Department of Health and Human Services July 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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.

In compliance with the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) 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: The National Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS); Type of Information Collection Request: NEW; Need and Use of Information Collection: The purpose of SPARCCS is to identify the beliefs, knowledge, attitudes, and practices of primary care physicians and cancer specialists regarding the components described by the Institute of Medicine's (IOM) 2005 report that described the essential components of cancer survivorship care within a health care delivery system. These data will inform the process of standardization of survivorship care practices; augment the data collected in other cancer survivorship studies such as the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS), and the Cancer Research Network; and monitor the progress made toward achieving NCI strategic goals of improving the quality of cancer care across the cancer control continuum. Two questionnaires, one sent to primary care physicians and one sent to medical oncologists, will be administered by mail to a randomly selected national sample of 2,200 physicians. Study participants will be 1,100 practicing physicians who are family practitioners, general internists, and obstetrician/gynecologists and 1,100 medical oncologists. Frequency of Response: Once. Affected Public: Individuals and Businesses. Type of Respondents: Primary care and medical oncology physicians practicing in a non-federal facility. The annual reporting burden is estimated at 903 hours as shown in Table 1. The total burden hours is estimated at 1,808 hours over the two year field period of the study. There are no capital, operating or maintenance costs to report.

This notice announces the 29th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is announcing the availability of a draft information sheet guidance entitled ``Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked QuestionsStatement of Investigator (Form FDA 1572).'' This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this draft information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This draft information sheet guidance provides FDA's responses to the most frequently asked questions.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 15, 2008 (73 FR 40582). The document announced the determination that SANOREX (mazindol) Tablets, 1 and 2 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. The document was published with an incorrect docket number. This document corrects that error.

This notice announces the 28th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the opportunity for an administrative hearing to be held on September 26, 2008 at the CMS Dallas Regional Office, 1301 Young Street, Room 1196, Dallas, Texas 75202, to consider whether Texas State plan provisions concerning payments for birthing center facility services comply with the requirements of the Social Security Act as discussed in the July 28, 2008 letter sent to the State and published herein.

This final rule prohibits Medicare Advantage (MA) organizations, including organizations offering MA plans to employer and union group health plan sponsors, from making midyear changes to non-prescription drug benefits, premiums, and cost-sharing submitted in their approved bids for a given contract year. This final rule also clarifies that MA organizations offering certain kinds of plans restricted to employer and union group health plan sponsors and not open to general enrollment may continue to offer benefit enhancements as they do currently, through means other than midyear benefit enhancements (MYBEs). Programs of all-inclusive care for elderly (PACE) are not subject to the provisions of this final rule and may continue to offer enhanced benefits as specified in our guidance for PACE plans.

This notice invites all organizations representing physicians to submit nominations for consideration to fill two seats on the Practicing Physicians Advisory Council (the Council) that will be vacated by current Council members in 2009. This notice also announces a quarterly meeting of the Council. The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.

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 National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following revised draft document available for public comment entitled ``Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/099-A/. Public Comment Period: July 24, 2008 through September 30, 2008. Status: Written comments may be mailed to the attention of Diane Miller, NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS-C34, Cincinnati, Ohio 45226, telephone (513) 533-8450, facsimile (513) 533-8285. Comments may also be submitted by e-mail to nioshdocket@cdc.gov. All material submitted to the Agency should reference the NIOSH Docket number 099-A. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Purpose: To obtain comments from the public on the revised draft document entitled, ``Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research,'' referred to as Roadmap. Asbestos has been a highly visible issue in public health for over three decades. Many advances have been made in the scientific understanding of worker health effects from exposure to asbestos and other elongated mineral particles (EMPs), and it is now well documented that fibers of asbestos minerals, when inhaled, can cause serious diseases in exposed workers. Yet, many questions and areas of scientific uncertainty remain. Background: As the Federal agency responsible for conducting research and making recommendations for the prevention of worker injury and illness, NIOSH is undertaking a reappraisal of how to ensure appropriate protection of workers from exposure to asbestos fibers and other EMPs. NIOSH prepared a first draft of the document ``Asbestos and Other Mineral Fibers: A Roadmap for Scientific Research,'' and invited comments at a public meeting, from the Internet, and from selected expert peer reviewers on the occupational health issues identified and the framework for research. As a result of comments received during the public and expert peer review process, NIOSH has substantially revised the earlier draft and is now inviting comments on a revised draft of the document with the new title ``Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research.'' The previous draft, public comments, peer review comments, and the responses to peer reviewers' comments on the previous draft can be found at https://www.cdc.gov/niosh/docket/NIOSHdocket0099.html. The purpose of the revised draft Roadmap is to outline major areas of controversy and to recommend a research agenda that can serve as a guide for the development of specific research programs within and across disciplines. The intended goal is to provide answers to current scientific questions, reduce scientific uncertainties, and provide a sound scientific foundation for future policy development so that optimal health protection can be assured. NIOSH is seeking comments on the scope and information used to support the development of a research framework for asbestos fibers and other EMPs. Of special interest are comments on the following revisions to the draft document: 1. A discussion of particle characteristics (e.g., dimension, chemistry) and their potential influence on biological responses (Sections 1.6.1, 1.6.2, 1.6.3, and 1.6.4). 2. Toxicological research with EMPs (Section 2.2). 3. Epidemiological studies of workers exposed to EMPs (Section 2.3.3). 4. Capabilities and limitations of analytical instruments used to identify EMPs (Section 2.4.2). Also of special interest are comments on the entirely new content in the document: 1. A rephrasing of the NIOSH recommended exposure limit (REL) for asbestos and related EMPs (Section 1.8.2). 2. The inclusion of ``How the proposed research could lead to the development of improved public health policies for asbestos and other EMPs'' (Section 2.5). 3. Clinical issues (Section 1.4). 4. Recommendations for clinical research (Section 2.3.4). NIOSH continues to be interested in available and forthcoming research results that can help answer the questions set forth in the Roadmap, as well as information on existing workplace exposure data, health effects, and control technologies. Submitted comments on the revised draft Roadmap should indicate the pertinent page(s) and line(s) in the draft document being addressed. Contact Person for Technical Information: Paul Middendorf, Office of the Director, NIOSH, CDC, telephone (513) 533-8606, e-mail pmiddendorf@cdc.gov.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``National Study of the Hospital Adverse Event Reporting Follow-Up Survey.'' 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.

The Health Resources and Services Administration (HRSA) received many substantive comments on the proposed rule and will consider these comments carefully. Based on a preliminary review of the comments, it appears that HRSA will need to make a number of changes in the proposed rule. Instead of issuing a final regulation as the next step, HHS will issue a new Notice of Proposed Rulemaking for further review and public comment prior to issuing a final rule.

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) is announcing the availability of a Sole Source to the Association of Food and Drug Officials (AFDO) to provide funding for a 3-year cooperative agreement award to support a Special Project Cooperative Agreement program. No other applications are solicited. This cooperative agreement is intended to have AFDO update and maintain the FDA Directory of State and Local Officials and to update the AFDO document ``State Food Safety Resource Survey (2000)'' by providing funding for additional personnel, equipment, and supplies to support activities related to these projects.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Roxana Gonzalez, Carnegie Mellon University: Based on reports submitted by Carnegie Mellon University's (CMU) inquiry and investigation committees, the Respondent's own admission in sworn testimony, and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Roxana Gonzalez, graduate student, Department of Social and Decision Sciences and Psychology, CMU, engaged in scientific misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grants R01 MH56880, R03 MH62376, and R24 MH67346. Specifically, PHS found that Ms. Gonzalez engaged in the following acts of scientific misconduct: 1. Respondent altered the main dependent variable (life events; life expectation) in the electronic file and the manipulation check variables for ease-of-thought generation so that the reported study results are largely unsupported in: (a) Publication: Lerner, J.S., & Gonzalez, R.M. ``Forecasting one's future based on fleeting subjective experiences.'' Personality and Social Psychology Bulletin 31:454-466, 2005; (b) 2005 Manuscript: Lerner, J. S., & Gonzalez, R. M. ``On perceiving the self as triumphant when happy or angry''; (c) Review Article: Lerner J. S., Tiedens, L.Z., & Gonzalez, R. M. ``Portrait of the angry decision maker: How appraisal tendencies shape anger's influence on cognition.'' Journal of Behavioral Decision Making: Special Issue on Emotion and Decision Making. 2. Respondent falsified cortisol values, and possibly cardiovascular measures and optimistic appraisals (as measured by LOT), so that a large portion of the mediation analyses of Table 3 does not reflect the data actually collected and analyzed for the study reported in a publication (Lerner, J.S., Gonzalez, R.M., Dahl, R.E., Hariri, A.R., & Taylor, S.E. ``Facial expressions of emotion reveal neuroendocrine and cardiovascular stress responses.'' Biological Psychiatry 58:743-750, 2005). Respondent further allowed one of her collaborators to report the results from this study at the Annual Meeting of the American Psychological Society held in Los Angeles, California in May 2005, although Respondent's collaborator did not know at the time that the results were tainted by Respondent's acts of research misconduct. 3. Respondent falsified the analyses based on participants' responses to the manipulation check items (including the data for self reported fear) in a study reported in a publication (Fischhoff, B., Gonzalez, R.M., Lerner, J.S., & Small, D.A. ``Evolving judgments of terrorism's risks: Foresight, hindsight, and emotion.'' Journal of Experimental Psychology: Applied 11:124-139, 2005. 4. Respondent falsified the main dependent variable (reservation price, BDM) in the electronic file for 48 of the 175 subjects participating in a study reported in a 2005 manuscript (Lerner, J.S., Gonzalez, R.M., Small, D.A., Lowenstein, G., & Dahl, R.E. ``Emotional influence on economic behavior among adolescents.''). Respondent directed the alteration of the paper files for those subjects in order to match the altered electronic file. One of Respondent's collaborators included a qualitative description of the results of the research that is the subject of this study in an NIH grant application, although Respondent's collaborator did not know at the time that the results were tainted by the Respondent's acts of research misconduct. ORI acknowledges Ms. Gonzalez' extensive cooperation with CMU's research misconduct proceedings. Ms. Gonzalez has entered into a Voluntary Exclusion Agreement (Agreement) in which she has voluntarily agreed, beginning on June 26, 2008: (1) To exclude herself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant or contractor to PHS, for a period of three (3) years; (2) That for a period of three (3) years, any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that uses the Respondent in any capacity on PHS supported research, or that submits a report of PHS-funded research in which the Respondent is involved, must concurrently submit a plan for supervision of the Respondent's duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of the respondent's research contribution; Respondent agrees to ensure that a copy of the supervisory plan is also submitted to ORI by the institution; Respondent agrees that she will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI; (3) for a period of three (3) years to ensure that any institution employing her submits, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS-funded research in which the Respondent is involved, a certification that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived, and that the data, procedures, analyses, and methodology are accurately reported in the application, report, manuscript or abstract; the Respondent must ensure that the institution sends a copy of the certification to ORI; and (4) to write ORI-approved letters to (a) collaborators/coauthors of the manuscripts and published papers cited above, stating what she falsified/fabricated and offering restitution; and (b) editors of the journals in which papers were published (even if they have been retracted/corrected) to state that her falsifications/fabrications were the underlying reason for the retraction/correction.

This notice with comment period describes the general criteria we intend to use to evaluate the efficiency and effectiveness of the Quality Improvement Organizations (QIOs) who will enter into contract with CMS under the 9th SOW on August 1, 2008. The evaluation of the QIOs' performance related to their Statement of Work (SOW) will be based on evaluation criteria specified within the themes, tasks, and subtasks set forth in the QIO's 9th SOW.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Brookhaven National Laboratory, Upton, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Brookhaven National Laboratory. Location: Upton, New York. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1947 through December 31, 2007.

This regulation revises Federal requirements for establishing and enforcing medical support obligations in Child Support Enforcement (CSE) program cases receiving services under title IV-D of the Social Security Act (the Act). The changes: require that all support orders in the IV-D program address medical support; redefine reasonable-cost health insurance; require health insurance to be accessible, as defined by the State; and make conforming changes to the Federal interstate, substantial-compliance audit, and State self-assessment requirements.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Nuclear Materials and Equipment Corporation (NUMEC) facility in Parks Township, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the SAM (Special Alloyed or Substitute Alloy Materials) Laboratories of Columbia University in New York City, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Linde Ceramics Plant, Tonawanda, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Linde Ceramics Plant. Location: Tonawanda, New York. Job Titles and/or Job Duties: All employees. Period of Employment: During the applicable covered residual radiation period from January 1, 1954 through July 31, 2006.

The Food and Drug Administration (FDA) is announcing the availability of draft Compliance Policy Guide Sec. 540.370 Fish and Fishery Products Decomposition (the draft CPG). The draft CPG, when final, will provide FDA staff with current regulatory action guidance relating to decomposition in fish and fishery products.

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 reporting requirements contained in existing FDA regulations governing State enforcement notifications.

This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we describe the proposed 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 would be applicable to services furnished on or after January 1, 2009. In addition, this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this proposed rule, we propose the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which these proposed changes would apply, and other pertinent ratesetting information for the CY 2009 ASC payment system. These changes would be applicable to services furnished on or after January 1, 2009.

The Food and Drug Administration (FDA) is announcing theavailability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of February 11, 2004 (69 FR 6788), entitled ``Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk.'' This SECG is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.

The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of October 4, 2002 (67 FR 62171). This SECG entitled ``Standard of Identity for White Chocolate'' is intended to set forth, in plain language, the requirements of the regulation and to help small businesses understand the regulation.

OIG is adopting in final form, without change, an interim final rule published on March 26, 2008 (73 FR 15937). We received no comments to the interim final rule. The interim final rule revised the process for advisory opinion requestors to submit payments for advisory opinion costs.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: CGMP for Phase 1 Investigational Drugs'' dated July 2008. The guidance provides assistance in applying relevant current good manufacturing practice (CGMP) requirements of the Federal Food, Drug, and Cosmetic Act (the act) to the manufacture of most investigational new drugs, including biological drugs, used in phase 1 clinical trials. FDA is issuing this guidance concurrently with a final rule published elsewhere in this issue of the Federal Register specifying that compliance with FDA's CGMP regulations is not required for most investigational drugs that are manufactured for use in phase 1 clinical trials. Therefore, FDA is recommending the approaches outlined in this guidance for complying with the statutory CGMP requirements in the act. The guidance announced in this notice finalizes the draft guidance entitled ``INDsApproaches to Complying with CGMP During Phase 1'' dated January 2006.

The Food and Drug Administration (FDA) is announcing its determination that SANOREX (mazindol) Tablets, 1 and 2 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mazindol tablets if all other legal and regulatory requirements are met.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director (OD), 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: Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and for Responsible Prospective Contractors, 42 CFR Part 50, Subpart F, and 45 CFR Part 94. Type of Information Collection Request: Revision of OMB No. 0925- 0417, expiration date November 30, 2008. Need and Use of the Information Collection: This is a request for OMB Approval for the information collection and recordkeeping requirements contained in the final rule 42 CFR Part 50, Subpart F and related recordkeeping requirements regarding contractors in Responsible Prospective Contractors, 45 CFR Part 94. The purpose of these regulations is to promote objectivity in research by requiring institutions to establish standards to ensure that there is no reasonable expectation that the design, conduct, or reporting of research will be biased by a conflicting financial interest of an investigator. Frequency of Response: On occasion. Affected Public: Individuals or households; business or other for- profit; not-for-profit institutions; State, Local or tribal government. Type of Respondents: Any public or private entity or organization. The annual reporting burden is as follows: Estimated Number of Respondents: 67,860; Estimated Number of Responses Per Respondent: 1.60; Averaged Burden Hours per Response: 3.40.; and Estimated Total Annual Burden Hours Requested: 220,280. The annualized cost to the public is estimated at $8,120,000. Operating Costs and/or maintenance costs are $4,633.00.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatDrug Establishment Registration and Drug Listing.'' This draft guidance document establishes a Pilot Program for industry to voluntarily submit drug establishment registration and drug listing information in an electronic format that FDA can process, review, and archive. The document provides guidance on what required and FDA-recommended information related to drug establishment registration and drug listing to submit and on how to electronically prepare and submit the information to FDA.

The Food and Drug Administration (FDA) is announcing the availability of final and proposed documents that have been prepared by Study Groups 1 and 5 of the Global Harmonization Task Force (GHTF), respectively. These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacture of products in the United States.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves.'' This guidance document provides information to FDA staff and industry about FDA's strategy for addressing further imports of surgeons' and patient examination gloves (medical gloves) from manufacturers/shippers whose medical gloves have failed to meet FDA's minimum acceptable quality criteria. The guidance and the strategy are intended to help assure that medical gloves imported to the United States meet FDA's minimum acceptable quality criteria and do not have defects that could compromise their effectiveness and pose a health hazard to healthcare professionals and patients who rely on medical gloves for protection from blood- and fluid-borne pathogens.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Voluntary Third-Party Certification Programs for Foods and Feeds.'' This draft guidance describes the general attributes FDA believes a voluntary third-party certification program should have in order to help ensure its certification is a reliable reflection that the foods and feeds from certified establishments are safe and meet applicable FDA requirements.

The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) in coordination with the Center for Veterinary Medicine (CVM), is announcing the availability of cooperative agreements funding to further enhance the infrastructure of State, territorial, and tribal animal feed safety and bovine spongiform encephalopathy (BSE) prevention programs. These cooperative agreements are intended to fund additional personnel, equipment, supplies, and training support activities related to the FDA ruminant feed ban (referred to as the BSE/ruminant feed ban), in State, territory, and tribal governments. FDA anticipates providing approximately $1 million in direct plus indirect costs in support of this program in fiscal year (FY) 2008. It is anticipated that four awards will be made for up to $250,000 per award per year for up to 2 years.

The U.S. Department of Health and Human Services (HHS) announces the fourth in a series of federal advisory committee meetings regarding the national health promotion and disease prevention objectives for 2020, to be held online (via WebEx software). This meeting will be the equivalent of an in-person meeting of the Committee, and will be open to the public. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 will review the nation's health promotion and disease prevention objectives and efforts to develop goals and objectives to improve the health status and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for developing and implementing the next iteration of national health promotion and disease prevention goals and objectives and provide recommendations for initiatives to occur during the initial implementation phase of the goals and objectives. HHS will use the recommendations to inform the development of the national health promotion and disease prevention objectives for 2020 and the process for implementing the objectives. The intent is to develop and launch objectives designed to improve the health status and reduce health risks for Americans by the year 2020.