Department of Health and Human Services January 2008 – Federal Register Recent Federal Regulation Documents

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the first meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on January 28, 2008, and from 9 a.m. to 5 p.m. on January 29, 2008, at the Hilton Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, MD 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Health Plan Management System (HPMS) ,'' System No. 09-70-4004, established at 63 Federal Register 43187 (August 12, 1998). We will broaden the scope of this system by including a new activity related to health plan and Part D plan management referred to as the Complaint Tracking Module (CTM). CTM will collect and maintain identifiable information on individuals who are, but not limited to, complainants, including beneficiaries, relatives and caregivers, Congresspersons and their staff, State Health Insurance Program representatives, and providers of service and their staff. The CTM stores complaint data, including, but not limited to, the following: Date complaint received; date of incident; issue level; complainant and/or beneficiary information; complaint summary; complaint category; complaint resolution summary; and plan resolution summary. Plans use the CTM to track the beneficiary complaints assigned to their organization, enter complaint case resolutions, and close out complaints. In addition, HPMS will collect information from health plans and Part D plan organizations pertaining to individuals who market and/or sell health insurance and prescription drug plan products on behalf of these plan organizations and who are licensed or authorized by a State Insurance Commissioner or other certifying agencies. We are sharing data pertaining to all agents/brokers to assist CMS and State Insurance Commissioners in improving oversight of the sales marketplace and in avoiding fraudulent sales practices that mislead and harm Medicare beneficiaries. 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. 09-70-0500. We will delete routine use number 1 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 propose to delete published routine use number 5 authorizing disclosure to a contractor for the purpose of collating, analyzing, aggregating or otherwise refining or processing records in this system or for developing, modifying and/or manipulating automated information systems software. We also propose to add a routine use for the release of information that permits disclosure to agency contractors, consultants, and CMS grantees that perform a task for the agency. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor, consultant, or grantee to fulfill its duties. We propose to delete published routine use number 2 authorizing disclosure to the Bureau of Census; published routine use number 7 authorizing disclosure to state Medicaid agencies; number 8 authorizing disclosure to an agency of a state Government, or established by state law, for purposes of determining the quality of health care services provided in the state; published routine use number 9 authorizing disclosure to another Federal or state agency; published routine use number 10 authorizing disclosure to other Federal agencies or states to support the administration of other Federal or state health care programs; and published routine use number 11 authorizing disclosure to the Social Security Administration. These routine uses duplicate the intended releases and as such will be combined into a single routine use to ``assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent to: (a) Contribute to the accuracy of CMS's proper payment of Medicare benefits, (b) enable such agency to administer a Federal health benefits program, or as necessary to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with federal funds; and (c) evaluate and monitor the quality of health care in the program and contribute to the accuracy of health plan operations.'' We will modify existing routine use number 6 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 for health care quality improvement projects. The modified routine use will be renumbered as routine use number 4. We propose to delete published routine use number 14 authorizing disclosures to any entity that makes payment for or oversees administration of health care services to combat fraud and abuse against such entity or the program or services administered by such entity. This disclosure provision falls outside the scope of the stated purpose for the collection of data maintained in this system. We will broaden the scope of this system by including 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'' apply when ever the system collects or maintain PHI. This system may contain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' will apply to the data disclosed from this system. The security classification previously reported as ``None'' will be modified to reflect that the data in this system is considered to be ``Level Three Privacy Act Sensitive.'' 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 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 this modified system is to collect and maintain information on Medicare beneficiaries enrolled in Medicare Health Plans in order to develop and disseminate information required by the Balanced Budget Act of 1997 that will inform beneficiaries and the public of indicators of health plan performance to help beneficiaries choose among health plans, support quality improvement activities within the plans, monitor and evaluate quality improvement activities within the plans, monitor and evaluate care provided by health plans; provide guidance to program management and policies, and provide a research data base for CMS and other researchers. 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 or consultant; (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 litigation involving the Agency; (6) combat fraud 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 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 Kemira Oyi has filed a petition proposing that the food additive regulations be amended to provide for the safe use of partially ammoniated formic acid as a pH control agent in swine feed.

The Administration for Children and Families (ACF) is proposing to amend the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations at 45 CFR 1355.40 and the appendices to part 1355 to modify the requirements for States to collect and report data to ACF on children in out-of-home care and in subsidized adoption or guardianship arrangements with the State. This proposed rule also implements the AFCARS penalty requirements of the Adoption Promotion Act of 2003 (Pub. L. 108-145).

Pursuant to section 814 of the Native American Programs Act of 1974, as amended by 42 U.S.C. 2991b-1, the Administration for Native Americans (ANA) herein describes its proposed interpretive rules, general statements of policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental) programs, Environmental Mitigation (hereinafter referred to as Mitigation), and Native American Healthy Marriage Initiative (hereinafter referred to as NAHMI). Under the stature, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, general statements of policy, and rules of agency procedure or practice and to give notice of the final adoption of such changes at least 30 days before the changes become effective. This notice also provides additional information about ANA's plan for administering the programs.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q8(R1) Pharmaceutical Development Revision 1.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance is an annex to the parent ICH guidance entitled ``Q8 Pharmaceutical Development'' (71 FR 29344, May 22, 2006) (ICH Q8). It provides further clarification of key concepts outlined in ICH Q8 and describes the principles of quality by design (QbD). The draft guidance is intended to show how concepts and tools (e.g., design space) outlined in ICH Q8 could be put into practice by the applicant for all dosage forms.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the University of California, Davis campus (UC Davis). The purpose of this MOU is to establish terms of collaboration between FDA and UC Davis, focused primarily but not exclusively, in the areas of the safety and security of foods and cosmetics, animal feeds and veterinary products. Beyond the collaborations in the traditional academic programs for training, research and outreach, this MOU will also include UC Davis extended partnerships such as the Western Institute for Food Safety and Security, and the Center for Produce Safety.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program.'' This guidance provides premarket approval application (PMA) applicants with information about the bioresearch monitoring (BIMO) review process. This includes a BIMO evaluation of clinical and nonclinical information in the PMA and certain PMA supplements as well as preapproval BIMO inspections. The procedural information outlined in this document should help applicants and FDA to better understand the BIMO review and inspection so it can proceed in a timely manner.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations.'' This guidance document explains for premarket approval application (PMA) applicants the process involved with the review of a PMA manufacturing section and inspection of the manufacturing operations described in the manufacturing section. This guidance is also generally applicable to the process involved with the review of manufacturing information in certain PMA supplements. The procedural information outlined in this document should help applicants and FDA schedule and complete their work in a timely manner.