[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Proposed Rules]
[Pages 23664-23666]
[FR Doc No: 2016-09366]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket Nos. FDA-2014-D-1584, FDA-2014-D-1696, FDA-2014-D-1856, and
FDA-2015-D-3581]

Draft Guidances Relating to the Regulation of Human Cells,
Tissues, and Cellular and Tissue-Based Products; Extension of Comment
Periods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment periods.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the draft guidance documents entitled
``Same Surgical Procedure Exception: Questions and Answers Regarding
the Scope of the Exception; Draft Guidance for Industry''; ``Minimal
Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based
Products; Draft Guidance for Industry and Food and Drug Administration
Staff''; ``Human Cells, Tissues, and Cellular and Tissue-Based Products
from Adipose Tissue: Regulatory Considerations; Draft Guidance for
Industry''; and ''Homologous Use of Human Cells, Tissues, and Cellular
and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.''
The Agency is taking this action to allow interested persons additional
time to submit comments and any new information.

DATES: FDA is extending the comment period on the four draft guidances
announced in the Federal Register (see SUPPLEMENTARY INFORMATION).
Submit either electronic or written comments by September 27, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or

anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-1584 for ``Same Surgical Procedure Exception under 21 CFR
1271.15(b): Questions and Answers Regarding the Scope of the Exception;
Draft Guidance for Industry''; Docket No. FDA-2014-D-1696 for ``Minimal
Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based
Products; Draft Guidance for Industry and Food and Drug Administration
Staff''; Docket No. FDA-2014-D-1856 for ``Human Cells, Tissues, and
Cellular and Tissue-Based Products from Adipose Tissue: Regulatory
Considerations; Draft Guidance for Industry''; or Docket No. FDA-2015-
D-3581 for ``Homologous Use of Human Cells, Tissues, and Cellular and
Tissue-Based Products; Draft Guidance for Industry and FDA Staff.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of October 23, 2014
(79 FR 63348), FDA announced the availability of a draft document
entitled ``Same Surgical Procedure Exception under 21 CFR 1271.15(b):
Questions and Answers Regarding the Scope of the Exception; Draft
Guidance for Industry'' dated October 2014.
    In the Federal Register of December 23, 2014 (79 FR 77012), FDA
announced the availability of a draft document entitled ``Minimal
Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based
Products; Draft Guidance for Industry and Food and Drug Administration
Staff'' dated December 2014.
    In the Federal Register of December 24, 2014 (79 FR 77414), FDA
announced 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.
    Following publication of these three notices of availability, FDA
received requests to allow interested persons additional time to
comment.
    In the Federal Register of October 30, 2015 (80 FR 66850), FDA
announced the availability of a draft document entitled ``Homologous
Use of Human Cells, Tissues, and Cellular and Tissue-Based Products;
Draft Guidance for Industry and FDA Staff'' dated October 2015.
    In the Federal Register of October 30, 2015 (80 FR 66845), FDA
announced a public hearing in a notice entitled ``Draft Guidances
Relating to the Regulation of Human Cells, Tissues, or Cellular or
Tissue-Based Products; Public Hearing; Request for Comments''.
    The draft guidances on same surgical procedure, minimal
manipulation, adipose tissue, and homologous use provide
recommendations for complying with the regulatory framework for human
cells, tissues, and cellular and tissue based products under 21 CFR
part 1271 that were to be discussed during the part 15 (21 CFR part 15)
hearing. In conjunction with the part 15 hearing and announcement of
availability of the homologous use draft guidance, in the Federal
Register of October 30, 2015 (80 FR 66847; 80 FR 66844; 80 FR 66849),
FDA reopened the comment periods on the same surgical procedure,
minimal manipulation, and adipose tissue draft guidances, respectively,
to allow potential respondents time to thoroughly evaluate and address
pertinent issues. Comments were requested by April 29, 2016. In this
notice FDA is extending the comment period to September 27, 2016.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the rescheduling of a 2-day part 15 public hearing to September 12 and
13, 2016, to obtain input from stakeholders on the four issued draft
guidance documents. In a separate document, FDA is also announcing a
public scientific workshop to identify and discuss scientific
considerations and challenges to help inform the development of human
cells, tissues, and cellular and tissue-based products subject to
premarket approval, including stem cell-based products.

    Dated: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09366 Filed 4-21-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 57 (Tuesday, March 25, 2014)]
[Proposed Rules]
[Pages 16239-16241]
[FR Doc No: 2014-06492]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0145; Directorate Identifier 2013-NM-183-AD]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Model FALCON 7X
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Dassault Aviation Model FALCON 7X airplanes. This proposed AD was
prompted by reports that the pintle pins installed on a certain number
of airplanes may be incorrectly protected against corrosion. This
proposed AD would require replacing certain pintle pins on the left-
and right-hand main landing gear (MLG) with a serviceable part. We are
proposing this AD to detect and correct pintle pins that have been
incorrectly corrosion-protected, which could cause the pintle pins to
shear under normal load and lead to the collapse of the MLG during
take-off or landing.

DATES: We must receive comments on this proposed AD by May 9, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
      Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Dassault Falcon Jet, P.O. Box 2000, South Hackensack, NJ 07606;
telephone<PHONE_NUMBER>; Internet http://www.dassaultfalcon.com. You may
view this referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0145; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM 116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0145;
Directorate Identifier

2013-NM-183-AD'' at the beginning of your comments. We specifically
invite comments on the overall regulatory, economic, environmental, and
energy aspects of this proposed AD. We will consider all comments
received by the closing date and may amend this proposed AD based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2013-0162, dated July 24, 2013 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:
    Messier-Bugatti-Dowty, the manufacturer of the landing gears of
the Falcon 7X aeroplanes, has advised that pintle pins Part Number
(P/N) 55-2355007-01 being installed on a certain number of
aeroplanes may be incorrectly protected against corrosion. These
pins are designed to shear in case of excessive loads on the main
landing gears so that structural damage would be contained after a
landing gear collapse. The cadmium-coating inside the bore of
suspect pins may not be compliant to the original thickness
specifications. Inspection of a few removed parts in service
revealed that traces of limited corrosion can be found on an
unstressed area of the pins. Messier-Bugatti-Dowty identified a list
of potentially affected pintle pins and subsequently, Dassault
Aviation identified on which aeroplanes those pintle pins were
installed.
    This condition, if not corrected, may lead to corrosion of the
pins and ultimately cause them to shear under normal load. This
could result in landing gear collapse during take-off or landing.
    To address this condition, Dassault Aviation, with the support
of Messier-Bugatti-Dowty, developed Service Bulletin (SB) F7X-182 to
provide instructions for removal of potentially affected pintle pins
and replacement with serviceable parts.
    For the reasons described above, this [EASA] AD requires
replacement of pintle pins on affected airplanes. This [EASA] AD
also prohibits installation of a potentially affected part on an
aeroplane.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-
2014-0145.

Relevant Service Information

    Dassault Aviation has issued Mandatory Service Bulletin 7X-182,
Revision 4, dated July 18, 2013. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 42 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replacement...........................  20 work-hours x $85 per         $17,000         $18,700        $785,400
                                         hour = $1,700.
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Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. Amend Sec.  39.13 by adding the following new airworthiness
directive (AD):

Dassault Aviation: Docket No. FAA-2014-0145; Directorate Identifier
2013-NM-183-AD.

(a) Comments Due Date

    We must receive comments by May 9, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Dassault Aviation Model FALCON 7X
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Main Landing
Gear.

(e) Reason

    This AD was prompted by reports that the pintle pins installed
on a certain number of airplanes may be incorrectly protected
against corrosion. We are issuing this AD to detect and correct
pintle pins that have been incorrectly corrosion-protected, which
could cause the pintle pins to shear under normal load and lead to
the collapse of the MLG during take-off or landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Replacement

    For airplanes having serial numbers 4 through 6 inclusive; 9,
12, 19, 21 through 25 inclusive; 29, 32, 33, 37, 39 through 42
inclusive; 45, 49 through 53 inclusive; 55, 56, 62, 63, 65, 67
through 69 inclusive; and 81, 82, 84, and 120: Within 2 months after
the effective date of this AD, replace the pintle pins having part
number (P/N) 55-2355007-01 on the left- and right-hand MLG with a
serviceable part, in accordance with the Accomplishment Instructions
of Dassault Aviation Mandatory Service Bulletin 7X-182, Revision 4,
dated July 18, 2013.

(h) Parts Installation Prohibition

    As of the effective date of this AD, no person may install a
pintle pin having P/N 55-2355007-01, with the following serial
numbers, on any airplane: EXC-0001, EXC-0003, EXC-0008, EXC-0009,
EXC-0010, EXC-0015, EXC-0017, EXC-0018, EXC-0019, EXC-0020, EXC-
0022, EXC-0023, EXC-0024, EXC-0025, EXC-0026, EXC-0027, EXC-0029,
EXC-0030, EXC-0031, EXC-0033, EXC-0037, EXC-0038, EXC-0040, EXC-
0041, EXC-0043, EXC-0044, EXC-0045, EXC-0046, EXC-0047, EXC-0050,
EXC-0051, EXC-0052, EXC-0053, EXC-0054, EXC-0057, EXC-0059, EXC-
0060, EXC-0061, EXC-0062, EXC-0063, EXC-0064, EXC-0065, EXC-0067,
EXC-0069, EXC-0072, EXC-0074, EXC-0075, EXC-0076, EXC-0077, EXC-
0078, EXC-0084, EXC-0091, EXC-0092, EXC-0093, EXC-0096, EXC-0098,
EXC-0099, EXC-0101, EXC-0102, EXC-0103, EXC-0106, EXC-0107, EXC-
0108, EXC-0109, EXC-0110, EXC-0111, EXC-0114, EXC-0115, EXC-0117,
EXC-0119, EXC-0120, EXC-0121, EXC-0122, EXC-0123, EXC-0124, EXC-
0125, EXC-0126, EXC-0127, EXC-0128, EXC-0129, EXC-0130, EXC-0131,
EXC-0132, EXC-0133, EXC-0134, EXC-0135, EXC-0136, EXC-0137, EXC-
0138, EXC-0139, EXC-0143, EXC-0144, EXC-0147, EXC-0148, EXC-0149,
EXC-0150, EXC-0152, EXC-0153, EXC-0154, EXC-0155, EXC-0158, EXC-
0162, EXC-0163, EXC-0164, EXC-0167, EXC-0168, EXC-0170, EXC-0172,
EXC-0173, EXC-0175, EXC-0177, EXC-0178, EXC-0183, EXC-0184, EXC-
0190, EXC-0192, EXC-0193, EXC-0194, EXC-0197, EXC-0198.

(i) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using the following service information:
    (1) Dassault Aviation Service Bulletin 7X-182, dated December
17, 2010.
    (2) Dassault Aviation Service Bulletin 7X-182, Revision 1, dated
December 7, 2011.
    (3) Dassault Aviation Service Bulletin 7X-182, Revision 2, dated
June 1, 2012.
    (4) Dassault Aviation Service Bulletin 7X-182, Revision 3, dated
February 26, 2013.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer, use these actions if they
are FAA-approved. Corrective actions are considered FAA-approved if
they were approved by the State of Design Authority (or its
delegated agent, or by the DAH with a State of Design Authority's
design organization approval). For a repair method to be approved,
the repair approval must specifically refer to this AD. You are
required to ensure the product is airworthy before it is returned to
service.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) issued EASA Airworthiness Directive 2013-0162, dated July 24,
2013, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating it in Docket No. FAA-2014-0145.
    (2) For service information identified in this AD, contact
Dassault Falcon Jet, P.O. Box 2000, South Hackensack, NJ 07606;
telephone<PHONE_NUMBER>; Internet http://www.dassaultfalcon.com. You
may view this service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on March 17, 2014.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-06492 Filed 3-24-14; 8:45 am]
BILLING CODE 4910-13-P