[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53161-53162]
[FR Doc No: 2015-21645]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0164]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Safety Labeling Changes--
Implementation of Section 505(o)(4) 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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the requirement to make safety
related labeling changes based upon new safety information that becomes
available after the drug or biological product is approved under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) or the Public
Health Service Act (PHS Act.)

DATES: Submit either electronic or written comments on the collection
of information by November 2, 2015.

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

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Guidance for Industry on Safety Labeling Changes--Implementation of
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (OMB
Control Number 0910-0734)--Extension

    Section 505(o)(4) of the FD&C Act (21 U.S.C. 355(o)(4)) authorizes
FDA to require, and if necessary, order labeling changes if FDA becomes
aware of new safety information that FDA believes should be included in
the labeling of certain prescription drug and biological products
approved under section 505 of the FD&C Act or section 351 of the PHS
Act (42 U.S.C. 262). Section 505(o)(4) of the FD&C Act applies to
prescription drug products with an approved new drug application (NDA)
under section 505(b) of the FD&C Act, biological products with an
approved biologics license application under section 351 of the PHS
Act, or prescription drug products with an approved abbreviated new
drug application under section 505(j) of the FD&C Act if the reference
listed drug with an approved NDA is not currently marketed. Section
505(o)(4) imposes timeframes for application holders to submit and FDA
staff to review such changes, and gives FDA new enforcement tools to
bring about timely and appropriate labeling changes. The guidance
provides information on the implementation of the new provisions,
including a description of the types of safety labeling changes that
ordinarily might be required under the new legislation, how FDA plans
to determine what constitutes new safety information, the procedures
involved in requiring safety labeling changes, and enforcement of the
requirements for safety labeling changes.
    FDA requires safety labeling changes by sending a notification
letter to the application holder. Under section 505(o)(4)(B), the
application holder must respond to FDA's notification by submitting a
labeling supplement or notifying FDA that the applicant does not
believe the labeling change is warranted and submitting a statement
detailing the reasons why the application holder does not believe a
change is warranted (a rebuttal statement).
    Based on FDA's experience to date with safety labeling changes
requirements under section 505(o)(4), we estimate that approximately 42
application holders will elect to submit approximately one rebuttal
statement each year and that each rebuttal statement will take
approximately 6 hours to prepare.
    In addition, in the guidance, FDA states that new labeling prepared
in

response to a safety labeling change notification should be available
on the application holder's Web site within 10 calendar days of
approval. FDA estimates that approximately 407 application holders will
post new labeling one time each year in response to a safety labeling
change notification and that the posting of the labeling will take
approximately 4 hours to prepare.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                                                                        Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rebuttal statement.................................................              42                1               42                6              252
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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 Third-Party Disclosure Burden \1\
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                                                  Number of
     Type of submission          Number of     disclosures per    Total annual    Average burden    Total hours
                                respondents       respondent      disclosures     per disclosure
----------------------------------------------------------------------------------------------------------------
Posting approved labeling on             407                1              407                4           1,628
 application holder's Web
 site.......................
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\1\ There are no capital costs or operating and maintenance costs associated with this collect of information.

    Dated: August 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21645 Filed 9-1-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Notices]
[Page 76897-76899]
[DOCID:fr28de05-165]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52986; File No. SR-PCX-2005-137]

Self-Regulatory Organizations; Pacific Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change and
Amendment No. 1 Thereto To Expand Its $2.50 Strike Price Program

December 20, 2005.
    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 December 14, 2005, the Pacific Exchange, Inc. (``PCX'' 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 PCX. On December 16, 2005,
PCX filed Amendment No. 1 to the proposed rule change.\3\ The Exchange
has filed the proposal as a ``non-controversial'' rule change pursuant
to Section 19(b)(3)(A) of the Act \4\ and Rule 19b-4(f)(6)
thereunder,\5\ which renders it effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 corrected an omission in the proposed rule
text.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 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

    PCX proposes to amend PCX Rule 6.4 Commentary .03 governing the
listing of options with strike price intervals of $2.50. Below is the
text of the proposed rule change. Proposed new language is in italics;
proposed deletions are in [brackets].
* * * * *

Rule 6.4. Series of Options Open for Trading

    (a)-(e)--No change.
    Commentary .01-.02--No change.

    .03 The Exchange may select [a limited number]up to 43 classes of
its listed options on individual stocks or Exchange-Traded Fund Shares
for which the interval of strike prices will be $2.50 where the strike
price is greater than $25 but less than [$50.] $75. The Exchange will
list $2.50 strikes prices between $50 and $75 provided the $2.50 strike
prices between $50 and $75 are no more than $10 from the closing price
of the underlying stock on its primary market on the preceding day. In
addition to those options selected by the Exchange, the strike price
interval may be $2.50 in any multiply traded option once another
exchange trading that option selects such options. An option class
shall remain in the $2.50 Strike Price Program until otherwise
designated by the Exchange and a decertification notice is sent to the
Options Clearing Corporation.
    .04-.07--No change.
* * * * *

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

    In its filing with the Commission, PCX 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
    PCX proposes to amend PCX Rule 6.4 Commentary .03 to allow the
listing of options with $2.50 strike price intervals for options with
strike prices between $50 and $75 on those option classes that have
been selected as part of the $2.50 Strike Price Program (``Program'').
PCX proposes to list options with $2.50 strike price intervals above
$50 only if the new strike price is within $10 of the closing price of
the underlying security on the previous trading day.
    Under the Program, initially adopted in 1995 as a joint program of
the options exchanges, exchanges were permitted to list options with
$2.50 strikes price intervals up to $50 on a total of 100 option
classes.\6\ The Program was later expanded and permanently approved in
1998 to allow the exchanges collectively to select up to 200 issues on
which to list options with $2.50 strike price intervals up to $50.\7\
Of the 200 available issues, PCX has been allocated 43 issues. This
proposal does not increase the number of issues that the PCX will be
allocated under the Program. In addition to an allocation from the 200
issues, each exchange is also permitted to list options with $2.50
strike price intervals on any option class that another exchange
selects as part of its Program. In addition, the Exchange proposes to
amend PCX Rule 6.4 Commentary .03 to note that an option class shall
remain in the Program until otherwise designated by the Exchange and a
decertification notice is sent to the Options Clearing Corporation.
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    \6\ See Securities Exchange Act Release No. 35993 (July 19,
1995), 60 FR 38073 (July 25, 1995) (approving File Nos. SR-Phlx-95-
08, SR-Amex-95-12, SR-PSE-95-07, SR-CBOE-95-19, and SR-NYSE-95-12).
    \7\ See Securities Exchange Act Release No. 40662 (November 12,
1998), 63 FR 64297 (November 19, 1998) (approving File Nos. SR-Amex-
98-21, SR-CBOE-98-29, SR-PCX-98-31, and SR-Phlx-98-26).
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    PCX believes that the experiences over the past ten years of
listing options series with strike prices at $2.50 intervals up to $50
have produced positive results.\8\ Specifically, this has stimulated
customer interest by creating additional trading opportunities, by
creating more flexibility in trading decisions, and by affording
customers the ability to more closely tailor investment strategies to
the precise movement of the underlying security. The proposal to expand
the listing of options with $2.50 strike price intervals is intended to
provide customers with greater flexibility in their investment choices
for those stocks priced between $50 and $75. PCX represents that
Options Price Reporting Authority has the capacity to accommodate the
increase of series added pursuant to this rule change.
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    \8\ Telephone conversation between Glenn Gsell, Director,
Regulation, PCX, and Theodore S. Venuti, Attorney, Division of
Market Regulation, Commission, on December 20, 2005.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act,\9\ in general, and furthers the objective of
Section 6(b)(5) of the Act,\10\ in particular, in that it is designed
to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 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.

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

    Comments on the proposed rule change were neither solicited nor
received.

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

    Because the foregoing rule change does not: (1) Significantly
affect the protection of investors or the public interest; (2) impose
any significant burden on competition; and (3) become operative for 30
days after the date of this filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and Rule 19b-4(f)(6) thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\13\
However, Rule 19b-4(f)(6)(iii) \14\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest.\15\ The Exchange has requested that
the Commission waive the 30-day pre-operative delay, and the Commission
hereby grants that request.\16\ The Commission believes that waiving
the 30-day pre-operative delay is consistent with the protection of
investors and in the public interest. This action will allow the
Exchange to immediately expand its Program to list options with $2.50
strike price intervals for options with strike prices between $50 and
$75.

The Commission notes that it recently approved similar expansions to
the $2.50 Strike Price Programs of the Chicago Board Options Exchange
(``CBOE'') and the American Stock Exchange (``Amex'').\17\ These
proposals were subject to a full notice-and-comment period, and no
negative comments were submitted. The Commission does not believe that
PCX's proposal raises any novel issues.
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    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ Id.
    \15\ In addition, Rule 19b-4(f)(6)(iii) requires that the
Exchange give the Commission written notice of its intent to file
the proposed rule change, along with a brief description and text of
the proposed rule change, at least five business days prior to the
date of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Commission has decided to waive
the five-day pre-filing notice requirement.
    \16\ For the purposes only of waiving the 30-day pre-operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \17\ See Securities Exchange Act Release Nos. 52892 (December 5,
2005), 70 FR 73492 (December 12, 2005) (approving SR-CBOE-2005-39)
and 52893 (December 5, 2005), 70 FR 73488 (December 12, 2005)
(approving SR-Amex-2005-067).
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    At any time within 60 days of the filing of the 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 Act.\18\
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    \18\ For purpose of calculating the 60-day period within which
the Commission may summarily abrogate the proposed rule change under
Section 19(b)(3)(C) of the Act, the Commission considers that period
to commence on December 16, 2005, the date that PCX filed Amendment
No. 1.
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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 No. SR-PCX-2005-137 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-9303.

All submissions should refer to File No. SR-PCX-2005-137. 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, 100 F Street, NE.,
Washington, DC 20549. Copies of such filing will also be available for
inspection and copying at the principal office of PCX. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File No. SR-PCX-2005-137 and should be
submitted on or before January 18, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Jonathan G. Katz,
Secretary.
[FR Doc. E5-7895 Filed 12-27-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Pages 79753-79754]
[FR Doc No: 2011-32859]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Certification:
Airmen Other Than Flight Crewmembers, Subpart C, Aircraft Dispatchers
and App. A Aircraft Dispatcher Courses

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The respondents to this information collection are FAR Part
135 and Part 121 operators seeking airman certification and approval of
aircraft

dispatcher courses. The FAA uses the information to ensure compliance
and adherence to the regulations.

DATES: Written comments should be submitted by February 21, 2012.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0648.
    Title: Certification: Airmen Other Than Flight Crewmembers, Subpart
C, Aircraft Dispatchers and App. A Aircraft Dispatcher Courses.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: Each applicant for an aircraft dispatcher certificate
or FAA approval of an aircraft dispatcher course must comply with 14
CFR part 65, subpart C and appendix A. Any paperwork is provided to the
local Flight Standards District Office of the FAA which oversees the
certificates and FAA approvals.
    Respondents: Approximately 36 applicants.
    Frequency: Information is collected as needed.
    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 4,679 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC on December 15, 2011.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2011-32859 Filed 12-21-11; 8:45 am]
BILLING CODE 4910-13-P