  From:       Richard Krock<EMAIL_ADDRESS>

  To:         Jodi Howard/RTP/USEPA/US@EPA

  Date:       09/24/2010 03:52 PM

  Subject:    VI Letter to EPA on Seasonality of PVC Production

Dear Ms. Howard,

The VI has made prior comments on the potential bias that seasonal
production rates may introduce into the PVC MACT rulemaking.  The
attached letter documents some of those periods of seasonal production
for your consideration.  Please do not hesitate to contact me with any
questions regarding the information or its impact on the survey
responses.  Thank you for the opportunity to submit this document for
the PVC rule development.

Regards,

Richard Krock
Technical Director

The Vinyl Institute
1737 King Street Suite 390
Alexandria, VA 22314
Direct:<PHONE_NUMBER>
Mobile:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>
Email<EMAIL_ADDRESS>http://www.vinylinfo.org
http://www.vinylindesign.com(See attached file: VI Letter to EPA on
Resin Seasonality 09-24-10.pdf)


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Chemicals, through the different steps from their production to their handling, transport and use, are a real danger for human health and the environment. People of any ages, from children to elderly, using many different languages and alphabets, belonging to various social conditions, including illiterates, are daily confronted to dangerous products (chemicals, pesticides, etc.).
To face this danger, and given the reality of the extensive global trade in chemicals and the need to develop national programs to ensure their safe use, transport and disposal, it was recognized that an internationally-harmonized approach to classification and labelling would provide the foundation for such programs. Once countries have consistent and appropriate information on the chemicals they import or produce in their own countries, the infrastructure to control chemical exposures and protect people and the environment can be established in a comprehensive manner.
The new system, which was called "Globally Harmonized System of Classification and Labelling of Chemicals (GHS)", addresses classification of chemicals by types of hazard and proposes harmonized hazard communication elements, including labels and safety data sheets. It aims at ensuring that information on physical hazards and toxicity from chemicals be available in order to enhance the protection of human health and the environment during the handling, transport and use of these chemicals. The GHS also provides a basis for harmonization of rules and regulations on chemicals at national, regional and worldwide level, an important factor also for trade facilitation.
While governments, regional institutions and international organizations are the primary audiences for the GHS, it also contains sufficient context and guidance for those in industry who will ultimately be implementing the requirements which have been adopted.
In its Plan of Implementation (para 22.(c)) adopted in Johannesburg on 4 September 2002, the World Summit on Sustainable Development (WSSD) encouraged countries to implement the GHS as soon as possible. Information about the status of implementation of the GHS by country is available (in English only) here.
The first edition of the GHS, which was intended to serve as the initial basis for the global implementation of the system, was adopted in December 2002 and published in 2003. Since then, the GHS has been updated, revised and improved every two years as needs arise and experience is gained in its implementation.
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[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48324-48325]
[FR Doc No: 2015-19740]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1399]

Guidance for Entities Considering Whether To Register as
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance entitled ``Guidance for Entities
Considering Whether to Register as Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance is
intended to inform entities that are considering registering as
outsourcing facilities under section 503B of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act), as added by the Drug Quality and
Security Act (DQSA), of the regulatory implications of registration as
an outsourcing facility.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance 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: Sara Rothman, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Guidance for Entities Considering Whether to Register as
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' On November 27, 2013, President Obama signed the
DQSA (Pub. L. 113-54) into law. The DQSA added a new section 503B to
the FD&C Act that created a category of entities called ``outsourcing
facilities.'' Section 503B(d)(4) of the FD&C Act (21 U.S.C. 353b(d)(4))
defines an outsourcing facility, in part, as a facility that complies
with all of the requirements of section 503B, including registering
with FDA as an outsourcing facility and paying associated fees. If the
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a
drug compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from certain sections
of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with adequate directions for use) and
section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)). Drugs compounded in outsourcing facilities are
not exempt from the requirements of section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing
practice for drugs).
    FDA has received questions about whether entities engaged in
various types of activities (e.g., a facility that is compounding only
non-sterile drugs or only repackaging biological products) should
register as an outsourcing facility. Because entities that register as
outsourcing facilities must pay a registration fee and FDA has
determined that fees paid pursuant to sections 503B and 744K of the
FD&C Act will not be refunded, FDA is issuing this guidance to answer
some of these questions and to provide potential registrants additional
information about the regulatory impact of registering as an
outsourcing facility.
    In the Federal Register of February 19, 2015 (80 FR 8871), FDA
issued a notice announcing the availability of the draft version of
this guidance. The comment period on the draft guidance ended on May
20, 2015. FDA received eleven comments on the draft guidance. Some of
the comments raised issues that were not directly pertinent to the
topics addressed in this guidance. FDA intends to consider those
comments as they relate to issues being addressed in other policy
documents being developed by the Agency.
    In response to received comments or on its own initiative, FDA made
the following changes as it finalized this guidance: (1) Removed the
reference to a separate guidance document that explains how outsourcing
facilities should report the products they compound to FDA because that
guidance is not directly related to the issue of entities considering
whether to register as outsourcing facilities; (2) noted that FDA has
issued separate guidance documents addressing some of the conditions of
section 503B and that it intends to publish additional guidance
addressing other conditions; (3) added a reference to FDA's draft
guidance regarding compounding animal drug products from bulk drug
substances, which addresses outsourcing facilities engaging in this
activity; and (4) made grammatical and other minor editorial changes
for clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on registering as an outsourcing facility
under section 503B of the FD&C Act. It does not create 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. Comments

    Interested persons may submit either electronic comments regarding
this document 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. 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.

III. 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: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19740 Filed 8-11-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7871-7873]
[FR Doc No: 2016-02982]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77089; File No. 4-694]

Program for Allocation of Regulatory Responsibilities Pursuant to
Rule 17d-2; Order Approving and Declaring Effective a Proposed Plan for
the Allocation of Regulatory Responsibilities Between the Financial
Industry Regulatory Authority, Inc. and the National Stock Exchange,
Inc.

February 9, 2016.
    On December 23, 2015, the National Stock Exchange, Inc. (``NSX'')
and the Financial Industry Regulatory Authority, Inc. (``FINRA'')
(together with NSX, the ``Parties'') filed with the Securities and
Exchange Commission (``Commission'' or ``SEC'') a plan for the
allocation of regulatory responsibilities, dated December 22, 2015
(``17d-2 Plan'' or the ``Plan''). The Plan was published for comment on
January 14, 2016.\1\ The Commission received no comments on the Plan.
This order approves and declares effective the Plan.
---------------------------------------------------------------------------

    \1\ See Securities Exchange Act Release No. 76856 (January 8,
2016), 81 FR 1971.
---------------------------------------------------------------------------

I. Introduction

    Section 19(g)(1) of the Securities Exchange Act of 1934
(``Act''),\2\ among other things, requires every self-regulatory
organization (``SRO'') registered as either a national securities
exchange or national securities association to examine for, and enforce
compliance by, its members and persons associated with its members with
the Act, the rules and regulations thereunder, and the SRO's own rules,
unless the SRO is relieved of this responsibility pursuant to Section
17(d) or Section 19(g)(2) of the Act.\3\ Without this relief, the
statutory obligation of each individual SRO could result in a pattern
of multiple examinations of broker-dealers that maintain memberships in
more than one SRO (``common members''). Such regulatory duplication
would add unnecessary expenses for common members and their SROs.
---------------------------------------------------------------------------

    \2\ 15 U.S.C. 78s(g)(1).
    \3\ 15 U.S.C. 78q(d) and 15 U.S.C. 78s(g)(2), respectively.
---------------------------------------------------------------------------

    Section 17(d)(1) of the Act \4\ was intended, in part, to eliminate
unnecessary multiple examinations and regulatory duplication.\5\ With
respect to a common member, Section 17(d)(1) authorizes the Commission,
by rule or order, to relieve an SRO of the responsibility to receive
regulatory reports, to examine for and enforce compliance with
applicable statutes, rules, and regulations, or to perform other
specified regulatory functions.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78q(d)(1).
    \5\ See Securities Act Amendments of 1975, Report of the Senate
Committee on Banking, Housing, and Urban Affairs to Accompany S.
249, S. Rep. No. 94-75, 94th Cong., 1st Session 32 (1975).
---------------------------------------------------------------------------

    To implement Section 17(d)(1), the Commission adopted two rules:
Rule 17d-1 and Rule 17d-2 under the Act.\6\ Rule 17d-1 authorizes the
Commission to name a single SRO as the designated examining authority
(``DEA'') to examine common members for compliance with the financial
responsibility requirements imposed by the Act, or by Commission or SRO
rules.\7\ When an SRO has been named as a common member's DEA, all
other SROs to which the common member belongs are relieved of the
responsibility to examine the firm for compliance with the applicable
financial responsibility rules. On its face, Rule 17d-1 deals only with
an SRO's obligations to enforce member compliance with financial
responsibility requirements. Rule 17d-1 does not relieve an SRO from
its

obligation to examine a common member for compliance with its own rules
and provisions of the federal securities laws governing matters other
than financial responsibility, including sales practices and trading
activities and practices.
---------------------------------------------------------------------------

    \6\ 17 CFR 240.17d-1 and 17 CFR 240.17d-2, respectively.
    \7\ See Securities Exchange Act Release No. 12352 (April 20,
1976), 41 FR 18808 (May 7, 1976).
---------------------------------------------------------------------------

    To address regulatory duplication in these and other areas, the
Commission adopted Rule 17d-2 under the Act.\8\ Rule 17d-2 permits SROs
to propose joint plans for the allocation of regulatory
responsibilities with respect to their common members. Under paragraph
(c) of Rule 17d-2, the Commission may declare such a plan effective if,
after providing for appropriate notice and comment, it determines that
the plan is necessary or appropriate in the public interest and for the
protection of investors; to foster cooperation and coordination among
the SROs; to remove impediments to, and foster the development of, a
national market system and a national clearance and settlement system;
and is in conformity with the factors set forth in Section 17(d) of the
Act. Commission approval of a plan filed pursuant to Rule 17d-2
relieves an SRO of those regulatory responsibilities allocated by the
plan to another SRO.
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 12935 (October 28,
1976), 41 FR 49091 (November 8, 1976).
---------------------------------------------------------------------------

II. Proposed Plan

    The proposed 17d-2 Plan is intended to reduce regulatory
duplication for firms that are common members of both NSX and FINRA.\9\
Pursuant to the proposed 17d-2 Plan, FINRA would assume certain
examination and enforcement responsibilities for common members with
respect to certain applicable laws, rules, and regulations.
---------------------------------------------------------------------------

    \9\ The proposed 17d-2 Plan refers to these common members as
``Dual Members.'' See Paragraph 1(c) of the proposed 17d-2 Plan. On
December 14, 2015, the Commission approved a proposal from NSX to
resume its status as a fully operational securities exchange and to
re-commence trading operations. See Securities Exchange Act Release
No. 76640 (December 14, 2015), 80 FR 79122 (December 18, 2015) (SR-
NSX-2015-05) (approval order).
---------------------------------------------------------------------------

    The text of the Plan delineates the proposed regulatory
responsibilities with respect to the Parties. Included in the proposed
Plan is an exhibit (the ``National Stock Exchange (``NSX'') Rules
Certification for 17d-2 Agreement with FINRA,'' referred to herein as
the ``Certification'') that lists every NSX rule, and select federal
securities laws, rules, and regulations, for which FINRA would bear
responsibility under the Plan for overseeing and enforcing with respect
to NSX members that are also members of FINRA and the associated
persons therewith (``Dual Members'').
    Specifically, under the 17d-2 Plan, FINRA would assume examination
and enforcement responsibility relating to compliance by Dual Members
with the rules of NSX that are substantially similar to the applicable
rules of FINRA,\10\ as well as any provisions of the federal securities
laws and the rules and regulations thereunder delineated in the
Certification (``Common Rules''). In the event that a Dual Member is
the subject of an investigation relating to a transaction on NSX, the
plan acknowledges that NSX may, in its discretion, exercise concurrent
jurisdiction and responsibility for such matter.\11\
---------------------------------------------------------------------------

    \10\ See paragraph 1(b) of the proposed 17d-2 Plan (defining
Common Rules). See also paragraph 1(f) of the proposed 17d-2 Plan
(defining Regulatory Responsibilities). Paragraph 2 of the Plan
provides that annually, or more frequently as required by changes in
either NSX rules or FINRA rules, the parties shall review and
update, if necessary, the list of Common Rules. Further, paragraph 3
of the Plan provides that NSX shall furnish FINRA with a list of
Dual Members, and shall update the list no less frequently than once
each calendar quarter.
    \11\ See paragraph 6 of the proposed 17d-2 Plan.
---------------------------------------------------------------------------

    Under the Plan, NSX would retain full responsibility for
surveillance and enforcement with respect to trading activities or
practices involving NSX's own marketplace, including, without
limitation, registration pursuant to its applicable rules of associated
persons (i.e., registration rules that are not Common Rules); its
duties as a DEA pursuant to Rule 17d-1 under the Act; and any NSX rules
that are not Common Rules.\12\
---------------------------------------------------------------------------

    \12\ See paragraph 2 of the proposed 17d-2 Plan.
---------------------------------------------------------------------------

III. Discussion

    The Commission finds that the proposed Plan is consistent with the
factors set forth in Section 17(d) of the Act \13\ and Rule 17d-2(c)
thereunder \14\ in that the proposed Plan is necessary or appropriate
in the public interest and for the protection of investors, fosters
cooperation and coordination among SROs, and removes impediments to and
fosters the development of the national market system. In particular,
the Commission believes that the proposed Plan should reduce
unnecessary regulatory duplication by allocating to FINRA certain
examination and enforcement responsibilities for common members that
would otherwise be performed by NSX and FINRA. Accordingly, the
proposed Plan promotes efficiency by reducing costs to common members.
Furthermore, because NSX and FINRA will coordinate their regulatory
functions in accordance with the Plan, the Plan should promote investor
protection.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78q(d).
    \14\ 17 CFR 240.17d-2(c).
---------------------------------------------------------------------------

    The Commission notes that, under the Plan, NSX and FINRA have
allocated regulatory responsibility for those NSX rules, set forth in
the Certification, that are substantially similar to the applicable
FINRA rules in that examination for compliance with such provisions and
rules would not require FINRA to develop one or more new examination
standards, modules, procedures, or criteria in order to analyze the
application of the rule, or a common member's activity, conduct, or
output in relation to such rule. In addition, under the Plan, FINRA
would assume regulatory responsibility for certain provisions of the
federal securities laws and the rules and regulations thereunder that
are set forth in the Certification. The Common Rules covered by the
Plan are specifically listed in the Certification, as may be amended by
the Parties from time to time.
    According to the Plan, NSX will review the Certification, at least
annually, or more frequently if required by changes in either the rules
of NSX or FINRA, and, if necessary, submit to FINRA an updated list of
Common Rules to add NSX rules not included on the then-current list of
Common Rules that are substantially similar to FINRA rules; delete NSX
rules included in the then-current list of Common Rules that are no
longer substantially similar to FINRA rules; and confirm that the
remaining rules on the list of Common Rules continue to be NSX rules
that are substantially similar to FINRA rules.\15\ FINRA will then
confirm in writing whether the rules listed in any updated list are
Common Rules as defined in the Plan. Under the Plan, NSX will also
provide FINRA with a current list of common members and shall update
the list no less frequently than once each quarter.\16\ The Commission
believes that these provisions are designed to provide for continuing
communication between the Parties to ensure the continued accuracy of
the scope of the proposed allocation of regulatory responsibility.
---------------------------------------------------------------------------

    \15\ See paragraph 2 of the Plan.
    \16\ See paragraph 3 of the Plan.
---------------------------------------------------------------------------

    The Commission is hereby declaring effective a Plan that, among
other things, allocates regulatory responsibility to FINRA for the
oversight and enforcement of all NSX rules that are substantially
similar to the rules of FINRA for common members of NSX and FINRA.
Therefore, modifications to the Certification need not be filed with
the Commission as an

amendment to the Plan, provided that the Parties are only adding to,
deleting from, or confirming changes to NSX rules in the Certification
in conformance with the definition of Common Rules provided in the
Plan. However, should the Parties decide to add a NSX rule to the
Certification that is not substantially similar to a FINRA rule; delete
a NSX rule from the Certification that is substantially similar to a
FINRA rule; or leave on the Certification a NSX rule that is no longer
substantially similar to a FINRA rule, then such a change would
constitute an amendment to the Plan, which must be filed with the
Commission pursuant to Rule 17d-2 under the Act.\17\
---------------------------------------------------------------------------

    \17\ The Commission also notes that the addition to or deletion
from the Certification of any federal securities laws, rules, and
regulations for which FINRA would bear responsibility under the Plan
for examining, and enforcing compliance by, common members, also
would constitute an amendment to the Plan.
---------------------------------------------------------------------------

IV. Conclusion

    This Order gives effect to the Plan filed with the Commission in
File No. 4-694. The Parties shall notify all members affected by the
Plan of their rights and obligations under the Plan.
    It is therefore ordered, pursuant to Section 17(d) of the Act, that
the Plan in File No. 4-694, between FINRA and NSX, filed pursuant to
Rule 17d-2 under the Act, is approved and declared effective.
    It is further ordered that NSX is relieved of those
responsibilities allocated to FINRA under the Plan in File No. 4-694.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Brent J. Fields,
Secretary.
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(34).
---------------------------------------------------------------------------

[FR Doc. 2016-02982 Filed 2-12-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62182-62184]
[FR Doc No: 2021-24431]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Product-Specific Guidances; Draft and Revised Draft Guidances 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 additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (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 guidances available to the public on FDA's website.
The guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on the draft
guidance by January 10, 2022 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-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' 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, 240-
402-7500.
     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 draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. 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: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 301-
796-2398 and/or [email protected].

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 guidances
available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website 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 guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on August 23, 2021 (86 FR 47112). This notice
announces draft product-specific guidances, either new or revised, that
are posted on FDA's website.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

    FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Artesunate.
Beclomethasone dipropionate monohydrate.
Bempedoic acid.
Bempedoic acid; Ezetimibe.
Cenobamate.
Ciclesonide.
Clascoterone.
Colesevelam hydrochloride.
Diclofenac potassium.
Dicyclomine hydrochloride.
Glucagon.
Lactitol.
Lemborexant.
Lurbinectedin.
Minocycline hydrochloride (multiple referenced listed drugs).
Opicapone.
Pemigatinib.
Potassium phosphate, dibasic; Potassium phosphate, monobasic (multiple
 referenced listed drugs).
Remimazolam besylate.
Riluzole.
Rimegepant sulfate.
Sodium iodide I-131.
Tenapanor hydrochloride.
Tucatinib.
------------------------------------------------------------------------

III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Alprazolam.
Aripiprazole.
Carbidopa; Levodopa.
Cetirizine hydrochloride.
Colesevelam hydrochloride (multiple referenced listed drugs).
Desloratadine.
Donepezil hydrochloride.
Lansoprazole.
Leuprolide acetate.
Leuprolide acetate; Norethindrone acetate.
Loratadine.
Methylphenidate.
Metoclopramide hydrochloride.
Mirtazapine.
Olanzapine.
Ondansetron.
Risperidone.
Rizatriptan benzoate.
Triamcinolone acetonide.
Zolmitriptan.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices

related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    FDA tentatively concludes that these draft guidances contain no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

V. Electronic Access

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

    Dated: November 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24431 Filed 11-8-21; 8:45 am]
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