Department of Health and Human Services March 2012 – Federal Register Recent Federal Regulation Documents

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA) to discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data. The meeting will be open to the public.

This notice announces our proposal to renew the Medicare Advantage ``deeming authority'' of the Utilization Review Accreditation Commission (URAC) for Health Maintenance Organizations and Preferred Provider Organizations for a term of 6 years. This new term of approval would begin May 26, 2012 and end May 25, 2018. This notice announces a 30-day period for public comments on the renewal of the application.

In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, the Health Resources and Services Administration (HRSA) is publishing a notice to alter the system of records for the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners, HHS/HRSA/BHPR. The System of Records Notice (SORN) 09-15-0054 was last published on October 1, 2010 (75 FR 60763). The Health Care Quality Improvement Act of 1986, as amended, title IV of Public Law 99-660 (42 U.S.C. 11101 et seq.) authorized the Secretary to establish a National Practitioner Data Bank (NPDB) to collect and release certain information relating to the professional competence and conduct of physicians, dentists, and other health care practitioners. By law, the information is releasable only to the specific entities described in the SORN. The law requires the maintenance of records such as medical malpractice payments, adverse licensure and clinical privilege actions, disciplinary actions taken by Boards of Medical Examiners, and professional review actions taken by entities against physicians, dentists, and other healthcare practitioners. Section 1921 of the Social Security Act, as amended, expands reporting to the NPDB to authorize maintenance of records of adverse licensure actions and negative actions or findings taken by a State licensing authority, peer review organization, or private accreditation entity against all health care practitioners or healthcare entities. The primary purpose of this alteration is to publish the Privacy Act exemptions that became necessary after implementation of Section 1921, which entitles law enforcement agencies to access NPDB information and which therefore requires a similar exemption from certain provisions of the Privacy Act that the Healthcare Integrity and Protection Data Bank (HIPDB) has for investigative materials. Because some of the records may be queried by law enforcement agencies for investigative purposes (i.e., as opposed to employment or other purposes), the system will be exempt from certain Privacy Act requirements to the extent necessary to avoid revealing law enforcement investigative interest and compromising law enforcement investigations. Another purpose of this alteration is to add a new routine use pertaining to system security, which is being added to other SORNs published by HHS.

Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of a one-day Tribal Consultation Session to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of this Consultation Session is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].

On March 22, 2012 the Office of the National Coordinator for Health Information Technology, located within the Department of Health and Human Services (HHS) published a notice in the Federal Register (77 FR 17060) announcing requirements and registration for a Beat Down Blood Pressure Video Challenge. This challenge will not be open to the public until Wednesday, March 28th. On 3/28, we encourage you to visit https://BloodPressure.Challenge.gov for a complete set of rules and requirements for this contest.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco ProductsSmall Entity Compliance Guide'' for a final rule published in the Federal Register of February 2, 2012. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand and comply with the regulation.

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 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 information collection on financial disclosure by clinical investigators.

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF). Qualification Requirements: Qualified applicants and nominees must at a minimum demonstrate knowledge, expertise and national leadership in the following areas: 1. The critical evaluation of research published in peer reviewed literature and in the methods of evidence review; 2. Clinical prevention, health promotion and primary health care; and 3. Implementation of evidence-based recommendations in clinical practice including at the clinician-patient level, practice level, and health system level. Some USPSTF members without primary health care clinical experience may be selected based on their expertise in methodological issues such as meta-analysis, analytic modeling or clinical epidemiology. For individuals with clinical expertise in primary health care, additional qualifications in methodology would enhance their candidacy. Additionally, the Task Force benefits from members with expertise in the following areas: Behavioral medicine Public health Health equity and the reduction of health disparities Application of science to health policy Communication of scientific findings to multiple audiences including health care professionals, policy makers and the general public. Candidates with experience and skills in any of these areas should highlight them in their nomination materials. Applicants must have no substantial conflicts of interest, whether financial, professional, or intellectual, that would impair the scientific integrity of the work of the USPSTF and must be willing to complete regular conflict of interest disclosures. Applicants must have the ability to work collaboratively with a team of diverse professionals who support the mission of the USPSTF. Applicants must have adequate time to contribute substantively to the work products of the USPSTF.

The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical issues raised by the ready availability of large-scale human genome sequence data, with regard to privacy and data access and the balancing of individual and societal interests.