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

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated February 2007. The guidance document assists establishments with making eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products. The guidance announced in this document finalizes the draft guidance, ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated May 2004. This guidance also finalizes the draft guidance, ``Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt- Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps),'' dated June 2002 (Docket No. 2002D-0266).

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Advisory Committee MeetingsPreparation and Public Availability of Information Given to Advisory Committee Members.'' This guidance is intended to provide information to industry sponsors, applicants, and petitioners on the development, preparation, or submission of briefing materials that will be given to advisory committee members as background information prior to open FDA advisory committee meetings. The guidance will help sponsors develop, organize, and submit advisory committee briefing materials for public release and should help minimize the time and resources spent in preparing these materials for public availability. The guidance also describes the process FDA intends to follow when we make briefing materials available to the public.

Notice is hereby given that an award is being made to the National Eligibility Workers Association: Professionals Associated Through Human Services of Cavalier, North Dakota, in the amount of $100,000 to develop a best practices handbook for front line social workers. NEW:PATHS is the only national organization dedicated to improving the personal and professional well-being of eligibility professionals and they are uniquely qualified to develop a handbook of best practices. Its members implement Temporary Assistance to Needy Families regulations, network with other eligibility professionals at local, regional, and national conferences and possess exceptional insights concerning Federal programs. NEW:PATHS has the capability of consulting with a national audience and its members are in direct contact with employment agencies to move participants from welfare to work and increase the percentage of families and children living in safe environments. After the appropriate reviews, it has been determined that this unsolicited proposal qualifies for funding. The period of this funding will extend from October 1, 2006 through March 31, 2008. Contact: Paul Maiers, Office of Family Assistance, Administration for Children and Families, 370 L'Enfant Promenade, SW., Washington, DC 20447, Telephone: 202-401-5438, E-mail: paul.maiers@acf.hhs.gov.

In accordance with the Privacy Act, we are proposing to modify or alter an existing SOR, ``Program Information Management System (PIMS),'' System No. 09-90-0052, published at 67 FR 57011, September 6, 2002. First, we propose to add a new authority, the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), to those under which OCR collects information. The Secretary of HHS has delegated to OCR the authority to enforce the confidentiality provisions of that statute. Second, we propose a new routine use which allows referrals of Age Discrimination Act Complaints to the Federal Mediation and Conciliation Service (FMCS), for purposes of mediation. Third, we give notice of a new routine use permitting disclosure of records to student volunteers, individuals working under a personal services contract, and other individuals performing functions for the Department but technically not having the status of OCR employees, if they need access to the records in order to perform their assigned agency functions. OCR invites interested parties to submit comments on the proposed additional authority and routine uses. See Effective Dates section for comment period.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.'' In recent years, the practice of complementary and alternative medicine (CAM) has increased in the United States, and we have seen increased confusion as to whether certain products used in CAM are subject to regulation under the Federal Food, Drug, and Cosmetic Act (the act) or Public Health Service Act (PHS Act). We have also seen an increase in the number of CAM products imported into the United States. Therefore, the draft guidance discusses when a CAM product is subject to the act or the PHS Act.

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 the information collection provisions in FDA's food labeling regulations.

The Food and Drug Administration (FDA) is publishing a proposed rule to reclassify pressure regulators for use with medical oxygen, currently class I devices included in the generic type of device called pressure regulator, into class II, subject to special controls in the form of a guidance document. Pressure regulators for use with all other medical gases will remain in class I, subject only to general controls. FDA is also proposing to establish a separate classification regulation for oxygen conserving devices (or oxygen conservers), now included in the generic type of device called noncontinuous ventilator. Oxygen conserving devices will continue to be classified in class II, but those that incorporate a built-in oxygen pressure regulator will become subject to the special controls guidance if the rule is finalized. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls draft guidance for industry and FDA staff entitled ``Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices.'' The agency is proposing this action because it believes that special controls are necessary to provide a reasonable assurance of safety and effectiveness for these devices.

The Health Resources and Services Administration published a notice in the Federal Register of December 6, 2006, soliciting comments on a proposed amendment to Policy Notice 99-02 which places a cumulative lifetime period of 24 months on short-term and emergency housing assistance under Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006. The amendment also specifies a requirement that the need for such assistance must be certified or documented by a case manager, social worker, or other licensed health care professional(s). HRSA received over 150 substantive comments from consumers and numerous organizations around the country in response to the December 6, 2006, notice.

NIGMS is initiating a strategic planning process that will culminate in the NIGMS Strategic Plan for 2008-2012. To assist with this process, NIGMS requests input from scientists, scientific organizations, and other interested parties. The goal of this strategic planning process is to identify Institute priorities and guide decision-making over the next five years. Information about NIGMS can be found at https://www.nigms.nih.gov/.

The Food and Drug Administration (FDA) has determined the regulatory review period for S8 OVER-THE-WIRE SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.