Lonnie Snowden PhD

• Professor of the Graduate School, Health Policy and Management

https://publichealth.berkeley.edu/people/lonnie-snowden/

This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are ``impracticable muscle relaxant succinylcholine order 100mg tegretol mastercard, unnecessary spasms in 7 month old buy 400mg tegretol overnight delivery, or contrary to the public interest muscle relaxant egypt trusted tegretol 400 mg. Any delay in the effective date of this rule would be contrary to the public interest because this rule is needed to provide for the safety of life on a navigable waterway of the United States muscle relaxant ibuprofen discount tegretol 100mg with amex. The purpose of the rule is to provide for the safety of life and vessels on a narrow waterway during bridge construction muscle relaxant yoga buy tegretol 400 mg with visa. Discussion of Rule From February 11 spasms near heart discount 400mg tegretol fast delivery, 2013 through March 11, 2013, construction will be conducted on the Indian Street Bridge in Palm City, Florida. The construction will impede the safe navigation of vessel traffic on a narrow waterway. If authorization to enter, transit through, anchor in, or remain within the safety zone is granted by the Captain of the Port Miami or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Miami or a designated representative. The Coast Guard will provide notice of the safety zone by Local Notice to Mariners, Broadcast Notice to Mariners, and onscene designated representatives. Regulatory Planning and Review this rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The economic impact of this rule is not significant for the following reasons: (1) the safety zone will be enforced for a maximum of 6 hours daily; (2) persons and vessels may enter, transit through, anchor in, or remain within the safety zone if authorized by the Captain of the Port Miami or a designated representative; (3) persons and vessels not authorized by the Captain of the Port Miami or designated representative to enter, transit through, anchor in, or remain within the safety zone may operate in the surrounding area during the enforcement period; and (4) the Coast Guard will provide advance notification of the safety zone to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners. Lucie Canal, Palm City, Florida to provide for the safety of life and vessels on a narrow waterway during bridge construction for the Indian Street Bridge. Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Miami or a designated representative. 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. This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to enter, transit through, anchor in, or remain within the safety zone established by this regulation during the respective enforcement period. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. Taking of Private Property this rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform this 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. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. Indian Tribal Governments this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, 7671 or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects this action is not a ``significant energy action' under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. This rule involves the establishment of a temporary safety zone to provide for the safety of life. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule. The term ``designated representative' means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels, and Federal, state, and local officers designated by or assisting the Captain of the Port Miami in the enforcement of the regulated area. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port Miami or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Miami or a designated representative. Publicly available docket materials are available either electronically through Subsequently, the State adopted the revision and submitted it to us on December 10, 2012. An air quality maintenance plan is required to show that an area will continue to maintain attainment of the applicable standard taking into account projections of future emissions. The motor vehicle emissions budgets are the amount of emissions from on-road motor vehicles that are consistent with the maintenance plan. If possible, please make the appointment at least two working days in advance of your visit. A public impose additional requirements beyond hearing was offered but was not those imposed by state law. A major rule cannot take effect until 60 days after it is published in the Federal Register. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action 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. Required Regulatory Analyses Under Executive Orders 13563 and 12866 and Regulatory Flexibility Act V. Executive Order 12988, Civil Justice Reform and Executive Order 13132, Federalism C. The proposed rule provided a 60-day public comment period that ended on December 13, 2011. This final rule contains provisions that apply to a variety of entities including academic institutions and biomedical centers, commercial manufacturing facilities, Federal, State, and local laboratories, including clinical and diagnostic laboratories, research facilities, exhibition facilities, and educational facilities. Responses to Public Comment We received nine comments from academic, private and government facilities. Definitions Commenters requested clarification about whether the definition of ``vector' should (1) include an exemption for animals meant for a zoo, (2) address pelts or other objects meant for museum use or (3) limit the definition to the importation of live animals. Prior to entry into the United States and regardless of the purpose for the importation, a permit will continue to be required for any live animal or animal product. The documentation may include a statement from a treating veterinarian, statement from a medical facility, medical certificate, or in the case of an animal product, documentary evidence, such as a veterinary or taxidermy certificate, describing how the material had been treated to render it noninfectious. Any live animal or animal product imported for scientific, educational or exhibition purposes. The term also includes the use for safety testing, potency testing, and other activities related to the production of medical products. The animal display must be open to the general public at routinely scheduled hours on 5 or more days of each week. The trained animal act must be routinely scheduled for multiple performances each week and open to the general public except for reasonable vacation and retraining periods. We agree with the commenter and are replacing the definition of ``infectious material' with an ``infectious substance' definition, which states ``any material that is known or reasonably expected to contain an infectious biological agent. Pathogens are defined as microorganisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals'). A commenter recommended defining the term ``biosafety measures,' which is used several times in the proposed regulatory language, to help importers prepare for use of these requirements and to assist in agency review of such measures before the issuance of a permit. While the commenter provided excellent references, we believe that citing only these references is limiting since there are other references that provide useful recommendations for safely working with a variety of human pathogens. Infectious Biological Agent One commenter noted that she was not aware of any medically important fungal agents that are communicable (transmissible from person to person), with the possible exception of dermatophyte agents (Epidermophyton, Microsporum, and Trichophyton). The commenter argued that the hazardous characteristics of dermatophyte agents are not sufficiently severe to merit regulation of these agents through the import permit mechanism. The commenter suggested that the regulatory text be clarified to list the fungal agents that would be regulated. The commenter further reasoned that Coccidioides species, Histoplasma capsulatum, and Blastomyces dermatitidis should no longer require an import permit since they do not cause communicable disease and are not transmissible from person to person. The commenter questioned if this will entail providing additional financing to bring importers into compliance, or is this ``offer to work with' the importer a distinctive part of the permit issuance process. If an importer is unable to address the inadequate biosafety measures identified, the importer would not receive a permit to import the infectious biological agent, infectious substance, or vector requested. We made no changes based on this comment since the proposed replacement language limits the specimens to human and animals and does not include environmental samples. Another commenter stated that the proposed rule leaves too much speculation about what is potentially infectious material. Accordingly, under these regulations the importer, as the initiator of the Import Permit request, must implement measures to ensure that the shipper will package, label, and ship the requested infectious substance, infectious biological agent, or vector in a manner that is safe and in compliance with all applicable legal requirements. Another commenter suggested that we amend the statement ``The importer is in compliance with all applicable laws concerning the packaging and shipment of infectious substance' to include ``and regulations' in the statement. We agreed with the commenter that the statement should be revised to include all laws and regulations. Therefore, we changed the language to read, ``The importer takes measures to help ensure that the shipper complies with all applicable legal requirements concerning the packaging, labeling, and shipment of infectious substances. Subsequent Transfer One commenter requested confirmation that an importer may still seek authorization for subsequent transfers of the items within the United States through the initial permit application. We confirm that an importer may still seek authorization for subsequent transfers of items within the United States in the initial permit application. The commenter stated it should be an institutional responsibility to ensure that an appropriate biosafety plan is in place. The commenter believed if an institution does not have a biosafety office or plan; it should not have the permit to import items that may pose any kind of risk. We agree that an entity that does not have a biosafety plan should not have a permit to import items that have the potential to pose a risk to public health and safety. To estimate the number of facilities that would require a biosafety inspection under this Part; we first identified those facilities that had previously applied to import agents which are capable of causing serious or potentially lethal disease in humans via the aerosol route. We also plan to coordinate these inspections with those we are already conducting under the Federal Select Agent Inspection Program to recognize greater efficiencies. We agree with this commenter and will review our Web site content on a regular ongoing basis to ensure that the content is consistent with the regulations and easy to find. Alternatives Considered In the proposed rule we discussed the alternative approaches we considered in development of this rulemaking in order to reduce burden for clinical/diagnostic laboratories or small businesses selling manufactured goods. Specifically, bats are known carriers of germs that cause disease in humans, including internal and external parasites, fungi, bacteria, and viruses. The commenter reasoned that if this material could be used to recover an infectious agent, its importation and subsequent transfer would be, for all intents and purposes, identical to the importation and subsequent transfer of an etiological agent. The commenter also reasoned that if the intent was the extraction of the genetic information only, and the recipient had no intention to retrieve the infectious agent from the nucleic acid preparation, then the need for the permit would seem not to be warranted. Transportation One commenter argued that the regulations should place the responsibility for compliance with all applicable laws and regulations concerning the packaging and shipment of infectious substances on the shipper since the only thing related to shipping that could be practically mandated for the recipient would be to open the shipment in a manner consistent with the expected hazard and report any spillage/leakage. The commenter stated that the importer could be required to obtain some type of affirmation from the shipper to the effect that the shipment is done in compliance with applicable regulations. Some of the biosafety measure implementation issues were serious enough to require the suspension of registration or other restrictions on biological work at these facilities. Because of these issues, we proposed to require specific biosafety measures to be implemented by the applicant. Second, we considered proposing a requirement that applicants develop and maintain a written biosafety plan commensurate with the hazard posed by the infectious biological agent, infectious material, and/or vector to be imported, and the level of risk given the intended use including what elements of the plan are essential to prevent exposures and dramatically reduce the incidence of laboratory acquired infections and protect the public health and the environment. We acknowledged that most, if not all, importers of etiological agents already have such biosafety plans. We based this on our experience with import permit submissions that address Section G (Receiving Laboratory Capabilities) of the permit application. We specifically sought comment from the public concerning the cost and burden of requiring a formal a written biosafety plan. We did not receive any comments specifically addressing the cost and burden of requiring a formal written biosafety plan. Finally, we proposed exemptions to allow importers to import certain material that is already approved or authorized by another Federal agency or material that has been determined not to be an infectious biological agent. Required Regulatory Analyses Under Executive Orders 12866 and 13563 Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It clarifies regulatory definitions, insures adequate biosafety measures, increases oversight through inspections, addresses permit exemptions and transportation requirements, and describes an appeal process when the permit request is denied. Based on past experience, we estimate that there will be approximately 2,000 applications for both import and distribution permit requests each year and that the average response time to complete the application is 20 minutes. We believe that the burden has been limited to requesting only essential information on the application, verifying information, when required, by telephone, and mailing information to the appropriate parties. With regard to the new requirement to have biosafety measures in place, our current experience from reviewing the information submitted for the import permit applications addressing Section G (Receiving Laboratory Capabilities). Based on our review of applications received between March 2011 and January 2012, we estimate that 98% (632 out of 644) of the applicants possess written biosafety plans and already follow standard biosafety practices and procedures. To estimate the number of facilities that would require a biosafety inspection, we first identified those facilities that applied to import agents to use in 7677 research, which may cause serious or potentially lethal disease after inhalation. From that list, we removed those facilities already subject to periodic biosafety inspections under the Federal Select Agent Regulations. We concluded that approximately 25 facilities would need to be inspected per year to verify that they have in place the appropriate biosafety measures. We plan to inspect these facilities once in a two year timeframe, assuming that no significant biosafety problems are identified. Alternatively, the agency head may certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. Small Business Administration defines a small business concern as one that is independently owned and operated, is organized for profit, and is not dominant in its field. Depending on the industry, eligibility for classification as a small business is based on the average number of employees for the preceding twelve months or on sales volume averaged over a three-year period. For example, a business is considered small if its annual revenue ranges between $2.

Use of H2 blockers in preterm neonates has been associated with an increased risk of fungal and late-onset bacterial sepsis muscle relaxant zanaflex buy tegretol 100mg online. Contraindications: Increased intracranial pressure spasms leg tegretol 200mg on-line, severe respiratory depression muscle relaxant chlorzoxazone side effects discount 200mg tegretol with amex, and severe liver or renal insufficiency spasms ms buy tegretol 200 mg on line. Indication: Prophylaxis for prevention of iron-deficiency anemia in preterm newborns muscle relaxant flexeril 10 mg cheap tegretol 200 mg on-line. When ordering muscle relaxant hamstring buy tegretol 200mg with visa, specify the exact amount in mg and clarify whether it is mg of elemental or salt form to avoid over- or under dosing. Iron supplementation may increase hemolysis if adequate vitamin E therapy is not supplied. Contraindications: Peptic ulcer disease, ulcerative colitis, enteritis, hemochromatosis, and hemolytic anemia. Drug interactions: Decreased absorption of both iron and tetracycline when given together. Observe stools (may color the stool black and may cause false-positive guaiac test for blood), and monitor for constipation. Gastric lavage with 1% to 5% sodium bicarbonate or sodium phosphate solution prevents additional absorption of iron. Indications: Treatment of systemic fungal infections, meningitis, and severe superficial mycoses. Alternative to amphotericin-B in patients with preexisting renal impairment or when concomitant therapy with other potentially nephrotoxic drugs is required. Prophylaxis: 3 mg/kg/dose once daily, 2 times/week for the first 2 weeks, then every other day for a total of 4 to 6 weeks (longer duration for infants with birth weight 1,000 g). Possible interference with metabolism of caffeine, midazolam, barbiturates, and phenytoin. Indication: Treatment of megaloblastic and macrocytic anemias as a result of folate deficiency. Clinical considerations: May mask hematologic defects of vitamin B12 deficiency but will not prevent progression of irreversible neurologic abnormalities, despite the absence of anemia. Indications: Management of generalized convulsive status epilepticus refractory to phenobarbital. Consider the amount of phosphate delivered by fosphenytoin in infants who require phosphate restriction. Fosphenytoin and bilirubin compete with phenytoin and displace phenytoin from plasma protein-binding sites. Adverse reactions: Hypotension, vasodilation, tachycardia, bradycardia, fever, hyperglycemia, neutropenia, thrombocytopenia, megaloblastic anemia, osteomalacia, and serious skin reactions. Monitoring parameters: Therapeutic levels: 10 to 20 mg/L total phenytoin or 1 to 2 mg/L unbound (free) phenytoin only. To provide diuresis and improve lung function when a greater diuretic effect than produced by chlorothiazide (Diuril) is needed. For long-term use, consider alternate day therapy or longer (dosing interval q48 to 72 h) in order to prevent toxicities. Monitoring: Follow daily weight changes, urine output, serum phosphate, and serum electrolytes. For infants with neutropenia, an absolute neutrophil count 500 or thrombocytopenia with a platelet count 25,000, use a decreased dose. Adverse reactions: Neutropenia, leukopenia, granulocytopenia, thrombocytopenia, and anemia. At the first sign of significant renal dysfunction, the dose of ganciclovir should be adjusted by either reducing the number of mg/dose or by prolonging the dosing interval. Indications: Active against gram-negative aerobic bacteria, some activity against coagulase-positive staphylococci, ineffective against anaerobes, streptococci. Drug interactions: Indomethacin decreases gentamicin clearance and prolongs its half-life. Increased neuromuscular blockade is observed when aminoglycosides are used with neuromuscular blocking agents. The risk of aminoglycoside-induced ototoxicity and/or nephrotoxicity is increased when used concurrently with loop diuretics. Neuromuscular weakness or respiratory failure may occur in infants with hypermagnesemia. Adverse reactions: Vestibular and irreversible auditory ototoxicity (associated with high trough levels) and renal toxicity (occurs in the proximal tubule, associated with high trough levels, usually reversible). Monitoring: Renal function (creatinine, urine output), drug peak, and trough levels. Guidelines for obtaining levels: Draw trough levels within 30 minutes before the next dose. Decreasing the dose by a specified percentage will result in an equal decrease in percentage of peak level. Precautions: Do not delay starting glucose infusion while awaiting effect of glucagon. Indications: To maintain patency of single- and double-lumen central catheters, thrombosis treatment. Adverse reactions: Heparin-induced thrombocytopenia reported in some heparinexposed newborns. Antidote: Protamine sulfate (1 mg/100 units of heparin given in the previous 4 hours). Add overfill in syringe upon dispensing for drug remaining in needle during frequent changes. Warnings: Hyaluronidase is neither effective nor indicated for treatment of extravasations of vasoconstrictive agents (phentolamine is the preferred agent for the treatment of extravasation with vasoconstrictive agents). Concurrent -blocker therapy recommended to reduce the magnitude of reflex tachycardia and to enhance antihypertensive effect. Drug interactions: Concurrent use with other antihypertensives allows reduced dosage requirements of hydralazine to 0. Adverse reactions: Hypochloremic alkalosis, volume depletion, displacement of bilirubin, blood dyscrasias, decreased serum potassium, sodium and magnesium levels, and increased levels of glucose, uric acid, and calcium. Precautions: Acute adrenal insufficiency may occur with abrupt withdrawal following long-term therapy or during periods of stress. Adverse reactions: Hypertension, salt retention, edema, cataracts, peptic ulcer, immunosuppression, hypokalemia, hyperglycemia, dermatitis, Cushing syndrome, and skin atrophy. Indications: Alloimmune thrombocytopenia and isoimmune hemolytic disease of the newborn causing hyperbilirubinemia. Decreasing rate or stopping infusion may help relieve some adverse effects (flushing, changes in pulse rate, and blood pressure fluctuation). Adverse reactions: Transient hypoglycemia, tachycardia, and hypotension (resolved with cessation of infusion). Tenderness, erythema, and induration at injection site and allergic manifestations. Clinical considerations: Hold enteral feeds until 12 hours after last indomethacin dose. Precautions: Use with caution in neonates with cardiac dysfunction and hypertension. Should not use in combination with glucocorticoids if possible, given an increased risk of spontaneous intestinal perforation. Drug interactions: Concurrent administration with digoxin and/or with aminoglycosides results in increased plasma concentrations of these respective agents. Spontaneous intestinal perforation is increased when used in combination with glucocorticoids. Monitoring: Follow blood glucose concentration every 30 minutes to 1 hour after starting infusion and after changes in infusion rate. Clinical considerations: Reduce loss of insulin that is due to adsorption to the plastic tubing by flushing tubing with a minimum of 25 mL of insulin solution before beginning the infusion. Adverse reactions: Hyperglycemic rebound, urticaria, anaphylaxis; may rapidly induce hypoglycemia, hypokalemia. Insulin resistance may develop with prolonged use and necessitate an increased dose. In infants with cardiac disease, begin with one-fourth of usual maintenance dose and increase weekly. Assess for signs of hypothyroidism: lethargy, poor feeding, constipation, intermittent cyanosis, and prolonged neonatal jaundice. In addition, closely assess for signs of thyrotoxicosis: hyperreactivity, tachycardia, tachypnea, fever, exophthalmos, and goiter. Adverse reactions: Hyperthyroidism, rash, weight loss, diarrhea, tachycardia, cardiac arrhythmias, tremors, fever, and hair loss. Prolonged over treatment can produce premature craniosynostosis and acceleration of bone age. Warning: Rhythmic myoclonic jerking movements have been observed in preterm infants. Precautions: Some preparations contain 2% benzyl alcohol and may be hazardous to neonates in high doses. Use with caution in infants with renal or hepatic impairment or myasthenia gravis. Drug interactions: Methadone metabolism accelerated by rifampin and phenytoin; this may precipitate withdrawal symptoms. Overdose: Associated with doses greater than 1 mg/kg/day, characterized by drowsiness, ataxia, extrapyramidal reactions, seizures, and methemoglobinemia (treat with methylene blue). Severe hypotension and seizures have been reported with rapid infusion in neonates. Decrease midazolam dose by 25% during prolonged concurrent narcotic administration. Encephalopathy reported in several infants sedated for 4 to 11 days with midazolam and fentanyl. In infants with decreased myocardial function, milrinone increases cardiac output, decreases pulmonary capillary wedge pressure, and decreases vascular resistance. It increases myocardial contractility and improves diastolic function by improving left ventricular diastolic relaxation without increasing myocardial oxygen consumption. Dosage/administration: Administer with a loading dose followed by a continuous infusion. Volume expanders may be needed to counteract the vasodilatory effect and potential decrease in filling pressures. Morphine causes histamine release leading to increased venous capacitance and suppression of adrenergic tone. Drug interactions: Blunting of peak aminoglycoside concentration when administered simultaneously with nafcillin. Adverse reactions: Agranulocytosis hypersensitivity, granulocytopenia, vein irritation, and nephrotoxicity (eosinophilia may precede renal damage). Not recommended as part of initial resuscitation of newborn with respiratory depression in the delivery room. Contraindications: Use with caution in infants with chronic cardiac disease, pulmonary disease, or coronary disease. Do not administer to newborns of narcotic dependent mothers, as it may precipitate seizures. Abrupt reversal may result in vomiting, diaphoresis, tachycardia, hypertension, and tremors. Indications: Treatment of shock that persists after adequate fluid volume replacement; severe hypotension; cardiogenic shock. Precautions: Blood/volume depletion should be corrected, if possible, before norepinephrine therapy; extravasation may cause severe tissue necrosis; do not give to patients with peripheral or mesenteric vascular thrombosis because ischemia may be increased and the area of infarct extended; use with caution in patients with occlusive vascular disease. Adverse reactions: Cardiac arrhythmias, bradycardia, tachycardia, dyspnea, hypertension, pallor; organ ischemia (due to vasoconstriction of renal and mesenteric arteries), ischemic necrosis, and sloughing of superficial tissue after extravasation. Indications: Treatment of susceptible cutaneous, mucocutaneous, and oropharyngeal fungal infections caused by Candida species. Continue oral therapy and topical application for 2 to 3 days beyond resolution of fungal infection. Eliminate factors contributing to fungal growth (wet, occlusive diapers, and the use of contaminated nipples). Indications: Pharmacologic management of persistent hyperinsulinemic hypoglycemia of infancy (nesidioblastosis), adjunct treatment of congenital and postoperative chylothorax. Chylothorax: 1 to 7 mcg/kg/hour continuous infusion; start low and titrate dose to effect (decreased chyle production). Precautions: Glucose tolerance; use with caution in patients with renal impairment. Monitoring: Cholelithiasis, blood sugar, thyroid function tests, fluid and electrolyte balance, and fecal fat. Indications: Short-term (8 weeks) treatment of documented reflux esophagitis or duodenal ulcer refractory to conventional therapy. Use with caution in infants with respiratory alkalosis due to high content of sodium bicarbonate in the oral suspension; avoid use in infants on sodium restriction. Precautions: History of hypersensitivity related to the use of other immunoglobulin preparations, blood products, or other medications. Adverse effects: Vomiting, diarrhea, rash, rhinitis, arrhythmia, fever, otitis media, upper respiratory infection and erythema, and moderate induration at the injection site. Indications: Skeletal muscle relaxation, increased pulmonary compliance during mechanical ventilation, facilitates endotracheal intubation.

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Examples include cleft palate and congenital heart disease such as tetralogy of Fallot muscle relaxant rotator cuff order tegretol 100 mg mastercard. A syndrome consists of a group of anomalies that are associated due to single or similar etiologies muscle relaxant potency order 100 mg tegretol fast delivery, with known or unknown cause muscle relaxant withdrawal symptoms purchase tegretol 200 mg fast delivery, such as Down syndrome due to trisomy 21 spasms in 8 month old generic tegretol 100mg without a prescription. A developmental field defect consists of a group of anomalies resulting from defective development of a related group of cells (developmental field) muscle relaxant clonazepam tegretol 100mg with visa. In this case spasms prostate cheap tegretol 200 mg line, the involved embryonic regions are usually spatially related but may not be contiguous in the infant. These events can compromise the fetal circulation and result in a major birth defect. Deformations can occur when physical forces act upon previously formed structures. Examples of deformations include uterine crowding or oligohydramnios that results in plagiocephaly or clubfeet. The development of more sensitive molecular technology is likely to establish etiology in more cases. A comprehensive history is an important step in evaluating an infant with a birth defect. Drug exposures should include prescribed drugs, such as antihypertensives (angiotensin-converting-enzyme inhibitors), seizure medications, antineoplastic agents (methotrexate), and illicit drugs. Other drugs that may result in birth defects include misoprostol (to induce abortions). Teratogenic agents tend to have their maximum effect during the embryonal period, from the beginning of the fourth to the end of the seventh week postfertilization, with exception of severe forms of holoprosencephaly when exposure may occur around or before 23 days (see Appendix B). Other exposures may include alcohol; physical agents, such as x-ray and high temperature; chemical agents; and tobacco (see Table 10. Results of first- and second-trimester screening, including triple and quad screens, should be obtained. Rapid and intense movements could be due to fetal seizures, while decreased General Newborn Condition 115 movement can be seen with spinal muscular atrophy, Prader-Willi syndrome, and other congenital myopathies. Is there a history of infertility, multiple miscarriages, multiple congenital anomalies, neonatal deaths, or children with developmental delay These can be secondary to a balanced chromosome rearrangement in one of the parents but unbalanced in the progeny. Various deformations, sagittal synostosis, and clubfeet can be caused by fetal constraints. Were there severe feeding difficulties necessitating parenteral nutrition or tube feedings The assessment of growth parameters is extremely valuable to determine growth patterns, such as restriction, overgrowth, disproportion, or microcephaly. In addition, precise measurements of anatomic structures and landmarks can aid the diagnostic evaluation process. Examples are ear length, eye measurements for hypertelorism or hypotelorism (widely or closely spaced eyes), finger length, and internipple distance. A thorough clinical evaluation is needed to document the presence of dysmorphic features: head shape. These need to be taken into consideration and the infant should be reexamined when these are no longer present. Chromosome studies are typically performed on whole blood drawn into sodium heparin tubes. In extremely ill infants, those with immunosuppression, or who have low T-cell counts (as in DiGeorge syndrome), cell growth may be impaired and cell stimulation fails. In this case, a punch skin biopsy may be performed to obtain chromosomes from skin fibroblasts. The disadvantage of using skin fibroblasts is the delay of up to several weeks before a result is available. These studies are done on unstimulated interphase cells, and the results are typically available in a few hours or overnight. This study is based on the comparison of a known genome from a normal individual against the test sample and is often done with a matched sex control. Chromosome microarrays can detect 12% to 16% more abnormalities than conventional cytogenetic studies (regular karyotype). Disadvantages of microarray testing include failure to detect inversions, balanced chromosome translocations, and low-level mosaicism. Both parents must be studied after the confirmation to determine if one of them is a carrier and to aid with the interpretation of the finding(s) in case it is a polymorphic variant. Consultation with a cytogeneticist or clinical genetics specialist is essential to interpret abnormal array results. The most common microdeletion syndromes detected in newborns are described in Table 10. They are caused by inherited or new mutations and often transmitted in a Mendelian fashion-like autosomal recessive, autosomal dominant, and/or X-linked disorders. These include spinal muscular atrophy; congenital adrenal hyperplasia (most commonly due to 21-hydroxylase deficiency); congenital myotonic dystrophy (only when inherited from an affected mother); osteogenesis imperfecta due to type I collagen Table 10. Brain imaging studies and fundoscopic exam could reveal brain calcifications and/or chorioretinitis. The differential for nonimmune hydrops also includes several rare lysosomal storage disorders (see Chap. In most states, mandatory newborn screening is done initially between 24 and 48 hours of age, with a second screen done between 1 and 2 weeks of age. The March of Dimes and the American College of Medical Genetics recommend 29 conditions for testing. Most of these conditions can be managed by medications and/or special diets and treatments in many can be life saving. The anion gap should be measured in cases of acidosis; if the anion gap is increased, measure lactic acid in whole plasma from a free-flowing blood sample (ideally arterial), and measure organic acids in urine. Ultrasonography: brain imaging, to detect major malformation and intracranial hemorrhage; abdominal ultrasound exam, to detect major liver and kidney anomalies and presence and position of testicles/ovaries; and echocardiography, to detect heart defects b. Muscle biopsy in children with severe hypotonia can be considered in conjunction with nerve biopsy to assess for disorders such as congenital muscular dystrophy, amyoplasia congenita, and hypomyelination syndromes. Sometimes, a muscle biopsy can be postponed until the infant is at least 6 months of age to gather better quality and more complete information. Autopsy studies in stillbirths or infants who died in the neonatal period may provide a diagnosis and help with counseling and recurrence risks. Good documentation should be obtained and radiographs should be considered in addition to pathologic exam. A sample of the placenta can also be submitted for genetic studies such as karyotyping. Patients with birth defects require close follow-up evaluation after hospital discharge either to aid in the diagnosis or to educate the family. Since approximately 50% of patients born with multiple congenital anomalies have no known diagnosis, the follow-up may reveal new findings that will contribute to the final diagnosis. This will help predict the natural history and allow a proper assessment of the recurrence risk. Infants suspected to be at risk for developmental delay should be referred for therapy services or early childhood intervention programs. Up-to-date online catalogue of Mendelian genetic disorders and traits with a useful search engine for the identification of syndromes. Triplets and higher order pregnancies (quadruplets, quintuplets, sextuplets, septuplets, etc. A major portion of the placenta and the fetal membranes originate from the zygote. The placenta consists of two parts: (i) a larger fetal part derived from the villous chorion and (ii) a smaller maternal part derived from the deciduas basalis. The chorion begins to form at day 3 after fertilization, and the amnion begins to form between days 6 and 8. This rate is influenced by several factors such as ethnicity (1 in 500 Asians, 1 in 125 in whites, and as high as 1 in 20 in African populations) and maternal age. The birth rate of triplet and higher order multiples peaked in 1998 at 194 per 100,000 live births. The rates for other higher order multiples (quadruplets and higher) 124 General Newborn Condition 125 declined by 21% in 2006 compared to peak rates in 1998 (194 per 100,000 live births). A dichorionic diamniotic placenta results when early splitting occurs at day 0 to 3 before chorion formation (which usually occurs about day 3) and before implantation. A monochorionic diamniotic placenta results when splitting occurs about day 4 to 7, at which time the blastocyst cavity has developed and the chorion has formed. Amnion formation occurs at day 6 to 8, and splitting of the egg after this time (day 4 to 7) results in a monochorionic monoamniotic placenta. At day 14 and thereafter, the primitive streak begins to form, and late splitting of the embryo at this time results in conjoined twins. Multiple gestational sacs can be detected by ultrasonography as early as 5 weeks and cardiac activity can be detected from more than one fetus at 6 weeks. First-trimester ultrasonography can best determine the chorionicity of a multiple gestation; chorionicity is more difficult to determine in the second trimester. From weeks 10 to 14, a fused dichorionic placenta may often be distinguished from a true monochorionic placenta by the presence of an internal dividing membrane or ridge at the placental surface (lambda sign). The dividing septum of a dichorionic placenta appears thicker and includes two amnions and two chorionic layers. In contrast, the dividing septum of a monochorionic placenta consists of two thin amnions. One placenta, same-sex fetuses, and absence of a dividing septum suggest monoamniotic twins, but absence of a dividing septum may also be due to septal disruption. Pathologic examination of the placenta(s) at birth is important in establishing and verifying chorionicity. Zygosity determines the degree of risk of chromosomal abnormalities in each fetus of a multiple gestation. Second-trimester maternal serum screening for women with multiples is limited because each fetus contributes variable levels of these serum markers. First-trimester ultrasonography to assess for nuchal translucency is a more sensitive and specific test to screen for chromosomal abnormalities. A secondtrimester ultrasonography exam is important in surveying each fetus for anatomic defects. Gestational diabetes has been shown in some studies to be more common in twin pregnancies. Spontaneous abortion occurs in 8% to 36% of multiple pregnancies with reduction to a singleton pregnancy by the end of the first trimester ("vanishing twin"). Possible causes include abnormal implantation, early cardiovascular developmental defects, and chromosomal abnormalities. Before fetal viability, the management of the surviving co-twin in a dichorionic pregnancy includes expectant management until term or close to term, in addition to close surveillance for preterm labor, fetal well-being, and fetal growth. The management of a single fetal demise in a monochorionic twin pregnancy is more complicated. The surviving co-twin is at high risk for ischemic multiorgan and neurologic injury that is thought to be secondary to hypotension or thromboembolic events. Termination of pregnancy may be offered as an option when single fetal demise occurs in a previable monochorionic twin pregnancy. In a large retrospective cohort study, the incidence of placental abruption was 6. Preterm premature rupture of membranes complicates 7% to 10% of twin pregnancies compared with 2% to 4% of singleton pregnancies. Preterm labor and birth occur in approximately 57% of twin pregnancies and in 76% to 90% of higher order multiple gestations. Approximately 66% of patients with twins and 91% of patients with triplets have cesarean delivery. Breech position of one or more fetuses, cord prolapse, and placental abruption are factors that account for the increased frequency of cesarean deliveries for multiple gestations. The average duration of gestation is shorter in multifetal pregnancies and further shortens as the number of fetuses increases. The mean gestational age at birth is 36, 33, and 29 and one-half weeks, respectively, for twins, triplets, and quadruplets. The likelihood of a birth weight 1,500 g is 8 and 33 times greater in twins and triplets or higher order multiples, respectively, compared with singletons. In two multicenter surveys, multiples occurred in 21% to 24% of births 1,500 g and in 30% of births 1,000 g. The mechanisms are likely uterine crowding, limitation of placental perfusion, anomalous umbilical cord insertion, infection, fetal anomalies, maternal complications. The smaller twin has an increased risk of fetal demise, perinatal death, and preterm birth. Five percent to 15% of twins and 30% of triplets have fetal growth discordance that is associated with a sixfold increase in perinatal morbidity and mortality. The death of one twin, which occurs in 9% of multiple pregnancies, is less common in the second and third trimesters. In this case, the co-twin is either completely resorbed if death occurs in the first trimester or is compressed between the amniotic sac of its co-twin and the uterine wall (fetus papyraceous). Other complications involving the surviving co-twin include antepartum stillbirth, preterm birth, placental abruption, and chorioamnionitis. In the event of a demise of one monochorionic twin, immediate delivery of the surviving co-twin should be considered after fetal viability.

The proposed change will not alter the operation or function of structures spasms compilation discount tegretol 400 mg, systems or components muscle relaxant suppository order 200 mg tegretol with mastercard. The response of the plant and the operators following a design basis accident is unaffected by this change muscle relaxant general anesthesia tegretol 100 mg overnight delivery. Therefore muscle relaxant methocarbamol tegretol 200mg with mastercard, the proposed chage will not create the possibility of a new or different kind of accident from any previously evaluated spasms between ribs 100 mg tegretol visa. Accident mitigation equipment will continue to function as assumed in the accident analysis spasms coronary artery tegretol 100 mg without prescription. Therefore, the proposed change does not involve a significant reduction in the margin of safety. The method in which the reactor water level is sensed and the reactor water level setpoints at which a trip is initiated are not impacted. The instrumentation response times and the instrumentation output to the equipment being tripped remains the same. Therefore, the proposed change does not involve a significant increase in the consequences of an accident previously evaluated. Furthermore, there will be no change in the types or significant increase in the amounts of any effluents released offsite. The proposed change does not alter the parameters within which the plant is operated. There are no setpoints at which protective or mitigative actions are initiated that are affected by the proposed change. This proposed change will not alter the manner in which equipment operation is initiated nor will the demands on mitigating equipment be changed. The instrumentation being added to the trip logic utilizes the same transmitters, and the same type of trip units and trip relays, as presently used to monitor reactor water level and initiate Emergency Core Cooling System operation. Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated. Margins of safety are established in the design of components, the configuration of components to meet certain performance parameters, and in the establishment of setpoints to initiate alarms or actions. The proposed amendment supports a change to the logic that trips the three feedwater pumps and the main turbine from a two-out-of-two initiation logic to a one-out-of-two twice initiation logic. The proposed amendment does not alter the setpoints at which the trip function occurs, the response time of the trip initiation logic, or the plant response following a valid trip signal. Notice of Issuance of Amendments to Facility Operating Licenses During the period since publication of the last biweekly notice, the Commission has issued the following amendments. 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 Federal Register as indicated. Brief description of amendment: the amendment revised Appendix B, Environmental Protection Plan (nonradiological) of the Clinton Facility Operating License. Effective date: As of the date of issuance and shall be implemented within 60 days. Brief description of amendment: the amendment changes Technical Specification Section 5. Effective date: As of the date of issuance and shall be implemented within 30 days from the date of issuance. The supplement contained clarifying information only, and did not change the initial no significant hazards consideration determination or expand the scope of the initial Federal Register notice. Brief description of amendments: the amendments deleted the Technical Specification requirements to maintain hydrogen recombiners and hydrogen/ oxygen monitors and related Surveillance Requirements. Effective date: As of the date of issuance and shall be implemented within 120 days. Effective date: As of the date of issuance and shall be implemented prior to resumption of operation from the 1R19 refueling outage scheduled for the fall of 2005. Date of application for amendment: December 6, 2004, as supplemented on June 14, 2005. Effective date: As of the date of issuance, and shall be implemented within 30 days. Brief description of amendment: the amendment revises a technical specification surveillance requirement to change the required frequency of the reactor building spray nozzle surveillance from once every 10 years to ``following maintenance that could result in nozzle blockage. Cook Nuclear Plant, Units 1 and 2, Berrien County, Michigan Date of application for amendments: February 25, 2005, as supplemented June 2, 2005. Effective date: As of the date of issuance and shall be implemented within 45 days. Brief description of amendments: the amendments approve the use of Generation of Thermal-Hydraulic Information Containment Version 7. Effective date: As of the date of issuance and shall be implemented within 30 days. The supplemental letter contained clarifying information and did not change the initial no significant hazards consideration determination and did not expand the scope of the original Federal Register notice. Effective date: As of the date of issuance, and shall be implemented within 60 days. Because of exigent or emergency circumstances associated with the date the amendment was needed, there was not time for the Commission to publish, for public comment before issuance, its usual Notice of Consideration of Issuance of Amendment, Proposed No Significant Hazards Consideration Determination, and Opportunity for a Hearing. The Commission has provided a reasonable opportunity for the public to comment, using its best efforts to make available to the public means of communication for the public to respond quickly, and in the case of telephone comments, the comments have been recorded or transcribed as appropriate and the licensee has been informed of the public comments. In such case, the license amendment has been issued without opportunity for comment. If there has been some time for public comment but less than 30 days, the Commission may provide an opportunity for public comment. Under its regulations, the Commission may issue and make an amendment immediately effective, notwithstanding the pendency before it of a request for a hearing from any person, in advance of the holding and completion of any required hearing, where it has determined that no significant hazards consideration is involved. The basis for this determination is contained in the documents related to this action. The Commission is also offering an opportunity for a hearing with respect to the issuance of the amendment. If there are problems in accessing the document, Effective date: As of the date of issuance, to be implemented within 60 days. Brief description of amendments: the amendments revise the Technical Specification 3. Effective date: As of the date of issuance and shall be implemented within 120 days from the date of issuance. Notice of Issuance of Amendments to Facility Operating Licenses and Final Determination of No Significant Hazards Consideration and Opportunity for a Hearing (Exigent Public Announcement or Emergency Circumstances) During the period since publication of the last biweekly notice, the Commission has issued the following amendments. If a request for a hearing or petition for leave to intervene is filed by the above date, the Commission or a presiding officer designated by the Commission or by the Chief Administrative Judge of the Atomic Safety and Licensing Board Panel, will rule on the request and/or petition; and the Secretary or the Chief Administrative Judge of the Atomic Safety and Licensing Board will issue a notice of a hearing or an appropriate order. The petition must also identify the specific contentions which the petitioner/ requestor seeks to have litigated at the proceeding. 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 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 contention must be one which, if proven, would entitle the petitioner to relief. A petitioner/requestor who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party. Each contention shall be given a separate numeric or alpha designation within one of the following groups: 1. Technical-primarily concerns/ issues relating to technical and/or health and safety matters discussed or referenced in the applications. Environmental-primarily concerns/issues relating to matters discussed or referenced in the environmental analysis for the applications. If a petitioner/requestor seeks to adopt the contention of another sponsoring petitioner/requestor, the petitioner/requestor who seeks to adopt the contention must either agree that the sponsoring petitioner/requestor shall act as the representative with respect to that contention, or jointly designate with the sponsoring petitioner/requestor a representative who shall have the authority to act for the petitioners/ requestors with respect to that contention. Since the Commission has made a final determination that the amendment involves no significant hazards consideration, if a hearing is requested, it will not stay the effectiveness of the amendment. A copy of the request for hearing and petition for leave to intervene should also be sent to the attorney for the licensee. Effective date: As of the date of its issuance and shall be implemented within 5 days. To help us process and review your statement more efficiently, please use only one method. All statements received will be posted without change; we do not edit personal identifying information from submissions. Sufficient time may not be available to accommodate all those wishing to provide oral testimony. The Co-Chairs of the Advisory Committee have reserved the right to select and limit the time of witnesses permitted to testify at the Advisory Committee meeting. Marsh, Director, Division of Licensing Project Management, Office of Nuclear Reactor Regulation. Advisory Committee on Smaller Public Companies Securities and Exchange Commission. The roundtables will focus on the process of capital formation for smaller companies since the enactment of the SarbanesOxley Act of 2002. The agenda for the Tuesday, September 20, session includes considering written statements that have been filed with the Advisory Committee in connection with the meeting and considering reports of subcommittees of the Advisory Committee. The Advisory Committee will also consider on Tuesday any recommendations proposed by Members or Official Observers for adoption by the full Advisory Committee. All interested persons are referred to the application(s) and/or declaration(s) for complete statements of the proposed transaction(s) summarized 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 19, 2005, the application(s) and/or declaration(s), as filed or as amended, may be granted and/or permitted to become effective. Summary of the Request Applicants request authority to issue the Additional Transition Bonds and engage in related transactions, as generally described below: 1. The Restructuring Law also required the Texas Commission to administer the requirement that integrated utilities separate their generating, transmission and distribution and retail sales functions. Background In addition to introducing competition to the Texas electric utility industry, by requiring integrated utilities to separate their generating, transmission and distribution and retail sales functions, Applicants state that the Texas Restructuring Law permits utilities to recover certain of certain ``stranded' or other ``transition' costs associated with transition to a competitive retail electric market in Texas. It also allows a utility to recover certain other transition costs by a true-up procedure. The statute requires these determinations to be made by the Texas Commission in ``true-up proceedings. The Restructuring Law permits a utility, its successors or a third-party assignee of a utility, to issue transition bonds. Applicants also ask that they be authorized to issue the different series, with different interest rates (which may be at fixed or floating rates) and amortizations of principal and that each series have classes with different interest rates and amortizations of principal. Applicants state that, in accordance with the requirements of the Restructuring Law, the Additional Transition Bonds will be required to be fully repaid within 15 years of the date of issuance. Applicants also explain that a financing order, once effective, is irrevocable and not subject to reduction, impairment or adjustment by the Texas Commission (including the transition charges authorized in the order), except for annual and interim true-up adjustments made under the Restructuring Law. Applicants state that the Restructuring Law does require the Texas Commission to review and adjust the transition charges at least annually, within 45 days of the anniversary of the date of the issuance of the transition bonds in order to: (1) Correct any overcollections or undercollections during the preceding 12 months and (2) provide for recovery of amounts sufficient to pay timely all debt service and other amounts and charges associated with the transition bonds. As noted above, the Restructuring Law permits a utility, its successors or a third party assignee of a utility, to issue transition bonds. Applicants state that the Restructuring Law requires the power generation company and the retail electric provider that are ``affiliated with' the former integrated electric utility to be parties to the application. Reliant Energy Retail Services was an applicant even though, at the time, it no longer had any legal affiliation with CenterPoint Energy or its subsidiaries. Applicants state that a trustee will be appointed under the indenture governing the Additional Transition Bonds and that the trustee, and its investment authority, will be subject to certain constraints. Applicants explain that these transactions or instruments, which may include surety bonds, financial guaranty insurance policies or letters of credit, among other things, are intended to protect against losses or delays in scheduled payments on the Additional Transition Bonds. They explain that interest rate swaps and other hedging arrangements may be used, among other things, to fix synthetically the interest on floating rate Additional Transition Bonds. Applicants also request an exemption from the ``at cost' requirements in connection with the servicing fee. Applicants propose that the servicer be entitled to receive an aggregate annual servicing fee under the terms of the transition property servicing agreement. Applicants propose that the fee be set at an annual level of not more than one percent of the initial principal amount of the Additional Transition Bonds. Applicants state that, although they expect the servicing fee to approximate the actual costs of providing the services, they cannot be certain that the servicing fee will meet the ``at cost' requirements of section 13(b) of the Act and other applicable rules. Applicants propose that the administrator be entitled to receive a fixed fee, plus reimbursable expenses. Indemnifications Applicants also request that they be authorized to enter into various indemnity agreements associated with the transition property sale agreement and transition property servicing agreement. To the extent that proceeds may not be applied to repay that loan, they may be distributed to Utility Holding and CenterPoint, either through dividend payments or the settlement of intercompany payables.

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