Nondiscrimination on the basis of age in programs or activities receiving federal financial assistance from HHS. Final rules

These final regulations implement provisions of the Age Discrimination Act of 1975, and the general, governmentwide regulation published in the Federal Register on June 12, 1979, codified at 45 CFR Part 90. The Age Discrimination Act of 1975 prohibits discrimination on the basis of age in programs or activities receiving federal financial assistance. The Act also contains certain exceptions that permit, under limited circumstances, use of age distinctions or factors other than age that may have a disproportionate effect on the basis of age. The Act applies to persons of all ages. These final regulations are designed to guide the actions of recipients of financial assistance from HHS. The regulations incorporate the basic standards for determining what is age discrimination that were set forth in the general regulations. They discuss the responsibilities of HHS recipients and the investigations, conciliation and enforcement procedures HHS will use to ensure compliance with the Act.     

Drive-through deliveries: in support of federal legislation to mandate insurer coverage of medically sound minimum lengths of postpartum stay for mothers and newborns

President Clinton signed the Newborns' and Mothers' Health Protection Act of 1996 into law on September 26, 1996. The Act requires insurers that provide maternity benefits to cover medically sound minimum lengths of inpatient, postpartum stays according to the joint guidelines of the American Academy of Pediatrics and the American College of Obstetrics and Gynecology. This Note discusses the historical context in which the necessity for passage of protective legislation arose, the interplay between state and federal statutes that created the need for federal legislation to provide desired protections for postpartum patients, and examines the provisions of the Act. This Note endorses the Newborns' and Mothers' Health Protection Act of 1996 as federal legislation necessary to protect postpartum patients from medically inappropriate insurer mandates while still allowing medical providers and their patients flexibility in medical decision making in the postpartum period.     

Forgotten Children of Immigration and Family Law: How The Absence of Legal Aid Affects Children in the United States

The absence of government‐appointed legal counsel in immigration proceedings adversely affects large numbers of children in the United States. Children born in the United States to parents without citizenship status (U.S.‐born children of noncitizen parents or UCNP) are harmed by a parent's detention and removal. Unaccompanied alien children (UAC) who have entered the country without legal status are adversely affected by their own detention and removal. The possibility of obtaining relief from removal is drastically diminished by the lack of legal representation. Currently UAC and immigrant parents are not entitled to court‐appointed attorneys. Any meaningful change in immigration law, such as a federal statutory amendment to provide UAC and immigrant parents with government‐appointed counsel is unlikely due to the present political dissension in Congress regarding this issue. Because UAC and immigrant parents are not entitled to government‐funded legal representation, a pro bono legal service system has developed, but is unable to meet the present need adequately. For immigrant parents, this Note proposes the adoption of a statute to allow the appointment of court liaisons in family court proceedings. The court liaison is a nonattorney who is familiar with the processes of the family court and ensures that immigrant parents are fully informed regarding all pertinent family court proceedings. For UAC, this Note proposes an amendment to the William Wilberforce Trafficking Victims Protection Reauthorization Act to mandate the appointment of a child advocate to all UAC. The child advocate is not a lawyer, but works with the UAC's attorney to provide the child with legal representation and advocacy.

Key Points for the Family Court Community:
• UCNP confront the loss of parents to detention and removal. Children are condemned to limbo, torn between absent biological parents and placement in foster care.
• The recent surge in the number of UAC who enter the United States by crossing the border from Mexico has been described as a humanitarian crisis. These children often remain alone without legal protection, vulnerable to detention and removal.
• Ideally, UAC and the immigrant parents would be provided with government‐funded legal representation in immigration proceedings. In the absence of the federal statutory reform necessary to make that a reality, state statutory reform to allow for the provision of court liaison programs for immigrant parents and federal statutory reform to allow the appointment of child advocates for UAC can begin to offer children and families needed legal support and advocacy.

     

Substance Abuse and Mental Health Services Administration; requirements applicable to protection and advocacy of individuals with mental illness; final rule--Center for Mental Health Services, SAMHSA. Final rule

On December 14, 1994, the Department of Health and Human Services (Department or HHS) published a Notice of Proposed Rulemaking to comply with the requirements of section 116 of the Protection and Advocacy for Mentally III Individuals Act of 1986 (Act) (42 U.S.C. 10801 et seq.) which required that the Secretary promulgate regulations for the implementation of authorized activities of Protection and Advocacy (P&A) Systems to protect and advocate the rights of individuals with mental illness. The Department is issuing this final rule to implement Titles I and III of the Act. These regulations will govern activities carried out by the P&A systems under the Act. The rule includes: definitions: basic requirements regarding determination of, eligibility for and use of allotments, grant administration, eligibility for protection and advocacy services, annual and financial status reports, and remedial actions; and requirements regarding program administration, priorities, the conduct of P&A activities, access of the P&As to residents, facilities and records and confidentiality. DATES: Effective Date: This regulation is effective November 14, 1997 except for the information collection requirements in sections 51.8, 51.10, 51.23 and 51.25. These sections will become effective upon approval under the Paperwork Reduction Act. A notice of approval will appear in the Federal Register.     

State hazardous waste programs; procedures for revision of state RCRA programs--EPA. Proposed rule

EPA is today proposing to amend its requirements under 40 CFR 271.21(e) (formerly Section 123.13(e)) for the approval and revision of authorized state hazardous waste programs. One purpose is to ensure that states applying for final authorization under the Resource Conservation and Recovery Act of 1976, as amended, (RCRA) do not have to revise their programs and applications to respond to federal regulatory changes occurring while the states' applications are being prepared or processed. The second purpose is to provide all authorized states with one full year (or two years, if there is a need for state legislative action) from the effective date of amended federal regulations to make the revisions in their programs required by such federal amendments. This action would provide the state with an additional six months since the existing regulation requires that program revisions be made within one year (or two years) after the promulgation of amended federal regulations.     

PROTECTING OUR CHILDREN FROM SEX OFFENDERS: HAVE WE GONE TOO FAR?

On July 27, 2006, U.S. President George W. Bush signed into law the Adam Walsh Child Protection and Safety Act. This federal statute was created to serve as a tougher, more modern improvement of its predecessor in the ongoing effort to protect children from dangerous sexual predators. However, the Act did not amend the controversial federal mandate that all 50 states include the crimes of kidnapping and false imprisonment against a minor, committed by a nonparent, and without any sexual motivation or misconduct, as a crime requiring a wrongdoer to register as a sex offender. This Note demonstrates how the kidnapping and false imprisonment requirements of the Adam Walsh Act have led to a misuse of state sex offender registries to the detriment of the children they claim to protect. The solution that this Note proposes will provide each individual state with the freedom to decide how, if at all, these contentious offenses will fit into its sex offender registry, taking into consideration the state's unique statutory language, available child protective resources, and constitutional limitations. As a result, petty criminals who do not pose any real or specific threat to children will no longer be grouped with the most dangerous and violent sexual predators, child protective funds will be better utilized, and the public's attention will be refocused on the real threats to children, thereby satisfying the spirit and purpose of the Adam Walsh Act.     

Minimum funding requirements and minimum funding excise taxes--Internal Revenue Service. Notice of proposed rulemaking

This document contains proposed regulations relating to the minimum funding requirements for employee pension benefit plans, and to excise taxes for failure to meet the minimum funding standards. Changes to the applicable tax law were made by the Employee Retirement Income Security Act of 1974. The regulations would provide the public with guidance needed to comply with that Act and would affect all pension plans subject to the provisions of the Act. The proposed amendments would apply generally for plan years beginning after 1975, but earlier (or later) in the case of some plans as provided for meeting the minimum funding requirements under the Act. The proposed rules pertaining to the frequency of actuarial valuations, and to the time for making contributions, generally would not be effective prior to the publication of final regulations.     

Cost principles for nonprofit organizations--Office of Management and Budget. Notice

This notice offers interested parties an opportunity to comment on a proposed revision to Circular A-122, "Cost Principles for Nonprofit Organizations." The proposed revision establishes special provisions for costs related to political advocacy. Similar revisions are being simultaneously proposed for civilian and defense contractors through appropriate actions by the Department of Defense, NASA and GSA, the three agencies with authority to issue procurement regulations. The purpose of these proposals is to ensure that federal tax dollars are not used, directly or indirectly, for the support of political advocacy. Over the past 25 years, the volume of federal activity conducted through grantees and contractors has dramatically grown. Sound management of federal grants and contracts has correspondingly gained in importance. The responsibility of the President through OMB to improve the management of the executive branch of government with a view to efficient and economical service, and to fulfill other statutory and constitutional responsibilities, extends to issues of grant and contract management no less than to issues of direct federal activity.     

CLOUD act agreements from an EU perspective

For many years, transatlantic cooperation between the EU and the US in the area of personal data exchange has been a subject of special interest on the part of lawmakers, courts – including supranational ones – NGOs and the public. When implementing recent reform of data protection law, the European Union decided to further strengthen guarantees of the protection of privacy in cyberspace. At the same time, however, it faced the practical problem of how to ensure compliance with these principles in relation to third countries. The approach proposed in the GDPR, which is based on a newly-defined territorial scope of application, clearly indicates an attempt to apply EU rules extraterritorially in relation to data processors in third countries.Irrespective of EU activity, the United States has also introduced its own regulations addressing the same problem. An example is the federal law adopted in 2018, specifying how to execute national court orders for the transfer of electronic data. The CLOUD Act was established in response to legal doubts raised in the Microsoft v United States case regarding the transfer of electronic data stored in the cloud by US obliged entities to law enforcement authorities, as well as in cases where this data is physically located in another country and its transfer could result in violating the legal norms of a foreign jurisdiction. The CLOUD Act also facilitates bilateral international agreements that enable the cross-border transfer of e-evidence for the purposes of ongoing criminal proceedings. Both the content of the new regulations and the model proposed by the US legislature for future agreements concluded on the basis of the CLOUD Act can be seen as an alternative to regulations arising from EU law.The purpose of this paper is to analyse the CLOUD Act and CLOUD Act Agreements from the perspective of EU law and, in particular, attempt to answer the question as to whether this new legal mechanism brings the EU and the USA closer to finding common ground with regard to a coherent model of exchange and protection of personal data.     

Severely handicapped infants with life-threatening conditions: federal intrusions into the decision not to treat

In recent years the federal government has attempted to intervene in certain family-medical decisions to withhold treatment from seriously handicapped newborns with life-threatening conditions. Invoking section 504 of the Rehabilitation Act of 1973, which prohibits discrimination against "otherwise qualified handicapped" individuals, the Reagan Administration promulgated regulations allowing federal government investigations of such decisions. Recently, the U.S. Supreme Court upheld lower court decisions invalidating these "Baby Doe" regulations. The federal government's fall-back position is reflected in the Child Abuse Prevention and Treatment Amendments of 1984, requiring states accepting funds under the Child Abuse Prevention and Treatment Act to establish and maintain procedures to assure that cases of medical neglect of handicapped infants are investigated by the states. Although the primary oversight of parental decision-making has been returned to the states where it has traditionally belonged, the federal government's definition of medical neglect of handicapped infants with life-threatening conditions is an ethically inadequate response to the complex needs of the handicapped child, the family, the medical profession, and society as a whole. After examining the relevance of Kantian, utilitarian, and Rawlsian ethical positions, the author contends that an effective governmental policy, capable of enforcement and acceptance by the public, must utilize the strengths of each philosophy and reflect the pragmatism of American society.     

Special report on labor and employment. The Department of Labor issues final regulations for the federal Family and Medical Leave Act

The FMLA is a complicated and comprehensive regulatory scheme, and it is impossible to review any but the most basic provisions in this article. The final regulations provide very detailed guidance on such issues as benefits continuation, reinstatement rights, notice requirements, and enforcement measures. Personnel policies and practices must be revised to be consistent with these final regulations, and care must be taken that leave policies do not restrict rights under the FMLA or unintentionally create expanded leave rights. In complying with the FMLA, employers must also keep in mind that there are complex interplays between the federal FMLA, state laws that provide family and medical leave, the Americans with Disabilities Act, and state workers' compensation laws, that can require expert advice depending on the particular circumstances.     

Pushing the environmental regulatory focus a step back: controlling the introduction of new chemicals under the Toxic Substances Control Act.

Environmental destruction and its attendant effects on the animal world, including human beings, has moved to the forefront of United States and worldwide policy. The effect of this deterioration on human health is unclear. Much debate focuses on the cases of cancer, along with other diseases, that are environmentally induced. Congress has responded with various environmental laws. These laws focus primarily on controlling chemicals placed into the environment, largely by industry. This Note proposes that such a singular focus is inadequate and ultimately costly. A more sensible and efficient strategy to environmental protection places emphasis on controlling inputs to the productive process before the need arises to contain such substances. The Toxic Substances Control Act of 1976 ("TSCA") takes this approach. This Note reviews the means by which TSCA attempted to accomplish its goals and concludes that TSCA's implementation has largely been ineffective. The Note then discusses three possible explanations for TSCA's failure. Finally, the Note proposes how TSCA might be made more effective in regulating new chemicals.     

Regulatory Science and the Data Quality Act

The importance of data quality was highlighted in an amendment attached to a 2000 law enacted by the 106th U.S. Congress. The law known as the “Data Quality Act” or the “Information Quality Act,” mandated that the Office of Management and Budget (OMB) issue guidance to federal agencies for “ensuring and maximizing the quality, objectivity, utilility, and integrity of information (including statistical information) disseminated by federal agencies.” In turn, OMB required more than 90 federal agencies such as the United States Environmental Protection Agency (EPA) to implement data quality guidelines. These guidelines have created a rigorous, if not rancorous, debate within the regulated community. This paper will provide a brief synopsis of the evolution of the Act, discuss how the Act and scientific uncertainty interrelate, and review the status of the Act's petition process for correcting government disseminated information.     

The Uniform Status of Children of Assisted Conception Act: does it protect the best interests of the child in a surrogate arrangement?

Medical technology is easing the plight of many infertile couples by offering such reproductive alternatives as in vitro fertilization, artificial insemination and surrogacy. In response to the changes in our society's definition of family, wrought by scientific advances, the National Conference of Commissioners on Uniform States Laws promulgated the Uniform Status of Children of Assisted Conception Act. The purpose of this Act is to protect the interests of children born through extraordinary medical procedures. This Note analyzes the Act's provisions regarding surrogacy and focuses on how the Commission's regulatory scheme fails to protect the child's interests. The Act's alternative of voiding the surrogacy contract also does not protect the child's interests. A more complete regulatory scheme which protects the adult parties' interests, as well as the child's, should be devised, as the adequacy of the adult parties' protection ultimately affects the child's well-being.     

Application of the HIPAA privacy rule to employer benefit plans and a compliance theory of statutory interpretation

The application of the federal privacy regulations promulgated pursuantto the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to employer benefit plans is arguably the most conceptually difficult area of a complex law. A purely textual reading of the Rule, when applied to employer plans, results in varying interpretations on some significant issues and puzzling results on others. This Article offers a practical approach for interpreting the rule when clear-cut answers are not provided by the text and DHHS guidance is nonexistent or unclear. In addition, this approach can be applied to the interpretation of other statutes and regulations.     

The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing

On January 4, 2002, President Bush signed into law the Best Pharmaceuticals for Children Act, which is the government's most comprehensive legislation regarding pediatric research to date. The Act offers pharmaceutical companies a six-month exclusivity term in return for their agreement to conduct pediatric tests on drugs. It also provides public funding and organizes private funding to help conduct pediatric research on those drugs that pharmaceutical companies opt not to test in children. This Note reviews the history of pediatric research and traces the development of the Best Pharmaceuticals for Children Act's unique incentive and public funding structure. The Note contends that, while the Act is comprehensive and promotes important pediatric studies, its incentive structure forces consumers and taxpayers to bear the costs of testing pharmaceuticals in children instead of the manufacturers who research, develop, and market those drugs. Congress should consider mandating pediatric studies in any future enactment of the legislation.     

Legal recourse for the cancer patient-returnee: the Rehabilitation Act of 1973

Recent advances in medical research have dramatically improved the survival rate for individuals with a history of cancer. Large numbers of these "cancer patient-returnees" encounter job discrimination since many employers believe that to hire or maintain them would pose substantial future business risks. This Note argues that cancer patient-returnees may seek relief under the Rehabilitation Act of 1973. The Note concludes that an employer's costs arising out of future risks are too insignificant to justify denial of job opportunities to cancer patient-returnees under the Act.     

Medicare, Medicaid, and Maternal and Child Health Services Block Grant programs; civil money penalties and assessments for false or improper claims--Department of Health and Human Services. Notice of proposed rulemaking

These proposed regulations are intended to strengthen the Department's ability to protect the health care financing programs against persons and organizations who defraud and abuse those programs. The regulations would specify procedures for implementing the authority provided to the Department by section 2105 of the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), as amended by section 137(b)(26) of the Tax Equity and Fiscal Responsibility Act of 1982 (Pub. L. 97-248), to impose civil money penalties and assessments administratively for the filing of false or certain other improper claims in the Medicare, Medicaid, or Maternal and Child Health Services Block Grant programs. The statute also permits an individual upon whom the Department imposes a civil money penalty or assessment to be suspended from participation in the Medicare and Medicaid programs. Until enactment of the civil money penalties legislation, the federal government had to rely upon litigation under the False Claims Act or criminal proceedings in order to compel restitution of funds falsely or improperly claimed under HHS health care financing programs.     

Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions

Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.     

A Need Not Being Met: Providing Paid Family and Medical Leave for All Americans

Many parents in the United States face the quandary of whether to take time off from work to care for themselves, their children, or other family member, understanding that their jobs may not be there upon return and they will receive no income during their leave. The Family and Medical Leave Act has not lifted this burden; it only provides for unpaid leave. Four states and several cities have implemented paid family and medical leave statutes with both employees and employers benefiting. This Note proposes a uniform paid family and medical leave statute based on other countries’ statutes; proposed federal legislation; and statutes in New York, California, and San Francisco.