[Federal Register Volume 80, Number 218 (Thursday, November 12, 2015)]
[Rules and Regulations]
[Pages 69880-69883]
[FR Doc No: 2015-28624]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0257; FRL-9934-89-Region 9]

Approval of Air Plans; California; Multiple Districts; Prevention
of Significant Deterioration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action under section 110 of the Clean Air Act (CAA or Act) to approve a
State Implementation Plan (SIP) revision for five California air
districts. The State of California (State) is required by the CAA to
adopt and implement a SIP-approved Prevention of Significant
Deterioration (PSD) permit program. This SIP revision incorporates PSD
rules for five local California air districts into the California SIP
to establish a PSD permit program for pre-construction review of
certain new and modified major stationary sources in attainment and
unclassifiable areas located within these districts. The local air
districts with PSD rules that are the subject of this action are the
Feather River Air Quality Management District (Feather River or
FRAQMD), Great Basin Unified Air Pollution Control District (Great
Basin or GBUAPCD), Butte County Air Quality Management District (Butte
or BCAQMD), Santa Barbara County Air Pollution Control District (Santa
Barbara or SBAPCD), and San Luis Obispo County Air Pollution Control
District (San Luis Obispo or SLOAPCD)--collectively, the Districts.

DATES: This rule is effective on December 14, 2015.

ADDRESSES: The EPA has established docket number EPA-R09-OAR-2015-0257
for this action. Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. Some docket
materials, however, may be publicly available only at the hard copy
location (e.g., voluminous records, maps, copyrighted material), and
some may not be publicly available in either location (e.g.,
confidential business information (CBI)). To inspect the hard copy
materials, please schedule an appointment during normal business hours
with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Lisa Beckham, EPA Region IX, (415)
972-3811<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we'', ``us'',
and ``our'' refer to the EPA.

Table of Contents

I. Background
II. The EPA's Evaluation of the SIP Revision
    A. Summary of the EPA's Proposed Action
    B. Public Comments and the EPA's Responses
    C. What action is the EPA finalizing?
III. The EPA's Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background

    Section 110(a) of the CAA requires states to adopt and submit
regulations for the implementation, maintenance and enforcement of the
primary and secondary NAAQS. Specifically, sections 110(a)(2)(C),
110(a)(2)(D)(i)(II), and 110(a)(2)(J) of the Act require such state
plans to meet the applicable requirements of section 165 relating to a
pre-construction permit program for the prevention of significant
deterioration of air quality and visibility protection. The rules
reviewed for this action are intended to implement a pre-construction
PSD permit program as required by section 165 of the CAA for certain
new and modified major stationary sources located in attainment and
unclassifiable areas. Because the State does not currently have a SIP-
approved PSD program within the Districts, the EPA is currently the PSD
permitting authority within these Districts under a Federal
Implementation Plan (FIP). Approval of the Districts' PSD rules into
the SIP will transfer PSD permitting authority from the EPA to the
Districts. The EPA will then assume the role of overseeing the
Districts' PSD permitting programs, as intended by the CAA.
    For a more detailed discussion of the District's rules, please
refer to our proposed approval. See 80 FR 44001 (July 24, 2015).

II. The EPA's Evaluation of the SIP Revision

A. Summary of the EPA's Proposed Action

    On July 24, 2015 (80 FR 44001), the EPA proposed approval of the
Districts' PSD rules into the California SIP. We proposed to approve
these rules because we determined that they satisfied the applicable
CAA requirements. Our proposed rule and related Technical Support
document (TSD) contain more information about the basis for this
rulemaking and our evaluation of the pertinent State SIP revision
submittals.

B. Public Comments and the EPA's Responses

    EPA's proposed approval action for this SIP revision provided a 30-
day public comment period. We did not receive any comments on our
proposed action.

C. What action is the EPA finalizing?

    The EPA is finalizing a SIP revision for each District's portion of
the California SIP, consistent with our proposed approval action. The
SIP revision will be codified in 40 CFR 52.220 by incorporating by
reference the rules listed in Table 1. On June 1, 2015, the California
Air Resources Board (CARB) requested the withdrawal from its earlier
SIP submittals of the portion of each District PSD rule that
incorporates by reference a particular federal PSD rule provision--40
CFR 52.21(b)(49)(v). As such, our approval of these local District
rules does not include the rules' incorporation by reference of 40 CFR
52.21(b)(49)(v).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
         Local  agency             Rule No.               Rule title                  Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
FRAQMD.........................        10.10  Prevention of Significant                 8/1/2011       4/22/2013
                                               Deterioration.
GBUAPCD........................          221  Prevention of Significant                 9/5/2012        2/6/2013
                                               Deterioration (PSD) Permit
                                               Requirements for New Major
                                               Facilities or Major Modifications
                                               in Attainment or Unclassifiable
                                               Areas.
BCAQMD.........................         1107  Prevention of Significant                6/28/2012        2/6/2013
                                               Deterioration (PSD) Permits.
SBAPCD.........................          810  Federal Prevention of Significant        6/20/2013       2/10/2014
                                               Deterioration (PSD).

SLOAPCD........................          220  Federal Prevention of Significant        1/22/2014       5/13/2014
                                               Deterioration.
----------------------------------------------------------------------------------------------------------------

    In addition, letters from the Districts to the EPA providing
certain clarifications regarding their PSD rules and the requirements
of 40 CFR 51.166 will be included as additional material in 40 CFR
52.220. We are also revising 40 CFR 52.270 to reflect that upon the
effective date of this final rule, each District will have a SIP-
approved PSD program and will no longer be subject to the FIP for the
PSD program. This SIP revision provides a federally approved and
enforceable mechanism for each of the Districts to issue pre-
construction PSD permits for certain new and modified major stationary
sources subject to PSD review within the relevant District.
    As discussed in the EPA's proposal, with the exception of San Luis
Obispo, the Districts requested approval to exercise their authority to
administer the PSD program with respect to those sources located in the
relevant District that have existing PSD permits issued by the EPA,
including authority to conduct general administration of these existing
permits, authority to process and issue any and all subsequent PSD
permit actions relating to such permits (e.g., modifications,
amendments, or revisions of any nature), and authority to enforce such
permits. Pursuant to the criteria in section 110(a)(2)(E)(i) of the
CAA, we have determined that the four Districts have the authority,
personnel, and funding to implement the PSD program within the relevant
District for existing EPA-issued permits and therefore are transferring
authority for such permits to the four Districts concurrent with the
effective date of the EPA's approval of the Districts' PSD program into
the SIP. The EPA intends to provide a copy of each such permit to the
relevant District.

III. The EPA's Final Action

    The EPA is approving five PSD rules submitted by CARB to establish
a PSD permit program for pre-construction review of certain new and
modified major stationary sources in attainment or unclassifiable
areas. We are approving these rules as a revision to the California SIP
pursuant to section 110(k)(3) of the Act. Specifically, we are
approving the rules listed in Table 1, except for the portion of each
rule that incorporates by reference 40 CFR 52.21(b)(49)(v), which was
subsequently withdrawn from CARB's request for SIP approval, as
explained in more detail in our proposal. See 80 FR at 44003-04. Our
determination is based, in part, on the clarifications provided by the
Districts related to the implementation of the PSD program, including
the clarifications related to Significant Impact Levels (SILs) and the
Significant Monitoring Concentrations (SMC) for PM2.5, in
letters dated November 13, 2014, November 25, 2014, December 16, 2014,
December 18, 2014, April 8, 2015, and April 15, 2015. See 80 FR at
44002-03. We are including these clarification letters as additional
material in 40 CFR 52.220.

IV. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the rules
listed in Table 1, with the exception of certain provisions
incorporated into those rules as discussed in Section III. The EPA has
made, and will continue to make, these documents generally available
electronically through www.regulations.gov and/or in hard copy at the
appropriate EPA office (see the ADDRESSES section of this preamble for
more information).

V. Statutory and Executive Order Reviews

    Under the CAA, 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, 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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 (Public Law 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, 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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by January 11, 2016. 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 CAA section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

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

    Dated: September 9, 2015.
Jared Blumenfeld,
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

0
2. Section 52.220 is amended by adding paragraphs (c)(428)(i)(E) and
(F), (c)(428)(ii), (c)(429)(i)(D), (c)(429)(ii), (c)(441)(i)(F),
(c)(441)(ii), (c)(442)(i)(H), and (c)(442)(ii) to read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (428) * * *
    (i) * * *
    (E) Great Basin Unified Air Pollution Control District.
    (1) Rule 221, ``Prevention of Significant Deterioration (PSD)
Permit Requirements for New Major Facilities or Major Modifications in
Attainment or Unclassifiable Areas,'' except for the incorporation by
reference of 40 CFR 52.21(b)(49)(v) into sections C. and D3, adopted on
September 5, 2012.
    (F) Butte County Air Quality Management District.
    (1) Rule 1107, ``Prevention of Significant Deterioration (PSD)
Permits,'' except for the incorporation by reference of 40 CFR
52.21(b)(49)(v) into sections 3 and 4.1, adopted on June 28, 2012.
    (ii) Additional materials.
    (A) Great Basin Unified Air Pollution Control District.
    (1) Letter dated November 13, 2014 from Theodore D. Schade, Great
Basin Unified Air Pollution Control District, to Gerardo Rios, United
States Environmental Protection Agency Region 9, regarding
clarifications of District Rule 221 and 40 CFR 51.166.
    (2) Letter dated April 15, 2015, from Phillip L. Kiddoo, Great
Basin Unified Air Pollution Control District, to Gerardo Rios, United
States Environmental Protection Agency Region 9, regarding additional
clarifications of District Rule 221 and 40 CFR 51.166.
    (B) Butte County Air Quality Management District.
    (1) Letter dated November 13, 2014, from W. James Wagoner, Butte
County Air Quality Management District, to Gerardo Rios, United States
Environmental Protection Agency Region 9, regarding clarifications of
District Rule 1107 and 40 CFR 51.166.
    (2) Letter dated April 8, 2015, from W. James Wagoner, Butte County
Air Quality Management District, to Gerardo Rios, United States
Environmental Protection Agency Region 9, regarding additional
clarifications of District Rule 1107 and 40 CFR 51.166.
    (429) * * *
    (i) * * *
    (D) Feather River Air Quality Management District.
    (1) Rule 10.10, ``Prevention of Significant Deterioration,'' except
for the incorporation by reference of 40 CFR 52.21(b)(49)(v) into
sections B and F.1, adopted on August 1, 2011.
    (ii) Additional materials.
    (A) Feather River Air Quality Management District.
    (1) Letter dated December 18, 2014 from Christopher D. Brown,
Feather River Air Quality Management District, to Gerardo Rios, United
States Environmental Protection Agency Region 9, regarding
clarifications of District Rule 10.10 and 40 CFR 51.166.
* * * * *
    (441) * * *
    (i) * * *
    (F) San Luis Obispo County Air Pollution Control District.
    (1) Rule 220, ``Federal Prevention of Significant Deterioration,''
except for the incorporation by reference of 40 CFR 52.21(b)(49)(v)
into sections B and D.3., amended on January 22, 2014.
    (ii) Additional materials.
    (A) San Luis Obispo County Air Pollution Control District.
    (1) Letter dated December 16, 2014 from Larry R. Allen, San Luis
Obispo County Air Pollution Control District, to Gerardo Rios, United
States Environmental Protection Agency Region 9, regarding
clarifications of District Rule 220 and 40 CFR 51.166.
    (442) * * *
    (i) * * *
    (H) Santa Barbara County Air Pollution Control District.
    (1) Rule 810, ``Federal Prevention of Significant Deterioration
(PSD),'' except for the incorporation by reference of 40 CFR
52.21(b)(49)(v) into sections B and D.3., amended on June 20, 2013.
    (ii) Additional materials.
    (A) Santa Barbara County Air Pollution Control District.
    (1) Letter dated November 25, 2014 from David Van Mullem, Santa
Barbara County Air Pollution Control District, to Gerardo Rios, United
States Environmental Protection Agency Region 9, regarding
clarifications of District Rule 810 and 40 CFR 51.166.
* * * * *

0
3. Section 52.270 is amended by adding paragraphs (b)(11) through (15)
to read as follows:

Sec.  52.270  Significant deterioration of air quality.

* * * * *
    (b) * * *
    (11) The PSD program for the Great Basin Unified Air Pollution
Control District (GBUAPCD), as incorporated by reference in Sec.
52.220(c)(428), is approved under Part C, Subpart 1, of the Clean Air
Act. For PSD permits previously issued by EPA pursuant to Sec.  52.21
to sources located in the GBUAPCD, this approval includes the authority
for the GBUAPCD to conduct general administration of these existing
permits, authority to process and issue any and all subsequent permit
actions relating to such permits, and authority to enforce such
permits.
    (12) The PSD program for the Butte County Air Quality Management
District (BCAQMD), as incorporated by reference in Sec.
52.220(c)(428), is approved under Part C, Subpart 1, of the Clean Air
Act. For PSD permits previously issued by EPA pursuant to Sec.  52.21
to sources located in the BCAQMD, this approval includes the

authority for the BCAQMD to conduct general administration of these
existing permits, authority to process and issue any and all subsequent
permit actions relating to such permits, and authority to enforce such
permits.
    (13) The PSD program for the Feather River Air Quality Management
District (FRAQMD), as incorporated by reference in Sec.
52.220(c)(429), is approved under Part C, Subpart 1, of the Clean Air
Act. For PSD permits previously issued by EPA pursuant to Sec.  52.21
to sources located in the FRAQMD, this approval includes the authority
for the FRAQMD to conduct general administration of these existing
permits, authority to process and issue any and all subsequent permit
actions relating to such permits, and authority to enforce such
permits.
    (14) The PSD program for the San Luis Obispo County Air Pollution
Control District (SLOAPCD), as incorporated by reference in Sec.
52.220(c)(441), is approved under Part C, Subpart 1, of the Clean Air
Act.
    (15) The PSD program for the Santa Barbara County Air Pollution
Control District (SBAPCD), as incorporated by reference in Sec.
52.220(c)(442), is approved under Part C, Subpart 1, of the Clean Air
Act. For PSD permits previously issued by EPA pursuant to Sec.  52.21
to sources located in the SBAPCD, this approval includes the authority
for the SBAPCD to conduct general administration of these existing
permits, authority to process and issue any and all subsequent permit
actions relating to such permits, and authority to enforce such
permits.

[FR Doc. 2015-28624 Filed 11-10-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 2, 2010 (Volume 75, Number 21)]
[Rules and Regulations]
[Page 5243-5244]
[DOCID:fr02fe10-9]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Parts 7, 10, and 40

[Docket No. OST-2009-0173]
RIN 2105-AD82

OST Technical Corrections

AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Final rule.

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SUMMARY: DOT is making corrections to amendments to a number of its
regulations that were published in the Federal Register on June 12,
2008 (73 FR 33326-30) to reflect reorganization of some elements of DOT
and the move of DOT's Headquarters site in Washington, DC.

DATES: The amendments are effective February 2, 2010.

FOR FURTHER INFORMATION CONTACT: Robert I. Ross, Office of the General
Counsel, C-60, Room W96-314, Department of Transportation, 1200 New
Jersey Avenue, SE., Washington, DC 20590; telephone<PHONE_NUMBER>; fax
202.366.9170; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: These corrections affect the following:
    1. DOT moved its Headquarters in Washington, DC to a new site.
    2. The Chief Information Officer has replaced the Assistant
Secretary for Administration as the DOT Chief Privacy Officer.
    3. A mistake was made in the definition of ``Department'' in our
Freedom of Information regulations.
    4. The list of exemptions in our Freedom of Information regulations
are reorganized and corrected to reflect the transfer of motor carrier
safety oversight from the Federal Highway Administration to the Federal
Motor Carrier Safety Administration.
    Since this amendment relates to departmental management,
organization, procedure, and practice, notice and comment are
unnecessary under 5 U.S.C. 553(b). Further, since the amendment
expedites the Department's ability to meet the statutory intent of the
applicable laws and regulations covered by this delegation, I find good
cause under 5 U.S.C. 553(d)(3) for the final rule to be effective on
the date of publication in the Federal Register.

Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

    This final rule is not considered a significant regulatory action
under Executive Order 12866 and DOT Regulatory Policies and Procedures
(44 FR 11034). It was not reviewed by the Office of Management and
Budget. There are no costs associated with this rule.

B. Executive Order 13132

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13132 (``Federalism''). This
final rule does not have a substantial direct effect on, or sufficient
federalism implications for, the States, nor would it limit the
policymaking discretion of the States. Therefore, the consultation
requirements of Executive Order 13132 do not apply.

C. Executive Order 13175

    This final rule has been analyzed in accordance with the principles
and criteria contained in Executive Order 13175 (``Consultation and
Coordination with Indian Tribal Governments''). Because this final rule
does not significantly or uniquely affect the communities of the Indian
tribal governments and does not impose substantial direct compliance
costs, the funding and consultation requirements of Executive Order
13175 do not apply.

D. Regulatory Flexibility Act

    Because no notice of proposed rulemaking is required for this rule
under the Administrative Procedure Act, 5 U.S.C. 553, the provisions of
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. We
also do not believe this rule would impose any costs on small entities
because it simply delegates authority from one official to another and
makes other nonsubstantive corrections. Therefore, I certify this final
rule will not have a significant economic impact on a substantial
number of small entities.

E. Paperwork Reduction Act

    This rule contains no information collection requirements under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

F. Unfunded Mandates Reform Act

    The Department of Transportation has determined that the
requirements of Title II of the Unfunded Mandates Reform Act of 1995 do
not apply to this rulemaking.

List of Subjects

49 CFR Part 7

    Freedom of information, Reporting and recordkeeping requirements.

49 CFR Part 10

    Penalties, Privacy.

49 CFR Part 40

    Administrative practice and procedure, Drug testing, Laboratories,
Reporting and recordkeeping requirements, Safety, Transportation.

0
For the reasons discussed in the preamble, Subtitle A of title 49, Code
of Federal Regulations, is amended as follows:

PART 7--PUBLIC AVAILABILITY OF INFORMATION

0
1. The authority citation for part 7 continues to read as follows:

    Authority:  5 U.S.C. 552; 31 U.S.C. 9701; 49 U.S.C. 322; E.O.
12600; 3 CFR, 1987 Comp., p. 235.

0
2. In Section 7.2, the introductory text of the definition of
`Department' is revised to read as follows:

Sec.  7.2  Definitions.

* * * * *
    Department means the Department of Transportation, including the
Office of the Secretary, the Office of Inspector General, and the
following DOT Operating Administrations, all of which may be referred
to as DOT components. Means of contacting each of these DOT components
appear in Sec.  7.15. This definition specifically excludes the Surface
Transportation Board, which has its own FOIA regulations (49 CFR Part
1001):
* * * * *

PART 10--MAINTENANCE OF AND ACCESS TO RECORDS PERTAINING TO
INDIVIDUALS

0
3. The authority citation for part 10 continues to read as follows:

    Authority:  5 U.S.C. 552a; 49 U.S.C. 322.

Sec.  10.77  [Amended]

0
4. In Sec.  10.77, paragraph (c) is amended by removing `Assistant
Secretary for Administration' and replacing it with `Chief Information
Officer'.

0
5. In Appendix to Part 10--Exemptions, paragraph A of Part II is
amended by removing paragraphs 3. through 12., and adding new
paragraphs 3. through 7. to read as follows:

Appendix to Part 10--Exemptions

* * * * *

Part II. Specific Exemptions

    A. * * *
    3. Federal Motor Carrier Safety Administration (FMCSA)
Enforcement Management Information System, maintained by the Chief
Counsel, FMCSA (DOT/FMCSA 002).
    4. DOT/NHTSA Investigations of Alleged Misconduct or Conflict of
Interest, maintained by the Associate Administrator for
Administration, National Highway Traffic Safety Administration (DOT/
NHTSA 458).
    5. Civil Aviation Security System (DOT/FAA 813), maintained by
the Office of Civil Aviation Security Policy and Planning, Federal
Aviation Administration.
    6. Suspected Unapproved Parts (SUP) Program, maintained by the
Federal Aviation Administration (DOT/FAA 852).
    7. Motor Carrier Management Information System (MCMIS),
maintained by the Federal Motor Carrier Safety Administration (DOT/
FMCSA 001).
* * * * *

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL
TESTING PROGRAMS

Sec.  40.213  [Amended]

0
6. In Sec.  40.213(a), remove the words, ``400 7th Street, SW., Room
10403'' and add, in their place, the words ``1200 New Jersey Avenue,
SE.''.

    Issued under authority delegated in 49 CFR 1.57(j) at
Washington, DC, on January 19, 2010.
Robert S. Rivkin,
General Counsel, Department of Transportation.
[FR Doc. 2010-1657 Filed 2-1-10; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: July 27, 2009 (Volume 74, Number 142)]
[Notices]
[Page 37079-37081]
[DOCID:fr27jy09-92]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60359; File No. SR-MSRB-2009-08]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Guidance on Disclosure and Other Sales Practice
Obligations to Individual and Other Retail Investors in Municipal
Securities

July 21, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 14, 2009, the Municipal Securities Rulemaking Board (``MSRB''),
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been substantially prepared by the MSRB. The MSRB has
designated the proposed rule change as constituting a stated policy,
practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule of the self-
regulatory organization pursuant to Section 19(b)(3)(A)(i) of the
Act,\3\ and Rule 19b-4(f)(1) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The MSRB has filed with the Commission a proposed rule change
consisting of interpretive guidance on disclosure and other sales
practice obligations of brokers, dealers and municipal securities
dealers (``dealers'') relating to sales of municipal securities to
individual and other retail investors. The text of the proposed rule
change is available on the MSRB's Web site (http://www.msrb.org), at
the MSRB's principal office, and at the Commission's Public Reference
Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the MSRB included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The MSRB has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The proposed rule change provides guidance to brokers, dealers and
municipal securities dealers (``dealers'') of their sales practice
obligations under MSRB rules as applied specifically to individual and
other retail investors. Among other things, the proposed rule change
updates guidance to dealers on (i) their obligations to disclose
material information about issuers, their securities and credit/
liquidity support for such securities in connection with the
fulfillment of their disclosure obligations under MSRB Rule G-17, (ii)
their obligations to use such material information in fulfilling their
suitability obligations under MSRB Rule G-19, and (iii) their fair
pricing obligations under MSRB Rules G-18 and G-30. The proposed rule
change also applies previous guidance on bond insurance rating
downgrades and wide-scale auction failures for municipal auction rate
securities (``ARS''), to municipal securities transactions in general
and specifically to transactions with individual and other retail
investors in variable rate demand obligations (``VRDOs'').
Disclosure
    The proposed rule change makes clear that dealers are responsible
under Rule G-17 for disclosing to their customers, at or prior to the
time of trade for any municipal securities transaction, all material
information about the transaction known by the dealer, as well as
material information about the security that is reasonably accessible
to the market, including information available from established
industry sources. Dealers must provide such disclosures notwithstanding
the availability to investors of comprehensive information from the
MSRB's Electronic Municipal Market Access system (EMMA) and other
established industry sources. Dealers are expected to establish
procedures reasonably designed to ensure that information known to the
dealer is communicated internally or otherwise

made available to relevant personnel in a manner reasonably designed to
ensure compliance with this disclosure obligation.
    The proposed rule change provides that, in general, information is
considered ``material'' if there is a substantial likelihood that its
disclosure would have been considered important or significant by a
reasonable investor. The duty to disclose material information to a
customer in a municipal securities transaction includes the duty to
give a complete description of the security, including a description of
the features that likely would be considered significant by a
reasonable investor and facts that are material to assessing the
potential risks of the investment. For VRDOs, ARS or other securities
for which interest payments may fluctuate, such material facts would
include a description of the basis on which periodic interest rate
resets are determined.
    The proposed rule change provides that the following information
will generally be material information required to be disclosed to
investors in credit/liquidity enhanced securities, including but not
limited to VRDOs, if known to the dealer or if reasonably available
from established industry sources: (i) The credit rating of the issue
or lack thereof; (ii) the underlying credit rating or lack thereof,
(iii) the identity of any credit enhancer or liquidity provider; and
(iv) the credit rating of the credit provider and liquidity provider,
including potential rating actions (e.g., downgrade). Additionally,
material terms of the credit facility or liquidity facility should be
disclosed (e.g., any circumstances under which a standby bond purchase
agreement (``SBPA'') would terminate without a mandatory tender). If
the remarketing agent for a VRDO has customarily or from time-to-time
taken tendered bonds into inventory to make it unnecessary to draw on
the liquidity facility for unremarketed bonds (thereby in effect
providing liquidity support), the fact that the remarketing agent is
not contractually obligated to maintain such practice will generally be
material information required to be disclosed to customers to which
VRDOs are sold. This list is not exhaustive. Other information may also
be material to investors in credit/liquidity enhanced securities.
    The proposed rule change reminds dealers that they are not relieved
of their suitability obligations under MSRB Rule G-19 or their fair
pricing obligations to their customers under MSRB Rules G-18 and G-30
simply by disclosing material information to the customer. The
information known by a dealer in connection with a municipal security,
together with the information available from established industry
sources, generally should inform the dealer, to the extent applicable,
in undertaking the necessary analyses and determinations needed to meet
these other customer protection obligations.
Suitability
    Under the proposed rule change, dealers are obligated to make a
suitability determination arising under Rule G-19 in connection with a
recommended transaction. This requires a meaningful analysis, taking
into consideration the information obtained about the investor and the
security, which establishes the reasonable grounds for believing that
the recommendation is suitable. Such suitability determinations are
required regardless of the apparent safety of a particular security or
issuer or the apparent wealth or sophistication of a particular
investor. Suitability determinations should be based on the
appropriately weighted factors that are relevant in any particular set
of facts and circumstances, and those factors may vary from transaction
to transaction. Factors to be considered include, but are not limited
to, the investor's financial profile, tax status, investment objectives
(including portfolio concentration/diversification), and the specific
characteristics and risks of the municipal security recommended to the
investor.
    In the proposed rule change, the MSRB notes that Section (c) of
Exchange Act Rule 15c2-12 provides that it is impermissible for a
dealer to recommend the purchase or sale of a municipal security unless
the dealer has procedures in place that provide reasonable assurance
that it will receive prompt notice of the specified material events
that are subject to the continuing disclosure obligations of the rule.
A dealer would be expected to have reviewed any applicable continuing
disclosures made available through EMMA or other established industry
sources and to have taken such disclosures into account in undertaking
its suitability determination.
    The proposed rule change provides guidance specifically with regard
to credit-enhanced securities. Facts relating to the credit rating of
the credit enhancer may affect suitability determinations, particularly
for investors who have conveyed to the dealer investment objectives
relating to credit quality of investments. In the case of recommended
VRDOs or any other securities that are viewed as providing significant
liquidity to investors, a dealer must consider both the liquidity
characteristics of the security and the investor's need for a liquid
investment when making a suitability determination. Facts relating to
the short-term credit rating, if any, of a letter of credit or SBPA
provider, or of any other third-party liquidity facility provider,
generally would affect suitability determinations in such securities.
To the extent that an investor seeks to invest in VRDOs due to their
liquidity characteristics, a suitability analysis also generally would
require a dealer, in recommending a VRDO to an individual investor, to
consider carefully the circumstances, if any, under which the liquidity
feature may no longer be effectively available to the customer.
    With respect to new products introduced into the municipal
securities market, the proposed rule change reminds dealers that they
must review the relevant disclosure documents to become familiar with
the specific characteristics of the product, including the tax
features, prior to recommending such products to their customers.
Pricing
    The proposed rule change provides that, as a general matter, in
addition to information about prices of transactions effected by
dealers and other market participants in a particular municipal
security, material information about a security available through EMMA
or other established industry sources may also be among the relevant
factors that the dealer should consider in connection with ensuring
fair pricing of its transactions with investors. Among other things,
dealers would be expected to have reviewed any applicable continuing
disclosures made available through EMMA or other established industry
sources and to have taken such disclosures into account in determining
a fair and reasonable transaction price. In addition, dealers should
consider the effect of ratings on the value of the securities involved
in customer transactions, and should specifically consider the effect
of information from rating agencies, both with respect to actual or
potential changes in the underlying rating of a security and with
respect to actual or potential changes in the rating of any third-party
credit enhancement applicable to the security.
    Dealers are reminded that an issuer's use of a retail order period
based on a perception that the retail order period will improve pricing
of the new issue for the issuer does not create a safe harbor for
dealers to engage in pricing that violates the fair pricing obligation

under Rule G-30. Large differences between institutional and individual
prices that exceed the price/yield variance that normally applies to
transactions of different sizes in the primary market provide evidence
that the duty of fair pricing to individual clients may not have been
met.
2. Statutory Basis
    The MSRB has adopted the proposed rule change pursuant to Section
15B(b)(2)(C) of the Act,\5\ which provides that the MSRB's rules shall:
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78o-4(b)(2)(C).

    Be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect
to, and facilitating transactions in municipal securities, to remove
impediments to and perfect the mechanism of a free and open market
in municipal securities, and, in general, to protect investors and
---------------------------------------------------------------------------
the public interest.

    The MSRB believes that the proposed rule change is consistent with
the Act because it will further investor protection by strengthening
and clarifying dealers' customer protection obligations relating to
sales of municipal securities to individual and other retail customers,
including but not limited to the duty to provide material information
to customers investing in municipal securities and to use material
information in fulfilling their suitability obligations and their fair
pricing obligations.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The MSRB does not believe that the proposed rule change will impose
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended, since it would
apply equally to all dealers.

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

    Written comments were neither solicited nor received on the
proposed rule change.

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

    The proposed rule change has become effective pursuant to Section
19(b)(3)(A)(i) of the Act \6\ and Rule 19b-4(f)(1) thereunder,\7\ in
that the proposed rule change constitutes a stated policy, practice, or
interpretation with respect to the meaning, administration, or
enforcement of an existing rule of the self-regulatory organization. At
any time within 60 days of the filing of the proposed rule change, the
Commission may summarily abrogate such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.\8\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A)(i).
    \7\ 17 CFR 240.19b-4(f)(1).
    \8\ See Section 19(b)(3)(C) of the Act, 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-MSRB-2009-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-MSRB-2009-08. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the MSRB. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MSRB-2009-08 and should be
submitted on or before August 17, 2009.

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

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-17820 Filed 7-24-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50141-50142]
[FR Doc No: 2017-23518]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0334]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Safety Reports for Human Drug and
Biological Products: Electronic Submission Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the requirements for electronic submission
of postmarketing safety reports for human drug and biological products.

DATES: Submit either electronic or written comments on the collection
of information by December 29, 2017.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 29, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 29, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2008-N-0334 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Postmarketing Safety Reports for
Human Drug and Biological Products: Electronic Submission
Requirements.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an

existing collection of information, before submitting the collection to
OMB for approval. To comply with this requirement, FDA is publishing
notice of the proposed collection of information set forth in this
document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Postmarketing Safety Reports for Human Drug and Biological Products:
Waivers From Electronic Submission Requirements--OMB Control Number
0910-0770--Extension

    This information collection supports FDA regulations. In the
Federal Register of June 10, 2014 (79 FR 33072), FDA published a final
rule entitled ``Postmarketing Safety Reports for Human Drug and
Biological Products: Electronic Submission Requirements.'' The final
rule amended FDA's postmarketing safety reporting regulations for human
drug and biological products under 21 CFR parts 310, 314, and 600 and
added part 329 to require that persons subject to mandatory reporting
requirements submit safety reports in an electronic format that FDA can
process, review, and archive. Specifically, this includes:
     manufacturers; packers; distributors; applicants with
approved new drug applications, abbreviated new drug applications, and
biologics licensing applications (BLAs); and those that market
prescription drugs for human use without an approved application must
submit postmarketing safety reports to the Agency (Sec. Sec.  310.305,
314.80, 314.98, and 600.80);
     manufacturers, packers, or distributors whose name appears
on the label of nonprescription human drug products marketed without an
approved application must report serious adverse events associated with
their products (section 760 of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 379aa)); and
     applicants with approved BLAs must submit biological lot
distribution reports to the Agency (Sec.  600.81).
    Under Sec. Sec.  310.305(e)(2), 314.80(g)(2), 329.100(c)(2),
600.80(h)(2), and 600.81(b)(2), those who are subject to these
postmarketing safety reporting requirements may request a waiver from
the electronic format requirement. While FDA currently has OMB approval
for the collection of postmarketing safety reports,\1\ this information
collection supports respondents seeking waivers from submitting those
reports in electronic format as required by the regulations.
---------------------------------------------------------------------------

    \1\ FDA currently has OMB approval for submission of
postmarketing safety reports under parts 310, 314, and 600. The
information collection for parts 310 and 314 is approved under OMB
control numbers 0910-0291 and 0910-0230. The information collection
for part 600 is approved under OMB control numbers 0910-0291 and
0910-0308. Submissions required by section 760 of the FD&C Act have
been approved under OMB control number 0910-0636.
---------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
310.305(e)(2)...................               1               1               1               1               1
314.80(g)(2)....................               5               1               5               1               5
329.100(c)(2)...................               1               1               1               1               1
600.80(h)(2)....................               5               1               5               1               5
600.81(b)(2)....................               1               1               1               1               1
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              13
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.

    In table 1 of this document, we estimate the burden associated with
the submission of waiver requests for postmarketing safety reports in
electronic format under Sec. Sec.  310.305(e)(2), 314.80(g)(2),
329.100(c)(2), 600.80(h)(2), and 600.81(b)(2). We expect few waiver
requests. We estimate that approximately one manufacturer will request
a waiver annually under Sec. Sec.  310.305(e)(2), 329.100(c)(2), and
600.81(b)(2), and approximately five manufacturers will request a
waiver annually under Sec. Sec.  314.80(g)(2) and 600.80(h)(2). We
estimate that each waiver request will take approximately 1 hour to
prepare and submit.

    Dated: October 24, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23518 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P