63922 Federal Register / Vol. 79, No. 207 / Monday, October 27, 2014 / Notices 

• limitations for use of the 

Galactomannan assay; 

• considerations for sample 

acquisition and documentation; 

• analysis of study results; and 

• performance characteristics of the 

assay. 

Innovative and improved DDTs can 

help streamline the drug development 

process, improve the chances for 

clinical trial success, and yield more 

information about a treatment and/or 

disease. DDTs include, but are not 

limited to, biomarkers, clinical outcome 

assessments and animal models. Refer 

to DDTs Qualification Programs at 

http://www.fda.gov/Drugs/

DevelopmentApprovalProcess/

DrugDevelopmentTools

QualificationProgram/default.htm for 

additional information. 

As stated previously in the Federal 

Register of January 7, 2014 (79 FR 831), 

FDA announced the availability of the 

guidance for industry entitled 

‘‘Qualification Process for Drug 

Development Tools,’’ which described 

the process that would be used to 

qualify DDTs and to make new DDT 

qualification recommendations 

available on FDA’s Web site at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm. CDER has 

developed this formal process to work 

with developers of these biomarker 

DDTs to guide the developers as they 

refine the tools and rigorously evaluate 

them for use in the regulatory context. 

Once qualified, DDTs will be publicly 

available for use in any drug 

development program for the qualified 

context of use. As described in the 

January 2014 guidance, biomarker DDTs 

should be developed and reviewed 

using this process. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 Galactomannan in serum and BAL 

fluid. 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 guidance contains an 

information collection that is 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 information collection has 

been approved under the OMB control 

numbers 0910–0001 and 0910–0014. 

The information requested in the 

guidance is currently submitted to FDA 

to support medical product 

effectiveness (see 21 CFR 312.30, 21 

CFR 314.50(d)(5), and 21 CFR 

314.126(b)(6)). 

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 either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://www.

regulations.gov. 

V. Reference 

The following reference has been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and is available 

electronically at http://

www.regulations.gov. 

1. De Pauw, B., T.J. Walsh, J.P. 

Donnelly, et al., ‘‘Revised Definitions of 

Invasive Fungal Disease from European 

Organization for Research and 

Treatment of Cancer/Invasive Fungal 

Infections Cooperative Group and the 

National Institute of Allergy and 

Infectious Diseases Mycoses Study 

Group (EORTC/MSG) Consensus 

Group,’’ Clinical Infectious Diseases 

(2008) 46: 1813–1821. 

Dated: October 21, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25532 Filed 10–24–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2013–1078] 

National Offshore Safety Advisory 

Committee 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of Federal Advisory 

Committee meetings. 

SUMMARY: The National Offshore Safety 

Advisory Committee and its 

Subcommittees will meet on November 

18 and 19, 2014, in Houston, TX, to 

discuss the safety of operations and 

other matters affecting the offshore oil 

and gas industry. These meetings are 

open to the public. 

DATES: Subcommittees of the National 

Offshore Safety Advisory Committee 

will meet on Tuesday, November 18, 

2014, from 1 p.m. to 4 p.m. and the full 

Committee will meet on Wednesday, 

November 19, 2014, from 8:30 a.m. to 

4:30 p.m. These meetings may end early 

if the Committee has completed its 

business, or they may be extended based 

on the number of public comments. All 

submitted written materials, comments, 

and requests to make oral presentations 

at the meetings should reach the Coast 

Guard (see FOR FURTHER INFORMATION

CONTACT) by November 1, 2014. Any 

written material submitted by the public 

will be distributed to the Committee and 

become part of the public record. 

ADDRESSES: The meetings will be held 

in the conference room of the American 

Bureau of Shipping, 15011 Katy 

Freeway, Suite 100, Houston, TX, 

77094, 832–391–3300, http://

www.eagle.org. 

For information on facilities or 

services for individuals with 

disabilities, or to request special 

assistance at the meetings, contact the 

individuals listed in FOR FURTHER

INFORMATION CONTACT section, as soon as 

possible. 

To facilitate public participation, we 

are inviting public comment on the 

issues to be considered by the 

Committee as listed in the ‘‘Agenda’’ 

section below. Written comments for 

distribution to Committee members 

must be submitted no later than 

November 1, 2014, if you want the 

Committee members to be able to review 

your comments before the meeting, and 

must be identified by docket number 

USCG–2013–1078 and submitted by one 

of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 207 / Monday, October 27, 2014 / Notices 63923 

(preferred method to avoid delays in 

processing). 

• Fax: (202) 493–2251. 

• Mail: Docket Management Facility 

(M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue SE., Washington, DC 20590– 

0001. 

• Hand Delivery: Same as mail 

address above, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. 

To avoid duplication, please submit 

comments using only one of the above 

methods. 

Instructions: All submissions must 

include the words ‘‘Department of 

Homeland Security’’ and the docket 

number for this action, USCG–2013– 

1078. All comments submitted will be 

posted without alteration at http://

www.regulations.gov including any 

personal information provided. You 

may review a Privacy Act notice 

regarding our public dockets in the 

January 17, 2008, issue of the Federal 

Register (73 FR 3316). 

Docket: For access to the docket to 

read documents or comments related to 

this notice, go to http://

www.regulations.gov, insert USCG– 

2013–1078 in the Search box, press 

Enter, and then click on the item you 

wish to view. 

A public oral comment period will be 

held during the meeting on November 

19, 2014, and speakers are requested to 

limit their comments to 3 minutes. 

Contact one of the individuals listed 

below to register as a speaker. 

FOR FURTHER INFORMATION CONTACT: 

Commander Thomas Kaminski, 

Designated Federal Official of the 

National Offshore Safety Advisory 

Committee, Commandant (CG–OES–2), 

U.S. Coast Guard, 2703 Martin Luther 

King Jr. Avenue SE., Stop 7509, 

Washington, DC 20593–7509; telephone 

(202) 372–1410, fax (202) 372–8382 or 

email Thomas.J.Kaminski@uscg.mil, or 

Mr. Scott Hartley, telephone (202) 372– 

1437, fax (202) 372–8382 or email 

Scott.E.Hartley@uscg.mil. If you have 

questions on viewing or submitting 

material to the docket, call Cheryl 

Collins, Program Manager, Docket 

Operations, telephone 202–366–9826 or 

1–800–647–5527. 

SUPPLEMENTARY INFORMATION: Notice of 

this meeting is given under the Federal 

Advisory Committee Act, Title 5 United 

States Code Appendix. The National 

Offshore Safety Advisory Committee 

provides advice and recommendations 

to the Department of Homeland Security 

on matters and actions concerning 

activities directly involved with or in 

support of the exploration of offshore 

mineral and energy resources insofar as 

they relate to matters within U.S. Coast 

Guard jurisdiction. 

A copy of all meeting documentation 

will be available at https://

homeport.uscg.mil/NOSAC. 

Alternatively, you may contact Mr. Scott 

Hartley as noted in the FOR FURTHER

INFORMATION CONTACT section above. 

Agenda 

Day 1 

The National Offshore Safety 

Advisory Committee Subcommittees 

will meet on November 18, 2014, from 

1 p.m. to 4 p.m. to review, discuss and 

formulate recommendations on the 

following matters: 

• Commercial Diving Safety on the 

Outer Continental Shelf; 

• Offshore Supply Vessel Purpose 

and Offshore Workers; and 

• Training of personnel on Mobile 

Offshore Units and Offshore Supply 

Vessels working on the Outer 

Continental Shelf. 

Day 2 

The National Offshore Safety 

Advisory full Committee will meet on 

November 19, 2014, from 8:30 a.m. to 

4:30 p.m. to review and discuss 

Subcommittee progress, reports and 

recommendations received from the 

above listed Subcommittees from their 

deliberations on November 18, 2014. 

The Committee will then use this 

information and consider public 

comments in formulating 

recommendations to the U.S. Coast 

Guard. Public comments or questions 

will be taken at the discretion of the 

Designated Federal Officer during the 

discussion and recommendation portion 

of the meeting as well as during the 

public comment period. A complete 

agenda for November 19, 2014, is as 

follows: 

(1) Current Business—Presentation 

and discussion of progress reports, final 

reports and recommendations from the 

Subcommittees and subsequent actions 

on: 

(a) Commercial Diving Safety on the 

Outer Continental Shelf; 

(b) Offshore Supply Vessel Purpose 

and Offshore Workers; and 

(c) Training of personnel on Mobile 

Offshore Units and Offshore Supply 

Vessels working on the Outer 

Continental Shelf. 

(2) Presentations and discussions of 

the following matters: 

(a) Offshore Service Vessel Dynamic 

Positioning Authority and Dynamic 

Positioning Operator Certification; 

(b) NorSafe U.S.A. Lifeboat Fall 

Testing; 

(c) American Bureau of Shipping 

Liquefied Natural Gas Bunkering; 

(d) Center for Offshore Safety 

Activities; and 

(e) American Petroleum Institute 

Recommended Practice 2D Operation 

and Maintenance of Offshore Cranes. 

(3) Public comment period. 

The agenda, progress reports, draft 

final reports, new task statements and 

presentations will be available 

approximately 7 days prior to the 

meeting at the https://

homeport.uscg.mil/NOSAC Web site or 

by contacting Mr. Scott Hartley. 

Minutes 

Meeting minutes will be available for 

public view and copying within 90 days 

following the meeting at the https://

homeport.uscg.mil/NOSAC Web site. 

Notice of Future 2014 National Offshore 

Safety Advisory Committee Meetings 

To receive automatic email notices of 

future National Offshore Safety 

Advisory Committee meetings in 2014, 

go to the online docket, USCG–2013– 

1078 (http://www.regulations.gov/

#!docketDetail:D=USCG-2013-1078), 

and select the sign-up-for-email-alerts 

option. 

Dated: October 22, 2014. 

J.G. Lantz, 

Director of Commercial Regulations and 

Standards, U.S. Coast Guard. 

[FR Doc. 2014–25472 Filed 10–24–14; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID FEMA–2014–0002] 

Final Flood Hazard Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final Notice. 

SUMMARY: Flood hazard determinations, 

which may include additions or 

modifications of Base Flood Elevations 

(BFEs), base flood depths, Special Flood 

Hazard Area (SFHA) boundaries or zone 

designations, or regulatory floodways on 

the Flood Insurance Rate Maps (FIRMs) 

and where applicable, in the supporting 

Flood Insurance Study (FIS) reports 

have been made final for the 

communities listed in the table below. 

The FIRM and FIS report are the basis 

of the floodplain management measures 

that a community is required either to 


tkelley on DSK3SPTVN1PROD with NOTICES