10114 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 

NIDILRR-funded grantees, including 

knowledge translation grantees and 

grantees involved with employment 

research. 

Final Priority 

We will announce the final priority in 

a notice in the Federal Register. We will 

determine the final priority after 

considering responses to this notice and 

other information available to the 

Department. 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 or 

in a Funding Opportunity Announcement 

posted at www.grants.gov. 

Executive Orders 12866 and 13563 

Regulatory Impact Analysis 

Under Executive Order 12866, the 

Secretary must determine whether this 

regulatory action is ‘‘significant’’ and, 

therefore, subject to the requirements of 

the Executive Order and subject to 

review by the Office of Management and 

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

Order 12866 defines a ‘‘significant 

regulatory action’’ as an action likely to 

result in a rule that may— 

(1) Have an annual effect on the 

economy of $100 million or more, or 

adversely affect a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal governments or 

communities in a material way (also 

referred to as an ‘‘economically 

significant’’ rule); 

(2) Create serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

(3) Materially alter the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or 

(4) Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

stated in the Executive Order. 

This proposed regulatory action is not 

a significant regulatory action subject to 

review by OMB under section 3(f) of 

Executive Order 12866. 

We have also reviewed this 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 proposed priority 

only upon a reasoned determination 

that its benefits would justify its costs. 

In choosing among alternative 

regulatory approaches, we selected 

those approaches that would maximize 

net benefits. Based on the analysis that 

follows, the Department believes that 

this proposed priority is consistent with 

the principles in Executive Order 13563. 

We also have determined that this 

regulatory action would not unduly 

interfere with State, local, and tribal 

governments in the exercise of their 

governmental functions. 

In accordance with both Executive 

Orders, the Department has assessed the 

potential costs and benefits, both 

quantitative and qualitative, of this 

regulatory action. The potential costs 

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. Projects 

similar to one envisioned by the 

proposed priority have been completed 

successfully, and the proposed priority 

would generate new knowledge through 

research. The new RRTC would 

generate, disseminate, and promote the 

use of new information that would 

improve outcomes for individuals with 

disabilities in the area of employment. 

Intergovernmental Review: This 

program is not subject to Executive 

Order 12372. 

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: February 19, 2015. 

Kathy Greenlee, 

Administrator. 

[FR Doc. 2015–03882 Filed 2–24–15; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

[CFDA Number: 84.133A–7] 

Proposed Priority—National Institute 

on Disability, Independent Living, and 

Rehabilitation Research—Disability 

and Rehabilitation Research Projects 

Program 

AGENCY: Administration for Community 

Living, HHS. 

ACTION: Notice of proposed priority. 

SUMMARY: The Administrator of the 

Administration for Community Living 

proposes a priority for the Disability and 

Rehabilitation Research Projects 

(DRRPs) Program administered by the 

National Institute on Disability, 

Independent Living, and Rehabilitation 

Research (NIDILRR). Specifically, this 

notice proposes a priority for Promoting 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10115 

Universal Design in the Built 

Environment. We take this action to 

focus research attention on an area of 

national need. We intend this priority to 

contribute to improved access to the 

built environment by individuals with 

disabilities. 

DATES: We must receive your comments 

on or before March 27, 2015. 

ADDRESSES: Submit your comments 

through the Federal eRulemaking Portal 

or via postal mail or commercial 

delivery. We will not accept comments 

submitted by fax or by email or those 

submitted after the comment period. To 

ensure that we do not receive duplicate 

copies, please submit your comments 

only once. In addition, please include 

the Docket ID at the top of your 

comments. 

• Federal eRulemaking Portal: Go to 

www.regulations.gov to submit your 

comments electronically. Information 

on using Regulations.gov, including 

instructions for accessing agency 

documents, submitting comments, and 

viewing the docket, is available on the 

site under ‘‘Are you new to the site?’’ 

• Postal Mail or Commercial Delivery: 

If you mail or deliver your comments 

about these proposed regulations, 

address them to Patricia Barrett, U.S. 

Department of Health and Human 

Services, 400 Maryland Avenue SW., 

Room 5142, Potomac Center Plaza 

(PCP), Washington, DC 20202–2700. 

Privacy Note: The Department’s 

policy is to make all comments received 

from members of the public available for 

public viewing in their entirety on the 

Federal eRulemaking Portal at 

www.regulations.gov. Therefore, 

commenters should be careful to 

include in their comments only 

information that they wish to make 

publicly available. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Barrett. 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: This 

notice of proposed priority is in concert 

with NIDRR’s currently approved LongRange Plan (Plan). The Plan, which was 

published in the Federal Register on 

April 4, 2013 (78 FR 20299), can be 

accessed on the Internet at the following 

site: www.ed.gov/about/offices/list/

osers/nidrr/policy.html. 

The Plan identifies a need for research 

and training regarding employment, 

community living and participation, 

and health and function of individuals 

with disabilities. To address this need, 

NIDILRR seeks to: (1) Improve the 

quality and utility of disability and 

rehabilitation research; (2) foster an 

exchange of research findings, expertise, 

and other information to advance 

knowledge and understanding of the 

needs of individuals with disabilities 

and their family members, including 

those from among traditionally 

underserved populations; (3) determine 

effective practices, programs, and 

policies to improve community living 

and participation, employment, and 

health and function outcomes for 

individuals with disabilities of all ages; 

(4) identify research gaps and areas for 

promising research investments; (5) 

identify and promote effective 

mechanisms for integrating research and 

practice; and (6) disseminate research 

findings to all major stakeholder groups, 

including individuals with disabilities 

and their family members in formats 

that are appropriate and meaningful to 

them. 

This notice proposes one priority that 

NIDILRR intends to use for one or more 

competitions in fiscal year (FY) 2015 

and possibly later years. NIDILRR is 

under no obligation to make an award 

under this priority. The decision to 

make an award will be based on the 

quality of applications received and 

available funding. NIDILRR may publish 

additional priorities, as needed. 

Invitation to Comment: We invite you 

to submit comments regarding this 

proposed priority. To ensure that your 

comments have maximum effect in 

developing the final priority, we urge 

you to identify clearly the specific topic 

within the priority that each comment 

addresses. 

We invite you to assist us in 

complying with the specific 

requirements of Executive Orders 12866 

and 13563 and their overall requirement 

of reducing regulatory burden that 

might result from this proposed priority. 

Please let us know of any further ways 

we could reduce potential costs or 

increase potential benefits while 

preserving the effective and efficient 

administration of the program. 

During and after the comment period, 

you may inspect all public comments by 

following the instructions found under 

the ‘‘Are you new to the site?’’ portion 

of the Federal eRulemaking Portal at 

www.regulations.gov. Any comments 

sent to NIDILRR via postal mail or 

commercial delivery can be viewed in 

Room 5142, 550 12th Street SW., PCP, 

Washington, DC, between the hours of 

8:30 a.m. and 4:00 p.m., Washington, 

DC time, Monday through Friday of 

each week except Federal holidays. 

Assistance to Individuals With 

Disabilities in Reviewing the 

Rulemaking Record: On request we will 

provide an appropriate accommodation 

or auxiliary aid to an individual with a 

disability who needs assistance to 

review the comments or other 

documents in the public rulemaking 

record for this notice. If you want to 

schedule an appointment for this type of 

accommodation or auxiliary aid, please 

contact the person listed under FOR

FURTHER INFORMATION CONTACT. 

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 selfsufficiency 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). 

Disability and Rehabilitation Research 

Projects 

The purpose of NIDILRR’s DRRPs, 

which are funded through the Disability 

and Rehabilitation Research Projects 

and Centers Program, is to improve the 

effectiveness of services authorized 

under the Rehabilitation Act by 

developing methods, procedures, and 

rehabilitation technologies that advance 

a wide range of independent living and 

employment outcomes for individuals 

with disabilities, especially individuals 

with the most significant disabilities. 

DRRPs carry out one or more of the 

following types of activities, as specified 

and defined in 34 CFR 350.13 through 

350.19: research, training, 

demonstration, development, 

utilization, dissemination, and technical 

assistance. 

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 (34 CFR 

350.40(a)). The approaches an applicant 

may take to meet this requirement are 

found in 34 CFR 350.40(b). Additional 

information on the DRRP program can 

be found at: www.ed.gov/rschstat/

research/pubs/res-program.html#DRRP. 

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

764(a). 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
10116 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 

Applicable Program Regulations: 34 

CFR part 350. 

Proposed Priority: This notice 

contains one proposed priority. 

Promoting Universal Design (UD) in the 

Built Environment 

Background: Universal Design is 

generally defined as the ‘‘design of 

products and environments that are 

usable by all people, to the greatest 

extent possible, without the need for 

adaptation or specialized design’’ 

(Mace, 1985; Ostroff, 2011). UD 

proponents seek to improve human 

performance, health and wellness, and 

social participation for the entire 

population including individuals with 

disabilities (Steinfeld & Maisel, 2012). 

NIDILRR grantees have substantially 

contributed to the development, 

refinement, and application of UD 

principles. In particular, the NIDILRRfunded Center for Universal Design at 

North Carolina State University (in 

collaboration with other researchers and 

practitioners) developed the seven 

‘‘Principles of Universal Design’’ (The 

Principles of Universal Design, 1997). 

These principles (equitable use, 

flexibility in use, simple and intuitive 

use, perceptible information, tolerance 

for error, low physical effort, and 

appropriate size and space for approach 

and use regardless of users’ body size, 

posture, and mobility) have increasingly 

guided designers, builders, developers, 

and other stakeholders in the provision 

of accessible housing and built 

environments. Examples of UD found in 

the built environment include: curb 

cuts, building ramps, automatic door 

openers, fully accessible restrooms, 

moving walkways, and wayfinding 

systems that facilitate user access and 

orientation. 

All NIDILRR-funded Rehabilitation 

Engineering Research Centers (RERCs) 

must incorporate UD principles in their 

research and development activities. 

Funded for the past 15 years, the RERC 

on Universal Design and the Built 

Environment is specifically charged 

with advancing the implementation of 

UD principles in the built environment. 

Center outcomes include a tool set for 

UD research and practice, prototypes for 

built environments, and UD standards. 

NIDILRR funding has contributed to the 

development of 35 state and local 

visitability ordinances and initiatives 

across the U.S, which require or 

encourage affordable and sustainable 

integration of basic accessibility features 

into all newly-built homes. NIDILRR 

funding also supported the inclusion of 

UD principles in a building manual 

which the New York City Department of 

Design and Construction adopted as the 

official reference for all architects 

working in the city (Center for Inclusive 

Design and Universal Access, 2003). 

Despite these notable outcomes, 

application of UD principles to the built 

environment has not become a 

mainstream practice (Ostroff, 2011; 

Dong 2011). Practical demonstrations of 

UD applications for buildings, homes, 

and outdoor environments, as well as a 

strengthened evidence-base for UD 

standards and strategies are yet needed. 

These needs will only increase as the 

baby boom generation ages while 

seeking to live and thrive in their own 

homes and communities (Federal 

Interagency Forum on Aging-Related 

Statistics, 2012). Making research-based 

knowledge about UD accessible to 

designers, developers, architects, and 

builders will help to advance UD 

implementation and realize the goals of 

improving human performance, health 

and wellness, and social participation 

for the entire population, including 

individuals with disabilities. 

Accordingly, NIDILRR aims to sponsor 

a DRRP on Promoting UD in the Built 

Environment to conduct research, 

knowledge translation, technical 

assistance, and training activities aimed 

at continued implementation of UD 

principles in the built environment. 

References 

Center for Inclusive Design and Universal 

Access, 2003. Universal Design New 

York 2: The NYC Guidebook to 

Accessibility and Universal Design. 

Buffalo New York: Idea Publications. 

Dong, H (2011). Global Perspectives and 

Reflections. In Trends in Universal 

Design. Tonsberg, Norway: The Delta 

Centre. 

Federal Interagency Forum on Aging-Related 

Statistics, (2012). Older Americans 2012: 

Key Indicators of Well-Being. 

(Washington, DC: U.S. Government 

Printing Office). 

Mace, R. (1985). Universal design, barrier free 

environments for everyone. Los Angeles: 

Designers West. 

Ostroff, E. (2011). Universal design: An 

evolving paradigm. In Preiser, W. & 

Smith K. (Eds.). Universal Design 

Handbook. New York, McGraw Hill. 

The Principles of Universal Design (1997). 

Version 2.0—4/1/97. Compiled by 

advocates of universal design, listed in 

alphabetical order: Bettye Rose Connell, 

Mike Jones, Ron Mace, Jim Mueller, Abir 

Mullick, Elaine Ostroff, Jon Sanford, Ed 

Steinfeld, Molly Story, and Gregg 

Vanderheiden. NC State University, The 

Center for Universal Design. 

Steinfeld, E. & Maisel, J.L. (2012). Universal 

Design: Creating Inclusive Environments. 

Hoboken, NJ: Wiley and Sons, Inc. 

Proposed Priority: The Administrator 

of the Administration for Community 

Living proposes a priority for a 

Disability and Rehabilitation Research 

Project on Promoting Universal Design 

in the Built Environment. The intended 

outcome of the DRRP on Universal 

Design is further adoption of universal 

design principles into mainstream 

architecture and the development and 

construction of built environments. The 

DRRP must contribute to this outcome 

by: 

(a) Conducting research activities 

toward developing evidence-based 

practices for UD implementation in 

commercial and private facilities, 

outdoor environments, and housing. 

(b) Creating measurable UD standards 

and guidelines to facilitate the 

implementation of UD principles in 

commercial and private facilities, 

outdoor environments, and housing. 

(c) Developing and promoting 

curricula on UD for university-level 

architecture, engineering, and design 

students. 

(d) Providing training and technical 

assistance to designers, architects, and 

builders to incorporate UD principles 

and features into their buildings, 

projects, and communities. 

(e) Providing training and technical 

assistance to NIDILRR’s engineering and 

assistive technology grantees to 

incorporate UD strategies and standards 

into development projects serving the 

needs of individuals with disabilities 

and the broader population. 

(f) Partnering with relevant 

stakeholders in carrying out all DRRP 

activities. Stakeholders include but are 

not limited to: Individuals with 

disabilities, professional organizations 

that teach design principles, 

researchers, engineers, planners, 

designers, developers, architects, and 

builders. 

Final Priority: We will announce the 

final priority in a notice in the Federal 

Register. We will determine the final 

priority after considering responses to 

this notice and other information 

available to the Department. 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 or 

in a Funding Opportunity Announcement 

posted at www.grants.gov. 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10117 

the Executive Order and subject to 

review by the Office of Management and 

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

Order 12866 defines a ‘‘significant 

regulatory action’’ as an action likely to 

result in a rule that may— 

(1) Have an annual effect on the 

economy of $100 million or more, or 

adversely affect a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal governments or 

communities in a material way (also 

referred to as an ‘‘economically 

significant’’ rule); 

(2) Create serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

(3) Materially alter the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or 

(4) Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

stated in the Executive Order. 

This proposed regulatory action is not 

a significant regulatory action subject to 

review by OMB under section 3(f) of 

Executive Order 12866. 

We have also reviewed this 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 proposed priority 

only upon a reasoned determination 

that its benefits would justify its costs. 

In choosing among alternative 

regulatory approaches, we selected 

those approaches that would maximize 

net benefits. Based on the analysis that 

follows, the Department believes that 

this proposed priority is consistent with 

the principles in Executive Order 13563. 

We also have determined that this 

regulatory action would not unduly 

interfere with State, local, and tribal 

governments in the exercise of their 

governmental functions. 

In accordance with both Executive 

Orders, the Department has assessed the 

potential costs and benefits, both 

quantitative and qualitative, of this 

regulatory action. The potential costs 

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. Projects 

similar to one envisioned by the 

proposed priority have been completed 

successfully, and the proposed priority 

would generate new knowledge through 

research. The new DRRP would 

generate, disseminate, and promote the 

use of new information that would 

improve accessibility of the built 

environment for individuals with 

disabilities. 

Intergovernmental Review: This 

program is not subject to Executive 

Order 12372. 

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: February 19, 2015. 

Kathy Greenlee, 

Administrator. 

[FR Doc. 2015–03888 Filed 2–24–15; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0362] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice Regulations for 

Finished Pharmaceuticals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by March 27, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0139. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES