Department of Health and Human Services February 29, 2008 – Federal Register Recent Federal Regulation Documents
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Frozen Concentrate for Lemonade Deviating From Identity Standard; Temporary Permit for Market Testing
The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Florida's Natural Growers, to market test a product designated as ``Frozen Concentrate for Lemonade 3+1 Ratio'' that deviates from the U.S. standard of identity for frozen concentrate for lemonade. The purpose of the temporary permit is to allow the applicant to measure customer acceptance of the product, identify mass production problems, and assess commercial feasibility.
Determination That MINOCIN (Minocycline Hydrochloride) Capsules Equivalent to 75 Milligrams Base Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that MINOCIN (minocycline hydrochloride) Capsules equivalent to (EQ) 75 milligrams (mg) base was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for minocycline hydrochloride capsules if all other legal and regulatory requirements are met.
New Animal Drugs; Albendazole
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.
Medicare Program; Changes to the Medicare Claims Appeal Procedures; Continuation of Effectiveness and Extension of Timeline for Publication of Final Rule
This notice announces the continuation of effectiveness of a Medicare interim final and the extension of the timeline for publication of the final rule. This notice is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if prior to the expiration of the timeline, the Secretary publishes in the Federal Register a notice of continuation and explains the exceptional circumstances justifying the extension of the timeline for publishing a final rule.
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.
Submission for OMB Review; Comment Request; Cancer Care for Uninsured Individuals: A Feasibility Study (NCI)
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.
Revisit User Fee Program for Medicare Survey and Certification Activities
This interim final rule with comment period implements the continuation of the revisit user fee program for Medicare Survey and Certification activities, in accordance with the statutory authority in the Continuing Appropriations Resolution entitled, ``Making further continuing appropriations for the fiscal year 2008, and for all other purposes,'' Public Law 110-149 (``Continuing Resolution'') signed into law on December 21, 2007. On September 19, 2007, we published a final rule that established a system of revisit user fees applicable to health care facilities that have been cited for deficiencies during initial certification, recertification or substantiated complaint surveys and require a revisit to confirm that previously-identified deficiencies have been corrected.
Medicare Program; Town Hall Meeting of the Medicare Evidence Development and Coverage Advisory Committee-April 30, 2008
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)).
Designation of Medically Underserved Populations and Health Professional Shortage Areas
This proposed rule would revise and consolidate the criteria and processes for designating medically underserved populations (MUPs) and health professional shortage areas (HPSAs), designations that are used in a wide variety of Federal government programs. These revisions are intended to improve the way underserved areas and populations are designated, by incorporating up-to-date measures of health status and access barriers, eliminating inconsistencies and duplication of effort between the two existing processes. These revisions are intended to reduce the effort and data burden on States and communities by simplifying and automating the designation process as much as possible while maximizing the use of technology. No changes are proposed at this time with respect to the criteria for designating dental and mental health HPSAs. Podiatric, vision care, pharmacy, and veterinary care HPSAs, which are no longer in use, would be abolished under the rules proposed below. Additional background information will be available for review on the web site of the Health Resources and Services Administration: https://bhpr.hrsa.gov/shortage. The methodology is also described in a journal article recently published in the Journal of Health Care for the Poor and Underserved entitled ``Designating Places and Populations as Medically Underserved: A Proposal for a New Approach'' (Ricketts et al, 2007).
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