[Federal Register Volume 85, Number 242 (Wednesday, December 16, 2020)]
[Notices]
[Pages 81531-81534]
[FR Doc No: 2020-27596]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90626; File Nos. SR-DTC-2020-015; SR-FICC-2020-016; SR-
NSCC-2020-019]

Self-Regulatory Organizations; The Depository Trust Company;
Fixed Income Clearing Corporation; National Securities Clearing
Corporation; Notice of Filings and Immediate Effectiveness of Proposed
Rule Changes To Amend the Clearing Agency Operational Risk Management
Framework

December 10, 2020.
    Pursuant to 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 December 1, 2020, The Depository Trust Company (``DTC''), Fixed
Income Clearing Corporation (``FICC''), and National Securities
Clearing Corporation (``NSCC,'' and collectively, the ``Clearing
Agencies'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule changes as described in Items I, II
and III below, which Items have been primarily prepared by the Clearing
Agencies. The Clearing Agencies filed the proposed rule changes
pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(3)
thereunder.\4\ The Commission is publishing this notice to solicit
comments on the proposed rule changes from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(3).
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I. Clearing Agencies' Statement of the Terms of Substance of the
Proposed Rule Changes

    The proposed rule changes consist of amendments to the Clearing
Agency Operational Risk Management Framework (``ORM Framework'' or
``Framework'') of Clearing Agencies. Specifically, the proposed rule
changes would (1) include a description of the Clearing Agencies'
incident management procedures; (2) update the ORM Framework to reflect
recent changes to group names and responsibilities, and other processes
and matters described in the Framework; and (3) enhance the
descriptions of certain matters within the ORM Framework to improve its
clarity and comprehensiveness, as further described below.

II. Clearing Agencies' Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Changes

    In their filings with the Commission, the Clearing Agencies
included statements concerning the purpose of and basis for the
proposed rule changes and discussed any comments they received on the
proposed rule changes. The text of these statements may be examined at
the places specified in Item IV below. The Clearing Agencies have
prepared summaries, set forth in sections A, B, and C below, of the
most significant aspects of such statements.

(A) Clearing Agencies' Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Changes

1. Purpose
    The Clearing Agencies adopted the ORM Framework \5\ to provide an
outline for how each of the Clearing Agencies manages its operational
risks. In this way, the Framework supports the Clearing Agencies'
compliance with Rules 17Ad-22(e)(17) of the Standards for Covered
Clearing Agencies (``Standards'') under the Act,\6\ as described in the
Initial Filing. In addition to setting forth the manner in which each
of the Clearing Agencies addresses these requirements, the ORM
Framework also contains a section titled ``Framework Ownership and
Change Management'' that, among other matters, describes the Framework
ownership and the required governance process for review and approval
of changes to the Framework.
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    \5\ See Securities Exchange Act Release No. 81745 (September 28,
2017), 82 FR 46332 (October 4, 2017) (SR-DTC-2017-014; SR-NSCC-2017-
013; SR-FICC-2017-017) (``Initial Filing'').
    \6\ 17 CFR 240.17Ad-22(e)(17).
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    In connection with the annual review and approval of the Framework
by the Boards of Directors of each of the Clearing Agencies (each a
``Board'' and collectively, the ``Boards''), the Clearing Agencies are
proposing to make certain revisions to the Framework.
    Such proposed changes would include a description of the Clearing
Agencies' incident management procedures in connection with its
information technology risk management. The proposed changes would also
update the ORM Framework to reflect recent changes to group names and
responsibilities, certain processes and other matters described in the
Framework. Finally, the proposed changes would enhance the descriptions
of certain matters within the ORM Framework to improve its clarity and
comprehensiveness. Each of these proposed changes are further described
below.
i. Proposed Amendments To Describe Incident Management Procedures
    First, the proposed changes would add a description of the Clearing
Agencies' incident management procedures in Section 5 of the Framework,
which currently describes information technology management. The
Clearing Agencies currently follow these incident management
procedures, which support the Clearing Agencies' compliance with the
requirements of Rule 17Ad-22(e)(17)(i) and (ii) and define the actions
that are taken following detection of systems incidents.\7\ The purpose
of these procedures, as proposed to be described in Section 5 of the
Framework, is to define the actions that are taken following the
detection of systems incidents. Generally, these actions include
identification and classification, investigation and diagnosis, and
resolution and recovery of the incidents that affect the Clearing
Agencies' systems.
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    \7\ 17 CFR 240.17Ad-22(e)(17)(i) and (ii).
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    The proposed change would be to include a description of these
existing procedures in the Framework in connection with its description
of information technology management. This proposed change would
improve the Framework by including this important aspect of operational
risk management and providing a more complete description of the
Clearing Agencies' processes that support their compliance with the
requirements of Rule 17Ad-22(e)(17)(i) and (ii).
ii. Proposed Amendments To Update the Framework
    Second, the proposed changes would update the ORM Framework to
reflect recent developments with respect to the names and
responsibilities of groups that take certain actions described in the
Framework. The proposed changes would also reflect updates to processes
and other matters described in the Framework, as described below. These
proposed changes do not substantively impact how the Clearing Agencies
manage operational risk in compliance with the requirements of Rule
17Ad-22(e)(17).\8\
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    \8\ 17 CFR 240.17Ad-22(e)(17).
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1. Proposed Change to the Name of Business Continuity Management
    Section 6 of the ORM Framework describes the Clearing Agencies'
management of business continuity risk and the business continuity
plans that

have been established and maintained by the Clearing Agencies in
compliance with the requirements of Rule 17Ad-22(e)(17)(iii).\9\ The
group responsible for these activities was previously called Business
Continuity Management. While the role and responsibilities of this risk
management function have not changed, its name has been changed to
``Business Continuity & Resiliency'' to reflect an increased focus on
strengthening the resiliency of the Clearing Agencies and the ability
of their systems to sustain and recover from numerous incidents. The
Framework would be updated to reflect the change to the name of this
group.
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    \9\ 17 CFR 240.17Ad-22(e)(17)(iii).
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2. Proposed Change To Revise Description of Document Repository
    Section 4.1 of the ORM Framework describes Risk Tolerance
Statements, which document the overall risk reduction or mitigation
objectives for the Clearing Agencies with respect to identified risks
to the Clearing Agencies. Risk Tolerance Statements also document the
risk controls and other measures used to manage identified risks,
including escalation requirements in the event of risk metric breaches.
Currently, Section 4.1 states that Risk Tolerance Statements are
located in the DTCC Enterprise Policy Repository.
    The name of the repository where all policies, procedures and
related documents are maintained has changed. Therefore, the Clearing
Agencies are proposing to update this Section of the Framework to refer
generally to the central repository for all policies, procedures and
related documents, rather than refer to the specific name of that
central repository. This proposed change would allow the Framework to
accurately describe where Risk Tolerance Statements are maintained,
notwithstanding this recent, and any potential future, change to the
name of that document management tool.
3. Proposed Change To Reflect Expansion of Operating Centers
    Section 6 of the ORM Framework, which describes business continuity
risk management, currently includes a statement that the operating
centers that support the Clearing Agencies are run from no fewer than
three geographic regions in the United States. Since the ORM Framework
was adopted the Clearing Agencies have expanded the geographic spread
and diversity of their operating centers. In order to reflect this
change, the ORM Framework would be updated to state that these
operating centers are run from geographic regions globally (i.e.,
without the limitation that they are located in the United States).
iii. Proposed Amendments To Clarify and Enhance Descriptions in the
Framework
    Finally, the proposed changes would enhance the descriptions of
certain matters within the ORM Framework to improve its clarity and
comprehensiveness, as described below.
1. Proposed Change To Describe Annual Approval of Framework by Boards
    Section 2 of the ORM Framework addresses the Framework's ownership
and change management. This section currently states that the Framework
should be reviewed by the document owner no less frequently than
annually but does not specify the regulatory requirement that the
Framework also be approved by the Boards on an annual basis. The
Clearing Agencies are proposing to amend Section 2 of the Framework to
include the requirement that the Framework be approved by the Boards,
or a duly authorized committee of the Boards, annually.
    Rule 17Ad-22(e)(3) under the Act requires that the Clearing
Agencies maintain a sound risk management framework for comprehensively
managing the risks that arise in or are borne by the Clearing Agencies,
including operational risks.\10\ Rule 17Ad-22(e)(3)(i) under the Act
requires that the risk management policies, procedures, and systems
that are maintained in compliance with Rule 17Ad-22(e)(3) be subject to
review on a specified periodic basis and be approved by the Boards
annually.\11\ As stated above, the Framework provides an outline for
how each of the Clearing Agencies manage operational risks, as required
by both Rules 17Ad-22(e)(3) and (17) under the Act.\12\ Therefore, the
ORM Framework is reviewed and approved by the Boards annually, as
required by Rule 17Ad-22(e)(3)(i) under the Act.\13\
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    \10\ 17 CFR 240.17Ad-22(e)(3).
    \11\ 17 CFR 240.17Ad-22(e)(3)(i).
    \12\ 17 CFR 240.17Ad-22(e)(3), (17).
    \13\ 17 CFR 240.17Ad-22(e)(3)(i).
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    The Clearing Agencies are proposing to amend Section 2 of the
Framework to state that the Framework shall be approved by the Boards,
or a duly authorized committee of the Boards, annually. The proposed
change would enhance the comprehensiveness of the Framework to specify
this requirement, which is aligned with the applicable requirements of
Rule 17Ad-22(e)(3)(i) under the Act.\14\
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    \14\ Id.
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2. Proposed Change To Clarify Description of Risk Profiles
    Section 4.2 of the ORM Framework describes the Risk Profiles, which
are tools used by the Operational Risk Management group within the
Group Chief Risk Office of The Depository Trust & Clearing Corporation
(``ORM'') \15\ to document risk assessments and consolidate pertinent
operational risk and control data, including, without limitation,
incidents, audit findings, compliance testing results, and risk
metrics, to support an overall assessment of the applicable Clearing
Agency Business' or Clearing Agency Support Area's inherent risk and
residual risk. The Clearing Agencies are proposing changes to this
Section to clarify and simplify the description of Risk Profiles.
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    \15\ The parent company of the Clearing Agencies is The
Depository Trust & Clearing Corporation (``DTCC''). DTCC operates on
a shared services model with respect to the Clearing Agencies. Most
corporate functions are established and managed on an enterprise-
wide basis pursuant to intercompany agreements under which it is
generally DTCC that provides a relevant service to a Clearing
Agency.
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    First, the proposed changes would clarify that the assessments
documented in Risk Profiles both (1) assess inherent risks, and (2)
identify residual risks. The proposed changes would do this by revising
the relevant sentence and by removing the current description of risk
acceptance of residual risks, which is a process that is separate from
the description of Risk Profiles. The proposed changes would focus the
description on the two types of risks that are relevant to the Risk
Profiles.
    Second, the proposed change would simplify the description of how
the Risk Profiles are created by removing reference to ORM as the
responsible group. Currently, both ORM and the Clearing Agency business
and support areas are jointly responsible for the tasks related to
creating and documenting Risk Profiles. Over time, the responsibility
for these tasks has shifted away from ORM, and to the Clearing Agency
business and support areas. The proposed changes would continue to
identify the crucial tasks related to the creation and maintenance of
Risk Profiles but would simplify this section of the Framework by
removing reference to the division of responsibilities among these
groups.
    Third, the proposed changes would clarify that Clearing Agency
businesses and support areas are responsible for the day-to-day
management of all risk applicable to their area. Currently, Section 4.2
states that these groups are only responsible for the management of
residual risks. The proposed change

would correct this statement and clarify these groups'
responsibilities.
    Finally, the proposed changes would clarify that the Clearing
Agency businesses and support areas are responsible for updating their
policies and procedures to support risk management at the Clearing
Agencies. Currently, the relevant sentence in Section 4.2 states that
such policies and procedures support operational risk management at the
Clearing Agencies. The proposed change would clarify the
responsibilities of these groups and the role of policies and
procedures in risk management.
3. Proposed Change To Clarify the Responsibilities of the ORM Group
    Section 4.3 of the ORM Framework describes the responsibilities of
ORM. Currently, this Section states that this group is responsible for
reviewing, revising and creating Risk Tolerance Statements. However,
ORM is responsible for working with the businesses that own the
relevant risks in reviewing, revising and creating Risk Tolerance
Statements. Therefore, the proposed changes would clarify ORM's
responsibilities with respect to Risk Tolerance Statements.
4. Proposed Changes To Clarify Description of Business Continuity Risk
Management
    Section 6 of the ORM Framework describes how the Clearing Agencies
manage business continuity risks. The Clearing Agencies are proposing
changes to this section to clarify the description of business
continuity risk management and to make this section more comprehensive.
    First, the proposed changes would include a reference to events
that have the potential to disrupt the Clearing Agencies' businesses in
a statement that refers generally to the types of events that could
impact the Clearing Agencies. This update would make the statement more
comprehensive by including events that are considered ``near-miss''
events, or events that did not have had an impact on the Clearing
Agencies but had the potential of causing an impact on their
businesses. This proposed change would align the description to current
practice, by which the Clearing Agencies take into account ``near-
miss'' events in its risk management processes.
    Second, the proposed changes would update the description of the
``tiers'' that are used to rank the criticality of the Clearing
Agencies' businesses and support areas. The proposed changes would not
impact the way these tiered rankings are applied and would align the
description in the Framework to the current description in the Clearing
Agencies' internal procedures. Among the updates to the description of
the tiers, the proposed changes would include a clarifying statement
that the Clearing Agencies' support areas are automatically assigned
the same tier as the Clearing Agency business that they support, and
would remove references to the Clearing Agency support areas in the
description of the process that results in a group's tier.
    Finally, the proposed changes to Section 6 would clarify statements
in connection with the creation of business impact analyses (``BIA''),
which are used to assign each Clearing Agency business with a tier. The
proposed changes would clarify, for example, that appropriate risk
controls may be applied with respect to an applicable Clearing Agency
business at any time, and not only during a business continuity event.
The proposed changes would also clarify that the BIA identify product
dependencies within an applicable Clearing Agency business. While the
process for creating BIA has not changed, the proposed changes to
Section 6 of the Framework would enhance the description of the process
by making it clearer and more comprehensive.
2. Statutory Basis
    The Clearing Agencies believe that the proposed changes are
consistent with Section 17A(b)(3)(F) of the Act \16\ and Rule 17Ad-
22(e)(3)(i), and (17)(i) and (ii) promulgated under the Act,\17\ for
the reasons described below.
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    \16\ 15 U.S.C. 78q-1(b)(3)(F).
    \17\ 17 CFR 240.17Ad-22(e)(17)(i) and (ii).
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    The Clearing Agencies believe that the proposed changes are
consistent with Section 17A(b)(3)(F) of the Act, which requires, in
part, that the rules of a registered clearing agency be designed to
promote the prompt and accurate clearance and settlement of securities
transactions, and to assure the safeguarding of securities and funds
which are in the custody or control of the clearing agency or for which
it is responsible, for the reasons described below.\18\ The proposed
changes would update and clarify the Framework and would make it more
comprehensive in how it describes operational risk management of the
Clearing Agencies, as described above. By creating clearer, updated and
more comprehensive descriptions, the Clearing Agencies believe the
proposed changes would make the ORM Framework more effective in
providing an overview of the important risk management activities
described therein.
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    \18\ 15 U.S.C. 78q-1(b)(3)(F).
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    As described in the Initial Filing, the risk management functions
described in the ORM Framework allow the Clearing Agencies to continue
the prompt and accurate clearance and settlement of securities and can
continue to assure the safeguarding of securities and funds which are
in their custody or control or for which they are responsible
notwithstanding the default of a member of an affiliated family. The
proposed changes to improve the clarity and accuracy of the
descriptions of these functions within the ORM Framework would assist
the Clearing Agencies in carrying out these risk management functions.
Therefore, the Clearing Agencies believe the proposed changes are
consistent with the requirements of Section 17A(b)(3)(F) of the
Act.\19\
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    \19\ Id.
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    Rule 17Ad-22(e)(3)(i) under the Act requires, in part, that each
covered clearing agency establish, implement, maintain and enforce
written policies and procedures reasonably designed to maintain a sound
risk management framework for comprehensively managing operational
risks that arise in or are borne by the covered clearing agency, which
includes risk management policies, procedures, and systems that are
subject to review on a specified periodic basis and approved by the
board of directors annually.\20\ As described above, the Framework is
currently approved by the Board annually, in compliance with the
requirements of Rule 17Ad-22(e)(3)(i). The proposed changes would
describe this annual approval in Section 2 of the Framework, where the
Framework's ownership and change management is addressed. By including
a description of the required annual Board approval of the Framework,
the proposed changes are consistent with the requirements of Rule 17Ad-
22(e)(3)(i) under the Act.\21\
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    \20\ 17 CFR 240.17Ad-22(e)(3)(i).
    \21\ Id.
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    Rule 17Ad-22(e)(17) under the Act requires, in part, that each
covered clearing agency establish, implement, maintain and enforce
written policies and procedures reasonably designed to manage the
covered clearing agency's operational risks by (i) identifying the
plausible sources of operational risk, both internal and external, and
mitigating their impact through the use of appropriate systems,
policies, procedures, and controls; and (ii) ensuring that systems have
a high degree of security, resiliency,

operational reliability, and adequate, scalable capacity.\22\
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    \22\ 17 CFR 240.17Ad-22(e)(17)(i) and (ii).
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    The Framework would be amended to include a description of the
Clearing Agencies' incident management procedures. As described above,
these procedures address how the Clearing Agencies detect, identify,
investigate and resolve incidents that affect the Clearing Agencies'
systems. These procedures are designed to help address the Clearing
Agencies' compliance with the requirements of Rule 17Ad-22(e)(17)(i)
and (ii).\23\ Therefore, the Clearing Agencies believe that the
proposed rule changes to include a description of these procedures in
the Risk Management Framework is consistent with Rule 17Ad-22(e)(17)(i)
and (ii).\24\
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    \23\ Id.
    \24\ Id.
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(B) Clearing Agencies' Statement on Burden on Competition

    The Clearing Agencies do not believe that the proposed changes to
the ORM Framework described above would have any impact, or impose any
burden, on competition. As described above, the proposed rule changes
would update the Framework and would improve the clarity and
comprehensiveness of the descriptions of certain matters within the
Framework. Therefore, the proposed changes are technical and non-
material in nature, relating mostly to the operation of the ORM
Framework rather than the risk management functions described therein.
As such, the Clearing Agencies do not believe that the proposed rule
changes would have any impact on competition.

(C) Clearing Agencies' Statement on Comments on the Proposed Rule
Changes Received From Members, Participants, or Others

    The Clearing Agencies have not solicited or received any written
comments relating to this proposal. The Clearing Agencies will notify
the Commission of any written comments received by the Clearing
Agencies.

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

    The foregoing rule changes have become effective pursuant to
Section 19(b)(3)(A) \25\ of the Act and paragraph (f) \26\ of Rule 19b-
4 thereunder. At any time within 60 days of the filing of the proposed
rule changes, the Commission summarily may temporarily suspend such
rule changes 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.
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    \25\ 15 U.S.C 78s(b)(3)(A).
    \26\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
changes are consistent with the Act. Comments may be submitted by any
of the following methods:

Electronic Comments

     Use the Commission's internet comment form
    (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-DTC-2020-015, SR-FICC-2020-016, or SR-NSCC-2020-019 on
the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549.

All submissions should refer to File Number SR-DTC-2020-015, SR-FICC-
2020-016, or SR-NSCC-2020-019. This file number should be included on
the subject line if email is used. To help the Commission process and
review your comments more efficiently, please use only one method. The
Commission will post all comments on the Commission's internet website
(http://www.sec.gov/rules/sro.shtml). Copies of the submission, all
subsequent amendments, all written statements with respect to the
proposed rule changes that are filed with the Commission, and all
written communications relating to the proposed rule changes between
the Commission and any person, other than those that may be withheld
from the public in accordance with the provisions of 5 U.S.C. 552, will
be available for website viewing and printing in the Commission's
Public Reference Room, 100 F Street NE, Washington, DC 20549 on
official business days between the hours of 10:00 a.m. and 3:00 p.m.
Copies of the filing also will be available for inspection and copying
at the principal office of the Clearing Agencies and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-DTC-2020-015, SR-FICC-2020-016, or SR-
NSCC-2020-019 and should be submitted on or before January 6, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
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    \27\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-27596 Filed 12-15-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35782-35783]
[FR Doc No: 2016-13169]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Pharmacy Compounding Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pharmacy Compounding Advisory
Committee. The general function of the committee is to provide advice
on scientific, technical, and medical issues concerning drug
compounding under sections 503A and 503B of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), and, as required, any other product for which
FDA has regulatory responsibility, and make appropriate recommendations
to the Agency. The meeting will be open to the public.

DATES: The meeting will be held on June 23, 2016, from 8:30 a.m. to 5
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring,

MD 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line, 1-800-
741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes
the conditions that must be satisfied for human drug products
compounded by a licensed pharmacist or licensed physician to be exempt
from the following three sections of the FD&C Act: (1) Section
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good
manufacturing practice (CGMP)); (2) section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning the labeling of drugs with adequate directions
for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval
of human drug products under new drug applications (NDAs) or
abbreviated new drug applications (ANDAs)).
    One of the conditions that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that a bulk drug
substance (active pharmaceutical ingredient) used in a compounded drug
product must meet one of the following criteria: (1) Complies with the
standards of an applicable United States Pharmacopoeia (USP) or
National Formulary monograph, if a monograph exists, and the USP
chapter on pharmacy compounding; (2) if an applicable monograph does
not exist, is a component of a drug approved by the Secretary of Health
and Human Services (the Secretary); or (3) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, appears on a list (the ``section 503A bulk drug
substances list'') developed by the Secretary through regulations
issued by the Secretary (see section 503A(b)(1)(A)(i) of the FD&C Act).
    FDA will discuss with the committee drugs proposed for inclusion on
the section 503A bulk drug substances list.
    Agenda: The committee intends to discuss six bulk drug substances
nominated for inclusion on the section 503A bulk drug substances list.
FDA intends to discuss the following nominated bulk drug substances:
Chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea
tree oil, and 2,3-Dimercapto-1-propanesulfonic acid (DMPS). The
nominators of these substances will be invited to make a short
presentation supporting the nomination. During the afternoon session,
the committee will receive updates on certain issues to follow up on
discussions from previous meetings, including the option for obtaining
access to investigational new drugs under expanded access.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
15, 2016. Oral presentations from the public will be scheduled between
approximately 9:30 a.m. and 9:40 a.m., 10:35 a.m. and 10:45 a.m., 11:40
a.m. and 11:50 a.m., 2:15 p.m. and 2:25 p.m., 3:20 p.m. and 3:30 p.m.,
and 4:40 p.m. and 4:50 p.m. Those individuals interested in making
formal oral presentations should notify Cindy Hong and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before June 10, 2016. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by June 13,
2016.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Cindy Hong at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13169 Filed 6-2-16; 8:45 am]
 BILLING CODE 4164-01-P


                            316(b) CONFERENCE CALL                      June 19, 2012 / 3:00  -  4:00 PM EDT                                  Draft Summary

PARTICIPANTS:

States:			                    Alabama Arizona Delaware Florida Illinois Indiana Kansas Louisiana Michigan Mississippi Nebraska New Jersey New York North Carolina Oklahoma Rhode Island South Carolina Texas Utah Virginia Wisconsin

EPA Headquarters: Rob Wood (EPA OST) Paul Shriner (EPA OST) Wendy Hoffman (EPA OST) Tom Born (EPA OST) Julie Hewitt (EPA OST) Richard Witt (EPA OGC)

EPA Regions: 1	Sharon Demeo

Other Stakeholders: Susan Kirsch (ACWA) 	 Tetra Tech: Kelly Meadows

INTRODUCTION

Susan Kirsch (ACWA) brought the meeting to order and conducted the roll call.  Ms. Kirsch stated that the purpose of the call was to provide EPA with an opportunity to summarize the content of two recently published Notices of Data Availability (NODAs) and to encourage discussion between the states and EPA.  ACWA also facilitated a follow-up discussion with the states in order to prepare a letter of comment on the notices.

DISCUSSION

EPA Presentation on the NODAs

Rob Wood (EPA OST) provided a brief summary of the two NODAs and the public comment periods for each.  He then turned to Paul Shriner and Julie Hewitt (both EPA OST) to present a more detailed summary of the two NODAs.

Mr. Shriner stated that a lot of commenters had submitted impingement data during the comment period for the proposed rule.  The first NODA summarizes that data and also lays out a number of potential revisions to the proposed rule that would enable more flexibility for complying with the final rule, while still maintaining uniform national standards.  Each of these potential alternatives is intended to achieve the same level of performance as the best technology available (BTA) option presented in the proposed rule.  The first NODA does not introduce any new information on addressing entrainment.

Specifically, the elements in the first NODA are:

   * Facilities with closed-cycle recirculating cooling systems (CCRSs) would be deemed to meet impingement mortality (IM) standards.  EPA did not intend for facilities to be required to install CCRSs solely to meet IM standards.  Additionally, the NODA attempts to develop a mechanism to give appropriate "credit" for all forms of flow reduction.    * Intake velocity standards may be refined, as EPA examines how to measure compliance and considers eliminating the requirements related to maximum screen blockage.  Additionally, EPA noted the distinction between a velocity cap (a specific technology) and low intake velocity (a compliance alternative); these are not the same and EPA continues to examine data on the performance of velocity caps in reducing IM.    * EPA continues to analyze the IM data used in developing national IM limits.  As noted, EPA received a large number of new studies (many of which did not provide IM data) and is also considering revising its acceptance criteria for the data.  Other aspects under consideration include the treatment of fragile species and species of concern, credit for existing technologies, facilities with extremely low impingement rates, and eliminating the requirement for barrier nets.

Ms. Hewitt then discussed the second NODA, which focuses on the results of EPA's stated preference survey.  She noted that there are several important documents that provide additional details on the survey and analysis of the data collected, each of which are in the docket for the NODAs and on EPA's website.

Most of the benefits discussed in the proposed rule were derived through revealed preference methods that monetized losses of commercial and recreational fish.  Commercial and recreational fish represent a very small portion of the fish impinged and entrained at most facilities.  As a result, EPA designed and fielded a stated preference survey (also known as a willingness to pay survey) to determine a value for the other portion of fish losses (e.g., forage fish).  A survey was developed for 4 regions (covering the entire continental U.S.), as well as one national-level survey, where respondents were presented with a series of questions and choices to elicit their values for fish protection.  EPA has presented preliminary results of the survey data in the second NODA; EPA is still considering how it will present the results in the final rule.  EPA continues to conduct further analyses to verify the statistical significance of the data and will also be conducting an external peer review of the entire survey and analysis.  EPA does not expect to publish another NODA once these ongoing analyses are complete, but the Agency is accepting comments on the approach for analyzing the survey data during the current comment period.

Mr. Wood stated that the first NODA provides a large volume of new data and additional flexibility.  He noted that EPA is also considering an option where IM is addressed on a site-specific basis, similar to the proposed approach for entrainment.  He noted, however, that this approach would place a substantial burden on the states.  Mr. Wood also stated that, although the results presented in the second NODA are preliminary, EPA is confident that they will be found to be accurate.  As a broad conclusion, EPA can infer that households are willing to pay a measurable amount to prevent fish from being killed at intake structures.

Questions and Answers

A participant asked if the stated preference survey was available online.  Ms. Hewitt stated that it is, but added that it is part of the docket for the Information Collection Request (ICR) for the survey and may be difficult to locate.  She noted that EPA will post or link the survey in a more prominent location.

Sue Rosenwinkle (New Jersey) stated that they were pleased to learn that the barrier net requirement would be removed.  Mr. Shriner stated that, previously, EPA did not have any data documenting the survival of shellfish on modified Ristroph screens.  As a result, EPA included the barrier net requirement.  However, additional data has been collected and added to the pool of data used to calculate the IM limits, allowing the barrier net requirement to be eliminated.

Ms. Kirsch asked if the IM limits had been recalculated in the NODA.  Mr. Shriner stated that they had not, but EPA welcomes any comments on the Agency's assumptions and methodology, which will ultimately play a large role in calculating the limit for the final rule.  He noted that he can't speculate as to whether the limit will go up or down.  Ms. Kirsch asked if the data received was more geographically diverse than the data used to calculate the IM limit for the proposed rule.  Mr. Shriner stated that it was, and that EPA's consideration of revisions to the acceptance criteria may also reintroduce data that had been excluded from the limit derivation in the proposed rule.

John DeFriece (Delaware) asked if entrainment would still be addressed on a best professional judgment (BPJ) basis.  Mr. Shriner stated that the NODA does not change that approach, but the issue is undecided for the final rule.  Ms. Hewitt added that Directors can consider costs and benefits in determining appropriate requirements for entrainment, and the results from the stated preference survey may facilitate a localized analysis of benefits.

Sharon Demeo (EPA Region 1) asked what time scale the willingness to pay values were based on.  Ms. Hewitt responded that the data presented in the NODA was on both a monthly and annual basis.  The range of values was $0.75 to $2.52 per percentage point increase in age-1 equivalents saved, per year, per household.

Ms. Rosenwinkle asked if a closed-cycle cooling option was being considered.  She also asked if CCRSs were a preapproved option for IM.  Mr. Shriner responded that closed-cycle systems are not preapproved for IM in the proposed rule or in the considerations presented in the NODA, but EPA recognizes that the flow reduction achieved by closed-cycle systems will generally meet the IM requirements.

A participant from Virginia asked about EPA's schedule for the rulemaking.  Richard Witt (EPA OGC) responded that EPA intends to fulfill its consent decree.  Mr. Wood added that EPA recognizes that the schedule is very tight, as the comment periods for the NODAs end in mid-July.  Mr. Witt stated that EPA has contacted the other parties in the consent decree and EPA will proceed accordingly.

There were no further questions for EPA.  ACWA and the states proceeded to have a discussion amongst themselves regarding comments on the NODAs.


Home / Trade and Development / Preference Programs / CBI

Caribbean Basin Initiative

The trade programs known collectively as the Caribbean Basin Initiative
(CBI) remain a vital element in the United States’ economic relations
with its neighbors in Central America and the Caribbean. The CBI is
intended to facilitate the economic development and export
diversification of the Caribbean Basin economies. Initially launched in
1983 through the Caribbean Basin Economic Recovery Act (CBERA), and
substantially expanded in 2000 through the U.S.-Caribbean Basin Trade
Partnership Act (CBTPA), the CBI currently provides 19 beneficiary
countries with duty-free access to the U.S. market for most goods.

CBTPA entered into force on October 1, 2000 and continues in effect
until September 30, 2008 or the date, if sooner, on which the FTAA or
another free trade agreement as described in legislation enters into
force between the United States and a CBTPA beneficiary country.

There are currently nineteen countries that benefit from the CBI program
and, therefore, may potentially benefit from CBTPA. These countries are:
Antigua and Barbuda, Aruba, Bahamas, Barbados, Belize, British Virgin
Islands, Costa Rica, Dominica, Grenada, Guyana, Haiti, Jamaica,
Montserrat, Netherlands Antilles,Panama, St. Kitts and Nevis, St. Lucia,
St. Vincent and the Grenadines, Trinidad and Tobago.

Website:
http://www.ustr.gov/Trade_Development/Preference_Programs/CBI/Section_In
dex.html


[Federal Register Volume 85, Number 12 (Friday, January 17, 2020)]
[Notices]
[Pages 3053-3057]
[FR Doc No: 2020-00729]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0578]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General Licensing
Provisions: Biologics License Application, Changes to an Approved
Application, Labeling, Revocation and Suspension, Postmarketing Studies
Status Reports, and Form FDA 356h

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
February 18, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0338.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

General Licensing Provisions: Biologics License Application, Changes to
an Approved Application, Labeling, Revocation and Suspension,
Postmarketing Studies Status Reports, and Form FDA 356h

OMB Control Number 0910-0338--Extension

    Under section 351 of the Public Health Services Act (42 U.S.C.
262), manufacturers of biological products must submit a license
application for FDA review and approval before marketing a biological
product in interstate commerce. Licenses may be issued only upon
showing that the establishment and the products for which a license is
desired meets standards prescribed in regulations designed to ensure
the continued safety, purity, and potency of such products. All such
licenses are issued, suspended, and revoked as prescribed by
regulations in part 601 (21 CFR part 601).
    Section 130(a) of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) by adding a new provision (section 506B of the
FD&C Act (21 U.S.C. 356b)) requiring reports of postmarketing studies
for approved human drugs and licensed biological products. Section 506B
of the FD&C Act provides FDA with additional authority to monitor the
progress of postmarketing studies that applicants have made a
commitment to conduct and requires the Agency to make publicly
available information that pertains to the status of these studies.
Under section 506B(a) of the FD&C Act, applicants that have committed
to conduct a postmarketing study for an approved human drug or licensed
biological product must submit to FDA a status report of the progress
of the study or the reasons for the failure of the applicant to conduct
the study. This report must be submitted within 1 year after the U.S.
approval of the application and then annually until the study is
completed or terminated.
    A summary of the collection of information requirements follows:
    Section 601.2(a) (21 CFR 601.2(a)) requires a manufacturer of a
biological product to submit an application on forms prescribed for
such purposes with accompanying data and information, including certain
labeling information, to FDA for approval to market a product in
interstate commerce. The container and package labeling requirements
are provided under Sec. Sec.  610.60 through 610.65 (21 CFR 610.60
through 610.65). The estimate for these regulations is

included in the estimate under Sec.  601.2(a) in table 1.
    Section 601.5(a) (21 CFR 601.5(a)) requires a manufacturer to
submit to FDA notice of its intention to discontinue manufacture of a
product or all products. Section 601.6(a) (21 CFR 601.6(a) requires the
manufacturer to notify selling agents and distributors upon suspension
of its license, and provide FDA of such notification.
    Section 601.12(a)(2) (21 CFR 601.12((a)(2)) requires, generally,
that the holder of an approved biologics license application (BLA) must
assess the effects of a manufacturing change before distributing a
biological product made with the change. Section 601.12(a)(4) requires,
generally, that the applicant must promptly revise all promotional
labeling and advertising to make it consistent with any labeling
changes implemented. Section 601.12(a)(5) requires the applicant to
include a list of all changes contained in the supplement or annual
report; for supplements, this list must be provided in the cover
letter. The burden estimates for Sec.  601.12(a)(2) are included in the
estimates for supplements (Sec. Sec.  601.12(b) and (c)) and annual
reports (Sec.  601.12(d)). The burden estimates for Sec.  601.12(a)(4)
are included in the estimates under 601.12(f)(4) in table 1.
    Sections 601.12(b)(1) and (3), (c)(1), (3), and (5), and (d)(1) and
(3) require applicants to follow specific procedures to submit
information to FDA of any changes, in the product, production process,
quality controls, equipment, facilities, or responsible personnel
established in an approved license application. The appropriate
procedure depends on the potential for the change to have a
substantial, moderate, or minimal adverse effect on the identity,
strength, quality, purity, or potency of the products as they may
relate to the safety or effectiveness of the product. Under Sec.
601.12(b)(4), an applicant may ask FDA to expedite its review of a
supplement for public health reasons or if a delay in making the change
described in it would impose an extraordinary hardship of the
applicant. The burden estimate for Sec.  601.12(b)(4) is minimal and
included in the estimate under Sec.  601.12(b)(1) and (3) in table 1.
    Section 601.12(e) requires applicants to submit a protocol, or
change to a protocol, as a supplement requiring FDA approval before
distributing the product. Section 601.12(f)(1) through (3) requires
applicants to follow specific procedures to report certain labeling
changes to FDA. Section 601.12(f)(4) requires applicants to report to
FDA advertising and promotional labeling and any changes.
    Under Sec.  601.14 (21 CFR 601.14), the content of labeling
required in 21 CFR 201.100(d)(3) must be in electronic format and in a
form that FDA can process, review, and archive. This requirement is in
addition to the provisions of Sec. Sec.  601.2(a) and 601.12(f). The
burden estimate for Sec.  601.14 is minimal and included in the
estimate under Sec. Sec.  601.2(a) (BLAs) and 601.12(f)(1) through (3)
(labeling supplements and annual reports) in table 1.
    Section 601.45 (21 CFR 601.45) requires applicants of biological
products for serious or life-threatening illnesses to submit to the
Agency for consideration, during the preapproval review period, copies
of all promotional materials, including promotional labeling as well as
advertisements.
    In addition to Sec. Sec.  601.2 and 601.12, there are other
regulations in 21 CFR parts 640, 660, and 680 that relate to
information to be submitted in a license application or supplement for
certain blood or allergenic products as follows: Sec. Sec.  640.6,
640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c), 640.64(c),
640.74(a) and (b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) and (d) (21
CFR 640.6, 640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c),
640.64(c), 640.74(a) and (b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) and
(d)).
    In table 1, the burden associated with the information collection
requirements in the applicable regulations is included in the burden
estimate for Sec. Sec.  601.2 and/or 601.12. A regulation may be listed
under more than one paragraph of Sec.  601.12 due to the type of
category under which a change to an approved application may be
submitted.
    There are also additional container and/or package labeling
requirements for certain licensed biological products including: Sec.
640.74(b)(3) and (4) for Source Plasma Liquid; Sec.  640.84(a) and (c)
(21 CFR 640.84(a) and (c)) for Albumin; Sec.  640.94(a) (21 CFR
640.94(a)) for Plasma Protein Fraction; Sec.  660.2(c) (21 CFR
660.2(c)) for Antibody to Hepatitis B Surface Antigen; Sec.  660.28(a)
through (c) (21 CFR 660.28(a) through (c)) for Blood Grouping Reagent;
Sec.  660.35(a) through (d) (21 CFR 660.35(a) through (d)) for Reagent
Red Blood Cells; Sec.  660.45 (21 CFR 660.45) for Hepatitis B Surface
Antigen; and Sec.  660.55(a) and (b) (21 CFR 660.55(a) and (b)) for
Anti-Human Globulin. The burden associated with the additional labeling
requirements for submission of a license application for these certain
biological products is minimal because the majority of the burden is
associated with the requirements under Sec. Sec.  610.60 through 610.65
or Sec.  809.10 (21 CFR 809.10). Therefore, the burden estimates for
these regulations are included in the estimate under Sec. Sec.  610.60
through 610.65 in table 1. The burden estimates associated with Sec.
809.10 are approved under OMB control number 0910-0485.
    Section 601.27(a) (21 CFR 601.27(a)) requires that applications for
new biological products contain data that are adequate to assess the
safety and effectiveness of the biological product for the claimed
indications in pediatric subpopulations, and to support dosing and
administration information. Section 601.27(b) provides that an
applicant may request a deferred submission of some or all assessments
of safety and effectiveness required under Sec.  601.27(a) until after
licensing the product for use in adults. Section 601.27(c) provides
that an applicant may request a full or partial waiver of the
requirements under Sec.  601.27(a) with adequate justification. The
burden estimates for Sec.  601.27(a) are included in the burden
estimate under Sec.  601.2(a) in table 1 because these regulations deal
with information to be provided in an application.
    Section 601.28 (21 CFR 601.28) requires sponsors of licensed
biological products to submit the information in Sec.  601.28(a)
through (c) to the Center for Biologics Evaluation and Research (CBER)
or to the Center for Drug Evaluation and Research (CDER) each year,
within 60 days of the anniversary date of approval of the license.
Section 601.28(a) requires sponsors to submit to FDA a brief summary
stating whether labeling supplements for pediatric use have been
submitted and whether new studies in the pediatric population to
support appropriate labeling for the pediatric population have been
initiated. Section 601.28(b) requires sponsors to submit to FDA an
analysis of available safety and efficacy data in the pediatric
population and changes proposed in the labeling based on this
information. Section 601.28(c) requires sponsors to submit to FDA a
statement on the current status of any postmarketing studies in the
pediatric population performed by, on or behalf of, the applicant. If
the postmarketing studies were required or agreed to, the status of
these studies is to be reported under Sec.  601.70 (21 CFR 601.70)
rather than under this section.
    Sections 601.33 through 601.35 (21 CFR 601.33 through 601.35)
clarify the information to be submitted in an application to FDA to
evaluate the safety and effectiveness of radiopharmaceuticals intended
for in vivo administration for diagnostic and monitoring use. The
burden estimates for Sec. Sec.  601.33 through 601.35 are included in
the burden estimate under

Sec.  601.2(a) in table 1 because these regulations deal with
information to be provided in an application.
    Section 601.70(b) requires each applicant of a licensed biological
product to submit annually a report to FDA on the status of
postmarketing studies for each approved product application. Each
annual postmarketing status report must be accompanied by a completed
transmittal Form FDA 2252 (Form FDA 2252 approved under OMB control
number 0910-0001). Under Sec.  601.70(d), two copies of the annual
report shall be submitted to FDA.
    Sections 601.91 through 601.94 (21 CFR 601.91 through 601.94)
concern biological products for which human efficacy studies are not
ethical or feasible. Section 601.91(b)(2) requires, in certain
circumstances, such postmarking restrictions as are needed to ensure
the safe use of the biological product. Section 601.91(b)(3) requires
applicants to prepare and provide labeling with relevant information to
patients or potential patients for biological products approved under
part 601, subpart H, when human efficacy studies are not ethical or
feasible (or based on evidence of effectiveness from studies in
animals). Section 601.93 provides that biological products approved
under part 601, subpart H are subject to the postmarketing
recordkeeping and safety reporting applicable to all approved
biological products. Section 601.94 requires applicants under part 601,
subpart H to submit to the Agency for consideration during the
preapproval review period copies of all promotional materials including
promotional labeling as well as advertisements. Under Sec. Sec.
601.91(b)(2) and 601.93, any potential postmarketing reports and/or
recordkeeping burdens would be included under the adverse experience
reporting (AER) requirements under 21 CFR part 600 (OMB control number
0910-0308). Therefore, any burdens associated with these requirements
would be reported under the AER information collection requirements
(OMB control number 0910-0308). The burden estimate for Sec.
601.91(b)(3) is included in the estimate under Sec. Sec.  610.60
through 610.65.
    Section 610.9(a) (21 CFR 610.9(a)) requires the applicant to
present certain information, in the form of a license application or
supplement to the application, for a modification of any particular
test method or manufacturing process or the conditions under which it
is conducted under the biologics regulations. The burden estimate for
Sec.  610.9(a) is included in the estimate under Sec. Sec.  601.2(a)
and 601.12(b) and (c) in table 1.
    Under Sec.  610.15(d) (21 CFR 610.15(d)), the Director of CBER or
the Director of CDER may approve, as appropriate, a manufacturer's
request for exceptions or alternatives to the regulation for
constituent materials. Manufacturers seeking approval of an exception
or alternative must submit a request in writing with a brief statement
describing the basis for the request and the supporting data.
    Section 640.120 (21 CFR 640.120) requires licensed establishments
to submit a request for an exception or alternative to any requirement
in the biologics regulations regarding blood, blood components, or
blood products. For licensed establishments, a request for an exception
or alternative must be submitted in accordance with Sec.  601.12;
therefore, the burden estimate for Sec.  640.120 is included in the
estimate under Sec.  601.12(b) in table 1.
    Section 680.1(c) requires manufacturers to update annually their
license file with the list of source materials and the suppliers of the
materials. Section 680.1(b)(3)(iv) requires manufacturers to notify FDA
when certain diseases are detected in source materials.
    Sections 600.15(b) and 610.53(b) (21 CFR 600.15(b) and 610.53(b))
require the submission of a request for an exemption or modification
regarding the temperature requirements during shipment and from dating
periods, respectively, for certain biological products. Section
606.110(b) (21 CFR 606.110(b)) requires the submission of a request for
approval to perform plasmapheresis of donors who do not meet certain
donor requirements for the collection of plasma containing rare
antibodies. Under Sec. Sec.  600.15(b), 610.53(b), and 606.110(b), a
request for an exemption or modification to the requirements would be
submitted as a supplement. Therefore, the burden hours for any
submissions under Sec. Sec.  600.15(b), 610.53(d), and 606.110(b) are
included in the estimates under Sec.  601.12(b) in table 1.
    Form FDA 356h, ``Application to Market a New or Abbreviated New
Drug or Biologic for Human Use,'' is used for the applicable
submissions to both CBER and CDER. The application form serves
primarily as a checklist for firms to gather and submit certain
information to FDA and helps to ensure that the application is complete
and contains all the necessary information, so that delays due to lack
of information may be eliminated. In addition, the form provides key
information to FDA for efficient handling and distribution to the
appropriate staff for review. FDA estimates an average of 24 hours to
complete the application form, which is included in the average burden
per response. The estimated burden hours for nonbiological product
submissions to CDER using Form FDA 356h are approved under OMB control
number 0910-0001 (an estimated 16,650 submissions x 24 hours = 399,600
hours).
    For advertisements and promotional labeling (e.g., circulars,
package labels, container labels, etc.) and labeling changes,
manufacturers of licensed biological products may submit to CBER or
CDER Form FDA 2253. Form FDA 2253 can also be submitted electronically.
Form FDA 2253 is approved under OMB control number 0910-0001.
    Respondents to this collection of information are manufacturers of
biological products. Under table 1, the numbers of respondents are
based on the estimated annual number of manufacturers that submitted
the required information to FDA or the number of submissions FDA
received in fiscal year 2018. Based on information obtained from FDA's
database systems, there are an estimated 424 licensed biologics
manufacturers. The total annual responses are based on the estimated
number of submissions (i.e., license applications, labeling and other
supplements, protocols, advertising and promotional labeling,
notifications) for a particular product received annually by FDA. The
hours per response are based on information provided by industry and
past FDA experience with the various submissions or notifications. The
hours per response include the time estimated to prepare the various
submissions or notifications to FDA, and, as applicable, the time
required to fill out the appropriate form and collate the
documentation. Additional information regarding these estimates is
provided below as necessary.
    Under Sec. Sec.  601.2 and 601.12, the estimated hours per response
are based on the average number of hours to submit the various
submissions. The estimated average number of hours is based on the
range of hours to complete a very basic application or supplement and a
complex application or supplement.
    Under section 601.6(a), the total annual responses are based on FDA
estimates that establishments may notify an average of 20 selling
agents and distributors of such suspension, and provide FDA of such
notification. The number of respondents is based on the estimated
annual number of suspensions of a biologic license. In

table 1, FDA is estimating one in case a suspension occurs.
    Under Sec. Sec.  601.12(f)(4) and 601.45, manufacturers of
biological products may use Form FDA 2253 to submit advertising and
promotional labeling (which can include multiple pieces). Based on
information obtained from FDA's database system, the estimate is based
on the number of submissions received using Form FDA 2253 for
advertising and promotional labeling.
    Under Sec. Sec.  601.28 and 601.70(b), FDA estimates that it takes
an applicant approximately 24 hours (8 hours per study x 3 studies)
annually to gather, complete, and submit the appropriate information
for each postmarketing status report (approximately 2 to 4 studies per
report) and the accompanied transmittal Form FDA 2252. Included in
these 24 hours is the time necessary to prepare and submit two copies
of the annual progress report of postmarketing studies to FDA under
Sec.  601.70(d).
    Under Sec.  610.15(d), FDA has received no submissions since the
implementation of the final rule (``Revision of the Requirements for
Constituent Materials'') in April 2011 (76 FR 20513, April 13, 2011).
Therefore, FDA is estimating one respondent and one annual request to
account for a possible submission to CBER or CDER of a request for an
exception or alternative for constituent materials under Sec.
610.15(d).
    There were a total of 3,398 amendments to an unapproved application
or supplement and resubmissions submitted using Form FDA 356h.
    In the Federal Register of September 19, 2019 (84 FR 49310), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                                                           Total
             21 CFR section                Form FDA No.      Number of     responses per   Total annual       Average burden per response        hours
                                                            respondents     respondent       responses                                            \10\
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.2(a) ,\2\ 610.60 through 610.65 \3\.            356h              36            1.28              46  860................................     39,560
601.5(a)................................              NA               8            1.13               9  0.33 (20 minutes)..................          3
601.6(a)................................              NA               1               1               1  0.33 (20 minutes)..................          1
601.12(a)(5)............................              NA             430           4.158           1,788  1..................................      1,788
601.12(b)(1) and (3) and (e) \4\........        \2\ 356h             166           4.843             804  80.................................     64,320
601.12(c)(1) and (3) \5\................        \2\ 356h             149            4.58             682  50.................................     34,100
601.12(c)(5)............................        \2\ 356h               7            1.14               8  50.................................        400
601.12(d)(1) and (3) \6\ and (f)(3) \8\.        \2\ 356h             245           3.575             876  24.................................     21,024
601.12(f)(1) \7\........................            2253              65           3.169             206  40.................................      8,240
601.12(f)(2) \7\........................            2253              43            2.05              88  20.................................      1,760
601.12(f)(4)/601.45 \9\.................            2253             134          145.86          19,545  10.................................    195,450
601.27(b)...............................              NA              12            1.08              13  24.................................        312
601.27(c)...............................              NA               2               1               2  8..................................         16
601.70(b) and (d)/601.28................            2252              65           3.169             206  24.................................      4,944
610.15(d)...............................              NA               1               1               1  1..................................          1
680.1(c)................................              NA               9               1               9  2..................................         18
680.1(b)(3)(iv).........................              NA               1               1               1  2..................................          2
Amendments/Resubmissions................            356h             136          24.985           3,398  20.................................     67,960
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................  ..............  ..............  ..............  ..............  ...................................    439,899
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The reporting requirements under Sec.  Sec.   601.14, 601.27(a), 601.33, 601.34, 601.35, 610.9(a), 640.17, 640.25(c), 640.56(c), 640.74(b)(2),
  660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under Sec.   601.2(a).
\3\ The reporting requirements under Sec.  Sec.   601.93(b)(3), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a) through (c),
  660.35(a) through (d), 660.45, and 660.55(a) and (b) are included under Sec.  Sec.   610.60 through 610.65.
\4\ The reporting requirements under Sec.  Sec.   601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 610.53(b), 606.110(b), 640.6, 640.17, 640.21(c),
  640.22(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under Sec.   601.12(b).
\5\ The reporting requirements under Sec.  Sec.   601.12(a)(2), 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate
  under Sec.   601.12(c).
\6\ The reporting requirement under Sec.   601.12(a)(2) is included in the estimate under Sec.   601.12(d).
\7\ The reporting requirement under Sec.   601.14 is included in the estimate under Sec.   601.12(f)(1) and (2).
\8\ The reporting requirement under Sec.  Sec.   601.12(a)(4) and 601.14 is included in the estimate under Sec.   601.12(f)(3).
\9\ The reporting requirement under Sec.   601.94 is included in the estimate under Sec.   601.45.
\10\ The numbers in this column have been rounded to the nearest whole number.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
                21 CFR section                    Number of     disclosures per    Total annual       Average burden per disclosure      Total hours \2\
                                                 respondents       respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.6(a).....................................               1               20               20   0.33 (20 minutes)....................               7
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The number in this column has been rounded to the nearest whole number.

    Our estimated burden for the information collection reflects an
overall increase of 105,948 hours and a corresponding decrease of 2,671
responses. We attribute this adjustment in the total hours to an
increase in the number of submissions we have received under Sec. Sec.
601.12(b)(1) and (3), (e), and (f)(4), and 601.45 over the last

few years. We attribute the decrease in total annual responses to a
decrease in responses received under Sec. Sec.  601.12(a)(5) and
601.27(b) over the last few years.

    Dated: January 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00729 Filed 1-16-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)]
[Notices]
[Pages 43831-43832]
[FR Doc No: 2015-18047]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2015-3001]
RIN 2120-AA64

Notice of Relocation; Change of Physical Address for the Federal
Aviation Administration Southwest Regional Office

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) is publishing this
notice to announce that the physical address of the FAA Southwest
Regional Office, which is specified in airworthiness directives (ADs)
issued by the Rotorcraft Directorate, is changing due to a relocation.

DATES: This notice is effective July 23, 2015.

FOR FURTHER INFORMATION CONTACT: Jim Grigg, Manager, Safety Management
Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy., Fort Worth,
Texas 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA Southwest Regional Office is relocating from 2601 Meacham
Blvd., Fort Worth, Texas 76137, to 10101 Hillwood Parkway, Fort Worth,
Texas 76177. The Office of the Regional Counsel and the Rotorcraft
Directorate are located in the FAA Southwest Regional Office. Service
information related to ADs that cannot be placed in the AD docket is
made reasonably available for review in the Office of the Regional
Counsel. Rotorcraft Directorate personnel provide further information
about ADs and approve AMOCs for ADs. The Office of the Regional Counsel
is relocating effective July 20, 2015. The Rotorcraft Directorate is
relocating effective July 27, 2015.

Conclusion

    Effective July 20, 2015, you may review service information related
to ADs issued by the Rotorcraft Directorate at the FAA, Office of the
Regional Counsel, 10101 Hillwood Pkwy., Fort Worth, Texas 76177.
    Effective July 27, 2015, mail correspondence regarding additional
information about ADs issued by the Rotorcraft Directorate to: Safety
Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy.,
Fort Worth, TX 76177.

    Issued in Fort Worth, Texas, on July 17, 2015.
Bruce E. Cain,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2015-18047 Filed 7-22-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Notices]
[Page 18901]
[FR Doc No: 2014-07496]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL13-62-000]

Independent Power Producers of New York, Inc. v. New York
Independent System Operator, Inc.; Notice of Amendment to Complaint

    Take notice that on March 25, 2014, Independent Power Producers of
New York, Inc. (IPPNY or Complainant) filed an amendment to its May 10,
2013, Complaint against New York Independent System Operator, Inc.
(NYISO or Respondent).
    IPPNY certifies that copies of the complaint were served on the
contacts of NYISO as listed on the Commission's list of Corporate
Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 14, 2014.

    Dated: March 28, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-07496 Filed 4-3-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72661-72663]
[FR Doc No: 2016-25384]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0353]

Qualification of Drivers; Exemption Applications; Implantable
Cardioverter Defibrillators

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

ACTION: Notice of applications for exemption; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from three individuals
for exemptions from the rules prohibiting operation of a commercial
motor vehicle (CMV) by persons with a current clinical diagnosis of
myocardial infarction, angina pectoris, coronary insufficiency,
thrombosis, or any other cardiovascular disease of a variety known to
be accompanied by syncope, dyspnea, collapse, or congestive heart
failure. If granted, the exemptions would enable these individuals to
operate CMVs for up to two years in interstate commerce.

DATES: Comments must be received on or before November 21, 2016.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2016-0353 using any of the
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE.,

Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket ID for this Notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov, at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-
113,Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5
p.m., e.t., Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations (FMCSRs) for a two-
year period if it finds ``such exemption would likely achieve a level
of safety that is equivalent to or greater than the level that would be
achieved absent such exemption.'' The statute also allows the Agency to
renew exemptions at the end of the two-year period. The three
individuals listed in this notice have requested an exemption from 49
CFR 391.41(b)(4), which applies to drivers who operates CMVs in
interstate commerce. Accordingly, the Agency will evaluate the
qualifications of each applicant to determine whether granting the
exemption will achieve the required level of safety mandated by
statute.
    The physical qualification standard found in 49 CFR 391.41(b)(4)
states that a person is physically qualified to drive a CMV if that
person

Has no current clinical diagnosis of myocardial infarction, angina
pectoris, coronary insufficiency, thrombosis, or any other
cardiovascular disease of a variety known to be accompanied by
syncope, dyspnea, collapse, or congestive cardiac failure.

    In addition to the regulations, FMCSA has published advisory
criteria\1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section D. Cardiovascular: Sec.  391.41(b)(4),
paragraph 4.] The advisory criteria states that ICDs are disqualifying
due to risk of syncope.
---------------------------------------------------------------------------

    \1\ See http://www.ecfr.gov/cgi-bin/text-idx?SID=e47b48a9ea42dd67d999246e23d97970&mc=true&node=pt49.5.391&rgn=div5#ap49.5.391_171.a and https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

Qualifications of Applicants

Gary Fancher

    Mr. Fancher is a 73 year old Class A CDL holder in Arkansas. A May
2016 cardiologist report indicates that Mr. Fancher's biventricular ICD
was implanted in December 2015 and ``since then he has done great
making remarkable progress''. ``His EF (ejection fraction) has nearly
normalized with optimal medication therapy and bi-V ICD optimization to
currently 45%.'' ``Patient denies syncope, pre-syncope, chest pain,
shortness of breath.'' ``His exercise capability has been totally
normalized.''

Henry McGuire

    Mr. McGuire is a 61 year old Class A CDL holder in Washington
State. An April 2016 report from Mr. McGuire's cardiologist indicates
that his ICD was implanted in 2001 and ``since following him (Mr.
McGuire) believes since implant he has never had a shock or ATP
therapy''. Mr. McGuire received an intrastate medical waiver by the
State of Washington that expires in April 2017.

Matthew Wilson

    Mr. Wilson is a 37 year old commercial motor vehicle driver in
Florida. An August 2016 letter from his cardiologist indicates that Mr.
Wilson's ICD was implanted in June 2014 and that '' this ICD device has
never deployed and was implanted as a precautionary due to Mr. Wilson's
past history''. Mr. Wilson is currently stable from heart failure
standpoint''.

II. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the date section
of the notice.

III. Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket number ``FMCSA-2016-0353'' and
click the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and materials received during the
comment period. FMCSA may issue a final determination any time after
the close of the comment period.

IV. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, go to http://www.regulations.gov and in the search box insert
the docket number FMCSA-2016-0175 and click ``Search.'' Next, click
``Open Docket Folder'' and you will find all documents and comments
related to this notice.

    Issued on: October 12, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-25384 Filed 10-19-16; 8:45 am]
 BILLING CODE 4910-EX-P