Department of Health and Human Services August 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements governing the registration of producers of drugs and listing of drugs in commercial distribution.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs.

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.

The Food and Drug Administration (FDA) is announcing the availability of a 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,'' dated August 2007. The guidance document provides recommendations for complying with the HCV ``Lookback'' requirements. This guidance document finalizes the guidance entitled, ``Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV)'' dated June 1999. Additionally, this guidance document supersedes the HCV sections of the FDA memorandum entitled, ``Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T-Lymphotropic Virus Type I (HTLV-I),'' dated July 19, 1996; and also supersedes the document entitled, ``Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV'' dated September 1998. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule entitled ``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').''

This notice announces the seventh and final meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). In addition, this notice announces the selection of a new member of the EMTALA TAG. The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the seventh meeting is to enable the EMTALA TAG to hear additional testimony, to further consider written responses from medical societies and other organizations on specific issues considered by the TAG at previous meetings, and to finalize the recommendations for the Secretary. However, the public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.

In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on September 20, 2007. The Panel advises and makes recommendations to the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

On September 5, 2007, the Office of the National Coordinator for Health Information Technology will lead a technical assistance public meeting to share information and answer detailed questions about plans to design and establish a successor to the American Health Information community, including information on the Notice of Funding Availability. The AHIC is a federally chartered advisory committee that provides input and recommendations to the Department of Health and Human Services (HHS) on how to make health records digital and interoperable, and how to assure that the privacy and security of those records are protected. (Please visit https://www.hhs.gov/healthit/community/ background/ for more information on the AHIC.) The AHIC charter specifies that the AHIC will develop and advance recommendations to the Secretary on a private-sector health information community initiative that will succeed the AHIC. The AHIC successor will bring together public and private, not-for-profit and for-profit entities that represent all sectors of the health community. This new public-private partnership will develop a unified approach to realize an effective, secure, interoperable nationwide health information system that improves the quality, safety, and efficiency of health care in the U.S. For the purposes of facilitating the establishment of the AHIC successor and convening a planning board, HHS will award a Cooperative Agreement that allows for substantial involvement by the Federal government. Once a new legal entity is established and after certain conditions are met, HHS will support that entity through additional funding that will enable initial operations and transition of specific AHIC responsibilities by late Fall 2008.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on a proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study of consumer evaluations of variations in communicating risk information in direct- to-consumer (DTC) prescription drug broadcast advertisements.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of glycerol ester of tall oil rosin (GETOR) to adjust the density of citrus oils used in the preparation of beverages and to provide for the use of steam stripping as a purification method for producing glycerol ester of wood rosin, gum rosin, or tall oil rosin. This action is in response to a petition filed by Georgia-Pacific Resins, Inc.

This notice announces those sites for which ATSDR has completed public health assessments and health consultations during the period from April 1, 2007, through June 30, 2007. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments or consultations were prepared in response to requests from the public.

In accordance with the requirements of the Privacy Act of 1974, we propose to modify an existing system titled, ``National Emphysema Treatment Trial (NETT), System No. 09-70-0531,'' established at 65 Federal Register 47995 (August 4, 2000). We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 4 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of routine uses number 5 and 6, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary or recipient practices that result in unnecessary cost to all federally-funded health benefit programs. Additionally, we will broaden the scope of this system by including the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' apply when ever the system collects or maintain PHI. This system may contain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' will apply to the data disclosed from this system. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system of records is to collect and maintain data that will allow CMS to provide secure data on participants in the randomized phase of the study, pay claims, and to monitor and evaluate the clinical trial. Information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement and policy functions performed within the agency or by a contractor, consultant, or CMS grantee; (2) assist another Federal or state agency to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support research, evaluation, or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATE section for comment period.

The U.S. Department of Health and Human Services (HHS) announces the establishment of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 and invites nominations for membership for the Committee.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance. Type of Information Request: Renewal (OMB No. 0925-0493). Need and Use of Information Collection: The study, MESA, is identifying and quantifying factors associated with the presence and progression of subclinical cardiovascular disease (CVD) that is, atherosclerosis and other forms of CVD that have not produced signs and symptoms. The findings provide important information on subclinical CVD in individuals of different ethnic backgrounds and provide information for studies on new interventions to prevent CVD. The aspects of the study that concern direct participant evaluation received a clinical exemption from OMB clearance (CE-99-11-08) in April 2000. OMB clearance is being sought for the contact of physicians and participant proxies to obtain information about clinical CVD events that participants experience during the follow-up period. Frequency of Response: Once per CVD event. Affected Public: Individuals. Types of Respondents: Physicians and selected proxies of individuals recruited for MESA. The annual reporting burden is as follows: Estimated Number of Respondents: 550; Estimated Number of Responses per Respondent: 1.0; and Estimated Total Annual Burden Hours Requested: 36.7. There are no capital, operating, or maintenance costs to report.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of July 31, 2007 (FR Doc. E7-14680), on page 41759, regarding Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915-0193). In the burden table, the total burden hours published are incorrect.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of polydextrose as a bulking agent, formulation aid, humectant, and texturizer in all foods, except meat and poultry, baby foods, and infant formula. This action is in response to a petition filed by Danisco USA, Inc.

This notice announces the 16th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).