[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48619-48620]
[FR Doc No: 2018-20909]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2138]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry: Adverse Event Reporting for Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by October
26, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0800.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed collection of information to OMB
for review and clearance.

Guidance for Industry: Adverse Event Reporting for Outsourcing
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic
Act

OMB Control Number 0910-0800--Extension

    This information collection supports Agency implementation of the
Drug Quality and Security Act (Pub. L. 113-54), which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding new section
503B (21 U.S.C. 353b). Under section 503B(b) of the FD&C Act, a
compounder can register as an outsourcing facility with FDA. If the
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a
drug compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from certain sections
of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with adequate directions for use) and
section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)). Drugs compounded in outsourcing facilities are
not exempt from the requirements of section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing
practice for drugs).
    Under section 503B(b)(5) of the FD&C Act, an outsourcing facility
must submit adverse event reports to FDA in accordance with the content
and format requirements established through guidance or regulation
under Sec.  310.305 (21 CFR 310.305) (or any successor regulations).
Accordingly, we developed the document, ``Guidance for Industry:
Adverse Event Reporting for Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act.'' For a copy of guidance
documents, go to https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, insert the title of the guidance document in the
``Search'' box and follow the prompts. The guidance explains electronic
reporting of adverse events in accordance with Sec.  310.305 with
respect to outsourcing facilities.
    Under Sec.  310.305(c)(1), manufacturers, packers, and distributors
of marketed prescription drug products that are not the subject of an
approved NDA or ANDA, including, as set forth in the guidance,
outsourcing facilities must submit to FDA adverse event reports within
15 calendar days of receiving the information and must submit follow-up
reports within 15 calendar days of receipt of new information about the
adverse event, or as requested by FDA. Outsourcing facilities must
submit the adverse event report in an electronic format that FDA can
process, review, and archive (collection of information is approved by
OMB control number 0910-0291). A copy of the current labeling of the
compounded drug product must be provided.
    Under Sec.  310.305(f), entities subject to the regulation must
maintain for 10 years the records of all adverse events required to be
reported under Sec.  310.305. The outsourcing facility should also
maintain records of its efforts to obtain the data elements described
in the draft guidance for each adverse event report.
    In the Federal Register of August 21, 2018 (83 FR 28854), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden for the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                  Compounding outsourcing facility                      Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Submission of adverse event reports' including copy of labeling and              55                1               55              1.1               61
 other information as described in the guidance....................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                Number of                       Average burden
                       Type of recordkeeping                            Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records of adverse events, including records of efforts to obtain                55                1               55               16              880
 the data elements for each adverse event report...................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This is the first extension of the information collection and we
have retained the currently approved burden estimate. Based on our
review of Agency data, we estimate that annually 55 outsourcing
facilities (``Number of Respondents'' and ``Total Annual Responses'' in
table 1) will submit adverse event reports to FDA as specified in the
guidance and that preparing and submitting this information will take
approximately 1.1 hours per registrant (``Average Burden per Response''
in table 1). Likewise, we estimate that annually 55 outsourcing
facilities (``Number of Recordkeepers'' in table 2) will maintain
records of adverse events as specified in the guidance and that
preparing and maintaining the records will take approximately 16 hours
per registrant (``Average Burden per Recordkeeping'' in table 2).

    Dated: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20909 Filed 9-25-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Notices]
[Page 25813-25814]
[DOCID:fr07my08-140]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57752; File No. SR-CBOE-2008-51]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Lowering the Appointment Cost of SPX Options

May 1, 2008.
    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 April 30, 2008, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been substantially prepared by
the Exchange. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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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 CBOE rules to lower the appointment
cost for options on the Standard & Poor's 500 (SPX). The text of the
proposed rule change is available on the Exchange's Web site (http://
www.cboe.org/Legal ), at the Exchange's Office of the Secretary and at
the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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 those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

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

1. Purpose
    The purpose of this rule change is to amend CBOE Rule 8.3 to lower
the appointment cost for SPX options. Presently, SPX has an appointment
cost of 1.0. CBOE proposes to reduce the appointment cost to .95
effective May 1, 2008. Members then could utilize the excess membership
capacity of .05 to hold an appointment and quote electronically in an
appropriate number of Hybrid 2.0 option classes, which promotes
competition and efficiency.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\5\ Specifically, the Exchange believes the
proposed rule change is consistent with the Section 6(b)(5) Act \6\
requirements that the rules of an exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts and, in general, to protect investors and the public
interest.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition 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 neither solicited nor received comments on the
proposal.

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

    Because the foregoing rule 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 if consistent with the protection of investors
and the public interest, provided that the self-regulatory organization
has given the Commission written notice of its intent to file the
proposed rule change 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,\7\ the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-4(f)(6)
thereunder.\9\ At any time within 60 days of the filing of such
proposed rule change, the Commission may summarily abrogate 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.
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    \7\ CBOE fulfilled this requirement.
    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
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    Under Rule 19b-4(f)(6) of the Act,\10\ the proposal does not become
operative for 30 days after the date of its filing, or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest. The Exchange has requested that
the Commission waive the 30-day operative delay, so that the proposal
may take effect on May 1, 2008. Lowering the appointment cost on SPX
options will allow Market-Makers who have an appointment in SPX
additional options classes in which they could act as Market-Makers.
Thus, the Exchange believes that waiving the 30-day operative period
will promote competition and efficiency without undue delay. The
Commission agrees and, consistent with the protection of investors and
the public interest, has determined to waive the 30-day

operative delay so that the proposal may take effect on May 1,
2008.\11\

IV. Solicitation of Comments
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    \10\ Id.
    \11\ For purposes only of waiving the operative date of this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
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    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2008-51 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-CBOE-2008-51. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room, 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
CBOE. 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-
CBOE-2008-51 and should be submitted on or before May 28, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-10039 Filed 5-6-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Page 42802]
[FR Doc No: 2015-17690]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-84-000]

Caithness Long Island II, LLC v. New York Independent System
Operator, Inc.; Notice of Complaint

    Take notice that on July 10, 2015, pursuant to sections 206 and 306
of the Federal Power Act, 16 U.S.C. 824e and 825e and Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206, Caithness Long Island II, LLC
(Complainant) filed a formal complaint against New York Independent
System Operator, Inc. (NYISO or Respondent) alleging that NYISO's
application of certain interconnection requirements to the Class Year
2015 Interconnection Facilities Study violates Commission policy and
the NYISO Open Access Transmission Tariff.
    The Complainant certify that copies of the complaint were served on
the contacts for NYISO as listed on the Commission's list of Corporate
Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 10, 2015.

    Dated: July 13, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-17690 Filed 7-17-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 146 (Tuesday, July 30, 2019)]
[Notices]
[Page 36908]
[FR Doc No: 2019-16111]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-1064-001.
    Applicants: Stingray Pipeline Company, L.L.C.
    Description: Request for Extension of Time to Implement NAESB 3.1
Standards Per Order No. 587-Y of Stingray Pipeline Company, L.L.C.
under RP19-1064.
    Filed Date: 7/19/19.
    Accession Number: 20190719-5060.
    Comments Due: 5 p.m. ET 7/25/19.

    Docket Numbers: RP19-1390-000.
    Applicants: Northern Border Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Future Sales of Capacity to be
effective 8/19/2019.
    Filed Date: 7/19/19.
    Accession Number: 20190719-5054.
    Comments Due: 5 p.m. ET 7/31/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 22, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-16111 Filed 7-29-19; 8:45 am]
BILLING CODE 6717-01-P