[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Notices]
[Pages 91988-91990]
[FR Doc No: 2016-30374]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rules 15Ba1-1 through 15Ba1-8, SEC File No. 270-619, OMB Control
No. 3235-0681.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information provided for in Rules 15Ba1-1 to 15Ba1-8 (17 CFR 240.15Ba1-
1 to 17 CFR 240.15Ba1-8)--Registration of Municipal Advisors, under the
Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) (the ``Act'').
The Commission plans to submit this existing collection of information
to the Office of Management and Budget for extension and approval.
    On September 20, 2013 (see 78 FR 67468, November 12, 2013), the
Commission adopted Rules 15Ba1-1 through 15Ba1-8 and Rule 15Bc4-1 under
the Act to establish the rules by which a municipal advisor must
obtain, maintain, and terminate its registration with the Commission.
In addition, the rules interpret the definition of the term ``municipal
advisor,'' interpret the statutory exclusions from that definition, and
provide certain additional regulatory exemptions. The rules became
effective on January 13,

2014; however, on January 13, 2014, the Commission temporarily stayed
such rules until July 1, 2014 (see 79 FR 2777, January 16, 2014).
Section 15B(a)(1) of the Act makes it unlawful for a municipal advisor
to provide advice to or on behalf of a municipal entity or obligated
person with respect to municipal financial products or the issuance of
municipal securities, or to undertake a solicitation of a municipal
entity or obligated person, unless the municipal advisor is registered
with the Commission. The rules, among other things (i) require
municipal advisors to file certain forms (i.e., Form MA, Form MA-A,
Form MA/A, Form MA-I, Form MA-I/A, Form MA-NR, and Form MA-W) with the
Commission to, as appropriate, obtain, maintain, or terminate their
registration with the Commission and maintain certain books and records
in accordance with the Act, and (ii) set forth how certain entities may
meet the requirements of the statutory exclusions or regulatory
exemptions from the definition of ``municipal advisor.''

Form MA

    The Commission estimates that approximately 75 respondents will
submit new Form MA applications annually in each of the next three
years. The Commission further estimates that each submission will take
approximately 3.5 hours. Thus, the total annual burden borne by
respondents for submitting an initial Form MA application will be
approximately 263 hours.\1\ The Commission estimates that respondents
submitting new Form MA applications would, on average, consult with
outside counsel for one hour, at a rate of $400/hour. Thus, the
Commission estimates that the average total annual cost that may by
incurred by all respondents filing new Form MA applications will be
$30,000.\2\ In addition to filing initial Form MA applications, the
rules require municipal advisors to amend Form MA once annually (Form
MA-A) and after the occurrence of any material event (Form MA/A). The
requirement to amend Form MA applies to all registered municipal
advisors. There are currently approximately 668 municipal advisors
registered with the Commission and, as noted above, the Commission
anticipates receiving 225 new Form MA submissions over the next three
years. Therefore, the Commission expects that the rules' requirement to
amend Form MA will apply to approximately 743 municipal advisors in
year one, approximately 818 municipal advisors in year two, and
approximately 893 municipal advisors in year three. The Commission
estimates that completing an annual amendment would take a municipal
advisor approximately 1.5 hours and completing a material event
amendment would take 0.5 hours. The Commission further estimates that
each municipal advisor will submit two amendments per year (one Form
MA-A and one Form MA/A). Thus, the Commission estimates that the
average annual burden borne by respondents for amending Form MA during
the three-year period will be approximately 1,636 hours.\3\
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    \1\ 75 respondents x 3.5 hours.
    \2\ 75 respondents x ($400/hour x 1 hour).
    \3\ 818 respondents x 2 hours.
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Form MA-I

    The Commission estimates that it will receive approximately 950 new
Form MA-I submissions annually. The Commission further estimates that
each Form MA-I submission will take approximately three hours to
complete. Thus, the total annual burden borne by respondents submitting
Form MA-I will be approximately 2,850 hours.\4\ The Commission also
estimates that a Form MA-I respondent will submit 1.7 updating
amendments per year (Form MA-I/A), and that each such amendment will
take approximately 0.5 hours to complete. There are currently
approximately 5,685 Form MA-Is on file with the Commission and, as
noted above, the Commission expects to receive 2,850 Form MA-I
submissions over the next three years. Therefore, the Commission
expects the rules' requirement to amend Form MA-I to apply to
approximately 6,635 Form MA-Is in year one, approximately 7,585 Form
MA-Is in year two, and approximately 8,535 Form MA-Is in year three.
Thus, the Commission estimates that the average annual burden borne by
respondents submitting Form MA-I amendments during the three-year
period will be approximately 6,447 hours.\5\
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    \4\ 950 submissions x 3 hours.
    \5\ 7,585 Form MA-I/As x (1.7 amendments x 0.5 hours).
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Form MA-W

    The Commission estimates that it will receive 40 new Form MA-W
submissions annually. The Commission further estimates that each Form
MA-W submission will take approximately 0.5 hours to complete. Thus,
the total annual burden borne by respondents submitting Form MA-W will
be approximately 20 hours.\6\
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    \6\ 40 respondents x 0.5 hours.
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Form MA-NR

    The Commission estimates that three municipal advisors will have a
non-resident general partner, non-resident managing agent, or non-
resident associated person and such advisors will submit a total of
approximately nine Form MA-NRs annually. The Commission further
estimates that each Form MA-NR submission will take approximately 1.5
hours to complete. Thus, the total annual burden borne by respondents
submitting Form MA-NR will be approximately 13.5 hours.\7\ In addition,
each respondent that submits a Form MA-NR must also provide an opinion
of counsel. The Commission estimates that such an opinion of counsel
would take three hours to complete, at a rate of $400/hour. Thus, the
Commission estimates that the total annual burden borne by respondents
providing an opinion of counsel will be approximately nine hours.\8\
The estimated average total cost that may be incurred by all
respondents providing an opinion of counsel will be $3,600.\9\
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    \7\ 3 respondents x (3 Form MA-NR submissions x 1.5 hours).
    \8\ 3 respondents x 3 hours.
    \9\ 3 respondents x (3.0 hours x $400/hour).
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Consent to Service of Process

    The Commission estimates that 75 new municipal advisors will have
to develop a template document to use in obtaining written consents to
service of process from their associated persons annually. The
Commission further estimates that each template document will take
approximately one hour to draft. Thus, the Commission estimates that
the total annual burden borne by respondents developing a template
document will be approximately 75 hours.\10\ In addition, the
Commission estimates that municipal advisors will need to obtain 950
new consents to service of process from associated persons annually.
The Commission further estimates that, after the written consents are
drafted, it will take municipal advisors approximately 0.10 hours to
obtain each consent. Thus, the Commission estimates that the total
annual burden borne by respondents obtaining consents to service of
process will be 170 hours.\11\
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    \10\ 75 respondents x 1 hour.
    \11\ 75 hours + (950 x 0.1 hours).
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Books and Records To Be Maintained by Municipal Advisors

    The Commission estimates 743, 818, and 893 municipal advisors will
be subject to the books and records rules during each of the next three
years, respectively. The Commission further

estimates that the average annual burden for a municipal advisor to
comply with the books and records requirement is approximately 182
hours. Thus, the Commission estimates that the average annual burden
borne by respondents to comply with the books and records requirements
during the three-year period will be approximately 148,876 hours.\12\
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    \12\ 818 respondents x 182 hours.
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Independent Registered Municipal Advisor Exemption

    The Commission estimates that approximately 150 persons will seek
to rely on the independent registered municipal advisor exemption
annually. The Commission further estimates that the one-time burden of
developing a written template disclosure document will be approximately
one hour. Thus, the Commission estimates that the total one-time burden
borne by respondents developing a template disclosure document will be
approximately 150 hours.\13\ The Commission also recognizes that
respondents will be subject to a recurring burden each time they seek
to rely on the exemption. The Commission estimates that respondents may
seek the exemption on approximately 7,400 transactions annually. The
Commission further estimates that the burden of obtaining the written
representations needed from the municipal entity or obligated person
client will be approximately 0.25 hours. Thus, the Commission estimates
that the total annual burden borne by respondents seeking to rely on
the independent registered municipal advisor exemption will be
approximately 1,850 hours.\14\
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    \13\ 150 respondents x 1 hour.
    \14\ 7,400 transactions x 0.25 hours.
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Definition of Municipal Escrow Investments Exemption

    The Commission estimates that approximately 700 respondents will
seek to rely on the municipal escrow investments exemption. The
Commission further estimates that the one-time burden of creating a
template document to use in obtaining the written representations
necessary to rely on the exemption will be approximately one hour.
Thus, the Commission estimates that the total one-time burden borne by
respondents developing a template document will be approximately 700
hours.\15\ The Commission also recognizes that respondents will be
subject to a recurring burden each time they seek to rely on the
exemption. The Commission estimates the respondents will seek to rely
on the exemption with approximately 8,620 municipal entity clients. The
Commission further estimates that the burden of obtaining the required
written representations from the respondent's client will be
approximately 0.25 hours. Thus, the Commission estimates that the total
annual burden borne by respondents seeking to rely on the municipal
escrow investments exemption will be approximately 2,155 hours.\16\
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    \15\ 700 respondents x 1 hour.
    \16\ 8,620 clients x 0.25 hours.
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Definition of Proceeds of Municipal Securities Exemption

    The Commission estimates that approximately 880 respondents will
seek to rely on the proceeds of municipal securities exemption. The
Commission further estimates that the one-time burden of creating a
template document to use in obtaining the written representations
necessary to rely on the exemption will be approximately one hour.
Thus, the Commission estimates that the total one-time burden borne by
respondents developing a template document will be approximately 880
hours.\17\ The Commission also recognizes that respondents will be
subject to a recurring burden each time they seek to rely on the
exemption. The Commission estimates that respondents will seek to rely
on the exemption in connection with services provided to approximately
25,420 clients. The Commission further estimates that the burden of
obtaining the required written consents from the respondent's client
will be approximately 0.25 hours. Thus, the Commission estimates that
the total annual burden borne by respondents seeking to rely on
proceeds of municipal securities exemption will be approximately 6,355
hours.\18\
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    \17\ 880 respondents x 1 hour.
    \18\ 25,420 clients x 0.25 hours.
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    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number. Please direct your
written comments to: Pamela C. Dyson, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100
F Street NE., Washington, DC 20549 or send an email to:
<EMAIL_ADDRESS>
    Dated: December 6, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-30374 Filed 12-16-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 76 (Thursday, April 19, 2018)]
[Notices]
[Pages 17447-17448]
[FR Doc No: 2018-08236]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0747]

Blasting and the Use of Explosives; Extension of the Office of
Management and Budget's (OMB) Approval of Information Collection
(Paperwork Requirements)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the Standard on
Blasting and the Use of Explosives.

DATES: Comments must be submitted (postmarked, sent, or received) by
June 18, 2018.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2011-0747,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the Docket Office's normal business hours, 10:00 a.m.
to 3:00 p.m., E.T.
    Instructions: All submissions must include the Agency name and the
OSHA docket number (OSHA-2011-0747) for the Information Collection
Request (ICR). All comments, including any personal information you
provide, are placed in the public docket without change, and may be
made available online at http://www.regulations.gov. For further
information on submitting comments, see the ``Public Participation''
heading in the section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the above address. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from the website. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the number below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Charles McCormick or Theda Kenney,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accord with the Paperwork Reduction Act of
1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657).
    The Standard on Blasting and the Use of Explosives (29 CFR part
1926, subpart

U) specifies a number of paperwork requirements. The following is a
brief description of the collection of information requirements
contained in the Subpart.

General Provisions (Sec.  1926.900)

    Sec.  1926.900(d)--Paragraph (d) states that employers must ensure
that explosives not in use are kept in a locked magazine, unavailable
to persons not authorized to handle explosives. The employers must
maintain an inventory and use record of all explosives--in use and not
in use. In addition, the employer must notify the appropriate
authorities in the event of any loss, theft, or unauthorized entry into
a magazine.
    Sec.  1926.900(k)(3)(i)--Paragraph (k)(3)(i) requires employers to
display adequate signs warning against the use of mobile radio
transmitters on all roads within 1,000 feet of blasting operations to
prevent the accidental discharge of electric blasting caps caused by
current induced by radar, radio transmitters, lighting, adjacent power
lines, dust storms, or other sources of extraneous electricity. The
employer must certify and maintain a record of alternative provisions
made to adequately prevent any premature firing of electric blasting
caps.
    Sec.  1926.900(o)--Employers must notify the operators and/or
owners of overhead power lines, communication lines, utility lines, or
other services and structures when blasting operations will take place
in proximity to those lines, services, or structures.
    Sec.  1926.903(d)--The employer must notify the hoist operator
prior to transporting explosives or blasting agents in a shaft
conveyance.
    Sec.  1926.903(e)--Employers must perform weekly inspections on the
electrical system of trucks used for underground transportation of
explosives. The weekly inspection is to detect any failure in the
system which would constitute an electrical hazard. The most recent
certification of inspection must be maintained and must include the
date of inspection, a serial number or other identifier of the truck
inspected, and the signature of the person who performed the
inspection.
    Sec.  1926.905(t)--The employer blaster must maintain an accurate
and up-to-date record of explosives, blasting agents, and blasting
supplies used in a blast. The employer must also maintain an accurate
running inventory of all explosives and blasting agents stored on the
operation.
    Sec.  1926.909(a)--Employers must post a code of blasting agents on
one or more conspicuous places at the operation. All employees also
shall familiarize themselves with the code and conform to it at all
times. Danger signs warning of blasting agents shall also be placed at
suitable locations.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    The Agency is requesting to maintain its current burden hours of
1,666.
    Type of Review: Extension of a currently approved collection.
    Title: Blasting and the Use of Explosives (29 CFR part 1926,
subpart U).
    OMB Control Number: 1218-0217.
    Affected Public: Businesses or other for-profits.
    Number of Respondents: 201.
    Number of Responses: 818.
    Frequency of Responses: On occasion.
    Average Time per Response: Various.
    Estimated Total Burden Hours: 1,666.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2011-0747). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information, such as social security number and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office.
    Information on using the http://www.regulations.gov website to
submit comments and access the docket is available at the website's
``User Tips'' link. Contact the OSHA Docket Office for information
about materials not available through the website, and for assistance
in using the internet to locate docket submissions.

V. Authority and Signature

    Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012 (77 FR
3912).

    Signed at Washington, DC, on April 16, 2018.
Loren Sweatt,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2018-08236 Filed 4-18-18; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12938-12939]
[FR Doc No: 2023-04177]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-E-4415]

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

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 VERZENIO 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 human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by May 1, 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 August 28, 2023. 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 May 1, 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 No.
FDA-2018-E-4415 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; VERZENIO.'' 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 or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for

example, half the testing phase must be subtracted as well as any time
that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, VERZENIO
(abemaciclib). VERZENIO is indicated:
     in combination with fulvestrant for the treatment of women
with hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative advanced or metastatic breast cancer with
disease progression following endocrine therapy and
     as monotherapy for the treatment of adult patients with
HR-positive, HER2-negative advanced or metastatic breast cancer with
disease progression following endocrine therapy and prior chemotherapy
in the metastatic setting.
    Subsequent to this approval, the USPTO received a patent term
restoration application for VERZENIO (U.S. Patent No. 7,855,211) from
Eli Lilly and Company, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated May 13, 2019, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of VERZENIO 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
VERZENIO is 2,907 days. Of this time, 2,760 days occurred during the
testing phase of the regulatory review period, while 147 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
October 15, 2009. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
October 15, 2009.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: May 5, 2017.
FDA has verified the applicant's claim that the new drug application
(NDA) for VERZENIO (NDA 208716) was initially submitted on May 5, 2017.
    3. The date the application was approved: September 28, 2017. FDA
has verified the applicant's claim that NDA 208716 was approved on
September 28, 2017.
    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 652 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: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04177 Filed 2-28-23; 8:45 am]
BILLING CODE 4164-01-P