[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57000-57002]
[FR Doc No: 2015-23571]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Bioequivalence Recommendations; Draft and
Revised Draft Guidances for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-

specific guidance on the design of BE studies to support abbreviated
new drug applications (ANDAs). In the Federal Register of June 11,
2010, FDA announced the availability of a guidance for industry
entitled ``Bioequivalence Recommendations for Specific Products'' that
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site. The BE
recommendations identified in this notice were developed using the
process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
these draft and revised draft guidances before it begins work on the
final versions of the guidances, submit either electronic or written
comments on the draft and revised draft product-specific BE
recommendations listed in this notice by November 20, 2015.

ADDRESSES: Submit written requests for single copies of the individual
BE guidances to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance recommendations.
    Submit electronic comments on the draft product-specific BE
recommendations to http://www.regulations.gov. Submit written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific BE recommendations and
provide a meaningful opportunity for the public to consider and comment
on those recommendations. Under that process, draft recommendations are
posted on FDA's Web site and announced periodically in the Federal
Register. The public is encouraged to submit comments on those
recommendations within 60 days of their announcement in the Federal
Register. FDA considers any comments received and either publishes
final recommendations or publishes revised draft recommendations for
comment. Recommendations were last announced in the Federal Register on
June 30, 2015 (80 FR 37273). This notice announces draft product-
specific recommendations, either new or revised, that are posted on
FDA's Web site.

II. Drug Products for Which New Draft Product-Specific BE
Recommendations are Available

    FDA is announcing the availability of a new draft guidance for
industry on product-specific BE recommendations for drug products
containing the following active ingredients:

Table 1--New Draft Product-Specific BE Recommendations for Drug Products
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Aclidinium bromide
Acyclovir
Aminocaproic acid
Apremilast
Benazepril hydrochloride; Hydrochlorothiazide
Brimonidine tartrate
Carbidopa; Levodopa
Ceritinib
Clobetasol propionate
Clomipramine hydrochloride
Clonidine hydrochloride
Cobicistat
Cysteamine bitartrate
Dapagliflozin propanediol; Metformin hydrochloride
Dasabuvir sodium; Ombitasvir; Paritaprevir; Ritonavir
Desvenlafaxine fumarate
Eslicarbazepine acetate
Esomeprazole magnesium
Ferric citrate
Fluticasone propionate (multiple reference listed drugs)
Formoterol fumarate
Idelalisib
Ledipasvir; Sofosbuvir
Levocarnitine
Loperamide hydrochloride; Simethicone
Mometasone furoate monohydrate
Naltrexone HCL; Bupropion HCL
Netupitant; Palonosetron hydrochloride
Nintedanib esylate
Nortriptyline hydrochloride
Pirfenidone
Pomalidomide
Ponatinib hydrochloride
Rivaroxaban
Ruxolitinib phosphate
Suvorexant
Tasimelteon
Tedizolid phosphate
Tramadol hydrochloride
Trimipramine maleate
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III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations are Available

    FDA is announcing the availability of a revised draft guidance for
industry on product-specific BE recommendations for drug products
containing the following active ingredients:

   Table 2--Revised Draft Product-Specific BE Recommendations for Drug
                                Products
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Acitretin
Amantadine hydrochloride
Benzonatate
Carbamazepine
Colesevelam hydrochloride
Cyclophosphamide
Dabigatran etexilate mesylate
Dasatinib
Desvenlafaxine succinate
Esomeprazole magnesium
Estradiol
Ethinyl estradiol; Norethindrone
Gabapentin
Isotretinoin
Minocycline hydrochloride
Naltrexone
Sevelamer carbonate
Sirolimus
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    For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, go to http://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft and revised draft guidances are being issued consistent
with FDA's good guidance practices regulation (21 CFR 10.115). These
guidances represent the Agency's current thinking on product-specific
design of BE studies to support ANDAs. They do not establish any rights
for anyone and are not binding on FDA or the public. You may use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

IV. Comments

    Interested persons may submit either electronic comments on any of
the specific BE recommendations posted on FDA's Web site to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments.

Identify comments with the docket number found in brackets in the
heading of this document. The guidances, notices, and received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: September 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23571 Filed 9-18-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42125-42127]
[FR Doc No: 2013-16864]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69955; File No. SR-OCC-2013-804]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing of an Advance Notice in Connection With a Proposed
Change to its Operations in the Form of a Private Offering by OCC of
Senior Unsecured Debt Securities

July 10, 2013.
    Pursuant to Section 806(e)(1) of the Payment, Clearing, and
Settlement Supervision Act of 2010 (``Clearing Supervision Act'') \1\
and Rule 19b-4(n)(1)(i) \2\ of the Securities Exchange Act of 1934
(``Exchange Act'') notice is hereby given that on June 10, 2013, The
Options Clearing Corporation (``OCC'') filed with the Securities and
Exchange Commission (``Commission'') the advance notice as described in
Items I and II below, which Items have been substantially prepared by
OCC.\3\ The Commission is publishing this notice to solicit comments on
the advance notice from interested persons.
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    \1\ 12 U.S.C. 5465(e)(1).
    \2\ 17 CFR 240.19b-4(n)(1)(i).
    \3\ OCC is a designated financial market utility and is required
to file advance notices with the Commission. See 12 U.S.C. 5465(e).
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I. Clearing Agency's Statement of the Terms of Substance of the Advance
Notice

    OCC is proposing to change its operations in the form of a private
offering of senior unsecured debt securities (``Offering'').

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Advance Notice

    In its filing with the Commission, OCC included statements
concerning the purpose of and basis for the advance notice and
discussed any comments it received on the advance notice. The text of
these statements may be examined at the places specified in Item IV
below. The clearing agency has prepared summaries, set forth in section
A below, of the most significant aspects of such statements.\4\
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    \4\ The Commission has modified the text of the summaries
prepared by the clearing agency.
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(A) Advance Notices Filed Pursuant to Section 806(e) of the Clearing
Supervision Act

Description of Change
    OCC states that the proposed Offering would provide OCC with access
to additional liquidity for working capital needs and general corporate
purposes. The aggregate principal amount of the senior unsecured debt
securities placed in the Offering is expected to be up to $100 million.
The proceeds of the Offering would be among the financial resources
used to satisfy the requirements applicable to OCC under CFTC
regulations.
    Among other things, OCC states that CFTC regulation Section
39.11(a)(2) \5\ requires a derivatives clearing organization (``DCO'')
to hold an amount of financial resources that, at a minimum, exceeds
the total amount that would enable the DCO to cover its operating costs
for a period of at least one year, calculated on a rolling basis. In
turn, CFTC regulation Section 39.11(e)(2) \6\ provides that these
financial resources must include unencumbered, liquid financial assets
(i.e., cash and/or highly liquid securities), equal to at least six
months' operating costs. OCC states that the Offering is intended to
contribute to OCC's compliance with the financial resources requirement
under CFTC regulation Section 39.11(a)(2) \7\ and the liquidity
requirements prescribed by CFTC regulation Section 39.11(e)(2).\8\ OCC
states that the proceeds of the offering would be invested in
instruments such as reverse repurchase agreements in which working
capital may be invested under OCC's By-Laws.
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    \5\ 17 CFR 39.11(a)(2).
    \6\ 17 CFR 39.11(e)(2).
    \7\ 17 CFR 39.11(a)(2).
    \8\ 17 CFR 39.11(e)(2).
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    Under the proposal, OCC would issue senior unsecured debt
securities through the Offering, which would be structured as a private
placement for which a broker-dealer registered with the Securities and
Exchange Commission under the Exchange Act would act as the exclusive
placement agent. Under the terms of the Offering, OCC would be required
to use any capital raised to finance its working capital needs or for
general corporate purposes.
    According to OCC, one of the conditions of OCC's proposed Offering
is the execution of definitive agreements. These agreements are
expected to include a number of conditions related to OCC's performance
under such agreements including, without limitation, certain covenants
and default provisions.
    OCC states that the Offering would involve a variety of customary
fees and expenses payable by OCC to the placement agent and the
noteholders, including but not limited to: (1) A placement agent fee
calculated as a

percentage of the aggregate principal amount of debt securities sold in
the Offering; and (2) other costs and expenses incurred by the
placement agent in relation to its activities in connection with the
Offering including, but not limited to, travel expenses and reasonable
fees of counsel. These fees and expenses may be paid out of the
proceeds of the Offering.
Anticipated Effect on and Management of Risk
    OCC states that any impact of the Offering on the risks presented
by OCC would be to reduce such risks by providing an additional source
of liquidity for the protection of OCC, its clearing members, and the
options market in general. OCC states that the Offering would provide
OCC with additional liquidity for working capital needs and general
corporate purposes and thereby assist OCC in satisfying the CFTC's
requirements with respect to liquidity under CFTC regulation Section
39.11.\9\
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    \9\ 17 CFR 39.11.
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    OCC states that, like any debt offering, the Offering would involve
risks. According to OCC, one risk associated with the Offering relates
to the need for OCC to maintain sufficient cash flow to support ongoing
interest payments to the noteholders. OCC states this risk is mitigated
by its conservative fiscal practices under which clearing and other
fees are assessed at a level designed to ensure that OCC has more than
sufficient funds to operate and satisfy liabilities, and refunds are
paid to clearing members only when it is clear that excess funds are
available. Clearing member refunds would be effectively subordinated to
interest payments on the notes sold in the Offering.
    OCC states that the Offering involves a risk of OCC's defaulting by
failing to make timely payment of principal or interest or to comply
with financial covenants, which would allow the noteholders to take
legal action against OCC to recover any losses resulting from a
default. However, OCC states that the risk of default from a payment
failure is mitigated because, as discussed above, OCC does not expect
to have difficulty making interest payments. Similarly, OCC states that
the tests included in the financial covenants will be established at
reasonable levels, making it unlikely that OCC would default by
violating these covenants. In addition, because the Offering would
involve the issuance of unsecured notes, OCC states that it would not
be at risk of the noteholders' liquidating OCC assets in the event of
OCC's default.
    The agreement with noteholders also requires OCC to make the
noteholders ``whole'' in the event OCC elects to prepay any outstanding
principal. According to OCC, this ``make-whole'' covenant poses risk to
the extent OCC is unable to immediately pay the outstanding interest
payments. OCC would mitigate the risk of having to make a large make-
whole payment by either electing not to call the notes prior to
termination or by waiting to call the notes until the make-whole
premium has been reduced by the passage of time to a smaller amount.
OCC expects to need the additional liquidity for the term of the notes
and to issue the notes at a time of favorable market conditions, and
accordingly OCC does not expect to call the notes prior to termination.
    According to OCC, one risk of obtaining capital through the
Offering as opposed to an unsecured line of credit is that OCC will
incur more expense in connection with the Offering given that it must
pay interest expense on the entire outstanding note balance as opposed
to a comparatively smaller commitment fee on a line of credit. However,
OCC states that this risk is justified by the difficulty in obtaining
an unsecured line of credit of a size comparable to that of the
Offering. Moreover, OCC states the risk is mitigated by OCC's
investment of the proceeds, which generates income to offset the
interest expense. In addition, by obtaining capital through the
Offering OCC avoids the funding risk associated with a line of credit.

III. Date of Effectiveness of the Advance Notice and Timing for
Commission Action

    OCC may implement the proposed change pursuant to Section
806(e)(1)(G) of the Clearing Supervision Act \10\ if it has not
received an objection to the proposed change within 60 days of the
later of (i) the date that the Commission received the advance notice
or (ii) the date the Commission receives any further information it
requested for consideration of the notice. The clearing agency shall
not implement the proposed change if the Commission has any objection
to the proposed change.
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    \10\ 12 U.S.C. 5465(e)(1)(G).
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    The Commission may extend the period for review by an additional 60
days if the proposed change raises novel or complex issues, subject to
the Commission providing the clearing agency with prompt written notice
of the extension. A proposed change may be implemented in less than 60
days from the date of receipt of the advance notice, or the date the
Commission receives any further information it requested, if the
Commission notifies the clearing agency in writing that it does not
object to the proposed change and authorizes the clearing agency to
implement the proposed change on an earlier date, subject to any
conditions imposed by the Commission.
    The clearing agency shall post notice on its Web site of proposed
changes that are implemented.
    The proposal shall not take effect until all regulatory actions
required with respect to the proposal are completed.\11\
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    \11\ OCC also filed the proposals contained in this advance
notice as a proposed rule change under Section 19(b)(1) of the
Exchange Act and Rule 19b-4 thereunder. See supra note 3.
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2013-804 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-OCC-2013-804. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the advance notice that are filed
with the Commission, and all written communications relating to the
advance notice between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549 on official business days between the hours of

10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of OCC and on OCC's
Web site (http://theocc.com/about/publications/bylaws.jsp). All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-OCC-2013-804 and should be
submitted on or before August 5, 2013.

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-16864 Filed 7-12-13; 8:45 am]
BILLING CODE 8011-01-P