[Federal Register: September 17, 2010 (Volume 75, Number 180)]
[Notices]
[Page 57016]
[DOCID:fr17se10-76]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-2541-000]

Maple Analytics, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

September 10, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Maple Analytics, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR Part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is September 30, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for 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 e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-23222 Filed 9-16-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22567-22569]
[FR Doc No: 2018-10257]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83197; File No. SR-BOX-2018-15]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend the Fee Schedule on the BOX Market LLC (``BOX'') Options Facility
To Amend Connectivity Fees and Establish Port Fees

May 9, 2018.
    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 April 27, 2018, BOX Options Exchange LLC (the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Exchange filed the
proposed rule change pursuant to Section 19(b)(3)(A)(ii) of the Act,\3\
and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change
    The Exchange is filing with the Securities and Exchange Commission
(``Commission'') a proposed rule change to amend the Fee Schedule on
the BOX Market LLC (``BOX'') options facility. While changes to the fee
schedule pursuant to this proposal will be effective upon filing, the
changes will become operative on May 1, 2018. The text of the proposed
rule change is available from the principal office of the Exchange, at
the Commission's Public Reference Room and also on the Exchange's
internet website at http://boxexchange.com.

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 Exchange proposes to amend Section VI. (Technology Fees) of the
Fee Schedule to establish Port Fees assessed to BOX Participants
connecting to BOX systems. The Exchange does not currently charge
Participants to access the BOX System through ports. The Exchange is
now proposing to assess fees for these connections.\5\ The Exchange
notes that these types of fees are commonly assessed within the
industry. Additionally, the Exchange proposes to amend Section VI.A.
(Connectivity Fees) to delete the table and applicable language and add
language that BOX will pass-through any connectivity fees to
Participants and non-Participants that are assessed to BOX by third-
party external vendors on behalf of a Participant or non-Participant.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 66871 (April 27,
2012), 77 FR 26323 (May 3, 2012) (In the Matter of the Application
of BOX Options Exchange LLC for Registration as a National
Securities Exchange). When BOX applied for registration as a
national securities exchange in 2012, it filed exhibits which
detailed the operations of the Exchange. Specifically, Exhibit E of
BOX's application provided an in-depth description of the means in
which Participants would gain access to the BOX systems through
certain connections and ports. These connections have been in place
since BOX's application approval in 2012. The Exhibit E is available
at https://www.sec.gov/rules/other/2012/boxapplication.htm.
---------------------------------------------------------------------------

Connectivity Fees
    The Exchange proposes to delete the table and applicable language
in Section VI.A (Connectivity Fees). Currently, Section VI.A
(Connectivity Fees) of the Fee Schedule states that market participants
are required to connect to the BOX network through datacenters owned
and operated by third-party vendors. The Fee Schedule includes a table
of connectivity fees associated with two datacenters, NY4 and 65
Broadway, where market participants can connect to BOX. The Exchange is
proposing to delete the table and data center specific language from
the Fee Schedule. The Exchange notes that no other exchanges include
this detail within their fee schedules and it has received Participant
feedback that the inclusion of this information is causing

confusion about the technology fees assessed by BOX.
    Next, the Exchange proposes to add language to Section VI.A. to
state that BOX will pass-through any connectivity fees to Participants
and non-Participants that are assessed to BOX by third-party external
vendors on behalf of a Participant or non-Participant connecting to BOX
(including cross-connects).\6\ The Exchange notes that the proposed
change is similar to fees at another options exchange.\7\
---------------------------------------------------------------------------

    \6\ The Exchange notes that market participants will continue to
be assessed fees by and billed directly by the datacenter pursuant
to their agreement with the datacenter. The Exchange is proposing
that any other fees assessed to BOX on behalf of a Participant or
non-Participant will be passed through to the market participants.
    \7\ See Miami International Securities Exchange LLC (``MIAX'')
Fee Schedule Section 5(c).
---------------------------------------------------------------------------

Port Fees
    The Exchange then proposes to establish fees for access and
services used by Participants via existing connections known as
``Ports.'' \8\ BOX currently provides three (3) types of ports,
including: (i) The Financial Information Exchange (``FIX'') Port, which
allows Participants to electronically send orders in all products
traded on the Exchange; (ii) the SOLA[supreg] Access Information
Language (``SAIL'') Port, which allows Market Makers and other
Participants to submit electronic quotes and orders to the Exchange;
and (iii) the Drop Copy Port, which provides a real-time feed
containing trade execution, trade correction, trade cancellation and
trade allocation for regular and complex orders on the Exchange. The
Exchange notes that Participants must connect to a minimum of one port
via FIX or SAIL and that there is no minimum or maximum number of ports
required for the Drop Copy Port.
---------------------------------------------------------------------------

    \8\ Within the industry, market participant access to an
Exchange is referred to as ``Ports,'' ``Sessions,'' and
``Gateways.'' See Securities Exchange Act Release No. 81903 (October
19, 2017), 82 FR 49450 (October 25, 2017)(SR-ISE-2017-91). In their
filing, ISE refers to these connections as ``sessions.'' See also
NYSE American LLC (``American'') Fee Schedule, General Note 4. NYSE
refers to these connections as customer ``gateways'' that provide
for order entry.
---------------------------------------------------------------------------

    BOX will assess monthly Port Fees on Participants in each month the
market participant is credentialed to use a Port in the production
environment and based upon the number of credentialed Ports that user
is entitled to use.
    The FIX Port Fees will be the following:

------------------------------------------------------------------------
                                                            BOX monthly
                                                           (per port per
                        FIX ports                           month) port
                                                               fees
------------------------------------------------------------------------
1st FIX Port............................................            $500
FIX Ports 2 through 5...................................             250
Additional FIX Ports over 5.............................             150
------------------------------------------------------------------------

    The Exchange notes that the proposed FIX Port fees are similar to
fees assessed at options exchanges within the industry.\9\
---------------------------------------------------------------------------

    \9\ See MIAX Fee Schedule. MIAX assesses the 1st FIX Port a fee
of $550 per month, FIX Ports 2 through 5 $350 per month per port and
additional FIX Ports over 5 $150 per month per port. See also NYSE
Arca, Inc. (``Arca'') Fee Schedule. For the Order Entry Port
(similar to the proposed FIX Port), Arca charges $450 per port per
month for ports 1 through 40 and assesses $150 per port per month
for 41 ports and above.
---------------------------------------------------------------------------

    The SAIL Port Fees will be the following:

------------------------------------------------------------------------
               SAIL ports                     BOX monthly port fees
------------------------------------------------------------------------
Market Makers..........................  $1000 per month for all Ports.
Other Participants.....................  500 per port per month (1-5
                                          Ports).
                                         $150 per month for each
                                          additional Port.
------------------------------------------------------------------------

    The Exchange also notes that the proposed SAIL Port fees are
similar to fees assessed at options exchanges in the industry.\10\
---------------------------------------------------------------------------

    \10\ See Nasdaq ISE, LLC (``ISE'') Fee Schedule. ISE assesses a
Specialized Quote Interface (``SQF'') Port Fee of $1,100 per port
per month for ISE Market Makers. The Exchange believes that the
proposed SAIL Port is similar to ISE's SQF Port because both Ports
allow Market Makers to directly connect to the respective Exchanges'
systems in order to provide quotes to the market. The Exchange notes
that BOX's SAIL Port differs from ISE's in that other Participants,
like Order Flow Providers (``OFP''), have the ability to connect to
the SAIL Port to enter orders to the BOX system. See also MIAX Fee
Schedule. MIAX assesses MIAX Express Interface (``MEI'') Port Fees
on Market Makers. Like ISE, MIAX's MEI Port is designated for Market
Maker quotes only. As mentioned above, BOX's proposed SAIL Port is
available to Market Makers and other Participants who wish to enter
orders through the SAIL Port.
---------------------------------------------------------------------------

    Further, BOX will assess Drop Copy Port Fees of $500 per port per
month for each month a Participant is credentialed to use a Drop Copy
Port. The Exchange notes that the proposed Drop Copy Port Fee is
similar to fees at another options exchange in the industry; \11\ and
that Participants are not required to connect to a minimum or maximum
amount of Drop Copy Ports.
---------------------------------------------------------------------------

    \11\ See MIAX Fee Schedule. MIAX assesses a FIX Drop Copy Port
Fee of $500 per month.
---------------------------------------------------------------------------

Other
    Lastly, the Exchange proposes to make non-substantive changes to
the Fee Schedule. Specifically, the Exchange proposes to renumber the
footnotes to reflect the proposed changes discussed above.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act, in general, and Section
6(b)(4) and 6(b)(5)of the Act,\12\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among BOX Participants and other persons using its facilities
and does not unfairly discriminate between customers, issuers, brokers
or dealers.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

Connectivity Fees
    The Exchange believes that removing the datacenter specific text
and table from Section VI.A of the Fee Schedule is reasonable,
equitable and not unfairly discriminatory. As discussed above, market
participants will continue to be assessed the applicable fees by and
billed directly by the datacenter pursuant to their agreement with the
datacenter. The Exchange believes that removing the table of associated
fees is reasonable, equitable and not unfairly discriminatory as it has
caused investor confusion with regard to connectivity fees assessed at
BOX.
    BOX believes it is reasonable, equitable and not unfairly
discriminatory to pass-through any connectivity fees that are charged
to BOX by third-party vendors on behalf of the Participant or non-
Participant. BOX believes it is reasonable and equitable to recover
these costs that were incurred on BOX for the benefit of the
Participant or non-Participant. The Exchange believes the proposed
change is reasonable as another exchange in the industry has a similar
provision in its fee schedule.\13\ Lastly, the Exchange believes that
the proposed change is equitable and not unfairly discriminatory
because it applies to all market participants, regardless of account
type.
---------------------------------------------------------------------------

    \13\ See supra note 7.
---------------------------------------------------------------------------

Port Fees
FIX and SAIL Port Fees
    The Exchange believes it is reasonable, equitable and not unfairly
discriminatory to assess FIX and SAIL Port Fees on Participants who use
such services. The FIX Port enables Participants to submit orders
electronically to the Exchange for processing, while the SAIL Port
enables Market Makers to submit quotes to the Exchange for processing.
The SAIL Port also allows other Participants to submit orders
electronically to the Exchange for

processing. The Exchange believes that the proposed fees for the FIX
Port are reasonable as they are within the range of comparable fees at
other competing options exchanges.\14\ Further, the Exchange believes
that the FIX Port Fees are equitable and not unfairly discriminatory
because the fees are assessed to all Participants who wish to enter
orders to the BOX system via the FIX Port, regardless of account type.
Further, the Exchange believes that the proposed tiered pricing model
for these fees is reasonable, equitable and not unfairly discriminatory
as this model is commonly used within the industry for port fees or the
equivalent.
---------------------------------------------------------------------------

    \14\ See supra note 9.
---------------------------------------------------------------------------

    The Exchange believes that the SAIL Port Fees are reasonable
because they are within the range of comparable fees at other competing
options exchanges.\15\ Further, the Exchange believes that charging
different fees for Market Makers and other market participants who wish
to use the SAIL Port is reasonable, equitable and not unfairly
discriminatory. BOX believes that charging a flat fee of $1,000 per
month for all SAIL Ports for Market Makers is reasonable as Market
Makers are required by the Exchange to connect to sixteen (16) SAIL
Ports while other Participants have the ability to choose whether to
connect through the FIX Port, the SAIL Port, or both.\16\ As such, the
Exchange believes that the proposed SAIL Port Fees are reasonable,
equitable and not unfairly discriminatory.
---------------------------------------------------------------------------

    \15\ See supra note 10.
    \16\ The Exchange requires Market Makers to connect to 16 Ports
in order to satisfy their membership requirements on BOX.
---------------------------------------------------------------------------

Drop Copy Port Fee
    The Exchange believes that the Drop Copy Port Fee is equitable and
not unfairly discriminatory because the Exchange is uniformly assessing
the Drop Copy Port Fees on all users that wish to subscribe to it,
regardless of account type. Further, the Exchange believes that the
proposed Drop Copy Port Fee is reasonable because it is identical to
fees charged by another exchange.\17\ Further, the Drop Copy Port Fee
is reasonable because it is offered as an optional service for those
users who wish to subscribe to it.
---------------------------------------------------------------------------

    \17\ See supra note 11.
---------------------------------------------------------------------------

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. Unilateral action by BOX in
establishing fees for services provided to its Participants and others
using its facilities will not have an impact on competition. As a small
Exchange in the already highly competitive environment for options
trading, BOX does not have the market power necessary to set prices for
services that are unreasonable or unfairly discriminatory in violation
of the Exchange Act. BOX's proposed fees, as described herein, are
comparable to and generally lower than fees charged by other options
exchanges for the same or similar services. Lastly, the Exchange
believes the proposed change will not impose a burden on intramarket
competition as the proposed fees are applicable to all Participants who
connect to BOX.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Exchange Act \18\ and Rule 19b-4(f)(2)
thereunder,\19\ because it establishes or changes a due, or fee.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \19\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend the rule
change if it appears to the Commission that the action is necessary or
appropriate in the public interest, for the protection of investors, or
would otherwise further 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 protected]. Please include
File Number SR-BOX-2018-15 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-BOX-2018-15. 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BOX-2018-15, and should be submitted on
or before June 5, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-10257 Filed 5-14-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Pages 37551-37552]
[FR Doc No: 2023-12206]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1275]

Demonstrating Bioequivalence for Type A Medicated Articles
Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly
Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #279 entitled
``Demonstrating Bioequivalence for Type A Medicated Articles Containing
Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in
Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and
Are Locally Acting; Draft Guidance for Industry.'' This draft guidance
describes an approach to satisfy the requirements for the completion of
the Bioequivalence technical section for generic Type A medicated
articles (TAMAs) containing poorly soluble, locally acting, active
pharmaceutical ingredients (APIs) that have little to no systemic
absorption, and for which blood level studies are not considered
appropriate to demonstrate product bioequivalence. The suggested
approach described in this draft guidance uses a combination of in
vitro and in vivo data to support a determination of bioequivalence to
address the unique challenges associated with demonstrating
bioequivalence of TAMAs containing poorly soluble, locally acting APIs
that have little to no systemic absorption.

DATES: Submit either electronic or written comments on the draft
guidance by August 7, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2023-D-1275 for ``Demonstrating Bioequivalence for Type A Medicated
Articles Containing Active Pharmaceutical Ingredient(s) Considered To
Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting.'' 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 the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ian Hendricks, Center for Veterinary
Medicine (HFV-172), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
#279 entitled ``Demonstrating Bioequivalence for Type A Medicated
Articles Containing Active Pharmaceutical Ingredient(s) Considered To
Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic
Bioavailability, and Are Locally Acting.'' Section 512(c)(2)(A)(vi) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
360b(c)(2)(A)(vi)) requires that generic new animal drug products be
shown to be bioequivalent to the reference listed new animal drug
(RLNAD), and section 512(n)(1)(E) of the FD&C Act requires that the
sponsor provide information to show that the proposed product is
bioequivalent to the RLNAD.
    FDA's Center for Veterinary Medicine (CVM) has issued guidance on
demonstrating bioequivalence through in vivo studies, and guidance on
product types that may be eligible for a waiver from the requirement to
perform in vivo bioequivalence studies, including oral solutions and
other solubilized forms, parenteral solutions, some topically applied
dosage forms (see Guidance for Industry #35, ``Bioequivalence
Guidance'') and TAMAs with APIs that are considered to be water soluble
(see Guidance for Industry #171, ``Demonstrating Bioequivalence for
Soluble Powder Oral Dosage Form Products, and Type A Medicated Articles
Manufactured from Active Pharmaceutical Ingredients Considered To Be
Soluble in Aqueous Media''). However, these guidance documents do not
specifically address the unique challenges associated with
demonstrating bioequivalence of TAMAs containing poorly soluble,
locally acting APIs. Therefore, this guidance is intended to address
these unique challenges. In particular, when the TAMA is not a
candidate for a waiver from the requirement to conduct in vivo blood
level bioequivalence studies, CVM recommends via this guidance that
product bioequivalence be demonstrated using alternative test
approaches to those relying exclusively on animal testing. This draft
guidance, when finalized, is intended to address these situations.
    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Demonstrating Bioequivalence for Type A Medicated Articles Containing
Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in
Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and
Are Locally Acting.'' 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in section 512(n)(1) of the FD&C Act have been approved
under OMB control number 0910-0669.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: May 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12206 Filed 6-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 88 (Wednesday, May 6, 2020)]
[Notices]
[Page 26974]
[FR Doc No: 2020-09648]

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

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:

    Docket Numbers: RP20-812-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Prepayments to be effective 6/
1/2020.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5029.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-813-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Recontracting to be effective
6/1/2020.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5030.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-814-000.
    Applicants: Bison Pipeline LLC.
    Description: Compliance filing 2020 Operational Purchases and Sales
Report.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5045.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-815-000.
    Applicants: Cheyenne Plains Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: EPC and FLU Computation Update
to be effective 6/1/2020.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5254.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-816-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Bay State to
UGI Energy 802106 to be effective 5/1/2020.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5113.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-817-000.
    Applicants: Ruby Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: Electric Power Charge and FLU
Update to be effective 6/1/2020.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5120.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-818-000.
    Applicants: Wyoming Interstate Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: FLU Recomputation Update to be
effective 6/1/2020.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5216.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-819-000.
    Applicants: Panhandle Eastern Pipe Line Company, LP.
    Description: Sec.  4(d) Rate Filing: Capacity Release Provision to
be effective 5/30/2020.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5272.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-820-000.
    Applicants: Southern Star Central Gas Pipeline, Inc.
    Description: Sec.  4(d) Rate Filing: Vol. 2--Negotiated Rate
Agreements--Scout and Conexus to be effective 5/1/2020.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5274.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-821-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Filing--May 1
2020 SWEPCO 1006888 to be effective 5/1/2020.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5344.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-828-000.
    Applicants: Cameron Interstate Pipeline, LLC.
    Description: Annual Report of Penalty Revenues of Cameron
Interstate Pipeline, LLC under RP20-828.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5438.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-829-000.
    Applicants: Cameron Interstate Pipeline, LLC.
    Description: Annual Report of Operational Imbalances and Cash-out
Activity of Cameron Interstate Pipeline, LLC under RP20-829.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5440.
    Comments Due: 5 p.m. ET 5/11/20.

    Docket Numbers: RP20-830-000.
    Applicants: Cameron Interstate Pipeline, LLC.
    Description: Annual Report of Transportation Imbalances and Cash-
out Activity of Cameron Interstate Pipeline, LLC under RP20-830.
    Filed Date: 4/29/20.
    Accession Number: 20200429-5441.
    Comments Due: 5 p.m. ET 5/11/20.

    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 date(s). 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: April 30, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-09648 Filed 5-5-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: June 30, 2008 (Volume 73, Number 126)]
[Rules and Regulations]
[Page 36803-36805]
[DOCID:fr30jn08-10]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 65

[Docket No. FEMA-B-7789]

Changes in Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Interim rule.

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

SUMMARY: This interim rule lists communities where modification of the
Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because
of new scientific or technical data. New flood insurance premium rates
will be calculated from the modified BFEs for new buildings and their
contents.

DATES: These modified BFEs are currently in effect on the dates listed
in the table below and revise the Flood Insurance Rate Maps (FIRMs) in
effect prior to this determination for the listed communities.
    From the date of the second publication of these changes in a
newspaper of local circulation, any person has ninety (90) days in
which to request through the community that the Mitigation Assistant
Administrator of FEMA reconsider the changes. The modified BFEs may be
changed during the 90-day period.

ADDRESSES: The modified BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Engineering
Management Branch, Mitigation Directorate, Federal Emergency Management
Agency, 500 C Street, SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The modified BFEs are not listed for each
community in this interim rule. However, the address of the Chief
Executive Officer of the community where the modified BFE
determinations are available for inspection is provided.
    Any request for reconsideration must be based on knowledge of
changed conditions or new scientific or technical data.
    The modifications are made pursuant to section 201 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 modified BFEs are the basis for the floodplain management
measures that the community is required to either adopt or to show
evidence of being already in effect in order to qualify or to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    These modified BFEs, 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 the other Federal, State, or regional entities.
The changed BFEs are in accordance with 44 CFR 65.4.
    National Environmental Policy Act. This interim rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This interim rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This interim rule involves no
policies that have federalism implications under Executive Order 13132,
Federalism.
    Executive Order 12988, Civil Justice Reform. This interim rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 65

    Flood insurance, Floodplains, Reporting and recordkeeping
requirements.

0
Accordingly, 44 CFR part 65 is amended to read as follows:

PART 65--[AMENDED]

0
1. The authority citation for part 65 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  65.4  [Amended]

0
2. The tables published under the authority of Sec.  65.4 are amended
as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Date and name of
         State and county           Location and case No.     newspaper where     Chief executive officer    Effective date of modification   Community
                                                           notice was published         of community                                             No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama: Madison..................  City of Huntsville     May 9, 2008; May 16,  The Honorable Loretta      September 15, 2008.............       010153
                                     (08-04-1222P).         2008; Madison         Spencer, Mayor, City of
                                                            County Record.        Huntsville, P.O. Box
                                                                                308, Huntsville, AL
                                                                                35804.
California: Placer................  City of Lincoln (07-   May 21, 2008; May     The Honorable Primo        September 25, 2008.............       060241
                                     09-0934P).             28, 2008; Roseville   Santini, Mayor, City of
                                                            Press-Tribune.        Lincoln, 640 Fifth
                                                                                Street, Lincoln, CA
                                                                                95648.
California: Placer................  Unincorporated areas   May 21, 2008; May     The Honorable Jim Holmes,  September 25, 2008.............       060239
                                     of Placer County (07-  28, 2008; Roseville   Chairman, Placer County,
                                     09-0934P).             Press-Tribune.        Board of Supervisors,
                                                                                175 Fulweiler Avenue,
                                                                                Auburn, CA 95603.
California: Shasta................  Unincorporated areas   May 21, 2008; May     The Honorable Mark         September 25, 2008.............       060358
                                     of Shasta County (08-  28, 2008; Valley      Cibula, Supervisor,
                                     09-0622P).             Post.                 District Two, Shasta
                                                                                County, 1450 Court
                                                                                Street, Suite 308B,
                                                                                Redding, CA 96001.
Florida: Polk.....................  City of Winter Haven   May 7, 2008; May 14,  The Honorable Nathaniel    September 11, 2008.............       120271
                                     (07-04-5629P).         2008; Polk County     Birdsong, Mayor, City of
                                                            Democrat.             Winter Haven, P.O. Box
                                                                                2277, Winter Haven, FL
                                                                                33883.
Indiana: Lake.....................  Town of St. John (08-  May 22, 2008; May     The Honorable Michael S.   May 16, 2008...................       180141
                                     05-1094P).             29, 2008; Post        Fryzel, Mayor, Town of
                                                            Tribune.              St. John, 10955 West
                                                                                93rd Avenue, St. John,
                                                                                IN 46373.
Kansas: Sedgwick..................  City of Goddard (08-   May 29, 2008; June    The Honorable Marcey       May 21, 2008...................       200500
                                     07-0155P).             6, 2008; Wichita      Gregory, Mayor, City of
                                                            Eagle.                Goddard, P.O. Box 667,
                                                                                Goddard, KS 67052.
Nevada: Clark.....................  City of Henderson (08- May 22, 2008; May     The Honorable James B.     September 17, 2008.............       320005
                                     09-0980X).             29, 2008; Las Vegas   Gibson, Mayor, City of
                                                            Review-Journal.       Henderson, 240 South
                                                                                Water Street, Henderson,
                                                                                NV 89015.
Texas: Brazos.....................  Unincorporated areas   May 14, 2008; May     The Honorable Amanda S.    September 16, 2008.............       481195
                                     of Brazos County (07-  21, 2008; Bryan       Matzke, Brazos County
                                     06-2185P).             College Station       Judge, 300 East 26th
                                                            Eagle.                Street, Suite 211,
                                                                                Bryan, TX 77803.
Texas: Brazos.....................  City of Bryan (07-06-  May 14, 2008; May     The Honorable D. Mark      September 16, 2008.............       480082
                                     2185P).                21, 2008; Bryan       Conlee, Mayor, City of
                                                            College Station       Bryan, 300 South Texas
                                                            Eagle.                Avenue, Bryan, TX 77803.
Texas: Gillespie..................  Unincorporated areas   May 28, 2008; June    The Honorable Mark         October 3, 2008................       480696
                                     of Gillespie County    4, 2008;              Stroeher, Gillespie
                                     (08-06-0677P).         Fredericksburg        County Judge, 101 West
                                                            Standard-Radio Post.  Main Street,
                                                                                Fredericksburg, TX 78624.
Texas: Lubbock....................  City of Lubbock (08-   May 23, 2008; May     The Honorable David A.     May 16, 2008...................       480452
                                     06-0728P).             30, 2008; Lubbock     Miller, Mayor, City of
                                                            Avalanche Journal.    Lubbock, P.O. Box 2000,
                                                                                Lubbock, TX 79457.
Texas: Parker.....................  Unincorporated areas   May 7, 2008; May 14,  The Honorable Mark Riley,  April 29, 2008.................       480520
                                     of Parker County (08-  2008; Weatherford     Parker County Judge, One
                                     06-0872P).             Democrat.             Courthouse Square,
                                                                                Weatherford, TX 76086.
Texas: Williamson.................  City of Cedar Park     May 29, 2008; June    The Honorable Bob Lemon,   May 16, 2008...................       481282
                                     (08-06-1336P).         5, 2008; Round Rock   Mayor, City of Cedar
                                                            Leader.               Park, 600 North Bell
                                                                                Boulevard, Cedar Park,
                                                                                TX 78613.
Wisconsin: Kenosha................  Village of Pleasant    May 30, 2008; June    The Honorable John         May 16, 2008...................       550613
                                     Prairie (08-05-        6, 2008; Kenosha      Steinbrink, Village
                                     2135P).                News.                 President, Village of
                                                                                Pleasant Prairie, 8640
                                                                                88th Avenue, Pleasant
                                                                                Prairie, WI 53158.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

    Dated: June 20, 2008.
David I. Maurstad,
Federal Insurance Administrator of the National Flood Insurance
Program, Department of Homeland Security, Federal Emergency Management
Agency.
[FR Doc. E8-14709 Filed 6-27-08; 8:45 am]

BILLING CODE 9110-12-P


Discussion of 0.079 ppm and 0.075 ppm Benefits Estimation Methodology

EPA employed a monitor rollback approach to estimate the benefits of
attaining an alternative standard of 0.079 ppm nationwide. This approach
likely understates the benefits that would occur due to implementation
of actual controls to reduce ozone precursor emissions because controls
implemented to reduce ozone concentrations at the highest monitor would
likely result in some reductions in ozone concentrations at attaining
monitors down-wind (i.e. the controls would lead to concentrations below
the standard in down-wind locations).  Therefore, air quality
improvements and resulting health benefits from full attainment would be
more widespread than we have estimated in our rollback analysis.

EPA calculated 0.075 ppm benefits by interpolating the 0.070 ppm
benefits estimates. This interpolation approach may overestimate
benefits relative to a modeled control scenario developed specifically
to attain the 0.075 ppm alternative. The interpolation method scales
down benefits only at the monitors we project to exceed 0.075 ppm—but
it still captures the benefits achieved by the 0.070 ppm regional
control strategy that occur outside of these projected non-attainment
areas. To the extent that a modeled emission control strategy to attain
0.075 ppm did does not include these broader regional emission
reductions, total benefits would be lower than those we have estimated
in this RIA.

Interpolation and monitor rollback methods of benefits estimation are
inherently different.  As described above, for the purposes of reviewing
this analysis, the reader should understand that the benefits described
for attaining a standard of 0.079 are likely understated, whereas the
estimated benefits of attaining a standard of 0.075 are likely
overstated.  We will develop and present consistent approaches for the
alternative standards for the final RIA.

 This procedure is detailed in Appendix 6A.


[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 24871-24874]
[FR Doc No: 2021-09805]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 information collection
associated with drug establishment registration and product listing
requirements.

DATES: Submit either electronic or written comments on the collection
of information by July 9, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 9, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2011-N-0742 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Registration of Producers of
Drugs and Listing of Drugs in Commercial Distribution.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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>.

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_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution--21 CFR Part 207

OMB Control Number 0910-0045--Revision

    This information collection supports implementation of drug
establishment registration and listing requirements governed by FDA.
These requirements are set forth in section 510 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and section 351 of
the Public Health Service Act (42 U.S.C. 262) and provide for
electronic submission of information. Agency regulations implementing
these provisions are found in part 207 (21 CFR part 207) and set forth
the scope, applicability, and content of information to be included in
submissions. Except as provided in Sec.  207.65, all information
submitted under part 207 must be transmitted to FDA in an electronic
format by using our electronic drug registration and listing system, in
a form that we can process, review, and archive. For more information
pertaining to drug establishment registration and listing, we invite
you to visit our website at: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.
    We are revising the information collection to include the
collection of certain information required by the Coronavirus Aid,
Relief, and Economic Security (CARES) Act. Section 3112 of the CARES
Act requires that registrants under section 510 of the FD&C Act must
annually report the amount of each drug listed that was manufactured,
prepared, propagated, compounded, or processed for commercial
distribution. Section 3112(e) also authorizes FDA to require that
registrants report this information electronically. Finally, section
3112(e) granted FDA the authority to require that registrants report
this information at the time a public health emergency is declared.
    To assist respondents to the information collection with the
current electronic reporting requirements, we issued the guidance
document entitled ``Providing Regulatory Submissions in Electronic
Format--Drug Establishment Registration and Drug Listing'' (June 2009),
available from our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing. Guidance on the submission of the reporting required in
section 3112(e) of the CARES Act is included on CDER's 2021 guidance
agenda available from our website at: https://www.fda.gov/media/134778/download. Agency guidance documents are issued consistent with our good
guidance practice regulations in 21 CFR 10.115, which provide for
public comment at any time.
    Registration under part 207: Unless otherwise exempt under section
510(g) of the FD&C Act or Sec.  207.13, all manufacturers, repackers,
relabelers, and salvagers must register each domestic establishment
that manufactures, repacks, relabels, or salvages a drug, or an animal
feed bearing or containing a new animal drug, and each foreign
establishment that manufactures, repacks, relabels, or salvages a drug,
or an animal feed bearing or containing a new animal drug that is
imported or offered for import into the United States. When operations
are conducted at more than one establishment and common ownership and
control among all the establishments exists, the parent, subsidiary, or
affiliate company may submit registration information for all
establishments. Private label distributors who do not also manufacture,
repack, relabel, or salvage drugs are not required to register under
part 207. We will accept registration or listing information submitted
by a private label distributor only if the distributor is acting as an
authorized agent for and submitting information that pertains to an
establishment that manufactures, repacks, relabels, or salvages drugs.
    Listing requirements under part 207: Under Sec.  207.41,
registrants must list each drug that it manufactures, repacks,

relabels, or salvages for commercial distribution. Each domestic
registrant must list each such drug regardless of whether the drug
enters interstate commerce. When operations are conducted at more than
one establishment, and common ownership and control exists among all
the establishments, the parent, subsidiary, or affiliate company may
submit listing information for any drug manufactured, repacked,
relabeled, or salvaged at any such establishment. A drug manufactured,
repacked, or relabeled for private label distribution must be listed in
accordance with the requirements in Sec.  207.41(c).
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
    Information collection                         Number of
  activity; 21 CFR/statutory       Number of     responses per   Total annual    Average burden     Total hours
           citation               respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Initial establishment                    1,480               2           2,960  1...............           2,960
 registration; Sec.  Sec.
 207.17, 207.21, and 207.25.
Annual review and update of             10,000               1          10,000  0.5 (30 minutes)           5,000
 registration information
 (including expedited
 updates); Sec.   207.29.
Initial listing (including               1,713            7.28          12,470  1.5.............          18,705
 National Drug Code); Sec.
 Sec.   207.33, 207.41,
 207.45, 207.49, 207.53,
 207.54, and 207.55.
June and December review and             5,300              20         106,000  0.75 (45                  79,500
 update (or certification) of                                                    minutes).
 listing; Sec.  Sec.   207.35
 and 207.57.
Waiver requests; Sec.   207.65               1               1               1  0.5 (30 minutes)               1
Public disclosure exemption                100               1             100  1...............             100
 request; Sec.   207.81(c).
Manufacturing amount                    12,800            22.5         288,000  0.25 (15                  72,000
 information; Section 3112                                                       minutes).
 CARES Act.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............         419,531  ................         178,266
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
        Information collection from guidance recommendations            Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing Standard Operating Procedures for creating and uploading            1,000                1            1,000               40           40,000
 the Structured Product Labeling file..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    According to internal data, we estimate 1,480 respondents will
submit 2,960 new establishment registrations annually. We estimate that
10,000 registrants will provide 10,000 annual reviews and updates of
registration information (including expedited updates) or reviews and
certifications that no changes have occurred. The estimates include the
registration of establishments for both domestic and foreign
manufacturers, repackers, relabelers, and drug product salvagers, and
registration information submitted by anyone acting as an authorized
agent for an establishment that manufactures, repacks, relabels, or
salvages drugs. The estimates include an additional 80 positron
emission tomography drug producers who are not exempt from registration
and approximately 30 manufacturers of plasma derivatives.
    We assume 1 hour is necessary for registrants to submit initial
registration information electronically for each new establishment. We
assume 30 minutes is necessary for each annual review and update of
registration information (including any expedited updates) or each
review and certification that no changes have occurred. Our estimate
reflects the average amount of time and effort necessary to register a
domestic or foreign establishment, and the average amount of time and
effort necessary to review and update registration information, or
review registration information and certify no changes have occurred.
    Based on the number of drugs listed annually since June 2009, we
estimate 1,713 registrants will report approximately 12,469 new
listings annually (including the information submitted to obtain a
labeler code and to reserve a National Drug Code (NDC) for future use).
Based on the number of drugs in our listing database and the current
number of changes to listing information submitted, we estimate 5,300
registrants will each report 20 reviews and updates (including the
information submitted to revise an NDC) for a total of 106,000
annually. The estimates for the number of drug listings include both
domestic and foreign listings, listings submitted by registrants for
products sold under their own names as well as products intended for
private label distribution, and information submitted related to an NDC
and to obtain a labeler code. The estimate for the number of drugs
subject to the listing requirements includes positron emission
tomography drugs and approximately 30 plasma derivatives. The estimates
for the number of June and December reviews and updates of listing
information include the number of changes to drug characteristics
pertaining to the drug product code to obtain a new NDC and the reports
of the withdrawal of an approved drug from sale under Sec.
314.81(b)(3)(iii) (21 CFR 314.81(b)(3)(iii)).
    Based on our experience with electronically listing submissions
since June 2009, we assume it takes 1 hour and 30 minutes to submit
information electronically for each drug listed for the first time (for
both foreign and domestic registrant listings). These estimates are an
average of the time it will take manufacturers, repackers, relabelers,
and drug product salvagers, with drug product salvagers taking

considerably less time than manufacturers. The estimates include the
time for submitting the content of labeling and other labeling in an
electronic format (for drugs subject to an approved marketing
application, the electronic submission of the content of labeling under
Sec.  314.50(l)(1)(i) is approved under OMB control number 0910-0001).
We assume it takes 45 minutes for each June and December review and
update. These estimates represent the average amount of time to review
and update listing information or to review and certify that no changes
have occurred. The estimates include the time for submitting any
labeling for each drug, changes to the drug's characteristics submitted
for a new NDC, and reports of the withdrawal of an approved drug from
sale under Sec.  314.81(b)(3)(iii).
    Finally, although we expect most respondents will already have
prepared a standard operating procedure (SOP) for the electronic
submission of drug establishment registration and drug listing
information, we estimate each year additional firms will need to create
an SOP as recommended in the guidance. We therefore estimate 1,000
firms will expend approximately 40 hours to prepare, review, and
approve an SOP, for a total of 40,000 hours annually.
    While we retain the currently approved burden estimates for
information collection associated with provisions in part 207, we have
adjusted our estimate upward by 72,000 hours and 288,000 responses to
account for information collection associated with the new
manufacturing amount information element required by the CARES Act.

    Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09805 Filed 5-7-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Notices]
[Pages 79557-79558]
[FR Doc No: 2016-27275]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0107; Notice 1]

The Goodyear Tire & Rubber Company, Receipt of Petition for
Decision of Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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

SUMMARY: The Goodyear Tire & Rubber Company (Goodyear), has determined
that certain Goodyear tires do not fully comply with paragraph S6.5(f)
of Federal Motor Vehicle Safety Standard (FMVSS) No. 119, New pneumatic
tires for motor vehicles with a GVWR of more than 4,536 kilograms
(10,000 pounds) and motorcycles. Goodyear filed a report dated
September 27, 2016, pursuant to 49 CFR part 573, Defect and
Noncompliance Responsibility and Reports. Goodyear then petitioned
NHTSA under 49 CFR part 556 for a decision that the subject
noncompliance is inconsequential as it relates to motor vehicle safety.

DATES: The closing date for comments on the petition is December 14,
2016.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver comments by hand to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) Web site at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and

times given above. The documents may also be viewed on the Internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:
    I. Overview: Pursuant to 49 U.S.C. 30118(d) and 30120(h) and their
implementing regulations at 49 CFR part 556, Goodyear submitted a
petition for an exemption from the notification and remedy requirements
of 49 U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential as it relates to motor vehicle safety.
    This notice of receipt of Goodyear's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Tires Involved: Affected are approximately 381 Goodyear G182
RSD size 11R22.5 LR G commercial truck tires manufactured between July
3, 2016, and August 20, 2016.
    III. Noncompliance: Goodyear explains that because the sidewall
markings on the reference side of the subject tires incorrectly
identify the number of plies as ``TREAD 4 PLIES STEEL CORD'' instead of
the correct labelling ``TREAD 5 PLIES STEEL CORD,'' the tires do not
meet the requirements of paragraph S6.5(f) of FMVSS No. 119.
    IV. Rule Text: Paragraph S6.5(f) of FMVSS No. 119 provides, in
pertinent part:

    S6.5 Tire markings. Except as specified in this paragraph, each
tire shall be marked on each sidewall with the information specified
in paragraphs (a) through (j) of this section . . .
    (f) The actual number of plies and the composition of the ply
cord material in the sidewall and, if different, in the tread area;
. . .

    V. Summary of Goodyear's Petition: Goodyear described the subject
noncompliance and stated its belief that the noncompliance is
inconsequential as it relates to motor vehicle safety.
    In support of its petition, Goodyear submitted the following:
    Goodyear believes this noncompliance is inconsequential to motor
vehicle safety because these tires were manufactured as designed and
meet or exceed all applicable Federal Motor Vehicles Safety performance
standards. All of the sidewall markings related to tire service (load
capacity, corresponding inflation pressure, etc.) are correct. Even
though the tires were labeled incorrectly as ``TREAD 4 PLIES STEEL
CORD'' on one side of the tires, the tires were manufactured with
``TREAD 5 PLIES STEEL CORD'', which is correctly marked on the opposite
tire sidewall. The mislabeling of these tires is not a safety concern
and also has no impact on the retreading and recycling industries. The
affected tire mold has already been corrected and all future production
will have the correct number of plies shown on both sidewalls.
    Goodyear noted that NHTSA has previously granted petitions for the
same noncompliance related to tire construction information on tires
because of surveys that show most consumers do not base purchases on
tire construction information found on the tire sidewall.
    Goodyear concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject tires that Goodyear no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve tire
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after Goodyear
notified them that the subject noncompliance existed.

    Authority:  49 U.S.C. 30118, 30120: Delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-27275 Filed 11-10-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36578-36579]
[FR Doc No: 2014-15026]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0192]

Agency Information Collection Activities; New Information
Collection or Revision of an Approved Information Collection: Motor
Carrier Records Change Form

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

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. The purpose of this ICR
entitled ``Motor Carrier Records Change Form,'' is to more efficiently
collect information the Office of Registration and Safety Information
(MC-RS) requires to process name and address changes and reinstatements
of operating authority. Currently, this data is being collected when
carriers request these changes from MC-RS, but without the use of a
formal data collection form.

DATES: We must receive your comments on or before August 26, 2014.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Docket Number FMCSA-2014-0192 using any of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9
a.m. and 5 p.m. e.t., Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments and
additional information on the exemption process, see the Public
Participation heading below. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement for the Federal Docket Management System
published in the Federal Register on January 17, 2008 (73 FR 3316), or
you may visit http://edocket.access.gpo.gov/2008/pdfE8-794.pdf.
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal Web site. If you want us to notify
you that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments online. Comments received

after the comment closing date will be included in the docket and will
be considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Jeff Secrist, Chief, East-South
Division, FMCSA Office of Registration & Safety Information, West
Building 6th Floor, 1200 New Jersey Avenue SE., Washington, DC 20590.
Telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Background: The Federal Motor Carrier Safety Administration (FMCSA)
registers for-hire motor carriers under 49 U.S.C. 13902, surface
freight forwarders under 49 U.S.C. 13903, and property brokers under 49
U.S.C. 13904. Each registration is effective from the date specified
under 49 U.S.C. 13905(c). 49 CFR part 365.413: ``Procedures for
changing the name or business form of a motor carrier, freight
forwarder, or property broker'' states that carriers must submit a
letter containing the required information to FMCSA's Office of
Registration and Safety Information (MC-RS), formerly sent to FMCSA's
IT Operations Division (MC-RIO), requesting the change; the new form
would assist entities in reporting this information accurately and
completely. 49 CFR 360.3(f) mentions fees that FMCSA collects for
``petition for reinstatement of revoked operating authority,'' but does
not provide any specifics for the content that petition should take.
    For-hire motor carriers, brokers and freight forwarders are
required to notify MC-RS when they change the name or address of the
company. Currently, the name change request can be filed online through
the Licensing and Insurance (L&I) Web site, or companies can fax or
mail a letter requesting either name or address changes. Carriers can
also request reinstatement of a revoked operating authority either via
fax or online via the Licensing & Insurance (L&I) Web site. But many
choose not to do so. About 40% of name changes and 60% of
reinstatements are filed online. Of the rest, most are filed by faxing
a request letter to MC-RS. All the address changes are received by
either fax or mail. The information collected is then entered in the
L&I database by FMCSA staff. This enables FMCSA to maintain up-to-date
records so that the agency can recognize the entity in question in case
of enforcement actions or other procedures required to ensure that the
carrier is fit, willing and able to provide for-hire transportation
services, and so that entities whose authority has been revoked can
resume operation if they are not otherwise blocked from doing so. But
the current method of collecting the data means that many requests
include incomplete data, and cannot be processed without additional
follow-up efforts by both FMCSA staff and the entities. This multi-
purpose form, therefore, would simplify the process of gathering the
information needed to process the entities' requests in a timely
manner, with the least amount of effort for all parties involved. This
multi-purpose form would be filed by registrants on a voluntary, as-
needed basis. This multi-purpose form could be put on the FMCSA Web
site so entities could access and print/fax/email the form to MC-RS.
    Users may report the following data points (whichever are relevant
to their records change request):
    1. What are the legal/doing business as names of the entity/
representative?
    2. What is the contact information of entity/representatives (phone
number, address, fax number, email address)?
    3. What are the requested changes to name or address of entity?
    4. What is the docket MC/MX/FX number of the entity?
    5. What is the US DOT number of the entity?
    6. Is there any change in ownership, management or control of the
entity?
    7. What kind of changes is the entity making to the company?
    8. Which authority does the entity/representative wish to
reinstate, motor carrier or broker?
    9. Does the entity/representative authorize the fee for the name
change or reinstatement?
    10. Does the entity/representative authorize the reinstatement of
operating authority or name/address change?
    11. What is the credit card information (name, number, expiration
date, address, date) for the card used to pay the fee?
    Title: Motor Carrier Records Change Form.
    OMB Control Number: 2126-00XX.
    Type of Request: New collection.
    Respondents: For-hire motor carriers, brokers and freight
forwarders.
    Estimated Number of Respondents: 22,300.
    Estimated Time per Response: 15 minutes per response.
    Expiration Date: N/A.
    Frequency of Response: On occasion.
    Estimated Total Annual Burden: 5,575 hours [22,300 annual responses
x 0.25 hours = 5,575].
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize or include your
comments in the request for OMB's clearance of this information
collection.

    Issued under the authority delegated in 49 CFR 1.87 on: June 18,
2014.
G. Kelly Regal,
Associate Administrator, Office of Research and Information Technology
and Chief Information Officer.
[FR Doc. 2014-15026 Filed 6-26-14; 8:45 am]
BILLING CODE P