Department of Health and Human Services November 2007 – Federal Register Recent Federal Regulation Documents

Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
Document Number: E7-23285
Type: Rule
Date: 2007-11-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.
Guidance for Industry and Food and Drug Administration Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability
Document Number: E7-23281
Type: Notice
Date: 2007-11-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle'' dated November 2007. The guidance document serves as the special control for the automated blood cell separator device operating on a centrifugal or filtration separation principle intended for the routine collection of blood and blood components, and describes a means by which the device may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify the automated blood cell separator device operating by centrifugal separation principle into class II (special controls).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Document Number: E7-23275
Type: Notice
Date: 2007-11-30
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Medicare Program; Home Health Prospective Payment System Refinement and Rate Update for Calendar Year 2008; Corrections
Document Number: E7-23272
Type: Rule
Date: 2007-11-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects typographical and technical errors that appeared in the August 29, 2007 Federal Register, entitled ``Medicare Program; Home Health Prospective Payment System Refinement and Rate Update for Calendar Year 2008.''
Proposed Collection; Comment Request; Process Evaluation of the Global Health Research Initiative Program for New Foreign Investigators (GRIP)
Document Number: E7-23235
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of section 3506(copyright)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Fogarty International Center (FIC), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Process evaluation of the Global Health Research Initiative Program for New Foreign Investigators (GRIP). Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will assess the outputs of the Global Health Research Initiative Program for New Foreign Investigators (GRIP) to date, assess the programs alignment with new strategic goals of the FIC, and identify potential directions for program enhancement. The primary objectives of the study are to determine if GRIP awards (1) promote productive re-entry of NIH-trained foreign investigators into their home countries, (2) increase the research capacity of the international scientists and institution, and (3) stimulate research on a wide variety of high priority health-related issues. The findings will provide valuable information concerning: (1) Specific research advances attributable to GRIP support; (2) specific capacity and career enhancing advances that are attributable to GRIP; (3) policy implications for GRIP at the program level based on survey responses, such as successes and challenges of the program's implementation, the GRIP support mechanism, etc. Frequency of Response: Once. Affected Public: None. Type of Respondents: Foreign researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 101; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.50; and Estimated Total Annual Burden Hours Requested: 50.5. The annualized cost to respondents is estimated at: $656.50. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Table 1 and Table 2 respectively present data concerning the burden hours and cost burdens for this data collection.
National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Availability of the Bisphenol A Expert Panel Report; Request for Public Comment
Document Number: E7-23234
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services
CERHR announces the availability of the final bisphenol A expert panel report on November 26, 2007, from the CERHR Web site (http://cerhr.niehs.nih.gov) or in print from CERHR (see ADDRESSES below). The expert panel report is an evaluation of the reproductive and developmental toxicity of bisphenol A conducted by an independent, 12-member expert panel composed of scientists from the public and private sectors convened by CERHR. CERHR invites the submission of public comments on this report (see SUPPLEMENTARY INFORMATION below). The expert panel met twice in public session (March 5-7, 2007 and August 6-8, 2007) to review and revise the draft expert panel report and reach conclusions regarding whether exposure to bisphenol A is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Corrections
Document Number: E7-23219
Type: Rule
Date: 2007-11-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the August 3, 2007 Federal Register, entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2008; Final Rule.''
Medicaid Integrity Program; Limitation on Contractor Liability
Document Number: E7-23217
Type: Rule
Date: 2007-11-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Medicaid Integrity Program (the Program) provides that the Secretary promote the integrity of the Medicaid program by entering into contracts with contractors that will review the actions of individuals or entities furnishing items or services (whether fee-for- service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of the plan approved under section 1115 of the Social Security Act; audit claims for payment of items or services furnished, or administrative services furnished, under a State plan; identify overpayments of individuals or entities receiving Federal funds; and educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This final rule will provide for limitations on a contractor's liability while performing these services under the Program. The final rule will, to the extent possible, employ the same or comparable standards and other substantive and procedural provisions as are contained in section 1157 (Limitation on Liability) of the Social Security Act.
Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Reopening of Comment Period
Document Number: E7-23211
Type: Notice
Date: 2007-11-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening to January 15, 2008, the comment period for the notice of public hearing that published in the Federal Register of July 20, 2007. In the notice of public hearing, FDA requested comments on the use of symbols to communicate nutrition information on food labels. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Rule for Over-the-Counter Antitussive Drug Products; Technical Amendment
Document Number: E7-23207
Type: Rule
Date: 2007-11-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations (exemption for certain drugs limited by new-drug applications to prescription sale, and warning and caution statements required by regulations for drugs) by removing the entries for carbetapentane citrate. This action is associated with FDA's determination that carbetapentane citrate has not been shown to be effective at the over-the-counter (OTC) doses stated in the exempting regulation. FDA made this determination in 1987 as part of its ongoing review of OTC drug products.
Government-Owned Inventions; Availability for Licensing
Document Number: E7-23194
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the United States 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.
Government-Owned Inventions; Availability for Licensing
Document Number: E7-23193
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services, National Institutes of Health
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.
Prospective Grant of Exclusive License: Development of FDA Approved HIV Resistance Diagnosis Kit
Document Number: E7-23191
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the invention embodied in U.S. Patent No. 5,714,313, issued February 03, 1998, entitled ``Simple Method For Detecting Inhibitors Of Retroviral Replication'' (HHS Ref. E-054-1991/ 1-US-01) (Inventors: David Garfinkel, Joan Curcio, Dwight Nissley and Jeffrey Strathern) (NCI), to AmiKana.BioLogics (Hereafter AmiKana), having a place of business in France. The patent rights in these inventions have been assigned to the United States of America.
Submission for OMB Review; Comment Request; Pretesting of NIAID's HIV Vaccine Research Communications Messages
Document Number: E7-23183
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), 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 August 28, 2007, page 49282 and allowed 60-days for public comment. One public comment was received and was addressed in the OMB request. The purpose of this notice is to allow an additional 30 days for public comment. Proposed Collection: Title: Pretesting of NIAID's HIV Vaccine Research Communications Messages. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for clearance to pretest messages, materials and program activities produced for the NIAID HIV Vaccine Research Education Initiative (NHVREI). The primary objectives of the pretests are to (1) assess audience knowledge, attitudes, behaviors and other characteristics for the planning/development of health messages, education products, communication strategies, and public information programs; and (2) pretest these health messages, products, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions. The information obtained from audience research and pretesting results in more effective messages, materials, and programmatic strategies. By maximizing the effectiveness of these messages and strategies for reaching targeted audiences, the frequency with which publications, products, and programs need to be modified is reduced. Frequency of Response: On occasion. Affected Public: Individuals. Type of Respondents: Adults at risk for HIV/AIDS, particularly those who are Black/African-American, Hispanic/Latino, or men who have sex with men; healthcare providers; representatives of organizations disseminating HIV-related messages or materials. The annual reporting burden is shown in the table below. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 07-5886
Type: Notice
Date: 2007-11-30
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the renewal of the generic information collection project: ``AHRQ Grants Reporting System (GRS).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104- 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Meeting of the National Biodefense Science Board
Document Number: 07-5885
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding its inaugural meeting. The meeting is open to the public.
Amendment to January 26, 2007 Declaration Under the Public Readiness and Emergency Preparedness Act
Document Number: 07-5884
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services
Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for pandemic countermeasures based on a credible risk that avian influenza viruses spread and evolve into strains capable of causing a pandemic of human influenza. Amendment: Whereas, the H7 and H9 subtypes of avian influenza viruses are viewed as likely candidates to evolve into an influenza virus strain capable of causing a pandemic of human influenza; and Whereas, in accordance with section 319F-3(b)(6) of the Public Health Service Act (42 U.S.C. 247d-6d(b)) (``the Act''), I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of these additional medical countermeasures with respect to the category of diseases and population described in sections II and IV of the declaration published in Federal Register on February 1, 2007 (72 FR 4710) (``the Original Declaration''); Therefore, pursuant to section 319F-3(b) of the Act, I have determined there is a credible risk that the spread of the H7 and H9 subtypes of avian influenza viruses and resulting disease could in the future constitute a public health emergency. In order to reflect the addition of medical countermeasures specific to the H7 and H9 subtypes of influenza viruses, the Original Declaration is hereby amended as follows: First ``whereas'' clause, first sentence, insert ``H7 and H9 vaccines'' following ``(H5N1).'' Second ``whereas'' clause, first sentence, insert ``H7 and H9'' following ``H5N1'' to read ``Whereas an H5N1, [H7 and H9] avian influenza viruse[s] may evolve into strain[s] * * *.'' In Section I, paragraph 2, first sentence insert ``H7 and H9'' following ``(H5N1)'' to read ``* * * pandemic countermeasure influenza A (H5N1, [H7 and H9]) vaccine[s].'' In Section I, paragraph 2, third sentence insert ``H7 and H9'' following ``(H5N1)'' to read ``* * * pandemic countermeasure influenza A (H5N1, [H7 and H9]) vaccine[s] * * *.'' In Section II, paragraph 1, insert ``or an H7 or H9'' following ``(H5N1).'' In Section VIII, strike the sentence ``This Declaration has not previously been amended.'' and replace it with: ``This is the first amendment to this Declaration. The Original Declaration was published in the Federal Register at 72 FR 4710.'' All other provisions of the Original declaration remain in full force. This amendment to the Declaration will be published in the Federal Register pursuant to section 319F-3(b)(4) of the Act.
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 07-5883
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 07-5882
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 07-5879
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 07-5878
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 07-5877
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services, National Institutes of Health
National Committee on Vital and Health Statistics: Meeting
Document Number: 07-5876
Type: Notice
Date: 2007-11-30
Agency: Department of Health and Human Services
Secondary Direct Food Additives Permitted in Food for Human Consumption
Document Number: E7-23182
Type: Rule
Date: 2007-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the food additive regulations to expand the conditions for the safe use of cetylpyridinium chloride (CPC) as an antimicrobial agent in a pre- chiller or post-chiller solution for application to raw poultry carcasses. This action is in response to a petition filed by Safe Foods Corp. (Safe Foods).
Gastrointestinal Drugs Advisory Committee; Notice of Meeting
Document Number: E7-23177
Type: Notice
Date: 2007-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E7-23164
Type: Notice
Date: 2007-11-29
Agency: Department of Health and Human Services, Centers for Medicare & Medicaid Services, Hhs, Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E7-23163
Type: Notice
Date: 2007-11-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Privacy Act of 1974; CMS Computer Match No. 2007-03; HHS Computer Match No. 0407; SSA Computer Match No. 1048; IRS Project No. 241
Document Number: E7-23139
Type: Notice
Date: 2007-11-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the renewal of an existing CMP between CMS, the Internal Revenue Service (IRS), and the Social Security Administration (SSA). We have provided information about the matching program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act provides an opportunity for interested persons to comment on the matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.
Risk Assessment of the Public Health Impact from Foodborne Listeria Monocytogenes in Soft-Ripened Cheese: Request for Comments and for Scientific Data and Information
Document Number: E7-23104
Type: Notice
Date: 2007-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment for Listeria monocytogenes in soft- ripened cheese. The purpose of the risk assessment is to ascertain the impact on public health from the reduction and/or prevention of L. monocytogenes growth and recontamination during the manufacturing and/ or processing of soft-ripened cheese.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 07-5866
Type: Notice
Date: 2007-11-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Sunscreen Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph; Extension of Comment Period
Document Number: 07-5853
Type: Proposed Rule
Date: 2007-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending to December 26, 2007, the comment period for the August 27, 2007, proposed rule to amend the final monograph for over-the-counter (OTC) sunscreen drug products (72 FR 49070). The comment period for the proposed rule was to end on November 26, 2007. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the State Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2008 Through September 30, 2009
Document Number: 07-5847
Type: Notice
Date: 2007-11-28
Agency: Office of the Secretary, Department of Health and Human Services
The Federal Medical Assistance Percentages and Enhanced Federal Medical Assistance Percentages for Fiscal Year 2009 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2008 through September 30, 2009. This notice announces the calculated ``Federal Medical Assistance Percentages'' and ``Enhanced Federal Medical Assistance Percentages'' that The U.S. Department of Health and Human Services (HHS) will use in determining the amount of Federal matching for State medical assistance (Medicaid) and State Children's Health Insurance Program (SCHIP) expenditures, and Temporary Assistance for needy Families (TANF) Contingency Funds, the federal share of Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Funds, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments. The table gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. Programs under title XIX of the Act existing each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands, while a program under the title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. Programs under title XXI began operating in fiscal year 1998. The percentages in this notice apply to State expenditures for most medical services and medical insurance services, and assistance payments for certain social services. The statute provides separately for Federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Act require the Secretary, HHS to publish the Federal Medical Assistance Percentages each year. The Secretary is to calculate the percentages, using formulas in sections 1905(b) and 1101(a)(8)(B), from the Department of Commerce's statistics of average income per person in each State and for the Nation as a whole. The percentages are within the upper and lower limits given in section 1905(b) of the Act. The percentages to be applied to the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 states. The ``Federal Medical Assistance Percentages'' are for Medicaid. Section 1905(b) of the Act specifies the formula for calculating Federal Medical Assistance Percentages as follows:
National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy
Document Number: E7-23090
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Behind the Counter Availability of Certain Drugs; Public Meeting; Comment Period Clarification
Document Number: E7-23026
Type: Notice
Date: 2007-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
In the Federal Register of October 4, 2007 (72 FR 56769), the Food and Drug Administration (FDA) published a notice that announced a public meeting to obtain comments regarding behind-the-counter (BTC) availability of human drugs. An incorrect date was published in that notice. This document clarifies that Docket No. 2007N-0356 will close on December 17, 2007.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-23015
Type: Notice
Date: 2007-11-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids
Document Number: E7-22991
Type: Proposed Rule
Date: 2007-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) proposes to issue this rule finding that certain nutrient content claims for foods, including conventional foods and dietary supplements, that contain omega-3 fatty acids, do not meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) and may not appear in food labeling. This rule is being proposed in response to three notifications submitted to FDA under the act. One notification concerning nutrient content claims for alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean Products, Inc. (the seafood processors notification); a second notification concerning nutrient content claims for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the Martek notification); and a third notification concerning nutrient content claims for DHA and EPA was submitted by Ocean Nutrition Canada, Ltd. (the Ocean Nutrition notification). FDA has reviewed the information included in the three notifications and is proposing to prohibit the nutrient content claims for DHA and EPA set forth in the three notifications because they are not based on an authoritative statement that identifies a nutrient level to which the claims refer, as required by the controlling statutory authority. FDA is also proposing to prohibit the nutrient content claims for ALA set forth in the seafood processors notification because they are based on a daily value that was determined by a different method than daily values already established for other nutrients. Because of the different methodology used to set the daily value, the ALA claims set forth in the seafood processors notification do not enable the public to comprehend the information provided in the claims and to understand the relative significance of such information in the context of the daily diet, as required by the controlling statutory authority. FDA is proposing to take no regulatory action with respect to the nutrient content claims for ALA set forth in the Martek notification. Therefore, if this proposed rule is finalized without change, these claims will be allowed to remain on the market.
New Animal Drugs For Use in Animal Feeds; Fenbendazole
Document Number: E7-22987
Type: Rule
Date: 2007-11-27
Agency: Food and Drug Administration, Department of Health and Human Services
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 Intervet Inc. The supplemental NADA provides for a revised food safety warning on labeling for fenbendazole Type A medicated article and Type B and Type C medicated horse feeds.
HIV/AIDS Bureau; Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements
Document Number: E7-22982
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice solicits comments on the HRSA proposed uniform waiver standards for Ryan White HIV/AIDS Program grantees requesting a core medical services waiver for Fiscal Year 2008 and beyond. Title XXVI of the Public Health Service Act (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program) requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation, effective Fiscal Year (FY) 2007. HRSA has issued guidance for obtaining a waiver for FY 2007 and seeks to issue waiver requirements for grantees under Parts A, B, and C of Title XXVI of the PHS Act for FY 2008 and future years.
Proposed Information Collection Activity; Comment Request
Document Number: 07-5842
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: 07-5841
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 07-5835
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 07-5832
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 07-5831
Type: Notice
Date: 2007-11-27
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates, the Ambulatory Surgical Center Payment System and CY 2008 Payment Rates, the Hospital Inpatient Prospective Payment System and FY 2008 Payment Rates; and Payments for Graduate Medical Education for Affiliated Teaching Hospitals in Certain Emergency Situations Medicare and Medicaid Programs: Hospital Conditions of Participation; Necessary Provider Designations of Critical Access Hospitals
Document Number: 07-5507
Type: Rule
Date: 2007-11-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. We describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2008. In addition, the rule sets forth the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which the final policies of the ASC payment system apply, and other pertinent rate setting information for the CY 2008 ASC payment system. Furthermore, this final rule with comment period will make changes to the policies relating to the necessary provider designations of critical access hospitals and changes to several of the current conditions of participation requirements. The attached document also incorporates the changes to the FY 2008 hospital inpatient prospective payment system (IPPS) payment rates made as a result of the enactment of the TMA, Abstinence Education, and QI Programs Extension Act of 2007, Public Law 110-90. In addition, we are changing the provisions in our previously issued FY 2008 IPPS final rule and are establishing a new policy, retroactive to October 1, 2007, of not applying the documentation and coding adjustment to the FY 2008 hospital-specific rates for Medicare-dependent, small rural hospitals (MDHs) and sole community hospitals (SCHs). In the interim final rule with comment period in this document, we are modifying our regulations relating to graduate medical education (GME) payments made to teaching hospitals that have Medicare affiliation agreements for certain emergency situations.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008; Revisions to the Payment Policies of Ambulance Services Under the Ambulance Fee Schedule for CY 2008; and the Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions
Document Number: 07-5506
Type: Rule
Date: 2007-11-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period addresses certain provisions of the Tax Relief and Health Care Act of 2006, as well as making other proposed changes to Medicare Part B payment policy. We are making these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This final rule with comment period also discusses refinements to resource-based practice expense (PE) relative value units (RVUs); geographic practice cost indices (GPCI) changes; malpractice RVUs; requests for additions to the list of telehealth services; several coding issues including additional codes from the 5-Year Review; payment for covered outpatient drugs and biologicals; the competitive acquisition program (CAP); clinical lab fee schedule issues; payment for renal dialysis services; performance standards for independent diagnostic testing facilities; expiration of the physician scarcity area (PSA) bonus payment; conforming and clarifying changes for comprehensive outpatient rehabilitation facilities (CORFs); a process for updating the drug compendia; physician self referral issues; beneficiary signature for ambulance transport services; durable medical equipment (DME) update; the chiropractic services demonstration; a Medicare economic index (MEI) data change; technical corrections; standards and requirements related to therapy services under Medicare Parts A and B; revisions to the ambulance fee schedule; the ambulance inflation factor for CY 2008; and amending the e-prescribing exemption for computer-generated facsimile transmissions. We are also finalizing the calendar year (CY) 2007 interim RVUs and are issuing interim RVUs for new and revised procedure codes for CY 2008. As required by the statute, we are announcing that the physician fee schedule update for CY 2008 is -10.1 percent, the initial estimate for the sustainable growth rate for CY 2008 is -0.1 percent, and the conversion factor (CF) for CY 2008 is $34.0682.
Determination That ELOXATIN (Oxaliplatin for Injection), 50 and 100 Milligrams Per Vial, Sterile Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: E7-22973
Type: Notice
Date: 2007-11-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that ELOXATIN (oxaliplatin for injection), 50 and 100 milligrams (mg) per vial, sterile lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for oxaliplatin sterile lyophilized powder for injection, 50 and 100 mg/ vial.
New Animal Drugs For Use in Animal Feeds; Florfenicol
Document Number: E7-22942
Type: Rule
Date: 2007-11-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for the use of florfenicol by veterinary feed directive (VFD) for the control of mortality in freshwater-reared salmonids due to furunculosis associated with Aeromonas salmonicida.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-22930
Type: Notice
Date: 2007-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-22920
Type: Notice
Date: 2007-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services