Department of Health and Human Services August 2005 – Federal Register Recent Federal Regulation Documents
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Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services
The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This final rule adopts, with certain revisions, the changes made to 5 CFR part 5501 in the interim final rule that was published on February 3, 2005, at 70 FR 5543. After considering comments to that rulemaking, this final rule: Clarifies the definition of an ``employee of a component;'' Amends the outside activity prior approval requirements applicable to employees of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH); Revises prior approval information collection requirements and the waiver provision applicable to the outside activities prohibitions; Removes professional associations and other science and health-related organizations from the list of entities with which NIH employees are prohibited from engaging in outside activities; Adds exceptions to the NIH outside activities prohibition for delivering a class lecture as part of a regularly scheduled university course, serving on data and safety monitoring boards and grant and scientific review committees, and presenting in Grand Rounds; Limits the prohibition on holding financial interests in substantially affected organizations to senior NIH employees, their spouses, and minor children only, permits investments in such organizations that do not exceed $15,000, and allows holdings capped at $50,000 in sector mutual funds that concentrate their investments in the securities of substantially affected organizations; and Revises the outside award limitations for senior NIH employees by applying an official responsibility test for matters potentially involving an award donor. In addition, the financial disclosure reporting requirements specified in new part 5502 that were added by the interim final rule of February 3, 2005, at 70 FR 5543, and amended by an interim final rule that was published on June 28, 2005, at 70 FR 37009, are adopted as final, subject to certain amendments. The requirement to file a supplemental disclosure of financial interests in substantially affected organizations is refocused to apply to NIH employees who file a public or confidential financial disclosure report and other NIH employees who are designated as investigators in an NIH clinical research protocol approved by an institutional review board. The due date for the initial report is also changed.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service (IHS) Background Investigations of Individuals in Position Involving Regular Contact With or Control Over Indian Children OPM-306.
The Department of Health and Human Services, as part of its continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the IHS is providing a 60-day advance opportunity for public comment on a proposed extension of current information collection activity to be submitted to the office of Management and Budget for review.
Submission for OMB Review; Comment Request; Survey of NIGMS Minority Opportunities in Research (MORE) Division Institutional Program Directors
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of General Medical Sciences (NIGMS), 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 22, 2005, pages 8594-8595 and allowed 60 days for public comment. No public comments were 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: Survey of NIGMS Minority Opportunities in Research (MORE) Division Institutional Program Directors. Type of Information Collection Request: NEW. Need and Use of Information Collection: NIGMS provides research and research training support in the basic biomedical sciences through a variety of programs and grant mechanisms. Several of these programs are targeted toward support of underrepresented minority students at various educational levels and research faculty at minority-serving institutions. Although significant resources are dedicated to funding these programs, there is a lack of quantitative information on program outcomes. This proposed one-time survey is part of a larger study that will provide NIGMS with the high- quality data needed to evaluate the educational outcomes and research activity of students and faculty who are supported by NIGMS training and research support programs. Data on student enrollment and highest degree received will be collected from institutional program directors in the following programs: Minority Access to Research Careers Undergraduate Student Training in Academic Research (U*STAR), Minority Biomedical Research Support Initiative for Minority Student Development (IMSD), and Minority Biomedical Research Support Research Initiative for Scientific Enhancement (RISE). Other data will be collected from existing sources, including grant records and Medline databases. Taken together, the data will be used as a baseline for future assessments, as well to further develop current programs and in the creation of proposals for new initiatives in minority recruitment and training. These results will be reported to the National Advisory General Medical Sciences Council (NAGMSC) and shared with the community of NIGMS grantees. Frequency of Response: Once. Affected Public: Individuals or households; Not-for-profits. Type of Respondents: Training grant program directors. The annual reporting burden is as follows:
Educational Workshops on Current Good Manufacturing Practices; Public Workshops
The Food and Drug Administration (FDA) is announcing a series of educational workshops on current good manufacturing practice (CGMP). The workshops, which will be held in collaboration with Peking University (Beijing, China) and the International Society for Pharmaceutical Engineering (ISPE), are intended to educate participants on current methods for compliance with good manufacturing practices (GMP). The workshops are being offered to help ensure effective CGMP programs and to further the common goals of FDA and providers of quality pharmaceutical products.
Office of Refugee Resettlement; Grant to Hebrew Immigrant Aid Society
Notice is hereby given that a noncompetitive single source program expansion supplement to an ongoing competitive award is being made to the Hebrew Immigrant Aid Society (HIAS) to provide additional training and technical assistance to organizations implementing Refugee Marriage Enrichment projects. The application is not within the scope of any existing or expected to be issued program announcement for the Fiscal Year 2006. This application is expected to address issues critical to the development and implementation of marriage education programs for refugees by providing valuable on-site training and technical assistance to grantees and sub-grantees that offer marital communication training to refugee couples. In September of 2003, ORR awarded HIAS a grant of $200,000 to develop a Refugee Family Enrichment program which included technical assistance to subgrantees. Because of their success in the development of their marriage enrichment program, in 2004 HIAS was awarded a noncompetitive single source program expansion supplement to an ongoing competitive award to expand its Technical Assistance Services Program to Refugee Family Enrichment project sites specified by ORR. HIAS has since provided over 600 hours of technical assistance to project sites operated by organizations across the country. Their technical assistance primarily supports the work of small Mutual Assistance Associations, and without it, these agencies might struggle to provide refugee clients with the programming they need in order to achieve self sufficiency. The proposed project period is September 30, 2005 September 29, 2006. Technical assistance to support grantees in developing better approaches to the delivery of services provided to refugees is authorized by section 412(c)(1)(A) of the Immigration and Nationality Act (8 U.S.C. 1522(c)(1)). ACF received one non-substantive comment from a private citizen which did not impact this grant project specifically.
Recruitment of Sites for Assignment of Corps Personnel
The Health Resources and Services Administration (HRSA) announces that the listing of entities and their Health Professional Shortage Area (HPSA) scores that will receive priority for the assignment of National Health Service Corps (NHSC) personnel (Corps Personnel, Corps members) for the period July 1, 2005 through June 30, 2006, is posted on the NHSC Web site at https://nhsc.bhpr.hrsa.gov/ resources/fedreg-hpol/. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program, the NHSC Loan Repayment Program, and Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs. Please note that not all vacancies associated with sites on this list will be for Corps members, but could be for individuals serving an obligation to the NHSC through the Private Practice Option.
Medicare Program; Prior Determination for Certain Items and Services
Section 938 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires the Secretary to establish a process for Medicare contractors to provide eligible participating physicians and beneficiaries with a determination of coverage relating to medical necessity for certain physicians' services before the services are furnished. This rule is intended to afford the physician and beneficiary the opportunity to know the financial liability for a service before expenses are incurred. This proposed rule would establish reasonable limits on physicians' services for which a prior determination of coverage may be requested and discusses generally our plans for establishing the procedures by which those determinations may be obtained.
Federal Guidelines for Requesting, Stockpiling, Distributing Potassium Iodide (KI) From the Strategic National Stockpile (SNS)
In accordance with the provisions of Section 127 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188, (the Bioterrorism Act), this document provides guidelines for State, local, and tribal governments, for the expanded distribution, stockpiling, and utilization of KI in the event of a radioactive iodine release from a commercial nuclear power plant incident. This program would extend coverage from the current ten mile radius up to twenty miles from a commercial nuclear power plant. This document is being published in the Federal Register to permit public input on this expanded coverage from a wider range of interested entities than was accomplished with a previous draft. Respondents are also invited to include comments as to whether or not employing measures of prophylaxis other than KI or continuing reliance upon established preventive measures without expanding the area of KI coverage would render the deployment of this expanded KI distribution unnecessary. Further background follows later in these draft guidelines. If individuals inhale or ingest radioactive iodine, administration of KI, when given prior to or within several hours after exposure, can reduce the risk of thyroid cancer among certain categories of persons. KI does not provide protection from external exposure or contamination with radioactive iodine nor does it provide general protection from other sources of ionizing radiation. The primary protective actions are evacuation of the area near the source of the plume, external decontamination of individuals affected, and preventing potentially contaminated food and milk from reaching consumers. Because radioactive iodine exposure at distances beyond 10 miles is likely to be due to contamination of the food and water supply, avoiding the consumption of food or water is expected to be the most effective protective measure for persons in this zone. The Federal Government, through the Nuclear Regulatory Commission, presently makes KI available to States upon their request for distribution to or stockpiling for individuals within 10 miles of a commercial nuclear power plant.
Able Laboratories, Inc.; Withdrawal of Approval of Ten Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of ten abbreviated new drug applications (ANDAs) held by Able Laboratories, Inc. (Able Labs), One Able Dr., Cranbury, NJ 08512. Able Labs has initiated a class II recall of the products covered by these ANDAs. The company has requested that the applications be withdrawn and has waived its opportunity for a hearing.
Draft Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information.'' This draft guidance provides recommendations on what chemistry, manufacturing, and controls information sponsors should include regarding reporting, identification, qualification, and setting acceptance criteria for impurities that are classified as degradation products in drug products when submitting an abbreviated new drug application (ANDA) or supplement to support changes in drug substance synthesis or process, formulation of the drug product, the manufacturing process, or components of the container/closure system.
Medicare Program; Conditions for Payment of Power Mobility Devices, including Power Wheelchairs and Power-Operated Vehicles
This interim final rule conforms our regulations to section 302(a)(2)(E)(iv) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173). This rule defines the term power mobility devices (PMDs) as power wheelchairs and power operated vehicles (POVs or scooters). It sets forth revised conditions for Medicare payment of PMDs and defines who may prescribe PMDs. This rule also requires a face-to-face examination of the beneficiary by the physician or treating practitioner and a PMD prescription and pertinent parts of the medical record that the durable medical equipment supplier maintains in records and makes available to CMS or its agents upon request. Finally, this rule discusses CMS' policy on documentation that may be requested by CMS or its agents to support a Medicare claim for payment, as well as the elimination of the Certificate of Medical Necessity for PMDs.
Notice: Request for Comments; National Registry of Evidence-Based Programs and Practices (NREPP)
The Substance Abuse and Mental Health Services Administration (SAMHSA) is committed to preventing the onset and reducing the progression of mental illness, substance abuse and substance related problems among all individuals, including youth. As part of this effort, SAMHSA is expanding and refining the agency's National Registry of Evidence-based Programs and Practices (NREPP) so that the system serves as a leading national resource for contemporary and reliable information on the scientific basis and practicality of interventions to prevent and/or treat mental illness and substance use and abuse. NREPP represents a major agency activity within SAMHSA's Science to Service initiative. The initiative seeks to accelerate the translation of research into practice by promoting the implementation of effective, evidence-based interventions for preventing and/or treating mental disorders and substance use and abuse. Of equal measure, the initiative emphasizes the essential role of the services community in providing input and feedback to influence and better frame the research questions and activities pursued by researchers in these areas. Through SAMHSA's Science to Service initiative, the agency ultimately seeks to develop a range of tools that will facilitate evidence-based decision-making in substance abuse prevention, mental health promotion, and the treatment of mental and substance use disorders. In addition to NREPP, SAMHSA is developing an informational guide of web-based resources on evidence-based interventions that will be available in 2006. SAMHSA also is exploring the feasibility of supporting a searchable web database of evidence-based information (e.g., systematic reviews, meta-analyses, clinical guidelines) for mental health and substance abuse prevention and treatment providers. Such a system could reduce the lag time between the initial development and broader application of research knowledge by serving as a real-time resource to providers for ``keeping current'' in ways that will enhance their delivery of high quality, effective services. In combination, these three toolsNREPP, guide to web-based resources, and database of evidence-based informationwould provide valuable information that can be used in a variety of ways by a range of interested stakeholders. With regard to NREPP, during the past two years, SAMHSA convened a series of scientific/stakeholder panels to inform the agency's expansion of the system to include interventions in all substance abuse and mental health treatment and prevention domains. These panels thoroughly assessed the existing NREPP review process and review criteria and provided comments and suggestions for refining and enhancing NREPP. As part of this expansion effort, SAMHSA also engaged a contractor to assess the NREPP process and review criteria, including how the system and criteria compare to other, similar evidence review and rating systems in the behavioral and social sciences. The cumulative results of these activities have guided efforts to refine the NREPP review process and review criteria, as well as inform the agency's plans for how such a system may be used to promote greater adoption of evidence-based interventions within typical community-based settings. This Federal Register Notice (FRN) provides an opportunity for interested parties to become familiar with and comment on SAMHSA's plans for expansion and use of NREPP.
Medicaid Program; Fiscal Year Disproportionate Share Hospital Allotments and Disproportionate Share Hospital Institutions for Mental Disease Limits
This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal fiscal years (FFYs) 2003 and 2004, and the preliminary Federal share DSH allotments for FFY 2005. It also announces the final FFYs 2003 and 2004, and the preliminary FFY 2005, limitations on aggregate DSH payments that States may make to institutions for mental disease (IMDs) and other mental health facilities. This notice also includes a background describing the methodology for determining the amounts of States' FFY DSH allotments for FFY 1998 and thereafter.
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of 16 new animal drug applications (NADAs) and 1 abbreviated NADA (ANADA) because they are no longer manufactured or marketed. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 16 new animal drug applications (NADAs) and 1 abbreviated NADA (ANADA) because the products are no longer manufactured or marketed. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of the NADAs.
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