[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44868-44872]
[FR Doc No: 2016-16352]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0578]

Agency Information Collection Activities; Proposed Collection;
Comment Request; General Licensing Provisions: Biologics License
Application, Changes to an Approved Application, Labeling, Revocation
and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 collection of information
relating to general licensing provisions for biologics license
applications (BLAs), changes to an approved application, labeling,
revocation and suspension, postmarketing studies status reports, and
Form FDA 356h.

DATES: Submit electronic or written comments on the collection of
information by September 9, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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-0578 for ``General Licensing Provisions: Biologics License
Application, Changes to an Approved Application, Labeling, Revocation
and Suspension, Postmarketing Studies Status Reports and Form FDA
356h.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852<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.

General Licensing Provisions: Biologics License Application, Changes to
an Approved Application, Labeling, Revocation and Suspension,
Postmarketing Studies Status Reports, and Form FDA 356h

OMB Control No. 0910-0338--Extension

    Under section 351 of the Public Health Services Act (the PHS Act)
(42 U.S.C. 262), manufacturers of biological products must submit a
license application for FDA review and approval before marketing a
biological product in interstate commerce. Licenses may be issued only
upon showing that the establishment and the products for which a
license is desired meets standards prescribed in regulations designed
to ensure the continued safety, purity, and potency of such products.
All such licenses are issued, suspended, and revoked as prescribed by
regulations in part 601 (21 CFR part 601).
    Section 130(a) of the Food and Drug Administration Modernization
Act (Pub. L. 105-115) amended the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by adding a new provision (section 506B of the FD&C Act
(21 U.S.C. 356b)) requiring reports of postmarketing studies for
approved human drugs and licensed biological products. Section 506B of
the FD&C Act provides FDA with additional authority to monitor the
progress of postmarketing studies that applicants have made a
commitment to conduct and requires the Agency to make publicly
available information that pertains to the status of these studies.
Under section 506B(a) of the FD&C Act, applicants that have committed
to conduct a postmarketing study for an approved human drug or licensed
biological product must submit to FDA a status report of the progress
of the study or the reasons for the failure of the applicant to conduct
the study. This report must be submitted within 1 year after the U.S.
approval of the application and then annually until the study is
completed or terminated.
    A summary of the collection of information requirements follows:
    Section 601.2(a) requires a manufacturer of a biological product to
submit an application on forms prescribed for such purposes with
accompanying data and information, including certain labeling
information, to FDA for approval to market a product in interstate
commerce. The container and package labeling requirements are provided
under Sec. Sec.  610.60 through 610.65 (21 CFR 610.60 through 610.65).
The estimate for these regulations is included in the estimate under
Sec.  601.2(a) in table 1.
    Section 601.5(a) requires a manufacturer to submit to FDA notice of
its intention to discontinue manufacture of a product or all products.
Section 601.6(a) requires the manufacturer to notify selling agents and
distributors upon suspension of its license, and provide FDA of such
notification.
    Section 601.12(a)(2) requires, generally, that the holder of an
approved BLA must assess the effects of a manufacturing change before
distributing a biological product made with the change. Section
601.12(a)(4) requires, generally, that the applicant must promptly
revise all promotional labeling and advertising to make it consistent
with any labeling changes implemented. Section 601.12(a)(5) requires
the applicant to include a list of all changes contained in the
supplement or annual report; for supplements, this list must be
provided in the cover letter. The burden estimates for Sec.
601.12(a)(2) are included in the estimates for supplements (Sec. Sec.
601.12(b) and (c)) and annual reports (Sec.  601.12(d)). The burden
estimates for Sec.  601.12(a)(4) are included in the estimates under
601.12(f)(4) in table 1.
    Sections 601.12(b)(1) and (3), (c)(1), (3), and (5), and (d)(1) and
(3) require applicants to follow specific procedures to submit
information to FDA of any changes, in the product, production process,
quality controls, equipment, facilities, or responsible personnel
established in an approved license application. The appropriate
procedure depends on the potential for the change to have a
substantial, moderate, or minimal adverse effect on the identity,
strength, quality, purity, or potency of the products as they may
relate to the safety or effectiveness of the product. Under Sec.
601.12(b)(4), an applicant may ask FDA to expedite its review of a
supplement for public health reasons or if a delay in making the change
described in it would impose an extraordinary hardship of the
applicant. The burden estimate for Sec.  601.12(b)(4) is minimal and
included in the estimate under Sec.  601.12(b)(1) and (3) in table 1.
    Section 601.12(e) requires applicants to submit a protocol, or
change to a protocol, as a supplement requiring FDA approval before
distributing the product. Section 601.12(f)(1) through (3) requires
applicants to follow specific procedures to report certain labeling
changes to FDA. Section 601.12(f)(4) requires applicants to report to
FDA advertising and promotional labeling and any changes.
    Under Sec.  601.14, the content of labeling required in 21 CFR
201.100(d)(3) must be in electronic format and in a form that FDA can
process, review, and archive. This requirement is in addition to the
provisions of Sec. Sec.  601.2(a) and 601.12(f). The burden estimate
for Sec.  601.14 is minimal and included in the estimate under
Sec. Sec.  601.2(a) (BLAs) and 601.12(f)(1) through (3) (labeling
supplements and annual reports) in table 1.
    Section 601.45 requires applicants of biological products for
serious or life-threatening illnesses to submit to the Agency for
consideration, during the pre-approval review period, copies of all
promotional materials, including promotional labeling as well as
advertisements.
    In addition to Sec. Sec.  601.2 and 601.12, there are other
regulations in 21 CFR parts 640, 660, and 680 that relate to
information to be submitted in a license application or supplement for
certain blood or allergenic products as follows: Sec. Sec.  640.6;
640.17; 640.21(c); 640.22(c); 640.25(c); 640.56(c); 640.64(c);
640.74(a) and (b)(2); 660.51(a)(4); and 680.1(b)(2)(iii) and (d).
    In table 1, the burden associated with the information collection
requirements in the applicable regulations is included in the burden
estimate for Sec. Sec.  601.2 and/or 601.12. A regulation may be listed
under more than one subsection of Sec.  601.12 due to the type of
category under which a change to an approved application may be
submitted.
    There are also additional container and/or package labeling
requirements for certain licensed biological products including: Sec.
640.74(b)(3) and (4) for Source Plasma Liquid; Sec.  640.84(a) and (c)
for Albumin; Sec.  640.94(a) for Plasma Protein Fraction; Sec.
660.2(c) for Antibody to Hepatitis B Surface Antigen; Sec.  660.28(a),
(b), and (c) for Blood Grouping Reagent; Sec.  660.35(a), (c through
g), and (i through m) for Reagent Red Blood Cells; Sec.  660.45 for
Hepatitis B Surface Antigen; and Sec.  660.55(a) and (b) for Anti-Human
Globulin. The burden associated with the additional labeling
requirements for submission of a license application for these certain
biological products is minimal because the majority of the burden is
associated with the requirements under Sec. Sec.  610.60 through 610.65
or 21 CFR 809.10. Therefore, the burden estimates for these regulations
are included in the estimate under Sec. Sec.  610.60 through 610.65 in
table 1. The burden estimates associated with Sec.  809.10 are approved
under OMB control number 0910-0485.

    Section 601.27(a) requires that applications for new biological
products contain data that are adequate to assess the safety and
effectiveness of the biological product for the claimed indications in
pediatric subpopulations, and to support dosing and administration
information. Section 601.27(b) provides that an applicant may request a
deferred submission of some or all assessments of safety and
effectiveness required under Sec.  601.27(a) until after licensing the
product for use in adults. Section 601.27(c) provides that an applicant
may request a full or partial waiver of the requirements under Sec.
601.27(a) with adequate justification. The burden estimates for Sec.
601.27(a) are included in the burden estimate under Sec.  601.2(a) in
table 1 since these regulations deal with information to be provided in
an application.
    Section 601.28 requires sponsors of licensed biological products to
submit the information in Sec.  601.28(a), (b), and (c) to the Center
for Biologics Evaluation and Research (CBER) or to the Center for Drug
Evaluation and Research (CDER) each year, within 60 days of the
anniversary date of approval of the license. Section 601.28(a) requires
sponsors to submit to FDA a brief summary stating whether labeling
supplements for pediatric use have been submitted and whether new
studies in the pediatric population to support appropriate labeling for
the pediatric population have been initiated. Section 601.28(b)
requires sponsors to submit to FDA an analysis of available safety and
efficacy data in the pediatric population and changes proposed in the
labeling based on this information. Section 601.28(c) requires sponsors
to submit to FDA a statement on the current status of any postmarketing
studies in the pediatric population performed by, on or behalf of, the
applicant. If the postmarketing studies were required or agreed to, the
status of these studies is to be reported under Sec.  601.70 rather
than under this section.
    Sections 601.33 through 601.35 clarify the information to be
submitted in an application to FDA to evaluate the safety and
effectiveness of radiopharmaceuticals intended for in vivo
administration for diagnostic and monitoring use. The burden estimates
for Sec. Sec.  601.33 through 601.35 are included in the burden
estimate under Sec.  601.2(a) in table 1 since these regulations deal
with information to be provided in an application.
    Section 601.70(b) requires each applicant of a licensed biological
product to submit annually a report to FDA on the status of
postmarketing studies for each approved product application. Each
annual postmarketing status report must be accompanied by a completed
transmittal Form FDA 2252 (Form FDA 2252 approved under OMB control
number 0910-0001). Under Sec.  601.70(d), two copies of the annual
report shall be submitted to FDA.
    Sections 601.91 through 601.94 concern biological products for
which human efficacy studies are not ethical or feasible. Section
601.91(b)(2) requires, in certain circumstances, such postmarking
restrictions as are needed to ensure the safe use of the biological
product. Section 601.91(b)(3) requires applicants to prepare and
provide labeling with relevant information to patients or potential
patients for biological products approved under part 601, subpart H,
when human efficacy studies are not ethical or feasible (or based on
evidence of effectiveness from studies in animals). Section 601.93
provides that biological products approved under subpart H are subject
to the postmarketing recordkeeping and safety reporting applicable to
all approved biological products. Section 601.94 requires applicants
under subpart H to submit to the Agency for consideration during
preapproval review period copies of all promotional materials including
promotional labeling as well as advertisements. Under Sec. Sec.
601.91(b)(2) and 601.93, any potential postmarketing reports and/or
recordkeeping burdens would be included under the adverse experience
reporting (AER) requirements under 21 CFR part 600 (OMB control number
0910-0308). Therefore, any burdens associated with these requirements
would be reported under the AER information collection requirements
(OMB control number 0910-0308). The burden estimate for Sec.
601.91(b)(3) is included in the estimate under Sec. Sec.  610.60
through 610.65.
    Section 610.9(a) requires the applicant to present certain
information, in the form of a license application or supplement to the
application, for a modification of any particular test method or
manufacturing process or the conditions which it is conducted under the
biologics regulations. The burden estimate for Sec.  610.9(a) is
included in the estimate under Sec. Sec.  601.2(a) and 601.12(b) and
(c) in table 1.
    Under Sec.  610.15(d), the Director of CBER or the Director of CDER
may approve, as appropriate, a manufacturer's request for exceptions or
alternatives to the regulation for constituent materials. Manufacturers
seeking approval of an exception or alternative must submit a request
in writing with a brief statement describing the basis for the request
and the supporting data.
    Section 640.120 requires licensed establishments to submit a
request for an exception or alternative to any requirement in the
biologics regulations regarding blood, blood components, or blood
products. For licensed establishments, a request for an exception or
alternative must be submitted in accordance with Sec.  601.12;
therefore, the burden estimate for Sec.  640.120 is included in the
estimate under Sec.  601.12(b) in table 1.
    Section 680.1(c) requires manufacturers to update annually their
license file with the list of source materials and the suppliers of the
materials. Section 680.1(b)(3)(iv) requires manufacturers to notify FDA
when certain diseases are detected in source materials.
    Sections 600.15(b) and 610.53(d) require the submission of a
request for an exemption or modification regarding the temperature
requirements during shipment and from dating periods, respectively, for
certain biological products. Section 606.110(b) (21 CFR 606.110(b))
requires the submission of a request for approval to perform
plasmapheresis of donors who do not meet certain donor requirements for
the collection of plasma containing rare antibodies. Under Sec. Sec.
600.15(b), 610.53(d), and 606.110(b), a request for an exemption or
modification to the requirements would be submitted as a supplement.
Therefore, the burden hours for any submissions under Sec. Sec.
600.15(b), 610.53(d), and 606.110(b) are included in the estimates
under Sec.  601.12(b) in table 1.
    In July 1997, FDA revised Form FDA 356h ``Application to Market a
New Drug, Biologic, or an Antibiotic Drug for Human Use'' to harmonize
application procedures between CBER and CDER. The application form
serves primarily as a checklist for firms to gather and submit certain
information to FDA. As such, the form, now entitled ``Application to
Market a New or Abbreviated New Drug or Biologic for Human Use,'' helps
to ensure that the application is complete and contains all the
necessary information so that delays due to lack of information may be
eliminated. In addition, the form provides key information to FDA for
efficient handling and distribution to the appropriate staff for
review. The estimated burden hours for nonbiological product
submissions to CDER using FDA Form 356h are approved under OMB control
number 0910-0001 (an estimated 3,200 submissions x 24 hours = 76,800
hours).

    For advertisements and promotional labeling (e.g., circulars,
package labels, container labels, etc.) and labeling changes,
manufacturers of licensed biological products may submit to CBER or
CDER Form FDA 2253. In August of 1998, FDA revised and harmonized Form
FDA 2253 so the form may be used to transmit specimens of promotional
labeling and advertisements for biological products as well as for
prescription drugs and antibiotics. The revised, harmonized form
updates the information about the types of promotional materials and
the codes that are used to clarify the type of advertisement or
labeling submitted, clarifies the intended audience for the
advertisements or promotional labeling (e.g., consumers, professionals,
news services), and helps ensure that the submission is complete. Form
FDA 2253 can also be submitted electronically. Form FDA 2253 is
approved under OMB control number 0910-0001.
    Respondents to this collection of information are manufacturers of
biological products. Under tables 1 and 2, the numbers of respondents
are based on the estimated annual number of manufacturers that
submitted the required information to FDA or the number of submissions
FDA received in fiscal year (FY) 2015. Based on information obtained
from FDA's database systems, there are an estimated 391 licensed
biologics manufacturers. The total annual responses are based on the
estimated number of submissions (i.e., license applications, labeling
and other supplements, protocols, advertising and promotional labeling,
notifications) for a particular product received annually by FDA. The
hours per response are based on information provided by industry and
past FDA experience with the various submissions or notifications. The
hours per response include the time estimated to prepare the various
submissions or notifications to FDA, and, as applicable, the time
required to fill out the appropriate form and collate the
documentation. Additional information regarding these estimates is
provided below as necessary.
    Under Sec. Sec.  601.2 and 601.12, the estimated hours per response
are based on the average number of hours to submit the various
submissions. The estimated average number of hours is based on the
range of hours to complete a very basic application or supplement and a
complex application or supplement.
    Under section 601.6(a), the total annual responses are based on FDA
estimates that establishments may notify an average of 20 selling
agents and distributors of such suspension, and provide FDA of such
notification. The number of respondents is based on the estimated
annual number of suspensions of a biologic license. In table 1, FDA is
estimating one in case a suspension occurs.
    Under Sec. Sec.  601.12(f)(4) and 601.45, manufacturers of
biological products may use Form FDA 2253 to submit advertising and
promotional labeling (which can include multiple pieces). Based on
information obtained from FDA's database system, there were an
estimated 11,676 submissions using Form FDA 2253 of advertising and
promotional labeling from 114 respondents.
    Under Sec. Sec.  601.28 and 601.70(b), FDA estimates that it takes
an applicant approximately 24 hours (8 hours per study x 3 studies)
annually to gather, complete, and submit the appropriate information
for each postmarketing status report (approximately two to four studies
per report) and the accompanied transmittal Form FDA 2252. Included in
these 24 hours is the time necessary to prepare and submit two copies
of the annual progress report of postmarketing studies to FDA under
Sec.  601.70(d). For FY 2015, there were 139 reports from 82
respondents.
    Under Sec.  610.15(d), FDA has received no submissions since the
implementation of the final rule in April 2011. Therefore, FDA is
estimating 1 respondent and 1 annual request to account for a possible
submission to CBER or CDER of a request for an exception or alternative
for constituent materials under Sec.  610.15(d).
    There were a total of 2,777 amendments to an unapproved application
or supplement and resubmissions submitted using Form FDA 356h.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
            21 CFR section                   Form FDA No.           Number of     responses per   Total annual     Average  burden per      Total hours
                                                                   respondents     respondent       responses            response              \10\
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601.2(a) \2\, 610.60 through 610.65    356h....................              28            1.36              38  860....................          32,680
 \3\.
601.5(a).............................  N/A.....................              12            0.75               9  0.33 (20 minutes)......               3
601.6(a).............................  N/A.....................               1               1               1  1......................               1
601.12(a)(5).........................  N/A.....................             537           24.41          13,108  1......................          13,108
601.12(b)(1)/(b)(3)/(e)..............  356h \2\................             164            3.66             600  80.....................          48,000
601.12(c)(1)/(c)(3) \5\..............  356h \2\................             120            4.78             574  50.....................          28,700
601.12(c)(5).........................  356h \2\................               7            1.14               8  50.....................             400
601.12(d)(1)/(d)(3) \6\/(f)(3) \8\...  356h \2\................             246            3.34             822  24.....................          19,728
601.12(f)(1) \7\.....................  2253....................              72            1.93             139  40.....................           5,560
601.12(f)(2) \7\.....................  2253....................              60            1.82             109  20.....................           2,180
601.12(f)(4)/601.45 \9\..............  2253....................             114          102.42          11,676  10.....................         116,670
601.27(b)............................  N/A.....................              20           16.50             330  24.....................           7,920
601.27(c)............................  N/A.....................              12            1.08              13  8......................             104
601.70(b) and (d)/601.28.............  2252....................              82            1.70             139  24.....................           3,336
610.15(d)............................  N/A.....................               1               1               1  1......................               1
680.1(c).............................  N/A.....................               9               1               9  2......................              18
680.1(b)(3)(iv)......................  N/A.....................               1               1               1  2......................               2
Amendments/Resubmissions.............  356h....................             125           22.22           2,777  20.....................          55,540
                                                                ----------------------------------------------------------------------------------------
    Total............................  ........................  ..............  ..............  ..............  .......................         333,951
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The reporting requirements under Sec.  Sec.   601.14, 601.27(a), 601.33, 601.34, 601.35, 610.9(a), 640.17, 640.25(c),
640.56(c), 640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under Sec.   601.2(a).
\3\ The reporting requirements under Sec.  Sec.   601.93(b)(3), 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b),
  and (c), 660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under Sec.  Sec.   610.60 through 610.65.

\4\ The reporting requirements under Sec.  Sec.   601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c),
  640.22(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under Sec.   601.12(b).
\5\ The reporting requirements under Sec.  Sec.   601.12(a)(2), 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate
  under Sec.   601.12(c).
\6\ The reporting requirement under Sec.   601.12(a)(2) is included in the estimate under Sec.   601.12(d).
\7\ The reporting requirement under Sec.   601.14 is included in the estimate under Sec.   601.12(f)(1) and (2).
\8\ The reporting requirement under Sec.  Sec.   601.12(a)(4) and 601.14 is included in the estimate under Sec.   601.12(f)(3).
\9\ The reporting requirement under Sec.   601.94 is included in the estimate under Sec.   601.45.
\10\ The numbers in this column have been rounded to the nearest whole number.

    Under table 2, the estimated recordkeeping burden of 1 hour is
based on previous estimates for the recordkeeping requirements
associated with the AER system.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Annual
                 21 CFR section                      Number of     disclosures per    Total annual      Average burden per disclosure    Total hours \2\
                                                    respondents       respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.6(a)........................................               1               20               20   0.33 (20 minutes).................               7
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the nearest whole number.

    Dated: July 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16352 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 37 (Monday, February 25, 2019)]
[Proposed Rules]
[Pages 5968-5969]
[FR Doc No: 2019-03195]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50, 312, and 812

[Docket No. FDA-2018-N-2727]
RIN 0910-AH52

Institutional Review Board Waiver or Alteration of Informed
Consent for Minimal Risk Clinical Investigations; Reopening of Comment
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the proposed rule that appeared in the
Federal Register of November 15, 2018. In the Federal Register of
December 20, 2018, the Agency extended the comment period until
February 13, 2019. The Agency is taking this action to reopen the
comment period to allow interested persons additional time to submit
comments due to technical issues with the Federal eRulemaking Portal
(https://www.regulations.gov) on February 13, 2019.

DATES: FDA is reopening the comment period on the proposed rule
published November 15, 2018 (83 FR 57378). Submit either electronic or
written comments by March 7, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 7, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-2727 for ``Institutional Review Board Waiver or Alteration
of Informed Consent for Minimal Risk Clinical Investigations.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the

claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Janet Norden, Office of Good Clinical
Practice, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 15, 2018
(83 FR 57378), FDA published a proposed rule with a 60-day comment
period to implement the statutory changes made to the Federal Food,
Drug, and Cosmetic Act by section 3024 of the 21st Century Cures Act
(Pub. L. 114-255) to allow for a waiver or alteration of informed
consent when a clinical investigation poses no more than minimal risk
to the human subject and includes appropriate safeguards to protect the
rights, safety, and welfare of human subjects. The proposed rule, if
finalized, would permit an institutional review board (IRB) to waive or
alter certain informed consent elements or to waive the requirement to
obtain informed consent, under limited conditions, for certain minimal
risk clinical investigations. Comments on the proposed rule will inform
FDA's rulemaking to establish regulations for IRB waiver or alteration
of informed consent for certain minimal risk clinical investigations.
    The Agency received a request for a 60-day extension of the comment
period for the proposed rule. This request conveyed concern that the
60-day comment period did not allow sufficient time to develop a
meaningful or thoughtful response to the proposed rule. FDA considered
the request and in the Federal Register of December 20, 2018 (83 FR
65322), the Agency extended the comment period for the proposed rule
for 30 days, until February 13, 2019. The Agency believed that a 30-day
extension allowed adequate time for interested persons to submit
comments without significantly delaying rulemaking on these important
issues.
    On February 13, 2019, the date that the comment period closed for
the proposed rule, the Federal eRulemaking Portal (https://www.regulations.gov) was unavailable to receive public comments from
5:35 p.m. until 7:40 a.m. on February 14, 2019. The Agency is aware
that interested persons attempted to submit comments during the period
of time that https://www.regulations.gov was unavailable. Therefore,
FDA is reopening the comment period for the proposed rule for 10 days,
until March 7, 2019 to allow additional time for interested persons to
submit comments.

    Dated: February 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03195 Filed 2-22-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Page 27010]
[FR Doc No: 2018-12443]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1725]

Advisory Committee; Peripheral and Central Nervous System Drugs
Advisory Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Peripheral and Central Nervous System Drugs Advisory
Committee by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Peripheral and Central Nervous System Drugs Advisory Committee for
an additional 2 years beyond the charter expiration date. The new
charter will be in effect until June 4, 2020.

DATES: Authority for the Peripheral and Central Nervous System Drugs
Advisory Committee will expire on June 4, 2020, unless the Commissioner
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Yinghua Wang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002; 301-
796-9001, email: [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Peripheral and Central Nervous System Drugs Advisory
Committee. The committee is a discretionary Federal advisory committee
established to provide advice to the Commissioner.
    The Peripheral and Central Nervous System Drugs Advisory Committee
advises the Commissioner or designee in discharging responsibilities as
they relate to helping to ensure safe and effective drugs for human use
and, as required, any other product for which FDA has regulatory
responsibility.
    The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of neurologic diseases.
    The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of neurology, neuropharmacology, neuropathology, otolaryngology,
epidemiology or statistics, and related specialties. Members will be
invited to serve for overlapping terms of up to 4 years. Almost all
non-Federal members of this committee serve as Special Government
Employees. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting member who is identified with industry interests.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/default.htm or
by contacting the Designated Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the fact that no change has been made
to the committee name or description of duties, no amendment will be
made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12443 Filed 6-8-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33802-33804]
[FR Doc No: 2021-13522]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92220; File No. SR-Phlx-2021-35]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Extend the
Implementation Date for Changing the Primary and Secondary Source of
Quotation Data of MEMX LLC

June 21, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 8, 2021, 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 and II 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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the implementation date for
changing the primary and secondary source of quotation data of MEMX LLC
(``MEMX'') in the list of proprietary and network processor feeds that
the Exchange utilizes for the handling, routing, and execution of
orders as well as regulatory compliance processes related to those
functions.
    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
    Phlx is filing this proposal to extend the implementation date for
changing the primary and secondary source of quotation data of MEMX in
the list of proprietary and network processor feeds that the Exchange
utilizes for the handling, routing, and execution of orders as well as
regulatory compliance processes related to those functions.
    Phlx proposed to amend Rule 3304 (Data Feeds Utilized) to change
the primary and secondary source of quotation data of certain market
centers in the list of proprietary and network processor feeds that the
Exchange utilizes for the handling, routing, and execution of orders as
well as regulatory compliance processes related to those functions.\3\
These changes were filed by Phlx on February 4, 2021 and published in
the Federal Register on February 23, 2021.\4\
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    \3\ The proposed changes were to change the primary and
secondary source of quotation data for MEMX and MIAX PEARL, LLC
(``MIAX PEARL''). The changes for MIAX PEARL have been completed.
Therefore, this proposal is only to extend the time period for
implementing MEMX.
    \4\ See Securities Exchange Act Release No. 91142 (February 17,
2021), 86 FR 11031 (February 23, 2021) (PHLX-2021-08)
(``Proposal'').
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    Phlx initially proposed to implement the proposed rule change no
later than ninety (90) days following the effective date of the
proposed rule change. Due to the need for additional system
configuration testing in advance of the date of launch, Phlx has
decided to delay implementation for MEMX until the Q3 2021. The
Exchange will announce the new implementation date in an Equity Trader
Alert at least ten days in advance of implementing the changes.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\6\ 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.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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    The purpose of this proposal is to inform the SEC and market
participants of the new implementation date for changing the primary
and secondary source of quotation data for MEMX. These enhancements
were proposed in a rule filing that was submitted to the SEC, and this
proposal does not make any substantive changes to that filing. Phlx is
delaying the implementation date to allow for additional system
configuration testing prior to implementation.

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. As explained above, the purpose
of this proposal is to inform the SEC and market participants of the
new implementation date for changing the primary and secondary source
of quotation data for MEMX, and the Exchange does not expect the date
change to place any burden on competition.

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

    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 from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-
4(f)(6) thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of 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.
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    A proposed rule change filed under Rule 19b-4(f)(6) \9\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\10\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has
requested that the Commission waive the 30-day operative delay. Waiver
of the operative delay would allow the Exchange to immediately extend
the implementation date for changing the primary and secondary source
of quotation data of MEMX to allow for additional system configuration
testing prior to implementation. The Commission believes that waiver of
the 30-day operative delay is consistent with the protection of
investors and the public interest. Accordingly, the Commission hereby
waives the operative delay and designates the proposed rule change
operative upon filing.\11\
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    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    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 change 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--Phlx-2021-35 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-2021-35. 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-Phlx-2021-35, and should be submitted on
or before July 16, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-13522 Filed 6-24-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 5, 2011 (Volume 76, Number 128)]
[Proposed Rules]
[Page 39038-39039]
[DOCID:fr05jy11-24]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0558; Airspace Docket No. 11-AEA-13]

Proposed Establishment of Class E Airspace; Lebanon, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E Airspace at Lebanon,
PA, to accommodate new Standard Instrument Approach Procedures at
Keller Brothers Airport. This action would enhance the safety and
airspace management of Instrument Flight Rules (IFR) operations at the
airport.

DATES: Comments must be received on or before August 19, 2011.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2011-0558; Airspace Docket No. 11-AEA-13, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this proposed rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2011-0558; Airspace Docket No. 11-AEA-13) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Annotators wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2011-0558; Airspace Docket No. 11-AEA-13.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/
publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
to request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace at Lebanon,
PA, providing the controlled airspace required to support the new RNAV
GPS standard instrument approach procedures for Keller Brothers
Airport. Controlled airspace extending upward from 700 feet above the
surface would be established for the safety and management of IFR
operations at the airport.
    Class E airspace designations are published in Paragraph 6005 of
FAA order 7400.9U, dated August 18, 2010, and effective September 15,
2010, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to

keep them operationally current. It, therefore, (1) Is not a
``significant regulatory action'' under Executive Order 12866; (2) is
not a ``significant rule'' under DOT Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a Regulatory Evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in subtitle VII, part, A, subpart I, section 40103. Under
that section, the FAA is charged with prescribing regulations to assign
the use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would establish Class E airspace at Keller
Brothers Airport, Lebanon, PA.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, effective September 15, 2010,
is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AEA PA E5 Lebanon, PA [New]

Keller Brothers Airport
    (Lat. 40[deg]917'30'' N., long. 76[deg]19'43'' W.)

That airspace extending upward from 700 feet above the surface
within a 10-mile radius of the Keller Brothers Airport.

    Issued in College Park, Georgia, on June 23, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-16660 Filed 7-1-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Notices]
[Page 12638]
[FR Doc No: 2018-05855]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2018-15]

Petition for Exemption; Summary of Petition Received; Imagery
Collection, LLC

AGENCY: Federal Aviation Administration (FAA).

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before April 11, 2018.

ADDRESSES: Send comments identified by docket number FAA-2018-0054
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Steven Barksdale<PHONE_NUMBER>,
Office of Rulemaking, Federal Aviation Administration, 800 Independence
Avenue SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.
Lirio Liu,
Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2018-0054.
    Petitioner: Imagery Collection, LLC.
    Section(s) of 14 CFR Affected: 91.319(a)(1) and 21.191(g).
    Description of Relief Sought: The petitioner requested an exemption
to conduct commercial aerial photography operation using experimental,
amateur-built Vans RV-7, RV-7A, RV-8 and RV-8A aircraft.

[FR Doc. 2018-05855 Filed 3-21-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 76 (Wednesday, April 20, 2011)]
[Notices]
[Page 22166]
[FR Doc No: 2011-9612]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[NHTSA Docket No. NHTSA-2011-0048]

Renewal of Charter for the National Emergency Medical Services
Advisory Council (NEMSAC)

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

ACTION: Notice.

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

SUMMARY: The Secretary of Transportation announces the renewal of the
National Emergency Medical Services Advisory Council to provide advice
and recommendations regarding emergency medical services (EMS) matters
to the U.S. Department of Transportation, National Highway Traffic
Safety Administration and through NHTSA to the Federal Interagency
Committee on Emergency Medical Services. The NHTSA's Office of EMS
serves as sponsor of the Advisory Council for the Secretary. The
purpose of this notice is to inform interested parties of the renewal
of NEMSAC.

FOR FURTHER INFORMATION CONTACT: Drew Dawson, Director, NHTSA Office of
EMS,<PHONE_NUMBER> or via e-mail at<EMAIL_ADDRESS>You may also
contact Noah Smith at the Office of EMS at<PHONE_NUMBER> or via e-mail
at<EMAIL_ADDRESS>The Office of EMS fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This notice of NEMSAC's charter renewal is
given under the Federal Advisory Committee Act, Public Law 92-463, as
amended (5 U.S.C. App.).

    Issued on: April 15, 2011.
Michael L. Brown,
Acting Associate Administrator for Research and Program Development.
[FR Doc. 2011-9612 Filed 4-19-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 79, Number 203 (Tuesday, October 21, 2014)]
[Proposed Rules]
[Pages 62933-62934]
[FR Doc No: 2014-24864]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2014-0688; FRL-9918-09-Region 7]

Approval and Promulgation of Implementation Plans; State of
Missouri, Control of Emissions From Hand-Fired Equipment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
the State Implementation Plan (SIP) revision submitted by the state of
Missouri on May 8, 2012, related to a Missouri rule titled ``Control of
Emissions from Hand-Fired Equipment.'' This SIP revision provides a
rule to allow the burning of discarded clean wood in non-residential
(commercial owned and operated) heating devices, with restrictions to
ensure environmentally-sound operation, in the St. Louis metropolitan
area.

DATES: Comments on this proposed action must be received in writing by
November 20, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2014-0688, by mail to Larry Gonzalez, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219. Comments may also be submitted electronically or
through hand delivery/courier by following the detailed instructions in
the ADDRESSES section of the direct final rule located in the rules
section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Larry Gonzalez, Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of the Federal
Register, EPA is approving the state's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. A detailed rationale for the approval is set
forth in the direct final rule. If no relevant adverse comments are
received in response to this action, no further activity is
contemplated in relation to this action. If EPA receives relevant
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed action. EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. Please note that if EPA receives
adverse comment on part of this rule and if that part can be severed
from the remainder of the rule, EPA may adopt as final those parts of
the rule that are not the subject of an adverse

comment. For additional information, see the direct final rule which is
located in the rules section of this Federal Register.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: September 24, 2014.
Karl Brooks,
Regional Administrator, Region 7.
[FR Doc. 2014-24864 Filed 10-20-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Notices]
[Pages 35503-35506]
[FR Doc No: 2011-15039]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64654; File No. SR-CBOE-2011-039]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of Proposed Rule Change To Trade Single
Stock Dividend Options

June 13, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 31, 2011, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I and II 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

    Chicago Board Options Exchange, Incorporated (``CBOE'' or
``Exchange'') proposes to amend certain of its rules to provide for the
listing and trading of options that overlie the ordinary cash dividends
paid by an issuer over an annual, semi-annual, or quarterly ``accrual
period.'' The options will be cash-settled, have European-style
exercise and be P.M.-settled. The text of the rule proposal is
available on the Exchange's Web site (http://www.cboe.org/legal), at
the Exchange's Office of the Secretary 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 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 those 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 parts of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to permit the Exchange
to list and trade options that overlie the ordinary cash dividends paid
by an issuer over an annual accrual period. The Exchange may also list
series of SSDOs with an accrual period of less than a year, but in no
event less than one quarter of a year. SSDOs will be cash-settled, have
European-style exercise and be P.M.-settled.
Product Design
    Each SSDO represents the accumulated ordinary dividend amounts paid
by a specific issuer over a specified accrual period. For purposes of
SSDOs, dividends are deemed to be ``paid'' on the ex-dividend date.
Each annual accrual period will run from the business day after the
third Friday of December through the third Friday of the following
December. For an SSDO with an accrual period of less than a year, the
accrual period runs from the business day after the third Friday of the
month beginning the accrual period through the third Friday of the
month ending the accrual period.\3\ An example of a quarterly accrual
period is one that will run from Monday, March 21, 2011 through Friday,
June 17, 2011.
---------------------------------------------------------------------------

    \3\ The Exchange will assign separate trading symbols to SSDOs
overlying the accumulated ex-dividends of the same issuer that have
different accrual periods.
---------------------------------------------------------------------------

    The underlying value for SSDOs will be equal to ten (10) times the
ex-dividend amounts of an issuer accumulated over the specified accrual
period. Each day, CBOE will calculate the aggregate daily dividend
totals for the specific issuer, which are summed up over any given
accrual period (e.g., quarterly, semi-annually, annually). During each
business day, CBOE will disseminate the underlying SSDO value,
multiplied by ten (10), through the Options Price Reporting Authority
(``OPRA''), the Consolidated Tape Association (``CTA'') tape and/or the
Market Data Index (``MDI'') feed.
Options Trading
    Each SSDO will be quoted in decimals and one point will be equal to
$100. The minimum price variation shall be established on a class-by-
class basis by the Exchange and shall not be less than $0.01. Exhibit 3
presents proposed contract specifications for SSDOs.
    The Exchange expects that the underlying index values for SSDOs
will be relatively low. As a result, the proposal permits the Exchange
to designate $0.01 as the minimum price variation for quotes and
believes that granular pricing will result in more pricing points. The
availability of more pricing points creates tighter spreads between
quotes, which in turn benefits investors.
    Similarly, the Exchange is proposing to list series at 1 point
($1.00) or greater strike price intervals if the strike price is equal
to or less than $200 and 2.5 points ($2.50) or greater strike price
intervals if the strike price exceeds $200. Because the underlying
value of an SSDO will fluctuate around a limited expected dividend
value range, the Exchange believes that a granular strike price
increment will provide investors with greater flexibility by allowing
them to establish positions that are better tailored to meet their
investment objectives. Below are examples of values underlying SSDOs
using past ordinary dividend payouts over varying accrual periods:

----------------------------------------------------------------------------------------------------------------
                                                               Ex-dividend       Cumulative
                     Ex-dividend date                            amount           dividend      SSDO Index value
----------------------------------------------------------------------------------------------------------------
                                         Example: Annual Accrual Period
                                   December 21, 2009 through December 17, 2010
----------------------------------------------------------------------------------------------------------------
Exxon Mobil Corporation (XOM):

    2/8/2010..............................................             $0.42             $0.42              4.20
    5/11/2010.............................................             $0.42             $0.84              8.40
    8/11/2010.............................................             $0.42             $1.26             12.60
    11/9/2010.............................................             $0.44             $1.70             17.00
General Electric Company (GE):
    12/23/2009............................................             $0.10             $0.10              1.00
    2/25/2010.............................................             $0.10             $0.20              2.00
    6/17/2010.............................................             $0.10             $0.30              3.00
    9/16/2010.............................................             $0.12             $0.42              4.20
                                                                             -----------------------------------
    12/22/2010............................................             $0.14             Not Included
----------------------------------------------------------------------------------------------------------------
                                       Example: Semi-Annual Accrual Period
                                     June 21, 2010 through December 17, 2010
----------------------------------------------------------------------------------------------------------------
ONEOK Partners, L.P. (OKS):
    1/27/2010.............................................             $1.11             Not Included
    4/28/2010.............................................             $1.12             Not Included
                                                                             -----------------------------------
    7/28/2010.............................................             $1.13             $1.13             11.30
    10/27/2010............................................             $1.14             $2.27             22.70
----------------------------------------------------------------------------------------------------------------
Caterpillar Inc. (CAT):
    1/15/2010.............................................             $0.42             Not Included
    4/22/2010.............................................             $0.42             Not Included
                                                                             -----------------------------------
    7/16/2010.............................................             $0.44             $0.44              4.40
    10/21/2010............................................             $0.44             $0.88              8.80
----------------------------------------------------------------------------------------------------------------
                                        Example: Quarterly Accrual Period
                                 December 21, 2010 through March 19, 2010 [sic]
----------------------------------------------------------------------------------------------------------------
International Business Machines
Corporation (IBM):
    2/8/2010 [sic]........................................             $0.55             $0.55              5.50
                                                                             -----------------------------------
    5/16/2010 [sic].......................................             $0.65             Not Included
    8/6/2010 [sic]........................................             $0.65             Not Included
    11/8/2010 [sic].......................................             $0.65             Not Included
----------------------------------------------------------------------------------------------------------------
Altria Group, Inc. (MO):
    3/11/2010 [sic].......................................             $0.35             $0.35              3.50
                                                                             -----------------------------------
    6/11/2010 [sic].......................................             $0.35             Not Included
    9/13/2010 [sic].......................................             $0.38             Not Included
    12/23/2010 [sic]......................................             $0.38             Not Included
----------------------------------------------------------------------------------------------------------------

    Initially, the Exchange will list in-, at- and out-of-the-money
strike prices and may open for trading up to five annual contract
months expiring in December for any single stock underlying an SSDO and
up to ten contract months for accrual periods of less than a year. The
Exchange is proposing to use the expected dividend (i.e., the aggregate
value of dividends that are expected to be paid by the issuer over a
given accrual period) amount for setting the initial strikes. Near-term
SSDOs will reflect dividends accumulating in the then-current accrual
period. All other SSDO options (i.e., contracts listed for trading that
are not in the then-current accrual period) will reflect dividends
expected in comparable accrual periods beyond the current accrual
period.
    The Exchange may open for trading additional series, either in
response to customer demand or as the price of the expected dividends
for an issuer changes.
    The Exchange is proposing to permit the listing of up to five
annual contract months that expire in December in different years for
any single stock underlying an SSDO. For example, the Exchange would be
permitted to list the following annual XOM contracts: December 2011,
December 2012, December 2013, December 2014 and December 2015. As shown
in the following table, each annual XOM SSDO contract features a one-
year accrual period that begins on the first business day following the
third Friday in December and ends on the respective XOM SSDO expiration
date. As of May 17, 2011, near-term XOM SSDO prices would reflect a
combination of actual dividend payouts of $0.91 ($0.44 on the ex-
dividend date of February 8, 2011 and $0.47 on the ex-dividend date of
May 11, 2011), plus any ordinary cash dividends expected to be paid
(estimated to be $0.94--$0.47 on two expected ex-dividend dates)
through December 16, 2011. Since the accrual periods for longer-dated
SSDOs expiring in December 2012, December 2013, December 2014 and
December 2015 have not yet begun, longer-dated SSDO prices would
reflect dividends that are expected to be paid during their respective
one-year accrual periods. The expected dividends for longer-dated SSDOs
listed in the table reflect an assumption of 5% dividend growth
annually through December 2015. In-, at- and out-of-the-money SSDO
strike prices would be listed relative to the Expected SSDO Index level
equal to ten

times the dividends expected during the relevant accrual period.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Accrual period end                                      Actual +
     Accrual period start date      date (SSDO expiration      Actual         Expected        expected      Expected SSDO           SSDO strikes
                                            date)             dividends       dividends       dividends      index level
--------------------------------------------------------------------------------------------------------------------------------------------------------
December 20, 2010.................  December 16, 2011....           $0.91           $0.94           $1.85          $18.50  16, 17, 18, 19, 20
December 19, 2011.................  December 21, 2012....  ..............            1.94            1.94           19.40  17, 18, 19, 20, 21
December 24, 2012.................  December 20, 2013....  ..............            2.04            2.04           20.40  19, 20, 21, 22, 23
December 23, 2013.................  December 19, 2014....  ..............            2.14            2.14           21.40  20, 21, 22, 23, 24
December 22, 2014.................  December 18, 2015....  ..............            2.25            2.25           22.50  21, 22, 23, 24, 25
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In addition, the Exchange is proposing to permit the listing of up
to ten contract months for accrual periods of less than a year. Near-
term SSDOs with accrual periods of less than a year will reflect
dividends accumulating in the then-current accrual period. All other
SSDOs will reflect dividends expected in comparable accrual periods
beyond the current accrual period.
Exercise and Settlement
    The proposed options will expire on the Saturday following the
third Friday of the expiring month. Trading in the expiring contract
month will normally cease at 3 p.m. Chicago time on the last day of
trading (ordinarily the Friday before expiration Saturday, unless there
is an intervening holiday). When the last trading day is moved because
of an Exchange holiday (such as when CBOE is closed on the Friday
before expiration), the last trading day for expiring options will be
Thursday.
    Exercise will result in delivery of cash on the business day
following expiration. SSDOs will be P.M.-settled. The Exchange is
proposing P.M.-settlement for SSDOs because options trading on
individual stocks are P.M. settled. As a result, the Exchange is
proposing to match the expiration style for SSDOs to individual stock
option exercise. The exercise-settlement amount will be equal [sic] ten
times the ordinary cash dividends paid by the issuer over the accrual
period. The exercise settlement amount is equal to the difference
between the exercise-settlement value and the exercise price of the
option, multiplied by the contract multiplier ($100).
    If the exercise settlement value is not available or the normal
settlement procedure cannot be utilized due to a trading disruption or
other unusual circumstance, the settlement value will be determined in
accordance with the rules and bylaws of the OCC.
Surveillance
    The Exchange will use the same surveillance procedures currently
utilized for each of the Exchange's other single stock options to
monitor trading in SSDOs. Such procedures include for example
monitoring dividend announcements. CBOE is confident that it has
adequate tools in place to surveil for market manipulation. The
Exchange represents that these surveillance procedures shall be
adequate to monitor trading in options on these option products. For
surveillance purposes, the Exchange will have complete access to
information regarding trading activity in the pertinent securities
whose dividend payment is the basis for particular SSDOs. Specifically,
as a member of the Intermarket Surveillance Group (``ISG''), the
Exchange is able to obtain this information from the exchanges listing
the securities whose dividend payment is the basis for particular
SSDOs. CBOE's access to information from the ISG and tools such as the
Exchange's large options positions reports should prove more than
sufficient for surveillance of market manipulation.
Position Limits
    Position and exercise limits for SSDOs will be the same as those
for standard options overlying the same security. While positions in
SSDOs will be aggregated with longer-dated positions in SSDOs with the
same underlying stock for position and exercise limits purposes, they
will not be aggregated with positions in the ordinary options overlying
the stock of the issuer paying the dividends underlying the SSDO. The
reason for not aggregating positions with ordinary options is that
SSDOs are based solely on expected dividends for an issuer and will
reflect the forward value of that expectation. In contrast, the value
of ordinary stock options reflect a variety of factors, of which
expected dividends is only one. Hence the pricing of ordinary options
versus SSDOs will differ dramatically and there is no need to aggregate
positions to prevent manipulative practices involving the underlying.
Exchange Rules Applicable
    A new Rule 5.9 is proposed to govern the listing and trading of
SSDOs. In addition, SSDOs will be margined in the same manner as single
stock options under Exchange Rule 12.3. Purchasers of puts or calls,
however, must be paid in full, even if there remains longer than nine
months until expiration for the position. For SSDOs, the aggregate
contract value on which the margin amount will be calculated will be
the product of the forward expected dividend amount for the accrual
period (as adjusted for any contract scaling factor) and the applicable
multiplier ($100).
    The Exchange hereby designates SSDO options as eligible for trading
as Flexible Exchange Options as provided for in Chapters XXIVA
(Flexible Exchange Options) and XXIVB (FLEX Hybrid Trading System).
Capacity
    CBOE has analyzed its capacity and represents that it believes the
Exchange and OPRA have the necessary systems capacity to handle the
additional traffic associated with the listing of new series that will
result from the introduction of SSDOs. This is particularly the case
since the value of SSDOs are predicated on expected dividend payments,
which are generally much less volatile than share prices. Hence, there
is less need to list numerous strike prices for each expiration date of
an SSDO or to have to add many new strikes over the life of an SSDO.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) \4\ of the Act, in general, and furthers the objectives of
Section 6(b)(5) \5\ in particular in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market in a manner consistent with the

protection of investors and the public interest. The Exchange believes
that the introduction of SSDOs will provide investors with the ability
to invest in options that settle to a value that represents the
accumulated dividend amounts paid by a specific issuer over a specified
accrual period. This will protect investors and the public interest by
allowing market participants to hedge against potential declines in
dividend income from long positions in the underlying stocks, which can
be significant over long holding periods. In addition, the Exchange
understands that dividend options trade in the other-the-counter [sic]
marketplace and believes that the introduction of SSDOs will attract
order flow to the Exchange, increase the variety of listed options to
investors, and provide a valuable hedging tool to investors. Similarly,
the proposed rule change will permit market participants to trade SSDOs
in an environment subject to exchange-based rules that provides price
transparency and eliminates contra-party risk through the role of the
OCC as issuer, thus removing impediments to a free and open market
consistent with the Act. Finally, SSDOs will be subject to CBOE's
rules, regulations and oversight, which provide enhanced investor
protection and market surveillance.
---------------------------------------------------------------------------

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

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

    CBOE 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.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) As the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2011-039 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2011-039. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference 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 such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-CBOE-2011-039 and should be
submitted on or before July 8, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-15039 Filed 6-16-11; 8:45 am]
BILLING CODE 8011-01-P