Department of Health and Human Services February 27, 2007 – Federal Register Recent Federal Regulation Documents

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.