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

The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or items that measure patient perspectives on the cultural awareness of the healthcare professionals providing care to those patients. This initiative is in response to the need to develop a new CAHPS[supreg] cultural competency survey. AHRQ is interested in incorporating this survey into an integrated set of carefully tested, standardized survey questionnaires and accompanying reports. The addition of the CAHPS[supreg] cultural competency component to the set is intended to empower consumers with quality of care information while also encouraging healthcare professionals to provide culturally competent care. The survey will be designed to assess the quality of care and services provided by healthcare professional in the context of cultural competency. Based on prior work, there are several functional areas that the planned instrument could assess such as: (1) Patient-provider communication (e.g., providers give clear explanations, patients feel that they get all the information they need,), (2) respect for patient preferences/shared decision-making (e.g., providers discuss pros and cons of treatment options, providers understand and takes into account patient's environment, family members are appropriately included in decisions), (3) experiences leading to trust or distrust (e.g., providers treat patients in a culturally sensitive or insensitive manner that led to trust or distrust), (4) experiences of discrimination (e.g., providers or staff treat patients with disrespect because of a patients' racial/ethnic backgrounds, insurance type/ status, lack of proficiency in English), (5) language access (e.g., availability of interpreter services and translated materials), and (6) alternative treatment (e.g., providers are open to discussion about traditional healers and remedies).

The Secretary of Health and Human Services, by authority of 42 U.S.C. 9836A, section 641A(b) of the Head Start Act, as amended (5 U.S.C. Appendix 2), has formed the Advisory Committee on Head Start Accountability and Educational Performance Measures (the Committee). The Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2). The function of the Committee is to help assess the progress of HHS in developing and implementing educational measures in the Head Start Program. This includes the Head Start National Reporting System (NRS). The Committee is to provide recommendations for integrating NRS with other ongoing assessments of the effectiveness of the program. The Committee will make recommendations as to how NRS and other assessment data can be included in the broader Head Start measurement efforts found in the Family and Child Experiences Survey (FACES), the National Head Start Impact Study, Head Start's Performance-Based Outcome System, and the ongoing evaluation of the Early Head Start program.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Evaluations of the Medicaid Reform Demonstrations (EMRD),'' System No. 09-70-0068, last published at 67 Federal Register 2216 (January 16, 2002). CMS is reorganizing its databases because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173) provisions and the large volume of information the Agency collects to administer the Medicare program. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained the system of records. The new assigned identifying number for this system should read: System No. 09- 70-0523. 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 contractor and/or consultants. The modified routine use will remain as routine use number 1. We propose to combine routine uses 2 and 3 to assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds. As they were duplicative of each other. 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 6 and 7, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We are modifying the language in the 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 MMA provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and provide data necessary to evaluate a series of Medicaid Reform Demonstrations that rely on waivers of section 1115 of the Social Security Act (the Act). This system will allow measurement of the effects of the demonstration on beneficiaries' eligibility, access to care, utilization, health care costs, satisfaction with care, quality of care and health status. The information retrieved from this system of records will also be disclosed to: (1) Support program administration, reporting, and regulator, reimbursement, and policy functions performed within the CMS or by a contractor, consultant, or grantee; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in a Federally-funded health benefits programs. We have provided background information about the modified 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 modified or altered routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

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.

An Application Information Meeting, hosted by the National Institute of Environmental Health Sciences (NIEHS), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute on Drug Abuse (NIDA), will be held on October 20, 2006, on the NIEHS campus in Research Triangle Park, North Carolina. The meeting will include an overview of the Exposure Biology Program, presentations on the five funding opportunities, an overview of the cooperative agreement mechanism and Grants Management and Review issues, and a question and answer session addressing RFA-related questions.

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 requiring that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle establish and maintain records sufficient to demonstrate that the human food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. These recordkeeping requirements provide documentation for the provisions in FDA's interim final rule entitled ``Use of Materials Derived From Cattle in Human Food and Cosmetics.'' FDA is requiring recordkeeping because manufacturers and processors of human food and cosmetics need records to ensure that their products do not contain prohibited cattle materials, and records are necessary to help FDA ensure compliance with the requirements of the interim final rule.

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.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2007. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.