Recordkeeping and reporting requirements for drug products containing gamma-hydroxybutyric acid (GHB). Final rule

DEA is amending its regulations to require additional recordkeeping and reporting requirements for drug products containing gamma-hydroxybutyric acid (GHB) for which an application has been approved under the Federal Food, Drug, and Cosmetic Act. DEA makes these changes under section 4 of the "Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000." These additional requirements are necessary to protect against the diversion of GHB for illicit purposes.     

Medicaid program; citizenship documentation requirements. Final rule

This final rule amends Medicaid regulations to implement the provision of the Deficit Reduction Act that requires States to obtain satisfactory documentary evidence of an applicant's or recipient's citizenship and identity in order to receive Federal financial participation. It also incorporates changes made to these requirements through section 405(c)(1)(A) of Division B of the Tax Relief and Health Care Act (TRHCA), Pub. L. 109-432, enacted December 20, 2006. This regulation provides States with guidance on the types of documentary evidence that may be accepted, including alternative forms of documentary evidence in addition to those described in the statute and the conditions under which this documentary evidence can be accepted to establish the applicant's citizenship.     

Over-the-counter human drugs; labeling requirements. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products. This final rule is intended to assist consumers in reading and understanding OTC drug product labeling so that consumers may use these products safely and effectively. This final rule will require all OTC drug products to carry the new, easy-to-read format and the revised content requirements within prescribed implementation periods.     

Prescriptions; dispensing controlled substances in institutional practitioner emergency rooms--Drug Enforcement Administration, Justice. Withdrawal of proposed rule

A Notice of Proposed Rulemaking published on September 17, 1982, would have amended Part 1306 of Title 21 of the Code of Federal Regulations to permit hospital emergency room personnel to dispense controlled substances to nonpatients when alternate pharmacy services were not available. This proposed action was initiated in response to requests from various state agencies and hospitals. After assessing the comments and objections to the proposal, the Drug Enforcement Administration (DEA) has determined that the need for the proposed rule change has not been established at this time and the proposal is therefore withdrawn for further study.     

Over-the-counter human drugs; labeling requirements; final rule; technical amendment. Food and Drug Administration, HHS. Final rule; technical amendment

The Food and Drug Administration (FDA) is amending the regulation that established a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products, and is amending several related OTC drug product labeling regulations. This amendment corrects and conforms several aspects of the new labeling requirements to other regulatory provisions and eliminates unnecessary text from the new labeling regulation.     

Schedule for rating disabilities; AL amyloidosis (primary amyloidosis). Final rule

The Department of Veterans Affairs (VA) is amending its Schedule for Rating Disabilities by updating the schedule of ratings for the hemic and lymphatic systems to include AL amyloidosis. This regulatory action is necessary to add AL amyloidosis as one of the disease conditions and establish criteria for disability evaluation to fully implement the decision by the Secretary of Veterans Affairs to grant presumptive service connection based on herbicide exposure for this disease. The intended effects are to provide consistency in disability ratings and to ease tracking of AL amyloidosis for statistical analysis.     

Respiratory protection--OSHA. Final rule; request for comment on paperwork requirements

This final standard, which replaces the respiratory protection standards adopted by OSHA in 1971 (29 CFR 1910.134 and 29 CFR 1926.103), applies to general industry, construction, shipyard, longshoring, and marine terminal workplaces. The standard requires employers to establish or maintain a respiratory protection program to protect their respirator-wearing employees. The standard contains requirements for program administration; worksite-specific procedures; respiratory selection; employee training; fit testing; medical evaluation; respiratory use; respirator cleaning, maintenance, and repair; and other provisions. The final standard also simplifies respirator requirements for employers by deleting respiratory provisions in other OSHA health standards that duplicate those in the final standard and revising other respirator-related provisions to make them consistent. In addition, the standard addresses the use of respirators in Immediately Dangerous to Life or Health (IDLH) atmospheres, including interior structural firefighting. During interior structural firefighting (an IDLH atmosphere by definition), self-contained breathing apparatus is required, and two firefighters must be on standby to provide assistance or perform rescue when two firefighters are inside the burning building. Based on the record in this rulemaking and the Agency's own experience in enforcing its prior respiratory protection standards, OSHA has concluded that compliance with the final rule will assist employers in protecting the health of employees exposed in the course of their work to airborne contaminants, physical hazards, and biological agents, and that the standard is therefore necessary and appropriate. The final respiratory protection standard covers an estimated 5 million respirator wearers working in an estimated 1.3 million workplaces in the covered sectors. OSHA's benefits analysis predicts that the standard will prevent many deaths and illnesses among respirator-wearing employees every year by protecting them from exposure to acute and chronic health hazards. OSHA estimates that compliance with this standard will avert hundreds of deaths and thousands of illnesses annually. The annual costs of the standard are estimated to be $111 million, or an average of $22 per covered employee per year.     

Continuation coverage requirements applicable to group health plans. Internal Revenue Service (IRS). Treasury. Final rule

The Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA) added health care continuation requirements that apply to group health plans. Coverage required to be provided under those requirements is referred to as COBRA continuation coverage. Proposed regulations interpreting the COBRA continuation coverage requirements were published in the Federal Register of June 15, 1987 and of January 7, 1998. This document contains final regulations based on these two sets of proposed regulations. The final regulations also reflect statutory amendments to the COBRA continuation coverage requirements since COBRA was enacted. A new set of proposed regulations addressing additional issues under the COBRA continuation coverage provisions is being published elsewhere in this issue of the Federal Register. The regulations will generally affect sponsors of and participants in group health plans, and they provide plan sponsors and plan administrators with guidance necessary to comply with the law.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human). Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is taking this action as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood products, including blood derivatives.     

Healthy Tomorrows Partnership for Children program (HTPC). Final rule

This Final Rule sets forth the Secretary's proposal to require HTPC grant recipients to contribute non-Federal matching funds in years 2 through 5 of the project period equal to two times the amount of the Federal Grant Award or such lesser amount determined by the Secretary for good cause shown.     

Temporary Assistance for Needy Families program (TANF). Administration for Children and Families, HHS. Final rule

The Administration for Children and Families (ACF) issues regulations governing key provisions of the new welfare block grant program enacted in 1996--the Temporary Assistance for Needy Families, or TANF, program. It replaces the national welfare program know as Aid to Families with Dependent Children (AFDC) and the related programs known as the Job Opportunities and Basic Skills Training Program (JOBS) and the Emergency Assistance (EA) program. These rules reflect new Federal, State, and Tribal relationships in the administration of welfare programs; a new focus on moving recipients into work; and a new emphasis on program information, measurement, and performance. They also reflect the Administration's commitment to regulatory reform.     

Addition of medical criteria for evaluating Down syndrome in adults. Social Security Administration (SSA). Final rule

We are adding a new listing to evaluate non-mosaic Down syndrome in adults. Our current regulations only include a listing for evaluating Down syndrome in children; we evaluate claims filed by adults with Down syndrome under other listings. We are establishing a separate adult listing for this disorder to acknowledge its lifelong impact and severity. We expect that these final rules will simplify and expedite our adjudication of claims filed by adults with non-mosaic Down syndrome.     

Extension of expiration date for the respiratory body system listings. Social Security Administration (SSA). Final rule

We adjudicate claims at the third step of our sequential evaluation process for evaluating disability using the Listing of Impairments (the Listings) under the Social Security and Supplemental Security Income (SSI) programs. This final rule extends until July 2, 2002, the date on which the respiratory body system listings will no longer be effective. We have made no revisions to the medical criteria in these listings; they remain the same as they now appear in the Code of Federal Regulations. This extension will ensure that we continue to have medical evaluation criteria in the listings to adjudicate claims for disability based on impairments in the respiratory body system at step three of our sequential evaluation process.     

Medical devices; exception from general requirements for informed consent. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled "Medical Devices; Exception From General Requirements for Informed Consent." This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. This final rule adds a requirement that the investigator submit the required documentation to FDA, in addition to submitting it to the reviewing Institutional Review Board (IRB).     

Medicare and Medicaid; requirements for long term care facilities--HCFA. Final rule

These final regulations revise and consolidate the requirements that facilities furnishing long term care are required to meet to participate in either or both the Medicare and Medicaid programs. They revise our February 2, 1989 (54 FR 5316) final regulations to reflect our response to comments submitted by the public and to conform them to statutory provisions that were not in effect when we issued the prior rule, and to include various minor and technical changes in the requirements made by the Omnibus Budget.     

Medicare and Medicaid; requirements for long term care facilities--HCFA. Final rule

In Federal Register document 91-22274, published on Thursday, September 26, 1991, beginning on page 48826, we amended Medicare and Medicaid rules applicable to requirements for long term care facilities. In addition to correcting typographical errors, we are making a limited number of technical corrections to our September 26, 1991 document to take into account changes made by other regulations, but not included in the document, or inconsistencies between preamble statements and the regulations text. All such technical corrections are explained in the preamble to this rule.     

Governing body requirements for health systems agencies--PHS. Final rule

This rule amends the portion of the Health Systems Agency Designation and Funding Regulation (March 26, 1976) prescribing the composition of health systems agency governing bodies and deletes the subsection of that regulation which limits the number of consecutive years a governing body member may serve. This rule is being issued pursuant to a court order.     

Clarification of registration requirements for individual practitioners. Final rule

The Drug Enforcement Administration (DEA) is amending its registration regulations to make it clear that when an individual practitioner practices in more than one State, he or she must obtain a separate DEA registration for each State. This amendment will make it easier for practitioners to understand the requirements of the Controlled Substances Act and its implementing regulations.