[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Proposed Rules]
[Pages 62658-62661]
[FR Doc No: 2011-26108]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1067; Directorate Identifier 2011-NM-034-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Model F.27 Mark
050 and F.28 Mark 0070 and 0100 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 the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    As required by current certification standards, each transport
aeroplane has passenger compartment exit signs and emergency
lighting strips installed to locate the emergency exits. A number of
these strips

and signs are not electrically powered, but are self illuminated by
means of a hydrogen isotope, known as Tritium. As this isotope
decays over time, these signs will [lose] their brightness.
    To remain compliant with regulations, Tritium exit signs and
lighting strips should be replaced when their brightness has
deteriorated below accepted levels. Currently, the Maintenance
Review Board (MRB) Maintenance Planning Document does not include an
inspection task for signs and strips containing Tritium.
    This condition, if not detected and corrected, could result in
insufficiently bright exit signs and lighting strips, preventing
safe evacuation during an emergency, possibly resulting in injury to
occupants.
* * * * *
The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by November 25,
2011.

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
Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150 AE
Nieuw-Vennep, the Netherlands; telephone +31 (0)252-627-350; fax +31
(0)252-627-211; e-mail<EMAIL_ADDRESS>
Internet http://www.myfokkerfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. 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; or in person at the Docket Operations office
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, Washington 98057-3356; telephone (425)
227-1137; 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-2011-1067;
Directorate Identifier 2011-NM-034-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 2010-0261, dated December 9, 2010 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    As required by current certification standards, each transport
aeroplane has passenger compartment exit signs and emergency
lighting strips installed to locate the emergency exits. A number of
these strips and signs are not electrically powered, but are self
illuminated by means of a hydrogen isotope, known as Tritium. As
this isotope decays over time, these signs will [lose] their
brightness.
    To remain compliant with regulations, Tritium exit signs and
lighting strips should be replaced when their brightness has
deteriorated below accepted levels. Currently, the Maintenance
Review Board (MRB) Maintenance Planning Document does not include an
inspection task for signs and strips containing Tritium.
    This condition, if not detected and corrected, could result in
insufficiently bright exit signs and lighting strips, preventing
safe evacuation during an emergency, possibly resulting in injury to
occupants.
    To correct this unsafe condition, EASA issued AD 2010-0200,
which required [a detailed visual] inspection of the brightness of
all Tritium exit signs and strips and, depending on findings,
replacement of insufficiently bright signs and lighting strips.
    Following the issuance of [EASA] AD 2010-0200, Fokker Services
discovered that one Service Bulletin (SB), SBF100-33-023, contained
errors in the two groups of aeroplane serial numbers and,
consequently, in the related instructions for those aeroplanes in
that SB.
    For the reasons described above, this new [EASA] AD retains the
requirements of EASA AD 2010-0200, which is superseded, amends the
Applicability and refers to Revision 1 of SBF100-33-023 for the
accomplishment instructions.

    Note: The MRB document will be updated before July 2011 to
include an appropriate maintenance task to ensure that the Tritium
exit signs and lighting strips meet the minimum brightness
requirements.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Fokker Services B.V. has issued Service Bulletins SBF50-33-038,
dated July 5, 2010; and SBF100-33-023, Revision 1, dated November 4,
2010. 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.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 4 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $340, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 2 work-hours and require parts costing $833, for a cost of
$1,003 per product. We have no way of determining the number of
products that may need these actions.

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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Fokker Services B.V.: Docket No. FAA-2011-1067; Directorate
Identifier 2011-NM-034-AD.

Comments Due Date

    (a) We must receive comments by November 25, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Fokker Services B.V. Model airplanes
identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD,
certificated in any category.
    (1) F.27 Mark 050 airplanes having serial numbers (S/N)s: 20104,
20105, 20121 through 20123 inclusive, 20130 through 20135 inclusive,
20141 through 20145 inclusive, 20150, 20156 through 20176 inclusive,
20178 through 20180 inclusive, 20182 through 20199 inclusive, 20202,
20204 through 20207 inclusive, 20210, 20211, 20213 through 20252
inclusive, 20254 through 20266 inclusive, 20270 through 20279
inclusive, 20281, 20283 through 20288 inclusive, 20296 through 20303
inclusive, 20306, 20307, 20312, 20313, 20316, 20317, 20328, 20331,
20333, and 20335.
    (2) F.28 Mark 0070 and 0100 airplanes having S/Ns: 11257, 11258,
11262, 11264 through 11266 inclusive, 11287, 11301, 11317, 11340,
11342, 11352 through 11356 inclusive, 11360, 11368 through 11370
inclusive, 11376, 11377, 11385, 11395, 11402, 11403, 11405 through
11408 inclusive, 11411 through 11419 inclusive, 11425 through 11428
inclusive, 11434 through 11437 inclusive, 11447 through 11449
inclusive, 11457 through 11459 inclusive, 11467, 11469, 11478,
11479, 11481, 11482, 11487, 11492 through 11495 inclusive, 11497,
11498, 11501, 11503, 11506, 11507, 11509, 11514, 11521, 11528,
11529, 11532, 11536 through 11541 inclusive, 11543, 11545, 11547,
11549, 11551, 11553 through 11583 inclusive, and 11585.
    (3) F.28 Mark 0100 airplanes, if in a post-Fokker Service
Bulletin SBF100-52-060 configuration, having S/Ns: 11244 through
11256 inclusive, 11259 through 11261 inclusive, 11263, 11267 through
11286 inclusive, 11288 through 11300 inclusive, 11302 through 11316
inclusive, 11318 through 11339 inclusive, 11341, 11343 through 11351
inclusive, 11357 through 11367 inclusive, 11371 through 11375
inclusive, 11378 through 11384 inclusive, 11386 through 11394
inclusive, 11396 through 11401 inclusive, 11404, 11409, 11410, 11420
through 11424 inclusive, 11429 through 11433 inclusive, 11438
through 11446 inclusive, 11450 through 11456 inclusive, 11460
through 11466 inclusive, 11468, 11470 through 11477 inclusive,
11480, 11483 through 11486 inclusive, 11488 through 11491 inclusive,
11496, 11499, 11500, 11502, 11504, 11505, 11508, 11510 through 11513
inclusive, 11515 through 11520 inclusive, 11522, 11523, and 11527.

Subject

    (d) Air Transport Association (ATA) of America Code 33: Lights.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    As required by current certification standards, each transport
aeroplane has passenger compartment exit signs and emergency
lighting strips installed to locate the emergency exits. A number of
these strips and signs are not electrically powered, but are self
illuminated by means of a hydrogen isotope, known as Tritium. As
this isotope decays over time, these signs will [lose] their
brightness.
    To remain compliant with regulations, Tritium exit signs and
lighting strips should be replaced when their brightness has
deteriorated below accepted levels. Currently, the Maintenance
Review Board (MRB) Maintenance Planning Document does not include an
inspection task for signs and strips containing Tritium.
    This condition, if not detected and corrected, could result in
insufficiently bright exit signs and lighting strips, preventing
safe evacuation during an emergency, possibly resulting in injury to
occupants.
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within six months after the effective date of this AD, do a
detailed visual inspection of the tritium exit signs and emergency
lighting strips for required brightness, in accordance with the
Accomplishment Instructions of Fokker Service Bulletin SBF50-33-038,
dated July 5, 2010; or SBF100-33-023, Revision 1, dated November 4,
2010; as applicable. If any exit signs or emergency lighting strips
are insufficiently bright, before further flight, replace the exit
signs or emergency lighting strips, in accordance with the

Accomplishment Instructions of Fokker Service Bulletin SBF50-33-038,
dated July 5, 2010; or SBF100-33-023, Revision 1, dated November 4,
2010; as applicable. A review of airplane maintenance records is
acceptable in lieu of the inspection in this paragraph if the
tritium exit signs and emergency lighting strips can be conclusively
determined to have been manufactured in 2003 or earlier, from that
review; however, the replacement in this paragraph must be
accomplished before further flight after doing the review.

Parts Installation

    (h) As of the effective date of this AD, no person may install
any tritium exit signs or emergency lighting strips if the
manufacturing date is seven years or more before the intended
installation date, or if the manufacturing date cannot be
determined; unless the tritium exit sign or emergency lighting strip
has been inspected in accordance with paragraph (g) of this AD, and
does not need replacement.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (i) Inspecting and replacing the tritium exit sign or emergency
lighting strip in accordance with Fokker Service Bulletin SBF100-33-
023, dated July 5, 2010, before the effective date of this AD is
acceptable for compliance with the corresponding inspection and
replacement required by paragraph (g) of this AD.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (j) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be e-mailed 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 or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (k) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2010-0261, dated December 9, 2010; Fokker Service Bulletin
SBF50-33-038, dated July 5, 2010; and Fokker Service Bulletin
SBF100-33-023, Revision 1, dated November 4, 2010; for related
information.

    Issued in Renton, Washington, on September 30, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-26108 Filed 10-7-11; 8:45 am]
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[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Notices]
[Page 40354]
[FR Doc No: 2020-14565]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Wednesday, July 8, 2020.

PLACE: The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street, NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matter of the closed meeting will consist of the
following topic:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: July 1, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-14565 Filed 7-1-20; 4:15 pm]
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[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64164-64166]
[FR Doc No: 2016-22471]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1112]

Health Canada and United States Food and Drug Administration
Joint Public Consultation on International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use; Public
Meeting and Webcast

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting and Webcast; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a regional public meeting (which will also be Webcast) entitled
``Health Canada and U.S. Food and Drug Administration Joint Public
Consultation on International Council for Harmonisation of Technical

Requirements for Pharmaceuticals for Human Use (ICH).'' The goal of
this meeting is to provide information and receive comments on the
current activities of ICH, as well as the upcoming ICH meetings in
Osaka, Japan, in November 2016. The topics to be discussed are the
topics for discussion at the forthcoming ICH Assembly Meeting in Osaka.
The purpose of this public meeting is to solicit public input prior to
the next ICH Assembly meeting and the Expert Working Group meetings in
Osaka, Japan, scheduled for November 6 through November 11, 2015.

DATES: The public meeting will be held on October 24, 2016, from 1 p.m.
to 3 p.m., EST. Registration to attend the meeting and requests for
oral presentations must be received by October 21, 2016; see the
SUPPLEMENTARY INFORMATION section for information on how to register
for the meeting. Interested persons may submit either electronic or
written comments to the public docket (see ADDRESSES) by October 19,
2016.

ADDRESSES: The meeting will be held at Sir Frederick G. Banting
Research Centre, 251 Sir Frederick Banting Driveway, Ottawa, ON K1Y
0M1, Canada. It will also be broadcast on the Web allowing participants
to join in person or via the Web.
    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-2016-N-1112 for ``Health Canada and U.S. Food and Drug
Administration Joint Public Consultation on International Council on
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use; Public Meeting.'' 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: Amanda Roache, Food and Drug
Administration, Center for Drug Evaluation and Research, Office of
Strategic Programs, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176,
Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The ICH, formerly known as the International Conference on
Harmonisation was established in 1990 as a joint regulatory/industry
project to improve, through harmonization, the efficiency of the
process for developing and registering new medicinal products in
Europe, Japan, and the United States without compromising the
regulatory obligations of safety and effectiveness. In 2015 the ICH was
reformed to make the ICH a true global initiative that expands beyond
the previous ICH members. More involvement from regulators around the
world is expected, as they will join their counterparts from Europe,
Japan, the United States, Canada, and Switzerland as ICH regulatory
members. The reforms build on a 25-year track record of successful
delivery of harmonized guidelines for global pharmaceutical
development, and their regulation. In recent years, many important
initiatives have been undertaken by regulatory authorities and industry
associations to promote international harmonization of regulatory
requirements. FDA has participated in many meetings designed to enhance
harmonization and is committed to seeking scientifically based
harmonized technical procedures for pharmaceutical development. One of
the goals of harmonization is to identify and then reduce differences
in technical requirements for medical product development among
regulatory Agencies. ICH was organized to provide an opportunity for
harmonization initiatives to be developed with input from both
regulatory and industry representatives. The ICH process has achieved
significant harmonization of

the technical requirements for the approval of pharmaceuticals for
human use in the ICH regions over the past two decades. The current ICH
process and structure can be found at the following Web site: http://www.ich.org. (FDA has verified the Web site addresses as of the date
this document publishes in the Federal Register, but Web sites are
subject to change over time.)

II. Webinar Attendance and Participation

A. Registration

    If you wish to attend the meeting, please register at the following
Web site: https://healthcanada-usfda_ich_consultation.eventbrite.ca.
Registrations may be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, the number of participants from each organization may be
limited based on space limitations. Registrants will receive
confirmation once they have been accepted. If you need special
accommodations because of a disability, please contact Amanda Roache
(see FOR FURTHER INFORMATION CONTACT) at least 7 days before the
Webinar.

B. Requests for Oral Presentations

    Interested persons may present data, information, or views orally
or in writing on issues pending at the public Webinar. Public oral
presentations will be scheduled between approximately 2:30 p.m. and 3
p.m. Time allotted for oral presentations may be limited to 5 minutes.
Those desiring to make oral presentations should notify Amanda Roache
(see FOR FURTHER INFORMATION CONTACT) by October 19, 2016, and submit a
brief statement of the general nature of the evidence or arguments they
wish to present; the names and addresses, telephone number, FAX, and
email of proposed participants; and an indication of the approximate
time requested to make their presentation. The agenda for the public
Webinar will be made available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm516166.htm.

    Dated: September 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22471 Filed 9-16-16; 8:45 am]
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