[Federal Register Volume 77, Number 68 (Monday, April 9, 2012)]
[Notices]
[Pages 21096-21097]
[FR Doc No: 2012-8489]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2011-0778; FRL-9342-7]

Agency Information Collection Activities; Proposed Collection;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR,
entitled: ``TSCA Section 5(a)(2) Significant New Use Rules for Existing
Chemicals'' and identified by EPA ICR No. 1188.11 and OMB Control No.
2070-0038, is scheduled to expire on November 30, 2012. Before
submitting the ICR to OMB for review and approval, EPA is soliciting
comments on specific aspects of the proposed information collection.

DATES: Comments must be received on or before June 8, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0778, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2011-0778. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is<PHONE_NUMBER>. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0778. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Abeer Hashem, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-3128; fax number:<PHONE_NUMBER>; 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:

I. What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits
comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of

information technology, e.g., permitting electronic submission of
responses. In particular, EPA is requesting comments from very small
businesses (those that employ less than 25) on examples of specific
additional efforts that EPA could make to reduce the paperwork burden
for very small businesses affected by this collection.

II. What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What information collection activity or ICR does this action apply
to?

    Affected entities: Entities potentially affected by this ICR are
companies that manufacture, process, import, or distribute in commerce
chemical substances or mixtures.
    Title: TSCA Section 5(a)(2) Significant New Use Rules for Existing
Chemicals.
    ICR Numbers: EPA ICR No. 1188.11.
    OMB Control Number: OMB Control No. 2070-0038.
    ICR Status: This ICR is currently scheduled to expire on November
30, 2012. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: Section 5 of the Toxic Substances Control Act (TSCA)
provides EPA with a regulatory mechanism to monitor and, if necessary,
control significant new uses of chemical substances. Section 5
authorizes EPA to determine by rule (i.e., a significant new use rule
(SNUR)), after considering all relevant factors, that a use of a
chemical substance represents a significant new use. If EPA determines
that a use of a chemical substance is a significant new use, section 5
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture, import, or process the
substance for that use.
    EPA uses the information obtained through this collection to
evaluate the health and environmental effects of the significant new
use. EPA may take regulatory actions under TSCA section 5, 6, or 7 to
control the activities for which it has received a SNUR notice. These
actions include orders to limit or prohibit the manufacture,
importation, processing, distribution in commerce, use, or disposal of
chemical substances. If EPA does not take action, section 5 also
requires EPA to publish a Federal Register document explaining the
reasons for not taking action. This information collection addresses
the reporting and recordkeeping requirements inherent in TSCA section 5
significant new use rules.
    Responses to the collection of information are mandatory (see 40
CFR part 721). Respondents may claim all or part of a notice
confidential. EPA will disclose information that is covered by a claim
of confidentiality only to the extent permitted by, and in accordance
with, the procedures in TSCA section 14 and 40 CFR part 2.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 8.1
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:
    Estimated Total Number of Potential Respondents: 4.
    Frequency of Response: On occasion.
    Estimated Total Average Number of Responses for Each Respondent:
1.7.
    Estimated Total Annual Burden Hours: 736 hours.
    Estimated Total Annual Costs: $63,779. This includes an estimated
burden cost of $63,779 and an estimated cost of $0 for capital
investment or maintenance and operational costs.

IV. Are there changes in the estimates from the last approval?

    There is a decrease of 440 hours (from 1,176 hours to 736 hours) in
the total estimated respondent burden compared with that identified in
the ICR currently approved by OMB. This decrease reflects EPA's updates
to the number of affected sites and responses and correction of
estimates from the previous ICR. Additional details are found in the
Supporting Statement. This change is an adjustment.

 V. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: April 3, 2012.
Louise Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2012-8489 Filed 4-6-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Pages 46300-46301]
[FR Doc No: 2014-18615]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2000-7006; FMCSA-2000-7165; FMCSA-2002-12294; FMCSA-
2004-17195; FMCSA-2006-24783; FMCSA-2010-0082; FMCSA-2010-0114; FMCSA-
2011-0324; FMCSA-2012-0160]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
29 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective September 21, 2014. Comments must be
received on or before September 8, 2014.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2000-
7006; FMCSA-2000-7165; FMCSA-2002-12294; FMCSA-2004-17195; FMCSA-2006-
24783; FMCSA-2010-0082; FMCSA-2010-0114; FMCSA-2011-0324; FMCSA-2012-
0160], using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: 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.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 29 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 29 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

Derric D. Burrell (AL)
Jack D. Clodfelter (NC)
Tommy J. Cross, Jr. (TN)
Daniel K. Davis, III (MA)
Richard L. Derick (NH)
Joseph A. Dunlap (OH)
Shawn B. Gaston (PA)
James F. Gereau (WI)
Esteban G. Gonzalez (TX)
Reginald I. Hall (TX)
James O. Hancock (IN)
Sherman W. Hawk, Jr. (MD)
George R. House (MO)
Robert C. Jeffres (WY)
Alfred C. Jewell, Jr. (WY)
John C. Lewis (SC)
Lewis V. McNeice (TX)
Elijah Mitchell (TX)
Larry D. Moss (CA)
Kevin J. O'Donnell (IL)
Gregory M. Preves (GA)
Daniel Salinas (OR)
Lee R. Sidwell (OH)
Ronald H. Sieg (MO)
David L. Slack (TX)
David M. Smith (IL)
Lee F. Taylor (NJ)
Jeffrey D. Wilson (CO)
Richard A. Yeager (GA)

    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provides a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file and retains a copy of the certification on his/her
person while driving for presentation to a duly authorized Federal,
State, or local enforcement official. Each exemption will be valid for
two years unless rescinded earlier by FMCSA. The exemption will be
rescinded if: (1) The person fails to comply with the terms

and conditions of the exemption; (2) the exemption has resulted in a
lower level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 29 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (65 FR 20245; 65 FR 33406; 65 FR 57320; 65 FR 57234; 67 FR
46016; 67 FR 57266; 67 FR 57267; 69 FR 17263; 69 FR 31447; 69 FR 51346;
69 FR 52741; 71 FR 27034; 71 FR 32185; 71 FR 41311; 71 FR 43557; 71 FR
50970; 71 FR 53489; 73 FR 42403; 73 FR 48270; 73 FR 51336; 75 FR 25918;
75 FR 25919; 75 FR 34210; 75 FR 39729; 75 FR 47888; 75 FR 50799; 75 FR
52062; 77 FR 7657; 77 FR 22059; 77 FR 38381; 77 FR 40945; 77 FR 40946;
77 FR 51846; 77 FR 52389). Each of these 29 applicants has requested
renewal of the exemption and has submitted evidence showing that the
vision in the better eye continues to meet the requirement specified at
49 CFR 391.41(b)(10) and that the vision impairment is stable. In
addition, a review of each record of safety while driving with the
respective vision deficiencies over the past two years indicates each
applicant continues to meet the vision exemption requirements. These
factors provide an adequate basis for predicting each driver's ability
to continue to drive safely in interstate commerce. Therefore, FMCSA
concludes that extending the exemption for each renewal applicant for a
period of two years is likely to achieve a level of safety equal to
that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by September 8, 2014.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 29 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket numbers FMCSA-2000-7006; FMCSA-
2000-7165; FMCSA-2002-12294; FMCSA-2004-17195; FMCSA-2006-24783; FMCSA-
2010-0082; FMCSA-2010-0114; FMCSA-2011-0324; FMCSA-2012-0160 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-2000-7006; FMCSA-2000-7165; FMCSA-2002-12294; FMCSA-2004-17195;
FMCSA-2006-24783; FMCSA-2010-0082; FMCSA-2010-0114; FMCSA-2011-0324;
FMCSA-2012-0160 and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to the
proposed rulemaking.

    Issued on: July 29, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-18615 Filed 8-6-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46498-46500]
[FR Doc No: 2017-21436]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1298]

Determination of Regulatory Review Period for Purposes of Patent
Extension; IMPELLA 2.5 SYSTEM

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 IMPELLA 2.5 SYSTEM 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
medical device.

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 Office, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-1298 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; IMPELLA 2.5 SYSTEM.'' 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 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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (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 medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device IMPELLA 2.5
SYSTEM. IMPELLA 2.5 SYSTEM is indicated for temporary (<=6 hours)
ventricular support during high risk percutaneous coronary
interventions (PCI) performed in elective or urgent, hemodynamically
stable patients with severe coronary artery disease and depressed left
ventricular ejection fraction, when a heart team, including a cardiac
surgeon, has determined high risk PCI is the appropriate therapeutic
option. Subsequent to this approval, the USPTO received a patent term
restoration application for IMPELLA 2.5 SYSTEM (U.S. Patent No.
5,911,685) from Abiomed Europe GmbH, and the USPTO requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated July 12, 2016, FDA advised the USPTO
that this medical device had undergone a regulatory review period and
that the approval of IMPELLA 2.5 SYSTEM 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
IMPELLA 2.5 SYSTEM is 3,227 days. Of this time, 2,858 days occurred
during the testing phase of the regulatory review period, while 369
days occurred during the approval phase. These periods of time were
derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: May 24, 2006. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective was May 24, 2006.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): March
20, 2014. FDA has verified the applicant's claim that the premarket
approval application (PMA) for IMPELLA 2.5 SYSTEM (PMA

P140003) was initially submitted on March 20, 2014.
    3. The date the application was approved: March 23, 2015. FDA has
verified the applicant's claim that PMA P140003 was approved on March
23, 2015.
    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 1,796 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. 2017-21436 Filed 10-4-17; 8:45 am]
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[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)]
[Rules and Regulations]
[Page 81744]
[FR Doc No: 2015-33049]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

Control Policy: End-User and End-Use Base

CFR Correction

    In Title 15 of the Code of Federal Regulations, Parts 300 to 799,
revised as of January 1, 2015, on page 414, in supplement no. 4 to part
744, remove the entry for ``Sergey Grinenko'' from ``GREECE'' and add
it in alphabetical order under ``GERMANY''.

[FR Doc. 2015-33049 Filed 12-30-15; 8:45 am]
 BILLING CODE 1505-01-D