery, or Hand Delivery: If you 
mail or deliver your comments about these proposed regulations, address 
them to Alli Moss, U.S. Department of Education, 400 Maryland Avenue 
SW., Room 4W319, Washington, DC 20202.
    Privacy Note: The Department's policy is to make all comments 
received from members of the public available for public viewing in 
their entirety on the Federal eRulemaking Portal at 
www.regulations.gov. Therefore, commenters should be careful to include 
in their comments only information that they wish to make publicly 
available.

FOR FURTHER INFORMATION CONTACT:  Allison Moss, U.S. Department of 
Education, 400 Maryland Avenue SW., Room 4W319, Washington, DC 20202. 
Telephone: (202) 205-7726 or by email: allison.moss@ed.gov.
    If you use a telecommunications device for the deaf (TDD) or text 
telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-
800-877-8339.

SUPPLEMENTARY INFORMATION: The Department published a notice of final 
regulations in the Federal Register (78 FR 49338) on August 13, 2013 to 
amend EDGAR. In this document, we propose further amendments to EDGAR 
to standardize a term and make other amendments to improve the 
consistency and clarity of these regulations.
    Invitation to Comment: We invite you to submit comments regarding 
these proposed regulations. To ensure that your comments have maximum 
effect in developing the final regulations, we urge you to identify 
clearly the specific section or sections of the proposed regulations 
that each of your comments addresses and to arrange your comments in 
the same order as the proposed regulations.
    We invite you to assist us in complying with the specific 
requirements of Executive Orders 12866 and 13563 and their overall 
requirement of reducing regulatory burden that might result from these 
proposed regulations. Please let us know of any further ways we could 
reduce potential costs or increase potential benefits while preserving 
the effective and efficient administration of the Department's programs 
and activities.
    During and after the comment period, you may inspect all public 
comments about these proposed regulations by accessing Regulations.gov. 
You may also inspect the comments in person in Room 4W335, 400 Maryland 
Avenue SW., Washington, DC, between 8:30 a.m. and 4:00 p.m., 
Washington, DC

[[Page 63063]]

time, Monday through Friday of each week except Federal holidays. 
Please contact the person listed under FOR FURTHER INFORMATION CONTACT.
    Assistance to Individuals with Disabilities in Reviewing the 
Rulemaking Record: On request we will provide an appropriate 
accommodation or auxiliary aid to an individual with a disability who 
needs assistance to review the comments or other documents in the 
public rulemaking record for these proposed regulations. If you want to 
schedule an appointment for this type of accommodation or auxiliary 
aid, please contact the person listed under FOR FURTHER INFORMATION 
CONTACT.

Background

References to the WWC Handbook

    The Department proposes to add a definition of ``What Works 
Clearinghouse Evidence Standards'' to 34 CFR part 77. This definition 
would incorporate the most recent version of the What Works 
Clearinghouse (WWC) Procedures and Standards Handbook (WWC Handbook), 
Version 3.0, which was made public in March 2014. Instead of continuing 
to separately cite the WWC Handbook in various provisions of parts 75 
and 77, we propose to add, to part 77, a single definition of the WWC 
Evidence Standards that incorporates the current version of the WWC 
Handbook, and then to use that defined term, as applicable, throughout 
parts 75 and 77.
    The WWC Handbook, first published in 2008, documents the systematic 
review process and the standards by which the WWC reviews studies. 
Version 3.0 of the WWC Handbook significantly expands the examples used 
to illustrate how the WWC Evidence Standards are applied in various 
contexts. Although previous versions of the WWC Handbook focused on 
only one WWC product--the intervention report--Version 3.0 includes 
information on several additional WWC products, including practice 
guides, single-study reviews, and quick reviews.
    By adding a definition of ``WWC Evidence Standards'' and updating 
the applicable references throughout 34 CFR parts 75 and 77 to 
incorporate the most recent version of the WWC Handbook, the Department 
will provide more effective guidance to applicants and grantees as they 
design and implement rigorous evaluations of their projects. Because 
Version 3.0 of the WWC Handbook provides further clarification, and 
does not introduce new requirements, on evaluation- and evidence-
related concepts, updating the citations does not substantively change 
the regulations in 34 CFR parts 75 or 77.

Special Consideration for Discretionary Grant Applications 
Demonstrating ``Evidence of Promise''

    Section 75.266 currently provides that the Secretary may give 
special consideration, through establishing a separate competition or 
awarding competitive preference, to discretionary grant applications 
supported by strong evidence of effectiveness or moderate evidence of 
effectiveness. In our experience using evidence in discretionary grant 
competitions, we think it may be beneficial to also include in 34 CFR 
75.266 (which we propose to redesignate as 34 CFR 75.226) a provision 
for giving special consideration to applications supported by evidence 
of promise, which is a less rigorous standard, because evidence of 
effectiveness in the education field continues to develop. By including 
evidence of promise in newly redesignated 34 CFR 75.226, we would allow 
more flexibility to discretionary grant programs oriented towards 
supporting evidence-based projects.

Definition of ``Large Sample''

    The Department proposes to modify the definition of ``large 
sample'' in 34 CFR part 77.1 to remove the requirement that analysis 
units be randomly assigned to treatment or control groups. In 
implementing our discretionary grant programs, we discovered a 
discrepancy between the existing definition, specifically its 
references to random assignment of students, teachers, classrooms, 
schools, or other single analysis units to treatment or control groups, 
and the definition of ``moderate evidence of effectiveness'' in 34 CFR 
77.1. Under the definition of ``moderate evidence of effectiveness,'' a 
quasi-experimental design study (as defined in 34 CFR 77.1) that 
includes a large sample could meet the standard, but many such studies 
do not randomly assign units of analysis to treatment or control 
groups. We propose to revise the definition of ``large sample'' to 
eliminate the random assignment of analysis units into treatment or 
control groups as a mandatory element. Therefore, for instance, a 
quasi-experimental design study with a sample of 350 or more students 
(or other single analysis units), or 50 or more groups (such as 
classrooms or schools) that contains 10 or more students, could meet 
the definition of ``moderate evidence of effectiveness'' in 34 CFR 
77.1.

Significant Proposed Regulations

    We group major issues according to subject, with appropriate 
sections of the proposed regulations referenced in parentheses. We 
discuss other substantive issues under the sections of the proposed 
regulations to which they pertain.
    Generally, we do not address proposed regulatory changes that are 
technical or otherwise minor in effect.

I. WWC Evidence Standards (34 CFR Parts 75 and 77)

    Current Regulations: The current regulations include multiple 
references to the WWC Evidence Standards, in each case accompanied by a 
footnote citing the WWC Handbook, throughout 34 CFR parts 75 and 77, as 
follows:
    1. Factors (viii) and (ix) of the selection criterion ``Quality of 
the project evaluation'' in 34 CFR 75.210(h); and
    2. Definitions in 34 CFR 77.1(c) of ``evidence of promise,'' 
``moderate evidence of effectiveness,'' ``quasi-experimental design 
study,'' ``randomized controlled trial,'' and ``strong evidence of 
effectiveness.''
    Proposed Regulations: In each provision of 34 CFR parts 75 and 77 
that references the WWC Evidence Standards, we propose to update the 
reference to use a common term, and to define that term in part 77 with 
reference to Version 3.0 of the WWC Handbook.
    Reasons: By updating all references to WWC Evidence Standards in 34 
CFR parts 75 and 77, and adding a common definition that references 
Version 3.0 of the WWC Handbook, we would: (1) Help ensure that 
applicants and grantees are aware of the most accurate and appropriate 
resources that are available relating to the WWC Evidence Standards; 
(2) no longer need the multiple footnotes that reference the current 
version of the WWC Handbook; and (3) streamline the process for 
updating our regulations to reflect future versions of the WWC 
Handbook.

II. Special Consideration of Applications Supported by ``Evidence of 
Promise'' and Clarification of That Definition (34 CFR 77.1(c))

    Current Regulations: Under 34 CFR 75.266, the Secretary may give 
special consideration to applications supported by strong or moderate 
evidence of effectiveness, by establishing a separate competition or 
awarding competitive preference. In 34 CFR 77.1(c), the definition of 
``evidence of promise'' references ``quasi-experimental study'' instead 
of ``quasi-experimental design

[[Page 63064]]

study,'' a term defined later in the section.
    Proposed Regulations: We propose to amend 34 CFR 75.266 to provide 
that the Secretary may give special consideration to applications 
supported by evidence of promise, and to redesignate that section as 34 
CFR 75.226. We also propose to amend the definition of ``evidence of 
promise'' to replace the reference to ``quasi-experimental study'' with 
``quasi-experimental design study,'' to clarify that the term used in 
the definition of ``evidence of promise'' is ``quasi-experimental 
design study,'' which is defined in 34 CFR 77.1(c). We also propose to 
change the paragraph designations in this definition for consistency.
    Reasons: We propose these changes in order to provide greater 
flexibility to discretionary grant programs that reward evidence-based 
projects in their competitions, to correct the definition of ``evidence 
of promise,'' and to provide applicants and grantees consistent and 
clear information when referencing that definition. We propose to 
redesignate 34 CFR 75.266 as 34 CFR 75.226 so that the section will be 
included under the subheading ``Selection Procedures'' in subpart D of 
part 75 instead of under the subheading ``Miscellaneous.''

III. Definition of ``Large Sample'' (34 CFR 77.1(c))

    Current Regulations: In 34 CFR 77.1(c), the definition of ``large 
sample'' currently refers to students, classrooms, schools, groups, or 
other single analysis units that ``were randomly assigned to a 
treatment or control group.''
    Proposed Regulations: We propose to remove the reference to random 
assignment to treatment or control groups in the definition of ``large 
sample.''
    Reasons: We propose this change to eliminate inconsistencies 
between the definition of ``large sample'' and the definition of 
``moderate evidence of effectiveness.'' We do not believe that random 
assignment to a treatment or control group is necessary because the 
concept of random assignment is embedded within the definition of 
randomized controlled trial (as defined in 34 CFR 77.1(c)). In order 
for the ``large sample'' definition to align fully with the ``moderate 
evidence of effectiveness'' definition, the ``large sample'' definition 
must not require that units of analysis be randomly assigned into 
treatment or control groups.

Executive Orders 12866 and 13563

Regulatory Impact Analysis
    Under Executive Order 12866, the Secretary must determine whether 
this regulatory action is ``significant'' and, therefore, subject to 
the requirements of the Executive order and subject to review by the 
Office of Management and Budget (OMB). Section 3(f) of Executive Order 
12866 defines a ``significant regulatory action'' as an action likely 
to result in a rule that may--
    (1) Have an annual effect on the economy of $100 million or more, 
or adversely affect a sector of the economy, productivity, competition, 
jobs, the environment, public health or safety, or State, local, or 
tribal governments or communities in a material way (also referred to 
as an ``economically significant'' rule);
    (2) Create serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impacts of entitlement grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles stated in the 
Executive order.
    This proposed regulatory action is not a significant regulatory 
action subject to review by OMB under section 3(f) of Executive Order 
12866.
    We have also reviewed these regulations under Executive Order 
13563, which supplements and explicitly reaffirms the principles, 
structures, and definitions governing regulatory review established in 
Executive Order 12866. To the extent permitted by law, Executive Order 
13563 requires that an agency--
    (1) Propose or adopt regulations only upon a reasoned determination 
that their benefits justify their costs (recognizing that some benefits 
and costs are difficult to quantify);
    (2) Tailor its regulations to impose the least burden on society, 
consistent with obtaining regulatory objectives and taking into 
account--among other things and to the extent practicable--the costs of 
cumulative regulations;
    (3) In choosing among alternative regulatory approaches, select 
those approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity);
    (4) To the extent feasible, specify performance objectives, rather 
than the behavior or manner of compliance a regulated entity must 
adopt; and
    (5) Identify and assess available alternatives to direct 
regulation, including economic incentives--such as user fees or 
marketable permits--to encourage the desired behavior, or provide 
information that enables the public to make choices.
    Executive Order 13563 also requires an agency ``to use the best 
available techniques to quantify anticipated present and future 
benefits and costs as accurately as possible.'' The Office of 
Information and Regulatory Affairs of OMB has emphasized that these 
techniques may include ``identifying changing future compliance costs 
that might result from technological innovation or anticipated 
behavioral changes.''
    We are issuing these proposed regulations only on a reasoned 
determination that their benefits would justify their costs. In 
choosing among alternative regulatory approaches, we selected those 
approaches that would maximize net benefits. Based on the analysis that 
follows, the Department believes that these proposed regulations are 
consistent with the principles in Executive Order 13563.
    We also have determined that this regulatory action would not 
unduly interfere with State, local, and tribal governments in the 
exercise of their governmental functions.
    In accordance with both Executive orders, the Department has 
assessed the potential costs and benefits, both quantitative and 
qualitative, of this regulatory action. The potential costs associated 
with this regulatory action are those resulting from statutory 
requirements and those we have determined to be necessary for 
administering the Department's programs and activities.

Clarity of the Regulations

    Executive Order 12866 and the Presidential memorandum ``Plain 
Language in Government Writing'' require each agency to write 
regulations that are easy to understand.
    The Secretary invites comments on how to make these proposed 
regulations easier to understand, including answers to questions such 
as the following:
     Are the requirements in the proposed regulations clearly 
stated?
     Do the proposed regulations contain technical terms or 
other wording that interferes with their clarity?
     Does the format of the proposed regulations (grouping and 
order of sections, use of headings, paragraphing, etc.) aid or reduce 
their clarity?
     Would the proposed regulations be easier to understand if 
we divided them into more (but shorter) sections? (A

[[Page 63065]]

``section'' is preceded by the symbol ``Sec.  '' and a numbered 
heading; for example, Sec.  77.1 Definitions that apply to Department 
regulations.)
     Could the description of the proposed regulations in the 
SUPPLEMENTARY INFORMATION section of this preamble be more helpful in 
making the proposed regulations easier to understand? If so, how?
     What else could we do to make the proposed regulations 
easier to understand?
    To send any comments that concern how the Department could make 
these proposed regulations easier to understand, see the instructions 
in the ADDRESSES section.

Regulatory Flexibility Act Certification

    The Secretary certifies that these proposed regulations would not 
have a significant economic impact on a substantial number of small 
entities because the proposed regulations primarily clarify and update 
regulations previously published in the Federal Register.

Paperwork Reduction Act of 1995

    These proposed regulations do not contain any changes to the 
Department's current information collection requirements.

Intergovernmental Review

    These proposed regulations affect direct grant programs of the 
Department that are subject to Executive Order 12372 and the 
regulations in 34 CFR part 79. One of the objectives of the Executive 
order is to foster an intergovernmental partnership and a strengthened 
federalism. The Executive order relies on processes developed by State 
and local governments for coordination and review of proposed Federal 
financial assistance.
    This document provides early notification of our specific plans and 
actions for these programs.

Assessment of Educational Impact

    In accordance with section 411 of the General Education Provisions 
Act, 20 U.S.C. 1221e-4, the Secretary particularly requests comments on 
whether these proposed regulations would require transmission of 
information that any other agency or authority of the United States 
gathers or makes available.
    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. Free 
Internet access to the official edition of the Federal Register and the 
Code of Federal Regulations is available via the Federal Digital System 
at: www.gpo.gov/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 Adobe 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. (Catalog of Federal Domestic Assistance Number does 
not apply.)

List of Subjects

34 CFR Part 75

    Accounting, Copyright, Education, Grant programs-education, 
Inventions and patents, Private schools, Reporting and recordkeeping 
requirements.

34 CFR Part 77

    Education, Grant programs-education.

    Dated: October 15, 2014.
Arne Duncan,
Secretary of Education.

    For the reasons discussed in the preamble, the Secretary proposes 
to amend parts 75 and 77 of title 34 of the Code of Federal Regulations 
as follows:

PART 75--DIRECT GRANT PROGRAMS

0
1. The authority citation for part 75 continues to read as follows:

    Authority:  20 U.S.C. 1221e-3 and 3474, unless otherwise noted.

0
2. Section 75.210 is amended by revising paragraphs (h)(2)(viii) and 
(ix) to read as follows.


Sec.  75.210  General selection criteria.

* * * * *
    (h) * * *
    (2) * * *
    (viii) The extent to which the methods of evaluation will, if well-
implemented, produce evidence about the project's effectiveness that 
would meet the What Works Clearinghouse Evidence Standards without 
reservations. * * *
    (ix) The extent to which the methods of evaluation will, if well-
implemented, produce evidence about the project's effectiveness that 
would meet the What Works Clearinghouse Evidence Standards with 
reservations.
* * * * *
0
3. Section 75.266 is redesignated as Sec.  75.226 and the newly 
redesignated section is revised to read as follows:


Sec.  75.226  What procedures does the Secretary use if the Secretary 
decides to give special consideration to applications supported by 
strong evidence of effectiveness, moderate evidence of effectiveness, 
or evidence of promise?

    (a) As used in this section, ``strong evidence of effectiveness'' 
is defined in 34 CFR 77.1(c);
    (b) As used in this section, ``moderate evidence of effectiveness'' 
is defined in 34 CFR 77.1(c);
    (c) As used in this section, ``evidence of promise'' is defined in 
34 CFR 77.1(c); and
    (d) If the Secretary determines that special consideration of 
applications supported by strong evidence of effectiveness, moderate 
evidence of effectiveness, or evidence of promise is appropriate, the 
Secretary may establish a separate competition under the procedures in 
34 CFR 75.105(c)(3), or provide competitive preference under the 
procedures in 34 CFR 75.105(c)(2), for applications supported by:
    (1) Evidence of effectiveness that meets the conditions set out in 
paragraph (a) of the definition of ``strong evidence of effectiveness'' 
in 34 CFR 77.1(c);
    (2) Evidence of effectiveness that meets the conditions set out in 
either paragraph (a) or (b) of the definition of ``strong evidence of 
effectiveness'' in 34 CFR 77.1(c);
    (3) Evidence of effectiveness that meets the conditions set out in 
the definition of ``moderate evidence of effectiveness;'' or
    (4) Evidence of effectiveness that meets the conditions set out in 
the definition of ``evidence of promise.''

(Authority: 20 U.S.C. 1221e-3 and 3474.)

PART 77--DEFINITIONS THAT APPLY TO DEPARTMENT REGULATIONS

0
4. The authority citation for part 77 continues to read as follows:

    Authority: 20 U.S.C. 1221e-3 and 3474, unless otherwise noted.

0
5. In Sec.  77.1 paragraph(c) is amended by:
0
A. Revising the definitions of Evidence of promise, Large sample, 
Moderate evidence of effectiveness, Quasi-experimental design study, 
Randomized controlled trial, and Strong evidence of effectiveness.

[[Page 63066]]

0
B. Adding, in alphabetical order, the definition of What Works 
Clearinghouse Evidence Standards.
    The revisions and addition read as follows:


Sec.  77.1  Definitions that apply to all Department programs.

* * * * *
    (c) * * *
* * * * *
    Evidence of promise means there is empirical evidence to support 
the theoretical linkage(s) between at least one critical component and 
at least one relevant outcome presented in the logic model for the 
proposed process, product, strategy, or practice. Specifically, 
evidence of promise means the conditions in paragraphs (a) and (b) of 
this section are met:
    (a) There is at least one study that is a--
    (1) Correlational study with statistical controls for selection 
bias;
    (2) Quasi-experimental design study that meets the What Works 
Clearinghouse Evidence Standards with reservations; or
    (3) Randomized controlled trial that meets the What Works 
Clearinghouse Evidence Standards with or without reservations.
    (b) The study referenced in paragraph (a) found a statistically 
significant or substantively important (defined as a difference of 0.25 
standard deviations or larger) favorable association between at least 
one critical component and one relevant outcome presented in the logic 
model for the proposed process, product, strategy, or practice.
* * * * *
    Large sample means an analytic sample of 350 or more students (or 
other single analysis units), or 50 or more groups (such as classrooms 
or schools) that contain 10 or more students (or other single analysis 
units).
* * * * *
    Moderate evidence of effectiveness means one of the following 
conditions is met:
    (a) There is at least one study of the effectiveness of the 
process, product, strategy, or practice being proposed that meets the 
What Works Clearinghouse Evidence Standards without reservations, found 
a statistically significant favorable impact on a relevant outcome 
(with no statistically significant and overriding unfavorable impacts 
on that outcome for relevant populations in the study or in other 
studies of the intervention reviewed by and reported on by the What 
Works Clearinghouse), and includes a sample that overlaps with the 
populations or settings proposed to receive the process, product, 
strategy, or practice.
    (b) There is at least one study of the effectiveness of the 
process, product, strategy, or practice being proposed that meets the 
What Works Clearinghouse Evidence Standards with reservations, found a 
statistically significant favorable impact on a relevant outcome (with 
no statistically significant and overriding unfavorable impacts on that 
outcome for relevant populations in the study or in other studies of 
the intervention reviewed by and reported on by the What Works 
Clearinghouse), includes a sample that overlaps with the populations or 
settings proposed to receive the process, product, strategy, or 
practice, and includes a large sample and a multi-site sample. (Note: 
multiple studies can cumulatively meet the large and multi-site sample 
requirements as long as each study meets the other requirements in this 
paragraph.)
* * * * *
    Quasi-experimental design study means a study using a design that 
attempts to approximate an experimental design by identifying a 
comparison group that is similar to the treatment group in important 
respects. These studies, depending on design and implementation, can 
meet What Works Clearinghouse Evidence Standards with reservations (but 
not What Works Clearinghouse Evidence Standards without reservations).
* * * * *
    Randomized controlled trial means a study that employs random 
assignment of, for example, students, teachers, classrooms, schools, or 
districts to receive the intervention being evaluated (the treatment 
group) or not to receive the intervention (the control group). The 
estimated effectiveness of the intervention is the difference between 
the average outcomes for the treatment group and for the control group. 
These studies, depending on design and implementation, can meet What 
Works Clearinghouse Evidence Standards without reservations.
* * * * *
    Strong evidence of effectiveness means one of the following 
conditions is met:
    (a) There is at least one study of the effectiveness of the 
process, product, strategy, or practice being proposed that meets the 
What Works Clearinghouse Evidence Standards without reservations, found 
a statistically significant favorable impact on a relevant outcome 
(with no statistically significant and overriding unfavorable impacts 
on that outcome for relevant populations in the study or in other 
studies of the intervention reviewed by and reported on by the What 
Works Clearinghouse), includes a sample that overlaps with the 
populations and settings proposed to receive the process, product, 
strategy, or practice, and includes a large sample and a multi-site 
sample. (Note: multiple studies can cumulatively meet the large and 
multi-site sample requirements as long as each study meets the other 
requirements in this paragraph.)
    (b) There are at least two studies of the effectiveness of the 
process, product, strategy, or practice being proposed, each of which: 
Meets the What Works Clearinghouse Evidence Standards with 
reservations, found a statistically significant favorable impact on a 
relevant outcome (with no statistically significant and overriding 
unfavorable impacts on that outcome for relevant populations in the 
studies or in other studies of the intervention reviewed by and 
reported on by the What Works Clearinghouse), includes a sample that 
overlaps with the populations and settings proposed to receive the 
process, product, strategy, or practice, and includes a large sample 
and a multi-site sample.
* * * * *
    What Works Clearinghouse Evidence Standards means the standards set 
forth in the What Works Clearinghouse Procedures and Standards Handbook 
(Version 3.0, March 2014), which can be found at the following link: 
https://ies.ed.gov/ncee/wwc/DocumentSum.aspx?sid=19.
* * * * *
[FR Doc. 2014-24929 Filed 10-21-14; 8:45 am]
BILLING CODE 4000-01-P
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