( September 15, 2004) 1 RISK SCREEN ON THE USE OF SUBSTITUTES FOR OZONE DEPLETING SUBSTANCES Proposed Substitute: IoGas   Sterilants 1, 3, and 6 End Use: Sterilization This risk screen does not contain Clean Air Act ( CAA) Confidential Business Information ( CBI) and, therefore, may be disclosed to the public.

1. INTRODUCTION Stratospheric ozone depleting substances ( ODS) are being phased out of production in response to a series of diplomatic and legislative efforts that have taken place over the past decade, including the Montreal Protocol and the Clean Air Act Amendments of 1990 ( CAA). The U. S. Environmental Protection Agency ( EPA), as authorized by Section 612 of the CAA, has developed a program to evaluate the human health and environmental risks posed by alternatives to ODS. The main purpose of EPA's program, called the Significant New Alternatives Policy ( SNAP) Program, is to identify acceptable and unacceptable substitutes for ODS in specific end uses.

EPA's decision on the acceptability of a substitute is based largely on the findings of a screening assessment of potential human health and environmental risks posed by the substitute in specific applications. EPA has already screened a large number of substitutes in many end uses within all of the major ODS using sectors, including refrigeration and air conditioning; solvent cleaning; foam blowing; aerosols; fire extinguishing; adhesives, coatings, and inks; and sterilization. The results of these risk screens are presented in a series of background documents that are available in this docket.

The purpose of this report is to supplement EPA's background document ( EPA, 1994) on the sterilant application of IoGas   blends, which are used as substitutes for blends of ethylene oxide ( EtO) and CFC 12, HCFC 22 or HCFC 124. IoGas   is a blend of EtO, carbon dioxide, and trifluoroiodomethane. EtO has been shown to exhibit toxicity upon inhalation and has been examined at length in the Background Document. The reader is referred to this reference for a detailed discussion of the methodologies used to conduct this risk screen. In addition, EPA's SNAP Program has previously found pure EtO to be an acceptable substitute for the use of EtO and CFC 12 blends in sterilization processes. Because EtO has previously been approved as a substitute under the SNAP program, the toxicity of this ODS substitute will not be discussed in detail in this document.

Occupational exposure and general population analyses were performed to ensure that use of the IoGas   in the applications listed above did not pose unacceptable risk to workers or the general public. Consumer exposure modeling was not performed because no consumer applications are proposed for the blend. ( September 15, 2004) 2 Section 2 of this report summarizes the results of the risk screen for the proposed substitute blends listed in Tables 1  3. The remainder of the report is organized similarly to the Background Document: Section 3 presents the toxicity values used for the risk screen, Section 4 presents the results of the atmospheric assessment, Sections 5, 6, and 7 discuss occupational, general population, and consumer exposures, respectively and Section 8 discusses potential increases in atmospheric releases of volatile organic compounds ( VOCs).

Table 1. Proposed Substitute Blend 1 Sterilant Blend ( Trade Name) Constituents Percent Composition by Weight Percent Composition by Volume CAS Number Ethylene oxide ( EtO) 75 21 8 Carbon Dioxide ( CO2) 124 38 9 IoGas   Trifluoroiodomethane ( CF3I) 2314 97 8 Table 2. Proposed Substitute Blend 3 Sterilant Blend ( Trade Name) Constituents Percent Composition by Weight Percent Composition by Volume Ethylene oxide ( EtO)

Carbon Dioxide ( CO2) IoGas   Trifluoroiodomethane ( CF3I) ( September 15, 2004) 3 Table 3. Proposed Substitute Blend 6 Sterilant Blend ( Trade Name) Constituents Percent Composition by Weight Percent Composition by Volume Ethylene oxide ( EtO)

Carbon Dioxide ( CO2) IoGas   Trifluoroiodomethane ( CF3I)

2. SUMMARY OF RESULTS IoGas   is recommended for SNAP approval for all the proposed end uses. EPA's risk screen indicates that the use of the proposed substitute and its constituents will be less harmful to the atmosphere than the continued use of CFC 12. Additionally, general population exposure to the substitute is expected to be below levels of concern for noncancer risks. EPA believes that by following existing regulations and installing the proper control systems, use or manufacture of IoGas   is not likely to pose a significant risk to consumers, workers, or the general public.

3. TOXICITY REFERENCE VALUES FOR SUBSTITUTES To assess potential health risks from exposure to this substitute for ODS in the sterilant sector; EPA identified the relevant toxicity threshold values, including available published occupational exposure limits. For the occupational exposure analysis provided in this risk screen, potential risks from chronic worker exposure were evaluated by comparing exposure concentrations to published values ( i. e., OSHA PELs) or to ones derived by EPA, namely acceptable exposure limits ( AELs) for purposes of evaluating exposure concerns. Potential risks from short term occupational exposures were also evaluated through comparison with published values ( i. e., OSHA STELs) or to ones derived by EPA, namely emergency guidance levels ( EGLs). Table 4 presents the toxicity reference values used in the analysis. ( September 15, 2004) 4 TABLE 4. Toxicity Reference Values for Substitutes Chemical Acceptable Exposure Level ( AEL) ppm Short term Exposure Limits ( STEL) ppm EtO 1a, b 5b CO2 5,000a 30,000e CF3I 150d 2,000c a Value presented above is the OSHA PEL. b OSHA EtO standard, 29 CFR 1910.1045. c EGL based on 2,000 ppm NOAEL for cardiotoxicity. d See Attachment 1. ICF 1998. " Recommendation for an Acceptable Exposure Limit for CF3I." e ACGIH, 2002 STEL.

4. ATMOSPHERIC MODELING This section presents EPA's assessment for the potential impact of each substitute on ozone depletion and global warming. The atmospheric lifetime ( ALT) of ethylene oxide is short, on the order of 50 to 200 days based on rapid destruction by radicals present in the lower atmosphere. For each blend, the combined ODP is less than 0.001 and the 100 year GWP, relative to CO2, is less than 1. Table 5 presents the ODP, GWP and ALT for each proposed substitute blend and its components.

Table 5. ODP, GWP, and ALT for Proposed Sterilization Substitutes Substitute ODP 100 Year GWP ( relative to CO2) ALT ( years)

EtO 0 < 1 0.3 CO2 0 1 100a CF3I < 0.0025 < 1 0.007 IoGas   Blend 1 < 0.001 < 1 NA IoGas   Blend 3 < 0.001 < 1 NA IoGas   Blend 6 < 0.001 < 1 NA a One hundred years represents CO2' s first atmospheric lifetime, which is defined as the time it takes for a compound to be reduced to 1/ e or 36.8% of its original concentration. Most gases only have one atmospheric lifetime because they follow pure exponential decay. However, for CO2, as time increases, the amount of time it takes to reduce CO2 to 36.8% of its concentration increases. Therefore, CO2' s second atmospheric lifetime is several hundreds of years. NA   Not applicable. ( September 15, 2004) 5 5. OCCUPATIONAL EXPOSURE AND RISK SCREENING ANALYSIS Sterilization workers may be exposed to trace amounts of IoGas   during manufacture, when filling containers, transporting containers, and charging sterilization equipment. In general, exposures are expected to occur only in cases of accidental leakages, discharges, or equipment rupture. Because the sterilant gases are normally handled only in gas tight systems at all times, no significant exposure is anticipated for any handling activities at the filling stage.

The estimated maximum duration of activity for workers handling the IoGas   sterilant under initial production capacity is 8 hours/ day, 150 days/ year. When IoGas   production is well established, then the estimated maximum duration of activity for workers is 8 hours/ day, 200 days/ year. According to the submission, average exposures can be kept below 0.1 ppm using local exhaust systems. It is estimated that in the case of a leak, exposure to IoGas   can be kept below 5 ppm by use of detectors, evacuation of personnel, and the use of self contained breathing apparatuses ( SCBA) ( IoGas   Submission 2003).

Using the estimated IoGas   exposure values presented in the submission ( average exposure of less than 0.1 ppm and high end exposure of 5 ppm), the average worker exposure to each constituent within a blend was estimated; these values are presented in Table 6 and 7. For EtO ( the most toxic constituent of the blend) the exposure estimates are less than the OSHA PEL of 1 ppm and the OSHA STEL of 5 ppm for the compound, with the exception of Blend 6 during high end exposure. Both the National Institute for Occupational Safety and Health ( NIOSH) and the AIHA Exposure Assessment Strategies Committee ( EASC) stipulate that 95% of exposures should be kept below the PEL ( AIHA 2002). Since sterilants have been shown to have average exposures below 0.1 ppm, the 5ppm high end exposure is expected to be a rare occurrence and within these PEL guidelines. Furthermore, manufacturers should be knowledgeable of how to minimize the risks associated with the use of EtO because EtO is so commonly used. Therefore, to ensure compliance with this OSHA PEL, and consequently guarantee worker safety, sterilization facilities should post signs that outline hygiene and handling procedures and train their employees on the proper handling of IoGas   . To ensure worker safety in the event of an accidental release or spill, workers must wear butyl rubber gloves and safety goggles. It is also recommended that workers wear butyl rubber aprons and shoes and that SCBA gear be made available to workers in the event of a release of IoGas   .

Average and high exposures to CO2 and CF3I are not expected to exceed toxicity threshold values. The average worker exposures to the constituents of IoGas   in a conventional 8 hour workday ( based on daily average exposure to 0.1 ppm of IoGas   ) are presented in Table 6. The exposure values are significantly less than the established AEL and PEL values for the compounds. Similarly, in the event of a leak ( high end exposure to 5 ppm of IoGas   ) a worker would be exposed to levels of CO2 and CF3I which are less than the established STEL values for the compounds ( Table 7).

The installation of an EtO detection system guarantees worker safety in the event of a leak in an occupational setting. Assuming protective actions are taken ( e. g., worker evacuation ( September 15, 2004) 6 or use of protective equipment) when concentrations of EtO reach the OSHA STEL of 5 ppm, exposures to CO2 and CF3I would accordingly remain below levels of concern.

Exposures at the end use, such as those which occur when a sterilization chamber door is opened in a health care facility, are expected to be minimal. At the end of a sterilization cycle, the chamber being sterilized will be flushed with air before being opened, and in many facilities, a fume hood will exhaust air from around the sterilization chamber to the outside. As a further precaution, ethylene oxide sensors are used to detect leaks and warn occupants to evacuate the area. Finally, chambers are pressure tested periodically and seals are replaced to prevent leaks as necessary.

Table 6: Average Exposure to IoGas   Blends 1, 3, and 6. Average Exposure of 0.1 ppm Blend 1 Blend 3 Blend 6 Long term Exposure Limits Short Term Exposure Limits EtO 1 5 CO2 5,000 30,000 CF3I 150 2,000 Table 7: High End Exposure to IoGas   Blends 1, 3, and 6. High End Exposure of 5 ppm Blend 1 Blend 3 Blend 6 Long term Exposure Limits Short Term Exposure Limits EtO 1 5 CO2 5,000 30,000 CF3I 150 2,000 Table 8: Exposure to Constituents of IoGas   Blends 1, 3, and 6 when Levels of EtO Reach the STEL At Concentrations of 5 ppm EtO Blend 1 Blend 3 Blend 6 Long term Exposure Limits Short Term Exposure Limits CO2 5,000 30,000 CF3I 150 2,000 ( September 15, 2004) 7 6. GENERAL POPULATION EXPOSURE This section screens potential risks to the general population from exposure to releases of the three components of the substitute blend examined in this report. Factory releases ( occurring during manufacture) and on site use of IoGas   for sterilization of equipment are examined in this section. Release of IoGas   is not expected during manufacturing, which consists of blending the components in the correct proportions, because the process is performed in gas tight systems.

When IoGas   is used in large contract sterilization chambers, the general population exposure may be limited either through the use of a catalytic oxidation system, which converts waste EtO into CO2 and water, or through the use of acid water scrubbers, which convert waste EtO into ethylene glycol. When acid water scrubbers are used, the remaining CO2 and CF3I are available for recovery and re use. When a catalytic oxidation system is employed, CF3I is converted to the acidic gases HF and HI. These acidic gases then are scrubbed out and neutralized with a base such as Ca( OH) 2, or an aqueous solution such as NaOH or KOH. One of the acidic products, HF, is classified as both a Hazardous Air Pollutant ( HAP) and as a substance regulated by OSHA and the Clean Water Act ( CWA). Air emissions, wastewater discharges, and occupational exposures of HF must all be controlled.

To prevent general population exposure, rooms or buildings being sterilized by IoGas   would first be prepared by sealing all doors, windows, and vents, while providing inlet and outlet ports for the gas. Depending on state regulations, gases released during the sterilization process may be diluted with air or passed through a scrubber, with or without a thermal oxidizer, to lower the concentration of ethylene oxide before being vented to the atmosphere.

When using IoGas   as a sterilant, the blend should not be vented untreated to the outside given the potential carcinogenicity of EtO ( Table 2). Furthermore, as a HAP, use of EtO should comply with air emissions standards established under the CAAA ( Ethylene Oxide Emissions Standards for Sterilization Facilities: Subpart O, 40 CFR 63.360). By following existing regulations and installing the proper control systems, EPA believes that factory or onsite releases are not likely to pose a significant threat to ambient air, surface water, or solid waste. Consequently, use of IoGas   is not expected to pose significant risk to the general population.

7. CONSUMER EXPOSURE Consumer exposure occurs through the use of products that have been sterilized with the compound. Some of the products for which this sterilant can be used are medical equipment and facilities, spices, and cosmetics. They can also be used to decontaminate buildings and vehicles. When sterilized equipment and products are properly aerated after sterilization, exposure to the IoGas   blend is negligible ( IoGas   SNAP Submission 2003). EPA believes that the existing safeguards are sufficient to ensure that consumer exposures and the associated risks are neglible. ( September 15, 2004) 8 8. VOLATILE ORGANIC COMPOUND ( VOC) ANALYSIS CF3I has been exempted from a listing as a VOC under CAA regulations ( 40 CFR 51.00). EtO has not been exempted from this listing, hence emissions should be controlled.

REFERENCES AIHA 2002 ( updated). AIHA's White Paper on Permissible Exposure Limits ( PELs). http:// www. aiha. org/ GovernmentAffairs PR/ html/ GAWPpermexpo. htm. Accessed on December 1, 2003.

IoGas   SNAP Submission. 2003. Significant New Alternatives Policy Program Submission to the United States Environmental Protection Agency.

EPA 1994. Significant New Alternatives Policy Technical Background Document: Risk Screen on the Use of Substitutes for Class I Ozone depleting Substances: Sterilization and Refrigeration and Air Conditioning. Stratospheric Protection Division. March, 1994.

ICF. 1998. " Recommendation for an Acceptable Exposure Limit for CF3I." Prepared by H. Clewell and G. Lawrence under EPA Contract No. 68 D5 0147, WA 2 09, Task 3 ( September 15, 2004) 9 ATTACHMENT 1 Recommendation for an Acceptable Exposure Limit for CF3I The purpose of this report is to recommend an Acceptable Exposure Limit ( AEL) for occupational exposure to trifluoroiodomethane ( CF3I). The limited toxicity studies that have been performed on CF3I include acute and subchronic inhalation exposures of rats, a reproductive toxicity screen in rats, cardiac sensitization evaluation in the dog, and tests of genotoxicity ( Salmonella typhimurium reverse mutation assay, mouse lymphoma forward mutation assay, and in vivo rat and mouse micronucleus assays).

Recommended AEL: 150 ppm ( 8 hr Time Weighted Average) with a Ceiling of 2,000 ppm Basis: TWA: Endpoint: Thyroid hormone alterations Study: Reproductive Toxicity Screen of Trifluoroiodomethane ( CF3I) in Sprague Dawley Rats ( Dodd et al. 1998) Protocol: whole body inhalation, 6 hrs/ day, 5 or 7 days/ wk, 16 animals/ sex/ dose Concentrations: 0.2, 0.7 and 2 % ( 2,000, 7,000 and 20,000 ppm)

NOAEL: not identified LOAEL: 0.2% LOAEL [ adj]: 2,000 ppm x 6 hr / 8 hr = 1,500 ppm LOAEL [ HEC]: 1,500 ppm Uncertainty/ Modifying Factors:

3  use of LOAEL 1  animal to human 3  human variability Ceiling:

Endpoint: Cardiac sensitization Study: Cardiac sensitization in dogs ( Kenny et al. 1995) Protocol: standard epinephrine challenge, 9 animals Concentrations: 0.1, 0.2, 0.4, and 1.0% ( 1,000, 2,000, 4,000, and 10,000 ppm)

NOAEL: 0.2% LOAEL: 0.4% ( September 15, 2004) 10 NOAEL [ adj]: 2,000 ppm NOAEL [ HEC]: 2,000 ppm Uncertainty/ Modifying Factors: None Justification:

TWA:

In a reproductive toxicity screen, Sprague Dawley rats were exposed via whole body inhalation to CF3I 6 hrs/ day, 5 or 7 days/ wk for 7 or 14 weeks ( Dodd et al. 1998). Thyroid hormone levels and micronucleus frequency were also evaluated in the study based on results reported in a previous study ( Kinkead et al. 1996). Serum concentrations of thyroid hormones were consistently altered in a dose related manner. Significant concentration related increases in thyroxine ( T4), reverse triiodothyronine ( rT3), and thyroid stimulating hormone ( TSH), and significant decreases in T3 were reported in males and females at all exposure levels, when compared to controls, with the exception of TSH in the mid concentration female rats and the low and mid concentration male rats after 14 weeks of exposure. Also, a statistically significant decrease in the male/ female sex ratio was reported in the offspring of the high concentration group. Because the thyroid hormone alterations were observed at lower exposure concentration, however, they were considered the critical effects.

A brief review of thyroid hormone regulation is useful to explain the observed spectrum of effects. Iodine is taken up by the thyroid, combined with tyrosine and other components to form thyroglobulin ( a high molecular weight glycoprotein), and a series of biochemical transformations result in the formation of the thyroid hormones T3 and T4 ( Capen and Martin 1989). Release of these hormones is controlled by a neuroendocrine feedback loop, involving the hypothalamus, pituitary gland, and the thyroid gland ( McDonald 1980). In response to demand for thyroid hormone, the hypothalamus releases thyroid stimulating hormone releasing factor, which in turn stimulates the pituitary gland to release TSH. The thyroid hormones T3 and T4 exert similar effects on target tissues, but T3 is more biologically active ( Capen and Martin 1989). T4 secreted into the circulation is converted to T3 by the enzyme 5' deiodinase. Excess T4 can be converted to an inactive form of T3, reverse T3 ( rT3), by another enzyme, 5 deiodinase.

The study authors proposed that the observed changes in thyroid hormone regulation were likely the result of CF3I interfering with 5' deiodinase, the enzyme responsible for the conversion of T4 to T3. Such a mechanism could explain the changes in T4, T3, rT3, and TSH levels reported following exposure to CF3I. The resulting decrease in T3 could lead to a loss of negative inhibition and a subsequent increase in TSH and T4, with the excess T4 partially converted to rT3.

Dosimetric adjustments: The human equivalent concentration ( HEC) was calculated using the rat blood: air partition coefficient of 1.75 and the human blood: air partition coefficient of 0.97 ( Williams et al. 1994, Vinegar and Jepson 1996). Because the human partition coefficient is smaller than the animal one, the default value of 1 was used instead. The exposure ( September 15, 2004) 11 duration of 6 hours/ day was adjusted for the normal 8 hour occupational exposure. This adjustment is important, because thyroid toxicity is likely related to the total amount of iodine released by CF3I metabolism ( the area under the curve of the metabolite's time course of elimination, ( i. e., metabolite concentration vs. time). No adjustment was made for days/ week, because the exposure of interest ( occupational) is also 5 days/ week. 1 Uncertainty factors: The rat appears to be a highly sensitive species for chemicals which cause disruption of thyroid hormone levels, due to an approximately 10 fold faster clearance ( i. e., shorter plasma half life) of T3 and T4 compared to the human ( Alison et al. 1994). Levels of 5' deiodinase inhibition that cause marked effects in the rat may not cause adverse effects in the human because the slower turnover in the human allows for a physiological " buffer," making it easier for humans to maintain normal physiological levels of T3. Because rats are much more sensitive to thyroid hormone disruptions, the indirect mechanism by which CF3I acts would only be active in humans following exposure to concentrations greater than those to which the rats were exposed.

The RfC dosimetry guidelines were followed for obtaining the HEC ( EPA 1994); therefore, the default animal to human uncertainty factor of 3 for differences in pharmacokinetics was not applied. Because the rat is more sensitive to thyroid effects than the human, as discussed above, the default uncertainty factor of 3 for pharmacodynamics was considered unnecessary. The modifying factor for use of a LOAEL was decreased to 3 ( the default is 10); the LOAEL in humans for thyroid toxicity is expected to be higher than that observed in rats due to the greater sensitivity of rats to these effects. An additional factor of 3 was applied to consider sensitive individuals, such as workers with under or over active thyroids. An overall uncertainty factor of 10 results.

Ceiling:

The dog epinephrine challenge results ( Kenny et al. 1995) indicate that CF3I at levels above 0.2% may exacerbate the cardiac effects of other stressors. However, the epinephrine challenge is a highly sensitive test for these effects, and it is not felt that any uncertainty factors are necessary when the HEC is based on equal exposure concentration.

Other comments:

Reproductive effects:

Because the uncertainty factors used in deriving an AEL based on thyroid effects were reduced from the default values, an AEL based on reproductive effects observed in rats at higher concentrations than the thyroid effects was calculated for comparison. A NOAEL for the reproductive effects reported in Dodd et al. ( 1998) would be 0.7% ( 7,000 ppm). To derive an 1Although the exposure period in the Dodd et al. ( 1998) study varied from 5 7 days/ week depending on the period of gestation, the majority of exposure occurred on a 5 day/ week basis. ( September 15, 2004) 12 Acceptable Exposure Level ( AEL) based on these reproductive effects, the NOAEL would be adjusted from a 6 hour/ day exposure to occupational exposures ( 8 hours/ day) resulting in a LOAEL [ HEC] of 5,250 ppm ( 7,000 ppm × 6 hours/ 8 hours). An uncertainty factor of 3 would be applied for extrapolation from animals to humans to account for differences in pharmacokinetics. An additional uncertainty factor of 10 would be applied in consideration of human variability, resulting in a total uncertainty factor of 30. Note that the uncertainty factor used to account for human variability for reproductive effects is higher than that used for thyroid effects ( i. e., 3 for thyroid vs. 10 for reproductive effects). In contrast to thyroid toxicity, adverse reproductive effects are generally considered to be irreversible and " silent." Thyroid toxicity can be easily diagnosed in the early stages and possibly treated, while adverse reproductive effects are generally not diagnosed until much later, if at all. Further, although the reproductive toxicity screen measured many endpoints of reproductive success ( e. g., fecundity, gestation length, pup number, pup sex ratio), it did not measure any histopathological effects on the males, dams, or pups, including but not limited to, effects on the thyroid and serum levels of thyroid hormones. Thus, the reproductive toxicity screen does not provide a comprehensive analysis of potential reproductive and developmental effects that might result from CF3I exposure. For this reason, a lower uncertainty factor of 3 for reproductive effects was not deemed appropriate. Application of the total uncertainty factor to the LOAEL [ HEC] ( 5,250 ppm/ 30) results in a recommended AEL of 175 ppm, a value that is slightly higher than the AEL of 150 ppm based on the thyroid effects. The recommended AEL based on the thyroid effects would be protective of both the thyroid and reproductive effects.

Evidence of carcinogenic potential:

A bone marrow micronucleus induction assay was performed as part of a 90 day noseonly inhalation study where rats were exposed to 0, 2, 4, and 8% ( 0, 20,000, 40,000 and 80,000 ppm) CF3I for 2 hours/ day, 5 days/ week for 30 or 90 days ( Kinkead et al. 1996 ). After 30 days of exposure, concentration related increases in micronucleus frequency were observed in the mid and high concentration males and females, with statistically significant positive trends reported for each sex.

Concentration related decreases in polychromatic erythrocyte/ normochromatic erythrocyte ( PCE/ NCE) ratios, an indicator of bone marrow toxicity, were observed in all treated males and females and statistically significant trends were reported. After 90 days of exposure, concentration related increases in micronucleus frequency and decreases in PCE/ NCE ratios were observed in all treated groups, with statistically significant trends also reported for each endpoint. Mitchell ( 1995a) conducted a bone marrow micronucleus assay, where male and female mice were exposed to 0, 2.5, 5 or 7.5% CF3I ( 0, 25,000, 50,000 or 70,000 ppm) via noseonly inhalation, 6 hours/ day for 3 consecutive days. Statistically significant concentrationrelated decreases in micronucleus frequency were reported in the low and mid concentration male and female mice.

In addition, statistically significant concentration related decreases in the ratio of PCE/ 1000 erythrocytes were reported at all exposure concentrations in female mice. However, in the study by Dodd et al. ( 1998) where male and female rats were exposed to 0, 0.2, 0.7 or ( September 15, 2004) 13 2.0% CF3I ( 0, 2,000, 7,000 or 20,000 ppm) via whole body inhalation for 7 or 14 weeks, there were no statistically significant changes in micronuclei frequency or in PCE/ NCE ratios. An Ames assay was positive ( Mitchell 1995b), while a forward mutation assay was negative ( Mitchell 1995c). Although CF3I is only slowly metabolized ( Williams et al. 1994), it is clear that it has the potential to cause genotoxic effects. However, it would be premature to base a quantitative risk assessment on these data. A full quantitative assessment for potential carcinogenicity would require data from a two year bioassay.

References Alison RH, Capen CC, Prentice DE. 1994. Neoplastic Lesions of Questionable Significance to Humans. Toxicol Pathol 22: 179 186.

Capen CC and Martin SL. 1989. The Effects of Xenobiotics on the Structure and Function of Thyroid Follicular and C Cells. Toxicol Pathol 17: 266 293.

Dodd DE, Leahy HF, Feldmann ML, Vinegar A. 1998. Reproductive Toxicity Screen of Trifluoroiodomethane ( CF3I) in Sprague Dawley Rats. Mantech Geo Centers Joint Venture Report for Air Force Research Laboratory, Wright Patterson AFB. AFRL HE WP TR 1998 0029.

Kenny TJ, Sheperd CK, Hardy CJ. 1995. Iodotrifluoromethane and Iodoheptafluorpropane Assessment of Cardiac Sensitisation Potential in Dogs. Huntingdon Research Centre, UK. Submitted to Armstrong Loboratories, Toxicology Division. Wright Patterson AFB, Ohio, USA.

Kinkead ER, Wolfe RE, Feldmann ML, Leahy HF, Flemming CD, English JH. 1996. 90 Day Nose Only Inhalation Toxicity Study of Trifluoromethane ( CF3I) in Male and Female Fischer Rats. Mantech Environmental Technologies Report for Armstrong Laboratories. AL/ OE TR 1996 0024.

Mitchell AD. 1995a. Genetic Toxicity Evaluation of Iodotrifluoromethane ( CF3I), Volume II of III, Results of In Vivo Mouse Bone Marrow Erythrocyte Micronucleus Testing. Genesys Study Number 94037. Genesys Research, Inc. Research Triangle Park, NC, USA.

Mitchell AD. 1995b. Genetic Toxicity Evaluation of Iodotrifluoromethane ( CF3I), Volume I of III, Results of Results of Salmonella typhimurium Histidine Reversion Assay ( Ames Assay). Genesys Study Number 94035. Genesys Research, Inc. Research Triangle Park, NC, USA Mitchell AD. 1995c. Genetic Toxicity Evaluation of Iodotrifluoromethane ( CF3I), Volume III of III, Results of the Foreward Mutation Assay Using L5178Y Mouse Lymphoma Cells. Genesys Study Number 94036. Genesys Research, Inc., Research Triangle Park, North Carolina, USA. ( September 15, 2004) 14 Vinegar A and Jepson GW. 1996. Cardiac sensitization thresholds of halon replacement chemicals predicted in humans by physiologically based pharmacokinetic modeling. Risk Analysis 16: 571 579.

Williams JR, et al. 1994. Gas Uptake of Bromotrifluoromethane ( Halon 1301) and Its Proposed Replacement Iodotrifluoromethane ( CF3I). Armstrong Laboratory, Toxicology Division, Wright Paterson AFB, OH.


[Federal Register Volume 85, Number 185 (Wednesday, September 23, 2020)]
[Notices]
[Pages 59845-59847]
[FR Doc No: 2020-20935]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89915; File No. SR-NASDAQ-2020-044]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Order
Granting Approval of Proposed Rule Change To Adopt Listing Rule IM-
5900-8 To Offer a Complimentary Global Targeting Tool to Acquisition
Companies Listed Pursuant to Nasdaq IM-5101-2 That Have Publicly
Announced Entering Into a Binding Agreement for a Business Combination

September 17, 2020.

I. Introduction

    On July 15, 2020, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to offer a complimentary global targeting tool to
an acquisition company that has publicly announced entering into a
binding agreement for a business combination. The proposed rule change
was published in the Federal Register on August 3, 2020.\2\ The
Commission received no comments on the proposal. This order grants
approval of the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ See Securities Exchange Act Release No. 89413 (July 28,
2020), 85 FR 46759 (``Notice'').
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II. Description of the Proposal

    Generally, Nasdaq does not permit the initial or continued listing
of a company that has no specific business plan or that has indicated
that its business plan is to engage in a merger or acquisition with an
unidentified company or companies. However, in the case of a company
whose business plan is to complete an initial public offering (``IPO'')
and engage in a merger or acquisition with one or more unidentified
companies within a specific period of time, Nasdaq will permit the
listing if the company meets all applicable initial listing
requirements, as well as certain additional conditions described in
Nasdaq Rule IM-5101-2 (Listing of Companies Whose Business Plan is to
Complete One or More Acquisitions). Rule IM-5101-2 requires, among
other things, that at least 90% of the gross proceeds from the IPO and
any concurrent sale by the company of equity securities must be
deposited in a ``deposit account,'' as that term is defined in the
rule, and that the company complete within 36 months, or a shorter
period identified by the company, one or more business combinations
having an aggregate fair market value of at least 80% of the value of
the deposit account (excluding any deferred underwriters fees and taxes
payable on the income earned on the deposit account) at the time of the
agreement to enter into the initial combination.\3\
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    \3\ See Rule IM-5101-2(a) and (b). Nasdaq IM-5101-2 also
requires that following each business combination, the combined
company must meet the requirements for initial listing. See infra
note 12. If the company does not meet the requirements for initial
listing following a business combination or does not comply with one
of the requirements set forth in the IM-5101-2, Nasdaq will issue a
Staff Delisting Determination under Nasdaq Rule 5810 to delist the
company's securities. See Rule IM-5101-2(d).
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    The Exchange proposes to adopt Nasdaq IM 5900-8, to allow Nasdaq,
through its affiliate Nasdaq Corporate Solutions, LLC, to offer a
company listed under IM-5101-2 (``Acquisition Company'') a
complimentary global

targeting tool following the public announcement that the company
entered into a binding agreement for the business combination intended
to satisfy the conditions in IM-5101-2(b) until 60 days following the
completion of the business combination or such time that the
Acquisition Company publicly announces that such agreement is
terminated.\4\
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    \4\ See proposed IM-5900-8. As set forth in Nasdaq IM-5900-7
(Services Offered to Certain Newly Listing Companies), the Exchange
currently offers certain newly listing companies complimentary
services to help them satisfy their obligations as public companies
related to governance and communications, and to provide
intelligence about their securities. These services are offered to
companies listing on the Global or Global Select Market, based on
market capitalization, in connection with their IPO in the United
States, including American Depository Receipts (other than a company
listed under IM-5101-2); upon emerging from bankruptcy; in
connection with a spin-off or carve-out from another company; in
connection with a Direct Listing as defined in IM-5315-1 (including
the listing of American Depository Receipts); or in conjunction with
a business combination that satisfies the conditions in IM-5101-2(b)
(``Eligible New Listings''). These complimentary services are also
offered, based on market capitalization, to companies (other than a
company listed under IM-5101-2) switching their listing from the New
York Stock Exchange to the Global or Global Select Markets
(``Eligible Switches''). Nasdaq does not currently offer
complimentary services to companies listing on the Nasdaq Capital
Market or to Acquisition Companies listing on any market tier. See
Nasdaq IM-5900-7. The Exchange stated that, in certain
circumstances, under the proposal an Acquisition Company may be
eligible to receive services under both IM-5900-7 and proposed IM-
5900-8 for a short period of time following the completion of a
business combination pursuant to IM-5101-2.
---------------------------------------------------------------------------

    Proposed Nasdaq IM-5900-8 states that, through this global
targeting tool, investor targeting specialists will help focus the
Acquisition Company's investor relations efforts on appropriate
investors, tailor messaging to their interests and measure the
company's impact on their holdings. The analyst team will help develop
a detailed plan aligning the targeting efforts with the company's long-
term ownership strategy. Such analysis will include addressable risks
and opportunities by region and investor type, and recommendations for
where to focus time. According to the Exchange, this service has a
retail value of approximately $44,000 per year.\5\
---------------------------------------------------------------------------

    \5\ See proposed IM-5900-8.
---------------------------------------------------------------------------

III. Discussion and Commission's Findings

    The Commission has carefully reviewed the proposed rule change and
finds that it is consistent with the requirements of Section 6 of the
Act.\6\ Specifically, the Commission believes it is consistent with the
provisions of Sections 6(b)(4) and (5) of the Act,\7\ in particular, in
that it is designed to provide for the equitable allocation of
reasonable dues, fees, and other charges among Exchange members,
issuers, and other persons using the Exchange's facilities, and is not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers. Moreover, the Commission believes that the
proposed rule change is consistent with Section 6(b)(8) of the Act \8\
in that it does not impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f. In approving this proposed rule change, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78f(b)(4) and (5).
    \8\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    The Commission believes that it is consistent with the Act for the
Exchange to offer a complimentary global targeting tool to all
Acquisition Companies \9\ following the public announcement of a
binding agreement to enter into a business combination intended to
satisfy the conditions in Nasdaq IM-5101-2(b) until 60 days following
the completion of the business combination or such time that the
Acquisition Company publicly announces that such agreement is
terminated. As stated in its proposal, the Exchange has observed that
once an Acquisition Company publicly announces a business combination
with an operating company, the Acquisition Company needs to identify
and target investors appropriate for the new business and specifically
target investors who are interested in investing in the acquired
business.\10\ The Exchange stated that such investor targeting may help
the Acquisition Company convey the long-term vision of the acquired
business to investors and diminish potential redemptions at the time of
the business combination with the operating company.\11\ In addition,
the Exchange believes that such diminished redemptions may help
Acquisition Companies remain in compliance with other listing
requirements, including the shareholder requirement for continued
listing.\12\ The Exchange further stated that offering the tool for 60
days following the completion of the business combination will allow
for a smooth transition to the traditional operating company model and
avoid disruption of the service during the completion of the business
combination transaction.\13\
---------------------------------------------------------------------------

    \9\ This would include Acquisition Companies listed on the
Nasdaq Capital, Global, and Global Select Markets. Nasdaq does not
currently offer complimentary services under IM-5900-7 to companies
listing on the Nasdaq Capital Market so this rule proposal will be
the first time the Exchange provides the same service on all three
listing tiers. See supra note 4.
    \10\ See Notice, supra note 2, at 46760.
    \11\ See id. The Acquisition Company's shareholders have the
right to redeem their shares for a pro rata share of that trust in
conjunction with the business combination. See IM-5101-2(d) and (e).
    \12\ See Notice, supra note 2, at 46761. Listing Rule 5450(a)(2)
requires at least 400 Total Holders for continued listing on the
Nasdaq Global Market. Listing Rule 5550(a)(3) requires at least 300
Public Holders for continued listing on the Nasdaq Capital Market.
The Commission notes, however, that these continued listing
requirements only apply during the continued listing of the
Acquisition Company prior to any business combination. Nasdaq IM-
5101-2 requires that, at the time of a business combination, the
combined company would need to meet all applicable initial listing
requirements. See supra note 3. For initial listing, among other
requirements, Listing Rule 5405(a)(3) requires at least 400 Round
Lot Holders on Nasdaq Global Market and Listing Rule 5505(a)(3)
requires at least 300 Round Lot Holders on Nasdaq Capital Market.
    \13\ See Notice, supra note 2, at 46761. The Exchange stated
that Acquisition Companies do not have operating businesses and,
therefore, do not generally need shareholder communication services,
market analytic tools or market advisory tools. As a result, these
companies do not receive complimentary services under Nasdaq IM-
5900-7, but would be eligible to receive services under IM-5900-7
when listing on the Nasdaq Global or Global Select Market in
conjunction with a business combination that satisfies the
conditions in IM-5101-2(b). See id. at 46760. See also IM-5900-7.
While the Exchange noted that a company may be eligible to receive
services under both IM-5900-7 and proposed IM-5900-8 for a short
period of time following the completion of a business combination,
the Commission notes that such eligibility would be restricted to
the global targeting tool and would be limited to no more than 60
days. See supra note 4.
---------------------------------------------------------------------------

    As noted in the order approving Nasdaq IM-5900-7, Section 6(b)(5)
of the Act does not require that all issuers be treated the same;
rather, the Act requires that the rules of an Exchange not unfairly
discriminate between issuers.\14\ The Commission believes that the
Exchange has reasonably justified treating an Acquisition Company that
has publicly announced that it has entered into a binding agreement to
enter into a business combination differently than other companies,
including Acquisition Companies that have not yet announced that they
have entered into a business combination. As discussed above,
Acquisition Companies have an increased need to focus on identifying
and communicating with shareholders and prospective investors following
the public announcement of entering into a business combination. In
addition, the Exchange stated that at this time in an Acquisition
Company's lifecycle, the company is transitioning to the traditional
operating company model

and the complimentary global targeting tool will help ease this
transition.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f(b)(5); see also Securities Exchange Act
Release No. 65963 (December 15, 2011), 76 FR 79262 (December 21,
2011) (approving NASDAQ-2011-122) (``2011 Approval Order'').
    \15\ See Notice, supra note 2, at 46761.
---------------------------------------------------------------------------

    The Commission also believes that describing in the Exchange's
rules the products and services available to listed companies and their
associated values adds greater transparency to the Exchange's rules and
to the fees applicable to such companies and will ensure that
individual listed companies, including Acquisition Companies, are not
given specially negotiated packages of products or services to list, or
remain listed, that would raise unfair discrimination issues under the
Act.\16\ The Commission has previously found that the package of
complimentary services offered to Eligible New Listings and Eligible
Switches, which includes the global targeting tool, is equitably
allocated among issuers consistent with Section 6(b)(4) of the Act.\17\
Based on the foregoing, the Commission believes that the Exchange has
provided a sufficient basis for offering a complimentary global
targeting tool to Acquisition Companies that have announced that they
have entered into a binding agreement to enter into a business
combination until 60 days following the completion of the business
combination (or such time that the Acquisition Company publicly
announces that such agreement is terminated), and that this change does
not unfairly discriminate among issuers and is consistent with the Act.
---------------------------------------------------------------------------

    \16\ See Exchange Act Release No. 79366, 81 FR 85663 at 85665
(approving SR-NASDAQ-2016-106) (``2016 Approval Order'') (citing
Securities Exchange Act Release No. 65127 (August 12, 2011), 76 FR
51449, 51452 (August 18, 2011) (approving NYSE-2011-20)). The
Commission notes that the Exchange also stated that no other company
will be required to pay higher fees as a result of the proposal and
that providing the complimentary global targeting tool will have no
impact on the resources available for its regulatory programs. See
Notice, supra note 2, at 46760.
    \17\ See 2016 Approval Order, supra note 16, at 85665.
---------------------------------------------------------------------------

    The Commission also believes that the Exchange is responding to
competitive pressures in the market for listings in making this
proposal. The Exchange stated in its proposal that it faces competition
in the market for listing services and the Commission understands that
the Exchange competes, in part, by offering complimentary services to
companies.\18\ The Exchange further stated it believes the offering of
the complimentary global targeting tool will provide an incentive to
Acquisition Companies to list on Nasdaq.\19\ Accordingly, the
Commission believes that the proposed rule reflects the current
competitive environment for exchange listings among national securities
exchanges, and is appropriate and consistent with Section 6(b)(8) of
the Act.\20\
---------------------------------------------------------------------------

    \18\ See Notice, supra note 2, at 46761. The Commission notes
that the complimentary services under the proposal will be provided
by Nasdaq Global Solutions, LLC, an affiliate of Nasdaq. The
Commission has previously stated that providing complimentary
services to its listed companies through an affiliate as opposed to
a third party vendor is among the different ways Nasdaq competes for
listings and provides services to listed companies and that this
reflects the competitive environment. See 2011 Approval Order, supra
note 14, at 79267. The Exchange also noted that other providers
could compete by offering similar services to Acquisition Companies.
See Notice, supra note 2, at 46761.
    \19\ See Notice, supra note 2, at 46760.
    \20\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\21\ that the proposed rule change (SR-NASDAQ-2020-044) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(2).
    \22\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-20935 Filed 9-22-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: March 24, 2009 (Volume 74, Number 55)]
[Rules and Regulations]
[Page 12236-12238]
[DOCID:fr24mr09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0846; Directorate Identifier 2008-NM-045-AD;
Amendment 39-15857; AD 2009-06-20]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 757-200, 757-200PF, and
757-300 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 certain
Boeing Model 757-200, 757-200PF, and 757-300 series airplanes. This AD
requires, for certain airplanes, measuring the electrical bond
resistance at certain stations and doing any applicable repair;
installing support brackets for the hot short protector and new support
clamps for the wire bundles; installing the equipment of the hot short
protector; and modifying an existing wire bundle and installing a new
wire bundle. This AD also requires, for certain other airplanes,
measuring the electrical bond resistance at certain stations, measuring
the electrical bonding resistance between the hot short protector and
rear spar web, and doing any applicable repair. This AD also requires
revising the Airworthiness Limitations section of the Instructions for
Continued Airworthiness. This AD results from fuel system reviews
conducted by the manufacturer. We are issuing this AD to prevent the
center fuel tank densitometer from overheating and becoming a potential
ignition source inside the fuel tank, which, in combination with
flammable fuel vapors, could result in a center fuel tank explosion and
consequent loss of the airplane.

DATES: This AD is effective April 28, 2009.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of April 28,
2009.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1, 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: Jen Pei, Aerospace Engineer, Systems
and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone
(425) 917-6409; 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
certain Boeing Model 757-200, 757-200PF, and 757-300 series airplanes.
That NPRM was published in the Federal Register on August 7, 2008 (73
FR 45895). That NPRM proposed to require, for certain airplanes,
measuring the electrical bond resistance at certain stations and doing
any applicable repair; installing support brackets for the hot short
protector and new support clamps for the wire bundles; installing the
equipment of the hot short protector; and modifying an existing wire
bundle and installing a new wire bundle. That NPRM also proposed to
require, for certain other airplanes, measuring the electrical bond
resistance at certain stations, measuring the electrical bonding
resistance between the hot short protector and rear spar web, and doing
any applicable repair. That NPRM also proposed to require revising the
Airworthiness Limitations section of the Instructions for Continued
Airworthiness.

Comments

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

Support for the NPRM

    Boeing concurs with the NPRM.

Request to Exempt Cargo-Only Airplanes

    Air Transport Association, on behalf of one of its members, UPS,
proposes that cargo-only airplanes be exempt from installing the hot
short protector specified in the NPRM, based on the same reasons used
to exclude cargo-only airplanes in Federal Aviation Regulations change,
``Reduction of Fuel Tank Flammability in Transport Category
Airplanes,'' Docket FAA-2005-22997 (Final Rule issued July 9, 2008,
amendment numbers 25-125, 26-2, 121-340, 125-55, and 129-46):
     Cargo operations are predominately at night when outside
temperatures are lower.
     Cargo operators turn off packs prior to takeoff.
     Cargo operators have fewer daily flights (2) compared to
passenger operators (4-6).
     The cost/benefit does not justify retrofit on current
cargo aircraft.
    UPS recommends that all cargo-only airplanes currently in operation
be exempt from the retrofit/installation portion of the NPRM and
service bulletin. UPS is of the opinion that changing the Instructions
for Continuing Airworthiness and maintenance programs to perform
bonding checks will be sufficient in addressing the potential short
issue in existing cargo-only airplanes. UPS does not object to new
cargo-only airplanes having the hot short protector installed.
    We do not agree with the request to exempt cargo-only airplanes
from the requirements of this AD. Although the fuel tank flammability
reduction rule (mentioned previously) provides important safety
improvements, it was not intended to address any specific identified
unsafe conditions. Instead, that rule provides an additional layer of
protection when unidentified and uncorrected fuel tank ignition sources
develop. This AD, however, addresses an identified ignition source in
the fuel tank system. While the factors mentioned by the operator may
reduce the probability that this ignition source will actually cause a
fuel tank explosion, they do not justify allowing this known ignition
source to continue to exist when practical means exist to eliminate it.
We have not changed the AD in this regard.

Actions Since NPRM Was Issued

    We have reviewed Airworthiness Limitation (AWL) No. 28-AWL-22 of
Subsection G of Section 9, D622N001-

9 Revision December 2008 of the Boeing 757 Maintenance Planning Data
(MPD) Document (``Revision December 2008 of the MPD''). In the NPRM we
referred to AWL No. 28-AWL-22 of Revision November 2007 of the MPD. AWL
No. 28-AWL-22 has not changed. We have revised paragraph (h) of this AD
to refer to AWL No. 28-AWL-22 of Revision December 2008 of the MPD;
added paragraph (k) to the AD giving credit for AWL No. 28-AWL-22 done
in accordance with Revisions January 2007, November 2007, and March
2008 of the MPD; and re-identified the subsequent paragraphs
accordingly.

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

    We estimate that this AD affects 433 airplanes of U.S. registry.
The following table provides the estimated costs for U.S. operators to
comply with this AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
               Action                  Work hours     Average labor        Parts \1\         Cost per product \1\    registered        Fleet cost \1\
                                                      rate per hour                                                   airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Groups 1-3; measurement,                          8             $80  Between $14,110 and    Between $14,750 and               432  Between $6,372,000
 installations, and modification.                                     $14,215.               $14,855.                               and $6,417,360.
Group 4; measurements..............               2             $80  None.................  $160.................               1  $160.
AWL Revision.......................               1             $80  None.................  $80..................             433  $34,640.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Depending on airplane configuration.

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:

2009-06-20 Boeing: Amendment 39-15857. Docket No. FAA-2008-0846;
Directorate Identifier 2008-NM-045-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective April 28,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 757-200, 757-200PF, and 757-
300 series airplanes, certificated in any category; as identified in
Boeing Alert Service Bulletin 757-28A0085, Revision 2, dated
December 11, 2007.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance (AMOC)
according to paragraph (m) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Unsafe Condition

    (d) This AD results from fuel system reviews conducted by the
manufacturer. We are issuing this AD to prevent the center fuel tank
densitometer from overheating and becoming a potential ignition
source inside the fuel tank, which, in combination with flammable
fuel vapors, could result in a center fuel tank explosion and
consequent loss of the airplane.

Compliance

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

Measurement, Installation, Modifications, Replacement, and Repair

    (f) For Groups 1 through 3 airplanes, as identified in Boeing
Alert Service Bulletin 757-28A0085, Revision 2, dated December 11,
2007 (``the service bulletin''): Within 60 months after the
effective date of this AD, do the measurement, installations,
modifications, replacement, and applicable repair by accomplishing
all the applicable actions specified in the Accomplishment
Instructions of the service bulletin. Do the applicable repair
before further flight.

Measure and Repair

    (g) For Group 4 airplanes, as identified in Boeing Alert Service
Bulletin 757-28A0085, Revision 2, dated December 11, 2007 (``the
service bulletin''): Within 60 months after the effective date of
this AD, do the measurements and applicable repair by accomplishing
all the applicable actions specified in the Accomplishment
Instructions of the service bulletin. Do the applicable repair
before further flight.

Airworthiness Limitations (AWLs) Revision for AWL No. 28-AWL-22

    (h) Concurrently with accomplishing the actions required by
paragraphs (f) and (g) of this AD, revise the AWLs section of the
Instructions for Continued Airworthiness (ICA) by incorporating AWL
No. 28-AWL-22 of Subsection G of Section 9, D622N001-9 Revision
December 2008 of the Boeing 757 Maintenance Planning Data (MPD)
Document.

No Alternative Critical Design Configuration Control Limitations
(CDCCLs)

    (i) After accomplishing the action specified in paragraph (h) of
this AD, no alternative CDCCLs may be used unless the CDCCLs are
approved as an AMOC in accordance with the procedures specified in
paragraph (k) of this AD.

Credit for Actions Done According to Previous Issues of the Service
Information

    (j) Actions done before the effective date of this AD in
accordance with Boeing Alert Service Bulletin 757-28A0085, Revision
1, dated April 16, 2007, are acceptable for compliance with the
requirements of paragraphs (f) and (g) of this AD.
    (k) Actions done before the effective date of this AD in
accordance with AWL No. 28-AWL-22 of Subsection G of Section 9
D622N001-9, Revision January 2007, Revision November 2007, or
Revision March 2008 of the Boeing 757 Maintenance Planning Data
(MPD) Document, are acceptable for compliance with the requirements
of paragraph (h) of this AD.

Terminating Action for AWLs Revision

    (l) Incorporating AWL No. 28-AWL-22 into the AWLs section of the
ICA in accordance with paragraph (g)(3) of AD 2008-10-11, amendment
39-15517, terminates the action specified in paragraph (h) of this
AD.

Alternative Methods of Compliance (AMOCs)

    (m)(1) The Manager, Seattle Aircraft Certification Office, FAA,
ATTN: Jen Pei, Aerospace Engineer, Systems and Equipment Branch,
ANM-130S, FAA, Seattle ACO, 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.

Material Incorporated by Reference

    (n) You must use Boeing Alert Service Bulletin 757-28A0085,
Revision 2, dated December 11, 2007; and Section 9, D622N001-9
Revision December 2008 of the Boeing 757 Maintenance Planning Data
(MPD) Document; as applicable; 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, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1, fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference 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 March 12, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E9-5962 Filed 3-23-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58296-58297]
[FR Doc No: 2013-23002]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC13-16-000]

Commission Information Collection Activities (FERC-604); Comment
Request

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Comment request.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory
Commission (Commission or FERC) is submitting the information
collection FERC-604 (Cash Management Agreements) to the Office of
Management and Budget (OMB) for review of the information collection
requirements. Any interested person may file comments directly with OMB
and should address a copy of those comments to the Commission as
explained below. The Commission issued a Notice in the Federal Register
(78 FR 29359, 5/20/2013) requesting public comments. FERC received no
comments on the FERC-604 and is making this notation in its submittal
to OMB.

DATES: Comments on the collection of information are due by October 23,
2013.

ADDRESSES: Comments filed with OMB (identified by FERC-604 and Docket
No. IC13-16-000) should be sent via email to the Office of Information
and Regulatory Affairs: oira--submission@

omb.gov. Attention: Federal Energy Regulatory Commission Desk Officer.
The Desk Officer may also be reached via telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Federal Energy
Regulatory Commission (identified by the Docket No. IC13-16-000) by
either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>by telephone at<PHONE_NUMBER>, and by fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-604, Cash Management Agreements.
    OMB Control No.: To be determined.
    Type of Request: Three-year approval of the FERC-604 information
collection requirements with no changes to the reporting requirements.
    Abstract: Cash management or ``money pool'' programs typically
concentrate affiliates' cash assets in joint accounts for the purpose
of providing financial flexibility and lowering the cost of borrowing.
    In a 2001 investigation, FERC staff found that balances in cash
management programs affecting FERC-regulated entities totaled
approximately $16 billion. Additionally, other investigations revealed
large transfers of funds (amounting to more than $1 billion) between
regulated pipeline affiliates and non-regulated parents whose financial
conditions were precarious. The Commission found that these and other
fund transfers and the enormous (mostly unregulated) pools of money in
cash management programs could detrimentally affect regulated rates.
    To protect customers and promote transparency, the Commission
issued Order 634-A (2003) requiring entities to formalize in writing
and file with the Commission their cash management agreements. The
Commission obtained OMB clearance for this new reporting requirement
under the FERC-555 information collection (OMB Control No. 1902-0098).
However, in subsequent extension requests to OMB for the FERC-555
collection, the Commission failed to include the cash management
agreement reporting burden as part of the estimates. In this
proceeding, the Commission rectifies the omission by seeking public
comment on the reporting requirement in order to update the OMB
clearance for cash management agreement filings. The Commission intends
to put the reporting requirements under the collection number ``FERC-
604'' and request a new OMB Control Number.
    The Commission implemented these requirements in 18 CFR 141.500,
260.400, and 357.5.
    Type of Respondents: Public utilities and licensees, natural gas
companies, and oil pipeline companies.
    Estimate of Annual Burden \1\: The Commission estimates the total
Public Reporting Burden for this information collection as:
---------------------------------------------------------------------------

    \1\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.

                                                          FERC-604: Cash Management Agreements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Annual number     Annual total    Average annual
                                                                        Number of       of responses      number of       burden hours   Estimated total
                                                                       respondents     per respondent     responses       per response    annual burden
                                                                                A                B    (A) x (B) = (C)              D                (C) x (D)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public utilities and licensees, natural gas companies, and oil               \2\ 25                1               25              1.5             37.5
 pipeline companies................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The total estimated annual cost burden to respondents is $2,625
[37.5 hours * $70 per hour \3\ = $2,625].
---------------------------------------------------------------------------

    \2\ This figure is based on the number of filings received by
the Commission for cash management agreements over the last several
years.
    \3\ This is a loaded cost (wages plus benefits) for a full-time
employee.
---------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: September 16, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-23002 Filed 9-20-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44846-44847]
[FR Doc No: 2014-18235]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4180-DR; Docket ID FEMA-2014-0003

New York; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of New York (FEMA-4180-DR), dated July 8, 2014,
and related determinations.

DATES: Effective Date: July 8, 2014.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 8, 2014, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of New York resulting from severe storms and flooding during the
period of May 13-22, 2014, is of sufficient severity and magnitude
to warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of New York.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Steven S. Ward, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of New York have been designated
as adversely affected by this major disaster:

    Allegany, Cattaraugus, Chautauqua, Delaware, Herkimer, Lewis,
Livingston, Ontario, Otsego, Steuben, and Yates Counties for Public
Assistance.

    All counties within the State of New York are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2014-18235 Filed 7-31-14; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Notices]
[Pages 54451-54452]
[FR Doc No: 2020-19300]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89693; File No. 265-33]

Asset Management Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting.

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

SUMMARY: Notice is being provided that the Securities and Exchange
Commission Asset Management Advisory Committee (``AMAC'') will hold a
public meeting on September 16, 2020, by remote means. The meeting will
begin at 9:00 a.m. (ET) and will be open to the public via webcast on
the Commission's website at www.sec.gov. Persons needing special
accommodations to take part because of a disability should notify the
contact person listed below. The public is invited to submit written
statements to the Committee. The meeting will include a discussion of
matters in the asset management industry relating to the ESG and
Private Investments Subcommittees; and improving diversity and
inclusion. It will also include a follow-up discussion on COVID-19
matters relating to AMAC's meeting of May 27, 2020.

DATES: The public meeting will be held on September 16, 2020. Written
statements should be received on or before September 11, 2020.

ADDRESSES: The meeting will be held by remote means and webcast on
www.sec.gov. Written statements may be submitted by any of the
following methods. To help us process and review your statement more
efficiently, please use only one method. At this time, electronic
statements are preferred.

Electronic Statements

     Use the Commission's internet submission form (http://www.sec.gov/rules/other.shtml); or
     Send an email message to<EMAIL_ADDRESS>Please
include File Number 265-33 on the subject line; or

Paper Statements

     Send paper statements to Vanessa Countryman, Federal
Advisory Committee Management Officer, Securities and Exchange
Commission, 100 F Street NE, Washington, DC 20549-1090. All submissions
should refer to File No. 265-33. This file number should be included on
the subject line if email is used. The Commission will post all
statements on the Commission's website at (http://www.sec.gov/comments/265-33/265-33.htm).
    Statements also will be available for website viewing and printing
in the Commission's Public Reference Room, 100 F Street NE, Room 1580,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. For up-to-date information on the availability
of the Public Reference Room, please refer to https://www.sec.gov/fast-answers/answerspublicdocshtm.html or call<PHONE_NUMBER>.
    All statements received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.

FOR FURTHER INFORMATION CONTACT: Christian Broadbent, Senior Special
Counsel, Sirimal Mukerjee, Branch Chief, or Angela Mokodean, Branch
Chief, at<PHONE_NUMBER>, Division of Investment Management, Securities
and Exchange Commission, 100 F Street NE, Washington DC 20549-3628.

SUPPLEMENTARY INFORMATION: In accordance with Section 10(a) of the
Federal Advisory Committee Act, 5 U.S.C.-App. 1, and the regulations
thereunder, Dalia Blass, Designated Federal Officer of the Committee,
has ordered publication of this notice.

    Dated: August 27, 2020.
Vanessa A. Countryman,
Committee Management Officer.
[FR Doc. 2020-19300 Filed 8-31-20; 8:45 am]
BILLING CODE P


[Federal Register: July 28, 2010 (Volume 75, Number 144)]
[Notices]
[Page 44273]
[DOCID:fr28jy10-90]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Radiological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    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: Radiological Devices Panel of the Medical
Devices 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 September 24, 2010, from
8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C
and D, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Shanika Craig, Food and Drug Administration, Center
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg 66,
rm. 1613, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), code<PHONE_NUMBER>. 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 September 24, 2010, the committee will discuss, make
recommendations, and vote on a premarket approval application for the
Selenia C Digital Breast Tomosynthesis System, sponsored by Hologic,
Inc. The Selenia C Digital Breast Tomosynthesis System is intended for
use in the same clinical applications as traditional mammographic
systems.
    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
September 16, 2010. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m., immediately
following lunch. Those desiring to make 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
September 9, 2010. 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 September 10,
2010.
    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 AnnMarie Williams,
Conference Management Staff,<PHONE_NUMBER>, 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: July 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-18416 Filed 7-27-10; 8:45 am]
BILLING CODE 4160-01-S