[Federal Register Volume 75, Number 236 (Thursday, December 9, 2010)]
[Notices]
[Pages 76740-76741]
[FR Doc No: 2010-30991]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-E-0044]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for BEPREVE 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 Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: 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 Patents and
Trademarks 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 recently approved for marketing the human drug product BEPREVE
(bepotastine besilate). BEPREVE is indicated for the treatment of
itching associated with allergic conjunctivitis. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for BEPREVE (U.S. Patent No. 6,780,877) from
Ube Industries, Ltd., and the Patent and Trademark Office requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated March 3, 2010, FDA advised the
Patent and Trademark Office that this human drug product had undergone
a regulatory review period and that the approval of BEPREVE represented
the first permitted commercial marketing or use of the product.
Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
BEPREVE is 964 days. Of this time, 663 days occurred during the testing
phase of the regulatory review period, while 301 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: January 20, 2007. The applicant claims January 19, 2007, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was January 20, 2007, 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: November
12, 2008. FDA has verified the applicant's claim that the new drug
application (NDA) 22-288 was submitted on November 12, 2008.
    3. The date the application was approved: September 8, 2009. FDA
has verified the applicant's claim that NDA 22-288 was approved on
September 8, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 631 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by February 7, 2011. 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 June 7, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (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.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies

of the petition. Identify comments with the docket number found in
brackets in the heading of this document. Comments and petitions that
have not been made publicly available on regulations.gov may be viewed
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-30991 Filed 12-8-10; 8:45 am]
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[Federal Register Volume 77, Number 59 (Tuesday, March 27, 2012)]
[Proposed Rules]
[Pages 18141-18143]
[FR Doc No: 2012-7361]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0300; Directorate Identifier 2011-NM-276-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. This
proposed AD was prompted by a design review which revealed the absence
of electrical insulation material between a wing or integral center
wing tank (ICWT) fuel quantity indication system (FQIS) probe and the
bottom of the tank structure. This condition, if not corrected, could,
under certain conditions, result in an ignition source in the tank
vapor space, which could result in a fuel tank explosion and consequent
loss of the airplane. This proposed AD would require, for all
airplanes, applying sealant below the FQIS probes in the wing tanks;
and for certain airplanes, applying sealant below the FQIS probes in
the ICWT. This proposed AD would also require revising the aircraft
maintenance program by revising the fuel airworthiness limitations and
incorporating critical design configuration control limitations
(CDCCLs). We are proposing this AD to prevent an ignition source in the
tank vapor space, which could result in a fuel tank explosion and
consequent loss of the airplane.

DATES: We must receive comments on this proposed AD by May 11, 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, 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; email<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-2012-0300;
Directorate Identifier 2011-NM-276-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 2011-0227, dated December 6, 2011 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    * * * [T]he FAA published Special Federal Aviation Regulation
(SFAR) 88, and the Joint Aviation Authorities (JAA) published
Interim Policy INT/POL/25/12. The design review conducted by Fokker
Services on the Fokker 70 and Fokker 100 in response to these
regulations revealed that the absence of electrical insulation
material between a wing or Integral Center Wing Tank (ICWT) Fuel
Quantity Indication System (FQIS) probe and the bottom of the tank
structure could, under certain conditions, result in an ignition
source in the tank vapour space.
    This condition, if not corrected, could result in a fuel tank
explosion and consequent loss of the aeroplane.
    For the reasons described above, this [EASA] AD requires the
application of sealant below the FQIS probes in the wing tanks and
below the FQIS probes in the ICWT, as applicable to aeroplane
configuration. * * *

The corrective actions also include revising the aircraft maintenance
program by revising the fuel airworthiness limitations and
incorporating CDCCLs. You may obtain further information by examining
the MCAI in the AD docket.
    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (66 FR 23086, May
7, 2001) (``SFAR 88,'' Amendment 21-78, and subsequent Amendments 21-82
and 21-83).
    Among other actions, SFAR 88 (66 FR 23086, May 7, 2001) requires
certain type design (i.e., type certificate (TC) and supplemental type
certificate (STC)) holders to substantiate that their fuel tank systems
can prevent ignition sources in the fuel tanks. This requirement
applies to type design holders for large turbine-powered transport
airplanes and for subsequent modifications to those airplanes. It
requires them to perform design reviews and to develop design changes
and maintenance procedures if their designs

do not meet the new fuel tank safety standards. As explained in the
preamble to the rule, we intended to adopt airworthiness directives to
mandate any changes found necessary to address unsafe conditions
identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    The Joint Aviation Authorities (JAA) has issued a regulation that
is similar to SFAR 88 (66 FR 23086, May 7, 2001). (The JAA is an
associated body of the European Civil Aviation Conference (ECAC)
representing the civil aviation regulatory authorities of a number of
European States who have agreed to co-operate in developing and
implementing common safety regulatory standards and procedures.) Under
this regulation, the JAA stated that all members of the ECAC that hold
type certificates for transport category airplanes are required to
conduct a design review against explosion risks.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Relevant Service Information

    Fokker Services B.V. has issued Fokker Service Bulletin SBF100-28-
067, dated September 2, 2011. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This Proposed AD

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

Costs of Compliance

    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 8 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $0 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these parts.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $2,720, or $680 per product.

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.
    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-2012-0300; Directorate
Identifier 2011-NM-276-AD.

(a) Comments Due Date

    We must receive comments by May 11, 2012.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to Fokker Services B.V. Model F.28 Mark 0070
and 0100 airplanes, certificated in any category, all serial
numbers.
    (2) This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections) and/or Critical
Design Configuration Control Limitations (CDCCLs). Compliance with
these actions and/or CDCCLs is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired
in the areas addressed by this AD, the operator may not be able to
accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (j)(1) of this AD. The request should include a
description of changes to the required actions that will ensure the
continued operational safety of the airplane.

(d) Subject

    Air Transport Association (ATA) of America Code 28: Fuel.

(e) Reason

    This AD was prompted by a design review which revealed the
absence of electrical insulation material between a wing or integral
center wing tank (ICWT) fuel quantity indication system (FQIS) probe
and the bottom of the tank structure. We are issuing this AD to
prevent an ignition source in the tank vapor space, which could
result in a fuel tank explosion and consequent loss of the airplane.

(f) Compliance

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

(g) Apply Sealant

    Do the actions specified in paragraphs (g)(1) and (g)(2) of this
AD, as applicable.
    (1) For all airplanes: At a scheduled opening of the fuel tanks,
but not later than 84 months after the effective date of this AD,
apply sealant below the probes in the wing tanks, in accordance with
Part 1 of the Accomplishment Instructions of Fokker Service Bulletin
SBF100-28-067, dated September 2, 2011.
    (2) For airplanes having serial numbers 11442 through 11585
inclusive, and equipped with an ICWT: At a scheduled opening of the
fuel tanks, but not later than 84 months after the effective date of
this AD, apply sealant below the probes in the ICWT, in accordance
with Part 2 of the Accomplishment Instructions of Fokker Service
Bulletin SBF100-28-067, dated September 2, 2011.

(h) Revise Maintenance Program

    Before further flight after doing any action required by
paragraph (g) of this AD, revise the aircraft maintenance program by
incorporating the fuel airworthiness limitation and the CDCCL
specified in paragraph 1.L.(1)(c) of Fokker Service Bulletin SBF100-
28-067, dated September 2, 2011.

(i) No Alternative Actions, Intervals, and/or CDCCLs

    After accomplishing the revision required by paragraph (h) of
this AD, no alternative actions (e.g., inspections), intervals, or
CDCCLs may be used unless the actions, intervals, or CDCCLs are
approved as an alternative method of compliance (AMOC) in accordance
with the procedures specified in paragraph (j)(1) of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer 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.

(k) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2011-0227, dated December 6, 2011; and
Fokker Service Bulletin SBF100-28-067, dated September 2, 2011; for
related information.

    Issued in Renton, Washington, on March 8, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-7361 Filed 3-26-12; 8:45 am]
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