33092 Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Rules and Regulations 

■ d. In newly designated paragraph (a), 

by removing from the first sentence the 

phrase ‘‘(see mailing addresses in 

§ 600.2)’’; and 

■ e. By adding new paragraph (b) to read 

as follows: 

§ 600.81 Distribution reports. 

(a) Reporting requirements. * * * 

(b)(1) Electronic format. Except as 

provided for in paragraph (b)(2) of this 

section, the distribution reports required 

under paragraph (a) of this section must 

be submitted to the Agency in an 

electronic format that FDA can process, 

review, and archive. FDA will issue 

guidance on how to provide the 

electronic submission (e.g., method of 

transmission, media, file formats, 

preparation and organization of files). 

(2) Waivers. An applicant may 

request, in writing, a temporary waiver 

of the requirements in paragraph (b)(1) 

of this section. These waivers will be 

granted on a limited basis for good 

cause shown. FDA will issue guidance 

on requesting a waiver of the 

requirements in paragraph (b)(1) of this 

section. Requests for waivers must be 

submitted in accordance with § 600.90. 

§ 600.90 [Amended] 

■ 11. Section 600.90 is amended by 

removing the phrase ‘‘licensed 

manufacturer’’ or ‘‘licensed 

manufacturer’s’’ each time it appears 

and by adding in its place the word 

‘‘applicant’’ or ‘‘applicant’s’’ 

respectively. 

Dated: June 4, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–13480 Filed 6–9–14; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF EDUCATION 

34 CFR Chapter III 

[Docket ID: ED–2014–OSERS–0013] 

Final Priority. National Institute on 

Disability and Rehabilitation 

Research—Rehabilitation Research 

and Training Centers 

[CFDA Number: 84.133B–4.] 

AGENCY: Office of Special Education and 

Rehabilitative Services, Department of 

Education. 

ACTION: Final priority. 

SUMMARY: The Assistant Secretary for 

Special Education and Rehabilitative 

Services announces a priority for the 

Rehabilitation Research and Training 

Center (RRTC) Program administered by 

the National Institute on Disability and 

Rehabilitation Research (NIDRR). 

Specifically, we announce a priority for 

an RRTC on Health and Function of 

Individuals with Physical Disabilities. 

The Assistant Secretary may use this 

priority for competitions in fiscal year 

(FY) 2014 and later years. We take this 

action to focus research attention on an 

area of national need. We intend the 

priority to contribute to improved 

outcomes of health and function of 

individuals with physical disabilities. 

DATES: This priority is effective July 10, 

2014. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Barrett, U.S. Department of 

Education, 400 Maryland Avenue SW., 

Room 5142, Potomac Center Plaza 

(PCP), Washington, DC 20202–2700. 

Telephone: (202) 245–6211 or by email: 

patricia.barrett@ed.gov. 

If you use a telecommunications 

device for the deaf (TDD) or a text 

telephone (TTY), call the Federal Relay 

Service (FRS), toll free, at 1–800–877– 

8339. 

SUPPLEMENTARY INFORMATION: Purpose of 

Program: The purpose of the Disability 

and Rehabilitation Research Projects 

and Centers Program is to plan and 

conduct research, demonstration 

projects, training, and related activities, 

including international activities, to 

develop methods, procedures, and 

rehabilitation technology that maximize 

the full inclusion and integration into 

society, employment, independent 

living, family support, and economic 

and social self-sufficiency of individuals 

with disabilities, especially individuals 

with the most severe disabilities, and to 

improve the effectiveness of services 

authorized under the Rehabilitation Act 

of 1973, as amended (Rehabilitation 

Act). 

Rehabilitation Research and Training 

Centers 

The purpose of the RRTCs, which are 

funded through the Disability and 

Rehabilitation Research Projects and 

Centers Program, is to achieve the goals 

of, and improve the effectiveness of, 

services authorized under the 

Rehabilitation Act through welldesigned research, training, technical 

assistance, and dissemination activities 

in important topical areas. These 

activities are designed to benefit 

rehabilitation service providers, 

individuals with disabilities, family 

members, policymakers, and other 

research stakeholders. Additional 

information on the RRTC program can 

be found at: http://www2.ed.gov/

programs/rrtc/index.html. 

Program Authority: 29 U.S.C. 762(g) and 

764(b)(2). 

Applicable Program Regulations: 34 

CFR part 350. 

We published a notice of proposed 

priority (NPP) for this program in the 

Federal Register on March 3, 2014 (79 

FR 11738). That notice contained 

background information and our reasons 

for proposing the particular priority. 

There are no differences between the 

proposed priority and this final priority. 

Public Comment: In response to our 

invitation in the notice of proposed 

priority, six parties submitted comments 

on the proposed priority. 

Generally, we do not address 

technical and other minor changes, or 

suggested changes the law does not 

authorize us to make under the 

applicable statutory authority. In 

addition, we do not address general 

comments that raised concerns not 

directly related to the proposed priority. 

Analysis of Comments and Changes: 

An analysis of the comments and of any 

changes in the priority since publication 

of the NPP follows. 

Comment: One commenter questioned 

the need for this priority. 

Discussion: This priority, creating an 

RRTC on Health and Function of 

Individuals with Physical Disabilities, 

would help achieve the goals of, and 

improve the effectiveness of services 

authorized under, the Rehabilitation 

Act. By creating an RRTC on Health and 

Function for Individuals with Physical 

Disabilities, we are fulfilling the 

purposes established in NIDRR’s LongRange Plan for Fiscal Years 2013–2017 

(Plan), which was published in the 

Federal Register on April 4, 2013 (78 FR 

20299). More specifically, as we discuss 

in the NPP, there is a need to better 

understand how specific health 

problems are interrelated with optimal 

health and function; how they may 

affect community participation, work 

productivity, and quality of life; and 

how they may be prevented or 

mitigated. We believe this priority will 

focus research attention on this area of 

national need. 

Changes: None. 

Comment: One commenter 

recommended that the RRTC should 

focus on technology-based interventions 

to improve health and function 

outcomes of individuals with 

disabilities. 

Discussion: NIDRR agrees that 

technology can be used to improve the 

health and function outcomes of 

individuals with physical disabilities. 

This is one of five broad areas described 

in the priority, under which applicants 

can propose research and related 

activities. NIDRR does not wish to limit 

applicants’ ability to address the other 

areas in the priority by requiring a focus 


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Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Rules and Regulations 33093 

on technology, as recommended by the 

commenter. The peer review process 

will determine the merits of each 

proposal. 

Changes: None. 

Comment: One commenter noted that 

several research centers working in the 

area of health and function for 

individuals with physical disabilities 

have focused their efforts on analysis of 

existing data. The commenter 

recommended that NIDRR revise the 

priority to require the RRTC to collect 

new data in order to advance the field. 

Discussion: Nothing in the priority 

precludes an applicant from proposing 

to engage in the collection and analysis 

of new data. However, NIDRR does not 

wish to revise the research requirements 

in the way suggested by the commenter 

because we believe the revisions would 

limit the number and breadth of 

applications submitted under this 

priority. The peer review process will 

determine the merits of each proposal. 

Changes: None. 

Comment: One commenter 

recommended that NIDRR revise the 

priority to require the RRTC to focus on 

at least two study populations or 

diagnostic groups, thereby promoting 

the generalizability of the RRTC’s 

findings. 

Discussion: Paragraph (a) of the 

proposed priority states that the RRTC 

can focus on individuals with physical 

disabilities as a group or on specific 

disability or demographic 

subpopulations of individuals with 

physical disabilities. NIDRR purposely 

does not require a minimum number of 

target populations because we do not 

want to limit the breadth and number of 

applications that can be submitted 

under this priority. 

Changes: None. 

Comment: One commenter asked 

NIDRR to further define and specify the 

limits of the term ‘‘physical disability.’’ 

The commenter noted that people with 

traumatic brain injury (TBI) or stroke, 

for example, have acquired cognitive or 

intellectual impairments, as well as 

physical impairments, and often receive 

clinical services from rehabilitation 

professionals with expertise in physical 

disabilities. The commenter requested 

clarification of the term ‘‘physical 

disability’’ to help applicants determine 

whether their proposed target 

population(s) are an appropriate fit 

within the priority. 

Discussion: We agree that some 

individuals with disabling conditions 

such as TBI or stroke could be 

considered in multiple target 

populations, including individuals with 

physical disabilities. NIDRR purposely 

outlines broad categories of target 

populations in its Plan and its priorities 

to allow applicants the flexibility to 

choose the disability category that is 

most relevant to their research questions 

and purposes. With this priority, we 

allow applicants to define and justify 

their target population within the broad 

category of individuals with physical 

disabilities. The peer review process 

will determine the merits of each 

proposal. 

Changes: None. 

Comment: One commenter noted that 

paragraph (c)(ii) of the priority requires 

the RRTC to provide training to 

rehabilitation providers and other 

disability service providers in order to 

facilitate more effective delivery of 

services. The commenter suggested that 

by limiting the recipients of the required 

training to service providers, NIDRR 

may be limiting the knowledge that is 

available to consumers and reinforcing 

the knowledge barrier between service 

providers and consumers. The 

commenter suggested that NIDRR 

modify paragraph (c)(ii) to require the 

RRTCs to provide training to consumers 

and service providers. 

Discussion: The requirements in 

paragraph (c)(ii) are based directly on 

the Federal regulations that govern 

administration of the RRTC program. 

The regulations in 34 CFR 350.22(b)(1) 

require that training be provided to 

rehabilitation personnel or 

rehabilitation research personnel. At the 

same time, nothing in the regulations or 

in the priority precludes applicants 

from proposing to provide training to 

individuals with disabilities in addition 

to rehabilitation or rehabilitation 

research providers (who may also have 

disabilities). It is up to the applicant to 

designate and justify training targets. 

The peer review process will determine 

the merits of each proposal. 

Changes: None. 

Final Priority 

The Assistant Secretary for Special 

Education and Rehabilitative Services 

establishes a priority for an RRTC on 

Health and Function of Individuals with 

Physical Disabilities. 

The RRTC must contribute to 

maximizing the health and function 

outcomes of individuals with physical 

disabilities by: 

(a) Conducting research activities in 

one or more of the following priority 

areas, focusing on individuals with 

physical disabilities as a group or on 

individuals in specific disability or 

demographic subpopulations of 

individuals with physical disabilities: 

(i) Technology to improve health and 

function outcomes for individuals with 

physical disabilities. 

(ii) Individual and environmental 

factors associated with improved access 

to rehabilitation and health care and 

improved health and function outcomes 

for individuals with physical 

disabilities. 

(iii) Interventions that contribute to 

improved health and function outcomes 

for individuals with physical 

disabilities. Interventions include any 

strategy, practice, program, policy, or 

tool that, when implemented as 

intended, contributes to improvements 

in outcomes for the specified 

population. 

(iv) Effects of government practices, 

policies, and programs on health care 

access and on health and function 

outcomes for individuals with physical 

disabilities. 

(v) Practices and policies that 

contribute to improved health and 

function outcomes for individuals with 

physical disabilities. 

(b) Focusing its research on one or 

more specific stages of research. If the 

RRTC is to conduct research that can be 

categorized under more than one of the 

research stages, or research that 

progresses from one stage to another, 

those stages must be clearly specified. 

The research stages and their definitions 

are in the final priorities and definitions 

published in the Federal Register on 

May 7, 2013 (78 FR 26513). 

(c) Serving as a national resource 

center related to health and function for 

individuals with physical disabilities, 

their families, and other stakeholders by 

conducting knowledge translation 

activities that include, but are not 

limited to: 

(i) Providing information and 

technical assistance to service 

providers, individuals with physical 

disabilities and their representatives, 

and other key stakeholders. 

(ii) Providing training, including 

graduate, pre-service, and in-service 

training, to rehabilitation providers and 

other disability service providers, to 

facilitate more effective delivery of 

services to individuals with physical 

disabilities. This training may be 

provided through conferences, 

workshops, public education programs, 

in-service training programs, and 

similar activities. 

(iii) Disseminating research-based 

information and materials related to 

health and function for individuals with 

physical disabilities. 

(iv) Involving key stakeholder groups 

in the activities conducted under 

paragraph (a) in order to maximize the 

relevance and usability of the new 

knowledge generated by the RRTC. 


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33094 Federal Register / Vol. 79, No. 111 / Tuesday, June 10, 2014 / Rules and Regulations 

Types of Priorities 

When inviting applications for a 

competition using one or more 

priorities, we designate the type of each 

priority as absolute, competitive 

preference, or invitational through a 

notice in the Federal Register. The 

effect of each type of priority follows: 

Absolute priority: Under an absolute 

priority, we consider only applications 

that meet the priority (34 CFR 

75.105(c)(3)). 

Competitive preference priority: 

Under a competitive preference priority, 

we give competitive preference to an 

application by (1) awarding additional 

points, depending on the extent to 

which the application meets the priority 

(34 CFR 75.105(c)(2)(i)); or (2) selecting 

an application that meets the priority 

over an application of comparable merit 

that does not meet the priority (34 CFR 

75.105(c)(2)(ii)). 

Invitational priority: Under an 

invitational priority, we are particularly 

interested in applications that meet the 

priority. However, we do not give an 

application that meets the priority a 

preference over other applications (34 

CFR 75.105(c)(1)). 

This notice does not preclude us from 

proposing additional priorities, 

requirements, definitions, or selection 

criteria, subject to meeting applicable 

rulemaking requirements. 

Note: This notice does not solicit 

applications. In any year in which we choose 

to use this priority, we invite applications 

through a notice in the Federal Register. 

Executive Orders 12866 and 13563 

Regulatory Impact Analysis 

Under Executive Order 12866, the 

Secretary must determine whether this 

regulatory action is ‘‘significant’’ and, 

therefore, subject to the requirements of 

the Executive order and subject to 

review by the Office of Management and 

Budget (OMB). Section 3(f) of Executive 

Order 12866 defines a ‘‘significant 

regulatory action’’ as an action likely to 

result in a rule that may— 

(1) Have an annual effect on the 

economy of $100 million or more, or 

adversely affect a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal governments or 

communities in a material way (also 

referred to as an ‘‘economically 

significant’’ rule); 

(2) Create serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

(3) Materially alter the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or 

(4) Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

stated in the Executive order. 

This final regulatory action is not a 

significant regulatory action subject to 

review by OMB under section 3(f) of 

Executive Order 12866. 

We have also reviewed this final 

regulatory action under Executive Order 

13563, which supplements and 

explicitly reaffirms the principles, 

structures, and definitions governing 

regulatory review established in 

Executive Order 12866. To the extent 

permitted by law, Executive Order 

13563 requires that an agency— 

(1) Propose or adopt regulations only 

upon a reasoned determination that 

their benefits justify their costs 

(recognizing that some benefits and 

costs are difficult to quantify); 

(2) Tailor its regulations to impose the 

least burden on society, consistent with 

obtaining regulatory objectives and 

taking into account—among other things 

and to the extent practicable—the costs 

of cumulative regulations; 

(3) In choosing among alternative 

regulatory approaches, select those 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity); 

(4) To the extent feasible, specify 

performance objectives, rather than the 

behavior or manner of compliance a 

regulated entity must adopt; and 

(5) Identify and assess available 

alternatives to direct regulation, 

including economic incentives—such as 

user fees or marketable permits—to 

encourage the desired behavior, or 

provide information that enables the 

public to make choices. 

Executive Order 13563 also requires 

an agency ‘‘to use the best available 

techniques to quantify anticipated 

present and future benefits and costs as 

accurately as possible.’’ The Office of 

Information and Regulatory Affairs of 

OMB has emphasized that these 

techniques may include ‘‘identifying 

changing future compliance costs that 

might result from technological 

innovation or anticipated behavioral 

changes.’’ 

We are issuing this final priority only 

on a reasoned determination that its 

benefits justify its costs. In choosing 

among alternative regulatory 

approaches, we selected those 

approaches that maximize net benefits. 

Based on the analysis that follows, the 

Department believes that this regulatory 

action is consistent with the principles 

in Executive Order 13563. 

We also have determined that this 

regulatory action does not unduly 

interfere with State, local, and tribal 

governments in the exercise of their 

governmental functions. 

In accordance with both Executive 

orders, the Department has assessed the 

potential costs and benefits, both 

quantitative and qualitative, of this 

regulatory action. The potential costs 

are those resulting from statutory 

requirements and those we have 

determined as necessary for 

administering the Department’s 

programs and activities. 

The benefits of the Disability and 

Rehabilitation Research Projects and 

Centers Program have been well 

established over the years, as projects 

similar to the one envisioned by the 

final priority have been completed 

successfully. The new RRTC will 

generate and promote the use of new 

knowledge that is intended to the health 

and function of individuals with 

disabilities. 

Accessible Format: Individuals with 

disabilities can obtain this document in 

an accessible format (e.g., braille, large 

print, audiotape, or compact disc) on 

request to the program contact person 

listed under FOR FURTHER INFORMATION

CONTACT. 

Electronic Access to This Document: 

The official version of this document is 

the document published in the Federal 

Register. Free Internet access to the 

official edition of the Federal Register 

and the Code of Federal Regulations is 

available via the Federal Digital System 

at: www.gpo.gov/fdsys. At this site you 

can view this document, as well as all 

other documents of this Department 

published in the Federal Register, in 

text or Adobe Portable Document 

Format (PDF). To use PDF you must 

have Adobe Acrobat Reader, which is 

available free at the site. 

You may also access documents of the 

Department published in the Federal 

Register by using the article search 

feature at: www.federalregister.gov. 

Specifically, through the advanced 

search feature at this site, you can limit 

your search to documents published by 

the Department. 

Dated: June 5, 2013. 

Michael K. Yudin, 

Acting Assistant Secretary for Special 

Education and Rehabilitative Services. 

[FR Doc. 2014–13498 Filed 6–9–14; 8:45 am] 

BILLING CODE 4000–01–P 


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