[Federal Register Volume 82, Number 195 (Wednesday, October 11, 2017)]
[Notices]
[Pages 47192-47193]
[FR Doc No: 2017-21835]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL18-3-000, QF87-560-012]

Applied Energy LLC; Notice of Waiver Request

    Take notice that on October 2, 2017, pursuant to section 292.205(c)
of the Federal Energy Regulatory Commission's (Commission) Rules of
Practices and Procedures implementing the Public Utility Regulatory
Policies Act of 1978, as amended, 18 CFR 292.205(c)(2017), Applied
Energy LLC (Applied Energy) requested a limited waiver of the operating
standard set forth in section 292.205(a)(1) of the Commission's
regulations and the efficiency standard set forth in section
292.205(a)(2) for the topping-cycle cogeneration facility owned and
operated by Applied Energy located at the United States Naval Station
in San Diego, California. Specifically, Applied Energy request waiver
of the operating and efficiency standards for calendar years 2017 and
2018, as more fully explained in its waiver request.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the

appropriate action to be taken, but will not serve to make protestants
parties to the proceeding. Any person wishing to become a party must
file a notice of intervention or motion to intervene, as appropriate.
Such notices, motions, or protests must be filed on or before the
comment date. Anyone filing a motion to intervene or protest must serve
a copy of that document on the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
Web site that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on October 23, 2017.

    Dated: October 4, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-21835 Filed 10-10-17; 8:45 am]
 BILLING CODE 6717-01-P


                                                         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                             REGION IX AIR DIVISION

                          Technical Support Document                                        for                               EPA's Rulemaking                                     for the                      California State Implementation Plan                                                        South Coast Air Quality Management District's  Rule 1111, Reduction of NOx Emissions From Natural-Gas-Fired, Fan-Type Central Furnaces

                                                           Prepared by: Kevin Gong

	August 4, 2015

Agency:	South Coast Air Quality Management District (SCAQMD)

SIP Approved Rule:	Adopted November 6, 2009, approved into the SIP August 4, 2010 in 75 FR 46845

Subject of this TSD:	SCAQMD Rule 1111, Reduction of NOx Emissions From Natural-Gas-Fired, Fan-Type Central Furnaces    *                         Submitted version was amended September 5, 2014    *                         Submitted to US EPA April 7, 2015

RULE SUMMARY Rule 1111 establishes oxides of nitrogen (NOx) emission limits from natural-gas fired fan-type central furnaces.

This rule is a point of sale rule that applies to all home and commercial furnaces with a rated heat capacity of less than 175,000 BTU, or for combination heating and cooling units with a cooling rate of less than 65,000 BTU.

The 2014 amendments extend a compliance date for one type of furnace and establish an emissions fee option for manufacturers unable to meet the requirements through a 36 month transition period following the compliance date.

The District estimated a NOx emissions reduction of 2.5 tons per day by 2023, from previous revisions to the rule according to the California Air Resources Board Rule Evaluation Form. There are no additional emissions reductions that would result from this amendment.

Other rule provisions include definitions, allowable test methods and procedures, certification procedures for furnaces, records requirements for manufacturers, and a rebate incentive program for early compliance.

EVALUATION CRITERIA  The following criteria were used to evaluate the submitted rule.

1.	Enforceability - Section 110(a)(2)(A) of the Clean Act Act (CAA) requires that the rule be enforceable. The Bluebook (Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations, EPA, May 25, 1988) and the Little Bluebook (Guidance Document for Correcting Common VOC & Other Rule Deficiencies, EPA Region 9, August 21, 2001) were used to help evaluate compliance with this requirement.

      2.	Stringency - Section 172(c)(1) of the CAA requires nonattainment areas to implement all reasonably available control measures (RACM), including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology (RACT), as expeditiously as practicable. In addition, ozone nonattainment areas classified as moderate or above must require RACT for all major sources of NOx (CAA § 182(f); 40 CFR § 51.912(a)).               SCAQMD regulates an ozone nonattainment area that is classified as an Extreme nonattainment area for the 1-hour and 8-hour ozone standards, and Nonattainment for the 2006 and 1997 24 hour PM2.5 standards (40 C.F.R. § 81.305). However, Rule 1111 regulates area sources that are too small to exceed the major source threshold and is therefore not subject to ozone RACT.              3.	SIP Relaxation - CAA Section 110(l) prohibits EPA from approving any SIP revision that would interfere with any applicable requirement concerning attainment and reasonable further progress (RFP) or any other applicable requirement of the CAA. In addition, CAA §193 prohibits the modification of any SIP-approved control requirement in effect before November 15, 1990, in a nonattainment area.              4.	Economic Incentive Programs (EIPs) - EPA's guidance (Improving Air Quality with Economic Incentive Programs, EPA-452/R/01-01-002, January 2001) outlines key principles that must be incorporated in an EIP in order to receive EPA SIP approval. Emission reductions generated through implementation of EIPs must be surplus, quantifiable, enforceable, and permanent, among other requirements.        EPA EVALUATION - A summary of our evaluation of the four criteria follows.

      1. 	The certification process, identification requirements for compliant and non-compliant units, and enforcement mechanisms in this point of sale rule are clear. However, the inclusion of the emission fee option and rebate incentive program both merit further analysis as EIPs.              2. 	The NOx emissions of furnace units subject to this rule do not exceed the major source threshold, and are not subject to ozone RACT requirements. Even if RACT were required, we believe that Rule 1111 implements RACT-level controls for NOx emissions for the following reasons:              	a)	The NOx emission limit for new furnaces is comparable to, or more stringent than, other limits in similar rules found in other jurisdictions (see, e.g., Bay Area Air Quality Management District Regulation 9, Rule 4 and Sacramento Metropolitan Air Quality Management District Rule 414).              	b)	This rule's development was a part of a technology forcing effort to assess and support the development of new furnace designs with lower NOx emissions rates compared to what was then commercially available. We are not aware of any efforts to develop applicable furnace technologies that have demonstrated that lower-emission units are technically and economically feasible.              	c)	EPA has not issued a Control Techniques Guideline for furnaces covered by this rule, and we are not aware of any other federal, state or local regulations or guidance suggesting more stringent requirements for these sources have been demonstrated to be technically and economically feasible.              3. 	There is a previous version of Rule 1111 approved by EPA into the SIP in 2010.               	The 2014 amendments extend the compliance date from October 1, 2014 to April 1, 2015 for one type of furnace. EPA received the 2014 amendments to Rule 1111 from CARB after April 1, 2015 and approval would therefore not relax the SIP in effect. A 300 day sell-through provision allows units manufactured before the applicable compliance date to be sold within the district after the new limits come into effect, as long as they still meet the old 40 nanograms NOx per Joule limit.               	The inclusion of a mitigation fee option for the sale of noncompliant units for up to 36 months after the compliance date effectively extends compliance deadlines. The District has addressed both of these relaxations of effective compliance dates through set-aside emissions reductions as documented in a May 20, 2015 letter addressing foregone NOx emissions reductions and the District's 2012 Air Quality Management Plan.              	We propose to determine that our approval of the submittal would comply with CAA §§110(l) and 193 because the proposed SIP revision would not interfere with the on-going process for ensuring that requirements for RFP and attainment of the NAAQS are met.       	       4.	The CAA explicitly allows states to use EIPs as measures in SIPs (§110(a)(2)(A)). Rule 1111 includes two provisions that are defined as EIPs under EPA's 2001 EIP guidance. The fee option for manufacturers allowing additional time to procure and sell compliant furnaces, and the rebate program for early adoption of compliant furnaces both fall under the definition of "financial mechanism programs."              	Evaluating an EIP's integrity involves analysis of the following four elements in the context of emissions and emissions reductions attributed to the program:  surplus, quantifiable, enforceable, and permanent.               	The rebate program was evaluated in a previously approved submittal and is already approved in the SIP. We will not evaluate the rebate provision in this TSD.               	The mitigation fee option is available for 36 months following a compliance date, and manufacturers wishing to use this flexibility must comply with additional administrative requirements to document the number of non-compliant units sold in a year in order to calculate the total amount of fees due to the District at the end of a year. The District's 2012 Air Quality Management Plan includes reductions from this rule (CMB-03, Table 4-4, page 4-22), starting in 2018 after the provisions allowing for a rebate for early compliance, or mitigation fee for late compliance, have expired.               	Any emissions reductions attributable to Rule 1111 while these EIPs are in operation cannot be credited in a SIP as surplus. As a result of this requirement from EPA's guidance, the District has included the expected reductions from this rule for that period in a set-aside account (Letter from Dr. Phillip Fine, dated May 20, 2015). Because the District acknowledges that emissions reductions will be foregone during the period in which the EIP is effective, there is no need to evaluate this EIP's integrity further.

RECOMMENDATIONS FOR THE NEXT RULE REVISION  -  We have no recommendations at this time for future revisions to this rule.

EPA ACTION         The submitted Rule 1111 fulfils relevant CAA requirements. EPA staff recommends the approval of Rule 1111 into the California State Implementation Plan.

REFERENCES

1.	South Coast Air Quality Management District Rule 1111, "Reduction of NOx Emissions From Natural-Gas-Fired, Fan-Type Central Furnaces," September 5, 2014.

2.	Letter dated April 7 2015, from Richard Corey, Executive Officer, California Air Resources Board, to Jared Blumenfeld, Regional Administrator, US EPA Region 9, with enclosures including "SCAQMD Staff Report  -  Proposed Amended Rule 1111  -  Reduction of NOx Emissions From Natural-Gas-Fired, Fan-Type Central Furnaces", Comments Attachment, and other SIP submittal documents.

3.	"Improving Air Quality with Economic Incentive Programs," January 2001 (EPA-452/R-01-001).

4.	"Final 2012 Air Quality Management Plan," South Coast Air Quality Management District, February 2013.

5.	Comment from Idalia Perez to South Coast Air Quality Management District, US EPA, July 18, 2014.

6.	Letter dated May 20, 2015 from Phillip Fine, Deputy Executive Officer, SCAQMD to Andrew Steckel, Rulemaking Office Chief, US EPA Region 9.

7.	Bay Area Air Quality Management District Regulation 9, Rule 4, "Nitrogen Oxides From Fan Type Residential Central Furnaces," December 7, 1983.

8.	Sacramento Metropolitan Air Quality Management District, Rule 414, "Water Heaters, Boilers, and Process Heaters Rated Less Than 1,000,000 BTU per Hour," March 25, 2010.

9.	Technical Support Document for EPA's Notice of Proposed Rulemaking for the California State Implementation Plan  -  South Coast Air Quality Management District's Rule 1111, Reduction of NOx Emissions from Natural Gas-Fired, Fan-Type Central Furnaces" by Idalia Perez, US EPA, June 2010.


[Federal Register: May 29, 2008 (Volume 73, Number 104)]
[Rules and Regulations]
[Page 30763-30765]
[DOCID:fr29my08-11]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0265; Directorate Identifier 2007-NM-213-AD;
Amendment 39-15531; AD 2008-11-09]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 727 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Boeing Model 727 airplanes. This AD requires repetitive inspections for
any cracking of or damage to the left side and right side flight deck
No. 2, No. 4, and No. 5 windows, as necessary, and corrective actions
if necessary. This AD results from reports of in-flight departure and
separation of the flight deck windows. We are issuing this AD to detect
and correct cracking in the vinyl interlayer or damage to the
structural inner glass panes of the flight deck No. 2, No. 4, and No. 5
windows, which could result in loss of a window and rapid loss of cabin
pressure. Loss of cabin pressure could cause crew communication
difficulties or crew incapacitation.

DATES: This AD is effective July 3, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 3,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-
2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Berhane Alazar, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6577; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
all Boeing Model 727 series airplanes. That NPRM was published in the
Federal Register on December 3, 2007 (72 FR 67873). That NPRM proposed
to require repetitive inspections for any cracking of or damage to the
left side and right side flight deck No. 2, No. 4, and No. 5 windows,
as necessary, and corrective actions if necessary.

Changes Made to This AD

    We have deleted paragraph (h)(4) of the NPRM and added a new
paragraph (h) to this AD specifying that installation of metallic
window blanks at cockpit eyebrow windows No. 4 and No. 5 in accordance
with Supplemental Type Certificate (STC) ST01704SE terminates the
initial and repetitive inspections for the flight deck No. 4 and No. 5
windows required by paragraph (f) of this AD. Incorporation of STC
ST01704SE is considered a terminating action, not an alternative method
of compliance (AMOC), since an AMOC can only be issued after an AD has
been issued. We have also reidentified the AMOC paragraph of the NPRM
as paragraph (i) in this AD.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from the two commenters.

Support for the NPRM

    Boeing supports the NPRM.

Request To Extend Compliance Times

    FedEx requests that we extend the compliance time to 36 months or
3,600 flight hours, whichever occurs later, for the initial inspections
of the flight deck No. 2, No. 4, and No. 5 windows and the repetitive
intervals for the No. 4 and No.

5 windows. FedEx states this extension will allow it to do the initial
inspections at a scheduled maintenance check. FedEx also states that
extending the repetitive interval will allow the repetitive inspections
of the No. 2, No. 4, and No. 5 to be done concurrently.
    We do not agree with the request to extend certain compliance
times. In developing an appropriate compliance time for this action, we
considered the urgency associated with the subject unsafe condition and
the practical aspect of accomplishing the required inspections within a
period of time that corresponds to the normal scheduled maintenance for
most affected operators. However, according to the provisions of
paragraph (i) of this AD, we may approve requests to adjust the
compliance time if the request includes data that show that the new
compliance time would provide an acceptable level of safety.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We also determined that
these changes will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    There are about 790 airplanes of the affected design in the
worldwide fleet. This AD affects about 431 airplanes of U.S. registry.
The required actions take about 2 work hours per airplane, at an
average labor rate of $80 per work hour. Based on these figures, the
estimated cost of the AD for U.S. operators is $68,960, or $160 per
airplane, per inspection cycle.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-11-09 Boeing: Amendment 39-15531. Docket No. FAA-2007-0265;
Directorate Identifier 2007-NM-213-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective July 3, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Boeing Model 727, 727C, 727-100, 727-
100C, 727-200, and 727-200F series airplanes, certificated in any
category.

Unsafe Condition

    (d) This AD results from reports of in-flight departure and
separation of the flight deck windows. We are issuing this AD to
detect and correct cracking in the vinyl interlayer or damage to the
structural inner glass panes of the flight deck No. 2, No. 4, and
No. 5 windows, which could result in loss of a window and rapid loss
of cabin pressure. Loss of cabin pressure could cause crew
communication difficulties or crew incapacitation.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Repetitive Inspections and Replacement

    (f) At the applicable times specified in Tables 1, 2, and 3 of
paragraph 1.E. of Boeing Alert Service Bulletin 727-56A0019, dated
June 6, 2007, except as provided by paragraph (g) of this AD: Do the
internal and external detailed inspections for any cracking of or
damage to the left side and right side flight deck No. 2, No. 4, and
No. 5 windows, as applicable, and do the applicable corrective
actions before further flight, by accomplishing all of the
applicable actions specified in the Accomplishment Instructions of
Boeing Alert Service Bulletin 727-56A0019, dated June 6, 2007.
Repeat the inspections thereafter at the applicable interval
specified in paragraph 1.E. of Boeing Alert Service Bulletin 727-
56A0019, dated June 6, 2007.

Exception to Compliance Times

    (g) Where Tables 1, 2, and 3 of paragraph 1.E. of Boeing Alert
Service Bulletin 727-56A0019, dated June 6, 2007, specify counting
the compliance time from ``* * * the date on this service
bulletin,'' this AD requires counting the compliance time from the
effective date of this AD.

Optional Terminating Action

    (h) Installation of metallic window blanks at cockpit eyebrow
windows No. 4 and No. 5 in accordance with Supplemental Type
Certificate ST01704SE terminates the initial and repetitive
inspections for the flight deck No. 4 and No. 5 windows required by
paragraph (f) of this AD. All other applicable actions required by
paragraph (f) of this AD must be fully complied with.

Alternative Methods of Compliance (AMOCs)

    (i)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested in
accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option

Authorization Organization who has been authorized by the Manager,
Seattle ACO, to make those findings. For a repair method to be
approved, the repair must meet the certification basis of the
airplane, and the approval must specifically refer to this AD.

Material Incorporated by Reference

    (j) You must use Boeing Alert Service Bulletin 727-56A0019,
dated June 6, 2007, to do the actions required by this AD, unless
the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington
98124-2207.
    (3) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on May 10, 2008.
Michael J. Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-11359 Filed 5-28-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Page 18558]
[FR Doc No: 2014-07325]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0796]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Testing Communications on Medical
Devices and Radiation-Emitting Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Testing Communications on Medical
Devices and Radiation-Emitting Products'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On December 20, 2013, the Agency submitted a
proposed collection of information entitled ``Testing Communications on
Medical Devices and Radiation-Emitting Products'' to OMB for review and
clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor,
and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. OMB has now
approved the information collection and has assigned OMB control number
0910-0678. The approval expires on March 31, 2017. A copy of the
supporting statement for this information collection is available on
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07325 Filed 4-1-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Page 23343]
[FR Doc No: 2016-09210]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, April
21, 2016 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit
consideration of the scheduled matter at the Closed Meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Adjudicatory matters; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

     Dated: April 14, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-09210 Filed 4-18-16; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 100 (Tuesday, May 26, 2015)]
[Notices]
[Page 30071]
[FR Doc No: 2015-12616]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-1714-000]

Targray Americas Inc.; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Targray Americas Inc.'s application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 8, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: May 19, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-12616 Filed 5-22-15; 8:45 am]
 BILLING CODE 6717-01-P


MEMORANDUM

DATE:		October 2, 2008

SUBJECT:	National Impacts for Proposed Reconsideration

FROM: 	Chris Sarsony

		engineering-environmental Management (e2M), Inc.

THROUGH:	John Crenshaw

		Eastern Research Group, Inc.

TO:		Lynn Dail

		U.S. Environmental Protection Agency

1.0	INTRODUCTION

On December 2, 1994, EPA promulgated technology-based emission standards
to control hazardous air pollutant (HAP) emissions of halogenated
solvents from halogenated solvent cleaning.  Pursuant to the Clean Air
Act (CAA) section 112(f), EPA evaluated the remaining risk to public
health and the environment following implementation of the
technology-based rule and determined that more stringent standards are
necessary in order to provide an ample margin of safety to protect
public health.

On August 17, 2006, EPA published proposed standards that provided
further reductions of methylene chloride (MC), perchloroethylene (PCE),
and trichloroethylene (TCE) beyond the 1994 national emission standards
for hazardous air pollutants (NESHAP), through application of a
facility-wide total MC, PCE, and TCE emission standard.  The EPA
received comments on the proposed rule from industry, states, solvent
manufacturers, industry associations and district air associations.
Industry’s comments were primarily submitted by four specific sectors:
narrow tubing manufacturing facilities (tube), facilities that
manufacture specialized products requiring continuous web cleaning
(web), aerospace manufacturing and maintenance facilities (aerospace),
and military depot maintenance facilities.  Comments and data submitted
by the four industry sectors focused on the unique nature and size of
the halogenated solvent cleaning machines used in the cleaning
operations.

A Notice of Data Availability (NODA) was issued on December 14, 2006 (71
FR 75184) to collect additional information from these four industry
sectors.  As a result of the NODA, EPA received significant comments
from responders associated with the above-noted industries, industry
associations, and commenters that were not associated with the
above-noted industries.  They provided additional data and information
on control costs and the technical feasibility of additional controls
that were directly relevant to the promulgation of the proposed
facility-wide emission limits.

On May 3, 2007, EPA promulgated the final rule titled:  National
Emission Standards for Hazardous Air Pollutants (NESHAP):  Halogenated
Solvent Cleaning (the Halogenated Solvent Cleaning rule)
(72 FR 25138), pursuant to sections 112(d)(6) and 112(f) of the Clean
Air Act (CAA).  The Halogenated Solvent Cleaning rule set facility-wide
emission limits for certain halogenated solvent cleaning machines and a
May 3, 2010, compliance deadline.

	Following promulgation of the Halogenated Solvent Cleaning rule, the
EPA Administrator received several petitions for reconsideration,
pursuant to CAA section 307(d)(7)(B).  On August 15, 2007, EPA informed
petitioners of its intent to initiate notice and comment rulemaking to
address the Petitions.

The purpose of this memorandum is to summarize the nationwide cost and
emission impacts associated with the control options presented in the
proposed notice of reconsideration of the final rule.  In Section 2.0
the changes to the impacts analyses are summarized.  Section 3.0
contains a discussion of the levels and format of the control options.
Section 4.0 summarizes the development of costs and percent emission
reduction estimates for individual control techniques.  Section 5.0
summarizes the results of the cost and emission reduction analysis for
all of the control options.

CHANGES TO IMPACTS METHODOLOGY RESULTING FROM PETITIONS FOR
RECONSIDERATION

Petitions for reconsideration filed in response to the May 3, 2007 final
Halogenated Solvent Cleaning rule (72 FR 25138) were received from the
Commonwealth of Pennsylvania Department of Environmental Protection,
Natural Resources Defense Council, Citizens for Pennsylvania’s Future,
Sierra Club, several state and federal legislators, and the Governor of
the Commonwealth of Pennsylvania.  The EPA has evaluated the information
provided in these letters along with additional information obtained
from publically available sources and contacts with manufacturers of
solvents and control equipment.  Based on the information collected,
EPA determined that the changes summarized in Table 1 would be
incorporated into the impacts analysis for the proposed reconsideration
of the final rule.

Unless a change is noted specifically in this document, the cost and
environmental impacts were determined using the same approach presented
in the April 13, 2007 memorandum titled “National Impacts for Final
Rule.”  Where analyses remain unchanged, the reader should refer to
the April 13, 2007 memorandum for a more complete discussion of the
analysis.  Specifically, the April 13, 2007 memorandum describes the
development of the 2002 degreasing database; the identification of
facilities within the web, tube, aerospace, and military depot
populations; the calculation of methylene chloride equivalent factors
based on the unit cancer risk; the development of the costs and emission
reduction estimates for the controls used for the main population and
the aerospace, military depot, and web populations; and the approach
used to apply costs for the individual controls to determine costs for
specific facilities.

Table 1 - Changes to Cost and Emissions Impacts Methodology Since

Publication of the Final Rule

Change	Effect	Notes

A web cleaning control option was added that requires 80% control only
for those facilities with a methylene chloride equivalent (MC EQ) above
60,000 kg/yr.	Two facilities (Somers Thin Strip and Arcos Alloys) have
MC EQ below 60,000 kg/yr.  Therefore, there are no additional cost
impacts for these two facilities.  Costs and emission reduction impacts
were calculated for the other 6 web facilities at 60,000 kg/yr MC EQ.
This option was added to focus emission reductions on the highest
emitting web cleaning facilities.

For tube manufacturers the following additional controls were added:

Vacuum Machine

CAD System

Switching from TCE to n-propyl bromide (nPB)	Previously, the only known
viable control for tube manufacturers was the addition of a side
chamber.  The addition of  vacuum machines, CAD systems, and switching
to nPB means that tube manufacturers can significantly or even totally
eliminate their halogenated HAP emissions.  	Controls added as a result
of information obtained from tube manufacturers after publication of the
final rule that indicated these controls were being used at tube
manufacturing facilities.

For facilities with web cleaning machines the following additional
controls were added:

CAD System

Switching from TCE to n-propyl bromide (nPB)	Previously, the only known
viable control for web facilities was the addition of automated gates,
lengthening the cleaning process area, providing an additional enclosure
around all distillation units, and modifying the capacity and process
structure of existing CADs.

The addition of  new CAD systems and switching to nPB means that tube
manufacturers can significantly or even totally eliminate their
halogenated HAP emissions.  	Controls added as a result of information
obtained after publication of the final rule that indicated that CAD was
being used at web facilities.  Information also indicated that nPB is an
acceptable substitute for TCE and is compatible with aluminum and steel.

CONTROL OPTIONS

Table 2 shows the control options that were evaluated for the proposed
notice of reconsideration of the final rule.  Table 3 shows the control
levels by solvent and for facilities using multiple solvents.  All of
the options evaluated are beyond the 1994 MACT levels.  The control
options for the main population, aerospace facilities, military depots,
and tube are in the form of facility-wide solvent cleaning emission
limits that apply to all PCE, TCE, and MC emissions from solvent
cleaning operations at a facility.  The control option evaluated for
facilities with web cleaning machines applies only to facilities with a
methylene chloride equivalent of greater than 60,000 kg/year.  If the
web facility’s MC EQ exceeds 60,000 kg/yr, the facility is required to
achieve an overall control efficiency of 80% for solvent cleaning
operations.

Table 2 - Emissions Control Options Evaluated for the Proposed Notice of
Reconsideration in kg/yr MC Equivalents

Degreasing Population

Option 1

Option 2

Option 3

Main Degreasing Population, (excludes those below)	60,000	60,000	60,000

Military Depot	100,000	100,000	100,000

Web	No Additional Control	No Additional Control	For facilities >60,000,
must achieve an 80% control efficiency

Tube	No Additional Control	60,000	60,000

Aerospace	No Additional Control	No Additional Control	100,000

Table 3 - Specific Control Level Components of Options 1, 2, and 3
Evaluated for the Proposed Notice of Reconsideration

Solvents Emitted

Control Levels in kg (lbs)

	Main Population	Military Depot

Web

Tube

Aerospace

PCE only	4,781 (10,540)	7,968 (17,567)	For Facilities with MC EQ above
60,000, must achieve an 80% overall control efficiency	4,781 (10,540)
7,968 (17,567)

TCE only	14,085 (31,051)	23,474 (51,751)

14,085 (31,051)	23,474 (51,751)

MC only	60,000 (132,276)	100,000 (220,460)

60,000 (132,276)	100,000 (220,460)

Multiple Solvents - MC Equivalent 	60,000 (132,276)	100,000 (220,460)

60,000 (132,276)	100,000 (220,460)

DETERMINATION OF COSTS FOR INDIVIDUAL CONTROLS

	Table 4 shows the individual controls, percent emission reductions, and
associated costs that were used for evaluating the cost impacts on the
main population of cleaning machines.  The percent emission reduction
values and costs shown in Table 4 have not changed as a result of the
reconsideration.

Table 4 - Controls Beyond MACT Applied to Main Population

Control Type	Description	% Emission Reduction (a) 	Total Capital Costs
Annualized Capital Costs	O&M Costs	Total Annual Emission Control Costs
(b)

Control Equipment Retrofits	1.5 Freeboard Ratio (1.5FBR), Working Mode
Cover (WC), Freeboard Refrigeration Device (FRD)	50	$25,645	$2,821
$2,015	$4,836

	1.5 Freeboard Ratio (1.5FBR)	30	$20,380	$2,242	$0	$2,242

	Carbon Adsorption System (CAD)	30	$162,687	$17,896	$8,948	$26,844

Solvent Switching	PCE to MC	11	$15,677	$1,725	$928	$2,653

	PCE to TCE	31	$0	$0	($2,022)c	($2,022)

	TCE to MC	(29)	$15,677	$1,725	$2,950	$4,675

Machine Replacement	Vacuum to Vacuum Cleaning Machine	95	$399,000
$37,663	$18,832	$56,495

a -  For the solvent switching options the percent emission reduction
reflects the amount of new solvent emitted relative to the amount of old
solvent emitted.  For the TCE to MC option it is estimated that
emissions of MC would be 29% more than the original TCE emissions.  The
primary benefit for the solvent switching options results from the lower
MIR cancer risk for the new solvents.  If the MIR values are taken into
account along with the change in emission reduction, the resulting
decrease in cancer risk are as follows:

	PCE to MC = 93%

	PCE to TCE = 77%

	TCE to MC = 70%

b – Does not include cost savings due to reduced solvent purchases.
The solvent savings were calculated for each specific unit based on the
volume of solvent emissions reduced and the cost of the specific solvent
in $/gal.

c – Values in ( ) indicate a cost savings.

	Table 5 shows the individual controls that were applied when evaluating
the cost impacts on the web, tube, aerospace, and military depot
cleaning machine populations.  The percent emission reduction estimates
and costs have not changed for the controls applied to the aerospace,
and military depot populations.  For the tube population, three new
controls were added as a result of information obtained since the
publication of the final rule.  These controls are the replacement of
existing cleaning equipment with a new vacuum-to-vacuum cleaning
machine, the addition of carbon adsorption, and switching from TCE to
n-propyl bromide (nPB).  For facilities with web cleaning machines, two
new controls were added as a result of information obtained since the
publication of the final rule.  These controls are the addition of
carbon adsorption and switching from TCE to n-propyl bromide (nPB).

Table 5 - Controls Beyond MACT Applied to the Web, Tube, Aerospace, and
Military Depot Cleaning Machine Populations

Industry Segment	Description	% Emission Reduction	Total Capital Costs
Annualized Capital Costs	O&M Costs	Total Annual Emission Control Costs
(a)

Aerospace	Vacuum Machine - Small - Baskets	95	$150,000	$14,159	$7,080c
$21,239

	Vacuum Machine - Small - Hanging	95	$242,000	$22,867	$11,434c	$34,301

	Vacuum Machine - Large - Baskets	95	$584,000	$55,125	$27,563c	$82,688

	Vacuum Machine - Large - Hanging	95	$788,800	$74,457	$37,229c	$111,686

	Enclosure, parts transporter, CAD, and distillation	50	$237,500	$26,076
$13,038c	$39,114

	Dual-Split Working-Mode Cover and Dual-Bank Freeboard Chillers	25
$44,000	$4,831	$2,416c	$7,247

	Enclosure	15	$108,000	$11,858	$5,929c	$17,787

Military Depot	RETRO - 1.5FBR, WC, FRD (b) 	50	$102,581	$11,284	$8,059
$19,343

Tube	Vacuum-to-Vacuum Cleaning Machine	99	$1,700,000	$160,468	$80,234c
$240,702

	Carbon Adsorption System	90	$1,000,000	$109,795	$54,897c	$164,692

	Switch from TCE to nPB	100	$0	$0	$0	$0

Web	Automated gates 	25	$50,000	$5,490	$2,745c	$8,235

	Carbon Adsorption System	50	$237,500	$26,076	$13,038 c	$39,114

	Switch from TCE to nPB	100	$0	$0	$0	$0

a – Does not include cost savings due to reduced solvent purchases or
cost increases due to the higher cost of solvent.  The solvent cost
savings or increases were calculated for each specific unit based on the
volume of solvent and the cost of the specific solvent in $/gal.

b – To account for the large size of the cleaning machine the costs
are 4 times those used for the main population).

c – O&M costs were assumed to be equal to half the annualized capital
costs.

	The basis of the percent emission reductions and costs for controls
that have not changed as a result of the reconsideration are explained
in detail in the April 13, 2007 memorandum titled “National Impacts
for Final Rule.”  The basis of the percent emission reductions and
costs for the controls added for the tube population are explained in
the following paragraphs.  As was done previously, all capital costs for
new systems were annualized based on a 20-year equipment lifetime and a
7% interest rate and retrofit equipment was annualized based on a
15-year equipment lifetime and a 7% interest rate.  The equipment
lifetimes were determined based on information from equipment
manufacturers.

Vacuum-to-Vacuum Cleaning Machine for Tube Manufacturers

	The percent emission reduction and costs for vacuum-to-vacuum cleaning
machines applied to the narrow tube manufacturer population were based
on information obtained from Salem Tube, Inc. for their Greenville, PA
tube manufacturing plant.  Salem Tube, Inc. submitted an application for
an Air Quality Plan Approval to Pymatuning Township on April 13, 2007.
A revision to the application was submitted by Salem Tube, Inc. to the
Pennsylvania Department of Environmental Protection (PA DEP) on July 24,
2007.  In the application, Salem Tube, Inc. indicates that they will be
installing a vacuum cleaning and degreasing system manufactured by EMO.
The system includes the following components:

A vacuum tight degreasing tank with lifting/lowering equipment for
vertical inclination of the tank;

Heated flood tank;

Supply unit with solvent evaporator, main distillation, additional
vacuum distillation, filtration, and activated carbon air filter system;

Control system with programmable logic control (PLC) and graphics
display with process visualization; and an

Extraction tank/water separator.

The cleaning tank can hold tubes 4 feet to 44 feet in length.  The tubes
are placed in the degreasing tank in baskets using an overhead crane,
the top cover of the degreasing tank is closed, and air is evacuated
from the chamber.  For immersion cleaning, the tank is flooded with hot
solvent and the tank can be inclined vertically.  When immersion
cleaning is finished the solvent is fed back into the flood tank through
a filter unit.  For vapor cleaning, solvent vapor is fed into the tank
from the solvent evaporator.  When solvent cleaning is complete the
solvent vapor is fed through a condenser and the pure solvent condensate
is fed back into the flood tank.  The tank is then rinsed with fresh air
which is fed to the integrated activated carbon air filter system to
ensure that any remaining solvent vapor is removed from the tank.  The
cleaning chamber is equipped with an infrared spectral photometer to
measure the solvent content at the end of each cycle and will only allow
the chamber to be opened when TCE levels are below 1 gram per cubic
meter.

	Salem Tube, Inc. estimated that this system will reduce their TCE
emissions to 262 lbs/year.  In the 2002 National Emissions Inventory,
emissions of TCE from this facility were reported at 104,000 lbs/year.
Therefore, this new system will reduce Salem Tube, Inc.’s TCE
emissions at the Greenville, PA facility by 103,738 lbs/year or over 99%
 [(103,738 lbs/year)/(104,000 lbs/year) = 99.7%].  A 99% reduction was
assumed for the purposes of the impact analysis.

	Salem Tube reports that the cost for this system will be $1.7 million.
As with other controls, the annual operating and maintenance costs were
assumed to be equal to half of the annualized capital costs.

Carbon Adsorption System for Tube Manufacturers

	Superior Tube in Collegeville, PA, and Accellent, Inc., also in
Collegeville, PA, have installed carbon adsorptions (CAD) systems to
control emissions of TCE from their solvent cleaning machines.

	Superior Tube installed their CAD system in 2001 to control emissions
of TCE from their 661 Vapor Degreaser.  Compliance tests conducted on
Superior Tube’s system showed that it had an average TCE removal
efficiency of 99.2%.  No cost estimate was provided for the installation
of the carbon adsorption unit at Superior Tube.

	In 2007 and early 2008, Accellent, Inc. installed a carbon adsorption
system comprised of four beds.  These beds serve only two of the four
TCE emissions sources – Plant #1 and Plant #2 Vapor Degreasers.
However, these two sources account for approximately 95% of 2006 TCE
emissions.  In their permit documents Accellent has proposed only a
25-35% reduction in TCE emissions from the installation of this CAD
system.  However, PA DEP believes “this is very conservative, as
emission reductions of 90% or greater usually result from this type of
installation.”  In their January 29, 2007 comment letter, Accellent
provided an estimated cost of $1.8 million dollars for the CAD system on
their two large degreasers.

	Based on the control efficiency of 99.2% for Superior Tube’s CAD
system and the expectation that Accellent’s CAD system will achieve a
90% control efficiency, a 90% control efficiency was used for the
impacts analysis.  The installed capital cost of a CAD system installed
on a tube manufacturing degreaser was estimated to be approximately $1
million/per unit.  This is a conservatively high estimate based on
Accellent’s costs of $1.8 million for a system serving 2 units.

Carbon Adsorption System for Web Cleaning Facilities

	Several web cleaning facilities, such as Alcoa (IA), American Safety
Razor (VA), and American Safety Razor (TN) already have CAD systems
installed.  Therefore, CAD is a demonstrated technology for this
population of solvent cleaning machines.  Cost for the purchase of the
CAD systems was not available for these facilities.  Therefore, costs
provided by Delta Airlines were used to estimate the costs for
installing CAD for web cleaning facilities.  The CAD system costs
provided by Delta Airlines include the CAD, an enclosure, distillation
unit, and parts transporter.  The cost estimate provided was for a
“large” solvent cleaning machine with a solvent-air-interface area
of 40ft2.  The percent reduction that Delta Airlines provided for this
system was 50%.

Switching from TCE to nPB for Tube Manufacturers and Web Cleaning
Facilities

 	Following publication of the final rule, EPA became aware that
Superior Tube, Inc. in Collegeville, PA, and Tube Methods, Inc. in
Bridgeport, PA, were switching from TCE to nPB for their solvent
cleaning operations.  Contacts with manufacturers of nPB

and information from other sources also indicated that nPB is an
acceptable replacement for TCE in solvent cleaning applications.,

	Since nPB is not a halogenated HAP, a switch from TCE to nPB will
result in a 100% reduction in halogenated HAP emissions.  According to
nPB manufacturers, other than adjusting certain equipment settings, no
equipment purchases or changes are necessary to switch to nPB.
Therefore, capital equipment costs for switching from TCE to nPB were
estimated to be zero for the cost analysis.  However, nPB does cost
considerably more than TCE - $2.25/lb for nPB versus $1.04/lb for TCE.
This additional cost was factored into the cost analysis by calculating
an increased solvent cost based on the amount of TCE previously used and
assuming that an equal amount of nPB is used at the higher price.
Manufacturers of nPB support the assumption that 1 lb of TCE will be
replaced with 1 lb of nPB.,

Automated Gates for Web Cleaning Facilities

	The costs and emission reduction estimates (25%) for automated gates
were obtained from American Safety Razor.

SUMMARY OF COSTS AND EMISSION REDUCTION RESULTS

	The costs and emission reductions for all units at all facilities were
totaled to yield the total national costs and emission reductions.
Table 6 summarizes the national capital costs, national annualized
capital costs, national O&M Costs, national solvent savings, and the
total national annual emission control costs for each control level
component.

	Table 6 shows that the capital costs and O&M costs are the greatest for
the main population at 60,000 kg/yr MC EQ and the tube population at
60,000 kg/yr MC EQ.  However, the main population and tube levels also
have the greatest emission reductions.  The significant solvent savings
for the main population at 60,000 MC EQ offset the capital and O&M costs
to yield a negative net annualized cost of control.  Therefore, for
every ton of emissions reduced, the facilities in the main population
will on average realize savings of $832.  However, for tube the cost
savings do not fully offset the capital costs, and therefore, a cost
effectiveness of $3,238/ton results.

	The 100,000 kg/yr MC EQ control level for the aerospace and 80% control
efficiency for web result in cost effectiveness values of $1,933/ton and
$2,774/ton, respectively.  These values reflect the fact that the
emission reductions, and thus the solvent savings, do not significantly
offset the capital costs.  The control level of 100,000 kg/yr MC EQ for
military depots shows a savings of $625/ton.

	Table 7 summarizes the national capital costs, national annualized
capital costs, national O&M Costs, national solvent savings, and the
total national annual emission control costs for each of the three
control options.  The control levels that make up each control option
are shown in Table 2.  The costs for the options are, therefore,
determined by combining the appropriate control level costs in Table 6.
For example, as shown in Table 2, Option 1 includes the main population
at 60,000 kg/yr MC EQ and the military depot population at 100,000 kg/yr
MC EQ.  All other populations have no additional control under option 1.
 Therefore, to determine the capital costs for option 1, the capital
costs of the main population of $15,117,235 (as shown in Table 6) are
added to the capital costs for military depots of $535,471 (as shown in
Table 6) to yield $15,652,706.  This same process was followed to
determine the costs for all three options as shown in Table 7.

	Table 7 shows that the capital costs, O&M costs, emission reductions,
and the size of the solvent credit increase from Option 1 to Option 2,
and from Option 2 to Option 3.  The lowest cost effectiveness value is
for Option 1 at -$821/ton.  The highest cost effectiveness value is for
Option 3 at $944/ton.

 	For additional details regarding the development of the costs and
emission reduction impacts for the proposed notice of reconsideration
refer to the cost spreadsheet in the rulemaking docket.

Description	Main Population without Tube, Web, Aerospace, and Military
Depots -

60,000 kg MC EQ	Aerospace -

100,000 kg MC EQ 	Military Depots -

100,000 kg MC EQ	Web -

80% Overall Efficiency for Facilities with MC EQ of > 60,000 MC EQ	Tube
-

60,000 kg MC EQ

1.  National Total Capital Costs	$15,117,235	$9,015,636	$535,471
$1,087,500	$21,924,000

2.  National Annualized Total Capital Costs	$1,446,203	$869,033	$58,902
$119,487	$2,225,190

3.  National Total Annual Operation and Maintenance Costs	$722,768
$435,516	$42,068	$59,743	$1,112,595

4.  National Emission Reduction (true tons)	1,591	324	89	291	921

5.  National Solvent Credit	-$3,492,430	-$677,887	-$156,631	$628,446
-$355,533

6.  National Net Annualized Cost of Control ($/yr)

[Annualized Total Capital Costs + O&M Costs + Solvent Credit]
-$1,323,459	$625,662	-$55,662	$807,676	$2,982,253

7.  National Cost Effectiveness ($/ton)

[Net Annualized Cost of Control/Emission Reduction]	-$832	$1,933	-$625
$2,774	$3,238

Table 6 – Summary of National Costs and Emission Reductions for
Specific Control Level Components of

Options 1, 2, and 3 Evaluated for the Proposed Notice of Reconsideration

Table 7 - Summary of National Costs and Emission Reductions for Options
1, 2, and 3

Evaluated for the Proposed Notice of Reconsideration

Description	Option 1	Option 2	Option 3

1.  National Total Capital Costs	$15,652,706	$37,576,706	$47,679,842

	2.  National Annualized Total Capital Costs	$1,505,105	$3,730,295
$4,718,815

	3.  National Total Annual Operation and Maintenance Costs	$764,836
$1,877,431	$2,372,690

	4.  National Emission Reduction (true tons)	1,680	2,601	3,216

	5.  National Solvent Credit	-$3,649,061	-$4,004,594	-$4,054,035

	6.  National Net Annualized Cost of Control ($/yr)

[Annualized Total Capital Costs + O&M Costs + Solvent Credit]
-$1,379,121	$1,603,132	$3,036,470

	7.  National Cost Effectiveness ($/ton)

[Net Annualized Cost of Control/Emission Reduction]	-$821	$616	$944

 Memorandum.  Chris Sarsony, engineering-environmental Management, Inc.
to Lynn Dail, U.S. EPA.  Re: National Impacts for Final Rule.  April 13,
2007.

 Joseph P. Pezze, Hillcrest Group Environmental Consultants to
Pymatuning Township Supervisors. Re: Plan Approval Application, New
Vacuum Degreaser, Existing Title V Permit #43-000142.  April 13, 2007.

 Joseph P. Pezze, Hillcrest Group Environmental Consultants to Ms.
Carrie Cooper, P.E., PA DEP NW Regional Office.  Re: Salem Tube, Inc,
New Degreasing System (revisions).  July 24,2007.

 Reference 3, Cover page.

 Reference 2, Section C, Page 16.

 Minor Operating Permit Modification Application, Summary of Requested
Permit Modifications. February 13, 2008.

 “Preliminary Report - Methods for Reducing TCE Emissions at
Accellent, Inc. and Superior Tube Co., Inc., Collegeville,
Pennsylvania,” prepared by Matson & Associates, Inc.  January 2008.
Page 4.

 “Progress of Emission Reduction Efforts” from PA DEP.  February 13,
2008.

 Docket item EPA-HQ-OAR-2002-0009-0126.

 Docket item EPA-HQ-OAR-2002-0009-0121.

Reference 7, Page 7.

 Telecommunication.  Jason Goldsmith, e2M with Jason Ridenour, Parts
Cleaning Technologies, February 18, 2008.  Re: Solvent Switching from
TCE to nPB.

 ID.

 ID.

 ID.

 Reference 7, Page 7.

 Docket item EPA-HQ-OAR-2002-0009-0125.

 PAGE

 PAGE   1


[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Pages 61690-61700]
[FR Doc No: 2016-21353]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1486]

Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Zika Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for detection of the Zika virus in
response to the Zika virus outbreak in the Americas. FDA issued this
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) as requested by Viracor-IBT Laboratories, Inc. The Authorization
contains, among other things, conditions on the emergency use of the
authorized in vitro diagnostic device. The Authorization follows the
February 26, 2016, determination by the Secretary of Health and Human
Services (HHS) that there is a significant potential for a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad and
that involves Zika virus. On the basis of such determination, the
Secretary of HHS declared on February 26, 2016, that circumstances
exist justifying the authorization of emergency use of in vitro
diagnostic tests for detection of Zika virus and/or diagnosis of Zika
virus infection, subject to the terms of any authorization issued under
the FD&C Act. The Authorization, which includes an explanation of the
reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of July 19, 2016.

ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces of attack with a biological, chemical,
radiological, or nuclear agent or agents; (3) a determination by the
Secretary of HHS that there is a public health emergency, or a
significant potential for a public health emergency, that affects, or
has a significant potential to affect, national security or the health
and security of U.S. citizens living abroad, and that involves a
biological, chemical, radiological, or nuclear agent or agents, or a
disease or condition that may be attributable to such agent or agents;
or (4) the identification of a material threat by the Secretary of
Homeland Security under section 319F-2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or
the health and security of U.S. citizens living abroad.
    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the

reasons for the action. Section 564 of the FD&C Act permits FDA to
authorize the introduction into interstate commerce of a drug, device,
or biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA\1\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that: (A) The product may be effective in diagnosing, treating,
or preventing (i) such disease or condition or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent, and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; and (4)
that such other criteria as may be prescribed by regulation are
satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.
    II. EUA Request for an In Vitro Diagnostic Device for Detection of
the Zika Virus
    On February 26, 2016, the Secretary of HHS determined that there is
a significant potential for a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves Zika virus.
On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on
the basis of such determination, the Secretary of HHS declared that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostic tests for detection of Zika virus and/or diagnosis of
Zika virus infection, subject to the terms of any authorization issued
under section 564 of the FD&C Act. Notice of the determination and
declaration of the Secretary was published in the Federal Register on
March 2, 2016 (81 FR 10878). On July 7, 2016, Viracor-IBT Laboratories,
Inc. requested, and on July 19, 2016, FDA issued, an EUA for the Zika
Virus Real-time RT-PCR test, subject to the terms of the Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
Authorization are available on the Internet at http://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of an in vitro diagnostic device for
detection of Zika virus subject to the terms of the Authorization. The
Authorization in its entirety (not including the authorized versions of
the fact sheets and other written materials) follows and provides an
explanation of the reasons for its issuance, as required by section
564(h)(1) of the FD&C Act:
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    Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21353 Filed 9-6-16; 8:45 am]
 BILLING CODE 4164-01-C


Assessing the Impact of Progress and Learning Curves on Clean Air Act Compliance Costs Cynthia J. Manson, Matthew B. Nelson, and James E. Neumann Industrial Economics, Incorporated Cambridge, MA September 30, 2001 ABSTRACT Economic analysis of the costs and benefits of regulations has long been an important regulatory decision making tool; it has been used in parts of the Federal government since the 1930' s, and has been required for major rules since Executive Order 12291 in 1981. The usefulness of these analyses depends on the accuracy of the underlying cost and benefit estimates. In prior work the authors established that three factors contribute to a tendency for regulatory cost estimates to be overestimated: ( 1) " learning by doing," or learning curve impacts, which refer to efficiency gains related to cumulative production; ( 2) innovation and technological change; and ( 3) cost reducing features of regulatory design. Most existing Agency cost estimates do not make adjustments to account for these factors.

This paper assesses methods and data available to improve the accuracy of regulatory cost projections, with particular focus on the practical application of progress and learning curves. The authors conclude that the learning curve concept has a sound theoretical and empirical basis, and that there is evidence that learning and progress do occur in the production of air pollution control devices, so that costs for these devices can be expected to decline over time, in real terms. The authors present three case studies that illustrate that a quantitative adjustment to cost estimates is practical and can often be justified. The presence of uncertainties in the quantitative effect of the application of progress curves, however, suggests that analysts should consider whether an explicit quantitative uncertainty analysis ought to be applied in all cases. The use of a single progress ratio may in some cases suggest more certainty in the anticipated pace of progress than is warranted; in some cases, a range of progress ratios might be more appropriate. The authors also present guidelines for the application of the progress curve literature to air pollution control regulatory cost estimates.


[Federal Register: December 2, 2008 (Volume 73, Number 232)]
[Notices]
[Page 73342]
[DOCID:fr02de08-90]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1791-DR]

Texas; Amendment No. 12 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Texas (FEMA-1791-DR), dated September 13, 2008, and
related determinations.

DATES: Effective Date: November 21, 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: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Stephen M.
DeBlasio Sr., of FEMA is appointed to act as the Federal Coordinating
Officer for this declared disaster.
    This action terminates my appointment of Sandy Coachman as Federal
Coordinating Officer for this disaster.

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

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-28545 Filed 12-1-08; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 77 (Tuesday, April 21, 2020)]
[Notices]
[Page 22246]
[FR Doc No: 2020-08373]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0269]

Agency Information Collection Activities; Renewal of a Currently-
Approved Information Collection Request: Request for Revocation of
Authority Granted

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

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for review
and approval and invites public comment. FMCSA requests approval to
renew an ICR titled ``Request for Revocation of Authority Granted.''

DATES: Please send your comments by May 21, 2020. OMB must receive your
comments by this date in order to act quickly on the ICR.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Jeff Secrist, Office of Registration
and Safety Information, Department of Transportation, Federal Motor
Carrier Safety Administration, West Building 6th Floor, 1200 New Jersey
Avenue SE, Washington, DC 20590. Telephone:<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    Office hours are from 9 a.m. to 5 p.m., Monday through Friday,
except Federal Holidays.

SUPPLEMENTARY INFORMATION:
    Title: Request for Revocation of Authority Granted.
    OMB Control Number: 2126-0018.
    Type of Request: Renewal of a currently approved information
collection.
    Respondents: Motor Carrier (motor carrier clerical staff).
    Estimated Number of Respondents: 5,901.
    Estimated Time per Response: 15 minutes (0.25 hours).
    Expiration Date: September 30, 2020.
    Frequency of Response: On occasion, as needed.
    Estimated Total Annual Burden: 1,475 hours.

Background

    FMCSA registers for-hire motor carriers of regulated commodities
under 49 U.S.C. 13902, surface freight forwarders under 49 U.S.C.
13903, and property brokers under 49 U.S.C. 13904. Each registration is
effective from the date specified under 49 U.S.C. 13905(c).
    Subsection (d) of 49 U.S.C. 13905 also provides that on application
of the registrant, the Secretary may amend or revoke a registration,
and hence the registrant's operating authority. Form OCE-46 allows
these registrants to apply voluntarily for revocation of their
operating authority or parts thereof. If the registrant fails to
maintain evidence of the required level of insurance coverage on file
with FMCSA, its operating authority will be revoked involuntarily.
Although the effect of both types of revocation is the same, some
registrants prefer to request voluntary revocation. For various
business reasons, a registrant may request revocation of some part, but
not all, of its operating authority.
    This information collection, which supports the DOT Strategic Goal
of Safety, reflects modified estimates of burden hours and costs. For
respondents, the program adjustment has resulted in increased total
burden hours and an increase in respondent costs. The burden hour
increase is due to an estimated increase in the number of annual
filings of Form OCE-46 from 3,501 to 5,901 per year, resulting in an
increase of 2,400 responses and 600 burden hours.
    The previous iteration of this ICR did not include estimated labor
costs for respondents; it only reported the estimated annual burden
hours. This version adds estimated labor costs according to best
practices. The estimated annual labor cost for industry resulting from
submitting Form OCE-46 is $49,527.
    The total annual respondent cost has decreased by $20,190. This
decrease is due to the fact that respondents may now file the form
online, at no charge. While the online submission option exists, FMCSA
still estimates that approximately 1,567 respondents will continue to
file the form by mail, which incurs notarization and postage fees.
    For the Federal Government, the program costs have increased by
$11,176. While this ICR revised the Federal labor wage load factor
downward to be consistent with the methodology used in other FMCSA
ICRs, the overall cost to the Federal Government increased due to the
increase in the number of forms received by FMCSA.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the FMCSA to perform it's functions; (2)
the accuracy of the estimated burden; (3) ways for the FMCSA to enhance
the quality, usefulness, and clarity of the collected information; and
(4) ways that the burden could be minimized without reducing the
quality of the collected information.

    Issued under the authority delegated in 49 CFR 1.87.
Kenneth Riddle,
Acting Associate Administrator,Office of Research and Registration.
[FR Doc. 2020-08373 Filed 4-20-20; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56687-56689]
[FR Doc No: 2022-19993]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-1080]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TAVALISSE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for TAVALISSE and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by November 14, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by March 14, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. eastern time at the end of

November 14, 2022. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received 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-2019-E-1080 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TAVALISSE.'' 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, 240-
402-7500.
     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 Sec.  10.20 (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>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product TAVALISSE
(fostamatinib disodium hexahydrate). TAVALISSE is indicated for the
treatment of thrombocytopenia in adult patients with chronic immune
thrombocytopenia who have had an insufficient response to a previous
treatment. Subsequent to this approval, the USPTO received a patent
term restoration application for TAVALISSE (U.S. Patent No. 7,449,458)
from Rigel Pharmaceuticals, Inc. and the USPTO requested FDA's
assistance in determining the patent's eligibility for patent term
restoration. In a letter dated June 12, 2019, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of TAVALISSE represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TAVALISSE is 4,564 days. Of this time, 4,198 days occurred during the
testing phase of the regulatory review period, while 366 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
October 20, 2005. FDA has verified the applicant's claim that the date
the investigational

new drug application became effective was on October 20, 2005.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: April 17,
2017. FDA has verified the applicant's claim that the new drug
application (NDA) for TAVALISSE (NDA 209299) was initially submitted on
April 17, 2017.
    3. The date the application was approved: April 17, 2018. FDA has
verified the applicant's claim that NDA 209299 was approved on April
17, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: September 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19993 Filed 9-14-22; 8:45 am]
BILLING CODE 4164-01-P