[Federal Register Volume 76, Number 13 (Thursday, January 20, 2011)]
[Notices]
[Page 3639]
[FR Doc No: 2011-1105]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.

    Name of Committee: Vaccines and Related Biological Products
Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 25, 2011,
between approximately 8:30 a.m. and 1:50 p.m.
    Location: DoubleTree Hotel Bethesda and Executive Meeting
Center, 8120 Wisconsin Ave., Bethesda, MD 20814.
    Contact Person: Donald W. Jehn or Denise Royster, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-
0314, or FDA Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area), and follow the prompts to
the desired center or product area. Please call the Information Line
for up-to-date information on this meeting. A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published
quickly enough to provide timely notice. Therefore, you should
always check the Agency's Web site and call the appropriate advisory
committee hot line/phone line to learn about possible modifications
before coming to the meeting.
    Agenda: On February 25, 2011, the committee will discuss and
make recommendations on the selection of strains to be included in
the influenza virus vaccine for the 2011-2012 influenza season. The
committee will also hear an update on Pandemic Influenza
Surveillance.
    FDA intends to make background material available to the public
no later than 2 business days before the meeting. If FDA is unable
to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at
the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting.
Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 18, 2011. Oral presentations from the public will be
scheduled between approximately 11:50 a.m. and 12:50 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present,
the names and addresses of proposed participants, and an indication
of the approximate time requested to make their presentation on or
before February 10, 2011. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person
will notify interested persons regarding their request to speak by
February 11, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to
electrical outlets.
    FDA welcomes the attendance of the public at its advisory
committee meetings and will make every effort to accommodate persons
with physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Donald W. Jehn or
Denise Royster at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory
committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for
procedures on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 12, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-1105 Filed 1-19-11; 8:45 am]
BILLING CODE 4160-01-P


1 Bullitt County, Kentucky Bullitt County is part of the Louisville, KY IN Metropolitan Statistical Area ( MSA) and is on the I 65 South interstate corridor. It is located directly south of Jefferson County, southwest of Spencer County, northwest of Nelson County, and northeast of Hardin County.

EPA s June 29, 2004, proposal on appropriate designations for Kentucky included Bullitt County as nonattainment based on the following criteria:

  EPA indicates that Bullitt County has significant emissions and close proximity to the violating MSA monitors.

  EPA indicates that Bullitt County has monitoring data very close to the PM2.5 standard, and that this indicates a potential to contribute to the PM2.5 violations in the area;

  EPA states that Bullitt County has relatively high traffic and commuting patterns;

  EPA states that Bullitt County s population growth is significant enough to contribute to PM2.5 violations in Jefferson County.

Emissions Data In Kentucky s original February recommendations, 1999 NEI data was used in the original analysis. That data documented that Bullitt County did not contribute a significant amount of suspect emissions in the seven county Metropolitan Statistical Area ( MSA), mandated for review by U. S. EPA.

In EPA s June 29, 2004, letters to states, EPA looked outside the original MSA boundaries to determine if large emissions contributions from adjacent areas were having an impact on PM2.5 levels in many of the areas. EPA also used the 2001 NEI which provided slightly newer data than had been recommended that states use.

Based on EPA s 2001 NEI data supplied to states, Bullitt County does not emit any pollutant over 10,000 TPY. In fact, Bullitt County emits less than 1% of SOx emissions from the counties recommended by EPA as having the potential to impact the violating monitors. A similar comparison can be made with both NOx and PM. Bullitt County s NOx emissions stand at 3% and PM at 5% of the total EPA recommended areas. In a detailed review of EPA s recommended nonattainment areas, Bullitt County ranks consistently low in potential emissions contributions within EPA s proposed nonattainment boundaries ( See Figures 1 4 below). Based on this data, Kentucky strongly objects to EPA s characterization of emissions from Bullitt County as being significant. 2 Figure 1 Louisville Area 2001 SOx Emissions Floyd, IN 43% Jefferson, KY 57% Oldham, KY 0%

Clark, IN 0%

Bullitt, KY 0% Harrison, IN 0% Scott, IN 0%

Figure 2 Louisville Area 2001 NOx Emissions Jefferson, KY 76%

Bullitt, KY 3% Scott, IN 1% Harrison, IN 3% Clark, IN 5% Floyd, IN 9% Oldham, KY 3% 3 Figure 3 Louisville Area 2001 PM Emissions Jefferson, KY 47% Oldham, KY 5% Bullitt, KY 5% Scott, IN 3% Harrison, IN 5% Clark, IN 10%

Floyd, IN 25%

Figure 4  5,000 5,000 15,000 25,000 35,000 45,000 55,000 65,000 75,000 85,000 Bullitt, KY Jefferson,

KY Oldham, KY Floyd, IN Clark, IN Harrison, IN Scott, IN T o n s p e r Y e a r Louisville Area 2001 Emissions PM SOx NOx VOC NH3 Carbon Crustal In Figure 5 below, the data from Jefferson County s speciation monitor on Barret Avenue indicates that sulfates and organic carbon are the major components of the PM2.5 values in the area. As can be seen in Figure 1 above, Bullitt County, Kentucky, contributes less than 1% of the SO2 and approximately 8% of the total organic carbon emissions ( Figure 6 below) in the counties recommended by EPA as having the potential to impact the violating monitor. In both instances, every other county with the exception of Oldham County, Kentucky and Harrison County, Indiana has a higher potential to contribute to the problem. 4 Figure 5 LMAPCD ( Barret) AIRS Code 212270007 POC 5 ( ROUTINE) Date( s): 1/ 3/ 03   12/ 29/ 03 Average Concentration ( µ g/ m 3)

Elemental Carbon 4% Crustal Component 3% Other 15%

Organic Carbon 25%

Ammonium 12% Sulfate 31% Nitrate 10%

Figure 6 Louisville Area 2001 Carbon Emissions Jefferson, KY 49% Bullitt, KY 8%

Oldham, KY 5% Floyd, IN 17% Scott, IN 3% Harrison, IN 5% Clark, IN 13%

Monitoring Data and Trends The monitor located in Bullitt County shows attainment with the PM2.5 standard. For the 2001 2003 timeframe the design value ( 14.9 µ g/ m 3)

approaches the annual standard but continues to demonstrate attainment. The 5 annual concentrations, for both the Bullitt County monitor and for the entire area continue to show a downward trend as depicted in Figures 7 and 8, which utilized data from the year 2000 through April 2004.

Figure 7 Louisville Area PM2.5 Trend Utilizing Most Current Available Data 12.0 13.0 14.0 15.0 16.0 17.0 18.0 19.0 2000 2001 2002 2003 2004 Year A n n u a l A r i th m e t i c M e a n ( m ic r o g r a m s / c u b i c m e t e r ) Bullitt 37th &

Southern Barret Beecher Watson As depicted in Figure 8 below, monitoring data for the Louisville area shows a 7%  12% decrease, depending on monitor location, from the year 2000 through 2003.

Monitoring data shows that Bullitt County is attaining the PM2.5 standard. Based on the continuing decline in PM2.5 levels throughout the region, all monitors within this region are anticipated to attain the PM2.5 standard without any additional controls being imposed on the area. The monitor with the highest design value in the entire region, located on 37 th and Southern in Jefferson County is anticipated to be in compliance with the standard by the end of 2005, if levels continue to decline as they have in the past. Based on air monitoring data so far in 2004, levels may decline more rapidly than in the past few years. 6 Figure 8 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0 20.0 Bullitt 37th & Southern Barret Beecher Watson PM Decreases in the Louisville Area 2000 2001 2002 2003 2004 2000 2003 shows decrease of 12% 2000 2003 shows decrease of 7% 2000 2003 shows decrease of 11% 2000 2003 shows decrease of 8% 2000 2003 shows decrease of 8%

Population Density and Growth EPA stated that 2002 population levels indicated Bullitt County had the potential to impact PM2.5 violations in the area. However, while Bullitt County has the fourth highest population in the MSA, the county itself comprises approximately only 6% of the entire MSA, and only 7% of the counties recommended by EPA as having the potential to impact the violating monitors. See Figure 9 below. 7 Figure 9 Traffic and Commuting Patterns EPA s position on traffic and commuting patterns in the June 29 th letter noted that Bullitt County has potentially significant numbers of commuters impacting the area. However, further in the document under a specific discussion of population levels, EPA states that population is not a factor in any county except Jefferson. In 2002 Bullitt County contributed only 7% of the VMT s in the area recommended by EPA as having the potential to impact the violating monitors. Based on data used by EPA in their analysis, Bullitt County had 19,730 commuters traveling into Jefferson County. This number is insignificant ( 6.5%) when compared to 303,624 Jefferson County commuters in 2002.

It is important to note that any possible impacts from population or commuter contributions from Bullitt County would be mitigated in the near future by national fuel programs referenced later in this document.

Therefore, Kentucky believes that Bullitt County does not have the population, commuter, or VMT potential to contribute to PM2.5 violations in the area.

Additional Information A further review of wind rose data shows that predominant winds generally come from the south southwest, which would typically show a contribution coming from Bullitt County ( See Figure 10). However, previous documented Louisville Area 2002 Population for USEPA Proposed PM2.5 Nonattainment Counties Jef f erson, KY 74%

Floyd, IN 8% Bullit t , KY 7%

Clar k, IN 11% 8 data outlining emissions contribution percentages in the area, population and commuter data show that activities actually occurring in Bullitt County would have little impact on PM2.5 levels within that county or on other counties within the MSA. Rather, it appears that the monitor located in Bullitt County is being impacted by emissions from other areas.

Clark Jefferson Floyd Harrison Oldham Bullitt Scott Figure 10 9 Using the NOAA HYSPLIT Model, a review of some of the highest PM2.5 level 24 hour periods was performed to attempt to determine possible contributions from Bullitt County. A separate analysis was performed on days when monitoring levels were high in Bullitt County and days when monitoring levels were high in other monitors within the region.

As can be seen in Attachments A through C on days when monitored values were highest in Bullitt County, wind patterns indicate a potential impact from both Jefferson County and Southern Indiana.

A separate review of days when monitored values were highest in Jefferson County and Southern Indiana, again show no impact coming from Bullitt County. See attachments D through L.

Additional Regional/ National Controls The implementation of new federal rules to decrease the amount of sulfur in both gasoline and diesel fuel will significantly decrease the amount of SO2 in the entire area. Because of the Low Sulfur Diesel Rule, in 2007, new clean engines operating on 15 ppm sulfur diesel fuel will reduce NOx emissions by 50%, and reduce PM emissions by more than 90%. Due to the Tier 2 Vehicle and Gasoline Sulfur program, by 2006 average national gasoline sulfur levels will be 90% lower.

Upon implementation of the Clean Air Interstate Rule ( CAIR) SO2 emissions from power plants will be reduced nationwide by 3.6 million tons in 2010 ( approximately 40 percent below current levels) and by another 2 million tons per year when the rules are fully implemented ( approximately 70 percent below current levels). NOx emissions would be cut by 1.5 million tons nationwide in 2010 and 1.8 million tons annually in 2015 ( about 65 percent below today s levels).

The first phase of compliance under the CAIR rule to reduce both SO2 and NOx emissions would be required by 2010, allowing substantial emission reductions in the area, by the proposed attainment date for PM2.5 nonattainment areas.

Conclusions Based on the factors discussed above, Kentucky believes that Bullitt County should be designated attainment for the PM2.5 standard.

  Kentucky believes that EPA s use of the weighted emissions scoring approach was skewed. Although attempting to have a standardized process to review violations of the PM2.5 standard throughout the nation 10 on the surface appears to make sense, each area is actually very different and emission contribution ratios are just one factor and should not alone be used to determine impacts.

  Emissions data, population, and commuter data show that the actual percentage of contribution from Bullitt County itself is exceptionally low compared to other counties within the region. This analysis actually points to the Bullitt County monitor being impacted by emissions from other counties within the region.

  PM2.5 levels continue to decline throughout the entire region. From a review of all monitors in the region, an average 9% decline in PM2.5 levels has occurred from 2000 through 2003. The Bullitt County monitor in the region is currently showing attainment of the annual PM2.5 standard using 2002 through 2004 data and other monitors are projected to come into compliance within a short period of time.

  A review of trajectory analysis on both days when the Bullitt County monitor is showing high PM2.5 values, as well as a separate review of a sampling of days when PM2.5 values are highest at other monitors within the region, show that Bullitt County is not impacting violating monitors on days when the levels are highest.

  Additional emission reductions on a national and regional level will provide substantial benefits in the region. The anticipated sulfur reductions due to the Low Sulfur Diesel Rule and the Tier 2 Vehicle and Gasoline Sulfur programs, and the Clean Air Interstate Rule ( CAIR) will further lower pollutant levels within this region.

Based on the above conclusions, Bullitt County, Kentucky should be designated attainment for the PM2.5 standard. To have this county designated nonattainment would invoke additional, substantial, unnecessary requirements on local government planning agencies. Especially since a thorough review of information shows that Bullitt County is being impacted by emissions coming from outside the county. Drastic emission reductions are scheduled to occur in the mobile sector throughout the next several years that will greatly impact pollutant levels in the area. Couple these changes with those anticipated by the CAIR provisions which will further reduce SOx and NOx emissions within the region, the air monitoring data demonstrating attainment of the PM2.5 Standard, and the downward trend in monitored values, and the conclusion must be that Bullitt County, Kentucky, should be designated attainment for the PM2.5 Standard.