Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices 12821 

• HTAC Subcommittee Updates 

• Open Discussion Period 

Public Participation: The meeting is 

open to the public. Individuals who 

would like to attend and/or to make oral 

statements during the public comment 

period must register no later than 5:00 

p.m. on Wednesday, April 15, 2015, by 

email at HTAC@nrel.gov. Entry to the 

meeting room will be restricted to those 

who have confirmed their attendance in 

advance. Please provide your name, 

organization, citizenship, and contact 

information. Anyone attending the 

meeting will be required to present 

government-issued identification. Those 

wishing to make a public comment are 

required to register. The public 

comment period will take place between 

8:30 a.m. and 9:00 a.m. on April 21, 

2015. Time allotted per speaker will 

depend on the number who wish to 

speak but will not exceed five minutes. 

Those not able to attend the meeting or 

have insufficient time to address the 

committee are invited to send a written 

statement by email to HTAC@nrel.gov. 

Minutes: The minutes of the meeting 

will be available within 45 days for 

public review at http://

hydrogen.energy.gov/advisory_

htac.html. 

Issued in Washington, DC in March 4, 

2015. 

LaTanya R. Butler, 

Deputy Committee Management Officer. 

[FR Doc. 2015–05531 Filed 3–10–15; 8:45 am] 

BILLING CODE 6450–01–P 

FEDERAL MINE SAFETY AND HEALTH 

REVIEW COMMISSION 

Sunshine Act Notice 

March 9, 2015. 

TIME AND DATE: 10:00 a.m., Tuesday, 

March 17, 2015 

PLACE: The Richard V. Backley Hearing 

Room, Room 511N, 1331 Pennsylvania 

Avenue NW., Washington, DC 20004 

(enter from F Street entrance) 

STATUS: Open 

MATTERS TO BE CONSIDERED: The 

Commission will consider and act upon 

the following in open session: 

Pocahontas Coal Co., LLC. v. Secretary 

of Labor, Docket No. WEVA 2014–202– 

R; and Pocahontas Coal Co., LLC v. 

Secretary of Labor, Docket Nos. WEVA 

2014–642–R, et al. (Issues include 

whether the Administrative Law Judges 

erred in ruling that they lacked 

jurisdiction to review a Notice of Pattern 

of Violations and a Notice of Safeguard, 

respectively.) 

Any person attending this meeting 

who requires special accessibility 

features and/or auxiliary aids, such as 

sign language interpreters, must inform 

the Commission in advance of those 

needs. Subject to 29 CFR 2706.150(a)(3) 

and 2706.160(d). 

FOR FURTHER INFORMATION CONTACT: 

Emogene Johnson (202) 434–9935/(202) 

708–9300 for TDD Relay/1–800–877– 

8339 for toll free. 

Sarah Stewart, 

Deputy General Counsel. 

[FR Doc. 2015–05633 Filed 3–9–15; 4:15 pm] 

BILLING CODE 6735–01–P 

FEDERAL MINE SAFETY AND HEALTH 

REVIEW COMMISSION 

Sunshine Act Notice 

March 9, 2015. 

TIME AND DATE: 11:00 a.m., Tuesday, 

March 17, 2015. 

PLACE: The Richard V. Backley Hearing 

Room, Room 511N, 1331 Pennsylvania 

Avenue NW., Washington, DC 20004 

(enter from F Street entrance). 

STATUS: Open. 

MATTERS TO BE CONSIDERED: The 

Commission will consider and act upon 

the following in open session: Secretary 

of Labor v. Paramont Coal Company 

Virginia, LLC, Docket Nos. VA 2010– 

369–R, et al. (Issues include whether the 

Administrative Law Judge erred in 

ruling that a particular violation of the 

standard governing conveyor belt 

alignment was not ‘‘significant and 

substantial.’’). 

Any person attending this meeting 

who requires special accessibility 

features and/or auxiliary aids, such as 

sign language interpreters, must inform 

the Commission in advance of those 

needs. Subject to 29 CFR 2706.150(a)(3) 

and 2706.160(d). 

FOR FURTHER INFORMATION CONTACT: 

Emogene Johnson (202) 434–9935/(202) 

708–9300 for TDD Relay/1–800–877– 

8339 for toll free. 

Sarah Stewart, 

Deputy General Counsel. 

[FR Doc. 2015–05637 Filed 3–9–15; 4:15 pm] 

BILLING CODE 6735–01–P 

FEDERAL MINE SAFETY AND HEALTH 

REVIEW COMMISSION 

Sunshine Act Notice: Cancellation of 

Meeting Notice 

March 6, 2015. 

The following Commission meeting 

has been cancelled. No earlier 

announcement of the cancellation was 

possible. 

TIME AND DATE: 10:00 a.m., Thursday, 

March 5, 2015 

PLACE: The Richard V. Backley Hearing 

Room, Room 511N, 1331 Pennsylvania 

Avenue NW., Washington, DC 20004 

(enter from F Street entrance) 

STATUS: Open 

MATTERS TO BE CONSIDERED: The 

Commission will consider and act upon 

the following in open session: 

Pocahontas Coal Co., LLC. v. Secretary 

of Labor, Docket No. WEVA 2014–202– 

R; and Pocahontas Coal Co., LLC v. 

Secretary of Labor, Docket Nos. WEVA 

2014–642–R, et al. (Issues include 

whether the Administrative Law Judges 

erred in ruling that they lacked 

jurisdiction to review a Notice of Pattern 

of Violations and a Notice of Safeguard, 

respectively.) 

Any person attending this meeting 

who requires special accessibility 

features and/or auxiliary aids, such as 

sign language interpreters, must inform 

the Commission in advance of those 

needs. Subject to 29 CFR 2706.150(a)(3) 

and 2706.160(d). 

CONTACT PERSON FOR MORE INFO: 

Emogene Johnson (202) 434–9935/(202) 

708–9300 for TDD Relay/1–800–877– 

8339 for toll free. 

Emogene Johnson, 

Administrative Assistant. 

[FR Doc. 2015–05589 Filed 3–9–15; 11:15 am] 

BILLING CODE 6735–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–76, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 80 FR 14117–1419, 

dated January 9, 2015) is amended to 

establish the Western States Division 

and Spokane Mining Research Division, 

National Institute for Occupational 

Safety and Health, Centers for Disease 

Control and Prevention. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: 

After the title and functional 

statement for the World Trade Center 

Health Program (CCP), National 


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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 


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