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. 

[FR Doc. 2014–25060 Filed 10–21–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2014–C–1552] 

Colorcon, Inc.; Filing of Color Additive 

Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of petition. 

SUMMARY: 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. 

DATES: The color additive petition was 

filed on September 22, 2014. 

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. 

SUPPLEMENTARY INFORMATION: 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. 

Dated: October 16, 2014. 

Dennis M. Keefe, 

Director, Office of Food Additive Safety, 

Center for Food Safety and Applied Nutrition. 

[FR Doc. 2014–25089 Filed 10–21–14; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Proposed Rules 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,’’ ‘‘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 


tkelley on DSK3SPTVN1PROD with PROPOSALS
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.’’ 

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 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Proposed Rules 63065 

‘‘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. 

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 

■ 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. 

§ 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. 

* * * * * 

■ 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. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
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. 

* * * * * 

(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 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: http://

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 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule. 

SUMMARY: The National Marine 

Fisheries Service (NMFS) publishes a 

proposed Annual Determination (AD) 

for 2015, pursuant to its authority under 


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