[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Rules and Regulations]
[Pages 42031-42032]
[FR Doc No: 2017-18811]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2011-N-0921]

Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption: What You Need To Know About the Food and
Drug Administration Regulation; Small Entity Compliance Guide;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a guidance for industry entitled
``Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption: What You Need to Know About the FDA
Regulation: Small Entity Compliance Guide.'' The small entity
compliance guide (SECG) is intended to help small entities comply with
the final rule entitled ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption.''

DATES: The announcement of the guidance is published in the Federal
Register on September 6, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): 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 Office, 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-2011-N-0921 for ``What You Need to Know About the FDA Regulation:
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption--Small Entity Compliance Guide.'' Received
comments 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 Office 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.
    See the SUPPLEMENTARY INFORMATION section for electronic access to
the SECG.

FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 27, 2015 (80 FR 74353), we
issued a final rule entitled ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption'' (the final
rule) that establishes science-based minimum standards for the safe
growing, harvesting, packing, and holding of produce, meaning fruits
and vegetables grown for human consumption. The final rule, which is
codified at 21 CFR part 112, became effective January 26, 2016, but has
staggered compliance dates starting January 26, 2017.
    We examined the economic implications of the final rule as required
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined
that the final rule will have a significant economic impact on a
substantial number of small entities. In compliance with section 212 of
the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-
121, as amended by Pub. L. 110-28), we are making available the SECG to
reduce the burden of determining how to comply by further explaining
and clarifying the actions that a small entity must take to comply with
the rule.
    We are issuing the SECG consistent with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The SECG represents the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This is not a significant regulatory action
subject to Executive Order 12866 and does not impose any additional
burden on regulated entities.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 112 have been approved under OMB
control number 0910-0816.

III. Electronic Access

    Persons with access to the Internet may obtain the SECG at either
https://www.fda.gov/FoodGuidances, or https://www.regulations.gov. Use
the FDA Web site listed in the previous sentence to find the most
current version of the guidance.

    Dated: August 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18811 Filed 9-5-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Notices]
[Pages 39820-39821]
[FR Doc No: 2015-17014]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Arrin Corporation, Gundaker/Jordan American
Holdings (a/k/a Jordan American Holdings, Inc.), Liberty Petroleum
Corporation, Mikojo Incorporated, Royal Invest International Corp., and
San Joaquin Bancorp; Order of Suspension of Trading

July 8, 2015.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Arrin Corporation (CIK No. 1427433) (``ARRI'' \1\), a revoked Nevada
corporation with its principal place of business in Bradenton, Florida,
with stock quoted on OTC Link (previously, ``Pink Sheets'') operated by
OTC Markets Group Inc. (``OTC Link'') because it has not filed any
periodic reports since the period ended March 31, 2011. On June 26,
2013, the Division of Corporation Finance (``Corporation Finance'')
sent a delinquency letter to ARRI requesting compliance with its
periodic reporting obligations at the address shown in its then-most
recent filing with the Commission, but ARRI did not receive the
delinquency letter due to its failure to maintain a valid address on
file with the Commission as required by Commission rules (Rule 301 of
Regulation S-T, 17 CFR 232.301 and Section 5.4 of the EDGAR Filer
Manual).
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    \1\ The short form of each issuer's name is also its ticker
symbol.
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    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Gundaker/Jordan American Holdings, Inc. (a/k/a Jordan American
Holdings, Inc.) (CIK No. 855663) (``JAHI''), a Florida corporation with
its principal place of business in Excello, Missouri, with stock quoted
on OTC Link, because it has not filed any periodic reports since the
period ended September 30, 2005. On March 19, 2015, Corporation Finance
sent a delinquency letter to JAHI requesting compliance with its
periodic reporting obligations at the address shown in its then-most
recent filing with the Commission, but JAHI did not receive the
delinquency letter due to its failure to maintain a valid address on
file with the Commission as required by Commission rules (Rule 301 of
Regulation S-T, 17 CFR 232.301 and Section 5.4 of the EDGAR Filer
Manual).
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Liberty Petroleum Corporation (CIK No. 59270) (``LBPE''), a Delaware
corporation with its principal place of business in New York, New York,
with stock quoted on OTC Link, because it has not filed any periodic
reports since the period ended June 30, 1987. On August 24, 2012,
Corporation Finance sent a delinquency letter to LBPE requesting
compliance with its periodic reporting obligations at the address shown
in its then-most recent filing with the Commission, but LBPE did not
receive the delinquency letter due to its failure to maintain a valid
address on file with the Commission as required by Commission rules
(Rule 301 of Regulation S-T, 17 CFR 232.301 and Section 5.4 of the
EDGAR Filer Manual).
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Mikojo Incorporated (CIK No. 1411085) (``MKJI''), a void Delaware
corporation with its principal place of business in Foster City,
California, with stock quoted on OTC Link, because it has not filed any
periodic reports since the period ended March 31, 2011. On April 29,
2013, Corporation Finance sent a delinquency letter to MKJI requesting
compliance with its periodic reporting

obligations at the address shown in its then-most recent filing with
the Commission, but MKJI did not receive the delinquency letter due to
its failure to maintain a valid address on file with the Commission as
required by Commission rules (Rule 301 of Regulation S-T, 17 CFR
232.301 and Section 5.4 of the EDGAR Filer Manual).
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Royal Invest International Corp. (CIK No. 1079574) (``RIIC''), a void
Delaware corporation with its principal place of business in Westport,
Connecticut, with stock quoted on OTC Link because it has not filed any
periodic reports since the period ended September 30, 2010. On June 26,
2013, Corporation Finance sent a delinquency letter to RIIC requesting
compliance with its periodic reporting obligations at the address shown
in its then-most recent filing with the Commission, but RIIC did not
receive the delinquency letter due to its failure to maintain a valid
address on file with the Commission as required by Commission rules
(Rule 301 of Regulation S-T, 17 CFR 232.301 and Section 5.4 of the
EDGAR Filer Manual).
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
San Joaquin Bancorp (CIK No. 1368883) (``SJQU''), a suspended
California corporation with its principal place of business in
Bakersfield, California, with stock quoted on OTC Link because it has
not filed any periodic reports since the period ended June 30, 2009. On
June 26, 2013, Corporation Finance sent a delinquency letter to SJQU
requesting compliance with its periodic reporting obligations at the
address shown in its then-most recent filing with the Commission, but
SJQU did not receive the delinquency letter due to its failure to
maintain a valid address on file with the Commission as required by
Commission rules (Rule 301 of Regulation S-T, 17 CFR 232.301 and
Section 5.4 of the EDGAR Filer Manual).
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EDT on July 8, 2015, through 11:59 p.m.
EDT on July 21, 2015.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-17014 Filed 7-8-15; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Notices]
[Page 52297]
[FR Doc No: 2017-24446]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2016-0632; FRL-9959-51-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Willingness To Pay Survey To Evaluate
Recreational Benefits of Nutrient Reductions in Coastal New England
Waters (New)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Willingness to Pay Survey to
Evaluate Recreational Benefits of Nutrient Reductions in Coastal New
England Waters (New)'' (EPA ICR No. 2558.01, OMB Control No. 2080-NEW)
to the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a request for
approval of a new collection. Public comments were previously requested
via the Federal Register (81 FR 78809) on 11/09/2016 during a 60-day
comment period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An Agency may not conduct or
sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before December 13,
2017.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
ORD-2016-0632, to (1) EPA online using www.regulations.gov (our
preferred method), by email to [email protected], or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
[email protected]. Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Marisa Mazzotta, U.S. Environmental
Protection Agency, Office of Research and Development, Atlantic Ecology
Division, 27 Tarzwell Drive, Narragansett, Rhode Island 02882;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Researchers at the EPA's Office of Research and
Development (ORD), Atlantic Ecology Division (AED) are piloting an
effort to better understand how reduced water quality due to nutrient
enrichment affects the economic prosperity, social capacity, and
ecological integrity of coastal New England communities. This project
proposes a survey to collect data for a case study of changes in
recreation demand and values due to changes in nutrients in
northeastern coastal waters. This includes the development of methods
and tools for estimating recreational values that can be applied in
other locations, either by EPA researchers, EPA's regional offices or
state partners. Cape Cod is in the midst of an extensive regional
planning effort related to its coastal waters, and this research can
provide helpful socio-economic information to decision makers about the
use of those waters. Because the 100-mile radius from Cape Cod includes
a large area of southern New England and the largest population centers
in New England, the results will be more broadly applicable to
residents of southern New England.
    One of the key water quality concerns on Cape Cod, and throughout
New England, is nonpoint sources of nitrogen, which lead to ecological
impairments in estuaries, with resultant socio-economic impacts. The
decisions needed to meet water quality standards are highly complex and
involve significant cross-disciplinary challenges in identifying,
implementing, and monitoring social and ecological management needs. We
will focus on understanding recreational uses as valued economic goods
in coastal New England (including beachgoing, swimming, fishing,
shellfishing, and boating).
    Form Numbers: 6000-02 and 6000-03.
    Respondents/affected entities: Individuals and Households.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 2,455 (total).
    Frequency of response: Once.
    Total estimated burden: 205 hours (per year). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $7,129 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in the Estimates: This is a new collection.

Courtney Kerwin,
Director, Collection Strategies Division.
[FR Doc. 2017-24446 Filed 11-9-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 107 (Tuesday, June 6, 2017)]
[Proposed Rules]
[Pages 25988-25989]
[FR Doc No: 2017-11378]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0277; Airspace Docket No. 17-ASO-9]

Proposed Establishment of Class E Airspace; Columbia, MS

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 extending
upward from 700 feet above the surface at Marion General Hospital
Heliport, Columbia, MS, to accommodate new area navigation (RNAV)
global positioning system (GPS) standard instrument approach procedures
(SIAPs) serving Marion General Hospital Heliport. Controlled airspace
is necessary for the safety and management of instrument flight rules
(IFR) operations at the heliport.

DATES: Comments must be received on or before July 21, 2017.

ADDRESSES: Send comments on this proposal to: U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Bldg. Ground Floor Rm. W12-140, Washington, DC 20590; Telephone: 1-800-
647-5527, or<PHONE_NUMBER>.You must identify the Docket No. FAA-2017-
0277; Airspace Docket No. 17-ASO-9, at the beginning of your comments.
You may also submit and review received comments through the Internet
at http://www.regulations.gov. You may review the public docket
containing the proposal, any comments received, and any final
disposition in person in the Dockets Office between 9:00 a.m. and 5:00
p.m., Monday through Friday, except Federal holidays.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC, 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

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:

Authority for This Rulemaking

    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 regulation is within the scope of that
authority as it would establish Class E airspace extending upward from
700 feet above the surface at Marion General Hospital Heliport,
Columbia, MS, to support IFR operations in standard instrument approach
procedures at the airport.

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-2017-0277 and Airspace Docket No. 17-ASO-9) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for address
and

phone number). You may also submit comments through the Internet at
http://www.regulations.gov.
    Persons 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-2017-0277; Airspace Docket No. 17-ASO-9.'' The postcard will be
date/time stamped and returned to the commenter.
    All communications received on or 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 through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/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
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays at the office
of the Eastern Service Center, Federal Aviation Administration, room
350, 1701 Columbia Avenue, College Park, Georgia 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace extending
upward from 700 feet above the surface within a 6.5-mile radius of
Marion General Hospital Heliport, Columbia, MS, providing the
controlled airspace required to support the new Copter RNAV (GPS)
standard instrument approach procedures for IFR operation at Marion
General Hospital Heliport.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, 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.

Regulatory Notices and Analyses

    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, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal would be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

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

0
1. The authority citation for part 71 continues to read as follows:

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016,
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO MS E5 Marion General, Columbia, MS [New]

Marion General Hospital Heliport, MS
    (Lat. 31[deg]15'17'' N., long. 89[deg]48'19'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Marion General Hospital Heliport.

    Issued in College Park, Georgia, on May 19, 2017.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2017-11378 Filed 6-5-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Notices]
[Pages 14569-14571]
[FR Doc No: 2013-05194]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0002]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final Notice.

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SUMMARY: New or modified Base (1% annual-chance) Flood Elevations
(BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries
or zone designations, and/or the regulatory floodway (hereinafter
referred to as flood hazard determinations) as shown on the indicated
Letter of Map Revision (LOMR) for each of the communities listed in the
table below are finalized. Each LOMR revises the Flood Insurance Rate
Maps (FIRMs), and in some cases the Flood Insurance Study (FIS)
reports, currently in effect for the listed communities. The flood
hazard determinations modified by each LOMR will be used to calculate
flood insurance premium rates for new buildings and their contents.

DATES: The effective date for each LOMR is indicated in the table
below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at www.msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and ninety (90) days have elapsed since that
publication. The Deputy Associate Administrator for Mitigation has
resolved any appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to
section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4105, and are in accordance with the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard determinations are the basis for
the floodplain management measures that the community is required
either to adopt or to show evidence of being already in effect in order
to remain qualified for participation in the National Flood Insurance
Program (NFIP).
    These new or modified flood hazard determinations, together with
the floodplain management criteria required by 44 CFR 60.3, are the
minimum that are required. They should not be construed to mean that
the community must change any existing ordinances that are more
stringent in their floodplain management requirements. The community
may at any time enact stricter requirements of its own or pursuant to
policies established by other Federal, State, or regional entities.
    These new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Chief executive officer       Community map                                       Community
         State and county           Location and case No.         of community             repository       Effective date of  modification      No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arkansas: Benton, (FEMA Docket      City of Centerton (12- The Honorable Bill         City Hall, 290 Main   December 6, 2012...............       050399
 No.: B-1274).                       06-2356P).             Edwards, Mayor, City of    Street, Centerton,
                                                            Centerton, P.O. Box 208,   AR 72719.
                                                            Centerton, AR 72719.
Florida: Nassau, (FEMA Docket No.:  Unincorporated areas   The Honorable Daniel B.    96135 Nassau Place,   December 20, 2012..............       120170
 B-1274).                            of Nassau County (12-  Leeper, Chairman, Nassau   Yulee, FL 32097.
                                     04-3609P).             County Board of
                                                            Commissioners, 96135
                                                            Nassau Place, Suite 1,
                                                            Yulee, FL 32097.
Minnesota: Hennepin, (FEMA Docket   City of Crystal (12-   The Honorable ReNae        City Hall, 4141       December 24, 2012..............       270156
 No.: B-1274).                       05-1144P).             Bowman, Mayor, City of     Douglas Drive
                                                            Crystal, 4141 Douglas      North, Crystal, MN
                                                            Drive North, Crystal, MN   55422.
                                                            55422.
New Mexico: Bernalillo, (FEMA       City of Albuquerque    The Honorable Richard J.   Development and       November 29, 2012..............       350002
 Docket No.: B-1274).                (12-06-1889P).         Berry, Mayor, City of      Building Services
                                                            Albuquerque, P.O. Box      Division, 600 2nd
                                                            1293, Albuquerque, NM      Street Northwest,
                                                            87103.                     Suite 201,
                                                                                Albuquerque, NM
                                                                                87102.
Oklahoma: Creek, (FEMA Docket No.:  Town of Kiefer (12-06- The Honorable West         City Hall, 401 East   December 24, 2012..............       400393
 B-1274).                            0981P).                Ashford, Mayor, Town of    Indiana Avenue,
                                                            Kiefer, P.O. Box 369,      Kiefer, OK 74041.
                                                            Kiefer, OK 74041.
Pennsylvania: Dauphin, (FEMA        Township of            The Honorable Frank        Susquehanna           December 24, 2012..............       420397
 Docket No.: B-1274).                Susquehanna (12-03-    Lynch, President,          Township, 1900
                                     0513P).                Township of Susquehanna    Linglestown Road,
                                                            Board of Commissioners,    Harrisburg, PA
                                                            1900 Linglestown Road,     17110.
                                                            Harrisburg, PA 17110.
Texas:
    Bexar, (FEMA Docket No.: B-     City of San Antonio    The Honorable Julian       Municipal Plaza, 114  December 6, 2012...............       480045
     1274).                          (12-06-0886P).         Castro, Mayor, City of     West Commerce
                                                            San Antonio, 100           Street, 7th Floor,
                                                            Military Plaza, San        San Antonio, TX
                                                            Antonio, TX 78205.         78205.
    Bexar, (FEMA Docket No.: B-     City of San Antonio    The Honorable Julian       Municipal Plaza, 114  December 13, 2012..............       480045
     1274).                          (12-06-0595P).         Castro, Mayor, City of     West Commerce
                                                            San Antonio, 100           Street, 7th Floor,
                                                            Military Plaza, San        San Antonio, TX
                                                            Antonio, TX 78205.         78205.
    Bexar, (FEMA Docket No.: B-     Unincorporated areas   The Honorable Nelson W.    Public Works          December 6, 2012...............       480035
     1274).                          of Bexar County (12-   Wolff, Bexar County        Department, 233
                                     06-1452P).             Judge, Paul Elizondo       North Pecos-La
                                                            Tower, 101 West Nueva      Trinidad, Suite
                                                            Street, 10th Floor, San    420, San Antonio,
                                                            Antonio, TX 78205.         TX 78207.
    Collin, (FEMA Docket No: B-     City of McKinney (11-  The Honorable Brian        City Hall, 222 North  December 21, 2012..............       480135
     1274).                          06-4743P).             Loughmiller, Mayor, City   Tennessee Street,
                                                            of McKinney, 222 North     McKinney, TX 75069.
                                                            Tennessee Street,
                                                            McKinney, TX 75069.
    Collin, (FEMA Docket No: B-     City of Weston (11-06- The Honorable Patti        City Hall, 210 South  December 21, 2012..............       481324
     1274).                          4743P).                Harrington, Mayor, City    McDonald Street,
                                                            of Weston, 301 Main        McKinney, TX 75069.
                                                            Street, Weston, TX 75097.
    Collin, (FEMA Docket No: B-     Unincorporated areas   The Honorable Keith Self,  Collin County         December 21, 2012..............       480130
     1274).                          of Collin County (11-  Collin County Judge,       Department of
                                     06-4743P).             2300 Bloomdale Road,       Public Works, 210
                                                            Suite 4192, McKinney, TX   South McDonald
                                                            75071.                     Street, McKinney,
                                                                                TX 75069.
    Dallas, (FEMA Docket No.: B-    City of Coppell (11-   The Honorable Karen Hunt,  City Engineering      December 10, 2012..............       480170
     1274).                          06-4512P).             Mayor, City of Coppell,    Department, 255
                                                            255 Parkway Boulevard,     Parkway Boulevard,
                                                            Coppell, TX 75019.         Coppell, TX 75019.
    Dallas and Denton, (FEMA        City of Lewisville     The Honorable Dean         City Hall, 1197 West  December 10, 2012..............       480195
     Docket No: B-1274).             (11-06-4512P).         Ueckert, Mayor, City of    Main Street,
                                                            Lewisville, 151 West       Lewisville, TX
                                                            Church Street,             75067.
                                                            Lewisville, TX 75029.
    Dallas, Denton and Tarrant,     Town of Flower Mound   The Honorable Tom Hayden,  Town Hall, 2121       December 10, 2012..............       480777
     (FEMA Docket No.: B-1274).      (11-06-4512P).         Mayor, Town of Flower      Cross Timbers Road,
                                                            Mound, 2121 Cross          Flower Mound, TX
                                                            Timbers Road, Flower       75028.
                                                            Mound, TX 75028.
    Denton, (FEMA Docket No.: B-    Town of Cross Roads    The Honorable Steve        Town Hall, 1401 Farm  December 10, 2012..............       481513
     1274).                          (12-06-0686P).         Smith, Mayor, Town of      to Market Road 424,
                                                            Cross Roads, 1401 Farm     Cross Roads, TX
                                                            to Market Road 424,        76227.
                                                            Cross Roads, TX 76227.
    Denton, (FEMA Docket No.: B-    Unincorporated areas   The Honorable Mary Horn,   Denton County         December 10, 2012..............       480774
     1274).                          of Denton County (12-  Denton County Judge, 110   Government Center,
                                     06-0686P).             West Hickory Street, 2nd   1505 East McKinney
                                                            Floor, Denton, TX 76201.   Street, Suite 175,
                                                                                Denton, TX 76209.
    Denton and Tarrant, (FEMA       City of Grapevine (11- The Honorable William D.   City Hall, 200 South  December 10, 2012..............       480598
     Docket No: B-1274).             06-4512P).             Tate, Mayor, City of       Main Street,
                                                            Grapevine, P.O. Box        Grapevine, TX 76051.
                                                            95104, Grapevine, TX
                                                            76099.
    Harris, (FEMA Docket No.: B-    City of Pearland (12-  The Honorable Tom Reid,    3519 Liberty Drive,   November 8, 2012...............       480077
     1274).                          06-1209P).             Mayor, City of Pearland,   Pearland, TX 77581.
                                                            3519 Liberty Drive,
                                                            Pearland, TX 77581.
    Travis, (FEMA Docket No.: B-    City of Austin (11-06- The Honorable Lee          Watershed Protection  December 3, 2012...............       480624
     1274).                          4564P).                Leffingwell, Mayor, City   Department, 505
                                                            of Austin, P.O. Box        Barton Springs
                                                            1088, Austin, TX 78767.    Road, 12th Floor,
                                                                                Austin, TX 78704.
    Travis, (FEMA Docket No.: B-    City of Austin (12-06- The Honorable Lee          Watershed Protection  December 10, 2012..............       480624
     1274).                          1380P).                Leffingwell, Mayor, City   Department, 505
                                                            of Austin, P.O. Box        Barton Springs
                                                            1088, Austin, TX 78767.    Road, 12th Floor,
                                                                                Austin, TX 78704.
    Wilson, (FEMA Docket No.: B-    Unincorporated areas   The Honorable Marvin       1420 3rd Street,      December 20, 2012..............       480230
     1274).                          of Wilson County (12-  Quinney, Wilson County     Floresville, TX
                                     06-2559P).             Judge, 1103 4th Street,    78114.
                                                            Floresville, TX 78114.

Virginia
    Arlington, (FEMA Docket No.: B- Unincorporated areas   The Honorable Mary Hughes  2100 Clarendon        December 17, 2012..............       515520
     1274).                          of Arlington County    Hynes, Chairman,           Boulevard,
                                     (12-03-0954P).         Arlington County Board,    Arlington, VA 22201.
                                                            2100 Clarendon
                                                            Boulevard, Arlington, VA
                                                            22201.
    Henrico, (FEMA Docket No.: B-   Unincorporated areas   The Honorable Frank J.     Henrico County        December 12, 2012..............       510077
     1274).                          of Henrico County      Thornton, Chairman,        Courthouse. 4301
                                     (12-03-0257P).         Henrico County Board of    East Parham Road,
                                                            Supervisors, P.O. Box      Richmond, VA 23229.
                                                            90775, Henrico, VA 23273.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Roy Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2013-05194 Filed 3-5-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: August 26, 2009 (Volume 74, Number 164)]
[Notices]
[Page 43118-43119]
[DOCID:fr26au09-41]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0162; FRL-8949-3]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Information Collection Request
for Proposed Regional Haze Regulations; EPA ICR No. 1813.07, OMB
Control No. 2060-0412

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before September 25,
2009.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2003-0162, to (1) EPA online using http://www.regulations.gov (our
preferred method), by e-mail<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Agency Information Collection Request Activities:
Proposed Collection and Comment Request for the Regional Haze
Regulations Docket, Docket ID No. EPA-HQ-OAR-2003-0162, Environmental
Protection Agency, Air and Radiation Docket and Information Center,
Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460,
and (2) OMB by mail to: Office of Information and Regulatory Affairs,
Office of Management and Budget OMB, Attention: Desk Office for EPA,
725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Mr. Todd Hawes, Air Quality Policy
Division, Office of Air Quality Planning and Standards, (C539-04),
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 8, 2009 (74 FR 21680), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments during the
comment period. Any additional comments on this ICR should be submitted
to EPA and OMB within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2003-0162, which is available for online viewing at
http://www.regulations.gov, or in person at the Air Docket in the EPA
Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave.,
NW., Washington, DC. The EPA/DC Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential

business information (CBI), or other information whose public
disclosure is restricted by statute. For further information about the
electronic docket, go to http://www.regulations.gov.
    Title: Proposed Regional Haze Regulations (Renewal).
    ICR numbers: EPA ICR No. 1813.07, OMB Control No. 2060-0412.
    ICR status: This ICR is scheduled to expire on October 31, 2009.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: This ICR is for activities related to the implementation
of EPA's 1999 regional haze rule for the time period between October
31, 2009, and October 30, 2012, and renews the previous ICR. The
regional haze rule, as authorized by sections 169A and 169B of the
Clean Air Act (CAA), requires States to develop implementation plans to
protect visibility in 156 Federally-protected Class I areas. Tribes may
choose to develop implementation plans. For this time period, States
will be completing their implementation plans to comply with the rule.
Before any agency, department, or instrumentality of the Federal
government engages in, supports in any way, provides financial
assistance for, licenses, permits, approves any activity, that agency
has the affirmative responsibility to ensure that such action conforms
to the State Implementation Plan (SIP) required under the regional haze
rule. Section 176(c) of the CAA (42 U.S.C. 7401 et seq.) require that
all Federal actions conform with the SIP requirements. Depending on the
type of action, the Federal entities must collect information
themselves, hire consultants to collect the information or require
applicants/sponsors of the Federal action to provide the information.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 37
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 859.
    Frequency of response: Annual.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 31,841 hours.
    Estimated total annual costs: $1,880,000, which is comprised of
labor costs exclusively. This includes $0 for both capital investment
and maintenance and operational costs.
    Changes in the Estimates. There are only minor revisions to the
cost estimates since the last renewal of this ICR (July 11, 2006; 71 FR
39104). The last collection request anticipated the program progressing
from the planning stages to implementation. That transition has been
somewhat delayed as most States were late in getting their
implementation plans submitted by the December 2007 deadline. Also, the
decision by the U.S. Court of Appeals for the DC Circuit to both vacate
(on July 11, 2008) and subsequently remand (on December 23, 2008) the
Clean Air Interstate Rule has added much uncertainty to the
implementation phase of the program. Consequently, the amount of effort
anticipated in July 2006 remains the same today, and burden estimates
are essentially unchanged, except for revised labor and wage rates
using 2007 cost estimates. Also, in 2006, it was estimated that one
Tribe would submit a SIP; however no Tribes elected to submit SIPs and
the number of respondents has been reduced by one.

    Dated: August 20, 2009.
John Moses,
Director, Collection of Strategies Division.
[FR Doc. E9-20600 Filed 8-25-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Notices]
[Pages 71398-71399]
[FR Doc No: 2011-29677]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65731; File No. SR-ISE-2011-74]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Remove the Requirement That its Members Pass the DTR
Examination Prior To Registering

November 10, 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 October 28, 2011, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II below, which items have been prepared by
the self-regulatory organization. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    Pursuant to the provisions of Section 19(b)(1) of the Act,\3\ the
Exchange is filing a proposed rule change to remove the requirement
that Designated Trading Representatives (``DTRs'') pass an examination
administered by the ISE before they can be approved by the Exchange to
enter quotations and orders on behalf of market makers.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.ise.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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

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

1. Purpose
    The Exchange rules governing registration, examination, and
continuing education requirements for ISE members previously only
applied to associated persons who conducted a public customer business.
Such persons were required, in part, to pass the General Securities
Representative examination (``Series 7'') and the ISE's Designated
Trading Representative examination (``DTR Exam'') to function as
representatives if accepting orders from non-member customers.\4\ ISE
members whose business was limited to proprietary securities trading
(``Prop Traders'') were only required to pass the DTR exam prior to
receiving approval to enter quotations and orders on the Exchange.
---------------------------------------------------------------------------

    \4\ See ISE Rule 602.
---------------------------------------------------------------------------

    The ISE recently amended its rules governing registration,
examination, and continuing education to require members, regardless of
whether they conduct a public business or proprietary securities
business, to register, qualify and comply with continuing education
requirements.\5\ To address the gap in registration and examination
requirements related to Prop Traders, the ISE, in conjunction with
other SROs,\6\ implemented a new examination for Prop Traders (``Series
56'') that is administered by the Financial Industry Regulatory
Authority on behalf of the SROs.\7\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 63843 (February 4,
2011), 76 FR 7885 (February 11, 2011) (SR-ISE-2010-115).
    \6\ The Series 56 examination program is shared by the ISE,
Boston Options Exchange, Inc., Chicago Board Options Exchange, Inc.,
C2 Options Exchange, Inc., Chicago Stock Exchange, Inc., NASDAQ OMX,
BX, NASDAQ OMX, PHLX, NASDAQ Stock Market LLC, National Stock
Exchange, Inc., New York Stock Exchange, LLC, and NYSE Amex,
Incorporated.
    \7\ The Series 56 examination tests a candidate's knowledge of
proprietary trading generally and the industry rules applicable to
trading of equity securities and listed options contracts. The
Series 56 examination covers, among other things, recordkeeping and
recording requirements, types and characteristics of securities and
investments, trading practices and display execution and trading
systems. While the examination is primarily dedicated to topics
related to proprietary trading, the Series 56 examination also
covers a few general concepts relating to customers. The Series 56
examination became available to ISE members on August 1, 2011.
---------------------------------------------------------------------------

    Because the ISE now requires all Prop Traders to pass the Series 56
examination prior to being approved for membership, the Exchange
believes that it is no longer necessary to administer its own exam.
Likewise, the associated persons who are required to pass the Series 7
examination prior to receiving approval to enter quotations and orders
on the Exchange, should no longer be required to also pass the DTR Exam
because the Series 7 is a much more comprehensive examination and tests
the candidate's knowledge of the subject matter applicable to
proprietary trading. Accordingly, the Exchange proposes to delete the
requirement that Designated Trading Representatives take the DTR Exam.
Such individuals will continue to be subject to the Exchange's
registration and other requirements specific [sic] Designated Trading
Representatives.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\8\ in general, and furthers the objectives of Section 6(b)(1) \9\
of the Act in particular, in that it is designed to enforce compliance
by Exchange members and persons associated with its members with the
rules of the Exchange. The Exchange also believes the proposed rule
change furthers the objectives of Section 6(c)(3) \10\ of the Act,
which authorizes ISE to prescribe standards of training, experience and
competence for persons associated with ISE members, in that this filing
establishes that ISE members must take and pass the Series 56
examination, which is being adopted by other SROs so as to create
market-wide consistency in the examination process, instead of
administering an ISE specific examination. ISE believes the Series 56
examination program establishes the appropriate

qualifications for an individual associated person that is required to
register as a Proprietary Trader under Exchange Rule 313, including,
but not limited to, Market-Makers, proprietary traders and individuals
effecting transactions on behalf of other broker-dealers. The Exchange
believes the Series 56 addresses industry topics that establish the
foundation for the regulatory and procedural knowledge necessary for
individuals required to register as Designated Trading Representatives
under ISE Rule 801.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(1).
    \10\ 15 U.S.C. 78f(c)(3).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is 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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not 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) \11\ of the Act and Rule 19b-
4(f)(6) \12\ thereunder. The Exchange provided the Commission with
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 the proposed rule
change.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay so that the proposed rule change may become effective
and operative upon filing with the Commission. The Commission believes
that such waiver will allow the Exchange to decommission the use of its
own examination for registration purposes in conjunction with the
Exchange's deadline for its membership to have taken and passed the
Series 56 examination. Waiver of the operative delay will help to
streamline the exam procedures, while simultaneously protecting
investors and the public interest. Therefore, the Commission designates
the proposal to be operative upon filing.\13\
---------------------------------------------------------------------------

    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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.

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-ISE-2011-74 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-ISE-2011-74. 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
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2011-74 and should be
submitted on or before December 8, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-29677 Filed 11-16-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65765-65768]
[FR Doc No: 2015-27271]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3534]

Bulk Drug Substances That Can Be Used To Compound Drug Products
in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic
Act; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of public docket.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is developing
a list of bulk drug substances (active ingredients) that can be used to
compound drug products in accordance with the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), although they are neither the subject of
an applicable United States Pharmacopeia (USP) or National Formulary
(NF) monograph nor components of FDA-approved drugs (503A bulks list).
The Agency previously solicited nominations for the list, but some of
the nominated substances were not supported by sufficient information
for FDA to evaluate them. FDA is establishing a public docket where
these substances can be renominated with sufficient supporting
information or to receive nominations of bulk drug substances that were
not previously nominated for consideration for inclusion on the 503A
bulks list. Interested parties can also submit comments on nominated
substances via this docket.

DATES: Nominations and comments may be submitted to this docket at any
time.

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-2015-N-3534 for ``Bulk Drug Substances That Can Be Used To Compound
Drug Products in Accordance With Section 503A of the Federal Food,
Drug, and Cosmetic Act; Establishment of a Public Docket.'' 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: Philantha Bowen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5175, Silver Spring, MD 20993-0002, 301-
796-2466.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 503A of the FD&C Act (21 U.S.C. 353a) describes the
conditions under which a compounded drug

product may be entitled to an exemption from certain sections of the
FD&C Act. Those conditions include that a licensed pharmacist in a
State licensed pharmacy or Federal facility or a licensed physician
compounds the drug product using bulk drug substances that: (1) Comply
with the standards of an applicable USP or NF monograph, if a monograph
exists, and the USP chapter on pharmacy compounding; (2) if such a
monograph does not exist, are drug substances that are components of
drugs approved by the Secretary; or (3) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, that appear on a list developed by the Secretary through
regulations issued by the Secretary under subsection (c) of section
503A. See section 503A(b)(1)(A)(i) of the FD&C Act. Under section
503A(c)(2) of the FD&C Act, the criteria for determining which
substances should appear on the 503A bulks list ``shall include
historical use, reports in peer reviewed medical literature, or other
criteria the Secretary may identify.''
    Section 503A refers to the definition of ``bulk drug substance'' in
FDA regulations at Sec.  207.3(a)(4) (21 CFR 207.3(a)(4)). See section
503A(b)(1)(A) of the FD&C Act. As defined in Sec.  207.3(a)(4), a
``bulk drug substance'' is any substance that is represented for use in
a drug and that, when used in the manufacturing, processing, or
packaging of a drug, becomes an active ingredient or a finished dosage
form of the drug, but the term does not include intermediates used in
the synthesis of such substances.
    An ``active ingredient'' is any component that is intended to
furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of disease, or to
affect the structure or any function of the body of man or other
animals. The term includes those components that may undergo chemical
change in the manufacture of the drug product and be present in the
drug product in a modified form intended to furnish the specified
activity or effect. See 21 CFR 210.3(b)(7).
    Any component other than an active ingredient is an ``inactive
ingredient.'' See 21 CFR 210.3(b)(8). Inactive ingredients used in
compounded drug products, which commonly include flavorings, dyes,
diluents, or other excipients, need not appear on the Secretary's list
of bulk drug substances to be eligible for use in compounding drug
products and will not be included on the list.
    In a notice dated November 27, 2013 (the November 27, 2013,
notice), published in the Federal Register of December 4, 2013 (78 FR
72841), FDA invited all interested persons to nominate bulk drug
substances for inclusion on a list of bulk drug substances that can be
used for compounding under section 503A of the FD&C Act. Over 2,000
substances were nominated. However, many of the nominations were for
substances that can be used for compounding without being on the list
because they are the subject of an applicable USP or NF monograph or
are a component of an FDA-approved drug. In addition, many of the
nominations were not for bulk drug substances used in compounding as
active ingredients, or did not include sufficient information to allow
FDA to evaluate the substance for inclusion on the list. To improve the
efficiency of the process for developing the 503A bulks list, FDA
reopened the nomination process in July 2014 (79 FR 37742, July 2,
2014) and provided more detailed information on what it needs to
evaluate nominations for the list. FDA stated that bulk drug substances
that were previously nominated would not be considered further unless
they were re-nominated with adequate support to permit a meaningful
evaluation. Substances that were already eligible for use in
compounding or that were not adequately supported would not be
evaluated for placement on the list.
    In response to the July 2, 2014, request for nominations,
approximately 740 unique substances were nominated. Of the nominated
substances, approximately 275 are already eligible for use in
compounding because they are either components of an approved drug or
the subject of an applicable USP or NF monograph. At least nine of the
nominated substances are not eligible for inclusion on the list because
they are either a finished drug product, a biological product subject
to licensure in a biologics license application (BLA), a
radiopharmaceutical drug product, a substance with no currently
accepted medical use that is included on Schedule I of the Controlled
Substances Act (21 U.S.C. 812(c)), or they appear on the list published
by FDA of substances that have been withdrawn or removed from the
market because such drug products or components of such drug products
have been found to be unsafe or not effective. Of the substances that
are not components of an FDA-approved drug or the subject of an
applicable USP or NF monograph, not biological products subject to
licensure in a BLA, not radiopharmaceuticals, do not appear on Schedule
I, and do not appear on the withdrawn or removed list, approximately
390 substances were nominated with insufficient supporting evidence for
FDA to evaluate them.

II. Establishment of a Docket

    As described in section III.B of the draft guidance entitled,
``Interim Policy on Compounding Using Bulk Drug Substances Under
Section 503A of the Federal Food, Drug, and Cosmetic Act,'' FDA is
establishing a public docket so that interested parties can comment on
nominated bulk drug substances, nominate bulk drug substances that were
not previously nominated for the 503A bulks list, or renominate with
adequate supporting information bulk drug substances that were
previously nominated but that were not supported by sufficient
information for FDA to evaluate them. Docket No. FDA-2013-N-1525 is
closed for comment. Therefore, this new docket can be used for
commenting on nominations submitted to that docket as well as for
submitting new nominations.
    As stated previously, under section 503A(c)(2) of the FD&C Act, the
criteria for determining which substances should appear on the 503A
bulk drugs list shall include historical use, reports in peer reviewed
medical literature, or other criteria the Secretary may identify. Based
on this statutory language and consultations with the USP and the
Pharmacy Compounding Advisory Committee (PCAC),\1\ FDA is considering
the use of the following four criteria to determine whether a bulk drug
substance is appropriate for use in compounding: (1) The physical and
chemical characterization of the substance; (2) any safety issues
raised by the use of the substance in compounded drug products; (3)
historical use of the substance in compounded drug products, including
information about the medical condition(s) the substance has been used
to treat and any references in peer-reviewed medical literature; and
(4) the available evidence of effectiveness or lack of effectiveness of
a drug product compounded with the substance, if any such evidence
exists. Therefore, to be considered for placement on the 503A bulks
list, this information should be submitted for each nominated
substance. FDA will

evaluate the nominated substances in consultation with the USP and the
PCAC.
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    \1\ See 64 FR 996, January 7, 1999 (proposed rule listing bulk
drug substances that may be used in pharmacy compounding). This
proposed rule was withdrawn in the November 27, 2013, notice but
sets forth additional background about the criteria used in the
evaluation of nominated bulk drug substances. The criteria were
discussed with the PCAC, the membership of which includes a USP
representative, at its meeting on February 22, 2015.
---------------------------------------------------------------------------

    Interested groups and individuals may nominate specific bulk drug
substances for inclusion on the 503A bulks list, renominate previously
nominated substances with additional information, or comment on
nominated substances. Nominations will only be evaluated if they are
for specific active ingredients that: (1) Meet the definition of a bulk
drug substance in Sec.  207.3(a)(4); (2) are not components of FDA-
approved drug products; and (3) are not substances that are the subject
of an applicable USP or NF monograph. To fully evaluate a bulk drug
substance using the criteria identified above, FDA needs the following
information about both the nominated bulk drug substance and the drug
product(s) that will be compounded using such substance:

A. Confirmation That the Nominated Substance Is a Bulk Drug Substance
and Is Not Already Eligible for 503A Compounding

     A statement that the nominated substance is an active
ingredient that meets the definition of ``bulk drug substance'' in
Sec.  207.3(a)(4), and an explanation of why the substance is
considered an active ingredient when it is used in the identified
compounded drug product(s), citing to specific sources that describe
the active properties of the substance.
     A statement that the nominator has searched for the active
ingredient in all three sections of the Orange Book (for prescription
drug products, over-the-counter drug products, and discontinued drug
products), available at http://www.accessdata.fda.gov/scripts/cder/ob/docs/queryai.cfm, and the drug substance did not appear in any of those
searches, confirming that the substance is not a component of any FDA-
approved product.
     A statement that the nominator has searched applicable USP
and NF drug monographs, available at http://www.uspnf.com, and the drug
substance is not the subject of such a monograph.

B. General Background on the Bulk Drug Substance

     Ingredient name;
     Chemical name;
     Common name(s);
     Identifying codes, as available, from FDA's Unique
Ingredient Identifiers (UNII) used in the FDA/USP Substance
Registration System, available at http://fdasis.nlm.nih.gov/srs/.
Because substance names can vary, this code, where available, will be
used by the Agency to confirm the exact substance nominated and to
identify multiple nominations of the same substance so the information
can be reviewed together.
     Chemical grade of the ingredient;
     Description of the strength, quality, stability, and
purity of the ingredient, and a copy of a certificate of analysis that
is representative of the characteristics of the nominated ingredient;
     Information about how the ingredient is supplied (e.g.,
powder, liquid); and
     Information about recognition of the substance in foreign
pharmacopeias and the status of its registration(s) in other countries,
including whether information has been submitted to the USP for
consideration of monograph development.

C. Information on the Drug Product That Will Be Compounded With the
Bulk Drug Substance

     Information about the dosage form(s) into which the bulk
drug substance will be compounded;
     Information about the strength(s) of the compounded drug
product(s);
     Information about the anticipated route(s) of
administration of the compounded product(s);
     A bibliography of safety and efficacy data for the drug
compounded using the nominated substance, if available,\2\ including
any relevant peer-reviewed medical literature; and
---------------------------------------------------------------------------

    \2\ FDA recognizes that the available safety and efficacy data
supporting consideration of a bulk drug substance for inclusion on
the list may not be of the same type, amount, or quality as is
required to support a new drug application.
---------------------------------------------------------------------------

     Information about the past and proposed use(s) of the
compounded drug product(s), including the rationale for its use and why
the compounded product(s), as opposed to an FDA-approved product, is
necessary. Information on the rationale for use of the bulk drug
substance and why a compounded drug product is necessary must be
specific to the compounded drug product at issue. General or
boilerplate statements regarding the need for compounded drug products
or the benefits of compounding generally will not be considered
sufficient to address this issue.

D. Process for Submitting Nominations and Comments

    Because the prior deadline for submitting nominations has passed,
FDA is opening this docket so that interested persons can submit
nominations of bulk drug substances and provide adequate support for
FDA to evaluate whether those substances should be placed on the 503A
bulks list. Bulk drug substances that were previously nominated and for
which inadequate information was provided \3\ need to be renominated
with the information identified above to be considered for inclusion on
the 503A bulks list. Nominators are encouraged to submit as much of the
information identified in this document as possible. Unless adequate
supporting data is received for a bulk drug substance, FDA will be
unable to consider it further for inclusion on the list.
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    \3\ As referenced above, a list of the substances in this
category is available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM467373.pdf.
---------------------------------------------------------------------------

    For efficient consolidation and review of nominations, nominators
are encouraged to submit their nominations in an editable Excel file.
Specifically, nominators are encouraged to format their nominations as
follows:

------------------------------------------------------------------------
     Column A--What information is        Column B--Put data specific to
               requested?                    the nominated substance
------------------------------------------------------------------------
What is the name of the nominated        Provide the ingredient name.
 ingredient?
Is the ingredient an active ingredient   Provide an explanation for why
 that meets the definition of ``bulk      it is considered an active
 drug substance'' in Sec.                 ingredient when it is used in
 207.3(a)(4)?                             specific compounded drug
                                          products, and provide
                                          citations to specific sources
                                          that describe its active
                                          properties.
Is the ingredient listed in any of the   Confirm whether the ingredient
 three sections of the Orange Book?       is a component of an FDA-
                                          approved product.
Were any drug monographs for the         Confirm whether the ingredient
 ingredient found in the USP or NF        is the subject of an
 monographs?                              applicable USP or NF
                                          monograph.
What is the chemical name of the         Chemical name.
 substance?
What is the common name of the           Common name.
 substance?
Does the substance have a UNII code?     UNII code.

What is the chemical grade of the        Provide the chemical grade.
 substance?
What is the strength, quality,           Provide the strength, quality,
 stability, and purity of the             stability, and purity
 ingredient?                              information and attach a
                                          certificate of analysis.
How is the ingredient supplied?          Describe how the ingredient is
                                          supplied (e.g., powder,
                                          liquid).
Is the substance recognized in foreign   List the foreign pharmacopeias
 pharmacopeias or registered in other     or other countries in which it
 countries?                               is registered.
Has information been submitted about     Put yes, no, or unknown. If
 the substance to the USP for             yes, state the status of the
 consideration of drug monograph          monograph, if known.
 development?
What dosage form(s) will be compounded   State the dosage form(s).
 using the bulk drug substance?
What strength(s) will be compounded      List the strength(s) of the
 from the nominated substance?            drug product(s) that will be
                                          compounded from the nominated
                                          substance, or a range of
                                          strengths, if known.
What are the anticipated route(s) of     List the route(s) of
 administration of the compounded drug    administration of the
 product(s)?                              compounded drug product(s).
Are there safety and efficacy data on    Provide a bibliography of
 compounded drugs using the nominated     safety and efficacy data for
 substance?                               the drug compounded using the
                                          nominated substance, if
                                          available, including any
                                          relevant peer-reviewed medical
                                          literature.
Has the bulk drug substance been used    Describe past uses of the bulk
 previously to compound drug              drug substance in compounding.
 product(s)?
What is the proposed use for the drug    Provide information on the
 product(s) to be compounded with the     proposed use of the compounded
 nominated substance?                     drug product.
What is the reason for use of a          Provide a rationale for the use
 compounded drug product rather than an   of a compounded drug product.
 FDA-approved product?
Is there any other relevant              Provide any other information
 information?                             you would like FDA to consider
                                          in evaluating the nomination.
------------------------------------------------------------------------

    In addition to nominating new substances or renominating substances
previously nominated without sufficient supporting information,
individuals and organizations will be able to comment via the docket
established by this notice on substances nominated for the 503A bulks
list that have not yet been addressed in a Notice of Proposed
Rulemaking (NPRM). Comments may be submitted regarding nominations
submitted to both this docket and Docket No. FDA-2013-N-1525. Comments
may provide any relevant information about particular bulk drug
substances, including that in support of, or in opposition to, the
placement of a nominated bulk drug substance on the 503A bulks list.
However, comments submitted should not address the 503A bulks list
generally or other matters related to the Agency's regulation of
compounding. Comments about nominated substances that have been
addressed by the Agency in an NPRM should be submitted to the docket
for the proposed rulemaking in which the substance is addressed.
    Please do not submit comments that have already been submitted to
other dockets. Such submissions are duplicative and not helpful to the
Agency. If comments on particular documents or issues are submitted to
this docket rather than the docket specifically opened for the
particular document or issue, the comment might not be considered as
the specific documents are being finalized and issues considered. FDA
will not respond to questions submitted to this docket.
    Information in the docket will be publicly available. Therefore, we
remind nominators and commenters not to submit personal or confidential
information.

    Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27271 Filed 10-26-15; 8:45 am]
BILLING CODE 4164-01-P