[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13908-13910]
[FR Doc No: 2017-05083]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80194; File No. SR-ISE-2017-20]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Correct a Typographical Error in Section 413 of the
Exchange's Rules

March 9, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 28, 2017, the International Securities Exchange, LLC
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 413 of the Exchange's Rules, as
described in further detail below.
    The text of the proposed rule change is available on the Exchange's
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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to correct a
typographical error. Rule 413(a) of the Rules of the

Exchange (the ``Rules''), which provides for exemptions from position
limits, presently states that ``hedge transactions and positions
established pursuant to paragraphs eight (8) and nine (9)'' thereunder
are ``subject to a position limit equal to five (5) times the standard
limit established under Rule 412(d).'' The reference in this text to
paragraphs (8) and (9) is incorrect. The Rule text should properly
reference paragraphs (6) and (8).
    Paragraph (6) of Rule 413(a) provides for a position limit
exemption for a long call position accompanied by a short put position
with the same strike price and a short call position accompanied by a
long put position with a different strike price (a ``box spread'').
Paragraph (8) provides for a position limit exemption for a listed
option position hedged on a one-for-one basis with an over-the-counter
(``OTC'') option position on the same underlying security. Meanwhile,
paragraph (9) merely states that for strategies described under
paragraphs (2)-(5) of subsection (a) of the Rule, one component of the
option strategy can be an OTC option contract guaranteed or endorsed by
the firm maintaining the proprietary position or carrying the customer
account.
    The Exchange notes that the position limit exemptions set forth in
the rules of other options exchanges, including ISE's sister exchange,
Phlx, as well as CBOE, provide for position limit exemptions for OTC
and box spread hedges of up to five times the standard limits.\3\
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    \3\ See PHLX Rule 1001(l) (providing that ``[h]edge transactions
and positions established pursuant to paragraphs (6) [OTC options
hedges] and (7) [box spread hedges] below are subject to a position
limit equal to five (5) times the standard limit . . .''); CBOE Rule
4.11, Interpretation .04(a) (providing that [h]edge transactions and
positions established pursuant to paragraphs six (6) [box spread
hedges] and seven (7) [OTC options hedges] are subject to a position
limit equal to five (5) times the standard limit . . .'').
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\4\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\5\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest. The Exchange
asserts that the proposed correction will serve the Act's goals by
ensuring that the Exchange's Rules are accurate.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act as it is designed to correct a
typographical error.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \6\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\7\
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    \6\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \7\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \8\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \9\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposal may become operative immediately upon filing. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because it will allow the Exchange to correct a typographical error
immediately and therefore reduce confusion in the application of the
Exchange's rules. Accordingly, the Commission hereby waives the
operative delay and designates the proposal operative upon filing.\10\
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    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 17 CFR 240.19b-4(f)(6)(iii).
    \10\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2017-20 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2017-20. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of

10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; 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-2017-20 and should be
submitted on or before April 5, 2017.
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    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-05083 Filed 3-14-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 246 (Tuesday, December 26, 2023)]
[Notices]
[Pages 88924-88926]
[FR Doc No: 2023-28310]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2818]

Rare Diseases: Considerations for the Development of Drugs and
Biological Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Rare
Diseases: Considerations for the Development of Drugs and Biological
Products.'' This guidance is intended to assist sponsors of drugs and
biological products for treatment of rare diseases in conducting
efficient and successful drug development programs through a discussion
of selected issues commonly encountered in rare disease drug
development. This guidance finalizes the draft guidance entitled ``Rare
Diseases: Common Issues in Drug Development'' issued on February 1,
2019.

DATES: The announcement of the guidance is published in the Federal
Register on December 26, 2023.

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, 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-D-2818 for ``Rare Diseases: Considerations for the Development
of Drugs and Biological Products.'' 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 between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Andrea Bell-Vlasov, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 240-
402-4977; or Anne Taylor, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Rare Diseases: Considerations for the Development of Drugs
and Biological Products.'' This guidance is intended to assist sponsors
of drugs and biological products for treatment of rare diseases in
conducting efficient and successful product development programs
through a discussion of selected issues commonly encountered in rare
disease drug development. This final guidance addresses important
aspects of drug and biological product development to support the
proposed clinical investigation(s), including nonclinical pharmacology/
toxicology; trial design and endpoint considerations to ensure quality
and interpretability of data; standard of evidence to establish safety
and effectiveness; and drug manufacturing considerations during drug
development.
    This guidance finalizes the draft guidance entitled ``Rare
Diseases: Common Issues in Drug Development'' issued February 1, 2019
(84 FR 1156). Changes made from the draft to the final guidance took
into consideration comments received. Major changes include the removal
of the natural history section (because this is addressed in a separate
guidance), additional considerations regarding nonclinical studies,
information on the use of external controls and early randomization, a
section discussing safety considerations, information on changes to
drug substance or manufacturing process, and sections discussing
participation of patients/patient groups in drug development programs
and pediatric considerations in rare disease drug development.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Rare Diseases: Considerations for the
Development of Drugs and Biological Products.'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521).
    The following collections of information in the final guidance have
been approved under OMB control number 0910-0001:
     Submitting under 21 CFR 314.50(c)(1)(iv) and (d)(3) (Sec.
314.50(c)(1)(iv) and (d)(3)) a summary of the nonclinical pharmacology
and toxicology section and the human pharmacokinetics and
bioavailability section of new drug application (NDAs);

     Submitting under Sec.  314.50(d)(1)(i) chemistry,
manufacturing, and controls information, including the drug substance,
for the content and format of an NDA for rare diseases; and
     Submitting under Sec.  314.50(d)(5) and (d)(5)(iv)
clinical data of a drug, including a description of any other data
information relevant to an evaluation of the safety and effectiveness
of a drug.
     Submissions under 21 CFR part 314, subpart H, to grant
accelerated approval of new drugs for serious or life-threatening
illnesses.
     Submissions under Sec. Sec.  312.47 and 312.82 for
requesting meetings with FDA about drug development programs.
    The following collections of information in the final guidance have
been approved under OMB control number 0910-0014:
     Submitting under 21 CFR 312.23(a)(6)(i) (Sec.
312.23(a)(6)(i)) a protocol for the duration of a trial and the
criteria to enter a trial and under Sec.  312.23(a)(6)(i),
(a)(6)(iii)(d) and (g) a description of an estimate of patients that
will be involved in a trial, including a description of the safety
exclusions and a description of clinical procedures, laboratory, or
other methods.
     Submitting under Sec.  312.23(a)(3)(i) a brief
introductory statement and general investigational plan, including the
route of administration of a drug;
     Submitting under Sec.  312.23(a)(7) and (a)(7)(iv)(a)
chemistry, manufacturing, and controls information for the content and
format of an investigational new drug application (IND) and the safety
and effectiveness of such information;
     Submitting under Sec.  312.23(a)(8) and (a)(8)(i)
pharmacology, toxicology, and drug disposition information for rare
diseases;
     Submitting under 312.23(a)(10)(iii) plans for assessing
pediatric safety and effectiveness;
     Submitting under Sec.  312.32(c)(1) IND safety reports;
     Submissions under Sec. Sec.  312.305(b) and 312.310(b) for
expanded access uses and treatment of an individual patient.
    The collections of information in 21 CFR part 316 for submitting
the content and format of NDAs for orphan drugs have been approved
under OMB control number 0910-0167. The collections of information
pertaining to postmarketing adverse drug experience reporting have been
approved under OMB control number 0910-0230. The collections of
information pertaining to expedited review programs for serious
conditions, accelerated approval, breakthrough therapy-designation, and
fast-track designation, have been approved under OMB control number
0910-0765. The collections of information in 21 CFR part 58 pertaining
to good laboratory practices have been approved under OMB control
number 0910-0119. The collection of information pertaining to current
good manufacturing practices have been approved under OMB control
number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28310 Filed 12-22-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Proposed Rules]
[Pages 57320-57323]
[FR Doc No: 2013-22655]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 16

[Docket Nos. FDA-2011-N-0143 and FDA-2011-N-0146]

Food and Drug Administration Food Safety Modernization Act:
Proposed Rules on Foreign Supplier Verification Programs and the
Accreditation of Third-Party Auditors/Certification Bodies; Public
Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meetings.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing two
public meetings to discuss two proposed rules aimed at strengthening
assurances that imported food meets the same safety standards as food
produced domestically. The Foreign Supplier Verification Programs
(FSVP) proposal establishes requirements for importers to verify that
their foreign suppliers are implementing the modern, prevention-
oriented food safety practices called for by the Food Safety
Modernization Act (FSMA) and achieving the same level of food safety as
domestic growers and processors. The second proposed rule on the
Accreditation of Third-Party Auditors/Certification Bodies would
strengthen the quality, objectivity, and transparency of foreign food
safety audits on which many U.S. food companies and importers currently
rely to help manage the safety of their global food supply chains. The
purpose of these public meetings is to solicit oral stakeholder and
public comments on the proposed rules and to inform the public about
the rulemaking process (including how to submit comments, data, and
other information to the rulemaking dockets), and to respond to
questions about the proposed rules.

DATES: See section II, ``How to Participate in the Public Meeting'' in
the SUPPLEMENTARY INFORMATION section of this document for date and
time of the public meetings, closing dates for advance registration,
and information on deadlines for submitting either electronic or
written comments to FDA's Division of Dockets Management.

ADDRESSES: See section II, ``How to Participate in the Public Meeting''
in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: For questions about registering for
the meetings, to register by phone, or to submit a notice of
participation by mail, FAX, or email: Lauren Montgomery, Teya
Technologies, LLC, 101 East 9th Ave., Suite 9B, Anchorage, Alaska
99501,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    For general questions about the meetings, to request an opportunity
to make an oral presentation at the public meetings, to submit the full
text, comprehensive outline, or summary of an oral presentation, or for
special accommodations due to a disability, contact: Juanita Yates,
Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1731, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FSMA (Pub. L. 111-353), was signed into law by President Obama on
January 4, 2011, to better protect public health by helping to ensure
the safety and security of the food supply. FSMA amends the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation
of a modernized, prevention-based food safety system. Among other
things, FSMA requires FDA to issue regulations requiring preventive
controls for human food and animal food, set standards for produce
safety, and require importers to have a program to verify that the food
products they bring into the United

States are produced in a manner consistent with U.S. standards.
    FSMA was the first major legislative reform of FDA's food safety
authorities in more than 70 years, even though FDA has increased the
focus of its food safety efforts on prevention for more than a decade.
In the Federal Register of January 16, 2013 (78 FR 3504 and 78 FR
3646), FDA announced the establishment of two dockets so that the
public can review the produce safety proposed rule and the preventive
controls proposed rule for human food and submit comments to the
Agency. These proposed rulemakings were the first of several key
proposals in furtherance of FSMA's food safety mandate. For information
on the produce safety proposed rule, the preventive controls rule, and
related fact sheets, see FDA's FSMA Web page located at http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.
    In the Federal Register of July 29, 2013 (78 FR 45730 and 78 FR
45782), FDA announced the second set of FSMA proposed rules and the
establishment of two additional dockets so that the public can review
the proposals on FSVP and the Accreditation of Third-Party Auditors/
Certification Bodies and submit comments to the Agency. Under the
proposed FSVP rule, those importing FDA-regulated food into the United
States will be held accountable for verifying that their suppliers
produce food in a manner consistent with U.S. standards. Under the
proposed rule that would establish the Accreditation of Third-Party
Auditors/Certification Bodies program, the FDA would recognize
accreditation bodies based on certain criteria such as competency and
impartiality. The accreditation bodies, which could be foreign
governments or their agencies or private companies, would in turn
accredit third-party auditors to audit and issue certifications for
foreign food facilities and food.
    FDA is announcing a series of public meetings entitled ``The Food
Safety Modernization Act Public Meetings on Proposed Rules for Foreign
Supplier Verification Programs (FSVP) and for the Accreditation of
Third-Party Auditors/Certification Bodies for Imported Food'' so that
the food industry, consumers, foreign governments, and other
stakeholders can better evaluate and comment on the proposals. These
meetings, following the Washington, DC public event on September 19 and
20, 2013, are the final two meetings FDA plans to hold during the
proposed rules' comment period. All three public meetings will have the
same agenda and are intended to facilitate and support the proposed
rules' evaluation and commenting process.

II. How To Participate in the Public Meetings

    FDA is holding the public meetings on the FSVP and the
Accreditation of Third-Party Auditors/Certification Bodies proposed
rules to inform the public about the rulemaking process, including how
to submit comments, data, and other information to the rulemaking
docket; to respond to questions about the proposed rules; and to
provide an opportunity for interested persons to make oral
presentations. Due to limited space and time, FDA encourages all
persons who wish to attend the meetings to register in advance. There
is no fee to register for the public meetings, and registration will be
on a first-come, first-served basis. Early registration is recommended
because seating is limited. Onsite registration will be accepted, as
space permits, after all preregistered attendees are seated.
    Those requesting an opportunity to make an oral presentation during
the time allotted for public comment at the meeting are asked to submit
a request and to provide the specific topic or issue to be addressed.
Due to the anticipated high level of interest in presenting public
comment and limited time available, FDA is allocating 3 minutes to each
speaker to make an oral presentation. Speakers will be limited to
making oral remarks; there will not be an opportunity to display
materials such as slide shows, videos, or other media during the
meeting. If time permits, individuals or organizations that did not
register in advance may be granted the opportunity to make an oral
presentation. FDA would like to maximize the number of individuals who
make a presentation at the meeting and will do our best to accommodate
all persons who wish to make a presentation or express their opinions
at the meeting.
    FDA encourages persons and groups who have similar interests to
consolidate their information for presentation by a single
representative. After reviewing the presentation requests, FDA will
notify each participant before the meeting of the approximate time
their presentation is scheduled to begin, and remind them of the
presentation format (i.e., 3-minute oral presentation without visual
media).
    While oral presentations from specific individuals and
organizations will be necessarily limited due to time constraints
during the public meeting, stakeholders may submit electronic or
written comments discussing any issues of concern to the administrative
record (the docket) for the rulemaking. All relevant data and
documentation should be submitted with the comments to the relevant
docket i.e., FSVP, Docket No. FDA-2011-N-0143, or accreditation of
third-party auditors, Docket No. FDA-2011-N-0146.
    Table 1 of this document provides information on participation in
the public meetings:

   Table 1--Information on Participation in the Meetings and on Submitting Comments to the Rulemaking Dockets
----------------------------------------------------------------------------------------------------------------
                                        Date          Electronic address         Address       Other information
----------------------------------------------------------------------------------------------------------------
Public meeting.................  October 10, 2013,                          Hyatt Regency      Onsite
                                  from 8:30 a.m.                             Miami, 400 SE      registration
                                  to 5 p.m. and                              Second Ave.,       both days from 8
                                  October 11,                                Miami, FL 33131.   a.m.-8:30 a.m.
                                  2013, from 8:30
                                  a.m. to 12:30
                                  p.m.
Advance registration...........  by October 1,      Individuals who wish    We encourage you   There is no
                                  2013.              to participate in       to use             registration fee
                                                     person are asked to     electronic         for the public
                                                     preregister at http://  registration if    meetings. Early
                                                     www.fda.gov/Food/       possible \1\.      registration is
                                                     NewsEvents/                                recommended
                                                     WorkshopsMeetingsConf                      because seating
                                                     erences/default.htm.                       is limited.

Request to make a Public         by September 24,   http://www.fda.gov/                        Requests made on
 Comment.                         2013.              Food/NewsEvents/                           the day of the
                                                     WorkshopsMeetingsConf                      meeting to make
                                                     erences/default.htm                        an oral
                                                     \2\.                                       presentation
                                                                                will be granted
                                                                                as time permits.
                                                                                Information on
                                                                                requests to make
                                                                                an oral
                                                                                presentation may
                                                                                be posted
                                                                                without change
                                                                                to http://www.regulations.gov gov, including
                                                                                any personal
                                                                                information
                                                                                provided.
Request special accommodations   by September 24,   Juanita Yates, email:   See FOR FURTHER    .................
 due to a disability.             2013<EMAIL_ADDRESS> INFORMATION
                                                     .gov.                   CONTACT.
Submit electronic or written     November 26, 2013  Docket Nos. FDA-2011-N-
 comments.                                           0143 and FDA-2011-N-
                                                     0146.
Public meeting.................  October 22, 2013,                          Hilton Long Beach  Onsite
                                  from 8:30 a.m.                             & Executive        registration
                                  to 5 p.m. and                              Meeting Center,    both days from 8
                                  October 23,                                701 West Ocean     a.m.-8:30 a.m.
                                  2013, from 8:30                            Blvd., Long
                                  a.m. to 12:30                              Beach, CA 90831.
                                  p.m..
Advance registration...........  by October 8,      Individuals who wish    We encourage you   There is no
                                  2013.              to participate in       to use             registration fee
                                                     person are asked to     electronic         for the public
                                                     preregister at http://  registration if    meetings. Early
                                                     www.fda.gov/Food/       possible \1\.      registration is
                                                     NewsEvents/                                recommended
                                                     WorkshopsMeetingsConf                      because seating
                                                     erences/default.htm.                       is limited.
Request to make a Public         by October 1,      http://www.fda.gov/                        Requests made on
 Comment.                         2013.              Food/NewsEvents/                           the day of the
                                                     WorkshopsMeetingsConf                      meeting to make
                                                     erences/default.htm                        an oral
                                                     \2\.                                       presentation
                                                                                will be granted
                                                                                as time permits.
                                                                                Information on
                                                                                requests to make
                                                                                an oral
                                                                                presentation may
                                                                                be posted
                                                                                without change
                                                                                to http://www.regulations.gov gov, including
                                                                                any personal
                                                                                information
                                                                                provided.
Request special accommodations   by October 1,      Juanita Yates, e-mail:  See FOR FURTHER
 due to a disability.             2013<EMAIL_ADDRESS> INFORMATION
                                                     .gov.                   CONTACT.
Submit electronic or written     November 26th,     Docket Nos. FDA-2011-N-
 comments.                        2013.              0143 and FDA-2011-N-
                                                     0146.
----------------------------------------------------------------------------------------------------------------
\1\ You may also register via email, mail, or FAX. Please include your name, title, firm name, address, and
  phone and FAX numbers in your registration information and send to: Lauren Montgomery, Teya Technologies, LLC,
  101 East 9th Ave., Suite 9B, Anchorage, Alaska 99501,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Onsite registration will also be available.
\2\ You may also request to make an oral presentation at the public meeting via email. Please include your name,
  title, firm name, address, and phone and FAX numbers as well as the full text, comprehensive outline, or
  summary of your oral presentation and send to: Juanita Yates, Center for Food Safety and Applied Nutrition,
  Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
III. Comments, Transcripts, and Recorded Video

    Information and data submitted voluntarily to FDA during the public
meeting will become part of the administrative record for the relevant
rulemaking and will be accessible to the public at http://www.regulations.gov. The transcript of the proceedings from the public
meeting will become part of the administrative record for each of the
rulemakings. Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov and at
FDA's FSMA Web site at: http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm. It may also be viewed at the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. A transcript will also be available in
either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. Written requests are to be sent to the Division of
Freedom of Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.

    Dated: September 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22655 Filed 9-17-13; 8:45 am]
BILLING CODE 4160-01-P