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

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 Pfizer, Inc. The supplemental NADA provides for use of albendazole oral suspension in nonlactating goats for the treatment of liver flukes.

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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 21, 2007 (Vol. 72, No. 245, p. 72741 and allowed 60-days for public comment. One public comment was received that questioned why the study was not funded by University of Alabama (UAB) funds. A response was made on February 8, 2008, that indicated that UAB was funding this study. 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: Cancer Care For Uninsured Individuals: A Feasibility Study. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this information collection is to assess the feasibility of obtaining health insurance information for participants of the Prostate, Lung, Colon and Ovarian (PLCO) Cancer Screening Trial participants from health care providers and self reports. The ultimate objective is to compare the health care utilization of insured and uninsured PLCO participants. The PLCO data provides a unique opportunity to study health care seeking behavior after an abnormal cancer screening test and the effect of lack of health insurance. Participants who had positive cancer screening tests were referred to their doctors for follow-up care. No additional care was provided by the trial. The study collected detailed information on tests received for diagnosis, clinical presentation of disease, and cancer treatment. Since the PLCO original data collection had not recorded the health insurance of participants at the time of their screening, it is necessary to collect it retrospectively. This feasibility study will request information from 50 physicians and 150 participants. The aims are to determine the: (1) Total number of physicians to be contacted to obtain insurance information on all PLCO participants who had a positive cancer screening test; (2) Percentage of physicians willing and able to provide insurance information; (3) Percentage of participants with and without insurance; (4) Number of participants for whom insurance status can be only determined by self report; (5) Percentage of PLCO participants who accept to respond to the survey; (6) Percentage of individuals who are willing to provide information on insurance status; and, (7) Potential proportion of PLCO participants without health insurance. These results will be used to design a study to examine the health care behavior of insured and uninsured PLCO participants. This is relevant to understand the results of the PLCO Cancer Screening Trial and other screening trials currently being conducted in the U.S. The success of these trials is conditional on participants' access to care following a recommendation for follow-up. Uninsured individuals may be more likely to join these trials than insured ones in order to get free preventive care. They may also be more likely to not seek, or delay seeking, care after an abnormal screening test even though they are encouraged to get care and they may be highly motivated to receive the best care possible. It is relevant for other decision makers to understand whether uninsured persons are receiving appropriate care after abnormal screening results. The efforts to control cancer disease and the loss of life associated with it are concentrated on population wide screening. These endeavors may be compromised if a significant proportion of the population does not get appropriate follow-up after screening or does not get the care known to be effective for their disease. Frequency of Response: One time. Affected Public: Individuals and households; businesses or other for-profit. Type of Respondents: Individuals older than 55 who participated in the PLCO Screening trial and physicians who provided care for them. The annual reporting burden is shown in the following table.

This notice announces a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (``Committee''). We are soliciting comments from the scientific community and the public on prioritizing research topics of importance to the Medicare population. This meeting is a follow up to the CMS Evidentiary Priorities MedCAC meeting, which was held on October 22, 2007 to establish a list of evidentiary priorities for research to improve the health of Medicare beneficiaries. The Committee generally provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Sanitation Facilities Construction Individual Applicant Records (SFCIA), System No. 09-17-004.'' Under the provisions of the Indian Sanitation Facilities Act, Pub. L. 86-121 (42 U.S.C. 2004a), IHS is charged with carrying out the functions to determine basic individual and home eligibility for sanitation services. The primary purpose of this system is to determine eligibility of individuals and homes for sanitation services; budget justification for appropriation and project development to serve eligible homes and persons with sanitation facilities; to monitor, track and report status and progress of services provided; to maintain records on and to verify individuals' eligibility for services; and to link with the IHS Resource and Patient Management System (RPMS) for purposes of verifying and determining individuals' eligibility. Information retrieved from this system may be disclosed to: (1) Congressional offices in response to a verified inquiry; (2) other Federal agencies or Tribes that provide funding for or are involved in providing sanitation facilities to individuals or communities, and may be disclosed to individuals or communities, and may be disclosed to individuals specifically involved in the process of providing sanitation facilities, including but not limited to Tribal officials, Tribal housing authorities, Tribal utilities, contractors, State and local entities and consultants; (3) support litigation involving the agency; (4) referrals to the appropriate agency, whether Federal, State, or local, charged with enforcing or implementing the statute or rule, regulation or order; (5) HHS contractors and subcontractors for the purpose of collecting, compiling, aggregating, analyzing, or refining records; (6) other Federal or Tribal entities that provide sanitation facilities at the request of these entities in conjunction with a computer-matching program conducted by these entities to detect or curtail fraud and abuse in similar types of program services; and (7) appropriate Federal agencies and Departmental contractors in the event of data breaches either suspected or confirmed. Effective Dates: IHS filed a new system report with the Chair of the House Committee on Oversight and Government Reform, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on February 28, 2008. To ensure that all parties have adequate time in which to comment, the new SOR, including routine uses, will become effective 40 days from the publication of the notice, or from the date it was submitted to OMB and the Congress, which is later, unless IHS invites comments on all portions of this notice.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system of records titled, ``Medicare Administrative Issue Tracker and Reporting of Operations (MAISTRO) System,'' System No. 09-70-0598. The purpose of the system is to capture and track casework/inquiries pertaining to Medicare Part A and Part B programs. The system will also provide a mechanism for recording data on a national level and will serve as a tool to leverage in performing analysis including identification of systemic trends. MAISTRO will record, track and monitor beneficiary and provider level inquiries & complaints. The system will contain information needed to research the inquiries, such as a beneficiary's health insurance claim number (HICN) or a Provider Identification Number (NPI). The primary purpose of the system is to collect and maintain information needed to provide a mechanism for CMS' central and regional office to capture, track, manage, report and trend inquiries, complaints and issues related to Fee-for-Service (FFS) programs. 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 CMS grantee; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) facilitate research on the quality and effectiveness of care provided, as well as epidemiological projects; (4) support litigation involving the Agency; and (5) combat fraud, waste, and abuse in certain 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 proposed routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.

In accordance with the requirements of the Privacy Act of 1974, CMS is deleting an existing system of records titled the ``Privacy Accountability Database (PAD),'' CMS System No. 09-70-0540, established at 67 FR 62482 (October 7, 2002).

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR titled, ``1- 800 Medicare Helpline (HELPLINE), System No. 09-70-0535,'' modified at 68 Federal Register 25379 (May 12, 2003). We propose to modify existing routine use number 2 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 6 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. 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 to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. 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 MMA and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the SOR is to provide general information to beneficiaries and future beneficiaries so that they can make informed Medicare decisions, maintain information on Medicare enrollment for the administration of the Medicare program, including the following functions: Ensuring proper Medicare enrollment, claims payment, Medicare premium billing and collection, coordination of benefits by validating and verifying the enrollment status of beneficiaries, and validating and studying the characteristics of persons enrolled in the Medicare program including their requirements for information. Information retrieved from this SOR will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by contractors, consultants, or CMS grantees; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist providers and suppliers of services for administration of Title XVIII of the Act; (4) assist third parties where the contact is expected to have information relating to the individual's capacity to manage his or her own affairs; (5) assist other insurers for processing individual insurance claims; (6) support litigation involving the Agency; and (7) combat fraud, waste, and abuse in certain 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 proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter existing system of records titled, ``Enrollment Data Base (EDB), System No. 09-70-0502, last modified 67 Federal Register 3203 (January 23, 2002). The EDB currently maintains enrollment-related data, data elements pertaining to Medicare Secondary Payer (MSP), and data regarding Direct billing and Third Part premium collection information for Medicare premiums. We are amending the purpose of the EDB to include maintaining enrollment and entitlement data currently maintained in the following CMS systems of records: Medicare Beneficiary Database (MBD), System No. 09-70-0536; and the Medicare Prescription Drug System (MARx), System No. 09-70- 4001. We are modifying the language in published routine use number 1 to permit disclosures to a grantee of a CMS-administered grant program 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 will modify existing routine use number 5 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 5. We will delete published routine use number 8 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 are modifying the language in the remaining disclosure provisions to provide a proper explanation as to the need for the disclosure and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. 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 system notices. The primary purpose of the SOR is to maintain information on Medicare enrollment for the administration of the Medicare program, including the following functions: Ensuring proper Medicare enrollment, claims payment, Direct billing and Third Party premium collection information, coordination of benefits by validating and verifying the enrollment status of beneficiaries, and validating and studying the characteristics of persons enrolled in the Medicare program including their requirements for information. Information retrieved from this SOR will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by agency contractors, consultants, or to a grantee of a CMS-administered grant; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist third parties where the contact is expected to have information relating to the individual's capacity to manage his or her own affairs; (4) assist providers and suppliers of services for administration of Title XVIII of the Act; (5) support Quality Improvement Organizations (QIO); (6) assist other insurers for processing individual insurance claims; (7) facilitate research on the quality and effectiveness of care provided, as well as payment-related and epidemiological projects; (8) support litigation involving the Agency; and (9) combat fraud and abuse in certain health benefits programs. We have provided background information about the new 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 proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

This final rule adds new regulations to require States to collect and report data to ACF on youth who are receiving independent living services and on the outcomes of certain youth who are in foster care or who age out of foster care. The final rule implements the data collection requirements of the Foster Care Independence Act of 1999 (Pub. L. 106-169) as incorporated into the Social Security Act.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products,'' dated February 2008. The guidance document provides recommendations to sponsors for using methods other than sterility testing to confirm the integrity of container and closure systems as part of stability testing for sterile biological products, human and veterinary drugs, and medical devices. The guidance document does not apply to sterility testing methods for product sterility testing prior to release, as container and closure system integrity tests cannot demonstrate a product's initial sterility. The guidance announced in this notice finalizes the draft guidance entitled ``Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products,'' dated January 1998.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables'' (the fresh-cut guidance or guidance). Previously, FDA announced the availability of the fresh-cut guidance as a ``draft final'' document, pending approval by the Office of Management and Budget (OMB) of the information collection provisions in the guidance. FDA is publishing this notice to announce that the fresh- cut guidance is now final. The text of the guidance has not changed from the previously published draft final version. The fresh-cut guidance complements FDA's current good manufacturing practice (CGMP) requirements for foods by providing specific guidance on the processing of fresh-cut produce. The fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready-to- eat form.