[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Rules and Regulations]
[Pages 5923-5927]
[FR Doc No: 2018-02677]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0204; FRL-9974-11-Region 9]

Air Quality State Implementation Plans; Approvals and
Promulgations: California; South Coast Moderate Area Plan for the 2006
PM2.5 Standards; Correction of Deficiency

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the
Reasonably Available Control Measures/Reasonably Available Control
Technology (RACM/RACT) and Reasonable Further Progress (RFP) elements
of California's Moderate area

plan for the 2006 24-hour fine particulate matter (PM2.5)
National Ambient Air Quality Standards (NAAQS or ``standards'') in the
Los Angeles--South Coast nonattainment area. The EPA is also finalizing
a determination that the State has corrected the deficiency that formed
the basis for the EPA's prior partial disapproval of the Moderate area
plan submitted for these NAAQS with respect to the RACM/RACT and RFP
elements. Today's action terminates the sanctions clocks triggered by
the partial disapproval of the Moderate area plan.

DATES: This rule is effective on March 14, 2018.

ADDRESSES: The EPA has established a docket for this action under
Docket No. EPA-R09-OAR-2015-0204. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed on
the website, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through http://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information.

FOR FURTHER INFORMATION CONTACT: Wienke Tax, EPA Region IX, (415) 947-
4192, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Summary of Proposed Action
II. Public Comments and EPA Responses
III. Final Action
IV. Statutory and Executive Order Reviews

I. Summary of Proposed Action

    On October 10, 2017 (82 FR 46951) we proposed to determine that
certain amendments to the South Coast Air Quality Management District's
(SCAQMD or ``District'') Regional Clean Air Incentives Program
(RECLAIM) submitted by California corrected the deficiency in the RACM/
RACT and RFP elements of the Moderate area plan for the 2006
PM2.5 NAAQS in the Los Angeles--South Coast nonattainment
area (``2012 PM2.5 Plan'' or ``plan'') that was the basis
for the EPA's prior partial disapproval of this plan. On this basis, we
proposed to approve the RACM/RACT and RFP elements of the 2012
PM2.5 Plan, as revised. The 2012 PM2.5 Plan
contained the State's and District's demonstration that attainment of
the 2006 PM2.5 NAAQS in the South Coast area by the December
31, 2015 Moderate area attainment date was impracticable.
    Simultaneously, we published an interim final determination to
defer sanctions based on our proposed finding that the SCAQMD's
amendments to RECLAIM corrected the deficiency in the RACM/RACT and RFP
elements of the 2012 PM2.5 Plan that formed the basis for
our prior partial disapproval of this plan (82 FR 46917).

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period,
which ended on November 9, 2017. During this period, we received one
comment letter from Earthjustice on behalf of the Sierra Club and
several anonymous comments. We summarize these comments and provide our
responses below.
    Comment #1: Earthjustice claims that a cap-and-trade program such
as RECLAIM cannot provide the basis for compliance with the Clean Air
Act (CAA or ``Act'') section 182 RACT requirement or the RACM
requirement, based on the plain language of the CAA that, according to
Earthjustice, requires all major sources to implement RACT. In support
of this contention, Earthjustice highlights the word ``all'' in CAA
section 182(b)(2) in connection with implementation of RACT at major
sources and claims that the legislative history for the CAA Amendments
of 1990 makes clear that the RACT requirement applies to all major
sources of NOX in an ozone nonattainment area. Earthjustice
also cites, without explanation, the RACM requirement for Moderate
PM2.5 nonattainment areas in CAA section 189(a)(1)(C) and
the Best Available Control Measures (BACM) requirement for Serious
PM2.5 nonattainment areas in 40 CFR 51.1010.
    Earthjustice asserts that the EPA's longstanding definition of RACT
supports an interpretation of the RACT requirement as applicable to
each and every major NOX source, not a collective emission
limitation for an entire class of sources located across a
nonattainment area or an entire state or region. Earthjustice claims
that reliance on an emissions trading program to meet the RACT
requirement for major NOX sources is tantamount to creating
a NOX exemption that is inconsistent with the explicit
NOX exemptions found at CAA section 182(f). Lastly,
Earthjustice cites an EPA proposed rule dated November 3, 2016 to
support its claim that emissions averaging in the South Coast does not
actually provide RACT-level reductions.
    Response #1: Earthjustice submitted substantively identical
comments on a separate proposed rule published June 15, 2017, in which
the EPA proposed to determine that the revised RECLAIM regulations
satisfy CAA RACT requirements for purposes of the ozone NAAQS in the
South Coast ozone nonattainment area (82 FR 27451).\1\ We responded to
these comments in our September 20, 2017 final rule approving
California's RACT state implementation plan (SIP) submission for the
South Coast area (82 FR 43850) and incorporate that response here (see
82 FR at 43853-54). Because Earthjustice has not explained how its
comments pertain to the specific RACM requirement in CAA section
189(a)(1)(C) or the BACM requirement in 40 CFR 51.1010 for purposes of
the PM2.5 NAAQS, we provide no further response on this
issue.
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    \1\ Earthjustice's prior comments on this issue are identical to
its comments here, except that its latest comments include two
unexplained references to ``RACM'' and unexplained citations to the
control requirements for PM2.5 nonattainment areas in CAA
section 189(a)(1)(C) and 40 CFR 51.1010.
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    Comment #2: Earthjustice contends that approval of California's
RACT determination would be arbitrary and capricious because the
RECLAIM rules, as amended in 2015, do not achieve aggregate emissions
reductions of NOX equivalent to those that would be achieved
through implementation of RACT level control at each major
NOX source in the South Coast. Earthjustice claims that the
record here shows that the additional 12 ton per day (tpd) reduction
adopted by the SCAQMD as part of the 2015 RECLAIM amendments does not
result in RACT/RACM level controls for NOX RECLAIM
facilities.
    Response #2: Earthjustice submitted substantively identical
comments on a separate proposed rule published June 15, 2017, in which
the EPA proposed to determine that the revised RECLAIM regulations
satisfy CAA RACT requirements for purposes of the ozone NAAQS in the
South Coast ozone nonattainment area (82 FR 27451). We responded to
these comments in our September 20, 2017 final rule approving
California's RACT SIP submission for the ozone NAAQS for the South
Coast area (82 FR 43850) and incorporate that response here (see 82 FR
at 43854-55).
    Comment #3: Earthjustice asserts that the EPA's approval of the
RACM/RACT and RFP elements of the 2012 PM2.5 Plan would
interfere with attainment of the PM2.5 NAAQS by 2019.
Earthjustice claims that the EPA failed to address how an additional 12
tpd reduction in

the NOX RECLAIM emissions cap on a ``back-loaded'' schedule
complies with the District's determination that the reductions are
necessary for PM2.5 attainment by 2019 or as expeditiously
as practicable. It also claims that the record shows that failure to
apply the front-loaded emission reduction schedule developed by SCAQMD
staff will interfere with expeditious attainment of the 2006
PM2.5 NAAQS. Earthjustice also references a program
environmental assessment (PEA) completed pursuant to California state
law, which listed as a project objective the need to bring the
NOX RECLAIM program up to date with best available retrofit
control technology (BARCT) requirements for existing sources under
California law, and asserts that the final PEA identified a need to
implement additional control measures to attain both the
PM2.5 and ozone NAAQS in the South Coast air basin.
    Response #3: These comments are not germane to this action.
Earthjustice suggests that SCAQMD should require reductions from
RECLAIM sources on a faster schedule for purposes of attaining the 2006
PM2.5 NAAQS by the applicable attainment date for a Serious
nonattainment area, i.e., in this case an area that must attain the
2006 PM2.5 NAAQS as expeditiously as practicable but no
later than the end of 2019. In this action, however, we are not
assessing whether the revised RECLAIM program meets Serious area
nonattainment plan requirements such as the BACM/BACT control
requirement or, as relevant here, assessing whether the schedule for
those reductions is consistent with the requirement to attain the 2006
PM2.5 NAAQS as expeditiously as practicable but no later
than 2019. This action addresses only a deficiency that the EPA
previously identified in the Moderate area plan for the South Coast
area.
    The 2012 PM2.5 Plan contained a demonstration under CAA
section 189(a)(1)(B)(ii) that attainment of the 2006 PM2.5
standards in the South Coast area by the Moderate area attainment date
of December 31, 2015, was impracticable.\2\ We partially approved and
partially disapproved the 2012 PM2.5 Plan based on a
deficiency in its RACM/RACT and RFP elements, both of which relied on
the RECLAIM program as amended in 2010.\3\ Following the State's
submission of RECLAIM rule amendments adopted in 2015 and a
demonstration that the amended program satisfies NOX RACT
requirements for covered sources,\4\ we proposed to determine that the
State had corrected the deficiency in the RACM/RACT and RFP elements of
the 2012 PM2.5 Plan and to approve these elements of the
Plan, as revised (82 FR 46951, October 10, 2017). These SIP revisions
corrected a deficiency in an impracticability demonstration, which did
not purport to show attainment by 2019. Comments pertaining to the
level of control necessary for the South Coast area to attain the
PM2.5 NAAQS as expeditiously as practicable and no later
than the applicable statutory attainment date should be raised in the
context of EPA's evaluation of a demonstration of attainment under CAA
section 189(a)(1)(B)(i) or section 189(b)(1)(A)(i), not in the context
of a demonstration that attainment by the outermost Moderate area
attainment date is impracticable under CAA section 189(a)(1)(B)(ii).
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    \2\ See 81 FR 22025, 22026 (April 14, 2016).
    \3\ Id. at 22027.
    \4\ On September 14, 2017, we approved the amended RECLAIM rules
into the SIP (82 FR 43176) and on September 20, 2017, we approved
the SCAQMD's ozone RACT SIP demonstration for the 2008 ozone NAAQS
based, in part, on a determination that major NOX sources
covered by the amended RECLAIM program are now subject to RACT-level
controls (82 FR 43850, 43856).
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    Our reclassification of the South Coast area from Moderate to
Serious for the 2006 PM2.5 NAAQS in October 2015 triggered a
requirement for California to submit a Serious area plan that provides
for attainment of the 2006 PM2.5 NAAQS in the South Coast as
expeditiously as practicable but no later than December 31, 2019, in
accordance with the requirements of part D of title I of the Act.\5\
The California Air Resources Board submitted a Serious area plan for
the 2006 PM2.5 NAAQS in the South Coast on April 27,
2017.\6\ We will evaluate the adequacy of the State's and District's
control strategy for purposes of timely attainment when we act on this
plan submission.
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    \5\ 81 FR 22025, 22026 (April 14, 2016) (citing October 20, 2015
reclassification action at 80 FR 63640, 63660).
    \6\ See letter dated April 27, 2017 from Richard W. Corey,
Executive Officer, CARB, to Alexis Strauss, Acting Regional
Administrator, EPA Region IX (transmitting Serious area plan for
2006 PM2.5 NAAQS to the EPA).
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    Comment #4: Earthjustice objects to the District's general approach
to distinguishing between BARCT and RACT-level control and argues that
the District has used an artificially narrow articulation of RACT to
evaluate only controls required under adopted regulations, instead of
considering technologies that have been applied in practice.
    Response #4: Earthjustice submitted identical comments on a
separate proposed rule published June 15, 2017, in which the EPA
proposed to determine that the revised RECLAIM regulations satisfy CAA
RACT requirements for purposes of the ozone NAAQS in the South Coast
ozone nonattainment area (82 FR 27451). We responded to these comments
in our September 20, 2017 final rule approving California's ozone RACT
SIP for the South Coast area (82 FR 43850) and incorporate that
response here (see 82 FR at 43855-56).
    Comment #5: Earthjustice asserts that the revised RECLAIM program
does not properly address RECLAIM trading credits from facilities that
shut down prior to 2016 and argues that the availability of such
credits has allowed major sources, particularly refineries, to avoid
installation of selective catalytic reduction and other readily
available NOX pollution controls. Earthjustice identifies
California Portland Cement as a retired facility whose credits have
significantly contributed to this problem.
    Response #5: Earthjustice submitted substantively identical
comments on a separate proposed rule published June 6, 2017, in which
the EPA proposed to approve the amended RECLAIM rules into the SIP (82
FR 25996), and a proposed rule published June 15, 2017, in which the
EPA proposed to determine that the amended RECLAIM rules satisfy CAA
RACT requirements for purposes of the ozone NAAQS in the South Coast
ozone nonattainment area (82 FR 27451). We responded to these comments
in both our September 14, 2017 final rule approving the amended RECLAIM
rules (82 FR 43176) and our September 20, 2017 final rule approving
California's ozone RACT SIP for the South Coast area (82 FR 43850) and
incorporate those responses here (see 82 FR at 43178 and 82 FR at
43855).
    Comment #6: Citing CAA section 110(a)(2)(E), Earthjustice asserts
that the EPA can approve a SIP revision only if it determines that the
provision is not inconsistent with state law and argues that ``the
current proposal violates California law because it is not equivalent
to BARCT'' and does not achieve command-and-control equivalence as
mandated by California's Health and Safety Code. Earthjustice claims
that the EPA therefore cannot make the determination required in
section 110 of the Act that the approval not interfere with compliance
with state law.
    Response #6: Earthjustice submitted substantively identical
comments on a separate proposed rule published June 6, 2017, in which
the EPA proposed to approve the amended RECLAIM rules into the SIP (82
FR 25996), and a

proposed rule published June 15, 2017, in which the EPA proposed to
determine that the amended RECLAIM rules satisfy CAA RACT requirements
for purposes of the ozone NAAQS in the South Coast ozone nonattainment
area (82 FR 27451). We responded to these comments in both our
September 14, 2017 final rule approving the amended RECLAIM rules (82
FR 43176) and our September 20, 2017 final rule approving California's
ozone RACT SIP for the South Coast area (82 FR 43850) and incorporate
those responses here (see 82 FR at 43178-79 and 82 FR at 43856).
    Comment #7: Earthjustice claims that the EPA cannot approve the
District's RACM determination because the District failed to comply
with state notice requirements in adopting the 2015 NOX
RECLAIM program amendments. Earthjustice cites a recent decision of the
California Superior Court for Los Angeles County (``state court'')
remanding the December 2015 NOX RECLAIM program amendments
on the basis that the District failed to comply with California Health
and Safety Code procedural requirements in adopting the amendments.
Earthjustice asserts that ``[b]ecause a California court has found the
[SCAQMD] violated state law in adopting the RECLAIM amendments, it
would be arbitrary and capricious for EPA to approve this determination
because it violates the Clean Air Act provisions in 42 U.S.C. [section]
7410.''
    Response #7: We disagree with the commenter's claim that the
referenced state court decision precludes EPA approval of the RACM/RACT
and RFP elements of the 2012 PM2.5 Plan. By order dated
November 6, 2017, the California Superior Court for the County of Los
Angeles remanded the SCAQMD Board's December 4, 2015 amendments to the
RECLAIM program based on the court's finding that the District violated
state procedural requirements in adopting the amendments.\7\ The court
did not, however, vacate the amendments to the program or find any
substantive flaw in the amended program.\8\ On November 16, 2017,
counsel for the SCAQMD confirmed that the RECLAIM program, as amended
December 4, 2015, remains in effect and that the District plans to
implement the amended program while considering its options for how to
respond to the remand.\9\ By email dated January 10, 2018, counsel for
the SCAQMD informed the EPA that the SCAQMD Governing Board had
authorized the District to file an appeal of the state court decision
and that this action would not affect the ongoing implementation of the
December 2015 RECLAIM amendments.\10\ If this appeal is denied (or is
otherwise unsuccessful) and the District either adopts further
revisions to the RECLAIM program or determines that the amended program
is deficient in some respect, we will reconsider today's action or take
appropriate remedial action to ensure that the RACM/RACT and RFP
elements of the 2012 PM2.5 Plan satisfy CAA requirements.
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    \7\ Order Granting the Petition for a Writ of Mandate in Part,
Superior Court for the State of California, County of Los Angeles,
Communities for a Better Environment et al. v. South Coast Air
Quality Management District, Case No. BS 161399 (November 6, 2017)
(finding that SCAQMD violated section 40726 of the California Health
& Safety Code by adopting the 2015 RECLAIM amendments without
providing additional public hearing or opportunity for comment).
    \8\ Id.
    \9\ Memorandum dated November 16, 2017, from Jeanhee Hong, EPA
Region IX, Office of Regional Counsel and Wienke Tax, EPA Region IX,
Air Division Planning Office, to Rulemaking docket EPA-R09-OAR-2015-
0204, RE: ``State court order concerning 2015 RECLAIM amendments.''
    \10\ Email dated January 10, 2018, from William Wong, Principal
Deputy District Counsel, SCAQMD, to Wienke Tax, EPA Region IX, RE:
``Jeanhee Hong and Wienke Tax email information.''
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    We note that we approved the amended RECLAIM rules into the SIP in
a previous rulemaking action (82 FR 43176, September 14, 2017) in which
we determined, inter alia, that the SIP submission containing the
amended rules satisfied the applicable CAA requirements for SIP
revisions, including the procedural requirements in CAA section 110(a)
and 40 CFR part 51, Appendix V.\11\ To the extent the commenter
intended to argue that a procedural flaw in the District's adoption of
the amended RECLAIM rules precludes the EPA's approval of those rules
into the SIP under CAA section 110, such arguments should have been
raised in comments on this prior rulemaking.
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    \11\ See 82 FR 25996, 25997 (June 6, 2017) (proposed rule) and
82 FR 43176 (September 14, 2017) (final rule). The EPA's regulations
in 40 CFR part 51, Appendix V require, inter alia, that each SIP
submission include evidence that the State followed all of the
procedural requirements of the State's laws and constitution in
adopting the plan. 40 CFR part 51, Appendix V, section 2.1(e). The
statutory deadline for filing a petition for judicial review of this
action was November 13, 2017 (see 82 FR 43176, 43179).
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    Other comments: We received several anonymous comments stating,
inter alia, that emissions of greenhouse gases (GHGs) and other
pollutants from California wildfires contribute to climate change and
regional and global air pollution including smog, particulate matter,
and toxics; that California should pay a carbon tax on GHG emissions
from wildfires; that oil and gas regulations should be rescinded; and
that the CAA must be enforced to preserve air quality and quality of
life.
    Response: These comments fail to identify any specific issue that
is germane to our action on the 2012 PM2.5 Plan.

III. Final Action

    The EPA is finalizing approval of the following elements of the
2012 PM2.5 Plan under CAA section 110(k)(3):
     The RACM/RACT element as meeting the requirements of CAA
sections 172(c)(1) and 189(a)(1)(C); and
     the RFP element as meeting the requirements of CAA section
172(c)(2).
    As a result of this approval, the offset sanction in CAA section
179(b)(2), which would have applied in the South Coast PM2.5
nonattainment area 18 months after the effective date of our partial
disapproval of the 2012 PM2.5 Plan dated April 14, 2016, and
the highway funding sanction in CAA section 179(b)(1), which would have
applied in the area six months after the offset sanction is imposed,
are permanently terminated. Additionally, this approval action removes
the obligation on the EPA to promulgate a federal implementation plan
because California has corrected the deficiencies and the EPA has
approved the related plan revisions.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities

under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 13, 2018. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Ammonia,
Incorporation by reference, Intergovernmental relations, Nitrogen
oxides, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: January 24, 2018.
Alexis Strauss,
Acting Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

Sec.  52.220   Identification of plan--in part.

0
2. Section 52.220 is amended by adding paragraph (c)(439)(ii)(B)(6) to
read as follows:
* * * * *
    (c) * * *
    (439) * * *
    (ii) * * *
    (B) * * *
    (6) The PM2.5-related portions of Appendix VI
(``Reasonably Available Control Measures (RACM) Demonstration'') of the
Final 2012 Air Quality Management Plan (December 2012).
* * * * *

Sec.  52.237   [Amended]

0
3. Section 52.237 is amended by removing and reserving paragraph
(a)(7).

[FR Doc. 2018-02677 Filed 2-9-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)]
[Rules and Regulations]
[Pages 31048-31050]
[FR Doc No: 2018-14325]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0613]
RIN 1625-AA00

Safety Zone; Canalside 4th of July Celebration, Buffalo River,
Buffalo, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters on the Buffalo River, Buffalo, NY. This safety zone is
intended to restrict vessels from portions of the Buffalo River during
the Canalside 4th of July Celebration fireworks display. This temporary
safety zone is necessary to protect mariners and vessels from the
navigational hazards associated with a fireworks display. Entry of
vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port Buffalo.

DATES: This rule is effective from 9:45 p.m. July 4, 2018 until 10:45
p.m. on July 5, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://

www.regulations.gov, type USCG-2018-0613 in the ``SEARCH'' box and
click ``SEARCH.'' Click on Open Docket Folder on the line associated
with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Michael Collet, Chief Waterways Management Division,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the event sponsor did not submit
notice to the Coast Guard with sufficient time remaining before the
event to publish an NPRM. Delaying the effective date of this rule to
wait for a comment period to run would be impracticable and contrary to
the public interest by inhibiting the Coast Guard's ability to protect
spectators and vessels form the hazards associated with a fireworks
display.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register because doing so would be
impracticable and contrary to the public interest. Delaying the
effective date would be contrary to the rule's objectives of enhancing
safety of life on the navigable waters and protection of persons and
vessels in vicinity of the fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Buffalo (COTP) has determined that a
fireworks display presents significant risks to the public safety and
property. Such hazards include premature and accidental detonations,
dangerous projectiles, and falling or burning debris. This rule is
needed to protect personnel, vessels, and the marine environment in the
navigable waters within the safety zone while the fireworks display
takes place.

IV. Discussion of the Rule

    This rule establishes a safety zone on July 4, 2018, from 9:45 p.m.
until 10:45 p.m. with a rain date of July 5, 2018 from 9:45 p.m. until
10:45 p.m. The safety zone will encompass all waters of the Buffalo
River, Buffalo, NY starting at position 42[deg]52'34.0'' N,
078[deg]52'54.7'' W then East to 42[deg]52'36.3'' N, 078[deg]52'48.6''
W then South to 42[deg]52'32.8'' N, 078[deg]52'45.4'' W then West to
42[deg]52'30.0'' N, 078[deg]52'51.9'' W then returning to the point of
origin.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Buffalo or his
designated on-scene representative. The Captain of the Port or his
designated on-scene representative may be contacted via VHF Channel 16.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the conclusion
that this rule is not a significant regulatory action. We anticipate
that it will have minimal impact on the economy, will not interfere
with other agencies, will not adversely alter the budget of any grant
or loan recipients, and will not raise any novel legal or policy
issues. The safety zone created by this rule will be relatively small
and enforced for a relatively short time. Also, the safety zone has
been designed to allow vessels to transit around it. Thus, restrictions
on vessel movement within that particular area are expected to be
minimal. Under certain conditions, moreover, vessels may still transit
through the safety zone when permitted by the Captain of the Port.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the

Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule
establishes a temporary safety zone. It is categorically excluded from
further review under paragraph L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T09-0613 to read as follows:

Sec.  165.T09-0613   Safety Zone; Canalside 4th of July Celebration,
Buffalo River, Buffalo, NY.

    (a) Location. The safety zone will encompass all waters of the
Buffalo River, Buffalo, NY starting at position 42[deg]52'34.0'' N,
078[deg]52'54.7'' W then East to 42[deg]52'36.3'' N, 078[deg]52'48.6''
W then South to 42[deg]52'32.8'' N, 078[deg]52'45.4'' W then West to
42[deg]52'30.0'' N, 078[deg]52'51.9'' W then returning to the point of
origin.
    (b) Enforcement period. This regulation will be enforced from 9:45
p.m. until 10:45 p.m. on July 4, 2018 with a rain date of July 5, 2018
from 9:45 p.m. until 10:45 p.m.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Buffalo or his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Buffalo is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Buffalo to act on his
behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone must contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
Buffalo or his on-scene representative may be contacted via VHF Channel
16. Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Buffalo, or his on-scene representative.

    Dated: June 27, 2018.
Joseph S. Dufresne,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2018-14325 Filed 7-2-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Notices]
[Pages 42744-42746]
[FR Doc No: 2012-17557]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0247]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Formal Meetings With Sponsors and Applicants for Prescription Drug
User Fee Act Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) 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 August
20, 2012.

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 0910-0429.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<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.

Guidance for Industry on Formal Meetings with Sponsors and Applicants
for Prescription Drug User Fee Act (PDUFA) Products--(OMB Control
Number 0910-0429)--(Extension)

    This information collection approval request is for FDA guidance on
the procedures for formal meetings between FDA and sponsors or
applicants regarding the development and review of PDUFA products. The
guidance describes procedures for requesting, scheduling, conducting,
and documenting such formal meetings. The guidance provides information
on how the Agency will interpret and apply section 119(a) of the Food
and Drug Administration Modernization Act (FDAMA), specific PDUFA goals
for the management of meetings associated with the review of human drug
applications for PDUFA products, and provisions of existing regulations
describing certain meetings (Sec. Sec.  312.47 and 312.82 (21 CFR
312.47 and 312.82)).
    The guidance describes two collections of information: The
submission of a meeting request containing certain information and the
submission of an information package in advance of the formal meeting.
Agency regulations at Sec.  312.47(b)(1)(ii), (b)(1)(iv), and (b)(2)
describe information that should be submitted in support of a request
for an End-of-Phase 2 meeting and a Pre-NDA meeting. The information
collection provisions of Sec.  312.47 have been approved by OMB (OMB
control number 0910-0014). However, the guidance provides additional
recommendations for submitting information to FDA in support of a
meeting request. As a result, FDA is submitting additional estimates
for OMB approval.

A. Request for a Meeting

    Under the guidance, a sponsor or applicant interested in meeting
with the Center for Drug Evaluation and Research (CDER) or the Center
for Biologics Evaluation and Research (CBER) should submit a meeting
request to the appropriate FDA component as an amendment to the
underlying application. FDA regulations (Sec. Sec.  312.23, 314.50, and
601.2 (21 CFR 312.23, 314.50, and 601.2)) state that information
provided to the Agency as part of an Investigational New Drug
Application (IND), New Drug Application (NDA), or Biological License
Application (BLA) must be submitted with an appropriate cover form.
Form FDA 1571 must accompany submissions under INDs and Form FDA 356h
must accompany submissions under NDAs and BLAs. Both forms have valid
OMB control numbers as follows: Form FDA 1571--OMB control number 0910
0014, and Form FDA 356h--OMB control number 0910 0338.
    In the guidance document, CDER and CBER ask that a request for a
formal meeting be submitted as an amendment to the application for the
underlying product under the requirements of Sec. Sec.  312.23, 314.50,
and 601.2; therefore, requests should be submitted to the Agency with
the appropriate form attached, either Form FDA 1571 or Form FDA 356h.
The Agency recommends that a request be submitted in this manner for
two reasons: (1) To ensure that each request is kept in the
administrative file with the entire underlying application and (2) to
ensure that pertinent information about the request is entered into the
appropriate tracking databases. Use of the information in the Agency's
tracking databases enables the Agency to monitor progress on the
activities attendant to scheduling and holding a formal meeting and to
ensure that appropriate steps will be taken in a timely manner.
    Under the guidance, the Agency requests that sponsors and
applicants include in meeting requests certain information about the
proposed meeting. Such information includes:
     Information identifying and describing the product;
     The type of meeting being requested;
     A brief statement of the purpose of the meeting;
     A list of objectives and expected outcomes from the
meeting;
     A preliminary proposed agenda;
     A draft list of questions to be raised at the meeting;
     A list of individuals who will represent the sponsor or
applicant at the meeting;
     A list of Agency staff requested to be in attendance;
     The approximate date that the information package will be
sent to the Agency; and
     Suggested dates and times for the meeting.
    This information will be used by the Agency to determine the
utility of the meeting, to identify Agency staff necessary to discuss
proposed agenda items, and to schedule the meeting.

B. Information Package

    A sponsor or applicant submitting an information package to the
Agency in advance of a formal meeting should provide summary
information relevant to the product and supplementary information
pertaining to any issue raised by the sponsor, applicant, or Agency.
The Agency recommends that information packages generally include:
     Identifying information about the underlying product;
     A brief statement of the purpose of the meeting;
     A list of objectives and expected outcomes of the meeting;
     A proposed agenda for the meeting;
     A list of specific questions to be addressed at the
meeting;
     A summary of clinical data that will be discussed (as
appropriate);
     A summary of preclinical data that will be discussed (as
appropriate); and
     Chemistry, manufacturing, and controls information that
may be discussed (as appropriate).
    The purpose of the information package is to provide Agency staff
the opportunity to adequately prepare for the meeting, including the
review of relevant data concerning the product. Although FDA reviews
similar information in the meeting request, the information package
should provide updated data that reflect the most current and accurate
information available to the sponsor or applicant. The Agency finds
that reviewing such information is critical to achieving a productive
meeting.
    The collection of information described in the guidance reflects
the current and past practice of sponsors and applicants to submit
meeting requests as amendments to INDs, NDAs, and BLAs and to submit
background information prior to a scheduled meeting. Agency regulations
currently permit such requests and recommend the submission of an
information package before an End-of-Phase 2 meeting (Sec.
312.47(b)(1)(ii) and (b)(1)(iv)) and a Pre-NDA meeting (Sec.
312.47(b)(2)).
    Description of Respondents: A sponsor or applicant for a drug or
biological product who requests a formal meeting with the Agency
regarding the development and review of a PDUFA product.
    Burden Estimate: Provided below is an estimate of the annual
reporting burden for the submission of meeting requests and information
packages under the guidance.

C. Request for a Formal Meeting

    Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 975 sponsors and
applicants (respondents) request approximately 2,014 formal meetings
with CDER annually and approximately 127 respondents request
approximately 253 formal meetings with CBER annually regarding the
development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent would spend
preparing the information to be submitted with a meeting request in
accordance with the guidance, is estimated to be approximately 10
hours. Based on FDA's experience, the Agency expects it will take
respondents this amount of time to gather and copy brief statements
about the product and a description of the purpose and details of the
meeting.

D. Information Package

    Based on data collected from the review divisions and offices
within CDER and CBER, FDA estimates that approximately 756 respondents
submitted approximately 1,394 information packages to CDER annually and
approximately 112 respondents submitted approximately 203 information
packages to CBER annually prior to a formal meeting regarding the
development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent would spend
preparing the information package in accordance with the guidance, is
estimated to be approximately 18 hours. Based on FDA's experience, the
Agency expects it will take respondents this amount of time to gather
and copy brief statements about the product, a description of the
details for the anticipated meeting, and data and information that
generally would already have been compiled for submission to the
Agency.
    As stated earlier, the guidance provides information on how the
Agency will interpret and apply section 119(a) of FDAMA, specific PDUFA
goals for the management of meetings associated with the review of
human drug applications for PDUFA products, and provisions of existing
regulations describing certain meetings (Sec. Sec.  312.47

and 312.82). The information collection provisions in Sec.  312.47
concerning End-of-Phase 2 meetings and Pre-NDA meetings have been
approved by OMB (OMB control number 0910 0014). However, the guidance
provides additional recommendations for submitting information to FDA
in support of a meeting request.
    In the Federal Register of March 20, 2012 (77 FR 16235), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received no comments on the information
collection.
    FDA estimates the burden of this collection of information as
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
Meeting requests and information     Number of     responses per   Total annual     burden per      Total hours
            packages                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Meeting Requests:
    CDER........................             975            2.06           2,014              10          20,140
    CBER........................             127            1.99             253              10           2,530
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............          22,670
Information Packages:
    CDER........................             756            1.84           1,394              18          25,092
    CBER........................             112            1.81             203              18           3,654
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............          28,746
                                 ===============================================================================
            Grand Total.........  ..............  ..............  ..............  ..............          51,416
----------------------------------------------------------------------------------------------------------------

    Dated: July 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17557 Filed 7-19-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Notices]
[Pages 4481-4482]
[FR Doc No: 2013-01247]

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

SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

 Order of Suspension of Trading; in the Matter of Medex, Inc.

January 17, 2013.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Medex, Inc. (``Medex'') because of questions regarding the accuracy of
assertions by Medex, and by others, in press releases and other public
statements to investors, and in promotional emails, concerning, among
other things: (i) The company's operations; and (ii) the company's
outstanding shares.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EST, on
January 17, 2013 through 11:59 p.m. EST, on January 31, 2013.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-01247 Filed 1-17-13; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Notices]
[Page 59149]
[FR Doc No: 2011-24450]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1981-DR; Docket ID FEMA-2011-0001]

North Dakota; Amendment No. 11 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for State of North Dakota (FEMA-1981-DR), dated May 10, 2011, and
related determinations.

DATES: Effective Date: September 14, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Deanne
Criswell, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Willie G. Nunn as Federal
Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-24450 Filed 9-22-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8061-8062]
[FR Doc No: 2016-03151]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2015-0606; FRL-9942-33-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; General Hazardous Waste Facility Standards
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``General

Hazardous Waste Facility Standards (Renewal)'' (EPA ICR No. 1571.11,
OMB Control No. 2050-0120) to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR,
which is currently approved through February 29, 2016. Public comments
were previously requested via the Federal Register (80 FR 65999) on
October 28, 2015 during a 60-day comment period. This notice allows for
an additional 30 days for public comments. A fuller description of the
ICR is given below, including its estimated burden and cost to the
public. 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.

DATES: Additional comments may be submitted on or before March 18,
2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
RCRA-2015-0606, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Norma Abdul-Malik, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Section 3004 of the Resource Conservation and Recovery
Act (RCRA), as amended, requires that the U.S. Environmental Protection
Agency develop standards for hazardous waste treatment, storage, and
disposal facilities (TSDFs) as may be necessary to protect human health
and the environment. Subsections 3004(a)(1), (3), (4), (5), and (6)
specify that these standards include, but not be limited to, the
following requirements:
     Maintaining records of all hazardous wastes identified or
listed under subtitle C that are treated, stored, or disposed of, and
the manner in which such wastes were treated, stored, or disposed of;
     Operating methods, techniques, and practices for
treatment, storage, or disposal of hazardous waste;
     Location, design, and construction of such hazardous waste
treatment, disposal, or storage facilities;
     Contingency plans for effective action to minimize
unanticipated damage from any treatment, storage, or disposal of any
such hazardous waste; and
     Maintaining or operating such facilities and requiring
such additional qualifications as to ownership, continuity of
operation, training for personnel, and financial responsibility as may
be necessary or desirable.
    The regulations implementing these requirements are codified in 40
CFR parts 264 and 265. The collection of this information enables the
EPA to properly determine whether owners/operators or hazardous waste
treatment, storage, and disposal facilities meet the requirements of
Section 3004(a) of RCRA.
    Form Numbers: None.
    Respondents/affected entities: Hazardous Waste Operators, State/
Local/Tribal governments.
    Respondent's obligation to respond: Mandatory (RCRA section 3004).
    Estimated number of respondents: 1,872.
    Frequency of response: On occasion.
    Total estimated burden: 672,417 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $41,759,144 (per year), includes $533,525
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is no change in hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2016-03151 Filed 2-16-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)]
[Rules and Regulations]
[Pages 61088-61091]
[FR Doc No: 2015-25495]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0677; Directorate Identifier 2013-NM-244-AD;
Amendment 39-18289; AD 2015-20-10]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace Corporation
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Gulfstream Aerospace Corporation Model GVI airplanes. This AD was
prompted by reports of corrosion on in-service air non-return valves.
This AD requires a revision to the Emergency Procedures section of the
airplane flight manual (AFM). This AD also requires a revision to the
maintenance or inspection program, as applicable, to incorporate
airworthiness limitations for the high pressure (HP) Stage 5 air non-
return valves. We are issuing this AD to ensure the flightcrew is
provided with

procedures to mitigate the risks associated with failure of the HP
Stage 5 air non-return valve. Failure of the HP Stage 5 air non-return
valve in the open position could result in engine instability and
uncommanded in-flight shutdown.

DATES: This AD is effective November 13, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 13,
2015.

ADDRESSES: For service information identified in this AD, contact
Gulfstream Aerospace Corporation, Technical Publications Dept., P.O.
Box 2206, Savannah, GA 31402-2206; telephone<PHONE_NUMBER>; fax 912-965-
3520; email<EMAIL_ADDRESS>Internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm. You may view this
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2015-0677.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0677; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Darby Mirocha, Continued Operational
Safety and Certificate Management, ACE-102A, FAA, Atlanta Aircraft
Certification Office (ACO), 1701 Columbia Avenue, College Park, GA
30337; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Gulfstream Aerospace
Corporation Model GVI airplanes. The NPRM published in the Federal
Register on March 31, 2015 (80 FR 17005). The NPRM was prompted by
reports of corrosion on in-service air non-return valves. Failure of
the HP Stage 5 air non-return valve in the open position could result
in engine instability and uncommanded in-flight shutdown. The NPRM
proposed to require a revision to the Emergency Procedures section of
the AFM and a revision to the maintenance or inspection program, as
applicable, to incorporate airworthiness limitations for the HP Stage 5
air non-return valves. We are issuing this AD to ensure the flightcrew
is provided with procedures to mitigate the risks associated with
failure of the HP Stage 5 air non-return valve.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (80 FR 17005, March 31,
2015) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (80 FR 17005, March 31, 2015) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the (NPRM 80 FR 17005, March 31, 2015).

Interim Action

    We consider this AD interim action. The manufacturer is currently
developing a modification that will positively address the unsafe
condition identified in this AD. Once this modification is developed,
approved, and available, we might consider additional rulemaking.

Related Service Information Under 1 CFR Part 51

    We reviewed Section 04-08-20, Normal Airstart--Automatic; Section
04-08-30, Manual Airstart--Starter Assist; and Section 04-08-40, Manual
Airstart--Windmilling; of Chapter 04, Emergency Procedures, of the
Gulfstream GVI (G650) AFM, Document Number GAC-AC-G650-OPS-0001,
Revision 5, dated August 12, 2013. This service information describes
revised procedures for in-flight engine restart and operating
procedures.
    In addition, we reviewed Section 05-10-10, Airworthiness
Limitations, of Chapter 05, Time Limits/Maintenance Checks, of the
Gulfstream GVI (G650) Maintenance Manual (MM), Revision 4, dated
September 30, 2013. This service information adds an airworthiness
limitation for the HP Stage 5 air non-return valve.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section of this
AD.

Costs of Compliance

    We estimate that this AD affects 52 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
AFM revision.......................  1 work-hour x $85 per hour               $0             $85          $4,420
                                      = $85.
MM revision........................  1 work-hour x $85 per hour                0              85           4,420
                                      = $85.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with

promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2015-20-10 Gulfstream Aerospace Corporation: Amendment 39-18289;
Docket No. FAA-2015-0677; Directorate Identifier 2013-NM-244-AD.

(a) Effective Date

    This AD is effective November 13, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Gulfstream Aerospace Corporation Model
GVI airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 36, Pneumatic.

(e) Unsafe Condition

    This AD was prompted by reports of corrosion on in-service air
non-return valves. We are issuing this AD to ensure the flightcrew
is provided with procedures to mitigate the risks associated with
failure of the high pressure (HP) Stage 5 air non-return valve.
Failure of the HP Stage 5 air non-return valve in the open position
could result in engine instability and uncommanded in-flight
shutdown.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Revision of the Airplane Flight Manual (AFM)

    Within 30 days after the effective date of this AD: Revise the
Emergency Procedures section of the AFM by inserting Section 04-08-
20, Normal Airstart--Automatic; Section 04-08-30, Manual Airstart--
Starter Assist; and Section 04-08-40, Manual Airstart--Windmilling;
of Chapter 04, Emergency Procedures; of the Gulfstream GVI (G650)
AFM, Document Number GAC-AC-G650-OPS-0001, Revision 5, dated August
12, 2013.

(h) Revision of Maintenance or Inspection Program

    Within 30 days after the effective date of this AD: Revise the
airplane maintenance manual or inspection program, as applicable, by
incorporating the requirement for the HP Stage 5 air non-return
valve from Section 05-10-10, Airworthiness Limitations, of Chapter
05, Time Limits/Maintenance Checks, of the Gulfstream GVI (G650)
Maintenance Manual (MM), Revision 4, dated September 30, 2013. The
initial compliance time for replacement of the HP Stage 5 air non-
return valve is at the applicable time specified in Section 05-10-
10, Airworthiness Limitations, of Chapter 05, Time Limits/
Maintenance Checks, of the Gulfstream GVI (G650) MM, Revision 4,
dated September 30, 2013, or within 30 days after the effective date
of this AD, whichever occurs later.

(i) No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised, as
required by paragraph (h) of this AD, no alternative actions (e.g.,
inspections) or intervals may be used unless the actions or
intervals are approved as an alternative method of compliance in
accordance with the procedures specified in paragraph (j) of this
AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    For more information about this AD, contact Darby Mirocha,
Continued Operational Safety and Certificate Management, ACE-102A,
FAA, Atlanta Aircraft Certification Office (ACO), 1701 Columbia
Avenue, College Park, GA 30337; phone:<PHONE_NUMBER>; fax: 404-474-
5606; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Section 04-08-20, Normal Airstart--Automatic, of Chapter 04,
Emergency Procedures, of the Gulfstream GVI (G650) Airplane Flight
Manual, Document Number GAC-AC-G650-OPS-0001, Revision 5, dated
August 12, 2013.
    (ii) Section 04-08-30, Manual Airstart--Starter Assist, of
Chapter 04, Emergency Procedures, of the Gulfstream GVI (G650)
Airplane Flight Manual, Document Number GAC-AC-G650-OPS-0001,
Revision 5, dated August 12, 2013.
    (iii) Section 04-08-40, Manual Airstart--Windmilling, of Chapter
04, Emergency Procedures, of the Gulfstream GVI (G650) Airplane
Flight Manual, Document Number GAC-AC-G650-OPS-0001, Revision 5,
dated August 12, 2013.
    (iv) Section 05-10-10, Airworthiness Limitations, of Chapter 05,
Time Limits/Maintenance Checks, of the Gulfstream GVI (G650)
Maintenance Manual, Revision 4, dated September 30, 2013.
    (3) For service information identified in this AD, contact
Gulfstream Aerospace Corporation, Technical Publications Dept., P.O.
Box 2206, Savannah, GA 31402-2206; telephone<PHONE_NUMBER>; fax 912-
965-3520; email<EMAIL_ADDRESS>Internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm.
    (4) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 30, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-25495 Filed 10-8-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)]
[Notices]
[Pages 66716-66717]
[FR Doc No: 2016-23419]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Flight
Operational Quality Assurance (FOQA) Program

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. Flight Operational Quality Assurance (FOQA) is a program
for the routine collection and analysis of digital flight data from
airline operations, including but not limited to digital flight data
currently collected pursuant to existing regulatory provisions. The FAA
requires certificate holders who voluntarily establish approved FOQA
programs to periodically provide aggregate trend analysis information
from such programs to the FAA.

DATES: Written comments should be submitted by October 28, 2016.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson by email at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0660.
    Title: Flight Operational Quality Assurance (FOQA) Program.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on July 6, 2016 (81 FR 44087). There were no comments.
The purpose of collecting, analyzing, aggregating, and reporting this
information is to identify potential threats to safety, and to enable
early corrective action before such threats lead to accidents. FOQA can
provide an objective source of information for FAA decision making,
including identification of the need for new rulemaking based on
observed trends in FOQA data. Title 14, Code of Federal Regulations (14
CFR), Subpart 13.401, stipulates that the FAA does not use FOQA
information in punitive enforcement action against an air carrier or
its employees, when that air carrier has an FAA approved FOQA program.
There are no legal or administrative requirements that necessitate this
rule. The rule is intended to encourage the voluntary implementation of
FOQA programs in the interest of safety enhancement.
    Respondents: 60 airline operators.
    Frequency: Information is collected monthly.

    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 720 hours.

    Issued in Washington, DC, on September 21, 2016.
Ronda Thompson,
FAA Information Collection Clearance Officer, Performance, Policy &
Records Management Branch, ASP-110.
[FR Doc. 2016-23419 Filed 9-27-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31327-31328]
[FR Doc No: 2021-12263]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0369]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Regulations Under the
Federal Import Milk Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, 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: Submit written comments (including recommendations) on the
collection of information by July 12, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0212. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, 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.

Regulations Under the Federal Import Milk Act (FIMA)--21 CFR Part 1210

OMB Control Number 0910-0212--Extension

    This information collection supports FDA regulations. Under FIMA
(21 U.S.C. 141-149), milk or cream may be imported into the United
States only by the holder of a valid import milk permit (21 U.S.C.
141). Before such permit is issued: (1) All cows from which import milk
or cream is produced must be physically examined and found healthy; (2)
if the milk or cream is imported raw, all such cows must pass a
tuberculin test; (3) the dairy farm and each plant in which the milk or
cream is processed or handled must be inspected and found to meet
certain sanitary requirements; (4) bacterial counts of the milk at the
time of importation must not exceed specified limits; and (5) the
temperature of the milk or cream at time of importation must not exceed
50 [deg]F (21 U.S.C. 142).
    Our regulations in part 1210 (21 CFR part 1210) implement the
provisions of FIMA. Sections 1210.11 and 1210.14 require reports on the
sanitary conditions of, respectively, dairy farms and plants producing
milk and/or cream to be shipped to the United States. Section 1210.12
requires reports on the physical examination of herds, while Sec.
1210.13 requires the reporting of tuberculin testing of the herds. In
addition, the regulations in part 1210 require that dairy farmers and
plants maintain pasteurization records (Sec.  1210.15) and that each
container of milk or cream imported into the United States bear a tag
with the product type, permit number, and shipper's name and

address (Sec.  1210.22). Section 1210.20 requires that an application
for a permit to ship or transport milk or cream into the United States
be made by the actual shipper. Section 1210.23 allows permits to be
granted based on certificates from accredited officials.
    Description of Respondents: Respondents include foreign dairy farms
and plants engaged in transporting milk and/or cream into the United
States. Respondents are from the private sector (for-profit
businesses).
    In the Federal Register of November 4, 2020 (85 FR 70182), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of
     21 CFR  section             Form FDA No.           Number of     responses per   Total annual       Average burden  per response       Total hours
                                                       respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.11..................  1996/Farm Inspection                   1             200             200  1.5................................             300
                            Report.
1210.12..................  1995/Report of Physical                1               1               1  0.5 (30 minutes)...................             0.5
                            Examination of Cows.
1210.13..................  1994/Report of                         1               1               1  0.5 (30 minutes)...................             0.5
                            Tuberculin Tests of
                            Cattle.
1210.14..................  1997/Score Card for                    1               1               1  2..................................               2
                            Sanitation Inspections
                            of Milk Plants.
1210.20..................  1993/Application for                   1               1               1  0.5 (30 minutes)...................             0.5
                            Permit to Ship or
                            Transport Milk and/or
                            Cream into United
                            States.
1210.23..................  1815/Certificate/                      1               1               1  0.5 (30 minutes)...................             0.5
                            Transmittal for an
                            Application.
                                                    ----------------------------------------------------------------------------------------------------
     Total...............  ........................  ..............  ..............  ..............  ...................................             304
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
          21 CFR section; activity               Number of      records per    Total annual        Average burden  per recordkeeping        Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
1210.15 Pasteurization; Equipment and                      1               1               1  0.05 (3 minutes)..........................            0.05
 Methods.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The Secretary of Health and Human Services has the discretion to
allow Form FDA 1815, a duly certified statement signed by an accredited
official of a foreign government, to be submitted in lieu of Forms FDA
1994 and 1995. In the past, Form FDA 1815 has been submitted in lieu of
these forms. Because we have not received any Forms FDA 1994 or 1995 in
the last 3 years, we assume no more than 1 will be submitted annually.
    No burden has been estimated for the tagging requirement in Sec.
1210.22 because the information on the tag is either supplied by us
(permit number) or is disclosed to third parties as a usual and
customary part of the shipper's normal business activities (type of
product, shipper's name and address). Under 5 CFR 1320.3(c)(2), the
public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the public
is not subject to review by OMB under the PRA. Under 5 CFR
1320.3(b)(2), the time, effort, and financial resources necessary to
comply with a collection of information are excluded from the burden
estimate if the reporting, recordkeeping, or disclosure activities
needed to comply are usual and customary because they would occur in
the normal course of business activities.
    Based on a review of the information collection since our last OMB
approval, we have decreased our burden estimate. The estimated number
of respondents and hours per response are based on our experience with
the import milk permit program and the average number of import milk
permit holders over the past 3 years. However, we have not received any
responses in the last 3 years. Therefore, we estimate that one or fewer
to be submitted annually. Although we have not received any responses
in the last 3 years, we believe these information collection provisions
should be extended to provide for the potential future need for a milk
importer.

    Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12263 Filed 6-10-21; 8:45 am]
BILLING CODE 4164-01-P