[Federal Register: November 12, 2008 (Volume 73, Number 219)]
[Rules and Regulations]
[Page 66737-66738]
[DOCID:fr12no08-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0585; Directorate Identifier 2008-NM-027-AD;
Amendment 39-15704; AD 2008-22-09]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 747SP Series 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 747SP series airplanes. This AD requires repetitive
lubrication of the rudder tab hinges and repetitive replacement of the
rudder tab control rods. This AD results from reports of freeplay-
induced vibration on the control surfaces on Boeing Model 727, 737,
757, and 767 airplanes. We are issuing this AD to prevent damage to the
control surface structure during flight, which could result in loss of
control of the airplane.

DATES: This AD is effective December 17, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of December 17,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-
2207; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com.

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: Kathleen Arrigotti, Aerospace
Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; 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 747SP series airplanes. That NPRM was published in the
Federal Register on May 23, 2008 (73 FR 30007). That NPRM proposed to
require repetitive lubrication of the rudder tab hinges and repetitive
replacement of the rudder tab control rods.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received from the one commenter.

Request To Revise Discussion Section of NPRM

    Boeing requests that we revise the Discussion section of the NPRM
to remove the statement that the affected control surfaces on Boeing
Model 727, 737, 757, and 767 airplanes and Boeing Model 747SP airplanes
are similar in design. Boeing states that the only similarity between
Model 727, 737, 757, and 767 airplanes and Model 747SP airplanes
pertains to flutter-critical unbalanced control surfaces of the
identified unsafe condition. Boeing requests that we revise that
section of the NPRM to state: ``There have been no reports of freeplay-
induced vibration of the 747SP rudder tabs. However, there have been
reports pertaining to flutter-critical unbalanced control surfaces on
727, 737, 757 and 767 airplanes. This lubrication and replacement will
help prevent conditions which allow excessive freeplay of control
surfaces.''
    We agree with Boeing that the Discussion section could be clarified
as Boeing specified. However, since that section of the preamble does
not reappear in the final rule, no change to the final rule is
necessary.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed.

Costs of Compliance

    We estimate that this AD affects 7 airplanes of U.S. registry. The
following table provides the estimated costs for U.S. operators to
comply with this AD. The average labor rate is $80 per work hour.

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
             Action               Work hours        Parts         Cost per product           Fleet cost
----------------------------------------------------------------------------------------------------------------
Lubrication....................            2  None.............  $160, per cycle..  $1,120, per cycle.
Replacement....................           16  $39,511..........  40,791, per cycle  285,537, per 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:

2008-22-09 Boeing: Amendment 39-15704. Docket No. FAA-2008-0585;
Directorate Identifier 2008-NM-027-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective December 17,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Boeing Model 747SP series airplanes.

Unsafe Condition

    (d) This AD results from reports of freeplay-induced vibration
on the control surfaces on Boeing Model 727, 737, 757, and 767
airplanes. We are issuing this AD to prevent damage to the control
surface structure during flight, which could result in loss of
control of the airplane.

Compliance

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

Repetitive Lubrication and Replacement

    (f) At the applicable compliance time listed in Paragraph 1.E.,
``Compliance,'' of Boeing Special Attention Service Bulletin 747-27-
2447, dated January 17, 2008, lubricate the rudder tab hinges and
replace the rudder tab control rods with new control rods. Repeat
the lubrication and replacement thereafter at the applicable repeat
interval listed in paragraph 1.E., ``Compliance,'' of the service
bulletin. Do all actions in accordance with the Accomplishment
Instructions of Boeing Special Attention Service Bulletin 747-27-
2447, dated January 17, 2008. Where Boeing Special Attention Service
Bulletin 747-27-2447, dated January 17, 2008, specifies a compliance
time after the date on the service bulletin, this AD requires
compliance within the specified compliance time after the effective
date of this AD.

Alternative Methods of Compliance (AMOCs)

    (g)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, ATTN: Kathleen Arrigotti, Aerospace Engineer, Airframe Branch,
ANM-120S, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; has the authority to
approve AMOCs for this AD, if requested using 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

    (h) You must use Boeing Special Attention Service Bulletin 747-
27-2447, dated January 17, 2008, 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; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (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 October 10, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-25689 Filed 11-10-08; 8:45 am]

BILLING CODE 4910-13-P


MEMORANDUM
To:
Margaret Sheppard, U.S. EPA
CC:
Rachel Schwartz, Sally Hamlin, Rebecca von dem Hagen, Bella Maranion, Cindy Newberg, U.S. EPA
From:
Kasey Knoell, Becky Ferenchiak, Jenny Tanphanich, Ed Carr, Mark Wagner, ICF International
Date:
February 24, 2014
Re:
Assessment of the Potential Impact of Hydrocarbon Refrigerants on Ground Level Ozone Concentrations (EPA Contract Number EP-W-10-031 Task Order 305, Task 01)

In response to technical direction received from EPA, ICF has prepared an assessment of the potential impact on ground level ozone concentrations caused by release of hydrocarbon refrigerants across refrigeration and air conditioning end uses. Refrigerant emissions were modeled from the U.S. EPA's Vintaging Model (VM_IO file_V4.4_11.6.12) and their impacts on ground level ozone were modeled using the CMAQ model (version 4.7.1). Releases of isobutane and propylene were modeled in Los Angeles, Houston, and Atlanta under three emissions scenarios: 1) all refrigeration and air conditioning (ref/AC) end-uses, 2) ref/AC excluding motor vehicle air-conditioners (MVACs), and 3) ref/AC excluding MVACs and chillers. A final scenario was modeled, in which limitations on the properties of hydrocarbons (e.g., flammability) are considered to determine which end-uses were likely to transition to hydrocarbon refrigerants. The remainder of this memorandum summarizes the results of this assessment. A quantitative analysis of the uncertainty levels can also be performed by undertaking additional CMAQ simulations if requested by the EPA TOCOR.

Please contact Mark Wagner at<PHONE_NUMBER> with any questions or comments.

Potential Impacts of Hydrocarbon Refrigerants on Ground-Level Ozone Concentrations
Executive Summary
Hydrocarbons are increasingly being considered for use in a number of refrigeration and air-conditioning (ref/AC) end-uses.  Although hydrocarbons have a low global warming potential (GWP) and are thus desirable alternatives to commonly used hydrofluorocarbons (HFCs), there is concern that use of hydrocarbons could negatively impact local air quality due to their high maximum incremental reactivity (MIR) values.
In order to evaluate their potential impact, three conservative hydrocarbon emission scenarios and one more realistic scenario were analyzed. The first three evaluate emissions of propylene and isobutane first from the entire refrigeration and air conditioning sector, second excluding motor vehicle air conditioning, and third excluding motor vehicle air conditioning and chillers.  A fourth scenario, evaluating emissions of a mix of propylene, isobutane, and propane, was developed based on SNAP hydrocarbon applications and UL Standards and represents a more realistic transition to hydrocarbons. The hydrocarbon emissions from these scenarios were estimated based on U.S. EPA's Vintaging Model, and their potential contributions to ozone concentrations were assessed using U.S. EPA's Community Multiscale Air Quality (CMAQ) model.
CMAQ modeling was performed for April through the end of September, as these months presented the largest releases of hydrocarbon refrigerant as well as weather conditions favorable for ozone formation. The ozone concentrations were estimated for the Atlanta, Houston and Los Angeles regions, due to their distinctive geographic setting and chronic high levels of ground level ozone, and then scaled for national emission estimates. The results of the CMAQ modeling indicated that hydrocarbon refrigerants under the most conservative scenario could potentially increase ground level ozone by up to 9% compared to the national ozone standard, but less than a 0.2% increase under the most realistic scenario.
The analysis performed is based on several assumptions and projections that cannot be known with certainty at this time.  These limitations are associated with both the unknown market penetration of alternatives and climate conditions, among other factors.
Introduction
Ozone-depleting substances (ODS) such as CFC-12, R-502, and HCFC-22 were historically used across the refrigeration and air-conditioning sector. Since identifying the damaging nature of CFCs and HCFCs, EPA moved swiftly to transition to alternatives. The phaseout of CFCs in 1996 and continued phasedown of HCFCs, has led the U.S. EPA Significant New Alternatives Policy (SNAP) program to review and approve a number of potential substitutes to these ODS. In particular, hydrocarbon refrigerants, which have zero ODP and low GWP, have already been recently approved for smaller refrigeration applications (e.g., domestic refrigeration, small retail food refrigeration, and vending machines) and have the potential to be used more broadly across the refrigeration and air-conditioning sector. Compared to the HFCs and HCFCs currently in use, which have high GWPs, hydrocarbons have the potential to significantly reduce climate impacts from the refrigeration and air conditioning sector.
Although the use of hydrocarbons could potentially mitigate greenhouse gas (GHG) emissions, it could also potentially contribute to increased levels of ground level ozone.  Hydrocarbons have high MIR values, and may influence local air quality if emitted in sufficiently high quantities. Table 1 provides a summary of the propensity of these refrigerants to form tropospheric ozone.
Table 1: Propensity of Refrigerants to Form Tropospheric Ozone
Compound
           North America Maximum Incremental Reactivity (MIR) Scale
                              (g-O3/g-substance)
                              Europe POCP Scalea
                               (Relative Units)
HCFC-22
                                    <0.1
                                      0.1
HFC-134a
                                    <0.1
                                      0.1
Propylene
                                     11.57
                                      112
Ethane[a]
                                     0.28
                                      12
Isobutane
                                     1.34
                                      31
Propane
                                     0.56
                                      18
Ethylene
                                     9.07
                                      100
      Source: IPCC 2005
      [a]The POCP value is the ozone creating potential of a compound relative to ethylene (ethene), expressed as an index where ethylene = 100.
      [b]EPA uses the reactivity of ethane as the threshold for determining whether a compound has negligible reactivity. Compounds that are less reactive than, or equally reactive to, ethane under certain assumed conditions may be deemed negligibly reactive and therefore suitable for exemption from the definition of a VOC (EPA 2012).

It should be noted that EPA is currently considering exempting certain hydrocarbons in certain end-uses from the ban on venting of refrigerant under §608 of the Clean Air Act. In order to evaluate the potential impact of the release of hydrocarbons during disposal, ICF modeled conservative and realistic hydrocarbon emission scenarios from the refrigeration/AC sector and assessed their impacts on ground-level ozone, taking into consideration this revision to the end-of-life management requirement.
The remainder of this report summarizes the methodology used and results in the following order:
         * Section 3: Hydrocarbon Emission Scenarios
         * Section 4: Impact on Ground-Level Ozone Concentrations
         * Section 5: Analysis Limitations
         * Section 6: Summary of Findings
         * Section 7: References
Hydrocarbon Emission Scenarios
Under this analysis, isobutane and propylene were each modeled under three conservative emissions scenarios for the refrigeration and air conditioning sector. A fourth, more realistic emissions scenario was also modeled, which considered more likely transitions to a variety of hydrocarbon refrigerants (i.e., isobutane, propylene, and propane) by end-use in the sector. The four emission scenarios considered are as follows:
   1) Scenario 1: the entire ref/AC sector: chillers, motor vehicle air conditioners (MVACs) (i.e., light-duty trucks and vehicles, trains, transit buses, school buses, and tour buses), residential and light commercial AC and heat pumps, retail food, cold storage warehouses, industrial process refrigeration, refrigerated transport, and household refrigeration and freezers;
   2) Scenario 2: the ref/AC sector excluding MVACs;
   3) Scenario 3: the ref/AC sector excluding MVACs and chillers; and
   4) Scenario 4: the ref/AC sector for end-use applications in which a SNAP submission has been received for a hydrocarbon or in which a UL Standard addressing flammable refrigerant is in place. See Appendix B for more information on the end uses included in this scenario.
In order to estimate their potential impact on ground-level ozone concentration, the national scale hydrocarbon emissions from each scenario were estimated using EPA's Vintaging Model (VM). These national emissions were then proportionally scaled to each urban area by population by county. For Los Angeles, three counties were used representing about 4.4% of the U.S. population; for Houston, eight counties representing about 2.0% of the U.S. population were used; and for Atlanta, ten counties representing about 1.4% of the U.S. population were used. These county level emissions were then spatially allocated to each emission grid cell based on population density. The remainder of this section provides a summary of the methodology used to estimate the national inventory of hydrocarbon emissions, as well as a description of each scenario considered.
Methodology for Emissions Estimates
The year 2030 was chosen as the analysis year for all scenarios, in order to conservatively estimate the impact of hydrocarbons. The majority of non-hydrocarbon equipment will have been retired by the year, due to the lifetimes of equipment (i.e., 5 to 27 years). In addition, a 2030 nationwide emission inventory was available for other emission sources and was used to estimate the baseline ozone concentration (without hydrocarbon refrigerants).  It was assumed that the hydrocarbon refrigerants would enter the market in 2012, and reach 100% market penetration in 2030. Output from the VM is provided on an annual basis; for the purposes of this analysis, the annual data was weighted on a monthly basis, and assumed that 11.9% of annual emissions occurred during each month from April to August.  Emissions of refrigerant are reasonably anticipated to occur primarily during the warmer spring and summer months, when air conditioning equipment is increasingly used. Emissions due to servicing MVACs are also expected to be higher during the spring and summer, with up to 80% of emissions due to repairs occurring April through August (MACS 2009). Furthermore, refrigerant emissions from servicing motor vehicle air conditioning systems were estimated at 47% of annual refrigerant emissions from motor vehicles (EPA 2008). This assumption was also applied for all scenarios to all stationary AC end-uses based on the assumption that seasonal emissions would follow similar patterns. Emissions of refrigerant from refrigeration equipment were assumed to occur equally year-round.
Smaller end-uses (i.e., end-uses with a charge size less than 200 kg) were assumed to have a 100% release of refrigerant upon disposal. Disposal release rates for larger end-uses (i.e., chillers, industrial process refrigeration systems, and large retail food systems) and servicing release rates for all end-uses were assumed to remain consistent with current VM assumptions, due to the assumed regulations and financial incentives for the end-user.
Each state implements individual emission and VOC regulations that inhibit venting. For example, Regulation 7:27-16.1a for New Jersey (which is a nonattainment area) requires the use of reasonably available control technology for equipment. Venting would violate this regulation. Maryland implements a regulation that states that a person may not cause or permit the discharge of VOC from any installation constructed on or after November 15, 1992 in excess of 20 pounds (9.07 kilograms) per day unless the discharge is reduced by 85 percent or more overall. In addition to state regulations, industry standards also restrict venting. Under OSHA regulations, facilities are required to demonstrate that 25 percent of the lower flammability limit (LFL) would not be exceeded at any point during venting of hydrocarbon refrigerants. Chillers and other large charge size commercial refrigeration systems do not currently implement the proper engineering controls that would be needed to allow for safe venting. The use of flares, stacks, or rapid emission controls may likely be required to meet these industry standards. Equipment would have to be modified to incorporate these controls, or venting would not be allowed. Furthermore, assuming 100% is vented during servicing of equipment is unrealistic from an economic perspective.  Even with a low cost refrigerant, such as propane or isobutane, venting a charge size of over 1,000 grams still represents a significant cost and provides an incentive to collect refrigerant, which also is in keeping with good maintenance and technician practices.
The reader is referred to Appendix A for a summary of detailed assumptions used in this analysis.
Conservative Emissions Scenarios
Hydrocarbons are currently being proposed for use in a wide range of ref/AC end-uses. To estimate the most conservative impact that releases of hydrocarbons could have on ground-level ozone, the first scenario considered under this analysis assumes release from the entire ref/AC sector. However, due to the characteristics associated with hydrocarbons (e.g., flammability), this may not be realistic. To assess more realistic, but still conservative scenarios, two additional scenarios were considered.  All three scenarios assume that the end-uses would be replaced with either propylene or isobutane. Propylene exhibits the highest MIR of hydrocarbons, and therefore represents the most conservative estimates. Propylene is also a proxy for the hydrocarbon blend R-443A, a substitute refrigerant under evaluation for use in residential air conditioning, because that blend contains more than 50% propylene. Isobutane has the highest MIR of the saturated hydrocarbons under evaluation and was used as a conservative proxy for isobutane, propane, and the hydrocarbon blend R-441A. R-441A contains more than 50% propane, as well as isobutane and other saturated hydrocarbons.
Table 2 presents the monthly emissions in 2030 which were assumed under Scenarios 1, 2, and 3. Under each scenario, 100% of the emissions were assumed to occur from either isobutane or propylene. In other words, the impact on local ozone concentrations were evaluated for six total CMAQ modeling scenarios.
Table 2: 2030 National Refrigerant Emissions under Scenarios 1, 2, and 3
Month
                           Scenario1 Emissions (MT)
                                 (All Ref/AC)

                           Scenario 2 Emissions (MT)
                                   (No MVAC)

                           Scenario 3 Emissions (MT)
                             (No MVAC or Chillers)

                            Isobutane or Propylene
                            Isobutane or Propylene
                            Isobutane or Propylene
January
                                     8,065
                                     5,894
                                     5,793
February
                                     8,065
                                     5,894
                                     5,793
March
                                     8,065
                                     5,894
                                     5,793
April
                                    13,404
                                     9,356
                                     9,140
May
                                    13,404
                                     9,356
                                     9,140
June
                                    13,404
                                     9,356
                                     9,140
July
                                    13,404
                                     9,356
                                     9,140
August
                                    13,404
                                     9,356
                                     9,140
September
                                     8,065
                                     5,894
                                     5,793
October
                                     8,065
                                     5,894
                                     5,793
November
                                     8,065
                                     5,894
                                     5,793
December
                                     8,065
                                     5,894
                                     5,793
  Note: Emissions of isobutane and propylene are equivalent; shaded months indicate those used in the analysis.
 Figure 1 presents the percent contribution of isobutane and propylene emissions by end-use under Scenarios 1 through 3. As illustrated in these charts, residential AC end-uses presented the most significant source of emissions across all three scenarios.

Figure 1. Percent Contribution of End-Use to Total Emissions under Scenarios 1-3

Note: Emissions under the residential and light commercial AC and heat pumps end-use (Res and Comm AC) consists of 43% from residential unitary AC, 4% from window AC, 2% from small commercial unitary AC, 0.2% from large commercial unitary AC, 0.2% from PTACs, and 0.1% from water and ground source HPs (relative to total emissions in Scenario 1). Emissions under the MVAC end-use consists of 15% from light-duty vehicles, 14% from light-duty trucks, 0.3% from school and tour buses, 0.1% from transit buses, and 0.1% from trains (relative to total emissions in Scenario 1).
Note: Emissions under the residential and light commercial AC and heat pumps end-use (Res and Comm AC) consists of 61% from residential unitary AC, 6% from window AC, 3% from small commercial unitary AC, 0.3% from large commercial unitary AC, 0.3% from PTACs, and 0.2% from water and ground source HPs (relative to total emissions in Scenario 2).

Note: Emissions under the residential and light commercial AC and heat pumps end-use (Res and Comm AC) consists of 63% from residential unitary AC, 6% from window AC, 3% from small commercial unitary AC, 0.4% from large commercial unitary AC, 0.3% from PTACs, and 0.2% from water and ground source HPs (relative to total emissions in Scenario 3).

Realistic Emissions Scenario
In addition to the three end-use scenarios, a fourth more realistic scenario (i.e., Scenario 4) was developed in which hydrocarbons were only modeled in refrigeration and air conditioning equipment for which a SNAP submission was received or for which there is a UL Standard in place regulating flammable refrigerants. Furthermore, the type of hydrocarbon (i.e., isobutane, propylene, or propane) or blend likely to be used in each end-use was also considered.  The reader is referred to Appendix B for additional information regarding the assumptions used under this scenario. Estimated emissions for the most realistic scenario are shown in Table 3.
  Table 3: 2030 National Refrigerant Emissions of under Scenario 4
Month
                           Scenario 4 Emissions (MT)
                        ("Most Realistic Scenario")

                                    Propane
                                   Isobutane
                                   Propylene
January
                                     1,266
                                      78
                                      183
February
                                     1,266
                                      78
                                      183
March
                                     1,266
                                      78
                                      183
April
                                     1,373
                                      84
                                      207
May
                                     1,373
                                      84
                                      207
June
                                     1,373
                                      84
                                      207
July
                                     1,373
                                      84
                                      207
August
                                     1,373
                                      84
                                      207
September
                                     1,266
                                      78
                                      183
October
                                     1,266
                                      78
                                      183
November
                                     1,266
                                      78
                                      183
December
                                     1,266
                                      78
                                      183
  Note: Shaded months indicate those used in the analysis
 Figure 2 presents the percent contributions of each refrigerant and each end-use to the total emissions under the Scenario 4.
Figure 2. Percent Contribution to Total Emissions under Scenario 4

Note: Emissions under the residential and light commercial AC and heat pumps end-use (Res and Comm AC) consists of 67% from window AC and 3% from PTACs (relative to total emissions in the  Scenario 4).

Impact on Ground Level Ozone Concentrations
Using EPA's CMAQ photochemical model version 4.7.1, a simulation of the potential ground-level ozone impacts under the hydrocarbon emission scenarios summarized in the previous section was performed. The remainder of this section describes the methodology and results of the CMAQ modeling, followed by a comparison of the results to the national standards of ambient air quality.
Methodology
The projected emissions of isobutane and propylene under Scenarios 1, 2, and 3, and the mix of isobutane, propylene, and propane under Scenario 4 described in Section 3 were input into the CMAQ to predict impacts on the local air quality.  Concentrations were only modeled from April through the end of September, as these months presented the largest releases of hydrocarbon refrigerant (see Table 2 and Table 3), as well as warmer air temperature and longer period of sunlight which increase the potential for ozone creation.
 The maximum increase in 8-hr ozone concentrations were estimated for the Atlanta, Houston and Los Angeles regions. These three cities were chosen based on their distinctive geographic setting and continuing and chronic problem with high levels of ground level ozone. Local refrigerant emissions were scaled from the national emission estimates to estimate reasonable conservative impacts.
The simulation was performed using 2005 hourly meteorological data at 36-km horizontal resolution with 14 vertical layers to model the maximum increase in 8-hour ground level ozone concentrations. The model used the carbon bond 05 chemical mechanism which explicitly includes 156 chemical reactions (EPA, 2010).  The 2030 nationwide emission inventory (NHTSA, 2012), as previously mentioned, was readily available and used to estimate the baseline ozone concentration (i.e., without hydrocarbon refrigerant).
Split factors for use in the carbon bond 05 chemical mechanism for isobutane, propylene, and propane were determined from the Emit Worksheet in the emitdb.xls workbook form. The split factors and related parameters used in processing the refrigerant emissions are presented in Table 4 below.
  Table 4. Mass Fractions of CB05 Species per gram of Emitted Compound (g/g)
Compound
                                Paraffin (PAR)
                           Molecular Weight (g/mole)
                                 Olefins (OLE)
                           Molecular Weight (g/mole)
                               Unreactive (UNR)
                           Molecular Weight (g/mole)
Isobutane
                                      1.0
                                     14.54
                                      0.0
                                       --
                                      0.0
                                       --
Propylene
                                      0.34
                                     14.03
                                     0.668
                                     28.06
                                      0.0
                                       --
Propane
                                      0.5
                                     14.70
                                      0.0
                                       --
                                      0.5
                                      14.7
Note: Paraffin compounds are saturated hydrocarbons. Paraffinic compounds consist only of hydrogen and carbon atoms; all bonds are single bonds, and the carbon atoms are not joined in cyclic structures, but instead form an open chain. Olefins are unsaturated chemical compounds containing at least one carbon-carbon double bond.

CMAQ Results
Table 5 summarizes the maximum increase in 8-hour ground-level ozone from the four scenarios for the Los Angeles, Houston, and Atlanta regions.
Table 5. Maximum Increase in the Daily 8-hour Ground Level Ozone from Hydrocarbon Refrigerants in 2030 for Three US cities
                       Refrigerant Type and Use Scenario
                                    Cities

Los Angeles                   8-hr O3 Maximum Change                     (ppb)
Houston                          8-hr O3 Maximum Change                     (ppb)
Atlanta                             8-hr O3 Maximum Change                        (ppb)
Isobutane
 Scenario 1
                                     0.72
                                     0.15
                                     0.05
 Scenario 2
                                     0.50
                                     0.10
                                     0.03
 Scenario 3
                                     0.49
                                     0.10
                                     0.03
Propylene
 Scenario 1
                                     6.61
                                     0.96
                                     0.56
 Scenario 2
                                     4.47
                                     0.67
                                     0.39
 Scenario 3
                                     4.37
                                     0.66
                                     0.38
Combination of Isobutane, Propylene and Propane (Scenario 4)
 Scenario 4
                                     0.15
                                     0.03
                                     0.01
ppb = parts per billion; O - 3 = ozone
In Los Angeles, isobutane under Scenario 1 resulted in a maximum increase in the 8-hr ozone concentration of 0.72 ppb. Propylene, as anticipated due to its high MIR, resulted in the most significant increases of ground-ozone concentrations; under Scenario 1, results for the Los Angeles region show that the maximum increase in the 8-hr ozone concentration is 6.61 ppb. Releases of isobutane and propylene under Scenarios 2 and 3 each show similar patterns to Scenario 1, but with smaller increases. Scenario 4 (i.e., the "most realistic" scenario) resulted in a peak 8-hr ozone increase of just 0.15 ppb for Los Angeles. These relatively small increases in ozone are about 75% associated with the use of propylene as a refrigerant and 21% from propane under this scenario (this is true of Scenario 4 under all locations). For all four scenarios, Los Angeles showed the largest ground-ozone concentration increases of all three cities.  Figure 3 shows the maximum increases and spatial extent of the 8-hour ozone concentration increase for isobutane Scenario 1, propylene Scenario 1, and Scenario 4 for Los Angeles. In these figures, yellow, orange, and red shading represent modeled changes in  ozone concentrations.
Figure 3.  Maximum 8-hour Ozone Increase for Los Angeles in 2030
(Clock-wise from Left: Scenario 1 Isobutane, Scenario 1 Propylene, and Scenario 4)

In Houston, isobutane under Scenario 1 resulted in a maximum increase in the 8-hr ozone concentration of 0.15 ppb. For the propylene Scenario 1, results for the Houston region show that the maximum increase in the 8-hr ozone concentration is 0.96 ppb. Releases of isobutane and propylene under Scenarios 2 and 3 each show similar patterns to Scenario 1, but with smaller increases. Scenario 4 (i.e., the "most realistic" scenario) resulted in a peak 8-hr ozone increase of just 0.03 ppb for Houston.  Figure 4 shows the maximum increases and spatial extent of the 8-hour ozone concentration increase for the isobutane Scenario 1, the propylene Scenario 1, and Scenario 4 for Houston.  In these figures, yellow, orange, and red shading represent modeled changes in ozone concentrations.

Figure 4. Maximum 8-hour Ozone Increase for Houston in 2030
(Clock-wise from Left: Scenario 1 Isobutane, Scenario 1 Propylene, and Scenario 4)

In Atlanta, isobutane under Scenario 1 resulted in a maximum increase in the 8-hr ozone concentration of 0.05 ppb. For the propylene Scenario 1, results for the Atlanta region show that the maximum increase in the 8-hr ozone concentration is 0.56 ppb. Releases of isobutane and propylene under Scenarios 2 and 3 each show similar patterns to Scenario 1, but with smaller increases. Scenario 4 (i.e., the "most realistic" scenario) resulted in a peak 8-hr ozone increase of just 0.01 ppb for Atlanta.  Figure 5 shows the maximum increases and spatial extent of the 8-hour ozone concentration increase for the isobutane Scenario 1, the propylene Scenario 1, and Scenario 4 for Los Angeles.  In these figures, yellow, orange, and red shading represent modeled changes in ozone concentrations.

Figure 5. Maximum 8-hour Ozone Increase for Atlanta in 2030
(Clock-wise from Left: Scenario 1 Isobutane, Scenario 1 Propylene, and Scenario 4)

Comparison to National Ambient Air Quality Ozone Standard
The current national ambient air quality 8-hour average ozone standard (NAAQS) is 75 ppb. The maximum change in ozone concentrations caused by each refrigerant across all scenarios and locations, and comparison to the national standard, is summarized in Table 6.
Table 6. Comparison of Maximum Increase in 8-hour Ozone Concentration Relative to the NAAQS
                          Refrigerant Type (Scenario)
                                    Maximum
                     8-hr O3 Increase (ppb)
                            Percent Increase over
            75 ppb 8-hr National Ambient Air Quality Ozone Standard
Isobutane (Scenario 1)
                                     0.72
                                      1%
Propylene (Scenario 1)
                                     6.61
                                      9%
Most Realistic Mix (Scenario 4)
                                     0.15
                                     0.2%
      ppb = parts per billion; O - 3 = ozone
With the exception of Los Angeles, all of the three regions are forecast to be in attainment of the current 8-hr 75 ppb ozone standard by 2030. Currently, the South Coast is demonstrating attainment by 2023 for the 1997 8-hr standard of 85 ppb. The deadline for demonstrating attainment of the 75 ppb standard is December 2015 and regions must show compliance by 2032.
Limitations of this Analysis
The analysis described above is based on numerous assumptions and projections that cannot be known with certainty at this time.  The following discussion recognizes these uncertainties and indicates various factors that have potential to impact and change the results of this analysis.
Market Modelling
         *       The market penetration assumptions used for this analysis assume hydrocarbons will be the sole replacement for HFCs across the refrigeration and air-conditioning sector.  However, the introduction of additional substitutes could potentially lower the penetration of hydrocarbons into the market, thus decreasing the emissions and ground level ozone impacts of hydrocarbons.
         *       EPA's Vintaging Model provides emissions estimates up to 2050. However, projected estimates are based on assumptions developed using current data and expert opinion regarding the near future, and cannot be reasonably expected to reflect future emissions with 100% accuracy.  Changes that may occur in the distant future (i.e., post-2020), such as regulatory measures and market events, will likely impact future emissions.
         *       Scenarios 1 through 3 in EPA's Vintaging Model does not account for reductions in emissions that may occur as a result of using hydrocarbons as a replacement for HFCs.  Factors such as refrigerant price, charge size restrictions, and advancements in leak-tightness of ref/AC systems are not adjusted for in the modeling.  Consequently, hydrocarbon emission projections are considered to be conservative.
         *       Although 2030 was chosen at the analysis year for this assessment because the hydrocarbon refrigerants were assumed to reach maximum market penetration by this time, some larger pieces of equipment with long lifetimes (i.e., lifetimes larger than 18 years) would not yet have reached end-of-life by 2030. Therefore, the effects of the disposal emissions from these pieces of equipment are not factored into this analysis. It should also be noted, however, that the remaining refrigerant charge in these large pieces of equipment are also more likely to be recovered given its economic value.
Air Quality Modelling
   * The air quality modeling used in this study was at 36-km resolution, as used in the Corporate Average Fuel Economy Standards, Passenger Cars and Light Trucks, Model Years 2017 - 2025, Final Environmental Impact Statement (NHTSA, 2012). In Appendix E: Air Quality Modeling and Health Impacts Assessment for Proposed Corporate Average Fuel Economy Standards for Passenger Cars and Light Trucks: Model Years 2017 - 2025, the model performance evaluation is discussed stating that, "EPA evaluated CMAQ model performance for the 2005 base year as part of the air quality modeling analysis to support the rulemaking for light-duty vehicle greenhouse gas emissions standards for MYs 2012-2016 (EPA, 2010).  Overall, the performance for the 2005 modeling platform was similar to that for other national- and regional-scale applications, and the model was able to reproduce historical concentrations of ozone and PM2.5 with low bias and error results."  All meteorological and emission inventory files were taken directly from the NHTSA study. The only modification was to include the emission changes due to refrigerants, as discussed in Section 2. Higher grid resolution (i.e., smaller grid cell) may potentially show higher ozone concentrations due to the mixing of air at the coarser resolution, however most refrigerant emissions are widely dispersed over a grid cell, so the effect of this limitation on the overall modeling results is likely minimal.
   * Further climate change impacts will result in region-specific changes that may impact ozone production rates. For example, increase (or decrease) in local cloud cover would lead to decrease (increase) local photolysis rates, resulting in reduced (increased) ozone production.
   * It is possible that larger impacts of VOC concentrations could have been noted if additional VOC-limited areas in the U.S. were modeled (e.g., Chicago). However, it is very unlikely that impacts for those areas would exceed that for Los Angeles. While the higher ozone concentrations observed in Los Angeles (8-hour ozone [2008] design value is 112 ppb; Chicago is 77 ppb) depends upon the local VOC-to-NOx ratio, it tends to be more sensitive to a given change in VOC. Therefore, while it is possible that a higher ozone value may have occurred in Chicago than Los Angeles on a given day, it is more likely that the Los Angeles area will have experienced a greater change in ozone due to increased VOCs over the course of the ozone season.
   * The changes in standards for other pollutants such as air toxics or criteria pollutants could affect the ozone precursor emissions.  For example, EPA recently lowered the 1-hour NO2 standard to 100 ppb and could potentially lower this value again in the future to 80 ppb as initially proposed.  In order to meet this standard, significant NOx emission reductions may be required, thus impacting the potential production of ground level ozone. The ozone air quality standard may be lowered in the future (historically the standard has been lowered a number of times) and would require additional reductions of ozone precursor emissions, which could increase the importance of hydrocarbon refrigerants to the production rate for ozone.
Summary of Findings
From the analysis summarized in the previous sections of this report, it is concluded that non-attainment resulting from hydrocarbon refrigerant emissions is not likely to be a major concern for local air quality. Hydrocarbon refrigerants could potentially increase ground level ozone by less than 1% under Scenario 4, but up to a 9% increase on a given day for the most reactive hydrocarbons (propylene) in the most extreme case.   However, in most cases this upper bound level of increase is not likely, as most ozone nonattainment areas are not VOC-limited (i.e., the formation of ozone in these areas  are not by limited by VOC emissions, but by other compounds such as nitrogen oxides [NOx]).  In fact, Scenario 4, the "most realistic" scenario for hydrocarbon refrigerant emission usage, showed a less than 0.2% increase in ground level ozone for the most extreme case.  Future changes that could alter these findings include: changes in cloud cover from global warming which could increase or decrease ground level ozone production; and future emission reduction measures that may be required to reduce ozone precursors which would could increase the relative importance of the hydrocarbon refrigerants on the production of ground level ozone.
References
Intergovernmental Panel on Climate Change (IPCC). 2005. Safeguarding the Ozone Layer and the Global Climate System: Issues Related to Hydrofluorocarbons and Perfluorocarbons. Available at: http://www.ipcc.ch/publications_and_data/_safeguarding_the_ozone_layer.htm.
MACS.  2009.  Email communication between Elvis Hoffpauir, MACS and Karen Thundiyil, EPA. 10 March.
National Highway Traffic Safety Administration (NHTSA), 2012. Final Environmental Impact Statement, Corporate Average Fuel Economy Standards, Passenger Cars and Light Trucks, Model Years 2017 - 2025, Appendix E: Air Quality Modeling and Health Impacts Assessment. NHTSA, July 2012.
United States Environmental Protection Agency (EPA). 2008. Vintaging Model, Version VM IO File v4.2 10-07-08.
United States Environmental Protection Agency (EPA). 2010. Operational Guidance Document CMAQ 4.7.1 Available at www.cmascenter.org.
United States Environmental Protection Agency (EPA). 2012. "Air Quality: Revision to Definition of Volatile Organic Compounds -- Exclusion of trans-1,3,3,3-tetrafluoropropene." Final Rule. 40 CFR Part 51. EPA-HQ-OAR-2010-0605; FRL-9679-2. June 22, 2012. Available online at: http://www.gpo.gov/fdsys/pkg/FR-2012-06-22/html/2012-15347.htm

 Appendix A
Table A-1. Scenarios 1, 2, and 3 Isobutane and Propylene Modeling Assumptions
 SNAP End-Use
Vintaging Model End-Use
                              Size Classification
                               Annual Leak Rate
                            Disposal Release Rate^
 Motor Vehicle Air Conditioning (MVAC)
MVAC Light-duty Vehicle*
                                     Small
                                      18%
                                     100%

MVAC Light-duty Trucks*
                                     Small
                                      18%
                                     100%

School & Tour Buses*
                                     Small
                                      10%
                                     100%

Transit Buses*
                                     Small
                                      10%
                                     100%

Trains*
                                     Small
                                      2%
                                     100%
 Chillers
Centrifugal Chillers**
                                     Large
                                      2%
                                      10%

Positive Displacement Chillers**
                                     Large
                                 1.5% to 2.5%
                                      10%

Screw Chillers**
                                     Large
                                      1%
                                      10%

Scroll Chillers**
                                     Large
                                     0.5%
                                      10%

Reciprocating Chillers**
                                     Large
                                     1.5%
                                      10%
 Industrial Process Refrigeration Systems
Industrial Process Refrigeration
                                     Large
                                  3% to 7.5%
                                  10% to 20%
 Cold Storage Warehouses
Cold Storage
                                     Large
                                   8% to 16%
                                      10%
 Retail Food Refrigeration
Large Retail Food
                                     Large
                                  14% to 28%
                                      10%

Medium Retail Food
                                     Small
                                   8% to 15%
                                     100%

Small Retail Food
                                     Small
                                      1%
                                     100%

Ice Makers
                                     Small
                                      5%
                                     100%
 Refrigerated Transport
Refrigerated Transport
                                     Small
                                  15% to 20%
                                     100%
 Household Refrigerators and Freezers
Refrigerated Appliances
                                     Small
                                      1%
                                     100%
 Residential Dehumidifiers
Dehumidifiers
                                     Small
                                     0.50%
                                     100%
 Residential and Light Commercial Air Conditioning and Heat Pumps
Window Units
                                     Small
                                     0.65%
                                     100%

Residential Unitary AC
                                     Small
                                      11%
                                     100%

Small Commercial Unitary AC
                                     Small
                                      9%
                                     100%

Large Commercial Unitary AC
                                     Small
                                      8%
                                     100%

Water & Ground Source HPs
                                     Small
                                      4%
                                     100%

Packaged Terminal AC/Packaged Terminal Heat Pumps (PTAC/PTHP)
                                     Small
                                      4%
                                     100%
^The assumed disposal release rates are dependent upon the size of the equipment. Equipment that is considered small (i.e., with a charge size less than 200 kg) are assumed to have a 100% release of the charge upon disposal. Equipment that is considered large (i.e., a charge size larger than 200 kg) has a disposal release rate that is consistent with what is currently assumed in the Vintaging Model for HFC refrigerants.
*Excluded from Scenario 1 and Scenario 2
**Excluded from Scenario 2

 Appendix B
Table B-1: Scenario 4 Modeling Assumptions
SNAP End-Use
Vintaging Model End-Use
                                      HC*
                             Market Penetration**
                                  Charge Size
                               Annual Leak Rate
                             Disposal Release Rate
Retail Food Refrigeration
Medium Retail Food
                                    Propane
                                     100%
                               1,500 to 12,500 g
                                   8% to 15%
                                     100%

Small Retail Food***
                                    Propane
                                      33%
                                     150 g
                                      1%
                                     100%

                                    R-441A
                                      33%
                                     150 g
                                      1%
                                     100%

                                   Isobutane
                                      33%
                                     150 g
                                      1%
                                     100%

Ice Makers
                                    Propane
                                     100%
                                     50 g
                                      5%
                                     100%
Refrigerated Transport
Refrigerated Transport
                                    R-441A
                                     100%
                                    2,130 g
                                  15% to 20%
                                     100%
Household Refrigerators and Freezers
Refrigerated Appliances
                                   Isobutane
                                      33%
                                     50 g
                                      1%
                                     100%

                                    Propane
                                      33%
                                     50 g
                                      1%
                                     100%

                                    R-441A
                                      33%
                                     50 g
                                      1%
                                     100%
Residential Dehumidifiers
Dehumidifiers
                                     None
                                     None
                                     None
                                     0.50%
                                     100%
Residential and Light Commercial Air Conditioning and Heat Pumps
Window Units
                                    R-441A
                                      33%
                                     1 kg
                                     0.65%
                                     100%

                                    R-443A
                                      33%
                                     1 kg
                                     0.65%
                                     100%

                                    Propane
                                      33%
                                     1 kg
                                     0.65%
                                     100%

Water & Ground Source HPs
                                    R-443A
                                      33%
                                     1 kg
                                      4%
                                     100%

                                    Propane
                                      33%
                                     1 kg
                                      4%
                                     100%

                                    R-441A
                                      33%
                                     1 kg
                                      4%
                                     100%

PTAC/PTHP
                                    R-443A
                                      33%
                                     1 kg
                                      4%
                                     100%

                                    R-441A
                                      33%
                                     1 kg
                                      4%
                                     100%

                                    Propane
                                      33%
                                     1 kg
                                      4%
                                     100%
*R-441A is a blend consisting of propane, n-butane, isobutane, and ethane; R-443A consists of propylene, propane, and isobutane. For purposes of this assessment, both R-441A and R-443A were considered to only contain the components included in this analysis, propane, isobutane, and propylene.
**In the absence of market penetration projections, it was assumed that the market was equally divided by the number of hydrocarbon substitutes available for each end-use.
***Water coolers and vending machines were assumed to be included under small retail food.


[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Proposed Rules]
[Pages 10740-10742]
[FR Doc No: 2014-03986]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2013-N-0402]

Generic Drug User Fee Amendments of 2012; Regulatory Science
Initiatives; Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing that will provide an overview of the current status of
regulatory science initiatives for generic drugs and an opportunity for
public input on research priorities in this area. FDA is seeking this
input from a variety of stakeholders--industry, academia, patient
advocates, professional societies, and other interested parties--as it
fulfills its commitment under the Generic Drug User Fee Amendments of
2012 (GDUFA) to develop an annual list of regulatory science
initiatives specific to generic drugs. FDA will take the information it
obtains from the public hearing into account in developing the fiscal
year (FY) 2015 Regulatory Science Plan.

DATES: The public hearing will be held on May 16, 2014, from 9 a.m. to
5 p.m. The public hearing may be extended or may end early depending on
the level of public participation.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
hearing participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Thushi Amini, Center for Drug
Evaluation and Research, Food and

Drug Administration, 7520 Standish Pl., MPN-1, Rm. 1444, Rockville, MD
20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>or Robert
Lionberger, Center for Drug Evaluation and Research, Food and Drug
Administration, 7520 Standish Pl., MPN-1, Rm. 1449, Rockville, MD
20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Registration and Requests for Oral
Presentations: The FDA Conference Center at the White Oak location is a
Federal facility with security procedures and limited seating.
Attendance will be free and on a first-come, first-served basis. If you
wish to attend (either in person or by Webcast (see Streaming Webcast
of the Public Hearing)) and/or present at the hearing, please register
for the hearing and/or make a request for oral presentations or
comments by email to<EMAIL_ADDRESS>by April 25,
2014. The email should contain complete contact information for each
attendee (i.e., name, title, affiliation, address, email address, and
telephone number). Those without email access can register by
contacting Thushi Amini by April 25, 2014 (see Contact Person).
    FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the topic, or topics, they wish to address (see section IV). This
will help FDA organize the presentations. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak. Once FDA notifies registered presenters of their scheduled
times, they are encouraged to submit an electronic copy of their
presentation to<EMAIL_ADDRESS>on or before May 9,
2014. Persons registered to make an oral presentation are encouraged to
arrive at the hearing room early and check in at the onsite
registration table to confirm their designated presentation time. An
agenda for the hearing and other background materials will be made
available 5 days before the hearing at http://www.fda.gov/Drugs/NewsEvents/ucm344710.htm.
    If you need special accommodations because of a disability, please
contact Thushi Amini (see Contact Person) at least 7 days before the
hearing.
    Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live Webcast of the hearing. To join the
hearing via the Webcast, please go to https://collaboration.fda.gov/regscipart15/.
    Comments: Regardless of attendance at the public hearing,
interested persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), 5600 Fishers Lane, Rm. 1061, Rockville, MD 20857.
The deadline for submitting comments to the docket is June 13, 2014. It
is only necessary to send one set of comments. Identify comments with
the docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
also be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.

I. Background

    In July 2012, Congress passed GDUFA (Title III of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is
designed to enhance public access to safe, high-quality generic drugs
and reduce costs to industry. To support this goal, FDA agreed in the
GDUFA commitment letter to work with industry and interested
stakeholders on identifying regulatory science research priorities
specific to generic drugs for each fiscal year covered by GDUFA. The
commitment letter outlines FDA's performance goals and procedures under
the GDUFA program for the years 2012-2017. The commitment letter can be
found at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.

II. FY 2013 Regulatory Science Priorities

    The FY 2013 regulatory science research priorities list was
developed by FDA and industry and included in the GDUFA commitment
letter. To implement the FY 2013 priorities list, the Office of Generic
Drugs awarded $17 million in external contracts and grants to initiate
new research studies during FY 2013. Four million dollars were
allocated to support internal research related to generic drugs. This
includes rapid response capabilities through equipment for FDA labs and
support for laboratory research fellows at FDA, as well as research
fellows to work on data analysis and coordination of internal
activities with external grants and contracts.

III. FY 2014 Regulatory Science Priorities

    On June 21, 2013, the Office of Generic Drugs held a public hearing
to gain input in developing the FY 2014 regulatory science priorities
list. This list was prepared based on internal Center for Drug
Evaluation and Research discussions, comments received from this public
hearing, and comments submitted to the public docket.
    The FY 2014 Regulatory Science Priorities are as follows:
    1. Postmarket evaluation of generic drugs,
    2. Equivalence of complex products,
    3. Equivalence of locally acting products,
    4. Therapeutic equivalence evaluation and standards, and
    5. Computational and analytical tools.

For more information on these topic areas, please visit http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm370952.htm.

IV. Purpose and Scope of the May 16, 2014, Public Hearing

    The purpose of the May 2014 public hearing is to obtain input from
industry and other interested stakeholders on the identification of
regulatory science priorities for FY 2015. To help fulfill FDA's
mission, FDA is particularly interested in receiving input on the
following topics:
    1. Current regulatory science challenges that limit the
availability of generic drugs,
    2. Regulatory science approaches to improve the preapproval
evaluation of therapeutic equivalence of generic drugs,
    3. Postapproval regulatory science approaches to ensure the
therapeutic equivalence of approved generic drugs,
    4. Prioritization of FY 2015 regulatory science research topics for
generic drugs based on public health impact, and
    5. The need for additional or revised draft guidance to clarify
FDA's scientific recommendations related to generic drug development.
    FDA will consider all comments made at this hearing or received
through the docket (see Comments) as it develops its FY 2015 GDUFA
Regulatory Science Plan. Additional information concerning GDUFA,
including the text

of the law and the commitment letter can be found on the FDA Web site
at http://www.fda.gov/gdufa.

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR Part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner and the Center for Drug Evaluation and Research. Under
Sec.  15.30(f), the hearing is informal and the rules of evidence do
not apply. No participant may interrupt the presentation of another
participant. Only the presiding officer and panel members may pose
questions; they may question any person during or at the conclusion of
each presentation. Public hearings under part 15 are subject to FDA's
policy and procedures for electronic media coverage of FDA's public
administrative proceedings (part 10, subpart C) (21 CFR Part 10,
subpart C)). Under Sec.  10.205, representatives of the media may be
permitted, subject to certain limitations, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
stipulated in Sec.  15.30(b) (see Transcripts). To the extent that the
conditions for the hearing, as described in this notice, conflict with
any provisions set out in part 15, this notice acts as a waiver of
those provisions as specified in Sec.  15.30(h).

    Dated: February 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03986 Filed 2-25-14; 8:45 am]
BILLING CODE 4160-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment
period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming
Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as
amended by the Family Smoking and Prevention and Tobacco Control Act (the
"Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No.
2014-09491. On behalf of myself, I am requesting that the comment period for
the Proposed Rule be extended by the FDA for an additional 105 days, from its
current 75-day period, to 180 days.

I wish to have the opportunity to provide the fullest and most relevant
comments I can provide on the Proposed Rule, but I know that I will need extra
time to thoroughly research and document my response.  Given the potentially
enormous impact this ruling will have on my life and the lives of many others
like me, I think the extension I am requesting would be of the
greatest benefit to all concerned.  This is an extremely complex issue and
hastily formulated or poorly researched comments will not suffice.

I know that e-cigarettes have greatly extended my life and after 31 years of smoking, and
trying several products and techniques, they have proven to be the only devices
that have helped me quit.  My health was clearly deteriorating at an accelerated
rate before I tried them.  For over 2 years now, I have completely eliminated smoking
from my life and drastically reduced my nicotine consumption.

I appreciate your consideration of my request and am happy to discuss this
issue with you further.