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

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-fifth meeting, at which, among other things, it will hear presentations on and discuss issues in two broad areas (1) organ transplantation and procurement and (2) newborn screening for genetic disorders. The discussions in both areas are continuations of previous Council discussions. Subjects discussed at past Council meetings (although not on the agenda for the June 2006 meeting) include: human dignity, therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, and lifespan-extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Filing Objections and Requests for a Hearing on a Regulation or Order'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Financial Disclosure by Clinical Investigators'' has been approved by the Office of Management and Budget (OMB) 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).

This document adopts the Smallpox Vaccine Injury Compensation Program (the Program) Administrative Implementation Interim Final Rule as the Final Rule with amendments, as follows: explains how the term ``child'' survivor is defined; updates the effective period of the Secretary's Declaration Regarding Administration of Smallpox Countermeasures (the Declaration); corrects an error in Sec. 102.20(d) to clarify that one of the Smallpox (Vaccinia) Vaccine Injury Table requirements to establish a covered Table injury is the first symptom or manifestation of onset of the injury in the Table time period specified; reflects the change in name from the Special Programs Bureau to the Healthcare Systems Bureau; provides the new address of the Bureau's Associate Administrator, and the new address of the Program Office; clarifies that no payments are authorized for fees or costs of personal representatives, including those of attorneys; and corrects a typographical error in Sec. 102.83(c) to make clear that the Secretary determines the timeframe for submission of required documentation.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 January 23, 2006, page 3312 and allowed 60-days for public comment. One public comment was received. The purpose of this notice 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. Proposed Collection: Title: Actigraph Accelerometer Validation Study Type of Information Collection Request: New. Need and Use of Information Collection: The NCI is collaborating with other NIH Institutes on a proposed longitudinal study of Hispanic subpopulations in the United States referred to as the Hispanic Community Health Study. The Hispanic population is now the largest minority population in the U.S. with a projected three-fold growth by 2050. Hispanic subgroups are influenced by a number of chronic disease risk factors associated with immigration from different cultural settings and environments. These factors include diet, physical activity, community support, working conditions, and access to health care. Hispanic groups have higher rates of obesity and diabetes than non-Hispanic groups, but have lower coronary disease and cancer (all sites) mortality. There are also observed differences in health outcomes between Hispanic subgroups. For example, Puerto Ricans have a four-fold higher asthma prevalence than Mexican-Americans. Hispanic populations are understudied with respect to many diseases and risk factors. Their projected population growth underscores the need for accurate evaluation of their disease burden and risk. A vast amount of research suggests that the level of physical activity influences many of the chronic diseases and conditions of interest, including obesity, diabetes, cardiovascular disease, and cancer. To better understand the relationship between physical activity and chronic disease, and to make specific activity prescriptions, it is necessary to be able to accurately assess levels and types of activity. In particular, better methods are needed to improve the validity and reliability of physical activity assessment instruments to better assess the frequency, duration, and intensity of physical activity. For that reason, NCI plans to evaluate the use of a new type of accelerometer, a small device worn on a belt at the waist that measures and records movement, capturing movement intensity and duration and associating it with clock-time. This new accelerometer will be used in the Hispanic Community Health Study and will allow examination of levels as well as patterns of activity. Physical activity was measured with accelerometers in the nationally representative 2003-2006 National Health and Nutrition Examination Survey (NHANES) (OMB: 0920- 0237, October 15, 2004, Vol 69, pp. 61253-61254). NHANES provides estimates for Mexican-American, but not other Hispanic subgroups. Between the time of the NHANES and the Hispanic Community Health Study, there has been a change in the technology of the accelerometer used in NHANES. To allow comparison of the physical activity data that will be collected from the four Hispanic subgroups in the Hispanic Community Study to the data collected with the previous technology used in NHANES, a cross-validation study is needed. The proposed study, the ActiGraph Accelerometer Validation Study, will serve this purpose. It is a cross-validation study comparing the two ActiGraph accelerometer models under different circumstances of walking or jogging in differing age groups and for both genders. Frequency of response: One-time study. Affected Public: Individuals. Type of Respondents: Healthy adults between the ages of 18-74 years. The annual reporting burden is as follows: Estimated Number of Respondents: 144; Estimated Number of Responses per Respondent: 1.14; Average Burden Hours Per Response: 0.66; and Estimated Total Annual Burden Hours Requested: 62. The annualized cost to respondents is estimated at: $1116.

The Office on Women's Health (OWH) within the Department of Health and Human Services (DHHS) is the government's champion and 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, namely mentoring partnerships (prot[eacute]g[eacute] and mentor) meant to strengthen the capacity of non-profit organizations that provide HIV/AIDS prevention services to women at risk and/or living with HIV/AIDS. Women of color represent over 80 percent of the reported AIDS cases. Younger women are increasingly at higher risk for HIV/AIDS. Thus, the Mentoring Partnership ProgramProt[eacute]g[eacute] intends to demonstrate how small, non-profit, community-based, faith-based, and women's service organizations will be strengthened, programs/service effectiveness increased, and gender-focused and culturally competent practices instituted so that efforts to reach women most at risk and/or living with HIV/AIDS are increased. The non-profit community-based, faith- based, and women's service organizations receive training to increase their competencies in operating a sound organization. Moreover, mentors prepare prot[eacute]g[eacute]s to compete for additional public and private funding. During the funding period, prot[eacute]g[eacute] organizations will demonstrate a gain in knowledge and skills by reaching more women with HIV/AIDS prevention education and support services. In order to improve HIV/AIDS program services to women, prot[eacute]g[eacute] grantees are also required to receive additional training by attending two HIV/AIDS prevention conferences (regional and national) and establish collaborative partnerships with the local health and social service departments for referral resources in areas such as primary health care, housing, education, job and/or trade training, to name a few.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Automated Survey Processing Environment (ASPEN) Complaints/Incidents Tracking System (ACTS),'' System No. 09-70-1519, last published at 68 FR 50795 (August 22, 2003). 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. 09-70-0565. We propose to delete published routine uses number 5 authorizing disclosures to the agency of a state government, number 8 authorizing disclosure to researchers, and number 12 authorizing disclosure to another agency or instrumentality of any governmental jurisdiction. Disclosures permitted under routine uses number 5 and 12 will be made a part of proposed routine use number 2. The scope of routine use number 2 will be broadened to allow for release of information to ``another Federal and/or state agency, an agency established by state law, or its fiscal agent.'' Routine use number 8 is being deleted because disclosure of ACTS data for research and evaluation purposes will be restricted to the release of aggregate data rather than individual- specific data. CMS proposes to exempt this system from the notification, access, correction and amendment provisions of the Privacy Act of 1974 (5 U.S.C. 552a (k) (2)) due to investigatory and law enforcement activities. We are modifying the language in the remaining 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 track and process complaints and incidents reported against Medicare and/or Medicaid certified providers and suppliers, and CLIA-certified laboratories, these include: skilled nursing facilities, nursing facilities, hospitals, home health agencies, end-stage renal disease facilities, hospices, rural health clinics, comprehensive outpatient rehabilitation facilities, outpatient physical therapy services, community mental health centers, ambulatory surgical centers, suppliers of portable X-Ray services, and intermediate care facilities for persons with mental retardation. The information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or grantee; (2) assist another Federal or state agency, an agency established by state law, or its fiscal agent; (3) assist Quality Improvement Organizations; (4) support constituent requests made to a Congressional representative; (5) support litigation involving the agency; (6) assist a national accreditation organization that has been granted deeming authority by CMS; (7) assist a state- mandated Protection and Advocacy System that provides legal representation and other advocacy services to beneficiaries; and (8) combat fraud and abuse in certain 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 Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Monsanto Chemical Company, Dayton, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Monsanto Chemical Company. Location: Dayton, Ohio. Job Titles and/or Job Duties: Directors and subordinates, physicists, chemists, technicians, and workers. Period of Employment: 1943-1949.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q8 Pharmaceutical Development.'' 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 describes the suggested contents for the pharmaceutical development section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The guidance also indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.

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 guidance on reagents for detection of specific novel influenza A viruses.