81_FR_29247 81 FR 29156 - National Institute on Disability, Independent Living, and Rehabilitation Research

81 FR 29156 - National Institute on Disability, Independent Living, and Rehabilitation Research

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 91 (May 11, 2016)

Page Range29156-29165
FR Document2016-10853

This rule implements the Workforce Innovation and Opportunity Act of 2014 and reflects 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 (HHS). The previous regulations were issued by the Department of Education. The rulemaking consolidates the NIDILRR regulations into a single part, aligns the regulations with the current statute and HHS policies, and provides guidance to NIDILRR grantees.

Federal Register, Volume 81 Issue 91 (Wednesday, May 11, 2016)
[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Rules and Regulations]
[Pages 29156-29165]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-10853]


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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: Final rule.

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SUMMARY: This rule implements the Workforce Innovation and Opportunity 
Act of 2014 and reflects 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 (HHS). The previous regulations were issued by the Department 
of Education. The rulemaking consolidates the NIDILRR regulations into 
a single part, aligns the regulations with the current statute and HHS 
policies, and provides guidance to NIDILRR grantees.

DATES: These final regulations are effective July 1, 2016.

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. Discussion of Final Rule

    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 to the Administration for Community Living 
(``ACL'') of the Department of Health and Human Services. As part of 
the transfer, the Administrator of ACL (Administrator) drafted a Notice 
of Proposed Rulemaking that was published on December 21, 2015, to 
implement the Workforce Innovation and Opportunity Act of 2014 and 
reflect the transfer of the National Institute on Disability, 
Independent Living, and Rehabilitation Research from the Department of 
Education to the Department of Health and Human Services.
    ACL received 13 unduplicated comments during the public comment 
period from individuals, state agencies, and organizations representing 
disability, rehabilitation, and aging constituencies. ACL has read and 
considered each of the comments received. We respond here to the most-
commonly-received comments and those that we believe require further 
discussion. Several comments raised issues that are specific to the 
commenter. Responding to such comments is beyond the scope of the final 
regulation. Nevertheless, we encourage commenters with individualized 
questions to contact NIDILRR directly at 202-401-4634--Option 5.
    Many of the comments expressed broad general support for the rule 
and the broader transfer of NIDILRR to the Administration for Community 
Living. Commenters expressed their support of the consolidation of 
existing NIDILRR regulations and alignment with HHS policies, a major 
goal of this rulemaking. Others expressed their approval of the 
elimination of unnecessary language from the regulatory text, while at 
the same time maintaining existing Department of Education language 
where it makes programmatic sense to do so. Finally, multiple 
commenters wrote in support of the inclusion of the stages of research, 
as well as the new stages of development.
    While no commenters expressed general opposition to the 
promulgation of the rule, several expressed their concerns about 
specific provisions of the proposed rule. We made changes to the 
regulatory text based on the comments as discussed below and we fixed a 
few non-substantive technical errors in the regulatory text. In 
addition, it has come to our attention that a selection criterion used 
at the Department of Education related to the quality of a proposed 
project's design was inadvertently omitted from this rule. This 
criterion is extremely valuable to the evaluation of applications for 
certain NIDILRR projects, and we have therefore included it verbatim at 
Sec.  1330.24(p) as one of the criteria the Director may consider in 
evaluating an application. Other than the changes discussed below, we 
adopt our discussion of the rule in the Notice of Proposed Rulemaking 
published December 21, 2015 (80 FR 79283).

A. Funding Out of Rank Order in Field-Initiated Competitions

    Comment: Six commenters (five organizations and one individual) 
raised concerns about a proposed change to Sec.  1330.25. The proposed 
regulation gives the NIDILRR director authority to fund out of rank 
order in field-initiated competitions when there is an opportunity to 
fund a project of significant interest to the agency. Concerns ranged 
from the change giving too much authority to political appointees to 
the potential undermining of the scientific integrity of the research 
process. Suggestions ranged from dropping this proposed change in the 
regulation to increasing the scoring threshold for use of the provision 
or to creating a requirement for a formal explanation by the NIDILRR 
director justifying the proposed change.
    Response: NIDILRR appreciates the concerns expressed by these 
commenters especially the focus on impartial peer review and its role 
in maintaining the scientific integrity of NIDILRR's research 
portfolio. Our goal in suggesting this change was to provide an 
opportunity for the Director to select applications that address 
critical agency goals in circumstances where these applications have 
high scores but would not be funded in a strictly rank order

[[Page 29157]]

framework. NIDILRR has long had the ability to fund out of rank order, 
and though it was rarely used, we added the 80 percent threshold in an 
effort to ensure the quality of NIDILRR-funded research. NIDILRR has 
expanded our field-initiated research opportunities in recent years, 
and we think that clarifying the requirements for funding out of rank 
order will ensure this quality, while also allowing for funding of 
compelling research opportunities. In such cases where an application 
may have otherwise gone unfunded in a strict rank-order process, we 
believe that the Director should have the ability to fund highly 
promising studies, while setting a minimum threshold for quality 
assurance and providing for public notification.
    After careful consideration of the concerns raised by the 
commenters, as well as a review of past applications, NIDILRR proposes 
to increase the threshold before funding out of rank order can be 
considered to a score of 85 points or above. We believe, based upon 
decades of staff experience with the grant review process, that this 
number strikes a reasonable balance between providing the Director the 
flexibility to fund applications which are uniquely promising and 
ensuring that all NIDILRR-funded research projects are of the quality 
and rigor for which NIDILRR is known. In addition, the regulation has 
been amended to require a public notification by the Director of any 
decision to fund out of rank order. Should it become advisable to raise 
this threshold further, we may revisit this threshold in the future. We 
take these steps to clarify our commitment to conducting rigorous peer 
review.

B. Publication of Funding Opportunities and Application Instructions

    Comment: In light of the new regulation's elimination of specific 
funding application instructions, two commenters suggested that NIDILRR 
update its Web site to provide clear information to applicants on 
funding opportunities and on the process of submitting applications.
    Response: NIDILRR shares these commenters' commitment to ensuring 
that potential grantees have adequate access to information on 
NIDILRR's research priorities and application processes. To this end, 
we are publishing funding forecast documents with links to necessary 
application information on the ACL Web site, and will endeavor at all 
times to maximize the transparency and wide dissemination of funding 
opportunities and application instructions.

C. Stages of Development

    Comment: One commenter, while supporting the stages of development 
in Sec.  1330.5, expressed concern that the rule doesn't make clear 
that the technology transfer plan requirement does not sufficiently 
convey the complexity of supply and demand and the behaviors of 
consumers and other stakeholders in their decisions to adopt and use 
technology.
    Response: The stages of development provide an organizational 
framework to guide prospective applicants in preparing their technical 
proposals. The stages are not prescriptive. For this reason, we believe 
that identifying the relevant stage(s) of development will allow the 
peer review process to better determine the extent to which proposed 
activities to facilitate and measure product adoption are necessary and 
appropriate and to determine the extent to which applicants understand 
contextual factors that might impact product adoption.

D. Disability Advisory Panels and Reviewer Training

    Comment: One organization made a number of suggestions related to 
NIDILRR's peer review process as described in Sec.  1330.22. This 
commenter recommended that NIDILRR form advisory panels with members 
with diverse disabilities, including physical, sensory, intellectual, 
and mental disabilities, to be assigned to each peer review panel to 
ensure that disability perspectives are considered in the funding 
decision.
    In addition, the commenter suggested reviewer training related to 
consistent weighting of scores, minimizing personal biases of 
reviewers, and reviewing and scoring application attachments. The 
commenter also suggested that NIDILRR provide training to the 
disability advisory panels to ensure that personal likes and dislikes 
of the reviewers not enter into the scoring.
    Response: NIDILRR strongly supports a diversity of perspectives on 
peer review panels and makes every effort to include reviewers who have 
disabilities as well as subject-matter expertise relevant to the 
research or development topic. We are constantly seeking to recruit 
new, qualified individuals with disabilities for these purposes. We 
require our peer reviewers to attend an orientation session and, if 
they are new to our system, participate in training sessions to ensure 
that they understand the technical requirements of the process. NIDILRR 
staff monitors each panel to ensure that the review is carried out in a 
professional manner and further to ensure that each application is 
treated fairly.
    To support the importance of research and development focused on 
the needs of individuals with disabilities, NIDILRR has already added a 
requirement that applicants must obtain input from individuals with 
disabilities and other stakeholders in shaping proposed research or 
development activities. NIDILRR is also finalizing approval of its 
Disability, Independent Living, and Rehabilitation Research Advisory 
Council (DILRRAC) which adheres to a statutory requirement that more 
than 50% of its membership be comprised of individuals with 
disabilities. We believe that this committee will provide valuable 
guidance regarding ways that we can improve the relevance of NIDILRR's 
research to individuals with disabilities. We are confident that all of 
these steps will address the commenters concerns without adding 
significant administrative burden and expense to the peer review 
process.

E. Collaboration

    Comment: Two commenters suggested additions to the peer review 
criterion on collaboration in Sec.  1330.24(k). Both suggested more 
specific requirements for collaboration with local and national 
consumer organizations, and one also included a recommendation for 
requiring meaningful collaboration with other relevant agencies, 
organizations, or institutions. In addition, one of the commenters 
suggested weighting the collaboration criterion more heavily.
    Response: NIDILRR strongly agrees that it is important to seek 
appropriate collaboration where relevant to the specific research or 
development project being proposed. To this end, we have long had a 
collaboration review element which is required for many funding 
priorities. We believe that this requirement is adequate, and that to 
require it of all research or development projects would be misguided, 
as collaboration may not be relevant for the research topic or stage of 
research or development being proposed.
    Specific weighting of review criteria is not prescribed by 
regulation so as to allow weighting as appropriate to the purpose and 
goals of each funding priority. More specific regulatory language on 
weighting would significantly limit NIDILRR's ability to match 
individual criteria with the topic of the priority at hand.

[[Page 29158]]

F. Notification of Review Scores and Comments

    Comment: Two commenters suggested the insertion into regulation a 
requirement that applicants will receive reviewer scores and comments 
within 30 days of NIDILRR decisions.
    Response: This is already a part of NIDILRR's grants management 
policy, and we make every effort to ensure that notification of scores 
and comments is provided within a 30 day timeframe. We believe that to 
specifically require this in regulation would be counter to the stated 
objectives of consolidating and simplifying the regulatory language, to 
which many commenters responded very favorably.

G. Posting of Applicant Scores

    Comment: One commenter suggested that NIDILRR post a list of 
applicants and aggregate scores on its Web site at the conclusion of a 
competition.
    Response: NIDILRR's goal is to fund rigorous and relevant research, 
as determine by an independent panel of individuals with subject-
specific expertise and with knowledge of and sensitivity to the needs 
of individuals with disabilities. We ask these reviewers to provide 
detailed and thoughtful comments on the proposals they review, and we 
send this feedback to applicants in an effort to help build capacity in 
disability and rehabilitation research. We do not believe that listing 
unsuccessful applicants and their scores would further this goal, and 
believe that doing so would be contrary to HHS grants policy with 
regard to applicant privacy.

H. Meaning of ``Product''

    Comment: One organization raised several questions about the 
meaning of the term ``product'' in our discussion of stages of 
development, specifically requesting that NIDILRR define the term and 
what it includes. A related comment recommended that NIDILRR provide 
clarification to the concept of ``proof of product'' to ensure that it 
includes functional requirements such as accessibility and usability or 
market viability requirements such as price or performance. This 
commenter also suggested that NIDILRR elaborate on its expectations of 
the attributes associated with the stages of development. Finally, 
there was one comment asking that there be consistent use of the term 
product in the document.
    Response: NIDILRR carefully considered these comments which helped 
us think about the extent to which we wanted to make the definition of 
``product'' to be enumerative or non-enumerative and to allow for 
changes in conceptualization over time. Our conclusion is that 
flexibility is needed and beneficial. To this end, we are defining 
products as potentially encompassing but not necessarily limited to 
models, methods, tools, applications, and devices. Applicants can 
associate proposed products to these types or clarify and defend why 
proposed products lie outside of these types. Finally, we agree that it 
would contribute to clarity to use the term, ``product'' consistently 
in the document, and we have made this change accordingly.

I. Removal of ``Scientific'' From Peer Review Panels

    Comment: A commenter suggested that NIDILRR remove the term 
``scientific'' from the description of its peer review panels.
    Response: NIDILRR's authorizing statute specifically requires the 
NIDILRR Director to provide for scientific review of all applications 
over which the Director has authority. 29 U.S.C. 762(f)(1). Given the 
statutory requirement, NIDILRR feels that it must adhere to this 
standard which confirms Congressional intent to ensure that NIDILRR 
carry out its peer review so that scientific expertise supports 
rigorous review that help ensures that NIDILRR funds the research that 
is likely to generate findings that will help improve the lives of 
individuals with disabilities. However, NIDILRR also notes that this 
section of the statute references inclusion of expertise regarding 
needs of individuals with disabilities and their families. To this end, 
we make every effort to have peer review panels that balance scientific 
expertise with knowledge relevant to individuals with disabilities and 
their families.

J. Role of the Director

    Comment: One organization asked for clarification of the role of 
the Director in conducting evaluation of applications for NIDILRR 
funding, specifically inquiring whether the Director has sole 
discretion over the review.
    Response: As stated in Sec.  1330.21, the NIDILRR Director is 
required to refer each application to a peer review panel that reviews 
the application using the applicable peer review criteria as defined in 
Sec.  1330.23. The ranking of the applications by the peer review 
panels determines which applicants are awarded funds, subject to 
special considerations in Sec.  1330.25.

K. Role of the Director, Consistency

    Comment: One commenter pointed out that, in Sec.  1330.24(d), the 
reference to Secretary should refer to the NIDILRR Director for 
consistency with the rest of the section.
    Response: We concur, and have corrected the regulatory text 
accordingly.

L. Applications Address the Needs of Individuals With Diverse 
Backgrounds

    Comment: One commenter suggested that the language in Sec.  1330.11 
be changed so that the Director must require that applicants 
demonstrate how they will address the needs of individuals with 
disabilities from minority backgrounds.
    Response: NIDILRR appreciates the concern behind this comment, and 
this language is often inserted into NIDILRR priorities. However, we 
feel that it is too prescriptive to require that the Director must do 
this in every instance, and that making this an absolute requirement 
will restrict the ability of the Director to establish criteria that 
support topics of research initiatives that may not benefit from such a 
requirement.

M. Composition of Panels

    Comment: One commenter suggested that the language in Sec.  1330.22 
be changed so that the Director shall take into account factors 
including does the peer review panels include knowledgeable individuals 
with disabilities or disability advocates such as parents or family 
members and does the panel include individuals from diverse 
populations.
    Response: NIDILRR appreciates the concern behind this comment. 
However, we feel that it is too prescriptive to require that the 
Director shall do this in every instance and that making this an 
absolute requirement will restrict the ability of the Director to 
establish peer review panels that best match the topics of proposed 
research proposals.

II. 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 rule is consistent with the 
priorities and principles set forth in Executive Order 12866. Executive 
Order 12866 encourages agencies, as

[[Page 29159]]

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 
considered input we received from the public including stakeholders. 
This final rule is not being treated as a ``significant regulatory 
action'' under section 3(f)(1) of Executive Order 12866. Accordingly, 
the final 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 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 regulation 
does not have a significant economic impact on these entities. This 
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 rule however, 
nor revising reporting requirements.

D. Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995 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 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 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 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 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.

List of Subjects in 45 CFR Part 1330

    Grant programs, Research, Scholarships and fellowships.

    Dated: April 20, 2016.
Kathy Greenlee,
Administrator, Administration for Community Living.
    Approved: May 2, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
    For the reasons stated in the preamble, the U.S. Department of 
Health and Human Services amends 45 CFR subchapter C by adding part 
1330 to read as follows:

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.
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:

[[Page 29160]]

    (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 Awards.
    (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 Procedure for Hearings under part 
80 of this title.
    (7) 45 CFR part 84--Nondiscrimination on the Basis of Handicap in 
Programs or Activities Receiving Federal Financial Assistance.
    (8) 45 CFR part 86--Nondiscrimination on the Basis of Sex in 
Education Programs or Activities Receiving 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 
from research to create materials, devices, systems, or methods 
beneficial to the target population, including design and development 
of prototypes and processes.
    (f) Products encompass models, methods, tools, applications, and 
devices, but are not necessarily limited to these types.


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. 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

[[Page 29161]]

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, 
applications, 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:
    (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 
these 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.  1330.23.


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

[[Page 29162]]

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 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:
    (i) Specific statutory selection criteria;
    (ii) Allowable activities;
    (iii) Application content requirements; or
    (iv) 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 85 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 Rehabilitation 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 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 Director 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;

[[Page 29163]]

    (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 product 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.
    (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.

[[Page 29164]]

    (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.
    (p) Quality of the project design. In determining the quality of 
the design of the proposed project, the Director considers one or more 
of the following factors:
    (1) The extent to which the goals, objectives, and outcomes to be 
achieved by the proposed project are clearly specified and measurable.
    (2) The quality of the methodology to be employed in the proposed 
project.
    (3) The extent to which the design of the proposed project includes 
a thorough, high-quality review of the relevant literature, a high-
quality plan for project implementation, and the use of appropriate 
methodological tools to ensure successful achievement of project 
objectives.
    (4) The extent to which the design of the proposed project is 
appropriate to, and will successfully address, the needs of the target 
population or other identified needs.
    (5) The extent to which the proposed development efforts include 
adequate quality controls and, as appropriate, repeated testing of 
products.
    (6) The extent to which the proposed project will be coordinated 
with similar or related efforts, and with other appropriate community, 
State, and Federal resources.
    (7) The extent to which the design of the proposed project reflects 
up-to-date knowledge from research and effective practice.
    (8) The extent to which the proposed project represents an 
exceptional approach to the priority or priorities established for the 
competition.


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 85 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.
    (c) If the Director funds an application out of rank order under 
paragraph (b) of this section, the public will be notified through a 
notice on the NIDILRR Web site or through other means deemed 
appropriate by the Director.

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 training and experience that indicate a potential for engaging 
in scientific research related to rehabilitation and independent living 
for individuals with disabilities.

[[Page 29165]]

    (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 Sec.  1330.2.

[FR Doc. 2016-10853 Filed 5-10-16; 8:45 am]
 BILLING CODE P



                                                29156             Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

                                                   (ii) Each director has one vote;                     DATES:  These final regulations are                   from the regulatory text, while at the
                                                   (iii) Positions on the board of                      effective July 1, 2016.                               same time maintaining existing
                                                directors may be designated for                         FOR FURTHER INFORMATION CONTACT:     Greg             Department of Education language
                                                individuals with specialized expertise,                 Pugh, Administration for Community                    where it makes programmatic sense to
                                                experience, or affiliation (for example,                Living, telephone (202) 795–7422                      do so. Finally, multiple commenters
                                                providers, employers, and unions); and                  (Voice). This is not a toll-free number.              wrote in support of the inclusion of the
                                                   (iv) [Reserved]                                      This document will be made available                  stages of research, as well as the new
                                                   (v) Limitation on government and                     in alternative formats upon request.                  stages of development.
                                                issuer participation. No representative                                                                          While no commenters expressed
                                                                                                        SUPPLEMENTARY INFORMATION:
                                                of any Federal, State or local                                                                                general opposition to the promulgation
                                                government (or of any political                         I. Discussion of Final Rule                           of the rule, several expressed their
                                                subdivision or instrumentality thereof)                    The Workforce Innovation and                       concerns about specific provisions of
                                                and no representative of any                            Opportunity Act of 2014 (‘‘WIOA,’’ Pub.               the proposed rule. We made changes to
                                                organization described in                               L. 113–128), signed into law on July 22,              the regulatory text based on the
                                                § 156.510(b)(1)(i) (in the case of a                                                                          comments as discussed below and we
                                                                                                        2014, included significant changes to
                                                representative of a State or local                                                                            fixed a few non-substantive technical
                                                                                                        Title II of the Rehabilitation Act of 1973.
                                                government or organization described in                                                                       errors in the regulatory text. In addition,
                                                                                                        The first of these is the insertion of a
                                                § 156.510(b)(1)(i), with respect to a State                                                                   it has come to our attention that a
                                                                                                        new name, the National Institute on
                                                in which the CO–OP issues policies),                                                                          selection criterion used at the
                                                                                                        Disability, Independent Living, and
                                                may serve on the CO–OP’s formation                                                                            Department of Education related to the
                                                                                                        Rehabilitation Research (‘‘NIDILRR,’’
                                                board or as a director on the                                                                                 quality of a proposed project’s design
                                                                                                        which was previously the National
                                                organization’s operational board.                                                                             was inadvertently omitted from this
                                                                                                        Institute on Disability and
                                                                                                                                                              rule. This criterion is extremely
                                                *       *     *    *     *                              Rehabilitation Research). WIOA also
                                                                                                                                                              valuable to the evaluation of
                                                  Dated: May 5, 2016.                                   relocates NIDILRR from the Department                 applications for certain NIDILRR
                                                Andrew M. Slavitt,                                      of Education to the Administration for                projects, and we have therefore
                                                                                                        Community Living (‘‘ACL’’) of the                     included it verbatim at § 1330.24(p) as
                                                Acting Administrator, Centers for Medicare
                                                & Medicaid Services.                                    Department of Health and Human                        one of the criteria the Director may
                                                                                                        Services. As part of the transfer, the                consider in evaluating an application.
                                                  Dated: May 5, 2016
                                                                                                        Administrator of ACL (Administrator)                  Other than the changes discussed
                                                Sylvia M. Burwell,
                                                                                                        drafted a Notice of Proposed                          below, we adopt our discussion of the
                                                Secretary, Department of Health and Human               Rulemaking that was published on
                                                Services.                                                                                                     rule in the Notice of Proposed
                                                                                                        December 21, 2015, to implement the                   Rulemaking published December 21,
                                                [FR Doc. 2016–11017 Filed 5–6–16; 4:15 pm]              Workforce Innovation and Opportunity                  2015 (80 FR 79283).
                                                BILLING CODE 4120–01–P                                  Act of 2014 and reflect the transfer of
                                                                                                        the National Institute on Disability,                 A. Funding Out of Rank Order in Field-
                                                                                                        Independent Living, and Rehabilitation                Initiated Competitions
                                                DEPARTMENT OF HEALTH AND                                Research from the Department of
                                                HUMAN SERVICES                                                                                                  Comment: Six commenters (five
                                                                                                        Education to the Department of Health                 organizations and one individual) raised
                                                45 CFR Part 1330                                        and Human Services.                                   concerns about a proposed change to
                                                                                                           ACL received 13 unduplicated                       § 1330.25. The proposed regulation
                                                                                                        comments during the public comment                    gives the NIDILRR director authority to
                                                RIN 0985–AA12                                           period from individuals, state agencies,              fund out of rank order in field-initiated
                                                                                                        and organizations representing                        competitions when there is an
                                                National Institute on Disability,
                                                                                                        disability, rehabilitation, and aging                 opportunity to fund a project of
                                                Independent Living, and Rehabilitation
                                                                                                        constituencies. ACL has read and                      significant interest to the agency.
                                                Research
                                                                                                        considered each of the comments                       Concerns ranged from the change giving
                                                AGENCY:  National Institute on Disability,              received. We respond here to the most-                too much authority to political
                                                Independent Living, and Rehabilitation                  commonly-received comments and                        appointees to the potential undermining
                                                Research; Administration for                            those that we believe require further                 of the scientific integrity of the research
                                                Community Living; HHS.                                  discussion. Several comments raised                   process. Suggestions ranged from
                                                ACTION: Final rule.                                     issues that are specific to the                       dropping this proposed change in the
                                                                                                        commenter. Responding to such                         regulation to increasing the scoring
                                                SUMMARY:  This rule implements the                      comments is beyond the scope of the                   threshold for use of the provision or to
                                                Workforce Innovation and Opportunity                    final regulation. Nevertheless, we                    creating a requirement for a formal
                                                Act of 2014 and reflects the transfer of                encourage commenters with                             explanation by the NIDILRR director
                                                the National Institute on Disability,                   individualized questions to contact                   justifying the proposed change.
                                                Independent Living, and Rehabilitation                  NIDILRR directly at 202–401–4634—                       Response: NIDILRR appreciates the
                                                Research (NIDILRR) from the                             Option 5.                                             concerns expressed by these
                                                Department of Education to the                             Many of the comments expressed                     commenters especially the focus on
                                                Department of Health and Human                          broad general support for the rule and                impartial peer review and its role in
                                                Services (HHS). The previous                            the broader transfer of NIDILRR to the                maintaining the scientific integrity of
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                                                regulations were issued by the                          Administration for Community Living.                  NIDILRR’s research portfolio. Our goal
                                                Department of Education. The                            Commenters expressed their support of                 in suggesting this change was to provide
                                                rulemaking consolidates the NIDILRR                     the consolidation of existing NIDILRR                 an opportunity for the Director to select
                                                regulations into a single part, aligns the              regulations and alignment with HHS                    applications that address critical agency
                                                regulations with the current statute and                policies, a major goal of this rulemaking.            goals in circumstances where these
                                                HHS policies, and provides guidance to                  Others expressed their approval of the                applications have high scores but would
                                                NIDILRR grantees.                                       elimination of unnecessary language                   not be funded in a strictly rank order


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                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                          29157

                                                framework. NIDILRR has long had the                     C. Stages of Development                              carried out in a professional manner and
                                                ability to fund out of rank order, and                     Comment: One commenter, while                      further to ensure that each application
                                                though it was rarely used, we added the                 supporting the stages of development in               is treated fairly.
                                                80 percent threshold in an effort to                    § 1330.5, expressed concern that the                     To support the importance of research
                                                ensure the quality of NIDILRR-funded                    rule doesn’t make clear that the                      and development focused on the needs
                                                research. NIDILRR has expanded our                      technology transfer plan requirement                  of individuals with disabilities,
                                                field-initiated research opportunities in               does not sufficiently convey the                      NIDILRR has already added a
                                                recent years, and we think that                         complexity of supply and demand and
                                                clarifying the requirements for funding                                                                       requirement that applicants must obtain
                                                                                                        the behaviors of consumers and other                  input from individuals with disabilities
                                                out of rank order will ensure this                      stakeholders in their decisions to adopt
                                                quality, while also allowing for funding                                                                      and other stakeholders in shaping
                                                                                                        and use technology.                                   proposed research or development
                                                of compelling research opportunities. In                   Response: The stages of development
                                                such cases where an application may                                                                           activities. NIDILRR is also finalizing
                                                                                                        provide an organizational framework to                approval of its Disability, Independent
                                                have otherwise gone unfunded in a                       guide prospective applicants in
                                                strict rank-order process, we believe that                                                                    Living, and Rehabilitation Research
                                                                                                        preparing their technical proposals. The
                                                the Director should have the ability to                                                                       Advisory Council (DILRRAC) which
                                                                                                        stages are not prescriptive. For this
                                                fund highly promising studies, while                                                                          adheres to a statutory requirement that
                                                                                                        reason, we believe that identifying the
                                                setting a minimum threshold for quality                 relevant stage(s) of development will                 more than 50% of its membership be
                                                assurance and providing for public                      allow the peer review process to better               comprised of individuals with
                                                notification.                                           determine the extent to which proposed                disabilities. We believe that this
                                                   After careful consideration of the                   activities to facilitate and measure                  committee will provide valuable
                                                concerns raised by the commenters, as                   product adoption are necessary and                    guidance regarding ways that we can
                                                well as a review of past applications,                  appropriate and to determine the extent               improve the relevance of NIDILRR’s
                                                NIDILRR proposes to increase the                        to which applicants understand                        research to individuals with disabilities.
                                                threshold before funding out of rank                    contextual factors that might impact                  We are confident that all of these steps
                                                order can be considered to a score of 85                product adoption.                                     will address the commenters concerns
                                                points or above. We believe, based upon                                                                       without adding significant
                                                decades of staff experience with the                    D. Disability Advisory Panels and                     administrative burden and expense to
                                                grant review process, that this number                  Reviewer Training                                     the peer review process.
                                                strikes a reasonable balance between                       Comment: One organization made a
                                                providing the Director the flexibility to               number of suggestions related to                      E. Collaboration
                                                fund applications which are uniquely                    NIDILRR’s peer review process as                         Comment: Two commenters suggested
                                                promising and ensuring that all                         described in § 1330.22. This commenter                additions to the peer review criterion on
                                                NIDILRR-funded research projects are of                 recommended that NIDILRR form
                                                the quality and rigor for which NIDILRR                                                                       collaboration in § 1330.24(k). Both
                                                                                                        advisory panels with members with
                                                is known. In addition, the regulation has                                                                     suggested more specific requirements
                                                                                                        diverse disabilities, including physical,
                                                been amended to require a public                                                                              for collaboration with local and national
                                                                                                        sensory, intellectual, and mental
                                                notification by the Director of any                                                                           consumer organizations, and one also
                                                                                                        disabilities, to be assigned to each peer
                                                decision to fund out of rank order.                                                                           included a recommendation for
                                                                                                        review panel to ensure that disability
                                                Should it become advisable to raise this                perspectives are considered in the                    requiring meaningful collaboration with
                                                threshold further, we may revisit this                  funding decision.                                     other relevant agencies, organizations,
                                                threshold in the future. We take these                     In addition, the commenter suggested               or institutions. In addition, one of the
                                                steps to clarify our commitment to                      reviewer training related to consistent               commenters suggested weighting the
                                                conducting rigorous peer review.                        weighting of scores, minimizing                       collaboration criterion more heavily.
                                                B. Publication of Funding Opportunities                 personal biases of reviewers, and                        Response: NIDILRR strongly agrees
                                                and Application Instructions                            reviewing and scoring application                     that it is important to seek appropriate
                                                                                                        attachments. The commenter also                       collaboration where relevant to the
                                                  Comment: In light of the new                          suggested that NIDILRR provide training               specific research or development project
                                                regulation’s elimination of specific                    to the disability advisory panels to                  being proposed. To this end, we have
                                                funding application instructions, two                   ensure that personal likes and dislikes               long had a collaboration review element
                                                commenters suggested that NIDILRR                       of the reviewers not enter into the                   which is required for many funding
                                                update its Web site to provide clear                    scoring.                                              priorities. We believe that this
                                                information to applicants on funding                       Response: NIDILRR strongly supports                requirement is adequate, and that to
                                                opportunities and on the process of                     a diversity of perspectives on peer                   require it of all research or development
                                                submitting applications.                                review panels and makes every effort to               projects would be misguided, as
                                                  Response: NIDILRR shares these                        include reviewers who have disabilities               collaboration may not be relevant for the
                                                commenters’ commitment to ensuring                      as well as subject-matter expertise                   research topic or stage of research or
                                                that potential grantees have adequate                   relevant to the research or development               development being proposed.
                                                access to information on NIDILRR’s                      topic. We are constantly seeking to
                                                research priorities and application                     recruit new, qualified individuals with                  Specific weighting of review criteria
                                                processes. To this end, we are                          disabilities for these purposes. We                   is not prescribed by regulation so as to
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                                                publishing funding forecast documents                   require our peer reviewers to attend an               allow weighting as appropriate to the
                                                with links to necessary application                     orientation session and, if they are new              purpose and goals of each funding
                                                information on the ACL Web site, and                    to our system, participate in training                priority. More specific regulatory
                                                will endeavor at all times to maximize                  sessions to ensure that they understand               language on weighting would
                                                the transparency and wide                               the technical requirements of the                     significantly limit NIDILRR’s ability to
                                                dissemination of funding opportunities                  process. NIDILRR staff monitors each                  match individual criteria with the topic
                                                and application instructions.                           panel to ensure that the review is                    of the priority at hand.


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                                                29158             Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

                                                F. Notification of Review Scores and                    enumerative and to allow for changes in               K. Role of the Director, Consistency
                                                Comments                                                conceptualization over time. Our                        Comment: One commenter pointed
                                                  Comment: Two commenters suggested                     conclusion is that flexibility is needed              out that, in § 1330.24(d), the reference to
                                                the insertion into regulation a                         and beneficial. To this end, we are                   Secretary should refer to the NIDILRR
                                                requirement that applicants will receive                defining products as potentially                      Director for consistency with the rest of
                                                reviewer scores and comments within                     encompassing but not necessarily                      the section.
                                                30 days of NIDILRR decisions.                           limited to models, methods, tools,                      Response: We concur, and have
                                                  Response: This is already a part of                   applications, and devices. Applicants                 corrected the regulatory text
                                                NIDILRR’s grants management policy,                     can associate proposed products to                    accordingly.
                                                and we make every effort to ensure that                 these types or clarify and defend why
                                                                                                        proposed products lie outside of these                L. Applications Address the Needs of
                                                notification of scores and comments is                                                                        Individuals With Diverse Backgrounds
                                                provided within a 30 day timeframe. We                  types. Finally, we agree that it would
                                                believe that to specifically require this               contribute to clarity to use the term,                   Comment: One commenter suggested
                                                in regulation would be counter to the                   ‘‘product’’ consistently in the document,             that the language in § 1330.11 be
                                                stated objectives of consolidating and                  and we have made this change                          changed so that the Director must
                                                simplifying the regulatory language, to                 accordingly.                                          require that applicants demonstrate how
                                                which many commenters responded                                                                               they will address the needs of
                                                                                                        I. Removal of ‘‘Scientific’’ From Peer                individuals with disabilities from
                                                very favorably.
                                                                                                        Review Panels                                         minority backgrounds.
                                                G. Posting of Applicant Scores                                                                                   Response: NIDILRR appreciates the
                                                                                                           Comment: A commenter suggested                     concern behind this comment, and this
                                                   Comment: One commenter suggested                     that NIDILRR remove the term
                                                that NIDILRR post a list of applicants                                                                        language is often inserted into NIDILRR
                                                                                                        ‘‘scientific’’ from the description of its            priorities. However, we feel that it is too
                                                and aggregate scores on its Web site at                 peer review panels.
                                                the conclusion of a competition.                                                                              prescriptive to require that the Director
                                                   Response: NIDILRR’s goal is to fund                     Response: NIDILRR’s authorizing                    must do this in every instance, and that
                                                rigorous and relevant research, as                      statute specifically requires the                     making this an absolute requirement
                                                determine by an independent panel of                    NIDILRR Director to provide for                       will restrict the ability of the Director to
                                                individuals with subject-specific                       scientific review of all applications over            establish criteria that support topics of
                                                expertise and with knowledge of and                     which the Director has authority. 29                  research initiatives that may not benefit
                                                sensitivity to the needs of individuals                 U.S.C. 762(f)(1). Given the statutory                 from such a requirement.
                                                with disabilities. We ask these reviewers               requirement, NIDILRR feels that it must               M. Composition of Panels
                                                to provide detailed and thoughtful                      adhere to this standard which confirms
                                                comments on the proposals they review,                  Congressional intent to ensure that                     Comment: One commenter suggested
                                                and we send this feedback to applicants                 NIDILRR carry out its peer review so                  that the language in § 1330.22 be
                                                in an effort to help build capacity in                  that scientific expertise supports                    changed so that the Director shall take
                                                disability and rehabilitation research.                 rigorous review that help ensures that                into account factors including does the
                                                We do not believe that listing                          NIDILRR funds the research that is                    peer review panels include
                                                unsuccessful applicants and their scores                likely to generate findings that will help            knowledgeable individuals with
                                                would further this goal, and believe that               improve the lives of individuals with                 disabilities or disability advocates such
                                                doing so would be contrary to HHS                       disabilities. However, NIDILRR also                   as parents or family members and does
                                                grants policy with regard to applicant                  notes that this section of the statute                the panel include individuals from
                                                privacy.                                                references inclusion of expertise                     diverse populations.
                                                                                                                                                                Response: NIDILRR appreciates the
                                                                                                        regarding needs of individuals with
                                                H. Meaning of ‘‘Product’’                                                                                     concern behind this comment. However,
                                                                                                        disabilities and their families. To this
                                                   Comment: One organization raised                                                                           we feel that it is too prescriptive to
                                                                                                        end, we make every effort to have peer                require that the Director shall do this in
                                                several questions about the meaning of                  review panels that balance scientific
                                                the term ‘‘product’’ in our discussion of                                                                     every instance and that making this an
                                                                                                        expertise with knowledge relevant to                  absolute requirement will restrict the
                                                stages of development, specifically                     individuals with disabilities and their
                                                requesting that NIDILRR define the term                                                                       ability of the Director to establish peer
                                                                                                        families.                                             review panels that best match the topics
                                                and what it includes. A related
                                                comment recommended that NIDILRR                        J. Role of the Director                               of proposed research proposals.
                                                provide clarification to the concept of                                                                       II. Impact Analysis
                                                                                                          Comment: One organization asked for
                                                ‘‘proof of product’’ to ensure that it
                                                                                                        clarification of the role of the Director             A. Executive Orders 12866 and 13563
                                                includes functional requirements such
                                                                                                        in conducting evaluation of applications                 Executive Orders 12866 and 13563
                                                as accessibility and usability or market
                                                viability requirements such as price or                 for NIDILRR funding, specifically                     direct agencies to assess all costs and
                                                performance. This commenter also                        inquiring whether the Director has sole               benefits of available regulatory
                                                suggested that NIDILRR elaborate on its                 discretion over the review.                           alternatives, and, if regulation is
                                                expectations of the attributes associated                 Response: As stated in § 1330.21, the               necessary, to select regulatory
                                                with the stages of development. Finally,                NIDILRR Director is required to refer                 approaches that maximize net benefits
                                                there was one comment asking that                       each application to a peer review panel               (including potential economic,
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                                                there be consistent use of the term                     that reviews the application using the                environmental, public health and safety
                                                product in the document.                                applicable peer review criteria as                    effects, distributive impacts, and
                                                   Response: NIDILRR carefully                          defined in § 1330.23. The ranking of the              equity). The Department has determined
                                                considered these comments which                         applications by the peer review panels                that this rule is consistent with the
                                                helped us think about the extent to                     determines which applicants are                       priorities and principles set forth in
                                                which we wanted to make the definition                  awarded funds, subject to special                     Executive Order 12866. Executive Order
                                                of ‘‘product’’ to be enumerative or non-                considerations in § 1330.25.                          12866 encourages agencies, as


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                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                            29159

                                                appropriate, to provide the public with                   ACL has determined that this rule                   PART 1330—NATIONAL INSTITUTE
                                                meaningful participation in the                         does not result in the expenditure by                 FOR DISABILITY, INDEPENDENT
                                                regulatory process. The rulemaking                      State, local, and Tribal governments in               LIVING, AND REHABILITATION
                                                implements the Workforce Innovation                     the aggregate, or by the private sector of            RESEARCH
                                                and Opportunity Act of 2014. In                         more than $100 million in any one year.
                                                developing the final rule, we considered                                                                      Subpart A—Disability, Independent Living,
                                                input we received from the public                       E. Congressional Review                               and Rehabilitation Research Projects and
                                                                                                                                                              Centers Program
                                                including stakeholders. This final rule is                This rule is not a major rule as
                                                not being treated as a ‘‘significant                    defined in 5 U.S.C. Section 804(2).                   Sec.
                                                regulatory action’’ under section 3(f)(1)                                                                     1330.1 General.
                                                of Executive Order 12866. Accordingly,                  F. Assessment of Federal Regulations                  1330.2 Eligibility for assistance and other
                                                                                                        and Policies on Families                                   regulations and guidance.
                                                the final rule has not been reviewed by                                                                       1330.3 Definitions.
                                                the Office of Management and Budget.                       Section 654 of the Treasury and                    1330.4 Stages of research.
                                                B. Regulatory Flexibility Analysis                      General Government Appropriations                     1330.5 Stages of development.
                                                                                                        Act of 1999 requires Federal agencies to              Subpart B—Requirements for Awardees
                                                  The Secretary certifies under 5 U.S.C.                determine whether a policy or
                                                605(b), the Regulatory Flexibility Act                  regulation may affect family well-being.              1330.10 General requirements for
                                                (Pub. L. 96–354), that this regulation                                                                            awardees.
                                                                                                        If the agency’s conclusion is affirmative,            1330.11 Individuals with disabilities from
                                                will not have a significant economic                    then the agency must prepare an impact
                                                impact on a substantial number of small                                                                           minority backgrounds.
                                                                                                        assessment addressing seven criteria
                                                entities. The primary impact of this                    specified in the law. These regulations               Subpart C—Selection of Awardees
                                                regulation is on entities applying for                  do not have an impact on family well-                 1330.20 Peer review purpose.
                                                NIDILRR funding opportunities,                          being as defined in the legislation.                  1330.21 Peer review process.
                                                specifically researchers, States, public                                                                      1330.22 Composition of peer review panel.
                                                or private agencies and organizations,                  G. Executive Order 13132                              1330.23 Evaluation process.
                                                institutions of higher education, and                                                                         1330.24 Selection criteria.
                                                                                                           Executive Order 13132 on                           1330.25 Additional considerations for
                                                Indian tribes and tribal organizations.                 ‘‘federalism’’ was signed August 4,
                                                The regulation does not have a                                                                                    field-initiated priorities.
                                                                                                        1999. The purposes of the Order are:
                                                significant economic impact on these                    ‘‘. . . to guarantee the division of                  Subpart D—Disability, Independent Living,
                                                entities. This rule is in fact significantly            governmental responsibilities between                 and Rehabilitation Research Fellowships
                                                shorter than, but with identical                        the national government and the States                1330.30 Fellows program.
                                                compliance requirements to, the                         that was intended by the Framers of the
                                                regulations it replaces.                                                                                      Subpart E—Special Projects and
                                                                                                        Constitution, to ensure that the                      Demonstrations for Spinal Cord Injuries
                                                C. Paperwork Reduction Act of 1995                      principles of federalism established by               1330.40 Spinal cord injuries program.
                                                  Under the Paperwork Reduction Act                     the Framers guide the executive
                                                                                                        departments and agencies in the                         Authority: 29 U.S.C. 709, 3343.
                                                of 1995, we are required to provide 60-
                                                day notice in the Federal Register and                  formulation and implementation of                     Subpart A—Disability, Independent
                                                solicit public comment before an                        policies, and to further the policies of              Living, and Rehabilitation Research
                                                information collection request is                       the Unfunded Mandates Reform Act                      Projects and Centers Program
                                                submitted to the Office of Management                   . . .’’
                                                and Budget (OMB) for review and                            The Department certifies that this rule            § 1330.1   General.
                                                approval. We are not introducing any                    does not have a substantial direct effect                (a) The Disability, Independent
                                                new information collections in this rule                on States, on the relationship between                Living, and Rehabilitation Research
                                                however, nor revising reporting                         the Federal government and the States,                Projects and Centers Program provides
                                                requirements.                                           or on the distribution of power and                   grants to establish and support:
                                                                                                        responsibilities among the various                       (1) The following Disability,
                                                D. Unfunded Mandates Reform Act                         levels of government.                                 Independent Living, and Rehabilitation
                                                   Section 202 of the Unfunded                             ACL is not aware of any specific State             Research and Related Projects:
                                                Mandates Reform Act of 1995 requires                    laws that would be preempted by the                      (i) Disability, Independent Living, and
                                                that a covered agency prepare a                         adoption of the regulation.                           Rehabilitation Research Projects;
                                                budgetary impact statement before                                                                                (ii) Field-Initiated Projects;
                                                promulgating a rule that includes any                   List of Subjects in 45 CFR Part 1330                     (iii) Advanced Rehabilitation
                                                Federal mandate that may result in                        Grant programs, Research,                           Research Training Projects; and
                                                expenditures by State, local, or Tribal                 Scholarships and fellowships.                            (2) The following Disability,
                                                governments, in the aggregate, or by the                                                                      Independent Living, and Rehabilitation
                                                                                                          Dated: April 20, 2016.
                                                private sector, of $100 million, adjusted                                                                     Research Centers:
                                                                                                        Kathy Greenlee,
                                                for inflation, or more in any one year.                                                                          (i) Rehabilitation Research and
                                                   If a covered agency must prepare a                   Administrator, Administration for                     Training Centers;
                                                                                                        Community Living.
                                                budgetary impact statement, section 205                                                                          (ii) Rehabilitation Engineering
                                                further requires that it select the most                  Approved: May 2, 2016.                              Research Centers.
                                                cost-effective and least burdensome                     Sylvia M. Burwell,                                       (b) The purpose of the Disability,
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                                                alternatives that achieves the objectives               Secretary, Department of Health and Human             Independent Living, and Rehabilitation
                                                of the rule and is consistent with the                  Services.                                             Research Projects and Centers Program
                                                statutory requirements. In addition,                      For the reasons stated in the                       is to plan and conduct research,
                                                section 203 requires a plan for                         preamble, the U.S. Department of Health               development, demonstration projects,
                                                informing and advising any small                        and Human Services amends 45 CFR                      training, dissemination, and related
                                                government that may be significantly or                 subchapter C by adding part 1330 to                   activities, including international
                                                uniquely impacted by a rule.                            read as follows:                                      activities, to:


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                                                29160             Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

                                                  (1) Develop methods, procedures, and                  § 1330.3   Definitions.                               the exploration and discovery stage of
                                                rehabilitation technology, that maximize                  As used in this part:                               research may also be used to inform
                                                the full inclusion and integration into                   (a) Secretary means the Secretary of                decisions or priorities;
                                                society, employment, education,                         the Department of Health and Human                       (b) Intervention development means
                                                independent living, family support, and                 Services.                                             the stage of research that focuses on
                                                economic and social self-sufficiency of                   (b) Administrator means the                         generating and testing interventions that
                                                individuals with disabilities, especially               Administrator of the Administration for               have the potential to improve outcomes
                                                individuals with the most severe                        Community Living.                                     for individuals with disabilities.
                                                disabilities; and                                         (c) Director means the Director of the              Intervention development involves
                                                  (2) Improve the effectiveness of                      National Institute on Disability,                     determining the active components of
                                                services authorized under the                           Independent Living, and Rehabilitation                possible interventions, developing
                                                Rehabilitation Act of 1973, 29 U.S.C.                   Research.                                             measures that would be required to
                                                701 et seq.                                               (d) Research is classified on a                     illustrate outcomes, specifying target
                                                                                                        continuum from basic to applied:                      populations, conducting field tests, and
                                                § 1330.2 Eligibility for assistance and                    (1) Basic research is research in which            assessing the feasibility of conducting a
                                                other regulations and guidance.                         the investigator is concerned primarily               well-designed intervention study.
                                                   (a) Unless otherwise stated in this part             with gaining new knowledge or                         Results from this stage of research may
                                                or in a determination by the NIDILRR                    understanding of a subject without                    be used to inform the design of a study
                                                Director, the following entities are                    reference to any immediate application                to test the efficacy of an intervention;
                                                eligible for an award under this                        or utility.                                              (c) Intervention efficacy means the
                                                program:                                                   (2) Applied research is research in                stage of research during which a project
                                                   (1) States.                                          which the investigator is primarily                   evaluates and tests whether an
                                                   (2) Public or private agencies,                      interested in developing new                          intervention is feasible, practical, and
                                                including for-profit agencies.                          knowledge, information, or                            has the potential to yield positive
                                                   (3) Public or private organizations,                 understanding which can be applied to                 outcomes for individuals with
                                                including for-profit organizations.                     a predetermined rehabilitation problem                disabilities. Efficacy research may assess
                                                   (4) Institutions of higher education.                or need.                                              the strength of the relationships
                                                   (5) Indian tribes and tribal                            (e) Development activities use                     between an intervention and outcomes,
                                                organizations.                                          knowledge and understanding gained                    and may identify factors or individual
                                                   (b) Other sources of regulation which                from research to create materials,                    characteristics that affect the
                                                may apply to awards under this part                     devices, systems, or methods beneficial               relationship between the intervention
                                                include but are not limited to:                         to the target population, including                   and outcomes. Efficacy research can
                                                   (1) 45 CFR part 16—Procedures of the                 design and development of prototypes                  inform decisions about whether there is
                                                Departmental Grant Appeals Board.                       and processes.                                        sufficient evidence to support ‘‘scaling-
                                                   (2) 45 CFR part 46—Protection of                        (f) Products encompass models,                     up’’ an intervention to other sites and
                                                Human Subjects.                                         methods, tools, applications, and                     contexts. This stage of research may
                                                   (3) 45 CFR part 75—Uniform                           devices, but are not necessarily limited              include assessing the training needed
                                                Administrative Requirements, Cost                       to these types.                                       for wide-scale implementation of the
                                                Principles, and Audit Requirements for                                                                        intervention, and approaches to
                                                HHS Awards.                                             § 1330.4   Stages of research.
                                                                                                                                                              evaluation of the intervention in real-
                                                   (4) 2 CFR parts 376 and 382—                            For any Disability, Independent                    world applications; and
                                                Nonprocurement Debarment and                            Living, and Rehabilitation Research                      (d) Scale-up evaluation means the
                                                Suspension and Requirements for Drug-                   Projects and Centers Program                          stage of research during which a project
                                                Free Workplace (Financial Assistance).                  competition, the Department may                       analyzes whether an intervention is
                                                   (5) 45 CFR part 80—                                  require in the application materials for              effective in producing improved
                                                Nondiscrimination under Programs                        the competition that the applicant                    outcomes for individuals with
                                                Receiving Federal Assistance through                    identify the stage(s) of research in which            disabilities when implemented in a real-
                                                the Department of Health and Human                      it will focus the work of its proposed                world setting. During this stage of
                                                Services—Effectuation of title VI of the                project or center. The four stages of                 research, a project tests the outcomes of
                                                Civil Rights Act of 1964.                               research are:                                         an evidence-based intervention in
                                                   (6) 45 CFR part 81—Practice and                         (a) Exploration and discovery mean                 different settings. The project examines
                                                Procedure for Hearings under part 80 of                 the stage of research that generates                  the challenges to successful replication
                                                this title.                                             hypotheses or theories through new and                of the intervention, and the
                                                   (7) 45 CFR part 84—                                  refined analyses of data, producing                   circumstances and activities that
                                                Nondiscrimination on the Basis of                       observational findings and creating                   contribute to successful adoption of the
                                                Handicap in Programs or Activities                      other sources of research-based                       intervention in real-world settings. This
                                                Receiving Federal Financial Assistance.                 information. This research stage may                  stage of research may also include well-
                                                   (8) 45 CFR part 86—                                  include identifying or describing the                 designed studies of an intervention that
                                                Nondiscrimination on the Basis of Sex                   barriers to and facilitators of improved              has been widely adopted in practice, but
                                                in Education Programs or Activities                     outcomes of individuals with                          lacks a sufficient evidence base to
                                                Receiving Federal Financial Assistance.                 disabilities, as well as identifying or               demonstrate its effectiveness.
                                                   (9) 45 CFR part 87—Equal Treatment                   describing existing practices, programs,
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                                                of Faith-Based Organizations.                           or policies that are associated with                  § 1330.5   Stages of development.
                                                   (10) 45 CFR part 91—                                 important aspects of the lives of                       For any Disability, Independent
                                                Nondiscrimination on the Basis of Age                   individuals with disabilities. Results                Living, and Rehabilitation Research
                                                in Programs or Activities Receiving                     achieved under this stage of research                 Projects and Centers Program
                                                Federal Financial Assistance from HHS.                  may inform the development of                         competition, the Department may
                                                   (11) 45 CFR part 93—New                              interventions or lead to evaluations of               require in the notice inviting
                                                Restrictions on Lobbying.                               interventions or policies. The results of             applications for the competition that the


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                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                           29161

                                                applicant identify the stage(s) of                         (b) In carrying out a development                  populations or areas that include
                                                development in which it will focus the                  activity under this program, an awardee               individuals from minority backgrounds.
                                                work of its proposed project or center.                 must create, using knowledge and                        (5) Providing outreach to individuals
                                                The three stages of development are:                    understanding gained from research,                   with disabilities from minority
                                                   (a) Proof of concept means the stage                 models, methods, tools, systems,                      backgrounds to ensure that they are
                                                of development where key technical                      materials, devices, applications, or                  aware of rehabilitation services, clinical
                                                challenges are resolved. Stage activities               standards that are adopted by and                     care, or training offered by the project.
                                                may include recruiting study                            beneficial to the target population.                    (6) Disseminating materials to or
                                                participants, verifying product                         Development activities span one or                    otherwise increasing the access to
                                                requirements; implementing and testing                  more stages of development.                           disability information among minority
                                                (typically in controlled contexts) key                     (c) In carrying out a training activity            populations.
                                                concepts, components, or systems, and                   under this program, an awardee shall
                                                resolving technical challenges. A                       conduct a planned and systematic                      Subpart C—Selection of Awardees
                                                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:
                                                may have started. Stage results establish                  (d) In carrying out a demonstration                  (a) Those activities supported by the
                                                that a product concept is feasible.                     activity under this program, an awardee               National Institute on Disability,
                                                   (b) Proof of product means the stage                 shall apply results derived from                      Independent Living, and Rehabilitation
                                                of development where a fully-integrated                 previous research, testing, or practice to            Research (NIDILRR) are of the highest
                                                and working prototype, meeting critical                 determine the effectiveness of a new                  scientific, administrative, and technical
                                                technical requirements is created. Stage                strategy or approach.                                 quality; and
                                                activities may include recruiting study                    (e) In carrying out a utilization                    (b) Activity results may be widely
                                                participants, implementing and                          activity under this program, a grantee                applied to appropriate target
                                                iteratively refining the prototype, testing             must relate research findings to                      populations and rehabilitation
                                                the prototype in natural or less-                       practical applications in planning,                   problems.
                                                controlled contexts, and verifying that                 policy making, program administration,
                                                all technical requirements are met. A                   and delivery of services to individuals               § 1330.21   Peer review process.
                                                technology transfer plan is typically                   with disabilities.                                      (a) The Director refers each
                                                ongoing in collaboration with the                          (f) In carrying out a dissemination                application for an award governed by
                                                transfer partner(s). Stage results                      activity under this program, a grantee                these regulations in this part to a peer
                                                establish that a product embodiment is                  must systematically distribute                        review panel established by the
                                                realizable.                                             information or knowledge through a                    Director.
                                                   (c) Proof of adoption means the stage                variety of ways to potential users or                   (b) Peer review panels review
                                                of development where a product is                       beneficiaries.                                        applications on the basis of the
                                                substantially adopted by its target                        (g) In carrying out a technical                    applicable selection criteria in
                                                population and used for its intended                    assistance activity under this program, a             § 1330.23.
                                                purpose. Stage activities typically                     grantee must provide expertise or
                                                include completing product                              information for use in problem-solving.               § 1330.22   Composition of peer review
                                                                                                                                                              panel.
                                                refinements; and continued
                                                                                                        § 1330.11 Individuals with disabilities from             (a) The Director selects as members of
                                                implementation of the technology                        minority backgrounds.
                                                transfer plan in collaboration with the                                                                       a peer review panel scientists and other
                                                                                                           (a) If the director so indicates in the            experts in disability, independent
                                                transfer partner(s). Other activities
                                                                                                        application materials or elsewhere, an                living, rehabilitation or related fields
                                                include measuring users’ awareness of
                                                                                                        applicant for assistance under this                   who are qualified, on the basis of
                                                the product, opinion of the product,
                                                                                                        program must demonstrate in its                       training, knowledge, or experience, to
                                                decisions to adopt, use, and retain
                                                                                                        application how it will address, in                   give expert advice on the merit of the
                                                products; and identifying barriers and
                                                                                                        whole or in part, the needs of                        applications under review.
                                                facilitators impacting product adoption.
                                                                                                        individuals with disabilities from                       (b) The scientific peer review process
                                                Stage results establish that a product is
                                                                                                        minority backgrounds.                                 shall be conducted by individuals who
                                                beneficial.
                                                                                                           (b) The approaches an applicant may                are not Department of Health and
                                                Subpart B—Requirements for                              take to meet this requirement may                     Human Services employees.
                                                Awardees                                                include one or more of the following:                    (c) In selecting members to serve on
                                                                                                           (1) Proposing project objectives                   a peer review panel, the Director may
                                                § 1330.10 General requirements for                      addressing the needs of individuals                   take into account the following factors:
                                                awardees.                                               with disabilities from minority                          (1) The level of formal scientific or
                                                   (a) In carrying out a research activity              backgrounds.                                          technical education completed by
                                                under this program, an awardee must:                       (2) Demonstrating that the project will            potential panel members.
                                                   (1) Identify one or more hypotheses or               address a problem that is of particular                  (2) The extent to which potential
                                                research questions;                                     significance to individuals with                      panel members have engaged in
                                                   (2) Based on the hypotheses or                       disabilities from minority backgrounds.               scientific, technical, or administrative
                                                research question identified, perform an                   (3) Demonstrating that individuals                 activities appropriate to the category of
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                                                intensive systematic study in                           from minority backgrounds will be                     applications that the panel will
                                                accordance with its approved                            included in study samples in sufficient               consider; the roles of potential panel
                                                application directed toward:                            numbers to generate information                       members in those activities; and the
                                                   (i) New or full scientific knowledge;                pertinent to individuals with disabilities            quality of those activities.
                                                or                                                      from minority backgrounds.                               (3) The recognition received by
                                                   (ii) Understanding of the subject or                    (4) Drawing study samples and                      potential panel members as reflected by
                                                problem being studied.                                  program participant rosters from                      awards and other honors from scientific


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                                                29162             Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

                                                and professional agencies and                           § 1330.24    Selection criteria.                         (ii) Each research hypothesis or
                                                organizations outside the Department.                      In addition to criteria established                research question, as appropriate, is
                                                  (4) Whether the panel includes                        under § 1330.23(a)(1), the Director may               theoretically sound and based on
                                                knowledgeable individuals with                          select one or more of the following                   current knowledge;
                                                disabilities, or parents, family members,               criteria in evaluating an application:                   (iii) Each sample is drawn from an
                                                guardians, advocates, or authorized                        (a) Importance of the problem. In                  appropriate, specified population and is
                                                representatives of individuals with                     determining the importance of the                     of sufficient size to address the
                                                disabilities.                                           problem, the Director considers one or                proposed hypotheses or research
                                                  (5) Whether the panel includes                        more of the following factors:                        questions, as appropriate, and to
                                                individuals from diverse populations.                      (1) The extent to which the applicant              support the proposed data analysis
                                                                                                        clearly describes the need and target                 methods;
                                                § 1330.23   Evaluation process.
                                                                                                        population.                                              (iv) The source or sources of the data
                                                  (a) The Director selects one or more of                  (2) The extent to which the proposed               and the data collection methods are
                                                the selection criteria to evaluate an                   activities further the purposes of the                appropriate to address the proposed
                                                application:                                            Rehabilitation Act.                                   hypotheses or research questions and to
                                                  (1) The Director establishes selection                   (3) The extent to which the proposed               support the proposed data analysis
                                                criteria based on statutory provisions                  activities address a significant need of              methods;
                                                that apply to the Program which may                     individuals with disabilities.                           (v) The data analysis methods are
                                                include, but are not limited to:                           (4) The extent to which the proposed               appropriate;
                                                  (i) Specific statutory selection criteria;            activities address a significant need of                 (vi) Implementation of the proposed
                                                  (ii) Allowable activities;                            rehabilitation service providers.                     research design is feasible, given the
                                                  (iii) Application content                                (5) The extent to which the proposed               current state of the science and the time
                                                requirements; or                                        activities address a significant need of              and resources available;
                                                  (iv) Other pre-award and post-award                   those who provide services to                            (vii) Input of individuals with
                                                conditions; or                                          individuals with disabilities.                        disabilities and other key stakeholders
                                                  (2) The Director may use a                               (6) The extent to which the applicant              is used to shape the proposed research
                                                combination of selection criteria                       proposes to provide training in a                     activities; and
                                                established under paragraph (a)(1) of                   rehabilitation discipline or area of study               (viii) The applicant identifies and
                                                this section and selection criteria from                in which there is a shortage of qualified             justifies the stage of research being
                                                § 1330.24 to evaluate a competition.                    researchers, or to a trainee population in            proposed and the research methods
                                                  (3) For Field-Initiated Projects, the                 which there is a need for more qualified              associated with the stage.
                                                Director does not consider § 1330.24(b)                 researchers.                                             (3) The extent to which anticipated
                                                (Responsiveness to the Absolute or                         (7) The extent to which the proposed               research results are likely to satisfy the
                                                Competitive Priority) in evaluating an                  project will have beneficial impact on                original hypotheses or answer the
                                                application.                                            the target population.                                original research questions, as
                                                  (b) In considering selection criteria in                 (b) Responsiveness to an absolute or               appropriate, and could be used for
                                                § 1330.24, the Director selects one or                  competitive priority. In determining the              planning additional research, including
                                                more of the factors listed in the criteria,             application’s responsiveness to the                   generation of new hypotheses or
                                                but always considers the factor in                      application package or the absolute or                research questions, where applicable.
                                                § 1330.24(n) regarding members of                       competitive priority published in the
                                                groups that have traditionally been                                                                              (4) The extent to which the stage of
                                                                                                        Federal Register, the Director considers
                                                underrepresented based on race, color,                                                                        research is identified and justified in the
                                                                                                        one or more of the following factors:
                                                national origin, gender, age, or                                                                              description of the research project(s)
                                                                                                           (1) The extent to which the applicant
                                                disability.                                                                                                   being proposed.
                                                                                                        addresses all requirements of the
                                                  (c) The maximum possible score for                    absolute or competitive priority.                        (d) Design of development activities.
                                                an application is 100 points.                              (2) The extent to which the                        In determining the extent to which the
                                                  (d) In the application package or a                   applicant’s proposed activities are likely            project design is likely to be effective in
                                                notice published in the Federal                         to achieve the purposes of the absolute               accomplishing project objectives, the
                                                Register, the Director informs applicants               or competitive priority.                              Director considers one or more of the
                                                of:                                                        (c) Design of research activities. In              following factors:
                                                  (1) The selection criteria chosen and                 determining the extent to which the                      (1) The extent to which the proposed
                                                the maximum possible score for each of                  design is likely to be effective in                   project identifies a significant need and
                                                the selection criteria; and                             accomplishing the objectives of the                   a well-defined target population for the
                                                  (2) The factors selected for                          project, the Director considers one or                new or improved product;
                                                considering the selection criteria and if               more of the following factors:                           (2) The extent to which the proposed
                                                points are assigned to each factor, the                    (1) The extent to which the research               project methodology is meritorious,
                                                maximum possible score for each factor                  activities constitute a coherent,                     including consideration of the extent to
                                                under each criterion. If no points are                  sustained approach to research in the                 which:
                                                assigned to each factor, the Director                   field, including a substantial addition to               (i) The proposed project shows
                                                evaluates each factor equally.                          the state-of-the-art.                                 awareness of the state-of-the-art for
                                                  (e) For all instances in which the                       (2) The extent to which the                        current, related products;
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                                                Director chooses to allow field-initiated               methodology of each proposed research                    (ii) The proposed project employs
                                                research and development, the selection                 activity is meritorious, including                    appropriate concepts, components, or
                                                criteria in § 1330.25 will apply,                       consideration of the extent to which:                 systems to develop the new or improved
                                                including the requirement that the                         (i) The proposed design includes a                 product;
                                                applicant must achieve a score of 85                    comprehensive and informed review of                     (iii) The proposed project employs
                                                percent or more of maximum possible                     the current literature, demonstrating                 appropriate samples in tests, trials, and
                                                points.                                                 knowledge of the state-of-the-art;                    other development activities;


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                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                           29163

                                                   (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:
                                                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 product will be                          another entity.                                       technology have a practical use for the
                                                developed and tested in an appropriate                     (8) The extent to which the proposed               information and are likely to adopt the
                                                environment.                                            didactic and classroom training                       practices or use the information or
                                                   (e) Design of demonstration activities.                                                                    technology, including new devices.
                                                                                                        programs emphasize scientific
                                                In determining the extent to which the                                                                           (2) The extent to which the utilization
                                                                                                        methodology and are likely to develop
                                                design of demonstration activities is                                                                         strategies are likely to be effective.
                                                                                                        highly qualified researchers.
                                                likely to be effective in accomplishing                                                                          (3) The extent to which the
                                                                                                           (9) The extent to which the quality
                                                the objectives of the project, the Director                                                                   information or technology is likely to be
                                                                                                        and extent of the academic mentorship,
                                                considers one or more of the following                                                                        of use in other settings.
                                                factors:                                                guidance, and supervision to be
                                                                                                        provided to each individual trainee are                  (i) Design of technical assistance
                                                   (1) The extent to which the proposed                                                                       activities. In determining the extent to
                                                demonstration activities build on                       of a high level and are likely to develop
                                                                                                        highly qualified researchers.                         which the design of technical assistance
                                                previous research, testing, or practices.                                                                     activities is likely to be effective in
                                                   (2) The extent to which the proposed                    (10) The extent to which the type,
                                                                                                        extent, and quality of the proposed                   accomplishing the objectives of the
                                                demonstration activities include the use                                                                      project, the Director considers one or
                                                of proper methodological tools and                      research experience, including the
                                                                                                        opportunity to participate in advanced-               more of the following factors:
                                                theoretically sound procedures to                                                                                (1) The extent to which the methods
                                                determine the effectiveness of the                      level research, are likely to develop
                                                                                                                                                              for providing technical assistance are of
                                                strategy or approach.                                   highly qualified researchers.
                                                                                                                                                              sufficient quality, intensity, and
                                                   (3) The extent to which the proposed                    (11) The extent to which the
                                                                                                                                                              duration.
                                                demonstration activities include                        opportunities for collegial and                          (2) The extent to which the
                                                innovative and effective strategies or                  collaborative activities, exposure to                 information to be provided through
                                                approaches.                                             outstanding scientists in the field, and              technical assistance covers all of the
                                                   (4) The extent to which the proposed                 opportunities to participate in the                   relevant aspects of the subject matter.
                                                demonstration activities are likely to                  preparation of scholarly or scientific                   (3) The extent to which the technical
                                                contribute to current knowledge and                     publications and presentations are                    assistance is appropriate to the target
                                                practice and be a substantial addition to               extensive and appropriate.                            population, including consideration of
                                                the state-of-the-art.                                      (g) Design of dissemination activities.            the knowledge level of the target
                                                   (5) The extent to which the proposed                 In determining the extent to which the                population, needs of the target
                                                demonstration activities can be applied                 design is likely to be effective in                   population, and format for providing
                                                and replicated in other settings.                       accomplishing the objectives of the
                                                   (f) Design of training activities. In                                                                      information.
                                                                                                        project, the Director considers one or                   (4) The extent to which the technical
                                                determining the extent to which the                     more of the following factors:
                                                design is likely to be effective in                                                                           assistance is accessible to individuals
                                                                                                           (1) The extent to which the content of             with disabilities.
                                                accomplishing the objectives of the                     the information to be disseminated:                      (j) Plan of operation. In determining
                                                project, the Director considers one or                     (i) Covers all of the relevant aspects of
                                                more of the following factors:                                                                                the quality of the plan of operation, the
                                                                                                        the subject matter; and                               Director considers one or more of the
                                                   (1) The extent to which the proposed                    (ii) If appropriate, is based on new
                                                training materials are likely to be                                                                           following factors:
                                                                                                        knowledge derived from research                          (1) The adequacy of the plan of
                                                effective, including consideration of                   activities of the project.
                                                their quality, clarity, and variety.                                                                          operation to achieve the objectives of
                                                                                                           (2) The extent to which the materials              the proposed project on time and within
                                                   (2) The extent to which the proposed
                                                                                                        to be disseminated are likely to be                   budget, including clearly defined
                                                training methods are of sufficient
                                                                                                        effective and usable, including                       responsibilities, and timelines for
                                                quality, intensity, and duration.
                                                   (3) The extent to which the proposed                 consideration of their quality, clarity,              accomplishing project tasks.
                                                training content:                                       variety, and format.                                     (2) The adequacy of the plan of
                                                   (i) Covers all of the relevant aspects of               (3) The extent to which the methods                operation to provide for using resources,
                                                the subject matter; and                                 for dissemination are of sufficient                   equipment, and personnel to achieve
                                                   (ii) If relevant, is based on new                    quality, intensity, and duration.                     each objective.
                                                knowledge derived from research                            (4) The extent to which the materials                 (k) Collaboration. In determining the
                                                activities of the proposed project.                     and information to be disseminated and                quality of collaboration, the Director
                                                   (4) The extent to which the proposed                 the methods for dissemination are                     considers one or more of the following
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                                                training materials, methods, and content                appropriate to the target population,                 factors:
                                                are appropriate to the trainees,                        including consideration of the                           (1) The extent to which the
                                                including consideration of the skill level              familiarity of the target population with             applicant’s proposed collaboration with
                                                of the trainees and the subject matter of               the subject matter, format of the                     one or more agencies, organizations, or
                                                the materials.                                          information, and subject matter.                      institutions is likely to be effective in
                                                   (5) The extent to which the proposed                    (5) The extent to which the                        achieving the relevant proposed
                                                training materials and methods are                      information to be disseminated will be                activities of the project.


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                                                29164             Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

                                                   (2) The extent to which agencies,                    accomplish all the proposed activities of             appropriate community, State, and
                                                organizations, or institutions                          the project.                                          Federal resources.
                                                demonstrate a commitment to                                (3) The extent to which the key                      (7) The extent to which the design of
                                                collaborate with the applicant.                         personnel are knowledgeable about the                 the proposed project reflects up-to-date
                                                   (3) The extent to which agencies,                    methodology and literature of pertinent               knowledge from research and effective
                                                organizations, or institutions that                     subject areas.                                        practice.
                                                commit to collaborate with the                             (4) The extent to which the project                  (8) The extent to which the proposed
                                                applicant have the capacity to carry out                staff includes outstanding scientists in              project represents an exceptional
                                                collaborative activities.                               the field.                                            approach to the priority or priorities
                                                   (l) Adequacy and reasonableness of                      (5) The extent to which key personnel              established for the competition.
                                                the budget. In determining the adequacy                 have up-to-date knowledge from
                                                and the reasonableness of the proposed                  research or effective practice in the                 § 1330.25 Additional considerations for
                                                                                                        subject area covered in the priority.                 field-initiated priorities.
                                                budget, the Director considers one or
                                                more of the following factors:                             (o) Adequacy and accessibility of                     (a) The Director reserves funds to
                                                   (1) The extent to which the costs are                resources. In determining the adequacy                support field-initiated applications
                                                reasonable in relation to the proposed                  and accessibility of the applicant’s                  funded under this part when those
                                                project activities.                                     resources to implement the proposed                   applications have been awarded points
                                                   (2) The extent to which the budget for               project, the Director considers one or                totaling 85 percent or more of the
                                                the project, including any subcontracts,                more of the following factors:                        maximum possible points under the
                                                is adequately justified to support the                     (1) The extent to which the applicant              procedures described in § 1330.23.
                                                proposed project activities.                            is committed to provide adequate                         (b) In making a final selection from
                                                   (3) The extent to which the applicant                facilities, equipment, other resources,               applications received when NIDILRR
                                                is of sufficient size, scope, and quality               including administrative support, and                 uses field-initiated priorities, the
                                                to effectively carry out the activities in              laboratories, if appropriate.                         Director may consider whether one of
                                                an efficient manner.                                       (2) The quality of an applicant’s past             the following conditions is met and, if
                                                   (m) Plan of evaluation. In determining               performance in carrying out a grant.                  so, use this information to fund an
                                                the quality of the plan of evaluation, the                 (3) The extent to which the applicant              application out of rank order:
                                                Director considers one or more of the                   has appropriate access to populations                    (1) The proposed project represents a
                                                following factors:                                      and organizations representing                        unique opportunity to advance
                                                   (1) The extent to which the plan of                  individuals with disabilities to support              rehabilitation and other knowledge to
                                                evaluation provides for periodic                        advanced disability, independent living               improve the lives of individual with
                                                assessment of progress toward:                          and clinical rehabilitation research.                 disabilities.
                                                   (i) Implementing the plan of                            (4) The extent to which the facilities,               (2) The proposed project
                                                operation; and                                          equipment, and other resources are                    complements or balances research
                                                   (ii) Achieving the project’s intended                appropriately accessible to individuals               activity already planned or funded by
                                                outcomes and expected impacts.                          with disabilities who may use the                     NIDILRR through its annual priorities or
                                                   (2) The extent to which the plan of                  facilities, equipment, and other                      addresses the research in a new and
                                                evaluation will be used to improve the                  resources of the project.                             promising way.
                                                performance of the project through the                     (p) Quality of the project design. In                 (c) If the Director funds an application
                                                feedback generated by its periodic                      determining the quality of the design of              out of rank order under paragraph (b) of
                                                assessments.                                            the proposed project, the Director                    this section, the public will be notified
                                                   (3) The extent to which the plan of                  considers one or more of the following                through a notice on the NIDILRR Web
                                                evaluation provides for periodic                        factors:                                              site or through other means deemed
                                                assessment of a project’s progress that is                 (1) The extent to which the goals,                 appropriate by the Director.
                                                based on identified performance                         objectives, and outcomes to be achieved
                                                measures that:                                          by the proposed project are clearly                   Subpart D—Disability, Independent
                                                   (i) Are clearly related to the intended              specified and measurable.                             Living, and Rehabilitation Research
                                                outcomes of the project and expected                       (2) The quality of the methodology to              Fellowships
                                                impacts on the target population; and                   be employed in the proposed project.
                                                   (ii) Are objective, and quantifiable or                 (3) The extent to which the design of              § 1330.30   Fellows program.
                                                qualitative, as appropriate.                            the proposed project includes a                          (a) The purpose of this program is to
                                                   (n) Project staff. In determining the                thorough, high-quality review of the                  build research capacity by providing
                                                quality of the project staff, the Director              relevant literature, a high-quality plan              support to highly qualified individuals,
                                                considers the extent to which the                       for project implementation, and the use               including those who are individuals
                                                applicant encourages applications for                   of appropriate methodological tools to                with disabilities, to perform research on
                                                employment from persons who are                         ensure successful achievement of                      rehabilitation, independent living, and
                                                members of groups that have                             project objectives.                                   other experiences and outcomes of
                                                traditionally been underrepresented                        (4) The extent to which the design of              individuals with disabilities.
                                                based on race, color, national origin,                  the proposed project is appropriate to,                  (b) The eligibility requirements for the
                                                gender, age, or disability. In addition,                and will successfully address, the needs              Fellows program are as follows:
                                                the Director considers one or more of                   of the target population or other                        (1) Only individuals are eligible to be
                                                the following:                                          identified needs.                                     recipients of Fellowships.
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                                                   (1) The extent to which the key                         (5) The extent to which the proposed                  (2) Any individual is eligible for
                                                personnel and other key staff have                      development efforts include adequate                  assistance under this program who has
                                                appropriate training and experience in                  quality controls and, as appropriate,                 training and experience that indicate a
                                                disciplines required to conduct all                     repeated testing of products.                         potential for engaging in scientific
                                                proposed activities.                                       (6) The extent to which the proposed               research related to rehabilitation and
                                                   (2) The extent to which the                          project will be coordinated with similar              independent living for individuals with
                                                commitment of staff time is adequate to                 or related efforts, and with other                    disabilities.


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                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                          29165

                                                   (3) This program provides two                        DEPARTMENT OF THE INTERIOR                            Background
                                                categories of Fellowships: Merit                                                                                 Our regulations at 50 CFR 17.11(b)
                                                Fellowships and Distinguished                           Fish and Wildlife Service
                                                                                                                                                              direct us to use the most recently
                                                Fellowships.                                                                                                  accepted scientific names for species on
                                                                                                        50 CFR Part 17
                                                   (i) To be eligible for a Distinguished                                                                     the List of Endangered and Threatened
                                                Fellowship, an individual must have                                                                           Wildlife (50 CFR 17.11(h)). Accordingly,
                                                                                                        [Docket No. FWS–R1–ES–2016–0006;                      on February 17, 2016, we published in
                                                seven or more years of research                         FXES11130900000C6–167–FF09E42000]
                                                experience in subject areas, methods, or                                                                      the Federal Register a direct final rule
                                                techniques relevant to disability and                                                                         (81 FR 8004) to revise the taxonomy and
                                                                                                        RIN 1018–BA89                                         nomenclature of eight Hawaiian bird
                                                rehabilitation research and must have a
                                                doctorate, other terminal degree, or                                                                          species listed under section 4 of the Act
                                                                                                        Endangered and Threatened Wildlife;
                                                comparable academic qualifications.                                                                           (16 U.S.C. 1531 et seq.). All of these
                                                                                                        Technical Corrections for Eight
                                                                                                                                                              changes are supported by peer-reviewed
                                                   (ii) The Director awards Merit                       Wildlife Species on the List of
                                                                                                                                                              scientific studies and reflect the
                                                Fellowships to individuals in earlier                   Endangered and Threatened Wildlife
                                                                                                                                                              taxonomy that has been accepted by the
                                                stages of their careers in research. To be              AGENCY:   Fish and Wildlife Service,                  American Ornithologists’ Union (AOU)
                                                eligible for a Merit Fellowship, an                     Interior.                                             in the most recent supplements to the
                                                individual must have either advanced                                                                          Check-list of North American Birds.
                                                                                                        ACTION: Partial withdrawal of direct
                                                professional training or experience in                  final rule.                                           Specific references relevant to each
                                                independent study in an area which is                                                                         species are cited in the text of the
                                                directly pertinent to disability and                    SUMMARY:   We, the U.S. Fish and                      February 17, 2016, direct final rule, and
                                                rehabilitation.                                         Wildlife Service (Service), are                       are posted as supporting documents at
                                                   (c) Fellowships will be awarded in the               withdrawing, in part, a February 17,                  http://www.regulations.gov under
                                                form of a grant to eligible individuals.                2016, direct final rule that revises the              Docket No. FWS–R1–ES–2016–0006.
                                                                                                        taxonomy of eight wildlife species                       Consequently, we published the
                                                   (d) In making a final selection of                   under the Endangered Species Act of                   direct final rule without a prior proposal
                                                applicants to support under this                        1973, as amended (Act). For the                       because we considered it a
                                                program, the Director considers the                     Newell’s Townsend’s shearwater                        noncontroversial action that was in the
                                                extent to which applicants present a                    (Puffinus auricularis newelli), we                    best interest of the public and should be
                                                unique opportunity to effect a major                    received significant adverse comments                 undertaken in as timely a manner as
                                                advance in knowledge, address critical                  relating to additional scientific research            possible. We stated that if we received
                                                problems in innovative ways, present                    relevant to its taxonomic classification;             significant adverse comments regarding
                                                proposals which are consistent with the                 therefore, we are withdrawing the                     the taxonomic changes for any of these
                                                Institute’s Long-Range Plan, build                      amendments in the direct final rule for               species, we would publish a document
                                                research capacity within the field, or                  this species only. The amendments in                  in the Federal Register withdrawing
                                                complement and significantly increases                  the direct final rule for the other seven             this rule for the appropriate species
                                                the potential value of already planned                  species (Oahu elepaio (Chasiempis                     before the effective date. Significant
                                                research and related activities.                        ibidis), Kauai akialoa (Akialoa                       adverse comments are comments that
                                                                                                        stejnegeri), akiapolaau (Hemignathus                  provide strong justifications as to why
                                                Subpart E—Special Projects and                          wilsoni), Kauai nukupuu (Hemignathus                  the rule should not be adopted or why
                                                Demonstrations for Spinal Cord                          hanapepe), Maui nukupuu                               it should be changed.
                                                Injuries                                                (Hemignathus affinis), Hawaii akepa                   Comments on the Direct Final Rule
                                                                                                        (Loxops coccineus), and Maui akepa
                                                § 1330.40   Spinal cord injuries program.               (Loxops ochraceus)) will be effective on                 We received three comments on the
                                                                                                        May 17, 2016.                                         direct final rule. One of these comments
                                                   (a) This program provides assistance
                                                                                                        DATES: Effective May 11, 2016, the
                                                                                                                                                              called our attention to recently
                                                to establish innovative projects for the
                                                                                                        Service withdraws amendatory                          published genetic research on
                                                delivery, demonstration, and evaluation                                                                       shearwaters (Martı́nez-Gómez et al.
                                                of comprehensive medical, vocational,                   instructions 2.f and 2.g published at 81
                                                                                                        FR 8007 on February 17, 2016.                         2015) that recommends maintaining the
                                                independent living, and rehabilitation                                                                        Hawaiian taxon newelli (Newell’s
                                                services to meet the wide range of needs                ADDRESSES: The direct final rule may be
                                                                                                                                                              Townsend’s shearwater, or Newell’s
                                                of individuals with spinal cord injuries.               found online at http://                               shearwater) as a subspecies of the
                                                   (b) The agencies and organizations                   www.regulations.gov under Docket No.                  Townsend’s shearwater, under the
                                                                                                        FWS–R1–ES–2016–0006.                                  scientific name Puffinus auricularis
                                                eligible to apply under this program are
                                                described in § 1330.2.                                  FOR FURTHER INFORMATION CONTACT:                      newelli. This recommendation is
                                                                                                        Marilet Zablan, Program Manager for                   contrary to the determination of the
                                                [FR Doc. 2016–10853 Filed 5–10–16; 8:45 am]
                                                                                                        Restoration and Endangered Species                    direct final rule and the AOU Checklist
                                                BILLING CODE P                                          Classification, U.S. Fish and Wildlife                Committee (Chesser et al. 2015) that
                                                                                                        Service, Pacific Regional Office,                     Newell’s shearwater is a distinct species
                                                                                                        Ecological Services, 911 NE 11th                      (Puffinus newelli). The commenter
                                                                                                        Avenue, Portland, OR 97232; telephone                 requested that this discrepancy be
jstallworth on DSK7TPTVN1PROD with RULES




                                                                                                        503–231–6131. Individuals who are                     further considered before we adopt the
                                                                                                        hearing impaired or speech impaired                   taxonomic change set forth in the direct
                                                                                                        may call the Federal Relay Service at                 final rule. Another commenter
                                                                                                        800–877–8337 for TTY (telephone                       discussed behavioral differences
                                                                                                        typewriter or teletypewriter) assistance              between Newell’s shearwater and
                                                                                                        24 hours a day, 7 days a week.                        Townsend’s shearwater, while also
                                                                                                        SUPPLEMENTARY INFORMATION:                            providing a link to an article


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Document Created: 2016-05-11 01:12:12
Document Modified: 2016-05-11 01:12:12
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThese final regulations are effective July 1, 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 Citation81 FR 29156 
RIN Number0985-AA12
CFR AssociatedGrant Programs; Research and Scholarships and Fellowships

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