Biological products; blood specificity designators; technical amendments--FDA. Final rule; technical amendments

The Food and Drug Administration (FDA) is amending the biologics regulations to correct certain omissions from the designators for blood specificities and make other minor, technical amendments. This action is being taken to clarify and improve the accuracy of the regulations.     

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.     

Investigational new drug application; exception from informed consent; technical amendment--FDA. Final rule

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to clarify that, within 30 days after the receipt of an IND for any clinical investigation involving an exception from informed consent, FDA will provide a written determination as to whether the investigation may begin. This action is intended to clarify a recent amendment to the IND regulations for clinical investigations involving an exception from informed consent that states that FDA will provide a written authorization within 30 days of receipt of the IND.     

Medical devices; hearing aids; technical data amendments. Direct final rule

The Food and Drug Administration (FDA) is amending its regulations governing hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. We are amending the regulations to require that manufacturers may use state-of-the-art methods to provide technical data in hearing aid labeling. FDA is also amending the regulations to update an address and remove an outdated requirement. FDA is amending the regulations in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment rulemaking to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.     

Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Interim final rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing an interim final rule to except human dura mater and human heart valve allografts, currently subject to application or notification requirements under the Federal Food, Drug, and Cosmetic Act (the act), from the scope of the definition of "human cells, tissues, or cellular or tissue-based products (HCT/P's)" subject to the registration and listing requirements contained in 21 CFR part 1271. That definition became effective on January 21, 2004. FDA is taking this action to assure that these products, which are currently subject to the act and therefore regulated under the current good manufacturing practice regulations set out in the quality system regulations in 21 CFR part 820 are not released from the scope of those regulations before a more comprehensive regulatory framework applicable to HCT/P's, including donor suitability requirements, good tissue practice regulations, and appropriate enforcement provisions, is fully in place. When that comprehensive framework is in place, FDA intends that human dura mater and human heart valves will be subject to it. FDA intends to revoke this interim final rule at that time.     

Medicare program; Medicare and laboratory certification program; enforcement procedures for laboratories--HCFA. Final rule

These regulations set forth the rules for sanctions that HCFA may impose on laboratories that are found not to meet Federal requirements. These include the principal sanctions of suspending, limiting, or revoking the laboratory's certificate issued under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and cancelling the laboratory's approval to receive Medicare payment for its services, and the alternative sanctions that may be imposed instead of or before the principal sanctions. These amendments are necessary to conform HCFA regulations to changes made in the law by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) and the 1988 amendments to section 353 of the Public Health Service Act (PHS Act). The latter are commonly referred to as "CLIA 88". The purpose of the amendments is to ensure that functioning laboratories are capable of providing accurate and reliable test results and that the health of individuals served by the laboratory and that of the general public is not adversely affected by laboratory operations and by testing procedures that do not meet the standards set forth in other subparts of part 493 of the HCFA regulations.     

Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations on institutional review boards (IRB's) and on informed consent to conform them to the "Federal Policy for the Protection of Human Research Subjects" (Federal Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations governing the protection of human subjects share a common core with the Federal Policy and implement the fundamental principles embodied in that policy.     

Food labeling: health claims and labeling statements; dietary fiber and cancer; antioxidant vitamins and cancer; omega-3 fatty acids and coronary heart disease; folate and neural tube defects; revocation. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is revoking its regulations codifying the agency's decision not to authorize the use of health claims for four substance-disease relationships in the labeling of foods, including dietary supplements: Dietary fiber and cancer, antioxidant vitamins and cancer, omega-3 fatty acids and coronary heart disease, and the claim that 0.8 milligram (mg) of folate in dietary supplement form is more effective in reducing the risk of neural tube defects than a lower amount in conventional food. This action is being taken in response to a decision of the U.S. Court of Appeals for the D.C. Circuit invalidating these regulations and directing FDA to reconsider whether to authorize the four health claims. This action will result in the removal of the regulations but does not constitute FDA authorization of the four claims. FDA is completing its reconsideration of the claims and expects to issue decisions on all four claims by October 10, 2000.     

Medicare program; waiver of recovery of overpayments--HCFA. Final rule

This final rule duplicates in HCFA's regulations the content of two sections of the Social Security Administration's regulations concerning waiver of recovery of overpayments. In the past, regulations in 20 CFR part 404 were applicable to both the Federal Old-Age, Survivors and Disability Insurance program (OASDI), which provides monthly Social Security checks directly to beneficiaries or their representatives, and the Medicare program. Since the Social Security Administration (SSA) is now independent of HHS, and SSA is restructuring its regulations to apply only to the OASDI program, we are establishing the content of these sections in 42 CFR part 405 to preserve provisions that are applicable to the Medicare program.     

Control of communicable diseases; apprehension and detention of persons with specific diseases; transfer of regulations. Food and Drug Administration and Centers for Disease Control and Prevention, HHS. Final rule

The Secretary of Health and Human Service (the Secretary) is transferring a portion of the Food and Drug Administration (FDA) "Control of Communicable Diseases" regulations to the Centers for Disease Control and Prevention (CDC). In general, these regulations provide the Secretary with the authority to apprehend, detain, or conditionally release individuals to prevent the spread of specified communicable diseases. The regulations implement the provisions of the Public Health Service Act (PHS Act) to prevent the introduction, transmission, or spread of communicable diseases from one State or possession into any other State or possession. CDC will have authority for interstate quarantine over persons, while FDA will retain regulatory authority over animals and other products that may transmit or spread communicable diseases. The Secretary is taking this action to consolidate regulations designed to control the spread of communicable diseases, thereby increasing the agencies' efficiency and effectiveness.     

Revisions to the requirements applicable to blood, blood components and source plasma; confirmation of effective date and technical amendment. Direct final rule; confirmation of effective date and technical amendment

The Food and Drug Administration (FDA) is confirming the effective date of February 19, 2008, for the direct final rule that appeared in the Federal Register of August 16, 2007 (72 FR 45883). The direct final rule amends the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. In addition, FDA is making technical amendments to the biologics regulations in response to comments received on the direct final rule.     

Revision of fee schedules; 100% fee recovery; clarification of size standards--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations concerning the payment of annual fees to clarify the provisions that identify the size standards used to determine whether an NRC licensee would qualify as a "small entity" under the Regulatory Flexibility Act for the purpose of paying a reduced annual fee. This clarification is necessary because the size standards presented in the regulations did not clearly indicate the complete range of size standards adopted by the NRC.     

Proposed procedural regulations--Equal Employment Opportunity Commission. Proposed regulations; request for comments

The Equal Employment Opportunity Commission is publishing for comment proposed procedural regulations (29 CFR Part 1626). These regulations advise the public as to the procedures the Commission proposes to follow in processing charges and issuing interpretations and opinions under the Age Discrimination in Employment Act. These regulations will complement the Commission's existing procedural regulations under Title VII of the Civil Rights Act of 1964.     

Medical use of byproduct material; proposed revision--NRC. Proposal rule

The Nuclear Regulatory Commission (NRC) is proposing a revision of its regulations governing the medical use of byproduct material. The proposed rule is one component of the Commission's overall program for revising its regulatory framework for medical use. The overall goals of this program are to focus NRC's regulations on those medical procedures that pose the highest risk to workers, patients, and the public, and to structure its regulations to be risk-informed and more performance-based, consistent with the NRC's "Strategic Plan for Fiscal Year 1997-Fiscal Year 2002". A notice in this issue of the Federal Register announcing the Commission's proposed revision of its 1979 "Medical use Policy Statement" for public comment is published elsewhere.     

Medicare and Medicaid programs; revaluation of assets; correction--HCFA. Correcting amendments

This document contains corrections to final regulations (BPD-311-F) that were published September 23, 1992 (F.R. Doc. 92-22582) (57 FR 43906). The regulations describe new limitations on the valuations of assets acquired as the result of changes in ownership occurring on or after July 18, 1984. These changes affect hospitals and skilled nursing facilities under the Medicare program, and hospitals, nursing facilities, and intermediate care facilities for the mentally retarded under the Medicaid program.     

Human tissue intended for transplantation--FDA. Interim rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing an interim rule to require certain infectious disease testing, donor screening, and recordkeeping to help prevent the transmission of AIDS and hepatitis through human tissue used in transplantation. The regulations are effective upon publication. FDA is taking this action in response to growing concerns that some human tissue products are being offered for transplantation use without even the minimum donor testing and screening needed to protect recipients against human immunodeficiency virus (HIV) infection and hepatitis infection. The new regulations require all facilities engaged in procurement, processing, storage, or distribution of human tissues intended for transplant to ensure that minimum required infectious disease testing has been performed and that records documenting such testing for each tissue are available for inspection by FDA. The regulations also provide authority for the agency to conduct inspections of such facilities and to detain, recall, or destroy tissue for which appropriate documentation is not available.     

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.