[Federal Register: July 28, 2009 (Volume 74, Number 143)]
[Notices]
[Page 37232]
[DOCID:fr28jy09-48]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Science Board to the Food and Drug Administration; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Science Board to the Food and Drug
Administration (Science Board).
    General Function of the Committee: The Science Board provides
advice primarily to the Commissioner of Food and Drugs and other
appropriate officials on specific complex and technical issues, as well
as emerging issues within the scientific community in industry and
academia. Additionally, the Science Board provides advice to the agency
on keeping pace with technical and scientific evolutions in the fields
of regulatory science, on formulating an appropriate research agenda,
and on upgrading its scientific and research facilities to keep pace
with these changes. It will also provide the means for critical review
of agency sponsored intramural and extramural scientific research
programs.
    Date and Time: The meeting will be held on Monday, August 17, 2009,
from 8 a.m. to 4 p.m.
    Addresses: Hilton Washington DC/Rockville Hilton, 1750 Rockville
Pike, Rockville, MD 20852.
    Contact Person: Carlos Pe[ntilde]a, Office of the Commissioner,
Food and Drug Administration (HF-33), 5600 Fishers Lane, Rockville, MD
20857,<PHONE_NUMBER>, or FDA Advisory Committee Information Line, 1-800-
741-8138<PHONE_NUMBER> in the Washington, DC area), code<PHONE_NUMBER>.
Please call the Information Line for up-to-date information on this
meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: The Science Board will hear about and discuss reports from
its subcommittees on the following: (1) The review of research at the
Center for Veterinary Medicine, and (2) the review of FDA's scientific
information technology infrastructure modernization initiatives. The
Science Board will hear about plans to establish an additional
subcommittee for the review of research at the Center for Food Safety
and Applied Nutrition. The Science board will also hear about and
discuss updates from the agency regarding the continued assessment of
Bisphenol-A (BPA) in FDA-regulated products.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm, click on the year 2009 and scroll down to the appropriate
advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 10, 2009. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before August 3, 2009. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by August 4,
2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Carlos Pe[ntilde]a
at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 22, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-17961 Filed 7-27-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 237 (Tuesday, December 10, 2019)]
[Rules and Regulations]
[Pages 67375-67378]
[FR Doc No: 2019-26584]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 100 and 165

[Docket Number USCG-2019-0908]
RIN 1625-AA08

Special Local Regulation; Temporary Change for Recurring Marine
Event in the Seventh Coast Guard District

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is temporarily changing the enforcement period
of a special local regulation for a recurring marine event in the
Seventh Coast Guard District and adding a temporary safety zone for
this event. These regulations apply to the St. Croix Christmas Boat
Parade and Fireworks Display in the vicinity of Protestant Cay in St.
Croix, USVI, which will take place this year on December 14, 2019. The
temporary special local regulation and temporary safety zone is needed
to protect personnel, vessels, and the marine environment from the boat
parade and fireworks display. Entry of vessels or persons into this
regulated area is prohibited unless specifically authorized by the
Captain of the Port San Juan.

DATES: This rule is effective on December 14, 2019, from 4 p.m. until
11 p.m.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0908 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Pedro Mendoza, Sector San Juan
Prevention Department, Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard did not receive
notice of the marine event from involved parties with sufficient time
to publish a NPRM and to receive public comments prior to the event. It
is impracticable to publish an NPRM because the Coast Guard did not
receive notice of the alternate date of the boat parade and the
addition of a fireworks display until October 31, 2019, and the special
local regulation is needed for December 14, 2019. This action is
necessary for the protection of life and property on the navigable
waters of the United States. Therefore, it would be contrary to the
public interest to postpone temporarily amending this special local
regulation.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
respond to the potential safety and security concerns associated with
power boat races.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 and 70041. The Captain of the Port San Juan (COTP) has determined
that potential hazards associated with the boat parade and fireworks
display on December 14, 2019, will be a safety concern for anyone
within the vicinity of the event. This rule is needed to protect
personnel, vessels, and the marine environment in the navigable waters
of Christiansted Harbor in the vicinity of Protestant Cay in St. Croix,
USVI.

IV. Discussion of the Rule

    This rule temporarily changes the date of the Christmas Boat Parade
in St. Croix, USVI and adds a fireworks display to the event
description. The special local regulation is from 4:00 p.m. until 11:00
p.m. on December 14, 2019. The temporary special local regulation will
cover all navigable waters of Christiansted Harbor approximately 200
yards from Protestant Cay. During the fireworks display, an exclusion
zone of 700 feet will be established around the deck barges at
approximate position 17[deg]45'3'' N, 064[deg]42'10'' W. The duration
of the temporary special local regulation is intended to protect
personnel, vessels, and the marine environment in these navigable
waters during the boat parade and fireworks display. No vessel or
person, other than the event participants, will be permitted to enter
the regulated area without obtaining permission from the COTP or a
designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the expected size,
location and available exceptions to the enforcement of the special
local regulation and safety zone. The regulated area will impact a
small designated area of Christiansted Harbor in the vicinity of
Protestant Cay in St. Croix, USVI during the event for seven hours on
December 14, 2019 and thus is limited in time and scope. Although
persons and vessels who are not participating in the event will not be
able to enter, transit through, anchor in, or remain within the
regulated area without authorization from the Captain of the Port San
Juan or a designated representative, they may operate in the
surrounding area during the enforcement period. Furthermore, the rule
will allow vessels to seek permission to enter the regulated area.
Persons and vessels may still enter, transit through, anchor in, or
remain within the regulated during the enforcement period if authorized
by the Captain of the Port San Juan or a designated representative. The
Coast Guard will issue a Local Notice to Mariners and a Broadcast
Notice to Mariners, allowing mariners to make alternative plans or seek
permission to transit the regulated area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
regulated area may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions

concerning its provisions or options for compliance, please call or
email the person listed in the FOR FURTHER INFORMATION CONTACT section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a special local regulation lasting only
seven hours that will prohibit entry within the regulated area during
the boat parade and fireworks display. It is categorically excluded
from further review under paragraphs L60(a) and L61 in Table 3-1 of the
Department of Homeland Security Directive 023-01. A Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR parts 100 and 165 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.T799-0908 to read as follows:

Sec.  100.T799-0908  Special Local Regulation; Christmas Boat Parade,
Christiansted Harbor, St. Croix, USVI.

    (a) Location. The following area is a special local regulation.
Christiansted Harbor, 200 yards off-shore surrounding Protestant Cay,
St. Croix, USVI, from surface to bottom, beginning in position
17[deg]45'3'' N, 064[deg]42'10'' W, around the cay and back to the
beginning position. During the fireworks display an exclusion zone of
700 feet is established around the deck barges at approximate position
17[deg]45'3'' N, 064[deg]42'10'' W. All coordinates are North American
Datum 1983.
    (b) Definitions. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, State, and local officers designated by or assisting the
Captain of the Port San Juan in the enforcement of the regulated areas.
    (c) Regulations. (1) Except for those persons and vessels
participating in boat parade or enforcing the special local regulation,
all persons and vessels are prohibited from entering, transiting
through, anchoring in, or remaining within the regulated area.
    (2) Persons and vessels may request authorization to enter, transit
through, anchor in, remain within the regulated area by contacting the
Captain of the Port San Juan by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16. Those in the
regulated area must comply with all lawful orders or directions given
to them by the Captain of the Port or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area by
Broadcast Notice to Mariners and on-scene designated representatives.
    (d) Enforcement period. This section will be enforced from 4 p.m.
until 11 p.m. on December 14, 2019.

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
3. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
4. Add Sec.  165.T07-0908 to read as follows:

Sec.  165.T07-0908  Safety Zone; Christmas Boat Parade Fireworks
Display, Christiansted Harbor, St. Croix, USVI.

    (a) Location. A safety zone is established approximately 700 feet
around the deck barges at approximate position 17[deg]45'3'' N,
064[deg]42'10'' W. All coordinates are North American Datum 1983.
    (b) Definitions. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast

Guard coxswains, petty officers, and other officers operating Coast
Guard vessels, and Federal, State, and local officers designated by or
assisting the Captain of the Port San Juan in the enforcement of the
regulated areas.
    (c) Regulations. (1) Except for those persons and vessels
participating in boat parade or enforcing the special local regulation,
all persons and vessels are prohibited from entering, transiting
through, anchoring in, or remaining within the regulated area.
    (2) Persons and vessels may request authorization to enter, transit
through, anchor in, remain within the regulated area by contacting the
Captain of the Port San Juan by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16. Those in the
regulated area must comply with all lawful orders or directions given
to them by the Captain of the Port or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area by
Broadcast Notice to Mariners and on-scene designated representatives.
    (d) Enforcement period. This section will be enforced from 4 p.m.
until 11 p.m. on December 14, 2019.

    Dated: December 5, 2019.
E. P. King,
Captain, U.S. Coast Guard, Captain of the Port San Juan.
[FR Doc. 2019-26584 Filed 12-9-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7747-7749]
[FR Doc No: 2018-03606]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-4020]

Determination of Regulatory Review Period for Purposes of Patent
Extension; OFEV

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for OFEV and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
23, 2018. Late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before April 23, 2018. The
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of April 23, 2018.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by August 21, 2018. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and

Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2015-E-4020 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; OFEV.'' Received comments, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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 Sec.  10.20 (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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product OFEV
(nintedanib esylate). OFEV is indicated for treatment of idiopathic
pulmonary fibrosis. Subsequent to this approval, the USPTO received a
patent term restoration application for OFEV (U.S. Patent No.
6,762,180) from Boehringer Ingelheim Pharma Gmbh & Co. KG, and the
USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated December 17,
2015, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of OFEV represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
OFEV is 3,480 days. Of this time, 3,313 days occurred during the
testing phase of the regulatory review period, while 167 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: April 7, 2005. The applicant claims April 8, 2005, as the
date the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was April 7,
2005, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: May 2,
2014. FDA has verified the applicant's claim that the new drug
application (NDA) for OFEV (NDA 205832) was initially submitted on May
2, 2014.
    3. The date the application was approved: October 15, 2014. FDA has
verified the applicant's claim that NDA 205832 was approved on October
15, 2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,822 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24 ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition

has been served upon the patent applicant. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03606 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34436-34438]
[FR Doc No: 2012-14071]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67131; File No. SR-ISE-2012-51]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing of Proposed Rule Change To Temporarily Suspend
the Requirements of ISE Rule 306 and Related ISE Rules Concerning the
Approval of New Members of the Exchange

June 5, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 5, 2012, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to temporarily suspend the requirements of
ISE Rule 306 and related ISE rules concerning approval of new member
organizations in order to approve Apex Clearing Corporation, f/k/a
Ridge Clearing and Outsourcing Solutions, Inc. (``Apex Clearing'') as
an ISE member organization, subject to Apex Clearing complying with
Exchange rules for a new member organization within 30 calendar days of
the date that Apex Clearing is provisionally approved as an ISE member
organization. The Exchange is also proposing to accept Apex Clearing's
assumption of all of the existing clearing agreements and arrangements
currently in effect between Penson Financial Services Inc. (``PFSI'')
and various other ISE member organizations by execution of a global
agreement thereto.
    The text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.ise.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes this rule filing to temporarily suspend the
requirements of ISE Rule 306 and related rules regarding the approval
of Members of the Exchange in order to immediately approve Apex
Clearing as an ISE Member. The Exchange proposes this temporary
suspension on an emergency basis to ensure that Apex Clearing can
continue the clearing operations of PFSI without unnecessary
disruption, which could have a significant collateral impact to a
number of other Members. The proposed temporary suspension is
contingent upon Apex having complied with all new Member Exchange rules
within 30 calendar days of the date Apex is provisionally approved as
an ISE Member pursuant to this filing.
    On May 31, 2012, Apex Clearing Holdings, LLC (``Apex Holdings''),
Apex Clearing Solutions, LLC, Broadridge Financial Solutions, Inc.
(``Broadridge''), PFSI and Penson Worldwide, Inc. (``PWI'') (together,
the ``Parties'') consummated a transaction resulting in a change in
ownership of Apex Clearing.\3\ Broadridge, Apex Holdings, PWI and PFSI
each made capital investments in Apex Holdings, the holding company
parent of Apex Clearing. PFSI also assigned all of its U.S. clearing
contracts and all customer and introducing broker proprietary accounts
along with key personnel to

Apex Clearing (the ``Transferring Accounts'').\4\
---------------------------------------------------------------------------

    \3\ Prior to the Transaction, Apex Clearing's name was Ridge
Clearing & Outsourcing Solutions, Inc. Prior to the transaction,
Ridge Clearing & Outsourcing Solutions, Inc. contributed its
outsourcing operations and all associated personnel and systems to
its affiliated entity, Broadridge Securities Processing Solutions,
LLC (``BSPS'') where it will continue to provide operations support
and outsourcing services to a number of broker-dealers, including
Apex Clearing.
    \4\ See Penson Worldwide, Inc. Form 8-K dated May 31, 2012.
---------------------------------------------------------------------------

    As a result of the transaction, Apex Clearing, which is not an ISE
member organization, will provide the clearing services currently
provided to the Transferring Accounts by PFSI. On May 31, 2012, Apex
Clearing submitted an application for approval as an ISE Member.
However, because of the expedited nature of the transaction, Apex
Clearing was unable to fully comply with ISE Rule 306 and related new
Member rules. Because of the need for seamless continuity with respect
to the Transferring Accounts, Apex Clearing has requested that the
Exchange temporarily suspend its new membership rules in order to
enable Apex Clearing's approval as a Member on an expedited basis.
Pursuant to its request, Apex Clearing will fully comply with the
Exchange's new member requirements within 30 calendar days of
provisional approval.
    ISE Rule 306 requires any person who proposes to apply to become a
Member of the Exchange to file an application with the Exchange submit
such information as may be required by the application and related ISE
rules. When a corporate acquisition concerns an asset transfer only,
and not an acquisition of the corporate entity, ISE membership status
cannot be transferred to the acquiring entity. The entity that proposes
to continue acquired business operations of an ISE Member must be
separately approved as an ISE Member.
    Among other things, to be approved as an ISE Member, the applicant
must:
     File with the Exchange an application and all documents
requested therein pursuant to ISE Rule 306.
     Ensure that all persons associated with the applicant who
meet the requirements of persons associated with Members under ISE Rule
304, consent to ISE jurisdiction as a Member or associated person.
     Submit to the Exchange partnership or corporate documents
as may be applicable including certificate of incorporation, by-laws,
and other corporate documents pursuant to ISE Rule 305.
    In addition, the Exchange reviews whether the applicant meets
federal and ISE capital requirements and whether it has adopted
controls and procedures to comply with Exchange rules.
    Due to the amount of information an applicant is required to
provide and have completed prior to being approved as a Member, the
Member approval process generally takes several weeks to complete. The
length of time varies based on the timing of the applicant's response
to requests for information and documentation.
    As proposed, Apex Clearing will continue the clearing and certain
other operations of PFSI as of June 6, 2012. In order to avoid
interruption of the services PFSI currently provides to other Exchange
Members, the ISE believes that Apex Clearing should be approved
immediately as an ISE Member. The Exchange notes that Apex Clearing is
already a registered broker dealer, a FINRA member and an OCC clearing
member, which is a prerequisite for becoming an ISE member organization
that is approved to clear transactions executed on the Exchange.
    The Exchange therefore proposes providing Apex Clearing with a
temporary suspension of ISE Rule 306 and related membership rules as
they relate to approval to operate an ISE Member and approval of a
proposed Member's associated persons, and immediately approve Apex
Clearing as a Member. As proposed this temporary suspension is
contingent upon:
     Apex Clearing providing the Exchange with sufficient
information to confirm that Apex Clearing will meet its capital
requirements as an ISE Member; and
     Within 30 calendar days of Apex Clearing's approval as an
ISE Member under this proposed filing, Apex Clearing and its approved
persons will have complied with the Exchange's new member organization
requirements as set forth in ISE Rules 304-306.
    As proposed, if Apex Clearing does not comply with all applicable
ISE member organization application requirements within 30 calendar
days of the effective date of this filing, its status as an approved
ISE Member will no longer be effective.
    In addition, the Exchange proposes to permit Apex Clearing to
assume all existing clearing agreements and arrangements currently in
effect with other ISE Members by execution of global agreements
thereto. Notice of such assumption will be provided to impacted Members
via email.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) \5\ of the Act, in general, and furthers the objectives of
Section 6(b)(5) \6\ in particular in that it is designed to promote
just and equitable principles of trade, to prevent fraudulent and
manipulative acts, to remove impediments to and to perfect the
mechanism for a free and open market and a national market system and,
in general, to protect investors and the public interest. The Exchange
believes that permitting the expeditious approval of Apex Clearing as
an ISE Member will avoid interruption of the services PFSI currently
provides to other Exchange Members. Based on information and
representations provided by Apex Clearing, a temporary suspension of
certain ISE membership rules is needed based on the expedited nature of
the transaction to enable seamless continuity with respect to the
transferring accounts. Consequently, the ISE believes that temporary
suspension of its Member requirements so that Apex Clearing can be
approved immediately as an ISE Member will help to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities and is consistent with the Act.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A)

of the Act \9\ and Rule 19b-4(f)(6)(iii) thereunder.\10\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires a self-regulatory organization to give the
Commission written notice of its intent to file the proposed rule
change at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Commission is waiving this five-day pre-filing
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\12\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Exchange has asked the Commission to waive the five-day pre-
filing requirement and the 30-day operative delay so that the proposed
rule change may become operative immediately upon filing. The
Commission notes that the Exchange is proposing that certain of its
rules relating to membership requirements be temporarily suspended so
that Apex Clearing can be provisionally approved as an ISE Member. The
proposed relief does not exempt Apex Clearing from Exchange rule
requirements governing Members. Apex Clearing would have a 30 calendar
day grace period within which to apply for and be approved under
relevant Exchange rules. Moreover, the Commission believes that waiver
of the 30-day operative delay is appropriate to ensure a smooth
transition of PFSI operations to Apex Clearing. In particular, given
the rapidity with which events have developed, waiver of the 30-day
operative delay is necessary to avoid significant disruption to PFSI's
existing customers and the market generally. Therefore, the Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest and designates the
proposed rule change as operative upon filing.\13\
---------------------------------------------------------------------------

    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2012-51 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2012-51. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2012-51 and should be
submitted on or before July 2, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-14071 Filed 6-8-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Proposed Rules]
[Pages 72863-72866]
[FR Doc No: 2011-30582]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1250; Directorate Identifier 2010-NM-031-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company 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
certain The Boeing Company Model 707-100 long body, -200, -100B long
body, and -100B short body series airplanes; Model 707-300, -300B, -
300C, and -400 series airplanes; and Model 720 and 720B series
airplanes. For certain airplanes, this proposed AD would require using
redefined flight cycle counts, determining the type of material of the
horizontal stabilizer, rear spar, upper chords, and lower chords on the
inboard and outboard ends of the rear spar; repetitively inspecting for
cracking of the horizontal stabilizer components; and repairing or
replacing the chord, or modification of chord segments made from 7079
aluminum, if necessary. For all airplanes, this proposed AD would
require inspecting certain structurally significant items, and
repairing discrepancies if necessary. This proposed AD was prompted by
reports of stress corrosion cracking in the chord segments made from
7079 aluminum in the horizontal stabilizer rear spar, and fatigue
cracking in the chord segments made from 7075 aluminum. We are
proposing this AD to detect and correct stress corrosion and/or fatigue
cracking in the horizontal stabilizer, which could compromise the
structural integrity of the stabilizer.

DATES: We must receive comments on this proposed AD by January 12,
2012.

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 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
(206) 544-5000, extension 1; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.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 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 Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Berhane Alazar, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone:
(425) 917-6577; fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
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-2011-1250;
Directorate Identifier 2010-NM-031-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 because of 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

    We have received numerous reports of stress corrosion cracking in
the chord segments made from 7079 aluminum in the Model 707 horizontal
stabilizer rear spar. 7079 aluminum is known to be susceptible to
stress corrosion cracking. Development of stress corrosion cracking was
slowed by the accomplishment of the actions specified in Boeing 707
Service Bulletin 3356, Revision 2, dated December 12, 1991; and Boeing
707 Service Bulletin 3381, Revision 2, dated January 31, 1991.
    In addition, we have received three reports of fatigue cracking in
the upper chords of the horizontal stabilizer rear spar near the side
of the body. These chords are made from 7075 aluminum. In all three
cases, the actions specified in Boeing 707/720 Service Bulletin A3313,
Revision 1, dated May 27, 1977, had been incorporated. The fatigue
cracking in either 7075 or 7079 material configuration has occurred
early in the life of the modified structure. The fatigue cracks were
generated by frequent training flights that included multiple touch-
and-go cycles, which are most prevalent with military operators. These
conditions, if not corrected, could result in stress corrosion and/or
fatigue cracking in the horizontal stabilizer, which could compromise
the structural integrity of the stabilizer.
    Parts made from 7079 aluminum have also been discovered on
airplanes that were not originally delivered with those parts.
Therefore, to adequately address the stress corrosion cracking in the
chord segments in the rear spar of the horizontal stabilizer, it is
necessary to determine the chord configuration on the airplane.
Furthermore, it is also necessary to carefully maintain a record of
that configuration until all chord segments of the rear spar of the
horizontal stabilizers that are made from 7079 aluminum have been
removed from the fleet. Since horizontal stabilizers can be swapped, it
is also necessary to implement the inspections for early fatigue
cracking on all airplanes, regardless of their current usage.

Relevant Service Information

    We have reviewed Boeing 707 Alert Service Bulletin A3515, dated
December

19, 2007 (for Model 707 airplanes); and Boeing 707 Alert Service
Bulletin A3516, dated April 4, 2008 (for Model 707 airplanes, and Model
720 and 720B series airplanes).
    Boeing 707 Alert Service Bulletin A3515 describes procedures for
the following actions:
     Counting flight-cycles to determine the compliance times.
     Determining the type of material of the horizontal
stabilizer, rear spar, upper chords, and lower chords on the inboard
and outboard ends of the rear spar.
     Repetitive special detailed inspections for cracking of
the upper chord on the inboard end of the rear spar of the left and
right side horizontal stabilizers.
     Repetitive high frequency eddy current inspections for
cracking of the web flanges of the upper and lower chords of the rear
spar of the left and right side horizontal stabilizers between
stabilizer stations 92.55 and 272.55 for 7079 aluminum components.
     Repetitive low frequency eddy current inspections for
cracking of the forward skin flanges of the upper and lower chords of
the rear spar in the left and right side horizontal stabilizers from
stabilizer stations -13.179 to 272.55 (for lower chords) and 92.55 to
272.55 (for upper chords) for 7079 aluminum components.
     Repetitive special detailed inspections for cracking of
the upper chord of the inboard side of the rear spar in the left and
right side horizontal stabilizers from stabilizer station -13.179 to
92.55 for 7079 aluminum components.
     Replacing certain chord components made from 7079
aluminum.
     Corrective actions, including replacing the chord(s) with
a new chord and contacting Boeing for repair instructions and doing the
repair.
    Boeing 707 Alert Service Bulletin A3516 specifies one-time
inspections of certain structurally significant items, and provides
procedures for counting flight cycles for determining the compliance
times for the inspections.

Related Rulemaking

    We issued AD 85-12-01, Amendment 39-5073 (50 FR 26690, June 28,
1985), for Model 707 and 720 airplanes, as revised (AD 85-12-01 R1,
Amendment 39-5439 (51 FR 36002, October 8, 1986). That AD requires
structural inspections and repairs or replacement on certain high time
airplanes that have exceeded their fatigue design life.

FAA's Determination and Requirements of This Proposed AD

    We are proposing this AD because we evaluated all relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of these same type
designs. This proposed AD would require accomplishing the actions
specified in the service information described previously, except as
discussed below. The requirements of this proposed AD do not affect the
requirements of AD 85-12-01 R1, Amendment 39-5439 (51 FR 36002, October
8, 1986).

Differences Between the Proposed AD and Service Information

    Paragraph (i) of this proposed AD specifies determining the
material of the structural components of the horizontal stabilizer in
accordance with Boeing 707 Alert Service Bulletin A3515, dated December
19, 2007. That service bulletin also specifies that this action be
repeated. We have determined that accomplishing this action one time
only will provide an adequate level of safety, provided that the
component material is determined before further flight on any replaced
horizontal stabilizer.
    Paragraph (i) of this proposed AD specifies a special detailed
inspection of the upper chords, in accordance with Boeing 707 Alert
Service Bulletin A3515, dated December 19, 2007. That service bulletin
specifies a compliance time of 180 days or 500 flight cycles (after the
date on the service bulletin). This proposed AD, however, would remove
the 500-flight-cycle compliance time to ensure that no airplane is
unintentionally grounded, because it is possible an operator might
exceed the flight-cycle grace period specified in paragraph (i) of this
proposed AD before completing the inspection for chord material
specified in paragraph (h) of this proposed AD. Similarly, paragraph
(k) of this proposed AD removes the 250- and 1000-flight-cycle
compliance times (specified in Boeing 707 Alert Service Bulletin A3515,
dated December 19, 2007) for the initial inspection. This proposed AD
would require these inspections within 180 days after the effective
date of the AD.
    Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007,
specifies to contact the manufacturer for instructions on how to repair
certain conditions, but this proposed AD would require repairing those
conditions in one of the following ways:
     Using a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) whom we have
authorized to make those findings.

Interim Action

    We consider this proposed AD interim action. If final action is
later identified, we might consider further rulemaking then.

Costs of Compliance

    We estimate that this proposed AD would affect 10 airplanes of U.S.
registry. The following table provides the estimated costs for U.S.
operators to comply with this proposed AD.

                                                                 Table--Estimated costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
              Action                      Work hours         Average labor       Parts         Cost per product      registered          Fleet cost
                                                             rate per hour                                            airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspections.......................  24 to 32..............             $85              $0  $2,040 to $2,720 per               10  $20,400 to $27,200
                                                                                inspection cycle.                      per inspection
                                                                                cycle.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.

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.
    You can find our regulatory evaluation and the estimated costs of
compliance 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:

The Boeing Company: Docket No. FAA-2011-1250; Directorate Identifier
2010-NM-031-AD.

Comments Due Date

    (a) We must receive comments by January 12, 2012.

Affected ADs

    (b) This AD affects AD 85-12-01, Amendment 39-5073 (50 FR 26690,
June 28, 1985), as revised by AD 85-12-01 R1, Amendment 39-5439, (51
FR 36002, October 8, 1986).

Applicability

    (c) This AD applies to The Boeing Company Model 707-100 long
body, -200, -100B long body, and -100B short body series airplanes;
Model 707-300, -300B, -300C, and -400 series airplanes; and Model
720 and 720B series airplanes; certificated in any category; as
identified in Boeing 707 Alert Service Bulletin A3515, dated
December 19, 2007, and Boeing 707 Alert Service Bulletin A3516,
dated April 4, 2008.

Subject

    (d) Air Transport Association (ATA) of America Code 55:
Stabilizers.

Unsafe Condition

    (e) This AD was prompted by reports of stress corrosion cracking
in the chord segments made from 7079 aluminum in the horizontal
stabilizer rear spar, and fatigue cracking in the chord segments
made from 7075 aluminum. The Federal Aviation Administration is
issuing this AD to detect and correct stress corrosion and/or
fatigue cracking in the horizontal stabilizer, which could
compromise the structural integrity of the stabilizer.

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.

Flight Cycle Counting Procedure

    (g) Flight cycles, as used in this AD, must be counted as
defined in Boeing 707 Alert Service Bulletin A3515, dated December
19, 2007 (for Model 707 airplanes); or Boeing 707 Alert Service
Bulletin A3516, dated April 4, 2008 (for Model 707 airplanes, and
Model 720 and 720B series airplanes).

Determine Material of the Components of the Horizontal Stabilizer

    (h) For airplanes identified in Boeing 707 Alert Service
Bulletin A3515, dated December 19, 2007: At the earlier of the times
specified in paragraphs (h)(1) and (h)(2) of this AD, determine the
type of material of the horizontal stabilizer, rear spar, upper
chords, and lower chords on the inboard and outboard ends of the
rear spar, in accordance with Part 2 of the Accomplishment
Instructions of Boeing 707 Alert Service Bulletin A3515, dated
December 19, 2007.
    (1) Within 180 days after the effective date of this AD.
    (2) Before further flight after any horizontal stabilizer is
replaced after the effective date of this AD.

Repetitive Inspections of 7075 Aluminum Components

    (i) For airplanes with horizontal stabilizer components made
from 7075 aluminum, as determined during the inspection required by
paragraph (h) of this AD: Within 180 days after the effective date
of this AD, and before further flight after any replacement of the
horizontal stabilizer, do a special detailed inspection for cracking
of the upper chord on the inboard end of the rear spar in the left
and right side horizontal stabilizers, from stabilizer station -
13.179 to 92.55, in accordance with Part 3 of the Accomplishment
Instructions of Boeing 707 Alert Service Bulletin A3515, dated
December 19, 2007. Repeat the inspections thereafter at intervals
not to exceed 500 flight cycles, and before further flight after any
replacement of the horizontal stabilizer, except as provided by
paragraph (j) of this AD. If any cracking is found, before further
flight, either repair the cracking in accordance with Part 3 of the
Accomplishment Instructions of Boeing 707 Alert Service Bulletin
A3515, dated December 19, 2007, except as required by paragraph (n)
of this AD; or replace the chord with a new chord, in accordance
with Part 6 of Boeing 707 Alert Service Bulletin A3515, dated
December 19, 2007.

    Note 1: For the purposes of this AD, a special detailed
inspection is ``an intensive examination of a specific item,
installation, or assembly to detect damage, failure, or
irregularity. The examination is likely to make extensive use of
specialized inspection techniques and/or equipment. Intricate
cleaning and substantial access or disassembly procedure may be
required.

    (j) For airplanes on which the chord is replaced with a new
chord in accordance with Part 6 of the Accomplishment Instructions
of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007:
Within 4,000 flight cycles after the chord replacement, do the
inspections required by paragraph (i) of this AD, and repeat the
inspections thereafter at the times specified in paragraph (i) of
this AD.

Repetitive Inspections of 7079 Aluminum Components

    (k) For airplanes with horizontal stabilizers that have
components of the chords of the rear spar made from 7079 aluminum,
as determined during the inspection required by paragraph (h) of
this AD: Within 180 days after the effective date of this AD, do the
actions required by paragraphs (k)(1), (k)(2), and (k)(3) of this
AD, and repeat those actions at the applicable intervals specified
in paragraphs (k)(1), (k)(2), and (k)(3) of this AD.
    (1) Do a special detailed inspection for cracking of the upper
chord of the inboard side of the rear spar in the left and right
side horizontal stabilizers from stabilizer station -13.179 to
92.55, in accordance with Part 3 of the Accomplishment Instructions
of Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007.
Repeat the inspection thereafter at intervals not to exceed 250
flight cycles or 180 days, whichever occurs first. If any cracking
is found during any inspection required by this paragraph, before
further flight, either repair the cracking, in accordance with Part
3 of the Accomplishment Instructions of Boeing 707 Alert Service
Bulletin A3515, dated December 19, 2007, except as required by
paragraph (n) of this AD; or replace the chord with a new chord, in
accordance with Part

6 of Boeing 707 Alert Service Bulletin A3515, dated December 19,
2007.
    (2) Do a high frequency eddy current inspection for cracking of
the web flanges of the upper and lower chords of the rear spar in
the left and right side horizontal stabilizers from stabilizer
stations 92.55 to 272.55, in accordance with Part 4 of the
Accomplishment Instructions of Boeing 707 Alert Service Bulletin
A3515, dated December 19, 2007. Repeat the inspection thereafter at
intervals not to exceed 1,000 flight cycles or 180 days, whichever
occurs first. If any cracking is found during any inspection
required by this paragraph, before further flight, do the actions
specified in paragraph (k)(2)(i) or (k)(2)(ii) of this AD.
    (i) Determine whether the cracking meets the limits specified in
Part 4 of the Accomplishment Instructions of Boeing 707 Alert
Service Bulletin A3515, dated December 19, 2007, and whether a
previous repair has been done; determine if all 7079 upper and lower
chord segments installed on the horizontal stabilizer have had the
Part II, Group 1, Preventative Modification specified in Boeing 707
Service Bulletin 3356 done; and do all applicable repairs and
modifications, in accordance with Boeing 707 Alert Service Bulletin
A3515, dated December 19, 2007. Do the actions required by this
paragraph in accordance with Part 4 of the Accomplishment
Instructions of Boeing 707 Alert Service Bulletin A3515, dated
December 19, 2007, except as required by paragraph (n) of this AD.
Do all applicable repairs and modifications before further flight.
    (ii) Replace the chord with a new chord, in accordance with Part
6 of Boeing 707 Alert Service Bulletin A3515, dated December 19,
2007.
    (3) Do low frequency eddy current (LFEC) inspections for
cracking of the forward skin flanges of the upper and lower chords
of the rear spar in the left and right side horizontal stabilizers
from stabilizer stations -13.179 to 272.55 (for lower chords) and
92.55 to 272.55 (for upper chords), in accordance with Part 5 of the
Accomplishment Instructions of Boeing 707 Alert Service Bulletin
A3515, dated December 19, 2007. Repeat the inspections thereafter at
intervals not to exceed 1,000 flight cycles or 180 days, whichever
occurs first. If any cracking is found during any inspection
required by this paragraph, before further flight, do the actions
specified in either paragraph (k)(3)(i) or paragraph (k)(3)(ii) of
this AD.
    (i) Repair cracking, and determine whether all 7079 upper and
lower chord segments installed on the horizontal stabilizer have had
the Part II--Preventative Modification specified in Boeing 707
Service Bulletin 3381 done, and do all applicable modifications, in
accordance with Boeing 707 Alert Service Bulletin A3515, dated
December 19, 2007. Do the actions required by this paragraph in
accordance with Part 5 of the Accomplishment Instructions of Boeing
707 Alert Service Bulletin A3515, dated December 19, 2007, except as
required by paragraph (n) of this AD. Do all applicable
modifications before further flight.
    (ii) Replace the chord with a new chord, in accordance with Part
6 of Boeing 707 Alert Service Bulletin A3515, dated December 19,
2007.

Modification/Chord Replacement

    (l) For airplanes identified in Boeing 707 Alert Service
Bulletin A3515, dated December 19, 2007, with horizontal stabilizers
that have rear spar chord components made from 7079 aluminum and
have not had embodied the modification of Part II of Boeing 707
Service Bulletin 3381, dated July 25, 1980; or Revision 1, dated
July 31, 1981: Before further flight after determining the type of
material in accordance with paragraph (h) of this AD, modify all
7079 chord segments still installed on the horizontal stabilizer, in
accordance with Part 5 of the Accomplishment Instructions of Boeing
707 Alert Service Bulletin A3515, dated December 19, 2007; or
replace the chord, in accordance with Part 6 of the Accomplishment
Instructions of Boeing 707 Alert Service Bulletin A3515, dated
December 19, 2007.

Supplemental Structural Inspection Document Inspections

    (m) For all airplanes: Within 180 days or 1,000 flight cycles
after the effective date of this AD, whichever occurs first, do the
inspections of the applicable structurally significant items
specified in and in accordance with the Accomplishment Instructions
of Boeing 707 Alert Service Bulletin A3516, dated April 4, 2008. If
any cracking is found, before further flight, repair in accordance
with the procedures specified in paragraph (q) of this AD. The
inspections required by AD 85-12-01 R1, Amendment 39-5439 (51 FR
36002, October 8, 1986), are still required, except, as of the
effective date of this AD, the flight-cycle interval for the
repetitive inspections specified in paragraph 1.E., ``Compliance,''
of Boeing 707 Alert Service Bulletin A3516, dated April 4, 2008,
must be counted in accordance with the requirements of paragraph (g)
of this AD.

Exceptions to the Service Information

    (n) If any cracking is found during any inspection required by
this AD, and Boeing 707 Alert Service Bulletin A3515, dated December
19, 2007, specifies to contact Boeing for appropriate action: Before
further flight, repair the cracking using a method approved in
accordance with the procedures specified in paragraph (q) of this
AD.
    (o) Where Boeing 707 Alert Service Bulletin A3515, dated
December 19, 2007, specifies that operators ``refer to'' NDT
procedures, the procedures must be done in accordance with the
service information identified in paragraphs (o)(1), (o)(2), and
(o)(3) of this AD, as applicable.
    (1) Subject 51-00-00, ``Structures-General,'' Figure 20,
``Electrical Conductivity Measurement for Aluminum,'' of Part 6-Eddy
Current, of the Boeing 707/720 Nondestructive Test Manual, Document
D6-48023, Revision 118, dated July 15, 2011.
    (2) Subject 55-10-07, ``Horizontal Stabilizer,'' of Part 6-Eddy
Current, of the Boeing 707/720 Nondestructive Test Manual, Document
D6-48023, Revision 118, dated July 15, 2011.
    (3) Subject 51-01-00, ``Orientation and Preparation for
Testing'' of Part 1-General, of the Boeing 707/720 Nondestructive
Test Manual, Document D6-48023, Revision 118, dated July 15, 2011.

Parts Installation

    (p) As of the effective date of this AD, no person may install
any horizontal stabilizer assembly with any chord segment having a
part number other than that identified in paragraph 2.C.2. of Boeing
707 Alert Service Bulletin A3515, dated December 19, 2007, on any
airplane.

Alternative Methods of Compliance (AMOCs)

    (q)(1) The Manager, Seattle Aircraft Certification Office, 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 manager of the ACO, send it to the attention of the
person identified in the Related Information section of this AD
Information may be emailed to<EMAIL_ADDRESS>    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.

Related Information

    (r) For more information about this AD, contact Berhane Alazar,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (s) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P. O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
(206) 544-5000, extension 1; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.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>.

    Issued in Renton, Washington, on November 10, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-30582 Filed 11-25-11; 8:45 am]
BILLING CODE 4910-13-P