77414 Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Proposed Rules 

can find and read the electronic form of 

all comments received into any FAA 

dockets, including the name of the 

individual sending the comment (or 

signing the comment for an association, 

business, labor union, etc.). DOT’s 

complete Privacy Act Statement can be 

found in the Federal Register published 

on April 11, 2000 (65 FR 19477–19478), 

as well as at http://DocketsInfo.dot.gov. 

Docket: Background documents or 

comments received may be read at 

http://www.regulations.gov at any time. 

Follow the online instructions for 

accessing the docket or Docket 

Operations in Room W12–140 of the 

West Building Ground Floor at 1200 

New Jersey Avenue SE., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Theodora Kessaris, New Program 

Implementation and Technical Support 

Branch, Flight Standards Service, 

Federal Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone: 202– 

267–8166; facsimile: 202–267–5229; 

email: Theodora.kessaris@faa.gov. 

Background 

On October 22, 2014, the FAA 

published a proposed a new chapter of 

FAA Order 8900.1 and a proposed new 

AC related to Aircraft Dispatcher 

Certification Courses. The new chapter 

in FAA Order 8900.1 chapter establishes 

Policy not previously addressed in FAA 

Orders or ACs. The associated AC, 65– 

XX, provides guidelines to operators 

and potential operators of Aircraft 

Dispatcher Certification Courses. On 

November 06, 2014, Sheffield School of 

Aeronautics placed a comment in this 

docket requesting the publication of 

additional supporting documents which 

contain policy related to Designated 

Aircraft Dispatcher Examiners (DADE). 

Additionally, Sheffield requested the 

FAA consider extending the comment 

period, which is scheduled to close on 

December 22, 2014. In response to these 

requests, we have extended the 

comment period for the Aircraft 

Dispatcher Certification Course Policy 

contained in this docket for another 60 

days to allow additional review by 

industry stakeholders. We have also 

made the DADE policy supporting 

documents available for review only, in 

their own respective docket, which is 

FAA–2011–1149. That particular 

docket, which is not open for comment, 

can be accessed at the following URL: 

http://www.regulations.gov/#!docket

Detail;D=FAA-2011-1149. 

The FAA does not anticipate any 

further extension of the comment period 

for the draft policy related to Aircraft 

Dispatcher Certification Courses, 

contained in this docket. 

The agency will consider all 

comments received by February 22, 

2015. Comments received after that date 

may be considered if consideration will 

not delay agency action on the review. 

A copy of the proposed order and AC 

is available for review in the assigned 

docket for the Order at http://

www.regulations.gov. 

Issued in Washington, DC, on December 

15, 2014. 

John Barbagallo, 

Deputy Director, FAA Flight Standards 

Service. 

[FR Doc. 2014–30221 Filed 12–23–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1271 

[Docket No. FDA–2014–D–1856] 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products From Adipose 

Tissue: Regulatory Considerations; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; request 

for comments on draft guidance. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Human Cells, Tissues, and Cellular 

and Tissue-Based Products (HCT/Ps) 

from Adipose Tissue: Regulatory 

Considerations; Draft Guidance for 

Industry’’ dated December 2014. The 

draft guidance document provides 

sponsors, clinicians, and other 

establishments that manufacture and 

use adipose tissue, with 

recommendations for complying with 

the regulatory framework for HCT/Ps. 

For purposes of applying the HCT/P 

regulatory framework, FDA considers 

connective tissue, including adipose 

tissue, to be a structural tissue. This 

draft guidance is not final nor is it in 

effect at this time. 

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 February 23, 

2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002 or to the 

Office of the Center Director, Guidance 

and Policy Development, Center for 

Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002 or you may send an email request 

to the Office of Combination Products at 

combination@fda.gov. If you are 

submitting a written request, send one 

self-addressed adhesive label to assist 

that office in processing your request. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 240–402–7800. 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: Lori 

J. Churchyard, 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; or Angela Krueger, Office of 

Device Evaluation, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1666, Silver Spring, 

MD 20993–0002, 301–796–6380; or 

Leigh Hayes, Office of Combination 

Products, Office of the Commissioner, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

5127, Silver Spring, MD 20993–0002, 

email: combination@fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Human 

Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps) from Adipose 

Tissue: Regulatory Considerations; Draft 

Guidance for Industry’’ dated December 

2014. FDA has recently received 

numerous inquiries regarding HCT/Ps 

from adipose tissues. This draft 

guidance document provides sponsors, 

clinicians, and other establishments that 

manufacture and use HCT/Ps from 

adipose tissue with the Agency’s current 

mstockstill on DSK4VPTVN1PROD with PROPOSALS

Federal Register / Vol. 79, No. 247 / Wednesday, December 24, 2014 / Proposed Rules 77415 

thinking with respect to regulatory 

considerations for adipose tissue. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. 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 requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

The draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information 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 in 21 CFR part 1271 have 

been approved under OMB control 

number 0910–0543. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. 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 draft guidance at either 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http://www.fda.gov/ 

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/default

.htm or http://www.fda.gov/ 

CombinationProducts/Guidance

RegulatoryInformation/default.htm or 

http://www.regulations.gov. Persons 

unable to download an electronic copy 

of the draft guidance entitled ‘‘Human 

Cells, Tissues, and Cellular and TissueBased Products from Adipose Tissue: 

Regulatory Considerations; Draft 

Guidance for Industry,’’ may send an 

email request to CDRHguidance@fda.hhs.gov to receive an 

electronic copy of the document. 

Dated: December 18, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30142 Filed 12–23–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2014–1001] 

RIN 1625–AA00 

Safety Zones; Annual Events 

Requiring Safety Zones in the Captain 

of the Port Lake Michigan Zone 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

amend its safety zones regulations for 

Annual Events in the Captain of the Port 

Lake Michigan zone. This proposed 

amendment updates 18 permanent 

safety zones, adds 5 new permanent 

safety zones, and reformats the 

coordinates for safety zones. These 

amendments and additions are 

necessary to protect spectators, 

participants, and vessels from the 

hazards associated with annual 

maritime events, including fireworks 

displays, boat races, and air shows, and 

improves the precision and 

compatibility of safety zone coordinates. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before January 23, 2015. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2014–1001 using any one of the 

following methods: 

(1) Federal eRulemaking Portal: 

http://www.regulations.gov. 

(2) Fax: 202–493–2251. 

(3) 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. 

(4) 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. 

See the ‘‘Public Participation and 

Request for Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section 

below for instructions on submitting 

comments. To avoid duplication, please 

use only one of these four methods. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this proposed 

rule, call or email Petty Officer Joseph 

McCollum, U.S. Coast Guard Sector 

Lake Michigan; telephone 414–747– 

7148, email Joseph.P.McCollum@

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. 

SUPPLEMENTARY INFORMATION: 

Table of Acronyms 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of Proposed Rulemaking 

A. Public Participation and Request for 

Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related materials. All 

comments received will be posted 

without change to http://

www.regulations.gov and will include 

any personal information you have 

provided. 

1. Submitting Comments 

If you submit a comment, please 

include the docket number for this 

rulemaking (USCG–2014–1001), 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. You 

may submit your comments and 

material online at http://

www.regulations.gov or by fax, mail, or 

hand delivery, but please use only one 

of these means. If you submit a 

comment online, it will be considered 

received by the Coast Guard when you 

successfully transmit the comment. If 

you fax, hand deliver, or mail your 

comment, it will be considered as 

having been received by the Coast 

Guard when it is received at the Docket 

Management Facility. We recommend 

that you include your name and a 

mailing address, an email address, or a 

telephone number in the body of your 

document so that we can contact you if 

we have questions regarding your 

submission. 

To submit your comment online, go to 

http://www.regulations.gov, click on the 

‘‘submit a comment’’ box, which will 

then become highlighted in blue. In the 

‘‘Document Type’’ drop down menu 

select ‘‘Proposed Rule’’ and insert 

‘‘USCG–2014–1001’’ in the ‘‘Keyword’’ 

box. Click ‘‘Search’’ then click on the 

balloon shape in the ‘‘Actions’’ column. 

If you submit your comments by mail or 

hand delivery, submit them in an 

unbound format, no larger than 81⁄2 by 

11 inches, suitable for copying and 

mstockstill on DSK4VPTVN1PROD with PROPOSALS