[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Notices]
[Pages 40071-40072]
[FR Doc No: 2015-16952]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0147]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and Food and Drug Administration Staff; Section 905(j) Reports:
Demonstrating Substantial Equivalence for Tobacco Products and
Demonstrating the Substantial Equivalence of a New Tobacco Product:
Responses to Frequently Asked Questions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August
12, 2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0673.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry and Food and Drug Administration Staff; Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products OMB Control Number 0910-0673--Extension

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L.
111-31) into law. The Tobacco Control Act amended the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) by adding a new chapter granting
FDA authority to regulate the manufacture, marketing, and distribution
of tobacco products to protect the public health generally and to
reduce tobacco use by minors. Section 905(j) of the FD&C Act (21 U.S.C.
387e(j)) authorizes FDA to establish the manner and form for the
submission of information related to substantial equivalence (SE). In
guidance documents issued under the Good Guidances Practices regulation
(21 CFR 10.115), FDA provides recommendations intended to assist
persons submitting reports under section 905(j) of the FD&C Act and
explains, among other things, FDA's interpretation of the statutory
sections related to substantial equivalence.
    In the Federal Register of March 5, 2015 (80 FR 11989), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment. The commenter
expressed a concern that small manufacturers have the burden of
conducting testing without a definitive guide on what will constitute
substantial equivalence. FDA has carefully considered the burden
associated with the submission of an SE report. The information needed
to demonstrate substantial equivalence is dependent on the new product
and the predicate product that the manufacturer identifies.
Nevertheless, to assist manufacturers in preparing SE reports, FDA has
issued guidance documents and participated in outreach such as webinars
to provide manufacturers with information. Moreover, manufacturers
seeking to demonstrate substantial equivalence may also contact FDA to
seek the Agency's input on the specific types of information that the
Agency believes will be necessary to support the manufacturer's section
905(j) report. The commenter also supported FDA's development of more
streamlined SE Reports but challenged ``new requirements on label
changes,'' and requested that FDA promulgate a rule on categorical
exclusions (environmental assessments). Although these comments are
outside of the scope of this PRA collection, FDA intends to consider
them as part of the Agency's other regulatory efforts as appropriate.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      No. of
            Activity                  No. of       responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and                   75               1              75             300          22,500
 910(a).........................
Product Quantity Change SE                   125               1             125              87          10,875
 Report.........................
Same Characteristics SE Report..             100               1             100              47           4,700
    Totals......................  ..............  ..............  ..............  ..............          38,075
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA's expectations regarding the tobacco
industry's use of the section 905(j) pathway to market their products.
Table 1 describes the annual reporting burden as a result of the
implementation of the SE requirements of sections 905(j) and 910(a) of
the FDC Act (21 U.S.C. 387j(a)). Based on current information, FDA now
estimates that it will receive 300 section 905(j) reports each year. Of
these 300 reports, FDA estimates that 75 of these reports will be
``full'' SE reports that take a manufacturer approximately 300 hours to
prepare. Under the newly issued guidance entitled, ``Demonstrating the
Substantial Equivalence of a New Tobacco Product: Responses to
Frequently Asked Questions,'' FDA is recommending that certain
modifications might be addressed in either a ``Same Characteristics SE
Report'' or ``Product Quantity Change Report.'' FDA estimates that it
will receive 100 Same Characteristics SE Reports and that it will take
a manufacturer approximately 47 hours to prepare this report. FDA
estimates that it will receive 125 Product Quantity Change SE Reports
and that it will take a manufacturer approximately 87 hours to prepare
this report. Therefore, FDA estimates the burden for submission of SE
information will be 38,075 hours.

    Dated: July 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16952 Filed 7-10-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 102 (Thursday, May 26, 2016)]
[Notices]
[Pages 33577-33579]
[FR Doc No: 2016-12436]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2015-0118]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt five individuals from
the regulatory requirement that interstate commercial motor vehicle
(CMV) drivers have ``no established medical history or clinical
diagnosis of epilepsy or any other condition which is likely to cause
loss of consciousness or any loss of ability to control a CMV.'' The
exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on October 22, 2015. The
exemptions expire on October 22, 2017.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-113,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.
e.t., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: 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 www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On September 21, 2015, FMCSA published a notice announcing receipt
of applications from eight individuals requesting an exemption from the
prohibition against persons with a clinical diagnosis of epilepsy or
any other condition that is likely to cause a loss of consciousness or
any loss of ability to operate a CMV in interstate commerce and
requested comments from the public (80 FR 57036). The public comment
period closed on October 21, 2015, and 13 comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to five individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(8).

    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person:

    Has no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause the loss of
consciousness or any loss of ability to control a CMV.

    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]
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    \1\ See http://www.ecfr.gov/cgi-bin/text-idx?SID=e47b48a9ea42dd67d999246e23d97970&mc=true&node=pt49.5.391&rgn=div5#ap49.5.391_171.a and https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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    The advisory criteria states that if an individual has had a sudden
episode of a non-epileptic seizure or loss of consciousness of unknown
cause that did not require anti-seizure medication, the decision
whether that person's condition is likely to cause the loss of
consciousness or loss of ability to control a CMV should be made on an
individual basis by the medical examiner in consultation with the
treating physician. Before certification is considered, it is suggested
that a 6-month waiting period elapse from the time of the episode.
Following the waiting period, it is suggested that the individual have
a complete neurological examination. If the results of the examination
are negative and anti-seizure medication is not required, then the
driver may be qualified.
    In those individual cases where a driver had a seizure or an
episode of loss of consciousness that resulted from a known medical
condition (e.g., drug reaction, high temperature, acute infectious
disease, dehydration, or acute metabolic disturbance), certification
should be deferred until the driver has recovered fully from that
condition, has no existing residual complications, and is not taking
anti-seizure medication.
    Drivers who have a history of epilepsy/seizures, off anti-seizure
medication and seizure-free for 10 years, may be qualified to operate a
CMV in interstate commerce. Interstate drivers with a history of a
single unprovoked seizure may be qualified to drive a CMV in interstate
commerce if seizure-free and off anti-seizure medication for a 5-year
period or more.
    As a result of medical examiners misinterpreting advisory criteria
as regulation, numerous drivers have been prohibited from operating a
CMV in interstate commerce based on the fact that they have had one or
more seizures and are taking anti-seizure medication, rather than an
individual analysis of their circumstances by a qualified medical
examiner based on the physical qualification standards and medical best
practices.
    In reaching the decision to grant these exemption requests, the
Agency considered the 2007 recommendations of the Agency's Medical
Expert Panel (MEP). The January 15, 2013 (78 FR 3069) Federal Register
notice provides the current MEP recommendations which is the criteria
the Agency uses to grant seizure exemptions.
    Five of the eight applicants have been seizure-free over a range of
10 to 25 years while taking anti-seizure medication and maintained a
stable medication treatment regimen for the last two years. In each of
these cases, the applicant's treating physician verified his or her
seizure history and supports the ability to drive commercially. A
summary of each applicant's seizure history was discussed in the
September 21, 2015 Federal Register notice and will not be repeated in
this notice.

III. Discussion of Comments

    Thirteen commenters responded to this notice, 11 of whom
specifically expressed support for applicant Billy Ray Hunter and two
in support of granting seizure exemptions in general.

IV. Basis for Exemption Determination

    The Agency has determined that five of the eight applicants should
be granted an exemption. Under 49 U.S.C. 31136(e) and 31315(b), FMCSA
may grant an exemption from the epilepsy/seizure standard in 49 CFR
391.41(b)(8) if the exemption is likely to achieve an equivalent or
greater level of safety than would be achieved without the exemption.
The exemption allows the applicants to operate CMVs in interstate
commerce.
    The Agency's decision regarding these exemption applications is
based on an individualized assessment of each applicant's medical
information, including the root cause of the respective seizure(s) and
medical information about the applicant's seizure history, the length
of time that has elapsed since the individual's last seizure, the
stability of each individual's treatment regimen and the duration of
time on or off of anti-seizure medication. In addition, the Agency
reviewed the treating clinician's medical opinion related to the
ability of the driver to safely operate a CMV with a history of seizure
and each applicant's driving record found in the Commercial Driver's
License Information System (CDLIS) for commercial driver's license
(CDL) holders, and interstate and intrastate inspections recorded in
the Motor Carrier Management Information System (MCMIS). For non-CDL
holders, the Agency reviewed the driving records from the State
Driver's Licensing Agency (SDLA). The Agency acknowledges the potential
consequences of a driver experiencing a seizure while operating a CMV.
However, the Agency believes the drivers granted this exemption have
demonstrated that they are unlikely to have a seizure and their medical
condition does not pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these five
applicants from the epilepsy/seizure standard in 49 CFR 391.41(b)(8) is
likely to achieve a level of safety equal to that existing without the
exemption. A decision will be made on the other three applicants on a
later date.

V. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and includes the following: (1)
Each individual must remain seizure-free and maintain a stable
treatment during the 2-year exemption period; (2) each individual must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each individual must undergo an annual medical examination by a
certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each
individual must provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy of his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the exemption when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Conclusion

    Based upon its evaluation of the five exemption applications, FMCSA
exempts the following drivers from the epilepsy/seizure standard in 49
CFR 391.41(b)(8), subject to the requirements cited above: Joshua Alan
Abel (MD); James E. Blosser, Jr. (VA); Jeremy H. Fryburg (PA); Jonathan
Robert Jones (WI); and Anthony Edward Martens (SD).

    In accordance with 49 U.S.C. 31315(b)(1), each exemption is valid
for 2 years, unless revoked earlier by FMCSA. The exemption will be
revoked if the following occurs: (1) The individual fails to comply
with the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained prior to being
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136 and 31315. If the
exemption is still effective at the end of the 2-year period, the
individual may apply to FMCSA for a renewal under procedures in effect
at that time.

    Issued on: May 19, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-12436 Filed 5-25-16; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 239 (Thursday, December 12, 2019)]
[Notices]
[Page 67937]
[FR Doc No: 2019-26765]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12766-007]

Notice of Application Tendered for Filing With the Commission and
Soliciting Additional Study Requests and Establishing Procedural
Schedule for Relicensing and a Deadline for Submission of Final
Amendments: Green Mountain Power Corporation

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New License for Transmission Line Project.
    b. Project No.: 12766-007.
    c. Date filed: November 22, 2019.
    d. Applicant: Green Mountain Power Corporation (Green Mountain
Power).
    e. Name of Project: Clay Hill Road Line 66 Transmission Project.
    f. Location: Along Clay Hill Road in the town of Hartland, Windsor
County, Vermont. No federal lands are occupied by the project works or
located within the project boundary.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: John Greenan, Green Mountain Power
Corporation, 2152 Post Road, Rutland, VT 05701; Phone at (802) 770-
2195, or email at<EMAIL_ADDRESS>    i. FERC Contact: Bill Connelly at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See 94 FERC 61,076
(2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: January 21, 2020.
    The Commission strongly encourages electronic filing. Please file
additional study requests and requests for cooperating agency status
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202)
502-8659 (TTY). In lieu of electronic filing, please send a paper copy
to: Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Washington, DC 20426. The first page of any filing should include
docket number P-12766-007.
    m. The application is not ready for environmental analysis at this
time.
    n. Project Description: The existing Clay Hill Road Line 66
Transmission Project consists of: (1) A 2.3-mile-long, 12.5-kilovolt,
three-phase electrical line mounted on top of Green Mountain Power
Corporation's regional distribution line (Line 66) along Clay Hill Road
from Pole 115 to 62x; and (2) appurtenant facilities. The project
serves as a primary transmission line for the North Hartland Project
No. 2816.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's website at http://www.ferc.gov using the eLibrary link.
Enter the docket number excluding the last three digits in the docket
number field to access the document. For assistance, contact FERC
Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    p. Procedural schedule and final amendments: The application will
be processed according to the following preliminary schedule. Revisions
to the schedule will be made as appropriate.

Issue Deficiency Letter (if necessary)--January 2020
Request Additional Information--January 2020
Issue Acceptance Letter--April 2020
Issue Scoping Document 1 for comments--May 2020
Request Additional Information (if necessary)--July 2020
Issue Scoping Document 2--August 2020
Issue Notice of Ready for Environmental Analysis--August 2020
Commission issues Environmental Assessment--February 2021

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

    Dated: December 6, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-26765 Filed 12-11-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 162 (Friday, August 21, 2015)]
[Notices]
[Pages 50896-50898]
[FR Doc No: 2015-20655]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75713; File No. SR-EDGX-2015-36]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Amend
Rule 13.8 To Describe the Market Data Product EDGX Book Viewer

August 17, 2015.
    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 August 7, 2015, EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend Rule 13.8 to describe a
market data product known as EDGX Book Viewer.
    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, 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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to add language to Rule 13.8 describing a
market data product known as EDGX Book Viewer. The proposal
memorializes in the Exchange's rules a data feed that is currently
available through the Exchange's public Web site free of charge. EDGX
Book Viewer is a data feed that disseminates, on a real-time basis, the
aggregated two-side quotations for up to five (5) price levels for all
displayed orders for securities traded on the Exchange and for which
the Exchanges reports quotes under the Consolidated Tape Association
(``CTA'') Plan or the Nasdaq/UTP Plan. EDGX Book Viewer also contains
the last ten (10) trades including time of trade, price and share
quantity. Book Viewer is currently available via www.batstrading.com
without charge. The Exchange will file a separate proposed rule change
with the Commission proposing fees to be charged for certain types of
access to EDGX Book Viewer as of September 1, 2015.\5\
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    \5\ The Exchange understands that its affiliated exchanges
intend to file identical proposed rule changes to adopt rules and
fees for the Book Viewer data feed with the Commission. The
Exchange's affiliates are EDGA Exchange, Inc., BATS Exchange, Inc.
and BATS Y-Exchange, Inc.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with

section 6(b) of the Act,\6\ in general, and furthers the objectives of
section 6(b)(5) of the Act,\7\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, 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 to protect investors and the public interest, and that it is not
designed to permit unfair discrimination among customers, brokers, or
dealers. This proposal is in keeping with those principles in that it
promotes increased transparency through the dissemination of EDGX Book
Viewer. The Exchange also believes this proposal is consistent with
section 6(b)(5) of the Act because it protects investors and the public
interest and promotes just and equitable principles of trade by
providing investors with an alternative for receiving market data as
requested by market data vendors and purchasers that expressed an
interest in exchange-only data for instances where consolidated data is
no longer required to be purchased and displayed. The proposed rule
change would benefit investors by facilitating their prompt access to
real-time depth-of-book information contained in EDGX Book Viewer. The
proposed rule change also removes impediments to and perfect the
mechanism of a free and open market and a national market system by
memorializing in the Exchange's rules a data feed that is currently
available through the Exchange's public Web site free of charge.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(5).
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    The Exchange also believes that the proposed rule change is
consistent with section 11(A) of the Act \8\ in that it supports (i)
fair competition among brokers and dealers, among exchange markets, and
between exchange markets and markets other than exchange markets and
(ii) the availability to brokers, dealers, and investors of information
with respect to quotations for and transactions in securities.
Furthermore, the proposed rule change is consistent with Rule 603 of
Regulation NMS,\9\ which provides that any national securities exchange
that distributes information with respect to quotations for or
transactions in an NMS stock do so on terms that are not unreasonably
discriminatory. EDGX Book Viewer is accessed and subscribed to on a
voluntary basis, in that neither the Exchange nor market data
distributors are required by any rule or regulation to make this data
available. Accordingly, distributors and subscribers can discontinue
use at any time and for any reason.
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    \8\ 15 U.S.C. 78k-1.
    \9\ See 17 CFR 242.603.
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    In adopting Regulation NMS, the Commission granted self-regulatory
organizations and broker-dealers increased authority and flexibility to
offer new and unique market data to consumers of such data. It was
believed that this authority would expand the amount of data available
to users and consumers of such data and also spur innovation and
competition for the provision of market data. The Exchange believes
that the data products proposed herein are precisely the sort of market
data products that the Commission envisioned when it adopted Regulation
NMS. The Commission concluded that Regulation NMS--by lessening
regulation of the market in proprietary data--would itself further the
Act's goals of facilitating efficiency and competition:
    [E]fficiency is promoted when broker-dealers who do not need the
data beyond the prices, sizes, market center identifications of the
NBBO and consolidated last sale information are not required to
receive (and pay for) such data. The Commission also believes that
efficiency is promoted when broker-dealers may choose to receive
(and pay for) additional market data based on their own internal
analysis of the need for such data.\10\
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    \10\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005) (File No. S7-10-04).

    By removing ``unnecessary regulatory restrictions'' on the ability
of exchanges to sell their own data, Regulation NMS advanced the goals
of the Act and the principles reflected in its legislative history.
    In addition, EDGX Book Viewer removes impediments to and perfects
the mechanism of a free and open market and a national market system
because EDGX Book Viewer provides investors with alternative market
data and competes with similar market data product currently offered by
the New York Stock Exchange, Inc. (``NYSE'') and the Nasdaq Stock
Market LLC (``Nasdaq'').\11\ The provision of new options for investors
to receive market data was a primary goal of the market data amendments
adopted by Regulation NMS.\12\ EDGX Book Viewer is precisely the sort
of market data product that the Commission envisioned when it adopted
Regulation NMS.
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    \11\ See Nasdaq Rule 7023(a)(1)(C) (describing Nasdaq TotalView
is a depth-of-book data feed that includes all orders and quotes
from all Nasdaq members displayed in the Nasdaq Market Center as
well as the aggregate size of such orders and quotes at each price
level in the execution functionality of the Nasdaq Market Center).
See also Nasdaq Book Viewer, a description of which is available at
https://data.nasdaq.com/Book Viewer.aspx (last visited July 29,
2015). See NYSE OpenBook available at http://www.nyxdata.com/openbook (last visited July 29, 2015) (providing real-time view of
the NYSE limit order book). See e.g., Securities Exchange Act
Release No. 71775 (March 24, 2014), 79 FR 17627 (March 28, 2014)
(SR-CBOE-2014-021) (Notice of Filing and Immediate Effectiveness of
Proposed Rule Change Related to the CBSX BBO Data Feed and the New
CBSX Book Depth Data Feed).
    \12\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, at 37503 (June 29, 2005) (Regulation NMS
Adopting Release).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposal is
not intended to address any competitive issues, but rather to
memorialize in the Exchange's rules a data feed that is currently
available through the Exchange's public Web site free of charge.
Nonetheless, the Exchange believes that the proposal will promote
competition by the Exchange offering a service similar to that offered
by the NYSE and Nasdaq.\13\ Thus, the Exchange believes this proposed
rule change is necessary to permit fair competition among national
securities exchanges. Therefore, the Exchange does not believe the
proposed rule change will result in any burden on competition that is
not necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \13\ See supra note 11.
---------------------------------------------------------------------------

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

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

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

    The Exchange has designated this rule filing as non-controversial
under section 19(b)(3)(A) of the Act \14\ and paragraph (f)(6) of Rule
19b-4 thereunder.\15\ The proposed rule change effects a change that:
(A) Does not significantly affect the protection of investors or the
public interest; (B) does not impose any significant burden on
competition; and (C) by its terms, does not become operative for 30
days after the date of the filing, or such shorter time as the

Commission may designate if consistent with the protection of investors
and the public interest; provided that the self-regulatory organization
has given 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.\16\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4.
    \16\ The Exchange has fulfilled this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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 No. SR-EDGX-2015-36 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 No. SR-EDGX-2015-36. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference 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 such filing will also 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 available publicly. All
submissions should refer to File No. SR- EDGX-2015-36 and should be
submitted on or before September 11,  2015.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-20655 Filed 8-20-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: December 7, 2009 (Volume 74, Number 233)]
[Notices]
[Page 64123-64124]
[DOCID:fr07de09-944]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2009-0349]

Pipeline Safety: Operator Qualification (OQ) Program
Modifications

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
DOT.

ACTION: Notice; Issuance of Advisory Bulletin.

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

SUMMARY: The Pipeline and Hazardous Materials Safety Administration
(PHMSA) is issuing this Advisory Bulletin to inform pipeline operators
about the standardized notification process for operator qualification
(OQ) plan transmittal from the operator to PHMSA. This Advisory
Bulletin also informs operators about the addition to PHMSA's glossary
of definitions of the terms ``Observation of on-the-job performance''
as applicable to determining employee qualification and ``Significant''
as applicable to OQ program modifications requiring notification.
Finally, it makes other miscellaneous clarifications to assist
operators in complying with OQ program requirements.

FOR FURTHER INFORMATION CONTACT: Warren Miller by phone at<PHONE_NUMBER>
or by e-mail at<EMAIL_ADDRESS>regarding the subject matter of
this Advisory Bulletin, or the Dockets Unit,<PHONE_NUMBER>, for copies
of this Advisory Bulletin or other material in the docket. All
materials in this docket may be accessed electronically at http://
dma.dot.gov. General information about the PHMSA Office of Pipeline
Safety (OPS) can be obtained by accessing OPS's Internet home page at
http://www.phmsa.dot.gov/pipeline.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 3, 2005, PHMSA issued a Direct Final Rule (70 FR 10332) on
qualification of pipeline personnel which amended the requirements for
pipeline operators to develop and maintain a written qualification
program for individuals performing covered tasks on pipeline
facilities. In response to implementation issues and questions that
arose after the rule was published, PHMSA has previously published
Advisory Bulletins regarding OQ programs. These bulletins remain
relevant:
     ADB-04-05, Operator Qualification Requirements, published
November 26, 2004.
     ADB-06-01, Notice to Operators of Natural Gas and
Hazardous Liquid Pipelines to Integrate Operator Qualification
Regulations into Excavation Activities, published January 17, 2006.
    Based on input from State pipeline safety program managers and the
PHMSA Federal and State OQ Team, PHMSA has developed a standardized
process for OQ plan transmittal from the operator to PHMSA. The team
also developed definitions of the terms ``Observation of on-the-job
performance'' as applicable to determining employee qualification and
``Significant'' as applicable to OQ program modifications requiring
notification. PHMSA has added these definitions to its glossary of
terms. Finally, the team identified other miscellaneous clarifications
to assist operators in complying with OQ program requirements.

II. Advisory Bulletin ADB-09-03

    To: Owners and Operators of Hazardous Liquid and Natural Gas
Pipeline Systems.
    Subject: Operator Qualification Programs.
    Advisory: This Advisory Bulletin informs pipeline operators about
the standardized notification process for operator qualification (OQ)
plan transmittal from the operator to PHMSA. This Advisory Bulletin
also informs operators about the addition to PHMSA's glossary of
definitions of the terms ``Observation of on-the-job performance'' as
applicable to determining employee qualification and ``Significant'' as
applicable to OQ program modifications requiring notification. Finally,
it makes other miscellaneous clarifications regarding OQ programs.

Standardized Plan Transmittal Process

    Operators should send notifications of significant modification of
an OQ Program to the OPS Information Resource Manager by e-mail at
<EMAIL_ADDRESS>or mail to U.S. Department of
Transportation, Pipeline and Hazardous Materials Safety Administration,
Office of Pipeline Safety, Information Resources Manager, 1200 New
Jersey Avenue, SE., East Building, 2nd Floor (PHP-10), Room E22-321,
Washington, DC 20590.

    Note:  Operators subject to regulation by State agencies are
required to send OQ notifications directly to each State agency.

    Regardless of the delivery method, each notification to PHMSA
should include:
    1. OPID(s), operator name(s), HQ address. Name of individual
submitting notification, Data/email/phone number, Commodity (gas/
liquid/both), PHMSA Region(s) where pipeline(s) operate, and names of
respective facilities or pipeline systems where changes apply.
    2. Complete Plan accompanied by revision/change log and effective
date of change(s). The plan should be notated such that changed areas
of the plan can be readily identified. Employee-specific information
(i.e., social security numbers) and testing material are not needed.

Definitions

    With respect to the use of ``Observation of on-the-job
performance'' as a means of determining employee qualification, PHMSA
has added a definition of this term to its glossary of terms on the
PHMSA Primis OQ Web site at http://primis.phmsa.dot.gov/oq/
glossary.htm. PHMSA also added a definition of the word ``significant''
to the glossary as it applies to modifications to an operator's OQ
program. The definitions read as follows:

Observation of On-The-Job Performance

    1. Observation without interaction during on-the-job performance
does not provide an adequate measurement of the knowledge and skills of
the individual;
    2. PHMSA has determined that there are no covered tasks to date
where observation of on-the-job performance is an adequate, sole method
for examining or testing qualification; and
    3. Observation of on-the-job performance does not measure the
individual's ability to recognize and react to abnormal operation
conditions (AOCs).

Significant

    As applicable to OQ program modifications, significant includes but
is not limited to: increasing evaluation intervals, increasing span of
control ratios, eliminating covered tasks, mergers and/or acquisition
changes,

evaluation method changes such as written vs. observation, and
wholesale changes made to OQ plan.

Miscellaneous Clarifications

    Finally, in order to clarify the requirements of 49 CFR 192.605(a)
and 195.402(a) as they apply to OQ and written OQ program reviews, the
following information is provided:
    1. The OQ process and procedures are an important part of an
operator's manual of written procedures for conducting normal
operations and maintenance activities and handling abnormal operations
and emergencies (Operations and Maintenance (O&M) Plan).
    a. Operators' review of their OQ Plan in accordance with Sec. Sec.
192.605(a) and 195.402(a) should be conducted in connection with their
reviews of their O&M Plans every 15 months, but at least once each
calendar year.
    b. Operators' ``periodic review of work'' being done in accordance
with Sec. Sec.  192.605(b)(8) and 195.402(c)(13), should include
evaluation of OQ procedure effectiveness to identify where corrective
actions are needed to address deficiencies. Examples of issues that
need to be reviewed to determine the effectiveness of an OQ Program:
     Adequacy of training for specific covered task(s),
     Adequacy of evaluation(s) to determine if individual has
required knowledge, skills, and abilities,
     Adequacy of individual to recognize AOC(s), and
     Adequacy of individual to take appropriate action after
AOC.
    2. Operators should ensure the record it maintains of its annual
O&M review, as required by Sec. Sec.  192.605(a) and 195.402(a),
specifically notes that the OQ Plan was included in the review. The
record should include the name of reviewer and date(s) of review.
Alternatively, the operator's review procedures may clearly indicate
which procedures are to be evaluated during the annual review.
    3. PHMSA will inspect annual review records to assure OQ Plans are
being evaluated and may take compliance action where non-compliance is
found.

    Issued in Washington, DC on November 25, 2009.
Byron Coy,
Acting Associate Administrator for Pipeline Safety.
[FR Doc. E9-29073 Filed 12-4-09; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 76, Number 94 (Monday, May 16, 2011)]
[Notices]
[Pages 28247-28248]
[FR Doc No: 2011-11931]

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SECURITIES AND EXCHANGE COMMISSION

Securities Act of 1933, Release No. 9206/May 11, 2011; Securities
Exchange Act of 1934, Release No. 64462/May 11, 2011; Order Directing
Funding for the Governmental Accounting Standards Board

    President Obama signed into law the Dodd-Frank Wall Street Reform
and Consumer Protection Act (``Dodd-Frank Act'') on July 21, 2010.\1\
The Dodd-Frank Act, among other things, added Section 19(g) to the
Securities Act of 1933 (``Securities Act'') to create a mechanism for
funding the Governmental Accounting Standards Board (``GASB'').\2\
---------------------------------------------------------------------------

    \1\ See Dodd-Frank Wall Street Reform and Consumer Protection
Act, Public Law 111-203, 124 Stat. 1376 (2010).
    \2\ See Section 978 of the Dodd-Frank Act.
---------------------------------------------------------------------------

    Section 19(g) of the Securities Act provides that the Commission
may, subject to the limitations imposed by Section 15B of the
Securities Exchange Act of 1934 (``Exchange Act''),\3\ require a
national securities association registered under the Exchange Act to
establish a reasonable annual accounting support fee to adequately fund
the annual budget of the GASB, and to establish rules and procedures,
in consultation with the principal organizations representing State
governors, legislators, local elected officials, and State and local
finance officers, to provide for the equitable allocation, assessment,
and collection of the accounting support fee from the members of the
association, and the remittance of all such accounting support fees to
the Financial Accounting Foundation.\4\
---------------------------------------------------------------------------

    \3\ See 15 U.S.C. 78o-4.
    \4\ See 15 U.S.C. 77s(g)(1).
---------------------------------------------------------------------------

    For purposes of this order and as provided in Securities Act
Section 19(g), the annual budget of the GASB is the annual budget
reviewed and approved according to the internal procedures of the
Financial Accounting Foundation.\5\ Any fees or funds collected shall
be used to support the efforts of the GASB to establish standards of
financial accounting and reporting recognized as generally accepted
accounting principles applicable to State and local governments of the
United States.\6\ The annual accounting support fees collected for a
fiscal year shall not exceed the recoverable annual budgeted expenses
of the GASB (which may include operating expenses, capital, and accrued
items).\7\
---------------------------------------------------------------------------

    \5\ See 15 U.S.C. 77s(g)(2).
    \6\ See 15 U.S.C. 77s(g)(3).
    \7\ See 15 U.S.C. 77s(g)(4).
---------------------------------------------------------------------------

    Accounting support fees collected and other receipts of the GASB
shall not be considered public monies of the United States.\8\ Nothing
in this order shall be construed to provide the Commission or any
national securities association direct or indirect oversight of the
budget or technical agenda of the GASB, or affect the setting of
generally accepted accounting principles by the GASB.\9\ In addition,
nothing in this order shall be construed to impair or limit the
authority of a State or local government to establish accounting and
financial reporting standards.\10\
---------------------------------------------------------------------------

    \8\ See 15 U.S.C. 77s(g)(5)(A).
    \9\ See 15 U.S.C. 77s(g)(5)(B).
    \10\ See 15 U.S.C. 77s(g)(5)(C).
---------------------------------------------------------------------------

    To provide for an independent and more reliable funding mechanism
for the GASB, the Commission has determined that the Financial Industry
Regulatory Authority, Inc. (``FINRA'') shall establish such a
reasonable accounting support fee and related rules and procedures to
provide funding for the GASB. Accordingly,
    It is ordered, pursuant to Section 19(g) of the Securities Act,
that FINRA establish (a) a reasonable annual accounting support fee to
adequately fund the annual budget of the GASB; and (b) rules and
procedures, in consultation with the principal organizations
representing State

governors, legislators, local elected officials, and State and local
finance officers, to provide for the equitable allocation, assessment,
and collection of the accounting support fee from its members, and the
remittance of all such accounting support fees to the Financial
Accounting Foundation.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-11931 Filed 5-13-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 6, 2009 (Volume 74, Number 86)]
[Notices]
[Page 20965-20966]
[DOCID:fr06my09-82]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0197]

Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Psychopharmacologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 9, 2009 from 8 a.m.
to 6 p.m. and June 10, 2009, from 8 a.m. to 5 p.m.
    Addresses: Electronic comments should be submitted to http://
www.regulations.gov. Enter ``FDA-2009-N-0197 Use of Antipsychotics for
Schizophrenia and Bipolar Disorder in Pediatric and Adolescent
Patients'' and follow the prompts to submit your statement. Written
comments should be submitted to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments received will be posted without
change, including any personal information provided. Comments received
on or before May 26, 2009, will be provided to the committee before the
meeting.
    Location: Marriott Conference Centers, UMUC Inn and Conference
Center, 3501 University Blvd. East, Adelphi, MD. The hotel telephone
number is<PHONE_NUMBER>.
    Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area), code<PHONE_NUMBER>. Please call the Information
Line for up-to-date information on this meeting. A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On both days, the committee will discuss safety and
efficacy issues for the following new drug applications (NDAs): (1) NDA
20-639/S-045 and S-046: SEROQUEL (quetiapine fumarate) Tablets,
AstraZeneca Pharmaceuticals LP, for the acute treatment of
schizophrenia in adolescents from 13 to 17 years of age, and the acute
treatment of bipolar mania in children from 10 to 12 years of age and
adolescents from 13 to 17 years of age; (2) NDA 20-825/S-032: GEODON
(ziprasidone hydrochloride) Capsules, Pfizer Inc., for the acute
treatment of manic or mixed episodes associated with bipolar disorder,
with or without psychotic features in children and adolescents ages
from 10 to 17 years of age; and (3) NDA 20-592/S-040 and S-041: ZYPREXA
(olanzapine) Tablets, Eli Lilly and Co., for the acute treatment of
manic or mixed episodes associated with bipolar I disorder and the
acute treatment of schizophrenia in adolescents. The committee will be
asked to vote on whether or not these products have been shown to be
effective and acceptably safe for these pediatric indications.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
26, 2009. Oral presentations from the public will be scheduled between
approximately 4 p.m. and 6 p.m. on June 9, 2009. Those desiring to make
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before May 22, 2009. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by May 26, 2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Diem-Kieu Ngo at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 28, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-10451 Filed 5-5-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 141 (Tuesday, July 27, 2021)]
[Notices]
[Pages 40231-40232]
[FR Doc No: 2021-15882]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2018-0206]

Air Ambulance and Patient Billing Advisory Committee Notice of
Public Meeting

AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Notice of public meeting.

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

SUMMARY: The U.S. Department of Transportation (Department or DOT) is
giving notice that a virtual public meeting of the Air Ambulance and
Patient Billing (AAPB) Advisory Committee will take place on August 11,
2021. The AAPB Advisory Committee will discuss the impact of the
Airline Deregulation Act (ADA) on States' ability to regulate air
ambulance operations and whether to recommend that the ADA be amended
as a means of improving the regulation of air ambulance providers.

DATES: The AAPB Advisory Committee will hold a virtual meeting on
August 11, 2021, from 1:00 p.m. to 4:00 p.m., Eastern Daylight Time.
Requests to attend the meeting must be received by August 10, 2021.
Requests for accommodations because of a disability must be received by
August 3, 2021. If you wish to speak during the meeting, you must
submit a written copy of your remarks to DOT by August 3, 2021.
Requests to submit written materials to be reviewed during the meeting
must be received no later than August 3, 2021.

ADDRESSES: The virtual meeting will be open to the public and held via
the Zoom Webinar Platform. Virtual attendance information will be
provided upon registration. An agenda will be available on the AAPB
Advisory Committee website at https://www.transportation.gov/airconsumer/AAPB at least one week before the meeting, along with
copies of the meeting minutes after the meeting.

FOR FURTHER INFORMATION CONTACT: To register and attend this virtual
meeting, please contact the Department by email at<EMAIL_ADDRESS>
Attendance is open to the public subject to any technical and/or
capacity limitations. For further information, contact Robert Gorman,
Senior Attorney, at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The FAA Reauthorization Act of 2018 (2018 FAA Act) requires the DOT
Secretary, in consultation with the Secretary of Health and Human
Services (HHS), to establish an advisory committee to review options to
improve the disclosure of charges and fees for air medical services,
better inform consumers of insurance options for such services, and
protect consumers from balance billing. On September 12, 2019, the
Department announced the creation of the AAPB Advisory Committee.
    The AAPB Advisory Committee held a public meeting on January 15-16,
2020. At that meeting, the AAPB Advisory Committee gathered information
about the air ambulance industry, air ambulance costs and billing, and
insurance and air ambulance payment systems. The AAPB Advisory
Committee also discussed disclosure and separation of charges, cost
shifting, and balance billing.
    On February 4, 2020, the Department established three
Subcommittees: (1) The Subcommittee on Disclosure and Distinction of
Charges and Coverage for Air Ambulance Services; (2) the Subcommittee
on Prevention of Balance Billing, and (3) the Subcommittee on State and
DOT Consumer Protection Authorities. On January 11, 2021, the
Subcommittees filed reports and draft recommendations for the full
Committee's review.
    The AAPB Advisory Committee held a second public meeting on May 27-
28, 2021. The Committee discussed the draft recommendations of the
Subcommittees and developed its own recommendations.\1\ At the
conclusion of the May 28 meeting, Committee members expressed an
interest in discussing the ADA's impact on States' ability to regulate
the activities of air ambulance services and in making recommendations
related to the ADA, Public Law 95-504, as a means of improving the
regulation of air ambulance providers. The Committee's Designated
Federal Officer (DFO) indicated that a supplemental Committee meeting
would be held to discuss and consider this matter, if the Department
determined that the Committee had authority to do so after a careful
review of the Committee's charter and the 2018 FAA Act. The Department
has now determined that the Committee has the authority to discuss and
make recommendations related to the ADA. While representatives of DOT
and HHS are voting members of the AAPB Advisory Committee, those two
representatives will abstain from voting on the merits of any
recommendation that the Committee may develop regarding the ADA.
---------------------------------------------------------------------------

    \1\ Presentations, Subcommittee reports, and other materials
from the first two public meetings are available for public review
on the AAPB Advisory Committee's docket, DOT-OST-2018-0206.
---------------------------------------------------------------------------

II. Summary of the Agenda

    During the August 11, 2021 meeting, the AAPB Advisory Committee
will deliberate the issue of whether and how to recommend that Congress
amend the ADA. A more detailed agenda will be made available at least
one week before the meeting at https://www.transportation.gov/airconsumer/AAPB.

III. Public Participation

    The meeting will be open to the public and attendance may be
limited due to virtual meeting constraints. To register, please send an
email to the Department as set forth in the FOR FURTHER INFORMATION
CONTACT section. The Department is committed to providing equal access
to this meeting for all participants. If you need alternative formats
or services because of a disability, such as sign language interpreter
or other ancillary aids, please contact the person listed in the FOR
FURTHER INFORMATION CONTACT section no later than August 3, 2021.
    Members of the public may also present written comments at any
time. The docket number referenced above (DOT-OST-2018-0206) has been
established for committee documents, including any written comments
that may be filed. At the discretion of the Chair, after completion of
the planned agenda, individual members of the public may provide
comments through the ``Q&A'' feature of the webinar platform or orally,
time permitting. Any oral comments presented must be limited to the
objectives of the committee and will be limited to five (5) minutes per
person. Individual members of the public who wish to present oral
comments must notify the Department of Transportation contact noted
above via email that they wish to attend and present oral comments no
later than August 3, 2021.
    Speakers are requested to submit a written copy of their prepared
remarks for inclusion in the meeting records and for circulation to
AAPB Advisory Committee members by August 3, 2021. All prepared remarks
submitted on time will be accepted and considered as part of the
meeting's record.

IV. Viewing Documents

    You may view documents mentioned in this notice at https://www.regulations.gov. After entering the docket number (DOT-OST-2018-
0206), click the tab labeled ``Browse & Comment on Documents'' and
choose the document to review.

    Issued in Washington, DC, this 21st day of July 2021.
John E. Putnam,
Acting General Counsel.
[FR Doc. 2021-15882 Filed 7-26-21; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15214-15217]
[FR Doc No: 2015-06497]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0742]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration of Producers of Drugs and Listing of
Drugs in Commercial Distribution

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 requirements for drug
establishment registration and drug listing.

DATES: Submit either electronic or written comments on the collection
of information by May 22, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<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.

Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution--21 CFR Part 207 (OMB Control Number 0910-0045)--Extension

    Requirements for drug establishment registration and drug listing
are set forth in section 510 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360), section 351 of the Public Health
Service Act (42 U.S.C.

262), and part 207 (21 CFR part 207). Fundamental to FDA's mission to
protect the public health is the collection of this information, which
is used for important activities such as postmarket surveillance for
serious adverse drug reactions, inspection of drug manufacturing and
processing facilities, and monitoring of drug products imported into
the United States. Comprehensive, accurate, and up to date information
is critical to conducting these activities with efficiency and
effectiveness.
    Under section 510 of the FD&C Act, FDA is authorized to establish a
system for registration of producers of drugs and for listing of drugs
in commercial distribution. To implement section 510 of the FD&C Act,
FDA issued part 207. Under current Sec.  207.20, manufacturers,
repackers, and relabelers that engage in the manufacture, preparation,
propagation, compounding, or processing of human or veterinary drugs
and biological products, including bulk drug substances and bulk drug
substances for prescription compounding, and drug premixes as well as
finished dosage forms, whether prescription or over-the-counter, are
required to register their establishment. In addition, manufacturers,
repackers, and relabelers are required to submit a listing of every
drug or biological product in commercial distribution. Owners or
operators of establishments that distribute under their own label or
trade name a drug product manufactured by a registered establishment
are not required either to register or list. However, distributors may
elect to submit drug listing information in lieu of the registered
establishment that manufactures the drug product. Foreign drug
establishments must also comply with the establishment registration and
product listing requirements if they import or offer for import their
products into the United States.
    Under current Sec.  207.21, establishments, both domestic and
foreign, must register with FDA within 5 days after beginning the
manufacture of drugs or biologicals, or within 5 days after the
submission of a drug application or biological license application. In
addition, establishments must register annually. Changes in individual
ownership, corporate or partnership structure, location, or drug
handling activity must be submitted as amendments to registration under
current Sec.  207.26 within 5 days of such changes. Under Sec.
207.20(b), private label distributors may request their own labeler
code and elect to submit drug listing information to FDA. In such
instances, at the time of submitting or updating drug listing
information, private label distributors must certify to the registered
establishment that manufactured, prepared, propagated, compounded, or
processed (which includes, among other things, repackaging and
relabeling) the listed drug that the drug listing submission was made.
Establishments must, within 5 days of beginning the manufacture of
drugs or biologicals, submit to FDA a listing for every drug or
biological product in commercial distribution at that time. Private
label distributors may elect to submit to FDA a listing of every drug
product they place in commercial distribution. Registered
establishments must submit to FDA drug product listing for those
private label distributors who do not elect to submit listing
information.
    Under Sec.  207.25, product listing information submitted to FDA by
domestic and foreign manufacturers must, depending on the type of
product being listed, include any new drug application number or
biological establishment license number, copies of current labeling and
a sampling of advertisements, a quantitative listing of the active
ingredient for each drug or biological product not subject to an
approved application or license, the NDC number, and any drug
imprinting information.
    In addition to the product listing information required, FDA may
also require, under Sec.  207.31, a copy of all advertisements and a
quantitative listing of all ingredients for each listed drug or
biological product not subject to an approved application or license;
the basis for a determination, by the establishment, that a listed drug
or biological product is not subject to marketing or licensing approval
requirements; and a list of certain drugs or biological products
containing a particular ingredient. FDA may also request, but not
require, the submission of a qualitative listing of the inactive
ingredients for all listed drugs or biological products, and a
quantitative listing of the active ingredients for all listed drugs or
biological products subject to an approved application or license.
    Under Sec.  207.30, establishments must update their product
listing information every June and December or, at the discretion of
the establishment, when any change occurs. These updates must include
the following information: (1) A listing of all drug or biological
products introduced for commercial distribution that have not been
included in any previously submitted list; (2) all drug or biological
products formerly listed for which commercial distribution has been
discontinued; (3) all drug or biological products for which a notice of
discontinuance was submitted and for which commercial distribution has
been resumed; and (4) any material change in any information previously
submitted. No update is required if no changes have occurred since the
previously submitted list.
    Historically, drug establishment registration and drug listing
information have been submitted in paper form using Form FDA 2656
(Registration of Drug Establishment/Labeler Code Assignment), Form FDA
2657 (Drug Product Listing), and Form FDA 2658 (Registered
Establishments' Report of Private Label Distributors) (collectively
referred to as FDA Forms). Changes in the FD&C Act resulting from
enactment of the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85) (FDAAA) require that drug establishment registration
and drug listing information be submitted electronically unless a
waiver is granted. Before the enactment of FDAAA, section 510(p) of the
FD&C Act expressly provided for electronic submission of drug
establishment registration information upon a finding that electronic
receipt was feasible, and section 510(j) of the FD&C Act provided that
drug listing information be submitted in the form and manner prescribed
by FDA. Section 224 of FDAAA, which amends section 510(p) of the FD&C
Act, now expressly, requires electronic drug listing in addition to
drug establishment registration. In certain cases, if it is
unreasonable to expect a person to submit registration and listing
information electronically, FDA may grant a waiver from the electronic
format requirement.
    In the Federal Register of June 1, 2009 (74 FR 26248), FDA
announced the availability of a guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Drug
Establishment Registration and Drug Listing'' (the 2009 guidance). The
document provides guidance to industry on the statutory requirement to
submit electronically drug establishment registration and drug listing
information. The guidance describes the types of information to include
for purposes of drug establishment registration and drug listing and
how to prepare and submit the information in an electronic format
(Structured Product Labeling (SPL) files) that FDA can process, review,
and archive. In addition to the information that previously was
collected on the FDA Forms, the guidance addresses

electronic submission of other required information as follows:
     For registered foreign drug establishments, the name,
address, and telephone number of its U.S. agent (Sec.  207.40(c));
     the name of each importer that is known to the
establishment (the U.S. company or individual in the United States that
is an owner, consignee, or recipient of the foreign establishment's
drug that is imported into the United States. An importer does not
include the consumer or patient who ultimately purchases, receives, or
is administered the drug, unless the foreign establishment ships the
drug directly to the consumer or the patient) (section 510(i)(1)(A) of
the FD&C Act); and
     the name of each person who imports or offers for import
(the name of each agent, broker, or other entity, other than a carrier,
that the foreign drug establishment uses to facilitate the import of
their drug into the United States) (section 510(i)(1)(A) of the FD&C
Act).
    FDA also recommends the voluntary submission of the following
additional information, when applicable:
     To facilitate correspondence between foreign
establishments and FDA, the email address for the U.S. agent, and the
telephone number(s) and email address for the importer and person who
imports or offers for import their drug;
     a site-specific Data Universal Numbering System number for
each entity (e.g., the registrant, establishments, U.S. agent,
importer);
     the NDC product code for the source drug that is repacked
or relabeled;
     distinctive characteristics of certain listed drugs, i.e.,
the flavor, the color, and image of the actual solid dosage form; and
     registrants may indicate that they view as confidential
the registrant's business relationship with an establishment, or an
inactive ingredient.
    In addition to this collection of information, there is an
additional burden for the following activities:
     preparing a standard operating procedure (SOP) for the
electronic submission of drug establishment registration and drug
listing information;
     creating the SPL file, including accessing and reviewing
the technical specifications and instructional documents provided by
FDA (accessible at http://www.fda.gov/oc/datacouncil/spl.html);
     reviewing and selecting appropriate terms and codes used
to create the SPL file (accessible at http://www.fda.gov/oc/datacouncil/spl.html);
     obtaining the digital certificate used with FDA's
electronic submission gateway and uploading the SPL file for submission
(accessible at http://www.fda.gov/esg/default.htm); and
     requests for waivers from the electronic submission
process as described in the draft guidance.
    When FDA published the 2009 guidance on submitting establishment
registration and drug listing information in electronic format, the
Agency also amended its burden estimates for OMB control number 0910-
0045 to include the additional burden for the collection of information
that had not been submitted using the FDA forms, and to create and
upload the SPL file. The amended burden estimates included the one-time
preparation of an SOP for creating and uploading the SPL file. Although
most firms will already have prepared an SOP for the electronic
submission of drug establishment registration and drug listing
information, each year additional firms will need to create an SOP. As
provided in Table 2 of this document, FDA estimates that approximately
1,000 firms will have to expend a one-time burden to prepare, review,
and approve an SOP, and the Agency estimates that it will take 40 hours
per recordkeeper to create 1,000 new SOPs for a total of 40,000 hours.
    In Tables 1 and 2, the information collection requirements of the
drug establishment registration and drug listing requirements have been
grouped according to the information collection areas of the
requirements.

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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New registrations, including new           1,400               2           2,800             4.5          12,600
 labeler codes requests.........
Annual updates of registration            10,000               1          10,000             4.5          45,000
 information....................
New drug listings...............           1,567               7          11,000             4.5          49,500
New listings for private label               146           10.06           1,469             4.5           6,611
 distributor....................
June and December updates of all           5,300              20         106,000             4.5         477,000
 drug listing information.......
Waiver requests.................               1               1               1               1               1
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    Total.......................  ..............  ..............  ..............  ..............         590,712
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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 Activity resulting from section                     Number of                        Average
    510(p) of the FD&C Act as        Number of      records per    Total annual     burden per      Total hours
        amended by FDAAA           recordkeepers   recordkeeper       records      recordkeeping
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One-time preparation of SOP.....           1,000               1           1,000              40          40,000
SOP maintenance.................           3,295               1           3,295               1           3,295
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    Total.......................  ..............  ..............  ..............  ..............          43,295
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\1\ There are no capital costs or operating and maintenance costs associated with the collection of information.

    Dated: March 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06497 Filed 3-20-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 28, 2006 (Volume 71, Number 249)]
[Notices]
[Page 78250]
[DOCID:fr28de06-131]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54986; File No. SR-NYSEArca-2006-58]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving
Proposed Rule Change and Amendment No. 1 Thereto Relating to Its
Regulatory Oversight Committee

December 21, 2006.

    On September 21, 2006, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend NYSE Arca Rule 3.3 to provide that the
Exchange's Regulatory Oversight Committee (the ``ROC'') shall be
comprised of at least three Public Directors, rather than all the
Public Directors. On October 20, 2006, the Exchange filed Amendment No.
1 to the proposed rule change. The proposed rule change, as amended,
was published for comment in the Federal Register on October 27,
2006.\3\ The Commission received no comments regarding the proposal.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 54638 (October 23,
2006), 71 FR 63059.
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    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange \4\ and, in
particular, the requirements of Section 6(b)(5) of the Act.\5\ Section
6(b)(5) requires, among other things, that the rules of an exchange be
designed to prevent fraudulent and manipulative acts, to promote just
and equitable principles of trade, and, in general, to protect
investors and the public interest. The Commission notes that the
proposed rule change, by establishing a minimum committee size for the
ROC, would allow the Exchange to reduce the ROC to three members. The
Commission notes that the proposed rule change would retain the
requirement that all members of the ROC be Public Directors.\6\
Accordingly, the Commission finds that the proposed rule change, as
amended, is consistent with the Act.
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    \4\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. 15 U.S.C. 78c(f).
    \5\ 15 U.S.C. 78f(b)(5).
    \6\ NYSE Arca's By-Laws define a ``Public Director'' as a person
from the public who will not be, or be affiliated with, a broker-
dealer in securities or employed by, or involved in any material
business relationship with, the Exchange or its affiliates. See
Section 3.02 of the NYSE Arca By-Laws.
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\7\ that the proposed rule change (SR-NYSEArca-2006-58), as
amended, is approved.
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    \7\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\8\
Florence E. Harmon,
Deputy Secretary.
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    \8\ 17 CFR 200.30-3(a)(12); 17 CFR 200.30-3(a)(44)
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 [FR Doc. E6-22261 Filed 12-27-06; 8:45 am]

BILLING CODE 8011-01-P