Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices 12823 

updated in accordance with the Meeting 

Management Goals section of the 

PDUFA Reauthorization Performance 

Goals and Procedures, Fiscal Years 2013 

through 2017. Significant changes from 

the 2009 guidance include: 

• Addition of the written response 

meeting format for pre-investigational 

new drug application and Type C 

meetings 

• Designation of a post-action meeting 

requested within 3 months after an 

FDA regulatory action other than 

approval as a Type A meeting 

• Designation of a post-action meeting 

requested 3 or more months after an 

FDA regulatory action other than 

approval as a Type B meeting 

• Designation of a meeting regarding 

risk evaluation and mitigation 

strategies or postmarketing 

requirements that occur outside the 

context of the review of a marketing 

application as a Type B meeting 

• Inclusion of a meeting package in 

Type A meeting requests 

• Designation of meetings to discuss the 

overall development program for 

products granted breakthrough 

therapy designation status as a Type 

B meeting 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on formal meetings between FDA and 

sponsors or applicants of PDUFA 

products. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information referred to in 

the guidance entitled ‘‘Formal Meetings 

Between the FDA and Sponsors or 

Applicants’’ have been approved under 

OMB control number 0910–0429. The 

collections of information for Form FDA 

1571 and end-of-phase 2 meetings have 

been approved under OMB control 

number 0910–0014, and collections of 

information for Form FDA 356h have 

been approved under OMB control 

number 0910–0338. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

http://www.fda.gov/BiologicsBlood

Vaccines/Guidance

ComplianceRegulatoryInformation/

default.htm, or http://www.

regulations.gov. 

Dated: March 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05523 Filed 3–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Arthritis Advisory Committee: Notice 

of Postponement of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is postponing the 

meeting of the Arthritis Advisory 

Committee scheduled for March 17, 

2015. The meeting was announced in 

the Federal Register of February 10, 

2015 (80 FR 7480). The postponement is 

due to information requests pending 

with the sponsor of the application. A 

future meeting date will be announced 

in the Federal Register. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie L. Begansky, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, email: 

AAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). Please call the 

Information Line for up-to-date 

information on this meeting. 

Dated: March 6, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05527 Filed 3–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Temporary Assistance for Needy 

Families Two-Parent Study. 

OMB No.: New Collection. 

Description: The Administration for 

Children and Families (ACF) is 

proposing an information collection 

activity as part of the Temporary 

Assistance for Needy Families TwoParent Study. Through this information 

collection, ACF seeks to gain an indepth, systematic understanding of the 

characteristics of two-parent families 

participating in or eligible to receive 

TANF, the variety of services two-parent 

families receive through TANF, how 

state policies may affect participation in 

TANF among two-parent families, and 

how the beliefs of staff and eligible 

families affect two-parent families’ 

participation in TANF. 

The proposed information collection 

consists of semi-structured interviews 

with key State and local staff, 

community-based organization 

representatives, and adult members of 

two-parent TANF or likely eligible 

families on questions of TANF policies, 

service delivery, and program context, 

as well as focus groups with adult 

members of two-parent TANF or likely 

eligible families. 

Respondents: State- and local-level 

TANF administrators and staff, 

representatives from community-based 

organizations, and adults from twoparent families on or likely eligible for 

TANF. 


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12824 Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument 

Total/Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Discussion Guide for use with state TANF directors ...................................... 10 1 1.5 15 

Discussion Guide for use with local TANF directors ....................................... 5 1 1.5 8 

Discussion Guide for use with local TANF front-line staff ............................... 15 1 1 15 

Discussion Guide for use with community-based organizations ..................... 5 1 1 5 

Discussion Guide for use with client focus groups ......................................... 112 1 1.5 168 

Discussion guide for use with client interviews ............................................... 25 1 1 25 

Estimated Total Annual Burden 

Hours: 236. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: OPRE Reports 

Clearance Officer. All requests should 

be identified by the title of the 

information collection. Email address: 

OPREinfocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Karl Koerper, 

OPRE Reports Clearance Officer. 

[FR Doc. 2015–05522 Filed 3–10–15; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Applications for New Awards; National 

Institute on Disability, Independent 

Living, and Rehabilitation Research— 

Advanced Rehabilitation Research 

Training Program 

AGENCY: Administration for Community 

Living, Department of Health and 

Human Services. 

ACTION: Notice. 

Overview Information 

National Institute on Disability, 

Independent Living, and Rehabilitation 

Research (NIDILRR)—Advanced 

Rehabilitation Research Training 

(ARRT) Program. 

Notice inviting applications for new 

awards for fiscal year (FY) 2015. 

Catalog of Federal Domestic Assistance 

(CFDA) Numbers: 84.133P–1, 84.133P–3, and 

84–133P–4. 

Note: This notice invites applications for 

three separate competitions. See the chart in 

the Award Information section of this notice 

for funding and other key information for 

each of the three competitions. 

DATES: 

Applications Available: March 11, 

2015. 

Note: On July 22, 2014, President Obama 

signed the Workforce Innovation 

Opportunity Act (WIOA). WIOA was 

effective immediately. One provision of 

WIOA transferred the National Institute on 

Disability and Rehabilitation Research 

(NIDRR) from the Department of Education to 

the Administration for Community Living 

(ACL) in the Department of Health and 

Human Services. In addition, NIDRR’s name 

was changed to the Institute on Disability, 

Independent Living, and Rehabilitation 

Research (NIDILRR). For FY 2015, all 

NIDILRR priority notices will be published as 

ACL notices, and ACL will make all NIDILRR 

awards. During this transition period, 

however, NIDILRR will continue to review 

grant applications using Department of 

Education tools. NIDILRR will post 

previously-approved application kits to 

grants.gov, and NIDILRR applications 

submitted to grants.gov will be forwarded to 

the Department of Education’s G–5 system 

for peer review. We are using Department of 

Education application kits and peer review 

systems during this transition year in order 

to provide for a smooth and orderly process 

for our applicants. 

Date of Pre-Application Meeting: 

April 1, 2015. 

Deadline for Transmittal of 

Applications: May 11, 2015. 

Full Text of Announcement 

I. Funding Opportunity Description 

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. The Program’s activities are 

designed to 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). 

Advanced Rehabilitation Research 

Training Program 

The purpose of NIDILRR’s ARRT 

program, which is funded through the 

Disability and Rehabilitation Research 

Projects and Centers Program, is to 

provide advanced research training and 

experience to individuals with 

doctorates, or similar advanced degrees, 

who have clinical or other relevant 

experience. ARRT projects train 

rehabilitation researchers, including 

researchers with disabilities, with 

particular attention to research areas 

that support the implementation and 

objectives of the Rehabilitation Act, and 

that improve the effectiveness of 

services authorized under the 

Rehabilitation Act. 

Additional information on the ARRT 

program can be found at: www.ed.gov/ 

rschstat/research/pubs/resprogram.html#ARRT. 

Priority: There is one priority for the 

three competitions, which will each 

address one of NIDILRR’s major 

domains of individual well-being: (a) 

Community living and participation, (b) 

employment, or (c) health and function. 

This priority is from the notice of final 

priority for this program, published in 

the Federal Register on June 11, 2013 

(78 FR 34901). 

Absolute Priority: For FY 2015 and 

any subsequent year in which we make 

awards from the list of unfunded 

applicants from these competitions, this 

priority is an absolute priority for each 

of the three competitions. Under 45 CFR 

part 75 we consider only applications 

that meet this program priority. 

This priority is: 


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