[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Proposed Rules]
[Pages 30968-30976]
[FR Doc No: 2019-13753]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 601

[Docket No. FDA-2019-N-1363]
RIN 0910-AH50

Biologics License Applications and Master Files

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to amend its regulations concerning the use of master files
for biological products. This action, if finalized, will allow certain
biological products approved under the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to continue to incorporate by reference information
about drug substances, drug substance intermediates, or drug products
contained in master files after those products are deemed to be
licensed under the Public Health Service Act (PHS Act) on March 23,
2020. The proposed rule also codifies FDA's practice of permitting
applications for biological products submitted under the PHS Act to
incorporate by reference information other than drug substance, drug
substance intermediate, or drug product information contained in a
master file. In addition, the proposed rule codifies FDA's practice of
permitting investigational new drug applications to incorporate by
reference any information contained in a master file for products
subject to licensure under the PHS Act.

DATES: Submit either electronic or written comments on the proposed
rule by August 27, 2019.

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 August 27, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 27, 2019. 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-2019-N-1363 for ``Biologics License Applications and Master
Files.'' 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Kavita Vyas, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 4154, Silver Spring, MD 20993-0002, 301-
796-4787<EMAIL_ADDRESS>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,
240-402-7911.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction
    B. FDA's Current Regulatory Framework
    C. Need for the Regulation
    D. History of the Rulemaking
IV. Legal Authority
V. Description of the Proposed Rule
    A. Proposed Provision of Paragraph (g)
    B. Proposed Provision of Paragraph (i)
    C. Proposed Provision of Paragraph (j)
    D. Proposed Provision of Paragraph (h)
    E. Proposed Records/Record Retention Requirements
    F. Proposed Enforcement Provisions
    G. Proposed Technical/Conforming Amendments
VI. Proposed Effective/Compliance Dates
VII. Preliminary Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. Reference

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA proposes to amend its regulations to implement certain aspects
of section 7002(e) of the Biologics Price Competition and Innovation
Act of 2009 (BPCI Act). The proposed rule is necessary to avoid
unnecessary disruptions with respect to biological products originally
approved under section 505 of the FD&C Act (21 U.S.C. 355) when their
applications are deemed to be licenses under the PHS Act and to prevent
potential drug shortages when those products are transitioned to being
regulated under section 351 of the PHS Act (42 U.S.C. 262). The
proposed rule will also update the regulation to reflect FDA's
longstanding practices regarding the use of master files referenced in
applications for biological products submitted under section 351 of the
PHS Act.

B. Summary of the Major Provisions of the Proposed Rule

    FDA proposes to amend its regulations concerning the use of master
files for biological products. The proposed rule would allow certain
biological products, originally approved in a new drug application
(NDA) under the FD&C Act, to continue relying on a drug master file for
information on a drug substance, drug substance intermediate, or drug
product (DS/DSI/DP) after the NDA is deemed to be a license for a
biological product under the PHS Act on March 23, 2020. The proposed
rule also codifies FDA's existing practice that a biological product in
a biologics license application (BLA) under the PHS Act may rely on a
master file, except for information regarding a drug substance, drug
substance intermediate, or drug product. In addition, the rule codifies
FDA's practice that an investigational new drug application (IND) for a
biological product may incorporate by reference any information,
including drug substance, drug substance intermediate, and drug product
information, contained in a master file.

C. Legal Authority

    FDA is proposing to amend its regulations, in part, to implement
section 7002(e) of the BPCI Act. FDA's authority for this rule also
derives from the biological product provisions of the PHS Act (42
U.S.C. 262 and 264), and the provisions of the FD&C Act (21 U.S.C. 321,
et seq.) applicable to drugs, including section 701 (21 U.S.C. 371);
the FD&C Act provisions are applicable to biological products under
section 351(j) of the PHS Act.

D. Costs and Benefits

    FDA anticipates that affected entities would incur minimal costs to
read and understand the rule. By allowing transitioned products to
continue to incorporate by reference information contained in existing
master files, FDA avoids imposing a potential new regulatory burden.
FDA projects that over 10 years at a discount rate of 7 percent the
proposed rule would generate annualized net cost savings ranging from
$0.3 million to $4.6 million with a primary estimate of $2.5 million;
over 10 years at a discount rate of 3 percent the proposed rule would
generate annualized net cost savings ranging from $0.3 million to $4.8

million with a primary estimate of $2.6 million.

   II--Table of Abbreviations/Commonly Used Acronyms in This Document
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        Abbreviation/acronym                     What it means
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BLA.................................  Biologics License Application.
BPCI Act............................  Biologics Price Competition and
                                       Innovation Act of 2009.
DMF.................................  Drug Master File.
DP..................................  Drug Product.
DS..................................  Drug Substance.
DSI.................................  Drug Substance Intermediate.
FD&C Act............................  Federal Food, Drug, and Cosmetic
                                       Act.
FDA.................................  U.S. Food and Drug Administration.
IND.................................  Investigational New Drug
                                       Application.
NDA.................................  New Drug Application.
PHS Act.............................  Public Health Service Act.
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III. Background

A. Introduction

    This proposed rule, when finalized, would amend FDA regulations
relating to the use of master files in applications for biological
products subject to regulation under the PHS Act. Section 7002(b)(1) of
the BPCI Act revised section 351(i) of the PHS Act, in part, to amend
the definition of a ``biological product'' to include a ``protein
(except any chemically synthesized polypeptide).'' \1\ A number of
products approved in NDAs under section 505 of the FD&C Act meet the
revised definition of biological product. Also, section 7002(e)(4) of
the BPCI Act provided that, on March 23, 2020, an application for a
biological product approved under section 505 of the FD&C Act ``shall
be deemed to be a license for the biological product under'' section
351 of the PHS Act. This rule implements FDA's interpretation of the
``deemed to be a license'' provision of the BPCI Act with respect to
the use of master files.\2\ In addition, this rule codifies current
Agency practices relating to the use of master files referenced in
applications for biological products.
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    \1\ On December 12, 2018, FDA issued a proposed rule regarding
its interpretation of the terms ``protein'' and ``chemically
synthesized polypeptide'' as used in section 351(i) of the PHS Act
(``Definition of the term `Biological Product' '', 83 FR 63817).
    \2\ For more information about FDA's interpretation of the
``deemed to be a license'' provision of the BPCI Act, see guidance
for industry entitled ``Interpretation of the `Deemed to be a
License' Provision of the Biologics Price Competition and Innovation
Act of 2009'' (December 2018). We update guidances periodically. To
make sure you have the most recent version of a guidance, check the
FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
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B. FDA's Current Regulatory Framework

1. What are master files?
    Master files are submissions to the Agency that may be used to
provide detailed, confidential information to the Agency about
facilities, processes, or articles used in the manufacturing,
processing, packaging, or storing of one or more human drugs.
Information contained in a master file can be used to support a
submission to FDA by an applicant or sponsor. The holder of a master
file can authorize one or more applicants or sponsors to incorporate by
reference information contained in the master file to support a
submission to FDA without having to disclose the information in that
master file (which may contain trade secrets or other confidential
commercial information) to the applicants or sponsors.3 4
The submission of a master file is at the sole discretion of the master
file holder. Ordinarily, FDA neither independently reviews nor approves
submissions to a master file; instead, the Agency reviews such
information only in the context of an application that incorporates by
reference information contained in that master file.
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    \3\ See, e.g., 21 CFR 314.420 and 47 FR 46622 at 46642 (October
19, 1982).
    \4\ The holder of a master file (including a drug master file)
who expects that information in the file will be incorporated by
reference both in a BLA and in an NDA or abbreviated new drug
application (ANDA) need only submit the master file to the Agency
once.
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    a. Drug master files. Some master files contain information that is
relevant to applications for drug products. For products regulated
under section 505 of the FD&C Act, FDA defines the term ``drug master
file'' (DMF) in its drug regulations (Sec.  314.420(a) (21 CFR
314.420(a))) and explicitly provides that ``[a]n investigational new
drug application or an application, abbreviated application, amendment,
or supplement may incorporate by reference all or part of the contents
of any drug master file in support of the submission'' if the holder of
the master file authorizes the incorporation (Sec.  314.420(b)).
Section 314.420 also describes several types of DMFs, each of which
typically contains certain kinds of information (Sec.  314.420(a)):
Drug substance, drug substance intermediate, and materials used in
their preparation, or drug product (referred to as Type II DMFs);
packaging materials (Type III); excipient, colorant, flavor, essence,
or materials used in their preparation (Type IV); and FDA-accepted
reference information (Type V). (See also FDA Guidance for Industry
entitled ``Drug Master Files: Guidelines,'' September 1989, available
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm (accessed March 2019).)
    b. Other master files. FDA also permits reference to master files
that are not addressed by Sec.  314.420, some of which contain
information that is relevant to applications for biological
products.\5\ The Agency's approach to the terminology for types of
master files used for products regulated under the PHS Act has
generally tracked its approach to the types of DMFs (e.g., Type II,
Type III) used for products regulated under the FD&C Act.
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    \5\ See, e.g., 21 CFR 601.51(a).
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2. Biologics License Applications and Master Files
    a. FDA generally permits BLAs to incorporate by reference
information contained in master files. Just as FDA permits NDAs and
ANDAs under the FD&C Act to incorporate by reference certain
information contained in DMFs, the Agency also generally permits
applications under the PHS Act (BLAs) to incorporate by reference
certain information contained in master files, including DMFs.
    For most categories of information and most application types
(including BLAs and INDs), the needs of master file holders, applicants
and sponsors, and FDA have been adequately met through this
incorporation-by-reference mechanism. This mechanism allows applicants
and sponsors to refer to information contained in master files without
having knowledge of the contents of those master files (Sec.  314.420;
47 FR 46622 at 46642). For products licensed under section 351 of the
PHS Act, FDA has permitted, and will generally continue to permit, the
use of information contained in most types of master files (such as
information about excipients, stabilizers, penetrants, or materials
used in the preparation of DS/DSI/DP) because the applicant generally
has the ability to independently identify and mitigate the risk posed
to product quality by such components. For example, applicants are
permitted to incorporate by reference in their BLA information on
container closures contained in a master file. This is the case because
an applicant can independently identify the risk to product quality
posed by a container closure (for example, by leachables in the
closure) by performing appropriate studies on stability and
adequateness for intended use and then taking steps to

mitigate any risks identified (for example, by implementing appropriate
testing and controls). Thus, in such cases, the feasibility of testing
to confirm the adequateness of intended container closures mitigates
the risks to quality arising from the applicant's lack of access to the
information contained in the master file.
    Accordingly, proposed Sec.  601.2(i) would codify FDA's
longstanding practice of permitting biological products in BLAs to
incorporate by reference most categories of information contained in
master files (other than information about DS/DSI/DP, discussed below).
    b. FDA currently does not permit biological products in BLAs to
incorporate by reference drug substance, drug substance intermediate,
or drug product information in master files. Although FDA's approach to
the use of master files in BLAs largely parallels its approach to the
use of DMFs in applications under the FD&C Act, there is a significant
difference: Unlike applications submitted under section 505 of the FC&C
Act, for biological products in BLAs, the Agency has, as a scientific
matter, expected applicants to submit information about DS/DSI/DP
directly to the BLA rather than incorporating it by reference to a
master file. (See, e.g., FDA Guidance for Industry entitled ``Quality
Considerations in Demonstrating Biosimilarity of a Therapeutic Protein
Product to a Reference Product'' April 2015, available at https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf (accessed March 2019).)
    The risk associated with the manufacture of complex biological
products is generally significantly higher than that associated with
the manufacture of chemical entities, which are often less complex.\6\
This is because most biological products tend to have certain features
(e.g., amino acid sequence, glycosylation, folding, cellular phenotype)
essential to their intended effect and can be very sensitive to changes
to their manufacturing process. In addition, biological products
derived from biological sources may be complex heterogeneous mixtures,
which provides another basis for having consistent process controls to
ensure quality.
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    \6\ The Agency recognizes that, in limited circumstances, this
may not always be the case; however, for purposes of administrative
efficiency and predictability, the Agency is proposing a bright line
between BLAs and NDAs regarding the referencing of master files for
DS/DSI/DP information for biological products.
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    For these reasons, the Agency considers the establishment and
function of a robust quality assurance program, with intimate knowledge
of all manufacturing steps, to be essential for controlling and
evaluating the process and the biological product, and for mitigating
product quality risks. The applicant for a BLA is expected to have
knowledge of and direct control over the manufacturing process for the
DS/DSI/DP for a biological product (21 CFR 601.2 and 601.20). Absent
this knowledge and control, the applicant generally cannot operate a
robust quality assurance program that independently identifies and
mitigates quality risks, which is critical to assuring the quality of a
biological product.
    As a scientific matter, given the complexity of biological
products, the Agency considers it generally impractical for the
applicant to confirm the DS/DSI/DP quality characteristics of a
biological product without complete knowledge of, and control over, all
aspects of the manufacturing process. FDA has concluded that the risk
to quality arising from the fragmentation of information about DS/DSI/
DP for a biological product between a master file and a BLA is very
difficult to mitigate. As a result, FDA believes that this type of
information is generally best submitted to the Agency directly in the
BLA, and that a BLA that incorporates by reference DS/DSI/DP
information for a biological product contained in a master file is
generally inconsistent with biological product licensing
requirements.7 8
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    \7\ FDA may permit, and generally will continue to permit, an
applicant to incorporate by reference certain information about a
product that is not the subject of the applicant's own BLA, such as
information about a comparator product used in studies intended to
support approval of the applicant's BLA. Incorporation of such
information by reference generally does not raise similar concerns
relating to an applicant's knowledge and control over all aspects of
the manufacturing process for the product that is the subject of the
applicant's own BLA.
    \8\ In lieu of the use of master files, other types of contract
manufacturing arrangements can be considered if the sponsor does not
intend to manufacture all aspects of the product for licensure and
the licensee assumes responsibility for compliance with the
applicable product and establishment standards. (See, e.g., FDA
guidance for industry entitled ``Cooperative Manufacturing
Arrangements For Licensed Biologics,'' November 2008, available at
<EMAIL_ADDRESS>(accessed March 2019).)
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    Accordingly, proposed Sec.  601.2(g) would codify FDA's
longstanding practice of not permitting a biological product in a BLA
to incorporate by reference information regarding DS/DSI/DP contained
in master files.
3. The Biologics Price Competition and Innovation Act of 2009
    Section 7002(b) of the BPCI Act amended, in part, the definition of
a ``biological product'' in the PHS Act to include a ``protein (except
any chemically synthesized polypeptide).'' \9\ Accordingly, under
section 351(i) of the PHS Act, a ``biological product'' is now defined
as ``a virus, therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic product, protein (except any
chemically synthesized polypeptide), or analogous product, or
arsphenamine or derivative of arsphenamine (or any other trivalent
organic arsenic compound), applicable to the prevention, treatment, or
cure of a disease or condition of human beings'' (section 351(i) of the
PHS Act; emphasis added).
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    \9\ See footnote 1.
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    Some protein products have historically been approved under section
505 of the FD&C Act. However, section 7002(e) of the BPCI Act provides
that a marketing application for a ``biological product'' must be
submitted under section 351 of the PHS Act (subject to certain
exceptions during a transition period ending on March 23, 2020).
Section 7002(e) of the BPCI Act also provides that, on March 23, 2020,
an application for a biological product approved under section 505 of
the FD&C Act ``shall be deemed to be a license for a biological product
under section 351'' of the PHS Act.\10\ Such approved applications are
referred to as ``deemed BLAs'' in this document.
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    \10\ See FDA Guidance for Industry entitled ``Interpretation of
the `Deemed to be a License' Provision of the Biologics Price
Competition and Innovation Act of 2009'' (December 2018). Available
at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM490264.pdf
(accessed March 2019).
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C. Need for the Regulation

1. The Biologics Price Competition and Innovation Act of 2009 and the
Use of Drug Master Files in BLAs
    The BPCI Act is silent about implementation of the ``deemed to be a
license for a biological product'' provision. In March 2016, FDA
published a draft guidance for industry entitled ``Interpretation of
the `Deemed to be a License' Provision of the Biologics Price
Competition and Innovation Act of 2009'' (see 81 FR 13373, March 14,
2016). Footnote 12 of that draft guidance explained that for sponsors
of proposed protein products who intend to submit a BLA, a Type II DMF
for a drug substance, drug substance intermediate, or drug product
would not be acceptable for a BLA

because a license holder is expected to have knowledge of and control
over the manufacturing process for the biological product for which it
has a license. The footnote went on to provide that FDA is considering
a mechanism that, in limited circumstances, would allow holders of
approved applications under section 505 of the FD&C Act that reference
a Type II DMF to continue to reference the DMF after the application is
deemed to be a license under the PHS Act on March 23, 2020. FDA
finalized this guidance in December 2018 (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM490264.pdf (accessed March 2019)), after considering
comments in its draft recommendations and without including the
corresponding footnote from the draft guidance because this proposed
rule would establish such a mechanism, while also codifying the general
longstanding practice that BLAs and INDs for biological products can
reference information in master files except, in the case of BLAs, for
DS/DSI/DP information for a biological product.
2. Mechanism To Permit the Continued Use of Currently Referenced DMFs
by ``Deemed BLAs''
    Biological products regulated under the FD&C Act have been able to
incorporate by reference DS/DSI/DP information contained in DMFs to
support the approval of NDAs. As explained above, for biological
products licensed under section 351 of the PHS Act, incorporating by
reference information contained in master files on DS/DSI/DP generally
is not permitted.
    This proposed regulation addresses, in part, a specific issue
related to implementation of the ``deemed to be a license'' provision
of the BPCI Act: Whether applications approved under section 505 of the
FD&C Act may continue to incorporate by reference DS/DSI/DP information
contained in DMFs once the applications are deemed to be BLAs subject
to licensure and regulation under the PHS Act.
    To date, FDA has identified approximately 89 applications approved
under the FD&C Act that will be deemed licensed under the PHS Act on
March 23, 2020. Approximately 17 of these applications incorporate by
reference information on DS/DSI/DP contained in DMFs. Furthermore, the
DS/DSI/DP information incorporated by reference into these 17
applications is drawn from only 7 DMFs. Thus, this use of DMFs for DS/
DSI/DP information involves a small subset of the deemed BLAs and only
a very small number of DMFs.
    In light of FDA's longstanding practice of not permitting a
biological product in a BLA to incorporate by reference information
regarding DS/DSI/DP contained in a master file, the Agency is
considering the appropriate regulatory approach to the relatively few
deemed BLAs that reference DS/DSI/DP information contained in DMFs. The
Agency is evaluating the risks and benefits of allowing these deemed
BLAs to continue incorporating by reference this type of information
from those DMFs. The analysis takes into account clinical
considerations and product availability, as well as the limited number
of applications and the limited number of DMFs that are involved. Based
on this analysis, the Agency proposes that for biological products, the
appropriate mechanism with respect to addressing incorporation by
reference of DS/DSI/DP information contained in DMFs would be to
implement the least disruptive approach.
    Some of the deemed BLAs that currently incorporate by reference
information contained in DMFs to support the application were approved
by the Agency based in part on DS/DSI/DP information contained in those
DMFs. Many of these products have been marketed for decades. Over this
period, none of these products have been withdrawn or removed from the
market for reasons of safety or effectiveness. For these products, the
Agency has no reason to believe that the March 23, 2020, transition in
and of itself introduces new risks to product safety, purity, and
potency.
    For some biological products, such as certain reproductive
hormones, treating the deemed BLAs like other applications for
biological products under the PHS Act with regard to the use of DS/DSI/
DP information contained in a DMF would present a considerable
challenge. Nearly all approved applications for these biological
products incorporate by reference DS/DSI/DP information contained in a
DMF. This incorporation by reference has resulted in drug substances
for these products of acceptable quality for decades. For example,
multiple Human Chorionic Gonadotropins from urinary sources have been
on the market since the mid-1970s using DMFs for information on the
drug substance, with changes to the product being handled through the
DMF pathway. Disallowing use of DMFs for these deemed BLAs would
curtail or halt production of these products, resulting in imminent or
immediate drug shortages with considerable negative impacts on public
health. FDA does not believe it was Congress's intent when enacting
section 7002(e) of the BPCI Act that deemed BLAs would need to be
removed from the market on March 23, 2020.
    Furthermore, the general concern about fragmentation of DS/DSI/DP
information associated with the use of DMFs is lessened in the case of
the deemed BLAs by the existence of generally longstanding
relationships between the deemed-BLA applicants and the DMF holders.
For example, the license holder of a deemed BLA may have accumulated
knowledge about the quality of the biological product supplied by the
DMF holder over an extended period. This accumulated knowledge allows
the deemed BLA holder to implement a more robust control strategy to
mitigate the risk to product quality posed by the applicant's limited
knowledge of the manufacturing process described in the DMF.
    In light of these facts, FDA believes that permitting a limited
number of deemed BLAs to continue to incorporate by reference DS/DSI/DP
information contained in a limited number of DMFs will, on balance,
protect and promote the public health. In contrast, if non-deemed BLAs
were to reference an existing DMF, they would generally not have the
benefit of this accumulated knowledge, and thus would not be able to
mitigate the resulting fragmentation of information and risk to product
quality as effectively. Similarly, while the lack of overt safety
signals and the absence of concerns about efficacy provide a rationale
for allowing a deemed BLA to continue to rely on DS/DSI/DP information
contained in a DMF, it may not be appropriate to extend this rationale
to a non-deemed BLA. For these reasons, in proposed Sec.  601.2(h), FDA
would permit only deemed BLAs that incorporate by reference information
on DS/DSI/DP contained in particular DMFs in their approved
applications under section 505 of the FD&C Act to continue doing so
after these products are deemed to be licensed under the PHS Act on
March 23, 2020. BLAs for other biological products will continue to not
be permitted to incorporate by reference DS/DSI/DP information
contained in a master file, consistent with FDA's longstanding
practice. Also, to enable innovation for deemed BLAs that reference an
existing DMF, it is important to preserve the ability to make changes
to the existing DMFs. Therefore, the proposed rule will permit holders
of existing DMFs referenced for deemed BLAs before transition to modify
these DMFs under Sec.  314.420 after March 23, 2020.

3. Investigational New Drug Applications and Master Files
    Section 314.420(b) provides that ``[a]n investigational new drug
application . . . may incorporate by reference all or part of the
contents of any drug master file in support of the submission'' with
the DMF holder's consent. In addition, FDA typically permits an IND for
a biological product to incorporate by reference information contained
in other master files, in addition to DMFs. Furthermore, it has been
FDA's practice to permit sponsors of INDs for biological products to
incorporate by reference DS/DSI/DP information contained in a master
file.
    FDA permits the use of DS/DSI/DP master files in biological product
INDs for several reasons. Exposure to the investigational product is
limited in the IND stage because it is only administered to subjects
enrolled in clinical trials, which are typically carried out in
controlled settings. Accordingly, the sponsor and FDA can mitigate risk
more effectively by closely monitoring patients in those trials, in
order to evaluate the safety of the investigational product, which is a
necessary component of the licensing process.
    Permitting the sponsor of an IND for a biological product to
incorporate by reference DS/DSI/DP information contained in master
files may also facilitate product development. Without this option, a
sponsor might choose not to make the significant investment to
manufacture the necessary DS/DSI/DP for a biological product at this
early stage of development. However, even in cases where an IND sponsor
of a biological product incorporates by reference DS/DSI/DP information
contained in a master file, FDA expects the sponsor to have knowledge
of and direct control of the manufacturing process by later stages of
development.
    Therefore, in proposed Sec.  601.2(j), FDA clarifies and codifies
this practice.

D. History of the Rulemaking

    In response to the BPCI Act, public meetings were held to discuss
various aspects of the statute. Also, public comments on the current
FDA practice for biological products of not accepting DMFs for
biological products in BLAs were received in the context of the draft
guidance for industry entitled ``Interpretation of the `Deemed to be a
License' Provision of the Biologics Price Competition and Innovation
Act of 2009'' (see 81 FR 13373). Comments, in part: (1) Urged FDA to
clarify its position on the use of Type II DMFs for applications that
will be deemed BLAs on March 23, 2020, and, at least for pancreatic
enzyme products, recommended FDA permit applications to reference Type
II DMFs after March 23, 2020, even if the application was not approved
as an NDA prior to the transition date; \11\ (2) urged FDA to adopt a
flexible approach toward the continued referencing of existing DMFs;
\12\ and (3) sought clarity on the use of other categories of DMFs
(e.g., Type III DMFs).\13\ FDA finalized this guidance in December 2018
after considering comments in its draft recommendations. With respect
to the comments concerning DMFs, the Agency undertook an analysis of
the number of DMFs, the number of applications referencing these DMFs,
and considered the consequences of not taking any action or taking the
proposed action. The Agency addressed all the concerns identified in
the public comments through the actions described in this proposed
rule, which includes allowing the incorporation by reference of DS/DP/
DSI information contained in DMFs, provided the DMFs were referenced
prior to the application being deemed a BLA on March 23, 2020, and
providing clarity on the use of other categories of DMFs in BLAs.
---------------------------------------------------------------------------

    \11\ See Comment from Curemark, LLC to Docket No. FDA-2015-D-
4750 (available at https://www.regulations.gov).
    \12\ See Comment from Pharmaceutical Research and Manufacturers
of America (PhRMA) to Docket No. FDA-2015-D-4750 (available at
https://www.regulations.gov).
    \13\ See Comments from Biotechnology Innovation Organization and
from Novo Nordisk, Docket No. FDA-2015-D-4750.
---------------------------------------------------------------------------

IV. Legal Authority

    FDA is proposing to amend its regulations, in part, to implement
certain aspects of section 7002(e) of the BPCI Act. FDA's authority for
this proposed rule also derives from the biological product licensing
provisions of the PHS Act and the provisions of the FD&C Act (21 U.S.C.
321, et seq.) applicable to drugs. Under these provisions, FDA has the
authority to issue regulations designed to ensure, among other things,
that biological products are safe, pure, and potent and manufactured in
accordance with current good manufacturing practice. FDA also has
general authority to promulgate regulations for the efficient
enforcement of the FD&C Act and the PHS Act, under section 701 of the
FD&C Act and section 351(j) of the PHS Act.

V. Description of the Proposed Rule

    We propose to amend Sec.  601.2 to add new paragraphs (g), (h),
(i), and (j). Specifically, the proposed rule will allow applications
for biological products approved under section 505 of the FD&C Act to
continue to incorporate by reference DS/DP/DSI information contained in
DMFs, provided the DMFs were referenced before March 23, 2020. Also,
this proposed rule essentially codifies, for biological products, the
longstanding Agency practices of permitting BLAs to incorporate by
reference information other than on DS/DP/DSI contained in master files
and INDs to incorporate any information contained in master files. FDA
is aware that there are combination products approved in BLAs under the
PHS Act and considers that the rationale described in this rule for
biological products also applies to the biological constituent part of
such combination products. FDA seeks comments on whether applications
for combination products submitted in BLAs under the PHS Act should be
permitted to incorporate by reference DS/DSI/DP information for any
non-biological constituent part (for example, the drug constituent part
of an antibody drug conjugate).

A. Proposed Provision of Paragraph (g)

    Proposed new paragraph (g) codifies the Agency's practice of not
permitting applications for biological products submitted under section
351 of the PHS Act to incorporate by reference information on DS/DSI/DP
contained in a master file. Deemed BLAs are excluded from this
provision and are addressed in proposed new paragraph (h).

B. Proposed Provision of Paragraph (i)

    Proposed new paragraph (i) codifies the Agency's practice of
permitting applications for biological products submitted under section
351 of the PHS Act to incorporate by reference information other than
DS/DSI/DP information contained in master files, including in DMFs.

C. Proposed Provision of Paragraph (j)

    Proposed new paragraph (j) codifies the Agency's practice of
permitting INDs to incorporate by reference information contained in
master files, including information on DS/DSI/DP.

D. Proposed Provision of Paragraph (h)

    Proposed new paragraph (h) addresses applications transitioning on
March 23, 2020, under section 7002(e) of the BPCI Act. It allows an
application for a biological product that has been approved under
section 505 of the FD&C Act and that incorporates by reference DS/DSI/
DP information contained in a DMF to continue to do so after that
application is deemed to be a BLA.

    The proposed rule is intended to preserve the status quo both for
the small number of deemed BLAs and for all other applications for
biological products submitted under section 351 of the PHS Act: Deemed
BLAs that incorporate by reference information on DS/DSI/DP contained
in a DMF at the time of their transition will be permitted to continue
to do so, but no other applications for biological products will be
permitted to incorporate by reference DS/DSI/DP information contained
in any master files.
    The proposed rule is not intended to alter a license holder's
ability to modify a product under Sec.  601.12 (21 CFR 601.12). The
proposed rule is also not intended to expand or reduce the changes
allowed to a deemed BLA that incorporates by reference information
contained in master files. Under the proposed rule, an applicant would
be permitted to supplement a deemed BLA within the same application, as
it would any other BLA under Sec.  601.12 and the applicable bundling
policy.\14\ However, if modifications to the deemed BLA are required
that could not be effected in a supplement and a new application is
required, that new BLA would not be considered a deemed BLA. As is the
case with other (non-deemed) applications for biological products, the
new BLA would not be permitted to reference DS/DSI/DP information
contained in any master file and would need to submit this information
as part of the new BLA itself.
---------------------------------------------------------------------------

    \14\ See guidance for industry entitled ``Submitting Separate
Marketing Applications and Clinical Data for Purposes of Assessing
User Fees'' (December 2004). Available at<EMAIL_ADDRESS>(accessed March 2019).
---------------------------------------------------------------------------

    The proposed rule is also not intended to limit or restrict the
changes that may be made to any master file, including a DMF for DS/
DSI/DP information.
    The proposed rule thus preserves the relationship between a DMF and
the application that references it. This ensures that the transition to
regulation under the PHS Act does not interrupt the supply of
biological products that have already been shown to be safe and
effective.

E. Proposed Records/Record Retention Requirements

    None; existing records and retention requirements will continue to
apply.

F. Proposed Enforcement Provisions

    None; existing enforcement regulations will continue to apply.

G. Proposed Technical/Conforming Amendments

    None necessary.

VI. Proposed Effective/Compliance Dates

    If finalized on or before February 22, 2020, this rule would take
effect on March 23, 2020.

VII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the proposed rule does not impose any new burdens, we
propose to certify that the proposed rule will not have a significant
economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $154 million, using the most current (2018) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    Table 1 summarizes our estimate of the annualized costs and the
annualized cost-saving benefits of the proposed rule.

                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                                ------------------------------------------
                Category                     Primary    Low estimate      High                                     Period                Notes
                                            estimate                    estimate    Year dollars    Discount       covered
                                                                                rate (%)       (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year.         $2.48         $0.33         $4.64          2017             7            10  Cost savings.
                                                 $2.56         $0.32         $4.80          2017             3            10  Cost savings.
    Annualized Quantified...............  ............  ............  ............  ............             7  ............  ..........................
    Qualitative.........................  ............  ............  ............  ............             3  ............  ..........................
Costs:
    Annualized Monetized $millions/year.         $0.00         $0.00         $0.00          2017             7            10  ..........................
                                                 $0.00         $0.00         $0.00          2017             3            10
    Annualized Quantified...............  ............  ............  ............  ............             7  ............  ..........................
    Qualitative.........................  ............  ............  ............  ............             3  ............  ..........................
Transfers:
    Federal Annualized Monetized          ............  ............  ............  ............             7  ............  ..........................
     $millions/year.                                                                                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To.............................  From:
                                          To:
--------------------------------------------------------------------------------------------------------------------------------------------------------

Other Annualized Monetized $millions/     ............  ............  ............  ............             7  ............  ..........................
 year.                                                                                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To.............................  From:
                                          To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
 State, Local or Tribal Government: None.
 Small Business: None.
 Wages: None.
 Growth: None.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in table 2 we estimate present
and annualized values of costs and cost savings over an infinite time
horizon. Based on these cost savings, this proposed rule would be
considered a deregulatory action under Executive Order 13771.

                                                            Table 2--E.O. 13771 Summary Table
                                                  [$ million in 2016 dollars over an infinite horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Lower bound                     Upper bound     Lower bound                     Upper bound
                                                               (7%)        Primary (7%)        (7%)            (3%)        Primary (3%)        (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................           $0.02           $0.02           $0.02           $0.02           $0.02           $0.03
Present Value of Cost-Savings...........................           $2.49          $18.66          $34.83           $2.80          $22.47          $42.14
Present Value of Net Costs..............................         ($2.47)        ($18.64)        ($34.81)         ($2.77)        ($22.45)        ($42.12)
Annualized Costs........................................           $0.00           $0.00           $0.00           $0.00           $0.00           $0.00
Annualized Cost-Savings.................................           $0.17           $1.31           $2.44           $0.08           $0.67           $1.26
Annualized Net Costs....................................         ($0.17)         ($1.30)         ($2.44)         ($0.08)         ($0.67)         ($1.26)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 314 and 21 CFR
part 601 have been approved under OMB control numbers 0910-0001 and
0910-0338, respectively.

X. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.

XII. Reference

    The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov.

1. FDA, Preliminary Regulatory Impact Analysis, ``Biologics License
Applications and Master Files.''

List of Subjects in 21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential
business information.
    Therefore, under the Public Health Service Act and under authority
delegated to the Commissioner of Food and Drugs, we propose that 21 CFR
part 601 be amended as follows:

PART 601--LICENSING

0
1. The authority citation for part 601 is revised to read as follows:

    Authority:  15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353,
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C.
216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322
(21 U.S.C. 355 note), sec 7002(e), Pub. L. 111-148, 124 Stat. 817.

0
2. Amend Sec.  601.2 by adding paragraphs (g), (h), (i), and (j) to
read as follows:

Sec.  601.2  Applications for biologics licenses; procedures for
filing.

* * * * *
    (g) Except as provided in paragraph (h) of this section, an
application for a biological product submitted to the Food and Drug
Administration for licensure under section 351 of the Public Health
Service Act; licensed under section 351 of the Public Health Service
Act; or deemed, under section 7002(e) of the Biologics Price
Competition and Innovation Act of 2009, to be licensed under section
351 of the Public Health Service Act may not incorporate by reference
drug substance, drug substance intermediate, or drug product
information contained in a master file, including a drug master file
submitted under Sec.  314.420 of this chapter. Amendments and
supplements submitted in support of these applications also may not
incorporate by reference such information contained in a master file.
    (h) An application for a biological product that:
    (1) Was approved under section 505 of the Federal Food, Drug, and
Cosmetic Act;
    (2) Was deemed on March 23, 2020, to be a license for the
biological product under section 351 of the Public Health Service Act;
and
    (3) On March 23, 2020, incorporated by reference drug substance,
drug substance intermediate, and/or drug product information contained
in a drug master file submitted under Sec.  314.420 of this chapter may
continue to incorporate by reference the information contained in that
drug master file after March 23, 2020. Amendments and supplements
submitted in support of these applications may also incorporate by
reference the information contained in that drug master file.
    (i) Nothing in paragraph (g) of this section limits or restricts an
application for a biological product submitted to the Food and Drug
Administration for licensure under section 351 of the Public Health
Service Act; licensed under section 351 of the Public Health Service
Act; or deemed, under section 7002(e) of the Biologics Price
Competition and Innovation Act of 2009, to be licensed under section
351 of the Public Health Service Act from incorporating by reference
information contained in any master file, including a drug master file
submitted under Sec.  314.420 of this chapter, that is not drug
substance, drug substance intermediate, or drug product information.
Amendments and supplements submitted in support of these applications
may also incorporate by reference such information contained in a
master file.
    (j) Nothing in paragraph (g) of this section limits or restricts an
investigational new drug application for a biological product from
incorporating by reference any information, including drug substance,
drug substance intermediate, and drug product information, contained in
a master file, including a drug master file submitted under Sec.
314.420 of this chapter.

    Dated: June 17, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.
    Dated: June 21, 2019.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-13753 Filed 6-27-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 234 (Thursday, December 7, 2017)]
[Notices]
[Pages 57799-57803]
[FR Doc No: 2017-26321]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82197; File No. SR-PEARL-2017-37]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend MIAX
PEARL Rules 517A, Aggregate Risk Manager for EEMs (``ARM-E''), and
517B, Aggregate Risk Manager for Market Makers (``ARM-M'')

December 1, 2017.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4

thereunder,\2\ notice is hereby given that on November 28, 2017, MIAX
PEARL, LLC (``MIAX PEARL'' or ``Exchange'') filed with the Securities
and Exchange Commission (``Commission'') a proposed rule change as
described in Items I, II, and III below, which Items have been prepared
by the Exchange. 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.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend Exchange Rules 517A,
Aggregate Risk Manager for EEMs (``ARM-E''), and 517B, Aggregate Risk
Manager for Market Makers (``ARM-M'').
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/rule-filings/pearl at MIAX
PEARL's principal office, and at the Commission's Public Reference
Room.

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 Exchange Rule 517A, ARM-E, to add
additional detail to subsection (b), and to adopt new rule text in
Interpretations and Policies .01, to state that immediate-or-cancel
(``IOC'') Orders \3\ are not EEM ARM Eligible Orders.\4\ The Exchange
also proposes to amend Exchange Rule 517B, ARM-M, to add additional
detail to subsection (b), and to adopt new rule text in Interpretations
and Policies .02, to state that immediate-or-cancel (``IOC'') Orders
are not MM ARM Eligible Orders.\5\
---------------------------------------------------------------------------

    \3\ An immediate-or-cancel order is an order that is to be
executed in whole or in part upon receipt. Any portion not so
executed is cancelled. See Exchange Rule 516(e).
    \4\ See Exchange Rule 517A(a).
    \5\ See Exchange Rule 517B(a).
---------------------------------------------------------------------------

ARM-E
    ARM-E protects MIAX PEARL Electronic Exchange Members (``EEMs'')
\6\ and assists them in managing risk by maintaining a counting program
(``EEM Counting Program'') \7\ for each participating EEM who has
submitted an order in an EEM Specified Option Class \8\ using a
specified market participant identifier (``MPID'') \9\ of the EEM and
delivered via the MEO Interface \10\ (an ``EEM ARM Eligible Order'').
The EEM Counting Program counts the number of contracts executed by an
EEM from an EEM ARM Eligible Order (the ``EEM ARM Contracts'') within a
specified time period that has been established by the EEM (the ``EEM
Specified Time Period'').\11\ The EEM Specified Time Period cannot
exceed 15 seconds.\12\ The Exchange currently provides that contracts
executed as a result of an immediate-or-cancel (``IOC'') order
submitted by such EEM are not included in a specific EEM's EEM Counting
Program.\13\
---------------------------------------------------------------------------

    \6\ The term ``Electronic Exchange Member'' or ``EEM'' means the
holder of a Trading Permit who is a Member representing as agent
Public Customer Orders or Non-Customer Orders on the Exchange and
those non-Market Maker Members conducting proprietary trading.
Electronic Exchange Members are deemed ``members'' under the
Exchange Act. See Exchange Rule 100.
    \7\ See Exchange Rule 517A(a).
    \8\ An ``EEM Specified Option Class'' is a class which the EEM
has designated as a class to be protected via ARM-E. See Exchange
Rule 517A(a).
    \9\ The term ``MPID'' means unique market participant
identifier. See Exchange Rule 100.
    \10\ The term ``MEO Interface'' means a binary order interface
used for submitting certain order types (as set forth in Rule 516)
to the MIAX PEARL System. See Exchange Rule 100.
    \11\ See Exchange Rule 517A(a).
    \12\ Id.
    \13\ See Exchange Rule 517A, Interpretations and Policies .01.
---------------------------------------------------------------------------

    The EEM may also establish for each EEM Specified Option Class an
EEM Allowable Engagement Percentage (the ``EEM Allowable Engagement
Percentage''),\14\ which is a number of contracts, divided by the size
of the orders, executed within the Specified Time Period, equal to or
over which the ARM-E will be triggered. When an execution of an EEM ARM
Contract from an EEM ARM Eligible Order occurs, the System \15\ will
look back over the EEM Specified Time Period to determine whether the
sum of contract executions from such EEM ARM Eligible Order during such
EEM Specified Time Period triggers the ARM-E.\16\
---------------------------------------------------------------------------

    \14\ See Exchange Rule 517A(c).
    \15\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
    \16\ See Exchange Rule 517A(c).
---------------------------------------------------------------------------

    The System will engage the ARM-E in a particular EEM Specified
Option Class when the EEM Counting Program has determined that an EEM
has executed during the EEM Specified Time Period a number of EEM ARM
Contracts from an EEM ARM Eligible Order equal to or above their EEM
Allowable Engagement Percentage. ARM-E will then, until the EEM sends a
notification to the System of the intent to reengage and submits a new
order in the EEM Specified Option Class: (i) Automatically cancel the
EEM ARM Eligible Orders in all series of that particular EEM Specified
Option Class and (ii) reject new orders by the EEM in all series of
that particular EEM Specified Option Class submitted using the MEO
Interface.\17\
---------------------------------------------------------------------------

    \17\ See Exchange Rule 517A(b).
---------------------------------------------------------------------------

    The Exchange now proposes to allow EEMs to submit orders with a
time in force of immediate-or-cancel to the Exchange during the time
that the ARM-E is engaged by amending Interpretations and Policies .01
to adopt new rule text to state, ``[i]mmediate-or-Cancel (``IOC'')
Orders submitted by an EEM using the MEO Interface are not EEM ARM
Eligible Orders.'' The Exchange also proposes to remove the existing
text in Interpretations and Policies .01 in its entirety which states,
``[t]he System does not include in a specific EEM's EEM Counting
Program contacts executed as a result of an immediate-or-cancel
(``IOC'') order submitted by such EEM.'' By adopting text that
explicitly states that IOC orders submitted by an EEM using the MEO
Interface are not EEM ARM Eligible Orders, there is no longer a need to
indicate that contracts executed as a result of an IOC order submitted
by an EEM are not included in the Counting Program, as only EEM ARM
Eligible Orders will be included in the EEM Counting Program.
    Additionally, Rule 517A(b) provides that when the ARM-E is engaged,
the System will, (i) automatically cancel the EEM ARM Eligible Orders
in all series of that particular EEM Specified Option Class and (ii)
reject new orders by the EEM in all series of that particular EEM
Specified Option Class submitted using the MEO Interface. The Exchange
now proposes to amend subsection (b)(ii) to state that the System will
reject EEM ARM Eligible Orders submitted by the EEM, thereby allowing
IOC orders to be submitted to the Exchange for trading when ARM-E is
engaged.

ARM-M
    ARM-M protects MIAX PEARL Market Makers \18\ and assists them in
managing risk by maintaining a counting program (``MM Counting
Program'') for each Market Maker who has submitted an order in an
option class (an ``MM Option Class'') delivered via the MEO Interface
(an ``MM ARM Eligible Order'').\19\ The MM Counting Program counts the
number of contracts executed by a Market Maker from an MM ARM Eligible
Order (the ``MM ARM Contracts'') within a specified time period that
has been established by the Market Maker or as a default setting, as
defined below (the ``MM Specified Time Period'').\20\ The MM Specified
Time Period cannot exceed 15 seconds whether established by the Market
Maker or as a default setting.\21\ The Exchange currently provides that
contracts executed as a result of an immediate-or-cancel (``IOC'')
order submitted by such MM are not included in a specific MM's MM
Counting Program.\22\
---------------------------------------------------------------------------

    \18\ The term ``Market Maker'' or ``MM'' means a Member
registered with the Exchange for the purpose of making markets in
options contracts traded on the Exchange and that is vested with the
rights and responsibilities specified in Chapter VI of the MIAX
PEARL Rules. See Exchange Rule 100.
    \19\ See Exchange Rule 517B(a).
    \20\ Id.
    \21\ Id.
    \22\ See Exchange Rule 517B, Interpretations and Policies .02.
---------------------------------------------------------------------------

    The Market Maker may also establish for each MM Option Class an MM
Allowable Engagement Percentage. When an execution of an MM ARM
Contract from an MM ARM Eligible Order occurs, the System will look
back over the MM Specified Time Period to determine whether the sum of
contract executions from such MM ARM Eligible Order during such MM
Specified Time Period triggers the ARM-M.\23\
---------------------------------------------------------------------------

    \23\ See Exchange Rule 517B(c).
---------------------------------------------------------------------------

    The System will engage the ARM-M in a particular MM Option Class
when the MM Counting Program has determined that a Market Maker has
executed during the MM Specified Time Period a number of MM ARM
Contracts from an MM ARM Eligible Order equal to or above their MM
Allowable Engagement Percentage. The ARM-M will then, until the Market
Maker sends a notification to the System of the intent to reengage and
submits a new order in the MM Option Class: (i) Automatically cancel
the MM ARM Eligible Orders in all series of that particular MM Option
Class and (ii) reject new orders by the Market Maker in all series of
that particular MM Option Class submitted using the MEO Interface.\24\
---------------------------------------------------------------------------

    \24\ See Exchange Rule 517B(b).
---------------------------------------------------------------------------

    The Exchange now proposes to allow Market Makers to submit orders
with a time in force of immediate-or-cancel to the Exchange during the
time that the ARM-M is engaged by amending Interpretations and Policies
.02 to state, ``[i]mmediate-or-Cancel (``IOC'') Orders submitted by a
Market Maker using the MEO Interface are not MM ARM Eligible Orders.''
The Exchange also proposes to remove the existing text in
Interpretations and Policies .02 in its entirety which states, ``[t]he
System does not include in a specific MM's MM Counting Program contacts
executed as a result of an immediate-or-cancel (``IOC'') order
submitted by such MM.'' By adopting text that explicitly states that
IOC orders submitted by a Market Maker using the MEO Interface are not
MM ARM Eligible Orders, there is no longer a need to indicate contracts
executed as a result of an IOC order submitted by a Market Maker are
not included in the Counting Program, as only MM ARM Eligible Orders
will be included in the MM Counting Program.
    Additionally, Rule 517B(b) provides that when the ARM-M is engaged,
the System will (i) automatically cancel the MM ARM Eligible Orders in
all series of that particular MM Option Class and (ii) reject new
orders by the Market Maker in all series of that particular MM Option
Class submitted using the MEO Interface. The Exchange now proposes to
amend subsection (b)(ii) to state that the System will reject new MM
ARM Eligible Orders submitted by the Market Maker, thereby allowing IOC
orders to be submitted to the Exchange for trading when ARM-M is
engaged.
    ARM-E and ARM-M are designed to mitigate the exposure risk of
resting orders on the Exchange. In the Exchange's experience an IOC
order is an order that is designed to target specific, identifiable
liquidity resting on the Book \25\ that the entering Member desires to
trade with. Thus, a Member entering an IOC order does not require the
risk management protection of either the ARM-E or ARM-M, as the Member
entering the IOC order has made an affirmative decision to attempt to
execute that transaction. The Exchange believes Members should not be
prevented from submitting these types of orders to the Exchange during
the time that the Aggregate Risk Manager is engaged as contracts
executed using these types of orders are not included in either the EEM
or MM Counting Program.\26\
---------------------------------------------------------------------------

    \25\ The term ``Book'' means the electronic book of buy and sell
orders and quotes maintained by the System. See Exchange Rule 100.
    \26\ See supra note 11 and 19.
---------------------------------------------------------------------------

    The Exchange believes this proposal will allow Members to continue
to be protected from the risks that the Aggregate Risk Manager is
designed to mitigate, and also allow Members to continue to submit
certain orders which Members desire to submit even during the time that
the Aggregate Risk Manager is engaged. The Exchange believes allowing
Members the ability to send IOC orders to the Exchange will improve
liquidity and order execution on the Exchange.
    The Exchange notes that the proposed rule change is similar to a
rule that is currently operative on the Exchange's affiliate, MIAX
Options Exchange (``MIAX Options''). Specifically, Interpretations and
Policies .01 to MIAX Options Rule 612, Aggregate Risk Manager, states
that eQuotes \27\ will remain in the System available for trading when
the Aggregate Risk Manager is engaged. IOC Orders on MIAX PEARL are
analogous to eQuotes on MIAX Options as eQuotes also have limited time-
in-force durations. For example, eQuotes on MIAX Options \28\ may be
Auction or Cancel (``AOC''),\29\ Opening Only (``OPG''),\30\ Immediate
or Cancel (``IOC''),\31\ or Fill or Kill (``FOK'').\32\ MIAX PEARL and
MIAX

Options have a number of common Members and where feasible the Exchange
strives to provide consistency between the markets so as to avoid
confusion among Members.
---------------------------------------------------------------------------

    \27\ An eQuote is a quote with a specific time in force that
does not automatically cancel and replace a previous Standard quote
or eQuote. An eQuote can be cancelled by the Market Maker at any
time, or can be replaced by another eQuote that contains specific
instructions to cancel an existing eQuote. See MIAX Options Exchange
Rule 517(a)(2).
    \28\ MIAX Options provides for a Day eQuote in its rules,
however this type of eQuote has not yet been enabled for trading on
the MIAX Options Exchange. See MIAX Options Exchange Rule 517(a)(i).
    \29\ An Auction or Cancel or ``AOC'' eQuote is a quote submitted
by a Market Maker to provide liquidity in a specific Exchange
process . . . with a time in force that corresponds with the
duration of that event and will automatically expire at the end of
that event. See MIAX Options Exchange Rule 517(a)(2)(ii). The
Exchange notes the current length of an auction on MIAX Options is
100 milliseconds and that the duration of an auction may be no less
than 100 milliseconds and no more than 1 second. See MIAX Options
Exchange Rule 515A(a)(2)(i)(C).
    \30\ An opening only or ``OPG'' eQuote is a quote that can be
submitted by a Market Maker only during the Opening . . . OPG
eQuotes will automatically expire at the end of the Opening Process.
See MIAX Options Exchange Rule 517(a)(2)(iii).
    \31\ An immediate or cancel or ``IOC'' eQuote is an eQuote
submitted by a Market Maker that must be matched with another quote
or order for an execution in whole or in part upon receipt into the
System. Any portion of the IOC eQuote not executed will be
immediately canceled. See MIAX Options Exchange Rule 517(a)(2)(iv).
    \32\ A fill or kill or ``FOK'' eQuote is an eQuote submitted by
a Market Maker that must be matched with another quote or order for
an execution in its entirety at a single price upon receipt into the
System or will be immediately cancelled. See MIAX Options Exchange
Rule 517(a)(a)(v).
---------------------------------------------------------------------------

    The Exchange will announce the implementation date of the proposed
rule change by Regulatory Circular to be published no later than 60
days following the operative date of the proposed rule. The
implementation date will be no later than 60 days following the
issuance of the Regulatory Circular.
2. Statutory Basis
    MIAX PEARL believes that its proposed rule change is consistent
with Section 6(b) of the Act \33\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \34\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in, securities, to remove impediments to and
perfect the mechanisms of a free and open market and a national market
system and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \33\ 15 U.S.C. 78f(b).
    \34\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that its proposal would promote just and
equitable principles of trade by permitting Members to use an order
type that is not an ARM Eligible Order during the time that the ARM is
engaged. Additionally, the Exchange believes this proposal will promote
just and equitable principles of trade by allowing Members to continue
to be protected from the risks that the Aggregate Risk Manager is
designed to mitigate, and also allow Members to continue to submit
certain orders which Members desire to submit even during the time the
Aggregate Risk Manager is engaged. ARM-E and ARM-M are designed to
mitigate the exposure risk of resting orders. An IOC order is an order
that is designed to target specific, identifiable liquidity resting on
the Book that the entering Member desires to trade with and thus the
Member entering the IOC order does not require the risk management
protection of either the ARM-E or ARM-M, as the Member entering the IOC
order has made an affirmative decision to attempt to execute that
transaction. Therefore, the Exchange believes Members should not be
prevented from submitting these types of Orders to the Exchange during
the time that the Aggregate Risk Manager is engaged. The Exchange
believes allowing Members the ability to send IOC orders to the
Exchange while the Aggregate Risk Manager is engaged promotes just and
equitable principles of trade by improving liquidity and order
execution on the Exchange.
    The Exchange believes its proposal will result in increased
liquidity on the Exchange which will contribute to the operation of a
fair and orderly market. The proposed treatment of IOC orders during
the time that the ARM is engaged is substantially similar to the
treatment of eQuotes on the Exchange's affiliate, MIAX Options.\35\
---------------------------------------------------------------------------

    \35\ See MIAX Options Rule 612, Interpretations and Policies
.01.
---------------------------------------------------------------------------

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed rule change will foster competition on the Exchange by
providing EEMs and Market Makers with the ability to submit IOC orders
during the time that the ARM is engaged and compete for executions.
    The Exchange does not believe the proposed rule change will impact
inter-market competition as the proposal is not designed to address
competitive issue and is limited in scope to the behavior of Members of
the Exchange.
    For the reasons stated, 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, and
believes the proposed change will enhance competition.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \36\ and Rule 19b-4(f)(6) \37\
thereunder.
---------------------------------------------------------------------------

    \36\ 15 U.S.C. 78s(b)(3)(A).
    \37\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    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. 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-PEARL-2017-37 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-PEARL-2017-37. 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 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 the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not react 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-
PEARL-2017-37 and should be submitted on or before December 28, 2017.
---------------------------------------------------------------------------

    \38\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\38\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-26321 Filed 12-6-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)]
[Notices]
[Pages 61560-61562]
[FR Doc No: 2017-28093]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14751-002]

Alpine Pacific Utilities Hydro, LLC; Notice of Application
Accepted for Filing With the Commission, Soliciting Motions To
Intervene and Protests, Ready for Environmental Analysis, Intent To
Waive Scoping, Soliciting Comments, Terms and Conditions,
Recommendations, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original Minor License.
    b. Project No.: 14751-002.
    c. Date filed: February 1, 2017.
    d. Applicant: Alpine Pacific Utilities Hydro, LLC.
    e. Name of Project: Fresno Dam Site Water Power Project.
    f. Location: On the Milk River in Hill County, Montana near the
town of Kremlin at the existing Bureau of Reclamation Fresno Dam.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Justin Ahmann, Alpine Pacific Utilities
Hydro, LLC, 75 Somers Road, Somers, Montana 59932,<PHONE_NUMBER>.
    i. FERC Contact: John Matkowski,<PHONE_NUMBER> or
[email protected].
    j. Deadline for filing motions to intervene and protests, comments,
terms and conditions, recommendations, and prescriptions: 60 days from
the issuance date of this notice; reply comments are due 105 days from
the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to

intervene and protests, comments, terms and conditions,
recommendations, and prescriptions using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at [email protected],<PHONE_NUMBER> (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426. The first page of any filing should
include docket number P-14751-002.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The proposed project would use the existing Fresno Dam, intake
with trashrack, and outlet structure owned and operated by the Bureau
of Reclamation and consist of the following new facilities: (1) Two
penstock adapters consisting of (i) a 72-inch diameter circular section
transitioning to (ii) a 72-inch-high by 60-inch wide rectangular
section that connects the existing outlet works to (2) a series of
rectangular concrete adapter boxes that apportion flow into either the
proposed turbines or to the existing gate house; (3) an underground
powerhouse containing one 875-kilowatt (kW) and one 625-kW Natel Energy
turbine with a total rated capacity of 1.5 megawatts; (4) two 5-foot-
wide by 6-foot-high, 85-foot-long concrete tailraces; (5) a 400-square-
foot switchyard; (6) an approximately 3.35-mile-long, 12.74-kilovolt
underground transmission line; and (7) appurtenant facilities. The
proposed project would have an average annual generation of 6,251
megawatt-hours.
    m. Due to the applicant's close coordination with state and federal
agencies during the preparation of the application and the lack of any
study requests submitted during pre-filing consultation and in response
to the Commission's tendering notice, we intend to waive scoping. Based
on a review of the application, resource agency consultation letters,
and comments filed to date, Commission staff intends to prepare a
single environmental assessment (EA). The issues that need to be
addressed in the EA have been adequately identified during the pre-
filing period, which included a public meeting and site visit, and no
new issues are likely to be identified through additional scoping. The
EA will assess the potential effects of project construction and
operation on geology and soils, aquatic, terrestrial, threatened and
endangered species, recreation and land use, aesthetic, and cultural
and historic resources.
    n. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant(s) named in this
public notice.
    Anyone may submit comments, a protest, or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, .211, and .214. In determining the appropriate action to
take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) bear in all capital letters the title PROTEST,
MOTION TO INTERVENE, NOTICE OF INTENT TO FILE COMPETING APPLICATION,
COMPETING APPLICATION, COMMENTS, REPLY COMMENTS, RECOMMENDATIONS, TERMS
AND CONDITIONS, or PRESCRIPTIONS; (2) set forth in the heading the name
of the applicant and the project number of the application to which the
filing responds; (3) furnish the name, address, and telephone number of
the person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments,
recommendations, terms and conditions or prescriptions must set forth
their evidentiary basis and otherwise comply with the requirements of
18 CFR 4.34(b). Agencies may obtain copies of the application directly
from the applicant. A copy of any protest or motion to intervene must
be served upon each representative of the applicant specified in the
particular application. A copy of all other filings in reference to
this application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    p. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.
    q. Procedural schedule: We intend to accept the consultation that
has occurred on this project during the pre-filing period as satisfying
our requirements for the standard 3-stage consultation process under 18
CFR 4.38 and for National Environmental Policy Act scoping and the
application will be processed according to the following procedural
schedule. Revisions to the schedule may be made as appropriate.

------------------------------------------------------------------------
               Milestone                           Target date
------------------------------------------------------------------------
Comments, recommendations, and terms     60 days from issuance of this
 and conditions due.                      notice.
Reply comments due.....................  105 days from issuance of this
                                          notice.
Notice of the availability of the EA...  August 2018.
------------------------------------------------------------------------

    Dated: December 21, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-28093 Filed 12-27-17; 8:45 am]
 BILLING CODE 6717-01-P