[Federal Register Volume 86, Number 86 (Thursday, May 6, 2021)]
[Rules and Regulations]
[Pages 24328-24336]
[FR Doc No: 2021-08840]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9, 721, and 725

[EPA-HQ-OPPT-2018-0777; FRL-10023-11]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (19-1.F)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances which were
the subject of premanufacture notices (PMNs) and a microorganism that
was the subject of a Microbial Commercial Activity Notice (MCAN). This
action requires persons to notify EPA at least 90 days before
commencing manufacture (defined by statute to include import) or
processing of any of these chemical substances for an activity that is
designated as a significant new use by this rule. This action further
requires that persons not commence manufacture or processing for the
significant new use until they have submitted a Significant New Use
Notice (SNUN), and EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken any risk
management

actions as are required as a result of that determination.

DATES: This rule is effective on July 6, 2021. For purposes of judicial
review, this rule shall be promulgated at 1 p.m. (e.s.t.) on May 20,
2021.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions. This action may also affect certain entities through pre-
existing import certification and export notification rules under TSCA,
which would include the SNUR requirements. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20 (or 40 CFR 725.920 for the MCAN
substance), any persons who export or intend to export a chemical
substance that is the subject of this rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and
must comply with the export notification requirements in 40 CFR part
707, subpart D.

B. How can I access the docket?

    The docket includes information considered by the Agency in
developing the proposed and final rules. The docket for this action,
identified by docket identification (ID) number EPA-HQ-OPPT-2018-0777,
is available at https://www.regulations.gov and at the Office of
Pollution Prevention and Toxics Docket (OPPT Docket), Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
    Due to the public health emergency, the EPA Docket Center (EPA/DC)
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide remote customer service via email, phone,
and webform. For the latest status information on EPA/DC services and
docket access, visit https://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical
substances which were the subject of PMNs P-17-382, P-18-41, P-18-70,
P-18-100, P-18-102, P-18-116, P-18-136, P-18-137, P-18-219, P-18-224,
P-18-225, P-18-233, P-18-279, and of MCAN J-18-41. These SNURs require
persons who intend to manufacture or process any of these chemical
substances for an activity that is designated as a significant new use
to notify EPA at least 90 days before commencing that activity.
    Previously, in the Federal Register of July 31, 2019 (84 FR 37199)
(FRL-9994-62), EPA proposed SNURs for these chemical substances. EPA
will address the other proposed SNURs in a subsequent Federal Register
document. More information on the specific chemical substances subject
to this final rule can be found in the Federal Register document
proposing the SNURs. The docket includes information considered by the
Agency in developing the proposed and final rules, including the public
comments received on the proposed rules that are described in Unit IV.

B. What is the Agency's authority for taking this action?

    TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit III.A.

C. Do the SNUR general provisions apply?

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA sections 5(b)
and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720.
Once EPA receives a SNUN, EPA must either determine that the
significant new use is not likely to present an unreasonable risk of
injury or take such regulatory action as is associated with an
alternative determination before manufacture or processing for the
significant new use can commence. If EPA determines that the
significant new use is not likely to present an unreasonable risk, EPA
is required under TSCA section 5(g) to make public, and submit for
publication in the Federal Register, a statement of EPA's findings.

III. Significant New Use Determination

A. Determination Factors

    TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In determining what would constitute a significant new use for the
chemical

substances that are the subject of these SNURs, EPA considered relevant
information about the toxicity of the chemical substances and potential
human exposures and environmental releases that may be associated with
the substances, in the context of the four bulleted TSCA section
5(a)(2) factors listed in this unit.
    During its review of the chemical substances that are the subjects
of these SNURs and as further discussed in Unit VI., EPA identified
potential risk concerns associated with other circumstances of use
that, while not intended or reasonably foreseen, may occur in the
future. EPA is designating those other circumstances of use as
significant new uses.

B. Procedures for Significant New Uses Claimed as Confidential Business
Information (CBI)

    By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1) and has referenced it to apply to other SNURs.
    Under these procedures a manufacturer or processor may request EPA
to determine whether a specific use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in 40 CFR
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
    If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.

IV. Public Comments

    EPA received public comments from two identifying entities on the
proposed rule. The Agency's responses are presented in the Response to
Public Comments document that is available in the docket for this rule.
EPA did not make changes to any of the proposed rules as a result of
these comments. Separately, EPA made changes to the SNUR proposed at 40
CFR 725.1079 for the microorganism which was the subject of MCAN J-18-
41. This SNUR, as proposed, included references to 40 CFR part 721.
These have been changed to refer instead to the equivalent provisions
in 40 CFR part 725, concerning reporting requirements and review
processes for microorganisms. The effect of the SNUR has not been
altered by these changes.

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping
requirements for chemical substances in 40 CFR part 721, subpart E, for
several chemicals that were the subject of PMNs, and in 40 CFR part 725
for one chemical substance that is a microorganism (MCAN J-18-41). In
Unit IV. of the proposed SNUR, EPA provided the following information
for each chemical substance:
     PMN or MCAN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Potentially useful information.
     CFR citation proposed to be assigned in the regulatory
text section. This final rule makes the final assignment to set the CFR
citation for the chemical.
    The regulatory text section of these rules specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits and other uses designated in the rules, may be
claimed as CBI.

VI. Rationale and Objectives of the Rule

A. Rationale

    The chemical substances that are the subjects of these SNURs
received ``not likely to present an unreasonable risk'' determinations
under TSCA section 5(a)(3)(C) based on EPA's review of the intended,
known, and reasonably foreseen conditions of use. However, EPA has
identified other circumstances that, should they occur in the future,
even if not reasonably foreseen, may present risk concerns.
Specifically, EPA has determined that deviations from the protective
measures identified in the PMN submissions could result in changes in
the type or form of exposure to the chemical substances, increased
exposures to the chemical substances, and/or changes in the reasonably
anticipated manner and methods of manufacturing, processing,
distribution in commerce, and disposal of the chemical substances.
These SNURs identify as a significant new use manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the protective measures identified in the submissions. As a
result, those significant new uses cannot occur without first going
through a separate, subsequent EPA review and determination process
associated with a SNUN.

B. Objectives

    EPA is issuing these SNURs because the Agency wants:
     To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
     To be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under TSCA section 5(a)(3)(C)
that the significant new use is not likely to present an unreasonable
risk, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant by the Administrator
under the conditions of use, or make a determination under TSCA section
5(a)(3)(A) or (B) and take the required regulatory action associated
with the determination, before manufacture or processing for the
significant new use of the chemical substance can occur.
    Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Inventory. Guidance on how
to determine if a chemical substance is on

the TSCA Inventory is available on the internet at https://www.epa.gov/tsca-inventory.

VII. Applicability of the Rules to Uses Occurring Before the Effective
Date of the Final Rule

    To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted, EPA concludes that the designated
significant new uses are not ongoing.
    When the chemical substances identified in this rule are added to
the TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, the identities of many of the chemical
substances subject to this rule have been claimed as confidential (per
40 CFR 720.85). Based on this, the Agency believes that it is highly
unlikely that any of the significant new uses described in the
regulatory text of this rule are ongoing.
    EPA designated July 31, 2019 (the date of FR publication of the
proposed rule) as the cutoff date for determining whether the new use
is ongoing. The objective of EPA's approach is to ensure that a person
cannot defeat a SNUR by initiating a significant new use before the
effective date of the final rule.
    Persons who began commercial manufacture or processing of the
chemical substances for a significant new use identified on or after
that date will have to cease any such activity upon the effective date
of the final rule. To resume their activities, these persons would have
to first comply with all applicable SNUR notification requirements and
EPA would have to take action under section 5 allowing manufacture or
processing to proceed.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, Order
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A)
requires such information to be submitted to EPA at the time of
submission of the SNUN.
    In the absence of a rule, Order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information known to or reasonably ascertainable by them (see 40
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. Unit IV. of the proposed rule
lists potentially useful information for all SNURs listed here.
Descriptions are provided for informational purposes. The potentially
useful information identified in Unit IV. of the proposed rule will be
useful to EPA's evaluation in the event that someone submits a SNUN for
the significant new use. Companies who are considering submitting a
SNUN are encouraged, but not required, to develop the information on
the substance, which may assist with EPA's analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol election. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h). For more
information on alternative test methods and strategies to reduce
vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    The potentially useful information described in Unit IV. of the
proposed rule may not be the only means of providing information to
evaluate the chemical substance associated with the significant new
uses. However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA sections 5(e) or 5(f).
EPA recommends that potential SNUN submitters contact EPA early enough
so that they will be able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.

IX. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40. According to 40 CFR 725.900, persons
submitting an MCAN for a significant new use of a microorganism must
comply with the same notification requirements and EPA regulatory
procedures as persons submitting an MCAN for a new microorganism,
including submission of test data on health and environmental effects
as described in 40 CFR 725.160. E-PMN software is available
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

X. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket for this rulemaking.

XI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review

    This action establishes SNURs for new chemical substances that were
the subject of PMNs. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011).

B. Paperwork Reduction Act (PRA)

    According to the PRA, 44 U.S.C. 3501 et seq., an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control

numbers for EPA's regulations in title 40 of the CFR, after appearing
in the Federal Register, are listed in 40 CFR part 9, and included on
the related collection instrument or form, if applicable.
    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
    The listing of the OMB control numbers of the collection
instruments and their subsequent codification in the table in 40 CFR
9.1 satisfies the display requirements of the PRA and OMB's
implementing regulations at 5 CFR part 1320. Since this ICR was
previously subject to public notice and comment prior to OMB approval,
and given the technical nature of the table in 40 CFR part 9, EPA finds
that further notice and comment to amend it is unnecessary. As a
result, EPA finds that there is ``good cause'' under section
553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C.
553(b)(3)(B)) to amend this table in 40 CFR 9.1 without further notice
and comment.

C. Regulatory Flexibility Act (RFA)

    Pursuant to the RFA section 605(b), 5 U.S.C. 601 et seq., I hereby
certify that promulgation of this SNUR does not have a significant
adverse economic impact on a substantial number of small entities. The
requirement to submit a SNUN applies to any person (including small or
large entities) who intends to engage in any activity described in the
final rule as a ``significant new use''. Because these uses are
``new,'' based on all information currently available to EPA, it
appears that no small or large entities presently engage in such
activities. A SNUR requires that any person who intends to engage in
such activity in the future must first notify EPA by submitting a SNUN.
Although some small entities may decide to pursue a significant new use
in the future, EPA cannot presently determine how many, if any, there
may be. However, EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13
in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018.
Only a fraction of these were from small businesses. In addition, the
Agency currently offers relief to qualifying small businesses by
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying small firms. Therefore, the
potential economic impacts of complying with this SNUR are not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published in the Federal Register of June 2,
1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general
determination that final SNURs are not expected to have a significant
economic impact on a substantial number of small entities, which was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

    This action does not have federalism implications because it is not
expected to have a substantial direct effect on 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, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action will not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes,
significantly or uniquely affect the communities of Indian Tribal
governments, and does not involve or impose any requirements that
affect Indian Tribes. Accordingly, the requirements of Executive Order
13175 (65 FR 67249, November 9, 2000), do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not a significant regulatory
action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, NTTAA
section 12(d), 15 U.S.C. 272 note, does not apply to this action.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).

K. Congressional Review Act (CRA)

    This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report containing this rule and other required
information to each House of the Congress and to the Comptroller
General of the United States. This action is not a ``major rule'' as
defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Parts 721 and 725

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: April 22, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
    Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended as follows:

PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.

0
2. In Sec.  9.1, amend the table by adding entries for Sec. Sec.
721.11278, 721.11282, 721.11283, 721.11285 through 721.11287, 721.11289
through 721.11294, and 721.11603 in numerical order under the
undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------

                                * * * * *
Significant New Uses of Chemical Substances.............

                                * * * * *
721.11278...............................................       2070-0012
721.11282...............................................       2070-0012
721.11283...............................................       2070-0012
721.11285...............................................       2070-0012
721.11286...............................................       2070-0012
721.11287...............................................       2070-0012
721.11289...............................................       2070-0012
721.11290...............................................       2070-0012
721.11291...............................................       2070-0012
721.11292...............................................       2070-0012
721.11293...............................................       2070-0012
721.11294...............................................       2070-0012

                                * * * * *
721.11603...............................................       2070-0012

                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add Sec. Sec.  721.11278, 721.11282, 721.11283, 721.11285 through
721.11287, 721.11289 through 721.11294, and 721.11603 to subpart E to
read as follows:

Subpart E --Significant New Uses for Specific Chemical Substances

* * * * *
Sec.
721.11278 Amides, tallow, N,N-bis(2-hydroxypropyl).
721.11282 2,5-Furandione, polymer with 2-ethyl-2-(hydroxymethyl)-
1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5(or
6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate.
721.11283 Waste plastics, polyester, depolymd. with glycols,
polymers with dicarboxylic acids (generic).
721.11285 Substituted alkanoic acid, polymer with alkylcarbonate,
alkanediols and isocyanate substituted carbomonocycles, sodium salt,
alkenoic acid substituted polyol reaction products-blocked
(generic).
721.11286 Alkenoic acid, ester with [oxybis(alkylene)]bis[alkyl-
substituted alkanediol], polymer with alkylcarbonate, alkanediols,
substituted alkanoic acid and isocyanate and alkyl substituted
carbomonocycle, sodium salt (generic).
721.11287 Castor oil, reaction products with soybean oil.
721.11289 1-Butanaminium,N,N,N-tributyl-,2(or 5)-
[[benzoyldihydrodioxo [(sulfophenyl) amino]heteropolycycle]oxy]-5(or
2)-(1,1-dimethylpropyl)benzenesulfonate (2:1) (generic).
721.11290 Alkylsilsesquioxane, ethoxy-terminated (generic).
721.11291 Polythioether, short chain diol polymer terminated with
aliphatic diisocyanate (generic).
721.11292 Alkenoic acid, polymer with alkenylcarbomonocycle,
[alkanediylbis (substituted alkylene)] bis[heteromonocycle] and
(alkylalkenyl) aromatic, salt (generic).
721.11293 Alkenoic acid, polymer with substituted alkyloxirane,
alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and
(alkylalkenyl) aromatic, salt (generic).
721.11294 Alkyl alkenoic acid, alkyl ester, telomer with alkylthiol,
substituted carbomonocycle, substituted alkyl alkyl alkenoate and
hydroxyalkyl alkenoate, tertbutyl alkyl peroxoate-initiated
(generic).
* * * * *
721.11603 Substituted heteromonocycle, polymer with substituted
alkanediol and diisocyanate substituted carbomonocyle, alkylene
glycol acrylate-blocked (generic).
* * * * *

Sec.  721.11278  Amides, tallow, N,N-bis(2-hydroxypropyl).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amides, tallow,
N,N-bis(2-hydroxypropyl) (PMN P-17-382; CAS No. 1454803-04-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposures. It is a significant
new use to process the substance resulting in an end use product
containing greater than 3% by weight of the substance.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=11.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c), (i), and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11282  2,5-Furandione, polymer with 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-
1H-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,5-Furandione,
polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-
hexahydro-4,7-methano-1H-inden-5(or 6)-yl ester, ester with 2,3-
dihydroxypropyl neodecanoate (PMN P-18-41) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(g). It is a significant new use to
manufacture (including import) the substance with the number average
molecular weight of less than 1000 daltons.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11283  Waste plastics, polyester, depolymd. with glycols,
polymers with dicarboxylic acids (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as waste
plastics, polyester, depolymd. with glycols, polymers with dicarboxylic
acids (PMN P-18-70) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

Sec.  721.11285  Substituted alkanoic acid, polymer with
alkylcarbonate, alkanediols and isocyanate substituted carbomonocycles,
sodium salt, alkenoic acid substituted polyol reaction products-blocked
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted alkanoic acid, polymer with alkylcarbonate, alkanediols and
isocyanate substituted carbomonocycles, sodium salt, alkenoic acid
substituted polyol reaction products-blocked (PMN P-18-100) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (j), and (o).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

Sec.  721.11286  Alkenoic acid, ester with [oxybis(alkylene)]bis[alkyl-
substituted alkanediol], polymer with alkylcarbonate, alkanediols,
substituted alkanoic acid and isocyanate and alkyl substituted
carbomonocycle, sodium salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, ester with [oxybis(alkylene)]bis[alkyl-substituted
alkanediol], polymer with alkylcarbonate, alkanediols, substituted
alkanoic acid and isocyanate and alkyl substituted carbomonocycle,
sodium salt (PMN P-18-102) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (j), and (o).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

Sec.  721.11287  Castor oil, reaction products with soybean oil.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as castor oil,
reaction products with soybean oil (PMN P-18-116) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (j). It is a significant new use to
process or use the substance in any manner that generates an aerosol or
mist. It is a significant new use to exceed the confidential annual
production volume stated in the PMN.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

Sec.  721.11289  1-Butanaminium,N,N,N-tributyl-,2(or 5)-
[[benzoyldihydrodioxo [(sulfophenyl) amino]heteropolycycle]oxy]-5(or
2)-(1,1-dimethylpropyl)benzenesulfonate (2:1) (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1-
butanaminium,N,N,N-tributyl-,2(or 5)- [[benzoyldihydrodioxo
[(sulfophenyl) amino]heteropolycycle]oxy]-5(or 2)-(1,1-
dimethylpropyl)benzenesulfonate (2:1) (PMN P-18-136) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=19.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c), (i), and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11290  Alkylsilsesquioxane, ethoxy-terminated (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylsilsesquioxane, ethoxy-terminated (PMN P-18-137) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:

    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=58.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11291  Polythioether, short chain diol polymer terminated
with aliphatic diisocyanate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polythioether, short chain diol polymer terminated with aliphatic
diisocyanate (PMN P-18-219) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the PMN substance with molecular
weight greater than 10,000 daltons. It is a significant new use to
manufacture the PMN substance with free isocyanate residuals greater
than 0.01% by weight.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11292  Alkenoic acid, polymer with alkenylcarbomonocycle,
[alkanediylbis (substituted alkylene)] bis[heteromonocycle] and
(alkylalkenyl) aromatic, salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, polymer with alkenylcarbomonocycle, [alkanediylbis
(substituted alkylene)] bis[heteromonocycle] and (alkylalkenyl)
aromatic, salt (PMN P-18-224) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure. It is a significant new
use to manufacture the substance to contain an acid content greater
than 20% by weight.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11293  Alkenoic acid, polymer with substituted alkyloxirane,
alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and
(alkylalkenyl) aromatic, salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, polymer with substituted alkyloxirane,
alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and
(alkylalkenyl) aromatic, salt (PMN P-18-225) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure. It is a significant new
use to manufacture the substance to contain an acid content greater
than 20% by weight.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11294  Alkyl alkenoic acid, alkyl ester, telomer with
alkylthiol, substituted carbomonocycle, substituted alkyl alkyl
alkenoate and hydroxyalkyl alkenoate, tertbutyl alkyl peroxoate-
initiated (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
alkenoic acid, alkyl ester, telomer with alkylthiol, substituted
carbomonocycle, substituted alkyl alkyl alkenoate and hydroxyalkyl
alkenoate, tertbutyl alkyl peroxoate-initiated (PMN P-18-233) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(w)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
* * * * *

Sec.  721.11603  Substituted heteromonocycle, polymer with substituted
alkanediol and diisocyanate substituted carbomonocyle, alkylene glycol
acrylate-blocked (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted heteromonocycle, polymer with substituted alkanediol and
diisocyanate substituted carbomonocyle, alkylene glycol acrylate-
blocked (PMN P-18-279) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (4), and (5). For purposes of Sec.  721.63(a)(4), only
persons subject to inhalation exposure from spray application of the
chemical substance are subject to these requirements. When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general, and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent

exposure, where feasible. For purposes of Sec.  721.63(a)(5)
respirators must provide a National Institute for Occupational Safety
and Health assigned protection factor of at least 1000.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (d) are applicable to manufacturers and processors of
this substance.
    (2) Limitation or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR
MICROORGANISMS

0
5. The authority citation for part 725 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

0
6. Add Sec.  725.1079 to read as follows:

Sec.  725.1079  Arsenic detecting strain of E. coli with extra-
chromosomal elements, including an intergeneric screening marker
(generic).

    (a) Microorganism and significant new uses subject to reporting.
(1) The genetically-modified microorganism identified generically as
arsenic detecting strain of E. coli with extra-chromosomal elements,
including an intergeneric screening marker (MCAN J-18-41) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) It is a significant new use to manufacture (excluding import)
the microorganism in the United States for any use.
    (ii) It is a significant new use to use the microorganism other
than to detect arsenic in small water samples.
    (b) Specific requirements. The provisions of subpart L of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
725.950(b)(2) through (4) are applicable to manufacturers and
processors of this microorganism.
    (2) Modification or revocation of certain notification
requirements. The provisions of Sec.  725.984 apply to this section.

[FR Doc. 2021-08840 Filed 5-5-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Notices]
[Pages 19248-19249]
[FR Doc No: E9-9557]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59802; File No. SR-FICC-2009-03]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Order Granting Approval of a Proposed Rule Change To Impose a Charge on
Members With a Fail-to-Deliver in Treasury Securities

April 20, 2009.

I. Introduction

    On February 25, 2009, The Fixed Income Clearing Corporation
(``FICC'') filed with the Securities and Exchange Commission
(``Commission'') proposed rule change SR-FICC-2009-03 pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'').\1\
Notice of the proposal was published in the Federal Register on March
19, 2009.\2\ The Commission received two comment letters.\3\ For the
reasons discussed below, the Commission is granting approval of the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ Securities Exchange Act Release No. 59569 (March 12, 2009),
74 FR 11797.
    \3\ Letters from Leslie Rosenthal, Rosenthal Collins Group,
L.L.C. (March 31, 2009) and Murray Pozmanter, Managing Director,
FICC (April 3, 2009).
---------------------------------------------------------------------------

II. Description

    The Treasury Markets Practices Group (``TMPG''), a group of market
participants that is active in the treasury securities market and is
sponsored by the Federal Reserve Bank of New York (``FRBNY''), has been
devising ways to address the persistent settlement fails in treasury
securities transactions that have arisen, according to the TMPG, due to
the recent market turbulence and low short-term interest rates. In
order to encourage market participants to resolve fails promptly, the
TMPG has proposed for adoption a ``best practice'' that would call for
the market-wide assessment of a charge on fail-to-deliver positions. As
part of the implementation of this ``best practice,'' the TMPG has
asked the Government Securities Division (``GSD'') of FICC to impose a
charge on failed positions involving treasury securities within FICC.
    The charge FICC is adopting will be equal to the product of net
money due on the failed position and three (3) percent per annum minus
the Target Fed funds target rate that is effective at 5 p.m. Eastern
Standard Time on the business day prior to the originally scheduled
settlement date and will be capped at three (3) percent per annum. The
charge will be applied daily and will be a debit on a member's GSD
monthly bill for a fail-to deliver position and a credit on a member's
GSD monthly bill for fail-to-receive position.
    The following example illustrates the manner in which the proposed
fails charge would apply.
    Member A fails to deliver today on a $50 million position on which
he is owed $50.1 million. The Target Fed funds rate yesterday at 5 p.m.
was one (1) percent. The fails charge will be the product of two (2)
percent per annum applied to the funds amount of $50.1 million, thus
equaling a charge of $2,783.33 for that day. The bill of the member
failing to deliver will reflect a debit of $2,783.33.
    In the event that FICC is the failing party because, for example,
it received securities too close to the close of the Fedwire for
redelivery, the fail charge will be distributed pro rata to the netting
members based upon usage of the GSD's services, which is the same
methodology that is used when FICC incurs finance charges.\4\
---------------------------------------------------------------------------

    \4\ FICC Rules, Section 6 of Rule 12.
---------------------------------------------------------------------------

    The rule change provides that the Credit and Market Risk Management
Committee of FICC's Board of Directors will retain the right to revoke
application of the charge if industry events or practices warrant such
revocation.

III. Comment Letters

    The Commission received two letters, one from a registered broker-
dealer raising concerns about the ``unintended consequences'' of the
proposed rule change and the other from FICC responding to the
commenter's letter.\5\ The broker-dealer, a member of FICC, raised
concerns that the pervasive fails situation that FICC intends to remedy
with the rule change no longer exists because the market corrected
itself when fails became an issue, and therefore the instances of fails
can be held to a minimum if the industry commits to follow best
practices. Further, this broker contends that the rule may potentially
increase counterparty risk because firms would shift from clearing
through FICC to clearing through individual counterparties, where fails
are more easily controlled, in an effort to avoid the fails penalty.
The unintended consequences of the rule change, the commenter asserted,
may be detrimental to the global market by reducing market liquidity
caused by the reduction in the supply of securities, by eroding
investor confidence, by decreasing securities available for lending,
and by

introducing the potential to game the system due to wider spreads
between bid and offer prices, resulting in allowing someone to take
advantage of those inadvertently caught in a fail situation.
---------------------------------------------------------------------------

    \5\ Supra note 3.
---------------------------------------------------------------------------

    In response to these concerns, FICC noted that FICC's delivery
allocation process, a process that matches buy obligations to sell
obligations and is applicable to all members, is necessary to ensure
that the clearing corporation remains flat. Accordingly, FICC contends,
the fails charge would not have any unique impact on the commenter's
firm. With regards to the concern that the fails charge may result in
firms shifting their business away from FICC in order to avoid a fails
charge, FICC agrees that applying the fails charge as proposed by the
rule would result in adverse consequences if the rest of the industry
does not adopt it. However, FICC argues, FICC would cease applying the
charge if the Credit and Market Risk Management Committee of FICC's
Board of Directors determines that industry events or practices warrant
such a revocation. Finally, FICC rejected the commenters assertions
regarding the proposed rule change's effect on market liquidity and
providing new opportunities for firms to ``game'' the system as
``highly speculative.'' Even if these adverse effects developed, FICC
argues that it would be able to respond by eliminating the fails charge
or taking other appropriate action.

IV. Discussion

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of a clearing agency be designed to promote the prompt and
accurate clearance and settlement of securities transactions, assure
the safeguarding of securities and funds which are in the custody or
control of the clearing agency or for which it is responsible, to
foster cooperation and coordination with persons engaged in the
clearance and settlement of securities transactions, to remove
impediments to and perfect the mechanism of a national system for the
prompt and accurate clearance and settlement of securities
transactions, and, in general, to protect investors and the public
interest.\6\ The Commission believes the rule change is consistent with
Act because the fails-to-deliver charge should discourage firms from
creating and maintaining persistent fails-to-deliver in treasury
securities, which if permitted to subsist, may adversely affect FICC's
ability to safeguard securities or funds in FICC's control or for which
it is responsible and to promptly and accurately clear and settle
securities transactions. In the event that the rule change does not
have the intended affect or produces other undesirable consequences,
FICC has the ability to eliminate the rule or take other appropriate
action to address any ensuing problems.\7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78q(b)(3)(F).
    \7\ Elimination or modification of the fails-to-deliver charge
would require FICC to file a proposed rule change pursuant to
Section 19(b) of the Act.
---------------------------------------------------------------------------

    Accordingly, for the reasons stated above the Commission believes
that the rule change is consistent with FICC's obligation under Section
17A of the Act.

V. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
in particular with the requirements of Section 17A of the Act and the
rules and regulations thereunder.\8\
---------------------------------------------------------------------------

    \8\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (File No. SR-FICC-2008-03) be and hereby
is approved.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-9557 Filed 4-27-09; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register: April 7, 2008 (Volume 73, Number 67)]
[Notices]
[Page 18792-18793]
[DOCID:fr07ap08-57]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2007-0059; FRL-8551-6]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Solvent Extraction for
Vegetable Oil Production (Renewal), EPA ICR Number 1947.04, OMB Control
Number 2060-0471

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before May 7, 2008.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2007-0059, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail
to: EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2223A,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On March 9, 2007 (72 FR 10735), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2007-0059, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: NESHAP for Solvent Extraction for Vegetable Oil Production
(Renewal).
    ICR Numbers: EPA ICR Number 1947.04, OMB Control Number 2060-0471.
    ICR Status: This ICR is scheduled to expire on July 31, 2008. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB. An
Agency may not

conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations in title
40 of the CFR, after appearing in the Federal Register when approved,
are listed in 40 CFR part 9, and displayed either by publication in the
Federal Register or by other appropriate means, such as on the related
collection instrument or form, if applicable. The display of OMB
control numbers in certain EPA regulations is consolidated in 40 CFR
part 9.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Solvent Extraction for Vegetable Oil Production
were proposed on May 26, 2000 (65 FR 34252), and promulgated on April
21, 2001.
    These standards apply to any existing, reconstructed, or new
vegetable oil production process, which are defined as a group of
continuous process equipment used to remove oil from oilseeds through
direct contact with an organic solvent such as n-hexane. The term
``oilseed'' refers to the following agricultural products: corn germ,
cottonseed, flax, peanut, rapeseed (source of canola oil), safflower,
soybean, and sunflower. A vegetable oil production process is only
subject to the regulation if it is a major source of hazardous air
pollutant (HAP) emissions, or is collocated with other sources that are
individually or collectively a major source of HAP emissions.
    Notification reports are required upon the construction,
reconstruction, or modification of any vegetable oil production
processor. Also required is one-time-only initial notification for
existing, new and reconstructed sources, and notification of an actual
startup date. Annual compliance reports are required, along with a
deviation report, an immediate startup, shutdown, and malfunction (SSM)
report, and a periodic SSM report. Affected entities must retain
reports and records for five years.
    Owners or operators of solvent extraction for vegetable oil
production facilities subject to the rule must maintain a file of these
measurements, and retain the file for at least five years following the
date of such measurements, maintenance reports, and records. All
reports are sent to the delegated state or local authority. In the
event that there is no such delegated authority, the reports are sent
directly to the EPA regional office. This information is being
collected to assure compliance with 40 CFR part 63, subpart GGGG, as
authorized in section 112 and 114(a) of the Clean Air Act. The required
information consists of emissions data and other information that have
been determined to be private.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB Control Number. The OMB Control Number for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 185
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Solvent extraction for vegetable oil
production.
    Estimated Number of Respondents: 101.
    Frequency of Response: Annually, initially and occasionally.
    Estimated Total Annual Hour Burden: 39,385.
    Estimated Total Annual Cost: $2,512,947 in labor costs. There are
no annualized capital/startup and annual O&M costs associated with this
ICR.
    Changes in the Estimates: There is no change in the labor hours or
cost in this ICR compared to the previous ICR. This is due to two
considerations. First, the regulations have not changed over the past
three years and are not anticipated to change over the next three
years. Secondly, the growth rate for the industry is very low, negative
or non-existent, so there is no significant change in the overall
burden.
    Since there are no changes in the regulatory requirements and there
is no significant industry growth, the labor hours and cost figures in
the previous ICR are used in this ICR and there is no change in burden
to industry.

    Dated: March 31, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
 [FR Doc. E8-7210 Filed 4-4-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28234-28236]
[FR Doc No: 2018-12968]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0286]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry: Formal Meetings Between the
Food and Drug Administration and Biosimilar Biological Product Sponsors
or Applicants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on formal meetings between FDA and biosimilar
biological product sponsors or applicants.

DATES: Submit either electronic or written comments on the collection
of information by August 17, 2018.

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 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time

at the end of August 17, 2018. 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-2013-D-0286 for ``Guidance for Industry: Formal Meetings Between
Between the FDA and Biosimilar Biological Product Sponsors or
Applicants.'' 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: 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 protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry: Formal Meetings Between the FDA and Biosimilar
Biological Product Sponsors or Applicants

OMB Control Number 0910-0802--Extension

    The Biologics Price Competition and Innovation Act of 2009, the
Biosimilar User Fee Act of 2012, and the recent passage of the
Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the
Food and Drug Administration Reauthorization Act of 2017, authorizes
user fees for biosimilar biological products. FDA has committed to
meeting certain performance goals in connection with the reauthorized
biosimilar user fee program. FDA developed a guidance for industry
entitled ``Formal Meetings Between FDA and Biosimilar Biological
Products Sponsors or Applicants'' to provide recommendations to
industry on formal meetings between FDA and sponsors or applicants
relating to the development and review of biosimilar biological
products regulated by the Center for Drug Evaluation and Research
(CDER) or the Center for Biologics Evaluation and Research (CBER) and
assist sponsors and applicants in generating and submitting meeting
requests and the associated meeting packages to FDA for biosimilar
biological products. The guidance describes FDA's current

thinking on how the Agency intends to interpret and apply certain
provisions of BsUFA II and provides information on specific performance
goals for the management of meetings associated with the development
and review of biosimilar biological products. The guidance includes two
types of information collections: (1) The submission of a meeting
request containing certain information and (2) the submission of the
information package(s) that accompany the meeting request. This
information collection supports this Agency guidance document.

A. Request for a Meeting

    Under the guidance, a sponsor or applicant interested in meeting
with CDER or CBER should submit a meeting request to the sponsor's or
applicant's application (i.e., investigational new drug application,
biologics license application). If there is no application, a sponsor
or applicant should submit the request to either the appropriate CDER
division director, with a copy sent to the division's chief of project
management staff, or to the division director of the appropriate
product office within CBER. However, a sponsor or applicant should only
submit such a request after first contacting the appropriate review
division or the Biosimilars Program staff, CDER, Office of New Drugs,
to determine to whom the request should be directed, how it should be
submitted, the appropriate format for the request, and to arrange for
confirmation of receipt of the request.
    Under the guidance, FDA requests that sponsors and applicants
incorporate certain information in the meeting request including:
    1. Product name,
    2. application number (if applicable),
    3. proposed proper name or proper name (post licensure),
    4. structure,
    5. reference product name,
    6. proposed indication(s) or context of product development,
    7. meeting type being requested (the rationale for requesting the
meeting type should be included),
    8. a brief statement of the purpose of the meeting, including a
brief background of the issues underlying the agenda and, as
applicable, a brief summary of completed or planned studies and
clinical trials or data the sponsor or applicant intends to discuss at
the meeting, the general nature of the critical questions to be asked,
and where the meeting fits in the overall development plans,
    9. a list of specific objectives/outcomes expected from the
meeting,
    10. a proposed agenda, including times required for each agenda
item,
    11. a list of questions grouped by discipline and a brief
explanation of the context and purpose of each question,
    12. a list of all individuals with their titles and affiliations
who will attend the requested meeting from the requestor's organization
and consultants,
    13. a list of FDA staff, if known, or disciplines asked to
participate in the requested meeting,
    14. suggested dates and times for the meeting, and
    15. the proposed format of the meeting (i.e., face to face meeting,
teleconference, or videoconference).
    This information is be used by FDA to facilitate formal meetings
with biosimilar biological product sponsors.

B. Information Package

    FDA requests that a sponsor or applicant submit a meeting package
to the appropriate review division with the meeting request. FDA
recommends that the information packages generally include:
    1. Product name and application number (if applicable),
    2. proposed proper name or proper name (post licensure),
    3. structure,
    4. reference product name,
    5. proposed indication(s) or context of product development,
    6. dosage form, route of administration, dosing regimen (frequency
and duration), and presentation(s),
    7. a list of all sponsor's or applicant's attendees and consultants
with their titles and affiliations who will attend the requested
meeting,
    8. background that includes a brief history of the development
program and the status of product development (e.g., chemistry,
manufacturing, and controls; nonclinical; and clinical, including any
development outside the United States, as applicable),
    9. a brief statement summarizing the purpose of the meeting,
    10. the proposed agenda,
    11. a list of questions for discussion grouped by discipline and
with a brief summary for each question to explain the need or context
for the question, and
    12. data to support discussion of the listed questions, organized
by discipline and question.
    The purpose of the meeting package is to provide FDA staff the
opportunity to adequately prepare for the meeting, including the review
of relevant data concerning the product.
    Description of Respondents: A sponsor or applicant for a biosimilar
biological product who requests a formal meeting with FDA regarding the
development and review of a biosimilar biological product.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
  Guidance for Industry: Formal
    Meetings Between FDA and         Number of       Number of     Total annual   Average burden
  Biosimilar Biological Product     respondents    responses per     responses     per response     Total hours
     Sponsors or Applicants                         respondent
----------------------------------------------------------------------------------------------------------------
CDER Meeting Requests...........              36             2.5              89              15           1,335
CBER Meeting Requests...........               2               1               2              15              30
CDER Information Packages.......              29             2.2              64              30           1,920
CBER Information Packages.......               2               2               4              30             120
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,405
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since the last OMB approval there has been an increase in meeting
requests with CDER and a corresponding increase in the number of
information packages. Accordingly, we have adjusted our estimate of
CDER meeting requests upward by six respondents. We attribute this
change to an increase in biosimilar product development.

    Dated: June 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12968 Filed 6-15-18; 8:45 am]
 BILLING CODE 4164-01-P