Department of Health and Human Services 2007 – Federal Register Recent Federal Regulation Documents
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Announcement of the Second Meeting of the Physical Activity Guidelines Advisory Committee
The U.S. Department of Health and Human Services (HHS) announces the second in a series of three federal advisory committee meetings on the Physical Activity Guidelines for Americans, to be held in Washington, DC. This meeting will be open to the public. The Physical Activity Guidelines Advisory Committee has been charged with reviewing existing scientific literature to identify where there is sufficient evidence to develop a comprehensive set of specific physical activity recommendations. The Committee will prepare a report to the Secretary of HHS that documents the scientific background and rationale for the issuance of Physical Activity Guidelines for Americans. The report will also identify areas where further scientific research is needed. The Committee's recommendations will be utilized by the Department to prepare the final Physical Activity Guidelines. The intent is to issue physical activity recommendations for all Americans that will be tailored as necessary for specific subgroups of the population.
Prospective Grant of Exclusive License: Use of Licensed Patent Rights for Development of Therapies for Prostatic Diseases
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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied the following patents or patent applications U.S. Patent No. 6,946,133 issued September 20, 2005 and U.S. Patent Application No. 11/606,929 filed December 1, 2006, as well as all continuations, divisionals, and issued and pending foreign counterparts [HHS Ref. No E-062-1996/0]; U.S. Patent Application Nos. 60/334,669 and 10/497,003 filed November 30, 2001 and August 24, 2004 respectively, as well as all continuations, divisionals, and issued and pending foreign counterparts [HHS Ref. No. E-124-2001/0, 1]; and U.S. Patent No. 6,165,460 issued December 26, 2000 and U.S. Patent Application No. 09/693,121 filed October 20, 2000; as well as all continuations, divisionals, and issued and pending foreign counterparts [HHS Ref. No E-200-1990/4] to BN ImmunoTherapeutics, which is located in Mountain View, CA. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for development of therapies for prostatic diseases. For the avoidance of doubt, said delivery formulation specifically excludes canary poxvirus vectors, NYVAC, eukaryotic expression vectors, aqueous-based delivery formulations, and recombinant yeast.
Government-Owned Inventions; Availability for Licensing
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.
Medicare Program; Delay of the Date of Applicability for Certain Provisions of Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III)
This final rule delays the date of applicability of certain specified compensation arrangements only, until December 4, 2008.
Oral Dosage Form New Animal Drugs; Chlortetracycline Powder
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth Holdings Corp. The supplemental NADA provides for label revisions for chlortetracycline soluble powder.
New Animal Drugs; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor address for IDEXX Pharmaceuticals, Inc.
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
This notice announces the 13th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 20th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the 21st meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)
National Toxicology Program (NTP); Report on Carcinogens (RoC); Availability of the Draft Background Documents for Aristolochic Acid Related Exposures (Two Candidate Substances: Botanical Products Containing Aristolochic Acid and Aristolochic Acid) and Riddelliine and Request for Public Comment on the Draft Background Documents; Announcement of the Aristolochic Acid Related Exposures and Riddelliine Expert Panel Meeting
The NTP announces the availability of the draft background documents for (1) aristolochic acid related exposures (the background document describes information on two candidate substances: Botanical products containing aristolochic acid and aristolochic acid) and (2) riddelliine on November 13, 2007, on the RoC Web site (https:// ntp.niehs.nih.gov/go/10091 see aristolochic acid related exposures or riddelliine) or in printed text from the RoC (see FOR FURTHER INFORMATION CONTACT below). The NTP invites the submission of public comments on the two draft background documents (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on January 24-25, 2008, at the Chapel Hill Sheraton Hotel, One Europa Drive, Chapel Hill, North Carolina 27514, to peer review the draft background documents for aristolochic acid related exposures and riddelliine and, once completed, make a recommendation regarding the listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for botanical products containing aristolochic acid, for aristolochic acid, and for riddelliine in the 12th Edition of the RoC (12th RoC). The RoC expert panel meeting is open to the public with time scheduled for oral public comments. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the NTP will post the final version of the background documents and the expert panel peer review reports on the RoC Web site.
Office of Family Assistance; Notice to Award Single-Source Expansion Supplement Grant
Notice is hereby given that a single-source program expansion is being made to Public Strategies, Inc., as the National Healthy Marriage Resource Center (NHMRC), located in Oklahoma City, OK, in the amount of $1,250,000 to conduct a national media campaign on the value of marriage and the skills needed to increase marital stability and health. Public Strategies, Inc. and their collaborative partners were competitively awarded on September 30, 2006 to operate the NHMRC. The goal of the NHMRC is to be the ``first stop shop'' for marriage education information, an experienced provider of training and technical assistance, and a major catalyst in advancing the healthy marriage field. Since healthy marriage is a nascent field, it is necessary for the NHMRC to promote healthy marriage on a broad, national level in order to achieve these stated goals. Research has repeatedly shown that a healthy marriage brings about good outcomes for individuals, families, and especially, for children. A national media campaign would significantly raise the awareness of the benefits of healthy marriage and the benefits of marriage education. The campaign would disseminate information that explains how marriage education can enhance a couple's ability to form and sustain a healthy marriage and describe the benefits to children being raised in healthy, married two parent households. Additionally, by promoting healthy marriage and marriage education on a national level, the NHMRC will encourage a national discussion and further the mission of ACF's Healthy Marriage Initiative to help couples and individuals, who have chosen marriage for themselves, gain greater access to marriage education services, on a voluntary basis, where they can acquire the skills and knowledge necessary to form and sustain a healthy marriage. After the appropriate reviews, it has been determined that this single-source expansion qualifies for funding. The period of this funding will extend from September 30, 2007 through September 29, 2011.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Privacy Act of 1974; Report of a Modified or Altered System
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an SOR titled ``Home Health Agency (HHA) Outcome and Assessment Information Set (OASIS),'' System No. 09-70-9002, last modified at 66 Federal Register 66903 (December 27, 2001). 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 information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09-70-0522. 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 contractors and/or consultants. The modified routine use will remain as routine use number 1. We will modify existing routine use number 4 that permits disclosure to Peer Review Organizations (PRO). Organizations previously referred to as PROs will be renamed to read: Quality Improvement Organizations (QIO). Information will be disclosed to QIOs relating to assessing and improving HHA quality of care. The modified routine use will remain as routine use number 4. CMS proposes to broaden the scope of the disclosure requirement for routine use number 5, authorizing disclosure to national accrediting organizations that have been approved by CMS for deeming authority for Medicare requirements for home health services. Information will be released to these organizations for only those facilities that they accredit and that participate in the Medicare program and if they meet the following requirements: (1) Provide identifying information for HHAs that have an accreditation status with the requesting deemed organization, (2) submission of a finder file identifying beneficiaries/patients receiving HHA services, (3) safeguard the confidentiality of the data and prevent unauthorized access, and (4) upon completion of a signed data exchange agreement or a CMS data use agreement. We will delete routine use number 7 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 published routine uses number 8 and 9, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers increasingly more to specific beneficiary or recipient practices that result in unnecessary cost to Federally-funded health benefit programs. 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 because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purposes of the SOR are to collect and maintain information to: (1) Study and help ensure the quality of care provided by home health agencies (HHA); (2) aid in administration of the survey and certification of Medicare/Medicaid HHAs; (3) enable regulators to provide HHAs with data for their internal quality improvement activities; (4) support agencies of the state government to determine, evaluate and assess overall effectiveness and quality of HHA services provided in the state; (5) provide for the validation, and refinements of the Medicare Prospective Payment System; (6) aid in the administration of Federal and state HHA programs within the state; and (7) monitor the continuity of care for patients who reside temporarily outside of the state. Information maintained in this system 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 and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent, for evaluating and monitoring the quality of home health care and contribute to the accuracy of health insurance operations; (3) support research, evaluation, or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects; (4) support the functions of Quality Improvement Organizations (QIO); (5) support the functions of national accrediting organizations; (6) support litigation involving the Agency; (7) combat fraud, waste, and abuse in certain health care 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 routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.
Privacy Act of 1974; Report of a Modified System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify an existing SOR titled, ``Individuals Authorized Access to Centers for Medicare & Medicaid Services (CMS) Computer Services (IACS), System No. 09-70-0064,'' most recently modified at 67 FR 48911 (July 26, 2002). 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 information in the Health Care Financing Administration systems of records. The new identifying number for this system should read: System No. 09-70-0538. We propose to broaden the scope of this system to include a CMS service planned to provide a centralized user provisioning and administration service that supports the creation, deletion, and lifecycle management of enterprise identities. This service creates accounts, supports Role Based Access Control (RBAC), and provides business application integration points. RBAC is a form flow approval process and enterprise identity audit and recertification based on the role of the individual. The business application integration point allows business application owners to use the form flow process of the user provisioning service to approve or deny requests for access to business applications. This modification will permit CMS to implement a unified framework for managing user information and access rights, for those individuals who apply for and are granted access across multiple CMS systems and business contexts. 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 contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 2 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. Finally, we will delete the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' does not apply because this system does not collect or maintain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' is not applicable to the data maintained in this system. 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 because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system has been to collect and maintain individually identifiable information to assign, control, track, and report authorized access to and use of CMS's computerized information and resources, for those individuals who apply for and are granted access across multiple CMS systems and business contexts. Information in this system will also be used to: (1) Support regulatory and policy functions performed within the Agency or by a contractor, consultant, or CMS grantee; and (2) support litigation involving the Agency related to this system. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that the ``routine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.
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