[Federal Register Volume 77, Number 26 (Wednesday, February 8, 2012)]
[Notices]
[Pages 6567-6568]
[FR Doc No: 2012-2757]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0067]

Assessment of Analgesic Treatment of Chronic Pain--A Public
Workshop; Request for Comments

AGENCY: Food and Drug Administration.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA), Center for Drug Evaluation
and Research (CDER), is announcing a public workshop to hear a
discussion of the available data on the efficacy of analgesics in the
treatment of chronic non-cancer pain (CNCP). The focus of the
presentations and discussions by scientific experts and other
stakeholder

groups will be on the available clinical data from both randomized
clinical trials and other studies of the efficacy of opioid analgesics,
and comparison of that data to the data from studies of non-opioid
analgesics used in the treatment of CNCP.
    Date and Time: The public workshop will be held on May 30, 2012,
from 1 p.m. to 5:15 p.m. and on May 31, 2012, from 8:30 a.m. to 5 p.m.
    Location: The workshop will be held at the Natcher Auditorium,
Natcher Conference Center, National Institutes of Health Campus, 45
Center Dr., Bethesda, MD 20892.
    Contacts: Mary C. Gross, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm.
6178, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Matthew
Sullivan, Center for Drug Evaluation, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 3160, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.
    Registration: If you wish to attend the workshop or provide oral
comments during the open session of the meeting, please email your
registration to CDER--ChronicPain--Workshop @FDA.HHS.GOV by May 15,
2012. Those without email access may register by contacting one of the
persons listed in the Contacts section of the document. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email address, and telephone number. Registration
is free and will be on a first-come, first-served basis. Registrants
will receive confirmation once they have been accepted for the
workshop. Onsite registration on the day of the meeting will be based
on space availability. If registration reaches maximum capacity, FDA
will post a notice closing the meeting registration for the workshop
at: http://www.fda.gov/Drugs/NewsEvents/ucm283979.htm.
    An open session of the meeting will be held between 3:45 p.m. and 5
p.m. on May 30, 2012, during which time public comments will be
accepted. We will try to accommodate all persons who wish to speak at
this open session; however, the duration of each speaker's testimony
may be limited by time constraints.
    Comments: Submit either electronic or written comments by August 1,
2012. Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
    If you need special accommodations due to a disability, contact
Mary Gross or Matthew Sullivan (see Contacts) at least 7 days in
advance.

SUPPLEMENTARY INFORMATION:

I. Introduction

    CNCP is a major cause of pain and disability for millions of
Americans. The prescribing of opioids for pain has risen steadily in
the United States over the past two decades, including the prescribing
of opioids to treat CNCP. Questions have been raised about the efficacy
of opioids in the treatment of CNCP, including which patients benefit
from the chronic use of opioids, the durability of analgesia provided
by opioid analgesics, and how best to manage the use of these drugs.
Addressing this uncertainty begins with a discussion of the available
scientific data on the use of opioids in chronic painful conditions.
The discussion will include health care professionals, clinical
investigators, regulators, manufacturers, patients, caregivers, and
advocacy groups. Where gaps in our knowledge are identified, it will be
important to discuss the research that needs to be undertaken to better
understand the effectiveness of all analgesics for the treatment of
chronic non-cancer pain, and opioid analgesics in particular.
    The purpose of the meeting is to provide a forum to discuss the
available data on the use of analgesics in the treatment of CNCP,
beginning with a discussion of the underlying mechanisms of chronic
pain and the epidemiology of chronic pain in the United States. Next,
data on the efficacy of opioids and other analgesics in the treatment
of chronic pain from a variety of sources will be reviewed. Those
sources will include randomized controlled trials, epidemiological
studies, case series and other types of studies. Patient and clinician
perspectives on the pharmaceutical treatment of CNCP will be presented
by people living with chronic pain and those who treat or care for
patients with chronic pain. Finally, a general assessment of the
available data and discussion of future research needs and next steps
will be used to inform future actions that can help guide appropriate
therapy for patients with CNCP.
    FDA will be considering the following questions during the
workshop:
    1. What is currently known about the mechanisms of chronic pain?
    2. How might this knowledge affect the use of pharmaceuticals
chronically for the treatment of pain?
    3. What is known regarding use of pain biomarkers (e.g.,
phenotyping, imaging, genotyping)?
    4. What is known about the sources of chronic pain, the populations
affected by it, and trends in current use of pharmaceuticals in its
treatment?
    5. What data are available from controlled trials that have
examined the use of pharmaceuticals in the treatment of chronic pain?
    6. What data are available from other sources on the use of
pharmaceuticals in the treatment of chronic pain?
    7. Can populations and individuals who would benefit from chronic
use of pharmaceuticals be identified?
    8. Can individuals at high risk for adverse effects be identified?
    9. What more should be known about the use of pharmaceuticals to
treat chronic pain?
    FDA will post the agenda and additional workshop background
material approximately 5 days before the workshop at http://www.fda.gov/Drugs/NewsEvents/ucm283979.htm.

II. Transcripts

    Please be advised that approximately 30 days after the public
workshop, a transcript will be available. It will be accessible at
http://www.regulations.gov and may be viewed at the Division of Dockets
Management (see Comments). A transcript will also be available in
either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. Written requests are to be sent to Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: February 2, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2757 Filed 2-7-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65889-65891]
[FR Doc No: 2019-25923]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2019-0631]

Agency Information Collection Activities: Requests for Comments;
Clearance of New Approval of Information Collection: Service
Availability Prediction Tool (SAPT)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for a new information collection.
The Federal Register Notice with a 60-day comment period soliciting
comments on the following collection of information was published on
August 22, 2019. The collection involves aircraft operators using pre-
flight availability predictions for navigation and surveillance and
submitting a request for an authorization from air traffic control
(ATC) via a web-based tool and application process. The collected
information is necessary to:
    (1) Predict whether an aircraft flying the proposed route of flight
will have sufficient position accuracy and integrity for:

(a) Navigation, via the Receiver Autonomous Integrity Monitoring (RAIM)
SAPT
(b) Surveillance, via the Automatic Dependent Surveillance--Broadcast
(ADS-B) SAPT

    (2) Allow operators to request authorization, via ADS-B Deviation
Authorization Preflight Tool (ADAPT), from ATC to operate aircraft that
do not fully meet ADS-B Out equipage or performance requirements, in
airspace that requires ADS-B Out.

DATES: Written comments should be submitted by December 30, 2019.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA and sent via email to<EMAIL_ADDRESS>
or faxed to<PHONE_NUMBER>, or mailed to the Office of Information and
Regulatory Affairs, Office of Management and Budget, Docket Library,
Room 10102, 725 17th Street NW, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: For further questions concerning this
action, contact Mr. David Gray, Deputy Director (Acting), Surveillance
Directorate, AJM-4, Air Traffic Organization, Federal Aviation
Administration, by email at<EMAIL_ADDRESS>or +1-202-267-0513.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility, and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-XXXX.
    Title: Service Availability Prediction Tool (SAPT).
    Form Numbers: Information is collected via a website specific to
SAPT at https://sapt.faa.gov.
    Type of Review: New information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on August 22, 2019. 84 FR 43861. Service Availability
Prediction Tool (SAPT) was developed by the United States (U.S.)
Department of Transportation (DOT), John A. Volpe National
Transportation Systems Center (Volpe Center) for the Surveillance and
Broadcast Services (SBS) organization within the FAA.
    The SAPT is intended for pilots, dispatchers, and commercial
operators to check their predicted navigation and surveillance
availability before a flight. The SAPT has three main components:
Receiver Autonomous Integrity Monitoring (RAIM) SAPT, Automatic
Dependent Surveillance-Broadcast (ADS-B) SAPT, and ADS-B Deviation
Authorization Pre-Flight Tool (ADAPT).
    RAIM SAPT use is voluntary and intended for pilots, dispatchers,
and commercial service providers using Technical Standard Order (TSO)-
C129 equipment to check the availability of Global Positioning System
(GPS) RAIM for a proposed route of flight, satisfying the area
navigation (RNAV) guidance as outlined in AC 90-100A Change 2,
Paragraph 10(5). RAIM SAPT users can view RAIM outage predictions on
RAIM Summary Displays to graphically view RAIM outage predictions for
specific equipment configurations. RAIM SAPT predictions are only
available through an XML-based web service. RAIM SAPT users can use the
XML-based web service, most commonly used by flight planning software,
to enter specific route of flight information by the operator checking
RAIM outage predictions. RAIM SAPT does not collect personally
identifiable information details about the operator(s).
    The ADS-B SAPT is provided to help operators comply with 14 CFR
91.225 and 91.227 by predicting whether operators will meet regulatory
requirements and to advise holders of FAA Exemption No. 12555 whether
back-up surveillance will be available where installed aircraft
avionics are not predicted to meet the requirements of 14 CFR
91.227(c)(1)(i) and (iii). For operators of aircraft equipped with TSO-
C129 (Selective Availability (SA)-On) GPS receivers, the operator may
run a preflight prediction using ADS-B SAPT as one option to help meet
their requirements. Information collected via ADS-B SAPT is comparable
to that already provided in flight plans, with the addition of some
information about the aircraft position source's TSO and related
capabilities. Operators using the ADS-B SAPT must enter aircraft
identification. The ADS-B SAPT does not collect other personally
identifiable information details about the operator. When an operator
performs a preflight availability prediction using the FAA's SAPT, the
SAPT retains a record of each transaction enabling the FAA to confirm
that an operator took preflight action. The FAA recommends that
operators using an alternate tool retain documentation that verifies
the completion of the satisfactory preflight availability prediction
for each intended route of flight. 84 FR 31713 (July 3, 2019).
    ADAPT is provided to make limited accommodations for those
operators desiring to fly without meeting the ADS-B equipage or
performance requirements, in certain circumstances. ADAPT allows
operators to create an air traffic authorization request to operate, as
allowed in 14 CFR 91.225(g). As a requirement for using ADAPT,
operators must first complete the ADS-B SAPT

``Flight Information Entry'' form to determine if there is sufficient
backup surveillance coverage throughout their planned flight. Operators
must enter their personal contact information to enable the FAA to
reply with either an approval, rejection, or pending decision. ADAPT
does collect personal identifying information to include name,
telephone number, and email. RAIM SAPT website offers a Grid Display
Tool and Summary Displays which can be used to graphically view RAIM
outage predictions for specific equipment configurations. It also
supports an XML-based web service for automated checking of RAIM
compliance (relative to the AC 90-100A rule) by flight planning
software. The following information is required:

(1) Aircraft Identification (as filed on the Flight Plan; optional)
(2) Route of Flight, including:
    (a) Waypoint Name (optional)
    (b) Lat/Long
    (c) Estimated time over (ETO)
    (d) Requested Horizontal Alert Limit (HAL) (optional; default =
555.6(NPA))
(3) Request Identifier (user-defined ID string; optional)
(4) Mask Angle (optional; default 5.0)
(5) Baro Aiding (true/false; optional; default = false)

    ADS-B SAPT predictions may be made using XML or using the SAPT
``Flight Information Entry'' form, which has been modeled after a
standard FAA Flight Plan form for ease of use. All the active fields of
the ``Flight Information Entry'' form require an operator to enter
relevant data. Operators may save and load active field information as
well as cut and paste from an International Civil Aviation Organization
(ICAO) Flight Plan. The following information is required:

(1) Aircraft Identification (or ``Call Sign'')
(2) Aircraft Type
(3) ADS-B Position Source TSO (or unequipped)
(4) ADS-B link TSO (or unequipped)
(5) Proposed Departure Time (UTC)
(6) Planned Altitude
(7) Departure Airport
(8) Destination Airport
(9) Route of Flight

    If the operator desires to fly an aircraft that is not equipped
with ADS-B or that is predicted to not meet the required position
performance, the operator may request an authorization from ATC to
deviate from the equipage or performance requirements of 14 CFR 91.225
or 91.227, under certain circumstances. To relieve the potential burden
on ATC facilities, the FAA developed the ADAPT to manage aircraft
operator requests for an ATC authorization. In addition to the
information required for ADS-B SAPT, the following information is
required for ADAPT:

(1) Pilot in Command (PIC)
(2) PIC Telephone Number
(3) PIC Email Address
(4) U.S. Civil Aircraft Registry Number or ICAO Address (hex, octal or
decimal)
(5) ADS-B Equipment Status (unequipped, inoperative, insufficient)
(6) Working Transponder with Altitude Reporting? Yes/No
(7) Affected en route ATC facilities
(8) Flight Classification: Part 91, 121, 129, or 135
(9) Reason for Request
(10) Certification of Truthfulness

    The SAPT or ADAPT ``Flight Information Entry'' form (the form is
the same and either can be selected) is used by the aircraft operator
to enter the specific flight details. SAPT will analyze the flight, and
if the aircraft is not predicted to the position accuracy requirements
of 14 CFR 91.227, the operator may submit a request to the FAA for an
ATC authorization using ADAPT. A non-equipped aircraft will
automatically fail the ADS-B performance requirements but the operator
is still required to first use ADS-B SAPT, because the SAPT analysis
provides alternate surveillance information that is necessary for
evaluating an ATC authorization request.
    Although forms used on the SAPT/ADAPT web pages are similar to
forms used for VFR/IFR flight plan filing, SAPT/ADAPT web forms are for
gathering operator information needed for prediction and application
process purposes only. Operator information submitted via SAPT/ADAPT
will not generate, nor should they be considered, formal IFR/VFR flight
plan submissions.
    For more information on the SAPT, see SAPT User Guide at: https://www.sapt.faa.gov/default.php.
    The FAA published a Federal Register Notice on SAPT on August 22,
2019. 84 FR 43861. The FAA received one response within the comment
period. The commenter expressed concern with regard to the requirement
to conduct subsequent predictions using SAPT when there are changes in
satellite constellation. The commenter is concerned that an ongoing
duty to execute an updated SAPT would be economically burdensome and
disruptive to operations. The commenter recommended that a change to
the satellite constellation not trigger an updated SAPT prediction
after a flight plan has been filed with ATC.
    After an operator receives a satisfactory preflight availability
prediction for an intended operation, there may be certain conditions
that warrant a subsequent prediction. There is no requirement to
continuously monitor Notices to Airmen (NOTAMs); rather, the
requirement to execute an updated SAPT is triggered only if the
operator becomes aware of the condition. A change in the GPS satellite
constellation, as indicated by a NOTAM, may have an effect on the
predicted GPS performance for the intended operation. If an operator
becomes aware of a change that could result in degraded GPS performance
for the intended route prior to receiving an initial ATC clearance, the
operator should conduct a subsequent preflight availability prediction
consistent with 14 CFR 91.103. The duty to conduct a subsequent
preflight availability prediction for an intended route of flight
ceases once an operator receives an ATC route clearance for the
intended operation.
    The FAA is seeking comments from the public regarding the
information that is collected for SAPT and its three main components:
RAIM SAPT, ADS-B SAPT, and ADAPT. The information provided in this
notice is solely to identify and collect information from the public on
the potential burden to an individual that may result from this
program.
    Respondents: These prediction tools are primarily intended for
pilots and dispatchers; anyone who is planning a flight which passes
through U.S. sovereign airspace using an aircraft whose GPS receiver(s)
is/are not guaranteed to meet certain performance requirements or whose
aircraft is not equipped to meet requirements of 14 CFR 91.225.
    Frequency: On occasion as part of flight planning and as required
by FAA policy.
    RAIM SAPT--3 minutes or less.
    ADS-B SAPT--3 minutes or less.

(It is anticipated that RAIM SAPT and ADS-B SAPT requests will be
automated into the eXtensible Markup Language (XML) that operators may
use to plan flights, eliminating manual data-entry)

    ADAPT--7 minutes or less (includes up to 2 minutes for FAA email
response).
    Estimated Total Annual Burden: Total estimate of burden hours:
    RAIM SAPT--estimating 224,475 annual responses (Part 121/129

Operators) is approximately 11,224 hours.
    ADS-B SAPT--estimating 271,099 annual responses (Part 121/129 and
General Aviation (GA) Operators) is approximately 13,555 hours.
    ADAPT--estimating 203,822.5 annual responses (General Aviation (GA)
Operators) is approximately 23,847 hours.

    Issued in Washington, DC.
David E. Gray,
Acting Deputy Director, Surveillance Services (AJM-4), Program
Management Organization, Air Traffic Organization, Federal Aviation
Administration.
[FR Doc. 2019-25923 Filed 11-27-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Page 62163]
[FR Doc No: 2021-24478]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP22-179-000.
    Applicants: Rover Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Summary of Negotiated Rate
Capacity Release Agreements on 11-2-21 to be effective 11/1/2021.
    Filed Date: 11/2/21.
    Accession Number: 20211102-5140.
    Comment Date: 5 p.m. ET 11/15/21.

    Docket Numbers: RP22-180-000.
    Applicants: Portland Natural Gas Transmission System.
    Description: Sec.  4(d) Rate Filing: NS Power to NS Mktg--Neg Rate
Amendment to be effective 11/1/2021.
    Filed Date: 11/2/21.
    Accession Number: 20211102-5159.
    Comment Date: 5 p.m. ET 11/15/21.

    Docket Numbers: RP22-181-000.
    Applicants: Northern Border Pipeline Company.
    Description: Compliance filing: Request for Waiver--Reservation of
Capacity to be effective N/A.
    Filed Date: 11/2/21.
    Accession Number: 20211102-5169.
    Comment Date: 5 p.m. ET 11/15/21.

    Docket Numbers: RP22-182-000.
    Applicants: Discovery Gas Transmission LLC.
    Description: Compliance filing: NAESB Version 3.2 Compliance Filing
(Order 587-Z) to be effective 6/1/2022.
    Filed Date: 11/3/21.
    Accession Number: 20211103-5030.
    Comment Date: 5 p.m. ET 11/15/21.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 3, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-24478 Filed 11-8-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18566-18567]
[FR Doc No: 2014-07333]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-E-0487; FDA-2012-E-0488; and FDA-2012-E-0489]

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

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 EYLEA 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 biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6284, 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 has approved for marketing the human biological product EYLEA
(aflibercept). EYLEA is indicated for the treatment of patients with
neovascular (Wet) Age-Related Macular Degeneration (AMD). Subsequent to
this approval, the U.S. Patent and Trademark Office received patent
term restoration applications for EYLEA (U.S. Patent Nos.: 7,070,959;
7,374,757; and 7,374,758) from Regeneron Pharmaceuticals, Inc., and the
Patent and Trademark Office requested FDA's assistance in determining
these patents' eligibility for patent term restoration. In a letter
dated August 7, 2012, FDA advised the Patent and Trademark Office that
this human drug product had undergone a regulatory review period and
that the approval of EYLEA 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
EYLEA is 2,349 days. Of this time, 2,075 days occurred during the
testing phase of the regulatory review period, while 274 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: June 15, 2005. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on June 15, 2005.
    2. The date the application was initially submitted with respect to
the human drug product under section 352 of the Public Health Service
Act (42 U.S.C. 262): February 18, 2011. The applicant claims February
17, 2011, as the date the biologics license application (BLA) for EYLEA
(BLA 125387/0) was initially submitted. However, FDA records indicate
that BLA 125387/0 was submitted on February 18, 2011.
    3. The date the application was approved: November 18, 2011. FDA
has verified the applicant's claim that BLA 125387/0 was approved on
November 18, 2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks either 775 or
1,118 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 June 2, 2014. 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 September 29, 2014. 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 electronic or
written petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07333 Filed 4-1-14; 8:45 am]
BILLING CODE 4160-01-P