[Federal Register Volume 77, Number 136 (Monday, July 16, 2012)]
[Notices]
[Pages 41837-41838]
[FR Doc No: 2012-17206]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67390; File No. SR-NSCC-2012-05]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Revise Its Fee Schedule

July 10, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 28, 2012, National Securities Clearing Corporation (``NSCC'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by NSCC. NSCC filed the proposal pursuant to Section
19(b)(3)(A)(ii) of the Act,\3\ and Rule 19b-4(f)(2) \4\ thereunder so
that the proposal was effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change aligns the fees associated with NSCC's
Mutual Fund Profile Service, Phases I and II, as set forth in NSCC's
fee schedule (Addendum A of NSCC's Rules), with the cost of delivering
this service. Details regarding the fee change are available in the
revised Addendum A set forth in Exhibit 5 to NSCC's rule filing, which
can be found on NSCC's Web site (http://www.dtcc.com/downloads/legal/rule_filings/2012/nscc/SR-NSCC-2012-05.pdf).

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

    In its filing with the Commission, NSCC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. NSCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\5\
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    \5\ The Commission has modified the text of the summaries
prepared by ICC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    The purpose of the proposed rule change is to align the fees
associated with NSCC's Mutual Fund Profile Service, Phases I and II, as
set forth in NSCC's fee schedule (Addendum A of NSCC's Rules), with the
cost of delivering this service.
    The proposed rule change is consistent with the requirements of the
Act, and the rules and regulations thereunder, because it updates the
NSCC fee schedule and provides for the equitable allocation of fees
among NSCC's members.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    NSCC does not believe that the proposed rule change will have any

impact, or impose any burden, on competition.

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

    NSCC has not solicited, and does not intend to solicit, comments
regarding this proposed rule change. NSCC has not received any
unsolicited written comments from interested parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) \6\ of the Act and Rule 19b-4(f)(2) \7\ thereunder
because it establishes or changes a due, fee, or other charge
applicable only to a member. At any time within 60 days of the filing
of the proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.
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    \6\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \7\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NSCC-2012-05 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NSCC-2012-05. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Section, 100 F Street
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filings will also be available for
inspection and copying at the principal office of NSCC and on NSCC's
Web site at http://www.dtcc.com/downloads/legal/rule_filings/2012/nscc/SR-NSCC-2012-05.pdf.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-NSCC-2012-05
and should be submitted on or before August 6, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Kevin O'Neill,
Deputy Secretary.
[FR Doc. 2012-17206 Filed 7-13-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 134 (Friday, July 12, 2019)]
[Notices]
[Pages 33314-33315]
[FR Doc No: 2019-14785]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2019-0066]

Agency Information Collection Activities; Notice and Request for
Comment; Crash Report Sampling System

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: The Department of Transportation (DOT) invites public comments
about our intention to request the Office of Management and Budget
(OMB) approval to extend an existing information collection. Before a
Federal agency can collect certain information from the public, it must
receive approval from the Office of Management and Budget (OMB). Under
procedures established by the Paperwork Reduction Act of 1995, before
seeking OMB approval, Federal agencies must solicit public comment on
proposed collections of information, including extensions and
reinstatement of previously approved collections.

DATES: Comments must be received on or before September 10, 2019.

ADDRESSES: You may submit comments [identified by Docket No. DOT-NHTSA-
2019-0066] through one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail or Hand Delivery: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, West Building,
Room W12-140, Washington, DC 20590; between 9 a.m. and 5 p.m., Monday
through Friday, except on Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jonae Anderson, State Data Reporting
Systems Division (NSA-120), Room W53-470, 1200 New Jersey Avenue SE,
Washington, DC 20590. Mrs. Anderson can also be reached via email at
<EMAIL_ADDRESS>or via telephone at<PHONE_NUMBER>. Please
identify the relevant collection of information by referring to its OMB
Control Number.

SUPPLEMENTARY INFORMATION:
    Title: Crash Report Sampling System (CRSS) Information Collection.
    OMB Control Number: 2127-0714.
    Type of Request: Modification of a currently approved collection of
information.
    Type of Review: Regular.
    Abstract: Under both the Highway Safety Act of 1966 and the
National Traffic and Motor Vehicle Safety Act of 1966 (Pub. L. 89-563,
Title 1, Sec. 106, 108, and 112) the National Highway Traffic Safety
Administration (NHTSA) has the responsibility to collect crash data
that support the establishment and enforcement of motor vehicle
regulations and highway safety programs. These regulations and programs
are developed to reduce fatalities and the property damage associated
with motor vehicle crashes. NHTSA's National Center for Statistics and
Analysis (NCSA) maintains a multidisciplinary approach to meet our
users' data needs utilizing an efficient combination of census, sample-
based, investigation, and existing State files to provide timely
information on traffic crashes. The Crash Report Sampling System (CRSS)
provides sample-based data on fatal, serious injury, and property-
damage-only (PDO) crashes that helps users understand highway safety
problem areas, develop countermeasures, and identify general data
trends.
    CRSS obtains data from a nationally representative probability
sample selected from police-reported motor vehicle traffic crashes.
Specifically, the CRSS data set includes crashes involving at least one
motor vehicle in transport on a trafficway that result in property
damage, injury, or a fatality. The crash reports sampled are chosen
from selected areas that reflect the geography, population, miles
driven, and the number of crashes in the United States. No additional
data beyond the selected crash reports is collected. Additionally, the
CRSS program neither collects nor publishes any personally identifiable
information. Once the crash reports are received they are coded and the
data is entered into the CRSS database.
    CRSS acquires national information on fatalities, injuries, and
property damage directly from existing State police crash reports. The
user population includes Federal and State agencies, automobile
manufacturers, insurance companies, and the private sector.
    Affected Public: Local Police Jurisdictions and State Crash
Database Owners.
    Estimated Number of Respondents: 320 Respondents.
    Respondents include a combination of State agencies that maintain
crash data report databases and local police jurisdictions that
investigate crashes and complete the crash reports.
    Frequency: Ongoing.

    The data is collected on an ongoing basis. For some respondents,
the data is automatically transferred to NHTSA through the new
electronic data transfer (EDT) program and transfers are as frequent as
daily. Other respondents send the data to NHTSA monthly.
    Estimated Total Annual Burden Hours: 35,680 hours.
    Per the below table, burden hours are calculated differently based
on the data collection method. The revised burden estimates in the
below table describe the burden for each data collection methods. These
estimates are based upon observation and review of the individual
Primary Sampling Units (PSU's) area documentation, which describes the
data collection protocols in detail.

----------------------------------------------------------------------------------------------------------------
                                                                     Hours per     Jurisdiction
                          Access method                            jurisdiction     (PJ/state)      Total hours
----------------------------------------------------------------------------------------------------------------
EDT (Implementation)............................................             200               3             600
EDT (Maintenance)...............................................               5               8              40
State Website...................................................              10              14             140
Web Service.....................................................              60               2             120
Manual..........................................................             470              74          34,780
                                                                 -----------------------------------------------
    Grand Total.................................................  ..............  ..............          35,680
----------------------------------------------------------------------------------------------------------------

    The total burden hour estimate of 35,680 hours represents an
increase of 28,400 hours over the previously estimated burden of 7,280
hours. The change in burden hours represents a recalculation designed
to more accurately estimate the time required to comply with the
collection. The previous calculation didn't account for the variety of
collection methods and the need maintaining cooperation with police
jurisdictions and State agencies to access crash report data.
Additionally, while establishing CRSS, respondents also realized the
need for additional administrative processes and formalized
arrangements to protect personal identifiable information. The prior
estimate of the burden associated with this collection was estimated
prior to CRSS's implementation and some of the factors affecting the
burden were unknown at the time of the prior submission.
    Estimated Total Annual Costs: $1,129,867.
    NHTSA estimated the total annual cost using the Bureau of Labor
Statistics' mean wage estimate for Court, Municipal, and License Clerks
(Standard Occupational Classification #43-4031 from May 2018) of
$19.76.\1\ Therefore, NHTSA estimates the hourly wage associated with
the estimated 35,680 burden hours to be $705,036.80 (35,680 hours x
$19.76 per hour = $705,036.80). The Bureau of Labor Statistics
estimates that for State and local government workers, wages represent
62.4% of total compensation.\2\ Therefore, the total cost associated
with this collection is estimated to be $1,129,867. This is an increase
of $1,129,867 over the last estimate of the cost of this information
collection because the previous estimate did not include the costs
associated with the burden hours.

    \1\ Occupational Employment and Wages, Bureau of Labor
Statistics, U.S. Department of Labor, May 2018, https://www.bls.gov/oes/current/oes434031.htm, last accessed June 28, 2019.
    \2\ Employer Costs for Employee Compensation-March 2019, Bureau
of Labor Statistics, U.S. Department of Labor, https://www.bls.gov/news.release/pdf/ecec.pdf, last accessed July 1, 2019.
---------------------------------------------------------------------------

    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (i) whether the proposed
collection of information is necessary for the Department's
performance; (ii) if the information will have practical utility; (iii)
the accuracy of the estimated burden of the proposed information
collection; (iv) ways to enhance the quality, utility, and clarity of
the information to be collected; and (v) ways to minimize the burden of
the collection of information on respondents including the use of
automated collection techniques or other forms of information
technology. The agency will summarize and/or include your comments in
the request for OMB's clearance of this information collection.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35, as amended; and 49 CFR 1:48.

Cem Hatipoglu,
Acting Associate Administrator, National Center for Statistics and
Analysis.
[FR Doc. 2019-14785 Filed 7-11-19; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Notices]
[Pages 2984-2985]
[FR Doc No: 2013-00647]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3030-019]

Antrim County; Notice of Application Tendered for Filing With the
Commission, Soliciting Additional Study Requests, and Establishing
Procedural Schedule for Relicensing and a Deadline for Submission of
Final Amendments

    Take notice that the following hydroelectric application has been
filed

with the Commission and is available for public inspection.
    a. Type of Application: Subsequent license.
    b. Project No.: P-3030-019.
    c. Date filed: December 21, 2012.
    d. Applicant: Antrim County.
    e. Name of Project: Elk Rapids Hydroelectric Project
    f. Location: On the Elk River in the village of Elk Rapids in
Antrim, Grand Traverse, and Kalkaskia counties, Michigan. The project
does not affect federal lands.
    g. Filed Pursuant to: Federal Power Act 16 USC 791 (a)-825(r).
    h. Applicant Contact: William Stockhausen, Elk Rapids Hydroelectric
Power, LLC, 218 West Dunlap Street, Northville, MI 48167; or at (248)
349-2833.
    i. FERC Contact: Lee Emery at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: February 19, 2013.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site http:[sol][sol]www.ferc.gov/docs-filing/efiling.asp. Commenters
can submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http:[sol][sol]www.ferc.gov/
docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>or toll free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. Although the Commission
strongly encourages electronic filing, documents may also be paper-
filed. To paper-file, mail an original and seven copies to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426.
    m. The application is not ready for environmental analysis at this
time.
    n. The existing Elk Rapids Hydroelectric Project is located on the
Elk River in Antrim, Grand Traverse, and Kalkaskia counties, Michigan.
The project consists of: (1) 2,560-acre Skegemog Lake; (2) 7,730-acre
Elk Lake; (3) a 121-foot-long, 52-foot-high, 26-foot-wide existing
powerhouse that spans the main channel of the Elk River, with an
operating head of 10.5 feet, (4) four 22-foot-wide bays with a trash
rack having a 1[frac34]-inch clear bar spacing; (5) two turbine-
generator units for a combined installed capacity of 0.700 megawatt;
(6) two turbine gates used to spill excess water; (7) a 14-foot-wide
overflow spillway equipped with stoplogs; (8) a 20-foot by 30-foot
substation enclosure; (9) a 50-foot-long underground 12.5-kilovolt
transmission line to connect the project substation to the local
utility distribution lines; and (10) other appurtenant facilities.
    The project operates in a run-of-river mode and the water surface
elevation is maintained at 590.8 feet Elk Rapids dam gage datum from
April 15 through November 1 and at 590.2 feet Elk Rapids dam gage datum
from November 1 through April 15. The average annual generation is
about 2,422 megawatt-hours.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http:[sol][sol]www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC Online Support. A copy is also available for
inspection and reproduction at the address in item h above.
    You may also register online at http:[sol][sol]www.ferc.gov/docs-
filing/esubscription.asp to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    p. With this notice, we are initiating consultation with the
Michigan State Historic Preservation Officer (SHPO), as required by
section 106 of the National Historic Preservation Act, and the
regulations of the Advisory Council on Historic Preservation, 36 CFR
800.4.
    q. Procedural schedule and final amendments: The application will
be processed according to the following preliminary Hydro Licensing
Schedule. Revisions to the schedule will be made as appropriate.

Issue Notice of Acceptance--March 2013
Issue Scoping Document 1 for comments--April 2013
Comments due on Scoping Document 1--June 2013
Issue Scoping Document 2--June 2013
Issue notice of ready for environmental analysis--September 2013
Issue Environmental Assessment (EA)--March 2014
Comments on due on EA--April 2014

    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: January 9, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-00647 Filed 1-14-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 149 (Friday, August 4, 2023)]
[Notices]
[Pages 51839-51840]
[FR Doc No: 2023-16614]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-5273, FDA-2019-E-5269, and FDA-2019-E-5271]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BARRICAID ANULAR CLOSURE DEVICE

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 BARRICAID ANULAR CLOSURE
DEVICE 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 medical device.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by October 3, 2023.
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 January 31, 2024. 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. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 3, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-2019-E-5273, FDA-2019-E-5269, and FDA-2019-E-5271 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; BARRICAID ANULAR CLOSURE DEVICE.'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/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,<PHONE_NUMBER>.

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 BARRICAID ANULAR
CLOSURE DEVICE. The BARRICAID ANULAR CLOSURE DEVICE is indicated for
reducing the incidence of reherniation and reoperation in skeletally
mature patients with radiculopathy (with or without back pain)
attributed to a posterior or posterolateral herniation, and confirmed
by history, physical examination, and imaging studies that demonstrate
neural compression using magnetic resonance imaging to treat a large
anular defect (between 4 and 6 millimeters (mm) tall and between 6 and
10 mm wide) following a primary discectomy procedure (excision of
herniated intervertebral disc) at a single level between L4 and S1.
Subsequent to this approval, the USPTO received patent term restoration
applications for BARRICAID ANULAR CLOSURE DEVICE (U.S. Patent Nos.
6,425,919; 7,524,333; 9,610,106) from Intrinsic Therapeutics, Inc., and
the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated January 21,
2020, FDA advised the USPTO that this medical device had undergone a
regulatory review period and that the approval of BARRICAID ANULAR
CLOSURE DEVICE 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
BARRICAID ANULAR CLOSURE DEVICE is 2,980 days. Of this time, 2,163 days
occurred during the testing phase of the regulatory review period,
while 817 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date a clinical investigation on humans is begun (21 CFR
60.22(c)(1)(iii): December 14, 2010. FDA has verified the applicant's
claim that the date the first clinical investigation in human subjects
involving the BARRICAID ANULAR CLOSURE DEVICE as part of a clinical
investigation filed with FDA to secure premarket approval of the device
began December 14, 2010.
    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): November
14, 2016. The applicant claims November 10, 2016, as the date the
premarket approval application (PMA) for BARRICAID ANULAR CLOSURE
DEVICE (PMA P160050) was initially submitted. However, FDA records
indicate that PMA P160050 was officially submitted on November 14,
2016.
    3. The date the application was approved: February 8, 2019. FDA has
verified the applicant's claim that PMA P160050 was approved on
February 8, 2019.
    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 676 days or 5 years 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: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16614 Filed 8-3-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 225 (Tuesday, November 23, 2010)]
[Proposed Rules]
[Pages 71376-71378]
[FR Doc No: 2010-29482]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 748

[Docket No. 100826397-0346-02]
RIN 0694-AE98

Simplified Network Application Processing System, On-Line
Registration and Account Maintenance

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Proposed rule.

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SUMMARY: The Bureau of Industry and Security (BIS) is proposing to
implement an on-line registration process for obtaining an account to
submit license applications and similar documents electronically. The
current registration process requires paper and facsimile submissions.
This proposed rule sets forth the information that parties registering
on-line would be required to provide to BIS and sets forth the duties
that registered parties would have with respect to keeping information
in their accounts current.

DATES: Comments must be received by BIS no later than January 24, 2011.

ADDRESSES: Comments may be submitted via to any of the following.
     The Federal e-rulemaking portal, regulations.gov. The
regulations.gov docket number for this rule is: BIS-2010-0037.
     Via e-mail at<EMAIL_ADDRESS>to RIN
0694-AE98 in the subject line.
     Mail or delivery to Regulatory Policy Division, Room 2705,
Bureau of Industry and Security, U.S. Department of Commerce,
Washington, DC 20230--refer to RIN 0694-AE98 in the comment.

FOR FURTHER INFORMATION CONTACT: Thomas W. Andrukonis, Director, Export
Management and Compliance Division, Office of Exporter Services,
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    BIS administers an export licensing program pursuant to the Export
Administration Regulations. In connection with this program, BIS
requires most parties to submit license applications, classification
requests, encryption registrations, License Exception AGR notifications
and foreign national review requests in connection with the License
Exceptions APP and CIV (herein ``work items'') electronically via BIS's
Simplified Network Application Processing (SNAP-R) system. Currently,
parties must register to use that system via a paper- or facsimile-
based process. BIS plans to replace that registration process with one
that is exclusively on-line.
    Organizations or individuals who submit work items would be
referred to as ``filing entities.'' Individuals who act on behalf of
filing entities would be known as ``individual users.'' For each filing
entity, at least one individual user would act as an ``account
administrator.'' An account administrator would be able to submit work
items on behalf of his or her filing entity and would have additional
responsibilities within the on-line registration system.
    An account administrator would have the ability to add and remove
individual users to or from the account of his or her filing entity.
The account administrator would also be able to designate other
individual users who are authorized to act on behalf of the same filing
entity as account administrators or to terminate an individual user's
account administrator status. The account administrator would be able
to deactivate the account of an individual user and reactivate the
account of a previously deactivated individual user. The account
administrator would be able to update the filing entity's identifying
information such as name and address and any individual user's
identifying information such as name and telephone number. The account
administrator would also be able to reset an individual user's
password.
    BIS anticipates that once this system is in place, the current
processes in which BIS employees create on-line accounts for filing
entities and add or remove new individual users to or from a filing
entity's account in response to written or facsimile communications
would cease. Account administrators for filing entities would handle
routine changes to the filing entities' accounts and BIS personnel
would become involved only if necessary to protect a government
interest such as preventing misuse of the SNAP-R system or if necessary
to assist someone attempting to register on-line or administer an
account.
    BIS intends to begin operating the on-line registration system on
the date of publication of the final rule, but proposes to phase in
mandatory use of on-line registration and account management according
to the following schedule.

New Filing Entities

    On the effective date of the final rule and for 30 days thereafter,
an individual registering a filing entity that does not currently have
a SNAP-R account would be able to use either the existing paper- and
facsimile-based process or the new on-line registration process
described in the following paragraph. Beginning 31 days after the
effective date of the final rule, the on-line registration process
would be mandatory for all new registrants.

Requirement To Designate an Account Administrator at the Time of
Electronic Registration

    A person registering on-line for a filing entity that does not have
a SNAP-R account, will be required to enter all of the identifying
information for the filing entity including a certification that the
person is authorized to register the filing entity and to act as
account administrator for the filing entity as well as his or her own
identifying information. That person will become the initial account
administrator for that filing entity.

Deadlines for Designating an Account Administrator If the Filing Entity
Was Not Registered Electronically

    Filing entities that are registered to use SNAP-R on the effective
date of the final rule and filing entities that elect to use the paper
and facsimile based process during the first 30 days following the
effective date of the final rule would be required to designate an
account administrator as described below.
    On the effective date of the final rule and for 90 days thereafter,
any individual user who is authorized to submit work items on behalf of
a filing entity would be able to continue to access SNAP-R, submit new
work items and perform any necessary tasks in connection with pending
work items. In addition, the first such individual user who designates
himself or herself as the account administrator would be required to
certify that he or she is authorized to act as account administrator
and would become the initial account administrator. BIS would inform
via e-mail all other individual users who are authorized to act for
that filing entity of the identity of the newly designated account
administrator.
    During the period beginning 91 days after the effective date of the
final rule and ending 180 days after the effective date of the final
rule, no individual user from a filing entity that does not have at
least one account administrator would be able to access the SNAP-R
system for any purpose other than to designate himself or herself as
account administrator for that filing entity and certify that he or she
is authorized to act as account administrator. As soon as

one individual user is designated as the account administrator, that
individual user as well as all of the other individual users from that
filing entity will regain full SNAP-R access.
    Beginning 181 days after the effective date of the final rule, all
filing entity accounts for which no account administrator has been
designated would become inactive. To use the account for any purpose,
an individual would have to log on to the SNAP-R Web site and furnish
all of the information that would be required to register a new filing
entity.

Rulemaking Requirements

    1. This rule has been determined to be not significant for purposes
of E.O. 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor is subject to a penalty for failure to
comply with, a collection of information, subject to the requirements
of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA),
unless that collection of information displays a currently valid Office
of Management and Budget (OMB) Control Number. This regulation contains
a collection previously approved by OMB under control number 0694-0096.
BIS believes that this rule will not materially affect the burden
imposed by that collection. Send comments regarding these burden
estimates or any other aspect of these collections of information,
including suggestions for reducing the burden, to Jasmeet Seehra,
Office of Management and Budget (OMB), by e-mail to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>; and to the Regulatory
Policy Division, Bureau of Industry and Security, Department of
Commerce, Room 2705, 14th Street, and Pennsylvania Ave., NW.,
Washington, DC 20230.
    3. This rule does not contain policies with Federalism implications
as that term is defined under E.O. 13132.
    4. The Chief Counsel for Regulation of the Department of Commerce
has certified to the Chief Counsel for Advocacy of the Small Business
Administration that this proposed rule, if adopted in final form, would
not have a significant economic impact on a substantial number of small
entities.

Economic Impact

    BIS believes that this rule will reduce the burden on small
entities. This rule will eliminate the current and archaic practice of
using a paper and facsimile based process for obtaining authorization
to submit work items electronically. It will also reduce the time
between initial submission of registration information and receipt of
authorization to use the electronic filing system. Finally, the system
will allow registered filing entities to add or remove individual users
without waiting for approval from BIS.
    BIS implemented a revised version of its Simplified Network
Applications Processing System (SNAP-R) in October 2006. The SNAP-R
system provides a Web based mechanism for parties to submit license
applications, classification requests, encryption registrations,
License Exception AGR notifications and foreign national review
requests in connection with License Exceptions APP and CIV
electronically and for BIS to respond electronically to each matter. In
October 2008, BIS made use of the SNAP-R system mandatory except in
five specified circumstances. SNAP-R is the vehicle through which BIS
receives most of the submissions for which SNAP-R is available. In
calendar year 2009, BIS received 27,245 submissions via SNAP-R and 55
submissions via paper. On-line processing provides advantages to the
government and to the parties submitting work items through reduced
processing times.
    Despite these advantages, BIS still requires parties registering to
use the SNAP-R on-line system and those who need to make changes to
their accounts to use paper or facsimile transmissions to do so. A
party wishing to register now obtains a description of the identifying
information that the party must submit and the text of a certification
that the party must make from the BIS Web site. The party copies the
information onto its letterhead and sends or faxes the paper document
to BIS. BIS personnel then assign a company identification number to
the filing entity and a personal identification number to each
individual user identified on the submission and communicate those
numbers to the appropriate representative of the filing entity and to
each individual user. A separate letter must be sent or faxed to BIS
each time a new individual user needs to be authorized to file on
behalf of the filing entity and BIS personnel issue a new personal
identification number to that person via telephone or e-mail. Finally,
a letter must be sent to BIS when an individual user no longer is
authorized to submit work items on behalf of the filing entity. BIS
personnel then deactivate that individual user's account.
    Under the procedure envisioned by this proposed rule, a potential
individual user, representing a filing entity would access a Web page
where he or she would enter the necessary identifying information about
himself or herself and about the filing entity which that person
represents. That individual would also certify on-line that he or she
is authorized to register the filing entity and to act as account
administrator for the filing entity. That individual would receive both
the company identification number and his or her personal
identification number via e-mail. Upon receipt of those numbers, that
individual user could submit work items on behalf of the filing entity.
He or she could also register new individual users for the filing
entity. Once registered, each such new individual user could log on and
begin submitting work items.
    The process will be entirely Web based and will not require users
to purchase hardware or software. Parties who do not have access to the
Internet would not be affected by this rule because they are exempt
from the requirement to submit work items electronically and thus would
not need to register to use SNAP-R.

Number of Small Entities

    BIS does not collect information about the size of the entities
that submit license applications, classification requests, and related
submissions via the SNAP-R system. In 2007, BIS made an attempt to
estimate the number of small entities that would be affected by the
rule requiring electronic submissions by the following method.
    BIS determined that 1,592 entities sent in two or more submissions
in 2006 (entities that make no more than one submission per year are
exempt from the electronic filing requirement). By reviewing public
information BIS determined that 252 of these entities could not
possibly be small entities because they had more than $100 million in
annual sales, had more than 5,000 employees or because they were United
States government agencies. BIS did not have a basis for determining
whether the remaining 1340 entities were small entities.
    Because many industries may be involved in exporting, BIS could not
directly relate its data to the ``Small Business Size Standards Matched
to North American Industry Classification System'' (the Standards
Table) published by the Small Business Administration (SBA). However,
BIS notes that the November 5, 2010, Standards Table designates
business as small based on either sales or number of employees,
depending on the industry. The maximum annual sales and maximum number
of employees listed in that document are $35.5 million and

1,500, respectively. Both numbers are far below the threshold selected
by BIS for screening entries as to size. A few entries in the Standards
Table are based on having no more than million in assets, but these
entries are financial institutions that are unlikely to be exporting
the kinds of items that require a specific authorization from BIS.
    Moreover, most of the categories in the Standards Table for which
the sales limit is relatively high are unlikely to be affected by this
rule because they are unlikely to engage in export or reexport
transactions that require specific authorization from BIS. Examples of
small entities at the higher end of the sales range of the Standards
Table include: Family Clothing Stores, Food Service Contractors and
Home Centers--$35.5 million each, Forest Fire Suppression--$17.5
million, New Single-Family Housing Construction Contractors--$33.5
million and Gasoline Stations with Convenience Stores--$27.0 million.

Conclusion

    Based on the information that it does know, BIS believes that most
categories of small entities identified by the Small Business
Administration are unlikely to be engaged in the kinds of transactions
that require specific authorization from BIS and thus would be unlikely
to use BIS's SNAP-R system. The exemption from the electronic filing
requirement that BIS's rules provide for parties making no more than
one submission per year and parties that lack access to the Internet
tend to further exclude small entities from the impact of this rule.
    Significantly, the effect of this rule on all affected entities is
likely to be a reduction in burden because this rule allows
implementation of an electronic registration procedure for an existing
electronic document filing system. In doing so, it replaces an existing
paper based registration system, allowing parties who need to submit
documents to BIS to register to do so in less time. Existing provisions
of the Export Administration Regulations require most parties to submit
work items electronically. This rule would not change that requirement
nor would it change any exceptions to that requirement. Parties who
qualify and who wish to submit work items on paper would not be subject
to the registration requirement of this rule. However, those who either
are required or choose to submit their work items electronically would
no longer be subjected to a paper based registration process before
they can begin electronic submissions. In addition, once registered
with an account administration in place, filing entities would no
longer have to submit information to BIS via paper or facsimile and
wait for a response from BIS in order to add or remove individual users
or to update identifying information.

List of Subjects in 15 CFR Part 748

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

    Accordingly, the Export Administration Regulations (15 CFR Parts
730-774) are proposed to be amended as follows:
    1. The authority citation for part 748 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 12, 2010, 75
FR 50681 (August 16, 2010).

    2. Section 748.7 is revised to read as follows:

Sec.  748.7  Registering for electronic submission of license
applications and related documents.

    (a) Scope. This section describes the procedures for registering to
submit electronic documents to BIS. The procedures in this section
apply to submission of export and reexport license applications (other
than Special Comprehensive Licenses and Special Iraq Reconstruction
Licenses), classification requests, encryption registrations, License
Exception AGR notifications and foreign national review requests under
License Exceptions APP or CIV.
    (b) Registration and Use of BIS's Simplified Network Applications
System--Redesign (SNAP-R). Parties wishing to submit electronically
must log on to [URL to be determined] to register. Upon initial
registration, the party (the filing entity) will have to supply the
name of the entity that will be submitting documents electronically and
its address and the name, telephone number, facsimile number and e-mail
address of the person who will act as account administrator. The person
will be required to certify that the information so supplied is correct
and complete, that the person has authority to register the entity that
will be making electronic submissions and that the person has authority
to act as an account administrator for that entity.
    (c) Role of account administrator. The account administrator is
able to add and remove individual users to and from the account of the
filing entity for which it is the account administrator. The account
administrator can also make individual users account administrators and
can terminate an individual user's administrator status. The account
administrator can deactivate the account of an individual user and
reactivate the account of a previously deactivated individual user. The
account administrator can update the filing entity's identifying
information such as name and address and any individual user's
identifying information such as name, telephone number, facsimile
number and e-mail address. The account administrator can reset
individual users' passwords.
    (d) Role of individual users. An individual user may submit to BIS
export and reexport license applications (other than Special
Comprehensive Licenses and Special Iraq Reconstruction Licenses),
classification requests, encryption registrations, License Exception
AGR notifications and foreign national review requests under License
Exceptions APP or CIV.
    (e) Effect of submission to BIS. BIS may refuse to accept an
electronic submission if it has reason to believe that the individual
user making the submission lacks authority to do so. However, BIS is
not obligated to conduct any checks to determine whether an individual
user has the necessary authority and will generally treat users as
acting within their authority. Acting through their account
administrators, parties have the ability to remove an individual user
when that individual user is no longer authorized to make submissions
on behalf of that party to BIS and should do so promptly.
    (f) Requirement to keep identifying information accurate and
current--(1) Filing entities. Filing entities must, through their
account administrators, update their identifying information such as
name, address and telephone number in their SNAP-R account as necessary
to keep that information accurate and current.
    (2) Individual users. Individual users must, through their account
administrators, update their identifying information such as name,
telephone number, facsimile number and e-mail address in their SNAP-R
accounts as necessary to keep that information accurate and current.

    Dated: November 15, 2010.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2010-29482 Filed 11-22-10; 8:45 am]
BILLING CODE 3510-33-P