12822 Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices 

Institute for Occupational Safety and 

Health (CC), insert the following: 

Western States Division (CCQ). The 

Western States Division (WSD) conducts 

research and provides technical assistance 

for the prevention of work-related illness, 

injury, and death; these activities are 

predominately focused on, but not limited to, 

occupational safety and health (OS&H) 

problems in the Western U.S., including 

Alaska and Hawaii. WSD conducts specific 

activities that provide actionable evidence to 

reduce OS&H hazards. To accomplish its 

mission, WSD: (1) Conducts prevention 

research for at risk populations; (2) facilitates 

the development of OS&H programs in states 

and regions that have minimal or limited 

OS&H public health program capacity and 

state-supporting infrastructure; (3) serves as a 

multi-regional resource to provide outreach, 

expert advice, and technical assistance on 

OS&H priority issues, including the 

development, dissemination, and diffusion of 

NIOSH research products; (4) enhances and 

facilitates NIOSH initiatives and programs; 

and (5) responds to requests for technical 

assistance and conducts site evaluations to 

support Division programs and priorities and 

other NIOSH initiatives and programs, 

including evaluating exposures to hazardous 

chemical, biological, physical, and 

radioactive agents and recommending 

appropriate controls. Research includes the 

development of viable strategies to evaluate 

and prioritize hazards, communicate risk, 

provide evidence for prevention 

recommendations, and building state OS&H 

(capacity or activities) through surveillance 

data and stakeholder input. At risk 

populations include, but are not limited to, 

(a) high-risk industries such as oil and gas 

extraction, fishing, and aviation; (b) 

underserved groups such as American 

Indian/Alaska Native and immigrant and 

contingent workers; and (c) workers engaged 

in particularly hazardous activities such as 

hydraulic fracturing, wind and other 

renewable energy development, wild land 

firefighting; and water and air transportation. 

After the title and functional 

statement for the Office of Mine Safety 

and Health Research (CCM), National 

Institute for Occupational Safety and 

Health (CC), insert the following: 

Spokane Mining Research Division 

(CCMG). (1) Provides leadership for 

prevention of work-related illness, injury, 

and death in the extractive industries with an 

emphasis on the special needs of these 

industries in western United States; (2) 

develops numerical models and conducts 

laboratory and field investigations to better 

understand the causes of catastrophic failures 

in underground metal/nonmetal mines that 

may lead to multiple injuries and fatalities; 

(3) develops new design practices and tools, 

control technologies, and work practices to 

reduce the risk of these global and local 

ground failures in underground metal/

nonmetal mines; (4) conducts numerical 

studies and field investigations to understand 

the problems of ventilating deep and 

multilevel underground mines, and develops 

improved design approaches and engineering 

controls to reduce the concentration of toxic 

substances in the mine air; (5) conducts 

laboratory and field studies to help leverage 

and support the Institute’s mining research 

program; (6) develops and recommends 

appropriate criteria for new standards, 

NIOSH policy, documents, or testimony 

related to health and safety in the extractive 

industries. 

James Seligman, 

Acting Chief Operating Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2015–05552 Filed 3–10–15; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1999–D–1315 (formerly 

1999–D–0296)] 

Formal Meetings Between the Food 

and Drug Administration and Sponsors 

or Applicants of Prescription Drug 

User Fee Act Products; Draft Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Formal Meetings 

Between the FDA and Sponsors or 

Applicants of Prescription Drug User 

Fee Act (PDUFA) Products.’’ This draft 

guidance provides recommendations to 

industry on formal meetings between 

FDA and sponsors or applicants relating 

to the development and review of drug 

or biological products (‘‘products’’). 

This draft guidance revises the guidance 

for industry entitled ‘‘Formal Meetings 

Between the FDA and Sponsors or 

Applicants’’ published May 19, 2009. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by June 9, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Bldg., 4th 

Floor, Silver Spring, MD 20993–0002, or 

the Office of Communication, Outreach, 

and Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http://www.

regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Rachel E. Hartford, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6312, 

Silver Spring, MD 20993–0002, 301– 

796–0319; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Formal Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products.’’ This draft guidance provides 

recommendations to industry on formal 

meetings between FDA and sponsors or 

applicants relating to the development 

and review of products regulated by the 

Center for Drug Evaluation and Research 

and the Center for Biologics Evaluation 

and Research. This draft guidance does 

not apply to abbreviated new drug 

applications, applications for biosimilar 

biological products, or submissions for 

medical devices. For the purposes of 

this draft guidance, ‘‘formal meeting’’ 

includes any meeting that is requested 

by a sponsor or applicant following the 

request procedures provided in this 

guidance and includes meetings 

conducted in any format (i.e., face to 

face, teleconference, videoconference, or 

written response). 

This draft guidance discusses the 

principles of good meeting management 

practices and describes standardized 

procedures for requesting, preparing for, 

scheduling, conducting, and 

documenting such formal meetings. The 

general principles in this draft guidance 

may be extended to other 

nonapplication-related meetings with 

external constituents, insofar as this is 

possible. 

This draft guidance revises the 

guidance for industry entitled ‘‘Formal 

Meetings Between the FDA and 

Sponsors or Applicants’’ published May 

19, 2009. This draft guidance is being 


Rmajette on DSK2VPTVN1PROD with NOTICES
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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