[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66745-66746]
[FR Doc No: 2013-26546]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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,'' which 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 January 6, 2014.

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, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, 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access to the draft guidance recommendations.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: Kris Andr[eacute], Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

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,'' which
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 20, 2013 (78 FR 37230). This notice announces
draft product-specific recommendations, either new or revised, that are
being posted on FDA's Web site concurrently with publication of this
notice.

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

    FDA is announcing new draft product-specific BE recommendations for
drug products containing the following active ingredients:

Table 1--New Draft Product-Specific BE Recommendations for Drug Products
------------------------------------------------------------------------

------------------------------------------------------------------------
B.................................  Bedaquiline fumarate.
                                    Bupropion hydrochloride.
C.................................  Clobazam.
E.................................  Etodolac (multiple reference listed
                                     drugs and dosage forms).
M.................................  Mesna.
                                    Methenamine hippurate.
                                    Methocarbamol.
N.................................  Nicotine (multiple reference listed
                                     drugs).
                                    Nicotine polacrilex (multiple
                                     reference listed drugs).
P.................................  Phentermine hydrochloride.
                                    Prednisone.
------------------------------------------------------------------------

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

    FDA is announcing revised draft product-specific BE recommendations
for drug products containing the following active ingredients:

   Table 2--Revised Draft Product-Specific BE Recommendations for Drug
                                Products
------------------------------------------------------------------------

------------------------------------------------------------------------
A.................................  Acitretin.
                                    Amphetamine aspartate; Amphetamine
                                     sulfate; Dextroamphetamine
                                     saccharate; Dextroamphetamine
                                     sulfate.
B.................................  Bumetanide.
                                    Bupropion hydrobromide.
                                    Bupropion hydrochloride (multiple
                                     reference listed drugs and dosage
                                     forms).
C.................................  Cefixime.
                                    Celecoxib.
                                    Colesevelam hydrochloride.
D.................................  Doxorubicin hydrochloride.
                                    Drospirenone; Ethinyl estradiol.
L.................................  Lanthanum carbonate.
                                    Lenalidomide.
O.................................  Oxybutynin chloride.
R.................................  Rivastigmine.
T.................................  Tacrolimus (multiple strengths).
                                    Testosterone (multiple reference
                                     listed drugs and dosage forms).
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific BE recommendations, please 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 create or confer any
rights for or on any person and do not operate to bind FDA or the
public. An alternative approach may be used if such approach 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: October 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26546 Filed 11-5-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 121 (Tuesday, June 24, 2014)]
[Notices]
[Pages 35838-35839]
[FR Doc No: 2014-14657]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72420; File No. SR-CME-2014-23]

Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Extend a Fee Waiver Program for Certain OTC FX Cleared-Only Products

June 18, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act''),\1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on June 9, 2014, Chicago Mercantile Exchange Inc.
(``CME'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change described in Items I, II and
III below, which Items have been primarily prepared by CME. CME filed
the proposal pursuant to Section 19(b)(3)(A) of the Act,\3\ and Rule
19b-4(f)(2) \4\ thereunder, so that the proposal was 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).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CME is proposing to extend an existing fee waiver program
supporting certain CME cleared-only over-the-counter (``OTC'') foreign
exchange (``FX'') products through December 31, 2014.
    The text of the proposed rule change is below. Italicized text
indicates additions; bracketed text indicates deletions.
* * * * *

CME OTC FX Fee Waiver Program

Program Purpose

    The purpose of this Program is to incentivize market
participants to submit transaction in the OTC FX products listed
below to the Clearing House for clearing. The resulting increase in
volume benefits all participant segments in the market.

Product Scope

    The following cleared only OTC FX products (``Products''):

1. CME Cleared OTC FX--Emerging Markets
    a. USDBRL, USDCLP, USDCNY, USDCOP, USDIDR, USDINR, USDKRW,
USDMYR, USDPEN, USDPHP, USDRUB, USDTWD Non-Deliverable Forwards.
    b. USDCZK, USDHUF, USDHKD, USDILS, USDMXN, USDPLN, USDSGD,
USDTHB, USDTRY, USDZAR Cash-Settled Forwards.
2. CME Cleared OTC FX--Majors
    a. AUDJPY, AUDUSD, CADJPY, EURAUD, EURCHF, EURGBP, EURJPY,
EURUSD, GBPUSD, NZDUSD, USDCAD, USDCHF, USDDKK, USDJPY, USDNOK,
USDSEK Cash-Settled Forwards.

Eligible Participants

    The temporary reduction in fees will be open to all market
participants and will automatically be applied to any transaction in
the Products submitted to the Clearing House for clearing.

Program Term

    Start date is February 1, 2012. End date is [June 30, 2014]
December 31, 2014.

Hours

    The Program will be applicable regardless of the transaction
time.

Program Incentives

    Fee Waivers. All market participants that submit transactions in
the Products to the Clearing House will have their clearing fees
waived.
* * * * *

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

    In its filing with the Commission, CME included statements
concerning the purpose 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. CME 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

    CME is registered as a derivatives clearing organization with the
Commodity Futures Trading Commission (``CFTC'') and currently offers
clearing services for many different futures and swaps products. With
this filing, CME proposes to make proposed changes to CME rules
governing certain cleared-only OTC FX products.
    The proposed changes would extend an existing fee waiver program
that applies to these OTC FX products.\5\ The only proposed changes are
modifying the current June 30, 2014 termination date for the current
fee waiver program to December 31, 2014.
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    \5\ See Exchange Act Release No. 34-71201 (December 30, 2013),
79 FR 688 (January 06, 2014) (SR-CME-2013-35).
---------------------------------------------------------------------------

    There is no limit to the number of participants that may
participate in the proposed fee waiver program; it will be open to all
market participants and will be automatically applied to all
transaction fees in the enumerated OTC FX products. The changes that
are described in this filing are limited to fee changes for OTC FX
products. The proposed changes would become effective on filing.
    The proposed fee changes are limited to CME's business as a
derivatives clearing organization clearing products under the exclusive
jurisdiction of the CFTC and do not materially impact CME's security-
based swap clearing business in any way. CME has also certified the
proposed rule changes that are the subject of this filing to the CFTC
in CFTC Submission 14-216.
    CME believes the proposed rule changes are consistent with the
requirements of the Exchange Act including Section 17A of the Exchange
Act.\6\ More specifically, the proposed rule changes establish or
change a member due, fee or other charge imposed by CME under Section
19(b)(3)(A)(ii) \7\ of the Securities Exchange Act of 1934 and Rule
19b-4(f)(2) \8\ thereunder. CME believes that the proposed fee change
is consistent with the requirements of the Securities Exchange Act of
1934 and the rules and regulations thereunder and, in particular, to
Section 17A(b)(3)(D),\9\ because the proposed fee changes apply equally
to all market participants and therefore the proposed changes provide
for the equitable allocation of reasonable dues, fees and other charges
among participants. CME also notes that it operates in a highly
competitive market in which market participants can readily direct
business to competing venues. As such, the proposed changes are
appropriately filed pursuant to

Section 19(b)(3)(A) \10\ of the Act and paragraph (f)(2) of Rule 19b-4
thereunder.
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    \6\ 15 U.S.C. 78q-1.
    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \8\ 17 CFR 240.19b-4(f)(2).
    \9\ 15 U.S.C. 78q-1(b)(3)(D).
    \10\ 15 U.S.C. 78s(b)(3)(A).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CME does not believe that the proposed rule change will have any
impact, or impose any burden, on competition. The proposed rule changes
extend a currently operating OTC FX fee waiver program for an
additional six months. These products are swaps under the exclusive
jurisdiction of the CFTC, and, as such, these proposed changes do not
affect the security-based swap clearing activities of CME in any way
and therefore do not impose any burden on competition that is
inappropriate in furtherance of the purposes of the Act.

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

    CME has not solicited, and does not intend to solicit, comments
regarding this proposed rule change. CME has not received any
unsolicited written comments from interested parties.

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

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A) \11\ of the Act and Rule 19b-4(f)(2)
thereunder.\12\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change 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_ADDRESS>Please include
File No. SR-CME-2014-23 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-CME-2014-23. 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 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 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 or
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 CME and on CME's
Web site at http://www.cmegroup.com/market-regulation/rule-filings.html.
    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-CME-2014-23 and
should be submitted on or before July 15, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-14657 Filed 6-23-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Notices]
[Pages 871-873]
[FR Doc No: 2022-28602]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0461]

Format and Content of a Risk Evaluation and Mitigation Strategy
Document; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Format and
Content of a REMS Document.'' This final guidance describes the format
for a proposed risk evaluation and mitigation strategy (REMS) document.
This format was created based on extensive stakeholder feedback. This
guidance finalizes the revised draft guidance of the same title issued
on October 12, 2017, and announces the availability of the technical
specifications document entitled ``REMS Document Technical Conformance
Guide.''

DATES: The announcement of the guidance is published in the Federal
Register on January 5, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2009-D-0461 for ``Format and Content of a REMS Document.'' 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 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 or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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.

FOR FURTHER INFORMATION CONTACT: Suzanne Robottom, Center for Drug
Evaluation and Research, Food and Drug Administration,10903 New
Hampshire Ave, Bldg. 22, Rm. 4475, Silver Spring, MD 20993-0002, 301-
796-3554, or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Format and Content of a REMS Document.'' Section 505-1 of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1)
authorizes FDA to require a REMS for certain drugs if FDA determines
that a REMS is necessary to ensure that the benefits of the drug
outweigh its risks (see section 505-1(a) of the FD&C Act). A REMS is a
required risk management strategy that can include one or more elements
to ensure that the benefits of a drug outweigh its risks (see section
505-1(e) of the FD&C Act). The REMS document should include concise
information that describes the goals and requirements of a REMS as they
relate to the elements described under the FD&C Act.
    In the Federal Register of October 12, 2017 (82 FR 47529), FDA
announced the availability of a revised draft guidance for industry
entitled ``Format and Content of a REMS Document.'' This draft guidance
communicated changes to the format of the REMS document based on
stakeholder feedback that REMS requirements are not communicated to
stakeholders in a clear and consistent manner. (For more general
information on REMS as well as a more comprehensive discussion of the
issues summarized in this paragraph, please refer to the Background
Materials http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM362078.pdf for the July 2013 REMS
Standardization and Evaluation Public Meeting.)
    This guidance finalizes the revised draft guidance entitled
``Format and Content of a REMS Document'' issued on October 12, 2017.
FDA considered comments received on the revised draft guidance as the
guidance was finalized. Changes from the revised draft guidance to the
final guidance include: revising the REMS document to add and clarify
requirements participants, including the applicants, must complete to
comply with the REMS, adding a reference to a new authority to require
certain packaging and safe disposal technologies for drugs that pose a
serious risk of abuse or overdose, adding a new section to list the
statutory elements of the REMS, adding a prompt to identify the risk
addressed by the REMS, and relocating the information contained in the
appendix of the guidance (i.e., REMS document template) to a technical
specifications document entitled ``REMS Document Technical Conformance
Guide'' available on FDA's website (https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/roles-different-participants-rems). In addition, editorial changes were made to improve clarity and
consistency between the guidance and the standardized text in the REMS
document template.
    The guidance, along with the new technical specifications document,
can be used for drafting a REMS document for a single product and
shared system REMS and includes recommendations for drafting a
Bifurcated REMS document.\1\
---------------------------------------------------------------------------

    \1\ A Bifurcated REMS Document is used when the approval of a
shared system REMS may coincide with tentative approval of an
abbreviated new drug application or section 505(b)(2) application
(described in section 505(b)(2) of the FD&C Act (21 U.S.C.
355(b)(2)). For more information, refer to the guidance for
industry, ``Development of a Shared System REMS'' (June 2018),
available at https://www.fda.gov/media/113869/download.
---------------------------------------------------------------------------

    The recommendations in this guidance and the associated technical
specifications document are intended to help ensure that REMS documents
are clear; understandable to stakeholders; and to the extent possible,
consistent in content and format, as well as support submission of a
REMS document in Structured Product Labeling format, which is required
starting December 28, 2022.\2\
---------------------------------------------------------------------------

    \2\ See guidance for industry entitled ``Providing Regulatory
Submissions in Electronic Format--Content of the Risk Evaluation and
Mitigation Strategies Document Using Structured Product Labeling
Format'' (December 2020).
---------------------------------------------------------------------------

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the format and content of a REMS document.
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. The 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 21 CFR part 314 pertaining to the submission of new
drug applications (NDAs), abbreviated new drug applications (ANDAs),
and supplements to NDAs and ANDAs have been approved under 0910-0001.
The collections of information in 21 CFR part 601 pertaining to
biologics license applications (BLAs) and supplements to BLAs have been
approved under OMB control number 0910-0338. The collections of
information pertaining to Medication Guides for prescription drug
products have been approved under OMB control number 0910-0393.

III. Electronic Access

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

guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or
https://www.regulations.gov.

    Dated: December 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28602 Filed 1-4-23; 8:45 am]
BILLING CODE 4164-01-P