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

In accordance with the requirements of the Privacy Act of 1974, we are proposing to create a new SOR titled, ``Data Collection Secondary to Coverage Decision (DCSCD) System, HHS/CMS/OCSQ, System No. 09-70-0547.'' 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 certain identified diagnoses are 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 criteria and are consistent with the trials discussed. Collection of these data elements allows that determination to be made. We are particularly interested in seeing evidence that would permit us to make a coverage or non-coverage decision, i.e., to move a diagnostic indication from coverage under a clinical trial or study to coverage or non-coverage based on definitive evidence of benefit, no benefit, or harm. If adequate new evidence is available, the decision may be changed to either ``coverage based on evidence of benefit,'' ``limited coverage'' or ``non-coverage based on evidence of harm or no benefit.'' The purpose of this system is to collect and maintain data on patients to review determinations of ``reasonable and necessary'' with respect to whether or not a particular item or service is covered nationally under title XVIII of the Act Sec. 1869(f)(1)(B). 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.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications.'' FDA is issuing this draft guidance to recommend an approach for determining whether a laboratory test may be performed by laboratories with a certificate of waiver under CLIA. This draft guidance replaces the previous draft guidance entitled ``Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver,'' March 1, 2001.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``How to Comply with the Pediatric Research Equity Act.'' This draft guidance provides recommendations on how to interpret the requirements of the Pediatric Research Equity Act (PREA), which requires pediatric studies of certain drugs and biological products to ensure that those products that are likely to be commonly used in children or that represent a meaningful therapeutic benefit over existing treatments contain adequate pediatric labeling for approved indications.

This notice announces those sites for which ATSDR has completed public health assessments during the period from April through June 2005. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.

The Food and Drug Administration (FDA) published a final rule in the Federal Register of October 31, 2003 (68 FR 62007). The final rule classified the endotoxin assay into class II (special controls). The agency classified the device into class II (special controls) in order to provide reasonable assurance of safety and effectiveness of the device. FDA is amending the agency's regulations to redesignate the section number listed in the Code of Federal Regulations (CFR) from Sec. 866.3610 to Sec. 866.3210.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to reinstate the information collection project: ``AHRQ-HRSA Chemical, Biological, Radiological, Nuclear and Explosive (All Hazards) Preparedness Questionnaire for Healthcare Facilities for 2004 (CBRNE)''. In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(C)(2)(A), AHRQ invites the public to comment on this proposed information collection. AHRQ obtained a six-month emergency collection approval for the first wave of this information collection. This reinstatement of the previous clearance approval coves the second wave of the same survey. The respondents will be queried as to their progress in achieving the preparedness goals reported in the first wave.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M5 Data Elements and Standards for Drug Dictionaries.'' 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 describes the data elements and standards that ICH recommends be made available to interested parties to assist in the development and maintenance of drug dictionaries. The draft guidance is intended to facilitate the exchange and practical use of medicinal product information at the international level, such as with postmarketing safety reporting.

The Food and Drug Administration (FDA) has determined that Penthrane (methoxyflurane) Inhalation Liquid, 99.9 percent, was withdrawn from sale for reasons of safety or effectiveness. The agency will not accept or approve abbreviated new drug applications (ANDAs) for methoxyflurane inhalation liquid, 99.9 percent.

This document corrects the notice that appeared in the Federal Register on August 29, 2005, (70 FR 51065), entitled ``Federal Guidelines for Requesting, Stockpiling, Distributing Potassium Iodide (KI) From the Strategic National Stockpile (SNS)'. We inadvertently omitted the DATES section of the notice to inform the public of how long we will be receiving comments. We are adding the DATES section to read as follows:

The Office of Global Health Affairs (OGHA) announces that up to $475,000 in fiscal year (FY) 2005 of funds is available for one (1) cooperative agreement to provide support to strengthen the management of women's and children's hospitals by the Afghan Ministry of Public Health (MOPH) in Kabul. This effort is an undertaking by the Department of Health and Human Services (HHS) in partnership with the Afghan MOPH. The primary goal of this project is to improve the quality of care at women's and children's health institutions in Afghanistan. The OGHA anticipates substantial HHS scientific and programmatic involvement in the administration of the quality improvement program. The project will be approved for up to a one-year period for a total of $475,000 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds

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 an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on medical device recall authority.