Department of Health and Human Services 2013 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2013, Vol. 78, P. 52204 and allowed 60-days for public comment. There were no public comments received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

On September 17, 2013, the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) held a public meeting concerning inward leakage performance requirements for the class of NIOSH-certified non-powered air-purifying particulate respirators approved as half-facepiece respirators for protection from particulate-only hazards. The purpose of this meeting was to share information and to seek stakeholder feedback, in identified topic areas, concerning the development of inward leakage performance standards. Questions concerning the identified topics of specific interest were included in the meeting notice published in the Federal Register on September 4, 2013. Written comments were to be received by October 18, 2013. HHS/CDC received a request from a stakeholder for additional time to comment on this notice. In consideration of this request HHS/CDC is reopening the public comment period through December 31, 2013.

The Food and Drug Administration (FDA or we) 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.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2013.

The Food and Drug Administration (FDA or we) is extending the comment period for the ``Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' that appeared in the Federal Register of August 19, 2013. We are taking this action to allow interested persons an opportunity to provide comment on the scope of issues the Agency should include in the Environmental Impact Statement (EIS), including their significance, as part of the scoping process for the EIS.

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: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 14th, 2013 and allowed 60 days for public comment. No substantive comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Centers for Disease Control and Prevention requests withdrawal from publication the 60-Day Federal Register Notice (FRN) 14 0210 concerning the List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products (FR Doc. 2013-26469), which was submitted on October 30, 2013 for public inspection in the Federal Register. The purpose behind this notice withdrawal request is that an original 60-day FRN was previously published on October 31, 2013 (Document Number2013-25799). A duplicate 60-day FRN was inadvertently published on November 5, 2013. Please disregard the duplicate FRN.

The Food and Drug Administration (FDA or we) is confirming the effective date of September 13, 2013, for the final rule that appeared in the Federal Register of August 13, 2013. The final rule amended the color additive regulations to provide for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Acrylamide in Foods.'' The draft guidance is intended to provide information that may help growers, manufacturers, and food service operators reduce acrylamide in certain foods. Acrylamide is a chemical that can form in some foods during certain types of high-temperature cooking. The draft guidance is intended to suggest a range of possible approaches to acrylamide reduction and not to identify specific recommended approaches.

The Food and Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and developed to ensure a single audit will provide efficient yet thorough coverage of the diverse international regulatory requirements of medical devices quality management systems and other specific regulatory requirements of the regulatory authorities participating in the pilot program. FDA will be participating in the MDSAP and will accept the resulting audit reports as a substitute for routine Agency inspections.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $459,505 (total costs) for up to five years to CADCA for the National Substance Abuse Leadership Forum Cooperative Agreement. Under this initiative, CADCA will provide training and technical assistance to a large number of community leaders across the country who are committed to behavioral health (i.e., prevention, recovery, resilience, and wellness); and address current issues related to the prevention and treatment of substance abuse, and/or mental disorders across the nation. Conference and training activities supported through this cooperative agreement include SAMHSA's Prevention Day, the Community Anti-Drug Coalitions of America's (CADCA) National Leadership Forum, and CADCA's Mid-Year Training Institute. These conferences serve as a portal for knowledge dissemination and state-of-the-art information transfer; and assist community leaders in developing effective local programs, practices, and policies that support national substance abuse prevention goals, outcomes and efforts, such as National Alcohol and Drug Addiction Recovery Month, National Substance Abuse Prevention Month, and underage drinking prevention. The CADCA Conference initiative directly supports SAMHSA's mission to reduce the impact of substance abuse and mental illness on America's communities. This is not a formal request for applications. Assistance will be provided only to CADCA based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SP-14-001. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Section 516 of the Public Health Services Act, as amended. Funds for a portion of this initiative are also authorized under Sections 509, 516 and 520A of the Public Health Service Act, as amended. Justification: Eligibility for this award is limited to CADCA. The purpose of this cooperative agreement is to provide training and technical assistance for thousands of members of community coalitions dedicated to preventing substance abuse through a national leadership conference. CADCA is the only national organization that has special expertise and unique broad, national-level experience in working with community anti-drug coalitions. For more than 18 years, coalitions and coalition leadership have turned to CADCA to obtain the assistance they need to implement, operate, and sustain effective local community anti- drug strategies. The CADCA will take advantage of the resources of multiple agencies located throughout the federal, state and local governments, philanthropies, and universities to bring the best available knowledge, information, and technology to local community anti-drug coalitions working to prevent and reduce drug use among the youth of America. CADCA is the only identified organization with the required experience and national reach to over 5,000 identified anti- drug coalitions across the country. CADCA has long been recognized in communities as well as states throughout the nation as the national voice for the advocacy and technical support of anti-drug coalitions. As such, it is uniquely qualified and positioned to carry out the requirements of this announcement. Contact: Cathy Friedman, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 8-1097, Rockville, MD 20857; telephone: (240) 276-2316; email: cathy.friedman@samhsa.hhs.gov.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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 FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. Where a patented product must receive FDA approval before marketing is permitted, the Office of Patents and Trademarks may add a portion of the FDA review time to the term of a patent. Petitioners may request reductions in the regulatory review time if FDA marketing approval was not pursued with ``due diligence.''

The Food and Drug Administration (FDA) is considering revising the guidance entitled ``Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds,'' and is seeking comments on this guidance before revisions are made.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-002, Addressing Methodological Challenges in Research for Patients With Multiple Chronic Conditions (R21)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.

The U.S. Department of Health and Human Services (HHS) solicits written comments regarding new objectives proposed to be added to Healthy People 2020 since the fall 2012 public comment period, as well as written comments proposing new objectives to be included within existing Healthy People 2020 Topic Areas. Public participation helps shape Healthy People 2020, its framework, objectives, organization, and targets. Healthy People 2020 will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2020 reflects current public health priorities and public input. The updated set of Healthy People 2020 objectives will be incorporated on www.HealthyPeople.gov. This set will reflect further review and deliberation by the Topic Area workgroups, Federal Interagency Workgroup on Healthy People 2020, and other Healthy People 2020 stakeholders.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

Through this notice, the Secretary of the U.S. Department of Health and Human Services (the Secretary) announces that all FDA- approved vaccines against seasonal influenza are covered under the National Vaccine Injury Compensation Program (VICP), which provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. Prior to this publication, trivalent influenza vaccines were included under Category XIV on the Vaccine Injury Table (Table) and will continue to be listed in that category. This notice serves to include all vaccines against seasonal influenza (not already covered under Category XIV) as covered vaccines under Category XVII of the Table (new vaccines covered under the VICP). This notice ensures that petitioners may file petitions relating to all vaccines against seasonal influenza (not already covered under the VICP) with the VICP even before such vaccines are added as a separate and distinct category to the Table through rulemaking.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The notice announces the meeting to peer review the Draft Report on Carcinogens (RoC) Monographs for ortho-Toluidine and Pentachlorophenol and By-products of its Synthesis (hereafter referred to as ``pentachlorophenol''). These documents were prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting, originally scheduled for October 7-8, 2013 (78 FR 51733), was cancelled due to the Federal government shutdown, and has been rescheduled for December 12-13, 2013. Written public comments previously submitted for the originally scheduled meeting are applicable for this meeting and do not need to be resubmitted. Persons planning to attend the meeting and/or present oral comments are asked to re-register.

The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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 National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Simone Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 301-435-0065, or Email your request, including your address to: glynnsa@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Incident HIV/Hepatitis B virus (HBV) infections in South African blood donors: Behavioral risk factors, genotypes and biological characterization of early infection, 0925-New, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH). Need and Use of Information Collection: South Africa has one of the highest burdens for HIV infection in the world. The HIV epidemic in South Africa is largely heterosexual, but risk factors for infections can change and so identifying factors that contribute to the recent spread of HIV in a broad cross-section of the otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in Africa. Small previous studies suggest that the risk factors for HIV among more recently acquired (incident) infections in blood donors may differ from those of more distant (prevalent) infections. Similarly risk factors for recently acquired HBV may be different than for prevalent HBV infections. The demographic and behavioral risks associated with incident HIV and incident HBV infection have, as yet, not been formally assessed in South African blood donors using analytical study designs. Due to the high rates of HIV and HBV infection in South African blood donors, a better understanding of these risk factors can be used to modify donor screening questionnaires so as to more accurately exclude high-risk blood donors and contribute to transfusion safety. Risk factor data from this research may also provide critical information for blood banking screening strategies in other countries. This study which provides a contemporary understanding of the current risk profiles for HIV and separately for HBV will also prospectively monitor genetic characteristics of recently acquired infections through genotyping and drug resistance profile testing, thus serving a US, South African, and global public health imperative to monitor the genotypes of HIV and HBV that have recently been transmitted. For HIV, the additional monitoring of drug resistance patterns in newly acquired infection is critical to determine if currently available antiretroviral medicines are capable of combating infection. Because the pace of globalization means these infections can cross borders easily, these study objectives have direct relevance for HIV and HBV control in the U.S. and globally. Further, the ability to identify recent HIV infections provides a unique opportunity to study the biology, host response and evolution of HIV disease at time points proximate to virus acquisition. Genotyping and host response information is scientifically important not only to South Africa, but to the U.S. and other nations since it will provide a broader global understanding of how to most effectively manage and potentially prevent HIV (e.g. through vaccine development). Efforts to develop vaccines funded by the National Institutes of Health and other US-based organizations may directly benefit from the findings of this study. The South African National Blood Service (SANBS) uses both individual donation Nucleic Acid Testing (ID-NAT) and serology tests (either antibody or antigen detection tests) to screen blood donors for HIV and Hepatitis-B Virus (HBV), among other infections. A positive NAT test precedes HIV antibody detection or HBV surface antigen detection by days to weeks in newly acquired HIV and HBV infections. A combined testing strategy using NAT and serology tests therefore confers the ability to detect most acute infections and discriminate between recent (incident) and more remotely acquired (prevalent) infection. Additional tests that exploit antibody maturation kinetics such as the HIV Limiting Antigen Avidity assay (LAg Avidity) can further assist to classify persons with an HIV antibody positive test as having a recently acquired (incident) or longer-term (prevalent) infection. Hepatitis B core antibody (anti-HBc) testing of NAT-positive and NAT and Hepatitis B Virus Surface Antigen (HBsAg) positive HBV infections allows classification of HBV infections as recently acquired or prevalent infections. Infections that are anti-HBc negative are recently acquired (incident). Leveraging this ability to classify HIV and HBV infections as incident or prevalent leads to three study objectives: ] 1. Objective 1 consists of evaluating the risk factors associated with having an incident HIV or HBV infection. To that end, a frequency matched case-control study will be conducted with two case groups: incident HIV infected blood donors and incident HBV infected blood donors, respectively. Risk factors in these two case groups will be compared to the risk factors provided by a group of controls (blood donors whose infectious tests are all negative). Cases and controls will be accrued from a geographically diverse donor pool. 2. Objective 2 consists of characterizing HIV clade and drug resistance profiles and determining viral loads in all cases of incident HIV infection, as well as characterizing HBV genotype and viral load in all incident HBV infections. 3. Objective 3 consists of following persons with incident and ``elite controller'' HIV infections prospectively for three additional visits at 2, 3, and 6 months following the index positive test(s). The term ``elite controllers'' refers to those who are HIV antibody positive, but with undetectable viral RNA (NAT negative) who are believed to have a natural ability to control viral replication without therapy. These studies will be useful in identifying appropriate HIV drug therapy regimens for this condition, as well as strategies for producing an effective HIV vaccine, which has eluded 30 years of HIV research. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden for Objectives 1 and 2 will be 395 hours for 483 subjects. The total estimated annualized burden for Objective 3 will be 32 hours for 35 respondents.

The Food and Drug Administration (FDA) is confirming the effective date of December 9, 2013, for the final rule that appeared in the Federal Register of July 25, 2013. The direct final rule amends the regulations regarding the prohibition on the sale, or other commercial or public distribution, of viable turtle eggs and live turtles with a carapace length of less than 4 inches to remove procedures for destruction. This document confirms the effective date of the direct final rule.

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 Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Design Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide guidance to those involved in designing clinical studies intended to support premarket submissions for medical devices and for FDA staff who review those submissions. This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements.

The purpose of this Request for Information (RFI) is to seek broad public input on the draft Strategic Plan for Fiscal Years (FY) 2014-2018 for the Office of Disease Prevention (ODP), National Institutes of Health (NIH).

The Office of Biotechnology Activities (OBA) is updating Appendix B (Classification of Human Etiologic Agents on the Basis of Hazard) of the NIH Guidelines by specifying the risk group (RG) classification for two organisms: Middle East Respiratory Syndrome coronavirus (MERS-CoV) and Pseudomonas aeruginosa. Background: The NIH Guidelines provide guidance to investigators and local Institutional Biosafety Committees (IBCs) for setting containment for research involving recombinant or synthetic nucleic acid molecules. Section II-A, Risk Assessment, instructs investigators and IBCs to make an initial risk assessment based on the RG of the agent that will be manipulated (see Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard). The RG of the agent often correlates with the minimum containment level required for experiments subject to the NIH Guidelines. Updating Appendix B by revising the risk groups for certain organisms, or adding new organisms, leads to more uniform containment recommendations that are commensurate with the biosafety risk. The resulting amendments are ``Minor Actions'' under Section IV-C- 1-(b)-2 of the NIH Guidelines and, therefore, will be implemented immediately upon publication in the Federal Register. However, the OBA welcomes public comment to inform any future changes to Appendix B.

In the March 11, 2013 issue of the Federal Register, we published a final rule entitled, ``Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2014''. This correcting amendment corrects several technical and typographical errors identified in the March 11, 2013 final rule.

The Food and Drug Administration (FDA) has determined that MOBAN (molindone hydrochloride (HCl)) tablets (5 milligrams (mg), 10 mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 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 MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for sickle cell disease. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of sickle cell disease on daily life and on available therapies for sickle cell disease.

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

The Food and Drug Administration (FDA) is announcing an opportunity to request a hearing on the Agency's proposal to withdraw approval of 14 new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.

This final notice announces our decision to approve the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.