Department of Health and Human Services January 16, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance entitled ``Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements,'' that was issued December 1999.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims.'' This guidance outlines the agency's approach to the review of the scientific evidence for health claims that meet the significant scientific agreement standard (SSA) and qualified health claims. Elsewhere in this issue of the Federal Register, FDA is announcing the withdrawal of the guidance documents entitled ``Guidance for Industry and FDA: Interim Evidence-Based Ranking System for Scientific Data'' and ``Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements.''

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)'' dated January 2009. The draft guidance document provides establishments that manufacture HCT[sol]Ps with recommendations for complying with CGTP requirements.

The Food and Drug Administration (FDA) is amending its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. FDA is amending the regulation because we now believe that data from additional BE studies may be important in our determination of whether the proposed formulation is bioequivalent to the reference listed drug (RLD), and are relevant to our evaluation of ANDAs in general. In addition, such data will increase our understanding of how changes in components, composition, and methods of manufacture may affect product formulation performance.

The Food and Drug Administration (FDA or the agency) is announcing the availability of a guidance for industry 187 entitled ``Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs.'' This guidance is intended to clarify FDA's requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. The guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the act) apply with respect to GE animals, including FDA's intent to exercise enforcement discretion regarding requirements for certain GE animals.

This document corrects technical errors that appeared in the final rule published in the Federal Register on December 24, 2008, entitled ``Regulation on the Organizational Integrity of Entities That Are Implementing Programs and Activities Under the Leadership Act'' (73 FR 78997).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Standards for Securing the Drug Supply ChainStandardized Numerical Identification for Prescription Drug Packages.'' This draft guidance is being issued under the Federal Food, Drug, and Cosmetic Act (the act), which requires FDA to develop standardized numerical identifiers for prescription drugs. We are also requesting responses from interested stakeholders to questions posed in this Federal Register notice related to the draft guidance.

This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations for cytology proficiency testing (PT), to reflect changes in cytology laboratory operations and practices. The proposed changes are based on recommendations received from the Clinical Laboratory Improvement Advisory Committee (CLIAC), input from the professional community, and government experience with the implementation of cytology PT. The proposed changes would amend certain definitions, lengthen the testing interval, require validation of cytology challenges before use in testing, increase the minimum number of cytology challenges per testing event, change the grading scheme, and allow flexibility to accommodate new technologies (for example, digital images, as they are implemented in cytology laboratory practice).

This final rule adopts modifications to two of the code set standards adopted in the Transactions and Code Sets final rule published in the Federal Register pursuant to certain provisions of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Specifically, this final rule modifies the standard medical data code sets (hereinafter ``code sets'') for coding diagnoses and inpatient hospital procedures by concurrently adopting the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD-10-CM Guidelines for Coding and Reporting, as maintained and distributed by the U.S. Department of Health and Human Services (HHS), hereinafter referred to as ICD-10-CM, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, including the Official ICD-10-PCS Guidelines for Coding and Reporting, as maintained and distributed by the HHS, hereinafter referred to as ICD-10-PCS. These new codes replace the International Classification of Diseases, 9th Revision, Clinical Modification, Volumes 1 and 2, including the Official ICD-9-CM Guidelines for Coding and Reporting, hereinafter referred to as ICD-9-CM Volumes 1 and 2, and the International Classification of Diseases, 9th Revision, Clinical Modification, Volume 3, including the Official ICD-9-CM Guidelines for Coding and Reporting, hereinafter referred to as ICD-9-CM Volume 3, for diagnosis and procedure codes, respectively.