[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46502-46503]
[FR Doc No: 2017-21435]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-E-0944, FDA-2014-E-0950, FDA-2014-E-0943, FDA-
2014-E-0945]

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

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 TECFIDERA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications 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
December 4, 2017. 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 April 3,
2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 4, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 4, 2017. 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.

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 Nos.
FDA-2014-E-0944, FDA-2014-E-0950, FDA-2014-E-0943, and FDA-2014-E-0945
for ``Determination of Regulatory Review Period for Purposes of Patent
Extension; TECFIDERA.'' 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 Office
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 Office. 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 TECFIDERA
(dimethyl fumarate). TECFIDERA is indicated for treatment of patients
with relapsing forms of multiple sclerosis. Subsequent to this
approval, the USPTO received patent term restoration applications for
TECFIDERA (U.S. Patent Nos. 6,509,376; 7,320,999; 7,619,001; and
7,803,840) from Biogen Idec International GmbH, and the USPTO requested
FDA's assistance in determining the patents' eligibility for patent
term restoration. In a letter dated November 4, 2015, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of TECFIDERA 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
TECFIDERA is 2,480 days. Of this time, 2,085 days occurred during the
testing phase and 395 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 14, 2006. FDA has verified the applicant's claim that
the date the investigational new drug application (IND) became
effective was on June 14, 2006.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: February
27, 2012. FDA has verified the applicant's claim that the new drug
application (NDA) for TECFIDERA (NDA 204063) was initially submitted on
February 27, 2012.
    3. The date the application was approved: March 27, 2013. FDA has
verified the applicant's claims that NDA 204063 was approved on March
27, 2013.
    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 applications for patent extension,
this applicant seeks 1,438 days, 1,144 days, 811 days, or 654 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: September 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21435 Filed 10-4-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 108 (Tuesday, June 5, 2012)]
[Notices]
[Pages 33228-33229]
[FR Doc No: 2012-13517]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2012-0424]

Great Lakes Pilotage Advisory Committee; Vacancies

AGENCY: Coast Guard, DHS.

ACTION: Request for applicants.

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SUMMARY: The Coast Guard seeks applications for membership on the Great
Lakes Pilotage Advisory Committee (GLPAC). The GLPAC provides advice
and makes recommendations to the Secretary of Homeland Security and the
Coast Guard on matters relating to Great Lakes pilotage, including
review of proposed Great Lakes pilotage regulations and policies.

DATES: Applicants should submit a cover letter and resume in time to
reach David Dean, the Alternate Designated Federal Officer (ADFO) on or
before July 1, 2012.

ADDRESSES: If you wish to apply for membership, your resume should be
submitted by one of the following methods:
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> Attn: Mr. David Dean, GLPAC ADFO.
     Mail: Mr. David Dean, GLPAC ADFO, Commandant (CG-WWM-2),
U.S. Coast Guard Headquarters, 2100 Second Street SW., Stop 7580,
Washington, DC 20593-7580.

FOR FURTHER INFORMATION CONTACT: Mr. David Dean, GLPAC ADFO, Commandant
(CG-WWM-2), U.S. Coast Guard Headquarters, 2100 Second Street SW., Stop
7580, Washington, DC 20593-7580; telephone<PHONE_NUMBER>, fax 202-372-
1909, or email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The GLPAC is an advisory committee
established in accordance with the provisions of the Federal Advisory
Committee Act (FACA) 5 U.S.C. (Pub. L. 92-463) and under the authority
of 46 U.S.C. 9307, as amended. GLPAC expects to meet twice per year but
may also meet at other times at the call of the Secretary. Further
information about GLPAC is available by searching on ``Great Lakes
Pilotage Advisory Committee'' at http://www.faca.gov.
    The Committee consists of seven members appointed by and serving at
the pleasure of the Secretary of Homeland Security upon recommendation
by the Coast Guard Commandant. To be eligible, applicants should have
particular expertise, knowledge, and experience regarding the
regulations and policies on the pilotage of vessels on the Great Lakes,
and at least 5 years of practical experience in maritime operations,
except as noted for the Special Government Employee position.
    We will consider applicants for two positions that expire or become
vacant on September 30, 2012.
     One member representing the interests of vessel operators
that contract for Great Lakes pilotage services. This appointment will
be as a representative member.
     One member with a background in finance or accounting, who
must be recommended to the Secretary by a unanimous vote of the other
members of the Committee and may be appointed without regard to the
requirement that each member have five years of practical experience in
maritime operations. This appointment will be as a Special Government
Employee as defined in section 202(a) of Title 18 United States Code.
As candidates for appointment as SGEs, applicants are required to
complete Confidential Financial Disclosure Reports (OGE Form 450).
Coast Guard may not release the reports or the information in them to
the public except under an order issued by a Federal court or as
otherwise provided under the Privacy Act (5 U.S.C. 552a). Applicants
can obtain this form by going to the Web site of the Office of
Government Ethics (www.oge.gov), or by contacting the individual listed
above. Applications which are not accompanied by a completed OGE Form
450 will not be considered.
    Members shall serve terms of office of up to three years and may be
reappointed. All members serve at their own expense but may receive
reimbursement for travel and per diem from the Federal Government.
    Registered lobbyists are not eligible to serve on federal advisory
committees. Registered lobbyists are lobbyists required to comply with
provisions contained in the Lobbying Disclosure

Act of 1995 (Pub. L. 110-81, as amended).
    The Department of Homeland Security (DHS) does not discriminate in
employment on the basis of race, color, religion, sex, national origin,
political affiliation, sexual orientation, gender identity, marital
status, disability and genetic information, age, membership in an
employee organization, or other non-merit factor. DHS strives to
achieve a widely diverse candidate pool for all of its recruitment
actions.
    To visit our online docket, go to http://www.regulations.gov enter
the docket number for this notice (USCG-2012-0424) in the Search box,
and click ``Go''. Please do not post your resume on this site. During
the vetting process, applicants may be asked to provide date of birth
and social security number.

    Dated: May 23, 2012.
D.A. Goward,
Director Marine Transportation Systems, U.S. Coast Guard.
[FR Doc. 2012-13517 Filed 6-4-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Proposed Rules]
[Pages 3725-3726]
[FR Doc No: 2012-1520]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2010-1075; FRL-9335-4]
RIN 2070-AB27

Proposed Significant New Use Rules on Certain Chemical
Substances; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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SUMMARY: EPA issued a proposed rule in the Federal Register of December
28, 2011, concerning proposed significant new use rules (SNURs) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
chemical substances rutile, tin zinc, calcium-doped (CAS No. 389623-01-
2) and rutile, tin zinc, sodium-doped (CAS No. 389623-07-8) which were
the subject of premanufacture notices (PMNs P-06-36 and P-06-37) and
TSCA section 5(e) consent orders issued by EPA. In order to address
public comments, EPA is extending the comment period. This document
extends the comment period for 30 days, from January 27, 2012 to
February 26, 2012.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPPT-2010-1075, must be received on or before February 26, 2012.

ADDRESSES: Follow the detailed instructions as provided under ADDRESSES
in the Federal Register document of December 28, 2011.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document extends the public comment
period established in the Federal Register of December 28, 2011 (76 FR
81441) (FRL-9329-4). In that document, EPA proposed SNURs under section
5(a)(2) of TSCA for the chemical substances rutile, tin zinc, calcium-
doped (CAS No. 389623-01-2) and rutile, tin zinc, sodium-doped (CAS No.
389623-07-8) which were the subject of premanufacture notices (PMNs P-
06-36 and P-06-37) and TSCA section 5(e) consent orders issued by EPA.
EPA received a comment in response to the proposed SNURs noting that
additional information detailing the Agency's evaluation and
determination under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I)
for the chemical substances was added to the docket. The commenter
requests that additional time be allotted to allow review of this
information. EPA is hereby extending the comment period, which was set
to end on January 27, 2012, to February 26, 2012 to allow for any
public comments in response to the additional information.
    To submit comments, or access the docket, please follow the
detailed instructions as provided under ADDRESSES in the December 28,
2011 Federal Register document. If you have questions, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: January 18, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2012-1520 Filed 1-24-12; 8:45 a.m.]
BILLING CODE 6560-50-P