Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human); companion document to direct final rule. Food and Drug Administration, HHS. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend 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applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements.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. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. FDA is taking this action because the proposed changes are noncontroversial and FDA anticipates that it will receive no significant adverse comment.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human). Food and Drug Administration, HHS. Direct 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applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements.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 issuing these amendments directly as a final rule because the agency believes they are noncontroversial and that there is little likelihood that there will be comments opposing the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments. If any significant adverse comment is received sufficient to terminate the direct final rule within 30 days after the comment period ends, FDA will consider such comments on the proposed rule in developing the final rule. FDA is issuing this rule 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 plasma derivatives.     

Revisions to the requirements applicable to blood, blood components, and source plasma. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Direct final rule

The Food and Drug Administration (FDA) is amending 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. FDA is issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that FDA will receive any significant comments opposing the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments. If FDA receives any significant adverse comment sufficient to terminate the direct final rule, FDA will consider such comments on the proposed rule in developing the final rule. FDA is issuing this rule 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, blood components, and Source Plasma.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human); confirmation in part and technical amendment. Food and Drug Administration, HHS. Direct final rule; confirmation in part and technical amendment

The Food and Drug Administration (FDA) is confirming in part the direct final rule that appeared in the Federal Register of May 14, 1999 (64 FR 26282). The direct final rule amends 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 confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is hereby amending Title 21 Code of Federal Regulations to reinstate the former provisions. In addition, FDA is correcting the precision of the value for protein concentration that was inadvertently omitted from the codified section of the direct final rule.     

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.     

Revisions to the requirements applicable to blood, blood components, and source plasma; confirmation in part and technical amendment. Food and Drug Administration, HHS. Direct final rule; confirmation in part and technical amendment

The Food and Drug Administration (FDA) is confirming in part the direct final rule issued in the Federal Register of August 19, 1999. 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. FDA is confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is amending Title 21 Code of Federal Regulations to reinstate the former provisions.     

Revisions to labeling requirements for blood and blood components, including source plasma. Final rule

The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.     

Revisions to the requirements applicable to blood, blood components and source plasma. Direct final rule

The Food and Drug Administration (FDA) is amending 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. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.     

Blood vessels recovered with organs and intended for use in organ transplantation. Final rule

The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are amending their regulations to include as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, or cellular or tissue-based products (HCT/Ps) (FDA regulation). The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We (HRSA and FDA) believe that this change will eliminate the burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction).     

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.     

Tamper-evident packaging requirements for over-the-counter human drug products--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations on tamper-resistant packaging to require that all over-the-counter (OTC) human drug products marketed in two-piece, hard gelatin capsules be sealed using a tamper-evident technology; to change the term "tamper-resistant" in the labeling of all OTC drug products to "tamper-evident;" and to specify that the required OTC drug product labeling statement must refer to all packaging features used to comply with the tamper-evident packaging requirements, including those on the secondary package, the immediate container or closure, and any capsule sealing technologies used. FDA is taking this action as a result of its continuing review of the potential public health threat posed by product tampering and to improve consumer protection by addressing specific vulnerabilities in the OTC drug market.     

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.     

Revisions to the general safety requirements for biological products--FD. Direct final rule

The Food and Drug Administration (FDA) is amending the biologics regulations by adding "cellular therapy products" to the list of products excepted from the general safety test (GST) and by adding an administrative procedure for obtaining exemptions from the GST requirements for other biological products. FDA is taking this action because the GST may not be relevant or necessary for biological products, including cellular therapy products, currently in various stages of development. This direct final rule is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiative, and is intended to reduce the burden of unnecessary regulations on biological products without diminishing the protection of the public health. Elsewhere in this Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws this direct final rule.     

Delegations of authority and organization--FDA. Final rule

The Food and Drug Administration (FDA) is revising the regulations to set forth the current organizational structure of the agency as well as the current addresses for headquarters and field offices.     

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.     

Current good manufacturing practice for blood and blood components; notification of consignees and transfusion recipients receiving blood and blood components at increased risk of transmitting hepatitis C virus infection ("lookback"). Final rule

The Food and Drug Administration (FDA) is requiring establishments collecting Whole Blood or blood components, including Source Plasma and Source Leukocytes, to establish, maintain, and follow an appropriate system for identifying blood and blood components previously donated by a donor who tests reactive for evidence of hepatitis C virus (HCV) infection on a subsequent donation identified either by current testing or after a review of historical testing records, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HCV infection. Such collections may be at increased risk of transmitting HCV infection. FDA is requiring collecting establishments to quarantine prior in-date blood and blood components from such a donor, to notify consignees of prior in-date blood and blood components from such a donor for quarantine purposes, and to perform further testing on the donor. FDA is also requiring consignees to notify transfusion recipients of blood and blood components from such a donor, as appropriate. In addition, FDA is revising the human immunodeficiency virus (HIV) "lookback" requirements for greater consistency with the HCV "lookback" requirements, and extending the record retention period to 10 years. FDA is taking this action to help ensure the continued safety of the blood supply and to help ensure that information is provided to recipients of blood and blood components that may have been at increased risk of transmitting HIV or HCV infection. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: 'Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV' (the "lookback" guidance). We are also issuing this final rule in conjunction with a companion interim final rule published by the Centers for Medicare and Medicaid Services (CMS) elsewhere in this issue of the Federal Register.     

Postmarketing studies for approved human drug and licensed biological products; status reports. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is revising the requirements for annual postmarketing status reports for approved human drug and biological products, and is requiring applicants to submit annual status reports for certain postmarketing studies of licensed biological products. This rule describes the types of postmarketing studies covered by these status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. This action will implement the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Form for reporting serious adverse events and product problems with human drug and biological products and devices; availability--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of a new form for reporting adverse events and product problems with human drug products, biologic products, medical devices (including in-vitro diagnostics), special nutritional products (dietary supplements, medical foods, infant formulas), and other products regulated by FDA. There are two versions of the form. One version of the form (FDA Form 3500) is available for use by health professionals for voluntary reporting; the other version of the form (FDA Form 3500A) is to be used by user facilities, distributors, and manufacturers for reporting that is required by statute or FDA regulations. The new form will simplify and consolidate the reporting of adverse events and product problems and will enhance agency-wide consistency in the collection of postmarketing data. This notice also responds to written comments the agency received on proposed versions of this form. Copies of both versions of the new form appear at the end of this document.     

Delegations of authority and organization; revised organization. Food and Drug Administration. Final rule

The Food and Drug Administration (FDA) is revising the regulation setting forth its organization structure. Several reorganizations have occurred since the structure was last issued. These revised regulations will present FDA's latest organization structure and give the latest addresses for the field organization.     

Beverages: bottled water. Final rule

The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by revising the existing allowable level for the contaminant arsenic. As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for arsenic at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers are also required to monitor their source water for arsenic as often as necessary, but at least once every year unless they meet the criteria for the source water monitoring exemptions under the CGMP regulations. This final rule will ensure that the minimum quality of bottled water, as affected by arsenic, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards.