Department of Health and Human Services December 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``MedWatch: Food and Drug Administration Medical Products Reporting Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Fluoro-Deoxy Glucose (FDG) Positron Emission Tomography (PET) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, Testicular and Other Cancers (PET 6), HHS/CMS/OCSQ, System No. 09-70-0549.'' National Coverage Determinations (NCD) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act (the Act) Sec. 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained in Part A or Part B, and must not be otherwise excluded from coverage. In our review of the other cancer indications, we found sufficient evidence to determine that PET scans are no longer experimental. However, the evidence was insufficient to reach a conclusion that FDG PET is reasonable and necessary in all instances. A sufficient inference of benefit, however, can be drawn to support limited coverage if certain safeguards for patients are provided. This inference is based on both the physiological basis for FDG PET usefulness in cancer, as well as, evidence of a positive benefit of FDG PET for patients with several other cancers for which there is evidence of sufficient quality to warrant coverage. The purpose of this system is to collect and maintain information on Medicare beneficiaries receiving FDG PET scans for indications for when there is not sufficient evidence to reach a firm conclusion that the scan is reasonable and necessary unless they are enrolled in an approved study. Information retrieved from this system 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 or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) to an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a Congressional representative; (5) support litigation involving the agency; and (6) 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.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system of records title, ``Implantable Cardioverter-Defibrillator (ICD) System, System No. 09- 70-0548.'' National coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act (the Act) Sec. 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be ``reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,'' Sec. 1862(a)(1)(A). CMS has determined that the evidence is adequate to conclude that an implantable cardioverter-defibrillator (ICD) is reasonable and necessary in several patient groups where certain criteria for these patients have been met. The reasonable and necessary determination requires that patients meet the ICD implantation criteria set forth in the decision memorandum and are consistent with the trials discussed. Collection of these data elements allows that determination to be made. The purpose of this system is to provide reimbursement for ICDs and assist in the collection of data on patients receiving an ICD for primary prevention to a data collection process to assure patient safety and protection and to determine that the ICD is reasonable and necessary. Information retrieved from this system 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 or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) to an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud 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.

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.

The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following conditions as part of FDA's ongoing review of over-the-counter (OTC) drug products: Bisoctrizole, up to 10 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients; and bemotrizinol, up to 10 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients. FDA reviewed time and extent applications (TEAs) for these conditions and determined that they are eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether these conditions can be generally recognized as safe and effective (GRAS/E) for their proposed OTC use.

The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following conditions as part of FDA's ongoing review of over-the-counter (OTC) drug products: Climbazole, 0.1 to 0.5 percent and 0.5 to 2.0 percent, as a dandruff control active ingredient in leave-on and rinse-off dosage forms, respectively. FDA has reviewed a time and extent application (TEA) for these conditions and determined that they are eligible for consideration in its OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether these conditions can be generally recognized as safe and effective (GRASE) for their proposed OTC use.

This notice announces the dates and locations of the Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (ASPE) Town Hall meetings to be held in calendar years 2005 and 2006 to solicit public comment on quantifying the economic impact of major Federal regulations governing the health care industry. These public meetings provide a forum for interested parties to make oral presentations and/or to submit written comments about the impact of regulations. In particular, commenters are requested to provide an estimate of the economic impact of Federal health care regulations, guidance documents, or paperwork requirements, and also to describe the methods used to calculate the economic impact of the regulations. The Town Hall meetings will be held in several cities across the country to provide an opportunity for input. In addition, individuals may also submit written comments for consideration regardless of their ability to attend the Town Hall meetings.

The Food and Drug Administration (FDA) is proposing to remove the regulation applicable to the status of specific products; Group A streptococcus. FDA is proposing to remove the regulation because the existing requirement for Group A streptococcus organisms and derivatives is both obsolete and a perceived impediment to the development of Group A streptococcus vaccines. The regulation was written to apply to a group of products that are no longer on the market. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. This proposed rule is a companion to the direct final rule published elsewhere in this issue of the Federal Register. We are taking this action because the proposed change is noncontroversial, and we do not anticipate any significant adverse comments. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

The Food and Drug Administration (FDA) is amending its regulations to reflect a change in the address for the American Society for Testing Materials (ASTM). This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.

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.