Business Law Study Set 13

Business

Quiz 6 :

Administrative Agencies

Quiz 6 :

Administrative Agencies

Question Type
search
arrow
Department of Health and Human Services has proposed new guidelines for the interpretation of federal statutes on gifts, incentives, and other benefits bestowed on physicians by pharmaceutical companies. The areas on which the interpretation focused follow: • Paying doctors to act as consultants or market researchers for prescription drugs • Paying pharmacies fees to switch patients to new drugs • Providing grants, scholarships, and anything more than nominal gifts to physicians for time, information sessions, and so on, on new drugs 35 The Office of Inspector General is handling the new rules interpretation and has established a public comment period of 60 days. Explain the purpose of the public comment period. What ethical issues do the regulations attempt to address?
Free
Essay
Answer:

Answer:

The Health and Human Services (HHS) was reviewing federal statutes which concerned limits to relations, and benefits received by doctor from drug companies. The purpose of the public comment process , is to give the public such as doctors, drug companies, patients etc. a chance to voice their views on their concerns.
Doctors have a duty to provide the most efficient care to their patients. However, the type of care may be affected by perks they received from drug companies, which may negatively affect patient outcome.

Tags
Choose question tag
close menu
arrow
planning commissioner and a real estate developer planned to meet to discuss rezoning certain land that would permit the real estate developer to construct certain buildings not allowed under the then-existing zoning law. A homeowners association claimed it had the right to be present at the meeting. This claim was objected to on the theory that the state's Open Meetings Act applied only to meetings of specified government units and did not extend to a meeting between one of them and an outsider. Was this objection valid?
Free
Essay
Answer:

Answer:

The Open Meeting Act of that state which limit public access may be preempted by Federal Open Meeting Law which allows public access to agency meetings. Hence, an agency can't deny public access for no good reason, especially as in this case a home owner association has legitimate interest on the local zoning.

Tags
Choose question tag
close menu
arrow
is the Federal Register? What role does it play in rulemaking? What is the difference between the Federal Register and the Code of Federal Regulations?
Free
Essay
Answer:

Answer:

The Federal Register is a publication that lists agencies proposed rules, final rules, changes, meetings, as well as presidential proclamations and executive orders. The register affects rulemaking of agencies by letting the public be informed and giving them an opportunity to make comments and be aware of rules. The current register can be found online at http://www.archives.gov/federal-register/
The Code of Federal Regulations list the general and permanent rules made by agencies. The differences in the two is that the register is frequently updated, whereas the code is finalized.

Tags
Choose question tag
close menu
arrow
Congress adopted a law to provide insurance to protect wheat farmers. The agency in charge of the program adopted regulations to govern applications for this insurance. These regulations were published in the Federal Register. Merrill applied for insurance, but his application did not comply with the regulations. He claimed that he was not bound by the regulations because he never knew they had been adopted. Is he bound by the regulations? [ Federal Crop Ins. Corp. v. Merrill, 332 U.S. 380]
Essay
Answer:
Tags
Choose question tag
close menu
arrow
Michigan Freedom of Information Act declares that it is the state's policy to give all persons full information about the actions of the government and that "the people shall be informed so that they may participate in the democratic process." The union of clerical workers at Michigan State University requested the trustees of the university to give them the names and addresses of persons making monetary donations to the university. Michigan State objected because the disclosure of addresses was a violation of the right of privacy. Decide. [ Clerical-Technical Union of Michigan State University v. Board of Trustees of Michigan State University, 475 N.W.2d 373 (Mich.)]
Essay
Answer:
Tags
Choose question tag
close menu
arrow
York City's charter authorized the New York City Board of Health to adopt a health code that it declared to have the force and effect of law. The board adopted a code that provided for the fluoridation of the public water supply. A suit was brought to enjoin the carrying out of this program on the grounds that it was unconstitutional and that money could not be spent to carry out such a program in the absence of a statute authorizing the expenditure. It was also claimed that the fluoridation program was unconstitutional because there were other means of reducing tooth decay; fluoridation was discriminatory by benefiting only children; it unlawfully imposed medication on children without their consent; and fluoridation was or may be dangerous to health. Was the code's provision valid? [ Paduano v. City of New York, 257 N.Y.S.2d 531]
Essay
Answer:
Tags
Choose question tag
close menu
arrow
Federal Register contained the following provision from the Environmental Protection Agency on January 14, 2002: We, the U.S. Fish and Wildlife Service (Service), announce the re-opening of the comment period on the proposed listing of Lomatium cookii (Cook ' s lomatium) and Limnanthes floccosa ssp. grandiflora (large-flowered wooly meadowfoam) as endangered species under the Endangered Species Act of 1973, as amended (Act). We are re-opening the comment period to provide the public an opportunity to review additional information on the status, abundance, and distribution of these plants, and to request additional information and comments from the public regarding the proposed rule. Comments previously submitted need not be resubmitted as they will be incorporated into the public record as part of this extended comment period; all comments will be fully considered in the final rule. DATES: We will accept public comments until March 15, 2002. What was the EPA doing and why? What could those who had concerns do at that point?
Essay
Answer:
Tags
Choose question tag
close menu
arrow
Diego Air Sports (SDAS) Center operates a sports parachuting business in Otay Mesa, California. SDAS offers training to beginning parachutists and facilitates recreational jumping for experienced parachutists. It indicates that the majority of SDAS jumps occur at altitudes in excess of 5,800 feet. The jump zone used by SDAS overlaps the San Diego Traffic Control Area (TCA). Although the aircraft carrying the parachutists normally operate outside the TCA, the parachutists themselves are dropped through it. Thus, the air traffic controllers must approve each jump. In July 1987, an air traffic controller in San Diego filed an Unsatisfactory Condition Report with the Federal Aviation Administration (FAA), complaining of the strain that parachuting was putting on the controllers and raising safety concerns. The report led to a staff study of parachute jumping within the San Diego TCA. This was followed by a letter in March 1988 from the FAA to SDAS, informing SDAS that "[e]ffective immediately parachute jumping within or into the San Diego TCA in the Otay Reservoir Jump Zone will not be authorized." The FAA stated that the letter was final and appealable. SDAS challenged the letter in federal court on grounds that it constituted rulemaking without compliance with required Administrative Procedure Act (APA) procedures. Who is correct in this dispute and why? [ San Diego Air Sports Center, Inc. v. FAA, 887 F.2d 966 (9th Cir.)]
Essay
Answer:
Tags
Choose question tag
close menu
arrow
Santa Monica adopted a rent control ordinance authorizing the Rent Control Board to set the amount of rents that could be charged. At a hearing before it, the board determined that McHugh was charging his tenants a rent higher than the maximum allowed. McHugh claimed that the action of the board was improper because there was no jury trial. Is McHugh correct? Why or why not? [ McHugh v. Santa Monica Rent Control Board, 777 P.2d 911 (Cal.)]
Essay
Answer:
Tags
Choose question tag
close menu
arrow
Consumer Product Safety Commission is reconsidering a rule it first proposed in 1997 that would require child-resistant caps on household products, including cosmetics. When the rule was first proposed in 1997, it was resisted by the cosmetics industry and abandoned. However, in May 2001, a 16-month-old baby died after drinking baby oil from a bottle with a pulltab cap. The proposed rule would cover products such as baby oil and suntan lotion and any products containing hydrocarbons such as cleansers and spot removers. The danger, according to the commission, is simply the inhalation by children, not necessarily the actual ingestion of the products. Five children have died from inhaling such fumes since 1993, and 6,400 children under the age of five were brought into emergency rooms and/or hospitalized for treatment after breathing in hydrocarbons. There is no medical treatment for the inhalation of hydrocarbons. Several companies in the suntan oil/lotion industry have supported the new regulations. The head of a consumer group has said, "We know these products cause death and injury. That is all we need to know." 34 What process must the CPSC follow to promulgate the rules? What do you think of the consumer group head's statement? Will that statement alone justify the rulemaking?
Essay
Answer:
Tags
Choose question tag
close menu
arrow
FDA was challenged by tobacco companies for its new rules that required the tobacco companies to put one of the FDA's 12 picture labels on its packaging. The tobacco companies argued that their First Amendment rights were violated by the rules, forcing them to speak in a certain way using government-mandated materials. The new labels were promulgated by both the FDA and the Department of Health and Human Services (HHS) pursuant to authority granted by Congress in 2009 under the Family Smoking Prevention and Tobacco Control Act. Under the law, the following nine textual statements were to be included on cigarette labels: WARNING: Cigarettes are addictive. WARNING: Tobacco smoke can harm your children. WARNING: Cigarettes cause fatal lung disease. WARNING: Cigarettes cause cancer. WARNING: Cigarettes cause strokes and heart disease. WARNING: Smoking during pregnancy can harm your baby. WARNING: Smoking can kill you. WARNING: Tobacco smoke causes fatal lung diseases in nonsmokers. WARNING: Quitting smoking now greatly reduces serious risks to your health. The act required that these warnings and graphic labels take up 50 percent of the cigarette package label and 20 percent of all cigarette ads. After publishing the proposed rule and receiving more than 1,700 comments, the FDA published its final rule in June 2011. Explain how the tobacco companies could challenge the rules. Discuss whether the rules will be set aside. [In the case of R.J. Reynolds Tobacco Company et al. v. FDA et al., 696 F.3d 1205 (D.C. Cir.)]
Essay
Answer:
Tags
Choose question tag
close menu
arrow
Following the events of September 11, 2001, in which four airplanes crashed as a result of the presence of terrorists on those flights, the FAA concluded that it needed to implement new procedures for airports and flights. The new procedures for security and flights took effect when the airports reopened five days later. Why did the FAA not need to go through the promulgation and public comment processes and time periods to have the new rules take effect?
Essay
Answer:
Tags
Choose question tag
close menu
arrow
Macon County Landfill Corp. applied for permission to expand the boundaries of its landfill. Tate and others opposed the application. After a number of hearings, the appropriate agency granted the requested permission to expand. Tate appealed and claimed that the agency had made a wrong decision on the basis of the evidence presented. Will the court determine whether the correct decision was made? [ Tate v. Illinois Pollution Control Board, 544 N.E.2d 1176 (Ill. App.)]
Essay
Answer:
Tags
Choose question tag
close menu
arrow
Tacoma-Pierce County Health Department conducted an investigation into the quality of care provided by ambulance service providers in its jurisdiction. On the basis of that investigation, the department issued a set of temporary rules and regulations that established minimum requirements for equipment, drugs, and service availability for ambulance service providers in Pierce County. The Tacoma News wanted to publish an article on the matter and sought discovery of everything that had led to the adoption of the regulations, including all details of the investigation made by the health department. The health department objected to disclosing the names of the persons who had volunteered information on which the department had based its action and the names of the ambulance companies. Were the names subject to a Freedom of Information Act (FOIA) request? [ Tacoma News, Inc. v. Tacoma-Pierce County Health Dept., 778 P.2d 1066 (Wash. App.)]
Essay
Answer:
Tags
Choose question tag
close menu
arrow
Endangered Species Act (ESA) charges the National Marine Fisheries Service (a federal agency) with the duty to ensure that any proposed action by the Council does not jeopardize any threatened or endangered species. The Steller sea lion is on the list of endangered species. The agency developed a North Pacific marine fishery plan that permitted significant harvest of fish by commercial fisheries in the area. Greenpeace, an environmental group, challenged the agency on the grounds that the plan was not based on a sufficient number of biological studies on the impact of the allowed fishing on the Steller sea lion. Greenpeace's biologic opinion concluded that the fishery plan would reduce the level of food for the sea lions by about 40 percent to 60 percent, if the juvenile fish were not counted in that figure. Greenpeace's expert maintained that counting juvenile fish was misleading because they were not capable of reproducing and the government agency's figure was, as a result, much lower at 22 percent. What would Greenpeace need to show to be successful in challenging the agency's fishery plan? [Greenpeace, American Oceans Campaign v National Marine Fisheries Service, 237 F Supp 2d 1181 (WD Wash)]
Essay
Answer:
Tags
Choose question tag
close menu