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

On November 7, 2005, the Administration for Children and Families (ACF) published a notice in the Federal Register soliciting comment regarding its proposal to replace the six data measures used as part of the assessment of State performance on the Federal Child and Family Services Review (CFSR) with six data composites (70 FR 67479). Based on the results of our data analyses and a review of comments from the field, ACF made the following decisions: The CFSR will use a State's performance on two individual data measures as part of the assessment of the State's substantial conformity with CFSR Safety Outcome 1Children are, first and foremost, protected from abuse and neglect. A national standard is established for each of these measures. The CFSR will use a State's performance on four data composites as part of the assessment of the State's substantial conformity with CFSR Permanency Outcome 1Children have permanency and stability in their living situations. A national standard is established for each of these data composites. This announcement presents the following information: The decisions made by the Children's Bureau regarding use of data composites for the Federal Child and Family Services Review (CFSR); The composites and additional data that will be used as part of the assessment of a State's substantial conformity with the CFSR requirements; and Descriptive statistics relevant to each composite and measure, including the score that will serve as the national standard for the second round of the CFSR. Where relevant, the announcement addresses key comments from the field in response to the Federal Register notice. The announcement also includes the following attachments: Attachment A: Data to be included in the CFSR State Data Profile. Attachment B: Methodology for Composite Construction.

The Office on Women's Health (OWH) and the Office of Minority Health (OMH) within the Office of Public Health and Science, and the Office of Research on Women's Health (ORWH) within the National Institutes of Health (NIH), Department of Health and Human Services (DHHS), are interested in establishing national faith-based and/or national community cardiovascular disease (CVD) prevention programs. The purpose of the programs is to reduce CVD mortality and morbidity among high-risk women in the United States through medical screening and risk behavior modification. The CVD prevention programs will be targeted towards high-risk racial and ethnic minority women, aged 40 years and older; however, all high-risk women shall be eligible to participate in the programs regardless of race, religion, or age. Each grantee shall implement one program in 10 faith-based or community-based sites across the United States, including urban and rural areas. The main goal will be for program participants to increase their level of physical activity and establish or maintain a healthy weight over the course of the program. The educational phase of the program shall consist of eight bi-weekly sessions that shall counsel women on all of the major risk factors for CVDsmoking, Type 2 diabetes, hypertension, cholesterol, obesity, and physical inactivity while primarily focusing on controlling weight and increasing physical activity. The maintenance phase of the project shall consist of regularly scheduled, interactive maintenance sessions that shall be designed by program participants. During both phases, participants will be screened for all six major CVD risk factors. All counseling and maintenance sessions shall include small group discussions and a physical activity component focused on reducing risk. These awards focus on President Bush's agenda to broaden Federal efforts to work with faith-based and community organizations. As such, each applicant must either: (1) Be a national faith-based or national community organization that has a network of at least 10 sites across the United States with large populations of high-risk racial and ethnic minority women, aged 40 years and older, or (2) partner with a national faith-based or national community organization that has a network of at least 10 sites across the United States with large populations of high- risk racial and ethnic minority women, aged 40 years and older. Non- profit and for profit organizations that meet the above criteria are eligible to apply. Faith-based organizations, community-based organizations, tribal entities, educational institutions, community health centers, and government entities that meet the above criteria are also eligible and encouraged to apply.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Complementary and Alternative Medicine (NCCAM), the National Institutes of Health (NIH), will submit to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. A notice of this proposed information collection was previously published in the Federal Register on February 22, 2006, pages 9135- 9136. To date, no public comments have been received. The purpose of this notice is to announce a final 30 days for public comment. NIH 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. Proposed Collection: Title: NCCAM Customer Service Data Collection. Type of Information Collection Request: Renewal. Need and Use of Information Collection: NCCAM provides the public, patients, families, health care providers, complementary and alternative medicine (CAM) practitioners, and others with the latest scientifically based information on CAM and information about NCCAM's programs through a variety of channels, including its toll-free telephone information service and its quarterly newsletter. NCCAM wishes to continue to measure customer satisfaction with NCCAM telephone interactions and the NCCAM newsletter and to assess which audiences are being reached through these channels. This effort involves a telephone survey consisting of 10 questions, which 25 percent of all callers are asked to answer, for an annual total of approximately 1,210 respondents, and a newsletter survey consisting of 10 questions, which is sent to all U.S.-based print newsletter subscribers and which Web users have the option of completing when they exit the page where the latest issue of the newsletter is posted, for an annual total of approximately 839 respondents. NCCAM uses the data collected from the surveys to help program staff measure the impact of their communication efforts, tailor services to the public and health care providers, measure service use among special populations, and assess the most effective media and messages to reach these audiences. Frequency of Response: Once for the telephone survey and periodically for the newsletter survey (to measure any changes in customer satisfaction). Affected Public: Individuals and households. Type of Respondents: For the telephone survey, patients, spouses/family/friends of patients, health care providers, physicians, CAM practitioners, or other individuals contacting the NCCAM Clearinghouse; for the newsletter survey, subscribers to the print NCCAM newsletter and visitors to the newsletter page on NCCAM's Web site. The annual reporting burden is as follows:

CERHR invites the submission of public comments on the draft NTP Brief for di-(2-ethylhexyl)phthalate (DEHP). The draft NTP Brief is available from the CERHR Web site (https://cerhr.niehs.nih.gov see ``CERHR Reports & Monographs'') or in hardcopy from CERHR (see ADDRESSES below). Public comments will be considered during the peer review and finalization of the NTP Brief.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following: Availability of opportunity for the Public to provide input on a proposed document:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the inventions embodied in: U.S. Provisional Patent Application S/N 60/378,408, filed May 6, 2002 (E-144-2002/0-US-01), PCT Application, PCT/US03/14292, filed May 6, 2003, (E-144-2002/0-PCT-02), converted into 03736557.4 (E-144-2002/0- EP-04) filed in Europe on December 3, 2004, and 2003237187 (E-144-2002/ 0-AU-05) filed in Australia on November 3, 2004, 10/513,725 (E-144- 2002/0-US-03) filed in USA on November 5, 2004, as well as 2,484,930 (E-144-2002/0-CA-06) filed in Canada on November 5, 2004, entitled ``Novel broadly cross-reactive HIV neutralizing human monoclonal antibodies selected from Fab phage display libraries using a novel strategy based on alternative antigen panning,'' Inventors: Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC), to Profectus Biosciences, Inc., having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America.

The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of titanium dioxide coated mica-based pearlescent pigments as color additives in food. This action is in partial response to a petition filed by EM Industries, Inc.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q9 Quality Risk Management.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk- based decisions.

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.

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 (the PRA).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Notice of Participation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.