Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Final rule

The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).     

Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule; correction--FDA. Proposed rule; correction

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of June 16, 1998 (63 FR 32772). The document proposed to amend the FDA regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The document was published with an error. This document corrects that error.     

Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license; correction--FDA. Proposed rule; correction

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of July 31, 1998 (63 FR 40858). The document proposed to amend the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Services Act. The document published with an incorrect address. This document corrects that error.     

Quality mammography standards; correcting amendment--FDA. Final rule; correcting amendment

The Food and Drug Administration (FDA) is correcting its regulations governing mammography, published in a document entitled "Quality Mammography Standards" that appeared in the Federal Register of October 28, 1997. The regulations are effective April 28, 1999; except section 900.12(b)(8)(i), (e)(4)(iii)(B), and (e)(5)(i)(B), which become effective October 28, 2002. The October 28, 1997, document was published with some inadvertent typographical errors. Some of those errors were corrected in a document entitled "Quality Mammography Standards; Correction" that appeared in the Federal Register of November 10, 1997, but additional typographical errors occurred in the publication of this document. In addition, since November 10, 1997, certain other problems with the text of the regulations have been identified that, if uncorrected, would lead to unforeseen and undesirable consequences. This document corrects those errors.     

Biological technical amendment--FDA. Final rule; technical amendment

The Food and Drug Administration (FDA) is amending the biologics regulations to make a minor, technical amendment. The pressure stated at which a sustained sterilization temperature is attained is incorrect. This document corrects that error.     

Investigational new drug applications; clinical holds; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing investigational new drug applications (IND's) for human drug and biological products. This proposed action would amend the IND clinical hold requirements to state that the agency will respond in writing to a sponsor's request that a clinical hold be removed from an investigation within 30-calendar days of the agency's receipt of the request and the sponsor's complete response to the issue(s) that led to the clinical hold. This proposed action is being taken in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). This proposed rule is a companion document to a direct final rule published elsewhere in this issue of the Federal Register. If FDA receives any significant adverse comment, the direct final rule will be withdrawn, and the comments will be considered in the development of a final rule using usual notice-and-comment rulemaking based on this proposed rule.     

Medicare program; physician financial relationships with, and referrals to, health care entities that furnish clinical laboratory services and financial relationship reporting requirements--HCFA. Final rule with comment period

This final rule with comment period provides that, if a physician or a member of a physician's immediate family has a financial relationship with an entity, the physician may not make referrals to the entity for the furnishing of clinical laboratory services under the Medicare program, except under specified circumstances. It contains revisions to our proposal of March 11, 1992, based on comments submitted by the public. Further, it incorporates the new expansions and exceptions created by the Omnibus Budget Reconciliation Act of 1993 and the amendments in the Social Security Act Amendments of 1994 (SSA '94), that are related to referrals for clinical laboratory services and have a retroactive effective date of January 1, 1992. In addition, we are responding to comments received on the interim final rule with comment period (published on December 3, 1991) that set forth Medicare reporting requirements for the submission by certain health care entities of information about their relationships with physicians. That document implemented the reporting requirements of section 1877(f) of the Social Security Act. This rule revises those requirements to incorporate the amendments to section 1877(f) made by SSA '94, to apply to any further reporting we may require.     

Medicare program; Medicare coverage of screening mammography; correction--HCFA. Correcting amendment

This document corrects a technical error that appeared in the final regulations published in the Federal Register on September 30, 1994 (59 FR 49826). Those regulations, in part, established conditions for coverage of diagnostic mammography that are similar to those we had established for screening mammography. This correcting amendment restates the applicability of diagnostic mammography to men as well as to women.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); Program for Persons with Disabilities; basic program--DoD. Final rule; administrative corrections

The Department of Defense published a final rule concerning the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) on June 30, 1997 (62 FR 35086). There were incorrect amendments published to the Program for Persons with Disabilities section of the CHAMPUS rule. This document corrects the administrative error.     

Interim rules for health insurance portability for group health plans and individual market health insurance reform: portability from group to individual coverage; and federal rules for access in the individual market; state alternative mechanisms to federal rules--HCFA. Interim rule; correction

Federal Register documents 97-8217 and 97-8275 in this issue include provisions that implement the health insurance portability, availability, and renewability provisions of the Health Insurance Portability and Accountability Act of 1996. Those documents contain a technical error in amendments because of differing effective dates. The rule with the earlier effective date establishes a new part in a subchapter established by the rule with the latter date. This document corrects the error.     

Medical devices; clinical chemistry and clinical toxicology devices; instrumentation for clinical multiplex test systems. Final rule

The Food and Drug Administration (FDA) is classifying instrumentation for clinical multiplex test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.     

Enrollment--provision of hospital and outpatient care to veterans. Department of Veterans Affairs. Final rule

This document amends VA's medical regulations. The Veterans' Health Care Eligibility Reform Act of 1996 mandates that VA implement a national enrollment system to manage the delivery of healthcare services. Accordingly, the medical regulations are amended to establish provisions consistent with this mandate. Starting October 1, 1998, most veterans were required to be enrolled in the VA healthcare system as a condition of receiving VA hospital and outpatient care. Veterans will be allowed to apply to be enrolled at any time. They will be eligible to be enrolled based on funding availability and their priority status. In accordance with statutory provisions, the final rule also states that some categories of veterans are eligible for VA hospital and outpatient care even if not enrolled. This document further establishes a "medical benefits package" setting forth, with certain exceptions, the hospital and outpatient care that will be provided to enrolled veterans and certain other veterans. Moreover, this document announces that VA will enroll all 7 priority categories of veterans for the period October 1, 1999 through September 30, 2000, unless it is necessary to change this determination by a subsequent rulemaking document.     

Enrollment--provision of hospital and outpatient care to veterans--VA. Proposed rule

This document proposes to amend VA's medical regulations. The Veterans' Health Care Eligibility Reform Act of 1996 mandates that VA implement a national enrollment system to manage the delivery of healthcare services. Accordingly, the medical regulations are proposed to be amended to establish provisions consistent with this mandate. Starting October 1, 1998, most veterans must be enrolled in the VA healthcare system as a condition of receiving VA hospital and outpatient care. Veterans would be allowed to apply to be enrolled at any time. They would be eligible to be enrolled based on funding availability and their priority status. In accordance with statutory provisions, the proposed rule also states that some categories of veterans would be eligible for VA hospital and outpatient care even if not enrolled. This document further proposes to establish a "medical benefits package" setting forth, with certain exceptions, the hospital and outpatient care that would be provided to enrolled veterans and certain other veterans.     

Medicare and Medicaid programs; requirements for physician incentive plans in prepaid health care organizations--HCFA. Final rule correction; notice of changes in compliance dates, with comment period

In the March 27, 1996, issue of the Federal Register, we published, at 61 FR 13430, a final rule with comment period that implements requirements in sections 4204(a) and 4731 of the Omnibus Budget Reconciliation Act of 1990 that concern physician incentive plans. In the preamble of that rule, we set forth dates by which prepaid health plans had to comply with certain of the rule's provisions. This document clarifies and changes some of those deadlines, and provides an opportunity for public comments on them. It does not otherwise change the requirements set forth in the rule. In addition this document corrects the March 27 rule's inadvertent reversal of the nomenclature change made by a previous final rule.     

Medical devices; humanitarian use of devices; companion to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend certain regulations governing humanitarian use devices. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is being issued under FDAMA and the act as amended.     

Medicare Program; physician performance standard rates of increase for fiscal year 1994 and physician fee schedule update for calendar year 1994--HCFA. Correction of final notice with comment period

This document corrects an error that occurred in the calculation of the fiscal year 1994 Medicare volume performance standard for surgical services and that appeared in the final notice with comment period published in the Federal Register on December 2, 1993 (58 FR 63856) entitled "Medicare Program; Physician Performance Standard Rates of Increase for Fiscal Year 1994 and Physician Fee Schedule Update for Calendar Year 1994." This notice also corrects a typographical error in a date.     

Health care programs: fraud and abuse; revisions to the PRO sanctions process-HHS. Correction to final regulations

This document corrects a technical error that appeared in 42 CFR part 1004 of the final rule published in the Federal Register on December 12, 1995 (60 FR 63634). The final rule was designed to revise and update the procedures governing the imposition and adjudication of program sanctions predicated on recommendations of State Utilization and Quality Control Peer Review Organizations. Specifically, this correction notice sets forth the corrected text for section 1004.110(f) which contained a typographical error in subparagraph (2).     

Medicaid program; limitation on provider-related donations and health care-related taxes; revision of waiver criteria for tax programs based exclusively on regional variations; correction--HCFA. Correcting amendment

This document contains a correction to the final regulations that were published in the Federal Register on August 13, 1993 [58 FR 43156]. These regulations revised the Medicaid regulations relating to limitations on federal financial participation [FFP] in State medical assistance expenditures when States receive funds from provider-related donations and revenues generated by certain health care-related taxes.     

Shifting Concepts: The Realignment of Dharmakīrti on Concepts and the Error of Subject/Object Duality in Pratyabhijñā Śaiva Thought

Contemporary scholars have begun to document the extensive influence of the sixth to seventh century Buddhist philosopher Dharmakīrti on Pratyabhijñā ?aiva thought. Utpaladeva (925–975) and Abhinavagupta’s (975–1025) adaptation of Dharmakīrti’s apoha (exclusion) theory provides a striking instance of the creative ways in which these ?aivas use Dharmakīrti’s ideas to argue for positions that Dharmakīrti would emphatically reject. Both Dharmakīrti and these ?aivas emphasize that the formation of a concept involves both objective and subjective factors. Working within a certain perceptual environment, factors such as a subject’s desires, habits, and conditioning lead him or her to form a concept (vikalpa) based on excluding what is not relevant to the accomplishment of his or her goal. However, the two differ in their account of the relationship between concepts and subject/object duality itself. While Dharmakīrti claims that the division of a cognition into subject, object, and awareness is nonconceptual, the subtly shifted definition of a concept that these ?aivas employ allows them to claim that the error of subject/object duality is actually conceptual. This seemingly small difference in their respective evaluations of the nature of subject/object error has surprisingly large consequences. If, as these ?aivas claim, any awareness involving a duality is conceptual, then subject and object are concepts. Moreover, if the formation of a concept requires desire, then some kind of desire must be inherent to consciousness itself before the formation of a limited subject/object pair. In short, ultimate consciousness must be ?iva, who possesses the freedom to will any and all possible realities.