[Federal Register Volume 82, Number 101 (Friday, May 26, 2017)]
[Notices]
[Pages 24351-24356]
[FR Doc No: 2017-10818]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0523]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Applications for Food and Drug Administration Approval
To Market a New Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the requirements governing applications for
FDA approval to market a new drug.

DATES: Submit either electronic or written comments on the collection
of information by June 26, 2017. Late, untimely filed comments will not
be considered. Electronic comments must be submitted on or before July
25, 2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time

at the end of July 25, 2017. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are postmarked or the delivery service acceptance receipt is on or
before that date.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2013-N-0523 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Applications for FDA Approval to
Market a New Drug.'' Received comments, those filed in a timely manner
(see DATES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Application for FDA Approval To Market a New Drug

OMB Control Number 0910-0001--Extension

    Under section 505(a) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially
marketed in the United States, imported, or exported from the United
States, unless an approval of an application filed with FDA under
section 505(b) or (j) of the FD&C Act is effective with respect to such
drug. The Agency has codified regulations regarding applications for
FDA approval to market a new drug under 21 CFR part 314. This
collection of information supports the regulatory requirements found in
those regulations. The collection of information is necessary for FDA
to make a scientific and technical determination whether the product is
safe and effective for use, and is summarized as follows:
    Section 314.50(a) requires that an application form (Form FDA 356h)
be submitted that includes information about the applicant, the
submission, and a checklist of enclosures.
    Section 314.50(b) requires that an index be submitted with the
archival

copy of the application and that it reference certain sections of the
application.
    Section 314.50(c) requires that a summary of the application be
submitted that presents a good general synopsis of all the technical
sections and other information in the application.
    Section 314.50(d) requires that the NDA contain the following
technical sections about the new drug: (1) Chemistry, manufacturing,
and controls; (2) nonclinical pharmacology and toxicology; (3) human
pharmacokinetics and bioavailability; (4) microbiology; (5) clinical
data; (6) statistical; and (7) pediatric use sections.
    Section 314.50(e) requires the applicant to submit samples of the
drug if requested by FDA. In addition, the archival copy of the
application must include copies of the label and all labeling for the
drug.
    Section 314.50(f) requires that case report forms and tabulations
be submitted with the archival copy.
    Section 314.50(h) requires that patent information, as described
under Sec.  314.53, be submitted with the application. However, burden
hours for Sec.  314.50(h) are approved under OMB control numbers 0910-
0513, Patent Certification Forms 3542 and 3542a and 0910-0786,
Abbreviated New Drug Applications and 505(b)(2) Applications and are
therefore not included among the estimates found in table 1.
    Section 314.50(i) requires that patent certification information be
submitted in section 505(b)(2) applications for patents claiming the
drug substance, drug product, or method of use. Sections
314.50(i)(1)(i)(C) and 314.54(i) and (j) require that patent
certification information be submitted for each patent listed in the
``Approved Drug Products with Therapeutic Equivalence Evaluations''
(the Orange Book) for a drug product approved in an NDA that is
pharmaceutically equivalent to the proposed drug product in the
original 505(b)(2) application and was submitted and was approved
before the original 505(b)(2) application was submitted. Burden for
these provisions is included under OMB control number 0910-0786.
    Section 314.50(j) requires that applicants who request a period of
marketing exclusivity submit certain information with the application.
    Section 314.50(k) requires that the application contain a financial
certification or disclosure statement or both.
    Section 314.50(l) requires that an archival, review, and field copy
of the application be submitted, including the content of labeling and
all labeling and labels.
    Section 314.52 requires that any notice of certification of
invalidity, unenforceability, or non-infringement of a patent to each
patent owner and the NDA holder be sent by a section 505(b)(2)
applicant that relies on a listed drug. A 505(b)(2) applicant is
required to amend its application at the time notice is provided to
include a statement certifying that the required notice has been
provided. A 505(b)(2) applicant also is required to amend its
application to document receipt of the required notice. Burden hours
for these provisions are included in OMB control number 0910-0786.
    Section 314.53 sets forth the patent information requirements for
applicants who submit applications or amendments to the application
filed under section 505(b)(2) of the FD&C Act or supplements to the
approved 505(b)(2) application. Burden hours for these collections are
approved in OMB control number 0910-0786.
    Section 314.54 sets forth the content requirements for applications
filed under section 505(b)(2) of the FD&C Act. The burden estimate for
505(b)(2) applications is included in table 1 under the estimates for
Sec.  314.50(a) through (g) and (i) through (l).
    Section 314.55 sets forth the assessment requirements for each
application. The burden estimate for 505(b)(2) applications is included
in table 1 under the estimates for Sec.  [thinsp]314.50(a) through (g)
and (i) through (l).
    Section 314.60 sets forth reporting requirements and patent
certification requirements for sponsors who amend an unapproved
505(b)(2) application. Burden hours for the Sec.  314.60(f) collections
are approved under OMB control number 0910-0786.
    Section 314.65 states that the sponsor must notify FDA when
withdrawing an unapproved application.
    Sections 314.70 and 314.71 require that supplements be submitted to
FDA for certain changes to an approved application.
    Section 314.72 requires sponsors to report to FDA any transfer of
ownership of an application.
    Section 314.80(c)(1) and (2) sets forth requirements for expedited
adverse drug experience postmarketing reports and followup reports, as
well as for periodic adverse drug experience postmarketing reports
(Form FDA 3500A).
    Section 314.80(i) establishes recordkeeping requirements for
reports of postmarketing adverse drug experiences. The burden hours for
Sec.  314.80(i) are approved under OMB control numbers 0910-0230,
Adverse Drug Experience Reporting and 0910-0291, MedWatch: FDA's
Medical Reporting Program and therefore burden estimates are not
included in table 1.
    Section 314.81(b)(1) requires that NDA and ANDA field alert reports
be submitted to FDA (Forms FDA 3331 and 3331a).
    Section 314.81(b)(2) requires that annual reports be submitted to
FDA (Form FDA 2252).
    Section 314.81(b)(3)(i) requires that drug advertisements and
promotional labeling be submitted to FDA (Form FDA 2253).
    Section 314.81(b)(3)(iii) sets forth reporting requirements for
sponsors who withdraw an approved drug product from sale. The burden
hours for Sec.  [thinsp]314.81(b)(3)(iii) are approved under OMB
control number 0910-0045, Registration of Producers of Drugs and
Listing of Drugs in Commercial Distribution and therefore are not
included in table 1.
    Section 314.90 sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec.  314.50 through 314.81.
The information collection burden estimate for NDA waiver requests is
included in table 1 under the estimates for each section that is in
part 314, subpart B.
    Section 314.93 sets forth requirements for submitting a suitability
petition to request a change from a listed drug in accordance with
Sec. Sec.  10.20 and 10.30. The burden hours for Sec.  [thinsp]314.93
are approved under OMB control number 0910-0191, Administrative
Practices and Procedures; Formal Evidentiary Public Hearing and are not
included in table 1.
    Section 314.94(a) through (d) require that an ANDA contain the
following information: (1) Application form; (2) table of contents; (3)
basis for ANDA submission; (4) conditions of use; (5) active
ingredients; (6) route of administration, dosage form, and strength;
(7) bioequivalence; (8) labeling; (9) chemistry, manufacturing, and
controls; (10) samples; and (11) patent certification.
    Section 314.95 requires that any notice of certification of
invalidity or non-infringement of a patent to each patent owner and the
NDA holder be sent by ANDA applicants.
    Section 314.96 sets forth requirements for amendments to an
unapproved ANDA.
    Section 314.97 sets forth requirements for submitting supplements
to an approved ANDA for certain changes to the application. Approval of
burden hours for information collections for

Sec. Sec.  314.95, through 314.97 are covered under OMB control number
0910-0786.
    Section 314.98(a) sets forth postmarketing adverse drug experience
reporting and recordkeeping requirements for ANDAs. The burden hours
for Sec.  314.98(a) are approved under OMB control numbers 0910-0230
and 0910-0291 and are not included in table 1.
    Section 314.98(b) requires other postmarketing reports for ANDAs:
(1) Field alert reports (Form FDA 3331a); (2) annual reports (Form FDA
2252); and (3) advertisements and promotional labeling (Form FDA 2253).
(The information collection burden estimate for field alert reports is
included in table 1 under Sec.  [thinsp]314.81(b)(1); the estimate for
annual reports is included under Sec.  314.81(b)(2); the estimate for
advertisements and promotional labeling is included under Sec.
314.81(b)(3)(i).)
    Section 314.99(a) requires that sponsors comply with certain
reporting requirements for withdrawing an unapproved ANDA and for a
change in ownership of an ANDA.
    Section 314.99(b) sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec.  314.92 through 314.99.
(The information collection burden estimate for ANDA waiver requests is
included in table 1 under the estimates for each section that is in
part 314, subpart C.)
    Section 314.101(a) states that if FDA refuses to file an
application, the applicant may request an informal conference with FDA
and request that the application be filed over protest.
    Section 314.107(c) requires notice to FDA by the first applicant to
submit a substantially complete ANDA containing a certification that a
relevant patent is invalid, unenforceable, or will not be infringed of
the date of first commercial marketing. The burden estimate for Sec.
314.107(c) is included in table 1 under the estimates for Sec.
314.50(a) through (g) and (i) through (l).
    Section 314.107(e) requires that an applicant submit a copy of the
entry of the order or judgment to FDA within 10 working days of a final
judgment. The burden estimate for Sec.  314.107(e) applications is
included in table 1 under the estimates for Sec.  314.50(a) through (g)
and (i) through (l) and is approved under OMB control number 0910-0786.
    Section 314.107(f) requires that ANDA or section 505(b)(2)
applicants notify FDA immediately of the filing of any legal action
filed within 45 days of receipt of the notice of certification. A
patent owner must also notify FDA of the filing of any legal action for
patent infringement. If the patent owner or approved application holder
who is an exclusive patent licensee waives its opportunity to file a
legal action for patent infringement within the 45-day period, the
patent owner or approved application holder may submit to FDA a waiver
in the specified format. The burden estimate for Sec.  314.107(f) is
included in table 1 under the estimates for Sec.  314.50 (a) through
(g) and (i) through (l) and is approved under OMB control number 0910-
0786.
    Section 314.110(b)(3) states that, after receipt of an FDA complete
response letter, an applicant must either: (1) Resubmit the application
addressing all the deficiencies identified in the complete response
letter; (2) withdraw the application or; (3) request an opportunity for
a hearing on the question of whether there are grounds for denying
approval of the application. The burden hours for Sec.  314.110(b)(3)
are included under parts 10 through 16 (21 CFR parts 10 through 16, OMB
control number 0910-0191) hearing regulations, in accordance with Sec.
314.201, and are not included in table 1.
    Section 314.122(a) requires that an ANDA or a suitability petition
that relies on a listed drug that has been voluntarily withdrawn from
sale must be accompanied by a petition seeking a determination whether
the drug was withdrawn for safety or effectiveness reasons. The burden
hours for Sec.  314.122(a) are approved under OMB control number 0910-
0191 and therefore are not included in table 1.
    Section 314.122(d) sets forth requirements for relisting petitions
for unlisted discontinued products. The burden hours for Sec.
314.122(d) are approved under OMB control number 0910-0191 and
therefore are not included in table 1.
    Sections 314.125 and 314.127 state that FDA may refuse to approve
an NDA or an ANDA and will provide the applicant written notice of an
opportunity for a hearing under Sec.  314.200 along with the reason for
refusal to approve the application, including lack of a patent
certification or statement with respect to each listed patent for an
approved drug product that is pharmaceutically equivalent to the drug
product for which the original 505(b)(2) application is submitted and
was approved before the original 505(b)(2) was submitted. The burden
hours for Sec. Sec.  314.125 and 314.127 (refuse to approve an ANDA)
are included under parts 10 through 16 hearing regulations (in
accordance with Sec.  314.201) and approved under OMB control number
0910-0191, and therefore are not included in table 1.
    Section 314.126(c) sets forth requirements for a petition to waive
criteria for adequate and well-controlled studies. The burden hours for
Sec.  314.126(c) are approved under OMB control number 0910-0191 and
therefore are not included in table 1.
    Sections 314.150(a) and (b) and 314.151(a) and (b) set forth
requirements for the withdrawal of approval of an NDA or ANDA and the
applicant's opportunity for a hearing and submission of comments. The
burden hours for Sec.  314.151(a) and (b) are included under parts 10
through 16 hearing regulations, in accordance with Sec.  314.201, and
approved under OMB control number 0910-0191 and therefore are not
included in table 1.
    Section 314.151(c) sets forth the requirements for withdrawal of
approval of an ANDA and the applicant's opportunity to submit written
objections and participate in a limited oral hearing. The burden hours
for Sec.  314.151(c) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, approved under OMB
control number 0910-0191, and therefore are not included in table 1.
    Section 314.153(b) sets forth the requirements for suspension of an
ANDA when the listed drug is voluntarily withdrawn for safety and
effectiveness reasons, and the applicant's opportunity to present
comments and participate in a limited oral hearing. The burden hours
for Sec.  314.152(b) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, approved under OMB
control number 0910-0191, and therefore are not included in table 1.
    Section 314.161(b) and (e) sets forth the requirements for
submitting a petition to determine whether a listed drug was
voluntarily withdrawn from sale for safety or effectiveness reasons.
The burden hours for Sec.  314.161(b) and (e) are approved under OMB
control number 0910-0191 and therefore are not included in table 1.
    Section 314.200(c), (d), and (e) requires that applicants or others
subject to a notice of opportunity for a hearing who wish to
participate in a hearing file a written notice of participation and
request for a hearing as well as the studies, data, and so forth,
relied on. Other interested persons may also submit comments on the
notice. This section also sets forth the content and format
requirements for the applicants' submission in response to notice of
opportunity for hearing. The burden hours for Sec.  314.200(c), (d),
and (e) are included under parts 10 through 16 hearing regulations, in
accordance with

Sec.  314.201, are approved under OMB control number 0910-0191, and
therefore are not included in table 1.
    Section 314.200(f) states that participants in a hearing may make a
motion to the presiding officer for the inclusion of certain issues in
the hearing. The burden hours for Sec.  314.200(f) are included under
parts 10 through 16 hearing regulations, in accordance with Sec.
314.201, are approved under OMB control number 0910-0191, and therefore
are not included in table 1.
    Section 314.200(g) states that a person who responds to a proposed
order from FDA denying a request for a hearing provide sufficient data,
information, and analysis to demonstrate that there is a genuine and
substantial issue of fact which justifies a hearing. The burden hours
for Sec.  314.200(g) are included under parts 10 through 16 hearing
regulations, in accordance with Sec.  314.201, are approved under OMB
control number 0910-0191, and therefore are not included in table 1.
    Section 314.420 states that an applicant may submit to FDA a drug
master file in support of an application, in accordance with certain
content and format requirements.
    Section 314.430 states that data and information in an application
are disclosable under certain conditions, unless the applicant shows
that extraordinary circumstances exist. The burden hours for Sec.
314.430 are included under parts 10 through 16 hearing regulations, in
accordance with Sec.  314.201, are approved under OMB control number
0910-0191, and therefore are not included in table 1.
    Section 314.530(c) and (e) states that if FDA withdraws approval of
a drug approved under the accelerated approval procedures, the
applicant has the opportunity to request a hearing and submit data and
information. The burden hours for Sec.  314.530(c) and (e) are included
under parts 10 through 16 hearing regulations, in accordance with Sec.
314.201, are approved under OMB control number 0910-0191, and therefore
are not included in table 1.
    Section 314.530(f) requires that an applicant first submit a
petition for stay of action before requesting an order from a court for
a stay of action pending review. The burden hours for Sec.  314.530(f)
are approved under OMB control number 0910-0191, and therefore are not
included in table 1.
    Section 314.550 requires an applicant with a new drug product being
considered for accelerated approval to submit copies of all promotional
materials to the FDA during the preapproval and post-approval periods.
    Section 314.610(b)(1) requires that applicants include a plan or
approach to postmarketing study commitments in applications for
approval of new drugs when human efficacy studies are not ethical or
feasible, and provide status reports of postmarketing study
commitments. The burden estimate for Sec.  314.610(b)(1) is included in
table 1 under the estimates for Sec. Sec.  314.50 (a) through (f), (k),
and (l) and 314.81(b)(2)).
    Section 314.610(b)(3) requires that applicants propose labeling to
be provided to patient recipients in applications for approval of new
drugs when human efficacy studies are not ethical or feasible. The
burden estimate for Sec.  314.610(b)(3) is included in table 1 under
the estimates for Sec.  314.50(e).
    Section 314.630 requires that applicants provide postmarketing
safety reporting for applications for approval of new drugs when human
efficacy studies are not ethical or feasible. The burden hours for
Sec.  314.630 are approved under OMB control numbers 0910-0230 and
0910-0291 and therefore not included in table 1.
    Section 314.640 requires that applicants provide promotional
materials for applications for approval of new drugs when human
efficacy studies are not ethical or feasible. The burden estimate for
Sec.  314.640 is included in table 1 under the estimates for Sec.
314.81(b)(3)(i)).
    Accordingly, we estimate the burden for this collection of
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 21 CFR Section/ [FDA Form No.]      Number of     responses per   Total  annual    burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
314.50(a)-(g), (i)-(l) [356h]--              378            1.33             503           1,921         966,263
 Content and format of a
 505(b)(1) or 505(b)(2)
 application....................
314.52--Non-infringement of                    7               3              21              16             336
 patents (NDAs).................
314.95--Non-infringement of                  209               3             627              16          10,032
 patents (ANDAs)................
314.60--Amendments..............             564            9.96           5,618              80         449,440
314.65--Withdrawal of unapproved              27           71.63            1934               2           3,868
 applications...................
314.70 and 314.71--Supplements               838            7.04           5,897             150         884,550
 and submissions................
314.72--Change of ownership.....             142            2.04             289               2             578
314.81--Other postmarketing                  342           19.98           6,834               8          54,672
 reports and 314.81(b)(1) [3331
 and 3331a] field alert reports.
314.81(b)(2) [2252]--Annual                  913            5.07            4632              40         185,280
 reports........................
314.81(b)(3)(i) [2253]--                     529           81.66          43,198               2          86,396
 Promotional labeling...........
314.94(a) and (d)--ANDA content.           180.5            3.75           676.5             480         324,720
314.96(a)(1)--Amendments to                  514           26.66          13,647              80       1,091,760
 unapproved ANDAs...............
314.97--Supplements to ANDAs....             343           17.57            6027              80         482,160
314.99(a)--Responsibilities of               265            7.04            1867               2           3,734
 ANDA Applicants................
314.101(a)--ANDA filing.........               1               1               1              .5              .5
                                                                                (30 minutes)
314.420--Drug Master Files......             500            2.06           1,028              61          62,708
314.550--Promotional material                 29            7.76             225             120          27,000
 and subpart H applications.....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............     4,633,497.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: May 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10818 Filed 5-25-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Page 3673]
[FR Doc No: 2015-01077]

-----------------------------------------------------------------------

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 17Ad-6 and 17Ad-7. SEC File No. 270-151, OMB Control No.
3235-0291.

    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 existing
collection of information provided for in Rule 17Ad-6 (17 CFR 240.17Ad-
6) and Rule 17Ad-7 (17 CFR 240.17Ad-7) under the Securities Exchange
Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange Act''). The Commission
plans to submit this existing collection of information to the Office
of Management and Budget for extension and approval.
    Rule 17Ad-6 requires every registered transfer agent to make and
keep current records about a variety of information, such as: (1)
Specific operational data regarding the time taken to perform transfer
agent activities (to ensure compliance with the minimum performance
standards in Rule 17Ad-2 (17 CFR 240.17Ad-2)); (2) written inquiries
and requests by shareholders and broker-dealers and response time
thereto; (3) resolutions, contracts, or other supporting documents
concerning the appointment or termination of the transfer agent; (4)
stop orders or notices of adverse claims to the securities; and (5) all
canceled registered securities certificates.
    Rule 17Ad-7 requires each registered transfer agent to retain the
records specified in Rule 17Ad-6 in an easily accessible place for a
period of six months to six years, depending on the type of record or
document. Rule 17Ad-7 also specifies the manner in which records may be
maintained using electronic, microfilm, and microfiche storage methods.
    These recordkeeping requirements are designed to ensure that all
registered transfer agents are maintaining the records necessary for
them to monitor and keep control over their own performance and for the
Commission to adequately examine registered transfer agents on an
historical basis for compliance with applicable rules.
    The Commission estimates that approximately 429 registered transfer
agents will spend a total of 214,500 hours per year complying with
Rules 17Ad-6 and 17Ad-7 (500 hours per year per transfer agent).
    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 on
respondents; 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 Dyson, Acting
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: January 16, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-01077 Filed 1-22-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 190 (Tuesday, October 3, 2023)]
[Notices]
[Pages 68186-68187]
[FR Doc No: 2023-21786]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98561; File No. SR-Phlx-2023-44]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Pricing
Schedule at Options 7, Section 4 Regarding Marketing Fees

September 27, 2023.
    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 September 13, 2023, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III, below,
which Items have been prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to a proposal to amend its Pricing Schedule
at Options 7, Section 4.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the Exchange 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. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to amend the Exchange's Pricing Schedule at
Options 7, Section 4 to specify the application of its marketing fees.
Today, the Exchange delineates pricing for multiply-listed options in
Options 7, Section 4, including marketing fees (``Marketing Fees'').
The Marketing Fees for multiply-listed options are assessed on Lead
Market Makers,\3\ Market Makers,\4\ and Directed Market Makers \5\ for
trades resulting from either Directed or non-Directed Customer Orders
\6\ that are delivered electronically and executed on the Exchange,
with certain specified exceptions, including the exclusion of
transactions in broad-based index options symbols listed in Options 7,
Section 5.A.
---------------------------------------------------------------------------

    \3\ The term ``Lead Market Maker'' applies to transactions for
the account of a Lead Market Maker (as defined in Options 2, Section
12(a)). A Lead Market Maker is an Exchange member who is registered
as an options Lead Market Maker pursuant to Options 2, Section
12(a). An options Lead Market Maker includes a Remote Lead Market
Maker which is defined as an options Lead Market Maker in one or
more classes that does not have a physical presence on an Exchange
floor and is approved by the Exchange pursuant to Options 2, Section
11.
    \4\ The term ``Market Maker'' is defined in Options 1, Section
1(b)(28) as a member of the Exchange who is registered as an options
Market Maker pursuant to Options 2, Section 12(a). A Market Maker
includes SQTs and RSQTs as well as Floor Market Makers.
    \5\ The term ``Directed Market Maker'' means a Market Maker that
receives a Directed Order in accordance with Options 2, Section 10.
    \6\ The term ``Directed Order'' means any order to buy or sell
which has been directed to a particular Lead Market Maker, RSQT, or
SQT by an Order Flow Provider, as defined in Options 2, Section 10.
To qualify as a Directed Order, an order must be delivered to the
Exchange via the System.
---------------------------------------------------------------------------

    The Exchange now proposes to amend the rule to specify that no
Marketing Fees will be assessed on transactions in options symbols
subject to Options 7, Section 5 pricing \7\ to make clear that the
exclusion also applies to all singly listed options subject to pricing
in Options 7, Section 5.C and Options 7, Section 5.D (in addition to
broad-based index options symbols in Options 7, Section 5.A, as
currently specified). The Exchange notes that this is not a change to
current practice; rather, the proposed changes are intended to
memorialize how the Exchange currently assesses Marketing Fees. Today,
the Exchange already indicates in the header of Options 7, Section 4
that the pricing set forth in Section 4 (including Marketing Fees)
applies only to multiply listed options excluding SPY and the broad-
based index options in Options 7, Section 5.A. Section 4 specifically
excludes the broad-based index options in Options 7, Section 5.A
because some of the symbols (like NDX) are multiply listed.
Furthermore, Options 7, Section 5 specifically indicates that the
pricing set forth in this Section 5 applies to index options and singly
listed options. By implication, options that are singly listed on Phlx,
and that are subject to Options 7, Section 5.C and Section 5.D pricing
are excluded from Options 7, Section 4 pricing like the Marketing Fees.
However, the Exchange believes that further clarity will be helpful by
explicitly stating this exclusion in the Marketing Fees portion of
Section 4 to avoid potential confusion by market participants and
investors.
---------------------------------------------------------------------------

    \7\ Options 7, Section 5 sets forth pricing for index and singly
listed options (includes options overlying FX Options, equities,
ETFs, ETNs, and indexes not listed on another exchange).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\8\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\9\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among members and issuers and other persons using any facility,
and is not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed changes in Options 7,
Section 4 to specify that no Marketing Fees will be assessed on
transactions in options symbols subject to Options 7, Section 5 pricing
are reasonable because the changes will make clear that the exclusion
also applies to all singly listed options subject to pricing in Options
7, Section 5.C and Options 7, Section 5.D (in addition to broad-based
index options symbols in Options 7, Section 5.A, as currently
specified). As discussed above, the proposed changes will not amend
current practice; rather, the proposed changes are intended to
memorialize how the Exchange currently assesses Marketing Fees. While
the Exchange already indicates which sections of its Pricing Schedule
apply to which options in the manner discussed above, the Exchange
believes that further clarity will be helpful by explicitly stating in
the Marketing Fees pricing program itself that all symbols subject to
Options 7, Section 5 pricing

will be excluded from the Marketing Fees in order to avoid potential
confusion by market participants and investors. The Exchange also
believes that it is reasonable to exclude singly listed options in
Options 7, Section 5 from the Marketing Fees because the purpose of
this program is to generate more Customer order flow to the Exchange.
Because singly listed options are exclusively listed products on Phlx,
the Exchange does not believe that applying Marketing Fees is necessary
for these products.
    Lastly, the Exchange believes that its proposal to memorialize that
all options symbols subject to Options 7, Section 5 pricing are
excluded from the Marketing Fees program set forth in Options 7,
Section 4 is equitable and not unfairly discriminatory because the
program will uniformly exclude all market participant orders in these
symbols. As noted above, the Exchange's proposal does not alter its
existing Marketing Fees program, but instead memorializes current
practice.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange does not believe
that its proposal would impose an undue burden on intra-market
competition. The proposed changes will memorialize current practice
that no Marketing Fees will be assessed on transactions in options
symbols subject to Options 7, Section 5 pricing, which will continue to
apply uniformly to all market participant orders in such symbols.
    In terms of inter-market competition, the Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited.

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

    No written comments were either solicited or received.

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) of the Act.\10\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    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: (i)
necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-Phlx-2023-44 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-Phlx-2023-44. 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 website (https://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 website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-Phlx-2023-44 and should be
submitted on or before October 24, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-21786 Filed 10-2-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 47 (Thursday, March 10, 2011)]
[Notices]
[Pages 13178-13179]
[FR Doc No: 2011-5484]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13968-000]

Qualified Hydro 36, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On January 3, 2011, Qualified Hydro 36, LLC filed an application,
pursuant to Section 4(f) of the Federal Power Act, proposing to study
the feasibility of the Kaskaskia Lock and Dam Hydroelectric Project No.
13968, to be located at the existing Kaskaskia Lock and Dam on the

Kaskaskia River, near the Town of Chester, in Randolph County,
Illinois. The Kaskaskia Lock and Dam is owned by the United States
government and operated by the U.S. Army Corps of Engineers.
    The proposed project would consist of: (1) A new 330-foot-long by
150-foot-wide by 60 foot-high reinforced concrete powerhouse; (2) a new
100-foot-long by 100-foot-wide tailrace channel; (3) a new 100-foot-
long by 100-foot-wide intake structure; (4) two horizontal bulb
turbines with a combined capacity of 8.0 megawatts; (5) a new 50 foot
by 60 foot, 10 MVA substation adjacent to the powerhouse; (6) a new-
47,500 foot-long, 34 to 69-kilovolt transmission line; and (7)
appurtenant facilities. The project would have an estimated annual
generation of 28.0 gigawatt-hours.
    Applicant Contact: Ramya Swaminathan, 33 Commercial Street,
Gloucester, MA 01930,<PHONE_NUMBER>.
    FERC Contact: Tyrone A. Williams,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, and competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance date of this notice.
Comments, motions to intervene, notices of intent, and competing
applications 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://www.ferc.gov/docs-filing/ferconline.asp) under the ``eFiling''
link. For a simpler method of submitting text only comments, click on
``Quick Comment.'' For assistance, please contact FERC Online Support
at FERCOnlineSupport.gov; call toll-free at<PHONE_NUMBER>; or, for
TTY, contact<PHONE_NUMBER>. Although the Commission strongly
recommends electronic filing, documents may also be paper-filed. To
paper-file, an original and eight copies should be mailed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426. For more information on how to
submit these types of filings please go to the Commission's Web site
located at http://www.ferc.gov/filing-comments.asp.
    More information about this project, including a copy of the
application can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13968) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: March 4, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-5484 Filed 3-9-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3265-3267]
[FR Doc No: 2019-01728]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85052; File No. SR-BOX-2019-01]

Self-Regulatory Organizations; BOX Exchange LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Clarify That
Multi-Leg Qualified Open Outcry Orders Are Permitted on the BOX Trading
Floor

February 5, 2019.
    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 January 30, 2019, BOX Exchange LLC (the ``Exchange'') 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 the self-regulatory organization. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to make multi-leg QOO Orders available on the
BOX Trading Floor. The text of the proposed rule change is available
from the principal office of the Exchange, at the Commission's Public
Reference Room and also on the Exchange's internet website at http://boxoptions.com.

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

    In its filing with the Commission, the self-regulatory organization
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. The self-regulatory organization
has prepared summaries, set forth in Sections A, B, and C below, of the
most significant aspects of such statements.

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

1. Purpose
    In August 2017, the Securities and Exchange Commission (``SEC'' or
``Commission'') approved the Exchange's proposal to adopt rules for an
open outcry trading floor.\3\ Among the approved rules was BOX Rule
7600(a)(4) which stated that ``QOO Orders may be multi-leg orders up to
four (4) legs, including Complex Orders as defined in Rule 7240(a)(5)
and tied to hedge orders as defined in IM-7600-2.'' \4\ The Exchange
notes that while this

rule currently allows for multi-leg QOO Orders that do not meet the
definition of a Complex Order \5\ to trade on the BOX Trading Floor,
such multi-leg QOO Orders are not currently traded. Due to technology
enhancements, the Exchange now proposes to make these multi-leg QOO
Orders available on the BOX Trading Floor.\6\ As such, the Exchange
proposes to add rule text that states that the priority rules for
Complex Orders contained in Rule 7240(b)(2) and (3) do not apply to
multi-leg QOO orders that are not Complex Orders (``multi-leg QOO
Orders''). Multi-leg QOO Orders must involve the simultaneous purchase
and/or sale of two or more different options series in the same
underlying security, for the same account, and for the purpose of
executing a particular investment strategy.\7\ Each component series of
a multi-leg QOO order must be executed at a price that is equal to or
better than the NBBO for that series subject to the exceptions of Rule
15010(b). Each component series of a multi-leg QOO order (1) may not
trade through any equal or better priced Public Customer bids or offers
on the BOX book for that series or any non-Public Customer bids or
offers on the BOX book for that series that are ranked ahead of or
equal to better priced Public Customer bids or offers, and (2) may not
trade through any non-Public Customer bids or offers for that series on
the BOX book that are priced better than the proposed execution
price.\8\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 81292 (August 2,
2017), 82 FR 37144 (August 8, 2017) (Order Approving a Proposed Rule
Change, as Modified by Amendment Nos. 1 and 2, To Adopt Rules for an
Open-Outcry Trading Floor).
    \4\ The Exchange notes it recently amended this rule to provide
the ability for the Exchange to determine the applicable number of
legs for a Complex QOO Order. See Securities Exchange Act Release
No. 84340 (October 2, 2018), 83 FR 50718 (October 9, 2018) (Notice
of Filing and Immediate Effectiveness SR-BOX-2018-30). In this
filing, the Exchange stated that only orders that meet the
definition of a Complex Order are allowed to trade on the BOX
Trading Floor. The Exchange now proposes, due to technology
enhancements, to make such multi-leg QOO Orders that do not meet the
definition of a Complex Order available on the BOX Trading Floor.
Upon approval, multi-leg QOO orders that are entered into the system
will be accepted and executed pursuant to Rule 7600(c). The Exchange
notes that Complex Order priority provisions do not apply to multi-
leg QOO Orders. Multi-leg QOO Orders are treated like single-leg QOO
Orders with respect to execution and priority.
    \5\ The term ``Complex Order'' means any order involving the
simultaneous purchase and/or sale of two or more different options
series in the same underlying security, for the same account, in a
ratio that is equal to or greater than one-to-three (.333) and less
than or equal to three-to-one (3.00) and for the purpose of
executing a particular investment strategy. See BOX Rule 7240(a)(7).
    \6\ The Exchange notes that NYSE Arca Inc. (``NYSE Arca'')
currently allows multi-leg orders to trade on their trading floor.
While NYSE Arca does not specifically provide in their rulebook that
multi-leg orders (that do not meet the definition of a Complex
Order) may trade on the trading floor, NYSE Arca distributed a
regulatory bulletin which detailed the rules of priority and order
protection in open outcry including multi-leg orders on the trading
floor. Specifically, the bulletin states, ``OTP Holders are reminded
that orders involving multiple legs that do not meet the definition
of a Complex Order, as defined in Rule 6.62(e) . . . do not have
priority over equal priced priority interest in the Consolidated
Book.'' See NYSE Arca Options RB-16-04. Given this language, the
Exchange believes that multi-leg orders that do not meet the
definition of a Complex Order are currently permitted on the NYSE
Arca trading floor. As such, the Exchange does not believe the
proposed clarification is novel; especially since current BOX rules
already allow for such orders to be traded on the Trading Floor. The
purpose of this filing is to advise market participants that multi-
leg QOO Orders will now be allowed to trade on the Trading Floor due
to recent technological enhancements.
    \7\ The Exchange notes multi-leg QOO Orders are the same as
Complex QOO Orders except for the ratio restrictions.
    \8\ The Exchange notes that similar functionality exists at NYSE
Arca with respect to execution and priority for single leg orders on
their trading floor. See NYSE Arca Rule 6.47-O(a)(3).
---------------------------------------------------------------------------

    The Exchange notes that the system will enforce the execution and
priority provisions in the proposed change. As such, multi-leg QOO
Orders will not be allowed to take advantage of the Complex Order
priority provisions in BOX Rule 7240(b)(2) and (3).
    The Exchange anticipates this enhanced functionality to be
available in the first quarter of 2019. The Exchange will distribute an
Informational Circular at least two weeks before the implementation
date.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\9\ in general, and Section
6(b)(5) of the Act,\10\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest. The Exchange believes that the proposed change discussed
herein protects investors and the public interest as it will reduce any
potential confusion regarding multi-leg QOO Orders on the BOX Trading
Floor. Further, the Exchange notes that similar functionality exists on
another options exchange with a trading floor.\11\ Also, the Exchange
believes the proposed change promotes just and equitable principles of
trade and removes impediments to and perfects the mechanism of a free
and open market and a national system because it mirrors the current
functionality for single leg orders on the Trading Floor. Lastly, the
Exchange believes the proposed change is consistent with the Act
because it is simply advising Participants of the technological
enhancement. Further, the functionality is available to all Floor
Participants.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ See supra note 6.
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
proposed clarification will promote competition by making the enhanced
functionality available to market participants. The Exchange notes that
similar functionality already exists on another trading floor.\12\ As
such, the Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \12\ Id.
---------------------------------------------------------------------------

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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \13\ and Rule 19b-4(f)(6) \14\
thereunder.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    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. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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-BOX-2019-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BOX-2019-01. 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BOX-2019-01 and should be submitted on
or before March 4, 2019.
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-01728 Filed 2-8-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Notices]
[Page 51080-51081]
[DOCID:fr18au10-114]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-P-0386]

Determination That DIASTAT (Diazepam Rectal Gel), 5 Milligrams/
Milliliter, 10 Milligrams/2 Milliliter, 15 Milligrams/3 Milliliter, and
20 Milligrams/4 Milliliter, Was Not Withdrawn From Sale for Reasons of
Safety or Effectiveness

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) has determined that
DIASTAT (diazepam rectal gel) (DIASTAT), 5 milligrams (mg)/milliliter
(mL), 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, was not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
diazepam rectal gel, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL,
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6312, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is
typically a version of the drug that was previously approved. Sponsors
of ANDAs do not have to repeat the extensive clinical testing otherwise
necessary to gain approval of a new drug application (NDA). The only
clinical data required in an ANDA are data to show that the drug that
is the subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
agency withdraws or suspends approval of the drug's NDA for reasons of
safety or effectiveness, or if FDA determines that the listed drug was
withdrawn from sale for reasons of safety or effectiveness (21 CFR
314.162). Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the agency
must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug.
    Lachman Consultant Services, Inc., submitted to FDA a citizen
petition dated May 15, 2006 (Docket No. FDA-2006-P-0386),\1\ under 21
CFR 10.30 requesting that the agency determine whether DIASTAT
(diazepam rectal gel), 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL,
was withdrawn from sale for reasons of safety or effectiveness. DIASTAT
(diazepam rectal gel) is the subject of approved NDA 20-648 held by
Valeant Pharmaceuticals International (Valeant) (formerly held by Xcel
Pharmaceuticals). DIASTAT (diazepam rectal gel) is an anticonvulsant
agent indicated for use in the management of selected, refractory
patients with epilepsy, on stable regimens of antiepileptic drugs, who
require intermittent use of diazepam to control bouts of increased
seizure activity.
---------------------------------------------------------------------------

    \1\ This citizen petition was originally assigned docket number
2006P-0209. The number changed to FDA-2006-P-0386 as a result of
FDA's transition to its new docketing system (Regulations.gov) in
January 2008.
---------------------------------------------------------------------------

    DIASTAT (diazepam rectal gel) was approved on July 29, 1997 (NDA
20-648). On September 15, 2005, FDA approved a supplement (NDA 20-648/
S-008) for a new delivery system of DIASTAT (diazepam rectal gel),
marketed under the trade name DIASTAT ACUDIAL. Following approval of
DIASTAT ACUDIAL, Valeant discontinued marketing DIASTAT (diazepam
rectal gel) (NDA 20-648) in the 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20
mg/4 mL strengths, and those strengths of the product were moved to the
``Discontinued Drug Product List'' section of the Orange Book. We note
that the original DIASTAT (diazepam rectal gel) and DIASTAT ACUDIAL
that replaced the original DIASTAT delivery system contain the same
diazepam gel formulation. Thus, the original diazepam gel formulation
is still being marketed, but in a different delivery system.
    After considering the citizen petitions, other information
submitted to the docket, and reviewing our records, FDA has determined
that DIASTAT (diazepam rectal gel), 5 mg/ mL, 10 mg/2 mL, 15 mg/3 mL,
and 20 mg/4 mL, was not withdrawn from sale for reasons of safety or
effectiveness. FDA has independently evaluated relevant literature and
data for possible postmarketing adverse events and has found no
information that would indicate that DIASTAT (diazepam rectal gel), 5
mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, was withdrawn from sale
for reasons of safety or effectiveness. Issues regarding the
appropriateness of permitting ANDAs referencing the discontinued
DIASTAT (diazepam rectal gel) to be marketed at the same time as
DIASTAT ACUDIAL are being addressed in a separate docket (FDA-2006-P-
0009).
    Accordingly, the agency will continue to list DIASTAT (diazepam
rectal gel), 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to DIASTAT (diazepam
rectal gel), 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL, and 20 mg/4 mL, may be
approved by the agency if all other legal and regulatory requirements
for the approval of ANDAs are met. If FDA determines that labeling for
this drug product should be revised to meet current standards, the
agency will advise ANDA applicants to submit such labeling.

    Dated: August 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-20327 Filed 8-17-10; 8:45 am]
BILLING CODE 4160-01-S