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Federal Aviation Administration (FAA), DOT.
Direct final rule; confirmation of effective date.
This document confirms the effective date of the direct final rule which revises Class D and Class E airspace at Topeka, Forbes Field, KS.
Brenda Mumper, Air Traffic Division, Airspace Branch, ACE-520A, DOT Regional Headquarters Building, Federal Aviation Administration, 901 Locust, Kansas City, MO 64196; telephone: (816) 329-2524.
The FAA published this direct final rule with a request for comments in the
Federal Aviation Administration (FAA) DOT.
Final Rule; correction.
The Federal Aviation Administration (FAA) published in the
September 15, 2005.
Larry Tonish, Airspace Specialist, Airspace Branch, AWP-520.1, Air Traffic Organization, Western Terminal Operations, Federal Aviation Administration, 15000 Aviation Boulevard, Lawndale, California 90261, telephone (310) 725-6539.
The FAA published a document in the
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Within a 4.3-mile radius of the South Lake Tahoe Airport.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of ionizing radiation for control of
This rule is effective August 16, 2005. Submit written or electronic objections and requests for a hearing by September 15, 2005. See section VI of this document for information on the filing of objections.
You may submit written or electronic objections and requests for a hearing identified by Docket No. 1999F-4372, by any of the following methods:
• Federal eRulemaking Portal:
• Agency Web site:
• E-mail:
• FAX: 301-827-6870.
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Lane A. Highbarger, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1204.
In a notice published in the
Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s)), a source of radiation used to treat food is defined as a food additive. The additive is not added to food literally, but is rather a source of radiation used to process or treat food such that, analogous to other food processing technologies, its use can affect the characteristics of the food. In the subject petition, the intended technical effect is for control of foodborne pathogens, including but not limited to
In evaluating the safety of a source of radiation to treat food intended for human consumption, the agency must identify the various effects that may result from irradiating the food and assess whether any of these effects pose a public health concern. In this regard, the following three areas of concern need to be addressed: (1) Potential toxicity, (2) nutritional adequacy, and (3) potential microbiological risk from the treated food. Each of these areas is discussed in detail in this document. FDA has fully considered the data and studies submitted in the subject petition as well as other data and information relevant to safety.
Based on a joint FAO/IAEA/WHO
[m]inimum absorbed dose should be sufficient to achieve the technological purpose and the maximum absorbed dose should be less than that which would compromise consumer safety, wholesomeness [of the food] or would adversely affect structural integrity, functional properties, or sensory attributes. The maximum absorbed dose delivered to a food should not exceed 10 kGy, except when necessary to achieve a legitimate technological purpose.
(Ref. 2) The original version of the standard explains in a footnote that “wholesomeness [in the context of the standard] refers to safety for consumption of irradiated foods from the toxicological point of view * * * and that irradiation up to an overall average dose of 10 kGy introduces no special nutritional or microbiological problems.”
FDA did not adopt the 1983 Codex recommendations because, at that time, it had not sufficiently analyzed the issues of nutritional adequacy and microbiological safety for all foods at all doses, nor had the agency pursued the analysis of toxicity beyond the examination of individual studies (62 FR 64107 at 64112, December 3, 1997).
At the request of one of its member states, WHO conducted a subsequent review and analysis of the safety data on irradiated food (Ref. 3). WHO
Scientists have compiled a large body of data regarding the effects of ionizing radiation on different foods under various conditions of irradiation. These data indicate that the effects of ionizing radiation on the characteristics of treated foods are a direct result of the chemical reactions induced by the absorbed radiation. The types and amounts of products generated by radiation-induced chemical reactions (“radiolysis products”) depend on both the chemical constituents of the food and on the specific conditions of irradiation. The principles of radiation chemistry also govern the extent of change, if any, in both the nutrient levels and the microbial load of irradiated foods. For a detailed discussion and evaluation of radiation chemistry, nutrition, toxicology, and microbiology related to irradiation of flesh-based foods under various conditions of use, see the agency's final rule permitting the irradiation of meat (62 FR 64107). In the current rulemaking, FDA has reviewed relevant data and information regarding radiation chemistry as it applies specifically to fresh or frozen molluscan shellfish irradiated at absorbed doses not to exceed 5.5 kGy.
The major components of fresh or frozen molluscan shellfish are water, protein, and lipid. Irradiation of water produces reactive hydroxyl and hydrogen radicals. These radicals can either recombine to form water, hydrogen gas, or hydrogen peroxide, or react with other components of molluscan shellfish. While the most significant effect of radiation-processing on the protein and lipid components of fresh or frozen molluscan shellfish results from the chemical reactions induced by hydroxyl radicals generated from the radiolysis of the water, radiolysis products of protein and lipid may also result from directly absorbed radiation. These radiolysis products, however, form in very small amounts and are usually the same as compounds found in foods that have not been irradiated (Ref. 4).
The amounts of radiolysis products generated in a particular food are directly proportional to the radiation dose. Therefore, FDA can draw conclusions about the amounts of radiolysis products expected to be generated at radiation doses relevant to the subject petition by extrapolating from data obtained at higher doses for foods of similar composition irradiated under similar conditions. In general, the types of products generated by irradiation are similar to those products produced by other methods of food processing, such as canning, cooking, etc., because all chemical reactions caused by the addition of energy must follow the laws of chemistry. The radiation chemistry of food is also strongly influenced by the physical state of the food (solid, liquid, dry, or frozen) during irradiation. For example, the extent of chemical change that occurs in a particular food in the dry or frozen state will be less than the change that occurs in the same food when liquid water is present, all other conditions (including dose and ambient atmosphere) being equal, because indirect reaction products from water will be minimized (Ref. 5).
During the course of reviewing chemical effects of irradiation as part of the evaluation of this and other petitions, FDA became aware of a reference that suggested that irradiating apple juice may produce furan (Ref. 6). Because furan has been shown to cause cancer in laboratory animals, FDA initiated research on whether the referenced report was accurate and whether furan was a common radiolysis product in food. FDA has confirmed that certain foods form furan in low quantities when irradiated and also that some foods form furan when heated. Studies on the irradiation of molluscan shellfish show that if furan is formed when molluscan shellfish are irradiated, it is formed at levels that are undetectable, or below the background levels of natural furan formation (Ref. 7). Therefore, the consumption of irradiated molluscan shellfish will not increase the amount of furan in the diet and is not an issue with this petition.
In the
With respect to proteins, several types of reactions can occur as a result of irradiation. One type of reaction is the breaking of a small number of peptide bonds to form polypeptides of shorter length than the original protein. Radiation-induced aggregation or cross-linking of individual polypeptide chains can also occur; these processes result in protein denaturation. In irradiated flesh foods, most of the radiolytic products derived from proteins have the same chemical composition regardless of the protein sources, but are altered in their secondary and tertiary structures. These changes are similar to those that occur as a result of heating, but in the case of irradiation, such changes are far less pronounced and the amounts of reaction products generated are far lower (Refs. 4 and 8). Studies have established that
The main effects of ionizing radiation on carbohydrates in foods have been reviewed previously in the literature and by WHO (Refs. 5, 10, and 11). One of the main effects of ionizing radiation is the abstraction of hydrogen from the carbon-hydrogen bonds of the carbohydrate, resulting in directly ionizing and exciting the carbohydrate molecule. Carbohydrate radicals may result from ionization of monosaccharides such as glucose or polysaccharides such as starch. Radiolysis products formed from starches of different origin are reported to be qualitatively similar (Refs. 5 and 11). In polysaccharides, the glycosidic linkages between constituent monosaccharide units may be broken, resulting in the shortening of polysaccharide chains and reduction in the viscosity of polysaccharides in solution. Starch may be degraded into dextrins, maltose, and glucose. Sugar acids, ketones, and other sugar monosaccharides may also be formed as a result of ionizing radiation. Irradiation of carbohydrates at doses up to 10 kGy has minimal effect on the carbohydrate functionality. The overall effects of ionizing radiation are the same as those caused by cooking and other food processing treatments. Carbohydrates that are present as a component of food are less sensitive to the effects of irradiation than pure carbohydrates (Ref. 5). No significant change in the carbohydrate composition of fresh or frozen molluscan shellfish is expected to occur under the conditions set forth in this regulation, i.e., a maximum absorbed dose of 5.5 kGy.
The meat final rule also discussed the radiation chemistry of lipids (predominantly triglycerides in meat). A variety of radiolysis products derived from lipids have been identified, including fatty acids, esters, aldehydes, ketones, alkanes, alkenes, and other hydrocarbons (Refs. 12 and 13). Identical or analogous compounds, however, are also found in foods that have not been irradiated. In particular, heating food produces the same types of compounds, but in amounts far greater than the trace amounts produced from irradiating food (Refs. 4 and 14). In addition, alkylcyclobutanones (ACBs), which are formed in small quantities when fats are exposed to ionizing radiation, have been identified in meat and poultry. The specific ACBs formed will depend on the fatty acid composition of the food. For example, 2-dodecylcyclobutanone (2-DCB) has been reported to be formed from palmitic acid in amounts from 0.3 to 0.6 microgram per gram lipid per kGy (μg/g lipid/kGy) from irradiated chicken (Ref. 15). Other researchers have found that (2--DCB) is formed at significantly lower rates, 0.04 μg/g lipid/kGy from ground beef (Ref. 16). For comparison, ground beef tallow contains approximately 25 percent palmitic acid and chicken fat contains approximately 22 percent palmitic acid.
One major difference between fish (including shellfish and finfish) and other flesh foods is the predominance of polyunsaturated fatty acids (PUFAs) in the lipid phase of fish. PUFAs are a subclass of lipids that have a higher degree of unsaturation in the hydrocarbon chain than the saturated (e.g., stearic acid) or monounsaturated (e.g., oleic acid) fatty acids. Due to the higher level of unsaturation, PUFAs are generally more readily oxidized than saturated fatty acids. Therefore, PUFAs could be more radiation-sensitive than other lipid components, as observed in some studies of irradiated oil. However, evidence from meat studies suggests that the protein component of meat may protect lipids from oxidative damage (Ref. 5). Because the lipid fraction of meat consists primarily of saturated and monounsaturated fatty acids with negligible quantities of PUFAs, FDA did not explicitly address the radiation chemistry of PUFAs in its previous reviews.
The effects of irradiation on PUFAs in fish have been described in several studies reviewed by FDA. Adams
Sant'ana and Mancini-Filho studied the effects of radiation on the distribution of fatty acids in fish (Ref. 19). They studied two monounsaturated fatty acids and seven PUFAs (including three different omega-3 fatty acids) before and after irradiation at doses up to 3 kGy. The authors observed insignificant changes in the concentration of total monounsaturated fatty acids and an approximately 13 percent decrease in total PUFAs at the highest dose, largely attributable to a loss of the long chain PUFAs, including docosahexaenoic acid. The overall change for essential fatty acids (e.g., linoleic and linolenic acids) was minimal (less than 3 percent). The authors also observed an increase in lipid oxidation based on levels of thiobarbituric acid reactive substances, but noted that antioxidants such as tocopherol protect against lipid oxidation (Ref. 4).
In addition, a study summarized in an International Consultative Group on Food Irradiation monograph compared the fatty acid composition of unirradiated and irradiated herring oil (Ref. 20). The profile for 12 fatty acids was compared to controls 1 day and 28 days after irradiation. Only two fatty acids appeared to have decreased by day 28 following irradiation at 50 kGy (Ref. 4).
Research conducted by FDA on various species of seafood also demonstrated that the concentrations of PUFAs are not significantly affected by irradiation (Refs. 21 and 22). Therefore, based on the totality of evidence, the agency concludes that no significant loss of PUFAs is expected to occur in the diet under the conditions of irradiation set forth in this regulation. In summary, FDA's review of the radiation chemistry of proteins and lipids in the subject petition raises no issues that have not been considered previously in the meat and poultry final rules (Ref. 4).
In the safety evaluation of irradiated meat and poultry, the agency examined all of the available data from toxicological studies relevant to the safety of irradiated flesh-based foods, including studies on fish high in PUFAs. These included 24 long-term feeding studies, 10 reproduction/teratology studies, and 15 genotoxicity studies with flesh-based foods irradiated at doses from 6 to 74 kGy. No toxicologically significant adverse effects attributable to irradiated flesh foods were observed in any of the studies (62 FR 64107 at 64112 and 64114).
The proposed maximum absorbed dose of 5.5 kGy for fresh and frozen molluscan shellfish in the subject petition is somewhat higher than the currently permitted maximum dose for the irradiation of non-frozen meat. However, FDA previously evaluated the long-term toxicological studies of flesh foods fed at a range that includes absorbed doses that are either similar to or considerably higher than the absorbed dose requested in this petition. In addition, the absorbed dose exceeded 50 kGy in many studies with no adverse effects reported. Therefore, these data demonstrate that molluscan shellfish irradiated at levels up to the dose proposed in this petition will not present a toxicological hazard (Ref. 8).
In summary, FDA has reviewed a large body of data relevant to the assessment of potential toxicity of irradiated foods. While all of the studies are not of equal quality or rigor, the agency concludes that the quantity and breadth of testing and the number and significance of endpoints assessed would have identified any real or meaningful risk. The overwhelming majority of studies showed no evidence of toxicity. On those few occasions when adverse effects have been reported, FDA finds that those effects have not been consistently produced in related studies conducted at a higher dose or longer duration, as would be expected if the effects were attributable to irradiation (62 FR 64107 at 64112 and 64114). Therefore, based on the totality of evidence, FDA concludes that irradiation of fresh and frozen molluscan shellfish under the conditions proposed in this petition does not present a toxicological hazard.
In general, the subject petition relies on published or other publicly available information or material from previous food additive petitions to address microbiological issues. The petitioner has documented that
Control of contaminating
Current Hazard Assessment and Critical Control Point plans in effect for molluscan shellfish require storage under proper conditions, including maintenance at controlled temperatures. Therefore, irradiation can serve as an effective method for the primary intended use of eliminating populations of
The subject petition includes data and information that support the effectiveness of the proposed irradiation of fresh and frozen molluscan shellfish at a maximum absorbed dose of 5.5 kGy to control
Based on the available data and information, FDA concludes that irradiation of fresh or frozen molluscan shellfish conducted in accordance with current good manufacturing practices will reduce or eliminate bacterial populations with no increased microbial risk from pathogens that may survive the irradiation process.
Lipids are a component of molluscan shellfish contributing approximately 20 to 30 percent to the caloric value of molluscan shellfish. PUFAs are a significant source of omega-3 and omega-6 fatty acids and are therefore nutritionally important components of the fat of molluscan shellfish. As noted in section II.A of this document, PUFA levels were not reduced significantly by ionizing radiation. Additionally, the amount of omega-3 and omega-6 PUFAs can vary widely within a single species and between species of molluscan shellfish. The omega-3 fatty acid content among most species varies within a factor of 2, and the total PUFA content can vary by more than a factor of 10 (omega-3 and omega-6 PUFAs) within an individual species. Furthermore, molluscan shellfish are only one of several fish sources of long chain PUFAs. Because of the variety of seafood sources of long chain PUFAs, the variation of fatty acid content in molluscan shellfish, and the observed insensitivity of PUFAs to irradiation, FDA concludes that irradiation of fresh
Molluscan shellfish contain several B-vitamins including thiamine, niacin, vitamin B6, and vitamin B12.
Irradiation of any food, regardless of the dose, has no effect on the levels of minerals that are present in trace amounts (Ref. 5). Levels of certain vitamins, on the other hand, may be reduced as a result of irradiation. The extent to which this reduction occurs depends on the specific vitamin, the type of food, and the conditions of irradiation. Not all vitamin loss is nutritionally significant, however, and the extent to which a reduction in a specific vitamin level is significant depends on the relative contribution of the food in question to the total dietary intake of the vitamin. While thiamine is among the most radiation sensitive, the more nutritionally significant vitamin in fish and shellfish, vitamin B12, is extremely resistant to radiation.
Based on the available data and information, FDA concludes that irradiation of fresh or frozen molluscan shellfish under the conditions set forth in the regulation in this document will have no adverse impact on the nutritional adequacy of the diet.
FDA has received numerous letters, primarily form letters, from individuals that state their opinions regarding the potential dangers and unacceptability of irradiating food. None of these letters contain any substantive information that can be used in a safety evaluation of irradiated molluscan shellfish.
Additionally, FDA received several comments from Public Citizen (PC) and the Center for Food Safety (CFS) requesting the denial of this and other food irradiation petitions. The comments were largely of a general nature and not necessarily specific to the petitioned requests. Some of the comments specifically questioned a report of a Joint FAO/IAEA/WHO Study Group on the wholesomeness of foods irradiated with doses above 10 kGy. Because the comments were addressed to the Docket for this rulemaking, the comments and FDA's response are discussed as follows:
(1) One comment states that the petition should be denied because there are four positive studies mentioned but mischaracterized in the 1999 FAO/IAEA/WHO report on high-dose irradiation. The comment states:
The 1999 FAO/IAEA/WHO report is the most detailed recent review of food irradiation safety. CFS [Center for Food Safety] anticipates that FDA will seek to rely on it. It is critical that FDA understand the defects in that report before making a determination on the above-referenced additive petition...the four studies were incorrectly classified as “negative for high-dose irradiation effect, possible effect of nutrition or diet.”* * *
The 1999 FAO/IAEA/WHO report acknowledged the Anderson
In the study performed by Anderson
(2) The comment states that “[a] thorough discussion of the Bugyaki
The 1999 FAO/IAEA/WHO report admitted that Bugyaki
In Bugyaki
The authors state that both the treated and untreated animals developed tumors. However, the tumors found in the treated animals were different than the tumors found in the untreated animals. The authors note that the treated animals had a slight increase in anatomic-pathological lesions; however, they go on to state that there was no well defined damage. Additionally, they state that there were alterations in the meiotic chromosomes of the treated animals. The authors conclude that animals consuming a large part of their diet irradiated at doses as high as 50 kGy may deserve special attention.
The comment provides no information to demonstrate why the Bugyaki
(3) The comment states:
The 1999 FAO/IAEA/WHO report states the study performed by Moutschen-Dahmen
The agency has previously addressed the study by Moutschen-Dahmen
There was no increase in post-implantation losses. Post-implantation losses, determined by counting dead embryos, are believed to be the most reliable and sensitive indicator of dominant lethality. The authors found only pre-implantation losses, which are much less sensitive than post-implantation losses and merely a measure of total implants dead or alive subtracted from the total number. In addition to the possibility that results of the study could be spurious, any number of factors other than dominant lethality may cause pre-implantation losses, such as a decrease in the number of eggs ovulated.
If these effects were real, one would expect to see some effect on post implantation losses at a lower dose because post-implantation losses are a much more sensitive indicator than pre-implantation losses, as mentioned previously.
The agency concluded:
Although the findings reported may be statistically significant, the authors were uncertain as to what to attribute these results. They concluded that the most probable mechanism by which these effects could be produced would be via chromosomal aberration. The studies necessary to establish an association between these effects and chromosomal aberrations were not conducted. Additional treatment levels below that conducted as mentioned previously to detect post-implantation losses or examinations of the 24 to 48 hour fertilized eggs could have proved better evidence of causality, but these studies were not conducted. Thus, although pre-implantation losses were observed, FDA concludes that there is no biological significance to this observation because it was not reproducible.
The comment provides no information to demonstrate why the Moutschen-Dahmen
(4) With regard to another study (Ref. 32), the comment states that:
The 1999 FAO/IAEA/WHO report admits the study showed “
In the study performed by Johnston-Arthur
The comment provides no information to demonstrate why the Johnston-Arthur
Finally, the agency notes that the subject of this regulation is the petition (FAP 9M4682) regarding shellfish and not the 1999 FAO/IAEA/WHO report on high-dose irradiation. In its review of the published literature on the safety of irradiated foods, the agency finds that properly conducted animal feeding studies showed no evidence of toxicity attributable to irradiated food. On the few occasions when studies reported adverse effects, the effects were not consistently reproduced in related studies conducted with similar foods irradiated to doses equal to or higher than those for which the adverse effects were reported, as would be expected if the reported effect were a toxic effect caused by a radiolysis product (62 FR 64107 at 64112 and 64114).
One comment submitted a paper (Kevesan and Swaminathan, 1971) that reviewed studies performed in the 1950s and 1960s on irradiated substrates and irradiated foods (Ref. 33). The comment states that numerous studies from the 1950s and 1960s found a variety of toxic effects in animal feeding and in vitro studies, which on the whole cast doubt on the safety of the technology. The comment asks FDA to “take a closer look at the host of past positive studies cited therein.”
The comment further states:
[A]ttempts to discount all of the past positive findings as aberrations, products of chance, or artifacts of diet will no longer suffice. These studies need further FDA review particularly in view of the 2003 Codex Alimentarius standard revision that allowed for higher absorbed doses of radiation than previously permitted.
The agency notes that the subject of FAP 9M4682 is the irradiation of molluscan shellfish to a maximum absorbed does of 5.5 kGy, not the recently revised Codex standard. Furthermore, the authors of the paper referenced by the comment do not come to the conclusion that the comment implies. Rather, the study's authors
FDA agrees with the conclusions of the review article in the context of studies performed prior to 1970. However, many properly conducted studies have been performed after this review was written. As previously noted in this document, the agency finds that properly conducted animal feeding studies showed no evidence of toxicity attributable to irradiated food. On the few occasions when studies reported adverse effects, the effects were not consistently reproduced in related studies conducted with similar foods irradiated to doses equal to or higher than those for which the adverse effects were reported, as would be expected if the reported effect were a toxic effect caused by a radiolysis product (62 FR 64107 at 64112 and 64114). The comment provides no additional information that would cause the agency to change its conclusion on the safety of irradiated food.
One comment submitted a paper (Verschuuren, Esch, and Kooy, 1971) describing the effects of feeding rats irradiated strawberry-powder and irradiated strawberry-juice (Ref 34). The comment states that rats fed “irradiated strawberry powder supplement showed a statistically significant growth deficit compared to the control animals fed the same diet, including the powder supplement, but which was unirradiated.” The comment goes on to state:
FDA's internal reviewers in 1981 and 1982 (reviews are attached to study) twice classified the Verschurren (
The comment misrepresents the conclusion of one of the reviewers who did the initial review of the study. Initially, the study was accepted by two reviewers. However, upon further review by one of the initial reviewers and a third reviewer, this paper was rejected in the secondary review because of inadequate diet and restricted food intake. The comment provides no information that would alter the agency's conclusion that some of the diets were incomplete and restricted. Moreover, the comment provides no information that explains why the consumption of irradiated strawberry-powder is relevant to the consumption of irradiated molluscan shellfish with a maximum absorbed dose of 5.5 kGy.
One comment states that a study conducted at Columbia University in 1954 “supports other studies that yielded adverse health effects, which our organizations have previously submitted to this docket.”
The comment submitted part of a report, “Termination Report—Part 1, Food Irradiation and Associated Studies, September 15, 1954,” which was conducted at Columbia University for the U.S. Atomic Energy Commission. The report compares the fertility of “Professor Sherman's high generation rats” that were fed either “Sherman diet 16” or a “modified Sherman diet”
FDA reviewers have previously reviewed a subsequent publication of a report of this study (Ref. 35). At the time of the study, it was not well recognized that irradiation of fat in the presence of air can stimulate oxidation leading to rancidity and high levels of peroxides. Such rancidity can lead to nutritional deficiencies due to the animals reducing their food consumption and destruction of vitamins. FDA reviewers concluded that it appears that littermates were mated and that the females were mated almost continually, allowing little time for rest between litters. If there was a nutritional or oil peroxidation and palatability problems with the diet, it would be exacerbated by the continuous breeding of the females. Considering the report's mention of considerable vitamin E destruction, the effects seen appear to be the result of a nutritionally inadequate diet, not toxicity, and would not be relevant to irradiation of molluscan shellfish.
One comment states that the petition should be denied because the number of positive mutagenicity studies (including those discussed previously that were identified by the comment as mischaracterized or ignored) compares favorably with the number of negative studies. The comment states that “[m]ore than one-third of both
The suggestion of the comment that FDA showed a “bias in the official posture” on the safety of the consumption of irradiated food is not supported by any substantive information.
The Bureau of Foods Irradiated Foods Committee (BFIFC) recommended that foods irradiated at a dose above 1 kGy be evaluated using a battery of mutagenicity tests to assess whether long-term feeding studies in animals were necessary (Ref. 36). Mutagenicity studies are primarily used to screen for potential mutagenic effects. Animal feeding studies are more reliable for determining the true mutagenic potential of a compound that is consumed in food (Ref 37). Moreover, one cannot draw valid conclusions from data simply by summing positive and negative results without fully evaluating the individual studies and assessing what conclusions such studies support and considering the totality of evidence. If the occasional report of a mutagenic effect were valid and significant to health, one should have seen consistent adverse toxicological effects in the many long term and reproduction studies with animals. This has not been the case.
The comment states that the petition should be denied because “[a] majority of Parliamentary Members voted for a provision that the EU's list of foods authorised (
The agency notes that the subject of this regulation is the petition (FAP 9M4682) to permit irradiating shellfish at a dose up to 5.5 kGy, not whether the maximum dose in the Codex General Standard for Irradiated Foods should be
One comment states that the petition should be denied because of a report published by the Organisation for Economic Co-Operation and Development (OECD) which states:
Hitherto available data indicate, however, that increased rates of mutation and chromosomal aberration will probably be induced in certain cases. Although experiments indicate that the genetical (
The comment goes on to state that “[r]ather than being refuted by subsequent evidence, the OECD's statement regarding likely induction of mutations and chromosomal aberration has been confirmed in many studies, cited in this and our earlier comments.”
The 1965 OECD report, entitled “Steering Committee for Nuclear Energy Study Group on Food Irradiation,” reflects scientific understanding at the time it was written (Ref. 38). The document is a compendium of published and unpublished (at the time) reports on the effect of irradiated substances on a variety of organisms. The report concluded that “it is impossible to arrive at any definite conclusion as to the presence or absence of genetic effects if irradiated food were used for human consumption or for animal feeding.” Furthermore, the report states that more rigorous studies should be performed and when contradictory results are found, the reasons should be determined. Since the report was compiled in 1965 numerous studies have been performed on the effects of consuming irradiated foods in multiple animal species and in humans. Starting in the 1980's, FDA has reviewed these and other studies, and while many of these studies cannot individually establish safety, they still provided important information that, when evaluated collectively, supports a conclusion that there is no reason to believe that irradiation of flesh foods presents a toxicological hazard. The comment provides no evidence to refute the agency's conclusion.
One comment states that “certain chemical by-products formed in food that has been irradiated, known as cyclobutanones, could be toxic enough to cause significant DNA damage, potentially leading to carcinogenic and mutagenic effects.” In addition, the comment states that “[t]wo major international food safety groups — CCFAC (Codex Committee on Food Additives and Contaminants), and SCF (The Scientific Committee on Food of the European Commission) — deemed the indications of toxicity strong enough to necessitate considerable additional study.”
2-ACBs have been reported as radiolysis products of fats (Refs. 39a and 39b). Studies performed by researchers have reported that certain alkylcyclobutanones can cause single strand DNA breaks detectable by the COMET
Also, contrary to what is implied by the comment, the Scientific Committee on Foods of the European Commission concluded, in July 2002, “[a]s the adverse effects noted refer almost entirely to
Moreover, researchers have recently demonstrated that 2-DCB does not induce mutations in the
One comment states that 2-DCB is a unique radiolysis byproduct of palmitic acid, and “[b]ecause palmitic acid appears in molluscan shellfish in varying quantities and high percentages, the FDA should refrain from considering the petition until potential cytotoxicity and genotoxicity of 2-DCB in each type of shellfish covered by the petition is thoroughly studied.”
FDA agrees that 2-DCB is a radiation by-product of triglycerides with esterified palmitic acid and that molluscan shellfish contain significant amounts of such triglycerides. FDA previously reviewed studies in which animals were fed diets containing irradiated meat, poultry, and fish which contain triglycerides with palmitic acid (62 FR 64107 at 64113), and concluded that no adverse effects were associated with the consumption of these irradiated flesh foods. The comment provides no evidence to refute the agency's conclusion regarding the irradiation of molluscan shellfish to a maximum absorbed dose that will not exceed 5.5 kGy.
One comment states that two studies by Delincée
In the first study cited, Delincée
In the second paper (Ref. 40), the authors administered 2-DCB to rats by pharyngeal tube at doses of 1.12 and 14.9 mg/kg body weight. They reported the higher concentration as equivalent to the amount found in 800 broiler chickens treated at 60 kGy (equivalent to approximately 40,000 wild eastern oysters irradiated at the maximum dose requested by the petition). They harvested colon cells from the rats 16 hours later and performed the COMET assay. Although the authors observed single strand DNA breaks at the higher concentration, no effect was seen at the lower concentration.
In its review of studies in which animals were fed diets containing beef irradiated at 56 kGy, pork at 56 kGy, poultry at 6 kGy, fish at 6 kGy, horse meat at 6.5 kGy, fish at 56 kGy, and others (62 FR 64107 at 64113), the agency found no evidence of toxicity attributable to the consumption of various flesh foods, which contain esterified palmitic acid and other fatty acids, and which should also contain 2-DCB and other alkylcyclobutanones.
Furthermore, the comment misrepresents the paper's conclusions. The comment states that the “failure to pass the 100-fold safety factor” means that 2-DCB fails the standard set under § 170.22, and therefore, the petition should be denied. Contrary to what the comment implies, the authors did not conclude that the “test failed the 100-fold safety factor.” Rather, the dose applied to the animals was set on the basis of calculations such that the lower dose would be equivalent to 100 times the amount of all 2-ACBs consumed if all fat in the diet were irradiated at a pasteurizing dose (3 kGy); and the larger dose was set to be 100 times the total alkylcyclobutanones from radiation sterilization (60 kGy) of all dietary fat. The authors noted that there was no effect at the lower dose and that the higher dose was equivalent to the amount from 800 radiation-sterilized broiler chickens and questioned this approach to the use of safety factors.
FDA notes that § 170.22 provides that “[e]xcept where evidence is submitted which justifies use of a different safety factor, a safety factor in applying animal experimentation data to man of 100 to 1 will be used.” FDA and food safety scientists worldwide have long agreed that the evaluation of the safety of irradiated foods requires consideration of the whole food, not the testing of each component (although identification of major radiolysis products will aid in the interpretation of data) (Ref. 5). Applying a 100-fold safety factor to a processed food is neither feasible nor rational. Similarly, testing each component of a food separately is impossible. There are too many components to test them all, and many food components that occur naturally will cause adverse effects if tested in isolation at an exaggerated dose. For example, naturally occurring food components, such as solanine from potatoes, tomatine from tomatoes or various vitamins and minerals, would cause toxic effects if consumed in amounts 100 times greater than normal. Thus, requiring a 100-fold safety factor for each component of a food (that occurs naturally or is produced through processing) is not appropriate.
An affidavit written by Dr. William Au that was submitted by CFS and PC, states that radiolysis compounds (e.g., 2-DCB) are formed during the irradiation of food and that “[t]heir potential health hazard has not been adequately evaluated. Without conclusive evidence of the potential health consequences of these products, the safety of irradiated food cannot be assured.”
The affidavit provides no basis to conclude that the multitude of studies on irradiated foods (which contain the radiolysis products referred to) are inappropriate for the evaluation of the safety of those foods. In FDA's review of the consumption of irradiated flesh foods for a previous petition on irradiated meat, FDA concluded that “the results of the available toxicological studies of irradiated flesh foods also demonstrates that a toxicological hazard is highly unlikely because no toxicologically significant adverse effects attributable to consumption of irradiated flesh foods were observed in any of these studies” (62 FR 64107 at 64114). As those foods would have contained the radiolysis products, including 2-DCB, produced by the irradiation of fats, Dr. Au is incorrect in stating that its potential hazard to health has not been evaluated.
One comment references a paper published in 2004 that summarizes the European testing of 2-ACBs. The comment quotes language from the paper stating that “the in vitro and in vivo experiments with laboratory animals demonstrated that 2-ACBs have potential toxicity,” and the comment states that “the paper concludes that as far as the possibility of health hazards from consuming irradiated food, ‘further research is highly required’” (Ref. 48). The comment concludes by asserting that “unfortunately, no comprehensive research on the toxicity of 2-ACBs has been undertaken to date, leaving this uncertainty as a huge obstacle to FDA's making a reliable decision on the five pending petitions.”
FDA disagrees that the conclusions of this paper would prevent completing
Although our results point towards toxic, genotoxic and even tumor promoting activity of certain highly pure 2-ACBs, it should be emphasized that these experimental data are
(Emphasis added) As previously noted in this document, FDA has reviewed studies in which animals were fed diets containing irradiated meat, poultry, and fish which contain triglycerides (62 FR 64107 at 64113). The agency concluded that no adverse effects were associated with the consumption of these irradiated flesh foods. The comment provides no additional information that would alter the agency's conclusion that the consumption of irradiated fat-containing foods does not present any health hazard.
One comment submitted a paper entitled
Raul
Many different chemicals, some of which occur naturally in the human body, are known to promote carcinogenesis (Ref. 51). Additionally, Dr. Rao states that colon cancer is largely influenced by dietary lipids such as animal fat. Moreover, FDA notes that Dr. Rao states that the precursor lipids (which will be consumed in millions of times greater amount than the 2-ACBs, 2-tDCB and 2-tDeCB) are influential in the promotion of colon cancer.
The data showed no significant difference in tumor incidence between treatment groups. Raul
Given the limitations of the animal model and study design, ambiguous data, and the absence of close relationship between the chemical exposure used in the study and the expected human exposure, the agency finds that the comment provides no substantial or reliable scientific information to show that there is reason to believe that the consumption of 2-ACBs will promote colon cancer. Moreover, the agency notes that long term feeding studies performed using irradiated foods that contain 2-ACBs did not show any promotion of colon cancer. The results of these latter long term feeding studies are more relevant than results from the Raul paper because the 2-ACBs were fed in the diet as in human exposure and the levels of exposure would still have been increased over usual dietary levels.
One comment states that the petition should be denied because six positive studies conducted by the Indian National Institute of Nutrition (NIN) were ignored in the 1999 FAO/IAEA/WHO report. The comment states that FDA should give full consideration to the NIN studies, most notably the children's study using freshly irradiated food. The comment also states that the validity of these studies is supported by expert commentary and two published defenses by the NIN researchers.
A commentary by Dr. William Au submitted with the comment states “[s]ome reports in the peer-reviewed literature on mutagenic activities of irradiated foods were not considered in the 1999 FAO/IAEA/WHO report (Bhaskaram and Sadasivan, 1975; Vijayalaxmi, 1975, 1976, 1978; Vijayalaxmi and Sadasivan, 1975; Vijayalaxmi and Rao, 1976).” “Although the observations from these studies are not confirmed by some publications in the literature, the positive findings have support from other publications (Bugyaki
The agency notes that the subject of this regulation is the petition (FAP 9M4682) submitted by NFI regarding shellfish, not the 1999 FAO/IAEA/WHO report on high-dose irradiation. The studies cited by the comment are not related to irradiated shellfish or other irradiated flesh foods.
The comment implies that FDA has not considered the cited studies despite the fact that FDA previously discussed the reason why some of the study reports could not be used to support a decision on irradiated foods (51 FR 13376 at 13385 and 13387). In 1986 FDA addressed the studies performed at the NIN (Ref. 54) and stated:
A committee of Indian scientists critically examined the techniques, the appropriateness of experimental design, the data collected, and the interpretations of NIN scientists who claimed that ingestion of irradiated wheat caused polyploidy in rats, mice, and malnourished children. After careful deliberation, this committee concluded that the bulk of these data are not only mutually contradictory, but are also at variance with well-established facts of biology. The committee was satisfied that once these data were corrected for biases that had given rise to these contradictions, no evidence of increased polyploidy was associated with ingestion of irradiated wheat.
The agency agreed with the conclusions of the committee of scientists that the studies
Moreover, the agency notes that adverse effects which should have been seen if the conclusions drawn by the NIN researchers were valid were not observed in studies performed using similar foods irradiated at higher doses and consumed for longer periods of time. Finally, we note that the paper by Maier cited in the comment by Dr. Au concluded that “* * * the consumption of irradiated wheat does not, therefore, pose any health risk to humans.”
One comment states that the petition should be denied because it does not contain specific data about the potential toxicity of irradiated molluscan shellfish. The comment concludes that “FDA cannot credibly assess the safety and wholesomeness of foods covered by the petition if no toxicology data were included in the petition.”
The petitioner (FAP 9M4682) did not submit copies of toxicological data specific to irradiated shellfish. However, as noted earlier, FDA has reviewed a large body of data relevant to the assessment of the potential toxicity of irradiated flesh foods. The agency disagrees with the statement that “FDA cannot credibly assess the safety and wholesomeness of foods covered by the petition if no toxicological data were included in the petition.” There was no reason to submit additional copies of studies that have previously been reviewed by FDA. The comment provides no basis to challenge FDA's reliance on these studies to assess the safety of irradiated molluscan shellfish.
One comment states that the petition should be denied because “* * * in the course of legalizing the irradiation of numerous classes of food over a 14-year span, the FDA relied on dozens of studies declared ‘deficient’ by agency toxicologists.”
FDA notes that the animal feeding studies reviewed in support of this petition (FAP 9M4682) were not considered deficient by agency scientists. Rather, they were considered acceptable or accepted with reservation by the agency scientists because even though all studies may not have met modern standards in all respects, they provided important information. Those studies categorized by FDA scientists as deficient were not relied on in the review of this petition. Although some of the studies accepted with reservation might not have been reported in full, used fewer animals, or examined fewer tissues than is common today, they still provide important information that, when evaluated collectively, supports the conclusion that consumption of molluscan shellfish irradiated under the conditions proposed in this petition is safe (Ref. 55).
One comment submitted by CFS and PC states that the petition should be denied because Delincée
The comment quotes selectively from the conclusions of Delincée regarding ACBs and omits other portions more relevant to this petition. For example, the sentence immediately prior to the sentence quoted states: “The requisite concentrations are very much higher than those that can be reached through the consumption of irradiated foods that contain fat.” Additionally, the authors note in the referenced article that “[i]t should be mentioned once again that in many animal feeding experiments with irradiated foods in which it is known that cyclobutanones was also in the feed, no evidence has been found to indicate an injury from irradiated foods that have been consumed.” In a comment to the docket in response to the statement made by CFS and PC, Dr. Delincée states that “[u]nfortunately, the authors Worth and Jenkins did not take my precautions into account but made a story about the ‘dangerous’ cyclobutanones. In my opinion they greatly exaggerate the risks of 2-alkylcyclobutanones (2-ACB), which we still do not know very much about” (Ref. 56).
One comment requests that the agency remove the food additive petition from the expedited review process.
FDA has established a process to give priority to petitions for technologies intended to reduce pathogen levels in foods (64 FR 517, January 5, 1999). FDA notes that petitions under expedited review are subject to all controls and requirements regarding safety data applicable to comparable petitions in the standard review process. Accordingly, valid scientific evidence, as defined by § 171.1 (21 CFR 171.1), is required to support the approval of an expedited petition. Likewise, the standards for safety and for data presentation are identical to the standard review process. The comment provides no information to support removing the petition from the expedited review process.
One comment requests that FDA review all of part 179 to determine if the regulations adequately protect the public health based on the best available scientific information.
This comment is outside the scope of this petition.
One comment states that the petition should be denied because “FDA did not review studies that met the protocols established by the National Academy of Sciences/National Research Council (NAS/NRC) as required by 21 CFR 170.20.”
The comment provides no information to demonstrate that the studies reviewed by the agency in support of this petition (FAP 9M4682) fail to meet the standards set forth under § 170.20 (21 CFR 170.20). Section 170.20 states:
The Commissioner will be guided by the principles and procedures for establishing the safety of food additives stated in current publications of the National Academy of Sciences-National Research Council. A petition will not be denied, however, by reason of the petitioner's having followed procedures other than those outlined in the publications of the National Academy of Sciences-National Research Council if, from available evidence, the Commissioner finds that the procedures used give results as reliable as, or more reliable than, those reasonably to be expected from the use of the outlined procedures.
FDA has consistently taken the position that many scientifically valid types of data may properly support a finding that the proposed use of a food additive will cause “no harm” to consumers. For example, § 170.20 which sets forth the general scientific criteria that FDA uses in evaluating a food additive petition, cites the “principles and procedures * * * stated in ‘current’ publications of the National Academy of Sciences, National Research Council” as a guide that the agency uses in its safety evaluation of food additives. NAS has written testing standards for both public and agency use, but these testing requirements have been stated in relatively general terms. In practice, FDA has applied toxicological criteria and exposure information that were current for the time in assessing the safety each food additive. The agency has continuously adjusted food additive testing recommendation as necessary to reflect both the steady progress of science and the most current information about population exposure to additives (Ref. 57).
FDA concludes that the data considered for this regulation, when
One comment states that the petition should be denied because the battery of experiments prescribed by the BFIFC to assess the potential toxicity and mutagenicity of irradiated food was based on the assumption that only 10 percent of the food supply would likely be irradiated and fell “[f]ar short of those battery prescribed by the FDA's Red Book, but the FDA [did] not comply with the
The agency notes that the subject of this regulation is the petition (FAP 9M4682) on shellfish, not the BFIFC report (Ref. 36) nor the FDA Red Book (Ref. 37).
The BFIFC report is an internal document prepared by FDA scientists that provides recommendations for evaluating the safety of irradiated foods based on the known effects of radiation on food and on the capabilities of toxicological testing. While the report and the commentary on it have aided FDA's thinking regarding the testing of irradiated foods, the report established no definitive requirements. BFIFC recognized that it may not be necessary to perform reproduction and chronic toxicity studies in cases where there was evidence that irradiated foods provided no mutagenic or other toxic effects that could be seen in shorter studies. Therefore, BFIFC recommended that in the absence of chronic and reproductive feeding studies, foods irradiated at a dose above 1 kGy be evaluated using a battery of mutagenicity tests, as well as 90-day feeding studies in two species (one rodent and one non-rodent). BFIFC also recommended that chronic studies would only be indicated when two of the four mutagenicity tests showed mutagenic effects, and that the reproductive toxicity tests would only be indicated when the 90-day studies showed a potential for effects on the reproductive system. Furthermore, BFIFC also recommended that foods should be considered generically as a class, based on their composition i.e., proteins, lipids, and carbohydrates. Consistent with these recommendations, FDA has considered several relevant chronic feeding studies, as well as the macronutrient composition of molluscan shellfish in the safety determination for this regulation. Therefore, there is no need to conduct additional mutagenicity studies to determine whether chronic studies are needed.
Finally, FDA's Red Book represents the agency's current thinking on the information needed for the safety assessment of
One comment states that the petition should be denied because there is evidence that the consumption of
The paper submitted by the comment purports to show a 3.4 percent increase in the amount of
The fat in beef has a natural background of
One comment states that the petition should be denied because the consumption of irradiated food may contribute to an increase in the number of still-born children. The comment provides three studies to substantiate this comment: (1) An unpublished report states that the consumption of irradiated potatoes increased the hemoglobin concentrations in healthy human volunteers; (2) a published study that shows that elevated hemoglobin levels were found in pigs consuming irradiated potatoes; and (3) a published study appearing to show that “high hemoglobin concentration at first measurement during antenatal care appears to be associated with increased risk of stillbirth, especially preterm and small-for-gestational age antepartum stillbirths.”
The comment suggests that the consumption of a high carbohydrate diet may increase hemoglobin levels and this may lead to an increase in the frequency of still born children among pregnant women who consume irradiated carbohydrates. FDA notes that consumption of shellfish would not contribute significant carbohydrates to the diet because the maximum proximate carbohydrate composition of shellfish is 10 percent or less.
The first study (1967) compares the hemoglobin and hematocrit levels of 7 human volunteers who, for 14 weeks, consumed potatoes that had been irradiated at 14 kGy (Ref. 61). The study does not include a baseline prior to feeding; it provides a single measurement. The hemoglobin values reported show a slight increase during the period of consumption of irradiated potato, but they are still within the normal range of hemoglobin values (Ref. 62). Additionally, there is no concurrent control group to demonstrate that the irradiated potatoes were the cause of the increase in hemoglobin values.
The second study (1966) submitted by the comment compares piglets fed both irradiated and non-irradiated potatoes (Ref. 63). The authors conclude that the pigs fed irradiated potatoes did not differ significantly from the control animals in the parameters measured,
The third study entitled “Maternal Hemoglobin Concentration During Pregnancy and Risk of Stillbirth” (2000) compares the hemoglobin concentration during antenatal care, the change in hemoglobin concentration during pregnancy and the risk of still birth (Ref. 64). The study compares the hemoglobin concentrations at first measurement of 702 primiparous (bearing first child) women with stillbirths occurring at 28 weeks or later to 702 primiparous women with live births. The authors concluded that high hemoglobin concentrations at first measurement appeared to be associated with an increased risk of stillbirth, especially preterm and small-for-gestational-age antepartum stillbirths. The authors note that the study was limited to primiparous women with singleton (first) pregnancies and that the conclusions can only be interpreted within that small sub-population. FDA also notes that the study did not investigate other potential confounding variables such as nutrition or physical activity.
FDA acknowledges that hemoglobin concentrations were not reported in studies such as the Bugyaki
In an affidavit written by Dr. William Au that was submitted by CFS and PC, he states that “[i]onizing radiation is a teratogen, mutagen, and carcinogen whereas some other procedures for food decontamination/sterilization such as heat and steam are not. Whenever other processing methods or combination of methods are equally effective in reducing the risk of foodborne disease are available, the use of radiation procedure should be avoided.”
While methods other than treatment with ionizing radiation are available to eliminate or reduce microbial contamination of food, the existence of such methods is not a reason to prohibit safe alternatives. Additionally, the act does not authorize FDA to arbitrarily limit other safe alternatives. The fact that radiation can be teratogenic, carcinogenic, or mutagenic when applied directly to living organisms is not relevant to the safety of irradiated shellfish. Most food processing techniques (such as grinding, slicing, boiling, roasting) would be harmful to living mammals but that is unrelated to the safety of the food. Irradiating the shellfish will not expose consumers to additional amounts of radiation.
One comment states that the petition should be denied because the BFIFC “* * *cautioned that even if 10 percent of the food supply were irradiated: ‘When irradiation results in the significant loss of micronutrients, enrichment may be considered appropriate.’” The comment goes on to state that to date, FDA has authorized the irradiation of several classes of food that comprise more than half of the U.S. food supply. “If the FDA approves the pending `ready-to-eat' petition [FAP 9M4697], an estimated 80-90 percent of the U.S. food supply would be eligible for irradiation.” The comment further states that “no analysis has been done of the nutritional deficiencies that would be created among the populace should 80-90 percent of the food supply be irradiated.”
The comment provides no information to conclude that irradiating 80-90 percent of the diet is probable or feasible. Additionally, molluscan shellfish are a small part of the food supply. The comment provides no basis for the statement that consumers will suffer nutritional deficiencies from being exposed to irradiated food.
FDA agrees that treatment of food with ionizing radiation, as with heat processing, decreases the levels of some nutrients and irradiation must be evaluated by considering the nutritional consequences on the diet as a whole. The agency has specifically addressed the impact of irradiation on vitamins and other nutritional components in the
Another comment states that a statement by D. R. Murray in
The comment provided the bulk of a chapter from this book and states that FDA must address the negative impact on fatty acids, vitamins, amino acids, carbohydrates and other essential components on food as a consequence of irradiation and in combination with cooking. The comment requests that the agency respond to the following four questions regarding the nutritional impact of irradiated foods.
• “What would be the impacts of irradiation as proposed on each important vitamin and other nutritional component in each different food type that is included?”
• “What would be the projected national rates of consumption of each different food type included in the petition after foreseeable market penetration of the product, e.g., after 5-10 years of marketing?”
• “How would this projected future consumption vary across age, ethnic, gender, economic status, education status, and other variables in the American population?”
• “To what extent would the various population groups likely be affected by the nutritional/vitamin impacts identified under question 1, above?”
In the review of this petition (FAP 9M4682), FDA considered whether the nutritional quality of irradiated molluscan shellfish would differ in any meaningful way from that of non-irradiated molluscan shellfish and concludes that consumption of irradiated molluscan shellfish will not result in nutritional deficiencies. FDA notes that foods are commonly processed more than once, such as by heating in the factory followed by
Based on the data and studies submitted in the petition and other information in the agency's files, FDA concludes that the proposed use of irradiation to treat fresh and frozen molluscan shellfish with absorbed doses that will not to exceed 5.5 kGy is safe, and therefore, the regulations in § 179.26 should be amended as set forth in this document.
In accordance with § 171.1(h), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the Information contact person (see
This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
The agency has carefully considered the potential environmental effects of this action. The agency has determined under 21 CFR 25.32(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see
The following sources are referred to in this document. References marked with an asterisk (*) have been placed on display at the Division of Dockets Management (see
1. WHO, “Wholesomeness of Irradiated Food: Report of a Joint FAO/IAEA/WHO Expert Committee,” World Health Organization Technical Report Series, No. 659, World Health Organization, Geneva, 1981.
2. Codex 2003, “Codex General Standard for Irradiated Foods (CODEX STAN 106-1983, Rev.-2003)” and “Recommended Code of Practice for the Operation of Radiation Facilities Used for the Treatment of Foods (CAC/RCP 19-1979, Rev.-2003).”
3.
*4. Memorandum for FAP 9M4682 from D. Folmer, FDA, to L. Highbarger, FDA, August 2, 2002.
5. Diehl, J.F.,
6. Seibersdorf Project Report, International Programme on Irradiation of Fruit and Fruit Juices, Chemistry and Isotopes Department, National Centre for Nuclear Energy, Madrid, Spain, vol. 8, 1966.
*7. Memorandum for FAP 9M4682 from K. Morehouse, FDA, to L. Highbarger, FDA, July 15, 2005.
*8. Memorandum for FAP 9M4695 from I. Chen, FDA, to L. Highbarger, FDA, April 7, 2003.
*9. Uderdal, B., J. Nordal, G. Lunde, and B. Eggum, “The Effect of Ionizing Radiation on the Nutritional Value of Fish (Cod) Protein,”
10. Von Sonntag, C., “Free-radical Reactions of Carbohydrates as Studies by Radiation Techniques,
11. WHO, “High-dose Irradiation: Wholesomeness of Food Irradiated With Doses Above 10 kGy,” World Health Organization Technical Report Series, No. 659, World Health Organization, Geneva, 1999.
*12. Delincée, H., “Recent Advances in Radiation Chemistry of Lipids,” in
*13. Kavalam, J.P., and W.W. Nawar, “Effects of Ionizing Radiation on Some Vegetable Fats,”
*14. Nawar, W.W., “Thermal Degradation of Lipids. A Review,”
*15. Crone A.V.J., Hamilton, J.T.G., and M.H. Stevenson, “Effect of Storage and Cooking on the Dose Response of 2-Dodecylcylobutanone, a Potential Marker for Irradiated Chicken,
*16. Gadgil, P., Hachmeister, K.A., Smith, J.S., and D.H. Kropf, “2-Alkylcyclobutanones as Irradiation Dose Indicators in Irradiated Ground Beef Patties,”
*17. Adams, S., G. Paul, D. Ehlerman, “Influence of Ionizing Radiation on the Fatty Acid Composition of Herring Fillets,”
*18. Armstrong, S.G., Wylie, S.G., and D.N. Leach, “Effects of Preservation by Gamma-Irradiation on the Nutritional Quality of Australian Fish,”
*19. Sant'Ana, L.S. and J. Mancini-Filho “Influence of the Addition of Antioxidants in Vivo on the Fatty Acid Composition of Fish Fillets”
*20. Status Report on Food Irradiation by Member Countries of the International Consultative Group on Food Irradiation, IAEA Headquarters, Vienna, Austria, October 20-22, 1998.
*21. Morehouse, K.M., Y. Ku, “Gas Chomatographic and Electron Spin Resonance Investigations of Gamma-Irradiated Shrimp,”
22. Morehouse, K.M., “Identification of Irradiated Seafood,” in
*23. Buck, J.D., “Potentially Pathogenic
24. Oliver, J.D. and Kaper, J.B., “Vibrio Species,” In M.P. Doyle, L. Beuchat and T.J. Montville (ed.) Food Microbiology, Fundamentals and Frontiers, 2d Ed., ASM Press, Herndon, VA, 2001.
*25. Memorandum for FAP 9M4682 from R. Merker, FDA, to L. Highbarger, FDA January 2, 2003.
26. Tauxe, R.W.,
27. Diehl, J.F.,
*28. Cotton, P.A., Subar, A.F., Friday, J.E., Cook, A., “Dietary Sources of Nutrients Among US Adults, 1994 to 1996,”
*29. Anderson D, M.J.L. Clapp, M.C.E. Hodge, and T.M. Weight, “Irradiated Laboratory Animal Diets—Dominant Lethal Studies in the Mouse,”
*30. Bugyaki L., A.R. Deschreiaer, and J. Moutschen, “Do Irradiated Foodstuffs Have a Radiomimetic Effect: II. Trials With Mice Fed Wheat Meal Irradiated at 5 MRad,”
*31. Moutschen-Dahmen M., J. Moutschen, and L. Ehrenberg, “Pre-implantation Death of Mouse Eggs Caused by Irradiated Food,”
*32. Johnston-Arthur T, M. Brena-Valle, K. Twanitz, R. Hruby, and G. Stehuk, “Mutagenicity of Irradiated Food in the Host-mediated Assay System,”
*33. Kesavan, P.C. and M.S. Swaminathan, “Cytotoxic and Mutagenic Effects of Irradiated Substances and Food Material,”
*34. Verschuurn, H.G., G.J. Esch, and J.G. Kooy,
*35. Memorandum from Food Additives Evaluation Branch, HFF-156 to C. Takaguchi, Petition Control Branch, December 28, 1982.
*36. Bureau of Foods Irradiated Foods Committee,
37. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, “Red Book II,” U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 1993, revised 2001.
*38. Organisation for Economic Co-Operation and Development, European Nuclear Energy Agency, Steering Committee for Nuclear Energy Study Group on Food Irradiation,
*39a. Miesch, M., B. Ndiye, C. Hasselmann, and E. Marchioni, “2-Alkylcyclobutanones as Markers for Irradiated Food Stuffs - I. Sysnthesis of Saturated and Unsaturated Standards,”
*39b. Horvatovich, P., Miesch, M, Hasselmann, C., and E. Marchioni, “Supercritical Fluid Extractin of Hydrocarbons and 2-alkylcyclobutanones for the Detection of Irradiated Foodstuffs,”
*40. Delincée H, B.L. Pool-Zobel, and G. Rechkemmer “Genotoxicity of 2-dodecyclcyclobutanone,”
*41. Memorandum for FAP 9M4682 from R. Sotomayer, FDA, to L. Highbarger, FDA, April 28, 2003.
*42. Sommers C.H., and R.H. Schiestl, “2-Dodecylcyclobutanone Does Not Induce Mutations in the Salmonella Mutagenicity Test or Intrachromosomal Recombination in Saccharomyces Cerevisiae,
*43. Sommers, H., “2-Dodecylcyclobutanone Does Not Induce Mutations in the
*44. Gadgil, P. and J.S. Smith, “Mutagenicity and Acute Toxicity Evaluation of 2-Dodecylcyclobutanone,”
*45. Delincée H, and BL Pool-Zobel, “Genotoxic Properties of 2-Dodecyclcyclobutanone, a Compound Formed on Irradiation of Food Containing Fat,”
*46. Henderson, L., A. Wolfreys, J. Fedyk, C. Bourner and S. Windebank “The Ability of the Comet Assay to Discriminate Between Genotoxins and Cytotoxins,”
*47. Victoria, A., J. Crone, J.T.G. Hamilton, and M. Hilary Stevenson, “Detection of 2-dodecylcyclobutanone in Radiation Sterilized Chicken Meat Stored for Several Years,”
*48. Marchioni, E., F. Raul, D. Burnouf, M. Miesch, H. Delincée, A. Hartwig, D. Werner, “Toxicological Study on 2-alkylcyclobutanones—Results of a Collaborative Study;”
*49. Raul, F., F. Gosse, H. Delincée, A. Hartwig,, E. Marchioni, M. Miesch, D. Werner, and D. Burnouf, “Food Borne Radiolytic Compounds (2-Alkylcyclobutanones) May Promote Experimental Colon Carcinogenesis,”
*50. Rao, C., “Do Irradiated Foods Cause or Promote Colon Cancer?,” Division of Nutritional Carcinogenesis, Institute for Cancer Prevention, American Health Foundation-Cancer center, Valhalla, NY, Unpublished, 2003. FDA notes that this article has now been published as a commentary in
51. Casserett & Doull's Toxicology, the Basic Science of Poisons, 2001.
*52. Memorandum for FAP 9M4682 from T. Twaroski, FDA, to L. Highbarger, FDA, July 14, 2005.
*53. Mori H., Y. Yamada, T. Kuno, and Y. Hirose, “Aberrant Crypt Foci and β-catenin Accumulated Crypts; Significance and Roles for Colorectal Carcinogenesis,”
*54. Kesavan, P.C. and P.V. Sukhatame. “Summary of the Technical Report on the Data of NIN,” Hyderabad and BARC, Bombay on the Biological Effects of Freshly Irradiated Wheat, Report submitted to the Indian Ministry of Health and Family Planning, 1976.
*55. Memorandum for FAP 4M4428, from D. Hattan, to FAP 4M4428; Further Evaluation of Toxicological Studies, November 20, 1997.
*56. Comment submitted by Henry Delincée to the docket.
57. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, “Red Book I,” U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 1982.
*58. Britto M.S., A.L.C.H. Villavicencio, and J. Mancini-filho, “Effects of Irradiation on
*59. Memorandum for FAP 9M4682 from K. Morehouse, FDA, to L. Highbarger, FDA, July 15, 2005.
*60. E-mail from Paul Kuznesof to L. Highbarger to be added to FAP 9M4682, April, 28, 2003.
*61. Jaarma, M., “Studies of Chemical and Enzymatical Changes in Potato Tubers and Some Highber Plants Caused by Ionizing Radiation, Including Studies on the Wholesomeness of γ-Irradiated Potato Tubers and Effects on Some Carbohydrates
*62. Memorandum 2 for FAP 9M4682 from T. Twaroski, FDA, to L. Highbarger, FDA, July 14, 2005, 2005.
*63. Jaarma, M., G. “Bengtsson On the wholesomeness of γ-irradiated Potatoes II. Feeding Experiments with Pigs”
*64. Stephansson, O., Dickman, P.W., Johansson, A., and S. Cnattingus, “Maternal Hemoglobin Concentration During Pregnancy and Risk of Stillbirth,”
Food additives, Food labeling, Food packaging, Radiation protection, Reporting and record keeping requirements, Signs and symbols.
21 U.S.C. 321, 342, 343, 348, 373, 374.
(b) * * *
Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending its regulation regarding the intrastate and interstate distribution of turtles to reflect a change in responsibility for administering the provisions of the regulations from FDA's Center for Food Safety and Applied Nutrition (CFSAN) to FDA's Center for Veterinary Medicine (CVM). FDA is taking this action to enable the agency to more effectively administer the provisions of this regulation.
This rule is effective August 16, 2005.
Joseph Paige, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9210, e-mail:
FDA is amending its regulations regarding the intrastate and interstate distribution of turtles (§ 1240.62 (21 CFR 1240.62)) to reflect the transfer of regulatory responsibility from CFSAN to CVM. Except as otherwise provided, § 1240.62 requires that viable turtle eggs and live turtles with a carapace length of less than 4 inches not be sold, held for sale, or offered for any other type of commercial or public distribution. FDA is amending this regulation because current expertise for addressing issues regarding this regulation is within CVM. Reassigning regulatory responsibility to CVM more effectively utilizes agency resources in administering the provisions of the regulation.
Publication of this document constitutes final action on this change under the Administrative Procedures Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulation is nonsubstantive. It merely reflects an organizational change.
Communicable diseases, Public health, Travel restrictions, Water supply.
42 U.S.C. 216, 243, 264, 271.
a. In paragraphs (c)(1)(i), (c)(1)(ii), (c)(1)(v), and (c)(2) by removing “Director of the Center for Food Safety and Applied Nutrition” each time it appears, and adding in its place “Director of the Center for Veterinary Medicine”.
b. In paragraph (c)(1)(ii) by removing “5100 Paint Branch Pkwy., College Park, MD 20740”, and adding in its place “7519 Standish Pl., Rockville, MD 20855”.
Environmental Protection Agency (EPA).
Direct final rule.
EPA is approving the State Implementation Plan (SIP) revision submitted by the state of Iowa for the purpose of approving the 2001 and 2004 updates to the Linn County Air Quality Ordinance. These revisions will help to ensure consistency between the applicable local agency rules and Federally-approved rules, and ensure Federal enforceability of the applicable parts of the local agency air programs.
This direct final rule will be effective October 17, 2005, without further notice, unless EPA receives adverse comment by September 15, 2005. If adverse comment is received, EPA will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Regional Material in EDocket (RME) ID Number R07-OAR-2005-IA-0003, by one of the following methods:
1. Federal eRulemaking Portal:
2. Agency Web site:
3. E-mail:
4. Mail: Heather Hamilton, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101.
5. Hand Delivery or Courier: Deliver your comments to Heather Hamilton, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101.
Heather Hamilton at (913) 551-7039, or by e-mail at
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This section provides additional information by addressing the following questions:
What Is a SIP?
What Is the Federal Approval Process for a SIP?
What Does Federal Approval of a State Regulation Mean to Me?
What Is Being Addressed in This Document?
Have the Requirements for Approval of a SIP Revision Been Met?
What Action Is EPA Taking?
Section 110 of the Clean Air Act (CAA) requires states to develop air pollution regulations and control strategies to ensure that state air quality meets the national ambient air quality standards established by EPA. These ambient standards are established under section 109 of the CAA, and they currently address six criteria pollutants. These pollutants are: carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide.
Each state must submit these regulations and control strategies to us for approval and incorporation into the Federally-enforceable SIP.
Each Federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin. These SIPs can be extensive, containing state regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations.
In order for state regulations to be incorporated into the Federally-enforceable SIP, states must formally adopt the regulations and control strategies consistent with state and Federal requirements. This process generally includes a public notice, public hearing, public comment period, and a formal adoption by a state-authorized rulemaking body.
Once a state rule, regulation, or control strategy is adopted, the state submits it to us for inclusion into the SIP. We must provide public notice and seek additional public comment regarding the proposed Federal action on the state submission. If adverse comments are received, they must be addressed prior to any final Federal action by us.
All state regulations and supporting information approved by EPA under section 110 of the CAA are incorporated into the Federally-approved SIP. Records of such SIP actions are maintained in the Code of Federal Regulations (CFR) at title 40, part 52, entitled “Approval and Promulgation of Implementation Plans.” The actual state regulations which are approved are not reproduced in their entirety in the CFR outright but are “incorporated by reference,” which means that we have approved a given state regulation with a specific effective date.
Enforcement of the state regulation before and after it is incorporated into the Federally-approved SIP is primarily a state responsibility. However, after the regulation is Federally approved, we are authorized to take enforcement action against violators. Citizens are also offered legal recourse to address violations as described in section 304 of the CAA.
The Iowa Department of Natural Resources (IDNR) requested EPA approval of the 2001 and 2004 revisions to the Linn County Air Quality Ordinance, Chapter 10, Air Quality, as a revision to the Iowa SIP. The changes were adopted by the Linn County Board of Supervisors on February 9, 2005, and became effective on March 1, 2005.
The following is a description of the revisions to the Linn County Air Quality Ordinance, Chapter 10, Air Quality, which are subject to this approval action:
The following definitions were changed in the Linn County Air Quality Ordinance, Chapter 10.2, “Definitions”: Air Quality Division or Air Pollution Control Agency, Board of Health, Major modification, Potential to emit, and Standard conditions. The definitions of Major modification and Potential to emit are consistent with approved state rules.
The following definitions were deleted from the Linn County Air Quality Ordinance, Chapter 10.2, “Definitions”: Health Department and Open fire.
Changes were made to the wording in 10.5(2)(b), “Public Notice Requirements.” The term “air pollution source” was removed and the term “stationary source” was added. Also, the term “major modification” was removed and the term “significant modification” was added. These changes were made to be consistent with state and Federal rules.
The section entitled “Duration of Permit” located at 10.5(2)(c) changed the adjustment period after the project completion date from sixty (60) days to ninety (90) days. The change in the adjustment period allows the potential permittee additional time to ensure that the source is operational prior to obtaining the Permit to Operate. In the Linn County program, the terms and conditions of the permit to install (construct) are converted to a source operating permit after the source becomes operational.
“Posting of Permit to Operate,” 10.5(3)(d), the term “permit number” was removed and was replaced with the term “emission point number.”
In section 10.5(9), “Exemptions from the Authorization to Install Permit and Permit to Operate Requirements,” exemptions a, e, f, and i were changed to be consistent with recent changes to the IDNR SIP. Exemption “a,” which refers to fuel-burning equipment for indirect heating and re-heating surfaces, added the term “cooling units” to the exemption, and added the term “per combustion unit” to the capacity section. Exemption “e,” which refers to residential heaters, cook stoves, or fireplaces, added untreated wood, untreated seeds or pellets, or other untreated vegetative materials to material that can be burned. Exemption “f” refers to laboratory equipment used exclusively for non-production chemical and physical analyses. The term “non-production” was defined in this exemption for clarification. Exemption “i,” which refers to capacity of gasoline, diesel, or oil storage tanks, was changed to reflect the capacity of 10,570 gallons or less of an annual throughput of less than 40,000 gallons.
Seven exemptions were added to 10.5(9) as follows: “o” added stationary internal combustion engines with a brake horsepower rating of less than 400, or a kilowatt output less than 300; “p” added cooling and ventilating equipment; “q” added equipment not related to the production of goods or services and used for academic purposes at educational institutions; “r” added any container, storage tank, or vessel that contains a fluid maximum true vapor pressure of less than 0.75 psia; “s” added equipment used for non-production activities or exhausted inside a building; “t” added manually operated equipment used for buffing, polishing, carving, cutting, drilling, machining, routing, sanding, sawing, scarfing, surface grinding or turning, and “u” added incinerators and pyrolysis cleaning furnaces with a rated refuse burning capacity of less than 25 pounds per hour. These additions are consistent with the approved state rules.
Two sections were added to 10.6 (10.6(3) and 10.6(4)) to explain fees for late permits (construction prior to permit issuance) and how fees are recommended.
Section 10.9(1) of the Linn County Air Quality Ordinance added the emission standard of 0.1 grain per dry standard cubic foot of exhaust gas from any process or Table 1, entitled “Allowable Rate of Emission Based on Process Weight Rate,” whichever is lowest.
With this approval, the name of 10.9 1.(g) is changed from “Grain Processing Plants,” to “Grain Handling and Processing Plants.” Changes made to this section correctly reflect the revised title of the section, as well as the changes made in 10.9(1).
Changes were made to section 10.9 1.(j) to include phosphoric acid manufacture, diammonium phosphate manufacture, nitrophosphate manufacture, and related calculations and definitions.
The revision to 10.9 1.(l) for incinerators included removing the phrase “objectionable odors”; 10.9 1.(l)(1) was revised to clarify that the discharge of particulate matter into the atmosphere shall not exceed 0.2 grain per standard cubic foot of exhaust gas adjusted to 12 percent carbon dioxide. This change further clarifies that an incinerator with a rated burning capacity of less than 1,000 pounds per hour should not exceed discharge of particulate matter into the atmosphere that exceeds 0.35 grains per standard cubic foot of exhaust gas adjusted to 12 percent carbon dioxide.
Section 10.9 1.(l)(2) was previously entitled “Smoke,” and is revised to read “Visible Emissions.” In addition to the name change, a provision was added to clarify that the appearance, density, or shade of opacity will not exceed the level specified in a federally-enforceable permit.
Section 10.10 A.(1)(c) identifies regulations for burning of agricultural structures which are defined in this section. The rule clarifies that weather must be favorable, and the structure must be at least one-fourth mile from any building inhabited by a person other than the landowner, a tenant or an employee thereof, unless a written affidavit is submitted to the Linn County Air Quality Division by the owner prior to the open burning. As with the update to the training fire rule, this section also clarifies removal of
Section 10.10 A.(1)(f), which refers to landscape wastes, added provisions stating that burning shall be conducted when weather conditions are favorable with respect to surrounding property.
The open burning of trees and tree trimmings was added to the Linn County Air Quality Ordinance at 10.10 A.(1)(h). This revision states that trees and tree trimmings may be burned at a site operated by a local governmental entity, provided the site is fenced and access controlled and conditions are favorable with respect to surrounding property. Provisions with regard to inhabited buildings are the same as with agricultural structures. This revision allows relocation of the burning operation if the burning could cause air pollution as defined in the Iowa Code (455B.131(3)).
Rules for open burning permits are found at 10.10 A.(2) of the Linn County Air Quality Ordinance. Provisions were added in this revision stating that open burning permits are valid for either 30 or 60 days from the date of issue at the request of the applicant. Fees are recommended by the Air Pollution Control Officer and established by resolution of the Linn County Board of Supervisors except for agencies or public districts that are exempt. This revision further adds that open burning permits are valid if the fee is paid, and the permit is signed by the Air Pollution Control Officer and the Fire Chief of the fire district having jurisdiction at the place of burning. The Air Pollution Control Officer has the authority to deny issuance of an open burning permit based on previous violations such as non-payment of fees, or if a person has a previous violation of this Ordinance.
Section 10.10 A.(3) updated the exemptions for open burning that include heating and recreational activities providing charcoal or clean wood material is used and the fire is no larger than three feet in diameter. The exemption for camp fires added outdoor fireplaces, and this exemption added the activity of cooking to “recreational activities.” In the section exempting fires for disposal of household rubbish, the burning of grass and leaves was removed, and wood, paper, cardboard, and other natural fiber products were added to the list of burnable materials. A limitation was added to this exemption stating that burning for the disposal of household rubbish at dwellings of more than four family units is not allowed. An exemption to allow for burning of paper seed bags was added as 10.10 A.(3)(d) provided that the bags resulted from activities that occurred on the premises.
The following is a description of changes to the Linn County Air Quality Ordinance which are not part of the EPA-approved SIP, and therefore, are not addressed in this rulemaking: 10.2, Definition of Federally Enforceable; 10.2, Definition of Maximum Achievable Control Technology (MACT); definition of MACT floor; 10.4(1), Title V Permits; 10.9(2), NSPS; 10.9(3), Emission Standards for HAPs; 10.9(4), Emission Standards for HAPs for Source Categories; 10.11, Emission of Objectionable Odors, and, 10.15, Variances.
The state submittal has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submittal also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in the technical support document which is part of this document, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.
EPA is approving a revision to the SIP submitted by the state of Iowa to approve the 2001 and 2004 updates to the Linn County Air Quality Ordinance. This revision will ensure consistency between the applicable local agency rules and Federally-approved rules, and ensure Federal enforceability of the applicable parts of the local agency air programs.
We are taking direct final action to approve this revision because this revision makes routine changes to the existing rules which are noncontroversial. Therefore, we do not anticipate any adverse comments. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have federalism implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.
In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 17, 2005. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
The EPA is approving a revision to the Oklahoma State Implementation Plan (SIP) submitted by the Secretary of the Environment on December 22, 2004 for Central Oklahoma. This revision will incorporate a Memorandum of Agreement (MOA) between the Oklahoma Department of Environmental Quality (ODEQ) and the Association of Central Oklahoma Governments (ACOG) into the Oklahoma SIP and includes a demonstration of attainment and maintenance for the 8-hour National Ambient Air Quality Standard (NAAQS) for ozone. The MOA outlines duties and responsibilities of each party for implementation of pollution control measures for the Central Oklahoma Early Action Compact (EAC) area. EPA is approving the photochemical modeling in support of the attainment demonstration for the 8-hour ozone standard within the Central Oklahoma EAC area and is approving the associated control measures. These actions strengthen the SIP in accordance with the requirements of sections 110 and 116 of the Federal Clean Air Act (the Act) and will result in emission reductions needed to help ensure attainment and maintenance of the 8-hour NAAQS for ozone.
This final rule is effective on September 15, 2005.
EPA has established a docket for this action under Regional Material in EDocket (RME) ID No. R06-OAR-2005-OK-0001. All documents in the docket are listed in the RME index at
The State submittal is also available for public inspection at the State Air Agency listed below during official business hours by appointment:
Oklahoma Department of Environmental Quality, Air Quality Division, 707 North Robinson, Oklahoma City, OK 73101-1677.
Carrie Paige, Air Planning Section (6PD-L), EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733, telephone (214) 665-6521,
Throughout this document, wherever “we,” “our,” and “us” is used, we mean EPA.
On May 13, 2005, EPA proposed approval of the Central Oklahoma EAC area's clean air action plan (Plan), the photochemical modeling in support of the attainment demonstration and related control measures as revisions to the SIP submitted to EPA by the State of Oklahoma. The proposal provides a detailed description of these revisions and the rationale for EPA's proposed actions, together with a discussion of the opportunity to comment. The public comment period for these actions closed on June 13, 2005. See the Technical Support Documents or our proposed rulemaking at 70 FR 25516 for more information. One adverse comment was received on EPA's proposed approval of the Central Oklahoma EAC Plan and 8-hour ozone attainment demonstration for the EAC area.
Today we are approving revisions to the Oklahoma SIP under sections 110 and 116 of the Act. The revisions demonstrate continued attainment and maintenance of the 8-hour ozone standard within the Central Oklahoma EAC area. The revisions include the Central Oklahoma EAC Plan, photochemical modeling and related control measures. The intent of the SIP revisions is to reduce ozone pollution and thereby maintain the 8-hour ozone standard.
We received one comment letter on the May 13, 2005 proposed rulemaking. The letter provided both supportive and adverse discourse, commending the State of Oklahoma for steps it has taken to improve air quality. The commenter opposes approval of the SIP revision because, should the area experience a violation of the 8-hour ozone standard, the SIP revision (1) provides for the deferment of the area's nonattainment designation to as late as December 31, 2007, and (2) relieves the area of its obligations under Title I, Subpart D of the Act. The commenter contends that EPA does not have the legal authority to defer the effective date of an area's nonattainment designation nor to relieve areas of the obligations of Part D of Title I of the Act when areas are violating the standard and designated nonattainment.
In the April 2004 designation rule (69 FR 23858), the Central Oklahoma EAC area was designated as attainment for the 8-hour ozone NAAQS. The commenter incorrectly asserts that this SIP revision provides for deferment of the designation of the area as nonattainment should the area experience a violation of the 8-hour ozone standard. Additionally, EPA's approval of this SIP does not alter the applicability of the redesignation provision of the Act should the Central Oklahoma EAC area experience a violation of the 8-hour ozone NAAQS in the future. Section 107(d)(3)(A) provides that EPA may redesignate an area “on the basis of air quality data, planning and control considerations, or any other air quality-related considerations.” Should the Central Oklahoma EAC area experience a violation of the 8-hour ozone NAAQS in the future, EPA would consider these statutory factors in determining whether to redesignate the area to nonattainment for the 8-hour ozone NAAQS. The commenter is also incorrect that this SIP approval relieves the Central Oklahoma EAC area of the requirements of Part D of Title I of the Act. These provisions apply to areas designated nonattainment. Because the Central Oklahoma EAC area is designated attainment for the 8-hour ozone NAAQS, these provisions do not apply in the Central Oklahoma EAC area.
EPA is approving the attainment demonstration, the Central Oklahoma EAC Plan, and the related control measures. We are incorporating these revisions, as well as the MOA, into the Oklahoma SIP. We have determined that the control measures included in the attainment demonstration are quantified, surplus, permanent, and are Federally enforceable once approved into the SIP. The modeling of ozone and ozone precursor emissions from sources in the Central Oklahoma EAC area demonstrate that the specified control strategies will provide for continued attainment of the 8-hour ozone NAAQS through December 31, 2007 and maintenance of that standard through 2012. We have reviewed the Plan and the attainment and maintenance demonstration and determined that they are consistent with the requirements of the Act, EPA's policy, and the EAC protocol.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason and because this action will not have a significant, adverse effect on the supply, distribution, or use of energy, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.
In reviewing SIP submissions under the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note), EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. section 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 17, 2005. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (
Environmental protection, Air pollution control, Intergovernmental relations, Nitrogen dioxides, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
(e) * * *
Merit Systems Protection Board.
Proposed rule with request for comments.
The Merit Systems Protection Board (MSPB or “the Board”) is revising its regulation governing actions filed by an administrative law judge (ALJ) who alleges a constructive removal under 5 U.S.C. 7521. The revision repeals the standard stated by the regulation for establishing such a removal in light of the Board's determination in recent cases that the ALJ must show involuntary separation from the position of ALJ. As discussed below, the revised standard for establishing the constructive removal of an ALJ is addressed in the Board's cases and will not be incorporated in the revised regulation, which is retained solely to provide procedural guidance for ALJ-initiated actions alleging violation of section 7521.
Written comments should be submitted on or before October 17, 2005.
Send or deliver comments to the Office of Clerk of the Board, U.S. Merit Systems Protection Board, 1615 M Street, NW., Washington, DC 20419; (202) 653-7200; fax: (202) 653-7130; or e-mail:
Bentley M. Roberts, Jr., Clerk of the Board, Merit Systems Protection Board, 1615 M Street, NW., Washington, DC 20419; (202) 653-7200; fax: (202) 653-7130; or e-mail:
The Board added 5 CFR 1201.142 to its regulations governing actions against ALJs “to cover the situation in which a complaint is filed by an administrative law judge rather than an agency.” 62 FR 48450 (Sept. 16, 1997). As promulgated, section 1201.142 provides that an ALJ “who alleges that an agency has interfered with the judge's qualified decisional independence so as to constitute an unauthorized action under 5 U.S.C. 7521 may file a complaint with the Board under this subpart.” The regulation reflects the Board's holding in
In
The U.S. Court of Appeals for the Federal Circuit reviewed the Board's
Accordingly, the Board is proposing to revise section 1201.142 to delete the stated standard for establishing constructive removal of an ALJ and thereby to repeal the
Administrative personnel, Actions against administrative law judges, Actions filed by administrative law judges.
For the reasons set forth in the Preamble, the MSPB proposes to amend 5 CFR 1201.142 as follows:
1. The authority citation for part 1201 continues to read as follows:
5 U.S.C. 1204 and 7701, and 38 U.S.C. 4331, unless otherwise noted.
2. Revise § 1201.142 to read as follows:
An administrative law judge who alleges a constructive removal or other action by an agency in violation of 5 U.S.C. 7521 may file a complaint with the Board under this subpart. The filing and serving requirements of § 1201.37 apply. Such complaints shall be adjudicated in the same manner as agency complaints under this subpart.
Agricultural Marketing Service, USDA.
Proposed rule.
This rule would increase the assessment rate and change the assessable unit established for the Kiwifruit Administrative Committee (Committee) for the 2005-06 and subsequent fiscal periods from $0.002 per pound of kiwifruit to $0.045 per 9-kilo volume-fill container or equivalent of kiwifruit. The Committee locally administers the marketing order which regulates the handling of kiwifruit grown in California. Authorization to assess kiwifruit handlers enables the Committee to incur expenses that are reasonable and necessary to administer the program. The fiscal period begins August 1 and ends July 31. The assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.
Comments must be received by September 6, 2005.
Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938, e-mail:
Shereen Marino, Marketing Specialist, California Marketing Field Office, Fruit and Vegetable Programs, AMS, USDA; Telephone: (559) 487-5901; Fax: (559) 487-5906; or George Kelhart, Technical Advisor, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; telephone: (202) 720-2491, Fax: (202) 720-8938. Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; telephone: (202) 720-2491, Fax: (202) 720-8938, or e-mail:
This rule is issued under Marketing Order No. 920, as amended (7 CFR part 920), regulating the handling of kiwifruit grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California kiwifruit handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as proposed herein would be applicable to all assessable kiwifruit beginning on August 1, 2005, and continue until amended, suspended, or terminated. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom.
Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This rule would increase the assessment rate and change the assessable unit established for the Committee for the 2005-06 and subsequent fiscal periods from $0.002 per pound of kiwifruit to $0.045 per 9-kilo volume-fill container or equivalent of kiwifruit.
The California kiwifruit marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers of California kiwifruit. They are familiar with the Committee's needs and the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed at a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.
For the 2004-05 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.
The Committee met on June 28, 2005, and unanimously recommended 2005-06 expenditures of $91,989 and an assessment rate of $0.045 per 9-kilo volume-fill container or equivalent of kiwifruit. In comparison, last year's budgeted expenditures were $91,839. The assessment rate of $0.045 per 9-kilo volume-fill container or equivalent is about $0.0003 per pound higher than the rate currently in effect. The higher assessment rate is needed because the 2004-2005 crop was smaller than expected and assessment income fell short of expenses. Reserve funds were used to meet the shortfall. The higher assessment rate should generate sufficient income to cover anticipated 2005-06 expenses and maintain an adequate reserve.
The following table compares major budget expenditures recommended by the Committee for the 2004-05 and 2005-06 fiscal periods:
The assessment rate recommended by the Committee was derived by the following formula: Anticipated expenses ($91,989), plus the desired 2006 ending reserve ($35,010), minus the 2005 beginning reserve ($15,524), divided by the total estimated 2005-06 shipments (2,475,000 9-kilo volume-fill containers). An additional $100 in interest income is also anticipated, bringing the total projected 2005-06 revenue to $111,475. This calculation requires the $0.045 per 9-kilo volume-fill container assessment rate. This rate should provide sufficient funds to meet the anticipated expenses of $91,839 and result in a July 2006 ending reserve of $35,010, which is within the authorized reserve permitted by the order. The authorized reserve is approximately one fiscal period's expenses (§ 920.41).
The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.
Although this assessment rate would be in effect for an indefinite period, the Committee would continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2005-06 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.
There are approximately 45 handlers of California kiwifruit subject to regulation under the marketing order and approximately 275 growers in the production area. Small agricultural service firms are defined by the Small Business Administration (13 CFR 121.201) as those whose annual receipts are less than $6,000,000, and small agricultural producers are defined as those whose annual receipts are less than $750,000.
None of the 45 handlers subject to regulation have annual kiwifruit sales of at least $6,000,000. In addition, six growers subject to regulation have annual sales exceeding $750,000. Therefore, a majority of the kiwifruit handlers and growers may be classified as small entities.
This rule would increase the assessment rate and change the assessable unit established for the Committee and collected from handlers for the 2005-06 and subsequent fiscal periods from $0.002 per pound of kiwifruit to $0.045 per 9-kilo volume-fill container or equivalent of kiwifruit. The Committee unanimously recommended 2005-06 expenditures of $91,989 and an assessment rate of $0.045 per 9-kilo volume-fill container or equivalent of kiwifruit. The proposed assessment rate of $0.045 is $0.0003 higher than the 2004-05 rate. The quantity of assessable kiwifruit for the 2005-06 fiscal period is estimated at 2,475,000 9-kilo volume-fill containers or equivalent of kiwifruit. Thus, the $0.045 rate should provide $111,375 in assessment income and be adequate to meet this year's expenses.
The following table compares major budget expenditures recommended by the Committee for the 2004-05 and 2005-06 fiscal years:
The Committee reviewed and unanimously recommended 2005-06 expenditures of $91,989, which included an increase in audit expenses. Prior to arriving at this budget, the Committee considered alternative expenditure levels, but ultimately decided that the recommended levels were reasonable to properly administer the order. The assessment rate recommended by the Committee was derived by the following formula: Anticipated expenses ($91,989), plus the desired 2006 ending reserve ($35,010), minus the 2005 beginning reserve ($15,524), divided by the total estimated 2005-06 shipments (2,475,000 9-kilo volume-fill containers). This calculation resulted in the $0.045 per 9-kilo volume-fill container assessment rate. This rate would provide sufficient funds to meet the anticipated expenses of $91,989 and result in a July 2006 ending reserve of $35,010, which is within the authorized reserve permitted by the order. The authorized reserve is approximately one fiscal period's expenses (§ 920.41). An additional $100 in interest income is also anticipated, bringing the total projected 2005-06 revenue to $111,475.
A review of historical information and preliminary information pertaining to the upcoming fiscal period indicates that the grower price for the 2005-06 season could be about $8.09 per 9-kilo volume-fill container or equivalent of kiwifruit. Therefore, the estimated assessment revenue for the 2005-06 fiscal period as a percentage of total grower revenue is estimated at about 0.56 percent.
This action would increase the assessment obligation imposed on
This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large California kiwifruit handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
A 20-day comment period is provided to allow interested persons to respond to this proposed rule. Twenty days is deemed appropriate because: (1) The 2005-06 fiscal period began on August 1, 2005, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable kiwifruit handled during such fiscal period; (2) the Committee needs to have sufficient funds to pay its expenses which are incurred on a continuous basis and; (3) handlers are aware of this action which was unanimously recommended by the Committee at a public meeting and is similar to other assessment rate actions issued in past years.
Kiwifruit, Marketing agreements, Reporting and record keeping requirements.
For the reasons set forth in the preamble, 7 CFR part 920 is proposed to be amended as follows:
1. The authority citation for 7 CFR part 920 continues to read as follows:
7 U.S.C. 601-674.
2. Section 920.213 is revised to read as follows:
On and after August 1, 2005, an assessment rate of $0.045 per 9-kilo volume-fill container or equivalent of kiwifruit is established for kiwifruit grown in California.
Federal Aviation Administration, DOT.
Proposed rule; withdrawal.
The FAA is withdrawing a notice of proposed rulemaking (NPRM). That NPRM proposed a new airworthiness directive (AD) that applies to certain Rolls-Royce plc (RR) models RB211-535C-37, RB211-535E4-37, RB211-535E4-B-37, and RB211-535E4-B-75 turbofan engines. The NPRM had applied to those engines with radial drive steady bearing part number (P/N) LK76084 installed, with fewer than 3,000 engine operating hours on the bearing. That proposed action would have required initial and repetitive visual inspections of the engine oil scavenge filter for evidence of radial drive steady bearing failure. If after finding evidence, the proposed action would have required a visual inspection of the radial drive steady bearing for damage and evidence of bearing debris. Since we issued that NPRM, RR notified us that all at-risk radial drive steady bearings are removed from service. RR also notified us that remaining bearings in service are now well over the 3,000-engine-operating-hour threshold and are no longer at risk. Accordingly, we withdraw the proposed rule.
Ian Dargin, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803-5299; telephone (781) 238-7178; fax (781) 238-7199.
The FAA proposed to amend 14 CFR part 39 with a proposed airworthiness directive (AD). The proposed AD applies to Rolls-Royce plc (RR) models RB211-535C-37, RB211-535E4-37, RB211-535E4-B-37, and RB211-535E4-B-75 turbofan engines. The proposed AD would have applied to those engines with radial drive steady bearing, P/N LK76084 installed, with fewer than 3,000 engine-operating-hours on the bearing. We published the proposed AD in the
Since the issuance of that NPRM, RR notified us that all at-risk radial drive steady bearings are removed from service. RR also notified us that the remaining bearings in service are now well over the 3,000-engine-operating-hour threshold and are no longer at risk.
Upon further consideration, we hereby withdraw the proposed rule for the following reasons:
• After RR notifying us of the removal from service and bearing threshold information, stated previously.
• AD 2000-09-14 (65 FR 30527, May 12, 2000) and AD 2001-19-05 (66 FR 49099, September 26, 2001) currently address the same radial drive steady bearing, P/N LK76084.
• AD 2000-09-14 and AD 2001-19-05 mandate replacing low-time bearings that are at risk.
Withdrawal of this notice of proposed rulemaking constitutes only such action, and does not preclude the agency from issuing another notice in the future, nor does it commit the agency to any course of action in the future.
Since this action only withdraws a notice of proposed rulemaking, it is neither a proposed nor a final rule. Therefore, Executive Order 12866, the Regulatory Flexibility Act, or DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979) do not cover this withdrawal.
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, the notice of proposed rulemaking, Docket 2003-NE-31-AD, published in the
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede an existing airworthiness directive (AD) that applies to all Model A300 B4-600 and A300 B4-600R series airplanes, and all Model A300 F4-605R airplanes. The existing AD currently requires repetitive inspections to detect cracks of certain attachment holes, installation of new fasteners, follow-on inspections or repair if necessary, and modification of the angle fittings of fuselage frame FR47. This proposed AD would revise certain inspection thresholds and intervals. This proposed AD would also add inspections to detect cracks of additional attachment holes. This proposed AD is prompted by reports of cracks found before the inspection thresholds in the existing AD and cracks found in nearby areas not inspected by the existing AD. We are proposing this AD to prevent fatigue cracking of the forward fitting of fuselage frame FR47, which could result in reduced structural integrity of the frame.
We must receive comments on this proposed AD by September 15, 2005.
Use one of the following addresses to submit comments on this proposed AD.
• DOT Docket Web site: Go to
• Government-wide rulemaking Web site: Go to
• Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, room PL-401, Washington, DC 20590.
• Fax: (202) 493-2251.
• Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For service information identified in this proposed AD, contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.
You can examine the contents of this AD docket on the Internet at
Dan Rodina, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425) 227-2125; fax (425) 227-1149.
We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed under
We will post all comments we receive, without change, to
You can examine the AD docket on the Internet at
On May 22, 2002, we issued AD 2002-11-04, amendment 39-12765 (67 FR 38193, June 3, 2002), for all Model A300 B4-600 and A300 B4-600R series airplanes, and all Model A300 F4-605R airplanes. That AD requires repetitive inspections to detect cracks of certain attachment holes, installation of new fasteners, follow-on inspections or repair if necessary, and modification of the angle fittings of fuselage frame FR47. That AD was prompted by reports of cracks found in the internal angle fittings of the wing center box at fuselage frame FR47 on airplanes that
Since we issued AD 2002-11-04, Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, issued French airworthiness directive F-2004-159, dated September 29, 2004. That airworthiness directive mandates a new repetitive inspection program for fuselage frame FR47 at certain fasteners of the center wing box angle fitting. Fatigue cracking on the forward fitting of fuselage frame FR47 at the level of the last fastener of the external angle fitting, if not detected and corrected in a timely manner, could result in reduced structural integrity of the airframe.
Airbus has issued Service Bulletin A300-57-6049, Revision 06, dated July 15, 2004. Revision 06 of the service bulletin describes the same procedures specified in Airbus Service Bulletin A300-57-6049, Revision 04, dated July 27, 2000 (Revision 04 was referenced as the appropriate source of service information for performing repetitive rotating probe inspections to detect cracking of the applicable attachment holes on the left and right internal angles of the wing center box; and for doing corrective actions; required by AD 2002-11-04). Revision 06 also specifies performing an inspection to detect cracking of additional holes. In addition, Revision 06 revises certain inspection thresholds and intervals. The service bulletin specifies thresholds ranging approximately from 10,400 flight cycles or 22,450 flight hours, whichever comes first, to 15,350 flight cycles or 23,000 flight hours, whichever comes first, depending on the configuration of the airplane. The service bulletin also specifies repetitive inspection intervals ranging approximately from 4,500 flight cycles or 9,700 flight hours, whichever comes first, to 4,850 flight cycles or 7,300 flight hours, whichever comes first. The service bulletin specifies a grace period of 1,400 flight cycles or 3,500 flight hours for airplanes having between 1,400 flight cycles or 3,500 flight hours below the threshold and 1,900 flight cycles or 4,600 flight hours above the threshold. The service bulletin also specifies a grace period of 700 flight cycles or 1,700 flight hours for airplanes that have exceeded the threshold by more than 1,900 flight cycles or 4,600 flight hours.
Airbus has also issued Service Bulletin A300-57-6086, Revision 01, dated April 2, 2002. Revision 01 of the service bulletin describes the same procedures specified in the original issue of Airbus Service Bulletin A300-57-6086, dated June 6, 2000 (the original issue was referenced as the appropriate source of service information for doing repetitive inspections to detect cracking of the applicable attachment holes in the horizontal flange of the internal corner angle fitting of fuselage frame FR47, and for doing corrective actions, required by AD 2002-11-04). Revision 01 of the service bulletin also revises a grace period for a threshold. Revision 01 of the service bulletin specifies a threshold of 13,400 flight cycles or 34,600 flight hours, whichever occurs first. The service bulletin also specifies repetitive intervals of 6,900 flight cycles or 17,700 flight hours, whichever occurs first. The service bulletin specifies a grace period of 1,400 flight cycles or 3,500 flight hours for airplanes having between 1,400 flight cycles or 3,500 flight hours below the threshold and 2,000 flight cycles or 5,000 flight hours above the threshold. The service bulletin specifies a grace period of 750 flight cycles or 1,700 flight hours for airplanes having exceeded the threshold by more than 2,000 flight cycles or 5,000 flight hours.
Airbus has also issued Service Bulletin A300-57-6050, Revision 03, dated May 31, 2001. Revision 03 describes the same procedures specified in Airbus Service Bulletin A300-57-6050, Revision 02, dated February 10, 2000 (Revision 02 was referenced as the appropriate source of service information for doing the modification of the left and right internal angle fittings of the wing center box required by AD 2002-11-04). Revision 03 of the service bulletin specifies a threshold of 15,100 flight cycles or 38,900 flight hours.
Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition.
The DGAC mandated the service information and issued French airworthiness directive F-2004-159, dated September 29, 2004, to ensure the continued airworthiness of these airplanes in France.
These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. We have examined the DGAC's findings, evaluated all pertinent information, and determined that AD action is necessary for airplanes of this type design that are certificated for operation in the United States. This proposed AD would supersede AD 2002-11-04. This proposed AD would require accomplishing the actions specified in the service bulletins described previously, except as described in “Differences Between the Proposed AD, Relevant Service Information, and French Airworthiness Directive.”
As stated previously in AD 2002-11-04, we find that for this proposed AD that all touch-and-go landings must be counted in determining the total number of landings between two consecutive inspections. Airbus Service Bulletin A300-57-6049, Revision 06, dated July 15, 2004, and Airbus Service Bulletin A300-57-6086, Revision 01, dated April 2, 2002, specify that operators need not count touch-and-go landings in determining the total number of landings between two consecutive inspections, when those landings are less than five percent of the landings between inspection intervals. Since fatigue cracking on the forward fitting of fuselage frame FR47 at the level of the last fastener of the external angle fitting is aggravated by landing, all touch-and-go landings must be counted.
Although Airbus Service Bulletin A300-57-6049, Revision 06, dated July 15, 2004; and Airbus Service Bulletin A300-57-6086, Revision 01, dated April 2, 2002; specify to submit certain information to the manufacturer, this proposed AD would not require those actions. We do not need this information from operators.
Where any of the service bulletins specify to contact the manufacturer for disposition of certain corrective actions, this proposed AD would require repair in accordance with a method approved by either the Manager, International Branch, ANM-116, FAA, Transport
These differences have been coordinated with the DGAC.
The following table provides the estimated costs for U.S. operators to comply with this proposed AD.
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.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 the proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the 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.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD. See the
Air transportation, Aircraft, Aviation safety, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing amendment 39-12765 (67 FR 38193, June 3, 2002) and adding the following new airworthiness directive (AD):
(a) The Federal Aviation Administration must receive comments on this AD action by September 15, 2005.
(b) This AD supersedes AD 2002-11-04, amendment 39-12765.
(c) This AD applies to Airbus Model A300 B4-601, B4-603, B4-620, and B4-622 airplanes; Model A300 B4-605R and B4-622R airplanes; A300 F4-605R airplanes; and A300 C4-605R Variant F airplanes; certificated in any category; except airplanes on which Airbus modification 12171 or 12249 has been accomplished or on which Airbus Service Bulletin A300-57-6069 has been accomplished.
(d) This AD was prompted by reports of cracks found before the inspection thresholds in the existing AD and cracks found in nearby areas not inspected by the existing AD. We are issuing this AD to prevent fatigue cracking of the forward fitting of fuselage frame FR47, which could result in reduced structural integrity of the frame.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(f) Perform a rotating probe inspection to detect cracking of the applicable attachment holes on the left and right internal angles of the wing center box in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6049, Revision 06, dated July 15, 2004. Do the inspection at the applicable time specified by paragraph 1.E.(2), Accomplishment Timescale, of Revision 06 of the service bulletin, except as required by paragraph (m) of this AD. Repeat the rotating probe inspection specified in this paragraph thereafter at intervals not to exceed the applicable interval specified in Revision 06 of the service bulletin, except that all touch-and-go landings must be counted in determining the total number of flight cycles between consecutive inspections.
(g) If no cracking is found during any inspection required by paragraph (f) of this AD: Prior to further flight, install new fasteners in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6049, Revision 06, dated July 15, 2004.
(h) If any cracking is found during any inspection required by paragraph (f) of this AD: Prior to further flight, perform applicable corrective actions (including reaming, drilling, drill-stopping holes, chamfering, performing follow-on inspections, and installing new or oversize fasteners) in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6049, Revision 06, dated July 15, 2004, except as required by paragraph (n) of this AD.
(i) Perform a rotating probe inspection to detect cracking of the applicable attachment holes in the horizontal flange of the internal corner angle fitting of fuselage frame FR47, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6086, Revision 01, dated April 2, 2002. Do the inspection at the applicable time specified in paragraph 1.E., Compliance, of Airbus Service Bulletin A300-57-6086, Revision 01, dated April 2, 2002, except as provided by paragraph (m) of this AD; or within 1,500 flight cycles after July 8, 2002 (the effective date of AD 2002-11-04, amendment 39-12765); whichever occurs later. Repeat the rotating probe inspection specified in this paragraph thereafter at intervals not to exceed the applicable interval specified in Airbus Service Bulletin A300-57-6086, dated June 6, 2000, except that all touch-and-go landings must be counted in determining the total number of flight cycles between consecutive inspections.
(j) If no cracking is found during any inspection required by paragraph (i) of this AD: Prior to further flight, install new fasteners in accordance with the service bulletin.
(k) If any cracking is found during any inspection required by paragraph (i) of this AD: Prior to further flight, perform applicable corrective actions (including inspecting hole T, reaming the holes, and installing oversize fasteners) in accordance with the service bulletin, except as required by paragraph (n) of this AD.
(l) Modify the left and right internal angle fittings of the wing center box. The modification includes performing a rotating probe inspection to detect cracking, repairing cracks, cold expanding holes, and installing medium interference fitting bolts. Perform the modification in accordance with Revision 03, dated May 31, 2001; and at the applicable time specified by paragraph 1.B.(4), Accomplishment Timescale, of Airbus Service Bulletin A300-57-6050, Revision 03, dated May 31, 2001; except as required by paragraphs (m) and (n) of this AD.
(m) Where the service bulletins specified in paragraphs (f), (i), and (l) of this AD specify a grace period relative to receipt of the service bulletin, this AD requires compliance within the applicable grace period following the effective date of this AD, if the threshold has been exceeded.
(n) If any crack is detected during any inspection required by this AD, and the applicable service bulletin specifies to contact the manufacturer for disposition of certain corrective actions: Prior to further flight, repair in accordance with a method approved by either the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate, or the Direction Générale de l'Aviation Civile (DGAC) (or its delegated agent).
(o) Actions accomplished prior to the effective date of this AD in accordance with Airbus Service Bulletin A300-57-6086, dated June 6, 2000, are acceptable for compliance with the requirements of paragraph (i) of this AD.
(p) Modifications accomplished prior to the effective date of this AD in accordance with Airbus Service Bulletin A300-57-6050, Revision 02, dated February 10, 2000; are acceptable for compliance with the requirements of paragraph (l) of this AD.
(q) Although Airbus Service Bulletin A300-57-6049, Revision 06, dated July 15, 2004; and Airbus Service Bulletin A300-57-6086, Revision 01, dated April 2, 2002; specify to submit certain information to the manufacturer, this AD does not include that requirement.
(r)(1) The Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2) AMOCs approved previously according to AD 2002-11-04, amendment 39-12765, are not approved as AMOCs with this AD.
(s) French airworthiness directive F-2004-159, dated September 29, 2004, also addresses the subject of this AD.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to change the regulations governing the operation of 10 drawbridges, and establish operating regulations for 2 drawbridges, all of which cross the Atlantic Intracoastal Waterway in Broward County, FL. The proposed rule would require all of these drawbridges to open twice an hour. The proposed schedule is based on a request from Broward County officials, a test the Coast Guard conducted from December, 2004, until February, 2005, and comments received from the public based on the test. The proposed schedule meets the reasonable needs of navigation while accommodating increased vehicular traffic throughout the county.
Comments and related material must reach the Coast Guard on or before October 1, 2005.
You may mail comments and related material to Commander (obr), Seventh Coast Guard District, 909 SE. 1st Avenue, Room 432, Miami, Florida 33131-3050. Commander (obr) maintains the public docket for this rulemaking. Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, will become part of this docket, (CGD07-04-136) and will be available for inspection or copying at Commander (obr), Seventh Coast Guard District, 909 SE. 1st Avenue, Room 432, Miami, Florida 33131-3050 between 8 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.
Mr. Gwin Tate, Seventh Coast Guard District, Bridge Branch, telephone number 305-415-6747.
We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for
We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to Bridge Branch, Seventh Coast Guard District, at the address under
At the request of Broward County, the Coast Guard published a temporary deviation, effective from December 1, 2004 to February 28, 2005, as a test regulation for 11 Broward County drawbridges (69 FR 67055, Nov. 16, 2004). The following bridges were covered by the temporary deviation: NE 14th Street, mile 1055.0, Atlantic Boulevard (SR 814), mile 1056.0, Commercial Boulevard (SR 870), mile 1059.0, Oakland Park Boulevard, mile 1060.5, East Sunrise Boulevard (SR 838), mile 1062.6, East Las Olas Boulevard, mile 1064.0, SE. 17th Street Causeway, mile 1065.9, Dania Beach Boulevard, mile 1069.4, Sheridan Street, mile 1070.5, Hollywood Beach Boulevard (SR 820), mile 1072.2, and Hallandale Beach Boulevard (SR 824), mile 1074.0. The Dania Beach Boulevard and Sheridan Street bridges currently do not have codified operating regulations. The Hillsboro Boulevard Bridge was not covered by the temporary deviation.
The test was conducted for approximately 90 days to collect data to determine the feasibility of changing the regulations on all drawbridges in Broward County crossing the Atlantic Intracoastal Waterway, to meet the increased demands of vehicular traffic and still provide for the reasonable needs of navigation. The test results indicated that the proposed schedule allowed both vehicular and vessel traffic the opportunity to predict, on a scheduled basis, when the bridges might be in the open position. We received 205 comments, 182 were in favor of the test schedules, 13 were in favor of keeping the existing schedules, 8 comments provided other recommended opening schedules, and 2 were general in nature. Those comments are being maintained in the docket and will be incorporated in the final rulemaking.
Public officials in Broward County requested the change in operating regulations to reduce burdens on county roadways and to standardize drawbridge openings throughout the county. The proposed rule would allow all drawbridges crossing the Atlantic Intracoastal Waterway in Broward County to operate on a standardized schedule that would meet the reasonable needs of navigation and address vehicular traffic congestion.
The Coast Guard proposes to change the operating regulations of 10 drawbridges, and establish operating regulations for the Dania Beach Boulevard and Sheridan Street drawbridges, all of which cross the Atlantic Intracoastal Waterway in Broward County. The existing regulations that govern the operation of the Broward County drawbridges are published in 33 CFR 117.5 and 33 CFR 117.261.
The proposed rule would stagger the bridge openings from north to south and allow a vessel traveling south at five knots to significantly reduce wait times to pass through open drawbridges. Drawbridges will either open on the hour and half hour or on the quarter and three-quarter hour. The results are that the following bridges will operate on the schedules below:
This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security.
We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. The proposed rule would provide timed openings for vehicular traffic and sequenced openings for vessel traffic and should have little economic impact.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which may be small entities: the owners or operators of vessels needing to transit the Intracoastal Waterway in the vicinity of the Broward County bridges.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This proposed rule would not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.
This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this proposed rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this proposed rule is categorically excluded, under figure 2-1, paragraph (32)(e) of the Instruction, from further environmental documentation.
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
1. The authority citation for part 117 continues to read as follows:
33 U.S.C. 499; Department of Homeland Security Delegation No. 0170.1; 33 CFR 1.05-1(g); section 117.255 also issued under the authority of Pub. L. 102-587, 106 Stat. 5039.
2. In § 117.261, revise paragraph (bb) and remove and reserve paragraphs (cc), (dd), (ee), (ff), (gg), (hh), (jj), and (kk).
(bb)
(2) NE. 14th Street bridge, mile 1055.0 at Pompano. The draw shall open on the quarter-hour and three-quarter hour.
(3) Atlantic Boulevard (SR 814) bridge, mile 1056.0 at Pompano. The draw shall open on the hour and half-hour.
(4) Commercial Boulevard (SR 870) bridge, mile 1059.0, at Lauderdale-by-the-Sea. The draw shall open on the hour and half-hour.
(5) Oakland Park Boulevard bridge, mile 1060.5 at Fort Lauderdale. The draw shall open on the quarter-hour and three-quarter hour.
(6) East Sunrise Boulevard (SR 838) bridge, mile 1062.6, at Fort Lauderdale. The draw shall open on the hour and half-hour.
(7) East Las Olas bridge, mile 1064 at Fort Lauderdale. The draw shall open on the quarter-hour and three-quarter hour.
(8) SE. 17th Street (Brooks Memorial) bridge, mile 1065.9 at Fort Lauderdale. The draw shall open on the hour and half-hour.
(9) Dania Beach Boulevard bridge, mile 1069.4 at Dania Beach. The draw shall open on the hour and half-hour.
(10) Sheridan Street bridge, mile 1070.5, at Fort Lauderdale. The draw shall open on the quarter-hour and three-quarter hour.
(11) Hollywood Beach Boulevard (SR 820) bridge, mile 1072.2 at Hollywood. The draw shall open on the hour and half-hour.
(12) Hallandale Beach Boulevard (SR 824) bridge, mile 1074.0 at Hallandale.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to change the operating regulations governing the Cortez (SR 684) bridge and the Anna Maria (SR 64) bridge across the Gulf Intracoastal Waterway, mile 89.2 in Anna Maria, Manatee County, Florida. This proposed rule would require the drawbridges to open on a 30-minute schedule if vessels are present. However, the drawbridges are not required to open during the morning and afternoon rush hours. This proposed action may improve the movement of vehicular traffic while not unreasonably interfering with the movement of vessel traffic.
Comments and related material must reach the Coast Guard on or before October 17, 2005.
You may mail comments and related material to Commander (obr), Seventh Coast Guard District, 909 SE. 1st Avenue, Room 432, Miami, FL, 33131, who maintains the public docket for this rulemaking. Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, will become part of this docket and are available for inspection or copying at the Seventh Coast Guard District Bridge Branch, between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays.
Mr. Michael Lieberum, Project Officer, Seventh Coast Guard District, Bridge Branch, at (305) 415-6744.
We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking (CGD07-05-097), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8
We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to the Seventh Coast Guard District Bridge Branch at the address under
The existing regulations of the Cortez (SR 684) bridge, mile 87.4, and Anna Maria (SR 64) bridge, mile 89.2 at Anna Maria, published in 33 CFR 117.287(d)(1) and (2) require the draw to open on signal, except that from 7 a.m. to 6 p.m., the draw need open only on the hour, twenty minutes past the hour and forty minutes past the hour if vessels are present.
On June 1, 2005, the City officials of Holmes Beach in cooperation with the cities of Anna Maria and Bradenton Beach and the Town of Longboat Key requested that the Coast Guard review the existing regulations governing the operation of the Cortez and Anna Maria bridges, because they think the current drawbridge regulations are not meeting the needs of vehicle traffic.
This proposed rule would require the Cortez (SR 684) and Anna Maria (SR 64) bridges, miles 87.4 and 89.2, at Anna Maria to open on the hour and half-hour if vessels are present, except that the draws need not open from 7:35 a.m. to 8:29 a.m. and from 4:35 p.m. to 5:29 p.m. The objective of this revision is to improve vehicle traffic flow on SR 684 and SR 64, especially during peak periods of increased road congestion.
This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).
We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This proposed rule would revise the existing bridge schedule to allow for improved vehicle traffic flow, while still providing ample scheduled openings for vessel traffic.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small business, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which may be small entities: The owners or operators of vessels needing to transit the Intracoastal Waterway in the vicinity of the Cortez and Anna Maria bridges, persons intending to drive over the bridge, and nearby business owners. The revision to the openings schedule would not have a significant impact on a substantial number of small entities for the following reasons. Vehicle traffic and small business owners in the area might benefit from the improved traffic flow that regularly scheduled openings will offer this area. Although bridge openings will be less frequent, vessel traffic will still be able to transit the Intracoastal Waterway in the vicinity of the Cortez and Anna Maria bridges pursuant to the revised openings schedule.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it,
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This proposed rule would not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this proposed rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this proposed rule is categorically excluded, under figure 2-1, paragraph (32)(e) of the Instruction, from further environmental documentation.
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
1. The authority citation for part 117 continues to read as follows:
33 U.S.C. 499; 33 CFR 1.05-1(g); Department of Homeland Security Delegation No. 0170.1; section 117.255 also issued under the authority of Pub. L. 102-587, 106 Stat. 5039.
2. Revise § 117.287(d)(1) and (2) to read as follows:
(d)(1) The draw of the Cortez (SR 684) bridge, mile 87.4, need open only on the hour and half-hour; except that from 7:35 a.m. to 8:29 a.m. and 4:35 p.m. and 5:29 p.m. the draw need not open.
(2) The draw of the Anna Maria (SR 64) bridge, mile 89.2, need open only on the hour and half-hour; except that from 7:35 a.m. to 8:29 a.m. and 4:35 p.m. to 5:29 p.m. the draw need not open.
Environmental Protection Agency (EPA).
Proposed rule.
EPA proposes to approve the State Implementation Plan (SIP) revision submitted by the state of Iowa for the purpose of approving the 2001 and 2004 updates to the Linn County Air Quality Ordinance, Chapter 10, Air Quality. These revisions will help to ensure consistency between the applicable local agency rules and Federally-approved rules, and ensure Federal enforceability of the applicable parts of the local agency air programs.
Comments on this proposed action must be received in writing by September 15, 2005.
Comments may be mailed to Heather Hamilton, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. Comments may also be submitted electronically or through hand delivery/courier; please follow the detailed instructions in the Addresses section of the direct final rule which is located in the rules section of this
Heather Hamilton at (913) 551-7039, or by e-mail at
In the final rules section of the
Fish and Wildlife Service, Interior.
Notice of reopening of public comment period.
We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the public comment period for the status review initiated by the 90-day finding on a petition to list
Comments must be submitted directly to the Service (see
If you wish to comment, you may submit your comments and materials by any one of the following methods:
1. You may submit written comments and information by mail or hand-delivery to Robert Pine, Field Supervisor, Austin Ecological Services Field Office, 10711 Burnet Road, Suite 200, Austin, Texas 78758.
2. Written comments may be sent by facsimile to 512/490-0974.
3. You may send your comments by electronic mail (e-mail) to
All comments and materials received, as well as supporting documentation used in preparation of the 90-day finding, will be available for public inspection, by appointment, during normal business hours at our Austin Ecological Services Field Office at the above address.
Robert Pine, Field Supervisor, Austin Ecological Services Office (telephone 512/490-0057, facsimile 512/490-0974).
Section 4(b)(3)(B) of the Act (16 U.S.C. 1531
On July 8, 2003, we received a petition requesting that we list
On February 1, 2005, we published our 90-day finding on the petition to list
Pursuant to 50 CFR 424.16(c)(2), we may extend or reopen a comment period upon finding that there is good cause to do so. We are currently gathering
With this document, we are reopening the public comment period on the 90-day finding and initiation of status review to complete and make available the results of our peer review on the report titled, “Genetic and morphological analysis of species limits in
Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home address, which we will honor to the extent allowable by law. If you wish us to withhold your name or address, you must state this request prominently at the beginning of your comments. However, we will not consider anonymous comments. To the extent consistent with applicable law, we will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety.
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Proposed rule; notice of availability of draft economic analysis.
We, the U.S. Fish and Wildlife Service (Service), announce the availability of the draft economic analysis for the proposal to designate critical habitat for the Pacific coast distinct population segment of the western snowy plover (
Comments must be submitted directly to the Service (see
If you wish to comment on the proposed rule or draft economic analysis, you may submit your comments and materials by any one of several methods:
1. You may submit written comments and information by mail or hand-delivery to the Arcata Fish and Wildlife Office, U.S. Fish and Wildlife Service, 1655 Heindon Road, Arcata, California 95521.
2. Written comments may be sent by facsimile to 707-822-8411.
3. You may send your comments by electronic mail (e-mail) to
You may obtain copies of the draft economic analysis by mail or by visiting our Web site at
Michael Long, Field Supervisor, Arcata Fish and Wildlife Office (telephone 707-822-7201; facsimile 707-822-8411).
We intend that any final action resulting from this proposal will be as accurate and as effective as possible. Therefore, we solicit comments or suggestions from the public, other concerned governmental agencies, the scientific community, industry, or any other interested party concerning the proposed rule and the draft economic analysis. On the basis of public comment, during the development of our final determination, we may find that areas proposed are not essential, are appropriate for exclusion under section
(1) The reasons why any habitat should or should not be determined to be critical habitat as provided by section 4 of the Act, including whether the benefits of designation will outweigh benefits of exclusion;
(2) Specific information on the distribution of the western snowy plover, the amount and distribution of the species' habitat, and which habitat is essential to the conservation of the species, and why;
(3) Land-use designations and current or planned activities in the subject area and their possible impacts on the species or proposed critical habitat;
(4) Whether our approach to listing or critical habitat designation could be improved or modified in any way to provide for greater public participation and understanding, or to assist us in accommodating public concerns and comments;
(5) Any foreseeable economic, environmental, or other impacts resulting from the proposed designation of critical habitat or coextensively from the listing, and in particular, any impacts on small entities or families;
(6) Whether the draft economic analysis identifies all State and local costs. If not, what other costs should be included;
(7) Whether the draft economic analysis makes appropriate assumptions regarding current practices and likely regulatory changes imposed as a result of the listing of the species or the proposed designation of critical habitat;
(8) Whether the draft economic analysis correctly assesses the effect on regional costs associated with the proposed designation;
(9) Whether the proposed designation will result in disproportionate economic impacts to specific areas that should be evaluated for possible exclusion from the final designation;
(10) Whether the draft economic analysis appropriately identifies all costs that could result from the designation or coextensively from the listing;
(11) Specific information that would help us further understand the effects of designation on small businesses that depend on recreation and tourism. Based on the information we receive on small business that depend on recreation and tourism, we are considering excluding areas based on disproportionate costs from the final designation per our discretion under section 4(b)(2) of the Act. We are specifically seeking comment along with additional information concerning our final determination for these three areas; and
(12) We are also considering excluding areas from the final designation, and are requesting comments on the benefits of excluding or including in critical habitat the areas as discussed in our proposed rule.
Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home addresses from the rulemaking record, which we will honor to the extent allowable by law. There also may be circumstances in which we would withhold from the rulemaking record a respondent's identity, as allowable by law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety. Comments and materials received will be available for public inspection, by appointment, during normal business hours at the above address.
If you wish to comment, you may submit your comments and materials concerning this proposal by any one of several methods (see
On December 17, 2004 (69 FR 75608), we proposed to designate as critical habitat a total of approximately 17,299 acres (ac) (7,001 hectares (ha)) within 35 units along the coasts of California, Oregon, and Washington. In developing this proposal, we evaluated those lands determined to contain habitat features essential to the conservation of the Pacific coast population of the western snowy plover to ascertain if any specific areas are appropriate for exclusion from critical habitat pursuant to section 4(b)(2) of the Act. Section 4(b)(2) requires us to take into account economic and other impacts resulting from designation, and allows us to exclude areas with essential habitat features if the benefits of exclusion outweigh those of designation. Additionally, the newly amended section 4(a)(3) requires exclusion of military lands subject to an Integrated Natural Resources Management Plan (INRMP) that benefits the species. We have excluded several units based on these provisions. Additionally, we have considered, but are not proposing, several areas that were either unoccupied at the time of listing (1993) or are unoccupied now.
For a discussion of previous Federal actions regarding the Pacific coast population of the western snowy plover, please see the December 7, 1999, final rule (64 FR 68508) and December 17, 2004, proposed rule (69 FR 75608) to designate critical habitat for the Pacific coast population of the western snowy plover. The December 7, 1999, final rule was remanded and partially vacated by the United States District Court for the District of Oregon on July 2, 2003, in order for us to conduct a new analysis of economic impacts (
Critical habitat identifies specific areas that are essential to the conservation of a listed species and that may require special management considerations or protection. If the proposed rule is made final, section 7 of the Act will prohibit adverse modification of critical habitat by any activity funded, authorized, or carried out by any Federal agency. Federal agencies proposing actions affecting areas designated as critical habitat must consult with us on the effects of their proposed actions, pursuant to section 7(a)(2) of the Act.
Section 4 of the Act requires that we consider economic and other relevant impacts prior to making a final decision on what areas to designate as critical habitat. We are announcing the availability of a draft economic analysis for the proposal to designate certain areas as critical habitat for the Pacific coast population of the western snowy plover. We may revise the proposal, or
Costs related to conservation activities for the proposed western snowy plover critical habitat pursuant to sections 4, 7, and 10 of the Act are estimated to be approximately $272.8 to $645.3 million over the next 20 years on a present value basis. In constant dollars, the draft economic analysis estimates there will be an economic impact of $514.9 to $1,222.7 million expressed in constant dollars over the next 20 years. The activities affected by plover protection may include recreation, plover management, real estate development, military base operations, and gravel extraction. Over three quarters of all future costs are associated with five central and southern California units, which include the following: Monterey to Moss Landing (CA-12C), Pismo Beach/Nipomo (CA-16), Morro Bay Beach (CA-15C), Jetty Road to Aptos (CA-12A), and Silver Strand (CA-27C). For further information, see the draft economic analysis; exhibits ES-6 and ES-7 provide detailed cost information for all activities on a unit-by-unit basis.
In accordance with Executive Order 12866, this document is a significant rule because it may raise novel legal and policy issues. However, based on our draft economic analysis, it is not anticipated that the proposed designation of critical habitat for the Pacific coast population of the western snowy plover will result in an annual effect on the economy of $100 million or more or affect the economy in a material way. Due to the timeline for publication in the
Under the Regulatory Flexibility Act (5 U.S.C. 601
According to the Small Business Administration (SBA), small entities include small organizations, such as independent nonprofit organizations, and small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents, as well as small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine if potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term significant economic impact is meant to apply to a typical small business firm's business operations.
To determine if the proposed designation of critical habitat for the Pacific coast population of the western snowy plover would affect a substantial number of small entities, we considered the number of small entities affected within particular types of economic activities (
If this proposed critical habitat designation is made final, Federal agencies must consult with us if their activities may affect designated critical habitat. Consultations to avoid the destruction or adverse modification of critical habitat would be incorporated into the existing consultation process.
In our draft economic analysis of this proposed designation, we evaluated the potential economic effects on small business entities and small governments resulting from conservation actions related to the listing of this species and proposed designation of its critical habitat. We evaluated small business entities in five categories: Habitat and plover management activities, beach-related recreation activities, residential and related development, activities on military lands, and commercial mining. Of these five categories, impacts of plover conservation to habitat and plover management, and activities on military lands are not anticipated to affect small entities as discussed in Appendix A of our draft economic analysis. The following summary of the information contained in Appendix A of the draft economic analysis provides the basis for our determination.
On the basis of our analysis of western snowy plover conservation measures, we determined that this proposed designation of critical habitat for the western snowy plover would result in potential economic effects to recreation. Section 4 of the draft economic analysis discusses impacts of restrictions on recreational activity at beaches containing potential critical habitat for the plover. Individual recreators may experience welfare losses as a result of foregone or diminished trips to the beach. If fewer trips are taken by recreators, then some local businesses serving these visitors may be indirectly affected. The scope of our analysis makes identification of the exact businesses that may be affected difficult. Presently, we do not believe that this proposed designation will have an effect on a substantial number of small businesses and would also not result in a significant effect to impacted small businesses; however, we are requesting additional information on the effects of this proposed designation for our determination in our final rule.
For development activities, a detailed analysis of impacts to these activities is presented in Section 5 of the draft economic analysis. For this analysis, we determined that two development projects occurring within the potential
For gravel mining activities, we have determined that five gravel mining companies exist within Unit CA-4D of the proposed designation of critical habitat. We determined that the annualized impact from plover conservation activities to these small businesses was approximately 0.5 percent of the total sales of these five mining companies. From this analysis, we have determined that this proposed designation would also not result in a significant effect to the annual sales of these small businesses impacted by this proposed designation.
Based on this data we have determined that this proposed designation would not affect a substantial number of small businesses involved in residential and related development and commercial gravel mining. Further, we have determined that this proposed designation would also not result in a significant effect to the annual sales of those small businesses impacted by this proposed designation. We also believe that this proposed designation would not affect a substantial number of small businesses involved in recreation and would not result in a significant effect to these businesses; however, we request further information on the impacts of this proposed designation to this economic sector for our final rulemaking. As such, we are certifying that this proposed designation of critical habitat would not result in a significant economic impact on a substantial number of small entities. Please refer to Appendix A of our draft economic analysis of this designation for a more detailed discussion of potential economic impacts to small business entities.
On May 18, 2001, the President issued Executive Order (E.O.) 13211 on regulations that significantly affect energy supply, distribution, and use. E.O. 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. The proposed rule is considered a significant regulatory action under E.O. 12866 due to it potentially raising novel legal and policy issues, but it is not expected to significantly affect energy supplies, distribution, or use. Appendix A of the draft economic analysis provides a detailed discussion and analysis of this determination. The draft economic analysis determines that none of the impacts of this proposed designation are relevant to energy supply, distribution, or use. Therefore we have determined that this proposed designation is not likely to produce “a significant adverse effect” as a result of western snowy plover conservation activities. Therefore, this action is not a significant action and no Statement of Energy Effects is required.
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501), the Service makes the following findings:
(a) This rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or tribal governments,” with two exceptions. It excludes “a condition of federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding” and the State, local, or tribal governments “lack authority” to adjust accordingly. (At the time of enactment, these entitlement programs were: Medicaid; AFDC work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement.) “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance; or (ii) a duty arising from participation in a voluntary Federal program.”
The designation of critical habitat does not impose a legally binding duty on non-Federal Government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions do not destroy or adversely modify critical habitat under section 7. Non-Federal entities that receive Federal funding, assistance, permits, or otherwise require approval or authorization from a Federal agency for an action may be indirectly impacted by the designation of critical habitat. However, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency. Furthermore, to the extent that non-Federal entities are indirectly impacted because they receive Federal assistance or participate in a voluntary Federal aid program, the Unfunded Mandates Reform Act would not apply; nor would critical habitat shift the costs of the large entitlement programs listed above on to State governments.
(b) The economic analysis discusses potential impacts of critical habitat designation for the western snowy plover including administrative costs, water management activities, oil and gas activities, concentrated animal feeding operations, agriculture, and transportation. The analysis estimates that costs of the rule could range from $272.8 to $645.3 million over the next 20 years. In constant dollars, the draft economic analysis estimates there will be an economic impact of $514.9 to $1,222.7 million over the next 20 years. Recreational activities are expected to experience the greatest economic impacts related to western snowy plover conservation activities. Impacts on small governments are not anticipated. For example, costs to recreators would not be expected to be passed on to entities that qualify as small governments. Consequently, for the reasons discussed above, we do not believe that the designation of critical habitat for the western snowy plover will significantly or uniquely affect small government entities. As such, a Small Government Agency Plan is not required.
In accordance with Executive Order 12630 (“Government Actions and Interference with Constitutionally Protected Private Property Rights”), we have analyzed the potential takings implications of proposing critical
The authority for this action is the Endangered Species Act of 1973 (16 U.S.C. 1531
U.S. Agency for International Development (USAID) has submitted the following information collections to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding this information collection are best assured of having their full effect if received within 30 days of this notification. Comments should be sent via e-mail to
U.S. Agency for International Development (USAID) has submitted the following information collections to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding this information collection are best assured of having their full effect if received within 30 days of this notification. Comments should be sent via e-mail to
Natural Resources Conservation Service (NRCS) in Oklahoma. U.S. Department of Agriculture.
Notice of Finding of No Significant Impact.
Pursuant to Section 102(2)(c) of the National Environmental Policy Act of 1969; the Council on Environmental Quality Regulations (40 CFR part 1500); and the Natural Resources Conservation Service Regulations (7 CFR part 650); the Natural Resources Conservation Service, U.S. Department of Agriculture, gives notice that an environmental impact statement is not being prepared for the Sallisaw Creek Watershed Site Nos. 32, 33, and 34 Sequoyah County, Oklahoma.
M. Darrel Dominick, State Conservationist, Natural Resources Conservation Service, 100 USDA, Suite 206, Stillwater, Oklahoma 74074, (405) 742-1206.
The environmental assessment of this federally assisted action indicates that the project will not cause significant local, regional, or national impacts on the environment. As a result of these findings, M. Darrel Dominick, State Conservationist, has determined that the preparation and review of an environmental impact statement is not needed for this project. The project purpose is flood control. The planned works of improvement include the
The Notice of a Finding of No Significant Impact (FONSI) has been forwarded to the Environmental Protection Agency and to various Federal, State, and local agencies and interested parties. A limited number of copies of the FONSI are available to fill single copy requests at the above address. Basic data developed during the environmental assessment are on file and may be reviewed by contacting M. Darrel Dominick. No administrative action on implementation of the proposal will be taken until 30 days after the date of this publication in the
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the Rural Utilities Service (RUS) invites comments on this information collection for which RUS intends to request approval from the Office of Management and Budget (OMB).
Comments on this notice must be received by October 17, 2005.
Richard C. Annan, Director, Program Development and Regulatory Analysis, Rural Utilities Service, 1400 Independence Ave., SW., STOP 1522, Room 5818, South Building, Washington, DC 20250-1522. Telephone: (202) 720-0784. Fax: (202) 720-4120.
The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8(d)]. This notice identifies an information collection that RUS is submitting to OMB for extension.
The RUS Form 595 is used as a requisition for advances of funds. The form helps to assure that loan funds are advanced only for the budget purposes and amount approved by RUS. According to the applicable provisions of the RUS loan contract, borrowers must certify with each request for funds to be approved for advance, which such funds are for projects previously approved.
When a prospective borrower requests and is granted an RUS loan, a loan contract is established between the Federal Government, acting through the RUS Administrator, and the borrower. At the time this contract is entered into, the borrower must provide RUS with a list of projects for which loan funds will be spent, along with an itemized list of the estimated costs of these projects. Thus, the borrower receives a loan based upon estimated cost figures.
RUS Form 219, Inventory of Work Orders, is one of the documents the borrower submits to RUS to support actual expenditures and an advance of loan funds. The form also serves as a connecting link and provides an audit trail that originates with the advance of funds and terminates with evidence supporting the propriety of expenditures for construction or retirement projects.
Copies of this information collection can be obtained from MaryPat Daskal, Program Development and Regulatory Analysis, at (202) 720-7853. Fax: (202) 720-4120.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the Rural Utilities Service (RUS) invites comments on this information collection for which RUS intends to request approval from the Office of Management and Budget (OMB).
Comments on this notice must be received by October 17, 2005.
Richard C. Annan, Director, Program Development and Regulatory Analysis, Rural Utilities Service, 1400 Independence Ave., SW., STOP 1522, Room 5818, South Building, Washington, DC 20250-1522. Telephone: (202) 720-0784. Fax: (202) 720-4120.
The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8(d)]. This notice identifies an information collection that RUS is submitting to OMB for reinstatement.
Comments are invited on: (a) Whether this collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology. Comments may be sent to Richard C. Annan, Director, Program Development and Regulatory Analysis, Rural Utilities Service, U.S. Department of Agriculture, STOP 1522, 1400 Independence Ave., SW., Washington, DC 20250-1522. Fax: (202) 720-0784.
• Appropriate standards and specifications are maintained;
• RUS loan security is not adversely affected; and
• Loan and loan guarantee funds are used effectively and for the intended purpose.
Standardization of forms by RUS results in substantial savings to:
• Borrowers—If standard forms were not used, borrowers would need to prepare their own documents at significant expense; and
• Government—If standard forms were not used, each document submitted by a borrower would require extensive and costly review by both RUS and the Office of General Counsel.
Copies of this information collection can be obtained from MaryPat Daskal, Program Development and Regulatory Analysis, at (202) 720-7853. Fax: (202) 720-4120.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the Rural Utilities Service (RUS) invites comments on this information collection for which RUS intends to request approval from the Office of Management and Budget (OMB).
Comments on this notice must be received by October 17, 2005.
Richard C. Annan, Director, Program Development and Regulatory Analysis, Rural Utilities Service, 1400 Independence Ave., SW., STOP 1522, Room 5818 South Building, Washington, DC 20250-1522. Telephone: (202) 720-0784. FAX: (202) 720-4120.
The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS is submitting to OMB for reinstatement.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Richard C. Annan, Director, Program Development and Regulatory Analysis, Rural Utilities Service, U.S. Department of Agriculture, STOP 1522, 1400 Independence Ave., SW., Washington, DC 20250-1522. FAX: (202) 720-4120.
Copies of this information collection can be obtained from MaryPat Daskal, Program Development and Regulatory Analysis, at (202) 720-7853. FAX: (202) 720-4120. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Import Administration, International Trade Administration, Department of Commerce.
August 16, 2005.
Stephen Bailey, AD/CVD Operations, Office 7, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone (202) 482-0193.
On May 10, 2005, the Department of Commerce (“the Department”) published the preliminary results of the administrative review of the antidumping duty order on oil country tubular goods (“OCTG”) from Mexico covering the period August 1, 2003, through July 31, 2004.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended by the Uruguay Round Agreements Act (“the Act”), requires the Department to issue the preliminary results of an administrative review within 245 days after the last day of the anniversary month of an antidumping duty order for which a review is requested and issue the final results within 120 days after the date on which the preliminary results are published. However, if it is not practicable to complete the review within the time period, section 751(a)(3)(A) of the Act allows the Department to extend these deadlines to a maximum of 365 days and 180 days, respectively.
Due to the complexity of issues present in this administrative review, such as universe of sales issues and constructed value calculations, as well as the Department's current demands of other proceedings, the Department has determined that it is not practicable to complete this review within the original time period. Accordingly, the Department is extending the time for completion of the final results, until no later than October 7, 2005, in accordance with section 751(a)(3)(A) of the Act.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
August 16, 2005.
Patrick Edwards, AD/CVD Operations, Office 7, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone (202) 482-8029.
On May 10, 2005, the Department of Commerce (“the Department”) published the preliminary results of the administrative review of the antidumping duty order on small diameter seamless carbon and alloy steel standard, line and pressure pipe (“line and pressure pipe”) from Brazil covering the period August 1, 2003, through July 31, 2004.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended by the Uruguay Round Agreements Act (“the Act”), requires the Department to issue the preliminary results of an administrative review within 245 days after the last day of the anniversary month of an antidumping duty order for which a review is requested and issue the final results within 120 days after the date on which the preliminary results are published. However, if it is not practicable to complete the review within the time period, section 751(a)(3)(A) of the Act allows the Department to extend these deadlines to a maximum of 365 days and 180 days, respectively.
Due to the complexity of issues present in this administrative review, such as model match characteristics and establishing the appropriate foreign like product, as well as the Department's current demands of other proceedings, the Department has determined that it is not practicable to complete this review within the original time period. Accordingly, the Department is extending the time limit for completion of the final results until no later than October 7, 2005, in accordance with section 751(a)(3)(A) of the Act.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
NAFTA Secretariat, United States Section, International Trade Administration, Department of Commerce.
Notice of decision and completion of the Extraordinary Challenge Committee.
On August 10, 2005, the Extraordinary Challenge Committee (ECC) issued its decision in the matter of Certain Softwood Lumber Products from Canada, Secretariat File No. ECC-2004-1904-01USA.
Caratina L. Alston, United States Secretary, NAFTA Secretariat, Suite 2061, 14th and Constitution Avenue, Washington, DC 20230, (202) 482-5438.
Chapter 19 of the North American Free-Trade Agreement (“Agreement”) establishes a mechanism to replace domestic judicial review of final determinations in antidumping and countervailing duty cases involving imports from a NAFTA country with review by independent binational panels. When a Request for Panel Review is filed, a panel is established to act in place of national courts to review expeditiously the final determination to determine whether it conforms with the antidumping or countervailing duty law of the country that made the determination.
Under Article 1904 of the Agreement, which came into force on January 1, 1994, the Government of the United States, the Government of Canada and the Government of Mexico established
(b) Except on the issue of export orientation, the Panel did not exceed its powers, authority or jurisdiction by failing to apply the appropriate standard of review;
(c) On the issue of export orientation, the Panel's failure to apply the appropriate standard of review was not material; and
(d) The conduct of Panelist Mastriani did not create a reasonable apprehension of bias.
In light of these conclusions (except with regard to the Panel's finding of no substantial evidence on the finding on issue export orientation), it is not necessary for us to determine whether, if the Panel had committed any of the errors alleged, they would have been material to the Panel's decision or threatened the integrity of the binational panel review process.
Accordingly, pursuant to NAFTA Annex 1904.13, this challenge is denied and the challenged decision of the Panel stands affirmed.
The Committee Members are hereby discharged from their duties effective August 11, 2005.
Commodity Futures Trading Commission.
10 a.m., Thursday, August 25, 2005.
1155 21st St., NW., Washington, DC, 9th Floor Commission Conference Room.
Closed.
Rule Enforcement Review.
Jean A. Webb, (202) 418-5100.
Department of Education.
The Acting Director, Regulatory Information Management Services, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before October 17, 2005.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Acting Director, Regulatory Information Management Services, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the
Responses: 25.
Burden Hours: 200.
Requests for copies of the proposed information collection request may be accessed from
Comments regarding burden and/or the collection activity requirements should be directed to Kathy Axt at her e-mail address
Department of Education.
Notice of proposed information collection requests.
The Acting Director, Regulatory Information Management Services, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
An emergency review has been requested in accordance with the Act (44 U.S.C. Chapter 3507 (j)), since public harm is reasonably likely to result if normal clearance procedures are followed. Approval by the Office of Management and Budget (OMB) has been requested by August 24, 2005.
Written comments regarding the emergency review should be addressed to the Office of Information and Regulatory Affairs, Attention: Rachel Potter, Desk Officer, Department of Education, Office of Management and Budget; 725 17th Street, NW., Room 10222, New Executive Office Building, Washington, DC 20503 or faxed to (202) 395-6974.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Director of OMB provide interested Federal agencies and the public an early opportunity to comment on information collection requests. The Office of Management and Budget (OMB) may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Acting Director, Regulatory Information Management Services, Office of the Chief Information Officer, publishes this notice containing proposed information collection requests at the beginning of the Departmental review of the information collection. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner, (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected, and (5) how might the Department minimize the burden of this collection on respondents, including through the use of information technology.
Responses: 737,209.
Burden Hours: 147,443.
Requests for copies of the information collection submission for OMB review may be accessed from
Comments regarding burden and/or the collection activity requirements should be directed to Joseph Schubart at
Department of Education.
The Acting Director, Regulatory Information Management Services, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before October 17, 2005.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Acting Director, Regulatory Information Management Services, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
Responses: 52.
Burden Hours: 2,080.
Requests for copies of the proposed information collection request may be accessed from
Comments regarding burden and/or the collection activity requirements should be directed to Kathy Axt at her e-mail address
Take notice that on August 3, 2005, CenterPoint Energy Gas Transmission Company (CEGT) tendered for filing as part of its FERC Gas Tariff, Sixth Revised Volume No. 1, First Revised Sheet No. 884, and Second Revised Sheet No. 885, to be effective March 31, 2005.
CEGT states that the purpose of this filing is to reflect the termination of negotiated rates with respect to a transaction.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Central Illinois Generation, Inc. (CIGI) filed an application for market-based rate authority, with an accompanying rate tariff. The proposed rate tariff provides for wholesale sales of energy, capacity and ancillary services at market-based rates. CIGI also requested waiver of various Commission regulations. In particular, CIGI requested that the Commission grant blanket approval under 18 CFR part 34 of all future issuances of securities and assumptions of liability by CIGI.
On October 25, 2002, the Commission granted the request for blanket approval under part 34, subject to the following:
Any person desiring to be heard or to protest the blanket approval of issuances of securities or assumptions of liability by CIGI should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure. 18 CFR 385.211, 385.214 (2004).
Notice is hereby given that the deadline for filing motions to intervene or protest, is August 19, 2005.
Absent a request to be heard in opposition by the deadline above, CIGI is authorized to issue securities and assume obligations or liabilities as a guarantor, endorser, surety, or otherwise in respect of any security of another person; provided that such issuance or assumption is for some lawful object within the corporate purposes of CIGI, compatible with the public interest, and is reasonably necessary or appropriate for such purposes.
The Commission reserves the right to require a further showing that neither public nor private interests will be adversely affected by continued approval of CIGI's issuances of securities or assumptions of liability.
Copies of the full text of the Director's Order are available from the Commission's Public Reference Room, 888 First Street, NE., Washington, DC 20426. The Order may also be viewed on the Commission's Web site at
Take notice that on July 29, 2005, Chandeleur Pipe Line Company (Chandeleur) tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 1, Fourth Revised Tariff Sheet No. 73, to become effective September 1, 2005.
Chandeleur states the filing is being made to reflect current negotiated rate transaction information as required by section 24.3 of Chandeleur's tariff. Chandeleur also states that the proposed change is necessary to delete the information for a contract reflecting a termination date of August 31, 2005.
Chandeleur states that it has served copies of the filing on its customers, State Commissions and interested parties.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the following application has been filed with the Commission and is available for public inspection:
a.
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e.
f.
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h.
i.
j.
All documents (original and eight copies) should be filed with: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Please include the project number (P-8929-003) on any comments or motions filed. Comments, protests, and interventions may be filed electronically via the internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages e-filings.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n. Comments, Protests, or Motions to Intervene—Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Responsive Documents—Any filings must bear in all capital letters the title “COMMENTS”, “RECOMMENDATIONS FOR TERMS AND CONDITIONS”, “PROTEST”, or “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
p. Agency Comments—Federal, State, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives.
q. Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
On August 3, 2005, Dominion Transmission, Inc. (Dominion), pursuant to section 7(b) of the Natural Gas Act, and Part 157 of the regulations of the Federal Energy Regulatory Commission (Commission) filed an abbreviated application for emergency abandonment of three wells at its Oakford Storage Complex located in Westmoreland County, Pennsylvania. Dominion states that deteriorated conditions of the wells' production casings necessitate this action to prevent rupture and gas leakage. Construction and operation of the storage field was originally authorized in 1950. This filing is available for review at the Commission or may be viewed on the Commission's Web site at
Questions concerning the application may be directed to Matthew R. Bley, Certificates Manager, Dominion Transmission, Inc., 120 Tredegar Street, Richmond, Virginia 23219, by calling (804) 819-2877, or facsimile (804) 819-2064.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 14 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding. However, a person does not have to intervene in order to have comments considered.
The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages intervenors to file electronically.
Take notice that on August 5, 2005, Eastern Shore Natural Gas Company (Eastern Shore) tendered for filing revised tariff sheets, proposed to be effective July 1, 2005, to eliminate its Cash Out Surcharge rate for the twelve-month period commencing July 1, 2005.
Eastern Shore states that, as a result of its Cash Out Account Balance at March 31, 2005 being in a refund position, Eastern Shore shall refund such balance of $386,237 to its customers. As a further result of such refund Eastern Shore shall also reduce its Cash Out Surcharge rate from $0.0033 to $0.0000 per dekatherm.
Eastern Shore states that section 35, of the General Terms & Conditions (GT & C) of its FERC Gas Tariff, entitled Cash Out Refund/Surcharge, provides that Eastern Shore will refund or surcharge for each annual billing period any difference between the revenues received and the costs incurred under the cash out provisions of its tariff.
The annual billing period referenced above shall be the twelve-month period commencing April 1st and ending the following March 31st. Subsequent to the end of each such annual billing period Eastern Shore shall compare the revenues received by it under the cash-out procedures to the costs incurred. If the revenues received exceed the costs incurred, then Eastern Shore shall refund the net overrecoveries to firm transportation customers on a pro rata basis in accordance with the transportation quantities Eastern Shore delivered during the annual billing period. If the revenues received are less than the costs incurred, then Eastern Shore shall recover the net under recoveries by means of a surcharge applicable to each dekatherm delivered to all firm and interruptible transportation customers. Such surcharge, to be effective July 1 of each year, shall be calculated by dividing the net under recovered balance by the total transportation quantities delivered by Eastern Shore during the annual billing period.
Eastern Shore states that copies of its filing has been mailed to its customers and interested state commissions.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the date as indicated below. Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 3, 2005, El Paso Natural Gas Company (EPNG) tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 1A, Seventh Revised Sheet No. 210 and Fifth Revised Sheets No. 210.01, to become effective September 3, 2005.
EPNG states that the tariff sheets extend the nomination deadline by fifteen minutes.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the following application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
All documents (original and eight copies) should be filed with: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Comments, protests, and interventions may be filed electronically via the Internet in lieu of paper. Any questions, please contact the Secretary's Office. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
Please include the docket number (DI05-3-000) on any comments, protests, or motions filed.
k.
When a Declaration of Intention is filed with the Federal Energy Regulatory Commission, the Federal Power Act requires the Commission to investigate and determine if the interests of interstate or foreign commerce would be affected by the project. The Commission also determines whether or not the project: (1) Would be located on a navigable waterway; (2) would occupy or affect public lands or reservations of the United States; (3) would utilize surplus water or water power from a government dam; or (4) if applicable, has involved or would involve any construction subsequent to 1935 that may have increased or would increase the project's head or generating capacity, or have otherwise significantly modified the project's pre-1935 design or operation.
l.
If the prototype is determined to be required to be licensed, Energetech requests the Commission to issue a license on the basis of the Rhode Island Coastal Resource Management Council's (CRMC) decision and the record established in connection therewith, adopting the same or similar license conditions or provisions to avoid conflicts. Further, Energetech requests that the Commission waive all of its requirements relating to applications for exemption from licensing and accept the application to the CRMC in its entirety (once determined to be technically and administratively complete) as a complete application for exemption for licensing, waive the procedural requirements for consideration for such an application from exemption from licensing, and grant Energetech such an exemption from licensing for the project.
m.
n. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
o. Comments, Protests, or Motions to Intervene—Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
p. Filing and Service of Responsive Documents—Any filings must bear in all capital letters the title “COMMENTS”, “PROTESTS”, and/or “MOTIONS TO INTERVENE”, as applicable, and the Docket Number of the particular application to which the filing refers. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
q. Agency Comments—Federal, State, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives.
Take notice that on July 29, 2005, Gas Transmission Northwest Corporation (GTN) tendered for filing as part of its
GTN states that this sheet is being filed to reflect the continuation of a negotiated rate agreement pursuant to evergreen provisions contained in the agreement.
GTN further states that a copy of this filing has been served on GTN's jurisdictional customers and interested state regulatory agencies.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on July 29, 2005, High Island Offshore System, L.L.C. (HIOS) tendered for filing as part of its FERC Gas Tariff, Third Revised Volume No. 1, Substitute Eighth Revised Sheet No. 170, to be made effective September 1, 2005.
HIOS states that the tariff sheet is being filed to correct the pagination of the tariff sheet filed on July 21, 2005, in compliance with the Federal Energy Regulatory Commission's Order No. 587-S issued May 9, 2005, requiring pipelines to adopt the standards promulgated by the Wholesale Gas Quadrant (WGQ) of the North American Energy Standards Board (NAESB).
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on July 29, 2005, Northern Natural Gas Company (Northern) tendered for filing to become part of its FERC Gas Tariff, Fifth Revised Volume No. 1, Substitute Seventh Revised Sheet No. 146 and Original Sheet No. 146A, with an effective date of July 16, 2005.
Northern states that it is filing the above-referenced tariff sheets in compliance with the Commission's July 15, 2005 Order conditionally accepting Northern's revisions to its IDD Rate Schedule with respect to IDD Inventory Allocations.
Northern further states that copies of the filing have been mailed to each of its customers and interested State Commissions.
Any person desiring to protest this filing must file in accordance with Rule 211 of the Commission's Rules of Practice and Procedure (18 CFR 385.211). Protests to this filing will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Such protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing a protest must serve a copy of that document on all the parties to the proceeding.
The Commission encourages electronic submission of protests in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 4, 2005, Northern Natural Gas Company (Northern) tendered for filing to become part of its FERC Gas Tariff, Fifth Revised Volume No. 1, the following tariff sheets proposed to be effective on May 1, 2005 and June 1, 2005 as follows:
Northern states that the above tariff sheets are being filed to incorporate the tariff language addressing the rate treatment for the Waterville storage point, approved by the Commission in Docket No. RP05-229-000, effective May 1, 2005, into the tariff sheets containing the settlement rates in Docket Nos. RP03-398-000 and RP04-155-000, effective May 1, 2005, and the tariff sheets containing Northern's fuel and unaccounted for percentages approved by the Commission in Docket No. RP05-296-000, effective June 1, 2005.
Northern further states that copies of the filing have been mailed to each of its customers and interested State Commissions.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice t hat on July 29, 2005, Paiute Pipeline Company (Paiute) filed a motion pursuant to section 4(e) of the Natural Gas Act and section 154.206(a) of the Commission's regulations to make effective on August 1, 2005 the rates and the tariff sheets that were previously accepted and suspended, subject to refund and hearing, in connection with Paiute's application for general rate relief in Docket No. RP05-163-000. As part of its motion, Paiute has tendered for acceptance Fourteenth Revised Sheet No. 10 of Second Revised Volume No. 1-A of its FERC Gas Tariff, to be effective August 1, 2005.
Paiute indicates that in order to comply with the requirements of section 4(e) of the Natural Gas Act and sections 154.206(a) and 154.303(c)(2) of the Commission's regulations, as well as the Commission's February 28, 2005 suspension order in this proceeding, Paiute is submitting its motion for filing (1) to revise the rates proposed in its application in this proceeding to reflect the exclusion of costs associated with facilities which will not be placed in service as of July 31, 2005; and (2) to move to place the revised rates and other previously accepted and suspended tariff sheets into effect.
Paiute states that it has served a copy of this filing upon each person designated on the official service list compiled by the Secretary in this proceeding, and upon all affected customers and interested state regulatory commissions.
Any person desiring to protest this filing must file in accordance with Rule 211 of the Commission's Rules of Practice and Procedure (18 CFR 385.211). Protests to this filing will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Such protests must be filed on or before the date as indicated below. Anyone filing a protest must serve a copy of that document on all the parties to the proceeding.
The Commission encourages electronic submission of protests in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 5, 2005, the Public Utility District No. 1 of Snohomish County, Washington filed a Petition for an Order Pursuant to the Commission's Exclusive Jurisdiction Declaring that a Termination Payment Charged by Enron Power Marketing, Inc. is Unjust, Unreasonable, Contrary to the Public Interest and/or Not Permitted under a Rate Schedule, or in the Alternative, Complaint Against Enron Power Marketing, Inc., pursuant to sections 205, 206, 306 and 309 of the Federal Power Act, 16 U.S.C. 824d, 824e, 825e and 825h, section 1290 (Relief For Extraordinary Violations) of the Energy Policy Act of 2005, and Rules 206 and 207 of the Federal Energy Regulatory Commission's Rules of Practice and Procedure, 18 CFR 385.206 and 385.207.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214) on or before 5 p.m. Eastern time on the specified comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Complainant. Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 4, 2005, Questar Pipeline Company (Questar), tendered for filing as part of its FERC Gas Tariff, First Revised Volume No. 1 and Original Volume No. 3, to be effective as indicated for each tariff sheet:
First Revised Thirty-Third Revised Sheet No. 5, effective June 1, 2005. First Revised Substitute Thirty-Fourth Revised Sheet No. 5, effective June 21, 2005. First Revised Substitute Thirty-Fifth Revised Sheet No. 5, effective July 25, 2005. First Revised Fifteenth Revised Sheet No. 5A, effective June 1, 2005. First Revised Sixteenth Revised Sheet No. 5A, effective June 21, 2005. First Revised Seventeenth Revised Sheet No. 5A, effective July 25, 2005.
First Revised Fortieth Revised Sheet No. 8, effective June 1, 2005. First Revised Forty-First Revised Sheet No. 8, effective August 15, 2005.
On June 17, 2005, Questar filed an uncontested offer of settlement to resolve all issued raised in these proceedings concerning Questar's Fuel Gas Reimbursement Percentage (FGRP). The Commission's July 26 order approved the settlement and directed Questar to file tariff sheets within ten days to implement the tariff provisions consistent with the settlement. Questar states that this filing was submitted in compliance with the Commission's directives.
In the intervening time period between the June 1, 2005, effective date of the settlement and the present time, additional tariff sheets have been filed in separate proceedings that contain the previous FGRP of 2.6 percent. This filing proposes to also submit conforming changes to those sheets consistent with the July 26 order. These revised tariff sheets will contain effective dates according to the proceedings in which they originated and will include the new FGRP of 2.1 percent and a corresponding footnote explaining the FGRP provisions.
Questar states that copies of this filing were served upon Questar's customers, the Public Service Commission of Utah and the Public Service Commission of Wyoming.
Any person desiring to protest this filing must file in accordance with Rule 211 of the Commission's Rules of Practice and Procedure (18 CFR 385.211). Protests to this filing will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Such protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing a protest must serve a copy of that document on all the parties to the proceeding.
The Commission encourages electronic submission of protests in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on July 12, 2005, Southern California Edison Company (SCE) and Mountainview Power Company LLC (MVL) submitted a request for waiver of the application of the application of Financial Accounting Standards Board Emerging Issues Task Force Issue No. 01-8 (EITF 01-8) and related lease accounting literature to their respective Form 1 financial statements.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 4, 2005, Southern Star Central Gas Pipeline, Inc. (Southern Star) tendered for filing its interruptible excess refund report for the one-month period ended October 2004.
Pursuant to Article V, section A of the November 27, 1996, Stipulation and Agreement (Settlement) in the above named docket, approved by order of the Commission dated March 7, 1997, and section 12 of the General Terms and Conditions (GT&C) of Southern Star's FERC Gas Tariff pertinent to the crediting of interruptible service revenues related to ITS/ISS and Authorized Overrun Service (ADS), Southern Star Central Gas Pipeline, Inc. (Southern Star) hereby files its interruptible excess refund report for the one-month period ended October 31, 2004.
Southern Star states that copies of the filing were served on all parties on the Commission's official service list in this proceeding.
Any person desiring to protest this filing must file in accordance with Rule 211 of the Commission's Rules of Practice and Procedure (18 CFR 385.211). Protests to this filing will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Such protests must be filed on or before the date as indicated below. Anyone filing a protest must serve a copy of that document on all the parties to the proceeding.
The Commission encourages electronic submission of protests in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 2, 2005, Tennessee Gas Pipeline Company (Tennessee) tendered for filing as part of its FERC Gas Tariff, Fifth Revised Volume No. 1, to become effective July 1, 2005:
Tennessee states that these tariff sheets are being filed to correct calculation errors made during the preparation of, and included in, the July 29, 2005, Termination of the GSR Interruptible Surcharge filing. Accordingly, Tennessee is submitting substitute revised tariff sheets to reflect the correct rates under Rate Schedules PAT, IT, and IT-X and Tennessee's Authorized Overrun Rate Schedules FT-A, FT-G, and FT-BH.
Any person desiring to protest this filing must file in accordance with Rule 211 of the Commission's Rules of Practice and Procedure (18 CFR 385.211). Protests to this filing will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Such protests must be filed in accordance with the provisions of Section 154.210 of the Commission's
The Commission encourages electronic submission of protests in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 4, 2005, Tennessee Gas Pipeline Company (Tennessee) tendered for filing as part of its FERC Gas Tariff, Fifth Revised Volume No. 1, the following tariff sheets, to become effective September 3, 2005:
Tennessee states that the purpose of Tennessee's filing is to revise certain of Tennessee's pro forma transportation and storage agreements (Service Agreements) to provide that for Service Agreements that are less than one year, notice of termination may be provided via PASSKEY, which is accessed from Tennessee's interactive Internet Web site.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 3, 2005, TransColorado Gas Transmission Company (TransColorado) tendered for filing a corrected version of its annual revenue sharing report in accordance with the provisions of the Settlement in Docket No. RP99-106 and the Commission's Order dated April 24, 2002.
TransColorado states that the corrected version of the report is intended to correct an error in the original version of the annual revenue sharing report that was submitted on June 1, 2005, and approved by the Commission in a letter order in Docket No. RP99-106-010, dated July 12, 2005. TransColorado requests expedited Commission action on the corrected annual revenue sharing report and commits to make refunds to its shippers within 10 days of Commission acceptance of the corrected annual revenue sharing report.
TransColorado states that a copy of this filing has been served upon all parties listed on the official service list in this proceeding.
Any person desiring to protest this filing must file in accordance with Rule 211 of the Commission's Rules of Practice and Procedure (18 CFR 385.211). Protests to this filing will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Such protests must be filed on or before the date as indicated below. Anyone filing a protest must serve a copy of that document on all the parties to the proceeding.
The Commission encourages electronic submission of protests in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 4, 2005, Transcontinental Gas Pipe Line Corporation (Transco) tendered for filing an executed copy of a second amendment to the May 4, 2001 negotiated rate service agreement under Rate Schedule FT, between Transco and Carolina Power & Light Company. Transco states that the filing is made to comply with the Commission's July 5, 2005 order in Docket No. RP96-359-024.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 1, 2005, Trunkline Gas Company, LLC (Trunkline), P. O. Box 4967, Houston, Texas 77210-4967, filed in Docket No. CP05-397-000, an abbreviated application pursuant to section 7(b) of the Natural Gas Act (NGA) to abandon, by sale, a lateral consisting of approximately 7.26 miles of 10-inch pipeline located in High Island A-376, Offshore Texas, and certain laterals in Blocks 268, 269 and 281, South Marsh Island Area (North Addition), Offshore, Louisiana to the Apache Corporation. Trunkline also requests a determination under section 1(b) of the NGA the upon abandonment the subject facilities with be non-jurisdictional gathering facilities, all as more fully set forth in the application which is on file with the Commission and open to public inspection. This filing may be also viewed on the Web at
Any questions regarding this application may be directed to William W. Grygar, Vice President, Rates and Regulatory Affairs, at (713) 989-7000, Trunkline Gas Company, LLC, 5444 Westheimer Road, Houston, Texas 77056.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, before the comment date of this notice, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 14 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link.
Take notice that on August 4, 2005, Wyoming Interstate Company (WIC) tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 2, the following tariff sheets to become effective September 5, 2005:
WIC states that these tariff sheets are filed to establish provisions regarding the reservation of capacity for future expansion projects.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
The following filings have been made with the Commission. The filings are listed in ascending order within each docket classification.
Take notice that on August 2, 2005, Dartmouth Power Associates Limited Partnership (Dartmouth Power) submitted an application requesting authorization under section 203 of the Federal Power Act of a disposition of jurisdictional facilities that would result from the proposed indirect transfer of 100 percent of the interests in Dartmouth Power to Morris Energy Group, LLC, or its wholly-owned subsidiary. Dartmouth Power states that it is a public utility within the meaning of section 201(e) of the Federal Power Act.
Take notice that on August 5, 2005, Ameren Services Company (Ameren Services), on behalf of Ameren Energy Development Company (AED), Ameren Energy Marketing Company (AEM), AmerenEnergy Medina Valley Cogen (No. 4), L.L.C. (Medina Valley), and Electric Energy, Inc. (EEI) (collectively, AED, AEM, Medina Valley and EEI are also referred to as Applicants), submitted an application pursuant to section 203 of the Federal Power Act, and Part 33 of the Commission regulations, 18 CFR Part 33, requesting all Commission authorizations and approvals necessary for AED to receive as a contribution from Ameren Energy Resources Company (AER) all of AER's stock ownership in AEM, and EEI, and through its acquisition of AmerenEnergy Medina Valley Cogen, (No. 4) L.L.C. (Medina No. 4), indirect ownership of Medina Valley.
Ameren Services states that this filing have been served on all affected state commissions.
On August 5, 2005, Boston Generating, LLC (Boston Generating) and its three wholly-owned subsidiaries, Mystic I, LLC, Mystic Development, LLC, and Fore River Development, LLC (Project Companies), Tyr Energy, LLC (Tyr), K Road BG Management LLC (K Road BG Management), EBG Holdings, LLC (EBG) and K Road BG LLC (“K Road BG”) (collectively, Applicants), submitted a request for authorization pursuant to Section 203 of the Federal Power Act for a change in control of Boston Generating's Project Companies by the replacement of the current asset manager, Tyr, with a new asset manager, K Road BG Management; to the extent required, authorization for the indirect disposition of jurisdictional assets as a result of certain proposed changes in the ownership, management and scope of operations of EBG; blanket authorization for certain categories of future transfers or changes of ownership or control of membership interests in EBG.
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (19 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protests to the Federal Energy Regulatory Commission,
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available to review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail
Take notice that the Commission received the following electric rate filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other and the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St. NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the web site that enables subscribers to receive email notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please email
Take notice that the Commission received the following electric rate filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other and the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St. NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail
Take notice that the following application has been filed with the
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
All documents (original and eight copies) should be filed with: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Comments, protests, and interventions may be filed electronically via the Internet in lieu of paper. Any questions, please contact the Secretary's Office. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at:
Please include the docket number (DI05-4-000) on any protests, comments or motions filed.
k.
When a Petition for Declaratory Order is filed with the Federal Energy Regulatory Commission, the Federal Power Act requires the Commission to investigate and determine if the interests of interstate or foreign commerce would be affected by the project. The Commission also determines whether or not the project: (1) Would be located on a navigable waterway; (2) would occupy or affect public lands or reservations of the United States; (3) would utilize surplus water or water power from a government dam; or (4) if applicable, has involved or would involve any construction subsequent to 1935 that may have increased or would increase the project's head or generating capacity, or have otherwise significantly modified the project's pre-1935 design or operation.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n. Comments, Protests, or Motions to Intervene—Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Responsive Documents—any filings must bear in all capital letters the title “COMMENTS”, “PROTESTS”, or “MOTIONS TO INTERVENE”, as applicable, and the Docket Number of the particular application to which the filing refers. A copy of any motion to intervene must also be served upon each representative of the applicant specified in the particular application.
p. Agency Comments—Federal, State, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the applicant's representatives.
The Federal Energy Regulatory Commission (Commission) hereby gives notice that on August 16, 2005, members of its staff will attend a stakeholder meeting on the California Independent System Operator Corporation's (CAISO) proposed Reliability Must Run (RMR) designations for 2006. This meeting will be held at the CAISO's facility, located at 151 Blue Ravine Road, Folsom, CA 95630.
Sponsored by the CAISO, the meeting is open to the public, and staff's attendance is part of the Commission's ongoing outreach efforts. The meeting may discuss matters at issue in Docket No. ER02-1656-000.
For further information, contact Katherine Gensler at
Take notice that an informal settlement conference will be convened in this proceeding commencing at 10 a.m. (EST) on Tuesday, August 16, 2005 and continuing, if necessary, on Wednesday, August 17, 2005 at 10 a.m. (EST) at the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, for the purpose
Any party, as defined by 18 CFR 385.102(c), or any participant as defined by 18 CFR 385.102(b), is invited to attend. Persons wishing to become a party must move to intervene and receive intervenor status pursuant to the Commission's regulations (18 CFR 385.214).
FERC conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an e-mail to
For additional information, please contact Lorna J. Hadlock (202-502-8737).
This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.
Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary, a copy of the communication, if written, or a summary of the substance of any oral communication.
Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.
Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).
The following is a list of off-the-record communications recently received in the Office of the Secretary. The communications listed are grouped by docket numbers in ascending order. These filings are available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Southwestern Power Administration, DOE.
Notice of public review and comment.
The Administrator, Southwestern Power Administration (Southwestern), has prepared Current and Revised 2005 Power Repayment Studies which show the need for an increase in annual revenues to meet cost recovery criteria. Such increased revenues are needed primarily to cover increased investments and replacements in hydroelectric generating and high-voltage transmission facilities and increased operation and maintenance expenses. The Administrator has developed proposed Integrated System rates, which are supported by a rate design study, to recover the required revenues. Beginning January 1, 2006, and thereafter, the proposed rates would increase annual system revenues approximately 7.1 percent from $124,552,200 to $133,342,029.
The consultation and comment period will begin on the date of publication of this
1. Public Information Forum—August 30, 2005, 9 a.m., Tulsa, OK.
2. Public Comment Forum—September 29, 2005, 9 a.m., Tulsa, OK.
The forums will be held in Southwestern's offices, Room 1460, Williams Center Tower I, One West Third Street, Tulsa, Oklahoma 74103.
Mr. Forrest E. Reeves, Assistant Administrator, Office of Corporate Operations, Southwestern Power Administration, U.S. Department of Energy, One West Third Street, Tulsa, Oklahoma 74103, (918) 595-6696,
Originally established by Secretarial Order No. 1865 dated August 31, 1943, Southwestern is an agency within the U.S. Department of Energy which was created by an Act of the U.S. Congress, entitled the Department of Energy Organization Act, Pub. L. 95-91, dated August 4, 1977. Guidelines for preparation of power repayment studies are included in DOE Order No. RA 6120.2 entitled Power Marketing Administration Financial Reporting. Procedures for Public Participation in Power and Transmission Rate Adjustments of the Power Marketing Administrations are found at title 10, part 903, subpart A of the Code of Federal Regulations (10 CFR part 903). Procedures for the confirmation and approval of rates for the Federal Power Marketing Administrations are found at title 18, part 300, subpart L of the Code of Federal Regulations (18 CFR part 300).
Southwestern markets power from 24 multi-purpose reservoir projects with hydroelectric power facilities constructed and operated by the U.S. Army Corps of Engineers. These projects are located in the states of Arkansas, Missouri, Oklahoma, and Texas. Southwestern's marketing area includes these States plus Kansas and Louisiana. The costs associated with the hydropower facilities of 22 of the 24 projects are repaid via revenues received under the Integrated System rates, as are those of Southwestern's transmission facilities, which consist of 1,380 miles of high-voltage transmission lines, 24 substations, and 46 microwave and VHF radio sites. Costs associated with the Sam Rayburn and Robert D. Willis Dams, two Corps of Engineers projects that are isolated hydraulically, electrically, and financially from the Integrated System are repaid under separate rate schedules and are not addressed in this notice.
Following Department of Energy guidelines, the Administrator, Southwestern, prepared a Current Power Repayment Study using existing system rates. The Study indicates that Southwestern's legal requirement to repay the investment in power generating and transmission facilities for power and energy marketed by Southwestern will not be met without an increase in revenues. The need for increased revenues is primarily due to increased Operations and Maintenance (O&M) power-related expenses for the U.S. Army's Corps of Engineers and increased investments in the hydroelectric generating facilities. Southwestern's operations and maintenance expenses have also increased from the previous power repayment studies. The Revised Power Repayment Study shows that additional annual revenues of $8,789,829, (a 7.1 percent increase), beginning January 1, 2006, are needed to satisfy repayment criteria.
A Rate Design Study has also been completed which allocates the revenue requirement to the various system rate schedules for recovery, and provides for transmission service rates in general conformance with FERC Order Nos. 888 (A-C). The proposed new rates would increase estimated annual revenues from $124,552,200 to $133,342,029 and would satisfy the present financial criteria for repayment of the project and transmission system investments within the required number of years. As indicated in the Integrated System Rate Design Study, this revenue would be developed primarily through increases in the charges for power sales capacity and energy and transmission services, to include some of the ancillary services for deliveries of both Federal and non-Federal power and associated energy from the transmission system of Southwestern.
A second component of the Integrated System rates for power and energy, the purchased power adder, produces revenues which are segregated to cover the cost of power purchased to meet contractual obligations. The purchased power adder is established to reflect what is expected to be needed by Southwestern to meet purchased power needs on an average annual basis. It has been increased from the existing rate to reflect the projected power costs based on present market rates. The Administrator's authority to adjust the purchased power adder annually at his discretion will remain the same.
Below is a general comparison of the existing and proposed system rates:
Opportunity is presented for Southwestern's customers and other interested parties to receive copies of the Integrated System Studies. If you desire a copy of the Integrated System Power Repayment Studies and Rate Design Study Data Package, submit your request to Mr. Forrest E. Reeves, Assistant Administrator, Office of Corporate Operations, Southwestern Power Administration, One West Third, Tulsa, OK 74103 (918) 595-6696.
A Public Information Forum is scheduled on August 30, 2005, to explain to the public the proposed rates and supporting studies. The proceeding will be transcribed. A chairman, who will be responsible for orderly procedure, will conduct the Forum. Questions concerning the rates, studies, and information presented at the Forum will be answered, to the extent possible, at the Forum. Questions not answered at the Forum will be answered in writing, except that questions involving voluminous data contained in Southwestern's records may best be answered by consultation and review of pertinent records at Southwestern's offices.
Persons interested in attending the Public Information Forum should indicate in writing (address cited above) by letter, email or facsimile transmission (918-595-6656) by August 22, 2005, their intent to appear at such Forum. If no one so indicates his or her intent to attend, no such Forum will be held.
A Public Comment Forum is scheduled on September 29, 2005, at which interested persons may submit written comments or make oral presentations of their views and comments related to the rate proposal. The proceeding will be transcribed. A chairman, who will be responsible for orderly procedure, will conduct the Forum. Southwestern's representatives will be present, and they and the chairman may ask questions of the speakers. Persons interested in attending the Public Comment Forum should indicate in writing (address cited above) by letter, e-mail or facsimile transmission (918-595-6656) by September 20, 2005, their intent to appear at such Forum. If no one so indicates his or her intent to attend, no such Forum will be held. Persons interested in speaking at the Forum should submit a request to Mr. Forrest E. Reeves, Assistant Administrator, Southwestern, at least seven (7) calendar days prior to the Forum so that a list of speakers can be developed. The chairman may allow others to speak if time permits.
A transcript of each Forum will be made. Copies of the transcripts may be obtained, for a fee, from the transcribing service. Copies of all documents introduced will also be available from the transcribing service upon request for a fee. Ten copies of all written comments, together with a diskette or compact disk in MS Word, on the proposed Integrated System Rates are due on or before November 14, 2005. Comments should be submitted to Forrest E. Reeves, Assistant Administrator, Southwestern, at the above-mentioned address for Southwestern's offices.
Following review of the oral and written comments and the information gathered in the course of the proceedings, the Administrator will submit the finalized Integrated System Rate Proposal, Power Repayment Studies, and Rate Design Study in support of the proposed rates to the Deputy Secretary of Energy for confirmation and approval on an interim basis, and subsequently to the Federal Energy Regulatory Commission (Commission) for confirmation and approval on a final basis. The Commission will allow the public an opportunity to provide written comments on the proposed rate increase before making a final decision.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act, this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. This ICR is scheduled to expire on October 31, 2005. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its estimated burden and cost.
Additional comments may be submitted on or before September 15, 2005.
Submit your comments, referencing docket ID number OECA-2005-0034, to (1) EPA online using EDOCKET (our preferred method), by e-mail to
Learia Williams, Compliance Assessment and Media Programs Division, Office of Compliance, (Mail Code 2223A), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564-4113; fax number: (202) 564-0050; e-mail address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On May 6, 2005 (70 FR 24020), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.
EPA has established a public docket for this ICR under Docket ID Number OECA-2005-0034, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Avenue, NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is: (202) 566-1752. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at
Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, Confidential Business Information (CBI), or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's
Owners or operators must submit initial notifications, performance tests, and periodic reports. Respondents are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to NESHAP.
Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated state or local authority. In the event that there is no such delegated authority, the reports are sent directly to the EPA regional office.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number. The OMB Control Numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/or instrument, if applicable.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act, this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. This ICR is scheduled to expire on September 30, 2005. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its estimated burden and cost.
Additional comments may be submitted on or before September 15, 2005.
Submit your comments, referencing docket ID number OECA-2004-0047, to (1) EPA online using EDOCKET (our preferred method), by e-mail to
Marcia B. Mia, Compliance Assessment and Media Programs Division (CAMPD), Office of Compliance (OC), 2223A, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-7042]; fax number: (202) 564-0050; e-mail address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On December 1, 2004, (69 FR 69909), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.
EPA has established a public docket for this ICR under Docket ID No. OECA-2004-0047, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Enforcement and Compliance Docket and Information Center Docket is: (202) 566-1752. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at
Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information (CBI), or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's
All existing sources must be in compliance with the requirements of subpart PPP within three years of the effective date (promulgation date) of standards for an affected source. All new sources must be in compliance with the requirements of subpart PPP upon startup or the promulgation date of standards for an affected source, whichever is later. Compliance is assumed through initial performance testing or design analysis, as appropriate, and ongoing compliance is demonstrated through parametric monitoring. Types of parameters
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number. The OMB Control Numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are identified on the form and/or instrument, if applicable.
Notification of demonstration of continuous monitoring system (CMS); Submittal of quality control plan for CMS; Notification of anticipated startup.
The Capital/Startup costs as calculated in this ICR's section 6(b)(iii) compared with the costs in the previous ICR have decreased. The previous ICR incorrectly calculated the capital/startup costs. This ICR renewal also includes the continued capital depreciation costs, per OMB's Terms of Clearance (TOC) for the previously approved ICR.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before September 15, 2005.
Submit your comments, referencing docket ID number RCRA-2005-0005, to (1) EPA online using EDOCKET (our preferred method), by e-mail to
Norma Abdul-Malik, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (703) 308-8753; fax number: (703) 308-8617; e-mail address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On April 7, 2005 (70 FR 17686), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.
EPA has established a public docket for this ICR under Docket ID No. RCRA-2005-0005, which is available for public viewing at the RCRA Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Avenue, NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the RCRA Docket is (202) 566-0270. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at
Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the
In 1995, EPA expanded the public participation requirements under the RCRA program by promulgating the RCRA Expanded Public Participation Rule (60 FR 63417; December 11, 1995). The rule responded to calls by the Administration and stakeholders (
The required activities and information are needed to help assure timely and effective public participation in the permitting process. The requirements are intended to provide equal access to information to all stakeholders in the permitting process: the permitting agency, the permit applicant, and the community where a facility is located. Some facilities may be required to develop information repositories to allow for expanded public participation and access to detailed facility information as part of the permitting process.
EPA sought to reduce the reporting frequency to the minimum that is necessary to ensure compliance with the rule. It would not be possible to collect this information less frequently and still assure that the requirements of permit and public involvement regulations are met by owners or operators. The reporting frequency is essential to assure that any changes in the trial burn plans or in the anticipated permit application contents are made known to EPA and to the public.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9 and are identified on the form and/or instrument, if applicable.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act, this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. This ICR is scheduled to expire on October 31, 2005. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its estimated burden and cost.
Additional comments may be submitted on or before September 15, 2005.
Submit your comments, referencing docket ID number OECA-2005-0025, to (1) EPA online using EDOCKET (our preferred method), by email to
Learia Williams, Compliance Assessment and Media Programs Division, Office of Compliance, (Mail Code 2223A), Environmental Protection
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On May 6, 2005 (70 FR 24020), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.
EPA has established a public docket for this ICR under Docket ID No. OECA-2005-0025, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Avenue, NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Enforcement and Compliance Docket and Information Center Docket is: (202) 566-1752. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at
Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, Confidential Business Information (CBI), or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's
Owners or operators of sulfuric acid plants are required to make the following one-time-only reports: notification of the date of construction or reconstruction; notification of actual startup dates; notification of any physical or operational change to an existing facility; notification of demonstration of the continuous emissions monitoring system (CEMS); notification date of the initial performance test; and the results of the initial performance test. After the initial recordkeeping and reporting requirements, semiannual reports are required if there has been an exceedance of control device operating parameters. Respondents are also required to maintain records of occurrence and duration of any startup, shutdown, or malfunction, or any period during which the monitoring system is inoperative. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number. The OMB Control Numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/or instrument, if applicable.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before September 15, 2005.
Submit your comments, referencing docket ID number OAR-2005-0017, to (1) EPA online using EDOCKET (our preferred method), by email to
Behram Shroff, Office of Air and Radiation, Office of Radiation and Indoor Air, Mail Code 6608J; Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 343-9707; fax number: (202) 343-2305; e-mail address:
The
EPA has established a public docket for this ICR under Docket ID Number OAR-2005-0017, which is available for public viewing at the Air and Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Air and Radiation Docket is: (202) 566-1742. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at
Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, Confidential Business Information (CBI), or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's
Information collected is used by EPA to ensure that public health continues to be protected from the hazards of airborne radionuclides by compliance with the standards mentioned above. If the information were not collected, it is unlikely that a violation of these standards would be identified and, thus, there would be no corrective action initiated to bring the facilities back into compliance. Compliance is demonstrated through emission testing and/or dose calculation. All facilities are required to calculate, monitor, and maintain their records for 5 years, as required by 40 CFR part 61, § 61.95. The results are also reported to EPA-HQ , EPA regions, and delegated states.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/or instrument, if applicable.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before September 15, 2005.
Submit your comments, referencing docket ID number OAR-2005-0088, to EPA online using EDOCKET (our preferred method), by email to
John Hall, Indoor Environments Division, mail code 6609J, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-343-9453; fax number: 202-343-2393; e-mail address:
EPA has established a public docket for this ICR under Docket ID number OAR-2005-0088, which is available for public viewing at the Air Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Air Docket is (202) 566-1744. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at
Any comments related to this ICR should be submitted to EPA within 60 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
This ICR will provide data for the purpose of informing EPA of the effectiveness of outreach products and services, and customer satisfaction with outreach products and services. The information collection is voluntary, and will be limited to non-sensitive data concerning the quality of outreach products and services. EPA will request feedback from a representative sample of those who receive products and services. The data collected will be used to estimate the rate of effectiveness of outreach products and services and no data collected will be used to make policy decisions.
To help fulfill the broad mandate of protecting human health and the environment, EPA provides outreach products and services to the general public. Outreach products and services provide the general public with the specific information necessary to achieve and maintain good indoor air quality. In addition to providing information on indoor air quality, these products and services describe ways people can work to improve the indoor air quality in their home, work place, school, etc. Specific behavioral changes are described in our products and services that will help improve indoor air quality. In order to determine the effectiveness of the products and
EPA believes that evaluating outreach products and services is necessary to ensure customer needs are met, as well as to maintain efficient and effective assistance. Understanding our customers' ability to use our tools and services in their practical applications, and the rates of use of these tools and services, will assist the Agency in planning its future outreach products and services efforts.
Each product feedback form has a burden time of five minutes per respondent. There are three general questions to be asked of all customers indicating customer satisfaction with various outreach products and services. These questions will identify ways that products can be strengthened to better meet our customers' needs and will indicate the means by which our customers heard about our products. A better understanding of how IED's customers learn about its issues and products will help IED better target its audiences.
Each of IED's products addresses particular IAQ issues and informs the customer of actions that can be taken to eliminate or reduce the IAQ problem. Behavioral change questions inform IED about what actions people have taken as a result of the products, and therefore indicate how effective the product is at affecting peoples' behaviors. IED has developed a question for each of the major topic areas covered by the division. One such question will be included in each product feedback form.
For a small subset of our products, there is value in understanding what the customer has learned from a particular product, in addition to what behavioral changes they have made. Effective behavior change is multi-dimensional and encompasses a set of attributes including reaction, knowledge, attitude, skills, intentions and behaviors. These attributes can be considered milestones along a roadmap which ultimately leads to behavioral outcomes. Therefore, we will be asking a fifth question of these audiences. This additional question will add no significant burden time to the recipient of the questionnaire.
The EPA would like to solicit comments to:
(i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(ii) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(iii) Enhance the quality, utility, and clarity of the information to be collected; and
(iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
Burden means 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. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
Environmental Protection Agency (EPA).
Notice; request for public comment.
In accordance with section 122(h) of the Comprehensive Environmental Response, Compensation, and Liability Act as amended (“CERCLA”), 42 U.S.C. 9622(h), notice is hereby given of a proposed administrative settlement for recovery of past response costs concerning the General Motors Corporation—Central Foundry Division Superfund Site located in Massena, St. Lawrence County, New York with the settling party, the General Motors Corporation. The settlement requires the settling party to pay $897,690.88, plus an additional sum for Interest on that amount calculated from April 21, 2004 through the date of payment to the General Motors—Central Foundry Division Superfund Site Special Account within the EPA Hazardous Substance Superfund in reimbursement of EPA's past response costs incurred with respect to the Site. The settlement includes a covenant not to sue the settling party pursuant to Section 107(a) of CERCLA, 42 U.S.C. 9607(a) for past response costs. For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate.
Comments must be submitted on or before September 15, 2005.
The proposed settlement is available for public inspection at USEPA, 290 Broadway, 17th Floor, New York, New York 10007-1866. A copy of the proposed settlement may be obtained from Marla E. Wieder, Assistant Regional Counsel, USEPA, 290 Broadway, 17th Floor, New York, New York 10007-1866, (212) 637-3184. Comments should reference the General Motors Corporation—Central Foundry Division Superfund Site, CERCLA Docket No. 02-2005-2027. To request a copy of the proposed settlement agreement, please contact the individual identified below.
Marla E. Wieder, Assistant Regional Counsel, USEPA, 290 Broadway, New York, New York 10007-1866, (212) 637-3184.
Copies of the standard can be obtained by contacting FASAB at (202) 512-7350. The standard is also available on FASAB's home page
Wendy M. Comes, Executive Director, 441 G St., NW., Mail Stop 6K17V, Washington, DC 20548, or call (202) 512-7350
Federal Advisory Committee Act. Pub. L. No. 92-463.
The following items have been deleted from the list of Agenda items scheduled for consideration at the August 5, 2005, Open Meeting and previously listed in the Commission's Notice of July 28, 2005.
The Federal Communications Commission will consider one additional item on the subject listed below.
The prompt and orderly conduct of Commission business permits less than 7-days notice be given for consideration of this item.
Action by the Commission, August 5, 2005. Chairman Martin; Commissioners Abernathy, Copps, and Adelstein voting to consider this item.
Additional information concerning this meeting may be obtained from Audrey Spivack or David Fiske, Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than August 30, 2005.
Board of Governors of the Federal Reserve System, August 10, 2005.
Board of Governors of the Federal Reserve System.
11:30 a.m., Monday, August 22, 2005.
Marriner S. Eccles Federal Reserve Board Building, 20th and C Streets, N.W., Washington, D.C. 20551.
Closed.
1. Personnel actions (appointments, promotions, assignments, reassignments, and salary actions) involving individual Federal Reserve System employees.
2. Any items carried forward from a previously announced meeting.
Michelle A. Smith, Director, Office of Board Members; 202-452-2955.
You may call 202-452-3206 beginning at approximately 5 p.m. two business days before the meeting for a recorded announcement of bank and bank holding company applications scheduled for the meeting; or you may contact the Board's Web site at
Board of Governors of the Federal Reserve System, August 12, 2005.
Office of the Chief Acquisition Officer, GSA.
Notice of request for comments regarding a renewal to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the General Services Administration has submitted to the Office of Management and Budget (OMB) a request to review and approve a renewal of a currently approved information collection requirement regarding identification of products with environmental attributes. A request for public comments was published at 70 FR 30729, May 27, 2005. No comments were received.
Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this
Submit comments on or before: September 15, 2005.
Linda Nelson, Procurement Analyst, Contract Policy Division, at telephone (202) 501-1900 or via email at
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to Ms. Jeanette Thornton, GSA Desk Officer, OMB, Room 10236, NEOB, Washington, DC 20503, and a copy to the Regulatory Secretariat (VIR), General Services Administration, Room 4035, 1800 F Street, NW., Washington, DC 20405. Please cite OMB Control No. 3090-0262, Identification of Products with Environmental Attributes, in all correspondence.
General Services Administration (GSA) requires contractors submitting Multiple Award Schedule Contracts to identify in their GSA price lists those products that they market commercially that have environmental attributes. The identification of these products will enable Federal agencies to maximize the use of these products to meet the responsibilities expressed in statutes and executive orders.
The Centers for Disease Control and Prevention (CDC) announces the intent to fund fiscal year (FY) 2005 funds for a cooperative agreement program to expand on preliminary findings of Inflammatory Bowel Disease (IBD) in the United States and enhance our understanding of the demographic and clinical characteristics of IBD, variations in clinical practice, and the impact of the disease. This announcement will build on a previous epidemiologic study of the disease and be used to target interventions for groups at high risk for IBD and inform best clinical practices.
The Catalog of Federal Domestic Assistance number for this program is 93.945.
Assistance will be provided only to the Crohn's and Colitis Foundation of America.
The Crohn's and Colitis Foundation of America is the only institution eligible to submit an application in response to this RFA. The CCFA was referenced by the House and Senate in their Labor/Health and Human Services/Education (L/HHS/Ed) Committee Reports. The House language states: “For the past five years, the Committee has encouraged CDC to work in partnership with the IBD community to establish a national IBD epidemiology program to further our understanding of these diseases. The Committee understands that the Crohn's and Colitis Foundation of America has provided financial support through the CDC Foundation to initiate this important program. Now that the project is established, the Committee encourages CDC to contribute to the project in order to expand the work in FY2005.” The Senate language states: “An epidemiological study of IBD is needed to gain a better understanding of the prevalence of IBD in the United States and the demographic characteristics of the IBD patient population. Over the last 3 years, the Crohn's and Colitis Foundation of America has provided the CDC with $750,000 to initiate the epidemiological study. Now that the project has been established through an investment by the patient community, the Committee has provided $800,000 to continue this study.” The Conference Committee recommended a total of $750,000.
The CCFA is a not-for-profit 501 (c)(03) organization, founded in 1967 “to cure and prevent Crohn's disease and ulcerative colitis through research, and to improve the quality of life of children and adults affected by these digestive disease through education and support”. Since 1967, CCFA has established itself as the leading agency in the country on IBD research. It has led the efforts in identifying the research needs and developing successful strategies to meet those needs. CCFA has a national scientific advisory committee comprised of nationally renowned physicians and scientists in the field of inflammatory bowel disease. This advisory committee is the only one of its kind in the country dedicated solely to identifying and supporting emerging areas of research that could lead to the understanding of the causes and disease course of IBD. Through this scientific advisory committee and other partnerships, CCFA has developed several major initiatives to advance IBD research.
For the past three years, the CCFA scientific advisory committee has worked with the CDC to establish the informational infrastructure needed to conduct IBD research. They have built a validated disease algorithm for identifying patients with IBD and estimating the prevalence of the disease. Only CCFA has access to these algorithms and the informational infrastructure. CCFA will use the algorithms and infrastructure created, to further describe the prevalence and incidence of IBD and the impact of various clinical practices on outcomes.
The mission of CCFA, the organization's extensive network of resources, and the existing collaborative efforts with the CDC make it highly probable that CCFA will successfully achieve the activities identified in Section 1 of this RFA. CCFA is the only not-for-profit national IBD organization that promotes and provides funding for much needed IBD research. This characteristic of CCFA is unmatched by any other public or private IBD specific organization currently conducting similar activities in the United States.
The CCFA has partnered with the CDC in the establishment and initiation of this study; therefore, it is the only eligible organization to collaborate in the completion of this study.
Approximately $700,000 is available in FY 2005 to fund this award. It is
For general comments or questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, telephone: 770-488-2700.
For technical questions about this program, contact: Brenda Colley Gilbert, Project Officer, 4770 Buford Highway N.E., Mailstop K-92, Atlanta, GA 30341, telephone: 770-488-8390, e-mail:
The Centers for Disease Control and Prevention (CDC) announces the intent to fund fiscal year (FY) 2005 funds for a grant program to the Jeffrey Modell Foundation for a National Campaign for Provider Education and Public Awareness about Primary Immunodeficiency (PI Disease). The purpose of the program is to strengthen the nation's capacity to carry out public health activities in the area of PI diseases by increasing physician education and public health awareness through the program for primary immune deficiency disease as implemented by the Jeffrey Modell Foundation. The objective is to disseminate educational information on a national level to public and private health care providers, educators, third-party payers, impacted families, and others who may help expedite clinical recognition and improve the health outcome for Americans with PI disease. The Catalog of Federal Domestic Assistance number for this program is 93.283.
Assistance will be provided only to the Jeffrey Modell Foundation (JMF) in accordance with language in the Conference Report to the fiscal year 2005 Appropriations (Pub. L. 108-447, H.R. Rep. No. 108-792 2004)which explains congressional intent that CDC continue to provide funding to JMF. The specific language is as follows:
“In each of last three years, Congress has made available funds for CDC to support the national physician education and public awareness campaign developed by the Jeffrey Modell Foundation. The Committee understands that the Foundation has leveraged more than seven dollars from donors and the media for every federal dollar appropriated and is a model of public-private cooperation. The Committee encourages the CDC to expand the reach of the Foundation's campaign to underserved communities, including African-American and Hispanic populations, and has provided sufficient funding to reach that critical goal. The Committee also encourages CDC to expand its programmatic activity on primary immune deficiency diseases to include pilot programs focused on newborn screening and school wellness.”
The Jeffrey Modell Foundation, Inc. (JMF) was established in 1987 to address early and precise diagnosis, meaningful treatments, and ultimately cures for Primary Immunodeficiency Diseases in memory of Jeffrey Modell, who died from pneumonia due to Primary Immunodeficiency at the age of 15. It is a multi-faceted nonprofit research foundation devoted to the early and precise diagnosis, meaningful treatment, and ultimate cure of PI. The Jeffrey Modell Foundation is focused on the following Primary Immunodeficiency treatment, education, awareness and research areas: Clinical and basic research to better understand and treat Primary Immunodeficiencies; function as a national and international source for the dissemination of information and education into the diagnosis and treatment of genetic immunodeficiencies; advocates on behalf of patients and families to assure access to excellent and comprehensive care; promote awareness of Primary Immunodeficiency diseases through programs involving lay, scientific, and medical communities; and addressing quality of life concerns for patients with Primary Immunodeficiency diseases. The activities that are conducted to achieve the above objectives and focuses consist of but are not limited to the following: Sponsored symposiums and workshops; support for research and training; and the provision of diagnostic, clinical, and education services. The Foundation supports a 24-hour-a-day national hotline, which offers information and referrals to immunologists at major medical centers around the country. We are not aware of another organization with a similar background, approach, and as broad a reach in the spectrum of issues related to Primary Immunodeficiency diseases such as the international focus, service delivery, and quality of life for PI patients and their families, and the other areas referenced above.
No other applications are solicited.
Approximately $2,458,778 is available in FY 2005 to fund this award. It is expected that the award will begin on or before August 31, 2005, and will be made for a 12-month budget period within a project period of up to five years. Funding estimates may change.
For general comments or questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, telephone: (770) 488-2700.
For technical questions about this program, contact: Leah Simpson, M.B.A., Project Officer, 2877 Brandywine Road, Suite 4847, Atlanta, GA 30341, telephone: (770) 488-8395, e-mail:
In India, the Emergency Plan seeks to engage both governmental and non-governmental institutions at all levels to bolster the provision of care and treatment to HIV-positive people, and to expand prevention activities to avoid new cases of HIV.
HHS' mission in India is to work with Indian and international partners to develop, evaluate and support effective implementation of interventions to prevent HIV and related illnesses, and to improve care and support of persons with HIV/AIDS. The program aims to build local capacity and promote in-country leadership and ownership of activities by focusing on national and local priorities, sharing experiences and technical information, coordinating activities with other programs, and using local expertise whenever possible.
Specifically, HHS' mission in India is to accomplish the following:
1. Provide support and training for HIV/AIDS prevention and care in health care facilities and in the community.
2. Establish training expertise for HIV/AIDS prevention and care and infrastructure development in Tamil Nadu, Andhra Pradesh and other states in India.
3. Strengthen the local and national response to HIV/AIDS in India through support and collaboration with the National AIDS Control Organization (NACO), State AIDS Control Societies, Networks of Positive People, the private, non-governmental and faith-based health sectors, and others.
The purpose of this program is to address the HIV-related health care needs in the south Indian state of Andhra Pradesh (the state most heavily affected by HIV in India, according to Government of India reports), and, to a lesser extent, in other states in India affected by the epidemic, by strengthening the existing health care infrastructure in the private/non-government/faith-based sectors and mobilizing local institutions to commit to quality HIV-related health care. Through this cooperative agreement, funds are available to encourage independent non-government and for-profit care institutions to join together to form new or improve existing care and training networks. The activities will initially be concentrated on the south Indian state of Andhra Pradesh during the first one to two years and could expand into other Indian states in subsequent years, at the discretion of HHS in India and the grantee with the approval of the Office of the U.S. Global AIDS Coordinator.
This competition will select one or more awardees that focus on Andhra Pradesh, and possibly one or more additional awardees to focus on other parts of the country, including one or more northern Indian states in areas in which the HIV epidemic is emerging. Applicants should clearly define in which State they will initially focus the activities of this cooperative agreement, and should keep in mind that scaling up care activities in Andhra Pradesh is our first priority.
Each awardee will seek to improve and expand the clinical care of persons living with HIV/AIDS (PLWHAs) within the recipient's institutions/network of institutions, with a focus on outpatient care. “Care: includes confidential, voluntary counseling and testing (VCT); treatment of opportunistic infections (OIs); staging of HIV; nutritional support; family counseling and support; treatment of sexually transmitted infections (STIs); treatment with anti-retroviral therapy (ART), when appropriate and economically feasible; and prevention of mother-to-child transmission (PMTCT).
The activities also follow the five-year strategy of the President's Emergency Plan for AIDS Relief and the three strategies of the National Center for HIV, STD and TB Prevention (NCHSTP) of the Centers for Disease Control and Prevention (CDC) within HHS: prevention, HIV/AIDS treatment and care, and surveillance and infrastructure development. The measurable outcomes of the program will be in alignment with the goals of HHS/CDC Strategy of the Emergency Plan and NCHSTP, to reduce HIV transmission and improve care of PLWHAs. They will also contribute to the goals of the President's Emergency Plan for AIDS Relief (Emergency Plan), which include the following:
• Within five years treat more than two million HIV-infected persons with effective combination anti-retroviral therapy.
• Provide care for ten million HIV-infected and affected persons, including those orphaned and left vulnerable by HIV/AIDS.
• Prevent seven million new infections.
Specific measurable outcomes of this program include, but are not limited to, routine reporting, which verifies responsible maintenance of program expenditures and program technical activities and confirms accountability of U.S. Government funds spent in India.
This announcement is only for non-research activities supported by HHS/CDC. If applicants propose research, HHS/CDC will not review the application. For the definition of “research,” please see the HHS/CDC Web site at the following Internet address:
Awardee activities for this program are as follows:
a. Identify project staffing needs (including administrative, management and technical staff); hire and train staff.
b. Identify furnishings, fittings, equipment and other fixed-asset procurement needs of the project and implementing partners, and acquire through transparent and competitive processes.
c. Within the first three months from the date of the award, develop a revised and updated strategic plan, to include goals, objectives, a monitoring plan, an implementation strategy, and a reporting system.
d. Improve and expand the clinical care of PLWHAs within the recipient's institutions/network of institutions with a focus on outpatient care. Care includes: confidential VCT; treatment of OIs; staging of HIV; nutritional support; family counseling and support; treatment of STIs; treatment with ART, when appropriate and economically feasible; and PMTCT.
e. Improve the HIV-related laboratory capacity of the recipient's institutions/network of institutions. The awardee should develop and implement a system of sharing expertise or technically difficult laboratory equipment within the network (and possibly with the medical community outside of the existing network). An acceptable alternative could be to organize a cost-efficient system of outsourcing some laboratory testing to independent quality labs.
f. Improve and expand HIV-related community outreach activities directly run or sponsored by the recipient's institutions/network of institutions as a whole. Outreach activities should be
g. Develop a functional relationship and linkages to national level, district level and/or state-level networks of HIV-positive people, where these positive networks already exist; and help develop such positive networks where they do not currently exist.
h. Develop and initiate a system for creating the human capacity to meet the above HIV care and support needs. This includes developing and implementing plans to increase interest in HIV care; remove any stigma and discrimination from applicant institutions; and provide ongoing, innovative hands-on training in local languages to medical personnel (physicians, nurses, pharmacists, lab technicians, community health workers, counselors, etc.) and management (institutional leaders, etc.).
i. Systematically document programmatic activities and institutional capacities over time. Awardees should use formal monitoring and evaluation tools, such as asset mapping, community assessments, and pre/post-evaluation of specific trainings or interventions, initially and then periodically, as appropriate.
j. Participate in HHS-sponsored meetings and other HIV-related meetings, conferences and/or workshops, as appropriate.
k. Make use of existing guidelines, curricula and clinical algorithms developed by the Indian National AIDS Control Organization (NACO), the World Health Organization (WHO), HHS, the Office of the U.S. Global AIDS Coordinator, the University of Washington International Training and Education Center for HIV/AIDS (I-TECH), and others, as appropriate.
l. Create and/or strengthen linkages with Indian federal and state Government health-care institutions, as appropriate (
m. Formalize the structures and rules of the applicant's networks of medical care institutions, if required. This includes creating by-laws, a management/leadership team, developing and/or strengthening decision-making processes, funding and accounting mechanisms, etc.
n. Provide in-kind support equal to or greater than 15 percent of the funding granted by HHS in year one, and 25 percent in years 2-5.
o. Provide HHS in India with semi-annual reports, according to guidelines developed by the Office of the U.S. Global AIDS Coordinator.
Comply with all HHS management requirements for meeting participation and progress and financial reporting for this cooperative agreement. (
In a cooperative agreement, HHS staff is substantially involved in the program activities, above and beyond routine grant monitoring.
HHS Activities for this program are as follows:
1. Organize an orientation meeting with the grantee to brief them on applicable U.S. Government, HHS, and Emergency Plan expectations, regulations and key management requirements, as well as report formats and contents. The orientation could include meetings with staff from HHS agencies and the Office of the U.S. Global AIDS Coordinator.
2. Review and approve the process used by the grantee to select key personnel and/or post-award subcontractors and/or subgrantees to be involved in the activities performed under this agreement, as part of the Emergency Plan for AIDS Relief Country Operational Plan review and approval process, managed by the Office of the U.S. Global AIDS Coordinator.
3. Review and approve grantee's annual work plan and detailed budget, as part of the Emergency Plan for AIDS Relief Country Operational Plan review and approval process, managed by the Office of the U.S. Global AIDS Coordinator.
4. Review and approve grantee's monitoring and evaluation plan, including for compliance with the strategic information guidance established by the Office of the U.S. Global AIDS Coordinator.
5. Meet on a monthly basis with grantee to assess monthly expenditures in relation to approved work plan and modify plans as necessary.
6. Meet on a quarterly basis with grantee to assess quarterly technical and financial progress reports and modify plans as necessary.
7. Meet on an annual basis with grantee to review annual progress report for each U.S. Government Fiscal Year, and to review annual work plans and budgets for subsequent year, as part of the Emergency Plan for AIDS Relief review and approval process for Country Operational Plans, managed by the Office of the U.S. Global AIDS Coordinator.
8. Provide technical assistance, as mutually agreed upon, and revise annually during validation of the first and subsequent annual work plans. This could include expert technical assistance and targeted training activities in specialized areas, such as strategic information, project management, confidential counseling and testing, palliative care, treatment literacy, and adult learning techniques.
9. Provide in-country administrative support to help grantee meet U.S. Government financial and reporting requirements.
Please note: Either HHS staff or staff from organizations that have successfully competed for funding under a separate HHS contract, cooperative agreement or grant will provide technical assistance and training.
Additional HHS activities for this program are as follows:
1. Provide input into the development of the overall program strategy, including collaboration in the selection of key personnel to be involved in the activities to be performed under this agreement.
2. Define, in collaboration with the grantee(s) and other HHS partners, the specific geographic reach of the grantee(s) activities, in consultation with the Office of the U.S. Global AIDS Coordinator.
3. Provide clearly defined goals and desired outcomes for activities; and provide ongoing technical assistance to the recipient, and its member institutions and external partners in local languages, if possible. This technical assistance could come directly from HHS staff or through in-country partners/contractors of the U.S. Government.
4. Help encourage and strengthen linkages to, and cooperation with, Indian Federal and State Government institutions and programs.
5. Convene meetings, workshops and consultations between recipients, with recipients and others (U.S. Government partners, HIV experts, etc.), as appropriate.
6. Collaborate in the development of a system for record-keeping and information access.
7. Collaborate in the development of a monitoring and evaluation system; and provide technical assistance, as
8. Assist, as needed, in appropriate analysis and interpretation of program evaluation data collected.
9. Provide support in all aspects of the implementation of the cooperative agreement. This will include, but will not be limited to, working with the network of institutions to review existing materials available in local languages for PLWHAs; develop information and education resources for PLWHAs; etc.
10. Provide and promote liaison and assist in coordinating activities, as required, between the awardee(s) and the activities to be performed under this agreement and other HHS and U.S. Government programs in India in training, care, support, and other activities.
HHS India staff, HHS/CDC Atlanta Staff or U.S. Government partners may provide technical and administrative/management assistance.
Throughout the project period, HHS' commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government, as determined by the annual review and approval of Country Operational Plans for the President's Emergency Plan for AIDS Relief, managed by the Office of the U.S. Global AIDS Coordinator.
Applications may be submitted by for-profit organizations, as well as public and private non-profit organizations, such as:
• Universities
• Colleges
• Research institutions
• Hospitals
• Community-based organizations
• Faith-based organizations
In addition, eligible applicants will:
• Be Indian owned/operated non-governmental organizations; network, trust or private enterprise.
• Have major ongoing organizational activity in the delivery of quality medical care (and/or the training of medical personnel in local language).
• Have established (or soon to be established) medical care activities in a minimum of four districts in Andhra Pradesh. If applying for one of the additional awards outside of Andhra Pradesh, have established medical care activities in a minimum of four districts in the Indian state of focus (applicant's choice).
• Be committed to ensuring expanded quality HIV medical and community care services within their network/organization, and to providing local/state-level leadership in HIV related issues.
• Be recognized and respected by the Government of India at both the national and state levels.
Competition for this cooperative agreement is limited to the types of organizations listed above because of the uniqueness of the activities for this project. Awardees must have specific knowledge and capability to work in urban and rural locations and in multiple and diverse geographic locations throughout India. The types of organizations listed above would have direct experience, and on-the-ground capacity and knowledge, to perform these activities in India.
Competition is limited to agencies that possess the following:
• A proven track record in developing and successfully managing effective and sustainable medical and community care activities and/or the training of medical personnel in local languages.
• Established medical and/or community care activities in several areas and the experience and ability to effectively link with other public and private health care institutions/providers to deliver quality care.
• The commitment to establish medical care activities in several areas and willingness and ability to effectively link with other health care institutions/providers to deliver quality care.
• Extensive knowledge of the Indian public and private health structure—from the national to the district levels.
• Credentials that allow the organization to work legally in India, and an existing office in one or more critical locations in India.
Furthermore, a guiding principle of the President's Emergency Plan for AIDS Relief, which implements assistance for HIV/AIDS in countries throughout the world, calls for the support and development of local expertise and capacity so national programs can achieve results and monitor and evaluate their activities for the long term. Through the President's Emergency Plan, HHS in India seeks to support and foster the development of indigenous leadership, which is critical to developing a sustainable and successful response to the AIDS epidemic in India. In adherence to these guiding principles, competition for the cooperative agreement is therefore limited to the organizations listed above.
Applicant must provide direct funds or in-kind services (equipment, supplies, salaries, etc.) of at least 15 percent of the annual HHS award for year one, and 25 percent for years two-five. [For example, if the applicant asked for $100,000 from HHS in the first year and $300,000 in year two, it must provide at least $15,000 in additional funds or in-kind services directly to the project in year one, and $75,000 in year two.]
If applicants request a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not be entered into the review process. You will be notified that your application did not meet the submission requirements.
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. We will notify you that your application did not meet submission requirements.
• HHS/CDC will consider late applications non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
• Applications that cannot provide supporting documentation (such as:
1. Proof of legal status in India.
2. Proof of work in the health sector.
•
To apply for this funding opportunity use application form PHS 5161-1.
If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 1-770-488-2700. We can mail application forms to you.
• Maximum number of pages: 20. If your narrative exceeds the page limit, we will only review the first pages within the page limit.
• Font size: 12 point unreduced.
• Double-spaced.
• Paper size: 8.5 by 11 inches.
• Page margin size: One inch.
• Printed only on one side of page.
• Held together only by rubber bands or metal clips; not bound in any other way.
• Number all pages of the application sequentially from page one (Application Face Page) to the end of the application, including charts, figures, tables, and appendices.
• Application must be submitted in English.
Your narrative should address activities to be conducted over the entire project period, and must include the following items in the order listed:
1. Executive Summary (one page) to include a brief description of your organization's strengths and a summary of activities that you are proposing under this RFA.
2. Narrative (to include four sections as follows):
• One or more map illustrations outlining the areas you currently serve and areas you hope to move into in the next two years. Clearly note on the map where your member institutions are located, as well as a general category of these institutions (
• A single detailed chart listing member institutions. Next to each unique institution or project site, list the activities being undertaken there, the number of technical staff (physicians, nurses, outreach workers, etc.), and any other relevant information concerning staff. Please provide an estimate of the size of the population being served by the staff, and anything else you feel is relevant to understanding your organization.
• How this network was, or will be, created and maintained.
• The scope of work that is conducted, or is proposed to be conducted, by the network.
• The mechanism in which this network makes decisions, gathers information, and communicates with its member institutions. If the network is not yet established, the mechanism in which it proposes to communicate.
• The structure of the network (or the proposed network), including staff (or proposed staff) and other active participants.
• The relationship between the network (or proposed network) leaders/staff and member institutions (
• Any plans on how the network or the proposed network will be strengthened.
• A summary of current HIV-related activities and care within the network or individual institutions.
• Letters of support by member institutions, network leaders and/or outside community groups (attach as appendix number one; NOT to be included in the 20 page limit).
• A detailed description of your proposed in-kind support for this project.
• A summary of any efforts, to date, to collect and analyze HIV-related data in the communities you serve (
3. Budget and Justification:
A budget and budget justification for the entire project period should be included. While summary budgets may be provided for years two through five, a full budget and budget justification for year one must be included. In the year one budget, the specific overhead costs should be clear. The applicant should clearly delineate what the CDC, via the cooperative agreement, will pay for and what the applicant institution (as part of the in-kind requirement) will pay for.
The following information must be included in the application appendices: Supporting documentation (
You may include additional information in the application appendices. The appendices will not count toward the narrative page limit. This additional information may include the following:
• Curriculum Vitas and/or Resumes.
• Organizational Charts/Maps.
• Letters of Support.
• A summary of current HIV-related activities and care programs being carried out within the network or individual institutions.
• Letters of support by member institutions, network leaders and/or outside community members/organizations.
• A detailed description of your proposed in-kind support for this project.
• A summary of any efforts, to date, to collect and analyze HIV-related data in the communities you serve (
You must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access
If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter.
Additional requirements that could require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”
You may submit your application electronically at
If you submit your application electronically with Grants.gov, your application will be electronically time/date stamped, which will serve as receipt of submission. You will receive an e-mail notice of receipt when HHS/CDC receives the application.
If you submit your application by the United States Postal Service or commercial delivery service, you must ensure the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after closing because: (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time; or (2) significant weather delays or natural disasters, you will have the opportunity to submit documentation of the carrier's guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.
If you submit a hard copy application, HHS/CDC will not notify you upon receipt of your submission. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 1-770-488-2700. Before calling, please wait two to three days after the submission deadline. This will allow time for us to process and log submissions.
This announcement is the definitive guide on application content, submission address, and deadline. It supersedes information provided in the application instructions. If your submission does not meet the deadline above, it will not be eligible for review, and we will discard it. We will notify you that you did not meet the submission requirements.
Executive Order 12372 does not apply to this program.
Restrictions, which you must take into account while writing your budget, are as follows:
• Funds may not be used for research.
• Awards will allow recipients reimbursement of pre-award costs, such as photocopying, fax, postage or delivery charges and translation.
• Funds may be spent for reasonable program purposes, including personnel, travel, supplies, and services. Equipment may be purchased if deemed necessary to accomplish program objectives; however, prior approval by HHS/CDC officials must be requested in writing.
• All requests for funds contained in the budget shall be stated in U.S. dollars. Once an award is made, HHS/CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.
• The costs that are generally allowable in grants to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut, and the World Health Organization (WHO). Indirect Costs will not be paid (either directly or through sub-award) to organizations located outside the territorial limits of the United States or to international organizations regardless of their location.
• The applicant may contract with other organizations under this program; however, the applicant must perform a substantial portion of the activities (including program management and operations, and delivery of prevention services for which funds are required).
• You must obtain an annual audit of these HHS/CDC funds (program-specific audit) by a U.S.-based audit firm with international branches and current licensure/authority in-country, and in accordance with International Accounting Standards or equivalent standard(s) approved in writing by HHS/CDC.
• A fiscal Recipient Capability Assessment may be required, prior to or post award, in order to review the applicant's business management and fiscal capabilities regarding the handling of U.S. Federal funds.
• Funds received from this announcement will not be used for the purchase of antiretroviral drugs for treatment of established HIV infection (with the exception of nevirapine in Prevention of Mother-to-Child Transmission (PMTCT) cases with prior written approval), occupational
• No funds appropriated under this announcement shall be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.
The U.S. Government is opposed to prostitution and related activities, which are inherently harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons.
Any entity that receives, directly or indirectly, U.S. Government funds in connection with this document (“recipient”) cannot use such U.S. Government funds to promote or advocate the legalization or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, condoms, and, when proven effective, microbicides.
A recipient that is otherwise eligible to receive funds in connection with this document to prevent, treat, or monitor HIV/AIDS shall not be required to endorse or utilize a multisectoral approach to combating HIV/AIDS, or to endorse, utilize, or participate in a prevention method or treatment program to which the recipient has a religious or moral objection. Any information provided by recipients about the use of condoms as part of projects or activities that are funded in connection with this document shall be medically accurate and shall include the public health benefits and failure rates of such use.
In addition, any recipient must have a policy explicitly opposing prostitution and sex trafficking. The preceding sentence shall not apply to any “exempt organizations” (defined as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Health Organization and its six Regional Offices, the International AIDS Vaccine Initiative or to any United Nations agency).
The following definition applies for purposes of this clause:
• Sex trafficking means the recruitment, harboring, transportation, provision, or obtaining of a person for the purpose of a commercial sex act. 22 U.S.C. 7102(9).
All recipients must insert provisions implementing the applicable parts of this section, “Prostitution and Related Activities,” in all subagreements under this award. These provisions must be express terms and conditions of the subagreement, must acknowledge that compliance with this section, “Prostitution and Related Activities,” is a prerequisite to receipt and expenditure of U.S. Government funds in connection with this document, and must acknowledge that any violation of the provisions shall be grounds for unilateral termination of the agreement prior to the end of its term. Recipients must agree that HHS may, at any reasonable time, inspect the documents and materials maintained or prepared by the recipient in the usual course of its operations that relate to the organization's compliance with this section, “Prostitution and Related Activities.”
All prime recipients that receive U.S. Government funds (“prime recipients”) in connection with this document must certify compliance prior to actual receipt of such funds in a written statement that makes reference to this document (
Recipients' compliance with this section, “Prostitution and Related Activities,” is an express term and condition of receiving U.S. Government funds in connection with this document, and any violation of it shall be grounds for unilateral termination by HHS of the agreement with HHS in connection with this document prior to the end of its term. The recipient shall refund to HHS the entire amount furnished in connection with this document in the event HHS determines the recipient has not complied with this section, “Prostitution and Related Activities.”
You may find guidance for completing your budget on the HHS/CDC Web site, at the following Internet address:
HHS/CDC recommends that you submit your application to Grants.gov early enough to resolve any unanticipated difficulties prior to the deadline. You may also submit a back-up paper submission of your application. We must receive any such paper submission in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement.
You must clearly mark the paper submission: “BACK-UP FOR ELECTRONIC SUBMISSION.”
The paper submission must conform to all requirements for non-electronic submission. If we receive both electronic and back-up paper submissions by the deadline, we will consider the electronic version the official submission.
We strongly recommended that you submit your grant application by using Microsoft Office products (
Applicants must provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. Applicants must submit these measures of effectiveness with the application and they will be an element of evaluation.
We will evaluate your application against the following criteria:
1. The current ability of the applicant and its member institutions to provide
Does the applicant show, through its' experience and the written proposal, that it has a firm understanding of health care and community outreach, along with expertise in the existing systems of health care delivery and medical training in India? Does the applicant's current network reach a large segment of the at-risk populations of the state?
2. Strength of applicant's existing or proposed network. (25 points).
Is the network firmly established and credible? Is there evidence of institutional support for establishing or strengthening their network? Is the existing or proposed network likely to be maintained during or beyond the project period? Does the network exhibit value beyond this project? Does the network have the commitment and interest to work collaboratively with outside groups and agencies?
3. Quality and feasibility of proposed activities. (25 points).
Does the applicant demonstrate an understanding of the national cultural and political context and the technical and programmatic areas covered by the project? Does the applicant display knowledge of the five-year strategy and goals of the President's Emergency Plan, such that it can build on these to develop a comprehensive, collaborative project to reach underserved populations in India and meet the goals of the Emergency Plan? Are the details of the proposed activities (for the entire project period) clearly presented in the application? While summary details for years three through five are acceptable, specific and clearly presented details for years one and two are required. Is staffing, professional personnel, and leadership in place; if not, is there a proposed plan to meet staffing needs to carry out the proposed program? Are program strategies well thought out and clearly defined, including evidence of innovation and creativity? Is scale up and sustainability addressed? Is there an effective monitoring and evaluation plan proposed, or currently in place, and can initial assessment activities be immediately started?
4. Commitment of the applicant and its member institutions to improving the quality and scope of HIV-related care. (25 points).
Is there evidence of leadership support and of evidence of current or past efforts to improve HIV care? Are there letters of support by outside groups and member organizations? Does the level and quality of in-kind support reflect a commitment to HIV care by the applicant? Does the applicant describe a plan to progressively build the capacity of local organizations and of target beneficiaries and communities to respond to the epidemic?
5. Budget. (Reviewed, but not scored).
Is the budget for conducting the activity itemized, well-justified, and consistent with stated activities and planned program activities?
The HHS/CDC Procurement and Grants Office (PGO) staff will review applications for completeness, and HHS Global AIDS program will review them for responsiveness. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will receive notification that their application did not meet submission requirements.
An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above. All persons who serve on the panel will be external to the U.S. Government Country Program Office. The panel may include both Federal and non-Federal participants.
In addition, the following factors could affect the funding decision:
It is possible for one organization to apply as lead grantee with a plan that includes partnering with other organizations, preferably local. Although matching funds are not required, preference will go to organizations that can leverage additional funds to contribute to program goals.
Applications will be funded in order by score and rank determined by the review panel. HHS/CDC will provide justification for any decision to fund out of rank order.
September 15, 2005.
Successful applicants will receive a Notice of Award (NoA) from the HHS/CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and HHS/CDC. An authorized Grants Management Officer will sign the NoA, and mail it to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of the application review by mail.
For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address:
The following additional requirements apply to this project:
• AR-4 HIV/AIDS Confidentiality Provisions
• AR-8 Public Health System Reporting Requirements
• AR-12 Lobbying Restrictions
• AR-14 Accounting System Requirements
• AR-25 Release and Sharing of Data
Applicants can find additional information on these requirements on the HHS/CDC Web site at the following Internet address:
You need to include an additional Certifications form from the PHS 5161-1 application ed in your Grants.gov electronic submission only. Refer to:
You must provide HHS/CDC with an original, plus two hard copies of the following reports:
1. Interim progress report, due no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:
a. Current budget period activities objectives.
b. Current budget period financial progress.
c. New budget period program proposed activity objectives.
d. Budget.
e. Measures of effectiveness.
f. Additional requested information.
2. Financial status report and annual progress report, no more than 90 days after the end of the budget period.
3. Final financial and performance reports, no more than 90 days after the end of the project period.
4. Annual progress report, due no less than 30 days after the end of the budget period. This report will include progress to date, plans for upcoming activities,
These reports must be mailed to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.
We encourage inquiries concerning this announcement.
For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341, telephone: 1-770-488-2700.
For program technical assistance, contact: Michael Friedman, MD, HHS/CDC, Global AIDS Program (India), Country Team, c/o U.S. Consulate General, 220 Mount Road, Chennai, India 600 006, telephone: 91-44-2811-2000, e-mail:
For financial, grants management, or budget assistance, contact: Shirley Wynn, Grants Management Specialist, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341, telephone: 770-488-1515, e-mail:
Applicants can find this and other HHS/CDC funding opportunity announcements on the HHS/CDC Web site, Internet address:
Over the same time period, as part of a collective national response, the Emergency Plan goals specific to Ethiopia are to treat at least 210,000 HIV-infected individuals; and care for 1,050,000 HIV-affected individuals, including orphans.
Under the leadership of the U.S. Global AIDS Coordinator, as part of the President's Emergency Plan, the U.S. Department of Health and Human Services (HHS) works with host countries and other key partners to assess the needs of each country and design a customized program of assistance that fits within the host nation's strategic plan.
HHS focuses on two or three major program areas in each country. Goals and priorities include the following:
• Achieving primary prevention of HIV infection through activities such as expanding confidential counseling and testing programs, building programs to reduce mother-to-child transmission, and strengthening programs to reduce transmission via blood transfusion and medical injections.
• Improving the care and treatment of HIV/AIDS, sexually transmitted diseases (STDs) and related opportunistic infections by improving STD management; enhancing care and treatment of opportunistic infections, including tuberculosis (TB); and initiating programs to provide anti-retroviral therapy (ART).
• Strengthening the capacity of countries to collect and use surveillance data and manage national HIV/AIDS programs by expanding HIV/STD/TB surveillance programs and strengthening laboratory support for surveillance, diagnosis, treatment, disease-monitoring and HIV screening for blood safety.
This announcement is only for non-research activities supported by HHS, including the Centers for Disease Control and Prevention (CDC). If an applicant proposes research activities, HHS will not review the application. For the definition of research, please see the HHS/CDC web site at the following Internet address:
Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the numerical goals of the President's Emergency Plan for AIDS Relief and HHS/CDC National Center for HIV, STD and TB Prevention (NCHSTP): Increase the proportion of HIV-infected people who are linked to appropriate prevention, care and treatment services, and strengthen the capacity nationwide to monitor the epidemic, develop and implement effective HIV prevention interventions and evaluate prevention programs.
Applicants should describe activities in detail as part of a four-year action plan (U.S. Government Fiscal Years 2005-2008 inclusive) that reflects the policies and goals outlined in the five-year strategy for the President's Emergency Plan.
The grantee will produce an annual operational plan in the context of this four-year plan, which the U.S. Government Emergency Plan team on the ground in Ethiopia will review as part of the annual Emergency Plan for AIDS Relief Country Operational Plan review and approval process managed by the Office of the U.S. Global AIDS Coordinator. The grantee may work on some of the activities listed below in the first year and in subsequent years, and then progressively add others from the list to achieve all of the Emergency Plan performance goals, as cited in the previous section. HHS/CDC, under the guidance of the U.S. Global AIDS Coordinator, will approve funds for activities on an annual basis, based on documented performance toward achieving Emergency Plan goals, as part of the annual Emergency Plan for AIDS Relief Country Operational Plan review and approval process.
Specific awardee activities for this program are as follows:
1. Conduct needs assessment to determine risk factors, target behaviors, barriers, facilitators, reinforcement mechanisms, communication channels, availability of services, family demographics/situations, etc. to inform the development prevention, care and treatment programs among people living with HIV/AIDS.
2. Develop/adapt or organize tools such as operations manuals, training manuals, and guidelines in the areas of, prevention of mother-to-child transmission (PMTCT) of HIV, confidential voluntary counseling and testing (VCT), sexually transmitted infections (STI), tuberculosis (TB), laboratory, and other technical areas as deemed appropriate for provision of interventions, trainings, and targeted monitoring and evaluations.
3. Institute the needed administrative and functional arrangements to coordinate the day-to-day activity of the project to guarantee effectiveness, efficiency, transparency and accountability.
4. Organize and procure necessary equipment and supplies in a transparent and competitive process, and coordinate services, trainings in local languages and targeted monitoring and evaluations.
5. Provide trainings on counseling and home-based care to PLWHA to improve the provision of care at the community level.
6. Establish self'care and anti-retroviral (ARV) treatment information resource center/section within the network of people living with HIV/AIDS to update members on current development including in ARV treatment.
7. Establish peer-support system among the network of people living with HIV/AIDS to facilitate health-seeking behavior and adherence to ARV treatment.
8. Engage PLWHA to closely work with public and private health facilities to strengthen adherence to care and treatment, including ARV drug adherence, such as linkage of health facilities to community/household activities.
9. Undertake activities geared towards prevention among HIV positives by following the “ABC” (Abstinence; Be faithful; and, for populations engaged in high-risk behavior,
10. Conduct culturally and age-appropriate workshops, seminars and popularization events in local languages related to HIV/AIDS prevention, control, and treatment.
11. Conduct targeted monitoring and evaluations of projects and in identified priority areas that require evidence for perusal in programs implementation, according to the strategic information guidance established by the U.S. Global AIDS Coordinator.
Winning applicants must comply with all HHS management requirements for meeting participation and progress and financial reporting for this cooperative agreement. (See HHS Activities and Reporting sections below for details.) Winning applicants must comply with all policy directives established by the Office of the U.S. Global AIDS Coordinator.
In a cooperative agreement, HHS staff is substantially involved in the program activities, above and beyond routine grant monitoring.
HHS Activities for this program are as follows:
1. Organize an orientation meeting with the grantee to brief it on applicable U.S. Government, HHS, and Emergency Plan expectations, regulations and key management requirements, as well as report formats and contents. The orientation could include meetings with staff from HHS agencies and the Office of the U.S. Global AIDS Coordinator.
2. Review and approve the process used by the grantee to select key personnel and/or post-award subcontractors and/or subgrantees to be involved in the activities performed under this agreement, as part of the Emergency Plan for AIDS Relief Country Operational Plan review and approval process, managed by the Office of the U.S. Global AIDS Coordinator.
3. Review and approve grantee's annual work plan and detailed budget, as part of the Emergency Plan for AIDS Relief Country Operational Plan review and approval process, managed by the Office of the U.S. Global AIDS Coordinator.
4. Review and approve grantee's monitoring and evaluation plan, including for compliance with the strategic information guidance established by the Office of the U.S. Global AIDS Coordinator.
5. Meet on a monthly basis with grantee to assess monthly expenditures in relation to approved work plan and modify plans as necessary.
6. Meet on a quarterly basis with grantee to assess quarterly technical and financial progress reports and modify plans as necessary.
7. Meet on an annual basis with grantee to review annual progress report for each U.S. Government Fiscal Year, and to review annual work plans and budgets for subsequent year, as part of the Emergency Plan for AIDS Relief review and approval process for
8. Provide technical assistance, as mutually agreed upon, and revise annually during validation of the first and subsequent annual work plans. This could include expert technical assistance and targeted training activities in specialized areas, such as strategic information, project management, confidential counseling and testing, palliative care, treatment literacy, and adult learning techniques.
Please note: Either HHS staff or staff from organizations that have successfully competed for funding under a separate HHS contract, cooperative agreement or grant will provide technical assistance and training.
Throughout the project period, HHS' commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government, as determined by the annual review and approval of Country Operational Plans, managed by the U.S. Global AIDS Coordinator.
Public and private non-profit and for-profit organizations may submit applications, such as:
• Public, non-profit organizations.
• Private, non-profit organizations.
• For-profit organizations.
• Small, minority-owned, and women-owned businesses.
• Colleges.
• Universities.
• Hospitals.
• Community-based organizations.
• Faith-based organizations.
In addition, applicants must meet the criteria listed below:
1. Be indigenous to Ethiopia.
2. Have the ability, and credibility to support culturally and age-appropriate prevention, care, support, and treatment activities by PLWHA in local languages at the community and facility level.
3. Documented experience in working with national and regional/local PLWHA associations and support groups.
4. Experience working with the Ethiopian Government, international organizations and community- and faith-based groups societies in the prevention and control of HIV/AIDS in Ethiopia.
Matching funds are not required for this program. Although matching funds are not required, preference will go to organizations that can leverage additional funds to contribute to program goals.
If you request a funding amount greater than the ceiling of the award range, HHS/CDC will consider your application non-responsive, and will not enter into the review process. We will notify you that your application did not meet the submission requirements.
• HHS/CDC will consider late applications non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
• Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.
To apply for this funding opportunity use application form PHS 5161-1.
HHS strongly encourages you to submit your application electronically by using the forms and instructions posted for this announcement at
Application forms and instructions are available on the HHS/CDC Web site, at the following Internet address:
If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700. We can mail application forms to you.
• Maximum number of pages: 25. If your narrative exceeds the page limit, we will only review the first pages within the page limit.
• Font size: 12 point unreduced.
• Double-spaced.
• Paper size: 8.5 by 11 inches.
• Page margin size: One inch.
• Printed only on one side of page.
• Held together only by rubber bands or metal clips; not bound in any other way.
• All pages should be numbered.
• Your application MUST be submitted in English.
Your narrative should address activities to be conducted over the entire project period, and must include the following items in the order listed:
• Project Context and Background (Understanding and Need).
• Project Strategy—Description and Methodologies.
• Project Goals.
• Project Outputs.
• Project Contribution to the Goals and Objectives of the Emergency Plan for AIDS Relief.
• Work Plan and Description of Project Components and Activities.
• Performance Measures.
• Timeline (
• Management of Project Funds and Reporting.
You may include additional information in the application appendices. The appendices will not count toward the narrative page limit. This additional information includes the following:
• Project Budget and Justification.
•
• Job descriptions of proposed key positions to be created for the activity.
• Quality-Assurance, Monitoring-and-Evaluation, and Strategic-Information Forms.
• Applicant's Corporate Capability Statement.
• Letters of Support.
• Evidence of Legal Organizational Structure.
• Applicants must provide documentation that substantiates their well-developed management and financial controls and ability to implement HIV activities with reach to rural areas of Ethiopia. Such proof could include, but is not limited to, annual, financial, and audit reports, etc.
The budget justification will not count in the narrative page limit.
Although the narrative addresses activities for the entire project, the applicant should provide a detailed budget only for the first year of activities, while addressing budgetary plans for subsequent years.
You must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy, and there is no charge. To obtain a DUNS number, access
For more information, see the HHS/CDC Web site at:
Additional requirements that could require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”
You may submit your application electronically at
If you submit your application electronically with Grants.gov, your application will be electronically time/date stamped, which will serve as receipt of submission. You will receive an e-mail notice of receipt when HHS/CDC receives the application.
If you submit your application by the United States Postal Service or commercial delivery service, you must ensure the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after closing because: (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will have the opportunity to submit documentation of the carriers guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as received by the deadline.
If you submit a hard copy application, HHS/CDC will not notify you upon receipt of your submission. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770-488-2700. Before calling, please wait two to three days after the submission deadline. This will allow time for us to process and log submissions.
This announcement is the definitive guide on application content, submission address, and deadline. It supersedes information provided in the application instructions.
If your submission does not meet the deadline above, it will not be eligible for review, and we will discard it. We will notify you that you did not meet the submission requirements.
Executive Order 12372 does not apply to this program.
Restrictions, which you must take into account while writing your budget, are as follows:
• Funds may not be used for research.
• Needle Exchange—No funds appropriated under this Act shall be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.
• Funds may be spent for reasonable program purposes, including personnel, training, travel, supplies and services. Equipment may be purchased and renovations completed if deemed necessary to accomplish program objectives; however, prior approval by HHS/CDC officials must be requested in writing.
• All requests for funds contained in the budget shall be stated in U.S. dollars. Once an award is made, HHS/CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.
• The costs that are generally allowable in grants to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut, and the World Health Organization, Indirect Costs will not be paid (either directly or through sub-award) to organizations located outside the territorial limits of the United states or to international organizations, regardless of their location.
• The applicant may contract with other organizations under this program; however, the applicant must perform a substantial portion of the activities (including program management and operations, and delivery of prevention services for which funds are required) relating to the management of sub-grants to local organizations and improving their capacity.
• You must obtain an annual audit of these HHS/CDC funds (program-specific audit) by a U.S.-based audit firm with international branches and current licensure/authority in-country, and in accordance with International Accounting Standards or equivalent standard(s) approved in writing by HHS/CDC.
• A fiscal Recipient Capability Assessment may be required, prior to or post award, to review the applicant's business management and fiscal capabilities regarding the handling of U.S. Federal funds.
The U.S. Government is opposed to prostitution and related activities, which are inherently harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons.
Any entity that receives, directly or indirectly, U.S. Government funds in connection with this document (“recipient”) cannot use such U.S. Government funds to promote or advocate the legalization or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities,
A recipient that is otherwise eligible to receive funds in connection with this document to prevent, treat, or monitor HIV/AIDS shall not be required to endorse or utilize a multisectoral approach to combating HIV/AIDS, or to endorse, utilize, or participate in a prevention method or treatment program to which the recipient has a religious or moral objection. Any information provided by recipients about the use of condoms as part of projects or activities that are funded in connection with this document shall be medically accurate and shall include the public health benefits and failure rates of such use.
In addition, any recipient must have a policy explicitly opposing prostitution and sex trafficking. The preceding sentence shall not apply to any “exempt organizations” (defined as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Health Organization and its six Regional Offices, the International AIDS Vaccine Initiative or to any United Nations agency).
The following definition applies for purposes of this clause:
• Sex trafficking means the recruitment, harboring, transportation, provision, or obtaining of a person for the purpose of a commercial sex act. 22 U.S.C. 7102(9).
All recipients must insert provisions implementing the applicable parts of this section, “Prostitution and Related Activities,” in all subagreements under this award. These provisions must be express terms and conditions of the subagreement, must acknowledge that compliance with this section, “Prostitution and Related Activities,” is a prerequisite to receipt and expenditure of U.S. government funds in connection with this document, and must acknowledge that any violation of the provisions shall be grounds for unilateral termination of the agreement prior to the end of its term. Recipients must agree that HHS may, at any reasonable time, inspect the documents and materials maintained or prepared by the recipient in the usual course of its operations that relate to the organization's compliance with this section, “Prostitution and Related Activities.”
All prime recipients that receive U.S. Government funds (“prime recipients”) in connection with this document must certify compliance prior to actual receipt of such funds in a written statement that makes reference to this document (
Recipients' compliance with this section, “Prostitution and Related Activities,” is an express term and condition of receiving U.S. Government funds in connection with this document, and any violation of it shall be grounds for unilateral termination by HHS of the agreement with HHS in connection with this document prior to the end of its term. The recipient shall refund to HHS the entire amount furnished in connection with this document in the event HHS determines the recipient has not complied with this section, “Prostitution and Related Activities.”
You may find guidance for completing your budget on the HHS/CDC web site, at the following Internet address:
HHS/CDC recommends that you submit your application to Grants.gov early enough to resolve any unanticipated difficulties prior to the deadline. You may also submit a back-up paper submission of your application. We must receive any such paper submission in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement.
You must clearly mark the paper submission: “BACK-UP FOR ELECTRONIC SUBMISSION.”
The paper submission must conform to all requirements for non-electronic submissions. If we receive both electronic and back-up paper submissions by the deadline, we will consider the electronic version the official submission.
We strongly recommended that you submit your grant application by using Microsoft Office products (
Submit the original and two hard copies of your application by mail or express delivery service to the following address: Technical Information Management—AA119, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341.
Applicants must provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. Applicants must submit these measures of effectiveness with the application, and they will be an element of evaluation.
An objective review panel appointed by HHS will evaluate each application against the following criteria:
Does the applicant provide a clear plan for the administration and management of the proposed activities, to manage the resources of the program, prepare reports, monitor and evaluate activities and audit expenditures?
Does the applicant's proposal demonstrate an understanding of how to develop, promote, implement, monitor and evaluate activities listed above? Does the applicant describe strategies that are pertinent and match those identified in the five-year strategy of the President's Emergency Plan and activities that are evidence-based, realistic, achievable, measurable and culturally appropriate in Ethiopia to achieve the goals of the Emergency Plan?
Does the applicant demonstrate the local experience and capability to achieve the goals of the project?
Are staff involved in this project qualified to perform the tasks described? CVs provided should include information that they are qualified to perform HIV/AIDS, prevention, care, support and treatment activities in the local languages? Are the staff roles clearly defined? Are professional personnel involved in this project qualified, including evidence of experience in working with HIV/AIDS, sexually transmitted infections, and tuberculosis?
Does the applicant demonstrate an understanding of the national cultural and political context and the technical and programmatic areas covered by the project? Does the applicant display knowledge of the five-year strategy and goals of the President's Emergency Plan, such that it can build on these to develop a comprehensive, collaborative project to reach underserved populations in Ethiopia and meet the goals of the Emergency Plan? Does the applicant demonstrate a clear and concise understanding of the general AIDS epidemic situation, the policy environment and current training and research needs in Ethiopia?
Is the itemized budget for conducting the project is reasonable and well-justified? Is the budget itemized, well-justified and consistent with the five-year strategy and goals of the President's Emergency Plan and Emergency Plan activities in Ethiopia?
The HHS/CDC Procurement and Grants Office (PGO) staff will review applications for completeness, and HHS Global AIDS program will review them for responsiveness. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will receive notification that their application did not meet submission requirements.
An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above. All persons who serve on the panel will be external to the U.S. Government Country Program Office in Ethiopia. The panel can include both Federal and non-Federal participants.
In addition, the following factors could affect the funding decision:
It is possible for one organization to apply as lead grantee with a plan that includes partnering with other organizations, preferably local. Although matching funds are not required, preference will be go to organizations that can leverage additional funds to contribute to program goals.
Applications will be funded in order by score and rank determined by the review panel. HHS/CDC will provide justification for any decision to fund out of rank order.
September 15, 2005.
Successful applicants will receive a Notice of Award (NoA) from the HHS/CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and HHS/CDC. An authorized Grants Management Officer will sign the NoA, and mail it to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of the application review by mail.
For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address:
The following additional requirements apply to this project:
• AR-4 HIV/AIDS Confidentiality Provisions
• AR-5 HIV Program Review Panel Requirements
• AR-7 Executive Order 12372
• AR-8 Public Health System Reporting Requirements
• AR-14 Accounting System Requirements
• AR-15 Proof of Non-Profit Status
Applicants can find additional information on these requirements on the HHS/CDC Web site at the following Internet address:
You need to include an additional Certifications form from the PHS 5161-1 application in your Grants.gov electronic submission only. Please refer to
You must provide HHS/CDC with an original, plus two hard copies, of the following reports (in English).
1. Interim progress report, due no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Measures of Effectiveness, including progress against the numerical goals of the President's Emergency Plan for AIDS Relief for Ethiopia.
f. Additional Requested Information.
2. Annual progress report, due no more than 60 days after the end of the budget period. Reports should include progress against the numerical goals of the President's Emergency Plan for AIDS Relief for Ethiopia.
3. Financial status report, due no more than 90 days after the end of the budget period.
4. Final financial and performance reports, no more than 90 days after the end of the project period.
Recipients must mail these reports to the Grants Management or Contract Specialist listed in the “Agency Contacts” section of this announcement.
We encourage inquiries concerning this announcement.
For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-2700.
For program technical assistance, contact: Tadesse Wuhib, MD, MPH, Country Director, HHS/CDC-Ethiopia, P.O. Box 1014, Entoto Road, Addis Ababa. Telephone: (Office) 251-1-66-95-33; (Cell) 251-9-228543. E-mail address:
For financial, grants management, or budget assistance, contact: Shirley Wynn, Grants Management Specialist, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-1515. E-mail:
Applicants can find this and other HHS funding opportunity
This program is authorized under Sections 307 and 317(k)(2) of the Public Health Service Act [42 U.S.C. Sections 242l and 247b(k)(2)], as amended, and under Public Law 108-25 (United States Leadership against HIV/AIDS, Tuberculosis and Malaria Act of 2004) [22 U.S.C. 7601].
Over the same time period, as part of a collective national response, the Emergency Plan goals specific to Côte d'Ivoire are to treat at least 77,000 HIV-infected individuals; care for 385,000 HIV-affected individuals, including orphans; and prevent 265,000 new HIV infections.
Under the leadership of the U.S. Global AIDS Coordinator, as part of the President's Emergency Plan, the U.S. Department of Health and Human Services (HHS) works with host countries and other key partners to assess the needs of each country and design a customized program of assistance that fits within the host nation's strategic plan.
This announcement is only for non-research activities supported by HHS, including the Centers for Disease Control and Prevention (CDC). If an applicant proposes research activities, HHS will not review the application. For the definition of research, please see the HHS/CDC Web site at the following Internet address:
Measurable outcomes of the program will be in alignment with the numerical goals of the President's Emergency Plan and the following performance goals for the National Center for HIV, STD, and TB Prevention (NCHSTP) of CDC, within HHS: By 2010, work with other countries, international organizations, the U.S. Department of State, U.S. Agency for International Development (USAID), and other partners to achieve the United National General Assembly Special Session on HIV/AIDS goal of reducing prevalence among persons 15 to 24 years of age.
The goals of the Emergency Plan include the following:
Number of individuals trained to provide HIV prevention interventions [Abstinence and Be Faithful (A/B); and for populations engaged in high-risk behavior,
a. Number of community outreach and/or mass-media (radio) HIV/AIDS prevention programs that are A/B focused.
b. Number of individuals reached through community outreach and/or mass-media (radio) HIV/AIDS prevention programs that are A/B focused.
a. Number of service outlets that provide the minimum package of PMTCT services (
b. Number of pregnant women provided with PMTCT, including confidential CT.
c. Number of pregnant women provided with a complete course of anti-retroviral prophylaxis in a PMTCT setting.
d. Number of health workers newly trained or retrained in the provision of PMTCT.
a. Number of CT service outlets that provide CT.
b. Number of clients who receive CT.
c. Number of people trained in CT.
a. Number of service outlets/programs.
b. Number of clients (OVC) served.
c. Number of persons trained in caring for OVC.
a. Number of service outlets/programs that provide general HIV-related palliative care.
b. Number of service outlets/programs that provide malaria care and/or referral.
c. Number of clients served with general HIV-related palliative care.
d. Number of persons trained to provide general HIV-related palliative care.
1. Number of clients served.
2. Number of persons trained in HIV treatment.
Number of persons trained in strategic information, according to guidance produced by the Office of the U.S. Global AIDS Coordinator.
Project-specific quantifiable milestones will be required to measure:
1. Indigenous capacity-building.
2. Progress toward sustainability.
The grantee will expand comprehensive HIV prevention and care, including: behavior-change communication (BCC); provision of supportive and palliative care to OVC and HIV affected families; and provision of/or linkages to PMTCT, CT and HIV treatment through health care centers, local non-governmental organizations (NGOs), community-based-organizations (CBOs) and/or faith-based organizations (FBOs), with a measurable and progressive reinforcement of the capacity of local structures to implement and sustain activities.
Applicants should describe activities, in detail, as part of a four-year action plan (U.S. Government Fiscal Years 2005-2008 inclusive) that reflects the policies and goals outlined in the five-year strategy for the President's Emergency Plan. The grantee will produce an annual operational plan in the context of this four-year plan, which the U.S. Government Emergency Plan team on the ground in Côte d'Ivoire will review as part of the annual Emergency Plan for AIDS Relief Country Operational Plan review and approval process managed by the Office of the U.S. Global AIDS Coordinator.
The grantee may work on some of the activities listed in this announcement in the first year and in subsequent years, and then progressively add others from the list to achieve all of the Emergency Plan performance goals as cited in the previous section. HHS/CDC, under the guidance of the U.S. Global AIDS Coordinator, will approve funds for activities on an annual basis, based on documented performance toward achieving Emergency Plan goals, as part of the annual Emergency Plan for AIDS Relief Country Operational Plan review and approval process.
Based on its competitive advantage and proven field experience, the winning applicant will undertake a broad range of activities to meet the numerical Emergency Plan targets outlined in this announcement. For each of these activities, the grantee will give priority to evidence-based, yet culturally adapted, innovative approaches including:
1. Assisting governmental and non-governmental structures, financially and/or technically, to re-establish and/or reinforce a range of prevention and palliative care interventions provided to persons living with HIV/AIDS (PLWHA) and their families in the regions where health care has been disrupted; and providing care, supported through a combination of technical assistance with capacity-building, and of small- to medium-size grants to local community- and faith-based organizations.
2. Implementation of BCC interventions, in partnership with local organizations (CBOs/NGOs/FBOs), journalist and artist networks, and traditional and elected authorities, in the geographic regions targeted, by building on existing tools and strategies. Interventions will respect and reflect local cultural and religious mores, and will aim to reduce HIV-related stigma; promote HIV testing as part of a comprehensive BCC strategy to reduce HIV transmission and as a routine part of medical care; and improve care, support, and treatment for PLWHA and family members, highly vulnerable youth, military, ex-combatants and other vulnerable populations. Evidence-based approaches will be used, which can include peer education, targeted condom social marketing to populations engaged in high-risk behavior,
3. Progressively build capacity members of AIDS service organizations (ASO) in program and financial management, monitoring and evaluation, resource mobilization, and/or the provision of community/home-based palliative care and anti-retroviral treatment.
4. Comply with all HHS/CDC management requirements for meeting participation and progress and financial reporting for this cooperative agreement. (See HHS/CDC activities and Reporting sections below for details.)
Willing applicants must comply with all HHS management requirements for meeting participation and progress and financial reporting for this cooperative agreement. (See HHS Activities and Reporting sections below for details.) Winning applicants must comply with all policy directives established by the Office of the U.S. Global AIDS Coordinator.
In a cooperative agreement, HHS staff is substantially involved in the program activities, above and beyond routine grant monitoring.
HHS Activities for this program are as follows:
1. Organize an orientation meeting to brief the grantee on applicable U.S. Government, HHS, and Emergency Plan expectations, regulations and key management requirements, as well as report formats and contents. The orientation could include meetings with staff from HHS agencies and the Office of the U.S. Global AIDS Coordinator.
2. Review and approve the process used by the grantee to select key personnel or post-award sub-contractors to be involved in the activities performed under this agreement, as part of the Emergency Plan for AIDS Relief Country Operational Plan review and approval process, managed by the Office of the U.S. Global AIDS Coordinator.
3. Review and approve grantee's annual work plan and detailed budget, as part of the Emergency Plan for AIDS Relief Country Operational Plan review and approval process, managed by the Office of the U.S. Global AIDS Coordinator.
4. Review and approve grantee's monitoring and evaluation plan, including for compliance with the strategic information guidance established by the Office of the U.S. Global AIDS Coordinator.
5. Meet with grantee, as necessary, to assess quarterly technical and financial progress reports and modify plans as necessary.
6. Meet on an annual basis with grantee to review annual progress report for each U.S. Government Fiscal Year, and to review annual work plans and budgets for subsequent year, as part of the Emergency Plan for AIDS Relief review and approval process for Country Operational Plans, managed by the Office of Global AIDS Coordinator.
7. Provide technical assistance, as mutually agreed upon and revised annually, during validation of the first and subsequent annual work plans. This can include expert technical assistance and targeted training activities in specialized areas, such as: strategic information; project management; confidential counseling and testing; palliative care; orphans and vulnerable children (OVC); treatment literacy; and adult learning techniques.
8. Provide in-country administrative support to help grantee meet U.S. Government financial and reporting requirements.
Either HHS staff or staff from organizations that have successfully competed for funding under a separate HHS contract, cooperative agreement or grant will provide technical assistance and training.
HHS involvement in this program is listed in the Activities Section above.
Throughout the project period, HHS' commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government, through the Emergency Plan for AIDS Relief review and approval process for Country Operational Plans, managed by the Office of the U.S. Global AIDS Coordinator.
Public and private non-profit and for-profit organizations may submit applications, such as:
• Public, non-profit organizations.
• Private, non-profit organizations.
• For-profit organizations.
• Small, minority-owned, and women-owned businesses.
• Universities.
• Colleges.
• Hospitals.
• Community-based organizations.
• Faith-based organizations.
While both U.S.-based and Ivorian organizations are eligible to apply, we will give preference to well-established Ivorian organizations, legally incorporated in Co
Matching funds are not required for this program. Although matching funds are not required, preference will go to organizations that can leverage additional funds to contribute to program goals.
If applicants request a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. We will notify you that your application did not meet the submission requirements.
• HHS/CDC will consider late applications non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
• Applicants may be U.S.-based or Ivorian, but we will give preference to existing organizations legally incorporated in Co
• Applicant must provide documentation that substantiates eligibility criteria. Such proof could include, but is not limited to, official documents that describe legal organizational status, annual, financial, and audit reports, etc.
•
To apply for this funding opportunity use application form PHS 5161-1.
HHS strongly encourages you to submit your application electronically by using the forms and instructions posted for this announcement at
Application forms and instructions are available on the HHS/CDC Web site, at the following Internet address:
If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at 770-488-2700. We can mail application forms to you.
• Maximum number of pages: 25. If your narrative exceeds the page limit, we will only review the first pages within the page limit.
• Font size: 12 point unreduced.
• Double-spaced.
• Paper size: 8.5 by 11 inches.
• Page margin size: One inch.
• Printed only on one side of page.
• Held together only by rubber bands or metal clips; not bound in any other way.
• Must be submitted in English.
Your narrative should address activities to be conducted over the entire project period, and must include the following items in the order listed:
• Project Context and Background (Understanding and Need).
• Project Strategy—Description and Methodologies.
• Project Goals.
• Project Outputs.
• Project Contribution to the Goals and Objectives of the Emergency Plan for AIDS Relief.
• Work Plan and Description of Project Components and Activities.
• Performance Measures.
• Timeline (
• Management of Project Funds and Reporting.
You may include additional information in the application appendices. The appendices will not count toward the narrative page limit. This additional information includes the following:
• Project Budget.
• Project Budget Notes.
•
• Job Descriptions (summaries of proposed key positions to be created for the activity).
• Quality-Assurance, Monitoring-and-Evaluation and Strategic-Information Forms.
• Applicant's Corporate Capability Statement.
• Letters of Support.
• Evidence of Legal Organizational Structure.
The budget justification will not count in the narrative page limit. Although the narrative addresses activities for the entire project, the applicant should provide a detailed budget only for the first year of activities and broad line items for the other project period years.
You must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy, and there is no charge. To obtain a DUNS number, access
If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter.
Additional requirements that could require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”
Applications may be submitted electronically at
If you submit your application electronically with Grants.gov, your application will be electronically time/date stamped, which will serve as receipt of submission. You will receive an e-mail notice of receipt when HHS/CDC receives the application.
If you submit your application by the United States Postal Service or commercial delivery service, you must ensure the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after closing because of: (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will have the opportunity to submit documentation of the carriers guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as received by the deadline.
If you submit a hard copy application, HHS/CDC will not notify you upon receipt of your submission. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at (770) 488-2700. Before calling, please wait two to three days after the submission deadline. This will allow time for us to process and log submissions.
This announcement is the definitive guide on application content, submission address, and deadline. It supersedes information provided in the application instructions. If your submission does not meet the deadline above, it will not be eligible for review, and we will discard it. We will notify you that you did not meet the submission requirements.
Executive Order 12372 does not apply to this program.
Restrictions, which you must take into account while writing your budget, are as follows:
• Funds may not be used for research.
• Reimbursement of pre-award costs is not allowed.
• Funds may be spent for reasonable program purposes, including personnel, travel, supplies, and services. Equipment may be purchased if deemed necessary to accomplish program objectives; however, prior approval by HHS/CDC Co
• All requests for funds contained in the budget shall be stated in U.S. dollars. Once an award is made, HHS/CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.
• The costs that are generally allowable in grants to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut and the World Health Organization, Indirect Costs will not be paid (either directly or through sub-award) to organizations located outside the territorial limits of the U.S. or to international organizations, regardless of their location.
• The applicant may contract with other organizations under this program; however, the applicant must perform a substantial portion of the activities
• You must obtain an annual audit of these HHS/CDC funds (program-specific audit) by a U.S.-based audit firm with international branches and current licensure/authority in-country, and in accordance with International Accounting Standards or equivalent standard(s) approved in writing by HHS/CDC.
• A Fiscal Recipient Capability Assessment may be required, prior to or post award, to review the applicant's business management and fiscal capabilities regarding the handling of U.S. Federal funds.
• Funds received from this announcement will not be used for the purchase of antiretroviral drugs for treatment of established HIV infection (with the exception of nevirapine in Prevention of Mother-to-Child Transmission (PMTCT) cases and with prior written approval), occupational exposures, and non-occupational exposures, and will not be used for the purchase of machines and reagents to conduct the necessary laboratory monitoring for patient care.
• No funds appropriated under this act shall be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.
The U.S. Government is opposed to prostitution and related activities, which are inherently harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons.
Any entity that receives, directly or indirectly, U.S. Government funds in connection with this document (“recipient”) cannot use such U.S. Government funds to promote or advocate the legalization or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, condoms, and, when proven effective, microbicides.
A recipient that is otherwise eligible to receive funds in connection with this document to prevent, treat, or monitor HIV/AIDS shall not be required to endorse or utilize a multisectoral approach to combating HIV/AIDS, or to endorse, utilize, or participate in a prevention method or treatment program to which the recipient has a religious or moral objection. Any information provided by recipients about the use of condoms as part of projects or activities that are funded in connection with this document shall be medically accurate and shall include the public health benefits and failure rates of such use.
In addition, any recipient must have a policy explicitly opposing prostitution and sex trafficking. The preceding sentence shall not apply to any “exempt organizations” (defined as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Health Organization and its six Regional Offices, the International AIDS Vaccine Initiative or to any United Nations agency).
The following definition applies for purposes of this clause:
• Sex trafficking means the recruitment, harboring, transportation, provision, or obtaining of a person for the purpose of a commercial sex act. 22 U.S.C. 7102(9).
All recipients must insert provisions implementing the applicable parts of this section, “Prostitution and Related Activities,” in all subagreements under this award. These provisions must be express terms and conditions of the subagreement, must acknowledge that compliance with this section, “Prostitution and Related Activities,” is a prerequisite to receipt and expenditure of U.S. Government funds in connection with this document, and must acknowledge that any violation of the provisions shall be grounds for unilateral termination of the agreement prior to the end of its term. Recipients must agree that HHS may, at any reasonable time, inspect the documents and materials maintained or prepared by the recipient in the usual course of its operations that relate to the organization's compliance with this section, “Prostitution and Related Activities.”
All prime recipients that receive U.S. Government funds (“prime recipients”) in connection with this document must certify compliance prior to actual receipt of such funds in a written statement that makes reference to this document (
Recipients' compliance with this section, “Prostitution and Related Activities,” is an express term and condition of receiving U.S. Government funds in connection with this document, and any violation of it shall be grounds for unilateral termination by HHS of the agreement with HHS in connection with this document prior to the end of its term. The recipient shall refund to HHS the entire amount furnished in connection with this document in the event HHS determines the recipient has not complied with this section, “Prostitution and Related Activities.”
You may find guidance for completing your budget on the HHS/CDC Web site, at the following Internet address:
HHS/CDC strongly encourages you to submit electronically at
HHS/CDC recommends that you submit your application to Grants.gov early enough to resolve any unanticipated difficulties prior to the deadline. You may also submit a back-up paper submission of your application. We must receive any such paper submission in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement. You must clearly mark the paper transmission: “BACK-UP FOR ELECTRONIC SUBMISSION.”
The paper submission must conform to all requirements for non-electronic submissions. If we receive both electronic and back-up paper submissions by the deadline, we will consider the electronic version the official submission.
We strongly recommend that you submit your grant application by using Microsoft Office products (
Submit the original and two hard copies of your application by mail or
Applicants must provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. Applicants must submit these measures of effectiveness with the application, and they will be an element of evaluation.
Does the applicant demonstrate an understanding of the national cultural and political context and the technical and programmatic areas covered by the project? Does the applicant display knowledge of five-year strategy and goals of the President's Emergency Plan, such that, it can build on these to develop a comprehensive, collaborative project to reach underserved populations in Co
Does the applicant describe a plan to progressively build the indigenous capacity of local organizations, and of target beneficiaries and communities, to respond to the epidemic, such that, if the applicant is not an Ivorian organization, at the end of the project period the applicant can turn over management of the project to a local partner or partners?
Does the applicant demonstrate the local experience and capability to achieve the goals of the project? Do the staff members have appropriate experience? Are the staff roles clearly defined? Does the applicant currently have the capacity to reach northern and western regions of Co
Does the applicant describe strategies that are pertinent and matched by those identified in the five-year strategy of the President's Emergency Plan and activities that are evidence-based, realistic, achievable, measurable and culturally appropriate in Co
Is there a plan to manage the resources of the program, prepare reports, monitor and evaluate activities, and audit expenditures?
Is the budget itemized, well-justified and consistent with the five-year strategy and goals of the President's Emergency Plan and Emergency Plan activities in Co
The HHS/CDC Procurement and Grants Office (PGO) staff will review applications for completeness, and the HHS Global AIDS program will review them for responsiveness. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will receive notification that their applications did not meet submission requirements.
An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above. All persons who serve on the panel will be external to the U.S. Government Country Program Office in Co
In addition, the following factors could affect the funding decision:
While U.S.-based organizations are eligible to apply, we will give preference to existing national/Ivorian organizations. It is possible for one organization to apply as lead grantee with a plan that includes partnering with other organizations, preferably local. Although matching funds are not required, preference will go to organizations that can leverage additional funds to contribute to program goals.
Applications will be funded in order by score and rank determined by the review panel. HHS/CDC will provide justification for any decision to fund out of rank order.
September 15, 2005.
Successful applicants will receive a Notice of Award (NoA) from HHS/CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and HHS/CDC. An authorized Grants Management Officer will sign the NOA, and mail it to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of the application review by mail.
45 CFR part 74 and part 92.
For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address:
The following additional requirements apply to this project:
• AR-4 HIV/AIDS Confidentiality Provisions
• AR-5 HIV Program Review Panel Requirements
• AR-8 Public Health System Reporting Requirements
• AR-12 Lobbying Restrictions
• AR-14 Accounting System Requirements
• AR-15 Proof of Non-Profit Status
• AR-21 Small, Minority, and Women-Owned Business
Applicants can find additional information on these requirements on the HHS/CDC Web site at the following Internet address:
You need to include an additional Certifications form from the PHS 5161-1 application in your Grants.gov electronic submission only. Please refer to
You must provide HHS/CDC with an original, plus two hard copies, of the following reports (in English):
1. Interim progress report, due no less than 90 days before the end of the
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Measures of Effectiveness, including progress against the numerical goals of the President's Emergency Plan for AIDS Relief for Côte d'Ivoire.
f. Additional Requested Information.
2. Annual progress report, due no more than 60 days after the end of the budget period. Reports should include progress against the numerical goals of the President's Emergency Plan for AIDS Relief for Côte d'Ivoire.
3. Financial status report, due no more than 90 days after the end of the budget period.
4. Final financial and performance reports, no more than 90 days after the end of the project period.
Recipients must mail these reports to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement. Copies of the reports must also be submitted to the Project Management Officer at the HHS/CDC Country Office in Co
The grantee is responsible for accurate translation of all reports, and should submit French-language versions to the local HHS/CDC office in Abidjan and English-language versions to the HHS/CDC Grants Office in the U.S., by the established deadlines. See the HHS/CDC project management officer in Abidjan for more details.
We encourage inquiries concerning this announcement. For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-2700.
For program technical assistance, contact: Monica Nolan, Director, HHS/CDC/Project RETRO-CI, 2010 Abidjan Place, Dulles, Virginia 20189-2010. Telephone: 225-21-25-41-89. E-mail:
For report mailing, contact: Jean-Claude Crinot, Project Management Officer, HHS/CDC /Project RETRO-CI, 01 BP 1712 Abidjan 01. Telephone: 225-21-21-42-50. E-mail:
For financial, grants management, or budget assistance, contact: Diane Flournoy, Grants Management Specialist, CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-2072. E-mail:
Applicants can find this and other HHS funding opportunity announcements on the HHS/CDC Web site, Internet address:
The Centers for Disease Control and Prevention (CDC) announces the intent to fund fiscal year (FY) 2005 funds for a cooperative agreement program to provide high-quality clinical care to PLWHAs in the Livingstone District of Southern Province of the Republic of Zambia. The Catalog of Federal Domestic Assistance number for this program is 93.067.
Assistance will be provided only to the Southern Province Health Office of the Republic of Zambia. No other applications are solicited. The current health system structure in Zambia consists of the MOH, which has the responsibility for policy guidance and strategic planning, and the Central Board of Health, which is responsible for the translation and implementation of government health policies. The country is administratively divided into nine Provinces and 72 districts. In the health sector, the Provincial Health Office provides technical support to the districts in the areas of management of service delivery, planning of health programs, priority setting and resource utilization. Within this framework the Southern Province Health Office is the only entity in Zambia qualified to collaborate with HHS as part of the Emergency Plan in Livingstone because it has the legal authority, expertise, and capacity to perform the key public health activities that are part of this cooperative agreement.
Approximately $200,000 is available in FY 2005 to fund this award September 15, 2005 and will be made for a 12-month budget period within a project period of up to five years. Funding estimates may change.
For general comments or questions about this announcement, contact:
Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, telephone: 770-488-2700.
For program technical assistance, contact: Marc Bulterys, Project Officer, 1600 Clifton Road NE, MS E-04, Atlanta, GA 30333, telephone: 011 260 1 250 955, e-mail:
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of hearing.
This notice announces an administrative hearing to be held on September 15, 2005, at 12 noon, in the Virginia Room 229, 150 S. Independence Mall, West, Suite 216, Philadelphia, Pennsylvania 19106, to reconsider our decision to disapprove Maryland's State Plan Amendment (SPA) 05-06.
Requests to participate in the hearing as a party must be received by the presiding officer by August 31, 2005.
Kathleen Scully-Hayes, Presiding Officer, CMS, Lord Baltimore Drive, Mail Stop LB-23-20, Baltimore, Maryland 21244, Telephone: (410) 786-2055.
This notice announces an administrative hearing to reconsider CMS' decision to disapprove Maryland State plan amendment (SPA) 05-06, which was submitted on January 25, 2005.
The amendment seeks approval to place what the State believes to be reasonable limits on the amounts of incurred necessary medical and remedial care expenses which must be deducted from a nursing facility resident's income under the post-eligibility treatment of income process.
Section 1902(r)(1)(A) of the Social Security Act (the Act) requires States to take into account, under the post-eligibility process, amounts for incurred medical and remedial care expenses that are not subject to payment by a third party. Section 1902(r)(1)(A)(ii) of the Act permits States to place “reasonable” limits on the amounts of necessary medical and remedial care expenses recognized under State law but not covered under the State plan. However, those reasonable limits must ensure nursing home residents are able to use their own funds to purchase necessary medical or remedial care not covered,
The SPA 05-06 proposes to limit the deduction of medical expenses to those incurred only during a period of eligibility for Medicaid. Thus, an individual who incurred medical expenses during the 3-month period prior to the date of application would not have any protection under the post-eligibility calculation for medical expenses incurred during that period unless he or she were determined to be eligible during that period.
In discussions with State Medicaid program staff, we confirmed this is the intent of the proposed amendment. While we believe some limitations imposed on the age of an incurred expense could be considered reasonable, we do not believe it would be reasonable for a State to exclude from post-eligibility protection an incurred medical expense that could be deducted from a person's income under the medically needy spenddown process. While the medically needy spenddown rules in Federal regulations at 42 CFR 435.831(g)(2) permit States to exclude expenses incurred earlier than 3 months before the month of application, Maryland proposes to only permit deduction under its post-eligibility process for expenses incurred while an individual is actually eligible for Medicaid.
The State's limitation would result in an individual being able to use certain incurred medical expenses to establish eligibility for Medicaid, but not being able to deduct those same expenses under the post-eligibility process. While the statue permits the State to establish reasonable limits on the amount of non-covered expenses, we do not believe the limit is reasonable if the result were to deny the individual the ability to pay for a non-covered expense used to establish eligibility during a budget period.
The intent of section 1902(r)(1) of the Act is to afford an institutionalized individual with income the ability to actually pay non-covered medical expenses for medical and remedial care. Section 1902(r)(1) of the Act was added to the Medicaid statute by the Medicare Catastrophic Coverage Act of 1988. The Conference Report explains it was enacted to reinstate policies set forth previously in Medicaid regulations before they were revised by the Department of Health and Human Services in February 1988. Under that revised regulation, Maryland would have had the authority to implement the limits it proposes in SPA 05-06. However, by enacting section 1902(r)(1) of the Act, Congress specifically rejected that approach.
Moreover, by not protecting income to pay for non-covered expenses which were used to establish eligibility under the medically needy spenddown, the State's proposed amendment undercuts the Medicaid statute's purpose of requiring States to deduct incurred expenses under the spenddown process. To the extent that Maryland's amendment fails to protect income to enable the individual to actually pay for these incurred expenses, we view the State's proposed limit as not being reasonable. As a result, we believe the limit does not meet the requirements of section 1902(a)(17) of the Act, as refined by section 1902(r)(1) of the Act. For individuals whose post-eligibility calculation is determined using the spousal impoverishment rules, specified at section 1924 of the Act and refined by section 1902(r)(1) of the Act, we believe the limit does not meet the requirements of section 1902(a)(51) of the Act, which requires the State plan to meet the requirements of section 1924 of the Act.
The issues to be considered during the hearing are whether the amendment's limit violates the requirements of sections 1902(a)(17) and 1902(a)(51) of the Act by imposing an unreasonable limit on expenses for medical and remedial care which will be protected under the post-eligibility process.
Section 1116 of the Act and Federal regulations at 42 CFR Part 430 establish Department procedures that provide an administrative hearing for reconsideration of a disapproval of a State plan or plan amendment. The CMS is required to publish a copy of the notice to a State Medicaid agency that informs the agency of the time and place of the hearing and the issues to be considered. If we subsequently notify the agency of additional issues that will be considered at the hearing, we will also publish that notice.
Any individual or group that wants to participate in the hearing as a party must petition the presiding officer within 15 days after publication of this notice, in accordance with the requirements contained in Federal regulations at 42 CFR 430.76(b)(2). Any interested person or organization that wants to participate as
Therefore, based on the reasoning set forth above, and after consultation with the Secretary as required under Federal regulations at 42 CFR 430.15(c)(2), CMS disapproved Maryland SPA 05-06. The notice to Maryland announcing an administrative hearing to reconsider the disapproval of its SPA reads as follows:
Dear Mr. Tornari: I am responding to your request for reconsideration of the decision to disapprove Maryland State plan amendment (SPA) 05-06, which was submitted on January 25, 2005.
In SPA 05-06, Maryland seeks approval to place what the State believes to be reasonable limits on the amounts of incurred necessary medical and remedial care expenses which must be deducted from a nursing facility resident's income under the post-eligibility treatment of income process.
Section 1902(r)(1)(A) of the Social Security Act (the Act) requires States to take into account, under the post-eligibility process, amounts for incurred medical and remedial care expenses that are not subject to payment by a third party. Section 1902(r)(1)(A)(ii) of the Act permits States to place “reasonable”
The SPA 05-06 proposes to limit the deduction of medical expenses to those incurred only during a period of eligibility for Medicaid. Thus, an individual who incurred medical expenses during the 3-month period prior to the date of application would not have any protection under the post-eligibility calculation for medical expenses incurred during that period unless he or she were determined to be eligible during that period.
In discussions with State Medicaid program staff, we confirmed this is the intent of the proposed amendment. While we believe some limitations imposed on the age of an incurred expense could be considered reasonable, we do not believe it would be reasonable for a State to exclude from post-eligibility protection an incurred medical expense that could be deducted from a person's income under the medically needy spenddown process. While the medically needy spenddown rules in Federal regulations at 42 CFR 435.831(g)(2) permit States to exclude expenses incurred earlier than 3 months before the month of application, Maryland proposes to only permit deduction under its post-eligibility process for expenses incurred while an individual is actually eligible for Medicaid.
The State's limitation would result in an individual being able to use certain incurred medical expenses to establish eligibility for Medicaid, but not being able to deduct those same expenses under the post-eligibility process. While the statute permits the State to establish reasonable limits on the amount of non-covered expenses, we do not believe the limit is reasonable if the result were to deny the individual the ability to pay for a non-covered expense used to establish eligibility during a budget period.
The intent of section 1902(r)(1) of the Act is to afford an institutionalized individual with income the ability to actually pay non-covered medical expenses for medical and remedial care. Section 1902(r)(1) of the Act was added to the Medicaid statute by the Medicare Catastrophic Coverage Act of 1988. The Conference Report explains it was enacted to reinstate policies set forth previously in Medicaid regulations before they were revised by the Department of Health and Human Services in February 1988. Under that revised regulation, Maryland would have had the authority to implement the limits it proposes in SPA 05-06. However, by enacting section 1902(r)(1) of the Act, Congress specifically rejected that approach.
Moreover, by not protecting income to pay for non-covered expenses which were used to establish eligibility under the medically needy spenddown, the State's proposed amendment undercuts the Medicaid statute's purpose of requiring States to deduct incurred expenses under the spenddown process. To the extent that Maryland's amendment fails to protect income to enable the individual to actually pay for these incurred expenses, we view the State's proposed limit as not being reasonable. As a result, we believe the limit does not meet the requirements of section 1902(a)(17) of the Act, as refined by section 1902(r)(1) of the Act. For individuals whose post-eligibility calculation is determined using the spousal impoverishment rules, specified at section 1924 of the Act and refined by section 1902(r)(1) of the Act, we believe the limit does not meet the requirements of section 1902(a)(51) of the Act, which requires the State plan to meet the requirements of section 1924 of the Act.
Based on the reasoning set forth above, and after consulting with the Secretary as required by Federal regulations at 42 CFR 430.15(c)(2), the Centers for Medicare & Medicaid Services (CMS) disapproved Maryland Medicaid SPA 05-06.
I am scheduling a hearing to be held on September 15, 2005, at 12:00 Noon in CMS” Philadelphia Regional Office, in the Virginia Room 229;150 S. Independence Mall, West; Suite 216; Philadelphia, Pennsylvania 19106, to reconsider our decision to disapprove Maryland's SPA 05-06. If this date is not acceptable, we would be glad to set another date that is mutually agreeable to the parties. The hearing will be governed by the procedures prescribed at 42 CFR, part 430.
The issues to be considered during the hearing are whether the amendment's limit violates the requirements of sections 1902(a)(17) and 1902(a)(51) of the Act by imposing an unreasonable limit on expenses for medical and remedial care which will be protected under the post-eligibility process.
I am designating Ms. Kathleen Scully-Hayes as the presiding officer. If these arrangements present any problems, please contact the presiding officer. In order to facilitate any communication which may be necessary between the parties to the hearing, please notify the presiding officer to indicate acceptability of the hearing date that has been scheduled and provide names of the individuals who will represent the State at the hearing. The presiding officer may be reached at (410) 786-2055.
Sincerely,
Section 1116 of the Social Security Act (42 U.S.C. section 1316); 42 CFR section 430.18.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by September 15, 2005.
OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.
Karen L. Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under sections 505, 512, 513, 515, and 903 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355, 360b, 360c, 360e, and 393), and section 351 of the Public Health Service Act (42 U.S.C. 262), FDA has the responsibility to ensure the safety and effectiveness of drugs, biologics, and devices. Under section 502(a) of the act (21 U.S.C. 352(a)), a drug or device is misbranded if its labeling is false or misleading. Under section 502(f)(1) of the act (21 U.S.C. 352(f)(1)), it is misbranded if it fails to bear adequate warnings, and under section 502(j) of the act (21 U.S.C.
Under section 4 of the Dietary Supplement Health and Education Act of 1994 (DSHEA) (21 U.S.C. 341), section 402 of the act (21 U.S.C. 342) is amended so that FDA must bear the burden of proof to show a dietary supplement is unsafe.
To carry out its responsibilities, the agency needs to be informed whenever an adverse event, product problem, or error with use of a medication or device occurs. Only if FDA is provided with such information will the agency be able to evaluate the risk, if any, associated with the product, and take whatever action is necessary to reduce or eliminate the public's exposure to the risk through regulatory action. To ensure the marketing of safe and effective products, certain adverse events must be reported. Requirements regarding mandatory reporting of adverse events or product problems have been codified in parts 310, 314, 600, 803, and 1271 (21 CFR parts 310, 314, 600, 803, and 1271), specifically §§ 310.305, 314.80, 314.98, 314.540, 600.80, 803.30, 803.50, 803.53, 803.56, and 1271.350(a).
To implement these provisions for reporting of adverse events, product problems, and medication/device use errors for FDA regulated products such as medications, devices, biologics, including human cells, tissues, and cellular and tissue-based products (HCT/Ps), special nutritional products, and cosmetics, as well as any other products that are regulated by FDA, two forms are available from the agency. Form FDA 3500 may be used for voluntary (i.e., not mandated by law or regulation) reporting by healthcare professionals and the public. Form FDA 3500A is used for mandatory reporting (i.e., required by law or regulation).
Respondents to this collection of information are healthcare professionals, hospitals and other user facilities (e.g., nursing homes, etc.), consumers, manufacturers of biological and drug products or medical devices, and importers.
The voluntary version of the form is used to submit all reports not mandated by Federal law or regulation. Individual health professionals are not required by law or regulation to submit reports to the agency or the manufacturer, with the exception of certain adverse reactions following immunization with vaccines as mandated by the National Childhood Vaccine Injury Act of 1986. Those mandatory reports are not submitted to FDA on Form FDA 3500 or Form FDA 3500A, but are submitted to the joint FDA/Centers for Disease Control and Prevention Vaccines Adverse Event Reporting System (VAERS) on the VAERS-1 form. (See
Hospitals are not required by Federal law or regulation to submit reports associated with drug products, biological products, or special nutritional products. However, hospitals and other user facilities are required by Federal law to report medical device-related deaths and serious injuries.
Manufacturers of dietary supplements do not have mandatory requirements for reporting adverse reactions to FDA. DSHEA puts the responsibility on FDA to prove that a particular product is unsafe. The agency depends on the voluntary reporting by health professionals and consumers of suspected adverse events associated with the use of dietary supplements.
In sections 505(j) and 704 of the act (21 U.S.C. 355(j) and 374), Congress has required that important safety information relating to all human prescription drug products be made available to FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the act. These statutory requirements regarding mandatory reporting have been codified by FDA under parts 310 (New Drugs) and 314 (Applications for FDA Approval to Market a New Drug), 600 (Biological Products: General), and 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products). Parts 310, 314, 600, and 1271 mandate the use of Form FDA 3500A for reporting to FDA adverse events that occur with drugs and biologics.
Section 519 of the act (21 U.S.C. 360i) requires manufacturers and importers, of devices intended for human use to establish and maintain records, make reports, and provide information as the Secretary of Health and Human Services may by regulation reasonably require to assure that such devices are not adulterated or misbranded and to otherwise assure their safety and effectiveness.
The Safe Medical Device Act of 1990, signed into law on November 28, 1990, amends section 519 of the act (21 U.S.C. 360i). The amendment requires that user facilities such as hospitals, nursing homes, ambulatory surgical facilities, and outpatient treatment facilities report deaths related to medical devices to FDA and to the manufacturer, if known. Serious illnesses and injuries are to be reported to the manufacturer or to FDA if the manufacturer is not known. These statutory requirements regarding mandatory reporting have been codified by FDA under part 803. Part 803 mandates the use of Form FDA 3500A for reporting to FDA on medical devices.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), Public Law 107-250, signed into law October 26, 2002, amended section 519 of the act. The amendment (section 303 of MDUFMA) requires FDA to revise the MedWatch forms to facilitate the reporting of information relating to reprocessed single-use devices, including the name of the reprocessor and whether the device has been reused.
The proposed modifications to Form FDA 3500 and Form FDA 3500A reflect changes that will bring the forms into conformation with current regulations, rules, and guidances. Modifications were also made to better reflect the range of reportable products and language was changed slightly to provide clarity. The changes should allow reporters to better utilize available space for data entry and offer voluntary reporters the opportunity to better characterize the suspected adverse event, product problem or error, and provide better quality safety-related data for agency evaluation.
FDA estimates the burden for completing the forms for this collection of information as follows:
In the
Several pharmaceutical manufacturers expressed concern over FDA's revision of mandatory Form FDA 3500A since FDA encourages electronic submission of postmarketing adverse event reports, and it would be an unfair burden to manufacturers who submit electronically to expend resources to change the form which would be used only in times of rare network or server outages. FDA disagrees with this comment. As described in a May 2001 draft guidance entitled “Providing Regulatory Submissions in Electronic Format Postmarketing Expedited Safety Reports”, manufacturers can send individual case safety reports (ICSRs) to FDA using either FDA's electronic data interchange (EDI) gateway or physical media (such as CD-ROM or digital tape). If the EDI gateway is not functional, regulatory requirements can be met by submitting ICSRs on physical media.
A number of manufacturers commented that certain sections of proposed Form FDA 3500A were based on proposed rules, regulations, and guidances. They noted that considerable resources would be required to modify computer systems and processes, and changes to the form should be based on current rules, regulations, and guidances. Likewise, such changes should be consistent with current International Conference on Harmonization (ICH) guidelines. FDA agrees with these comments and has based the final revised Form FDA 3500A on current rules, regulations, and guidances to the extent possible. Proposed reformatting of Form FDA 3500A has also been minimized based on these comments. In addition, to allow mandatory reporters time to make the necessary changes to their computer systems and processes to conform to the revised Form FDA 3500A , FDA is granting a grace period of 1 year. During this transition period FDA will accept both the newly effective Form FDA 3500A and the prior version of the form.
Device manufacturers commented that there were unnecessary changes made to the form pertaining only to device reporting. FDA agrees and has minimally altered the device sections of the final forms. FDA additionally recognizes the burden this places on device manufacturers as they were recently required to make computer and process changes based on the modified Form FDA 3500A as mandated by MDUFMA.
Some comments noted that FDA underestimated the burden of the proposed collection of information, only capturing time required to complete the form and not capturing the significant resources required to modify and validate the forms. One drug manufacturer estimated that 50 to 60 hours per computerized system would be required to modify and validate the changes to the form. FDA acknowledges these comments and has made an effort to modify Form FDA 3500A to the minimum extent possible to conform with current rules, regulations, and guidances in order to minimize this burden to industry.
Several comments noted that FDA did not include instructions to revised Form FDA 3500 and Form FDA 3500A, which resulted in a lack of clarity in modified sections and lack of definition regarding newly added terminology. FDA acknowledges these comments. Both the previous and newly revised Form FDA 3500A along with the newly revised voluntary Form FDA 3500, with instructions for both forms, will be made available upon OMB approval on FDA's MedWatch Web site at
One comment requested consistency in formatting of dates throughout both forms. FDA agrees and has conformed to a mm/dd/yyyy format throughout both forms.
FDA proposed several changes to section B.2 (Outcomes Attributed to Adverse Event) of both forms. A number of comments were received regarding this proposal. The “Not Serious” and “No Harm” checkboxes elicited comments that clarification was required regarding when these boxes would be used, and that these boxes do not conform to any current rules, regulations, or guidances, including
In section B.5 of both forms, the proposed checkboxes “Product Used During Pregnancy” and “Product Used During Breast Feeding” produced concern as these new data fields introduce divergence from ICH standards and appear to duplicate information that is usually provided in the narrative section and in coded adverse event terms. FDA agrees and has not included these checkboxes in the final forms. As a result, the term “Pregnancy” has been returned to the examples in section B.7 (Other Relevant History) on both Form FDA 3500 and Form FDA 3500A.
A few comments noted the removal of the term “if known” from several fields of the forms and questioned this action as a new requirement for these data. The final forms do not contain the term “if known” in any of the fields for reasons of form consistency. This should not be interpreted as a new requirement. If information is not known for any of the fields, they should be left blank. This is reflected in the revised instructions.
Several comments questioned the addition of the Unique Identifier Number (Unique ID) to proposed section D.9 of both forms. Unique ID is required under § 1271.350 for reporting of adverse events for HCT/Ps.
One comment recommended the addition of “Solicited” and “Spontaneous” checkboxes to Form FDA 3500A. FDA has not accepted this recommendation. As described in an August 1997 guidance for industry entitled “Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report,” information concerning potential adverse experiences derived during planned contacts and active solicitation of information from patients should be handled as safety information obtained from a postmarketing study. Section G of the previous and revised Form FDA 3500A contains a checkbox for “Study” which captures such information.
One comment requested that FDA include information on drug name, dose, frequency, route, dates of diagnosis for use, and event abated/reappeared after reintroduction on one line of Form FDA 3500 and Form FDA 3500A. FDA disagrees since these changes would decrease form clarity and would require costly and unnecessary computer and process revisions.
One comment noted that the MedWatch program needs to do the following: (1) Enhance the quality, utility, and clarity of information to be collected; (2) data entry accuracy needs to be improved; and (3) the public version of the adverse events database needs to be posted in a timely manner, and FDA needs to vigorously enforce mandatory reporting requirements. FDA acknowledges these comments regarding FDA programs and processes. However, the comment did not suggest specific changes to Form FDA 3500 or Form FDA 3500A .
In the final versions of Form FDA 3500 and Form FDA 3500A, there are some differences. FDA proposed adding two checkboxes to section B.1: “Product Use Error” and “Product Switch”. Since there is currently no requirement to report medication, device, or other regulated product errors, these boxes do not appear on the final version of Form FDA 3500A . However, “Product Use Error” will be included on the voluntary Form FDA 3500, as the agency has become aware that voluntary reporters who wish to submit medication and other product use errors to FDA are not certain that Form FDA 3500 can be used for this purpose. FDA encourages voluntary reporting of product use errors.
The “Product Switch” checkbox does not appear on the final Form FDA 3500A , however, a revised checkbox “Problem with different manufacturer of same medicine,” does appear on Form FDA 3500 to enable voluntary reporters to more clearly submit reports directly to FDA that involve adverse events or product problems related to brand-to-generic, generic-to-brand, one generic to another generic, or other therapy changes relating to the same active ingredient produced by different manufacturers.
FDA proposed reformatting changes in sections A and D of both forms to conserve space on the forms. These changes do not appear on the final Form FDA 3500A; however, section D (Suspect Product(s)) of revised Form FDA 3500 is modified. FDA believes the collection of data in specific boxes for dose/amount, frequency, and route increases clarity and enhances the likelihood that these data would be obtained from consumers and healthcare professionals who voluntarily submit reports directly to FDA.
Several comments were received on new section C (Product Availability). Pharmaceutical manufacturers expressed concern that the practice of obtaining, storing, and analyzing returned products would significantly impact their working practice and goes beyond current regulations and guidances. FDA agrees with these comments and the “Product Availability” question has been returned to the “Suspect Medical Device” section of Form FDA 3500A . However, the revised voluntary Form FDA 3500 contains the new section C, to enable FDA to collect such information particularly for products that currently do not have mandatory adverse event reporting requirements, such as special nutritional products and cosmetics.
Food and Drug Administration, HHS.
Notice of meetings; request for comments.
The Food and Drug Administration (FDA) is announcing a series of public meetings entitled “Vision 2006—A Conversation With the American Public,” in three cities. This forum will be an open format in which consumers can interact directly with the agency's leadership to discuss what is on the public's mind. It will also be an opportunity for the agency to update the public on current agency programs, engage the public in discussion, and obtain consumer input on specific
See table 1, section III, of the
See table 1, section III, of the
New medical products have played a critical role in improving the lives of millions of Americans, providing much-needed treatments and cures for a wide range of illnesses. New advances in food technology and nutrition have enabled consumers to improve their health and well-being in countless ways. As we move forward in the 21st century, Americans are rightly concerned that advances in science should continue to translate into better products and technologies that can benefit their health.
FDA lies at a critical juncture to enable these kinds of advances in science, technology, and health. The agency is responsible for protecting and promoting the public health by ensuring the safety and effectiveness of most human and animal drugs; biological products such as vaccines, cellular therapies, and blood; medical devices; tissues, and radiation-emitting products such as x-ray machines. We are also responsible for ensuring the safety and wholesomeness of food (including animal feed and dietary supplements) and cosmetics. Many Americans are rightly interested in FDA's programs, and the steps that the agency is taking to ensure that the promise of better science translates into longer lives with fewer problems from today's diseases. Consumers also want the opportunity to participate, in a meaningful way, in our work, whether we are discussing a complex scientific issue, proposing a regulation to address a particular problem, or implementing a new law.
We are holding these public meetings to help enhance this dialogue. This series of meetings will be an open forum in which consumers can interact directly with the agency's top leadership, including its leading scientists, to discuss what is on the public's mind.
We already provide similar opportunities for the public to engage in the agency's decisionmaking processes. We encourage people to take advantage of these regular opportunities to provide the agency with critical input into its programs. For example, the agency hosts frequent public meetings to discuss specific topics, reserves time during advisory committee meetings for public input, and invites the public to submit written or electronic comments on our rules. In 2004, we received more than 140,000 comments (including form letters) on rules, notices, and other matters. But the series of public meetings being announced in this document is a unique gathering of all of the agency's top leadership, including FDA Commissioner of Food and Drugs Lester Crawford, to provide direct feedback in an open forum on a broad range of issues of interest to the public.
Through the public meetings we are announcing in this document, we are also offering an opportunity for the public to hear more about, and to give us input on, specific programs or initiatives that we are currently pursuing to better protect and advance the public health. Public input will help us shape the agency's agenda for 2006 and beyond, as we commence our second century of serving the American public. Among some of the topics that we hope to discuss at the meetings are new opportunities to advance the safe use of medical products, increase the public health benefits of direct-to-consumer advertising, guarantee the safety and reliability of dietary supplements, and improve the science of drug development by lowering the cost of new medical products and speeding access to better medical technologies through the agency's “Critical Path” initiative. We also hope to discuss our continuing efforts to increase public understanding of, and involvement in, the agency's scientific and regulatory processes—for example, through our advisory committee process and through improved, direct communication with consumers.
Through this open dialogue, the agency's leadership hopes to gain valuable insight from those who benefit from its regulatory efforts. FDA appreciates all of the consumer interest in its activities, and the agency's programs have benefited greatly from the feedback FDA receives from its many constituencies. To increase the transparency of our decisionmaking process, we are developing new, and expanding existing, communications channels to provide targeted information about new products to the public. We believe patients, healthcare professionals, and consumers will find the information useful in their individual treatment decisions. In an era when more and more of the products that people use are personalized to their individual needs, especially medical products and dietary choices, communicating the unique risks and benefits of individual products, and matching them to patients' individual needs, becomes paramount.
We want to ensure the information we provide and new efforts we are undertaking provide maximum value to consumers. Among the many questions we would like the public to consider are the following:
• What information do you expect to receive from FDA regarding the benefits and risks of new food and medical products?
• Where do you currently get information about these products, and how beneficial is this information in helping to inform the decisions you make?
• What additional information, if any, do you believe should be provided to enable you to discuss with your physician or other health care provider the benefits and risks of products for a health condition you have or think you might have?
• What additional steps can FDA take to improve its communication with consumers and build on your confidence in its activities and its mission?
If you would like to submit comments on any of the issues discussed in this document, please send your comments
We will hold public meetings in three cities to discuss the issues described earlier in this document. The meetings are scheduled from 10 a.m. to 4 p.m.
The meeting dates, times, and locations are as follows:
If you wish to make a presentation at or to attend any meeting, please register online at
We will try to accommodate all persons who wish to make a presentation. The time allotted for presentations will depend on the number of people who wish to speak on a given topic, and the meeting schedule at each location. Similarly, the time allotted to each topic may vary depending on the expressed interests of persons registering for a particular meeting. To obtain updates on the meetings, please visit
We will prepare transcripts of each meeting. You may request a copy of a meeting transcript by writing to our Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857. We anticipate that transcripts will be available approximately 30 business days after the public meetings at a cost of 10 cents per page. The transcripts will also be available for public examination at the Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301)-443-1129.
The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995:
The regulations for the Health Professions Student Loan (HPSL) Program and Nursing Student Loan (NSL) Program contain a number of reporting and recordkeeping requirements for schools and loan applicants. The requirements are essential for assuring that borrowers are aware of rights and responsibilities that schools know the history and status of each loan account that schools pursue aggressive collection efforts to reduce default rates, and that they maintain adequate records for audit and assessment purposes. Schools are free to use improved information technology to manage the information required by the regulations.
The burden estimates are as follows:
Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: John Kraemer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503.
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104-13), the Health Resources and Services Administration (HRSA) will publish periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans, call the HRSA Reports Clearance Officer on (301) 443-1129.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques of other forms of information technology.
The Nursing Scholarship Program (NSP or “Nursing Scholarship”) is a competitive Federal program which awards scholarships to individuals for attendance at schools of nursing. The scholarship consists of payment of tuition, fees, other reasonable educational costs, and a monthly support stipend. In return, the students agree to provide a minimum of 2 years of full-time clinical service (or an equivalent part-time commitment, as approved by the NSP) at a health care facility with a critical shortage of nurses.
Nursing scholarship recipients must be willing and are required to fulfill their NSP service commitment at a health care facility with a critical shortage of nurses in the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Territory of Guam, the Commonwealth of the Northern Marianas, the U.S. Virgin Islands, the Territory of American Samoa, the Republic of Palau, the Republic of the Marshall Islands or the Federated States of Micronesia. Students who are uncertain of their commitment to provide nursing in a health care facility with a critical shortage of nurses in the United States are advised not to participate in this program.
The NSP needs to collect data to determine an applicant's eligibility for the program, to monitor a participant's continued enrollment in a school of nursing, to monitor a participant's compliance with the NSP service obligation, and to obtain data on its program to ensure compliance with legislative mandates and prepare annual reports to Congress. The following information will be collected: (1) From the applicants and/or the schools, general applicant and nursing school data such as full name, location, tuition/fees, and enrollment status; (2) from the schools, on an annual basis, data concerning tuition/fees and student enrollment status; and (3) from the participants and their health care facilities with a critical shortage of nurses, on a biannual basis, data concerning the participant's employment status, work schedule and leave usage.
Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33 Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Written comments should be received with 60 days of this notice.
Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443-1129.
The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995:
The HEAL program assures the availability of funds for loans to eligible students who desire to borrow money to pay for their educational costs. HEAL Lenders use the Lenders Application for Insurance Claim to request payment from the Federal government for federally insured loans lost due to borrowers death, disability, bankruptcy, or default. The Request for Collection Assistance form is used by HEAL lenders to request Federal assistance with the collection of delinquent payments from HEAL borrowers.
Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: John Kraemer, Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Children's Study Advisory Committee.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Child Health and Human Development Council.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The intramural programs and projects and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the intramural programs and projects, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
The notice is being published less than 15 days prior to the meeting due to the urgent need to meet timing limitations imposed by the intramural research review cycle.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, National Library of Medicine.
The meeting will be open the public as indicated below, with attendance limited to space available. Individuals who plan to attend and special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Library of Medicine, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance into the building by non-government employees. Persons without a government I.D. will need to show a photo I.D. and sign-in at the security desk upon entering the building.
(Catalogue of Federal Domestic Assistance Program Nos. 93.879, Medical Library Assistance, National Institutes of Health, HHS)
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Recambinant DNA Advisory Committee.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
OMB's “Mandatory Information Requirements for Federal Assistance Program Announcements” (45 FR 39592, June 11, 1980) requires a statement concerning the official government programs contained in the Catalog of Federal Domestic Assistance. Normally NIH lists in its announcements the number and title of affected individual programs for the guidance of the public. Because the guidance in this notice covers virtually every NIH and Federal research program in which DNA recombinant molecule techniques could be used, it has been determined not to be cost effective or in the public interest to attempt to list these programs. Such a list would likely require several additional pages. In addition, NIH could not be certain that every Federal program would be included as many Federal agencies, as well as private organizations, both national and international, have elected to follow the NIH Guidelines. In lieu of the individual program listing, NIH invites readers to direct questions to the information address above about whether individual programs listed in the Catalog of Federal Domestic assistance are affected.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
The National Survey on Drug Use and Health (NSDUH), formerly the National Household Survey on Drug Abuse (NHSDA), is a survey of the civilian, noninstitutionalized population of the United States 12 years old and older. The data are used to determine the prevalence of use of tobacco products, alcohol, illicit substances, and illicit use of prescription drugs. The results are used by SAMHSA, ONDCP, Federal government agencies, and other organizations and researchers to establish policy, direct program activities, and better allocate resources.
For the 2006 NSDUH, additional questions are being planned regarding self-help drug treatment, use of additional hallucinogens, prescription drugs and over the counter medications, respondent's place of residence, and alcohol consumption practices. To maintain the respondent burden at 60 minutes per interview, a few questions will be deleted. The remaining modular components of the questionnaire will remain essentially unchanged except for minor modifications to wording.
As with all NSDUH/NHSDA surveys conducted since 1999, the sample size of the survey for 2006 will be sufficient to permit prevalence estimates for each of the fifty states and the District of Columbia.
The total annual burden estimate is shown below:
Written comments and recommendations concerning the proposed information collection should be sent by September 15, 2005 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974.
Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services (CMHS), has funded an Initiative to Reduce/Eliminate Seclusion and Restraint (S/R) which consists of 8 State Incentive Grants to Build Capacity for Alternatives to Restraint and Seclusion (SM04-007) and a Coordinating Center to Support S/R State Incentive Grants. This initiative is designed to promote the implementation and evaluation of best practice approaches to reducing the use of restraint and seclusion in mental health facilities. Grantees consist of 8 sites (state mental health agencies), most of which will be implementing interventions in multiple facilities (a total of 49 facilities). These include
With input from multiple experts in the field of restraint and seclusion and alternatives to restraint and seclusion, the project created a common core of data collection instruments that will be used for this cross-site project. The facilities will complete four different instruments: (1) Facility/Program Characteristics Inventory (information about type of facilities, characteristics of persons served, staffing patterns, and unit specific data); (2) Inventory of Seclusion and Restraint Reduction Interventions; (3) Treatment Episode Data (admission data for all clients/patients); and (4) Event Data (data about the use of restraint and seclusion). Data will be submitted by the sites electronically via a secured Web site.
The Facility/Program Characteristic Inventory and Inventory of Seclusion and Restraint Reduction Intervention will be collected annually. The Treatment Episode Data and Event Data will be collected monthly.
The resulting data will help to identify the: (1) Number of programs adopting best practices involving alternative approaches to restraint and seclusion; and (2) program's impact of reducing restraint and seclusion use and adoption of alternative practices. The estimated annual response burden to collect this information is as follows:
Written comments and recommendations concerning the proposed information collection should be sent by September 15, 2005 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974.
Pursuant to Pub. L. 92-463, notice is hereby given of the meeting of the Substance Abuse and Mental Health Services Administration (SAMHSA) Drug Testing Advisory Board on September 7-8, 2005.
A portion of the meeting will be open and will include a roll call, general announcements, a Department of Health and Human Services drug testing program update, a Department of Transportation drug testing program update, and a Nuclear Regulatory Commission drug testing program update.
Attendance by the public will be limited to space available. Public comments are welcome. Please communicate with the individual listed below as contact to make arrangements to comment or to request special accommodations for persons with disabilities.
The Board will also meet to develop the analytical and administrative policies for the final revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Program that were published as proposed revisions in the
Substantive program information and a roster of Board members may be obtained by accessing the SAMHSA workplace Web site (
Closed: September 7, 2005; 9:30 a.m.-4:30 p.m.
Closed: September 8, 2005; 8:30 a.m.-Noon.
Pursuant to Public Law 92-463, notice is hereby given of a Teleconference Meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council to be held in September 2005.
The meeting will include the review, discussion and evaluation of grant
Substantive program information and a roster of Council members may be obtained by accessing the SAMHSA Advisory Council Web site (
Office of State and Local Government Coordination and Preparedness, DHS.
Notice and request for comment.
The Department of Homeland Security (DHS), as part of its continuing effort to reduce paperwork and respondents' burden, invites the general public to take this opportunity to comment on this proposed information collection as required by the Paperwork Reduction Act 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently, the Office of State and Local Government Coordination and Preparedness (OOSLGCP) is soliciting comments concerning a proposed new collection, Staffing for Adequate Fire and Emergency Response (SAFER) Grant Application.
Comments are encouraged and will be accepted until October 17, 2005. This process is conducted in accordance with 5 CFR 1320.10.
You may submit comments, identified by docket number DHS-2005-0054, by
• EPA Federal Partner EDOCKET Web Site:
• Federal eRulemaking Portal:
• E-mail:
• Mail: Office of State and Local Government Coordination and Preparedness, Grants Program Office, 810 7th Street, NW., Washington, DC 20531.
Tom Harrington 202-786-9791 (this is not a toll free number).
Interested persons are invited to participate in this Information Collection Request by submitting written data, views, or arguments on all aspects of the proposed Information Collection Request. OSLGCP also invites comments that relate to the economic, environmental, or federalism affects that might result from this Information Collection Request. Comments that will provide the most assistance to the OSLGCP in developing these procedures will reference a specific portion of the Information Collection Request, explain the reason for any recommended change, and include data, information, or authority that support such recommended change. See
Office for Domestic Preparedness, Office of State and Local Government Coordination and Preparedness, Department of Homeland Security.
Notice of guidance.
The Department of Homeland Security is publishing this Notice to provide details and guidance regarding the 2005 program year Assistance to Firefighters Grant Program. The program makes grants directly to fire departments and nonaffiliated emergency medical services organizations for the purpose of enhancing first-responders' ability to protect the health and safety of the public as well as that of first-responder personnel facing fire and fire-related
15 U.S.C. 2229, 2229a.
Brian Cowan, Director, Fire Grants Program Office, Office of State and Local Government Coordination and Preparedness, 810 Seventh Street, NW., Washington, DC 20531.
For fiscal year 2005, Congress appropriated $650,000,000 to carry out the activities of the Assistance to Firefighters Grant Program (AFG program). The Department of Homeland Security (DHS) is authorized to spend up to $32,500,000 for administration of the AFG program (five percent of the appropriated amount). In addition, DHS has set aside no less than $32,500,000 of the funds (five percent of the appropriation) for the Fire Prevention and Safety Grant Program in order to make grants to, or enter into contracts or cooperative agreements with, national, State, local or community organizations or agencies, including fire departments, for the purpose of carrying out fire prevention and injury prevention programs. This leaves approximately $585,000,000 for competitive grants to fire departments and nonaffiliated EMS organizations, with nonaffiliated emergency medical service (EMS) organizations' awards limited to two percent of the appropriation or $13,000,000.
The purpose of the AFG program is to award grants directly to fire departments and nonaffiliated EMS organizations to enhance their ability to protect the health and safety of the public, as well as that of first-responder personnel, with respect to fire and fire related hazards. DHS will award the grants on a competitive basis to the applicants that first address the AFG program's priorities then provide the best narrative. Applicants whose requests best address the program's priorities will be reviewed by a panel made up of fire service personnel. The panel will review the narrative and assess the application with respect to the clarity of the project to be funded, the organization's financial need, the benefit to be derived from their project, and the extent to which the grant would enhance the applicant's daily operations and/or how the grant would positively impact the applicant's ability to protect life and property.
The AFG Program for fiscal year 2005 generally mirrors previous years' programs with two significant changes. See
There are limits as to the amount of funding that a grantee may be awarded from the Assistance to Firefighters Grant Program in any fiscal year. These limits are based on population served. A grantee that serves jurisdiction with 500,000 people or less may not receive grant funding in excess of $1,000,000 in any fiscal year. A grantee that serves a jurisdiction with more than 500,000 but not more than 1,000,000 people may not receive grants in excess of $1,750,000 in any fiscal year. A grantee that serves a jurisdiction with more than 1,000,000 people may not receive grants in excess of $2,750,000 in any fiscal year. DHS may waive these established limits to any grantee serving a jurisdiction of 1,000,000 or less if DHS determines that extraordinary need for assistance warrants the waiver; however, no grantee, under any circumstance, may receive in excess of $2,750,000 in any fiscal year.
Grantees must share in the costs of the projects funded under this grant program. Fire departments and nonaffiliated EMS organizations that serve populations of less than 20,000 must match the Federal grant funds with an amount of non-Federal funds equal to five (5) percent of the total project cost. Fire departments and nonaffiliated EMS organizations serving areas with a population between 20,000 and 50,000, inclusive, must match the Federal grant funds with an amount of non-Federal funds equal to ten (10) percent of the total project cost. Fire departments and nonaffiliated EMS organizations that serve populations of over 50,000 must match the Federal grant funds with an amount on non-Federal funds equal to twenty (20) percent of the total project costs. All non-Federal funds must be in cash,
Under the provisions of 15 U.S.C. 2229a, DHS must ensure that fire departments that have either all-volunteer forces of firefighting personnel or combined forces of volunteer and career firefighting personnel receive a portion of the total grant funding that is not less than the proportion of the United States population that those departments protect. According to a 2004 survey by the National Fire Protection Association (NFPA), volunteer and combination departments protect 55 percent of the population of the United States and career departments protect 45 percent of the population. Therefore, DHS will ensure that no less than 55 percent of the funding available for grants will be awarded to volunteer and combination departments. Assuring this minimum level of funding for volunteer and combination departments has not been a problem in the past as over 90 percent of applicants are volunteer or combination departments. There is no minimum funding level for career departments.
After the panel evaluation's preliminary determination, DHS will make award decisions using rank order. DHS may deviate from rank order and make funding decisions based on the type of department (career, combination, or volunteer), and the size and character of the community the applicant serves (urban, suburban, or rural).
In addition to the grants available to fire departments in fiscal year 2005 through the competitive grant program, DHS will set aside no less than $32,500,000 of the funds available under the Assistance to Firefighter Grant Program in order to make grants to, or enter into contracts or cooperative agreements with, national, State, local or community organizations or agencies, including fire departments, for the purpose of carrying out fire prevention and injury prevention programs.
In accordance with the statutory requirement to fund fire prevention activities, support to Fire Prevention and Safety Grant activities will concentrate on organizations that focus on the prevention of injuries to children from fire. In addition to this priority, DHS is also placing an emphasis on funding innovative projects that focus on protecting children under fourteen, seniors over sixty-five, and firefighters. Since the victims of burns experience both short- and long-term physical and psychological effects, DHS is also placing a priority on programs that focus on reducing the immediate and long-range effects of fire and burn injuries, and primarily those affecting children.
A Notice of Funds Availability will be issued to announce the pertinent details of the Fire Prevention and Safety Grant portion of this program.
The application period for the AFG grants opened on March 7, 2005, and closed on April 8, 2005. Approximately 20,972 applications were received. These applications were evaluated in the preliminary screening process to determine which applications best addressed the program's established priorities. This preliminary screening was based on the applicants' answers to the activity-specific questions. Each activity within an application was scored and applications that had multiple activities will have had the scores prorated based on the amount of funding requested for each activity.
The best applications as determined in the preliminary step were deemed to be in the “competitive range.” All applications in the competitive range were subject to a second level review by a technical evaluation panel made up of individuals from the fire service including, but not limited to, firefighters, fire marshals, and fire training instructors. The panelists assessed the application's merits with respect to the clarity and detail provided in the narrative about the project, the applicant's financial need, and the project's purported benefit to be derived from the cost.
Using the evaluation criteria included herein, the panelists independently scored each application before them and then discussed the merits and shortcomings of the application in an effort to reconcile any major discrepancies. A consensus on the score was not required. The assigned score reflects the degree to which the applicant: Clearly related their proposed project including the project's budget; demonstrated financial need; detailed a high benefit to cost value of the proposed activities; and demonstrated significant enhancements to the daily operation of the organization and/or how the grant would positively impact the applicant's ability to protect life and property. The highest scoring applications resulting from this second level of review were then considered for award.
DHS will select a sufficient number of awardees from this one application period to obligate all of the available grant funding. Awards will be announced over several months as the decisions are made. Applicants that are not to receive funding will be notified as soon as feasible throughout the process. Awards will not be made in any specified order,
Each year, the appropriate office in the Department of Homeland Security conducts a criteria development meeting to develop the program's priorities for the coming year. DHS brings together a panel of fire service professionals representing nine major fire service organizations. The organizations that are represented include the International Association of Fire Chiefs (IAFC), the International Association of Firefighters (IAFF), the National Volunteer Fire Council (NVFC), the National Fire Protection Association (NFPA), the National Association of State Fire Marshals (NASFM), the International Association of Arson Investigators (IAAI), the North American Fire Training Directors (NAFTD), and the Congressional Fire Service Institute (CFSI). The criteria development panel is charged with making recommendations to the grants program office regarding the creation and/or modification of program priorities as well as development of criteria and definitions as necessary.
The 2005 reauthorization of the AFG requires that the program office publish each year in the
DHS modified or did not adopt the criteria development panel's recommendations as follows:
• In the vehicle acquisition program, DHS disagreed with recommendations made by the criteria development panel for the 2005 program, and kept the panel's input from the 2004 program in place. DHS believes the recommended changes for the 2005 program would have been too restrictive in that they did not offer enough latitude and diversity in the selections of vehicles. DHS believes that the recommended priorities downplayed the diversified needs of urban and suburban departments while favoring the needs of rural departments.
• For the “modifications to facilities” activity, the criteria development panel provided DHS with a directory of initiatives that they would like DHS to consider as eligible under this activity. DHS has elected to stay with a relatively shorter list of eligible initiatives (vehicle exhaust extraction systems, sprinkler systems, smoke/fire alarm systems, and emergency generators). DHS has limited the number of initiatives to those focused on protection and safety for the firefighting and emergency responders, versus providing a more comfortable working environment. DHS has limited the number of eligible initiatives because certain modifications to facilities may have to undergo a historic and/or environmental review and DHS is in the process of establishing procedures to assure that all Federal regulations are followed in this respect.
• DHS placed more value on projects that affect regional benefits than the criteria development panel recommended. If, for example, two projects achieved similar scores, but one represented a regional effort, DHS would be more likely to fund that project, to further encourage regional efforts, as such efforts tend to improve interoperability.
• Wherever the program priorities took call volume into consideration, DHS elected to develop and use its own matrix, rather than the criteria panels, to provide more diversity in the possible scoring levels.
• The criteria panel wanted to require training as a pre-requisite for any grant. DHS determined that this requirement would be impracticable, as there was no guidance from the criteria panel as to what types(s) of training would satisfy each and every eligible use of funds under this broad program.
• The criteria panel recommended that DHS double the number of thermal
Specific rating criteria for each of the eligible programs and activities follow below. These rating criteria will provide an understanding of the grant program's priorities and the expected cost effectiveness of any proposed projects.
(1)
(i)
Applications were rated more highly for those proposed programs that benefit the highest percentage of applicable personnel within a fire department or those proposed programs that will be open to other departments in the region. Training that brings the department into statutory (
Due to the inherent differences between urban, suburban, and rural firefighting characteristics, DHS has developed different priorities in the training activity for departments that service these different types of communities. However, chemical / biological / radiological / nuclear / explosives (CBRNE) awareness training has a high benefit and will receive the highest consideration regardless of the type of community served.
For fire departments serving rural communities, DHS believes that funding basic, operational-level firefighting training, operational-level rescue training, driver training, or first-responder EMS, EMT-B, and EMT-I training (
Conversely, for departments that are serving urban or suburban communities, DHS believes there is a higher benefit to be gained by funding specialized training, such as mass casualty, HazMat, advance rescue and EMS, or inspector training than the funding of officer training, safety officer training, or operations training, which in turn has a higher benefit than basic-, operational-, or awareness-level activities. Training designated to enhance multi-jurisdictional capabilities will be afforded a slightly higher rating.
(ii)
DHS believes the greatest benefit will be realized by supporting new wellness and fitness programs, and therefore, applications that reflected them were accorded higher competitive ratings than those applicants that already employ a wellness/fitness program. Finally, since participation is critical to achieving any benefits from a wellness or fitness program, applications that include them are given higher competitive ratings to departments whose wellness and fitness programs mandate or provide incentives for participation.
(iii)
DHS believes this grant program will achieve the greatest benefits if DHS provides funds to fire departments purchasing basic firefighting, rescue, EMS, and CBRNE preparedness equipment that they have never owned prior to the grant or to replace used or obsolete firefighting equipment. The second priority will be to fund departments that are seeking to expand into new mission areas, and therefore those departments will receive a lower competitive rating than departments seeking reserve equipment. Additionally, among departments that serve similar types of communities, those that have high call volumes will be afforded a higher competitive rating than those that have low call volumes; in other words, those departments that are required to respond more often will receive a higher competitive rating then those that respond infrequently.
The purchase of equipment that brings the department into statutory (
(iv)
Due to safety benefits afforded firefighters, for applications that include a request for personal alert safety system (PASS) devices, DHS will only consider funding applications that are requesting equipment that meets current national standards,
(v)
(2)
Regardless of the type of community served, DHS believes that there is more benefit to be realized by funding fire departments that own few or no vehicles of the type they are seeking than there would be by providing vehicle funding to a department with numerous vehicles of that same type. When assessing the number of vehicles a department has within a particular class, all vehicles with similar functions are included. For example, the following can be classified in the “pumper” category: pumpers, engines, pumper/tankers, (with less than 1,250 gallon capacity), rescue-pumpers, quints (with aerials less than 76 feet in length), and urban interface vehicles such as Type I, II or III. Pumpers with water capacity in excess of 1,250 gallons would be considered a tanker/tender.
A higher competitive rating in the apparatus category is given to fire departments that own few or no firefighting vehicles relative to other departments serving similar types of communities. Also a higher competitive rating is given to departments that have an aged fleet of firefighting vehicles, and to those with old, high-mileage vehicles. A higher competitive rating is also given to departments that respond to a significant number of incidents relative to other departments servicing similar communities.
No competitive advantage has been assigned to the purchase of standard model commercial vehicles versus custom vehicles, or the purchase of used vehicles versus new vehicles in the preliminary evaluation of applications. It has been noted that depending on the type and size of department, the technical evaluation panelists often prefer low-cost vehicles when evaluating the cost-benefit section of the project narratives. Panelists may be provided with guidance for use in their evaluation of the reasonableness of vehicle costs. DHS reserves the right to instill funding limits on requests for vehicles whose costs DHS deems excessive or otherwise not in the best interest of the program. Finally, DHS will allow each fire department to apply for only one vehicle per year.
(3)
DHS may make grants for the purpose of enhancing the provision of emergency medical services for nonaffiliated EMS organizations. Funding for these organizations is limited to no more than two percent (2%) of the appropriated amount. DHS believes that it is more cost-effective to enhance or expand an existing emergency medical service organization by providing training and/or equipment than it would be to create a new service. As such, communities that do not
(1)
There are five different activities available for funding under this program area: EMS training, EMS equipment, EMS personal protective equipment, wellness and fitness, and modifications to facilities. Requests for equipment and training to prepare for response to incidents involving CBRNE are available under the applicable equipment and training activities.
(i)
(ii)
(iii)
(iv)
(v)
(2)
Due to the inherent benefits of an ambulance or any transport vehicle to an EMS service provider, DHS deems these types of vehicles to be the highest priority. Due to the costs associated with obtaining and outfitting non-transport rescue vehicles, DHS believes non-transport rescue vehicles should have a lower competitive rating than transport vehicles. Vehicles that have a very narrow function, such as aircraft, boats, and all-terrain vehicles, will receive the lowest competitive rating. Due to the very limited funding for EMS vehicle awards, DHS anticipates that this program will be very competitive. As such, it is unlikely that DHS will fund any vehicles that are not listed as a “Priority One” this year. The following chart delineates the priorities in this program area.
While there are many inherent differences between urban, suburban, and rural communities, DHS has not differentiated priorities in this year's EMS vehicle program for different types of communities.
Along with the priorities illustrated above, DHS believes that there is more benefit to be realized by funding
(3) Administrative Costs. Panelists will assess the reasonableness of the administrative costs requested in each application and determine if it is reasonable and in the best interest of the program.
U.S. Citizenship and Immigration Services, DHS.
Notice.
The designation of Liberia for Temporary Protected Status (TPS) will expire on October 1, 2005. This Notice extends the designation of Liberia for 12 months, until October 1, 2006, and sets forth procedures necessary for nationals of Liberia and aliens having no nationality who last habitually resided in Liberia with TPS to re-register and to apply for an extension of their employment authorization documents (EADs) for the additional 12-month period. Re-registration is limited to persons who registered under the current designation (which was announced on August 25, 2004). Certain nationals of Liberia (or aliens having no nationality who last habitually resided in Liberia) who previously have not applied for TPS under the current designation may be eligible to apply under the late initial registration provisions.
The extension of TPS for Liberia is effective October 1, 2005, and will remain in effect until October 1, 2006. The 60-day re-registration period begins August 16, 2005 and will remain in effect until October 17, 2005.
Colleen Cook, Residence and Status Services, Office of Programs and Regulations Development, U.S. Citizenship and Immigration Services, Department of Homeland Security, 111 Massachusetts Avenue, NW., 3rd Floor, Washington, DC 20529, telephone (202) 514-4754.
Under section 244 of the Immigration and Nationality Act (Act), 8 U.S.C. 1254a, the Secretary of Homeland Security, after consultation with appropriate agencies of the Government, is authorized to designate a foreign state (or part thereof) for TPS. 8 U.S.C. 1254a(b)(1). The Secretary of Homeland Security may then grant TPS to eligible nationals of that foreign state (or aliens having no nationality who last habitually resided in that state). 8 U.S.C. 1254a(a)(1).
At least 60 days before the expiration of the TPS designation or any extension thereof, section 244(b)(3)(A) of the Act requires the Secretary of Homeland Security to review, after consultation with appropriate agencies of the Government, the conditions in a foreign state designated for TPS to determine whether the conditions for a TPS designation continue to be met and, if so, the length of an extension of the TPS designation. 8 U.S.C. 1254a(b)(3)(A). If the Secretary of Homeland Security determines that the foreign state no longer meets the conditions for the TPS designation, he shall terminate the designation, as provided in section 244(b)(3)(B) of the Act. 8 U.S.C. 1254a(b)(3)(B). Finally, section 244(b)(3)(C) of the Act provides for the extension of TPS for an additional period of 6 months (or, in the discretion of the Secretary, a period of 12 or 18 months) unless the Secretary determines, at least 60 days before the designation or extension is due to end, that a foreign state (or part thereof) no longer meets the conditions for designation. 8 U.S.C. 1254a(b)(3)(C).
On August 25, 2004, the Secretary of Homeland Security published a Notice in the
Over the past year, DHS and DOS have continued to review conditions in Liberia. Based on this review, the Department of Homeland Security has determined that a 12-month extension is warranted because the extraordinary and temporary conditions that prompted designation still persist. Further, DHS has determined that it is not contrary to the national interest of the United States to permit aliens who are eligible for TPS based on the designation of Liberia to remain temporarily in the United States. 8 U.S.C. 1254a(b)(1)(C).
On June 16, 2005, DOS recommended (DOS Recommendation) an extension of Liberia for TPS for 12-months. Although disarmament and demobilization of the warring factions has been completed with the disarmament of over 100,000 ex-combatants, funding shortfalls and a lack of sufficient rehabilitation and reintegration programs have the potential to destabilize the security situation in Liberia, and have led to riots among ex-combatants in Ganta.
The assisted and spontaneous return of refugees and internally displaced
The Liberian economy continues to perform well below the pre-war level. Despite two percent growth in GDP in the past year, the Liberian economy operates at about one-third of its pre-war level, with a GDP of less than U.S. $500 million, compared with U.S. $1 billion in 1988. (RIC Report, June 2005). The National Transitional Government of Liberia (NTGL) is unable to provide employment (unemployment is at 85 percent) or essential social services.
Based upon this review, the Secretary of Homeland Security, after consultation with appropriate Government agencies, finds that the conditions that prompted the re-designation of Liberia for TPS continue to be met. 8 U.S.C. 1254a(b)(3)(A). There are extraordinary and temporary conditions in Liberia that prevent aliens who are nationals of Liberia (or aliens having no nationality who last habitually resided in Liberia) from returning in safety, assuming these aliens meet the other statutory requirements for TPS. The Secretary of Homeland Security also finds that it is not contrary to the national interest of the United States to permit aliens who meet the eligibility requirements of TPS to remain temporarily in the United States. 8 U.S.C. 1254a(b)(1)(C). On the basis of these findings, the Secretary of Homeland Security concludes that the designation of Liberia for TPS should be extended for an additional 12-month period. 8 U.S.C. 1254a(b)(3)(C).
Following inter-agency consultation on conditions in Liberia, the Department is optimistic that elections scheduled for October 2005 will further stabilize conditions in Liberia. One million Liberians have registered to vote in the elections and, currently, there are 18 registered political parties and 43 presidential candidates. (RIC Report, June 2005).
Yes. If you already have received benefits through the TPS designation of Liberia, your benefits will expire on October 1, 2005. Accordingly, you must comply with the re-registration requirements described below in order to maintain TPS benefits through October 1, 2006. TPS benefits include temporary protection against removal from the United States, as well as employment authorization, during the TPS designation period. 8 U.S.C. 1254a(a)(1).
All persons previously granted TPS under the current designation of Liberia who wish to maintain such status must re-register under the extension by filing the following:
(1) Form I-821, Application for Temporary Protected Status, without fee;
(2) Form I-765, Application for Employment Authorization (see the chart below to determine whether you must submit the $175 filing fee with Form I-765) or a fee waiver request; and
(3) A biometric service fee of $70 if you are 14 years of age or older, or if you are under 14 and are requesting an Employment Authorization Document (EAD). The biometric service fee will not be waived. 8 CFR 103.2(e)(4)(i), (iii).
(4) Unlike previous registration periods, TPS applicants do not need to submit photographs with the TPS application because a photograph will be taken when the applicant appears at an USCIS Application Support Center (ASC) for collection of biometrics.
Please note that the Form I-821 has been revised and only the form with Revision Date 11/5/04 will be accepted. Submissions of older versions of Form I-821 will be rejected. Submit the completed forms and applicable fee(s), if any, to the USCIS Chicago, IL Lockbox during the 60-day re-registration period that begins August 16, 2005 and ends October 17, 2005. An interim EAD will not be issued unless the Form I-765, as part of the TPS registration package, has been pending with USCIS more than 90 days after all requested initial evidence has been received, including collection of the applicant's biometrics at an ASC.
The Form I-821, Form I-765, fees, and all supporting documentation should be filed at the USCIS Chicago, IL Lockbox at:
Please note that these addresses are not the same as where you submitted your forms to register for the current TPS designation. Aliens re-registering or late initial registering for TPS under the designation of Liberia should not bring or send their TPS forms and fees directly to a USCIS district office. Failure to follow these instructions will delay processing of your TPS re-registration application and may result in your application being returned to you.
TPS forms are available from the toll-free USCIS Forms line, 1-800-870-3676, from your local USCIS district office, or from the USCIS Web site:
(1) Although all re-registrants must submit the Form I-765, only those re-registrants requesting an EAD, regardless of age, must submit the $175 filing fee or a properly documented fee waiver request pursuant to 8 CFR 244.20.
(2) Persons between the ages of 14 and 65 (inclusive) filing under the late initial registration provisions who are requesting an EAD must also submit the $175 fee or a fee waiver request pursuant to 8 CFR 244.20.
(3) Aliens who are submitting Form I-765 only for data-gathering purposes (as explained in the chart below) are not required to submit a $175 filing fee, nor
Note that TPS re-registrants and applicants for late initial registration may wish to consider whether obtaining an EAD will be helpful to them for reasons other than verifying employment eligibility (for example, as a photo identity document and/or additional evidence of lawful presence in the United States in order to demonstrate eligibility for a driver's license in some states).
All aliens 14 years of age and older who are re-registering for TPS, renewing temporary treatment benefits, or filing for late initial registration must submit the $70 biometric service fee. In addition, since a photograph, signature, and fingerprint are required to produce an EAD, any applicant under the age of 14 choosing to apply for an EAD must submit the $70 biometric service fee. The biometric service fee will not be waived. 8 CFR 103.2(e)(4)(i), (iii).
No. TPS is a temporary benefit that does not lead to lawful permanent residence by itself or confer any other immigration status. 8 U.S.C. 1254a(e), (f)(1), and (h). TPS also does not cure any immigration status violations or periods of unlawful presence that may have accrued prior to an alien's grant of TPS, following withdrawal of TPS, or after termination of a TPS designation. When a country's TPS designation is terminated, TPS beneficiaries will have the same immigration status they held prior to TPS (unless that status has since expired or been terminated), or any other status they may have acquired while registered for TPS. Accordingly, if an alien held no lawful immigration status prior to being granted TPS and did not obtain any other status during the TPS period, he or she will have no lawful status upon the termination of the TPS designation. Once the Secretary determines that a TPS designation should be terminated, aliens who had TPS under that designation are expected to plan for their departure from the United States and may wish to apply for immigration benefits for which they may be eligible.
Yes. Registration for TPS does not prevent you from applying for another non-immigrant status, from filing for adjustment of status based on an immigrant petition, or from applying for any other immigration benefit or protection. 8 U.S.C. 1254a(a)(5). For the purposes of change of nonimmigrant status and adjustment of status, an alien is considered as being in, and maintaining, lawful status as a nonimmigrant during the period in which the alien is granted TPS. 8 U.S.C. 1254a(f)(4).
An application for TPS does not affect an application for asylum or any other immigration benefit. Denial of an application for asylum or any other immigration benefit does not affect an applicant's TPS eligibility, although the grounds for denying one form of relief may also be grounds for denying TPS. For example, a person who has been convicted of a particularly serious crime is not eligible for asylum or TPS. 8 U.S.C. 1158(b)(2)(A)(ii); 8 U.S.C. 1254a(c)(2)(B)(ii).
No. This is a Notice of an extension of the TPS designation of Liberia, not a Notice re-designating Liberia for TPS. An extension of a TPS designation does not change the required dates of continuous residence and continuous physical presence in the United States. This extension does not expand TPS availability to those beyond the current TPS eligibility requirements for Liberia. To be eligible for benefits under this extension, nationals of Liberia (or aliens having no nationality who last habitually resided in Liberia) must have been continuously physically present since August 25, 2004, and continuously resided in the United States since October 1, 2002.
Yes. There are certain criminal and terrorism-related inadmissibility grounds that render an alien ineligible for TPS. 8 U.S.C. 1254a(c)(2)(A)(iii). Further, aliens who have been convicted of any felony, or two or more misdemeanors, committed in the United States are ineligible for TPS under section 244(c)(2)(B) of the Act, 8 U.S.C. 1254a(c)(2)(B), as are aliens described in the bars to asylum in section 208(b)(2)(A) of the Act, 8 U.S.C. 1158(b)(2)(A).
Some aliens who did not file for TPS during the initial registration period may be eligible for late initial registration under 8 U.S.C. 1254a(c)(1)(A) and (c)(2) and 8 CFR 244.2(f)(2) and (g). To apply for late initial registration an applicant must:
(1) Be a national of Liberia (or alien who has no nationality and who last habitually resided in Liberia);
(2) Have continuously resided in the United States since October 1, 2002;
(3) Have been continuously physically present in the United States since August 25, 2004; and
(4) Be admissible as an immigrant, except as provided under section 244(c)(2)(A) of the Act, and not ineligible under section 244(c)(2)(B) of the Act.
Additionally, the applicant must be able to demonstrate that during the
(1) Was a nonimmigrant or had been granted voluntary departure or any relief from removal;
(2) Had an application for change of status, adjustment of status, asylum, voluntary departure, or any relief from removal or change of status pending or subject to further review or appeal;
(3) Was a parolee or had a pending request for reparole; or
(4) Is the spouse or child of an alien currently eligible to be a TPS registrant.
An applicant for late initial registration must file an application for late registration within 60 days of the expiration or termination of the above-described conditions. 8 CFR 244.2(g). All late initial registration applications for TPS pursuant to the TPS extension of Liberia should be submitted to the USCIS lockbox address listed above.
At least 60 days before this extension of the TPS designation for Liberia expires on October 1, 2006, the Secretary of Homeland Security, after consultation with appropriate agencies of the Government, will review conditions in Liberia and determine whether the conditions for this TPS designation continue to be met at that time, or whether the TPS designation should be terminated. 8 U.S.C. 1254a(b)(3). Notice of that determination, including the basis for the determination, will be published in the
By the authority vested in the Secretary of Homeland Security under sections 244(b)(3)(A) and (b)(3)(C) of the Act, DHS has determined, after consultation with the appropriate Government agencies, that the conditions that prompted designation of Liberia for TPS continue to be met. Accordingly, DHS orders as follows:
(1) The designation of Liberia under section 244(b)(1)(C) of the Act is extended for an additional 12-month period from October 1, 2005, to October 1, 2006. 8 U.S.C. 1254a(b)(3)(C).
(2) There are approximately 3,792 nationals of Liberia (or aliens having no nationality who last habitually resided in Liberia) who have been granted TPS and who are eligible for re-registration.
(3) To maintain TPS, a national of Liberia (or an alien having no nationality who last habitually resided in Liberia) who was granted TPS during the current designation must re-register for TPS during the 60-day re-registration period from August 16, 2005 until October 17, 2005.
(4) To re-register, the alien must file the following: (1) Form I-821, Application for Temporary Protected Status, without fee; (2) Form I-765, Application for Employment Authorization; and (3) a biometric services fee of $70 if the alien is age 14 or older, or if the alien is under age 14 and requesting an EAD. Applications submitted without the required fees will be returned to the applicant. If the alien requests an EAD, he or she must submit $175 or a properly documented fee waiver request, pursuant to 8 CFR 244.20, with the Form I-765. An alien who does not request employment authorization must still file Form I-765 along with Form I-821, but he or she is not required to submit the fee or a fee waiver request for filing Form I-765. Failure to re-register without good cause will result in the withdrawal of TPS. 8 U.S.C. 1254a(c)(3)(C). Aliens who have previously registered for TPS but whose applications remain pending should follow these instructions to renew temporary treatment benefits. Some persons who had not previously applied for TPS may be eligible for late initial registration under 8 CFR 244.2.
(5) At least 60 days before this extension ends on October 1, 2006, the Secretary of Homeland Security, after consultation with appropriate agencies of the Government, will review the designation of Liberia for TPS and determine whether the conditions for designation continue to be met. 8 U.S.C. 1254a(b)(3)(A). Notice of that determination, including the basis for the determination, will be published in the
(6) Information concerning the extension of designation of Liberia for TPS will be available at local USCIS offices upon publication of this Notice and on the USCIS Web site at
Coast Guard, DHS.
Notice of meetings.
The Navigation Safety Advisory Council (NAVSAC) will meet as required to discuss various issues relating to the safety of navigation. The meeting will be open to the public.
NAVSAC will meet on Wednesday, September 7, 2005, from 8:30 a.m. to 4 p.m.; Thursday, September 8, 2005, from 8:30 a.m. to 4 p.m.; and Friday, September 9, 2005, from 8:30 a.m. to 1 p.m. The meetings may close early if all business is finished. Written material for and requests to make oral presentations at the meeting should reach the Coast Guard on or before August 21, 2005. Requests to have a copy of your material distributed to each member of the Committee or working groups prior to the meeting should reach the Coast Guard on or before August 21, 2005.
NAVSAC will meet in the Marriott Crystal Gateway Hotel, 1700 Jefferson Davis Highway, Arlington, VA 22202. Send written material and requests to make oral presentations to Mr. John Bobb, Commandant (G-MW), U.S. Coast Guard Headquarters, G-MW, Room 1406, 2100 Second Street SW., Washington, DC 20593-0001. This notice and related documents are available on the Internet at
Mr. John Bobb, Executive Secretary, telephone 202-267-2384, fax 202-267-4700, or e-mail at:
Notice of these meetings is given under the Federal Advisory Committee Act, 5 U.S.C. App. 2 (Pub. L. 92-463, 86 Stat. 770, as amended).
The agenda includes the following items to be discussed:
(1) Regulated Navigation Areas and Security Zones.
(2) Enhanced Loran.
(3) Right Whale Proposed Regulations.
(4) Navigation Bridge Visibility.
(5) Report on the initial meeting of the Committee on the Maritime Transportation System.
(6) Report on Automatic Identification Systems.
(7) Report of Electronic Charting Systems and Electronic Charting Display Information Systems.
All meetings are open to the public. Please note that the meetings may close early if all business is finished. At the chairs discretion, members of the public may make oral presentations during the meetings. If you would like to make an
For information on facilities or services for individuals with disabilities or to request special assistance at the meetings, contact Executive Secretary as soon as possible.
Coast Guard, DHS.
Request for comments; notice of public meeting.
In accordance with the requirements in Title 33 Code of Federal Regulations (CFR), Section 127.009, the U.S. Coast Guard Captain of the Port (COTP) Long Island Sound, is preparing a Letter of Recommendation as to the suitability of Long Island Sound for liquefied natural gas (LNG) marine traffic. This Letter of Recommendation will encompass the marine safety and security aspects associated with the proposed Broadwater LNG facility. The letter of recommendation is in response to a Letter of Intent submitted by Broadwater Energy, a joint venture of Shell Oil and TransCanada Corporation, to construct and operate an offshore floating, storage and regasification unit (FSRU) for liquefied natural gas (LNG) in the New York State waters of Long Island Sound. Because the proposed facility would be located in state waters, the Federal Energy Regulatory Commission (FERC) is the lead Federal agency for this proposed project. The COTP Long Island Sound is soliciting written comments and related material, and will join FERC at four public meetings seeking comments, pertaining specifically to maritime safety and security aspects of the proposed LNG facility. In preparation for issuance of a letter of recommendation and the completion of certain other regulatory mandates, the COTP Long Island Sound will consider comments received from the public as input into the Coast Guard's assessment of potential waterway safety and port security issues associated with the proposed facility.
All written comments and related material must reach the Coast Guard on or before October 7, 2005. In addition, four public meetings will be held regarding this proposal, on the following dates and locations:
• September 13, 2005, at Stony Brook University, Charles B. Wang Center, RT 25A, Stony Brook, NY;
• September 14, 2005, at Shoreham-Wading River Middle School (Albert Prodell Middle School), 100 Randall Road, Shoreham, NY;
• September 20, 2005, at E. Lyme High School, 30 Chesterfield Road, East Lyme, CT; and
• September 21, 2005, at Branford High School, 185 East Main Street, Branford, CT;
All four public meetings will be held from 7 p.m. to 10 p.m. The comment period associated with the public meeting will remain open until October 7, 2005.
You may submit comments identified by Coast Guard docket number USCG-2005-21863, to the Docket Management Facility at the U.S. Department of Transportation. Comments submitted to the Coast Guard should relate to the marine safety and security aspects associated with the proposed Broadwater LNG facility. To avoid duplication, please use only one of the following methods:
1. Web site:
2. Mail: Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Washington, DC 20590-0001.
3. Fax: (202) 493-2251.
4. Delivery: Room PL-401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is (202) 366-9329.
5. Federal eRulemaking Portal:
You may also submit comments relating to the maritime safety and security of the proposed facility to Commanding Officer, U.S. Coast Guard Sector Long Island Sound. All comments received by Sector Long Island Sound will be forwarded to the Docket Management Facility. Duplicate copies of comments submitted to the Docket Management Facility need not be submitted to the COTP Long Island Sound. COTP Long Island Sound will review and consider all comments submitted to the Docket Management Facility as well as those received directly.
If you have questions on this notice, contact LT Andrea Logman at Coast Guard Sector Long Island Sound by one of the methods listed below:
(1) Phone at (203) 468-4429;
(2) E-mail at
(3) Fax to (203) 468-4445.
If you have questions on viewing or submitting material to the docket, call Andrea M. Jenkins, Program Manager, Docket Operations, telephone (202) 366-0271.
We encourage you to submit written comments and related material pertaining specifically to marine safety and security aspects associated with the proposed Broadwater LNG facility. If you do so, please include your name and address, identify the docket number for this notice (USCG-2005-21863) and give the reason for each comment. You may also submit your comments and related material by mail, electronically or hand delivery, as described in
If you submit comments by mail or hand delivery, submit them in an unbound format, no larger than 8
All comments received will be posted, without charge, to
To view comments, as well as documents mentioned in this preamble as being available in the document, go to
Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's Privacy Act Statement in the
Due to the scope and complexity of this project, we have decided to jointly hold four public meetings with FERC to allow the public the opportunity to comment on the proposed LNG facility. The dates and locations of these meetings are listed under
In accordance with the requirements of 33 CFR 127.007, Shell Oil and TransCanada Corporation under the joint company Broadwater LNG, submitted a letter of Intent on November 9, 2004, notifying the COTP Long Island Sound that they intend to construct and operate an offshore FSRU for LNG, named Broadwater Energy, in the New York State waters of Long Island Sound. An Amendment to the Letter of Intent was submitted on April 26, 2005, updating the location of the proposed FSRU. The proposed location of the FSRU is approximately nine (9) miles off the coast of Riverhead, New York, and about 11 miles from the nearest Connecticut shoreline.
FERC will be the lead agency for the Environmental Impact Statement (EIS) mandated by the National Environmental Policy Act. To help FERC make sure that the EIS covers the Coast Guard's Letter of Recommendation and other actions under this proposal, the Coast Guard will serve as a cooperating agency.
The proposed FSRU would serve as an LNG import terminal. LNG carriers (ships) would berth at the FSRU and LNG would be transferred from the carriers to the storage tanks located on the FSRU. The Broadwater FSRU is designed to have an onboard LNG storage capacity of up to 350,000 cubic meters (m
LNG would be delivered to the terminal in double-hulled LNG carriers. Typical LNG carriers currently have a carrying capacity of 135,000 m
The U.S. Coast Guard exercises regulatory authority over LNG facilities which affect the safety and security of port areas and navigable waterways under Executive Order 10173, the Magnuson Act (50 U.S.C. 191), the Ports and Waterways Safety Act of 1972, as amended (33 U.S.C. 1221,
Upon receipt of a letter of intent from an owner or operator intending to build a new LNG facility, the Coast Guard COTP conducts an analysis that results in a letter of recommendation issued to the owner or operator and to the state and local governments within whose jurisdictions the proposed facility lies, addressing the suitability of the waterway to accommodate LNG vessels. Specifically, the letter of recommendation addresses the suitability of the waterway based on:
• The physical location and layout of the facility and its berthing and mooring arrangements.
• The LNG vessels' characteristics and the frequency of LNG shipments to the facility.
• Commercial, industrial, environmentally sensitive, and residential areas in and adjacent to the waterway used by the LNG vessels en route to the facility.
• Density and character of marine traffic on the waterway.
• Bridges or other manmade obstructions in the waterway.
• Depth of water.
• Tidal range.
• Natural hazards, including rocks and sandbars.
• Underwater pipelines and cables.
• Distance of berthed LNG vessels from the channel, and the width of the channel.
In addition, the Coast Guard will review and approve the facility's operations manual and emergency response plan (33 CFR 127.019), as well as the facility's security plan (33 CFR 105.410). The Coast Guard will also provide input to other Federal, State, and local government agencies reviewing the project.
FERC is the lead Federal agency responsible for licensing LNG facilities located on shore and within state waters. Under an interagency agreement, the Coast Guard will provide input to, and coordinate with, FERC on maritime safety and security aspects of the proposed Broadwater LNG project. FERC will be the lead agency for the Environmental Impact Statement (EIS) mandated by the National Environmental Policy Act. To help FERC make sure that the EIS covers the Coast Guard's Letter of Recommendation and other actions under this proposal, the Coast Guard will serve as a cooperating agency.
In order to complete a thorough analysis and fulfill the regulatory mandates cited above, the COTP Long Island Sound will be conducting an assessment of the various safety and security aspects associated with the proposed Broadwater LNG proposed project. This assessment will be accomplished through a series of workshops focusing on the areas of waterways safety, port security, and consequence management, with involvement from a broad cross-section of government and port stakeholders with expertise in each of the respective areas. The workshops will be by invitation only. However, comments
Additional information about the Broadwater LNG project is available from FERC's Office of External Affairs at 1-866-208-FERC or on the FERC Internet Web site (
Office of the Chief Information Officer, HUD.
Notice.
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
The information is used by HUD to analyze the financial position of borrower potentially in default for the purpose of evaluating compromises, partial settlement offers, and payment arrangements. It is required of a small percentage of debtors to establish repayment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Approval Number (2502-0098) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-6974.
Wayne Eddins, Reports Management Officer, AYO, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail
Copies of available documents submitted to OMB may be obtained from Mr. Eddins or Ms. Deitzer or from HUD's Web site at
This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
This notice also lists the following information:
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended.
Office of the Assistant Secretary for Housing, HUD.
Notice.
The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Wayne Eddins, Reports Management Officer, Department of Housing and Urban Development, 451 7th Street, SW., L'Enfant Plaza Building, Room 8202, Washington, DC 20410.
Willie Spearmon, Director, Office of Housing Assistance and Grant Administration, Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410, telephone (202) 708-3000 (this is not a toll free number) for copies of the proposed forms and other available information.
The Department is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).
This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond; including the use of appropriate automated collection techniques or other forms of information technology,
This notice also lists the following information:
The Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, as amended.
Office of the Chief Information Officer, HUD.
Notice.
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
The data collection requirements consist of an electronic lender certification process whereby the lender certifies to its eligibility to participate in the Lender Insurance program. It also states that lenders must provide electronic copies of loan applications and supporting documents at FHA's request.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2502-Pending) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-6974.
Wayne Eddins, Reports Management Officer, AYO, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail
This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information collection described below. This notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
This notice also lists the following information:
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended.
Office of the Chief Information Officer, HUD.
Notice.
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Lender provides information required to determine the eligibility of a mortgage to be insured under Section 513 of the Housing and Community Development Act of 1992 (Section 106 of the Energy Policy Act of 1992).
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2502-Pending) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-6974.
Wayne Eddins, Reports Management Officer, AYO, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail
This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information collection described below. This notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
This notice also lists the following information:
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended.
Office of the Secretary, HUD.
Notice of extension of application submission date for applicants submitting applications from areas affected by Hurricane Dennis.
This notice announces the extension of submission deadline dates for two programs announced in the Fiscal Year 2005 SuperNOFA, the Rural Housing and Economic Development (RHED) NOFA and the Public Housing Neighborhood Networks NOFA, for those applicants located within the states significantly affected by Hurricane Dennis including Alabama,
For the Public Housing Neighborhood Networks NOFA, contact the Public and Indian Housing Information Resource Center toll-free at 1-800-955-2232 and for Indian Tribes and Tribally Designated Housing Entities (TDHE), call toll-free at 1-800-561-5913.
For the Rural Housing and Economic Development NOFA, contact Jackie Williams, Director, Office of Rural Housing and Economic Development, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410-7000; telephone (202) 708-2290 (this is not a toll-free number).
Hearing- or speech-impaired persons may access these telephone numbers by calling the toll-free Federal Information Relay Service on 1-800-877-8339.
On March 21, 2005 (70 FR 13575), HUD published its FY2005 SuperNOFA, which announced the availability of approximately $2.26 billion in HUD assistance. In a
Due to Hurricane Dennis, which caused widespread power outages in the states of Alabama, Florida, Georgia, and Mississippi, the Department is extending the deadline for the RHED and Public Housing Neighborhood Networks NOFAs to August 22, 2005. This extension affects only applicants located in these four states. HUD will accept applications to the RHED program NOFA and Public Housing Neighborhood Networks program NOFA from applicants in the four affected states either through Grants.gov, or in hard copy (paper) submission consistent with the instructions in the March 21, 2005, SuperNOFA General Section, except that these affected applicants are not required to obtain a waiver from the electronic submission requirement and HUD recommends applicants use an overnight delivery method to ensure timely receipt of paper applications. Hard copy submissions should be sent to the appropriate address listed as follows:
Department of Housing and Urban Development, Attn: Anice M. Schverish, 451 Seventh Street, SW., Room 3236, Washington, DC 20410-5000.
(Applicants to the Public Housing Neighborhood Networks Program should submit an original and two copies of the application.)
Department of Housing and Urban Development, Attn: Jackie L. Williams, Office of Rural Housing and Economic Development, 451 Seventh Street, SW., Room 7137, Washington, DC 20410-7000.
(Applicants to the RHED program should submit an original and two copies of the application.)
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
This notice advises mortgagees that are required by the Home Mortgage Disclosure Act (HMDA) and Regulation C of the Federal Reserve Board (Board) to submit HMDA data to HUD to submit their annual HMDA reports, due on or before March 1st of each year, to the Board of Governors of the Federal Reserve, and not to HUD.
Effective September 15, 2005.
Jerry Fasick, Office of Evaluation, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410-8000, telephone (202) 755-7500 (this is not a toll-free number). Hearing- or speech-impaired individuals may access this number through TTY by calling the toll-free Federal Information Relay Service at (800) 877-8339.
All mortgagees, lenders, and loan correspondents that meet the requirements of Regulation C of the Board (see 12 U.S.C. part 203) must report each year data required by HMDA (12 U.S.C. 2801
(i)(A) Originated (made credit decision on) home purchase loans, including refinancing of home purchase loans, that equaled at least 10 percent of its loan-origination volume, measured in dollars; or
(B) Originated (made credit decision on) home purchase loans, including refinancings of home purchase loans, that equaled at least $25 million; and
(ii) On the preceding December 31, had a home or branch office in a Metropolitan Statistical Area/Metropolitan Division (MSA/MD); or received applications for, originated or repurchased five or more home purchase loans, home improvement loans, or refinancings on property located in an MSA/MD; and
(iii)(A) On the preceding December 31, had total assets of more than $10 million, counting the assets of any parent corporation; or
(B) In the preceding calendar year, originated (made credit decision on) at least 100 home purchase loans, including refinancings of home purchase loans.
HMDA requires at 12 U.S.C. 2803(h) that supervised lenders, whether or not they are lenders approved by the Federal Housing Administration (FHA), submit their HMDA data to their appropriate supervising agencies,
The FFIEC HMDA data entry software is available for download from the FFIEC HMDA Web site. Note that the next scheduled release of the software, Version 3.10, for calendar year 2005 data collection is available by download from the FFIEC HMDA Web site. The software is free and can be utilized for editing, reporting and submitting HMDA information.
The FFIEC HMDA Web site provides detailed information on the required file specifications for HMDA reporting (
In addition, an institution's HMDA data must be edited prior to submission using the FFIEC HMDA edits (
If an institution utilizes a third-party vendor's software package, the institution can still take advantage of the benefits of the HMDA Data Entry Software by using the editing and reporting features. The software includes editing and reporting features to help the institution verify, complete, and analyze the institution's HMDA data. The ‘Import' feature will accept a valid ‘hmda.dat' file created in a third-party vendor's software that meets the HMDA file specifications. Once the file has been successfully imported into the software, the user can utilize the editing and reporting features. The ‘Export to Regulatory Agency via Internet e-mail' feature creates a validity error-free encrypted file that can be transmitted via Internet e-mail directly to the Board at
Please note that reel tape submissions are not an accepted media type. Internet e-mail submission is the preferred electronic method to transmit an institution's data. Other electronic submission media types that can be used are diskette and CD-ROM. However, regardless of the media type chosen, users must follow the HMDA file specifications and edits.
Send the encrypted e-mail file to
Federal Reserve Board, ATTN: HMDA Processing, HUD, 20th & Constitution Avenue, NW., MS N502, Washington, DC 20551-0001.
Questions regarding the processing and reporting of HMDA data should be addressed to
The information collection requirements contained in this notice have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and assigned OMB control number 2502-0529. In accordance with the Paperwork Reduction Act, HUD may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a currently valid OMB number.
Fish and Wildlife Service, Interior.
Notice; request for comments.
We (Fish and Wildlife Service) will submit the collection of information described below to OMB for approval under the provisions of the Paperwork Reduction Act. We will use this information to determine which project proposals should be funded in accordance with the Marine Turtle Conservation Act (Pub. L. 108-266).
You must submit comments on or before October 17, 2005.
Send your comments and suggestions on specific requirements to the Information Collection Clearance Officer, Fish and Wildlife Service, MS 222-ARLSQ, 4401 N. Fairfax Drive, Arlington, VA 22203.
To request a copy of the information collection submission, explanatory information, and/or related forms, contact Hope Grey, Information Collection Clearance Officer, at 703-358-2482 or electronically at
OMB regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Proposals submitted for funding under the Marine Turtle Conservation Act are subject to a panel review, comprised of in-house and select outside technical experts. The information collected under this program's Notice of Funding Availability includes: a project summary and narrative; letter of appropriate government endorsement; brief curricula vitae for key project personnel; and complete standard forms 424, 424a and 424b. Proposals from U.S. applicants also include a copy of the organization's Negotiated Indirect Cost Rate Agreement (NIRCA) (if applicable) and a complete DI-2010. The project summary and narrative is the basis for this information collection request for approval, and allows the review panel to assess how well the project addresses the priorities identified by the Act. As all of the projects under this Act will be conducted outside the United States, the letter of appropriate government endorsement ensures that the proposed activities will not meet with local resistance or work in opposition to locally identified priorities and needs. Brief curricula vitae for key project personnel allow the review panel to assess the qualifications of project staff to effectively carry out the project goals and objectives. Although the standard forms are only required for U.S. financial assistance applicants, we ask all applicants to submit these forms in order to allow for more uniformity across all proposals. As all Federal entities are required to honor the indirect cost rates an organization has negotiated with their cognizant agency, we require all organizations with a NICRA to submit the agreement paperwork with their proposals to verify how their rate is applied in their proposed budget. The DI-2010 is a required form for all U.S. financial assistance applicants.
The information requested in this collection, outside of the required standard forms, is considered the minimum information necessary to allow the review panel sufficient technical, financial, and administrative information to determine the merits of each proposal, and to select the best projects for funding.
We invite comments concerning this collection on: (1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility; (2) the accuracy of the agency's estimate of burden on the public; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond.
Fish and Wildlife Service, Department of the Interior.
Notice of availability of the Draft Comprehensive Conservation Plan and Environmental Assessment for Crocodile Lake Naitonal Wildlife Refuge in Monroe County, Florida.
The Fish and Wildlife Service announces that a Draft Comprehensive Conservation Plan and Environmental Assessment for Crocodile Lake National Wildlife Refuge are available for review and comment. The National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997, requires the Service to develop a comprehensive conservation plan for each national wildlife refuge. The purpose in developing a comprehensive conservation plan is to provide refuge managers with a 15-year strategy for achieving refuge purposes and contributing toward the mission of the National Wildlife Refuge System, consistent with sound principles of fish and wildlife management, conservation, legal mandates, and Service policies. In addition to outlining broad management direction on conserving wildlife and their habitats, plans identify wildlife-dependent recreational opportunities available to the public, including opportunities for hunting, fishing, wildlife observation, wildlife observation, wildlife photography, and environmental education and interpretation.
Significant issues address in the draft plan include: threatened and endangered species; migratory birds, habitat restoration; invasive exotic species control; funding and staffing; and land acquisition.
Individuals wishing to comment on the Draft Comprehensive Conservation Plan and Environmental Assessment for Crocodile Lake National Wildlife Refuge should do so no later than October 17, 2005. Public comments were requested, considered, and incorporated throughout the planning process. Public outreach has included public scoping meetings, planning updates, and a
Requests for copies of the Draft Comprehensive Conservation Plan and Environmental Assessment should be addressed to the Florida Keys National Wildlife Refuge Complex, 28950 Watson Boulevard, Big Pine Key, Florida 33043; Telephone 305/872-2239. The plan and environmental assessment may also be accessed and downloaded from the Service's Internet Web site
The Service developed three alternatives for managing the refuge and chose Alternative 2 as the preferred alternative.
Serving as a basis for each alternative, goals and sets of objectives and
This alternative reflects actions that include supporting recovery efforts for federally listed species, restoring hammocks, restoring wetlands, and acquiring lands from willing sellers within the acquisition boundary. Monitoring of plants and animals would be limited due to staffing constraints and limited research interest. Habitat management actions are intended to benefit all wildlife by maintaining habitat integrity.
Management coordination would occur between the refuge and the adjacent state botanical preserve. Coordination would be limited because of staffing constraints and remain focused on invasive exotics control, habitat restoration, and threatened and endangered species. Since the refuge is closed to the public, visitors would continue to be directed to the state botanical preserve. The preserve has infrastructure to accommodate visitors who want to experience being in a hardwood hammock or mangrove forest.
The refuge would remain staffed with a refuge manager and periodic interns. Researchers would be accommodated when projects benefit the refuge. The refuge would remain closed to public and commercial access.
This alternative is the preferred alternative for managing the refuge. Under this alternative, existing management activities would continue, and some activities would be expanded. This alternative proposes to add an additional full-time biological technician to allow for expansion of activities such as monitoring, exotics control, and restoration.
The staff member would help support the additional activities proposed under this alternative.
Increasing efforts related to exotics control, pest management, and monitoring are characteristic of this alternative. This increased management actions would help to achieve the long-term goals and objectives in a timelier manner than under the “no action” alternative. This alternative would result in a more ecosystem-based management approach that views the refuge as a single system rather than separate habitat types. Federally listed species would still be of primary concern, but needs of other resident and migratory wildlife would also be considered.
A more proactive approach to land acquisition would be taken in order to purchase remaining inholdings. The refuge would actively contact owners of inholdings and seek to acquire the parcels. There are roughly 400 acres of inholdings that the refuge wants to acquire in order to restore distributed habitats on those parcels. Acquiring inholdings would also ensure that connectivity of refuge habitats is maintained.
This alternative is an expanded version of Alternative 2 that allows for opening the refuge to limited public use. The refuge was established as a closed refuge and the possibility of allowing public use was considered for this alternative. Restoration of habitats may provide an opportunity to incorporate nature trails that provide access to the refuge.
These potential nature trails would need to be located in areas that would result in no disturbance to wildlife since they would be located in areas that were disturbed. The trails would also provide interpretive signs to educate visitors about refuge resources.
In addition to the nature trails, there would be a strengthening of the refuge friends group in order to provide guided tours of the refuge. Refuge staff would train volunteers to conduct tours of areas that are only accessible with a guide. This approach would open the refuge and allow visitors to experience the refuge while minimizing disturbance to sensitive wildlife areas.
Opening the entire refuge to general public use and access was rejected since it would create too much disturbance to sensitive wildlife. Additionally, a full-time refuge ranger and law enforcement officer would need to be added to the staff to handle the influx of visitors. The Florida Keys receive approximately 4 million visitors per year and even a fraction of a percent of those visitors stopping at the refuge would cause impacts of unacceptable levels.
Active habitat manipulation to emulate natural disturbances (
Crocodile Lake National Wildlife Refuge is in north Key Largo approximately 40-miles south of Miami, Florida, on County Road 905. The refuge headquarters is 1.8 miles north of the U.S. Highway 1 and County Road 905 split in Key Largo, Florida. The refuge was established as a closed refuge and is not open to the general public.
Crocodile Lake National Wildlife Refuge was established in 1980 to protect critical breeding and nesting habitat for the endangered American crocodile and other wildlife. The refuge is currently comprised of 6,700 acres including 650 acres of open water. It contains a mosaic of habitat types, including tropical hardwood hammock, mangrove forest, and salt marsh. These habitats are critical for hundreds of plants and animals including six federally listed species. The refuge is unusual in that not all of the critical habitat areas are in a pristine,
The refuge protects one of the largest remaining tracts of tropical hardwood hammock, which is a globally threatened habitat type. These diverse forests are home to hundreds of plants and animals including the federally listed Key Largo woodrat, Key Largo cotton mouse, Schaus swallowtail butterfly, Stock Island tree snail, and eastern indigo snake. These species require hammocks in order to survive. Unfortunately, most of the hammocks in Key Largo have been eliminated by development, which has lead to considerable population declines in these already imperiled species.
This notice is published under the authority of the National Wildlife Refuge System Improvement Act of 1977, Public Law 105-57.
Fish and Wildlife Service, Interior.
Notice.
Jeffrey and Patricia Adams (Applicants) request an incidental take permit (ITP) pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973 (16 U.S.C. 1531
The Applicants' Habitat Conservation Plan (HCP) describes the mitigation and minimization measures proposed to address the effects of the project to the scrub-jay. These measures are outlined in the
Written comments on the ITP application, HCP, and Screening Form should be sent to the Service's Regional Office (see
Persons wishing to review the application, HCP, and Screening Form may obtain a copy by writing the Service's Southeast Regional Office at the address below. Please reference permit number TE096080-0 in such requests. Documents will also be available for public inspection by appointment during normal business hours at the Southeast Regional Office, U.S. Fish and Wildlife Service, 1875 Century Boulevard, Suite 200, Atlanta, Georgia 30345 (Attn: Endangered Species Permits), or at the South Florida Ecological Services Field Office, U.S. Fish and Wildlife Service, 1339 20th Street, Vero Beach, Florida 32960-3559 (Attn: Field Supervisor).
Mr. David Dell, Regional HCP Coordinator, Southeast Regional Office (see
If you wish to comment, you may submit comments by any one of several methods. Please reference permit number TE096080-0 in such comments. You may mail comments to the Service's Southeast Regional Office (see
The Florida scrub-jay is geographically isolated from other species of scrub-jays found in Mexico and the western United States. The scrub-jay is found exclusively in peninsular Florida and is restricted to xeric uplands (well-drained, sandy soil habitats supporting a growth of oak-dominated scrub). Increasing urban and agricultural development has resulted in habitat loss and fragmentation, which has adversely affected the distribution and numbers of scrub-jays. The total estimated population is between 7,000 and 11,000 individuals.
The decline in the number and distribution of scrub-jays in west-central Florida has been exacerbated by tremendous urban growth in the past 50 years. Historical commercial and residential development has occurred
The scrub-jays reported using the subject residential lot and adjacent properties are part of a larger complex of scrub-jays located in a matrix of urban and natural settings in southern Sarasota County. The project site represents a portion of an isolated scrub-jay territory. Scrub-jays in urban areas are particularly vulnerable and typically do not successfully produce young that survive to adulthood. Persistent urban growth in this area is likely to result in further reductions in the amount of suitable habitat for scrub-jays. Increasing urban pressures are also likely to result in the continued degradation of scrub-jay habitat as fire exclusion slowly results in vegetative overgrowth. Thus, over the long term, scrub-jays are unlikely to persist in urban settings, and conservation efforts for this species should target acquisition and management of large parcels of land outside the direct influence of urbanization.
Construction of the project's infrastructure and facilities would result in harm to scrub-jays, incidental to the carrying out of these otherwise lawful activities. Habitat alteration associated with the proposed residential construction would reduce the availability of foraging, sheltering, and possible nesting habitat for one family of scrub-jays. The Applicants propose to conduct clearing activities outside of the nesting season. The Applicants propose to remove any exotic vegetation from the lot and maintain the remaining area in native vegetation for use by the resident scrub-jays. The Applicants propose to replace any scrub oaks and wax myrtles that might be removed during land clearing. The Applicants propose to avoid landscaping with trees that would grow tall (greater than 30 feet) and potentially provide perch trees for predators that could prey on scrub-jays on this lot and surrounding unimproved lots. The Applicants would not have any free-roaming cats as they can be a potential predator on young scrub-jays.
The Applicants also propose to mitigate the take of scrub-jays through contribution of $4,000 to the Sarasota County Scrub-jay Mitigation Plan Fund administered by Sarasota County. Funds in this account are earmarked for use in the conservation and recovery of scrub-jays and may include habitat acquisition, restoration, and management. The Applicants assert that the $4,000 payment is the maximum extent of mitigation practicable for them while still allowing them to implement on-site mitigation measures.
The Service has determined that the HCP is a low-effect plan that is categorically excluded from further NEPA analysis, and does not require the preparation of an Environmental Assessment or Environmental Impact Statement. This preliminary information may be revised based on our review of any public comments that we receive in response to this notice. Low-effect HCPs are those involving: (1) Minor or negligible effects on federally listed or candidate species and their habitats, and (2) minor or negligible effects on other environmental values or resources. The Applicants' HCP qualifies for the following reasons:
1. Approval of the HCP would result in minor or negligible effects on the Florida scrub-jay population as a whole. The Service does not anticipate significant direct or cumulative effects to the Florida scrub-jay population as a result of the project.
2. Approval of the HCP would not have adverse effects on known unique geographic, historic, or cultural sites, or involve unique or unknown environmental risks.
3. Approval of the HCP would not result in any significant adverse effects on public health or safety.
4. The project does not require compliance with Executive Order 11988 (Floodplain Management), Executive Order 11990 (Protection of Wetlands), or the Fish and Wildlife Coordination Act, nor does it threaten to violate a Federal, State, local, or tribal law or requirement imposed for the protection of the environment.
5. Approval of the Plan would not establish a precedent for future actions or represent a decision in principle about future actions with potentially significant environmental effects.
The Service has determined that approval of the Plan qualifies as a categorical exclusion under NEPA, as provided by the Department of the Interior Manual (516 DM 2, Appendix 1, and 516 DM 6, Appendix 1). Therefore, no further NEPA documentation will be prepared.
The Service will evaluate the HCP and comments submitted thereon to determine whether the application meets the requirements of section 10(a) of the Act. If it is determined that those requirements are met, the ITP will be issued for incidental take of the Florida scrub-jay. The Service will also evaluate whether issuance of the section 10(a)(1)(B) ITP complies with section 7 of the Act by conducting an intra-Service section 7 consultation. The results of this consultation, in combination with the above findings, will be used in the final analysis to determine whether or not to issue the ITP.
Fish and Wildlife Service, Interior.
Notice of receipt of applications.
The following applicants have applied for scientific research permits to conduct certain activities with endangered species pursuant to section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended.
To ensure consideration, written comments must be received on or before September 15, 2005.
Written comments should be submitted to the Chief, Endangered Species Division, Ecological Services, P.O. Box 1306, Room 4102, Albuquerque, New Mexico 87103. Documents and other information submitted with these applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act. Documents will be available for public inspection, by appointment only, during normal business hours at the U.S. Fish and Wildlife Service, 500 Gold Ave. SW, Room 4102, Albuquerque, New Mexico. Please refer to the respective permit number for each application when submitting comments. All comments received, including names and addresses, will become part of the official administrative record and may be made available to the public.
Chief, Endangered Species Division, (505) 248-6920.
Applicant requests a new permit for research and recovery purposes to allow survey and collection for Sacramento prickly poppy (
Applicant requests an amendment to an existing permit to conduct presence/absence surveys for interior least tern (
Applicant requests a new permit for research and recovery purposes to allow survey and collection for Huachuca water-umbel (
16 U.S.C. 1531,
Fish and Wildlife Service, Interior.
Notice of review.
The U.S. Fish and Wildlife Service (Service) announces a 5-year review of the Tooth Cave ground beetle (
To allow adequate time to conduct this review, information submitted for our consideration must be received on or before November 14, 2005. However, we will continue to accept new information about any listed species at any time.
Information submitted on this species should be sent to the Field Supervisor, attention 5-year Review, U.S. Fish and Wildlife Service, Austin Ecological Services Field Office, 10711 Burnet Road, Suite 200, Austin, Texas 78758. Information received in response to this notice of review will be available for public inspection by appointment, during normal business hours, at the same address.
Robert Pine, at the U.S. Fish and Wildlife Service, Austin Ecological Services Field Office, 10711 Burnet Road, Suite 200, Austin, Texas 78758, 512-490-0057 x -248.
Section 4(c)(2)(A) of the Act (16 U.S.C. 1531
Our regulations at 50 CFR 424.21 require that we publish a notice in the
If we find that there is new information concerning Tooth Cave ground beetle indicating a change in classification may be warranted, we may propose a new rule that could either reclassify the species from endangered to threatened (downlist) or remove the species from the List (delist). If we determine that a change in classification is not warranted, then this species will remain on the List under its current status of endangered. Any change in Federal classification would require a separate rule-making process.
A 5-year review considers all new information available at the time of the review. These reviews will consider the best scientific and commercial data that have become available since the current listing determination or most recent status review of each species, such as:
A. Species biology, including but not limited to population trends, distribution; abundance, demographics, and genetics;
B. Habitat conditions, including but not limited to amount, distribution, and suitability;
C. Conservation measures that have been implemented to benefit the species;
D. Threat status and trends (see five factors under heading “How do we determine whether a species is endangered or threatened?”); and
E. Other new information, data, or corrections, including but not limited to taxonomic or nomenclatural changes, identification of erroneous information contained in the List of Endangered and Threatened Wildlife and Plants, and improved analytical methods.
The Tooth Cave ground beetle is a very small invertebrate found only underground in caves and karst features in Williamson and Travis Counties, Texas, in and near the Austin metropolitan area. The continued existence of this species depends on the ecological stability of the karst environments in which it is found. The Tooth Cave ground beetle is known only from the Cedar Park and Jollyville karst fauna regions as delineated by Veni & Associates (1992, Geologic controls on cave development and the distribution of cave fauna in the Austin, Texas, region, Report to U.S. Fish and Wildlife Service, v+77 pp.). Karst fauna regions are geographic areas delineated based on geologic continuity, hydrology, and the distribution of rare karst invertebrate species. There are seven karst fauna regions delineated in Williamson and Travis Counties.
The primary threat to the Tooth Cave ground beetle is habitat loss due to encroaching urban development. The species occurs in an area of central Texas that is undergoing continued
The List of Endangered and Threatened Wildlife and Plants (List) is found in 50 CFR 17.11 (wildlife) and 17.12 (plants). Amendments to the List through final rules are published in the
We are especially interested in: (1) The results of survey and monitoring efforts that provide a better understanding of current population numbers and the status, security, and location of karst features that provide habitat for this species; (2) recent information regarding the impacts of urban development on the karst environment within the range of the Tooth Cave ground beetle; (3) the impacts of red imported fire ants on the species; and (4) additional site-specific information on protective measures currently in place for this species and its habitat and the expected longevity of those measures.
The following definitions are provided to assist those persons who consider submitting information regarding the species being reviewed:
A.
B.
C.
Section 4(a)(1) of the Act establishes that we determine whether a species is endangered or threatened based on one or more of the five following factors:
A. The present or threatened destruction, modification, or curtailment of its habitat or range;
B. Overutilization for commercial, recreational, scientific, or educational purposes;
C. Disease or predation;
D. The inadequacy of existing regulatory mechanisms; or
E. Other natural or manmade factors affecting its continued existence.
We request any new information concerning the status of Tooth Cave ground beetle. See “What information is considered in the review?” for specific criteria. Information submitted should be supported by documentation such as maps, bibliographic references, methods used to gather and analyze the data, and/or copies of any pertinent publications, reports, or letters by knowledgeable sources. Our practice is to make comments, including names and home addresses of respondents, available for public review. Individual respondents may request that we withhold their home addresses from the supporting record, which we will honor to the extent allowable by law. There also may be circumstances in which we may withhold from the supporting record a respondent's identity, as allowable by law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment. We will not consider anonymous comments, however. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety.
This document is published under the authority of the Endangered Species Act (16 U.S.C. 1531
Bureau of Land Management, Interior.
Notice of realty action.
This notice announces the proposed sale of two small parcels of public land, totaling 3.89 acres, located in Lane County, Oregon at not less than appraised market value. These parcels are proposed to be sold through modified competitive procedures.
Submit comments on or before September 30, 2005.
Address all written comments concerning this Notice to Steven Calish, Siuslaw Field Manager, Bureau of Land Management (BLM) Eugene District Office, P.O. Box 10226, Eugene, Oregon 97440. Electronic format submittal will not be accepted.
Cheryl Adcock (BLM), Realty Specialist, at (541) 683-6145.
The following described public lands in Lane County, Oregon are suitable for sale under Sections 203 and 209 of the Federal Land Policy and Management Act of 1976 (90 Stat. 2750, 43 U.S.C. 1713 and 1719). These lands are difficult and uneconomic to manage as a part of the public lands and are not suitable for management by another Federal agency. No significant resource values will be affected by this disposal. The parcels proposed for sale are identified as suitable for disposal in the Eugene District Record of Decision and Resource Management Plan, dated June, 1995. The parcels proposed for sale are identified as follows:
The area described contains 1.4 acres. The appraised fair market value for Parcel I, including merchantable timber, is $7,600.
The area described contains 2.49 acres. The appraised fair market value for Parcel II, including merchantable timber, is $24,100.
In accordance with 43 CFR 2710.0-6(c)(3)(ii), modified competitive sale procedures are appropriate to protect on-going uses, to assure compatibility of the possible uses with adjacent lands, and avoid dislocation of existing users. There is no public access to Parcel II. Both Parcel I and Parcel II are irregularly shaped and are part of a survey hiatus identified by the BLM in 1999.
Bidding for Parcel I is open only to the following adjacent landowners (designated bidders): Gayla Wardwell, Richard W. Guelker, Helen L. Guelker, Joshua R. John, and Douglas L. Gross.
Bidding for Parcel II is open only to the following adjacent landowners (designated bidders): Laurie Riley, Duane Riley, Brenda L. Neely, Joseph A. Neely, Wanda Parr, Michael W. Parr, David D. Little and Weyerhaeuser Company.
Both parcels will be offered for sale at public auction beginning at 10:00 a.m. (local time) on October 20, 2005, at 2890 Chad Drive, Eugene, Oregon, 97401-9336. Sale will be by sealed bid only. All sealed bids must be received by the BLM's Eugene District Office at 2890 Chad Drive, Eugene, Oregon, 97401-9336, (mailing address: P.O. Box 10226, Eugene, Oregon 97440) prior to 10:00 a.m. on October 20, 2005. Bid envelopes must be marked on the lower left front corner either, “Sale Parcel I (OR 55523)” or “Sale Parcel II (OR 60928)”. Bids must be for not less than the appraised market value for each parcel specified in this Notice. Each sealed bid shall be accompanied by a certified check, postal money order, bank draft, or cashier's check made payable to the “Department of the Interior, BLM” for not less that 10 percent of the amount bid.
Under modified competitive sale procedures, the written sealed bids will be opened and an apparent high bid will be declared at the sale. The apparent high bidder and the other designated bidders will be notified by mail. In case of a tie of bids submitted by interested designated bidders, the interested designated bidders would be given an opportunity to submit a written agreement as to the division of lands, or an additional sealed bid, meeting the above-stated requirements, within 30 days written notification of eligibility. At that time, the high bidder would be awarded the property. The total purchase price for the land shall be paid within 180 days of the date of this sale.
If either or both of the parcels are not sold on October 20, 2005, the parcel will be re-offered on a continuing basis in accordance with the competitive sale procedures described in 43 CFR 2711.3-1. Sealed bids prepared and submitted in the manner described above, will be accepted from any qualified bidder. Bids will be opened at 10 a.m. (local time), on the 14th day of each month thereafter, through December 14, 2005, unless an apparent high bid is declared prior to that date.
Federal law requires that public land may be sold only to either (1) citizens of the United States, 18 years of age or over; (2) corporations subject to the laws of any State or of the United States; (3) a State, State instrumentality or political subdivision authorized to hold property; (4) an entity legally capable of conveying and holding lands or interests therein under the laws of the State within which the lands to be conveyed are located. Certifications and evidence to this effect will be required of the purchaser prior to issuance of a patent.
The following rights, reservations, and conditions will be included in the patent conveying the land:
1. A right-of-way for ditches and canals will be reserved to the United States under the authority of the Act of August 30, 1890 (26 Stat. 291; 43 U.S.C. 945).
2. The patent will include a notice and indemnification statement under the Comprehensive Environmental Response, Compensation and Liability Act. All parcels are subject to the requirements of section 120(h)(42 U.S.C. section 9620) holding the United States harmless from any release of hazardous materials that may have occurred as a result of the unauthorized use of the property by other parties. No warranty of any kind, express or implied, is given by the United States as to the title, physical condition or potential uses of the parcel of land proposed for sale.
3. The patent will be issued subject to all valid existing rights and reservations of record.
A successful bid for the parcel will constitute an application for conveyance of the mineral estate in accordance with Section 209 of the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1719). A nonrefundable fee of $50.00 will be required from the prospective purchaser for purchase of the mineral interests. Those mineral interests, to be conveyed simultaneously with the sale of the land, have been determined to have no known mineral value.
In accordance with the goals in BLM Manual 2801.62A.1. and 2801.62B., the purchaser, if it is not Douglas L. Gross, at closing, will be required to grant an easement to Douglas L. Gross, for an existing driveway and utility line, which crosses Parcel I (OR 55523).
The land described herein is hereby segregated from appropriation under the public land laws, including the mining laws, pending disposition of the action or 270 days from the date of publication of this notice, whichever occurs first.
Detailed information concerning this land sale, including the reservations, sale procedures and conditions, appraisal, planning and environmental documents, and mineral report, is available for review at the Eugene District Office, Bureau of Land Management, 2890 Chad Drive, Eugene, Oregon, 97401-9336.
Objections will be reviewed by the Eugene District Manager, who may sustain, vacate, or modify this realty action. In the absence of any objections, this proposal will become the final determination of the Department of the Interior.
Comments, including names, street addresses, and other contact information of respondents, will be available for public review. Individual respondents may request confidentiality. If you wish to request that BLM consider withholding your name, street address, and other contact information (such as: Internet address, FAX or phone number) from public review or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your comment. The BLM will honor requests for confidentiality on a case-by-case basis to the extent allowed by law. The BLM will make available for public inspection in their entirety all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined that there is no violation of 19 U.S.C. 1337 by Dominant Semiconductors Sdn. Bhd. (“Dominant”) with regard to United States Patent No. 6,576,930 and that the Commission has determined to remand the investigation with respect to certain other patents to the presiding administrative law judge.
Wayne Herrington, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205-3090, or Michelle Walters, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 708-5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation based on a complaint filed by Osram GmbH and Osram Opto Semiconductors GmbH, both of Germany (collectively, “Osram”). 69 FR 32609 (June 10, 2004). In the complaint, as supplemented and amended, Osram alleged violations of section 337 of the Tariff Act of 1930 in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain light-emitting diodes and products containing the same by reason of infringement of various claims of United States Patent Nos. 6,066,861, 6,277,301, 6,613,247, 6,245,259, 6,592,780 (collectively, the “Particle Size Patents”), United States Patent No. 6,576,930 (the “ ‘930 patent”), United States Patent Nos. 6,376,902, 6,469,321, 6,573,580 (collectively, the “Lead Frame Patents”), and United States Patent No. 6,716,673 (the “ ‘673 patent”).
On May 10, 2005, the presiding administrative law judge (“ALJ”) issued his final initial determination (“ID”) finding the sole remaining respondent Dominant in violation of section 337, but only with respect to the ‘673 patent. The ALJ concluded that the asserted claims of the Particle Size Patents are invalid for indefiniteness, that the ‘930 patent and the Lead Frame Patents are not infringed by Dominant's accused products, and that Osram does not meet the technical prong of the domestic industry requirement with respect to the ‘930 patent.
On June 24, 2005, the Commission determined to review the ALJ's findings and conclusions regarding the Particle Size Patents, the ‘930 patent, and the Lead Frame Patents. 70 FR 37431 (June 29, 2005). The Commission declined to review the ALJ's determination of violation of section 337 with respect to the ‘673 patent.
Having examined the record of this investigation, including the ALJ's final ID and the submissions of the parties, the Commission has (1) determined that the Particle Size Patents are not invalid for indefiniteness with respect to the phrase “mean grain diameter d
Further, the Commission has determined to deny Osram's motion to admit the prosecution history of United States Application No. 10/616,783 into the record. The Commission, however, has determined to grant Dominant's motion for extension of time to submit its Response of Respondent Dominant Semiconductors Sdn. Bhd. to the Notice of Commission Determination to Review a Final Determination on Violation of Section 337.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in section 210.45 of the Commission's Rules of Practice and Procedure (19 CFR 210.45).
By order of the Commission.
The Foreign Claims Settlement Commission, pursuant to its regulations (45 CFR part 405) and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of meetings for the transaction of Commission business and other matters specified, as follows:
All meetings are held at the Foreign claims Settlement Commission, 600 E Street, NW., Washington, DC. Requests for information, or advance notices of intention to observe an open meeting, may be directed to: Administrative Officer, Foreign Claims Settlement Commission, 600 E Street, NW., Room
Office of Justice Programs (OJP), Justice.
Notice of meeting.
This is an announcement of a meeting of the Global Justice Information Sharing Initiative (Global) Federal Advisory Committee (GAC) to discuss the Global Initiative, as described at
The meeting will take place on Thursday, October 20, 2005, from 9 a.m. to 3 p.m. e.t.
The meeting will take place at the Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway, Arlington, VA 22202; phone: (703) 486-1111.
J. Patrick McCreary, Global Designated Federal Employee (DFE), Bureau of Justice Assistance, Office of Justice Programs, 810 7th Street, Washington, DC 20531; phone: (202) 616-0532 (note: this is not a toll-free number); e-mail:
This meeting is open to the public. Due to security measures, however, members of the public who wish to attend this meeting must register with J. Patrick McCreary at the above address at least seven (7) days in advance of the meeting. Registrations will be accepted on a space available basis. Access to the meeting will not be allowed without registration. All attendees will be required to sign in at the meeting registration desk. Please bring photo identification and allow extra time prior to the meeting.
Anyone requiring special accommodations should notify J. Patrick McCreary at least seven (7) days in advance of the meeting.
The GAC will act as the focal point to explore and recommend policies regarding national justice information sharing issues in support of the Administration's justice priorities.
The GAC will support the development of justice information sharing concepts. It will advise the Attorney General, and the President (through the Attorney General); and local, state, tribal, and federal policymakers in the executive, legislative, and judicial branches. The GAC will also promote strategies for accomplishing justice information sharing capabilities.
Interested persons whose registrations have been accepted may be permitted to participate in the discussions at the discretion of the meeting chairman and with approval of the DFE.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed revision of the “Local Area Unemployment Statistics (LAUS) Program.” A copy of the proposed information collection request (ICR) can be obtained by contacting the individual listed below in the Addresses section of this notice.
Written comments must be submitted to the office listed in the Addresses section below on or before October 17, 2005.
Send comments to Amy A. Hobby, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue, NE., Washington, DC 20212, telephone number 202-691-7628 (This is not a toll free number.)
Amy A. Hobby, BLS Clearance Officer, telephone number 202-691-7628. (See Addresses section.)
The BLS has been charged by Congress (29 U.S.C. Section 1 and 2) with the responsibility of collecting and publishing monthly information on employment, the average wage received, and the hours worked by area and industry. The process for developing residency-based employment and unemployment estimates is a cooperative Federal-State program which uses employment and unemployment inputs available in State Workforce Agencies.
The labor force estimates developed and issued in this program are used for economic analysis and as a tool in the implementation of Federal economic policy in such areas as employment and economic development under the Workforce Investment Act and the Public Works and Economic Development Act, among others.
The estimates also are used in economic analysis by public agencies and private industry, and for State and area funding allocations and eligibility determinations according to legal and administrative requirements. Implementation of current policy and legislative authorities could not be accomplished without collection of the data.
The reports and manual covered by this request are integral parts of the LAUS program insofar as they insure and/or measure the timeliness, quality, consistency, and adherence to program directions of the LAUS estimates and related research.
The BLS is revising the information collection request that makes up the LAUS program. All aspects of the program are automated. All data are entered directly into BLS-provided systems.
The BLS, as part of its responsibility to develop concepts and methods by which States prepare estimates under the LAUS program, developed a manual for use by the States. The manual explains the conceptual framework for the State and area estimates of employment and unemployment, specifies the procedures to be used,
The increase in the number of responses from the last collection is due to the increase in the number of areas covered by the program.
The Bureau of Labor Statistics is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they also will become a matter of public record.
The U.S. Nuclear Regulatory Commission (the Commission, NRC) is considering issuance of an amendment to Facility Operating License No. NFP-6, issued to Entergy Operations Incorporated (the licensee), for operation of Arkansas Nuclear One Unit 2 (ANO-2), located in Pope county.
The proposed amendment would define spent fuel loading restrictions for the Holtec International HI-STORM 100 Cask System Multi-Purpose Canister (MPC)-32. The licensee will be removing spent fuel from the spent fuel pool and placing it in dry storage as early as September 2005. This activity will restore the full-core offload capability at ANO-2.
The licensee believed that the calculation that considered the requirements of 10 CFR 50.68 for loading/unloading an MPC-32 met the criteria of 10 CFR 50.59 and 10 CFR 50.36, and did not require NRC review and approval. However, based on Regulatory Information Summary (RIS) 2005-05, “Regulatory Issues Regarding Criticality Analyses for Spent Fuel Pools and Independent Spent Fuel Storage Installations,” the licensee submitted a pre-application letter to the NRC outlining the plans to submit a non-exigent technical specification (TS) change and justification for continued operations without prior NRC approval based on guidance contained in Administrative Letter 98-10, “Dispositioning of Technical Specifications that are Insufficient to Assure Plant Safety,” and Generic Letter 91-18, “Information to Licensees Regarding Two NRC Inspection Manual Sections on Resolution of Degraded and Nonconforming Conditions and on Operabiltiy.” In a teleconference between the licensee and the NRC staff held on July 19, 2005, the NRC stated that it did not believe ANO-2 was in compliance with 10 CFR 50.68 and, therefore, the proposed change required NRC approval prior to proceeding with cask loading activities.
Before issuance of the proposed license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act) and the Commission's regulations.
Pursuant to 10 CFR 50.91(a)(6) for amendments to be granted under exigent circumstances, the NRC staff must determine that the amendment request involves no significant hazards consideration. Under the Commission's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The fuel handling accidents described below can be postulated to increase reactivity. However, for these accident conditions, the double contingency principle of ANS N16.1-1975 is applied. This states that it is unnecessary to assume two unlikely, independent, concurrent events to ensure protection against a criticality accident. Thus, for accident conditions, the presence of soluble boron in the SFP [spent fuel pool] water can be assumed as a realistic initial condition since its absence would be a second unlikely event.
Loading/unloading a storage cask in the SFP does not affect the previously evaluated fuel handling accidents (
The cask configuration for the storage cask (MPC-32) is sufficiently similar to spent fuel racks in the SFP as to not induce new or different spent fuel assembly damage in the unlikely event of the occurrence of a fuel handling accident during storage cask loading/unloading activities. The fuel handling accident includes four drop scenarios (fuel drop horizontally on a cask, fuel drop on a fuel assembly, fuel drop next to a cask, and a fuel drop on the cask basket). The same equipment and procedural controls for controlling fuel within the SFP are utilized when loading/unloading a storage
Loading/unloading a storage cask will have no impact on the boron dilution event probability. The same controls for prohibiting a dilution event during spent fuel movement activities in the SFP are in use when loading/unloading fuel in a cask located in the cask pit.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The storage casks have the same basic design and control of a SFP rack. The cask cell walls are thicker than the SFP rack walls; the outside wall on the cask is thicker than the SFP racks and the space for mishandling is tighter than around the racks. When the cask loading pit gate is open and the Technical Specifications are applicable, the pit is in direct communications with the spent fuel pool. Boron concentrations and decay heat removal for fuel in the cask loading pit is controlled in the same manner as it is for fuel in the spent fuel pool proper.
An accident analysis for the MPC-32 was performed assuming the same SFP rack accidents that are discussed in the ANO-2 SAR [safety analysis report]. The ANO-2 TS boron concentration assures that a subcritical margin is maintained during any postulated accident condition (
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The ANO-2 TSs require for criticality concerns in the SFP that k
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
The Commission is seeking public comments on this proposed determination. Any comments received within 14 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of the 14-day notice period. However, should circumstances change during the notice period, such that failure to act in a timely way would result, for example, in derating or shutdown of the facility, the Commission may issue the license amendment before the expiration of the 14-day notice period, provided that its final determination is that the amendment involves no significant hazards consideration. The final determination will consider all public and State comments received. Should the Commission take this action, it will publish in the
Written comments may be submitted by mail to the Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and should cite the publication date and page number of this
The filing of requests for hearing and petitions for leave to intervene is discussed below.
Within 60 days after the date of publication of this notice, the licensee may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings and Issuance of Orders” in 10 CFR Part 2. Interested persons should consult a current copy of 10 CFR 2.309, which is available at the Commission's PDR, located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also identify the specific contentions which the petitioner/requestor seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner/requestor shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner/requestor must also provide references to those specific sources and documents of which the petitioner/requestor is aware and on which the petitioner/requestor intends to rely to establish those facts or expert opinion. The petitioner/requestor must provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner/requestor to relief. A petitioner/requestor who fails to satisfy these
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing.
If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment.
Nontimely requests and/or petitions and contentions will not be entertained absent a determination by the Commission or the presiding officer of the Atomic Safety and Licensing Board that the petition, request and/or the contentions should be granted based on a balancing of the factors specified in 10 CFR 2.309(c)(1)(i)-(viii).
A request for a hearing or a petition for leave to intervene must be filed by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; (2) courier, express mail, and expedited delivery services: Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff; (3) E-mail addressed to the Office of the Secretary, U.S. Nuclear Regulatory Commission,
For further details with respect to this action, see the application for amendment dated July 21, 2005, which is available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the ADAMS Public Electronic Reading Room on the Internet at the NRC Web site
For the Nuclear Regulatory Commission.
The U.S. Nuclear Regulatory Commission (the Commission) is considering issuance of amendments to Facility Operating License Nos. DPR-24 and DPR-27 issued to Nuclear Management Company, LLC (the licensee), for operation of the Point Beach Nuclear Plant (PBNP), Units 1 and 2, located in the Town of Two Creeks, Manitowoc County, Wisconsin.
The proposed amendments would revise the licensing basis as described in the Point Beach Nuclear Plant Final Safety Analysis Report to incorporate the proposed Unit 1 reactor vessel head (RVH) drop analysis and the revised Unit 2 RVH drop analysis.
Before issuance of the proposed license amendments, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act), and the Commission's regulations.
The Commission has made a proposed determination that the amendment requests involve no significant hazards consideration. Under the Commission's regulations in title 10 of the Code Of Federal Regulations (10 CFR), section 50.92, this means that operation of the facility in accordance with the proposed amendments would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:
1. Would the proposed amendment involve a significant increase in the probability or consequences of any accident previously evaluated?
Response: No.
The proposed change incorporates the revised heavy load analysis into the PBNP FSAR. This analysis involves the postulated drop of the RVH [reactor vessel head] over a reactor vessel containing fuel assemblies. Assuming that the BMI [bottom mounted instrument] tubes are severed as a result of displacement of the reactor vessel, a decrease in reactor coolant inventory will occur. Thus, a RVH drop can be postulated as an initiator of a Loss of Coolant Accident (LOCA) under shutdown conditions.
A RVH drop is of sufficiently low probability such that, for Unit 1, the probability of a LOCA is not significantly increased over the current licensing basis large break LOCA. For Unit 2, the probability is unchanged from the previously approved RVH drop analysis.
For Unit 1, supplemental administrative controls have been established to assure continued availability of multiple independent sources of water to provide core cooling and makeup water well in excess of the postulated LOCA. Containment closure will also be established during this evolution. No pressurization of the reactor coolant system will occur as a result of this postulated event. For Unit 2, the previously approved administrative controls have been revised, consistent with those submitted for Unit 1 herein, to provide additional makeup water capacity.
The calculated radiological consequences of the postulated RVH drop are within those calculated for the current licensing basis large break LOCA. Therefore, the consequences of a LOCA are not increased. The proposed change is consistent with safety analysis assumptions and resultant consequences. All Technical Specifications are satisfied and required equipment is operable. Therefore, this change would not
2. Would the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
For Unit 1, the proposed change incorporates the revised heavy load analysis into the PBNP FSAR. This analysis involves the postulated drop of the RVH over a reactor vessel containing fuel assemblies. Assuming that the BMI tubes are severed as a result of displacement of the reactor vessel, a decrease in reactor coolant inventory will occur. Thus, a RVH drop can be postulated as an initiator of a LOCA under shutdown conditions.
Adequate core cooling and makeup water remains available from core cooling water systems. Maintaining core cooling and makeup and closing containment assures that the drop of a RVH is bounded by the existing licensing basis analysis for a LOCA. The drop of a RVH was previously evaluated by the NRC for Unit 2 in a safety evaluation dated June 24, 2005. Therefore, the proposed changes would not create the possibility of a new or different kind of accident from any previously evaluated.
3. Would the proposed amendment result in a significant reduction in a margin of safety?
Response: No.
For Unit 1, the proposed change incorporates the revised heavy load analysis into the PBNP FSAR. This analysis involves the postulated drop of the RVH over a reactor vessel containing fuel assemblies. Assuming that the BMI tubes are severed as a result of displacement of the reactor vessel, a decrease in reactor coolant inventory will occur. Thus, a RVH drop can be postulated as an initiator of a LOCA under shutdown conditions.
The frequency and consequences of a RVH drop are comparable to or within those of the current licensing basis large break LOCA. The proposed change does not alter any safety limits, limiting safety system settings, or limiting conditions for operation as defined in the Technical Specifications. The drop of a RVH was previously evaluated by the NRC for Unit 2 in a safety evaluation dated June 24, 2005. Therefore, the proposed amendment does not result in a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendments until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendments before expiration of the 60-day period provided that its final determination is that the amendments involve no significant hazards consideration. In addition, the Commission may issue the amendments prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Written comments may be submitted by mail to the Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and should cite the publication date and page number of this
The filing of requests for hearing and petitions for leave to intervene is discussed below.
Within 60 days after the date of publication of this notice, the licensee may file a request for a hearing with respect to issuance of the amendments to the subject facility operating license and any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309, which is available at the Commission's PDR, located at One White Flint North, Public File Area O1F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also identify the specific contentions which the petitioner/requestor seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner/requestor shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner/requestor must also provide references to those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner/requestor who fails to satisfy
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing.
If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment.
Nontimely requests and/or petitions and contentions will not be entertained absent a determination by the Commission or the presiding officer of the Atomic Safety and Licensing Board that the petition, request and/or the contentions should be granted based on a balancing of the factors specified in 10 CFR 2.309(c)(1)(i)-(viii).
A request for a hearing or a petition for leave to intervene must be filed by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; (2) courier, express mail, and expedited delivery services: Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff; (3) E-mail addressed to the Office of the Secretary, U.S. Nuclear Regulatory Commission,
For further details with respect to this action, see the application for amendments dated July 24, 2005, which is available for public inspection at the Commission's PDR, located at One White Flint North, File Public Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Weeks of August 15, 22, 29, and September 5, 12, 19, 2005.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and closed.
This meeting will be Web cast live at the Web address—
There are no meetings scheduled for the week of August 22, 2005.
There are no meetings scheduled for the week of August 29, 2005.
There are no meetings scheduled for the week of September 12, 2005.
There are no meetings scheduled for the week of September 19, 2005. *The schedule for Commission meetings is subject to change on short notice. To verify the status of meetings call (recording)—(301) 415-1292. Contact person for more information: Michelle Schroll, (301) 415-1662.
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
This notice is distributed by mail to several hundred subscribers; if you no longer wish to receive it, or would like to be added to the distribution, please contact the Office of the Secretary, Washington, DC 20555 (301-415-1969). In addition, distribution of this meeting notice over the Internet system is available. If you are interested in receiving this Commission meeting schedule electronically, please send an electronic message to
Pursuant to section 189a. (2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (the Commission or NRC staff) is publishing this regular biweekly notice. The Act requires the Commission publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This biweekly notice includes all notices of amendments issued, or proposed to be issued from July 22, 2005, to August 4, 2005. The last biweekly notice was published on August 2, 2005 (70 FR 44400).
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below.
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination. Within 60 days after the date of publication of this notice, the licensee may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request for a hearing and a petition for leave to intervene.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Written comments may be submitted by mail to the Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and should cite the publication date and page number of this
Within 60 days after the date of publication of this notice, the licensee may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309, which is available at the Commission's PDR, located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the petitioner/requestor seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner/requestor shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner/requestor intends to rely in proving the contention at the hearing. The petitioner/requestor must also provide references to those specific sources and documents of which the petitioner is aware and on which the petitioner/requestor intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing.
If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment.
A request for a hearing or a petition for leave to intervene must be filed by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; (2) courier, express mail, and expedited delivery services: Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff; (3) E-mail addressed to the Office of the Secretary, U.S. Nuclear Regulatory Commission,
Nontimely requests and/or petitions and contentions will not be entertained absent a determination by the Commission or the presiding officer of the Atomic Safety and Licensing Board that the petition, request and/or the contentions should be granted based on a balancing of the factors specified in 10 CFR 2.309(a)(1)(I)-(viii).
For further details with respect to this action, see the application for amendment which is available for public inspection at the Commission's PDR, located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the ADAMS Public Electronic Reading Room on the Internet at the NRC Web site,
1. Does not involve a significant increase in the probability or consequences of an accident previously evaluated.
The proposed change revises Surveillance Requirement [SR] 3.6.1.6.2 to require performance of functional testing of each suppression chamber-to-drywell vacuum breaker every 92 days, within 12 hours after any discharge of steam to the suppression chamber from the safety/relief valves, and within 12 hours following an operation that causes any of the vacuum breakers to open.
The proposed change does not involve physical changes to any plant structure, system, or component. The suppression chamber-to-drywell vacuum breakers only provide an accident mitigation function. As such, the probability of occurrence for a previously analyzed accident is not impacted by the change to the surveillance frequency for these components. The consequences of a previously analyzed accident are dependent on the initial conditions assumed for the analysis, the behavior of the fuel during the analyzed accident, the availability of successful functioning of the equipment assumed to operate in response to the analyzed event, and the setpoints at which these actions are initiated. No physical change to suppression chamber-to-drywell vacuum breakers is being made as a result of the proposed change, nor does the change alter the manner in which the vacuum breakers operate. As a result, no new failure modes of the suppression chamber-to-drywell vacuum breakers are being introduced. The proposed quarterly surveillance frequency for the suppression chamber-to-drywell vacuum breakers is consistent with the American Society of Mechanical Engineers (ASME) Code frequency for testing these valves, will avoid unnecessary cycling and wear of the vacuum breakers, and will improve the reliability of the vacuum breakers. Based on this evaluation, there is no significant increase in the consequences of a previously analyzed event.
Therefore, the proposed change to the surveillance frequency for the suppression chamber-to-drywell vacuum breakers does not involve a significant increase in the probability or consequences of an accident previously analyzed.
2. Does not create the possibility of a new or different type of accident from any accident previously evaluated.
The proposed change to the surveillance frequency for the suppression chamber-to-drywell vacuum breakers does not involve any physical alteration of plant systems, structures, or components. No new or different equipment is being installed. No installed equipment is being operated in a different manner. There is no alteration to the parameters within which the plant is normally operated or in the setpoints that initiate protective or mitigative actions. As a result no new failure modes are being introduced. Therefore, the proposed change to the surveillance frequency for the suppression chamber-to-drywell vacuum breakers does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does not involve a significant reduction in the margin of safety.
The proposed change revises SR 3.6.1.6.2 to require performance of functional testing of each vacuum breaker every 92 days, within 12 hours after any discharge of the steam to the suppression chamber from the safety/relief valves, and within 12 hours following an operation that causes any of the vacuum breakers to open. The operability and functional characteristics of the suppression chamber-to-drywell vacuum breakers remains unchanged. The margin of safety is established through the design of the plant structures, systems, and components, through the parameters within which the plant is operated, through the establishment
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. The proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
The increase in the allowed secondary containment bypass leakage limit in SR 3.6.1.3.11 and the increase in the total Main Steam Isolation Valve (MSIV) leakage rate limit have been evaluated in a revision to the analysis of the Loss of Coolant Accident (LOCA). Based on the results of the analysis, it has been demonstrated that, with the requested change, the dose consequences of this limiting Design Basis Accident (DBA) are within the regulatory guidance provided by the NRC [Nuclear Regulatory Commission] for use with the AST [alternative source term]. This guidance is presented in 10 CFR 50.67, Regulatory Guide 1.183, ”Alternative Radiological Source Terms For Evaluating Design Basis Accidents At Nuclear Power Reactors,” and Standard Review Plan (SRP) Section 15.0.1. The proposed change also updates the design basis value for the Control Room Envelope (CRE) unfiltered inleakage based on actual test results. This is acceptable because the assumed value in the analysis is more than three times the worst case test value. The proposed change does not affect the normal design or operation of the facility before the accident; rather, it affects leakage limit assumptions that constitute inputs to the evaluation of the consequences. The radiological consequences of the analyzed LOCA have been evaluated using the plant licensing basis for this accident. The results conclude that the control room and offsite doses remain within applicable regulatory limits. Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. The proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
The change in leakage limits does not affect the design, functional performance or normal operation of the facility. Similarly, it does not affect the design or operation of any component in the facility such that new equipment failure modes are created. As such the proposed change will not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. The proposed change does not involve a significant reduction in the margin of safety.
This proposed license amendment involves changes in leakage rate limits for the secondary containment bypass leakage and MSIV leakage. The revised leakage rate limits are used in the LOCA radiological analysis in conjunction with the revised CRE unfiltered inleakage limit. The analysis has been performed using conservative methodologies. Safety margins and analytical conservatisms have been evaluated and have been found acceptable. The analyzed LOCA event has been carefully selected and margin has been retained to ensure that the analysis adequately bounds postulated event scenario. The dose consequences of this limiting event are within the acceptance criteria presented in 10 CFR 50.67, Regulatory Guide 1.183 and SRP Section 15.0.1. The margin of safety is that provided by meeting the applicable regulatory limits. The effect of the revision to the Technical Specification requirements has been analyzed and doses resulting from the pertinent design basis accident have been found to remain within the regulatory limits. The change continues to ensure that the doses at the exclusion area and low population zone boundaries, as well as the control room, are within the corresponding regulatory limits. Therefore, the proposed change will not involve a significant reduction in a margin of safety.
The NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
This change was proposed by the industry's Technical Specification Task Force (TSTF) and is designated TSTF-372, Revision 4. The NRC staff issued a notice of opportunity for comment in the
Criterion 1—The Proposed Change Does Not Involve a Significant Increase in the Probability or Consequences of an Accident Previously Evaluated.
The proposed change allows a delay time for entering a supported system TS when the
Criterion 2—The Proposed Change Does Not Create the Possibility of a New or Different Kind of Accident from any Previously Evaluated.
The proposed change does not involve a physical alteration of the plant (no new or different type of equipment will be installed). Allowing delay times for entering supported system TS when inoperability is due solely to inoperable snubbers, if risk is assessed and managed, will not introduce new failure modes or effects and will not, in the absence of other unrelated failures, lead to an accident whose consequences exceed the consequences of accidents previously evaluated. The addition of a requirement to assess and manage the risk introduced by this change will further minimize possible concerns. Thus, this change does not create the possibility of a new or different kind of accident from an accident previously evaluated.
Criterion 3—The Proposed Change Does Not Involve a Significant Reduction in a Margin of Safety.
The proposed change allows a delay time for entering a supported system TS when the inoperability is due solely to an inoperable snubber, if risk is assessed and managed. The postulated seismic event requiring snubbers is a low-probability occurrence and the overall TS system safety function would still be available for the vast majority of anticipated challenges. The risk impact of the proposed TS changes was assessed following the three-tiered approach recommended in Regulatory Guide 1.177. A bounding risk assessment was performed to justify the proposed TS changes. The proposed LCO 3.0.8 defines limitations on the use of the provision and includes a requirement for the licensee to assess and manage the risk associated with operation with an inoperable snubber. The net change to the margin of safety is insignificant. Therefore, this change does not involve a significant reduction in a margin of safety.
The NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
This change was proposed by the industry's Technical Specification Task Force (TSTF) and is designated TSTF-359. The NRC staff issued a notice of opportunity for comment in the
Criterion 1—The Proposed Change Does Not Involve a Significant Increase in the Probability or Consequences of an Accident Previously Evaluated.
The proposed change allows entry into a mode or other specified condition in the applicability of a TS, while in a TS condition statement and the associated required actions of the TS. Being in a TS condition and the associated required actions is not an initiator of any accident previously evaluated. Therefore, the probability of an accident previously evaluated is not significantly increased. The consequences of an accident while relying on required actions as allowed by proposed LCO 3.0.4, are no different than the consequences of an accident while entering and relying on the required actions while starting in a condition of applicability of the TS. Therefore, the consequences of an accident previously evaluated are not significantly affected by this change. The addition of a requirement to assess and manage the risk introduced by this change will further minimize possible concerns. Therefore, this change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
Criterion 2—The Proposed Change Does Not Create the Possibility of a New or Different Kind of Accident from any Previously Evaluated.
The proposed change does not involve a physical alteration of the plant (no new or different type of equipment will be installed). Entering into a mode or other specified condition in the applicability of a TS, while in a TS condition statement and the associated required actions of the TS, will not introduce new failure modes or effects and will not, in the absence of other unrelated failures, lead to an accident whose consequences exceed the consequences of accidents previously evaluated. The addition of a requirement to assess and manage the risk introduced by this change will further minimize possible concerns. Thus, this change does not create the possibility of a new or different kind of accident from an accident previously evaluated.
Criterion 3—The Proposed Change Does Not Involve a Significant Reduction in a Margin of Safety.
The proposed change allows entry into a mode or other specified condition in the applicability of a TS, while in a TS condition statement and the associated required actions of the TS. The TS allow operation of the plant without the full complement of equipment through the conditions for not meeting the TS LCO. The risk associated with this allowance is managed by the imposition of required actions that must be performed within the prescribed completion times. The net effect of being in a TS condition on the margin of safety is not considered significant. The proposed change does not alter the required actions or completion times of the TS. The proposed change allows TS conditions to be entered, and the associated required actions and completion times to be used in new circumstances. This use is predicated upon the licensee's performance of a risk assessment and the management of plant risk. The change also eliminates current allowances for utilizing required actions and completion times in similar circumstances, without assessing and managing risk. The net change to the margin of safety is insignificant. Therefore, this change does not involve a significant reduction in a margin of safety.
The NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No. This proposed change deletes an administrative requirement for NRC approval of an engineering evaluation to resolve a non-conforming and degraded condition that is required by NRC Generic Letter 91-18 (GL), Rev. 1, “Information to Licensees Regarding NRC Inspection Manual Section on Resolution of Degraded and Nonconforming Conditions”. The SRVs will be maintained operable, inspected, and tested to perform their safety function as required by the current Specifications and any SRV non-conforming or degraded condition will be addressed in accordance with GL 91-18. The proposed change also deletes a Note regarding installed two-stage Target Rock SRVs. The deletion of an administrative requirement and the Note does not change the plant response to the design basis accident and does not increase the probability of inadvertent SRV operation. Therefore, the proposed change does not significantly increase the probability or consequences of any previously evaluated accidents.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No. The safety function of the SRVs is to provide over-pressure protection of the primary coolant pressure boundary and also for the automatic functions to rapidly depressurize the primary system to a pressure at which low-pressure cooling systems can provide makeup. The proposed change deletes an administrative requirement and a Note related to installed two-stage Target Rock SRVs, and does not introduce any new modes of equipment operation or failure. Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No. The ability of the SRVs to perform their safety function is maintained during operation and will continue to be tested as required in accordance with TS 3/4.13, Inservice Code Testing. The proposed change deletes an administrative requirement that is adequately addressed by following GL 91-18, Rev. 1. Deletion of an administrative requirement does not reduce the margin of safety. Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No. This proposed change deletes the requirement to exercise the MSIV's twice per week at power. The MSIVs will continue to be full stroke tested by the Inservice Testing Program. The MSIVs will continue to be able to perform their accident mitigation function. The plant response to the design basis accident will not change and the probability of inadvertent MSIV closure will not be increased. Therefore, the proposed change does not significantly increase the probability or consequences of any previously evaluated accidents.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No. The safety function of the MSIVs is to isolate the main steam lines in case of design basis accidents to limit the loss of reactor coolant and/or limit the release of radioactive materials. The proposed change does not introduce any new modes of equipment operation or failure. Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No. The ability of the MSIVs to perform their safety function is tested during the MSIV full stroke fast closure test in accordance with TS 3.13, Inservice Testing Program. The proposed change deletes a high-risk surveillance. Deletion of the high-risk surveillance does not reduce the margin of safety. Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Add a NRC previously approved Siemans Power Corporation (SPC) topical report reference for determination of fuel assembly critical power for previously loaded Global Nuclear Fuel (GNNF) GE14 fuel which will be co-resident with reloaded Framatome ANP ATRIUM-10 fuel.
2. Add a NRC previously approved Framatome Advanced Nuclear Power, Inc. (FRA-ANP) topical report reference for an uprated methodology for evaluation of loss coolant accident (LOCA) conditions.
The proposed changes are the result of a redesign to untilize Framatome ANP ATRIUM-10 fuel during the Unit 1 Refueling Outage 11 currently scheduled for February 2006.
Criterion 1—Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed changes will add two additional NRC approved topical report references to the list of administratively controlled analytical methods in Technical Specification (TS) 5.6.5, “Core Operating Limits Report (COLR),” that can be used to determine core operating limits. TS 5.6.5 lists NRC approved analytical methods used at LaSalle County Station (LSCS) to determine core operating limits.
LSCS Unit 1 is scheduled to reload Framatome ANP ATRIUM-10 fuel during the Unit 1 Refueling Outage 11currently scheduled for February 2006. The proposed changes to TS Section 5.6.5 will add FRA-ANP methodologies to determine overall core operating limits for future core configurations. This change will require the listing of additional analytical methods for evaluating LOCA conditions and determining the critical power performance of the GE14 fuel. Thus, the proposed changes will allow LSCS to use the most recent FRA-ANP LOCA methodology for evaluation of ATRIUM-10 fuel and SPC critical power correlations to determine the critical power for the GE14 fuel.
The addition of approved methods to TS Section 5.6.5 has no effect on any accident initiator or precursor previously evaluated and does not change the manner in which the core is operated. The methods have been reviewed to ensure that the output accurately models predicted core behavior, have no effect on the type or amount of radiation released, and have no effect on predicted offsite doses in the event of an accident. Additionally the methods do not change any key core parameters that influence any accident consequences. Thus, the proposed changes do not have any effect on the probability of an accident previously evaluated.
The methodology conservatively establishes acceptable core operating limits such that the consequences of previously analyzed events are not significantly increased.
The proposed changes in the administratively controlled analytical methods do not affect the ability of LSCS to successfully respond to previously evaluated accidents and does not affect radiological assumptions used in the evaluations. Thus, the radiological consequences of any accident previously evaluated are not increased.
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
Criterion 2—Does the proposed change create the possibility of a new or different kind of accident from any previously evaluated?
Response: No.
The proposed changes involve TS 5.6.5 do not affect the performance of any LSCS structure, system, or component credited with mitigating any accident previously evaluated. The insertion of fuel, which has been analyzed with NRC approved methodologies, will not affect the control parameters governing unit operation or the response of plant equipment to transient conditions. The proposed changes do not introduce any new modes of system operation or failure mechanism.
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any previously evaluated.
Criterion 3—Do the proposed changes involve a significant reduction in the margin of safety.
Response: No.
The proposed changes will add two additional references to the list of administratively controlled analytical methods in TS 5.6.5 that can be used to determine core operating limits. The proposed changes do not modify the safety limits or setpoints at which protective actions are initiated and do not change the requirements governing operation or availability of safety equipment assumed to operate to preserve the margin of safety. Therefore, LSCS has determined that the proposed changes provide an equivalent level of protection as that currently provided.
Therefore, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the requested amendments involve no significant hazards consideration.
Plant-specific stability calculations are now required as part of the resolution to several generic issues associated with OPRM operability. One of the outcomes from this resolution was a change in the OPRM enabled region of the power to flow map. The thermal power level for enabling the OPRMs for Cycle 10 became > 27.2 percent rated thermal power. Since the current TS SR requirement is > 28.6 percent, the new TS SR thermal power level value is considered a non-conservative TS. The Perry Nuclear Power Plant (PNPP) is currently requiring the OPRMs to be enabled at ≥ 23.8 percent thermal power level through administrative controls. These controls will remain in place until such time that this license amendment is approved (reference NRC Administrative Letter 98-10, “Dispositioning of Technical Specifications That Are Insufficient to Assure Plant Safety,” dated December 12, 1998).
1. The proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
The proposed change involves the use of a revised thermal power level to establish the OPRM enabled region. The OPRM enabled region is that area on the power to flow map where the OPRM System is activated to detect and suppress potential instability events. If reactor operations result in entrance into this region and a core instability is detected, the OPRM System will automatically initiate a reactor scram. The revised enabled region provides assurance that the requirements of 10CFR50, Appendix A, General Design Criteria 10 and 12 remain satisfied for current and future core designs. Though the initiation of instability events are dependent upon thermal power levels and core flows, the revision to the enabled region thermal power level value does not increase the possibility of such an event. Once the OPRMs are enabled, the OPRM System would still mitigate an instability event, if detected. The revised enabled region does not impact any OPRM detection or mitigation actions for instability events.
The OPRMs are designed to detect and suppress potential instability events. As such, the OPRMs are not credited to provide any type of detection or mitigation actions for transients or accidents described within the PNPP Updated Final Safety Analysis Report (USAR) other than instability events. Hence, revising the OPRMs enabled region will not impact the transients or accidents described within the PNPP Updated Safety Analysis Report (USAR) other than instability events.
Since the OPRMs will be enabled at a thermal power lower than analytically required, the potential for additional scrams exists. However, since the possibility of an instability event occurring in the range between the revised thermal power level and the analytical value is remote, the probability of an additional scram from occurring is not significantly increased.
Therefore, since no significant changes are being made to the plant or its design, the probability or the consequences of an accident have not increased over those previously evaluated.
2. The proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
The proposed change involves the use of a revised thermal power level to establish the OPRM enabled region. The use of a revised thermal power level to establish the OPRM enabled region does not involve a physical modification to any plant system or component, including the fuel. The revised enabled region provides assurance that the requirements of 10CFR50, Appendix A, General Design Criteria 10 and 12 remain satisfied for current and future core designs. Though the initiation of instability events are dependent upon thermal power levels and core flows, the revision to the enabled region thermal power level value does not increase the possibility of such an event, or introduce any new or different events. Once the OPRMs are enabled, the OPRM System detects and mitigates an instability event if detected. The revised enabled region does not impact any mitigation actions.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. The proposed change does not involve a significant reduction in a margin of safety.
The proposed change involves the use of a revised thermal power level to establish the OPRM enabled region. Once the OPRMs are enabled, the OPRM System mitigates an instability event if detected. The revised enabled region does not impact any mitigation actions. The use of a revised thermal power level to establish the OPRM enabled region does not involve a physical modification to any plant system or component, including the fuel. The revised enabled region provides assurance that the requirements of 10CFR50, Appendix A, General Design Criteria 10 and 12 remain satisfied for current and future core designs. The revised enabled region restores the margin of protection provided by the OPRMs, which had been reduced as fuel and core designs have evolved since 1994. Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
This change was proposed by the industry's Technical Specification Task Force (TSTF) and is designated TSTF-359. The NRC staff issued a notice of opportunity for comment in the
Criterion 1—The Proposed Change Does Not Involve a Significant Increase in the Probability or Consequences of an Accident Previously Evaluated.
The proposed change allows entry into a mode or other specified condition in the applicability of a TS, while in a TS condition statement and the associated required actions of the TS. Being in a TS condition and the associated required actions is not an initiator of any accident previously evaluated. Therefore, the probability of an accident previously evaluated is not significantly increased. The consequences of an accident while relying on required actions as allowed by proposed LCO 3.0.4, are no different than the consequences of an accident while entering and relying on the required actions while starting in a condition of applicability of the TS. Therefore, the consequences of an accident previously evaluated are not significantly affected by this change. The addition of a requirement to assess and manage the risk introduced by this change will further minimize possible concerns. Therefore, this change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
Criterion 2—The Proposed Change Does Not Create the Possibility of a New or Different Kind of Accident from any Previously Evaluated.
The proposed change does not involve a physical alteration of the plant (no new or different type of equipment will be installed). Entering into a mode or other specified condition in the applicability of a TS, while in a TS condition statement and the associated required actions of the TS, will not introduce new failure modes or effects and will not, in the absence of other unrelated failures, lead to an accident whose consequences exceed the consequences of accidents previously evaluated. The addition of a requirement to assess and manage the risk introduced by this change will further minimize possible concerns. Thus, this change does not create the possibility of a new or different kind of accident from an accident previously evaluated.
Criterion 3—The Proposed Change Does Not Involve a Significant Reduction in a Margin of Safety.
The proposed change allows entry into a mode or other specified condition in the applicability of a TS, while in a TS condition statement and the associated required actions of the TS. The TS allow operation of the plant without the full complement of equipment through the conditions for not meeting the TS LCO. The risk associated with this allowance is managed by the imposition of required actions that must be performed within the prescribed completion times. The net effect of being in a TS condition on the margin of safety is not considered significant. The proposed change does not alter the required actions or completion times of the TS. The proposed change allows TS conditions to be entered, and the associated required actions and completion times to be used in new circumstances. This use is predicated upon the licensee's performance of a risk assessment and the management of plant risk. The change also eliminates current allowances for utilizing required actions and completion times in similar circumstances, without assessing and managing risk. The net change to the margin of safety is insignificant. Therefore, this change does not involve a significant reduction in a margin of safety.
The NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. The probability of occurrence or the consequences of an accident previously evaluated are not significantly increased.
Neither the code/CHF correlation pair nor the Statistical DNBR Evaluation Methodology make any contribution to the potential accident initiators and thus cannot increase the probability of any accident. Further, since both the deterministic and statistical DNBR limits meet the required design basis of avoiding DNB with 95% probability at a 95% confidence level, the use of the new code/correlation and Statistical DNBR Evaluation Methodology do not increase the potential consequences of any accident. Finally the addition of a full core DNB design limit provides increased assurance that the consequences of a postulated accident which included radioactive release would be minimized because the overall number of rods in DNB would not exceed the 0.1% level. All the pertinent evaluations to be performed as part of the cycle specific reload safety analysis to confirm that the existing safety analyses remain applicable have been performed with VIPRE-D/BWU and found to be acceptable. The use of a different code/correlation pair will not increase the probability of an accident because plant systems will not be operated in a different manner, and system interfaces will not change. The use of the VIPRE-D/BWU code/correlation pair will not result in a measurable impact on normal operating plant releases, and will not increase the predicted radiological consequences of accidents postulated in the UFSAR [Updated Final Safety Analysis Report]. Therefore, neither the probability of occurrence nor the consequences of any accident previously evaluated is significantly increased.
2. The possibility for a new or different type of accident from any accident previously evaluated is not created.
The use of VIPRE-D/BWU and its applicable fuel design limits for DNBR does not impact any of the applicable design criteria and all pertinent licensing basis criteria will continue to be met. Demonstrated adherence to these standards and criteria precludes new challenges to components and systems that could introduce a new type of accident. Setpoint safety analysis evaluations have demonstrated that the use of VIPRE-D/BWU is acceptable. All design and performance criteria will continue to be met and no new single failure mechanisms will be created. The use of VIPRE-D/BWU code/correlation or the Statistical DNBR Evaluation Methodology does not involve any alteration to plant equipment or procedures that would introduce any new or unique operational modes or accident precursors. Therefore, the possibility for a new or different kind of accident from any accident previously evaluated is not created.
3. The margin of safety is not significantly reduced. North Anna Technical Specification 2.1 specifies that any DNBR limit Established by any used code/correlation must provide at least 95% non-DNB probability at a 95% confidence level. The use of VIPRE-D/BWU with the SDLs [Statistical Design Limits] listed in this package provides that protection, just as LYNXT/BWU [LYNXT thermal-hydraulic computer code with the AREVA BWU CHF correlations] and applicable SDLs did. The required DNBR margin of safety for the North Anna Nuclear units, which in this case is the margin between the 95/95 DNBR limit and clad failure, is therefore not reduced. Therefore, the margin of safety as defined in the Bases to the North Anna Units 1 and 2 Technical Specifications is not significantly reduced.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Do changes involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed changes do not significantly increase the probability or consequences of an accident previously evaluated in the UFSAR [Updated Final Safety Analysis Report]. The proposed changes correct errors in the unit designations used in the f
2. Do changes create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed changes do not create the possibility of a new or different kind of accident from any accident already evaluated in the UFSAR. The proposed changes correct errors in the unit designations used in the f
3. Do changes involve a significant reduction in the margin of safety?
The proposed changes do not involve a significant reduction in a margin of safety. The proposed changes correct errors in the unit designations used in the f
The NRC staff has reviewed the licensee's analysis and, based on this
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.
Notice of Consideration of Issuance of Amendment to Facility Operating License, Proposed No Significant Hazards Consideration Determination, and Opportunity for a Hearing in connection with these actions was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.12(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items are available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management Systems (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated July 29, 2005.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated July 25, 2005.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated July 28, 2005.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated August 1, 2005.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated July 27, 2005.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated July 25, 2005.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated July 26, 2005.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated August 4, 2005.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated July 18, 2005.
The Commission's related evaluation of the amendment, state consultation, and final NSHC determination are contained in a safety evaluation dated July 28, 2005.
For the Nuclear Regulatory Commission.
Office of Personnel Management.
Notice.
The President adjusted the rates of basic pay and locality payments for certain categories of Federal employees effective in January 2005. This notice documents those pay adjustments for the public record.
Carey Johnston, Center for Pay and Performance Policy, Division for Strategic Human Resources Policy, Office of Personnel Management; (202) 606-2858; FAX (202) 606-0824; or e-mail to
On December 30, 2004, the President signed Executive Order 13368 (70 FR 1147, January 5, 2005), which implemented the January 2005 pay adjustment. The President made these adjustments consistent with Public Law 108-447, December 8, 2004, which authorized an overall average pay increase of 3.5 percent for General Schedule (GS) employees.
Schedule 1 of Executive Order 13368 provides the rates for the 2005 General Schedule and reflects a 2.5 percent across-the-board increase. Executive Order 13368 also includes the percentage amounts of the 2005 locality payments. (
The publication of this notice satisfies the requirement in section 5(b) of Executive Order 13368 that the Office of Personnel Management (OPM) publish appropriate notice of the 2005 locality payments in the
GS employees receive locality payments under 5 U.S.C. 5304. Locality payments apply in the 48 contiguous States and the District of Columbia. In 2005, locality payments ranging from 11.72 percent to 26.39 percent apply to GS employees in 32 locality pay areas. These 2005 locality pay percentages, which replaced the locality pay percentages that were applicable in 2004, became effective on the first day of the first pay period beginning on or after January 1, 2005. An employee's locality-adjusted annual rate of pay is computed by increasing his or her scheduled annual rate of basic pay (as defined in 5 U.S.C. 5302(8) and 5 CFR 531.602) by the applicable locality pay percentage. (
Executive Order 13368 establishes the new Executive Schedule, which incorporates the 2.5 percent increase required under 5 U.S.C. 5318 (rounded to the nearest $100). By law, Executive Schedule officials are not authorized to receive locality payments.
Executive Order 13368 establishes the range of rates of basic pay for senior executives in the Senior Executive Service (SES), as established pursuant to 5 U.S.C. 5382. The minimum rate of basic pay for the SES may not be less than the minimum rate payable under 5 U.S.C. 5376 for senior-level positions ($107,550 in 2005), and the maximum rate of basic pay may not exceed the rate for level III of the Executive Schedule ($149,200 in 2005). The maximum rate of the SES rate range will increase to level II of the Executive Schedule ($162,100 in 2005) for SES members covered by performance appraisal systems that are certified under 5 U.S.C. 5307(d) as making meaningful distinctions based on relative performance. By law, SES members are not authorized to receive locality payments. Agencies with certified performance appraisal systems in 2005 for senior executives and/or senior-level (SL) and scientific or professional (ST) positions must also apply a higher aggregate limitation on pay—up to the Vice President's salary ($208,100 in 2005).
The Executive order adjusted the rates of basic pay for administrative law judges (ALJs) by 2.5 percent (rounded to the nearest $100). The maximum rate of basic pay for ALJs is set by law at the rate for level IV of the Executive Schedule, which is now $140,300. (
The rates of basic pay for members of Contract Appeals Boards are calculated as a percentage of the rate for level IV of the Executive Schedule. (
On December 13, 2004, the President's Pay Agent extended the 2005 locality-based comparability payments to certain categories of non-GS employees. The Governmentwide categories include employees in SL/ST positions, ALJs, and Contract Appeals Board members. The maximum locality rate of pay for these employees is the rate for level III of the Executive Schedule ($149,200 in 2005).
OPM published “Salary Tables for 2005” (OPM Doc. 124-48-6) in June 2005. This publication provides complete salary tables incorporating the 2005 pay adjustments, information on general pay administration matters, locality pay area definitions, Internal Revenue Service withholding tables, and other related information. The rates of pay shown in this publication are the official rates of pay for affected employees and are hereby incorporated as part of this notice. You may purchase copies of “Salary Tables for 2005” from the Government Printing Office (GPO) by calling (202) 512-1800 (outside the DC area: 1-866-512-1800) or FAX (202) 512-2250. You may order copies directly from GPO on the Internet at
On July 7, 2005, MS Structured Asset Corp., a Delaware corporation (“Issuer”), filed an application with the Securities and Exchange Commission (“Commission”), pursuant to Section 12(d) of the Securities Exchange Act of 1934 (“Act”)
The Board of Directors (“Board”) of the Issuer approved resolutions on July 1, 2005, to withdraw the Security from listing and registration on NYSE. The Issuer stated that the following reasons factored into the Board's decision to withdraw the Security from NYSE. First, 100% of the assets of the trust in which the Security evidences an undivided beneficial interest are debentures issued by Sears Roebuck Acceptance Corp. (“SRAC”). Second, on June 2, 2005, the Commission issued an order approving the application of SRCA to voluntarily delist its debt securities listed on NYSE.
The Issuer stated that the Security was issued in a particular type of asset-backed securities (“ABS”) transaction known as a “repackaging”, in which the ABS constitute pass through interests in debt of an unrelated third party (“SRAC”). The SATURNS Trust 2003-1 (“Trust”) has no assets other than SRAC debentures that were purchased in the secondary market. The Issuer has no relationship to the issuer of the underlying debentures (SRAC) and has no ability to make substantive disclosure about SRAC for purposes of the Trust reporting obligation in relation to the Security. Instead, the Issuer's Security reporting obligation in relation to the Security have referred holders of the Security to publicly available reports and financial statements in relation to SRAC that were filed by SRAC. Because SRAC has ceased its reporting, there are no longer any publicly available reports about SRAC to which holders of the Security can be referred. Since it is essentially impossible for the Issuer to provide such materials because the Issuer has no right to receive such materials from SRAC, the documents governing the Security provide that the Trust should terminate following a termination of public reporting by the SRAC. The Issuer and the Trustee for the Trust have entered into an agreement which amended the documents governing the Security to allow, as an alternative, that the NYSE listing of the Security can be withdrawn and the Issuer can terminate its reporting obligations in relation to the Security. Holders of the Security who would prefer to have the previous termination terms of the Trust apply in relation to their Security are being given a right to opt out of the amendment.
The Issuer stated in its application that it has complied with NYSE's rules governing an issuer's voluntary withdrawal of a security from listing and registration by complying with all applicable laws in effect in the State of Delaware, and by providing NYSE with the required documents governing the removal of securities from listing and registration on NYSE.
The Issuer's application relates solely to the withdrawal of the Security from listing on the NYSE and from registration under Section 12(b) of the Act,
Any interested person may, on or before September 2, 2005, comment on the facts bearing upon whether the application has been made in accordance with the rules of NYSE, and what terms, if any, should be imposed by the Commission for the protection of investors. All comment letters may be submitted by either of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, Station Place, 100 F Street, NE., Washington, DC 20549-9303.
All submissions should refer to File Number 1-16443. This file number should be included on the subject line if e-mail is used. To help us process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
The Commission, based on the information submitted to it, will issue an order granting the application after the date mentioned above, unless the Commission determines to order a hearing on the matter.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Pub. L. 94-409, that the Securities and Exchange Commission will hold the following meeting during the week of August 15, 2005:
A Closed Meeting will be held on Wednesday, August 17, 2005 at 10 a.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters may also be present.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (9)(B), and (10) and 17 CFR 200.402(a) (3), (5), (6), (7), 9(ii) and (10) permit consideration of the scheduled matters at the Closed Meeting.
Commissioner Glassman, as duty officer, voted to consider the items listed for the closed meeting in closed session and that no earlier notice thereof was possible.
The subject matters of the Closed Meeting scheduled for Wednesday, August 17, 2005, will be:
Formal orders of investigations;
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings of an enforcement nature; and an
Adjudicatory matter.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact:
The Office of the Secretary at (202) 551-5400.
Notice is hereby given that the following filing(s) has/have been made with the Commission under provisions of the Act and rules promulgated under the Act. All interested persons are referred to the application(s) and/or declaration(s) for complete statements of the proposed transaction(s) summarized below. The application(s) and/or declaration(s) and any amendment(s) is/are available for public inspection through the Commission's Branch of Public Reference.
Interested persons wishing to comment or request a hearing on the application(s) and/or declaration(s) should submit their views in writing by September 6, 2005, to the Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-9303, and serve a copy on the relevant applicant(s) and/or declarant(s) at the address(es) specified below. Proof of service (by affidavit or, in the case of an attorney at law, by certificate) should be filed with the request. Any request for hearing should identify specifically the issues of facts or law that are disputed. A person who so requests will be notified of any hearing, if ordered, and will receive a copy of any notice or order issued in the matter. After September 6, 2005, the application(s) and/or declaration(s), as filed or as amended, may be granted and/or permitted to become effective.
Gulf Power Company (“Gulf Power”), One Energy Place, Pensacola, Florida, 32520, a wholly-owned utility subsidiary of The Southern Company (“Southern”), a registered holding company, has filed an amendment to its original declaration/application (“Amended Declaration”) under sections 6(a), 7, and 12(c) of the Act and rules 42, 53 and 54 under the Act.
By order dated June 27, 2003 (Holding Company Act Release No. 27690) (“Original Order”) Gulf Power was authorized to issue up to $450 million principal amount of senior debentures, senior promissory notes or other senior debt instruments, first mortgage bonds and preferred stock (“Senior Security Limitation”) through March 31, 2006 (“Authorization Period”).
Gulf Power proposes that each issuance of preference stock, with par or stated value of up to $100 per share (“Preference Stock”), will be sold for the best price obtainable (after giving effect to the purchasers' compensation) but for a price to Gulf Power (before giving effect to the purchasers' compensation) of not less than 98% of the par or stated value per share.
The terms of each series of Preference Stock will be established by amendment to Gulf Power's Articles of Incorporation. Each series may have a cumulative sinking fund which would retire a certain number of shares of the series annually, commencing at a specified date after the sale. In connection with the sinking fund, Gulf Power may have the non-cumulative option of redeeming up to an additional like number of shares of the series annually.
Gulf Power may determine that, in light of the current market conditions at the time any series of the Preference Stock is offered, it is in the best interest of Gulf Power and its investors and consumers that the terms of the Preference Stock provide for an adjustable dividend rate to be determined on a periodic basis, rather than a fixed rate dividend. In that event, Gulf Power proposes that the rate of dividends on the Preference Stock for an initial period would be a fixed amount or rate per annum. Periodically thereafter, the rate would be adjusted by periodic auction or remarketing procedures, or in accordance with a formula or formulae based upon certain reference rates, or by other predetermined methods.
Gulf Power states that except as modified below, the transaction described in the Amended Declaration will be subject to the parameters applicable to the transactions listed in the Original Order.
At all times during the Authorization Period, Gulf Power represents that it will maintain a common equity ratio of at least thirty percent of its consolidated capitalization (common equity, preferred stock, preference stock and long-term and short-term debt) as reflected in its most recent Form 10-K or Form 10-Q filed with the Commission adjusted to reflect changes in capitalization since the balance sheet date, unless otherwise authorized. With respect to the securities issuance authority proposed in the Amended Declaration: (1) Within four business days after the occurrence of a Ratings Event, Gulf Power will notify the Commission of its occurrence (by means of a letter, via fax, email or overnight mail to the Office of Public Utility Regulation) and (2) within 30 days after the occurrence of a Ratings Event, Gulf Power will submit a post-effective amendment to the Amended Declaration explaining the material facts and circumstances relating to that Ratings Event (including the basis on which taking into account the interests of investors, consumers and the public as well as other applicable criteria under the Act, it remains appropriate for Gulf Power to issue the securities for which authorization is sought in the Amended Declaration, so long as Gulf Power continues to comply with the other applicable terms and conditions specified in the Commission's order authorizing the transactions requested in the Amended Declaration). Furthermore, no securities authorized as a result of the Amended Declaration will be issued following the 60th day after a Ratings Event if any downgraded rating has not been upgraded to investment grade. Gulf Power also requests that the Commission reserve jurisdiction through the remainder of the Authorization Period over the issuance of any authorized securities pursuant to the Amended Declaration that are prohibited from being issued after the 60th day following a Ratings Event, if no revised rating reflecting an investment grade rating has been issued.
A “Ratings Event” will be deemed to have occurred if, during the Authorization Period (1) any outstanding security of Gulf Power that is rated is downgraded below investment grade; (2) any security to be issued by Gulf Power pursuant to the authorization sought in the Amended Declaration upon original issuance is rated below investment grade; or (3) any outstanding security of Southern that is rated is downgraded below investment grade. For purposes of this provision, a security will be deemed to be rated “investment grade” if it is rated investment grade by at least one
The effective cost of money on the Preference Stock will not exceed competitive market rates available at the time of issuance for securities having the same or reasonably similar terms and conditions issued by similar companies of reasonably comparative credit quality.
The proceeds from the sales of any series of Preference Stock may be used to redeem or otherwise retire Gulf Power's outstanding debt or preferred and preference stock if considered advisable. In addition proceeds may be used to pay a portion of its cash requirements to carry on its electric utility business.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
On May 16, 2005, the Chicago Board Options Exchange, Incorporated (“CBOE” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change was published for comment in the
The Commission finds that the proposed rule change, as amended, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The MSRB has filed with the SEC a proposed rule change consisting of an amendment to Rule G-37(c), concerning solicitation and coordination of payments to political parties, and Q&A guidance on supervisory procedures related to Rule G-37(d), on indirect violations. The text of the proposed rule change is available on the MSRB's Web site (
In its filing with the Commission, the MSRB included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The MSRB has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Rule G-37(c) prohibits a dealer and its municipal finance professionals (“MFPs”) from soliciting any person or political action committee (“PAC”) to make or coordinate contributions to an official of an issuer with which the dealer is engaging or is seeking to engage in municipal securities business. The proposed amendments would also prohibit the dealer and certain MFPs
The proposed Q&A guidance provides that, in order to ensure compliance with Rule G-27(c) as it relates to payments to political parties or PACs and Rule G-37(d), each dealer must adopt, maintain and enforce written supervisory procedures reasonably designed to ensure that neither the dealer nor its MFPs are using payments to political parties and non-dealer controlled PACs to contribute indirectly to an official of an issuer.
The Qs&As seek to provide dealers with more guidance as they develop procedures to ensure compliance with both the language and the spirit of Rule G-37. The Qs&As emphasize the necessity for adequate supervisory procedures to ensure compliance with Rule G-37(d) not only with respect to payments to political parties, but also with respect to contributions to and disbursements by dealer-affiliated (but not controlled) PACs. The Board reminds dealers that a failure to implement satisfactory written procedures to ensure compliance with Rule G-37(d) could subject the dealer to enforcement actions by the appropriate regulatory authorities.
The MSRB believes that the proposed rule change is consistent with Section 15B(b)(2)(C) of the Act,
The MSRB believes that the proposed rule change is consistent with the Act because it will help inhibit practices that create the appearance of attempting to influence the awarding of municipal securities business through an indirect violation of Rule G-37. The MSRB also believes that the Q&A guidance will facilitate dealer compliance with Rule G-27, on supervision, and Rule G-37(d)'s prohibitions on indirect rule violations.
The MSRB does not believe that the proposed rule change will result in any burden on competition not necessary or appropriate in furtherance of the purposes of the Act since it would apply equally to all dealers.
On February 15, 2005 the MSRB published for industry comment draft amendments to Rule G-37(c), concerning solicitation and coordination of payments to political parties, and draft Q&A guidance on supervisory procedures related to Rule G-37(d), on indirect violations (the “Notice”).
Of the seven commentators, one commentator, American Municipal, supports the adoption of the amendments to Rule G-37 and the proposed Qs&As because they will strengthen the effectiveness of the rule in preventing improper political contributions.
The remaining five commentators express support for the MSRB's efforts to eliminate any vestiges of pay-to-play in the municipal securities industry, whether they are in the form of a direct or indirect contribution to an issuer official. However, ABASA, BMA
Current Rule G-37(c) operates as an absolute prohibition on soliciting contributions for an official of an issuer with which the dealer is engaging or seeking to engage in municipal securities business and is not symmetrical with Rule G-37(b) because there is no
The MSRB determined that allowing dealers or certain MFPs to solicit other persons to make political party or PAC payments in states and localities where they are engaging or seeking to engage in municipal securities business creates at least the appearance of attempting to influence the awarding of municipal securities business through such payments. Moreover, without the proposed prohibition, it would be very difficult for enforcement agencies to detect such potential indirect violations because the parties solicited do not have to disclose the payments. Additionally, the arguably stricter prohibition can be justified because a violation of Rule G-37(c) does not result in an automatic ban on business.
By voicing a concern that dealers who make such payments to parties or PACs
Moreover, the proposed Qs&As do not broaden the sphere of activity that is prohibited by Rule G-37. A violation of Rule G-37(d) still will only occur when the payment is made to other entities “as a means to circumvent the rule.” Rule G-37(d), which prohibits anyone from “directly or indirectly, through or by any other person or means” doing what sections (b) and (c) prohibit has previously been challenged on the grounds that it is unconstitutionally vague. The United States Court of Appeals in
The commentators also object to the suggestion that dealers make inquiries to essentially “follow the money” to reasonably ensure that the party or PAC is not supporting one or a limited number of issuer officials (the “activity test”) on the grounds that it is unclear. BMA asserts that the language is unclear because it could mean one of two things: (1) If the party or PAC that receives the contribution supports even one issuer official, then an indirect ban is triggered; or (2) the dealer must determine that the party's or PAC's expenditures on issuer officials constitute a large enough portion of its total expenditures such that an indirect ban is triggered. BMA and UBS ask the MSRB to revise its guidance to suggest a test based on objective criteria. UBS suggests that this objective criteria include a “dilution standard” that would need to include at least the following elements: (1) A threshold—50%, 60% or 70%—of a party's or PAC's expenditures used for non-issuer purposes that would be sufficient to overcome a presumption that the committee supported one or a limited number of issuer officials, and (2) a time period over which the party committee or PAC would be required to examine when calculating the threshold percentage.
With regard to the “activity test” comments, the MSRB's existing Q&A guidance on this issue already states that dealers that make contributions to organizations such as political parties or PACs (as well as dealers that allow MFPs to make such payments) have a duty to make inquiries of such organizations in order to ascertain how the contributed funds will be used.
However, the MSRB has determined to revise the guidance and remove some of the specific due diligence suggestions to focus on reminding dealers that each dealer is required under Rule G-27, on supervision, to evaluate its own circumstances and develop written supervisory procedures reasonably designed to ensure that the conduct of the municipal securities activities of the dealer and its associated persons are in compliance with Rule G-37(d), on indirect violations. After evaluating its own circumstances, a dealer could determine that adequate supervisory procedures would include some of the commentators' suggested due diligence procedures.
In 1995, the MSRB filed and the SEC approved amendments to Rule G-37's disclosure requirements to require dealers to record and report all
In addition, in August 2003, when the MSRB published a notice on indirect rule violations of Rule G-37, the MSRB referenced the 1995 SEC Approval Order and specifically stated that, “The party payment disclosure requirements were intended to assist in severing any connection between payments to political parties (
The BMA states that, while the proposed Qs&As suggest that a broker-dealer establish an informational barrier between it and its affiliated PAC, the MSRB does not clarify what it means by the term “affiliated PAC.” The BMA also states that the MSRB should clarify “affiliated PAC” to mean a PAC that is controlled by a wholly owned affiliate of the broker-dealer.
Within 35 days of the date of publication of this notice in the
A. By order approve such proposed rule change, or
B. Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
All submissions should refer to File Number SR-MSRB-2005-12. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
On March 12, 2004, the National Association of Securities Dealers, Inc. (“NASD”) filed with the Securities and Exchange Commission (“Commission”), pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Commission received one comment letter on the proposed rule change.
•
The commenter stated that certain member firms' systems are not able to execute agency crosses if the order resides with the market maker, but the systems are able to proprietarily buy from the market seller and allocate to the market buyer at the same price (
Second, the commenter expressed concern that flickering quotes would create significant compliance and technological challenges for member firms because the rule requires member firms to cross marketable limit orders even if such limit orders were marketable only for a brief period of time.
•
The commenter stated that NASD should specifically exclude certain types of market orders from the rule's protection.
•
The commenter suggested that the proposed rule change should only apply to orders executed on Nasdaq or in the over-the-counter (“OTC”) market because the New York Stock Exchange already has a similar rule.
•
The commenter stated that the proposed rule change should allow firms to more fully utilize information barriers to segregate non-market making desks from other customer order flows.
In response to the comments, the NASD amended the filing.
Regarding the commenter's concern that the proposal would require a member to cross a marketable limit order even if that limit order were marketable only for a brief period of time due to flickering quotes, NASD responded that because the proposal would require the matching of both marketable and non-marketable limit orders that would meet the requirements of the pending market order, the changing marketability or non-marketability of a particular limit order as a result of flickering quotes is not an issue. The NASD recognized that flickering quotes may increase the difficulty in determining the appropriate price of a market order, but such quotes would not dictate whether a particular marketable or non-marketable limit order should be crossed pursuant to the proposed rule.
In response to the commenter's suggestion that certain order types should be excluded from the rule's protection, NASD clarified how NASD Rule 2111 would apply to the order types mentioned. First, regarding “not held” orders, NASD stated that for orders for which a customer has granted the member discretion with respect to time or price, those orders would not be considered market orders for the purposes of the rule. Second, regarding orders where the customer specifically asks that the order be handled on an agency basis, the NASD stated that, with regard to those orders where no other regulation limits or prohibits a principal transaction, the rule would apply. Third, with respect to orders for accounts where the member is bound by another regulation limiting or prohibiting principal transactions with customer orders, NASD noted that, consistent with prior interpretations of Manning, the obligation to execute a trade with a customer following a separate proprietary trade on the same side of the market does not apply if the orders subject to the restrictions are sent to another broker-dealer for execution; the obligations under NASD Rule 2111 apply, however, if such orders are not routed elsewhere for execution. NASD reiterated that these interpretations do not change a member's best execution obligations under NASD Rule 2320.
Concerning the commenter's argument that the proposal should apply only to orders executed on Nasdaq or in the OTC market, NASD stated that the proposal is based on a member's obligations relating to just and equitable principles of trade with respect to the treatment of customer market orders, and therefore NASD believes that the proposed rule should apply to customer market orders regardless of where the orders are ultimately executed.
In response to the commenter's suggestion that the proposal should allow firms to more fully utilize information barriers to segregate non-market making desks from other customer order flows, NASD stated that it has issued guidance in connection with Manning concerning the extent to which a trading desk other than the firm's market-making desk could trade for its own account while the market-making desk held protected customer limit orders on its books.
The Commission has reviewed carefully the proposed rule change, the comment letter, and NASD's response, and finds that the proposed rule change, as amended, is consistent with the requirements of the Act and rules and regulations thereunder applicable to a national securities association
Regarding the commenter's concerns that so long as a customer's market orders are executed at the proper price under the rule, the proposed rule change should not mandate that the orders be crossed, the NASD amended NASD Rule 2111(c) to allow for members to execute a customer order as a riskless principal to satisfy the crossing requirement. Regarding the commenter's concern that under the rule a firm must cross a marketable limit order even if the order were only marketable for a brief period of time, the NASD recognized that flickering quotes may increase the difficulty in determining the appropriate price of a market order, but such quotes would not dictate whether a particular marketable or non-marketable limit order should be crossed pursuant to the proposed rule. The Commission believes that the proposed rule change reasonably addresses the manner in which member firms need to execute customer market orders under various market conditions. The requirements of the rule are only triggered if the member fails to execute a market order fully and promptly.
The Commission agrees with the NASD's analysis with respect to whether certain types of market orders should be excluded from the rule. The Commission believes that the proposed rule change allows sufficient flexibility to accommodate those order types by, for example, not considering a “not held” order to be a “market” order for purposes of the proposed rule change.
Concerning the commenter's argument that the rule should only apply to orders executed on Nasdaq or in the OTC market, the Commission agrees with NASD that applying the proposed rule change to NASD members executing customer market orders across all equities markets will help better assure that customer orders receive the protections of the rule, regardless of where the orders ultimately are executed. The commenter did not state that the NASD rule is inconsistent with the NYSE's rule.
In response to the commenter's assertion that the proposed rule change should permit firms to more fully utilize information barriers to segregate non-market making desks from other customer order flows, the Commission believes the NASD's position—that its existing Manning guidance with respect to information barriers will apply to the proposed rule change—adequately addresses the commenter's concern.
The Commission finds good cause to approve Amendment No. 2 before the 30th day after the date of publication of notice of filing in the
Interested persons are invited to submit written data, views, and arguments concerning Amendment No. 2, including whether Amendment No. 2 is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-9303.
All submissions should refer to File Number SR-NASD-2004-045. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange, through its wholly owned subsidiary PCXE, proposes to trade shares of the following exchange traded funds (“ETFs”) based on three Vanguard International Equity Indices pursuant to unlisted trading privileges (“UTP”) based on PCXE Rule 5.5(j)(3):
• Morgan Stanley Capital International Inc. (“MSCI”) Europe Index (ticker symbol: VGK)
• MSCI Pacific Index (ticker symbol: VPL); and
• MSCI Emerging Markets Select Index (ticker symbol: VWO).
The text of the proposed rule change is available from the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item III below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to trade, pursuant to UTP, Vanguard Index Participation Equity Receipts, which are securities issued by the three funds (“VIPER Shares”). The MSCI Europe Index and the MSCI Pacific Index are market-capitalization-weighted indices that are designed to measure developed market equity performance in Europe and the Pacific region, respectively. Each MSCI country index is created separately and then aggregated, without change, into the larger regional index. The MSCI Europe Index is comprised of securities from 16 of 50 countries for which MSCI has indices.
The Exchange deems these VIPER Shares to be equity securities, thus rendering trading in these securities subject to the Exchange's existing rules governing the trading of equity securities. PCX will trade these ETFs during the hours that the Intraday Indicative Value (“IIV”) is disseminated.
The Exchange understands that the listing exchange, Amex, will disseminate the following information for each ETF on a daily basis through the facilities of the Consolidated Tape Association (“CTA”): Recent net asset value (“NAV”), shares outstanding, and estimated cash amount and total cash amount per creation unit. In addition, the Exchange understands that Amex will make the following information available on its Web site: Daily trading volume, closing price, NAV, and final dividend amounts to be paid for each VIPER Share. The closing prices of the deposit securities are readily available from, as applicable, the relevant exchanges, automated quotation systems, published or other public sources in the relevant country, or on-line information services such as Bloomberg or Reuters. The exchange rate information required to convert such information into U.S. dollars is also readily available in newspapers and other publications and from a variety of on-line services.
To provide updated information relating to each ETF for use by investors, professionals, and persons wishing to create or redeem the VIPER Shares, Amex disseminates through the facilities of the CTA: (1) continuously throughout the trading day, last sale information for each ETF; and (2) every 15 seconds throughout the trading a day, the estimated IIV of each ETF as calculated by a third party.
The IIV may not reflect the value of all securities included in the applicable underlying index. In addition, the IIV does not necessarily reflect the precise composition of each index at a particular point in time. Therefore, the IIV on a per-share basis disseminated during Amex's regular trading hours should not be viewed as a real-time
For the MSCI Pacific Index, there is no overlap in trading hours between the foreign markets and Amex. Therefore, for this fund, the IIV utilizes closing prices (in applicable foreign currency prices) in the principal foreign market for securities in the fund portfolio, and converts the price to U.S. dollars. Those values are updated every 15 seconds during Amex trading hours to reflect changes in exchange rates between the U.S. dollar and the applicable foreign currency.
The MSCI Europe Index and Emerging Markets Select Index, both of which include companies trading in markets with trading hours overlapping regular Amex trading hours, the third-party calculator updates the applicable IIV every 15 seconds to reflect price changes in the principal foreign market and converts such prices into U.S. dollars based on the current exchange rate. When the foreign market or markets are closed but Amex is open for trading, the IIV is updated every 15 seconds to reflect changes in exchange rates after the foreign markets close.
The Exchange represents that, if the MSCI ceases to maintain or to calculate the value of the index on a periodic basis or if the value of the index ceases to be widely available, the Exchange would cease trading these VIPER Shares.
In connection with the trading of these three ETFs, PCX would inform its Equity Trading Permit (“ETP”) Holders in an Information Circular of the special characteristics and risks associated with trading these ETFs, including how the VIPER Shares are created and redeemed, the requirement that ETP Holders deliver a prospectus or product description to investors purchasing any of these ETFs prior to or concurrently with the confirmation of a transaction, applicable Exchange rules, how information about the value of the underlying index is disseminated, trading information, and the applicability of suitability rules. The Information Circular will also discuss any applicable exemptive, no-action, and interpretive relief granted by the Commission.
Before an ETP Holder recommends a transaction in one of the proposed ETFs, the ETP Holder must determine that the ETF is suitable for the customer as set forth in PCXE Rule 9.2(a)-(b).
The Exchange intends to utilize its existing surveillance procedures applicable to derivative products to monitor trading in these ETFs. The Exchange believes that these procedures are adequate to monitor such trading.
The Exchange believes that the proposal is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
Written comments on the proposed rule change were neither solicited nor received.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, as amended, is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, Station Place, 100 F Street, NE., Washington, DC 20549-9303.
All submissions should refer to File Number SR-PCX-2005-74. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site
The Commission finds that the proposed rule change, as amended, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
In addition, the Commission believes that the proposal is consistent with Section 12(f) of the Act,
The Commission further believes that the proposal is consistent with Section 11A(a)(1)(C)(iii) of the Act,
Finally, the Commission notes that, if any of these ETFs should be delisted by Amex, the original listing exchange, PCX would no longer have authority to trade the ETF pursuant to this order.
In support of this proposal, the Exchange has made the following representations:
1. PCX surveillance procedures are adequate to properly monitor the trading of these ETFs on a UTP basis.
2. Prior to the commencement of trading of these ETFs on the Exchange, PCX will distribute an information circular to its members explaining the terms, characteristics, and risks of trading these ETFs.
3. PCX will require an ETP Holder with a customer that purchases shares of any of these ETFs on the Exchange to provide that customer with a product prospectus and will note this prospectus delivery requirement in the information circular.
The Commission finds good cause for approving this proposal before the thirtieth day after the publication of notice thereof in the
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is proposing to amend its Schedule of Fees and Charges (“Schedule”), as follows: (1) implement new initial listing fees specifically for common stock issued in initial public offerings (“IPOs”)
The text of the proposed rule change is available on PCX's Web site,
In its filing with the Commission, PCXE included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in item IV below. PCXE has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to increase certain portions of its listing fees and make a number of related modifications. PCXE has determined that such increases are necessary to help ensure sufficient cost recovery resulting from expenditures for operations, technology and infrastructure incurred in connection with ArcaEx's listings initiative.
(a) Initial Listing Fees. Currently, the one-time initial listing fee for common stock is based on whether the issue is dually listed on the New York Stock Exchange, the American Stock Exchange, or the Nasdaq National Market. If an issue is dually listed, the initial listing fee is fixed at $10,000 per issue; otherwise, the initial listing fee is fixed at $20,000 per issue. The initial listing fee for additional classes of common stock, preferred stock, warrants, debit instruments, purchase rights and units is $2,500, regardless of whether such securities are also listed elsewhere. These fees apply to each issue listed, regardless of shares outstanding or listing tier classification.
PCXE proposes initial listing fees specifically for common stock listed in conjunction with IPOs. For IPOs listed exclusively on Tier I,
The Exchange
For IPOs listed exclusively on Tier II,
For IPOs that dually list, the Exchange proposes an exemption from initial listing fees. The Exchange also proposes an exemption from initial listing fees for Transfer Listings, whether exclusively or dually listed. These exemptions apply regardless of Tier classification or shares outstanding. The Exchange believes these exemptions are appropriate in order for the Exchange to effectively compete for dual listings.
The Exchange proposes to implement these new IPO and Transfer Listing fees for all listing applications submitted on or after April 1, 2005, should the Commission approve the proposed rule change. The current fees will continue to apply to issues already listed or applications that are pending as of March 31, 2005.
(b) Annual Maintenance Fees. Currently, the annual maintenance fees are fixed and based on whether the issue is dually listed on the New York Stock Exchange, American Stock Exchange, or the Nasdaq National Market. For dually listed securities, the maintenance fee is $1,000 per issue; otherwise, the maintenance fee is $2,000 per issue. For each additional issue, the annual maintenance fee is $500. The annual minimum fee is $1,000 and the annual maximum fee is $5,000. Moreover, annual maintenance fees are not incurred in the year of listing; rather, they are payable beginning in the first full calendar year following the year of listing.
The Exchange proposes to adopt specific annual maintenance fees for exclusive IPO listings. For Tier I exclusive IPO listings, PCXE proposes to adopt annual maintenance fees based on the aggregate total shares outstanding, as follows:
For Tier II exclusive IPO listings, PCXE proposes to adopt an annual maintenance fee of $12,500, regardless of shares outstanding. Consistent with current practice, the Exchange will not assess these annual maintenance fees for the year of listing, but rather, will first assess them for the first full calendar year following the year of listing.
For dual IPO and Transfer Listings, the Exchange proposes an exemption from annual maintenance fees for the first 12 calendar months following listing for competitive purposes.
PCXE proposes to implement these revised annual maintenance fees for all listing applications submitted on or after April 1, 2005, should the Commission approve the proposed rule change. For all issues already listed, and listing applications pending, as of March 31, 2005, the current annual maintenance listing fees will continue to apply.
In addition, the Exchange proposes to increase the maximum annual maintenance fee payable by a single issuer for all issues listed from $5,000 to $90,000, in order to be consistent with the fee changes proposed herein. Annual maintenance fees will not be pro-rated or reduced for securities that delist for any reason.
(c) Additional Shares Listing Fee. Currently, the fee applicable to issuers to list additional shares is $.0025 per share listed, with a $500 minimum and a $7,500 maximum per application. The maximum total charge per year is $15,000.
The Exchange proposes to make a number of modifications to the Additional Shares Listing Fee. For all exclusive listings, including exclusive IPO and transfer listings, the Exchange proposes to eliminate the per share fee entirely for the first 99,999 additional shares per application. The Exchange proposes to eliminate the fee on these shares so as not to assess issuers for small additional issuances and also to enhance its ability to effectively compete with other marketplaces.
For all dual listings, the Exchange proposes to eliminate the fee entirely for the first 99,999 additional shares per application in order to effectively compete with other marketplaces. The Exchange also proposes to eliminate the fee on these shares so as not to assess issuers for small additional issuances. For such listings, the $.0025 per share fee will be assessed beginning on each additional share listed above 99,999. The Exchange also proposes to modify the annual maximum charge applicable to such listings to $14,000 so as to provide for an increased limitation for listed issuers that choose to list additional shares, which will result in charges that are beyond the current maximum charges. The minimum and maximum charge per application will remain unchanged. The Exchange further proposes an exemption from such additional share fees for all dual IPO and dual transfer listings for the 12 calendar months after listing. Thereafter, such listings will be subject to the additional shares listing fee as set forth above.
Lastly, for dually listed American Depositary Receipts (“ADRs”) and American Depositary Shares (“ADSs”) only, the Exchange proposes to decrease the maximum additional shares listing charge per year to $10,000 and maintain the minimum charge per application at $500 and the maximum per application charge at $7,500. These fees shall only be assessed on the ADRs and ADSs that are listed. The Exchange's proposed revisions to the additional shares listing fees, as applicable, will apply to all currently listed issuers starting April 1, 2005, should the Commission approve the proposed rule change.
PCXE proposes to implement the revised initial and annual maintenance listings fees, as applicable, for all applications submitted on or after April 1, 2005, should the Commission approve the proposed rule change. For all issues listed, and listing applications pending, as of March 31, 2005, the current initial and annual maintenance listing fees will continue to apply. The Exchange's proposed revisions to the additional shares listing fees will apply going forward to all currently listed issuers starting April 1, 2005, should the Commission approve the proposed rule change.
The Exchange believes that the proposal is consistent with Section 6(b)
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange did not solicit or receive any written comments with respect to the proposed rule change.
Within 35 days of the date of publication of this notice in the
A. By order approve the proposed rule change, or
B. Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, Station Place, 100 F Street, NE., Washington, DC 20549-9303.
All submissions should refer to File Number SR-PCX-2005-19. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
The following Agreements were filed with the Department of Transportation under the sections 412 and 414 of the Federal Aviation Act, as amended (49 U.S.C. 1382 and 1384) and procedures governing proceedings to enforce these provisions. Answers may be filed within 21 days after the filing of the application.
The following Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits were filed under Subpart B (formerly Subpart Q) of the Department of Transportation's Procedural Regulations (
Federal Aviation Administration (FAA), DOT.
Request for public comments.
The FAA is requesting public comment on the City of Beverly, Massachusetts' request to change 10.3 acres of vacant land located in the approach to Runway 34 to industrial use. The land will be sold to an abutter for expansion of a manufacturing building. The land was acquired under FAAP 9-19-026-D603. The disposition
Comments must be received on or before September 15, 2005.
Documents are available for review by appointment by contacting Mr. Robert Mezzetti, Airport Manager at Beverly Municipal Airport, 46 L.P. Hendersen Road, Beverly, Massachusetts 01915, Telephone 978-921-6072 or by contacting Donna R. Witte, Federal Aviation Administration, 16 New England Executive Park, Burlington, Massachusetts, Telephone 781-238-7624.
Donna R. Witte at the Federal Aviation Administration, 12 New England Executive Park, Burlington, Massachusetts 01803. Telephone 781-238-7624.
Section 125 of The Wendell H. Ford Aviation Investment and Reform Act for the 21st Century (AIR 21) requires the FAA to provide an opportunity for public notice and comment to the “waiver” or “modification” of a sponsor's Federal obligation to use certain airport property for aeronautical purposes.
Federal Aviation Administration, DOT.
Notice of intent of waiver with respect to land.
The Federal Aviation Administration (FAA) is giving notice that a portion of the airport property will be exchanged with the Southern Illinois University. A portion of the property to be exchanged (.0254 acre) was originally acquired in fee on July 20, 1948, with partial Federal funding. The remaining property (.7266 acre was acquired by Southern Illinois Airport Authority (SIAA) on August 16, 2001, in a previous exchange with the Southern Illinois University (SIU). This release will be an even exchange of land (.752+/-acre) between SIAA and SIU. The Exhibit ‘A’ Property Line Map (Exhibit 1) and the Airport Layout Plan (Exhibit 2) depicts the exchange.
The University proposes to construct four (4) buildings which will result in the new Transportation Education Center at the airport. The sponsor anticipates greater future opportunities for the airport due to the reputation of the University and its renowned programs. It has been determined that one of the buildings will cause a line-of-site obstruction with the Air Traffic Control Tower if it is built in its proposed location. In order to eliminate the conflict, an even exchange of the property and a different construction location has been proposed.
In accordance with section 47107(h) of title 49, United States Code, this notice is required to be published in the
Comments must be received on or before September 15, 2005.
E. Lindsay Butler, Program Manager, 2300 East Devon Avenue, Des Plaines, IL 60018. Telephone Number 847-294-7723/FAX Number 847-294-7046. Documents reflecting this FAA action may be reviewed at this same location or at the Southern Illinois Airport, Carbondale-Murphysboro, Illinois.
This notice announces that the FAA intends to authorize the exchange of the subject airport property at Southern Illinois Airport, Carbondale-Murphysboro, Illinois. Approval does not constitute a commitment by the FAA to financially assist in exchange of the subject airport property nor a determination that all measures covered by the program are eligible for grant-in-aid funding from the FAA. If appropriate, the disposition of proceeds from the exchange of the airport property will be in accordance with FAA's Policy and Procedures Concerning the Use of Airport Revenue, published in the
Federal Aviation Administration (FAA), DOT.
Amendment to notice published August 3, 2005, page 44716.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted on or before September 15, 2005. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Judy Street on (202) 267-9895.
Send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW., Washington, DC 20503, Attention FAA Desk Officer.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of request for information (RFI).
FMCSA invites comments, suggestions and creative ideas on new operational concepts that will improve commercial vehicle safety inspections through more thorough performance-based inspections. Commercial vehicle roadside safety inspections represent one of the most effective tools for monitoring and regulating the condition of the in-use commercial vehicle fleet, as well as for auditing and enforcing driver and operational-related safety practices, including hours of service, proper driver credentialing, and other safety aspects of commercial vehicle equipment and operations. New technologies such as advanced sensor and on-board diagnostics as well as wireless communications offer the potential for dramatically improving the effectiveness and efficiency of the roadside commercial vehicle safety inspection process. This Request for Information directly supports the Agency's top priority initiative—Comprehensive Safety Analysis 2010, or CSA-2010—which is a top-to-bottom review of how FMCSA can best develop and manage programs that are most effective in improving motor carrier safety.
Send your comments on or before October 17, 2005.
You may submit comments identified by any of the following methods. Please identify your comments by the FMCSA Docket Number FMCSA-2005-22097.
• Web site:
• Fax: (202) 493-2251.
• Mail: U.S. Department of Transportation, Docket Management Facility, 400 Seventh Street, SW., Plaza level, Washington, DC 20590-0001.
• Hand Delivery: Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
• Federal eRulemaking Portal: Go
Jeff Loftus, Federal Motor Carrier Safety Administration, Office of Research and Technology at (202) 385-2363
Statistics show there are 8 million trucks and buses that travel 208 billion miles on our nation's highways each year, and commercial vehicle miles traveled are forecasted to grow approximately 2 percent annually. In addition, truck traffic will increase approximately 25 percent over the next 10 years. Therefore, the need for developing new innovative inspection concepts-of-operation that leverage new technologies, result in more thorough performance-based inspections, and improve cost effectiveness is a high priority for FMCSA.
Commercial vehicle roadside safety inspections, targeted to higher risk carriers (as determined by prior roadside inspection and crash history), and conducted annually by 10,000 roadside safety inspectors, uncover some type of violation related to the vehicle condition, driver credentials, or hours of service in well over 80% of all inspections. In 2004, the approximately 3 million roadside safety inspections resulted in 1 million out-of-service violations and 7.2 million total violations.
FMCSA is attempting to develop feasible operational concepts for partially or fully automating the commercial vehicle inspection process. Greater automation has the potential to improve the quality of inspections, increase the number of vehicles screened and inspected, and/or enable faster inspections, resulting in improved effectiveness, efficiency, and most of all safety
Under the current safety inspection process, vehicle and driver inspections are delineated by different “levels”. The North American Standard Driver/Vehicle Inspection or “Level 1” inspection involves all driver documentation and a complete vehicle inspection. The time taken for a Level 1 inspection is typically about 30-40 minutes, so improving the speed with which inspections are performed would be a benefit to carriers in terms of their operational efficiency.
There are 5 additional inspection levels. A Level 2 inspection, called a “Walkaround Driver/Vehicle Inspection,” is the same as a Level 1, except there is no checking under the vehicle. A Level 3 inspection, called a “Driver Only Inspection,” involves only a review of driver documentation and carrier credentials. A Level 4 inspection, called a “Special Study,” can involve any aspect of the inspection process and is usually done for data-gathering purposes. A Level 5 inspection, called a “Vehicle Only Inspection,” includes only the vehicle portion of a Level 1 inspection (conducted without a driver present). Finally, a Level 6 inspection, called “Enhanced Radioactive Inspection,” is the most comprehensive inspection of all due to the hazardous material in the cargo.
In addition, the Federal Highway Administration's (FHWA) Office of
This project falls under the DOT Intelligent Transportation Systems (ITS) Program. Section 5204(j)(2) of the Transportation Equity Act for the 21st Century, Pub. L. 105-178 (TEA-21), provides that an ITS project involving surveys, questionnaires, or interviews is exempt from the requirements of the Paperwork Reduction Act, Chapter 35 of Title 44 of the U.S. Code. TEA-21 Section 5204(j)(2) states: “Any survey, questionnaire, or interview that the Secretary considers necessary to carry out the evaluation of any test, deployment project, or program assessment activity under this subtitle shall not be subject to chapter 35 of title 44.” 23 U.S.C.A. 502 Note.
The purpose of this effort is to request information on new technology concepts that can help improve the efficiency, effectiveness, and long-term results of performance-based commercial vehicle safety inspections. Information collected will serve as one of many inputs into an exploratory research and technology project looking at various advanced inspection concepts for getting data from the vehicle to the roadside. The project is not directly related to FMCSA's Advance Notice of Proposed Rulemaking titled, “Electronic On-Board Recorders for Hours-of-Service Compliance,” Docket FMCSA-2004-18940, published in the
1. For the existing safety inspection levels (1-6) referred to above, current procedures for conducting these are for the most part “manual”,
2. Considering both vehicle and driver-related inspection items, which systems or parameters might lend themselves to being accurately monitored by on-board sensors? Please comment on all that apply.
3. If some of the items identified in question 2 are NOT currently available in an electronic format on most vehicles (
4. In the future, if on-board technology could be used to monitor vehicle and driver status and electronically maintain driver history, and if these data are wirelessly transmitted to the inspection site, please rank order the following in terms of usefulness for selecting (screening) vehicles for further (manual) inspection (1 being most important and 12 being the least important):
5. The items identified in the response to questions 2 through 4 might be used to define a “safety data message set” that could be transmitted via wireless communication to the roadside for the purposes of automated screening and/or inspection of commercial vehicles. Please comment on the feasibility of implementing a new screening and/or inspection system that utilizes such a safety data message set. What key issues (technical, economic, institutional, operational, etc.) would need to be addressed to develop and implement such an inspection concept?
6. If on-board technology, as described above, were implemented for screening commercial vehicles, how should the information be presented to inspectors? (select one)
(a) A simple fault/no-fault for each system based on predetermined “rules” or algorithms that define “fault” using system-specific performance measures. For example, a listing of those systems or items for which a “failure” was detected would be transmitted to the inspection site.
(b) A “snapshot” of recently recorded performance or operational values being measured for each system (
(c) Actual real-time feeds of parameters being measured by the on-board diagnostic equipment, (
(d) Other.
7. When/how should this information be available to the inspection site?” (select one).
(a) Well before the inspection station (perhaps 2 miles) so that a decision to inspect/not inspect can be made and a return signal sent within sufficient time to allow the truck to enter or bypass the station.
(b) Upon entering the exit ramp for inspection, but before scales/scale house at about the same point where WIM equipment is often positioned.
(c) In front of scale house to allow visual inspection.
(d) Anytime/anywhere while vehicle is on the highway upon request from any computer terminal (including mobile).
(e) Other.
8. If the on-board sensors report all vehicle systems are functioning properly, what other conditions/information would be needed in order for the commercial vehicle to be permitted to bypass the inspection station, even if it were randomly sampled for inspection? (select one)
(a) None. If all sensors report no fault, the truck may bypass the station.
(b) Would still need/want USDOT registration number to check carrier history.
(c) Would still need/want CDL or other license information to check driver history.
(d) For trucks randomly sampled for inspection, no matter what information about the carrier, driver or truck was transmitted, the truck would still need to pass in front of inspectors at slow speed to allow for quick visual inspection.
(e) Other.
9. Please rank the following concerns/challenges with implementing an “automated” wireless type of safety inspection concept, with 1 being the greatest concern and 5 being the least concern.
(a) _Privacy concerns
(b) _Electronic falsification of data
(c) _Accuracy of measured data
(d) _Operator resistance to implementation
(e) _Added operational and maintenance requirements
(f) _Other (please specify)
10. Regarding driver HOS violations, what would be sufficient to transmit to the inspection station? (select one)
(a) A simple “in-violation” versus “no-violation” signal.
(b) Information that indicates if an operator is approaching a violation threshold.
(c) The actual HOS for each rule (
(d) The complete logbook regardless of status of violation.
(e) Other.
11. Regarding the options described below, which would you deem more helpful for improving the overall screening, inspection process, and safety of commercial vehicles and why? (select one)
Comments:
12. What technology for wirelessly transmitting data from the vehicle to the roadside inspection site should be favored and why? (select one)
Comments:
13. As noted earlier, on average, a heavy duty commercial vehicle (tractor-trailer) is likely to receive an inspection approximately once per year with trucks from higher risk carriers often inspected more frequently. How frequently would inspections need to occur before carriers and operators (particularly high-risk carriers) would begin to significantly modify their behavior relative to vehicle maintenance and driver compliance? Once a month? Once a week? Other? If a subset of inspection information could be electronically screened at all inspection sites (
14. If such a program were implemented on a national scale (together with high-speed WIM technology), it could reduce the amount of time vehicles spend at roadside inspection facilities. Depending on the cost of implementing such technology from the motor carrier's perspective, the increase in efficiency may well be cost beneficial. However, it has been argued that such new technology systems are often adopted by “good carriers” and, as such, they do little to improve the safety of poorer performing carriers. Please comment on possible strategies and approaches for implementing a nationwide wireless vehicle inspection program that would encourage broad-based participation from a significant percentage of motor carriers. Could a voluntary program with incentives be successful (identify and explain potential incentives)? Should a phased-in regulatory approach be considered? Other?
15. Please provide any other comments on the safety benefits, technical barriers, institutional challenges and/or costs of implementation associated with a wireless, automated safety inspection program.
As a supplement to North County Transit District's (NCTD) Petition for Approval of Shared Use and Waiver of Certain Federal Railroad Administration Regulations (the waiver was granted by the FRA on June 24, 2003), NCTD seeks a permanent waiver of compliance from additional sections of Title 49 of the CFR for operation of its SPRINTER rail line between Oceanside, CA and Escondido, CA.
In this regard, NCTD has advanced the design and construction of the SPRINTER rail line towards implementation and in the process, has identified the following additional regulations from which it hereby seeks waivers: 49 CFR part 223 Safety Glazing Standards—Locomotives, Passenger Cars and Cabooses, Section 223.9(c), and part 229 Railroad Locomotive Safety Standards, Section 229.125(a).
As a result of the comments received by FRA concerning this waiver petition, FRA has determined that a public hearing is necessary before a final decision is made on this petition. A public hearing was originally scheduled for July 27, 2005. However, due to the unavailability of some of the interested parties, FRA opened the public hearing and announced that a second public hearing would be scheduled in this matter. Accordingly, a public hearing is set to begin at 9:30 a.m. on September 14, 2005, in Rooms 4438 and 4440 at the Department of Transportation Headquarters Nassif Building, 400 7th Street, SW., Washington, DC 20590. Interested parties are invited to present oral statements at this hearing.
The hearing will be informal and conducted in accordance with FRA's Rules of Practice (49 CFR part 211.25) by a representative designated by FRA. FRA's representative will make an opening statement outlining the scope of the hearing, as well as any additional procedures for the conduct of the hearing. The hearing will be a non-adversarial proceeding in which all interested parties will be given the opportunity to express their views regarding this waiver petition without cross-examination. After all initial statements have been completed, those persons wishing to make a brief rebuttal will be given an opportunity to do so in the same order in which initial statements were made. Additional procedures, if necessary for the conduct of the hearing, will be announced at the hearing.
In addition, FRA is extending the comment period in this proceeding until September 23, 2005. FRA reserves the right to announce a further extension of the comment period for the purpose of receiving post-hearing submissions should that appear appropriate in the judgment of the Board based on testimony received at the public hearing.
All communications concerning these proceedings should identify the appropriate docket number (Waiver Petition Docket Number FRA-2002-11809) and must be submitted to the Docket Clerk, DOT Docket Management Facility, Room PL-401 (Plaza Level), 400 7th Street, SW., Washington, DC 20590. All written communications concerning these proceedings are available for examination during regular business hours (9 a.m.-5 p.m.) at the above facility. All documents in the public docket are also available for inspection and copying on the Internet at the docket facility's Web site at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
The Central New York Railroad Corporation, Norfolk Southern Corporation, and New York, Susquehanna and Western Railway Corporation have jointly petitioned the Federal Railroad Administration (FRA) seeking approval of the proposed discontinuance and removal of the interlocking, automatic block signal, and traffic control systems, on the single and double main tracks, between CP Sparrow Bush, milepost 89.9, near Port Jervis, New York, and, CP BD, milepost 213.0, near Binghamton, New York, a distant of approximately 123 miles. This block signal application proceeding is identified as Docket Number FRA-2005-21015.
FRA has issued a public notice seeking comments of interested parties and is conducting its own field investigation in this matter. However, after examining the carrier's proposal and numerous letters of comments from interested parties; FRA has determined that a public hearing is necessary before a final decision is made on this proposal. FRA is also extending the comment period to one week beyond the date of the public hearing. If information received at the public hearing warrants the need to extend the comment period further, a separate notice will be published indicating such extension.
Accordingly, a public hearing is hereby set for 9 a.m. daylight-saving time, on Wednesday, September 28, 2005, in Conference Room 1, on the 18th floor, of the State Office Building, at 44 Hawley Street, in Binghamton, New York 13901. Interested parties are invited to present oral statements at the hearing.
The hearing will be an informal one and will be conducted in accordance with Rule 25 of the FRA Rules of Practice (49 CFR part 211.25), by a representative designated by the FRA.
The hearing will be a non adversary proceeding and, therefore, there will be no cross-examination of persons presenting statements. The FRA representative will make an opening statement outlining the scope of the hearing. After all initial statements have been completed, those persons wishing to make brief rebuttal statements will be given the opportunity to do so in the same order in which they made their initial statements. Additional procedures, if necessary for the conduct of the hearing, will be announced at the hearing.
In addition, FRA is extending the comment period to October 5, 2005. All communications concerning these proceedings should identify the appropriate docket number (
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Maritime Administration's (MARAD's) intention to request extension of approval for three years of a currently approved information collection.
Comments should be submitted on or before October 17, 2005.
Richard Walker, Maritime Administration, 400 Seventh Street Southwest, Washington, DC 20590. Telephone: 202-366-5076, Fax: 202-366-6988; or e-mail:
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel VIKING IV.
As authorized by Pub. L. 105-383 and Pub. L. 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket 2005-22107 at
Submit comments on or before September 15, 2005.
Comments should refer to docket number MARAD-2005 22107. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. DOT Dockets, Room PL-401, Department of Transportation, 400 7th St., SW., Washington, DC 20590-0001. You may also send comments electronically via the Internet at
Michael Gordon, U.S. Department of Transportation, Maritime Administration, MAR-830 Room 7201, 400 Seventh Street, SW., Washington, DC 20590. Telephone 202-366-5468.
As described by the applicant the intended service of the vessel VIKING IV is:
By order of the Maritime Administrator.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comments.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. Currently, the OCC is soliciting comments concerning an information collection titled “Bank Secrecy Act/Money Laundering Risk Assessment.”
Written comments should be submitted by August 24, 2005.
Direct all written comments to the Communications Division, Office of the Comptroller of the Currency, Public Information Room, Mailstop 1-5, 250 E Street, SW., Washington, DC 20219. In addition, comments may be sent by facsimile transmission to (202) 874-5274, or by electronic mail to
Additionally, you should send a copy of your comments to Mark Menchik, OMB Desk Officer, Office of Management and Budget, New Executive Office Building, Room 3208, Washington, DC 20503. Electronic mail address is
You can request additional information or a copy of the collection from Mary H. Gottlieb or Camille Dixon, (202) 874-5090, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 250 E Street, SW., Washington, DC 20219.
The OCC has submitted the Bank Secrecy Act/Anti-Money Laundering Risk Assessment (Risk Assessment) to OMB under the emergency processing procedures in 5 CFR 1320.13. Further, the OCC has requested OMB action under these procedures by August 24, 2005. Thereafter, the OCC will seek clearance of the Risk Assessment under OMB's standard procedures.
All comments will be considered in formulating the subsequent submission and become a matter of public record. Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
(b) The accuracy of the agency's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8846, Credit for Employer Social Security and Medicare Taxes Paid on Certain Employee Tips.
Written comments should be received on or before October 17, 2005, to be assured of consideration.
Direct all written comments to Glenn Kirkland, Internal Revenue Service, Room 6516, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Allan Hopkins, at (202) 622-6665, or at Internal Revenue Service, Room 6516, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the Internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice.
An open meeting of the Wage & Investment Reducing Taxpayer Burden (Notices) Issue Committee of the Taxpayer Advocacy Panel will be conducted (via teleconference). The Taxpayer Advocacy Panel is soliciting public comments, ideas and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Thursday, September 1, 2005, from 12 p.m. to 1 p.m. e.t.
Sallie Chavez at 1-888-912-1227, or 954-423-7979.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Wage & Investment Reducing Taxpayer Burden (Notices) Issue Committee of the Taxpayer Advocacy Panel will be held Thursday, September 1, 2005, from 12 p.m. to 1 p.m. e.t. via a telephone conference call. If you would like to have the TAP consider a written statement, please call 1-888-912-1227 or 954-423-7979, or write Sallie Chavez, TAP Office, 1000 South Pine Island Road, Suite 340, Plantation, FL 33324. Due to limited conference lines, notification of intent to participate in the telephone conference call meeting must be made with Sallie Chavez. Ms. Chavez can be reached at 1-888-912-1227 or 954-423-7979, or post comments to the Web site:
The agenda will include: various IRS issues.
Internal Revenue Service (IRS) Treasury.
Notice.
An open meeting of the Area 5 Taxpayer Advocacy Panel will be conducted. The Taxpayer Advocacy Panel is soliciting public comment, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Monday, September 12, 2005, at 2 p.m. central time.
Mary Ann Delzer at 1-888-912-1227, or (414) 297-1604.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Area 5 Taxpayer Advocacy Panel will be held Monday, September 12, 2005, at 2 p.m. central time via a telephone conference call. You can submit written comments to the panel by faxing to (414) 297-1623, or by mail to Taxpayer Advocacy Panel, Stop1006MIL, 310 West Wisconsin Avenue, Milwaukee, WI 53203-2221, or you can contact us at
The agenda will include the following: various IRS issues.
Internal Revenue Service (IRS), Treasury.
Notice.
An open meeting of the Area 3 Taxpayer Advocacy Panel will be conducted (via teleconference). The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Tuesday, September 6, 2005, from 11 a.m. to 12 p.m. e.t.
Sallie Chavez at 1-888-912-1227, or 954-423-7979.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Area 3 Taxpayer Advocacy Panel will be held Tuesday, September 6, 2005, from 11 a.m. to 12 p.m. e.t. via a telephone conference call. If you would like to have the TAP consider a written statement, please call 1-888-912-1227 or 954-423-7979, or write Sallie Chavez, TAP Office, 1000 South Pine Island Rd., Suite 340, Plantation, FL 33324. Due to limited conference lines, notification of intent to participate in the telephone conference call meeting must be made with Sallie Chavez. Ms. Chavez can be reached at 1-888-912-1227 or 954-423-7979, or post comments to the Web site:
The agenda will include: Various IRS issues.
Internal Revenue Service (IRS) Treasury.
Notice.
An open meeting of the Joint Committee of the Taxpayer Advocacy Panel will be conducted. The Taxpayer Advocacy Panel is reviewing public comment, ideas, and suggestions on improving customer service at the Internal Revenue Service brought forward by the Area and Issue Committees.
The meeting will be held Thursday, September 15, 2005, 1 p.m. to 5 p.m., Friday, September 16, 2005, 8:30 a.m. to 5 p.m., and Saturday, September 17, 2005, 8 a.m. to Noon, Pacific time.
Barbara Toy at 1-888-912-1227, or 414-297-1611.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Joint Committee of the Taxpayer Advocacy Panel (TAP) will be held Thursday, September 15, 2005, 1 p.m. to 5 p.m., Friday, September 16, 2005, 8:30 a.m. to 5 p.m., and Saturday, September 17, 2005, 8 a.m. to noon, Pacific time, at the Flamingo Las Vegas, 3555 Las Vegas Boulevard South, Las Vegas, NV 89109. If you would like to have the Joint Committee of TAP consider a written statement, please call 1-888-912-1227 or 414-297-1611, or write Barbara Toy, TAP Office, MS-1006MIL, 310 West Wisconsin Avenue, Milwaukee, WI 53203-2221, or FAX to 414-297-1623, or you can contact us at
The agenda will include the following: Monthly committee summary report, discussion of issues brought to the joint committee, office reports, and discussion of next meeting.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, has submitted the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before September 15, 2005.
Denise McLamb, Records Management Service (005E3), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 273-8030, FAX (202) 273-5981 or e-mail:
Send comments and recommendations concerning any aspect of the information collection to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 (202) 395-7316. Please refer to “OMB Control No. 2900-0014” in any correspondence.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521) this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, has submitted the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before September 15, 2005.
Denise McLamb, Records Management Service (005E3), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 273-8030, FAX (202) 273-5981 or e-mail:
Send comments and recommendations concerning any aspect of the information collection to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 (202) 395-7316. Please refer to “OMB Control No. 2900-0618” in any correspondence.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
The Department of Veterans Affairs (VA) gives notice under Pub. L. 92-463 (Federal Advisory Committee Act) that a meeting of the Geriatrics and Gerontology Advisory Committee (GGAC) will be held on September 14-15, 2005. On September 14, 2005 the meeting will be held in Room 230, VA Central Office, 810 Vermont Avenue, NW., Washington, DC, from 8:30 a.m., until 5 p.m. On September 15, 2005, the meeting will be held at the American Legion Building, 1608 K Street, NW., Washington, DC, from 9 a.m., until 12 p.m. This meeting is open to the public.
The purpose of the Committee is to provide advice to the Secretary of Veterans Affairs and the Under Secretary for Health on all matters pertaining to geriatrics and gerontology by assessing the capability of VA health care facilities to meet the medical, psychological, and social needs of older veterans and by evaluating VA facilities designated as Geriatric Research, Education, and Clinical Centers (GRECCs).
The meeting will feature presentations on VA research initiatives in areas that affect aging, the White House Conference on Aging, and performance oversight of the VA Geriatric Research, Education, and Clinical Centers.
No time will be allocated at this meeting for receiving oral presentations from the public. Interested parties can provide written comments for review by the Committee in advance of the meeting to Mrs. Marcia Holt-Delaney, Office of Geriatrics and Extended Care (114), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420. Individuals who wish to attend the meeting should contact Mrs. Delaney, Program Analyst, at (202) 273-8540.
By direction of the Secretary.
In proposed rule document 05-14296 beginning on page 41635 in the issue of July 20, 2005, make the following correction:
On page 41638, in Table 5, in the second column, in the entry second from the bottom, the Travel and Operating Costs figure should read, “8.28.”
In proposed rule document 05-15053 appearing on page 44075 in the issue of Monday, August 1, 2005, make the following correction:
In the first column, under the heading
In rule document 05-15218 beginning on page 44470 in the issue of Wednesday, August 3, 2005, make the following corrections:
1. On page 44475, in §81.305, in the first column, the heading “
2. On the same page, in §81.305, in the first column, under the corrected heading “
In notice document E5-4117 beginning on page 44707 in the issue of Wednesday, August 3, 2005, make the following correction:
On page 44709, in the first column, in the first full paragraph, in the last last line, “August 23, 2005” should read “August 24, 2005”.
In rule document 05-15311 beginning on page 44465 in the issue of Wednesday, August 3, 2005, make the following corrections:
1. On page 44466, in § 71.1, in the first column, under
2. On the same page, in § 71.1, in the first column, under
Office of Foreign Assets Control, Treasury.
Interim final rule.
The Office of Foreign Assets Control of the U.S. Department of the Treasury is amending and reissuing in their entirety the Burmese Sanctions Regulations to implement Executive Order 13310 of July 28, 2003, which placed new sanctions on Burma.
You may submit comments by any of the following methods:
• Federal eRulemaking Portal:
• Agency Web Site:
• Fax: Chief of Records, (202) 622-1657.
• Mail: Chief of Records, ATTN: Request for Comments, Office of Foreign Assets Control, Department of the Treasury, 1500 Pennsylvania Avenue, NW., Washington, DC 20220.
Chief of Licensing, tel.: (202) 622-2480 or Chief of Policy Planning and Program Management, tel.: (202) 622-4855, Office of Foreign Assets Control, or Chief Counsel, tel.: (202) 622-2410, Office of Chief Counsel (Foreign Assets Control), Department of the Treasury, Washington, DC 20220 (not toll free numbers).
This file is available for download without charge in ASCII and Adobe Acrobat readable (*.PDF) formats at
On May 20, 1997, in response to the Burmese government's large-scale repression of, and violence against, the democratic opposition, President Clinton issued Executive Order 13047, determining that these actions and policies of the Government of Burma constituted an unusual and extraordinary threat to the national security and foreign policy of the United States and declaring a national emergency to deal with that threat. Executive Order 13047 prohibits new investment in Burma by U.S. persons and any facilitation by a U.S. person of new investment in Burma by a foreign person.
On July 28, 2003, the Burmese Freedom and Democracy Act of 2003 (BFDA) was signed into law, to restrict the financial resources of Burma's ruling military junta, the State Peace and Development Council (SPDC). The BFDA requires the President to ban the importation into the United States of products of Burma, beginning 30 days after the date of enactment of the BFDA, as well as to consider blocking the assets of certain SPDC members and taking steps to prevent further financial or technical assistance to Burma until certain conditions are met.
To implement the BFDA and to take additional steps with respect to the Government of Burma's continued repression of the democratic opposition in Burma, the President issued Executive Order 13310 (the “Order”) on July 28, 2003. The Order blocks all property and interests in property of the persons listed in the Annex to the Order and of certain persons determined, at a future point, by the Secretary of the Treasury, in consultation with the Secretary of State, to meet the criteria set forth in the Order. It also bans the importation into the United States of products of Burma (while waiving the ban where it would conflict with the international obligations of the United States under certain conventions on diplomatic and consular relations and similar agreements) and the exportation or reexportation to Burma of financial services from the United States or by U.S. persons. The Order exempts from its blocking and financial service prohibitions any transactions pursuant to pre-May 21, 1997 agreements between a U.S. person and any entity in Burma. It authorizes the Secretary of the Treasury, in consultation with the Secretary of State, to take such actions, including the promulgation of rules and regulations, as may be necessary to carry out the purposes of the Order.
In implementation of the Order, the Office of Foreign Assets Control (“OFAC”) is amending the Burmese Sanctions Regulations, 31 CFR part 537 (the “Regulations”), and, due to the extensive nature of these amendments, reissuing the Regulations in their entirety. Section 537.201 of the Regulations implements section 1 of the Order and blocks all property and interests in property of (1) persons listed in the Annex to the Order; and (2) persons determined by the Secretary of the Treasury, in consultation with the Secretary of State, to be senior officials of the Government of Burma or of certain Burmese political organizations, or to be owned or controlled by, or acting for or on behalf of, any person whose property or interests in property are blocked pursuant to the Order.
Section 537.202 of the Regulations implements section 2 of the Order. Section 537.202(a) prohibits the exportation or reexportation of financial services to Burma from the United States or by U.S. persons, wherever located. The term
Section 537.203 of the Regulations implements section 3 of the Order and prohibits the importation into the United States of articles that are products of Burma.
The pre-existing prohibition on new investment in Burma is set forth in § 537.204.
Section 537.206 of the Regulations implements section 4 of the Order and prohibits any transaction by a U.S. person or within the United States that evades or avoids, or that has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in the Order.
Exemptions from the prohibitions contained in the Regulations are set forth in § 537.210. Paragraphs (a), (b) and (d) of § 537.210 contain the exemptions from the President's powers under the International Emergency Economic Powers Act (50 U.S.C. 1702), as set forth in § 203 of that act. Paragraph (c) of section 537.210 implements section 13 of the Order by exempting from the prohibitions contained in the Regulations activities undertaken pursuant to pre-May 21, 1997 contracts, other than those for the importation of Burmese products, between U.S. persons and either the Government of Burma or a nongovernmental entity in Burma.
Subpart C of the Regulations contains definitions of terms used in the Regulations. Subpart D contains interpretations clarifying the prohibitions of this part. Transactions otherwise prohibited by this part but found to be consistent with U.S. policy may be authorized by a general license contained in subpart E of the Regulations or by a specific license issued pursuant to the procedures described in subpart D of the Reporting, Procedures and Penalties Regulations set forth in part 501 of chapter V of title 31, Code of Federal Regulations. Penalties for violations of the Regulations are set forth in subpart G of part 537.
As part of several general licenses issued prior to the publication of these regulations, OFAC had authorized certain transfers through financial institutions whose property or interests in property were blocked pursuant to § 537.201(a), provided that the account was not on the books of a financial institution that was a U.S. person. The text explaining this authorization has been removed from particular license sections and, to denote general application, appears in § 537.404, an interpretive section that explains the circumstances under which transactions incident to licensed transactions are authorized.
Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) (the “APA”) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. However, this rule is being issued in interim form, and comments will be considered in the development of final regulations. Accordingly, the Department encourages interested persons who wish to comment to do so at the earliest possible time to permit the fullest consideration of their views. Comments may address the impact of the Regulations on the submitter's activities, whether of a commercial, noncommercial or humanitarian nature, as well as changes that would improve the clarity and organization of the Regulations.
The period for submission of comments will close October 17, 2005. The Department will consider all comments postmarked before the close of the comment period in developing final regulations. Comments received after the end of the comment period will be considered if possible, but their consideration cannot be assured. The Department will not accept public comments accompanied by a request that a part or all of the submission be treated confidentially because of its business proprietary nature or for any other reason. The Department will return such submissions to the originator without considering them in the development of final regulations. In the interest of accuracy and completeness, the Department requires comments in written form.
All public comments on these Regulations will be a matter of public record. Copies of the public record concerning these Regulations will be made available not sooner than November 14, 2005 and will be obtainable from OFAC's Web site
Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting and Procedures Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been previously approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
Administrative practice and procedure, Banks, Banking, Blocking of assets, Burma, Exports, Foreign trade, Humanitarian aid, Imports, Information, Investments, Loans, New Investment, Penalties, Reporting and recordkeeping requirements, Services, Specially Designated Nationals, Transportation.
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C 1601-1651, 1701-1706; Sec. 570, Pub. L. 104-208, 110 Stat. 3009; Pub. L. 108-61, 117 Stat. 864; E.O. 13047, 62 FR 28301, 3 CFR 1997 Comp., p. 202; E.O. 13310, 68 FR 44853, 3 CFR 2004 Comp., p. 241.
This part is separate from, and independent of, the other parts of this chapter, with the exception of part 501 of this chapter, the recordkeeping and reporting requirements and license application and other procedures of which apply to this part. Actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. Differing foreign policy and national security circumstances may result in differing interpretations of similar language among the parts of this chapter. No license or authorization contained in or issued pursuant to those other parts authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to any other provision of law or regulation authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to this part relieves the involved parties from complying with any other applicable laws or regulations.
(a) Except as authorized by regulations, orders, directives, rulings, instructions, licenses or otherwise, and notwithstanding any contracts entered into or any license or permit granted prior to 12:01 a.m. eastern daylight time, July 29, 2003, all property and interests in property of the following persons that are in the United States, that hereafter come within the United States, or that are or hereafter come within the possession or control of U.S. persons, including their overseas branches, are blocked and may not be transferred, paid, exported, withdrawn or otherwise dealt in:
(1) Any person listed in the Annex to Executive Order 13310 of July 28, 2003 (68 FR 44853, July 30, 2003); and
(2) Any person determined by the Secretary of the Treasury, in consultation with the Secretary of State,
(i) To be a senior official of the Government of Burma, the State Peace and Development Council of Burma, the Union Solidarity and Development Association of Burma, or any successor entity to any of the foregoing, or
(ii) To be owned or controlled by, or acting or purporting to act for or on behalf of, directly or indirectly, any person whose property or interests in property are blocked pursuant to this section.
NOTE TO PARAGRAPH (a) OF § 537.201:
The names of persons whose property or interests in property are blocked pursuant to § 537.201(a) are announced in the
(b) Unless otherwise authorized by this part or by a specific license expressly referring to this section, any dealing in any security (or evidence thereof) held within the possession or control of a U.S. person and either registered or inscribed in the name of or known to be held for the benefit of any person whose property or interests in property are blocked pursuant to paragraph (a) of this section is prohibited. This prohibition includes but is not limited to the transfer (including the transfer on the books of any issuer or agent thereof), disposition, transportation, importation, exportation, or withdrawal of any such security or the endorsement or guaranty of signatures on any such security. This prohibition applies irrespective of the fact that at any time (whether prior to, on, or subsequent to 12:01 a.m. eastern daylight time, July 29, 2003) the
Except as authorized, and notwithstanding any contracts entered into or any license or permit granted prior to July 29, 2003, the exportation or reexportation of financial services to Burma, directly or indirectly, from the United States or by a U.S. person, wherever located, is prohibited.
Except as otherwise authorized, and notwithstanding any contracts entered into or any license or permit granted prior to August 28, 2003, the importation into the United States of any article that is a product of Burma is prohibited.
NOTE TO § 537.203: Section 3(b) of the Burmese Freedom and Democracy Act of 2003 provides that the prohibition contained in this section may be waived by the President for any or all articles that are a product of Burma if the President determines and notifies specified committees of Congress that to do so is in the national interest of the United States. Therefore, the Office of Foreign Assets Control will not issue licenses authorizing transactions prohibited under this section in the absence of such a waiver process. The President's waiver functions and authorities under section 3(b) have been delegated to the Secretary of State.
Except as otherwise authorized, new investment, as defined in § 537.311, in Burma by U.S. persons is prohibited.
NOTE TO § 537.204: Section 570 of the Foreign Operations, Export Financing, and Related Programs Appropriations Act, 1997 (
(a) Except as otherwise authorized, U.S. persons, wherever located, are prohibited from approving, financing, facilitating, or guaranteeing a transaction by a person who is a foreign person where the transaction would be prohibited if performed by a U.S. person or within the United States.
(b) With respect to new investment in Burma, the prohibition against facilitation does not include the entry into, performance of, or financing of a contract to sell or purchase goods, services, or technology unless such contract includes any of the activities described in § 537.311(a)(2), (3) or (4).
NOTE TO § 537.205: This section's prohibitions include, but are not limited to, the approval, financing, facilitation, or guarantee of transactions prohibited by either section 570 of the Foreign Operations, Export Financing, and Related Programs Appropriations Act, 1997 (Pub. L. 104-208), or the Burmese Freedom and Democracy Act of 2003 (Pub. L. 108-61). The prohibitions of these two statutes may be waived by the President upon the making of certain determinations and notification to Congress. Therefore, the Office of Foreign Assets Control will not issue licenses authorizing the approval, financing, facilitation, or guarantee of the transactions prohibited by these statutes in the absence of such waivers.
(a) Any transaction by a U.S. person or within the United States on or after the effective date that evades or avoids, has the purpose of evading or avoiding, or attempts to violate any of the prohibitions set forth in this part is prohibited.
(b) Any conspiracy formed to violate any of the prohibitions set forth in this part is prohibited.
NOTE TO § 537.206:
(a) Any transfer after July 28, 2003, that is in violation of any provision of this part or of any regulation, order, directive, ruling, instruction, or license issued pursuant to this part, and that involves any property or interest in property blocked pursuant to § 537.201(a), is null and void and shall not be the basis for the assertion or recognition of any interest in or right, remedy, power, or privilege with respect to such property or property interests.
(b) No transfer before July 29, 2003 shall be the basis for the assertion or recognition of any right, remedy, power, or privilege with respect to, or any interest in, any property or interest in property blocked pursuant to § 537.201(a), unless the person with whom such property is held or maintained, prior to that date, had written notice of the transfer or by any written evidence had recognized such transfer.
(c) Unless otherwise provided, an appropriate license or other authorization issued by or pursuant to the direction or authorization of the Director of the Office of Foreign Assets Control before, during, or after a transfer shall validate such transfer or make it enforceable to the same extent that it would be valid or enforceable but for the provisions of the International Emergency Economic Powers Act (50 U.S.C. 1701-1706), this part, and any regulation, order, directive, ruling, instruction, or license issued pursuant to this part.
(d) Transfers of property that otherwise would be null and void or unenforceable by virtue of the provisions of this section shall not be deemed to be null and void or unenforceable as to any person with whom such property was held or maintained (and as to such person only) in cases in which such person is able to establish to the satisfaction of the Director of the Office of Foreign Assets Control each of the following:
(1) Such transfer did not represent a willful violation of the provisions of this part by the person with whom such property was held or maintained;
(2) The person with whom such property was held or maintained did not have reasonable cause to know or suspect, in view of all the facts and circumstances known or available to such person, that such transfer required a license or authorization issued pursuant to this part and was not so licensed or authorized, or, if a license or authorization did purport to cover the transfer, that such license or authorization had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained; and
(3) The person with whom such property was held or maintained filed with the Office of Foreign Assets Control a report setting forth in full the circumstances relating to such transfer promptly upon discovery that:
(i) Such transfer was in violation of the provisions of this part or any regulation, ruling, instruction, license, or other direction or authorization issued pursuant to this part;
(ii) Such transfer was not licensed or authorized by the Director of the Office of Foreign Assets Control; or
(iii) If a license did purport to cover the transfer, such license had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained.
NOTE TO PARAGRAPH (d) OF § 537.207: The filing of a report in accordance with the provisions of paragraph (d)(3) of this section shall not be deemed evidence that the terms of paragraphs (d)(1) and (d)(2) of this section have been satisfied.
(e) Except to the extent otherwise provided by law or unless licensed pursuant to this part, any attachment, judgment, decree, lien, execution, garnishment, or other judicial process is null and void with respect to any property in which, at or since 12:01 a.m. eastern daylight time, July 29, 2003, there existed an interest of a person whose property or interests in property are blocked pursuant to § 537.201(a).
(a) Except as provided in paragraph (c) or (d) of this section, or as otherwise directed by the Office of Foreign Assets Control, any U.S. person holding funds, such as currency, bank deposits, or liquidated financial obligations, subject to § 537.201(a) shall hold or place such funds in a blocked interest-bearing account located in the United States.
(b)(1) For purposes of this section, the term
(i) In a federally-insured U.S. bank, thrift institution, or credit union, provided the funds are earning interest at rates that are commercially reasonable; or
(ii) With a broker or dealer registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934, provided the funds are invested in a money market fund or in U.S. Treasury bills.
(2) For purposes of this section, a rate is commercially reasonable if it is the rate currently offered to other depositors on deposits or instruments of comparable size and maturity.
(3) Funds held or placed in a blocked account pursuant to this paragraph (b) may not be invested in instruments the maturity of which exceeds 180 days. If interest is credited to a separate blocked account or subaccount, the name of the account party on each account must be the same.
(c) Blocked funds held in instruments the maturity of which exceeds 180 days at the time the funds become subject to § 537.201(a) may continue to be held until maturity in the original instrument, provided any interest, earnings, or other proceeds derived therefrom are paid into a blocked interest-bearing account in accordance with paragraph (b) or (d) of this section.
(d) Blocked funds held in accounts or instruments outside the United States at the time the funds become subject to § 537.201(a) may continue to be held in the same type of accounts or instruments, provided the funds earn interest at rates that are commercially reasonable.
(e) This section does not create an affirmative obligation for the holder of blocked tangible property, such as chattels or real estate, or of other blocked property, such as debt or equity securities, to sell or liquidate such property at the time the property becomes subject to § 537.201(a). However, the Office of Foreign Assets Control may issue licenses permitting or directing such sales in appropriate cases.
(f) Funds subject to this section may not be held, invested, or reinvested in a manner that provides immediate financial or economic benefit or access to any person whose property or interests in property are blocked pursuant to § 537.201(a), nor may their holder cooperate in or facilitate the pledging or other attempted use as collateral of blocked funds or other assets.
(a) Except as otherwise authorized, and notwithstanding the existence of any rights or obligations conferred or imposed by any international agreement or contract entered into or any license or permit granted before 12:01 a.m. eastern daylight time, July 29, 2003, all expenses incident to the maintenance of physical property blocked pursuant to § 537.201(a) shall be the responsibility of the owners or operators of such property, which expenses shall not be met from blocked funds.
(b) Property blocked pursuant to § 537.201(a) may, in the discretion of the Director, Office of Foreign Assets Control, be sold or liquidated and the net proceeds placed in a blocked interest-bearing account in the name of the owner of the property.
(a)
(b)
NOTE TO PARAGRAPH (b)(1) of § 537.210: Section 537.203 prohibits the importation of products of Burma into the United States pursuant to the Burmese Freedom and Democracy Act of 2003. Therefore, the importation into the United States of information or informational materials that are products of Burma is not exempt from the prohibition set forth in § 537.203. However, such transactions are authorized by the general license set forth in § 537.515.
(2) This section does not exempt from regulation or authorize transactions related to information or informational materials not fully created and in existence at the date of the transactions, or to the substantive or artistic alteration or enhancement of informational materials, or to the provision of marketing and business consulting services. Such prohibited transactions include, but are not limited to, payment of advances for information or informational materials not yet created and completed (with the exception of prepaid subscriptions for widely-circulated magazines and other periodical publications); provision of services to market, produce or co-produce, create, or assist in the creation of information or informational materials; and, with respect to information or informational materials imported from persons whose property or interests in property are blocked pursuant to § 537.201(a), payment of royalties with respect to income received for enhancements or alterations made by U.S. persons to such information or informational materials.
(3) This section does not exempt from regulation or authorize transactions incident to the exportation of software subject to the Export Administration Regulations, 15 CFR parts 730-774, or to the exportation of goods, technology or software, or to the provision, sale, or leasing of capacity on telecommunications transmission facilities (such as satellite or terrestrial network connectivity) for use in the transmission of any data. The exportation of such items or services and the provision, sale, or leasing of such capacity or facilities to a person whose property or interests in property are blocked pursuant to § 537.201(a) are prohibited.
(c)
(d)
NOTE TO § 537.211:
The terms
(a) The term
(b)
The term
(a) With respect to prohibited transfers or other dealings in blocked property or interests in property of persons listed in the Annex to Executive Order 13310 of July 28, 2003 (68 FR 44853, July 30, 2003), 12:01 a.m. eastern daylight time, July 29, 2003;
(b) With respect to prohibited transfers or other dealings in blocked property or interests in property of persons designated pursuant to § 537.201(a)(2), the earlier of the date on which either actual notice or constructive notice is received of such person's designation;
(c) With respect to the exportation or reexportation of financial services to Burma prohibited by § 537.202, 12:01 a.m. eastern daylight time, July 29, 2003;
(d) With respect to the importation into the United States of products of Burma prohibited by § 537.203, 12:01 a.m. eastern daylight time, August 28, 2003;
(e) With respect to new investment prohibited by § 537.204, 12:01 a.m. eastern daylight time, May 21, 1997.
The term
The term
(a) The transfer of funds, directly or indirectly, from the United States or by a U.S. person, wherever located, to Burma; or
(b) The provision, directly or indirectly, to persons in Burma of insurance services, investment or brokerage services (including but not limited to brokering or trading services regarding securities, debt, commodities, options or foreign exchange), banking services, money remittance services; loans, guarantees, letters of credit or other extensions of credit; or the service of selling or redeeming traveler's checks, money orders and stored value.
NOTE TO § 537.305: This defined term has not appeared in other parts of 31 CFR chapter V and is specifically tailored to further the goals of the sanctions prohibitions set forth in this part.
The term
The term
(a) For purposes of this part, the term
NOTE TO PARAGRAPH (a) OF § 537.307: To be considered information or informational materials, artworks must be classified under chapter heading 9701, 9702, or 9703 of the Harmonized Tariff Schedule of the United States.
(b) The term
(1) That were, as of April 30, 1994, or that thereafter become, controlled for export pursuant to section 5 of the Export Administration Act of 1979, 50 U.S.C. App. 2401-2420 (1979) (the “EAA”), or section 6 of the EAA to the extent that such controls promote the nonproliferation or antiterrorism policies of the United States; or
(2) With respect to which acts are prohibited by 18 U.S.C. chapter 37.
Except as otherwise provided in this part, the term
(a) Except as otherwise specified, the term
(b) The term
(c) The term
NOTE TO § 537.309:
(a) The term
(1) The entry into a contract that includes the economic development of
(2) The entry into a contract providing for the general supervision and guarantee of another person's performance of a contract that includes the economic development of resources located in Burma;
(3) The purchase of a share of ownership, including an equity interest, in the economic development of resources located in Burma; or
(4) The entry into a contract providing for the participation in royalties, earnings, or profits in the economic development of resources located in Burma, without regard to the form of the participation.
(b) The term
The term
The term
The term
The terms
The term
The term
The term
The term
The term
The term
The term
(a) Is a “broker” or “dealer” in securities within the meanings set forth in the Securities Exchange Act of 1934;
(b) Holds or clears customer accounts; and
(c) Is registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934.
The term
Except as otherwise specified, reference to any provision in or appendix to this part or chapter or to any regulation, ruling, order, instruction, direction, or license issued pursuant to this part refers to the same as currently amended.
Unless otherwise specifically provided, any amendment, modification, or revocation of any provision in or appendix to this part or chapter or of any order, regulation, ruling, instruction, or license issued by or under the direction of the Director of the Office of Foreign Assets Control does not affect any act done or omitted, or any civil or criminal suit or proceeding commenced or pending prior to such amendment, modification, or revocation. All penalties, forfeitures, and liabilities under any such order, regulation, ruling, instruction, or license continue and may be enforced as if such amendment, modification, or revocation had not been made.
(a) Whenever a transaction licensed or authorized by or pursuant to this part results in the transfer of property (including any property interest) away from a person, such property shall no longer be deemed to be property blocked pursuant to § 537.201(a), unless there exists in the property another interest that is blocked pursuant to § 537.201(a) or any other part of this chapter, the transfer of which has not been effected pursuant to license or other authorization.
(b) Unless otherwise specifically provided in a license or authorization issued pursuant to this part, if property (including any property interest) is transferred or attempted to be transferred to a person whose property or interests in property are blocked pursuant to § 537.201(a), such property shall be deemed to be property in which that person has an interest and therefore blocked.
(a) Any transaction ordinarily incident to a licensed transaction and necessary to give effect thereto is also authorized, except:
(1) A transaction, not explicitly authorized within the terms of the license, by or with a person whose property or interests in property are blocked pursuant to § 537.201(a), except as provided in paragraph (b) of this section; or
(2) A transaction, not explicitly authorized within the terms of the license, involving a debit to a blocked account or a transfer of blocked property, except as provided in paragraph (b) of this section.
(b) Transactions licensed pursuant to subpart E of this part and those transactions falling within the scope of paragraph (a) of this section are authorized even though they may involve transfers to or from an account of a financial institution whose property or interests in property are blocked pursuant to § 537.201(a), provided that the account is not on the books of a financial institution that is a U.S. person.
(a) Except as provided in § 537.210, the prohibitions on transactions involving blocked property contained in § 537.201 apply to services performed in the United States or by U.S. persons, wherever located, including by an overseas branch of an entity located in the United States:
(1) On behalf of or for the benefit of a person whose property or interests in property are blocked pursuant to § 537.201(a); or
(2) With respect to property interests subject to § 537.201.
(b)
NOTE TO § 537.405: See §§ 537.507 and 537.508 on licensing policy with regard to the provision of certain legal or medical services, respectively.
The prohibitions in § 537.201 on transactions involving blocked property apply to transactions by any U.S. person in a location outside the United States with respect to property that the U.S. person knows, or has reason to know, is held in the name of a person whose property or interests in property are blocked pursuant to § 537.201(a) or in which the U.S. person knows, or has reason to know, a person whose property or interests in property are blocked pursuant to § 537.201(a) has or has had an interest since the effective date.
Pursuant to § 537.201, no debits may be made to a blocked account to pay obligations to U.S. persons or other persons, except as authorized by or pursuant to this part.
A setoff against blocked property (including a blocked account), whether by a U.S. bank or other U.S. person, is a prohibited transfer under § 537.201 if effected after the effective date.
Section 537.210(c) exempts from all prohibitions contained in this part, except those contained in § 537.203, activities undertaken by a U.S. person pursuant to an agreement entered into prior to May 21, 1997, between a U.S. person and the Government of Burma or a nongovernmental entity in Burma. A U.S. person who is a party to a pre-May 21, 1997 agreement falling outside the scope of § 537.203 may enter into subsequent agreements with foreign persons where such agreements are pursuant to, or in exercise of rights under, the pre-May 21, 1997 agreement and are specifically contemplated by the pre-May 21, 1997 agreement. The exercise of rights under a pre-May 21, 1997 agreement falling outside the scope of § 537.203 may include the exercise of options to extend the contract, depending on such factors as the degree of specificity with which the option to extend is described in the pre-May 21, 1997 agreement, and the degree to which the party wishing to renew can enforce its decision to exercise the option.
Section 537.204 prohibits new investment in Burma by U.S. persons. Section 537.311 defines the term
(a) Entry into contracts for supervision and guarantee at the highest level of project management, such as entry into a contract with a development project's sponsor or owner to become a prime contractor or general manager for a development project;
(b) Entry into subcontracts where the functional scope of the subcontractor's obligations is substantially similar to that of a prime contractor's or general manager's obligations for a development project; or
(c) Entry into a contract or subcontract where the consideration includes a share of ownership in, or participation in the royalties, earnings or profits of, the economic development of resources located in Burma.
The purchase, directly or indirectly, from the Government of Burma or a nongovernmental entity in Burma of shares of ownership, including an equity interest, in the economic development of resources located in Burma is prohibited unless the purchase is pursuant to an agreement entered into prior to May 21, 1997.
(a) The purchase of shares in a third-country company that is engaged in the economic development of resources located in Burma is prohibited by § 537.204 where the company's profits are predominantly derived from the company's economic development of resources located in Burma.
(b) If a U.S. person holds shares in an entity which subsequently engages predominantly in the economic development of resources located in Burma or subsequently derives its income exclusively or predominantly from such economic development, the U.S. person is not required to relinquish its shares, but may not purchase additional shares. Divestiture of the shares in such an entity to a foreign person—otherwise constituting the facilitation of that foreign person's investment in Burma—is authorized under general license pursuant to § 537.524.
The sale to a foreign person of a U.S. person's equity or income interest in a development project in Burma constitutes facilitation of that foreign person's investment in Burma, unless pursuant to a pre-May 21, 1997 agreement. Such a sale, however, is authorized by general license under § 537.524.
For provisions relating to licensing procedures, see part 501, subpart D, of this chapter. Licensing actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part.
(a) No license or other authorization contained in this part, or otherwise issued by or under the direction of the Director of the Office of Foreign Assets Control, authorizes or validates any transaction effected prior to the issuance of the license, unless specifically provided in such license or authorization.
(b) No regulation, ruling, instruction, or license authorizes any transaction prohibited under this part unless the regulation, ruling, instruction or license is issued by the Office of Foreign Assets Control and specifically refers to this part. No regulation, ruling, instruction, or license referring to this part shall be deemed to authorize any transaction prohibited by any provision of this chapter unless the regulation, ruling, instruction, or license specifically refers to such provision.
(c) Any regulation, ruling, instruction, or license authorizing any transaction otherwise prohibited by this part has the effect of removing a prohibition or prohibitions contained in this part from the transaction, but only to the extent specifically stated by its terms. Unless the regulation, ruling, instruction, or license otherwise specifies, such an authorization does not create any right, duty, obligation, claim, or interest in, or with respect to, any property which would not otherwise exist under ordinary principles of law.
The Director of the Office of Foreign Assets Control reserves the right to exclude any person, property, or transaction from the operation of any license or from the privileges conferred by any license. The Director of the Office of Foreign Assets Control also reserves the right to restrict the applicability of any license to particular persons, property, transactions, or classes thereof. Such actions are binding upon all persons receiving actual or constructive notice of the exclusions or restrictions.
Any payment of funds or transfer of credit in which a person whose property or interests in property are blocked pursuant to § 537.201(a) has any interest, that comes within the possession or control of a U.S. financial institution, must be blocked in an account on the books of that financial institution. A transfer of funds or credit by a U.S. financial institution between blocked accounts in its branches or offices is authorized, provided that no transfer is made from an account within the United States to an account held outside the United States, and further provided that a transfer from a blocked account may only be made to another blocked account held in the same name.
NOTE TO § 537.504: Please refer to § 501.603 of this chapter for mandatory reporting requirements regarding financial transfers.
(a) A U.S. financial institution is authorized to debit any blocked account held at that financial institution in payment or reimbursement for normal service charges owed it by the owner of that blocked account.
(b) As used in this section, the term
Subject to the requirements of § 537.208, U.S. financial institutions are authorized to invest and reinvest assets blocked pursuant to § 537.201, subject to the following conditions:
(a) The assets representing such investments and reinvestments are credited to a blocked account or subaccount which is held in the same name at the same U.S. financial institution, or within the possession or control of a U.S. person, but funds shall not be transferred outside the United States for this purpose;
(b) The proceeds of such investments and reinvestments shall not be credited to a blocked account or subaccount under any name or designation that differs from the name or designation of the specific blocked account or subaccount in which such funds or securities were held; and
(c) No immediate financial or economic benefit accrues (
(a) The provision of the following legal services to or on behalf of persons whose property or interests in property are blocked pursuant to § 537.201(a) is authorized, provided that all receipts of payment of professional fees and reimbursement of incurred expenses must be specifically licensed:
(1) Provision of legal advice and counseling on the requirements of and compliance with the laws of any jurisdiction within the United States, provided that such advice and counseling are not provided to facilitate transactions in violation of this part;
(2) Representation of persons when named as defendants in or otherwise made parties to domestic U.S. legal, arbitration, or administrative proceedings;
(3) Initiation and conduct of domestic U.S. legal, arbitration, or administrative proceedings in defense of property interests subject to U.S. jurisdiction;
(4) Representation of persons before any federal or state agency with respect to the imposition, administration, or enforcement of U.S. sanctions against such persons; and
(5) Provision of legal services in any other context in which prevailing U.S. law requires access to legal counsel at public expense.
(b) The provision of any other legal services to persons whose property or interests in property are blocked pursuant to § 537.201(a), not otherwise authorized in this part, requires the issuance of a specific license.
(c) Entry into a settlement agreement affecting property or interests in property or the enforcement of any lien, judgment, arbitral award, decree, or other order through execution, garnishment, or other judicial process purporting to transfer or otherwise alter or affect property or interests in property blocked pursuant to § 537.201(a) is prohibited except to the extent otherwise provided by law or unless specifically licensed in accordance with § 537.207(e).
The provision of nonscheduled emergency medical services in the United States to persons whose property or interests in property are blocked pursuant to § 537.201(a) is authorized, provided that all receipt of payment for such services must be specifically licensed.
All transactions and activities otherwise prohibited by this part that are for the conduct of the official business of the United States Government, the United Nations, the World Bank, or the International Monetary Fund are authorized. This section does not authorize any importation into the United States of any article that is a product of Burma.
All transactions that are related to funds transfers otherwise prohibited by §§ 537.201 and 537.202 and that are for the conduct of diplomatic or consular activities of third-country diplomatic or consular missions in Burma are authorized.
U.S. diplomatic or consular officials entering the United States directly or indirectly from Burma are authorized to engage in all transactions incident to the importation into the United States of products of Burma as accompanied baggage or household effects, provided that such products are not intended for any other person or for sale and are not otherwise prohibited from importation under applicable United States laws.
All transactions incident to the importation into the United States of any article that is a product of Burma that is destined for official or personal use by personnel employed by a diplomatic mission or consulate in the United States are authorized, provided that such article is not intended for any other person or for sale and is not otherwise prohibited from importation under applicable United States laws.
All transactions in connection with the importation into the United States or the exportation from the United States of diplomatic pouches and their contents are authorized.
(a) A U.S. person who maintained a residence in Burma prior to July 28, 2003, is authorized to import into the United States personal and household effects that are products of Burma, including accompanied baggage and articles for family use, provided the imported items were purchased by the U.S. person prior to July 28, 2003, have been actually used abroad by the U.S. person or by other family members arriving from the same foreign household, are not intended for any other person or for sale, and are not otherwise prohibited from importation.
(b) A national of Burma who arrives in the United States after July 28, 2003, is authorized to import into the United States personal and household effects that are products of Burma, including accompanied baggage and articles for family use, provided the imported items are ordinarily incident to the Burmese national's arrival in the United States, have been actually used abroad by the Burmese national or by other family members arriving from the same foreign household, are not intended for any other person or for sale, and are not otherwise prohibited from importation.
The importation of information or informational materials that are products of Burma and all transactions directly incident to such importation are authorized.
(a) The importation of an article that is a product of Burma, otherwise prohibited by § 537.203, is authorized, provided the article was purchased prior to July 28, 2003, shipped from Burma to the United States prior to August 28, 2003, and is not property in which a person whose property or
(b) All transactions otherwise prohibited by §§ 537.201 and 537.202 that are directly incident to the importation into the United States of an article that is a product of Burma are authorized, provided that:
(1) The importation is authorized pursuant to paragraph (a) of this section; or
(2) The importation occurred prior to August 28, 2003, and was not from a person whose property or interests in property are blocked pursuant to § 537.201(a).
(c) All transactions otherwise prohibited by §§ 537.201 and 537.202 that are directly incident to the importation into a country other than the United States or Burma of an article that is a product of Burma are authorized, provided that:
(1) The article was purchased prior to July 28, 2003, shipped from Burma prior to August 28, 2003, and is not property in which a person whose property or interests in property are blocked pursuant to § 537.201(a) has an interest; or
(2) The importation occurred prior to August 28, 2003, and was not from a person whose property or interests in property are blocked pursuant to § 537.201(a).
(d) Financing agreements with respect to the importations described in paragraphs (a), (b) and (c) of this section may be performed only according to their terms and may not be extended or renewed.
(a)(1) U.S. depository institutions, U.S. registered brokers or dealers in securities, and U.S. registered money transmitters are authorized to process transfers of funds to or from Burma or for or on behalf of an individual ordinarily resident in Burma in cases in which the transfer involves a noncommercial, personal remittance, provided the following conditions are met:
(i) The transfer is not by, to, or through a person whose property or interests in property are blocked pursuant to § 537.201(a), except as explained in § 537.404 of this part; and
(ii) Total remittances to the territory of Burma in any consecutive 3-month period do not exceed $300 per Burmese household, regardless of the number of individuals comprising the household.
(2) Noncommercial, personal remittances do not include charitable donations to or for the benefit of an entity or funds transfers for use in supporting or operating a business.
NOTE TO PARAGRAPH (a) OF § 537.517: U.S. persons may make charitable donations to nongovernmental organizations in Burma that are authorized to operate pursuant to § 537.523, provided that the donations are made pursuant to § 537.523 and the terms of the authorization.
(b) The transferring institutions identified in paragraph (a) of this section may rely on the originator of a funds transfer with regard to compliance with paragraph (a) of this section, provided that the transferring institution does not know or have reason to know that the funds transfer is not in compliance with paragraph (a) of this section.
(c) This section does not authorize transactions with respect to property blocked pursuant to § 537.201, except as explained in § 537.404(b) of this part.
All transactions otherwise prohibited by §§ 537.201 and 537.202 that are ordinarily incident to an exportation to Burma of goods, technology or services, other than financial services, are authorized, provided the exportation is not to or on behalf of a person whose property or interests in property are blocked pursuant to § 537.201(a). This section does not authorize a financial institution that is a U.S. person to advise or confirm any financing by a person whose property or interests in property are blocked pursuant to § 537.201(a).
Except as prohibited by § 537.203, U.S. persons are authorized to engage in any activity, or any transaction incident to an activity, undertaken pursuant to an agreement entered into prior to 12:01 a.m., eastern daylight time, on May 21, 1997, or pursuant to the exercise of rights under such an agreement, provided that the parties to the agreement include:
(a) The Government of Burma or a nongovernmental entity in Burma, and
(b) An entity organized under the laws of a foreign state.
NOTE TO § 537.519: The authorization contained in § 537.519 pertains to pre-May 21, 1997 contracts between foreign business entities and either the Government of Burma or a nongovernmental entity in Burma. Pre-May 21, 1997 contracts between U.S. persons and the Government of Burma or a nongovernmental entity in Burma are exempt from all prohibitions contained in this part except those contained in § 537.203.
Payments to Burma of charges for services rendered by the Government of Burma in connection with the overflight of Burma or emergency landing in Burma of aircraft owned or operated by a U.S. person or registered in the United States are authorized.
The operation of an account in a U.S. financial institution for an individual ordinarily resident in Burma, other than an individual whose property or interests in property are blocked pursuant to § 537.201(a), is authorized, provided that each transaction processed through the account:
(a) Is of a personal nature and not for use in supporting or operating a business;
(b) Does not involve a transfer directly or indirectly to Burma or for the benefit of individuals ordinarily resident in Burma unless authorized by § 537.517; and
(c) Is not otherwise prohibited by this part.
(a) All of the following transactions in connection with patent, trademark, copyright or other intellectual property protection in the United States or Burma, except for those transactions prohibited by § 537.203, are authorized:
(1) The filing and prosecution of any application to obtain a patent, trademark, copyright or other form of intellectual property protection;
(2) The receipt of a patent, trademark, copyright or other form of intellectual property protection;
(3) The renewal or maintenance of a patent, trademark, copyright or other form of intellectual property protection; and
(4) The filing and prosecution of opposition or infringement proceedings with respect to a patent, trademark, copyright or other form of intellectual property protection, or the entrance of a defense to any such proceedings.
(b) This section authorizes the payment of fees currently due to the United States Government, or of the reasonable and customary fees and charges currently due to attorneys or representatives within the United States, in connection with the transactions authorized in paragraph (a) of this section. Payment effected pursuant to the terms of this paragraph may not be made from a blocked account.
(c) This section authorizes the payment of fees currently due to the
(d) Nothing in this section affects obligations under any other provision of law.
(a) Specific licenses may be issued on a case-by-case basis authorizing nongovernmental organizations to engage in transactions otherwise prohibited by §§ 537.201 and 537.202 that are necessary for their humanitarian or religious activities in Burma. Applications for specific licenses must include:
(1) The organization's name in English, in the language of origin, and any acronym or other names used to identify the organization;
(2) Address and phone number of the organization's headquarters location;
(3) Identification of field offices and partner offices, including addresses and organizational names used;
(4) Identification of key staff, such as directors and senior officers, at the organization's headquarters and partner offices, including the nationality, citizenship, current country of residence, place and date of birth, and current position of each person identified;
(5) Identification of subcontracting organizations, if any, to the extent known or contemplated at the time of the application;
(6) Existing sources of income, such as official grants, private endowments, commercial activities;
(7) Financial institutions that hold deposits on behalf of or extend lines of credit to the organization (names of individuals and organizations shall be provided in English, in the language of origin, and shall include any acronym or other names used to identify the individuals or organizations);
(8) Independent accounting firms, if employed in the production of the organization's financial statements (names of individuals and organizations shall be provided in English, in the language of origin, and shall include any acronym or other names used to identify the individuals or organizations);
(9) A detailed description of the organization's humanitarian, environmental or religious activities and projects in countries or geographic areas subject to economic sanctions pursuant to this chapter V, including, if applicable, a summary of all information provided in grant proposals or funding requests made in connection with the proposed activities;
(10) Most recent official registry documents, annual reports, and annual filings with the pertinent government, as applicable; and
(11) Names and addresses of organizations to which the applicant currently provides or proposes to provide funding, services or material support, to the extent known at the time of the application, as applicable.
(b) This section does not authorize transfers from blocked accounts.
NOTE TO § 537.523: Authorization pursuant to this section does not excuse a U.S. person from compliance with other applicable U.S. laws governing the exportation or reexportation of U.S.-origin goods, software, or technology (including technical data).
All transactions, except those prohibited by § 537.203, related to the divestiture or transfer to a foreign person of a U.S. person's share of ownership, including an equity interest, in the economic development of resources located in Burma are authorized. U.S. persons participating in such a transaction valued at more than $10,000 are required, within 10 business days after the transaction takes place, to file a report for statistical purposes with the Office of Foreign Assets Control, U.S. Treasury Department, 1500 Pennsylvania Avenue NW.-Annex, Washington, DC 20220.
To the extent otherwise prohibited, U.S. citizens who reside on a permanent basis in Burma are authorized to pay their personal living expenses and engage in other transactions in Burma ordinarily incident to their routine and necessary personal maintenance.
(a) To the extent that such activities are not exempt from this part, and subject to the restrictions set forth in paragraphs (b) through (d) of this section, U.S. persons are authorized to engage in all transactions necessary and ordinarily incident to the publishing and marketing of manuscripts, books, journals, and newspapers (collectively, “written publications”), in paper or electronic format. This section does not apply if the parties to the transactions described in this paragraph include the State Peace and Development Council of Burma or the Union Solidarity and Development Association of Burma, or any successor entity to any of the foregoing entities, or any person, other than personnel of academic and research institutions, acting or purporting to act directly or indirectly on behalf of the foregoing entities with respect to the transactions described in this paragraph. Pursuant to this section, the following activities are not prohibited, provided that U.S. persons ensure that they are not engaging, without specific authorization, in the activities identified in paragraph (d) of this section:
(1) Commissioning and making advance payments for identifiable written publications not yet in existence, to the extent consistent with industry practice;
(2) Collaborating on the creation and enhancement of written publications;
(3) Augmenting written publications through the addition of items such as photographs, artwork, translation, and explanatory text;
(4) Substantive and artistic editing of written publications;
(5) Payment of royalties for written publications;
(6) Creating or undertaking a marketing campaign to promote a written publication; and
(7) Other transactions necessary and ordinarily incident to the publishing and marketing of written publications as described in this paragraph (a).
(b) This section does not authorize transactions constituting the exportation or reexportation of financial services from the United States or by U.S. persons to Burma that are not necessary and ordinarily incident to the publishing and marketing of written publications as described above. For example, this section does not authorize U.S. persons to transfer funds to Burma relating to the following:
(1) The provision or receipt of individualized or customized services (including, but not limited to, accounting, legal, design, or consulting services), other than those necessary and ordinarily incident to the publishing and marketing of written publications, even though such individualized or customized services are delivered through the use of information and informational materials;
(2) The creation or undertaking of a marketing campaign for any person with respect to any service or product other than a written publication, or the
(3) The operation of a publishing house, sales outlet, or other office in Burma.
(c) This section does not authorize U.S. persons to engage in transactions constituting the exportation or reexportation of financial services to Burma that relate to the services of publishing houses or translators in Burma unless such activity is primarily for the dissemination of written publications in Burma.
(d) This section does not authorize:
(1) The importation into the United States of any article that is a product of Burma other than information and informational materials;
(2) Transactions constituting the exportation or reexportation of financial services from the United States or by U.S. persons to Burma that relate to the development, production, design, or marketing of technology specifically controlled by the International Traffic in Arms Regulations, 22 CFR parts 120 through 130 (ITAR), the Export Administration Regulations, 15 CFR parts 730 through 774 (EAR), or the Department of Energy Regulations set forth at 10 CFR part 810.
(3) Transactions constituting the exportation or reexportation of financial services from the United States or by U.S. persons to Burma that relate to the exportation of information or technology subject to the authorization requirements of 10 CFR part 810, or Restricted Data as defined in section 11(y) of the Atomic Energy Act of 1954, as amended, or of other information, data, or technology the release of which is controlled under the Atomic Energy Act and regulations therein;
(4) Transactions constituting the exportation or reexportation of financial services from the United States or by U.S. persons to Burma that relate to the exportation of information subject to license application requirements under the EAR. These EAR license application requirements cover not only the exportation of information controlled on the Commerce Control List, 15 CFR part 774, but also the exportation of any information subject to the EAR where a U.S. person knows or has reason to know that the information will be used, directly or indirectly, with respect to certain nuclear, missile, chemical and biological weapons, and nuclear-maritime end-uses. In addition, U.S. persons are precluded from exporting any information subject to the EAR to certain restricted end-users, as provided in the Commerce Department's end-user and end-use based controls set forth at 15 CFR part 744; or
(5) Transactions constituting the exportation or reexportation of financial services from the United States or by U.S. persons to Burma that relate to the exportation of information subject to licensing requirements under the ITAR, or exchanges of information that are subject to regulation by other government agencies.
For provisions relating to required records and reports, see part 501, subpart C, of this chapter. Recordkeeping and reporting requirements imposed by part 501 of this chapter with respect to the prohibitions contained in this part are considered requirements arising pursuant to this part.
(a) Attention is directed to section 206 of the International Emergency Economic Powers Act (the “Act”) (50 U.S.C. 1705), which is applicable to violations of the provisions of any license, ruling, regulation, order, direction, or instruction issued by or pursuant to the direction or authorization of the Secretary of the Treasury pursuant to this part or otherwise under the Act. Section 206 of the Act, as adjusted by the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, as amended, 28 U.S.C. 2461 note), provides that:
(1) A civil penalty not to exceed $11,000 per violation may be imposed on any person who violates or attempts to violate any license, order, or regulation issued under the Act;
(2) Whoever willfully violates or willfully attempts to violate any license, order, or regulation issued under the Act, upon conviction, shall be fined not more than $50,000, and if a natural person, may also be imprisoned for not more than 10 years; and any officer, director, or agent of any corporation who knowingly participates in such violation may be punished by a like fine, imprisonment, or both.
(b) The criminal penalties provided in the Act are subject to increase pursuant to 18 U.S.C. 3571.
(c) Attention is also directed to 18 U.S.C. 1001, which provides that whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device, a material fact, or makes any materially false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry shall be fined under title 18, United States Code, or imprisoned not more than five years, or both.
(d) Violations of this part may also be subject to relevant provisions of other applicable laws.
(a)
(b)
(2)
(c)
(a)
(1)
(2)
(b)
(c)
(1) A written response must include the respondent's full name, address, telephone number, and facsimile number, if available, or those of the representative of the respondent.
(2) A written response should either admit or deny each specific violation alleged in the prepenalty notice and also state if the respondent has no knowledge of a particular violation. If the written response fails to address any specific violation alleged in the prepenalty notice, that alleged violation shall be deemed to be admitted.
(3) A written response should include any information in defense, evidence in support of an asserted defense, or other factors that the respondent requests the Office of Foreign Assets Control to consider. Any defense or explanation previously made to the Office of Foreign Assets Control or any other agency must be repeated in the written response. Any defense not raised in the written response will be considered waived. The written response also should set forth the reasons why the respondent believes the penalty should not be imposed or why, if imposed, it should be in a lesser amount than proposed.
(d)
(e)
(f)
(g)
(a)
(b)
(2) The penalty notice shall inform the respondent that payment or arrangement for installment payment of the assessed penalty must be made within 30 days of the date of mailing of the penalty notice by the Office of Foreign Assets Control.
(3) The penalty notice shall inform the respondent of the requirement to furnish the respondent's taxpayer identification number pursuant to 31 U.S.C. 7701 and that such number will be used for purposes of collecting and reporting on any delinquent penalty amount.
(4) The issuance of the penalty notice finding a violation and imposing a monetary penalty shall constitute final agency action. The respondent has the right to seek judicial review of that final agency action in federal district court.
In the event that the respondent does not pay the penalty imposed pursuant to this part or make payment arrangements acceptable to the Director of the Office of Foreign Assets Control within 30 days of the date of mailing of the penalty notice, the matter may be referred for administrative collection measures by the Department of the Treasury or to the United States Department of Justice for appropriate action to recover the penalty in a civil suit in a federal district court.
For license application procedures and procedures relating to amendments, modifications, or revocations of licenses; administrative decisions; rulemaking; and requests for documents pursuant to the Freedom of Information and Privacy Acts (5 U.S.C. 552 and 552a), see part 501, subpart D, of this chapter.
Any action that the Secretary of the Treasury is authorized to take pursuant to Executive Order 13047 of May 20, 1997 (62 FR 28299, May 22, 1997) and Executive Order 13310 of July 28, 2003 (68 FR 44853, July 30, 2003), and any further Executive orders relating to the national emergency declared therein, may be taken by the Director of the Office of Foreign Assets Control or by any other person to whom the Secretary of the Treasury has delegated authority so to act.
For approval by the Office of Management and Budget (“OMB”) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) of information collections relating to record keeping and reporting requirements, licensing procedures (including those pursuant to statements of licensing policy), and other procedures, see § 501.901 of this chapter. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.
Environmental Protection Agency (EPA).
Proposed rule.
This proposed regulation would amend the “Guidelines Establishing Test Procedures for the Analysis of Pollutants” under section 304(h) of the Clean Water Act (CWA), by adding analytical test procedures for enumerating the bacteria,
Comments must be received on or before October 17, 2005.
Submit your comments, identified by Docket ID No. OW-2004-0014, by one of the following methods:
I. Federal eRulemaking Portal:
II. Agency Web site:
III. E-mail:
IV. Mail: Water Docket, Environmental Protection Agency, Mailcode: 4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
V. Hand Delivery: EPA Water Center, EPA West Building, Room B102, 1301 Constitution Avenue, NW., Washington, DC, Attention Docket ID No. OW-2004-0014. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
Robin K. Oshiro, Office of Science and Technology (4303-T); Office of Water, U.S. Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, (202) 566-1075 (e-mail:
EPA Regions, as well as States, Territories and Tribes authorized to implement the National Pollutant Discharge Elimination System (NPDES) program, issue permits that must comply with the technology-based and water quality-based requirements of the Clean Water Act (CWA). In doing so, NPDES permitting authorities, including States, Territories, and Tribes, make several discretionary choices when they write a permit. These choices include the selection of pollutants to be measured, monitoring requirements, permit conditions (
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your facility is regulated by this action, you should carefully examine the applicability language at 40 CFR 122.1, (NPDES purpose and scope), 40 CFR 136.1 (NPDES permits and CWA), 40 CFR 503.32 (Sewage sludge and pathogens). If you have questions regarding the applicability of this action to a particular entity, consult the appropriate person listed in the preceding
1.
2.
I. Identify the rulemaking by docket number and other identifying information (subject heading,
II. Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
III. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
IV. Describe any assumptions and provide any technical information and/or data that you used.
V. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
VI. Provide specific examples to illustrate your concerns, and suggest alternatives.
VII. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
VIII. Make sure to submit your comments by the comment period deadline identified.
3.
EPA is proposing this action pursuant to the authority of sections 301(a), 304(h), 405(d) and (e), and 501(a) of the Clean Water Act (“CWA” or the “Act”), 33 U.S.C. 1311(a), 1314(h), 1361(a). Section 301(a) of the Act prohibits the discharge of any pollutant into navigable waters unless, among other things, the discharge complies with a National Pollutant Discharge Elimination System (NPDES) permit issued under section 402 of the Act. Section 304(h) of the Act requires the Administrator of the EPA to “ * * * promulgate guidelines establishing test procedures for the analysis of pollutants that shall include the factors which must be provided in any certification pursuant to [section 401 of this Act] or permit application pursuant to [section 402 of this Act].” Section 501(a) of the Act authorizes the Administrator to “ * * * prescribe such regulations as are necessary to carry out this function under [the Act].” EPA generally codifies its test procedures in the Code of Federal Regulations (including analysis and sampling requirements) for CWA programs at 40 CFR part 136, though some specific requirements are in other sections (
This proposal would make available membrane filter (MF) methods and a suite of Multiple Tube Fermentation (MTF) methods (
EPA selected the methods based on data generated by EPA laboratories, or submissions to the ATP program. Since multiple studies using different method versions and different statistical analyses generated the EPA laboratory data, the test procedures in today's rule must be evaluated against the end-users' needs based on data quality objectives. EPA recommends that all new proposed
Membrane filtration is a direct-plating method in which sample dilutions/volumes are filtered through 0.45 μm membrane filters that are subsequently transferred to petri plates containing selective primary isolation agar or an absorbent pad saturated with selective broth. The total sample volume to be analyzed may be distributed among multiple filters and diluted as needed, based on the anticipated water sample type, quality, and character (
Membrane filtration is applicable to most tertiary treated wastewaters but has limitations where an underestimation of organism density is likely, such as water samples with high turbidity, toxic compounds, large numbers of non-coliform (background) bacteria. In addition, membrane filtration may have limitations where organisms are damaged by chlorine or toxic compounds, such as can be found in primary and some secondary treated wastewaters. To minimize these interferences, replicates of smaller sample dilutions/volumes may be filtered and the results combined. When the MF method has not been used previously on an individual water type, parallel tests should be conducted with a Multiple Tube Fermentation (MTF) to demonstrate applicability, lack of interferences, and at least comparable (
In Multiple Tube Fermentation (MTF) tests, the number of tubes/wells producing a positive reaction provides an estimate of the original, undiluted density (
The multiple-tube fermentation methodology is useful for detecting low concentrations of organisms (<100/100 mL), particularly in samples containing heavy particulate matter, toxic compounds (
Unless a large number of tubes are used (five tubes per dilution/volume or more), the precision of multiple-tube tests can be very poor. Precision is improved when the results from several samples from the same sampling event are processed, estimated separately, and then mathematically combined using the geometric mean. Further background information on multiple-tube tests is available in the Standard Methods for the Examination of Water and Wastewater (1998).
A statistical comparison of results obtained by the MF and MTF methods showed that the MF method is more precise in enumerating target organisms than the MTF test, but differences in recovery were generally not statistically significant. However, based on susceptibility to interferences, MF tests may underestimate the number of viable bacteria, and the MTF method may overestimate the concentration because of the built-in positive bias of the method (Thomas, 1955). Because of susceptibility of some MF tests to interferences, verification of some MF results with confirmatory multiple-tube tests is critical. Additionally, some MTF tests require confirmation tests because of the false positive/false negative rates of the particular media. In general, although numerical results may not be identical, data from each method yield similar water quality information based on performance.
EPA is proposing several methods for enumerating
For the multiple-tube procedure, a well-mixed sample and/or sample dilution/volume is added to tubes containing predispensed media. Tubes are then capped and mixed vigorously to dissolve the media. Alternatively, this procedure can be performed by adding appropriate amounts of substrate media to a bulk diluted sample (with appropriate dilutions for enumeration), then mixing and dispensing into multiple-tubes. The number of tubes, and number of dilutions/volumes are determined based on the type, quality, and character of the water sample. A multiple-well procedure may be performed with sterilized disposable packets. The commercially available Quanti-Tray® or Quanti-Tray®/2000 multiple-well tests uses Colilert® or Colilert-18® media to determine
After the appropriate incubation period, each tube or well is compared to the reference color “comparator” provided with the media. If the sample has a yellow color greater or equal to the comparator, the presence of total coliforms is verified, and the tube or well is then checked for fluorescence under long-wavelength UV light (366-nm). The presence of fluorescence greater than or equal to the comparator is a positive test for
EPA is proposing several methods for enumerating enterococci in wastewater. Brief descriptions of the proposed MF and MTF methods are provided below. In Table 2, methods in the same horizontal row use the same technique, but are published by different entities.
EPA is proposing methods for enumerating fecal coliforms in sewage sludge (Table 3). Brief descriptions of the proposed MTF methods are provided below.
1. LT-EC Medium (EPA Method 1680). The multiple-tube fermentation method for enumerating fecal coliforms in sewage sludge uses multiple-tubes and dilutions/volumes in a two-step procedure to determine fecal coliform concentrations (USEPA, 2004c). In the first step, or “presumptive phase,” a series of tubes containing lauryl tryptose broth (LTB) are inoculated with undiluted samples and/or dilutions/volumes of the samples and mixed. Inoculated tubes are incubated for 24 ± 2 h at 35 ± 0.5 °C. Each tube then is swirled gently and examined for growth (
Results of the MTF procedure using LTB/EC media are reported in terms of MPN/g dry weight calculated from the number of positive EC tubes and percent total solids (dry weight basis).
2. A-1 Medium (EPA Method 1681). The multiple-tube fermentation method for enumerating fecal coliforms in sewage sludge uses multiple-tubes and dilutions/volumes in a procedure to determine fecal coliform concentrations (USEPA 2004d). It should be noted that the Triton X-100 (polyethylene glycol p-isoloctylphenyl ether) is extremely volatile, and thus the medium must be used within one week (and preferably on the day of) preparation. In the first step, a series of tubes containing A-1 broth are inoculated with undiluted samples and/or dilutions/volumes of the samples and mixed. Inoculated tubes are incubated for 3 h at 35 ± 0.5 °C, then transferred to a water bath at 44.5 °C ± 0.2 °C. After 21 ± 2 h, tubes are examined for growth (
Results of the MTF procedure using A-1 media are reported in terms of MPN/g calculated from the number of positive A-1 tubes and percent total solids (dry weight basis).
EPA is also proposing methods for enumerating
a. Multiple Tube Fermentation (MTF) Tests for
The plates are examined for the appearance of motility surrounding inoculations, as evidenced by a “whitish halo” of growth approximately 2 cm from the center of the spot. Growth from the outer edge of the halo is streaked onto labeled XLD plates for isolation with a sterile inoculating needle or loop. Two halos and chosen are stabbed using an inoculating loop into the halo's outer edge, which is then streaked onto individual XLD plates (one spot per XLD plate) that are then incubated for 18 to 24 hours at 36 °C ± 1.5 °C. After incubation, one of the plates is submitted to biochemical confirmation (the other is refrigerated for reference). Pink to red colonies with black centers on XLD plates are considered
In the confirmatory phase, isolated colonies exhibiting
To confirm cultures via polyvalent O antiserum, growth on the slant portion of TSI (regardless of whether TSI is positive or negative) is emulsified using sterile physiological saline, and two discrete drops of emulsified growth are placed onto a slide. One drop of polyvalent O antiserum is to be added to the first drop of emulsified growth, and one drop of sterile saline is added to the second drop of emulsified growth as a visual comparison. The slide is observed under magnification for an agglutination reaction which indicates a positive result. In order for the original TSB tube to be considered positive for
A total solids determination is performed on a representative sewage sludge sample and is used to calculate MPN/g dry weight.
EPA is not proposing the use of EPA Method 1103.1 (mTEC) for
EPA is not proposing to extend the holding time from 6 hours to 24 hours for fecal coliforms using Method 1680 (LTB/EC) from Class A aerobically digested sewage sludge or for
EPA requests public comments on the proposed methods for the bacterial indicators of fecal contamination. EPA invites comments on the technical merit, applicability, and implementation of the proposed
40 CFR part 136, Table I currently includes microbial (bacterial, and protozoan) methods for use in both wastewater and ambient waters. For clarification purposes, EPA proposes to move those methods which are applicable to ambient waters to a new Table IG.
40 CFR part 136, Table II specifies sampling, preservation, and holding time requirements. This proposal would make additions to these tables for sewage sludge methods added to Table IA. In addition, clarification is provided for the holding time for bacterial tests.
Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the Agency must determine whether the regulatory action is “significant” and therefore subject to OMB review and the requirements of the Executive Order. The Executive Order defines “significant regulatory action” as one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
It has been determined that this proposed rule is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to Executive Order 12866 review.
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
Burden means 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. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of this rule on small entities for methods under the Clean Water Act, small entity is defined as: (1) A small business that meets RFA default definitions (based on SBA size standards) found in 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant
This proposed regulation would approve testing procedures for the measurement of
EPA analyzed the annualized cost estimates to regulated entities (small governmental jurisdictions that have publically-owned treatment works (POTWs) and small businesses with water quality-based discharge permits) for adoption of the newly proposed test methods for
The savings for facilities to shift from fecal coliform testing to
We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, tribal, and local governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation of why that alternative was not adopted.
Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for the notification of potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal
This rule contains no Federal mandates (under the regulatory provisions of Title II of UMRA) for State, local, or tribal governments or the private sector. The rule imposes no enforceable duty on any State, local, or tribal governments or the private sector. In fact, this rule should (on the whole) save money for governments and the private sector by increasing method flexibility, and allowing these entities to reduce monitoring costs by taking advantage of innovations. Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA.
EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. This rule makes available testing procedures for
Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects 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.”
This proposed rule does not have federalism implications. It will not have substantial direct effects 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, as specified in Executive Order 13132. This rule makes available testing procedures for
In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comment on this proposed rule from State and local officials.
Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.”
“Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and the Indian tribes.”
This proposed rule does not have tribal implications. It will not have substantial direct effects on Tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. This rule makes available testing procedures for
In the spirit of Executive Order 13175, and consistent with EPA policy to promote communications between EPA and Tribal governments, EPA specifically solicits comment on this proposed rule from Tribal officials.
Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.
This proposed rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action makes available testing procedures for
This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995, (“NTTAA”), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This proposed rulemaking involves technical standards. Therefore, the Agency conducted a search to identify potentially applicable voluntary consensus standards. EPA's search of the technical literature revealed several consensus methods appropriate for enumerating
Environmental protection, Incorporation by reference, Reporting and recordkeeping requirements, Water pollution control.
For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations, is proposed to be amended as follows:
1. The authority citation for part 136 continues to read as follows:
Secs. 301, 304(h), 307, and 501(a) Pub. L. 95-217, 91 Stat. 1566,
2. Section 136.3 is amended as follows:
a. In paragraph (a) by revising Table IA.
b. In paragraph (a) by adding Table IG after the footnotes of Table IF.
c. In paragraph (b) by revising references 54, 55, 56 and 59, and adding references 63 through 65.
d. In paragraph (e) by revising the entry for Table IA and adding an entry for Table IG in Table II.
(a) * * *
(b) * * *
(54) USEPA. 2004. Method 1103.1: Escherichia coli (E. coli) in Water by Membrane Filtration Using membrane-Thermotolerant Escherichia coli Agar (mTEC). U.S. Environmental Protection Agency, Office of Water, Washington, DC December 2004, EPA-821-R-04-024. Table IG, Note 19.
(55) USEPA. 2004. Method 1106.1: Method 1600: Enterococci in Water by Membrane Filtration using membrane-Enterococcus-Esculin Iron Agar (mE-EIA). December 2004. U.S. Environmental Protection Agency, Office of Water, Washington DC EPA-821-R-04-022. Table IG, Note 23.
(56) USEPA. 2004. Method 1603:
(59) USEPA. 2004. Method 1600: Enterococci in Water by Membrane Filtration using membrane-Enterococcus Indoxyl-β-D-Glucoside Agar (mEI). December 2004. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA-821-R-04-023. Table IA, Note 18, and Table IG, Note 24.
(63) USEPA. 2004. Method 1680: Fecal Coliforms in Sewage Sludge by Multiple-Tube Fermentation Using Lauryl-Tryptose E. coli (LT-EC) Broth. December 2004. U.S. Environmental Protection Agency, Office of Water, Washington DC EPA-821-R-04-026. Table IA, Note 22.
(64) USEPA. 2004. Method 1681: Fecal Coliforms in Sewage Sludge by Multiple-Tube Fermentation Using A-1 Broth. December 2004. U.S. Environmental Protection Agency, Office of Water, Washington DC EPA-821-R-04-027. Table IA, Note 23.
(65) USEPA. 2004. Method 1682:
(e) * * *