Department of Health and Human Services June 2006 – Federal Register Recent Federal Regulation Documents

This correcting amendment corrects a technical error identified in the final rule that appeared in the April 21, 2006 Federal Register entitled ``Requirements for Providers and Suppliers to Establish and Maintain Medicare Enrollment.'' In that final rule, we require all providers and suppliers (other than physicians or practitioners who have elected to ``opt-out'' of the Medicare program) to: (1) Complete an enrollment form and submit specific information to us; and (2) periodically update and certify the accuracy of their enrollment information to receive and maintain billing privileges in the Medicare program. The final rule also implements statutory provisions requiring us to ensure that all Medicare providers and suppliers are qualified to provide the appropriate health care services. The effective date of the final rule was June 20, 2006.

This document corrects errors in the final rule that appeared in the May 9, 2006 Federal Register entitled ``Inpatient Psychiatric Facilities Prospective Payment System Update for Rate Year Beginning July 1, 2006 (RY 2007).''

The Office on Women's Health (OWH) in the Department of Health and Human Services (DHHS) is the government's focal point for women's health issues, and works to redress inequities in research, health care services, and education that have historically placed the health of women at risk. The OWH coordinates women's health efforts within DHHS to eliminate disparities in health status and supports culturally sensitive educational programs that encourage women to take personal responsibility for their own health and wellness. To that end, OWH has established public/private partnerships to address critical women's health issues nationwide. These partnerships are with non-profit community-based, faith-based, and women's service organizations (CBOs, FBOs, WSOs) innovating intergenerational approaches for HIV/AIDS prevention education targeting women disproportionately impacted by HIV/AIDS across the lifespan. African American and Latino women constituted 25 percent of the U.S. female population in 2002, but 81.5 percent of the reported female AIDS cases (65 percent were among African Americans and 16.5 percent were among Hispanics). (1) The number of Asian/Pacific Islanders and American Indian/Alaskan Native women living with AIDS continues to rise, with an approximately 10 percent increase each year over the past 5 years. (2) Women disproportionately impacted by HIV/AIDS are vulnerable for the disease because they lack accurate information about the virus; are impacted by cultural factors that decrease their abilities to protect themselves against HIV; have low to no condom negotiation skills; are faced with low socioeconomic circumstances; suffer from sexual abuse; struggle with violence and other traumas perpetrated against women, and lack information and skills to share sexual health information with other female members in the family. To this end, the Intergenerational Approaches to HIV/AIDS Prevention Education with Women Across the Lifespan Pilot Program intends to: (1) Develop a cross-generational HIV/AIDS prevention education program to establish effective and/or increase communication about sexual health between African American, Native American/American Indian, Hispanic/Latino, and Asian/Pacific Islander women at risk for or living with HIV/AIDS with other female family and/or kinship network members 12+ years old; (2) provide opportunities for African American, Native American/American Indian, Hispanic/Latino, and Asian/Pacific Islander women and other female members of the family 12+ years old to know their serostatus; and (3) address the age-, gender-, cultural-, spiritual-, and language-specific needs of African American, Native American/American Indian, Hispanic/ Latino, and Asian/Pacific Islander women and other female members of the family 12+ years old regarding their sexual health issues, particularly HIV/AIDS prevention so they may decrease their risks for disease. This program builds on Minority AIDS Initiative- and Office on Women's Health-funded Women and HIV/AIDS Programs (e.g., Model Mentorship Program; HIV Prevention Education for Young Women Attending Minority Academic Institutions) by addressing HIV/AIDS issues using the strength of familial and kinship networks, as well as women-specific vulnerabilities to acquiring the virus.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Fogarty International Center (FIC), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 14, 2006, page 7780-7781, and allowed 60-days for public comment. No comments were received from this notification regarding the cost and hour burden estimates. One comment was received suggesting that the Federal Government should not be funding international work until all Amercians are cared for. We note that through partnerships in training and research with scientists from around the world, including those in developing countries, we are able to identify new strategies and new understandings of disease processes, including for AIDS, TB, and chronic diseases such as heart disease, that affect all Americans. The purpose of this announcement is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Questions and Answers Regarding Establishment and Maintenance of Records (Edition 3).'' The guidance responds to various questions raised about section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulation, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. Persons covered by the regulation who employ 500 or more full-time equivalent employees (FTEs) had to be in compliance by December 9, 2005, and those who employ 11-499 FTEs had to be in compliance by June 9, 2006. Persons who employ 10 or fewer FTEs have until December 11, 2006 to be in compliance. ``Person'' includes an individual, partnership, corporation, and association.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This interim final rule implements the statutory changes enacted in the reauthorization of the Temporary Assistance for Needy Families (TANF) program in the Deficit Reduction Act of 2005. This legislation reauthorizes the TANF program through fiscal year (FY) 2010 with a renewed focus on work, program integrity and strengthening families through healthy marriage promotion and responsible fatherhood. The interim final rule addresses the work and program integrity changes of the new law.

CDC began charging fees to conduct sanitation inspections of cruise vessels in 1988. The purpose of these charges is to recover full costs of operating the Vessel Sanitation Program. CDC is requesting comments to the modified fee schedule; the modified fee schedule includes an additional vessel size, the ``mega-sized'' vessel, for any vessel that is greater than 120,000 Gross Registered Tons (GRT). A modified fee schedule would go into effect in the beginning of the next fiscal year, October 2007.

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 draft guidance for industry (137) entitled ``Analytical Methods Description for Type C Medicated Feeds.'' This draft guidance provides our recommendations for describing methods for analyzing new animal drugs in Type C medicated feeds.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA revises labeling of oxytetracycline soluble powder with the current genus for the causative bacteria for American foul brood of honeybees.