Registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule.     

Administrative detention of food for human or animal consumption under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation that provides procedures for the detention of an article of food, if an officer or qualified employee of FDA has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals ("administrative detention"). The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which authorizes the use of administrative detention and requires regulations establishing procedures for instituting on an expedited basis certain enforcement actions against perishable food subject to a detention order.     

Exemption of certain systems of records under the Privacy Act. Final rule

This final rule exempts four systems of records (SORs) from subsections (c)(3), (d)(1) through (d)(4), (e)(4)(G) and (H), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2): The Automated Survey Processing Environment (ASPEN) Complaint/ Incidents Tracking System (ACTS), HHS/CMS, System No. 09-70-0565; the Health Insurance Portability and Accountability Act (HIPAA) Information Tracking System (HITS), HHS/CMS, System No. 09-70-0544; the Organ Procurement Organizations System (OPOS), HHS/CMS, System No. 09-70- 0575; and the Fraud Investigation Database (FID), HHS/CMS, System No. 09-70-0527.     

Health maintenance organizations--PHS. Final rule

This rule amends the Public Health Service regulations on health maintenance organizations (HMOs) to elaborate on the 1981 amendments to the HMO statute regarding member protection in the event of insolvency, community rating by class, and primary care within the service area of a non-metropolitan HMO. In addition, the rule removes regulatory provisions that are considered unnecessary or burdensome, such as the specification of contractual provisions, and increases one of the regulatory limits on copayments to permit HMOs to become more competitive. These amendments are made after consideration of public comments on the notice of proposed rulemaking (NPRM) published on March 22, 1983.     

Health maintenance organizations--PHS. Final rule; confirmation of interim rule

This document finalizes, without change, the interim rule published on January 12, 1983, that amends the Public Health Service regulations on Federal qualification of health maintence organizations (HMOs) to provide for greater flexibility for already existing prepaid health care delivery systems to become transitionally qualified HMOs.     

Public Health Service policies on research misconduct. Final rule

This final rule removes 42 CFR part 50, subpart A, "Responsibilities of Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science," and replaces it with a new, more comprehensive part 93, "Public Health Service Policies on Research Misconduct." The proposed part 93 was published for public comment on April 16, 2004. The final rule reflects both substantive and non-substantive amendments in response to public comments and to correct errors and improve clarity, but the general approach of the NPRM is retained. The purpose of the final rule is to implement legislative and policy changes applicable to research misconduct that occurred over the last several years, including the common Federal policies and procedures on research misconduct issued by the Office of Science and Technology Policy on December 6, 2000.     

Public Health Service--Grants for allied health projects. Final rule

These regulations set forth requirements for grants to: (a) Establish regional or State systems to assure that allied health and nursing personnel needs in the area are met by coordinating and managing allied health professions and nursing education and training within and among educational institutions and their clinical affiliates; (b) Establish or improve recruitment, training, and retraining programs for allied health personnel; and (c) Establish career ladders and advancement programs for practicing allied health personnel. These regulations implement section 796 of the Public Health Service Act.     

Exemption of certain systems of records under the Privacy Act. Proposed rule

This proposed rule would exempt the four system of records from subsections (c)(3), (d)(1) through (d)(4),(e)(4)(G) and (H), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a (k)(2): The Automated Survey Processing Environment (ASPEN) Complaint/Incidents Tracking System ("ACTS"), HHS/CMS, System No. 09-70-0565; the Health Insurance Portability and Accountability Act (HIPAA) Information Tracking System ("HITS"), HHS/CMS, System No. 09-70-0544; the Organ Procurement Organizations System ("OPOS"), HHS/CMS, System No. 09-70-0575; and the Fraud Investigation Database ("FID"), HHS/CMS, System No. 09-70-0527.     

Occupational Safety and Health Administration--Access to employee exposure and medical records. Final rule

This final occupational safety and health standard, promulgated today as a revised 29 CFR 1910.20, provides for employee, designated representative, and OSHA access to employer-maintained exposure and medical records relevant to employees exposed to toxic substances and harmful physical agents. Access is also assured to employer analyses using exposure and medical records. The final standard requires long term preservation of these records, contains provisions concerning informing employees of their rights under the standard, and includes provisions protective of trade secret information.     

The Veterans Millennium Health Care and Benefits Act. Department of Veterans Affairs. Final rule

This document amends Department of Veterans Affairs (VA) adjudication regulations to reflect changes made by the Veterans Millennium Health Care and Benefits Act. These changes concern payment of dependency and indemnity compensation to the surviving spouses of certain former prisoners of war; the provision of health care, education and home loan benefits to surviving spouses upon termination of their remarriages; and the addition of bronchiolo-alveolar carcinoma to the list of diseases that VA presumes are the result of exposure to radiation during active military service.     

Medical loss ratio requirements under the Patient Protection and Affordable Care Act. Final rule

This final rule amends the regulations implementing medical loss ratio (MLR) standards for health insurance issuers under the Public Health Service Act in order to establish notice requirements for issuers in the group and individual markets that meet or exceed the applicable MLR standard in the 2011 MLR reporting year.     

Public Health Service--Grants for graduate programs in health administration. Final rule

This rule sets forth requirements for Programs for Grants for Graduate Programs in Health Administration under section 791 of the Public Health Service Act (42 U.S.C. 295h), as amended by the Health Professions Educational Assistance Act of 1976 (Pub. L. 94-484).     

Medicaid program; eligibility changes under the Affordable Care Act of 2010. Final rule, Interim final rule

This final rule implements several provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). The Affordable Care Act expands access to health insurance coverage through improvements to the Medicaid and Children's Health Insurance (CHIP) programs, the establishment of Affordable Insurance Exchanges ("Exchanges"), and the assurance of coordination between Medicaid, CHIP, and Exchanges. This final rule codifies policy and procedural changes to the Medicaid and CHIP programs related to eligibility, enrollment, renewals, public availability of program information and coordination across insurance affordability programs.     

Omnibus Budget Reconciliation Act of 1993--VA. Final rule

This document amends the Department of Veterans Affairs (VA) adjudication regulations to extend the date concerning limitation of pension benefits for veterans and surviving spouses receiving Medicaid-covered nursing home care. This amendment is necessary to conform the regulations to statutory provisions.     

Technical revisions to conform to the Caregivers and Veterans Omnibus Health Services Act of 2010. Final rule

This final rule amends Department of Veterans Affairs (VA) medical regulations to incorporate statutory amendments. Certain statutes authorizing VA health care benefits were amended by the Caregivers and Veterans Omnibus Health Services Act of 2010. The statutory amendments affect enrollment in certain health care priority categories and exempt catastrophically disabled veterans from copayment requirements.     

Public Health Service--Health maintenance organizations; requirements for a health maintenance organization. Final regulations

This rule amends the Public Health Service regulations by setting forth revised requirements for the organization and operation of federally qualified health maintenance organizations (HMOs). These amendments are made as a result of (1) public comments on the interim regulations published on July 18, 1979, and (2) public comments on the notice of proposed rulemaking (NPRM) governing relationships between federally qualified HMOs and other parties, also published on July 18, 1979.     

Bioterrorism meets privacy: an analysis of the Model State Emergency Health Powers Act and the HIPAA privacy rule

Ms. Bruce's paper analyzes the interplay between the Model State Emergency Health Powers Act and the HIPAA Privacy Rule. The article begins by examining specific relevant provisions of the Act and Rule. Next, it traces the history of public health law through the court system and then uses this foundation to discuss how the Model State Emergency Health Powers Act and the HIPAA Privacy Rule could co-exist, protecting Americans in the case of a bioterror attack, while being appropriately sensitive to the confidentiality of private health information.     

Implementation of the Methamphetamine Production Prevention Act of 2008. Final rule

In October 2008, the President signed the Methamphetamine Production Prevention Act of 2008 (MPPA), which clarifies the information entry and signature requirements for electronic logbook systems permitted for the retail sale of scheduled listed chemical products. On March 23, 2010, DEA published a Notice of Proposed Rulemaking to implement the provisions of the MPPA and make its regulations consistent with the new requirements. This action finalizes without change the Notice of Proposed Rulemaking published on March 23, 2010. The Final Rule will make it easier for regulated sellers to maintain electronic logbooks by allowing greater flexibility as to how information may be captured.