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

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.

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.

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.

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.''

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.