Direct Grant Programs and Definitions That Apply to Department Regulations, 63062-63066 [2014-24929]
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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:
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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:
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• 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
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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
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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.
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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
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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.
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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
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(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
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‘‘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.
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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
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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
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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.
■
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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.
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*
*
*
*
*
(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]
=======================================================================
-----------------------------------------------------------------------
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
[[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