80_FR_79527 80 FR 79283 - National Institute on Disability, Independent Living, and Rehabilitation Research

80 FR 79283 - National Institute on Disability, Independent Living, and Rehabilitation Research

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 244 (December 21, 2015)

Page Range79283-79292
FR Document2015-31907

This proposed rule would implement the Workforce Innovation and Opportunity Act of 2014 and reflect the transfer of the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) from the Department of Education to the Department of Health and Human Services. The previous regulations were issued by the Department of Education. The rulemaking will consolidate the NIDILRR regulations into a single part, align the regulations with the current statute and HHS policies, and will provide guidance to NIDILRR grantees.

Federal Register, Volume 80 Issue 244 (Monday, December 21, 2015)
[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Proposed Rules]
[Pages 79283-79292]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31907]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 1330

RIN 0985-AA12


National Institute on Disability, Independent Living, and 
Rehabilitation Research

AGENCY: National Institute on Disability, Independent Living, and 
Rehabilitation Research; Administration for Community Living; HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would implement the Workforce Innovation 
and Opportunity Act of 2014 and reflect the transfer of the National 
Institute on Disability, Independent Living, and Rehabilitation 
Research (NIDILRR) from the Department of Education to the Department 
of Health and Human Services. The previous regulations were issued by 
the Department of Education. The rulemaking will consolidate the 
NIDILRR regulations into a single part, align the regulations with the 
current statute and HHS policies, and will provide guidance to NIDILRR 
grantees.

DATES: Comments are due on or before February 19, 2016.

ADDRESSES: You may submit comments in one of following ways (no 
duplicates, please): Written comments may be submitted through any of 
the methods specified below. Please do not submit duplicate comments.
     Federal eRulemaking Portal: You may (and we encourage you 
to) submit electronic comments on this regulation at http://www.regulations.gov. Follow the instructions under the ``submit a 
comment'' tab. Attachments should be in Microsoft Word, WordPerfect, or 
Excel; however, we prefer Microsoft Word.
     Regular, Express, or Overnight Mail: You may mail written 
comments to the following address only: Administration for Community 
Living, Attention: NIDILRR NPRM, U.S. Department of Health and Human 
Services, Washington, DC 20201. Please allow sufficient time for mailed 
comments to be received before the close of the comment period.
     Individuals with a Disability: We will provide an 
appropriate accommodation, including alternative formats, upon request. 
To make such a request, please contact Marlina Moses-Gaither, (202) 
795-7409 (Voice) or at marlina.moses-gaither@acl.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Greg Pugh, Administration for 
Community Living, telephone (202) 795-7422 (Voice). This is not a toll-
free number. This document will be made available in alternative 
formats upon request.

SUPPLEMENTARY INFORMATION: 

I. Workforce Innovation and Opportunity Act of 2014

    The Workforce Innovation and Opportunity Act of 2014 (``WIOA,'' 
Pub. L. 113-128), signed into law on July 22, 2014, included 
significant changes to Title II of the Rehabilitation Act of 1973. The 
first of these is the insertion of a new name, the National Institute 
on Disability, Independent Living, and Rehabilitation Research 
(``NIDILRR,'' which was previously the National Institute on Disability 
and Rehabilitation Research). WIOA also relocates NIDILRR from the 
Department of Education (``ED'') to the Administration for Community 
Living (``ACL'') of the Department of Health and Human Services.

II. Programs Authorized by Title II of the Rehabilitation Act of 1973, 
as Amended by WIOA

A. Disability, Independent Living, and Rehabilitation Research Projects 
and Centers

    The purpose of the Disability and Rehabilitation Research Projects 
and Centers program is to plan and conduct research, development, 
demonstrations, training, dissemination, and related activities, 
including international activities, to maximize the full inclusion and 
integration into society, employment, independent living, family 
support, and economic and social self-sufficiency of individuals with 
disabilities, especially individuals with the most severe disabilities, 
and improve the effectiveness of services authorized under the 
Rehabilitation Act of 1973, 29 U.S.C. 701 et seq.
    To this end, NIDILRR provides grants to establish and support:
     Disability, Independent Living, and Rehabilitation 
Research Projects;
     Field Initiated Projects;
     Advanced Rehabilitation Research Training Projects;
     Rehabilitation Research and Training Centers; and
     Rehabilitation Engineering Research Centers.
    Eligible entities for awards under this program include States, 
public or private agencies and organizations, institutions of higher 
education, and Indian tribes and tribal organizations.

B. Research Fellowships

    The purpose of the Research Fellowships program is to build 
research capacity by providing support to highly qualified individuals, 
including those who are individuals with disabilities, to perform 
research on rehabilitation and independent living of individuals with 
disabilities. Any individual is eligible for assistance under this 
program who has training and experience that indicate a potential for 
engaging in scientific research related to the solution of 
rehabilitation problems of individuals with disabilities. The program 
provides grants to support two categories of Fellowships: Distinguished 
Fellowships (for those with seven or more years of relevant research 
experience) and Merit Fellowships (for individuals in earlier stages of 
their careers in research).

C. Special Projects and Demonstrations for Spinal Cord Injuries

    The Special Projects and Demonstrations for Spinal Cord Injuries 
program provides assistance to establish innovative projects for the 
delivery, demonstration, and evaluation of comprehensive medical, 
vocational, and other rehabilitation services to meet the wide range of 
needs, including independent living, of individuals with spinal cord 
injuries. The entities eligible for an award under these Projects and 
Demonstrations are the same as for Disability and Rehabilitation 
Research Projects and Centers.

III. Discussion of Proposed Rule

    Department of Education regulations governing the National 
Institute on Disability and Rehabilitation Research are found at 34 CFR 
parts 350, 356, and 359. Part 350 sets forth regulations addressing the 
Disability and Rehabilitation Research Projects and Centers Program; 
part 356 sets forth regulations addressing Disability and 
Rehabilitation Research Fellowships; and part 359 sets forth 
regulations addressing Special Projects and Demonstrations for Spinal 
Cord Injuries. ACL proposes to streamline the NIDILRR regulations and 
to consolidate them into one part, 45 CFR part 1330. In our 
regulations, we propose to eliminate regulatory language included in 
the corresponding ED regulations that does not add further 
interpretation to the statutory language. We also propose to eliminate 
unnecessary regulatory

[[Page 79284]]

language that already exists in other documents and that need not be 
included in regulatory language, such as the application materials or 
terms and conditions of grant awards. The remainder of the proposed 
rule is derived largely from the previous ED language, with significant 
deviations noted below.
45 CFR Part 1330
    We propose creating a new part to 45 CFR, part 1330, entitled 
National Institute for Disability, Independent Living, and 
Rehabilitation Research. We expect the Department of Education will be 
issuing regulations at a later date rescinding 34 CFR parts 350, 356, 
and 359.
Subpart A--Disability, Independent Living, and Rehabilitation Research 
Projects and Centers Program
    Subpart A will contain general requirements for the main NIDILRR 
grant program.
    Proposed Sec.  1330.1 explains what projects are funded under the 
program, and the purpose of the program. This section will provide a 
valuable framework to potential applicants for NIDILRR funding, as the 
statute does not specify specific funding opportunities. The provisions 
largely incorporate language from the corresponding regulations at 34 
CFR 350.1 and 350.2.
    Proposed Sec.  1330.2 contains information on what entities are 
eligible to receive assistance under the program, and is derived 
substantially from the authorizing statute. It also cites other 
regulations that apply to the awards under part 1330, including the 
Uniform Administrative Requirements, Cost Principles, and Audit 
Requirements for HHS Awards, codified at part 75 of 45 CFR, rather than 
the EDGAR regulations which govern Department of Education financial 
assistance. In addition, all entities receiving assistance are subject 
to the HHS Grants Policy Statement, available at http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf. Other than citing to the HHS Grant 
and other applicable regulations, the proposed rule is generally the 
same as 34 CFR 350.3 and 350.4.
    Proposed Sec.  1330.3 contains definitions of terms used throughout 
the proposed rules.
    Proposed Sec.  1330.4 defines the stages of research funded by 
NIDILRR, and requires applicants to identify which stage(s) of research 
they propose to undertake. This is a significant addition as compared 
to existing ED regulations and represents a major safeguard to 
NIDILRR's scientific integrity. We believe that asking applicants to 
identify the stage of research they are proposing would help applicants 
clarify the expected outcomes of their proposed research and would help 
us better categorize our research investments and tailor our review 
process. The proposed change would also help us select reviewers who 
are knowledgeable about the topic and able to assess the relationship 
between the identified stage of research and the proposed research 
design. This would increase the likelihood that we fund research that 
contributes to the evolution of knowledge on a topic. The stages of 
research reflect a progression in the development of knowledge from 
describing the status, needs, and challenges of individuals with 
disabilities to developing and testing interventions to widespread 
adoption of effective practices, programs, and policies that improve 
their status, respond to their needs, and reduce their challenges with 
the aim of supporting independence, integration, productivity, and 
self-determination.
    Proposed Sec.  1330.5 defines the stages of development funded by 
NIDILRR, and applicants are expected to identify which stage(s) of 
development they propose to undertake. We believe that asking 
applicants to identify the stage(s) of development will help them to 
better document and communicate proposed development projects and 
expected outcomes and help us better categorize development projects, 
select reviewers, and tailor our review process. This will increase the 
likelihood of funding development projects that contribute to products 
meeting significant needs of individuals with disabilities. ACL 
especially solicits comments on these stages of development, and the 
addition of a requirement to identify the stage(s) of development 
proposed for funding.
Subpart B--Requirements for Awardees
    Subpart B contains general requirements for awardees under the 
NIDILRR research program.
    Proposed Sec.  1330.10 identifies the activities which are eligible 
to receive funding.
    Proposed Sec.  1330.11, in accordance with 29 U.S.C. 718(c), when 
so indicated in application materials or elsewhere, requires applicants 
to demonstrate in their applications how they will address the needs of 
people with disabilities from minority backgrounds.
Subpart C--Selection of Awardees
    Subpart C describes what processes NIDILRR will use in the 
selection of awardees.
    Proposed Sec.  1330.20 explains the purpose and importance of peer 
review
    Proposed Sec.  1330.21 states that peer review will be used in the 
selection of awardees. Peer review is viewed as integral to the 
continuing independence and scientific integrity of NIDILRR's work. In 
addition, 29 U.S.C. 762(f)(1) provides that the NIDILRR Director 
``shall provide for scientific peer review of all applications for 
financial assistance for research, training, and demonstration projects 
over which the Director has authority.''
    Proposed Sec.  1330.22 establishes the composition of peer review 
panels, and the factors used by the Director to select members for 
these panels. In accordance with 29 U.S.C. 762(f)(1), employees of the 
U.S. Department of Health and Human Services are excluded from peer 
review panels.
    Proposed Sec.  1330.23 contains the evaluation process used in 
determining which applications to fund, including the selection of 
evaluation criteria, scoring, and notification requirements. This 
process is largely statutory, stating that the selection criteria are 
based on statutory provisions that apply to the Program.
    Proposed Sec.  1330.24 is an extensive list of criteria from which 
the Director may select in evaluating applications, and for the most 
part is verbatim of Sec.  350.54 of 34 CFR. An important proposed 
addition to Sec.  1330.24 is language which allows for the assessment 
of either hypotheses or research questions, as appropriate to the 
proposed research. In addition, language is proposed which adds clarity 
as to the evaluation of the ``appropriateness'' of research samples, 
specifically two elements: The extent to which the sampling process 
yields research participants who are appropriate to the purpose of the 
study (i.e., representative and inclusive of social, ethnic, 
socioeconomic, disability-related, and other differences that are 
important to the outcomes and implications of the research); and 
whether the sample size is sufficient to reasonably expect that 
differences resulting from the proposed intervention can be detected in 
the population being studied.
    We also propose a factor for assessing the feasibility of 
implementing a proposed research design. This factor will assist peer 
reviewers to evaluate the quality of the research design, and whether 
it can be successfully completed, especially in light of the time and 
resources available. We propose to add this assessment factor to ensure 
that we sponsor high-quality research that can be carried out by the 
applicant. Without a factor related to

[[Page 79285]]

feasibility, we could fund technically well-designed research proposals 
that cannot realistically be completed, given limitations in time, 
resources, and current knowledge.
    Additional proposed factors in this rule not included in ED 
regulations include the extent to which applicants obtain and use input 
from individuals with disabilities and other stakeholders to shape the 
proposed research activities. Another proposed factor requires that 
applicants identify and justify the stage of research to establish that 
the proposed research has a foundation in the current state of 
knowledge on the topic.
    An important proposed addition to this section is a factor which 
allows for the assessment of development projects. Proposed factors and 
sub-factors are intended to improve the rigor and clarity of 
documentation and communication for proposed development projects; 
facilitate high quality peer-review; and subsequent management and 
oversight of funded projects. Conceptually, these factors span the 
research basis supporting a significant need and target population for 
a product; methodological elements common and appropriate to most 
development projects; and demonstration that the product is or is 
likely to be adopted by the target population and used for its intended 
purpose. ACL particularly solicits comments on this factor.
    Proposed Sec.  1330.25 contains selection criteria specifically for 
field-initiated priorities New to proposed Sec.  1330.25 is authority 
for NIDILRR to fund out of rank order for all competitions conducted 
under Sec.  1330.25 provided that the application receives a peer 
review score of at least 80 percent or more of available points and 
represents a unique opportunity to advance the rehabilitation knowledge 
to improve the lives of individuals with disabilities, complements 
research investment already planned or funded, or addresses research in 
a new and promising way. This will allow NIDILRR to take advantage of a 
unique opportunity to advance the field, complement our investment in a 
particular research area, or build capacity in one of our research 
domains or broad priority areas, while maintaining quality standards.
Subpart D--Disability, Independent Living, and Rehabilitation Research 
Fellowships
    Subpart D contains information on programs awarding funding to 
research fellows, along with the eligibility requirements and selection 
criteria for these programs. This is significantly streamlined as 
compared to part 356 in the ED rules, but is included to signify that 
the program discussed in that part continue under HHS' administration. 
In keeping with established ED practice, these fellowships will be 
funded by grants to eligible fellows, as HHS believes that this 
supports the development of new and existing researchers in the fields 
of disability, independent living, and rehabilitation research.
Subpart E--Special Projects and Demonstrations for Spinal Cord Injuries
    Subpart E contains information on projects focusing on spinal cord 
injuries and eligibility requirements for these awards. This is 
significantly streamlined as compared to part 359 in the ED rules, but 
is included for the reasons stated in subpart D.
    Existing ED regulations not carried over to this proposed rule are 
as follows:

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             ED citation                                  Title                         Reason for deletion
----------------------------------------------------------------------------------------------------------------
Sec.   350.10........................  What are the general requirements for       Summarizes Rehabilitation
                                        Disability and Rehabilitation Research      Act, does not add new
                                        Projects?                                   information.
Sec.   350.11........................  What are the general requirements for a     Summarizes Rehabilitation
                                        Field-Initiated Project?                    Act, does not add new
                                                                                    information.
Sec.   350.12........................  What are the general requirements for an    Summarizes Rehabilitation
                                        Advanced Rehabilitation Research Training   Act, does not add new
                                        Project?                                    information.
Part 350, Subpart C..................  What Rehabilitation Research and Training   Summarizes Rehabilitation
                                        Centers Does the Secretary Assist?          Act, does not add new
                                                                                    information.
Part 350, Subpart D..................  What Rehabilitation Engineering Research    Summarizes Rehabilitation
                                        Centers Does the Secretary Assist?          Act, does not add new
                                                                                    information. Requirements
                                                                                    for advisory committees from
                                                                                    Sec.   350.34 and Sec.
                                                                                    350.35 will be included in
                                                                                    application materials and
                                                                                    grant terms & conditions,
                                                                                    where appropriate.
Sec.   350.41........................  What State agency review must an applicant  No longer used by NIDILRR.
                                        under the Disability and Rehabilitation
                                        Research Projects and Centers Program
                                        obtain?
Part 350, Subpart G..................  What Conditions Must Be Met After an        Requirements are either
                                        Award?                                      already stated in the
                                                                                    statute or are subject to
                                                                                    the HHS-specific award
                                                                                    requirements. In addition,
                                                                                    other post-award conditions
                                                                                    may be included in
                                                                                    application materials and
                                                                                    grant terms & conditions,
                                                                                    where appropriate.
Sec.   356.3.........................  What regulations apply to this program?     Same regulations apply as in
                                                                                    Sec.   1330.4.
Sec.   356.4.........................  What definitions apply to this program?     Not used by NIDILRR.
Part 356, Subpart B..................  What Kinds of Activities Does the           Not used by NIDILRR.
                                        Department Support Under This Program?
Part 356, Subpart C..................  How Does One Apply For Assistance Under     Subject to same requirements
                                        This Program?                               as established in Sec.
                                                                                    1330.10.
Part 356, Subpart D..................  How Does the Secretary Select a Fellow?     Subject to same criteria as
                                                                                    established in Sec.
                                                                                    1330.23.
Part 356, Subpart E..................  What Conditions Have To Be Met By A         When not already stated in
                                        Fellow?                                     statute, requirements will
                                                                                    be included in application
                                                                                    materials, terms &
                                                                                    conditions, or contract
                                                                                    requirements where
                                                                                    appropriate.
Part 356, Subpart F..................  What Are the Administrative                 When not already stated in
                                        Responsibilities of a Fellow?               statute, requirements will
                                                                                    be included in application
                                                                                    materials, terms &
                                                                                    conditions, or contract
                                                                                    requirements where
                                                                                    appropriate.
Sec.   359.3.........................  What regulations apply to this program?     Same regulations apply as in
                                                                                    Sec.   1330.4.
Sec.   359.4.........................  What definitions apply to this program?     Not used by NIDILRR.

[[Page 79286]]

 
Part 359, Subpart B..................  What Kinds of Activities Does the           Summarizes Rehabilitation
                                        Secretary Assist Under This Program?        Act, does not add new
                                                                                    information.
Sec.   359.30........................  How is peer review conducted under this     Same as in part 1330, subpart
                                        program?                                    C.
Sec.   359.31........................  What selection criteria does the Secretary  Same as in part 1330, subpart
                                        use in reviewing applications under this    C.
                                        program?
Sec.   359.32........................  What additional factors does the Secretary  Summarizes Rehabilitation
                                        consider in making a grant under this       Act, does not add new
                                        program?                                    information.
----------------------------------------------------------------------------------------------------------------

IV. Impact Analysis

A. Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives, and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). The 
Department has determined that this proposed rule is consistent with 
the priorities and principles set forth in Executive Order 12866. 
Executive Order 12866 encourages agencies, as appropriate, to provide 
the public with meaningful participation in the regulatory process. The 
rulemaking implements the Workforce Innovation and Opportunity Act of 
2014. In developing the final rule, we will consider input we received 
from the public including stakeholders. This proposed rule is not being 
treated as a ``significant regulatory action'' under section 3(f)(1) of 
Executive Order 12866. Accordingly, the proposed rule has not been 
reviewed by the Office of Management and Budget.

B. Regulatory Flexibility Analysis

    The Secretary certifies under 5 U.S.C. 605(b), the Regulatory 
Flexibility Act (Pub. L. 96-354), that this regulation will not have a 
significant economic impact on a substantial number of small entities. 
The primary impact of this proposed regulation is on entities applying 
for NIDILRR funding opportunities, specifically researchers, States, 
public or private agencies and organizations, institutions of higher 
education, and Indian tribes and tribal organizations. The proposed 
regulation does not have a significant economic impact on these 
entities. This proposed rule is in fact significantly shorter than, but 
with identical compliance requirements to, the regulations it replaces.

C. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before an information collection request is submitted to the 
Office of Management and Budget (OMB) for review and approval. We are 
not introducing any new information collections in this proposed rule 
however, nor revising reporting requirements.

D. Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded 
Mandates Act) requires that a covered agency prepare a budgetary impact 
statement before promulgating a rule that includes any Federal mandate 
that may result in expenditures by State, local, or Tribal governments, 
in the aggregate, or by the private sector, of $100 million, adjusted 
for inflation, or more in any one year.
    If a covered agency must prepare a budgetary impact statement, 
section 205 further requires that it select the most cost-effective and 
least burdensome alternatives that achieves the objectives of the rule 
and is consistent with the statutory requirements. In addition, section 
203 requires a plan for informing and advising any small government 
that may be significantly or uniquely impacted by a rule.
    ACL has determined that this proposed rule does not result in the 
expenditure by State, local, and Tribal governments in the aggregate, 
or by the private sector of more than $100 million in any one year.

E. Congressional Review

    This proposed rule is not a major rule as defined in 5 U.S.C. 
Section 804(2).

F. Assessment of Federal Regulations and Policies on Families

    Section 654 of the Treasury and General Government Appropriations 
Act of 1999 requires Federal agencies to determine whether a policy or 
regulation may affect family well-being. If the agency's conclusion is 
affirmative, then the agency must prepare an impact assessment 
addressing seven criteria specified in the law. These proposed 
regulations do not have an impact on family well-being as defined in 
the legislation.

G. Executive Order 13132

    Executive Order 13132 on ``federalism'' was signed August 4, 1999. 
The purposes of the Order are: ``. . . to guarantee the division of 
governmental responsibilities between the national government and the 
States that was intended by the Framers of the Constitution, to ensure 
that the principles of federalism established by the Framers guide the 
executive departments and agencies in the formulation and 
implementation of policies, and to further the policies of the Unfunded 
Mandates Reform Act . . .''
    The Department certifies that this proposed rule does not have a 
substantial direct effect on States, on the relationship between the 
Federal government and the States, or on the distribution of power and 
responsibilities among the various levels of government.
    ACL is not aware of any specific State laws that would be preempted 
by the adoption of the regulation.

    Dated: December 15, 2015.
Kathy Greenlee,
Administrator, Administration for Community Living.
    Approved: December 15, 2015.
Sylvia M. Burwell,
Secretary, U.S. Department of Health and Human Services.

List of Subjects in 45 CFR Part 1330

    Grant programs, Research, Scholarships and fellowships.

    For reasons set forth in the preamble, under the authority at 29 
U.S.C. 709 and 3343, the Department of Health and Human Services 
proposes to add part 1330 of subchapter C title 45 to read as set forth 
below:

PART 1330--NATIONAL INSTITUTE FOR DISABILITY, INDEPENDENT LIVING, 
AND REHABILITATION RESEARCH

Subpart A--Disability, Independent Living, and Rehabilitation Research 
Projects and Centers Program
Sec.
1330.1 General.
1330.2 Eligibility for assistance and other regulations and 
guidance.

[[Page 79287]]

1330.3 Definitions.
1330.4 Stages of research.
1330.5 Stages of development.
Subpart B--Requirements for Awardees
1330.10 General requirements for awardees.
1330.11 Individuals with disabilities from minority backgrounds.
Subpart C--Selection of Awardees
1330.20 Peer review purpose.
1330.21 Peer review process.
1330.22 Composition of peer review panel.
1330.23 Evaluation process.
1330.24 Selection criteria.
1330.25 Additional considerations for field-initiated priorities.
Subpart D--Disability, Independent Living, and Rehabilitation Research 
Fellowships
1330.30 Fellows program.
Subpart E--Special Projects and Demonstrations for Spinal Cord Injuries
1330.40 Spinal cord injuries program.

    Authority: 29 U.S.C. 709, 3343.

Subpart A--Disability, Independent Living, and Rehabilitation 
Research Projects and Centers Program


Sec.  1330.1  General.

    (a) The Disability, Independent Living, and Rehabilitation Research 
Projects and Centers Program provides grants to establish and support--
    (1) The following Disability, Independent Living, and 
Rehabilitation Research and Related Projects:
    (i) Disability, Independent Living, and Rehabilitation Research 
Projects;
    (ii) Field-Initiated Projects;
    (iii) Advanced Rehabilitation Research Training Projects; and
    (2) The following Disability, Independent Living, and 
Rehabilitation Research Centers:
    (i) Rehabilitation Research and Training Centers;
    (ii) Rehabilitation Engineering Research Centers.
    (b) The purpose of the Disability, Independent Living, and 
Rehabilitation Research Projects and Centers Program is to plan and 
conduct research, development, demonstration projects, training, 
dissemination, and related activities, including international 
activities, to--
    (1) Develop methods, procedures, and rehabilitation technology, 
that maximize the full inclusion and integration into society, 
employment, education, independent living, family support, and economic 
and social self-sufficiency of individuals with disabilities, 
especially individuals with the most severe disabilities; and
    (2) Improve the effectiveness of services authorized under the 
Rehabilitation Act of 1973, 29 U.S.C. 701 et seq.


Sec.  1330.2  Eligibility for assistance and other regulations and 
guidance.

    (a) Unless otherwise stated in this part or in a determination by 
the NIDILRR Director, the following entities are eligible for an award 
under this program:
    (1) States.
    (2) Public or private agencies, including for-profit agencies.
    (3) Public or private organizations, including for-profit 
organizations.
    (4) Institutions of higher education.
    (5) Indian tribes and tribal organizations.
    (b) Other sources of regulation which may apply to awards under 
this part include but are not limited to:
    (1) 45 CFR part 16--Procedures of the Departmental Grant Appeals 
Board.
    (2) 45 CFR part 46--Protection of Human Subjects.
    (3) 45 CFR part 75--Uniform Administrative Requirements, Cost 
Principles, and Audit Requirements for HHS Award.
    (4) 2 CFR parts 376 and 382--Nonprocurement Debarment and 
Suspension and Requirements for Drug-Free Workplace (Financial 
Assistance).
    (5) 45 CFR part 80--Nondiscrimination under Programs Receiving 
Federal Assistance through the Department of Health and Human 
Services--Effectuation of title VI of the Civil Rights Act of 1964.
    (6) 45 CFR part 81--Practice and Procedures--Practice and Procedure 
for Hearings Act under part 80 of this title.
    (7) 45 CFR part 84--Nondiscrimination on the Basis of Handicap in 
Programs and Activities Receiving or Benefiting from Federal Financial 
Assistance.
    (8) 45 CFR part 86--Nondiscrimination on the Basis of Sex in 
Education Programs and Activities Receiving or Benefiting from Federal 
Financial Assistance.
    (9) 45 CFR part 87--Equal Treatment of Faith-Based Organizations.
    (10) 45 CFR part 91--Nondiscrimination on the Basis of Age in 
Programs or Activities Receiving Federal Financial Assistance from HHS.
    (11) 45 CFR part 93--New Restrictions on Lobbying.


Sec.  1330.3  Definitions.

    As used in this part:
    (a) Secretary means the Secretary of the Department of Health and 
Human Services
    (b) Administrator means the Administrator of the Administration for 
Community Living
    (c) Director means the Director of the National Institute on 
Disability, Independent Living, and Rehabilitation Research.
    (d) Research is classified on a continuum from basic to applied:
    (1) Basic research is research in which the investigator is 
concerned primarily with gaining new knowledge or understanding of a 
subject without reference to any immediate application or utility.
    (2) Applied research is research in which the investigator is 
primarily interested in developing new knowledge, information, or 
understanding which can be applied to a predetermined rehabilitation 
problem or need.
    (e) Development activities use knowledge and understanding gained 
form research to create materials, devices, systems, or methods 
beneficial to the target population, including design and development 
of prototypes and processes.


Sec.  1330.4  Stages of research.

    For any Disability, Independent Living, and Rehabilitation Research 
Projects and Centers Program competition, the Department may require in 
the application materials for the competition that the applicant 
identify the stage(s) of research in which it will focus the work of 
its proposed project or center. The four stages of research are--
    (a) Exploration and discovery mean the stage of research that 
generates hypotheses or theories through new and refined analyses of 
data, producing observational findings and creating other sources of 
research-based information. This research stage may include identifying 
or describing the barriers to and facilitators of improved outcomes of 
individuals with disabilities, as well as identifying or describing 
existing practices, programs, or policies that are associated with 
important aspects of the lives of individuals with disabilities. 
Results achieved under this stage of research may inform the 
development of interventions or lead to evaluations of interventions or 
policies. The results of the exploration and discovery stage of 
research may also be used to inform decisions or priorities;
    (b) Intervention development means the stage of research that 
focuses on generating and testing interventions that have the potential 
to improve outcomes for individuals with disabilities. Intervention 
development involves determining the active components of possible 
interventions, developing measures that would be required to illustrate 
outcomes, specifying target populations, conducting field tests, and 
assessing the feasibility of conducting a well-designed intervention 
study.

[[Page 79288]]

Results from this stage of research may be used to inform the design of 
a study to test the efficacy of an intervention;
    (c) Intervention efficacy means the stage of research during which 
a project evaluates and tests whether an intervention is feasible, 
practical, and has the potential to yield positive outcomes for 
individuals with disabilities. Efficacy research may assess the 
strength of the relationships between an intervention and outcomes, and 
may identify factors or individual characteristics that affect the 
relationship between the intervention and outcomes. Efficacy research 
can inform decisions about whether there is sufficient evidence to 
support ``scaling-up'' an intervention to other sites and contexts. 
This stage of research may include assessing the training needed for 
wide-scale implementation of the intervention, and approaches to 
evaluation of the intervention in real-world applications; and
    (d) Scale-up evaluation means the stage of research during which a 
project analyzes whether an intervention is effective in producing 
improved outcomes for individuals with disabilities when implemented in 
a real-world setting. During this stage of research, a project tests 
the outcomes of an evidence-based intervention in different settings. 
The project examines the challenges to successful replication of the 
intervention, and the circumstances and activities that contribute to 
successful adoption of the intervention in real-world settings. This 
stage of research may also include well-designed studies of an 
intervention that has been widely adopted in practice, but lacks a 
sufficient evidence base to demonstrate its effectiveness.


Sec.  1330.5  Stages of development.

    For any Disability, Independent Living, and Rehabilitation Research 
Projects and Centers Program competition, the Department may require in 
the notice inviting applications for the competition that the applicant 
identify the stage(s) of development in which it will focus the work of 
its proposed project or center. The three stages of development are--
    (a) Proof of concept means the stage of development where key 
technical challenges are resolved. Stage activities may include 
recruiting study participants, verifying product requirements; 
implementing and testing (typically in controlled contexts) key 
concepts, components, or systems, and resolving technical challenges. A 
technology transfer plan is typically developed and transfer partner(s) 
identified; and plan implementation may have started. Stage results 
establish that a product concept is feasible.
    (b) Proof of product means the stage of development where a fully-
integrated and working prototype, meeting critical technical 
requirements is created. Stage activities may include recruiting study 
participants, implementing and iteratively refining the prototype, 
testing the prototype in natural or less-controlled contexts, and 
verifying that all technical requirements are met. A technology 
transfer plan is typically ongoing in collaboration with the transfer 
partner(s). Stage results establish that a product embodiment is 
realizable.
    (c) Proof of adoption means the stage of development where a 
product is substantially adopted by its target population and used for 
its intended purpose. Stage activities typically include completing 
product refinements; and continued implementation of the technology 
transfer plan in collaboration with the transfer partner(s). Other 
activities include measuring users' awareness of the product, opinion 
of the product, decisions to adopt, use, and retain products; and 
identifying barriers and facilitators impacting product adoption. Stage 
results establish that a product is beneficial.

Subpart B--Requirements for Awardees


Sec.  1330.10  General requirements for awardees.

    (a) In carrying out a research activity under this program, an 
awardee must--
    (1) Identify one or more hypotheses or research questions;
    (2) Based on the hypotheses or research question identified, 
perform an intensive systematic study in accordance with its approved 
application directed toward--
    (i) New or full scientific knowledge; or
    (ii) Understanding of the subject or problem being studied.
    (b) In carrying out a development activity under this program, an 
awardee must create, using knowledge and understanding gained from 
research, models, methods, tools, systems, materials, devices, systems, 
applications, devices, or standards that are adopted by and beneficial 
to the target population. Development activities span one or more 
stages of development.
    (c) In carrying out a training activity under this program, an 
awardee shall conduct a planned and systematic sequence of supervised 
instruction that is designed to impart predetermined skills and 
knowledge.
    (d) In carrying out a demonstration activity under this program, an 
awardee shall apply results derived from previous research, testing, or 
practice to determine the effectiveness of a new strategy or approach.
    (e) In carrying out a utilization activity under this program, a 
grantee must relate research findings to practical applications in 
planning, policy making, program administration, and delivery of 
services to individuals with disabilities.
    (f) In carrying out a dissemination activity under this program, a 
grantee must systematically distribute information or knowledge through 
a variety of ways to potential users or beneficiaries.
    (g) In carrying out a technical assistance activity under this 
program, a grantee must provide expertise or information for use in 
problem-solving.


Sec.  1330.11  Individuals with disabilities from minority backgrounds.

    (a) If the director so indicates in the application materials or 
elsewhere, an applicant for assistance under this program must 
demonstrate in its application how it will address, in whole or in 
part, the needs of individuals with disabilities from minority 
backgrounds.
    (b) The approaches an applicant may take to meet this requirement 
may include one or more of the following:
    (1) Proposing project objectives addressing the needs of 
individuals with disabilities from minority backgrounds.
    (2) Demonstrating that the project will address a problem that is 
of particular significance to individuals with disabilities from 
minority backgrounds.
    (3) Demonstrating that individuals from minority backgrounds will 
be included in study samples in sufficient numbers to generate 
information pertinent to individuals with disabilities from minority 
backgrounds.
    (4) Drawing study samples and program participant rosters from 
populations or areas that include individuals from minority 
backgrounds.
    (5) Providing outreach to individuals with disabilities from 
minority backgrounds to ensure that they are aware of rehabilitation 
services, clinical care, or training offered by the project.
    (6) Disseminating materials to or otherwise increasing the access 
to disability information among minority populations.

Subpart C--Selection of Awardees


Sec.  1330.20  Peer review purpose.

    The purpose of peer review is to insure that--

[[Page 79289]]

    (a) Those activities supported by the National Institute on 
Disability, Independent Living, and Rehabilitation Research (NIDILRR) 
are of the highest scientific, administrative, and technical quality; 
and
    (b) Activity results may be widely applied to appropriate target 
populations and rehabilitation problems.


Sec.  1330.21  Peer review process.

    (a) The Director refers each application for an award governed by 
those regulations in this part to a peer review panel established by 
the Director.
    (b) Peer review panels review applications on the basis of the 
applicable selection criteria in Sec.  1330.24.


Sec.  1330.22  Composition of peer review panel.

    (a) The Director selects as members of a peer review panel 
scientists and other experts in disability, independent living, 
rehabilitation or related fields who are qualified, on the basis of 
training, knowledge, or experience, to give expert advice on the merit 
of the applications under review.
    (b) The scientific peer review process shall be conducted by 
individuals who are not Department of Health and Human Services 
employees.
    (c) In selecting members to serve on a peer review panel, the 
Director may take into account the following factors:
    (1) The level of formal scientific or technical education completed 
by potential panel members.
    (2) The extent to which potential panel members have engaged in 
scientific, technical, or administrative activities appropriate to the 
category of applications that the panel will consider; the roles of 
potential panel members in those activities; and the quality of those 
activities.
    (3) The recognition received by potential panel members as 
reflected by awards and other honors from scientific and professional 
agencies and organizations outside the Department.
    (4) Whether the panel includes knowledgeable individuals with 
disabilities, or parents, family members, guardians, advocates, or 
authorized representatives of individuals with disabilities.
    (5) Whether the panel includes individuals from diverse 
populations.


Sec.  1330.23  Evaluation process.

    (a) The Director selects one or more of the selection criteria in 
Sec.  1330.24 to evaluate an application;
    (1) The Director establishes selection criteria based on statutory 
provisions that apply to the Program which may include, but are not 
limited to--
    (A) Specific statutory selection criteria;
    (B) Allowable activities;
    (C) Application content requirements; or
    (D) Other pre-award and post-award conditions; or
    (2) The Director may use a combination of selection criteria 
established under paragraph (a)(1) of this section and selection 
criteria from Sec.  1330.24 to evaluate a competition.
    (3) For Field-Initiated Projects, the Director does not consider 
Sec.  1330.24(b) (Responsiveness to the Absolute or Competitive 
Priority) in evaluating an application.
    (b) In considering selection criteria in Sec.  1330.24, the 
Director selects one or more of the factors listed in the criteria, but 
always considers the factor in Sec.  1330.24(n) regarding members of 
groups that have traditionally been underrepresented based on race, 
color, national origin, gender, age, or disability.
    (c) The maximum possible score for an application is 100 points.
    (d) In the application package or a notice published in the Federal 
Register, the Director informs applicants of--
    (1) The selection criteria chosen and the maximum possible score 
for each of the selection criteria; and
    (2) The factors selected for considering the selection criteria and 
if points are assigned to each factor, the maximum possible score for 
each factor under each criterion. If no points are assigned to each 
factor, the Director evaluates each factor equally.
    (e) For all instances in which the Director chooses to allow field-
initiated research and development, the selection criteria in Sec.  
1330.25 will apply, including the requirement that the applicant must 
achieve a score of 80 percent or more of maximum possible points.


Sec.  1330.24  Selection criteria.

    In addition to criteria established under Sec.  1330.23(a)(1), the 
Director may select one or more of the following criteria in evaluating 
an application:
    (a) Importance of the problem. In determining the importance of the 
problem, the Director considers one or more of the following factors:
    (1) The extent to which the applicant clearly describes the need 
and target population.
    (2) The extent to which the proposed activities further the 
purposes of the Act.
    (3) The extent to which the proposed activities address a 
significant need of individuals with disabilities.
    (4) The extent to which the proposed activities address a 
significant need of rehabilitation service providers.
    (5) The extent to which the proposed activities address a 
significant need of those who provide services to individuals with 
disabilities.
    (6) The extent to which the applicant proposes to provide training 
in a rehabilitation discipline or area of study in which there is a 
shortage of qualified researchers, or to a trainee population in which 
there is a need for more qualified researchers.
    (7) The extent to which the proposed project will have beneficial 
impact on the target population.
    (b) Responsiveness to an absolute or competitive priority. In 
determining the application's responsiveness to the application package 
or the absolute or competitive priority published in the Federal 
Register, the Director considers one or more of the following factors:
    (1) The extent to which the applicant addresses all requirements of 
the absolute or competitive priority.
    (2) The extent to which the applicant's proposed activities are 
likely to achieve the purposes of the absolute or competitive priority.
    (c) Design of research activities. In determining the extent to 
which the design is likely to be effective in accomplishing the 
objectives of the project, the Director considers one or more of the 
following factors:
    (1) The extent to which the research activities constitute a 
coherent, sustained approach to research in the field, including a 
substantial addition to the state-of-the-art.
    (2) The extent to which the methodology of each proposed research 
activity is meritorious, including consideration of the extent to 
which--
    (i) The proposed design includes a comprehensive and informed 
review of the current literature, demonstrating knowledge of the state-
of-the-art;
    (ii) Each research hypothesis or research question, as appropriate, 
is theoretically sound and based on current knowledge;
    (iii) Each sample is drawn from an appropriate, specified 
population and is of sufficient size to address the proposed hypotheses 
or research questions, as appropriate, and to support the proposed data 
analysis methods;
    (iv) The source or sources of the data and the data collection 
methods are appropriate to address the proposed hypotheses or research 
questions and to

[[Page 79290]]

support the proposed data analysis methods;
    (v) The data analysis methods are appropriate;
    (vi) Implementation of the proposed research design is feasible, 
given the current state of the science and the time and resources 
available;
    (vii) Input of individuals with disabilities and other key 
stakeholders is used to shape the proposed research activities; and
    (viii) The applicant identifies and justifies the stage of research 
being proposed and the research methods associated with the stage.
    (3) The extent to which anticipated research results are likely to 
satisfy the original hypotheses or answer the original research 
questions, as appropriate, and could be used for planning additional 
research, including generation of new hypotheses or research questions, 
where applicable.
    (4) The extent to which the stage of research is identified and 
justified in the description of the research project(s) being proposed.
    (d) Design of development activities. In determining the extent to 
which the project design is likely to be effective in accomplishing 
project objectives, the Secretary considers one or more of the 
following factors:
    (1) The extent to which the proposed project identifies a 
significant need and a well-defined target population for the new or 
improved product;
    (2) The extent to which the proposed project methodology is 
meritorious, including consideration of the extent to which--
    (i) The proposed project shows awareness of the state-of-the-art 
for current, related products;
    (ii) The proposed project employs appropriate concepts, components, 
or systems to develop the new or improved product;
    (iii) The proposed project employs appropriate samples in tests, 
trials, and other development activities.
    (iv) The proposed project conducts development activities in 
appropriate environment(s);
    (v) Input from individuals with disabilities and other key 
stakeholders is obtained to establish and guide proposed development 
activities; and
    (vi) The applicant identifies and justifies the stage(s) of 
development for the proposed project; and activities associated with 
each stage.
    (3) The new device or technique will be developed and tested in an 
appropriate environment;
    (e) Design of demonstration activities. In determining the extent 
to which the design of demonstration activities is likely to be 
effective in accomplishing the objectives of the project, the Director 
considers one or more of the following factors:
    (1) The extent to which the proposed demonstration activities build 
on previous research, testing, or practices.
    (2) The extent to which the proposed demonstration activities 
include the use of proper methodological tools and theoretically sound 
procedures to determine the effectiveness of the strategy or approach.
    (3) The extent to which the proposed demonstration activities 
include innovative and effective strategies or approaches.
    (4) The extent to which the proposed demonstration activities are 
likely to contribute to current knowledge and practice and be a 
substantial addition to the state-of-the-art.
    (5) The extent to which the proposed demonstration activities can 
be applied and replicated in other settings.
    (f) Design of training activities. In determining the extent to 
which the design is likely to be effective in accomplishing the 
objectives of the project, the Director considers one or more of the 
following factors:
    (1) The extent to which the proposed training materials are likely 
to be effective, including consideration of their quality, clarity, and 
variety.
    (2) The extent to which the proposed training methods are of 
sufficient quality, intensity, and duration.
    (3) The extent to which the proposed training content--
    (i) Covers all of the relevant aspects of the subject matter; and
    (ii) If relevant, is based on new knowledge derived from research 
activities of the proposed project.
    (4) The extent to which the proposed training materials, methods, 
and content are appropriate to the trainees, including consideration of 
the skill level of the trainees and the subject matter of the 
materials.
    (5) The extent to which the proposed training materials and methods 
are accessible to individuals with disabilities.
    (6) The extent to which the applicant's proposed recruitment 
program is likely to be effective in recruiting highly qualified 
trainees, including those who are individuals with disabilities.
    (7) The extent to which the applicant is able to carry out the 
training activities, either directly or through another entity.
    (8) The extent to which the proposed didactic and classroom 
training programs emphasize scientific methodology and are likely to 
develop highly qualified researchers.
    (9) The extent to which the quality and extent of the academic 
mentorship, guidance, and supervision to be provided to each individual 
trainee are of a high level and are likely to develop highly qualified 
researchers.
    (10) The extent to which the type, extent, and quality of the 
proposed research experience, including the opportunity to participate 
in advanced-level research, are likely to develop highly qualified 
researchers.
    (11) The extent to which the opportunities for collegial and 
collaborative activities, exposure to outstanding scientists in the 
field, and opportunities to participate in the preparation of scholarly 
or scientific publications and presentations are extensive and 
appropriate.
    (g) Design of dissemination activities. In determining the extent 
to which the design is likely to be effective in accomplishing the 
objectives of the project, the Director considers one or more of the 
following factors:
    (1) The extent to which the content of the information to be 
disseminated--
    (i) Covers all of the relevant aspects of the subject matter; and
    (ii) If appropriate, is based on new knowledge derived from 
research activities of the project.
    (2) The extent to which the materials to be disseminated are likely 
to be effective and usable, including consideration of their quality, 
clarity, variety, and format.
    (3) The extent to which the methods for dissemination are of 
sufficient quality, intensity, and duration.
    (4) The extent to which the materials and information to be 
disseminated and the methods for dissemination are appropriate to the 
target population, including consideration of the familiarity of the 
target population with the subject matter, format of the information, 
and subject matter.
    (5) The extent to which the information to be disseminated will be 
accessible to individuals with disabilities.
    (h) Design of utilization activities. In determining the extent to 
which the design of utilization activities is likely to be effective in 
accomplishing the objectives of the project, the Director considers one 
or more of the following factors:
    (1) The extent to which the potential new users of the information 
or technology have a practical use for the information and are likely 
to adopt the practices or use the information or technology, including 
new devices.
    (2) The extent to which the utilization strategies are likely to be 
effective.

[[Page 79291]]

    (3) The extent to which the information or technology is likely to 
be of use in other settings.
    (i) Design of technical assistance activities. In determining the 
extent to which the design of technical assistance activities is likely 
to be effective in accomplishing the objectives of the project, the 
Director considers one or more of the following factors:
    (1) The extent to which the methods for providing technical 
assistance are of sufficient quality, intensity, and duration.
    (2) The extent to which the information to be provided through 
technical assistance covers all of the relevant aspects of the subject 
matter.
    (3) The extent to which the technical assistance is appropriate to 
the target population, including consideration of the knowledge level 
of the target population, needs of the target population, and format 
for providing information.
    (4) The extent to which the technical assistance is accessible to 
individuals with disabilities.
    (j) Plan of operation. In determining the quality of the plan of 
operation, the Director considers one or more of the following factors:
    (1) The adequacy of the plan of operation to achieve the objectives 
of the proposed project on time and within budget, including clearly 
defined responsibilities, and timelines for accomplishing project 
tasks.
    (2) The adequacy of the plan of operation to provide for using 
resources, equipment, and personnel to achieve each objective.
    (k) Collaboration. In determining the quality of collaboration, the 
Director considers one or more of the following factors:
    (1) The extent to which the applicant's proposed collaboration with 
one or more agencies, organizations, or institutions is likely to be 
effective in achieving the relevant proposed activities of the project.
    (2) The extent to which agencies, organizations, or institutions 
demonstrate a commitment to collaborate with the applicant.
    (3) The extent to which agencies, organizations, or institutions 
that commit to collaborate with the applicant have the capacity to 
carry out collaborative activities.
    (l) Adequacy and reasonableness of the budget. In determining the 
adequacy and the reasonableness of the proposed budget, the Director 
considers one or more of the following factors:
    (1) The extent to which the costs are reasonable in relation to the 
proposed project activities.
    (2) The extent to which the budget for the project, including any 
subcontracts, is adequately justified to support the proposed project 
activities.
    (3) The extent to which the applicant is of sufficient size, scope, 
and quality to effectively carry out the activities in an efficient 
manner.
    (m) Plan of evaluation. In determining the quality of the plan of 
evaluation, the Director considers one or more of the following 
factors:
    (1) The extent to which the plan of evaluation provides for 
periodic assessment of progress toward--
    (i) Implementing the plan of operation; and
    (ii) Achieving the project's intended outcomes and expected 
impacts.
    (2) The extent to which the plan of evaluation will be used to 
improve the performance of the project through the feedback generated 
by its periodic assessments.
    (3) The extent to which the plan of evaluation provides for 
periodic assessment of a project's progress that is based on identified 
performance measures that--
    (i) Are clearly related to the intended outcomes of the project and 
expected impacts on the target population; and
    (ii) Are objective, and quantifiable or qualitative, as 
appropriate.
    (n) Project staff. In determining the quality of the project staff, 
the Director considers the extent to which the applicant encourages 
applications for employment from persons who are members of groups that 
have traditionally been underrepresented based on race, color, national 
origin, gender, age, or disability. In addition, the Director considers 
one or more of the following:
    (1) The extent to which the key personnel and other key staff have 
appropriate training and experience in disciplines required to conduct 
all proposed activities.
    (2) The extent to which the commitment of staff time is adequate to 
accomplish all the proposed activities of the project.
    (3) The extent to which the key personnel are knowledgeable about 
the methodology and literature of pertinent subject areas.
    (4) The extent to which the project staff includes outstanding 
scientists in the field.
    (5) The extent to which key personnel have up-to-date knowledge 
from research or effective practice in the subject area covered in the 
priority.
    (o) Adequacy and accessibility of resources. In determining the 
adequacy and accessibility of the applicant's resources to implement 
the proposed project, the Director considers one or more of the 
following factors:
    (1) The extent to which the applicant is committed to provide 
adequate facilities, equipment, other resources, including 
administrative support, and laboratories, if appropriate.
    (2) The quality of an applicant's past performance in carrying out 
a grant.
    (3) The extent to which the applicant has appropriate access to 
populations and organizations representing individuals with 
disabilities to support advanced disability, independent living and 
clinical rehabilitation research.
    (4) The extent to which the facilities, equipment, and other 
resources are appropriately accessible to individuals with disabilities 
who may use the facilities, equipment, and other resources of the 
project.


Sec.  1330.25  Additional considerations for field-initiated 
priorities.

    (a) The Director reserves funds to support field-initiated 
applications funded under this part when those applications have been 
awarded points totaling 80 percent or more of the maximum possible 
points under the procedures described in Sec.  1330.23.
    (b) In making a final selection from applications received when 
NIDILRR uses field-initiated priorities, the Director may consider 
whether one of the following conditions is met and, if so, use this 
information to fund an application out of rank order:
    (1) The proposed project represents a unique opportunity to advance 
rehabilitation and other knowledge to improve the lives of individual 
with disabilities.
    (2) The proposed project complements or balances research activity 
already planned or funded by NIDILRR through its annual priorities or 
addresses the research in a new and promising way.

Subpart D--Disability, Independent Living, and Rehabilitation 
Research Fellowships


Sec.  1330.30  Fellows program.

    (a) The purpose of this program is to build research capacity by 
providing support to highly qualified individuals, including those who 
are individuals with disabilities, to perform research on 
rehabilitation, independent living, and other experiences and outcomes 
of individuals with disabilities.
    (b) The eligibility requirements for the Fellows program are as 
follows:
    (1) Only individuals are eligible to be recipients of Fellowships.
    (2) Any individual is eligible for assistance under this program 
who has

[[Page 79292]]

training and experience that indicate a potential for engaging in 
scientific research related to rehabilitation and independent living 
for individuals with disabilities.
    (3) This program provides two categories of Fellowships: Merit 
Fellowships and Distinguished Fellowships.
    (i) To be eligible for a Distinguished Fellowship, an individual 
must have seven or more years of research experience in subject areas, 
methods, or techniques relevant to disability and rehabilitation 
research and must have a doctorate, other terminal degree, or 
comparable academic qualifications.
    (ii) The Director awards Merit Fellowships to individuals in 
earlier stages of their careers in research. To be eligible for a Merit 
Fellowship, an individual must have either advanced professional 
training or experience in independent study in an area which is 
directly pertinent to disability and rehabilitation.
    (c) Fellowships will be awarded in the form of a grant to eligible 
individuals.
    (d) In making a final selection of applicants to support under this 
program, the Director considers the extent to which applicants present 
a unique opportunity to effect a major advance in knowledge, address 
critical problems in innovative ways, present proposals which are 
consistent with the Institute's Long-Range Plan, build research 
capacity within the field, or complement and significantly increases 
the potential value of already planned research and related activities.

Subpart E--Special Projects and Demonstrations for Spinal Cord 
Injuries


Sec.  1330.40  Spinal cord injuries program.

    (a) This program provides assistance to establish innovative 
projects for the delivery, demonstration, and evaluation of 
comprehensive medical, vocational, independent living, and 
rehabilitation services to meet the wide range of needs of individuals 
with spinal cord injuries.
    (b) The agencies and organizations eligible to apply under this 
program are described in 45 CFR 1330.2.

[FR Doc. 2015-31907 Filed 12-18-15; 8:45 am]
 BILLING CODE P



                                                                    Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Proposed Rules                                            79283

                                               recordkeeping requirements, Volatile                      • Individuals with a Disability: We                   Eligible entities for awards under this
                                               organic compounds.                                      will provide an appropriate                           program include States, public or
                                                  Authority: 42 U.S.C. 7401 et seq.                    accommodation, including alternative                  private agencies and organizations,
                                                                                                       formats, upon request. To make such a                 institutions of higher education, and
                                                 Dated: December 8, 2015.
                                                                                                       request, please contact Marlina Moses-                Indian tribes and tribal organizations.
                                               Ron Curry,                                              Gaither, (202) 795–7409 (Voice) or at
                                               Regional Administrator, Region 6.                                                                             B. Research Fellowships
                                                                                                       marlina.moses-gaither@acl.hhs.gov.
                                               [FR Doc. 2015–31662 Filed 12–18–15; 8:45 am]            FOR FURTHER INFORMATION CONTACT: Greg
                                                                                                                                                                The purpose of the Research
                                               BILLING CODE 6560–50–P                                  Pugh, Administration for Community                    Fellowships program is to build
                                                                                                       Living, telephone (202) 795–7422                      research capacity by providing support
                                                                                                       (Voice). This is not a toll-free number.              to highly qualified individuals,
                                               DEPARTMENT OF HEALTH AND                                This document will be made available                  including those who are individuals
                                               HUMAN SERVICES                                          in alternative formats upon request.                  with disabilities, to perform research on
                                                                                                                                                             rehabilitation and independent living of
                                                                                                       SUPPLEMENTARY INFORMATION:
                                               45 CFR Part 1330                                                                                              individuals with disabilities. Any
                                                                                                       I. Workforce Innovation and                           individual is eligible for assistance
                                               RIN 0985–AA12
                                                                                                       Opportunity Act of 2014                               under this program who has training
                                               National Institute on Disability,                                                                             and experience that indicate a potential
                                                                                                          The Workforce Innovation and
                                               Independent Living, and Rehabilitation                                                                        for engaging in scientific research
                                                                                                       Opportunity Act of 2014 (‘‘WIOA,’’ Pub.
                                               Research                                                                                                      related to the solution of rehabilitation
                                                                                                       L. 113–128), signed into law on July 22,
                                                                                                                                                             problems of individuals with
                                               AGENCY:  National Institute on Disability,              2014, included significant changes to
                                                                                                                                                             disabilities. The program provides
                                               Independent Living, and Rehabilitation                  Title II of the Rehabilitation Act of 1973.
                                                                                                                                                             grants to support two categories of
                                               Research; Administration for                            The first of these is the insertion of a              Fellowships: Distinguished Fellowships
                                               Community Living; HHS.                                  new name, the National Institute on                   (for those with seven or more years of
                                               ACTION: Proposed rule.
                                                                                                       Disability, Independent Living, and                   relevant research experience) and Merit
                                                                                                       Rehabilitation Research (‘‘NIDILRR,’’                 Fellowships (for individuals in earlier
                                               SUMMARY:   This proposed rule would                     which was previously the National                     stages of their careers in research).
                                               implement the Workforce Innovation                      Institute on Disability and
                                               and Opportunity Act of 2014 and reflect                 Rehabilitation Research). WIOA also                   C. Special Projects and Demonstrations
                                               the transfer of the National Institute on               relocates NIDILRR from the Department                 for Spinal Cord Injuries
                                               Disability, Independent Living, and                     of Education (‘‘ED’’) to the                            The Special Projects and
                                               Rehabilitation Research (NIDILRR) from                  Administration for Community Living                   Demonstrations for Spinal Cord Injuries
                                               the Department of Education to the                      (‘‘ACL’’) of the Department of Health                 program provides assistance to establish
                                               Department of Health and Human                          and Human Services.                                   innovative projects for the delivery,
                                               Services. The previous regulations were                                                                       demonstration, and evaluation of
                                                                                                       II. Programs Authorized by Title II of
                                               issued by the Department of Education.                                                                        comprehensive medical, vocational, and
                                                                                                       the Rehabilitation Act of 1973, as
                                               The rulemaking will consolidate the                                                                           other rehabilitation services to meet the
                                                                                                       Amended by WIOA
                                               NIDILRR regulations into a single part,                                                                       wide range of needs, including
                                               align the regulations with the current                  A. Disability, Independent Living, and                independent living, of individuals with
                                               statute and HHS policies, and will                      Rehabilitation Research Projects and                  spinal cord injuries. The entities eligible
                                               provide guidance to NIDILRR grantees.                   Centers                                               for an award under these Projects and
                                               DATES: Comments are due on or before                       The purpose of the Disability and                  Demonstrations are the same as for
                                               February 19, 2016.                                      Rehabilitation Research Projects and                  Disability and Rehabilitation Research
                                               ADDRESSES: You may submit comments                      Centers program is to plan and conduct                Projects and Centers.
                                               in one of following ways (no duplicates,                research, development, demonstrations,                III. Discussion of Proposed Rule
                                               please): Written comments may be                        training, dissemination, and related
                                               submitted through any of the methods                    activities, including international                      Department of Education regulations
                                               specified below. Please do not submit                   activities, to maximize the full inclusion            governing the National Institute on
                                               duplicate comments.                                     and integration into society,                         Disability and Rehabilitation Research
                                                  • Federal eRulemaking Portal: You                    employment, independent living, family                are found at 34 CFR parts 350, 356, and
                                               may (and we encourage you to) submit                    support, and economic and social self-                359. Part 350 sets forth regulations
                                               electronic comments on this regulation                  sufficiency of individuals with                       addressing the Disability and
                                               at http://www.regulations.gov. Follow                   disabilities, especially individuals with             Rehabilitation Research Projects and
                                               the instructions under the ‘‘submit a                   the most severe disabilities, and                     Centers Program; part 356 sets forth
                                               comment’’ tab. Attachments should be                    improve the effectiveness of services                 regulations addressing Disability and
                                               in Microsoft Word, WordPerfect, or                      authorized under the Rehabilitation Act               Rehabilitation Research Fellowships;
                                               Excel; however, we prefer Microsoft                     of 1973, 29 U.S.C. 701 et seq.                        and part 359 sets forth regulations
                                               Word.                                                      To this end, NIDILRR provides grants               addressing Special Projects and
                                                  • Regular, Express, or Overnight Mail:               to establish and support:                             Demonstrations for Spinal Cord Injuries.
                                               You may mail written comments to the                       • Disability, Independent Living, and              ACL proposes to streamline the
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                                               following address only: Administration                  Rehabilitation Research Projects;                     NIDILRR regulations and to consolidate
                                               for Community Living, Attention:                           • Field Initiated Projects;                        them into one part, 45 CFR part 1330.
                                               NIDILRR NPRM, U.S. Department of                           • Advanced Rehabilitation Research                 In our regulations, we propose to
                                               Health and Human Services,                              Training Projects;                                    eliminate regulatory language included
                                               Washington, DC 20201. Please allow                         • Rehabilitation Research and                      in the corresponding ED regulations that
                                               sufficient time for mailed comments to                  Training Centers; and                                 does not add further interpretation to
                                               be received before the close of the                        • Rehabilitation Engineering Research              the statutory language. We also propose
                                               comment period.                                         Centers.                                              to eliminate unnecessary regulatory


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                                               79284                Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Proposed Rules

                                               language that already exists in other                   believe that asking applicants to identify               Proposed § 1330.20 explains the
                                               documents and that need not be                          the stage of research they are proposing              purpose and importance of peer review
                                               included in regulatory language, such as                would help applicants clarify the                        Proposed § 1330.21 states that peer
                                               the application materials or terms and                  expected outcomes of their proposed                   review will be used in the selection of
                                               conditions of grant awards. The                         research and would help us better                     awardees. Peer review is viewed as
                                               remainder of the proposed rule is                       categorize our research investments and               integral to the continuing independence
                                               derived largely from the previous ED                    tailor our review process. The proposed               and scientific integrity of NIDILRR’s
                                               language, with significant deviations                   change would also help us select                      work. In addition, 29 U.S.C. 762(f)(1)
                                               noted below.                                            reviewers who are knowledgeable about                 provides that the NIDILRR Director
                                                                                                       the topic and able to assess the                      ‘‘shall provide for scientific peer review
                                               45 CFR Part 1330                                                                                              of all applications for financial
                                                                                                       relationship between the identified
                                                 We propose creating a new part to 45                  stage of research and the proposed                    assistance for research, training, and
                                               CFR, part 1330, entitled National                       research design. This would increase                  demonstration projects over which the
                                               Institute for Disability, Independent                   the likelihood that we fund research                  Director has authority.’’
                                               Living, and Rehabilitation Research. We                 that contributes to the evolution of                     Proposed § 1330.22 establishes the
                                               expect the Department of Education will                 knowledge on a topic. The stages of                   composition of peer review panels, and
                                               be issuing regulations at a later date                  research reflect a progression in the                 the factors used by the Director to select
                                               rescinding 34 CFR parts 350, 356, and                   development of knowledge from                         members for these panels. In accordance
                                               359.                                                    describing the status, needs, and                     with 29 U.S.C. 762(f)(1), employees of
                                                                                                       challenges of individuals with                        the U.S. Department of Health and
                                               Subpart A—Disability, Independent                                                                             Human Services are excluded from peer
                                               Living, and Rehabilitation Research                     disabilities to developing and testing
                                                                                                       interventions to widespread adoption of               review panels.
                                               Projects and Centers Program                                                                                     Proposed § 1330.23 contains the
                                                                                                       effective practices, programs, and
                                                  Subpart A will contain general                       policies that improve their status,                   evaluation process used in determining
                                               requirements for the main NIDILRR                       respond to their needs, and reduce their              which applications to fund, including
                                               grant program.                                          challenges with the aim of supporting                 the selection of evaluation criteria,
                                                  Proposed § 1330.1 explains what                      independence, integration, productivity,              scoring, and notification requirements.
                                               projects are funded under the program,                  and self-determination.                               This process is largely statutory, stating
                                               and the purpose of the program. This                       Proposed § 1330.5 defines the stages               that the selection criteria are based on
                                               section will provide a valuable                         of development funded by NIDILRR,                     statutory provisions that apply to the
                                               framework to potential applicants for                   and applicants are expected to identify               Program.
                                               NIDILRR funding, as the statute does                    which stage(s) of development they                       Proposed § 1330.24 is an extensive list
                                               not specify specific funding                            propose to undertake. We believe that                 of criteria from which the Director may
                                               opportunities. The provisions largely                   asking applicants to identify the stage(s)            select in evaluating applications, and for
                                               incorporate language from the                           of development will help them to better               the most part is verbatim of § 350.54 of
                                               corresponding regulations at 34 CFR                     document and communicate proposed                     34 CFR. An important proposed
                                               350.1 and 350.2.                                        development projects and expected                     addition to § 1330.24 is language which
                                                  Proposed § 1330.2 contains                           outcomes and help us better categorize                allows for the assessment of either
                                               information on what entities are eligible               development projects, select reviewers,               hypotheses or research questions, as
                                               to receive assistance under the program,                and tailor our review process. This will              appropriate to the proposed research. In
                                               and is derived substantially from the                   increase the likelihood of funding                    addition, language is proposed which
                                               authorizing statute. It also cites other                                                                      adds clarity as to the evaluation of the
                                                                                                       development projects that contribute to
                                               regulations that apply to the awards                                                                          ‘‘appropriateness’’ of research samples,
                                                                                                       products meeting significant needs of
                                               under part 1330, including the Uniform                                                                        specifically two elements: The extent to
                                                                                                       individuals with disabilities. ACL
                                               Administrative Requirements, Cost                                                                             which the sampling process yields
                                                                                                       especially solicits comments on these
                                               Principles, and Audit Requirements for                                                                        research participants who are
                                                                                                       stages of development, and the addition
                                               HHS Awards, codified at part 75 of 45                                                                         appropriate to the purpose of the study
                                                                                                       of a requirement to identify the stage(s)
                                               CFR, rather than the EDGAR regulations                                                                        (i.e., representative and inclusive of
                                                                                                       of development proposed for funding.
                                               which govern Department of Education                                                                          social, ethnic, socioeconomic,
                                               financial assistance. In addition, all                  Subpart B—Requirements for Awardees                   disability-related, and other differences
                                               entities receiving assistance are subject                 Subpart B contains general                          that are important to the outcomes and
                                               to the HHS Grants Policy Statement,                     requirements for awardees under the                   implications of the research); and
                                               available at http://www.hhs.gov/asfr/                   NIDILRR research program.                             whether the sample size is sufficient to
                                               ogapa/aboutog/hhsgps107.pdf. Other                        Proposed § 1330.10 identifies the                   reasonably expect that differences
                                               than citing to the HHS Grant and other                  activities which are eligible to receive              resulting from the proposed
                                               applicable regulations, the proposed                    funding.                                              intervention can be detected in the
                                               rule is generally the same as 34 CFR                      Proposed § 1330.11, in accordance                   population being studied.
                                               350.3 and 350.4.                                        with 29 U.S.C. 718(c), when so                           We also propose a factor for assessing
                                                  Proposed § 1330.3 contains                           indicated in application materials or                 the feasibility of implementing a
                                               definitions of terms used throughout the                elsewhere, requires applicants to                     proposed research design. This factor
                                               proposed rules.                                         demonstrate in their applications how                 will assist peer reviewers to evaluate the
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                                                  Proposed § 1330.4 defines the stages                 they will address the needs of people                 quality of the research design, and
                                               of research funded by NIDILRR, and                      with disabilities from minority                       whether it can be successfully
                                               requires applicants to identify which                   backgrounds.                                          completed, especially in light of the
                                               stage(s) of research they propose to                                                                          time and resources available. We
                                               undertake. This is a significant addition               Subpart C—Selection of Awardees                       propose to add this assessment factor to
                                               as compared to existing ED regulations                    Subpart C describes what processes                  ensure that we sponsor high-quality
                                               and represents a major safeguard to                     NIDILRR will use in the selection of                  research that can be carried out by the
                                               NIDILRR’s scientific integrity. We                      awardees.                                             applicant. Without a factor related to


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                                                                          Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Proposed Rules                                                79285

                                               feasibility, we could fund technically                         development projects; and                             Subpart D—Disability, Independent
                                               well-designed research proposals that                          demonstration that the product is or is               Living, and Rehabilitation Research
                                               cannot realistically be completed, given                       likely to be adopted by the target                    Fellowships
                                               limitations in time, resources, and                            population and used for its intended                     Subpart D contains information on
                                               current knowledge.                                             purpose. ACL particularly solicits                    programs awarding funding to research
                                                 Additional proposed factors in this                          comments on this factor.                              fellows, along with the eligibility
                                               rule not included in ED regulations                               Proposed § 1330.25 contains selection              requirements and selection criteria for
                                               include the extent to which applicants                         criteria specifically for field-initiated             these programs. This is significantly
                                               obtain and use input from individuals                          priorities New to proposed § 1330.25 is               streamlined as compared to part 356 in
                                               with disabilities and other stakeholders                                                                             the ED rules, but is included to signify
                                                                                                              authority for NIDILRR to fund out of
                                               to shape the proposed research                                                                                       that the program discussed in that part
                                                                                                              rank order for all competitions
                                               activities. Another proposed factor                                                                                  continue under HHS’ administration. In
                                               requires that applicants identify and                          conducted under § 1330.25 provided
                                                                                                              that the application receives a peer                  keeping with established ED practice,
                                               justify the stage of research to establish                                                                           these fellowships will be funded by
                                               that the proposed research has a                               review score of at least 80 percent or
                                                                                                              more of available points and represents               grants to eligible fellows, as HHS
                                               foundation in the current state of                                                                                   believes that this supports the
                                               knowledge on the topic.                                        a unique opportunity to advance the
                                                                                                                                                                    development of new and existing
                                                 An important proposed addition to                            rehabilitation knowledge to improve the
                                                                                                                                                                    researchers in the fields of disability,
                                               this section is a factor which allows for                      lives of individuals with disabilities,               independent living, and rehabilitation
                                               the assessment of development projects.                        complements research investment                       research.
                                               Proposed factors and sub-factors are                           already planned or funded, or addresses
                                               intended to improve the rigor and                              research in a new and promising way.                  Subpart E—Special Projects and
                                               clarity of documentation and                                   This will allow NIDILRR to take                       Demonstrations for Spinal Cord Injuries
                                               communication for proposed                                     advantage of a unique opportunity to                    Subpart E contains information on
                                               development projects; facilitate high                          advance the field, complement our                     projects focusing on spinal cord injuries
                                               quality peer-review; and subsequent                            investment in a particular research area,             and eligibility requirements for these
                                               management and oversight of funded                             or build capacity in one of our research              awards. This is significantly streamlined
                                               projects. Conceptually, these factors                          domains or broad priority areas, while                as compared to part 359 in the ED rules,
                                               span the research basis supporting a                           maintaining quality standards.                        but is included for the reasons stated in
                                               significant need and target population                                                                               subpart D.
                                               for a product; methodological elements                                                                                 Existing ED regulations not carried
                                               common and appropriate to most                                                                                       over to this proposed rule are as follows:

                                                           ED citation                                                 Title                                                  Reason for deletion

                                               § 350.10 ...............................    What are the general requirements for Disability and            Summarizes Rehabilitation Act, does not add new infor-
                                                                                            Rehabilitation Research Projects?                                mation.
                                               § 350.11 ...............................    What are the general requirements for a Field-Initiated         Summarizes Rehabilitation Act, does not add new infor-
                                                                                            Project?                                                         mation.
                                               § 350.12 ...............................    What are the general requirements for an Advanced               Summarizes Rehabilitation Act, does not add new infor-
                                                                                            Rehabilitation Research Training Project?                        mation.
                                               Part 350, Subpart C .............           What Rehabilitation Research and Training Centers               Summarizes Rehabilitation Act, does not add new infor-
                                                                                            Does the Secretary Assist?                                       mation.
                                               Part 350, Subpart D .............           What Rehabilitation Engineering Research Centers                Summarizes Rehabilitation Act, does not add new infor-
                                                                                            Does the Secretary Assist?                                       mation. Requirements for advisory committees from
                                                                                                                                                             § 350.34 and § 350.35 will be included in application
                                                                                                                                                             materials and grant terms & conditions, where appro-
                                                                                                                                                             priate.
                                               § 350.41 ...............................    What State agency review must an applicant under the            No longer used by NIDILRR.
                                                                                            Disability and Rehabilitation Research Projects and
                                                                                            Centers Program obtain?
                                               Part 350, Subpart G .............           What Conditions Must Be Met After an Award?                     Requirements are either already stated in the statute or
                                                                                                                                                             are subject to the HHS-specific award requirements.
                                                                                                                                                             In addition, other post-award conditions may be in-
                                                                                                                                                             cluded in application materials and grant terms &
                                                                                                                                                             conditions, where appropriate.
                                               § 356.3 .................................   What regulations apply to this program?                         Same regulations apply as in § 1330.4.
                                               § 356.4 .................................   What definitions apply to this program?                         Not used by NIDILRR.
                                               Part 356, Subpart B .............           What Kinds of Activities Does the Department Support            Not used by NIDILRR.
                                                                                             Under This Program?
                                               Part 356, Subpart C .............           How Does One Apply For Assistance Under This Pro-               Subject to same requirements as established in
                                                                                             gram?                                                           § 1330.10.
                                               Part 356, Subpart D .............           How Does the Secretary Select a Fellow?                         Subject to same criteria as established in § 1330.23.
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                                               Part 356, Subpart E .............           What Conditions Have To Be Met By A Fellow?                     When not already stated in statute, requirements will be
                                                                                                                                                             included in application materials, terms & conditions,
                                                                                                                                                             or contract requirements where appropriate.
                                               Part 356, Subpart F .............           What Are the Administrative Responsibilities of a Fel-          When not already stated in statute, requirements will be
                                                                                            low?                                                             included in application materials, terms & conditions,
                                                                                                                                                             or contract requirements where appropriate.
                                               § 359.3 .................................   What regulations apply to this program?                         Same regulations apply as in § 1330.4.
                                               § 359.4 .................................   What definitions apply to this program?                         Not used by NIDILRR.



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                                               79286                     Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Proposed Rules

                                                           ED citation                                                Title                                                  Reason for deletion

                                               Part 359, Subpart B .............          What Kinds of Activities Does the Secretary Assist              Summarizes Rehabilitation Act, does not add new infor-
                                                                                            Under This Program?                                             mation.
                                               § 359.30 ...............................   How is peer review conducted under this program?                Same as in part 1330, subpart C.
                                               § 359.31 ...............................   What selection criteria does the Secretary use in re-           Same as in part 1330, subpart C.
                                                                                            viewing applications under this program?
                                               § 359.32 ...............................   What additional factors does the Secretary consider in          Summarizes Rehabilitation Act, does not add new infor-
                                                                                            making a grant under this program?                              mation.



                                               IV. Impact Analysis                                           information collection request is                     G. Executive Order 13132
                                                                                                             submitted to the Office of Management                    Executive Order 13132 on
                                               A. Executive Orders 12866 and 13563
                                                                                                             and Budget (OMB) for review and                       ‘‘federalism’’ was signed August 4,
                                                  Executive Orders 12866 and 13563                           approval. We are not introducing any                  1999. The purposes of the Order are:
                                               direct agencies to assess all costs and                       new information collections in this                   ‘‘. . . to guarantee the division of
                                               benefits of available regulatory                              proposed rule however, nor revising                   governmental responsibilities between
                                               alternatives, and, if regulation is                           reporting requirements.                               the national government and the States
                                               necessary, to select regulatory
                                                                                                             D. Unfunded Mandates Reform Act                       that was intended by the Framers of the
                                               approaches that maximize net benefits
                                                                                                                                                                   Constitution, to ensure that the
                                               (including potential economic,
                                                                                                                Section 202 of the Unfunded                        principles of federalism established by
                                               environmental, public health and safety
                                                                                                             Mandates Reform Act of 1995                           the Framers guide the executive
                                               effects, distributive impacts, and
                                                                                                             (Unfunded Mandates Act) requires that                 departments and agencies in the
                                               equity). The Department has determined
                                                                                                             a covered agency prepare a budgetary                  formulation and implementation of
                                               that this proposed rule is consistent
                                                                                                             impact statement before promulgating a                policies, and to further the policies of
                                               with the priorities and principles set
                                                                                                             rule that includes any Federal mandate                the Unfunded Mandates Reform Act
                                               forth in Executive Order 12866.
                                                                                                             that may result in expenditures by State,             . . .’’
                                               Executive Order 12866 encourages                                                                                       The Department certifies that this
                                                                                                             local, or Tribal governments, in the
                                               agencies, as appropriate, to provide the                                                                            proposed rule does not have a
                                                                                                             aggregate, or by the private sector, of
                                               public with meaningful participation in                                                                             substantial direct effect on States, on the
                                                                                                             $100 million, adjusted for inflation, or
                                               the regulatory process. The rulemaking                                                                              relationship between the Federal
                                                                                                             more in any one year.
                                               implements the Workforce Innovation                                                                                 government and the States, or on the
                                               and Opportunity Act of 2014. In                                  If a covered agency must prepare a
                                                                                                             budgetary impact statement, section 205               distribution of power and
                                               developing the final rule, we will                                                                                  responsibilities among the various
                                               consider input we received from the                           further requires that it select the most
                                                                                                             cost-effective and least burdensome                   levels of government.
                                               public including stakeholders. This                                                                                    ACL is not aware of any specific State
                                               proposed rule is not being treated as a                       alternatives that achieves the objectives
                                                                                                                                                                   laws that would be preempted by the
                                               ‘‘significant regulatory action’’ under                       of the rule and is consistent with the
                                                                                                                                                                   adoption of the regulation.
                                               section 3(f)(1) of Executive Order 12866.                     statutory requirements. In addition,
                                                                                                             section 203 requires a plan for                         Dated: December 15, 2015.
                                               Accordingly, the proposed rule has not
                                               been reviewed by the Office of                                informing and advising any small                      Kathy Greenlee,
                                               Management and Budget.                                        government that may be significantly or               Administrator, Administration for
                                                                                                             uniquely impacted by a rule.                          Community Living.
                                               B. Regulatory Flexibility Analysis                                                                                    Approved: December 15, 2015.
                                                                                                                ACL has determined that this
                                                 The Secretary certifies under 5 U.S.C.                      proposed rule does not result in the                  Sylvia M. Burwell,
                                               605(b), the Regulatory Flexibility Act                        expenditure by State, local, and Tribal               Secretary, U.S. Department of Health and
                                               (Pub. L. 96–354), that this regulation                        governments in the aggregate, or by the               Human Services.
                                               will not have a significant economic                          private sector of more than $100 million              List of Subjects in 45 CFR Part 1330
                                               impact on a substantial number of small                       in any one year.
                                               entities. The primary impact of this                                                                                  Grant programs, Research,
                                               proposed regulation is on entities                            E. Congressional Review                               Scholarships and fellowships.
                                               applying for NIDILRR funding                                                                                          For reasons set forth in the preamble,
                                               opportunities, specifically researchers,                        This proposed rule is not a major rule              under the authority at 29 U.S.C. 709 and
                                               States, public or private agencies and                        as defined in 5 U.S.C. Section 804(2).                3343, the Department of Health and
                                               organizations, institutions of higher                         F. Assessment of Federal Regulations                  Human Services proposes to add part
                                               education, and Indian tribes and tribal                       and Policies on Families                              1330 of subchapter C title 45 to read as
                                               organizations. The proposed regulation                                                                              set forth below:
                                               does not have a significant economic                             Section 654 of the Treasury and
                                               impact on these entities. This proposed                       General Government Appropriations                     PART 1330—NATIONAL INSTITUTE
                                               rule is in fact significantly shorter than,                   Act of 1999 requires Federal agencies to              FOR DISABILITY, INDEPENDENT
                                               but with identical compliance                                 determine whether a policy or                         LIVING, AND REHABILITATION
                                                                                                                                                                   RESEARCH
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                                               requirements to, the regulations it                           regulation may affect family well-being.
                                               replaces.                                                     If the agency’s conclusion is affirmative,            Subpart A—Disability, Independent Living,
                                                                                                             then the agency must prepare an impact                and Rehabilitation Research Projects and
                                               C. Paperwork Reduction Act of 1995                            assessment addressing seven criteria                  Centers Program
                                                 Under the Paperwork Reduction Act                           specified in the law. These proposed                  Sec.
                                               of 1995, we are required to provide 60-                       regulations do not have an impact on                  1330.1 General.
                                               day notice in the Federal Register and                        family well-being as defined in the                   1330.2 Eligibility for assistance and other
                                               solicit public comment before an                              legislation.                                               regulations and guidance.



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                                                                    Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Proposed Rules                                           79287

                                               1330.3     Definitions.                                 § 1330.2 Eligibility for assistance and                 (d) Research is classified on a
                                               1330.4     Stages of research.                          other regulations and guidance.                       continuum from basic to applied:
                                               1330.5     Stages of development.                          (a) Unless otherwise stated in this part             (1) Basic research is research in which
                                               Subpart B—Requirements for Awardees                     or in a determination by the NIDILRR                  the investigator is concerned primarily
                                               1330.10 General requirements for awardees.              Director, the following entities are                  with gaining new knowledge or
                                               1330.11 Individuals with disabilities from              eligible for an award under this                      understanding of a subject without
                                                   minority backgrounds.                               program:                                              reference to any immediate application
                                                                                                          (1) States.                                        or utility.
                                               Subpart C—Selection of Awardees                            (2) Public or private agencies,                      (2) Applied research is research in
                                               1330.20 Peer review purpose.                            including for-profit agencies.                        which the investigator is primarily
                                               1330.21 Peer review process.                               (3) Public or private organizations,               interested in developing new
                                               1330.22 Composition of peer review panel.               including for-profit organizations.                   knowledge, information, or
                                               1330.23 Evaluation process.                                (4) Institutions of higher education.              understanding which can be applied to
                                               1330.24 Selection criteria.                                (5) Indian tribes and tribal                       a predetermined rehabilitation problem
                                               1330.25 Additional considerations for field-            organizations.
                                                   initiated priorities.                                                                                     or need.
                                                                                                          (b) Other sources of regulation which                (e) Development activities use
                                               Subpart D—Disability, Independent Living,               may apply to awards under this part                   knowledge and understanding gained
                                               and Rehabilitation Research Fellowships                 include but are not limited to:                       form research to create materials,
                                               1330.30 Fellows program.                                   (1) 45 CFR part 16—Procedures of the               devices, systems, or methods beneficial
                                                                                                       Departmental Grant Appeals Board.                     to the target population, including
                                               Subpart E—Special Projects and                             (2) 45 CFR part 46—Protection of
                                               Demonstrations for Spinal Cord Injuries                                                                       design and development of prototypes
                                                                                                       Human Subjects.                                       and processes.
                                               1330.40 Spinal cord injuries program.                      (3) 45 CFR part 75—Uniform
                                                  Authority: 29 U.S.C. 709, 3343.                      Administrative Requirements, Cost                     § 1330.4   Stages of research.
                                                                                                       Principles, and Audit Requirements for                   For any Disability, Independent
                                               Subpart A—Disability, Independent                       HHS Award.                                            Living, and Rehabilitation Research
                                               Living, and Rehabilitation Research                        (4) 2 CFR parts 376 and 382—                       Projects and Centers Program
                                               Projects and Centers Program                            Nonprocurement Debarment and                          competition, the Department may
                                                                                                       Suspension and Requirements for Drug-                 require in the application materials for
                                               § 1330.1    General.                                    Free Workplace (Financial Assistance).                the competition that the applicant
                                                  (a) The Disability, Independent                         (5) 45 CFR part 80—                                identify the stage(s) of research in which
                                               Living, and Rehabilitation Research                     Nondiscrimination under Programs                      it will focus the work of its proposed
                                               Projects and Centers Program provides                   Receiving Federal Assistance through                  project or center. The four stages of
                                               grants to establish and support—                        the Department of Health and Human                    research are—
                                                  (1) The following Disability,                        Services—Effectuation of title VI of the                 (a) Exploration and discovery mean
                                               Independent Living, and Rehabilitation                  Civil Rights Act of 1964.                             the stage of research that generates
                                               Research and Related Projects:                             (6) 45 CFR part 81—Practice and                    hypotheses or theories through new and
                                                  (i) Disability, Independent Living, and              Procedures—Practice and Procedure for                 refined analyses of data, producing
                                               Rehabilitation Research Projects;                       Hearings Act under part 80 of this title.
                                                  (ii) Field-Initiated Projects;                                                                             observational findings and creating
                                                                                                          (7) 45 CFR part 84—                                other sources of research-based
                                                  (iii) Advanced Rehabilitation                        Nondiscrimination on the Basis of
                                               Research Training Projects; and                                                                               information. This research stage may
                                                                                                       Handicap in Programs and Activities                   include identifying or describing the
                                                  (2) The following Disability,                        Receiving or Benefiting from Federal
                                               Independent Living, and Rehabilitation                                                                        barriers to and facilitators of improved
                                                                                                       Financial Assistance.                                 outcomes of individuals with
                                               Research Centers:                                          (8) 45 CFR part 86—
                                                  (i) Rehabilitation Research and                                                                            disabilities, as well as identifying or
                                                                                                       Nondiscrimination on the Basis of Sex                 describing existing practices, programs,
                                               Training Centers;                                       in Education Programs and Activities
                                                  (ii) Rehabilitation Engineering                                                                            or policies that are associated with
                                                                                                       Receiving or Benefiting from Federal                  important aspects of the lives of
                                               Research Centers.
                                                                                                       Financial Assistance.                                 individuals with disabilities. Results
                                                  (b) The purpose of the Disability,
                                                                                                          (9) 45 CFR part 87—Equal Treatment
                                               Independent Living, and Rehabilitation                                                                        achieved under this stage of research
                                                                                                       of Faith-Based Organizations.
                                               Research Projects and Centers Program                                                                         may inform the development of
                                                                                                          (10) 45 CFR part 91—
                                               is to plan and conduct research,                                                                              interventions or lead to evaluations of
                                                                                                       Nondiscrimination on the Basis of Age
                                               development, demonstration projects,                                                                          interventions or policies. The results of
                                                                                                       in Programs or Activities Receiving
                                               training, dissemination, and related                                                                          the exploration and discovery stage of
                                                                                                       Federal Financial Assistance from HHS.
                                               activities, including international                        (11) 45 CFR part 93—New                            research may also be used to inform
                                               activities, to—                                         Restrictions on Lobbying.                             decisions or priorities;
                                                  (1) Develop methods, procedures, and                                                                          (b) Intervention development means
                                               rehabilitation technology, that maximize                § 1330.3    Definitions.                              the stage of research that focuses on
                                               the full inclusion and integration into                   As used in this part:                               generating and testing interventions that
                                               society, employment, education,                           (a) Secretary means the Secretary of                have the potential to improve outcomes
                                               independent living, family support, and                 the Department of Health and Human                    for individuals with disabilities.
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                                               economic and social self-sufficiency of                 Services                                              Intervention development involves
                                               individuals with disabilities, especially                 (b) Administrator means the                         determining the active components of
                                               individuals with the most severe                        Administrator of the Administration for               possible interventions, developing
                                               disabilities; and                                       Community Living                                      measures that would be required to
                                                  (2) Improve the effectiveness of                       (c) Director means the Director of the              illustrate outcomes, specifying target
                                               services authorized under the                           National Institute on Disability,                     populations, conducting field tests, and
                                               Rehabilitation Act of 1973, 29 U.S.C.                   Independent Living, and Rehabilitation                assessing the feasibility of conducting a
                                               701 et seq.                                             Research.                                             well-designed intervention study.


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                                               79288                Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Proposed Rules

                                               Results from this stage of research may                 may have started. Stage results establish                (d) In carrying out a demonstration
                                               be used to inform the design of a study                 that a product concept is feasible.                   activity under this program, an awardee
                                               to test the efficacy of an intervention;                   (b) Proof of product means the stage               shall apply results derived from
                                                  (c) Intervention efficacy means the                  of development where a fully-integrated               previous research, testing, or practice to
                                               stage of research during which a project                and working prototype, meeting critical               determine the effectiveness of a new
                                               evaluates and tests whether an                          technical requirements is created. Stage              strategy or approach.
                                               intervention is feasible, practical, and                activities may include recruiting study                  (e) In carrying out a utilization
                                               has the potential to yield positive                     participants, implementing and                        activity under this program, a grantee
                                               outcomes for individuals with                           iteratively refining the prototype, testing           must relate research findings to
                                               disabilities. Efficacy research may assess              the prototype in natural or less-                     practical applications in planning,
                                               the strength of the relationships                       controlled contexts, and verifying that               policy making, program administration,
                                               between an intervention and outcomes,                   all technical requirements are met. A                 and delivery of services to individuals
                                               and may identify factors or individual                  technology transfer plan is typically                 with disabilities.
                                               characteristics that affect the                         ongoing in collaboration with the                        (f) In carrying out a dissemination
                                               relationship between the intervention                   transfer partner(s). Stage results                    activity under this program, a grantee
                                               and outcomes. Efficacy research can                     establish that a product embodiment is                must systematically distribute
                                               inform decisions about whether there is                 realizable.                                           information or knowledge through a
                                               sufficient evidence to support ‘‘scaling-                  (c) Proof of adoption means the stage              variety of ways to potential users or
                                               up’’ an intervention to other sites and                 of development where a product is                     beneficiaries.
                                               contexts. This stage of research may                    substantially adopted by its target                      (g) In carrying out a technical
                                               include assessing the training needed                   population and used for its intended                  assistance activity under this program, a
                                               for wide-scale implementation of the                    purpose. Stage activities typically                   grantee must provide expertise or
                                               intervention, and approaches to                         include completing product                            information for use in problem-solving.
                                               evaluation of the intervention in real-                 refinements; and continued
                                                                                                       implementation of the technology                      § 1330.11 Individuals with disabilities from
                                               world applications; and
                                                                                                                                                             minority backgrounds.
                                                  (d) Scale-up evaluation means the                    transfer plan in collaboration with the
                                               stage of research during which a project                transfer partner(s). Other activities                    (a) If the director so indicates in the
                                               analyzes whether an intervention is                     include measuring users’ awareness of                 application materials or elsewhere, an
                                               effective in producing improved                         the product, opinion of the product,                  applicant for assistance under this
                                               outcomes for individuals with                           decisions to adopt, use, and retain                   program must demonstrate in its
                                               disabilities when implemented in a real-                products; and identifying barriers and                application how it will address, in
                                               world setting. During this stage of                     facilitators impacting product adoption.              whole or in part, the needs of
                                               research, a project tests the outcomes of               Stage results establish that a product is             individuals with disabilities from
                                               an evidence-based intervention in                       beneficial.                                           minority backgrounds.
                                               different settings. The project examines                                                                         (b) The approaches an applicant may
                                               the challenges to successful replication                Subpart B—Requirements for                            take to meet this requirement may
                                               of the intervention, and the                            Awardees                                              include one or more of the following:
                                                                                                                                                                (1) Proposing project objectives
                                               circumstances and activities that                       § 1330.10 General requirements for                    addressing the needs of individuals
                                               contribute to successful adoption of the                awardees.                                             with disabilities from minority
                                               intervention in real-world settings. This                  (a) In carrying out a research activity            backgrounds.
                                               stage of research may also include well-                under this program, an awardee must—                     (2) Demonstrating that the project will
                                               designed studies of an intervention that                   (1) Identify one or more hypotheses or             address a problem that is of particular
                                               has been widely adopted in practice, but                research questions;                                   significance to individuals with
                                               lacks a sufficient evidence base to                        (2) Based on the hypotheses or                     disabilities from minority backgrounds.
                                               demonstrate its effectiveness.                          research question identified, perform an                 (3) Demonstrating that individuals
                                                                                                       intensive systematic study in                         from minority backgrounds will be
                                               § 1330.5   Stages of development.
                                                                                                       accordance with its approved                          included in study samples in sufficient
                                                  For any Disability, Independent                      application directed toward—
                                               Living, and Rehabilitation Research                                                                           numbers to generate information
                                                                                                          (i) New or full scientific knowledge;              pertinent to individuals with disabilities
                                               Projects and Centers Program                            or
                                               competition, the Department may                                                                               from minority backgrounds.
                                                                                                          (ii) Understanding of the subject or                  (4) Drawing study samples and
                                               require in the notice inviting                          problem being studied.
                                               applications for the competition that the                                                                     program participant rosters from
                                                                                                          (b) In carrying out a development
                                               applicant identify the stage(s) of                                                                            populations or areas that include
                                                                                                       activity under this program, an awardee
                                               development in which it will focus the                                                                        individuals from minority backgrounds.
                                                                                                       must create, using knowledge and                         (5) Providing outreach to individuals
                                               work of its proposed project or center.                 understanding gained from research,                   with disabilities from minority
                                               The three stages of development are—                    models, methods, tools, systems,
                                                  (a) Proof of concept means the stage                                                                       backgrounds to ensure that they are
                                                                                                       materials, devices, systems,                          aware of rehabilitation services, clinical
                                               of development where key technical                      applications, devices, or standards that
                                               challenges are resolved. Stage activities                                                                     care, or training offered by the project.
                                                                                                       are adopted by and beneficial to the                     (6) Disseminating materials to or
                                               may include recruiting study                            target population. Development                        otherwise increasing the access to
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                                               participants, verifying product                         activities span one or more stages of                 disability information among minority
                                               requirements; implementing and testing                  development.                                          populations.
                                               (typically in controlled contexts) key                     (c) In carrying out a training activity
                                               concepts, components, or systems, and                   under this program, an awardee shall                  Subpart C—Selection of Awardees
                                               resolving technical challenges. A                       conduct a planned and systematic
                                               technology transfer plan is typically                   sequence of supervised instruction that               § 1330.20   Peer review purpose.
                                               developed and transfer partner(s)                       is designed to impart predetermined                     The purpose of peer review is to
                                               identified; and plan implementation                     skills and knowledge.                                 insure that—


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                                                                    Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Proposed Rules                                           79289

                                                 (a) Those activities supported by the                 that apply to the Program which may                      (3) The extent to which the proposed
                                               National Institute on Disability,                       include, but are not limited to—                      activities address a significant need of
                                               Independent Living, and Rehabilitation                     (A) Specific statutory selection                   individuals with disabilities.
                                               Research (NIDILRR) are of the highest                   criteria;                                                (4) The extent to which the proposed
                                               scientific, administrative, and technical                  (B) Allowable activities;                          activities address a significant need of
                                               quality; and                                               (C) Application content requirements;              rehabilitation service providers.
                                                 (b) Activity results may be widely                    or                                                       (5) The extent to which the proposed
                                               applied to appropriate target                              (D) Other pre-award and post-award                 activities address a significant need of
                                               populations and rehabilitation                          conditions; or                                        those who provide services to
                                               problems.                                                  (2) The Director may use a                         individuals with disabilities.
                                               § 1330.21   Peer review process.                        combination of selection criteria                        (6) The extent to which the applicant
                                                                                                       established under paragraph (a)(1) of                 proposes to provide training in a
                                                 (a) The Director refers each                                                                                rehabilitation discipline or area of study
                                                                                                       this section and selection criteria from
                                               application for an award governed by                                                                          in which there is a shortage of qualified
                                                                                                       § 1330.24 to evaluate a competition.
                                               those regulations in this part to a peer                                                                      researchers, or to a trainee population in
                                               review panel established by the                            (3) For Field-Initiated Projects, the
                                                                                                       Director does not consider § 1330.24(b)               which there is a need for more qualified
                                               Director.                                                                                                     researchers.
                                                 (b) Peer review panels review                         (Responsiveness to the Absolute or
                                                                                                       Competitive Priority) in evaluating an                   (7) The extent to which the proposed
                                               applications on the basis of the
                                                                                                       application.                                          project will have beneficial impact on
                                               applicable selection criteria in
                                                                                                          (b) In considering selection criteria in           the target population.
                                               § 1330.24.
                                                                                                       § 1330.24, the Director selects one or                   (b) Responsiveness to an absolute or
                                               § 1330.22   Composition of peer review                  more of the factors listed in the criteria,           competitive priority. In determining the
                                               panel.                                                  but always considers the factor in                    application’s responsiveness to the
                                                  (a) The Director selects as members of               § 1330.24(n) regarding members of                     application package or the absolute or
                                               a peer review panel scientists and other                groups that have traditionally been                   competitive priority published in the
                                               experts in disability, independent                      underrepresented based on race, color,                Federal Register, the Director considers
                                               living, rehabilitation or related fields                national origin, gender, age, or                      one or more of the following factors:
                                               who are qualified, on the basis of                      disability.                                              (1) The extent to which the applicant
                                               training, knowledge, or experience, to                     (c) The maximum possible score for                 addresses all requirements of the
                                               give expert advice on the merit of the                  an application is 100 points.                         absolute or competitive priority.
                                               applications under review.                                 (d) In the application package or a                   (2) The extent to which the
                                                  (b) The scientific peer review process               notice published in the Federal                       applicant’s proposed activities are likely
                                               shall be conducted by individuals who                   Register, the Director informs applicants             to achieve the purposes of the absolute
                                               are not Department of Health and                        of—                                                   or competitive priority.
                                               Human Services employees.                                  (1) The selection criteria chosen and                 (c) Design of research activities. In
                                                  (c) In selecting members to serve on                 the maximum possible score for each of                determining the extent to which the
                                               a peer review panel, the Director may                   the selection criteria; and                           design is likely to be effective in
                                               take into account the following factors:                   (2) The factors selected for                       accomplishing the objectives of the
                                                  (1) The level of formal scientific or                considering the selection criteria and if             project, the Director considers one or
                                               technical education completed by                        points are assigned to each factor, the               more of the following factors:
                                               potential panel members.                                maximum possible score for each factor                   (1) The extent to which the research
                                                  (2) The extent to which potential                                                                          activities constitute a coherent,
                                                                                                       under each criterion. If no points are
                                               panel members have engaged in                                                                                 sustained approach to research in the
                                                                                                       assigned to each factor, the Director
                                               scientific, technical, or administrative                                                                      field, including a substantial addition to
                                                                                                       evaluates each factor equally.
                                               activities appropriate to the category of                                                                     the state-of-the-art.
                                                                                                          (e) For all instances in which the
                                               applications that the panel will                                                                                 (2) The extent to which the
                                                                                                       Director chooses to allow field-initiated
                                               consider; the roles of potential panel                                                                        methodology of each proposed research
                                                                                                       research and development, the selection
                                               members in those activities; and the                                                                          activity is meritorious, including
                                                                                                       criteria in § 1330.25 will apply,
                                               quality of those activities.                                                                                  consideration of the extent to which—
                                                  (3) The recognition received by                      including the requirement that the
                                                                                                       applicant must achieve a score of 80                     (i) The proposed design includes a
                                               potential panel members as reflected by                                                                       comprehensive and informed review of
                                               awards and other honors from scientific                 percent or more of maximum possible
                                                                                                       points.                                               the current literature, demonstrating
                                               and professional agencies and                                                                                 knowledge of the state-of-the-art;
                                               organizations outside the Department.                   § 1330.24    Selection criteria.                         (ii) Each research hypothesis or
                                                  (4) Whether the panel includes
                                                                                                         In addition to criteria established                 research question, as appropriate, is
                                               knowledgeable individuals with
                                                                                                       under § 1330.23(a)(1), the Director may               theoretically sound and based on
                                               disabilities, or parents, family members,
                                                                                                       select one or more of the following                   current knowledge;
                                               guardians, advocates, or authorized
                                                                                                       criteria in evaluating an application:                   (iii) Each sample is drawn from an
                                               representatives of individuals with
                                                                                                         (a) Importance of the problem. In                   appropriate, specified population and is
                                               disabilities.
                                                  (5) Whether the panel includes                       determining the importance of the                     of sufficient size to address the
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                                               individuals from diverse populations.                   problem, the Director considers one or                proposed hypotheses or research
                                                                                                       more of the following factors:                        questions, as appropriate, and to
                                               § 1330.23   Evaluation process.                           (1) The extent to which the applicant               support the proposed data analysis
                                                 (a) The Director selects one or more of               clearly describes the need and target                 methods;
                                               the selection criteria in § 1330.24 to                  population.                                              (iv) The source or sources of the data
                                               evaluate an application;                                  (2) The extent to which the proposed                and the data collection methods are
                                                 (1) The Director establishes selection                activities further the purposes of the                appropriate to address the proposed
                                               criteria based on statutory provisions                  Act.                                                  hypotheses or research questions and to


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                                               79290                Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Proposed Rules

                                               support the proposed data analysis                      likely to be effective in accomplishing                  (9) The extent to which the quality
                                               methods;                                                the objectives of the project, the Director           and extent of the academic mentorship,
                                                  (v) The data analysis methods are                    considers one or more of the following                guidance, and supervision to be
                                               appropriate;                                            factors:                                              provided to each individual trainee are
                                                  (vi) Implementation of the proposed                     (1) The extent to which the proposed               of a high level and are likely to develop
                                               research design is feasible, given the                  demonstration activities build on                     highly qualified researchers.
                                               current state of the science and the time               previous research, testing, or practices.                (10) The extent to which the type,
                                               and resources available;                                   (2) The extent to which the proposed               extent, and quality of the proposed
                                                  (vii) Input of individuals with                      demonstration activities include the use              research experience, including the
                                               disabilities and other key stakeholders                 of proper methodological tools and                    opportunity to participate in advanced-
                                               is used to shape the proposed research                  theoretically sound procedures to                     level research, are likely to develop
                                               activities; and                                         determine the effectiveness of the                    highly qualified researchers.
                                                  (viii) The applicant identifies and                  strategy or approach.                                    (11) The extent to which the
                                               justifies the stage of research being                      (3) The extent to which the proposed               opportunities for collegial and
                                               proposed and the research methods                       demonstration activities include                      collaborative activities, exposure to
                                               associated with the stage.                              innovative and effective strategies or                outstanding scientists in the field, and
                                                  (3) The extent to which anticipated                  approaches.                                           opportunities to participate in the
                                               research results are likely to satisfy the                 (4) The extent to which the proposed
                                                                                                                                                             preparation of scholarly or scientific
                                               original hypotheses or answer the                       demonstration activities are likely to
                                                                                                                                                             publications and presentations are
                                               original research questions, as                         contribute to current knowledge and
                                                                                                                                                             extensive and appropriate.
                                               appropriate, and could be used for                      practice and be a substantial addition to
                                                                                                                                                                (g) Design of dissemination activities.
                                               planning additional research, including                 the state-of-the-art.
                                                                                                          (5) The extent to which the proposed               In determining the extent to which the
                                               generation of new hypotheses or                                                                               design is likely to be effective in
                                               research questions, where applicable.                   demonstration activities can be applied
                                                                                                       and replicated in other settings.                     accomplishing the objectives of the
                                                  (4) The extent to which the stage of                                                                       project, the Director considers one or
                                               research is identified and justified in the                (f) Design of training activities. In
                                                                                                       determining the extent to which the                   more of the following factors:
                                               description of the research project(s)                                                                           (1) The extent to which the content of
                                               being proposed.                                         design is likely to be effective in
                                                                                                       accomplishing the objectives of the                   the information to be disseminated—
                                                  (d) Design of development activities.                                                                         (i) Covers all of the relevant aspects of
                                               In determining the extent to which the                  project, the Director considers one or
                                                                                                       more of the following factors:                        the subject matter; and
                                               project design is likely to be effective in
                                                                                                          (1) The extent to which the proposed                  (ii) If appropriate, is based on new
                                               accomplishing project objectives, the
                                                                                                       training materials are likely to be                   knowledge derived from research
                                               Secretary considers one or more of the
                                                                                                       effective, including consideration of                 activities of the project.
                                               following factors:
                                                                                                       their quality, clarity, and variety.                     (2) The extent to which the materials
                                                  (1) The extent to which the proposed
                                                                                                          (2) The extent to which the proposed               to be disseminated are likely to be
                                               project identifies a significant need and
                                                                                                       training methods are of sufficient                    effective and usable, including
                                               a well-defined target population for the
                                                                                                       quality, intensity, and duration.                     consideration of their quality, clarity,
                                               new or improved product;                                   (3) The extent to which the proposed
                                                  (2) The extent to which the proposed                                                                       variety, and format.
                                                                                                       training content—                                        (3) The extent to which the methods
                                               project methodology is meritorious,                        (i) Covers all of the relevant aspects of
                                               including consideration of the extent to                                                                      for dissemination are of sufficient
                                                                                                       the subject matter; and                               quality, intensity, and duration.
                                               which—                                                     (ii) If relevant, is based on new
                                                  (i) The proposed project shows                                                                                (4) The extent to which the materials
                                                                                                       knowledge derived from research                       and information to be disseminated and
                                               awareness of the state-of-the-art for                   activities of the proposed project.
                                               current, related products;                                                                                    the methods for dissemination are
                                                                                                          (4) The extent to which the proposed               appropriate to the target population,
                                                  (ii) The proposed project employs                    training materials, methods, and content
                                               appropriate concepts, components, or                                                                          including consideration of the
                                                                                                       are appropriate to the trainees,
                                               systems to develop the new or improved                                                                        familiarity of the target population with
                                                                                                       including consideration of the skill level
                                               product;                                                                                                      the subject matter, format of the
                                                                                                       of the trainees and the subject matter of
                                                  (iii) The proposed project employs                                                                         information, and subject matter.
                                                                                                       the materials.
                                               appropriate samples in tests, trials, and                  (5) The extent to which the proposed                  (5) The extent to which the
                                               other development activities.                           training materials and methods are                    information to be disseminated will be
                                                  (iv) The proposed project conducts                   accessible to individuals with                        accessible to individuals with
                                               development activities in appropriate                   disabilities.                                         disabilities.
                                               environment(s);                                            (6) The extent to which the                           (h) Design of utilization activities. In
                                                  (v) Input from individuals with                      applicant’s proposed recruitment                      determining the extent to which the
                                               disabilities and other key stakeholders                 program is likely to be effective in                  design of utilization activities is likely
                                               is obtained to establish and guide                      recruiting highly qualified trainees,                 to be effective in accomplishing the
                                               proposed development activities; and                    including those who are individuals                   objectives of the project, the Director
                                                  (vi) The applicant identifies and                    with disabilities.                                    considers one or more of the following
                                               justifies the stage(s) of development for                  (7) The extent to which the applicant              factors:
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                                               the proposed project; and activities                    is able to carry out the training                        (1) The extent to which the potential
                                               associated with each stage.                             activities, either directly or through                new users of the information or
                                                  (3) The new device or technique will                 another entity.                                       technology have a practical use for the
                                               be developed and tested in an                              (8) The extent to which the proposed               information and are likely to adopt the
                                               appropriate environment;                                didactic and classroom training                       practices or use the information or
                                                  (e) Design of demonstration activities.              programs emphasize scientific                         technology, including new devices.
                                               In determining the extent to which the                  methodology and are likely to develop                    (2) The extent to which the utilization
                                               design of demonstration activities is                   highly qualified researchers.                         strategies are likely to be effective.


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                                                                    Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Proposed Rules                                            79291

                                                 (3) The extent to which the                              (2) The extent to which the budget for             project, the Director considers one or
                                               information or technology is likely to be               the project, including any subcontracts,              more of the following factors:
                                               of use in other settings.                               is adequately justified to support the                   (1) The extent to which the applicant
                                                 (i) Design of technical assistance                    proposed project activities.                          is committed to provide adequate
                                               activities. In determining the extent to                   (3) The extent to which the applicant              facilities, equipment, other resources,
                                               which the design of technical assistance                is of sufficient size, scope, and quality             including administrative support, and
                                               activities is likely to be effective in                 to effectively carry out the activities in            laboratories, if appropriate.
                                               accomplishing the objectives of the                     an efficient manner.                                     (2) The quality of an applicant’s past
                                               project, the Director considers one or                     (m) Plan of evaluation. In determining             performance in carrying out a grant.
                                               more of the following factors:                          the quality of the plan of evaluation, the               (3) The extent to which the applicant
                                                 (1) The extent to which the methods                   Director considers one or more of the                 has appropriate access to populations
                                               for providing technical assistance are of               following factors:                                    and organizations representing
                                               sufficient quality, intensity, and                         (1) The extent to which the plan of                individuals with disabilities to support
                                               duration.                                               evaluation provides for periodic                      advanced disability, independent living
                                                 (2) The extent to which the                           assessment of progress toward—                        and clinical rehabilitation research.
                                               information to be provided through                         (i) Implementing the plan of                          (4) The extent to which the facilities,
                                               technical assistance covers all of the                  operation; and                                        equipment, and other resources are
                                               relevant aspects of the subject matter.                    (ii) Achieving the project’s intended              appropriately accessible to individuals
                                                 (3) The extent to which the technical                 outcomes and expected impacts.                        with disabilities who may use the
                                               assistance is appropriate to the target                    (2) The extent to which the plan of                facilities, equipment, and other
                                               population, including consideration of                  evaluation will be used to improve the                resources of the project.
                                               the knowledge level of the target                       performance of the project through the
                                               population, needs of the target                         feedback generated by its periodic                    § 1330.25 Additional considerations for
                                               population, and format for providing                    assessments.                                          field-initiated priorities.
                                               information.                                               (3) The extent to which the plan of                  (a) The Director reserves funds to
                                                 (4) The extent to which the technical                 evaluation provides for periodic                      support field-initiated applications
                                               assistance is accessible to individuals                 assessment of a project’s progress that is            funded under this part when those
                                               with disabilities.                                      based on identified performance                       applications have been awarded points
                                                 (j) Plan of operation. In determining                 measures that—                                        totaling 80 percent or more of the
                                               the quality of the plan of operation, the                  (i) Are clearly related to the intended            maximum possible points under the
                                               Director considers one or more of the                   outcomes of the project and expected                  procedures described in § 1330.23.
                                               following factors:                                      impacts on the target population; and                   (b) In making a final selection from
                                                 (1) The adequacy of the plan of                          (ii) Are objective, and quantifiable or            applications received when NIDILRR
                                               operation to achieve the objectives of                  qualitative, as appropriate.                          uses field-initiated priorities, the
                                               the proposed project on time and within                    (n) Project staff. In determining the              Director may consider whether one of
                                               budget, including clearly defined                       quality of the project staff, the Director            the following conditions is met and, if
                                               responsibilities, and timelines for                     considers the extent to which the                     so, use this information to fund an
                                               accomplishing project tasks.                            applicant encourages applications for                 application out of rank order:
                                                 (2) The adequacy of the plan of                       employment from persons who are                         (1) The proposed project represents a
                                               operation to provide for using resources,               members of groups that have                           unique opportunity to advance
                                               equipment, and personnel to achieve                     traditionally been underrepresented                   rehabilitation and other knowledge to
                                               each objective.                                         based on race, color, national origin,                improve the lives of individual with
                                                 (k) Collaboration. In determining the                 gender, age, or disability. In addition,              disabilities.
                                               quality of collaboration, the Director                  the Director considers one or more of                   (2) The proposed project
                                               considers one or more of the following                  the following:                                        complements or balances research
                                               factors:                                                   (1) The extent to which the key                    activity already planned or funded by
                                                 (1) The extent to which the                           personnel and other key staff have                    NIDILRR through its annual priorities or
                                               applicant’s proposed collaboration with                 appropriate training and experience in                addresses the research in a new and
                                               one or more agencies, organizations, or                 disciplines required to conduct all                   promising way.
                                               institutions is likely to be effective in               proposed activities.
                                               achieving the relevant proposed                            (2) The extent to which the                        Subpart D—Disability, Independent
                                               activities of the project.                              commitment of staff time is adequate to               Living, and Rehabilitation Research
                                                 (2) The extent to which agencies,                     accomplish all the proposed activities of             Fellowships
                                               organizations, or institutions                          the project.
                                               demonstrate a commitment to                                (3) The extent to which the key                    § 1330.30   Fellows program.
                                               collaborate with the applicant.                         personnel are knowledgeable about the                   (a) The purpose of this program is to
                                                 (3) The extent to which agencies,                     methodology and literature of pertinent               build research capacity by providing
                                               organizations, or institutions that                     subject areas.                                        support to highly qualified individuals,
                                               commit to collaborate with the                             (4) The extent to which the project                including those who are individuals
                                               applicant have the capacity to carry out                staff includes outstanding scientists in              with disabilities, to perform research on
                                               collaborative activities.                               the field.                                            rehabilitation, independent living, and
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                                                 (l) Adequacy and reasonableness of                       (5) The extent to which key personnel              other experiences and outcomes of
                                               the budget. In determining the adequacy                 have up-to-date knowledge from                        individuals with disabilities.
                                               and the reasonableness of the proposed                  research or effective practice in the                   (b) The eligibility requirements for the
                                               budget, the Director considers one or                   subject area covered in the priority.                 Fellows program are as follows:
                                               more of the following factors:                             (o) Adequacy and accessibility of                    (1) Only individuals are eligible to be
                                                 (1) The extent to which the costs are                 resources. In determining the adequacy                recipients of Fellowships.
                                               reasonable in relation to the proposed                  and accessibility of the applicant’s                    (2) Any individual is eligible for
                                               project activities.                                     resources to implement the proposed                   assistance under this program who has


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                                               79292                Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Proposed Rules

                                               training and experience that indicate a                       Notice of proposed NEPA
                                                                                                       ACTION:                                               procedures consistent with the CEQ
                                               potential for engaging in scientific                    implementation rule; request for public               regulations. The Denali Commission
                                               research related to rehabilitation and                  comment.                                              proposes the following NEPA
                                               independent living for individuals with                                                                       implementing procedures for complying
                                               disabilities.                                           SUMMARY:   The Denali Commission                      with NEPA and the CEQ regulations.
                                                  (3) This program provides two                        proposes to establish 45 CFR Chapter IX               The remaining sections of
                                               categories of Fellowships: Merit                        and to add regulations for implementing               SUPPLEMENTARY INFORMATION will
                                               Fellowships and Distinguished                           the National Environmental Policy Act                 provide background. Following the
                                               Fellowships.                                            of 1969 (NEPA), as amended, and                       SUPPLEMENTARY INFORMATION is the text
                                                  (i) To be eligible for a Distinguished               invites public comment on the proposed                of the proposed procedures.
                                               Fellowship, an individual must have                     rule. All comments will be considered
                                               seven or more years of research                         in preparing the final regulations, which             Background
                                               experience in subject areas, methods, or                will be made available to the public on                 In accordance with CEQ regulations
                                               techniques relevant to disability and                   the Commission’s internet site at http://             (40 CFR 1507.3), the Commission
                                               rehabilitation research and must have a                 www.denali.gov.                                       consulted with the CEQ prior to
                                               doctorate, other terminal degree, or                    DATES: Comments and related material                  publication of the proposed rule. On
                                               comparable academic qualifications.                     must be received by January 20, 2016.                 August 10, 2004, the Commission
                                                  (ii) The Director awards Merit                       ADDRESSES: You may submit comments                    published a proposed rule in the
                                               Fellowships to individuals in earlier                   to this rule by any of the following                  Federal Register (69 FR 48435) and
                                               stages of their careers in research. To be              methods:                                              invited public comment. The
                                               eligible for a Merit Fellowship, an                       Federal eRulemaking Portal: http://                 Commission considered the comments
                                               individual must have either advanced                    www.regulations.gov. Follow the                       received on the 2004 proposed rule. On
                                               professional training or experience in                                                                        March 6, 2006, however, the
                                                                                                       instructions for submitting comments.
                                               independent study in an area which is                     Mail, Hand Delivery, or Courier:                    Commission published a notice in the
                                               directly pertinent to disability and                                                                          Federal Register withdrawing the 2004
                                                                                                       Denali Commission, Attn: NEPA
                                               rehabilitation.                                                                                               proposed rule (71 FR 13563). At the
                                                                                                       Comments; 510 L Street, Suite 410;
                                                  (c) Fellowships will be awarded in the                                                                     time, the Commission intended to adopt
                                               form of a grant to eligible individuals.                Anchorage, AK 99501.
                                                                                                         All written comments will be                        guidelines for implementing NEPA
                                                  (d) In making a final selection of
                                                                                                       available for public inspection during                instead of promulgating a final rule.
                                               applicants to support under this
                                                                                                       regular work hours at the 510 L Street,               Since that time, however, the
                                               program, the Director considers the
                                                                                                       Suite 410 address listed above.                       Commission has concluded that the
                                               extent to which applicants present a
                                                                                                       FOR FURTHER INFORMATION CONTACT: Mr.                  approach outlined in the 2004 proposed
                                               unique opportunity to effect a major
                                                                                                       John Whittington, 907–271–1414.                       rule was appropriate and is issuing this
                                               advance in knowledge, address critical
                                                                                                       SUPPLEMENTARY INFORMATION:
                                                                                                                                                             revised version of the proposed rule for
                                               problems in innovative ways, present
                                                                                                                                                             review and comment before proceeding
                                               proposals which are consistent with the
                                                                                                       General                                               to promulgate a final rule. The
                                               Institute’s Long-Range Plan, build
                                                                                                          Introduced by Congress in 1998, the                rulemaking process maximizes public
                                               research capacity within the field, or
                                                                                                       Denali Commission (Commission) is an                  involvement during the development of
                                               complement and significantly increases
                                                                                                       innovative federal-state partnership                  the regulations, and once finalized,
                                               the potential value of already planned
                                                                                                       designed to provide critical utilities,               regulations provide a consistent NEPA
                                               research and related activities.
                                                                                                       infrastructure, and economic support                  approach internally and with
                                               Subpart E—Special Projects and                          throughout Alaska. With the creation of               cooperating agencies.
                                               Demonstrations for Spinal Cord                          the Commission, Congress                                The proposed rule published today
                                               Injuries                                                acknowledged the need for increased                   reflects the Commission’s consideration
                                                                                                       inter-agency cooperation and focus on                 of and responses to the public
                                               § 1330.40    Spinal cord injuries program.                                                                    comments received on the 2004
                                                                                                       Alaska’s remote communities. Since its
                                                  (a) This program provides assistance                 first meeting in April 1999, the                      proposed rule.
                                               to establish innovative projects for the                Commission is credited with providing                 Responses to 2004 Comments
                                               delivery, demonstration, and evaluation                 numerous cost-shared infrastructure
                                               of comprehensive medical, vocational,                   projects across the State that exemplify                 The Commission received, reviewed
                                               independent living, and rehabilitation                  effective and efficient partnership                   and considered two letters of comment
                                               services to meet the wide range of needs                between federal and state agencies, and               on the August 10, 2004 Federal Register
                                               of individuals with spinal cord injuries.               the private sector.                                   notice. The comments and changes are
                                                  (b) The agencies and organizations                      The National Environmental Policy                  discussed below by section and
                                               eligible to apply under this program are                Act (NEPA) and implementing                           paragraph of the proposed rule. All
                                               described in 45 CFR 1330.2.                             regulations promulgated by the Council                sections addressed in the comment
                                               [FR Doc. 2015–31907 Filed 12–18–15; 8:45 am]            on Environmental Quality (CEQ) (40                    letters are discussed.
                                               BILLING CODE P                                          CFR parts 1500–1508) establish a broad                Subpart A—General
                                                                                                       national policy to protect the quality of
                                                                                                       the human environment and to ensure                   Section 900.103    Terms and
                                                                                                                                                             Abbreviations
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                                               DENALI COMMISSION                                       that environmental considerations and
                                                                                                       associated public concerns are given                    A comment was made to clarify the
                                               45 CFR Chapter IX                                       careful attention and appropriate weight              term ‘‘applicant’’ in subsection (a)(2).
                                                                                                       in all decisions of the federal                       We reviewed the subsection and have
                                               National Environmental Policy Act
                                                                                                       government. Sections 102(2) of NEPA                   clarified that an applicant can be a
                                               Implementing Procedures and
                                                                                                       and 40 CFR 1505.1 and 1507.3 require                  federal, state and local government or
                                               Categorical Exclusions
                                                                                                       federal agencies to develop and, as                   non-governmental partner or
                                               AGENCY:     Denali Commission.                          needed, revise implementing                           organization and also added ‘‘An


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Document Created: 2015-12-19 02:56:51
Document Modified: 2015-12-19 02:56:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesComments are due on or before February 19, 2016.
ContactGreg Pugh, Administration for Community Living, telephone (202) 795-7422 (Voice). This is not a toll- free number. This document will be made available in alternative formats upon request.
FR Citation80 FR 79283 
RIN Number0985-AA12
CFR AssociatedGrant Programs; Research and Scholarships and Fellowships

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