[Federal Register Volume 79, Number 137 (Thursday, July 17, 2014)]
[Rules and Regulations]
[Pages 41647-41649]
[FR Doc No: 2014-16760]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2014-0388 FRL-9913-84-Region 10]

Approval and Promulgation of State Implementation Plans; Idaho:
Portneuf Valley PM10 Maintenance Plan Amendment to the Motor
Vehicle Emissions Budgets

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve a State Implementation Plan (SIP) revision
submitted by the State of Idaho (Idaho or the State) on April 21, 2014,
to amend the Portneuf Valley maintenance plan for particulate matter
with an aerodynamic diameter less than or equal to a nominal 10
micrometers (PM10). The SIP revision updates the on-road
motor vehicle emissions inventory and motor vehicle emissions budgets
(MVEBs) using the EPA's Motor Vehicle Emissions Simulator (MOVES2010b)
and the most recent road dust emission factors. This rulemaking action
approves the SIP revision and thereby makes the MVEBs available for
transportation conformity purposes. The EPA is approving this SIP
revision because it is consistent with the Clean Cir Act (CAA).

DATES: This rule is effective on September 15, 2014, without further
notice, unless the EPA receives adverse comment by August 18, 2014. If
the EPA receives adverse comment, we will publish a timely withdrawal
in the Federal Register informing the public that the rule will not
take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2014-0388, by any of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Karl Pepple, U.S. EPA Region 10, Office of Air,
Waste and Toxics (AWT-107), 1200 Sixth Avenue, Suite 900, Seattle, WA
98101.
     Hand Delivery/Courier: U.S. EPA Region 10, 1200 Sixth
Avenue, Suite 900, Seattle, WA 98101. Attention: Karl Pepple, Office of
Air, Waste and Toxics, AWT-107. Such deliveries are only accepted
during normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R10-OAR-
2014-0388. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA without going through
www.regulations.gov your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters, any form of encryption, and be free of any
defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., 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. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Office of Air, Waste
and Toxics, U.S. EPA Region 10, 1200 Sixth Avenue, Seattle, WA 98101.

FOR FURTHER INFORMATION CONTACT: Karl Pepple at telephone number: (206)
553-1778, email address<EMAIL_ADDRESS>or the above EPA, Region
10 address.

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

I. Background for This Action

    In 2004, Idaho requested that the EPA redesignate the Portneuf
Valley area from nonattainment to attainment for PM10 and
submitted a maintenance plan (2004 maintenance plan) that demonstrated
attainment of the PM10 NAAQS through 2020. The EPA approved
Idaho's submittal on July 13, 2006 (71 FR 39574). The 2004 maintenance
plan included an on-road motor vehicle emissions inventory and MVEBs
for PM10, volatile organic compounds (VOC) and nitrogen
oxides (NOX).
    The MVEBs serve as a ceiling on emissions from an area's planned
transportation system. Under section 176(c) of the CAA, transportation
plans and projects must ``conform'' to (i.e., be consistent with) the
SIP before they can be adopted or approved. Conformity to the SIP means
that transportation activities will not cause new air quality
violations, worsen existing air quality violations, or delay timely
attainment of the NAAQS or delay an interim milestone. The MVEB is the
mechanism

the EPA has identified for carrying out the demonstration of
consistency with the SIP. For more information about MVEBs see the
preamble to the November 24, 1993, transportation conformity rule (58
FR 62188).
    In the 2004 maintenance plan, the on-road motor vehicle emissions
inventory and MVEBs were developed using the EPA's motor vehicle
emission factor model, MOBILE6, and paved road dust emissions factors
calculated with the 1995 version of the EPA's AP-42, Compilation of Air
Pollutant Emission Factors (AP-42).\1\ Throughout this document, we
refer to the on-road vehicle emissions inventory and MVEBs in the 2004
maintenance plan as the ``existing'' on-road vehicle emissions
inventory and MVEBs.
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    \1\ For information on paved road dust emission factors, see AP-
42, chapter 13, section 2.1, http://www.epa.gov/ttn/chief/ap42/index.html#toc.
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    On March 2, 2010 (75 FR 9411), the EPA published a notice of
availability of the MOVES2010 model for use in developing MVEBs for
SIPs and for conducting transportation conformity analyses. The
MOVES2010 model is the EPA's state of the art tool for estimating
highway emissions. The EPA subsequently released two minor model
revisions: MOVES2010a in September 2010, and MOVES2010b in April 2012.
On February 4, 2011 (76 FR 6328), the EPA announced an update to the
AP-42 method for estimating paved road dust emissions (2011 AP-42).
MOVES2010 and the 2011 AP-42 paved road dust emissions factors are
required to be used in new regional emissions analyses for
transportation conformity determinations in the Portneuf Valley
PM10 maintenance area. Idaho and the Bannock Transportation
Planning Organization examined how the new methods would affect future
transportation conformity determinations. Idaho opted to submit a SIP
revision to update the existing MVEBs with MOVES2010b, the 2011 AP-42
paved road dust emission factors, and the latest planning assumptions.
The EPA received Idaho's SIP revision on April 21, 2014.

II. The EPA's Evaluation of Idaho's SIP Revision

    Idaho's SIP revision changed only the on-road motor vehicle
emissions in the 2004 maintenance plan. The SIP revision updated the
on-road vehicle emissions inventory and the MVEBs using MOVES2010b and
the 2011 AP-42 paved road dust emissions factors and used the latest
planning assumptions. Idaho explained that the point and area source
emissions in the 2004 maintenance plan remained unchanged. The growth
assumptions remained valid as did the control strategy assumptions for
categories other than on-road vehicles. However, Idaho documented major
changes in sand usage for wintertime antiskid treatments since the
analysis used in the 2004 maintenance plan and this change resulted in
a significant reduction in paved road dust emissions estimates as
calculated using the 2011 AP-42 paved road dust method. As a result of
the updated modeling and planning assumptions, the on-road emissions
inventory has lower estimates for direct PM10 emissions and
higher estimates for NOX and VOC emissions than the existing
on-road emissions inventory did. The EPA notes that the increases in
emissions estimates for NOX and VOC are not due to increases
in emissions from on-road motor vehicles, but rather because MOVES2010
provides more accurate emissions estimates than the MOBILE6 model did.
    To assess the maximum effect of the updated modeling and planning
assumptions on net PM10 emissions in the airshed, Idaho used
a 100% conversion rate for NOX to ammonium nitrate to
compare the updated on-road emissions inventory to the existing MVEBs.
Based on this analysis, the net PM10 calculated emissions
were lower in the updated on-road emissions inventory than in the
existing MVEBs. Although the results of the analysis showed greater
PM10 emissions in the updated on-road emissions inventory
from secondary particle formation than in the existing MVEBs, it showed
lower PM10 emissions from directly emitted PM10.
Thus, Idaho concluded that the reductions in paved road dust emissions
estimates were greater than the increases that occurred from the
MOBILE6 to MOVES2010b modeling changes.
    As provided for in the transportation conformity rule (40 CFR
93.124(a)), Idaho developed updated MVEBs by adding a safety margin to
the updated on-road emissions inventory estimates. The safety margin
was calculated from the difference in emissions between the updated on-
road emissions inventory and the existing MVEBs.\2\ Idaho demonstrated
that the net PM10 calculated emissions in the updated and
existing MVEBs were equivalent. The updated MVEBs for the years 2011
and 2020 are shown in the table below.
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    \2\ Idaho added a 3.1% safety margin to the on-road emissions
estimates for the 2011 MVEB and a 31.5% safety margin for the 2020
MVEB.

             Updated MVEBs for the Portneuf Valley PM10 Area
                             [Tons per year]
------------------------------------------------------------------------
                     Year                        PM10     NOX      VOC
------------------------------------------------------------------------
2011.........................................      415    1,364      903
2020.........................................      498      856      651
------------------------------------------------------------------------

    The EPA evaluated the updated on-road vehicle emission inventory
and the MVEBs in Idaho's SIP revision and concluded that the SIP
continues to demonstrate its purpose of maintaining the PM10
NAAQS through the year 2020 because the total PM10 emissions
from on-road vehicles in the SIP revision are equivalent to the total
PM10 emissions from on-road vehicles in the 2004 maintenance
plan.

III. Final Action

    The EPA is taking direct final action to approve the SIP revision
submitted on April 21, 2014, by the State of Idaho to the Portneuf
Valley PM10 Maintenance Plan. The SIP revision includes
MVEBs that were developed with the MOVES2010b model the 2011 AP-42
paved road dust emission factors. Upon the effective date of our
approval, the MOBILE6-based budgets in the existing SIP will no longer
be applicable for transportation conformity purposes.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. 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 Order
12866 (58 FR 51735, October 4, 1993);
     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 CAA; and
     does not provide the 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, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because it will not impose substantial direct costs on tribal
governments or preempt tribal law.
    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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 15, 2014. 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. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that the EPA
can withdraw this direct final rule and address the comment in the
proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements. (See CAA section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxides, Particulate Matter, Reporting and
recordkeeping requirements, and Volatile organic compounds.

    Dated: July 2, 2014.
Dennis J. McLerran,
Regional Administrator, Region 10.
    For the reasons set out in the preamble, title 40, chapter I 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 N--Idaho

0
2. Section 52.670 is amended in paragraph (e) by adding two entries to
the end of the table to read as follows:

Sec.  52.670  Identification of plan.

* * * * *
    (e) * * *

                    EPA-Approved Idaho Nonregulatory Provisions and Quasi-Regulatory Measures
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                                        Applicable
      Name of SIP provision            geographic or          State        EPA approval date        Comments
                                    nonattainment area   submittal date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Portneuf Valley PM10               Portneuf Valley.....         7/13/06  71 FR 39574.........  .................
 Nonattainment Area Plan
 and Maintenance Plan............
Portneuf Valley PM10 Maintenance   Portneuf Valley.....        04/21/14  07/17/14 [Insert      .................
 Plan--Revision.                                                          page number where
                                                                          the document
                                                                          begins].
----------------------------------------------------------------------------------------------------------------

0
3. Section 52.672 is amended by adding paragraph (e)(2) to read as
follows:

Sec.  52.672  Approval of plans.

* * * * *
    (e) * * *
    (2) The EPA approves as a revision to the Idaho State
Implementation Plan, the Portneuf Valley PM10 Maintenance
Plan Amendment submitted by the State on April 21, 2011, revising the
Portneuf Valley PM10 Nonattainment Area Plan and Maintenance
Plan that was approved at 71 FR 39574 (July 13, 2006).
* * * * *
[FR Doc. 2014-16760 Filed 7-16-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 5, 2008 (Volume 73, Number 173)]
[Notices]
[Page 51829-51830]
[DOCID:fr05se08-59]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369] (formerly Docket No. 2007D-0168)

Publication of Guidances for Industry Describing Product-Specific
Bioequivalence Recommendations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of additional draft and revised draft product-specific
bioequivalence (BE) recommendations. The recommendations provide
product-specific guidance on the design of BE studies to support
abbreviated new drug applications (ANDAs). In the Federal Register of
May 31, 2007 (72 FR 30388), FDA announced the availability of a draft
guidance for industry, ``Bioequivalence Recommendations for Specific
Products,'' explaining the process that would be used to make product-
specific BE recommendations available to the public on FDA's Web site.
The BE recommendations identified in this notice were developed using
the process described in that guidance.

DATES: Submit written or electronic comments on the draft product-
specific BE recommendations listed in this notice by December 4, 2008.

ADDRESSES: Submit written requests for single copies of the individual
BE guidances to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft product-specific BE
recommendations to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to http://www.regulations.gov. See
the

SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 31, 2007 (72 FR 30388), FDA
announced the availability of a draft guidance for industry,
``Bioequivalence Recommendations for Specific Products,'' that
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://
www.fda.gov/CDER/GUIDANCE/bioequivalence/default.htm. As described in
that draft guidance, FDA adopted this process as a means to develop and
disseminate product-specific BE recommendations and provide a
meaningful opportunity for the public to consider and comment on those
recommendations. Since that notice was published we have published a
correction notice concerning Bioequivalence Recommendations for
Specific Products on October 25, 2007 (72 FR 60683). This notice
includes draft product-specific recommendations either newly posted or
updated since the Federal Register notice dated October 25, 2007,
through April 30, 2008.

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

    The following draft BE product-specific recommendations have been
newly posted since the FR notice dated October 25, 2007:
    (1) Abacavir Sulfate; Lamivudine
    (2) Alendronate Sodium
    (3) Alfuzosin HCl
    (4) Alprazolam
    (5) Amoxicillin; Clavulanate Potassium (multiple RLDs)
    (6) Amprenavir
    (7) Aripiprazole
    (8) Armodafinil
    (9) Atovaquone
    (10) Azithromycin
    (11) Balsalazide Disodium
    (12) Bupropion HCl (updated)
    (13) Carbamazepine (multiple dosage forms)
    (14) Cefdinir
    (15) Cefixime
    (16) Cetirizine HCl; Pseudoephedrine HCl
    (17) Ciprofloxacin; Ciprofloxacin HCl
    (18) Ciprofloxacin HCl
    (19) Clarithromycin
    (20) Darunavir Ethanolate
    (21) Delavirdine Mesylate
    (22) Dexmethylphenidate
    (23) Diltiazem HCl (multiple dosage forms; multiple RLDs)
    (24) Divalproex Sodium
    (25) Doxycycline (multiple dosage forms)
    (26) Eprosartan Mesylate; Hydrochlorothiazide
    (27) Esterified Estrogens
    (28) Eszopiclone
    (29) Ethambutol HCl
    (30) Ethinyl Estradiol; Levonorgestrel (multiple RLDs)
    (31) Fenofibrate
    (32) Fluvastatin Sodium (multiple dosage forms)
    (33) Fosamprenavir Calcium
    (34) Glimepiride; Rosiglitazone Maleate
    (35) Lamivudine
    (36) Linezolid
    (37) Lisinopril
    (38) Lopinavir; Ritonavir
    (39) Memantine HCl
    (40) Mesalamine
    (41) Metoprolol Succinate (updated)
    (42) Minocycline HCl
    (43) Nelfinavir Mesylate
    (44) Nevirapine
    (45) Omeprazole; Sodium Bicarbonate; Magnesium Hydroxide
    (46) Oxymorphone HCl (multiple dosage forms)
    (47) Paliperidone
    (48) Paricalcitol
    (49) Phenytoin
    (50) Pimozide
    (51) Posaconazole
    (52) Quinine Sulfate
    (53) Saquinavir Mesylate (multiple dosage forms)
    (54) Solifenacin Succinate
    (55) Tenofovir Disoproxil Fumarate
    (56) Tinidazole
    (57) Tipranavir
    (58) Tolterodine Tartrate
    (59) Tramadol HCl
    (60) Trospium Chloride
    (61) Varenicline Tartrate
    (62) Zafirlukast
    (63) Zalcitabine
    (64) Zileuton
    (65) Zolmitriptan
    (66) Zonisamide

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

    The following five product-specific recommendations previously made
available on FDA's Web site have been updated:
    1. Risedronate Sodium
    2. Fosinopril Sodium; Hydrochlorothiazide
    3. Fluoxetine HCl; Olanzapine
    4. Erlotinib HCl
    5. Morphine Sulfate
For a complete history of previous Federal Register notices pertaining
to product-specific BE recommendations, please go to http://
www.regulations.gov and enter FDA-2007-D-0369.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on any of the specific
BE recommendations posted on FDA's Web site. Two copies of mailed
comments are to be submitted, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The guidance, notices, and
received comments are available for public examination in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: August 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20580 Filed 9-4-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Notices]
[Page 35695]
[FR Doc No: 2015-15267]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Request for Comments;
Revision of an Existing Information Collection: Medical Standards and
Certification

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and
Office of Management and Budget (OMB) regulations, the FAA invites
public comments about our intention to request OMB approval to revise
an existing information collection. The information collected is used
to determine if applicants are medically qualified to perform the
duties associated with the class of airman medical certificate sought.
The FAA intends to revise the information it is collecting via FAA form
8500-8, in part, to respond to recommendations made in an April 2014
General Services Administration report entitled ``FAA Should Improve
Usability of its Online Application System and Clarity of the Pilot's
Medical Form.''

DATES: Comments should be submitted by August 21, 2015.

ADDRESSES: Send comments to the FAA at the following address: Ronda
Thompson, Room 300, Federal Aviation Administration, ASP-110, 950
L'Enfant Plaza SW., Washington, DC 20024.
    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.
    The FAA is seeking comments only with regard to the burden
associated with the information collection activity under OMB Control
Number 2120-0034. As such, any comments received that cite this notice
but are outside of the scope of the collection activity under OMB
Control Number 2120-0034 will not be addressed.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson at<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0034.
    Title: Medical Standards and Certification.
    Form Numbers: FAA forms 8500-7, 8500-8, and 8500-14.
    Type of Review: Revision of an existing information collection.
    Background: The Secretary of Transportation collects this
information under the authority of 49 U.S.C. 40113; 44701; 44510;
44702; 44703; 44709; 45303; and 80111. The airman medical certification
program is implemented by Title 14 Code of Federal Regulations (CFR)
parts 61 and 67 (14 CFR parts 61 and 67). The FAA determines if
applicants are medically qualified to perform the duties associated
with the class of airman medical certificate sought.
    Respondents: Approximately 414,300 applicants for airman medical
certificates.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 1.5 hours.
    Estimated Total Annual Burden: 598,950 hours.

    Issued in Washington, DC, on June 16, 2015.
Ronda Thompson,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, ASP-110.
[FR Doc. 2015-15267 Filed 6-19-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)]
[Rules and Regulations]
[Page 49164]
[FR Doc No: 2016-17765]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2016-0517]

Special Local Regulation; Annual Marine Events on the Colorado
River, Between Davis Dam (Bullhead City, Arizona) and Headgate Dam
(Parker, Arizona) Within the San Diego Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the special local regulations for
the Bullhead City River Regatta marine event on the navigable waters of
the Colorado River on August 13, 2016. This action is necessary to
provide for the safety of the participants, crew, spectators, safety
vessels, and general users of the waterway. Our regulation for the
annual marine events on the Colorado River, between Davis Dam (Bullhead
City, Arizona) and Headgate Dam (Parker, Arizona) identifies the
regulated area for this event. During the enforcement period, no
spectator shall anchor, block, loiter, nor impede the through transit
of participants or official patrol vessels within this regulated area
unless authorized by the Captain of the Port, or a designated
representative.

DATES: The regulations in 33 CFR 100.1102 will be enforced from 6 a.m.
through 6 p.m. on August 13, 2016 for Item 16 in Table 1 of 33 CFR
100.1102.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
publication, call or email Petty Officer Randolph Pahilanga, Waterways
Management, U.S. Coast Guard Sector San Diego, CA; telephone 619-278-
7656<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    The Coast Guard will enforce the special local regulations in 33
CFR 100.1102 for the Bullhead City River Regatta in 33 CFR 100.1102,
Table 1, Item 16 of that section from 6 a.m. to 6 p.m. on August 13,
2016. This action is necessary to provide for the safety of the
participants, crew, spectators, safety vessels, and general users of
the waterway. Our regulation for the annual marine events on the
Colorado River, between Davis Dam (Bullhead City, Arizona) and Headgate
Dam (Parker, Arizona) identifies the regulated entities for this event.
Under the provisions of 33 CFR 100.1102, no spectator shall anchor,
block, loiter, nor impede the through transit of participants or
official patrol vessels within this regulated area of the Colorado
River unless authorized by the Captain of the Port, or his designated
representative. The Coast Guard may be assisted by other Federal,
state, or local law enforcement agencies in enforcing this regulation.
    This document is issued under authority of 33 CFR 100.1102 and 5
U.S.C. 552(a). In addition to this document in the Federal Register,
the Coast Guard will provide the maritime community with extensive
advance notification of this enforcement period via the Local Notice to
Mariners and local advertising by the event sponsor.
    If the Captain of the Port or his designated representative
determines that the regulated area need not be enforced for the full
duration stated on this document, he or she may use a Broadcast Notice
to Mariners or other communications coordinated with the event sponsor
to grant general permission to enter the regulated area.

    Dated: June 18, 2016.
E.M. Cooper,
Commander, U.S. Coast Guard, Acting Captain of the Port San Diego.
[FR Doc. 2016-17765 Filed 7-26-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Page 18341]
[FR Doc No: 2017-07916]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

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

ACTION: Notice of Unified Carrier Registration Plan Board of Directors
meeting.

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TIME AND DATE:  The meeting will be held on April 28, 2017, from 1:00
p.m. to 4:00 p.m. Eastern Daylight Time.

PLACE:  The meetings will be open to the public at the Hampton Inn,
3398 Piedmont Rd. NE., Atlanta, GA 30305, and via conference call.
Those not attending the meetings in person may call 1-877-422-1931,
passcode<PHONE_NUMBER>, to listen and participate in the meetings.

STATUS:  Open to the public, however, the Board may vote to close
portions of the meeting to the public to deliberate on matters
involving confidential commercial or financial information.

MATTERS TO BE CONSIDERED:  The Unified Carrier Registration Plan Board
of Directors (the Board) will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement and to
that end, may consider matters properly before the Board.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors at<PHONE_NUMBER>.

    Issued on: April 14, 2017.
Larry W. Minor,
Associate Administrator, Office of Policy, Federal Motor Carrier Safety
Administration.
[FR Doc. 2017-07916 Filed 4-14-17; 4:15 pm]
 BILLING CODE 4910-EX-P


To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OW-2011-0443, which is available for online viewing at www.regulations.gov, or in person viewing at the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Water Docket is<PHONE_NUMBER>. An electronic version of the public docket is available at www.regulations.gov. This site can be used to submit or view public comments, to access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select "search," then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number (EPA-HQ-OW-2011-0443) and the OMB Control Number 2040-0090 in any correspondence.


[Federal Register Volume 87, Number 94 (Monday, May 16, 2022)]
[Notices]
[Pages 29753-29754]
[FR Doc No: 2022-10189]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4534]

Reducing Microbial Food Safety Hazards in the Production of Seed
for Sprouting; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Reducing Microbial Food Safety Hazards in the Production of Seed for
Sprouting.'' This final guidance is intended to inform the sprout seed
industry (seed growers, conditioners, packers, holders, suppliers, and
distributors) of FDA's serious concern with the continuing outbreaks of
foodborne illness associated with the consumption of raw and lightly
cooked sprouts and provide FDA's recommendations to firms throughout
the production chain of seed for sprouting.

DATES: The announcement of the guidance is published in the Federal
Register on May 16, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-4534 for ``Reducing Microbial Food Safety Hazards in the
Production of Seed for Sprouting: Guidance for Industry.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential

with a heading or cover note that states ``THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.'' We will review this copy, including the
claimed confidential information, in our consideration of comments. The
second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Food Safety, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.
Send two self-addressed adhesive labels to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Patricia Homola, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>; or Lauren Kleinman, Center
for Food Safety and Applied Nutrition, Office of Regulations and Policy
(HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Reducing Microbial Food Safety Hazards in the Production of
Seed for Sprouting.'' This guidance is intended to inform the sprout
seed industry (seed growers, conditioners, packers, holders, suppliers,
and distributors) of our serious concern with the continuing outbreaks
of foodborne illness associated with the consumption of raw and lightly
cooked sprouts and provide our recommendations to firms throughout the
production chain of seed for sprouting. We are issuing the guidance
consistent with our good guidance practices regulation (21 CFR 10.115).
The guidance represents the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
    In the Federal Register of June 25, 2019 (84 FR 29867), we
announced a draft guidance for industry and gave interested parties an
opportunity to submit comments by August 26, 2019, for us to consider
before beginning work on the final version of the guidance. We received
10 comments on the draft guidance and have modified the final guidance
where appropriate. Changes to the guidance include the addition of
examples, information about the scope of recommendations pertaining to
cleaning and sanitizing of wet and dry food contact surfaces,
information about testing seed for sprouting, research related to the
source of contamination in sprout-related outbreaks, and updated
recommendations related to proximity of seed growing operations to a
domestic animal raising farm. The guidance announced in this notice
finalizes the draft guidance dated June 2019.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov. Use the FDA website listed in
the previous sentence to find the most current version of the guidance.

    Dated: May 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10189 Filed 5-13-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Notices]
[Page 60307]
[DOCID:fr10oc08-99]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1798-DR]

Puerto Rico; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Commonwealth of Puerto Rico (FEMA-1798-DR), dated
October 1, 2008, and related determinations.

DATES: Effective Date: October 1, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 1, 2008, the President declared a major disaster under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:

    I have determined that the damage in certain areas of the
Commonwealth of Puerto Rico resulting from severe storms and
flooding beginning on September 21, 2008, and continuing, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act).
Therefore, I declare that such a major disaster exists in the
Commonwealth of Puerto Rico.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance in the
designated areas, Hazard Mitigation throughout the Commonwealth, and
any other forms of assistance under the Stafford Act that you deem
appropriate. Consistent with the requirement that Federal assistance
be supplemental, any Federal funds provided under the Stafford Act
for Hazard Mitigation and Other Needs Assistance will be limited to
75 percent of the total eligible costs. If Public Assistance is
later requested and warranted, Federal funds provided under that
program also will be limited to 75 percent of the total eligible
costs, except for any particular projects that are eligible for a
higher Federal cost-sharing percentage under the FEMA Public
Assistance Pilot Program instituted pursuant to 6 U.S.C. 777.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Justo Hernandez, of FEMA is
appointed to act as the Federal Coordinating Officer for this declared
disaster.
    The following areas of the Commonwealth of Puerto Rico have been
designated as adversely affected by this declared major disaster:

    The municipalities of Guayama, Humacao, Maunabo, Patillas,
Ponce, Salinas, Santa Isabel, and Yabucoa.
    All municipalities within the Commonwealth of Puerto Rico are
eligible to apply for assistance under the Hazard Mitigation Grant
Program.

(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.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
 [FR Doc. E8-24101 Filed 10-9-08; 8:45 am]

BILLING CODE 9111-23-P